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Sample records for postmarketing surveillance program

  1. 522 Postmarket Surveillance Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the...

  2. Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

    Science.gov (United States)

    Singh, G

    2001-05-01

    The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

  3. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Brainstorming opportunities for postmarketing surveillance of chemicals : Workshop report

    NARCIS (Netherlands)

    Olthof ED; van Drongelen A; Graven C; Herremans J; de Kaste D; Ossendorp B; Piersma AH; GZB; V&Z

    2017-01-01

    On behalf of the Ministry of Health a survey was prepared of possibilities for setting up a 'post-marketing surveillance' (PMS)-system for chemical substances in consumer products, including food. With such a system, (long-term) health effects of substances which are already on the market may be

  5. A mortality index for postmarketing surveillance of new medications.

    Science.gov (United States)

    Rose, J C; Unis, A S

    2000-03-01

    The rate of introduction of new pharmaceuticals is growing as a result of advances in molecular pharmacology and targeted drug development. The Fatal Toxicity Index (FTI) has been proposed as a means for monitoring drug toxicity through post-marketing surveillance. The FTI requires data regarding the general availability of a particular agent in the community which, in the US, is proprietary. The authors propose a Mortality Index as an alternative method for calculating relative lethality that does not rely on proprietary information for postmarketing surveillance. Using data from the Toxic Exposure Surveillance System (TESS) a Mortality Index was calculated from the proportion of deaths occurring among all patients who present to a health care facility with an overdose on the same agent or class of agents. The average Mortality Index for various drugs or drug classes for the years 1989 to 1997 is reported. Because the Mortality Index for desipramine appeared much greater than that for the other tricyclics, a chi-squared analysis was performed. The authors conclude, based on this analysis, that desipramine is significantly more likely to lead to death after overdosage than any other tricyclic antidepressant in the study. Also, the Mortality Index appeared to identify the impact of pediatric formulations on overdose lethality. We conclude that the Mortality Index may be a useful tool for determining the safety of agents during the postmarketing surveillance phase.

  6. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    Science.gov (United States)

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  7. Risk management and post-marketing surveillance of CNS drugs.

    Science.gov (United States)

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  8. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What should I consider when designing my plan to conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket surveillance...

  9. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    Science.gov (United States)

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-06-01

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  10. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  12. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false If I stop marketing the device subject to postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

  13. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Science.gov (United States)

    2012-08-30

    ... Contact Person) no later than September 5, 2012. No commercial or promotional material will be permitted... develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze... implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical...

  15. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  16. Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.

    Directory of Open Access Journals (Sweden)

    Joseph R Egger

    Full Text Available BACKGROUND: Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect issues with performance in real-time. METHODS AND FINDINGS: Using HIV antibody screening test data from New York City STD clinics, we developed a formal, statistical method of prospectively detecting temporal clusters of poor performance of a screening test. From 2005 to 2008, New York City, as well as other states, observed unexpectedly high false-positive (FP rates in an oral fluid-based rapid test used for screening HIV. We attempted to formally assess whether the performance of this HIV screening test statistically deviated from both local expectation and the manufacturer's claim for the test. Results indicate that there were two significant temporal clusters in the FP rate of the oral HIV test, both of which exceeded the manufacturer's upper limit of the 95% CI for the product. Furthermore, the FP rate of the test varied significantly by both STD clinic and test lot, though not by test operator. CONCLUSIONS: Continuous monitoring of surveillance data has the benefit of providing information regarding test performance, and if conducted in real-time, it can enable programs to examine reasons for poor test performance in close proximity to the occurrence. Techniques used in this study could be a valuable addition for postmarketing surveillance of test performance and may become particularly important with the increase in rapid testing methods.

  17. Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

    Science.gov (United States)

    Gagliardi, Anna R; Umoquit, Muriah; Lehoux, Pascale; Ross, Sue; Ducey, Ariel; Urbach, David R

    2013-03-01

    Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices. Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system. Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system. These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

  18. Current French system of post-marketing drug surveillance.

    Science.gov (United States)

    Albengres, E; Gauthier, F; Tillement, J P

    1990-07-01

    The French system of drug surveillance is characterized by several original features: thirty regional centres are selected to cover all of France to collect, analyze and enter the adverse drug events in the national data bank. The system is based on a bank of well documented files submitted to a decision of imputation; the report of severe events by prescribers is mandatory; cases are collected either by spontaneous reporting (routine) or by direct request (intensive validation study); the system is being involved in studies of epidemiological type as carried out by the national system of health or a few societies of medicine as well as by the centres themselves in cooperative works on defined populations.

  19. Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China

    Science.gov (United States)

    Cui, Fuqiang; Liang, Xiaofeng; Wang, Fuzhen; Zheng, Hui; Hutin, Yvan J; Yang, Weizhong

    2014-01-01

    China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China. We reviewed the published literature (in Chinese and English) and the published Chinese regulatory documents on hepatitis A vaccine development, production, and postmarketing surveillance of AEFI. We described the safety, immunogenicity, and efficacy of hepatitis A vaccines and horizontal transmission of live HAV vaccine in China. In clinical trials, live HAV vaccine was associated with fever (0.4%–5% of vaccinees), rash (0%–1.1%), and elevated alanine aminotransferase (0.015%). Inactivated HAV vaccine was associated with fever (1%–8%), but no serious AEFIs were reported. Live HAV vaccine had seroconversion rates of 83% to 91%, while inactivated HAV vaccine had seroconversion rates of 95% to 100%. Community trials showed efficacy rates of 90% to 95% for live HAV and 95% to 100% for inactivated HAV vaccine. Postmarketing surveillance showed that HAV vaccination resulted in an AEFI incidence rate of 34 per million vaccinees, which accounted for 0.7% of adverse events reported to the China AEFI monitoring system. There was no difference in AEFI rates between live and inactivated HAV vaccines. Live and inactivated HAV vaccines manufactured in China were immunogenic, effective, and safe. Live HAV vaccine had substantial horizontal transmission due to vaccine virus shedding; thus, further monitoring of the safety of virus shedding is warranted. PMID:24681843

  20. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  1. Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

    Science.gov (United States)

    Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

    2018-03-01

    Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

  2. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing.

    Science.gov (United States)

    Wesolowski, Laura G; MacKellar, Duncan A; Facente, Shelley N; Dowling, Teri; Ethridge, Steven F; Zhu, Julia H; Sullivan, Patrick S

    2006-08-01

    Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the

  3. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  4. Safety and Antihypertensive Effect of Selara® (Eplerenone: Results from a Postmarketing Surveillance in Japan

    Directory of Open Access Journals (Sweden)

    Shoko Takahashi

    2016-01-01

    Full Text Available Prospective postmarketing surveillance of Selara (eplerenone, a selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan. The change in blood pressure after initiation of eplerenone treatment was also examined. Patients with essential hypertension who were eplerenone-naïve were recruited regardless of the use of other antihypertensive drugs. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. Patients received 50–100 mg of eplerenone once daily and were observed for 12 weeks. No treatments including antihypertensive drugs were restricted during the surveillance period. Across Japan, 3,166 patients were included for safety analysis. The incidence of adverse drug reactions was 2.4%. The major adverse drug reactions observed were hyperkalemia (0.6%, dizziness, renal impairment, and increased serum potassium (0.2% each. The mean systolic blood pressure decreased from 152.1±19.0 mmHg to 134.8±15.2 mmHg at week 12, and the mean diastolic blood pressure decreased from 85.8±13.7 mmHg to 77.7±11.4 mmHg. There were no significant new findings regarding the type or incidence of adverse reactions, and eplerenone had a clinically significant antihypertensive effect, leading to favorable blood pressure control.

  5. Recommendations for postmarketing surveillance studies in haemophilia and other bleeding disorders.

    Science.gov (United States)

    Lassila, R; Rothschild, C; De Moerloose, P; Richards, M; Perez, R; Gajek, H

    2005-07-01

    Prospective surveillance studies to monitor drug safety in the postapproval period are rarely employed systematically, although they are of greatest value for caregivers, drug users and regulatory authorities. Safety issues have affected not only conventional pharmaceuticals, but also especially coagulation factors in haemophilia treatment. The reputation of postmarketing surveillance (PMS) studies has been questionable, mainly due to their misuse to solicit prescriptions. Other weaknesses include inappropriate design, lack of standardized observation, limited follow-up periods, absence of rigour in identifying potential adverse drug effects, and infrequent publication. Although well-designed clinical trials represent the gold standard for generating sound clinical evidence, a number of aspects would make PMS studies valuable, if properly conducted. One of their main advantages is broader inclusion, and absence of an 'experimental' design. Lack of proper guidelines, and standardization may constitute a reason for the generally low quality of PMS studies. This paper proposes guidelines for haemophilia-specific PMS studies, in order to improve the acceptance of a basically valuable tool. In the absence of consistent regulatory guidance it will be especially important that the design and supervision of PMS studies involves physicians from the beginning. This will not only make such studies more scientifically relevant, but also help to implement them into daily clinical practice. Specifically in haemophilia, PMS studies may provide valuable data on clinical outcomes, or Quality of Life, which is of great importance when considering adequate standards of care in haemophilia patients.

  6. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  7. The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes.

    Science.gov (United States)

    Köckerling, Ferdinand; Simon, Thomas; Hukauf, Martin; Hellinger, Achim; Fortelny, Rene; Reinpold, Wolfgang; Bittner, Reinhard

    2017-06-07

    To assess the role of registries in the postmarketing surveillance of surgical meshes. To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry. The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834). Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P manufacturing company must be taken into account.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.

  8. A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

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    Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

    2014-01-01

    Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

  9. [The role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  10. Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.

    Science.gov (United States)

    Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R

    2012-01-01

    Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

  11. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    Science.gov (United States)

    Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

    2012-01-01

    Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

  12. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

    Directory of Open Access Journals (Sweden)

    Yamamoto K

    2011-04-01

    Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

  13. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  14. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  15. Results of a customer-based, post-market surveillance survey of the HeRO access device.

    Science.gov (United States)

    Fusselman, Maureen

    2010-08-01

    In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

  16. Safety and efficacy of lansoprazole injection in upper gastrointestinal bleeding: a postmarketing surveillance conducted in Indonesia.

    Science.gov (United States)

    Syam, Ari F; Setiawati, Arini

    2013-04-01

    to assess the safety and effectiveness of lansoprazole injection (Prosogan®) in patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis. this study was a multicenter observational postmarketing study of lansoprazole (Prosogan®) injection. Patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis were given intravenous lansoprazole for a maximum of 7 days or until the bleeding stopped and the patients were able to take oral doses of lansoprazole. Primary outcome of the study was cessation of bleeding. Some laboratory parameters were also measured. among a total of 204 patients evaluable for safety, there was no adverse event reported during the study. A total of 200 patients were eligible for efficacy evaluation, 125 patients (62.5%) were males. Among these patients, upper GI bleeding stopped in 20 patients (10.0%) on day 1, in 71 patients (35.5%) on day 2, 75 patients (37.5%) on day 3, 24 patients (12.0%) on day 4, and 7 patients (3.5%) on day 5, making a cumulative of 197 patients (98.5%) on day 5. The hemostatic effect was rated as 'excellent' if the bleeding stopped within 3 days, and 'good' if the bleeding stopped within 5 days. Thus, the results were 'excellent' in 166 patients (83.0%) and 'good' in 31 patients (15.5%). These results were not different between males and females, between age below 60 years and 60 years and above, and between baseline Hb below 10 g/dL and 10 g/dL and above. the results of this observational postmarketing study in 200 patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis demonstrated that intravenous lansoprazole twice a day was well tolerated and highly effective.

  17. Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

    Directory of Open Access Journals (Sweden)

    Katagiri H

    2018-01-01

    Full Text Available Hideaki Katagiri,1 Masanori Taketsuna,2 Shinpei Kondo,3 Kenta Kajimoto,4 Etsuko Aoi,5 Yuka Tanji1 1Bio Medicine, 2Statistical Sciences, 3Post Marketing Study Management, 4Scientific Communications, Medicines Development Unit Japan, 5Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., Kobe, Japan Objective: The objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.Methods: In this multicenter, postmarketing surveillance (PMS study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration. Safety was assessed by reporting treatment-emergent adverse events (TEAEs and adverse drug reactions (ADRs. The Positive and Negative Syndrome Scale – Excited Component (PANSS-EC score was used to evaluate effectiveness at baseline and at 2 hours (after each administration, 2 days, and 3 days (end of the observational period from the last administration of the IM olanzapine injection.Results: The safety analysis set included 999 patients, and the initial dose of 10 mg was administered to 955 patients. TEAEs were reported in 28 patients (36 events, the most common of which were dyslalia (5 patients, akathisia and somno­lence (4 patients each, hepatic function abnormal (3 patients, and constipation and dehydration (2 patients each. One serious adverse event of akathisia occurred during the observation period. The PANSS-EC score (mean ± standard deviation was 23.3±6.4 (n=625 at baseline, 16.9±7.0 (n=522 at 2 hours after initial injection, and 14.9±6.5 (n=650 at the last observation carried forward.Conclusion: The results of this Japanese PMS study demonstrated that IM olanzapine is safe and has a

  18. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    Science.gov (United States)

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-12-01

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  19. [Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

    Science.gov (United States)

    Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

    2018-02-01

    To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

  20. A Postmarket Surveillance Study on Electro-Neuro-Adaptive-Regulator Therapy

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    Rod P. Bonello

    2014-01-01

    Full Text Available The Electro-Neuro-Adaptive-Regulator (ENAR device is a hand-held electrotherapy which is applied using energetic medicine principles and aspects of acupuncture theory. The aim of this paper is to report the findings of a postmarket survey of persons who have used the ENAR device. The conditions for which the therapy was used and its perceived effectiveness are discussed. A web-based survey of Australian recipients of ENAR therapy was completed by 481 respondents. Most (76% used ENAR exclusively for pain relief for musculoskeletal disorders, especially back, shoulder, and neck pain; 8% used ENAR exclusively for nonmusculoskeletal disorders; while 16% used ENAR for both. Respondents reported a mean reduction in pain of 70% (t(423 = 38.73, P<.001 and functional improvement of 62% (t(423 = 10.45, P<.001 using 11-point numerical rating scales. Following ENAR treatment, medication reduction was reported by 91% of respondents. Most respondents reported high satisfaction following ENAR therapy, with between 15 and 20% achieving complete pain relief. The self-delivery of ENAR may, in part, account for the high level of satisfaction.

  1. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-05-01

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  2. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  3. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    Science.gov (United States)

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  4. Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Percy S

    2003-07-01

    Full Text Available Introduction: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. Results: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. Conclusion: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

  5. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  6. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  7. 77 FR 9256 - Design and Methodology for Postmarket Surveillance Studies Under Section 522 of the Federal Food...

    Science.gov (United States)

    2012-02-16

    ... postmarket setting. 2. Who is the target audience for this public workshop? Who should attend this public workshop? This workshop is open to all interested parties. The target audience is professionals in the...

  8. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

    Science.gov (United States)

    Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

    2013-08-01

    Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

  9. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  10. Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

    Science.gov (United States)

    Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

    2018-05-01

    Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

  11. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

    Science.gov (United States)

    Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

    2013-10-10

    Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

  12. Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

    Science.gov (United States)

    Mehta, Rashi I; Mehta, Rupal I

    2018-03-19

    Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.

  13. Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.

    Science.gov (United States)

    Kanda, Yoshiko; Kayama, Tomoko; Okamoto, Shinji; Hashimoto, Masako; Ishida, Chiemi; Yanai, Tomoko; Fukumoto, Mitsuru; Kunihiro, Eiichi

    2012-12-01

    Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000. This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice. Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.

  14. Post-marketing surveillance of CustomBone Service implanted in children under 7 years old.

    Science.gov (United States)

    Frassanito, Paolo; Tamburrini, Gianpiero; Massimi, Luca; Di Rocco, Concezio; Nataloni, Angelo; Fabbri, Greta; Caldarelli, Massimo

    2015-01-01

    The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group. Twenty-eight children under 7 years old (range, 2.5-6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year. Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %). The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.

  15. National Cardiac Device Surveillance Program Database

    Data.gov (United States)

    Department of Veterans Affairs — The National Cardiac Device Surveillance Program Database supports the Eastern Pacemaker Surveillance Center (EPSC) staff in its function of monitoring some 11,000...

  16. A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

    Science.gov (United States)

    Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

    2018-04-01

    Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

  17. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  18. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  19. In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

    Directory of Open Access Journals (Sweden)

    Zaid AN

    2016-09-01

    Full Text Available Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, 2Pharmacare Ltd, Ramallah, Palestine Objectives: The objectives of this study were to evaluate the general quality of the most prescribed products of valsartan (VL; alone or in combination and to evaluate their efficacy and safety among Palestinian population through in vivo postmarketing surveillance. Patients and methods: The first part was pharmacopeial quality control assay, including dissolution, disintegration, friability, and weight uniformity for VL. The second part was a 3-month cardiology clinics, observational, postmarketing surveillance pilot study that included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as monotherapy or combination therapy. The end points were reduction in blood pressure (BP and the rate of incidence of adverse effects (AEs at weeks 4 and 8. Results: According to our quality control tests, all VL products showed high-quality standards according to the international guidelines. A reduction in BP was observed at weeks 4 and 8, and no significant difference was observed between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of the AEs were of mild-to-moderate intensity. In general, the most frequently reported AEs included headache (17.5%, dizziness (11.75%, and weakness (11.7%. No serious AEs or death cases were reported during the study period. Conclusion: High quality of VL tablet products was used; hence, the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension. Keywords: valsartan

  20. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--I. Gram-positive bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, and carbapenems. Changes in the bacterial susceptibility for CZOP were also evaluated with the resistance ratio calculated with breakpoint MIC. Sixteen species (2,363 strains) of Gram-positive bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus epidermidis (MSSE), methicillin-resistant Staphylococcus epidermidis (MRSE), Staphylococcus haemolyticus, Staphylococcus saprophyticus, Enterococcus faecalis, Enterococcus faecium, Enterococcus avium, Streptococcus pyogenes, Streptococcus agalactiae, penicillin-susceptible Streptococcus pneumoniae (PSSP), penicillin-intermediate resistant S. pneumoniae (PISP), penicillin-resistant S. pneumoniae (PRSP), Streptococcus milleri group and Peptostreptococcus spp. The antibacterial activity of CZOP either against MSSA or MSSE was preferable (MIC90: 2 or 0.5 micrograms/mL) and comparable to those of other cephems. CZOP was also effective on MRSE (MIC90: 16 micrograms/mL) but not on MRSA. CZOP and other cephems had low antibacterial activity against S. haemolyticus (MIC90: 64 micrograms/mL). The antibacterial activity of CZOP against S. saprophyticus was comparable to or higher than those of other cephems, but the MIC90 of CZOP in 2001 was higher than those in 1996-2000 (32 vs 1-2 micrograms/mL). The antibacterial activity of CZOP against E. faecalis was comparable to that of cefpirome (CPR; MIC90: 16 micrograms/mL) and higher than those of other cephems. No antibacterial activity of CZOP against E. faecium and E. avium was observed, like other drugs. The antibacterial activity of CZOP against S. pyogenes

  1. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, carbapenems, monobactams, and penicillins. Changes in CZOP susceptibility among bacteria were also evaluated with the bacterial resistance ratio calculated from the breakpoint MIC. Twenty-five species (4,154 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter aerogenes, Serratia marcescens, Serratia liquefaciens, Citrobacter freundii, Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Acinetobacter baumannii, Acinetobacter Iwoffii, Burkholderia cepacia, Stenotrophomonas maltophilia, Bacteroides fragilis group, and Prevotella/Porphyromonas. CZOP preserved its antibacterial activity against M. (B.) catarrhalis (MIC90: 4 micrograms/mL) and showed comparable activity to carbapenems against H. influenzae (MIC90: 1 microgram/mL). The antibacterial activity of CZOP against E. coli was preferable (MIC90: 0.125 microgram/mL) and comparable to those of cefpirome (CPR), cefepime (CFPM), and imipenem (IPM). The MIC90 of CZOP against K. pneumoniae and K. oxytoca was 1 and 0.25 microgram/mL, respectively. The MIC90 of CZOP against E. cloacae increased during 6 years (32 to 128 micrograms/mL). The antibacterial activity of CZOP against E. aerogenes was preferable (MIC90: 1 microgram/mL). The antibacterial activities of CZOP against S. marcescens and S. liquefaciens were relatively potent (MIC90: 0.5 and 0.25 microgram/mL) and comparable to those of CPR, CFPM, and carumonam. CZOP preserved comparable antibacterial

  2. Reactor Vessel Surveillance Program for Advanced Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Kyeong-Hoon; Kim, Tae-Wan; Lee, Gyu-Mahn; Kim, Jong-Wook; Park, Keun-Bae; Kim, Keung-Koo

    2008-10-15

    This report provides the design requirements of an integral type reactor vessel surveillance program for an integral type reactor in accordance with the requirements of Korean MEST (Ministry of Education, Science and Technology Development) Notice 2008-18. This report covers the requirements for the design of surveillance capsule assemblies including their test specimens, test block materials, handling tools, and monitors of the surveillance capsule neutron fluence and temperature. In addition, this report provides design requirements for the program for irradiation surveillance of reactor vessel materials, a layout of specimens and monitors in the surveillance capsule, procedures of installation and retrieval of the surveillance capsule assemblies, and the layout of the surveillance capsule assemblies in the reactor.

  3. Post-tensioning system surveillance program

    International Nuclear Information System (INIS)

    Drew, G.E.

    1979-01-01

    Nuclear power plant containment structure post-tensioning system tendon surveillance program is described in detail. Data collected over three yearly post-tensioning system Surveillance Programs is presented and evaluated to correlate anticipated stress losses with actual losses. In addition corrosion protected system performance is analyzed

  4. Surveillance of adverse effects following vaccination and safety of immunization programs.

    Science.gov (United States)

    Waldman, Eliseu Alves; Luhm, Karin Regina; Monteiro, Sandra Aparecida Moreira Gomes; Freitas, Fabiana Ramos Martin de

    2011-02-01

    The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.

  5. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Science.gov (United States)

    Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

    2015-01-01

    This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

  6. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

    2009-12-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

  7. Retrospective hospital based surveillance of intussusception in children in a sentinel paediatric hospital: benefits and pitfalls for use in post-marketing surveillance of rotavirus vaccines.

    Science.gov (United States)

    Lloyd-Johnsen, C; Justice, F; Donath, S; Bines, J E

    2012-04-27

    Evaluation of the safety of rotavirus vaccines, particularly with respect to the risk of intussusception, is recommended for countries planning to introduce rotavirus vaccines into the National Immunisation Program. However, as prospective studies are costly, require time to conduct and may be difficult to perform in some settings, retrospective hospital based surveillance at sentinel sites has been suggested as an option for surveillance for intussusception following introduction of rotavirus vaccines. To assess the value of retrospective hospital based surveillance to describe clinical and epidemiological features of intussusception in children aged <24 months and to investigate any temporal association between receipt of a rotavirus vaccine and intussusception. A retrospective chart review of all patients diagnosed with intussusception at Royal Children's Hospital, Melbourne, Australia over an 8-year period including before and after rotavirus vaccine introduction into the National Immunisation Program, was conducted using patients identified by a medical record database (ICD-10-CM 56.1). Patient profile, clinical presentation, treatment and outcome were analysed along with records of immunisation status obtained using the Australian Childhood Immunisation Register. A 9% misclassification rate of discharge diagnosis of intussusception was identified on critical chart review. The incidence rate of intussusception at the Royal Children's Hospital over the study period was 1.91 per 10,000 infants <24 months (95% CI 1.65-2.20). Intestinal resection was required in 6.5% of infants (95% CI 3.6%, 11.0%). Intussusception occurred within 30 days after vaccination in 2 of 27 patients who had received at least 1 dose of a rotavirus vaccine. Valuable data on the incidence, clinical presentation and treatment outcomes of intussusception can be obtained from data retrieved from hospital medical records in a sentinel paediatric hospital using standardised methodology. However

  8. Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.

    Science.gov (United States)

    Okubo, Sumiko; Nishiuma, Shinichi; Kobayashi, Noriko; Taketsuna, Masanori; Taniai, Hisashi

    2012-11-01

    Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%). In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

  9. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    Directory of Open Access Journals (Sweden)

    Nobuyuki Yagi

    2014-05-01

    Full Text Available Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7% of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%. No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  10. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Directory of Open Access Journals (Sweden)

    Nawroth F

    2015-04-01

    Full Text Available Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm. Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population. The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%, 50.0 IU (n=1,056 from N=3,189; 33.1%, and 75.0 IU (n=738 from N=3,189; 23.1% on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%, 50.0 IU (n=922 from N=3,189; 28.9%, and 75.0 IU (n=895 from N=3,189; 28.1% on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation

  11. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    Science.gov (United States)

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  12. [Investigation of the factors that contribute to the onset of insomnia in hypertensive patients by using a post-marketing surveillance database].

    Science.gov (United States)

    Tanabe, Naoto; Fujita, Toshiharu; Fujii, Yosuke; Orii, Takao

    2011-01-01

    Many factors contribute to the onset of insomnia. However, few studies have identified the factors related to the onset of insomnia in hypertensive patients. We conducted a pharmacoepidemiologic study to examine the incidence of insomnia in hypertensive patients by using a post-marketing surveillance database. The insomnia onset was defined as the time of first prescription of hypnotics. The insomnia incidence rate in hypertensive patients under antihypertensive therapy was 0.77/100 person-years. The median insomnia onset date was 5 weeks. The insomnia type in 50.2% of the patients was difficulty in initiating sleep. We assessed the factors contributing to insomnia by using a nested case-control design. We selected 10 time-matched controls for every case. The hypotensive effect induced by antihypertensive therapy on the case group was lesser than that on the control group (pchannel blockers (OR, 0.62; 95% CI, 0.43-0.90) compared with angiotensin-converting enzyme inhibitors; female sex (OR, 1.76; 95% CI, 1.27-2.44); complication of gastric/duodenal disorders (OR, 2.35; 95% CI, 1.14-4.86) or musculoskeletal system/connective tissue disorders (OR, 2.43; 95% CI, 1.23-4.79); and concomitant antihypertensive therapy (OR, 0.44; 95% CI, 0.31-0.63). This study identified the potential factors that may help to predict insomnia onset in hypertensive patients under antihypertensive therapy.

  13. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    Science.gov (United States)

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  14. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    Science.gov (United States)

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  15. Clinical significance and epidemiologic analyses of Mycobacterium avium and Mycobacterium intracellulare lung disease from post-marketing surveillance.

    Science.gov (United States)

    Suzuki, Katsuhiro; Kurashima, Atsuyuki; Tatsuno, Kinji; Kadota, Jun-Ichi

    2018-01-01

    In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens. Among the patients analyzed (n = 368), 67.4% had M. avium infection and 32.6% had M. intracellulare infection. Stratified analysis revealed no significant differences between the ratio of the two pathogens based on gender, disease type, complication, past medical history, or smoking history. However, the percentage of patients with M. intracellulare infection was significantly higher among those with underlying lung disease than among those without lung disease (p = 0.0217). The percentage of patients with M. intracellulare infection rose significantly with age (p = 0.0296). This age-related change was more significant in women (p = 0.0018). When district-wise analysis was performed for Japan, the percentage of M. intracellulare infection was higher in the Chugoku/Shikoku and Kyushu districts whereas the percentage of M. avium infection was higher in the other districts. This survey revealed some differences in the clinical and epidemiologic features of M. avium and M. intracellulare infection. The significant predominance of M. avium infection among relatively young women is suggestive of an increase in the M. avium/M. intracellulare infection ratio among women in the future. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  16. New England States environmental radiation surveillance programs

    International Nuclear Information System (INIS)

    Molloy, E.J.

    1980-01-01

    An overview of the environmental radiation surveillance programs in the New England States from the viewpoint of their organization and administration is provided. Moreover, the specific monitoring and analytical programs conducted at selected sites in each state is detailed with emphasis on sample types, collection frequencies, and analysis. Also, a comparison is made between the programs of all the states in order to determine the reasons for their differences

  17. Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

    Science.gov (United States)

    Haneda, Masakazu; Kadowaki, Takashi; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years]. During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from

  18. Community-Operated Environmental Surveillance Program

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the environmental surveillance activities with which citizens living near the Hanford Site have been participating. Local teachers have been managing and operating three special radiological air sampling stations located in Richland, Basin City, and Franklin County, Washington. Other expansion efforts of this program are also described.

  19. Community-Operated Environmental Surveillance Program

    International Nuclear Information System (INIS)

    Anon.

    1995-01-01

    This section of the 1994 Hanford Site Environmental Report summarizes the environmental surveillance activities with which citizens living near the Hanford Site have been participating. Local teachers have been managing and operating three special radiological air sampling stations located in Richland, Basin City, and Franklin County, Washington. Other expansion efforts of this program are also described

  20. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

    Science.gov (United States)

    Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

    2018-03-01

    Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

  1. Risk Factor for Diabetes Mellitus and High Blood Glucose With HMG-CoA Reductase Inhibitors Using a Postmarketing Surveillance Database in Japan.

    Science.gov (United States)

    Hashiguchi, Masayuki; Maruyama, Junya; Shimizu, Mikiko; Takahashi, Daichi; Shiga, Tsuyoshi

    2018-02-20

    To investigate whether 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statin) use is associated with an increased risk of diabetes mellitus and hyperglycemia, we performed a nested case-control study using a postmarketing surveillance database in Japan. The database cohort included 26,849 cases of statin use and 5308 cases of other lipid-lowering drug use in patients with hyperlipidemia. Participants received at least 1 type of statin, had a clear medication history of statin use, and had no complications of diabetes mellitus. Cases were defined as onset of diabetes mellitus or hyperglycemia during statin intake. For each case, 20 controls were randomly selected and matched by time point. The factors associated with an increased risk of diabetes mellitus and hyperglycemia during statin intake examined included sex, age, body mass index, statin use duration, complications, concomitant medication, and clinical laboratory tests. Statin-associated diabetes mellitus or hyperglycemia was identified based on abnormal elevation of blood glucose concentrations beyond the reference range. A total of 19,868 patients met the inclusion criteria, of whom 24 were patients in the case group. Two complicating factors, fatty liver (adjusted odds ratio 16.10) and hyperuricemia (adjusted odds ratio 28.96), were extracted for onset of diabetes mellitus or hyperglycemia. Nonalcoholic fatty liver was associated with diabetes mellitus, obesity, and insulin resistance, and hyperuricemia was associated with lifestyle. This study suggested that the onset of diabetes mellitus or hyperglycemia might be increased with statin use in patients with complications of fatty liver and hyperuricemia. © 2018, The American College of Clinical Pharmacology.

  2. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

    Science.gov (United States)

    Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

    2018-02-01

    To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

  3. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    Science.gov (United States)

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  4. Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

    Science.gov (United States)

    Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

    2017-10-01

    Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

  5. Psychosocial functioning in patients with schizophrenia treated with aripiprazole - an office-based real-world setting. Results from the German post-marketing surveillance study.

    Science.gov (United States)

    Bergmann, F; Zacher, A; Nass, A; Urban, R; Werner, C; Spevakné-Göröcs, T; Kungel, M; Ebrecht, M; Modell, S

    2009-05-01

    Aripiprazole (ABILIFY) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. Soon after its approval in Germany for treatment of schizophrenia, a 12-month post-marketing surveillance study was initiated that included 1 096 patients cared for by 408 office-based psychiatrists and/or neurologists in private practice. The aim was to gain further insights into safety and efficacy of aripiprazole in an outpatient real-life setting focusing on general health, well-being and psychosocial functioning. Efficacy was rated by using standard CGI, SF-12 and SIWM-PsySo instruments for severity of disease, physical and mental health outcomes and psychosocial state, respectively. Safety was evaluated according to the reports of adverse events. Mean total daily dose of aripiprazole increased from 15.4 mg at the visit after 1 month to 17.6 mg at the visits after 6 to 12 months, the most frequently administered maintenance dose being 15 mg. Within the observation period significant improvements of CGI, SF-12 and SIWM-PsySo scores over time versus baseline values were observed (pmuch" or "very much" improved. Aripiprazole was overall well tolerated; 19.9% of patients discontinued treatment after 12 months. Adverse effects in general were moderate to mild and corresponded to the known tolerability profile of aripiprazole. Psychotic side effects reported were probably due to a recurrence of the underlying schizophrenic disorder. The results indicate that aripiprazole may be an efficacious and safe treatment option for pre-treated patients with schizophrenia also in a naturalistic psychiatrist/neurologist practice setting with effects on health and psychosocial functioning and a comparably low dropout rate.

  6. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

    International Nuclear Information System (INIS)

    Endrikat, J.; Schwenke, C.; Prince, M.R.

    2015-01-01

    Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

  7. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    Science.gov (United States)

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. [Susceptibility surveillance of clinical isolates to fluoroquinolone antimicrobial agents from 2003 to 2008: post-marketing study of prulifloxacin].

    Science.gov (United States)

    Kawai, Shin; Yoshida, Atsushi; Okazaki, Mitsuhiro; Tsujihara, Yoshito; Inuzuka, Kazuhisa; Takeuchi, Kazuhide; Yamashita, Naoko; Onodera, Makoto; Hiraishi, Toru; Ida, Takashi; Maebashi, Kazunori

    2010-06-01

    Yearly changes in the susceptibility of clinical isolates to ulifloxacin (UFX) and other fluoroquinolones were examined through surveys over 3 periods. In the first survey, 534 strains derived from 19 species were collected from clinical specimens during 6 months from December 2003 to May 2004. In the same way, 805 strains were collected from December 2005 to May 2006 in the second survey, and 863 strains were from December 2007 to May 2008 in the third survey. Over these 3 study periods, the susceptibilities of fluoroquinolones against methicillin-susceptible Staphylococcus aureus and Escherichia coli were decreased. The isolation frequency of levofloxacin-nonsusceptible strain was increased from 0% to 11.8% and from 14.6% to 20.8%, respectively. MIC90s of UFX against these pathogens were also increased, but its MIC90 for E. coli was 2 to 4 times lower than that of levofloxacin. On the other hand, the susceptibility of strains of Klebsiella pneumoniae to UFX was increased. Among the fluoroquinolones tested, UFX showed the most potent activity against Pseudomonas aeruginosa, and no changes in the MIC90s occurred during the surveillance. Although one strain of Streptococcus pneumoniae isolated in the third study period showed levofloxacin-resistance (MIC, 8 microg/mL), there were nearly no changes in the MIC90s of any agents tested including UFX against S. pneumoniae during the surveillance. As for other bacterial species, a tendency to increase in resistance to UFX was not observed. The activity of UFX against Salmonella spp. and Shigella spp. was superior/equal to those of fluoroquinolones tested.

  9. Advanced neutron source materials surveillance program

    International Nuclear Information System (INIS)

    Heavilin, S.M.

    1995-01-01

    The Advanced Neutron Source (ANS) will be composed of several different materials, one of which is 6061-T6 aluminum. Among other components, the reflector vessel and the core pressure boundary tube (CPBT), are to be made of 6061-T6 aluminum. These components will be subjected to high thermal neutron fluences and will require a surveillance program to monitor the strength and fracture toughness of the 6061-T6 aluminum over their lifetimes. The purpose of this paper is to explain the steps that were taken in the summer of 1994 toward developing the surveillance program. The first goal was to decide upon standard specimens to use in the fracture toughness and tensile testing. Second, facilities had to be chosen for specimens representing the CPBT and the reflector vessel base, weld, and heat-affected-zone (HAZ) metals. Third, a timetable had to be defined to determine when to remove the specimens for testing

  10. Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.

    Science.gov (United States)

    Kadowaki, Takashi; Haneda, Masakazu; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications. We also examined whether eating patterns affected safety and efficacy of teneligliptin. We analyzed baseline data from survey forms collected in RUBY between May 2013 and June 2017, including patient characteristics, metabolic parameters, and eating patterns (eating three meals per day or not; timing of evening meal) before teneligliptin treatment was initiated. Safety and efficacy of 12 months' teneligliptin (20-40 mg/day) treatment was assessed. Data from 10,532 patients were available for analysis. Most patients who did not eat three meals per day (n  =757) or who ate their evening meal after 10 PM (n  =206) were 64 years old or younger. At baseline, glycated hemoglobin (HbA1c), fasting blood glucose, triglycerides, total and low-density lipoprotein cholesterol, body mass index, alanine aminotransferase, and aspartate aminotransferase levels were higher in those patients who did not eat three meals per day (p < 0.05) or who ate their evening meal late (p < 0.05). Diabetic complications were more common in patients who did not eat three meals per day. Treatment with teneligliptin reduced HbA1c over 6 or 12 months across all eating patterns, with a low incidence of adverse drug reactions. Eating patterns may be associated with altered metabolic parameters and diabetic complications among Japanese patients with T2DM. Teneligliptin may be well tolerated and improve hyperglycemia in patients

  11. Postmarket Requirements and Commitments

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical...

  12. Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

    Science.gov (United States)

    Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai

    2017-01-01

    In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

  13. Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

    Science.gov (United States)

    Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2017-11-01

    Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

  14. Application of DNA barcoding in forest biosecurity surveillance programs

    Science.gov (United States)

    Leland M. Humble; Jeremy R. deWaard

    2011-01-01

    The ability to distinguish non-indigenous species from the background diversity of native taxa is critical to the success of surveillance programs for detecting new introductions. Surveillance programs for alien taxa rely on the precise diagnosis of species, which can be complicated by sizable trap samples, damaged specimens, immature life stages, and incomplete...

  15. Extension of the surveillance program at NPP Paks

    International Nuclear Information System (INIS)

    Gillemot, F.

    1992-01-01

    In WWER-440 reactors the surveillance specimens are located in accelerated irradiation positions. After five years all specimens are withdrawn and the operational changes are not monitored. At Paks NPP a new surveillance program extension is started to eliminate of this disadvantage of the original program. (author)

  16. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg in 3,762 hemodialysis patients with intractable pruritus

    Directory of Open Access Journals (Sweden)

    Kozono H

    2018-01-01

    Full Text Available Hideki Kozono,* Hiroshi Yoshitani,* Ryoko Nakano* Pharmaceutical and Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, Japan *The authors contributed equally to this work Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Patients and methods: Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores were collected and analyzed. Results: In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69% patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients, constipation (34 [0.90%], somnolence (32 [0.85%], dizziness (23 [0.61%], nausea (13 [0.35%], and malaise (9 [0.24%]. No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491 of patients during the first 12 weeks and in 84.95% (2,167/2,551 on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant

  17. Evaluation of the novel respiratory virus surveillance program: Pediatric Early Warning Sentinel Surveillance (PEWSS).

    Science.gov (United States)

    Armour, Patricia A; Nguyen, Linh M; Lutman, Michelle L; Middaugh, John P

    2013-01-01

    Infections caused by respiratory viruses are associated with recurrent epidemics and widespread morbidity and mortality. Routine surveillance of these pathogens is necessary to determine virus activity, monitor for changes in circulating strains, and plan for public health preparedness. The Southern Nevada Health District in Las Vegas, Nevada, recruited five pediatric medical practices to serve as sentinel sites for the Pediatric Early Warning Sentinel Surveillance (PEWSS) program. Sentinel staff collected specimens throughout the year from ill children who met the influenza-like illness case definition and submitted specimens to the Southern Nevada Public Health Laboratory for molecular testing for influenza and six non-influenza viruses. Laboratory results were analyzed and reported to the medical and general communities in weekly bulletins year-round. PEWSS data were also used to establish viral respiratory seasonal baselines and in influenza vaccination campaigns. The surveillance program was evaluated using the Centers for Disease Control and Prevention's (CDC's) Updated Guidelines for Evaluating Public Health Surveillance Systems. PEWSS met three of six program usefulness criteria and seven of nine surveillance system attributes, which exceeded the CDC Guidelines evaluation criteria for a useful and complete public health surveillance program. We found that PEWSS is a useful and complete public health surveillance system that is simple, flexible, accessible, and stable.

  18. Medical surveillance program for uranium workers in Grants, New Mexico

    International Nuclear Information System (INIS)

    Valdivia, A.A.

    1981-01-01

    A medical surveillance program at the Grants Clinic in Grants, New Mexico designed for early detection of pre-invasive and invasive lung neoplasms is discussed. The parameters of the surveillance profile are: age, race, mining history, smoking history, radiation exposure, chest x-rays, and sputum cytology. The best tool is the cytological examination of the sputum

  19. Irradiation temperature measurements in the surveillance program

    International Nuclear Information System (INIS)

    Pav, T.; Krhounek, V.

    1991-01-01

    Evaluation of the diamond monitor method for the determination of the irradiation temperature in the surveillance programme of WWER-440 reactors is discussed. One of the difficulties with the practical application of the method is that the measured values of irradiation temperature are unlikely high. Using a thermodynamical model of the processes in the annealing of the irradiated diamond crystals, it was shown that experimental difficulties came from the principles of the method used. An analysis was performed of the thermal field inside the capsule of the surveillance chain in operational conditions, using the finite element method. The diamond monitor method was suggested to be eliminated from the surveillance programme and the use was proposed of the value of 273+-3 degC (as the most likely value) for the irradiation temperature of surveillance samples in WWER-440 reactors. (Z.S.). 3 tabs., 6 figs., 4 refs

  20. Quality assurance applied to an environmental surveillance program

    International Nuclear Information System (INIS)

    Oakes, T.W.; Shank, K.E.; Eldridge, J.S.

    1977-01-01

    A discussion of a quality assurance program applied to environmental surveillance activities is presented. This includes the philosophy and concepts of quality assurance, along with a detailed assessment of the sources of uncertainty in a monitoring program. The role management must play for a successful program is also discussed, and the quality assurance program implemented at Oak Ridge National Laboratory is presented

  1. Master schedule for CY-1978. Hanford Environmental Surveillance Routine Program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Myers, D.A.; Fix, J.J.

    1977-12-01

    This report provides the current schedule of data collection for the routine environmental surveillance program at the Hanford Site. No results are presented in this report. The data collected are available in routine reports issued by the Environmental Evaluations staff

  2. Master schedule for CY-1981 Hanford environmental surveillance routine program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Sula, M.J.; Eddy, P.A.

    1980-12-01

    The current schedule of data collection for the routine environmental surveillance program at the Hanford Site is provided. Questions about specific entries should be referred to the authors since modifications to the schedule are made during the year and special areas of study, usually of short duration, are not scheduled. The environmental surveillance program objectives are to evaluate the levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in Manual Chapter 0513, and to monitor Hanford operations for compliance with applicable environmental criteria given in Manual Chapter 0524 and Washington State Water Quality Standards. Air quality data obtained in a separate program are also reported. The collection schedule for potable water is shown but it is not part of the routine environmental surveillance program. Schedules are presented for the following subjects: air, Columbia River, sanitary water, surface water, ground water, foodstuffs, wildlife, soil and vegetation, external radiation measurement, portable instrument surveys, and surveillance of waste disposal sites

  3. A model surveillance program based on regulatory experience

    International Nuclear Information System (INIS)

    Conte, R.J.

    1980-01-01

    A model surveillance program is presented based on regulatory experience. The program consists of three phases: Program Delineation, Data Acquistion and Data Analysis. Each phase is described in terms of key quality assurance elements and some current philosophies is the United States Licensing Program. Other topics include the application of these ideas to test equipment used in the surveillance progam and audits of the established program. Program Delineation discusses the establishment of administrative controls for organization and the description of responsibilities using the 'Program Coordinator' concept, with assistance from Data Acquisition and Analysis Teams. Ideas regarding frequency of surveillance testing are also presented. The Data Acquisition Phase discusses various methods for acquiring data including operator observations, test procedures, operator logs, and computer output, for trending equipment performance. The Data Analysis Phase discusses the process for drawing conclusions regarding component/equipment service life, proper application, and generic problems through the use of trend analysis and failure rate data. (orig.)

  4. Master schedule for CY-1980 Hanford Environmental Surveillance Routine Program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Houston, J.R.; Eddy, P.A.

    1979-12-01

    The current schedule of data collection for the routine environmental surveillance program at the Hanford Site is presented. The enviromental surveillance program objectives are to evaluate the levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in Manual Chapter 0513, and to monitor Hanford operations for compliance with applicable environmental criteria given in Manual Chapter 0524 and Washington State Water Quality Standards. Data are reported on the following topics: air; Columbia River; sanitary water; surface water; ground water; foodstuffs; wildlife; soil and vegetation; external radiation measurement; portable instrument surveys; and surveillance of waste disposal sites;

  5. The analysis of reactor vessel surveillance program data

    International Nuclear Information System (INIS)

    Norris, E.B.

    1979-01-01

    Commercial nuclear power reactor vessel surveillance programs are provided by the reactor supplier and are designed to meet the requirements of ASTM Method E 185. (3). Each surveillance capsule contains sets of Charpy V-notch (Csub(v)) specimens representing selected materials from the vessel beltline region and some reference steel, tension test specimens machined from selected beltline materials, temperature monitors, and neutron flux dosimeters. Surveillance capsules may also contain fracture mechanics specimens machined from selected vessel beltline materials. The major steps in the conduct of a surveillance program include (1) the testing of the surveillance specimens to determine the exposure conditions at the capsule location and the resulting embrittlement of the vessel steel, (2) the extrapolation of the capsule results to the pressure vessel wall, and (3) the determination of the heatup and cooldown limits for normal, upset, and test operation. This paper will present data obtained from commercial light water reactor surveillance programs to illustrate the methods of analysis currently in use at Southwest Research Institute and to demonstrate some of the limitations imposed by the data available. Details concerning the procedures for testing the surveillance capsule specimens will not be included because they are considered to be outside of the scope of this paper

  6. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  7. CONSTITUTIONALITY AND LEGALITY OF NSA SURVEILLANCE PROGRAM

    Science.gov (United States)

    2013-12-01

    Committee Headquarters in what would eventually culminate as the Watergate Scandal . While the far reaching consequences of the Watergate scandal are...the Church Committee that investigated the Watergate Scandal , recommended the FBI be limited to only investigating “conduct rather than ideas or...TSP wiretapping scandal , the Bush Administration instead attempted to codify into law greater surveillance powers for intelligence agencies. When TSP

  8. Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

    Science.gov (United States)

    Butler, Stephen F; McNaughton, Emily C; Black, Ryan A; Cassidy, Theresa A

    2018-01-02

    Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. Estimates of abuse, unadjusted and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation. Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also appears to be abused less often by alternate ROAs (e.g., snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse. Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

  9. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

    Science.gov (United States)

    Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

    2017-09-01

    To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

  10. Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.

    Science.gov (United States)

    Takeuchi, Tsutomu; Ishida, Kota; Shiraki, Katsuhisa; Yoshiyasu, Takashi

    2018-01-01

    Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs. Safety and effectiveness populations included 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years. Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower compared with previously reported incidences after TAC treatment in PMS, and all of the observed ADRs were already known. A statistically significant improvement was observed in the primary effectiveness variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24. TAC is well tolerated and effective when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

  11. Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study.

    Science.gov (United States)

    Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Uno, Satoshi

    2018-02-01

    Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

  12. Master schedule for CY-1982 Hanford environmental surveillance routine program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Sula, M.J.; Eddy, P.A.

    1981-12-01

    This report provides the current schedule of data collection for the routine environmental surveillance program at the Hanford Site. The environmental surveillance program objectives are to evaluate and report the levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in DOE Order 5484.1. The routine sampling schedule provided does not include samples which are planned to be collected during FY-1982 in support of special studies or for quality control purposes. In addition, the routine program outlined in this schedule is subject to modification during the year in response to changes in Site operations, program requirements, or unusual sample results. Sampling schedules are presented for the following: air; Columbia River; sanitary water; surface water; ground water; foodstuffs; wildlife; soil and vegetation; external radiation measurements; portable instrument surveys; and surveillance of waste disposal sites

  13. Process monitoring using a Quality and Technical Surveillance Program

    International Nuclear Information System (INIS)

    Rafferty, C.A.

    1995-01-01

    The purpose of process monitoring using a Quality and Technical Surveillance Program was to help ensure manufactured clad vents sets fully met technical and quality requirements established by the manufacturer and the customer, and that line and program management were immediately alerted if any aspect of the manufacturing activities drifted out of acceptable limits. The Quality and Technical Surveillance Program provided a planned, scheduled approach to monitor key processes and documentation illuminated potential problem areas early enough to permit timely corrective actions to reverse negative trends that, if left uncorrected, could have resulted in deficient hardware. Significant schedule and cost impacts were eliminated

  14. Process monitoring using a quality and technical surveillance program

    International Nuclear Information System (INIS)

    Rafferty, C.A.

    1995-01-01

    The purpose of process monitoring using a quality and technical surveillance program was to help ensure that manufactured clad went sets fully met technical and quality requirements established by the manufacturer and the customer and that line and program management were immediately alerted if any aspect of the manufacturing activities drifted out of acceptable limits. The quality and technical surveillance program provided a planned, scheduled approach to monitor key processes and documentation and certification systems to prevent noncompliances or any manufacturing discrepancies. These surveillances illuminated potential problem areas early enough to permit timely corrective actions to reverse negative trends that, if left uncorrected, could have resulted in deficient hardware. Significant schedule and cost impacts were eliminated. copyright 1995 American Institute of Physics

  15. Quality-control activities of the Hanford Environmental Surveillance Program

    International Nuclear Information System (INIS)

    Price, K.R.; Jaquish, R.E.

    1982-01-01

    A comprehensive approach to quality control (QC) has been developed by the Pacific Northwest Laboratory for the Hanford Environmental Surveillance Program. The framework of quality control for the surveillance program has been documented in a QC implementation guide wherein QC requirements are specified and specific responsibilities and authorities are described. Subjects in the guide include the collection, analysis, and reporting of samples as well as equipment calibration and maintenance, training, audits, and record keeping. A QC file and library have been established to store pertinent documentation, records, and references for ready access

  16. Enhanced surveillance program FY97 accomplishments. Progress report

    Energy Technology Data Exchange (ETDEWEB)

    Mauzy, A. [ed.; Laake, B. [comp.

    1997-10-01

    This annual report is one volume of the Enhanced Surveillance Program (ESP) FY97 Accomplishments. The complete accomplishments report consists of 11 volumes. Volume 1 includes an ESP overview and a summary of selected unclassified FY97 program highlights. Volume 1 specifically targets a general audience, reflecting about half of the tasks conducted in FY97 and emphasizing key program accomplishments and contributions. The remaining volumes of the accomplishments report are classified, organized by program focus area, and present in technical detail the progress achieved in each of the 104 FY97 program tasks. Focus areas are as follows: pits; high explosives; organics; dynamics; diagnostics; systems; secondaries; nonnuclear materials; nonnuclear components; and Surveillance Test Program upgrades.

  17. 3013/9975 Surveillance Program Interim Summary Report

    Energy Technology Data Exchange (ETDEWEB)

    Dunn, K.; Hackney, B.; McClard, J.

    2011-06-22

    The K-Area Materials Storage (KAMS) Documented Safety Analysis (DSA) requires a surveillance program to monitor the safety performance of 3013 containers and 9975 shipping packages stored in KAMS. The SRS surveillance program [Reference 1] outlines activities for field surveillance and laboratory tests that demonstrate the packages meet the functional performance requirements described in the DSA. The SRS program also supports the complexwide Integrated Surveillance Program (ISP) [Reference 2] for 3013 containers. The purpose of this report is to provide a summary of the SRS portion of the surveillance program activities through fiscal year 2010 (FY10) and formally communicate the interpretation of these results by the Surveillance Program Authority (SPA). Surveillance for the initial 3013 container random sampling of the Innocuous bin and the Pressure bin has been completed and there has been no indication of corrosion or significant pressurization. The maximum pressure observed was less than 50 psig, which is well below the design pressure of 699 psig for the 3013 container [Reference 3]. The data collected during surveillance of these bins has been evaluated by the Materials Identification and Surveillance (MIS) Working Group and no additional surveillance is necessary for these bins at least through FY13. A decision will be made whether additional surveillance of these bins is needed during future years of storage and as additional containers are generated. Based on the data collected to date, the SPA concludes that 3013 containers in these bins can continue to be safely stored in KAMS. This year, 13 destructive examinations (DE) were performed on random samples from the Pressure & Corrosion bin. To date, DE has been completed for approximately 30% of the random samples from the Pressure & Corrosion bin. In addition, DE has been performed on 6 engineering judgment (EJ) containers, for a total of 17 to date. This includes one container that exceeded the 3013

  18. 3013/9975 Surveillance Program Interim Summary Report

    International Nuclear Information System (INIS)

    Dunn, K.; Hackney, B.; McClard, J.

    2011-01-01

    The K-Area Materials Storage (KAMS) Documented Safety Analysis (DSA) requires a surveillance program to monitor the safety performance of 3013 containers and 9975 shipping packages stored in KAMS. The SRS surveillance program (Reference 1) outlines activities for field surveillance and laboratory tests that demonstrate the packages meet the functional performance requirements described in the DSA. The SRS program also supports the complexwide Integrated Surveillance Program (ISP) (Reference 2) for 3013 containers. The purpose of this report is to provide a summary of the SRS portion of the surveillance program activities through fiscal year 2010 (FY10) and formally communicate the interpretation of these results by the Surveillance Program Authority (SPA). Surveillance for the initial 3013 container random sampling of the Innocuous bin and the Pressure bin has been completed and there has been no indication of corrosion or significant pressurization. The maximum pressure observed was less than 50 psig, which is well below the design pressure of 699 psig for the 3013 container (Reference 3). The data collected during surveillance of these bins has been evaluated by the Materials Identification and Surveillance (MIS) Working Group and no additional surveillance is necessary for these bins at least through FY13. A decision will be made whether additional surveillance of these bins is needed during future years of storage and as additional containers are generated. Based on the data collected to date, the SPA concludes that 3013 containers in these bins can continue to be safely stored in KAMS. This year, 13 destructive examinations (DE) were performed on random samples from the Pressure and Corrosion bin. To date, DE has been completed for approximately 30% of the random samples from the Pressure and Corrosion bin. In addition, DE has been performed on 6 engineering judgment (EJ) containers, for a total of 17 to date. This includes one container that exceeded the 3013

  19. LWR-PV Surveillance Dosimetry Improvement Program review graphics

    International Nuclear Information System (INIS)

    McElroy, W.N.; Gold, R.; Gutherie, G.L.

    1979-10-01

    A primary objective of the multilaboratory program is to prepare an updated and improved set of dosimetry, damage correlation, and the associated reactor analysis ASTM standards for LWR-PV irradiation surveillance programs. Supporting this objective are a series of analytical and experimental validation and calibration studies in Benchmark Neutron Fields, reactor Test Regions, and operating power reactor Surveillance Positions. These studies will establish and certify the precision and accuracy of the measurement and predictive methods which are recommended for use in these standards. Consistent and accurate measurement and data analysis techniques and methods, therefore, will have been developed and validated along with guidelines for required neutron field calculations that are used to (1) correlate changes in material properties with the characteristics of the neutron radiation field and (2) predict pressure vessel steel toughness and embrittlement from power reactor surveillance data

  20. Targeted surveillance for postnatal hearing loss: a program evaluation.

    Science.gov (United States)

    Beswick, Rachael; Driscoll, Carlie; Kei, Joseph; Glennon, Shirley

    2012-07-01

    The importance of monitoring hearing throughout early childhood cannot be understated. However, there is a lack of evidence available regarding the most effective method of monitoring hearing following the newborn screen. The goal of this study was to describe a targeted surveillance program using a risk factor registry to identify children with a postnatal hearing loss. All children who were born in Queensland, Australia between September 2004 and December 2009, received a bilateral 'pass' on newborn hearing screening, and had at least one risk factor, were referred for targeted surveillance and were included in this study. The cohort was assessed throughout early childhood in accordance with Queensland's diagnostic assessment protocols. During the study period, 7320 (2.8% of 261,328) children were referred for targeted surveillance, of which 56 were identified with a postnatal hearing loss (0.77%). Of these, half (50.0%) were identified with a mild hearing loss, and 64.3% were identified with a sensorineural hearing loss. In regards to risk factors, syndrome, craniofacial anomalies, and severe asphyxia had the highest yield of positive cases of postnatal hearing loss for children referred for targeted surveillance, whereas, low birth weight, bacterial meningitis, and professional concern had a particularly low yield. Limitations of the targeted surveillance program were noted and include: (1) a lost contact rate of 32.4%; (2) delays in first surveillance assessment; (3) a large number of children who required on-going monitoring; and (4) extensive diagnostic assessments were completed on children with normal hearing. Examination of the lost contact rate revealed indigenous children were more likely to be documented as lost contact. In addition, children with one risk factor only were significantly more likely to not attend a surveillance appointment. Positive cases of postnatal hearing loss were detected through the targeted surveillance program. However, the

  1. Master schedule for CY-1979 Hanford environmental surveillance routine program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Houston, J.R.; Eddy, P.A.

    1978-12-01

    The current schedule of data collection for the routine environmental surveillance program at the Hanford Site, as conducted by the Environmental Evaluation Section of Battelle, Pacific Northwest Laboratory for the Department of Energy (DOE), is given. Modifications to the schedule are made during the year and special areas of study, usually of short duration, are not scheduled. The environmental surveillance program objectives are to evaluate the levels of radioactive and nonradioactive pollutants in the Hanford environs, and to monitor Hanford operations for compliance with applicable environmental criteria and Washington State Water Quality Standards. Air quality data are obtained in a separate program administered by the Hanford Environmental Health Foundation. The collection schedule for potable water is shown but it is not part of the routine environmental surveillance program. Water quality data for Hanford Site potable water systems are published each year by the Hanford Environmental Health Foundation. The data collected are available in routine reports issued by the Environmental Evaluations staff. Groundwater data and evaluation are reported in the series, ''Radiological Status of the Groundwater Beneath the Hanford Project for...,'' the latest issue being PNL-2624 for CY-1977. Data from locations within the plant boundaries are presented in the annual ''Environmental Status of the Hanford Site for...'' report series, the most recent report being PNL-2677 for 1977. Data from offsite locations are presented in the annual ''Environmental Surveillance at Hanford for...'' series of reports, the latest being PNL-2614 for 1977

  2. Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

    Science.gov (United States)

    Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2018-01-01

    To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  3. Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

    Science.gov (United States)

    Won, Ji Eon; Chu, Ji Yeon; Choi, Hyunah Caroline; Chen, Yun; Park, Hyun Jun; Dueñas, Héctor José

    2018-05-01

    The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (peffective in Korean men with BPH/LUTS in a real-world clinical setting. Copyright © 2018 Korean Society for Sexual Medicine and Andrology.

  4. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    Science.gov (United States)

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  6. Materials surveillance program for C-E NSSS reactor vessels

    International Nuclear Information System (INIS)

    Koziol, J.J.

    1977-01-01

    Irradiation surveillance programs for light water NSSS reactor vessels provide the means by which the utility can assess the extent of neutron-induced changes in the reactor vessel materials. These programs are conducted to verify, by direct measurement, the conservatism in the predicted radiation-induced changes and hence the operational parameters (i.e., heat-up, cooldown, and pressurization rates). In addition, such programs provide assurance that the scheduled adjustments in the operational parameters are made with ample margin for safe operation of the plant. During the past 3 years, several documents have been promulgated establishing the criteria for determining both the initial properties of the reactor vessel materials as well as measurement of changes in these initial properties as a result of irradiation. These documents, ASTM E-185-73, ''Recommended Practice for Surveillance Tests for Nuclear Reactor Vessels,'' and Appendix H to 10 CFR 50, ''Reactor Vessel Material Surveillance Program Requirements,'' are complementary to each other. They are the result of a change in the basic philosophy regarding the design and analysis of reactor vessels. In effect, the empirical ''transition temperature approach,'' which was used for design, was replaced by the ''analytical fracture mechanics approach.'' The implementation of this technique was described in Welding Research Council Bulletin 1975 and Appendix G to ASME Code Section III. Further definition of requirements appears in Appendix G to 10 CFR 50 published in July 1973. It is the intent of this paper to describe (1) a typical materials surveillance program for the reactor vessel of a Combustion Engineering NSSS, and (2) how the results of such programs, as well as experimental programs provide feed-back for improvement of materials to enhance their radiation resistance and thereby further improve the safety and reliability of future plants. (author)

  7. Extending cluster lot quality assurance sampling designs for surveillance programs.

    Science.gov (United States)

    Hund, Lauren; Pagano, Marcello

    2014-07-20

    Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

  8. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax in the Vaccine Adverse Event Reporting System (VAERS in the United States, 1990‒2015.

    Directory of Open Access Journals (Sweden)

    Pedro L Moro

    2016-07-01

    Full Text Available In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur, was licensed for use in the United States.To assess adverse events (AEs after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS, a spontaneous reporting surveillance system.We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness, and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS. Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB data mining was used to identify disproportional AE reporting after HDCV.VAERS received 1,611 reports after HDCV; 93 (5.8% were serious. Among all reports, the three most common AEs included pyrexia (18.2%, headache (17.9%, and nausea (16.5%. Among serious reports, four deaths appeared to be unrelated to vaccination.This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

  9. Surveillance

    DEFF Research Database (Denmark)

    Albrechtslund, Anders; Coeckelbergh, Mark; Matzner, Tobias

    Studying surveillance involves raising questions about the very nature of concepts such as information, technology, identity, space and power. Besides the maybe all too obvious ethical issues often discussed with regard to surveillance, there are several other angles and approaches that we should...... like to encourage. Therefore, our panel will focus on the philosophical, yet non-ethical issues of surveillance in order to stimulate an intense debate with the audience on the ethical implications of our enquiries. We also hope to provide a broader and deeper understanding of surveillance....

  10. Safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension: a sub-group analysis based on Japan post-marketing surveillance.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Suzuki, Nahoko; Murakami, Masahiro

    2017-12-01

    To evaluate the long-term safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This is an observational surveillance of PAH patients receiving tadalafil in the contracted sites. A sub-group analysis was performed of 391 pediatric PAH patients (Effectiveness measurements included change in World Health Organization (WHO) functional classification of PAH, cardiac catheterization (pulmonary arterial pressure: PAP), and echocardiography (tricuspid regurgitation pressure gradient: TRPG). Survival rate was also measured. The mean patient age was 5.7 ± 5.34 years. Associated PAH (APAH) and idiopathic PAH (IPAH) accounted for 76.0% and 17.6%, respectively, of the PAH patients. Patients were followed for up to 2 years. Among 391 patients analyzed for safety, the overall incidence rate of ADRs was 16.6%. The common ADRs (≥ 1%) were headache (2.8%), hepatic function abnormal, platelet count decreased (1.3% each), and epistaxis, (1.0%). Eleven patients (2.8%) reported 16 SADRs. Three patients died secondary to SADRs. For the effectiveness analysis, the incidence of WHO functional class improvement at 3 months, 1 year, and 2 years after the initiation of tadalafil and last observation in pediatric patients were 16.5%, 19.7%, and 16.3%, respectively. Both PAP and TRPG showed a statistically significant reduction at last observation. This manuscript reveals the use of tadalafil in the real-world pediatric population with an acceptable safety profile in Japan.

  11. Sustainable Monitoring and Surveillance Systems to Improve HIV Programs: Review.

    Science.gov (United States)

    Low-Beer, Daniel; Mahy, Mary; Renaud, Francoise; Calleja, Txema

    2018-04-24

    HIV programs have provided a major impetus for investments in surveillance data, with 5-10% of HIV program budgets recommended to support data. However there are questions concerning the sustainability of these investments. The Sustainable Development Goals have consolidated health into one goal and communicable diseases into one target (Target 3.3). Sustainable Development Goals now introduce targets focused specifically on data (Targets 17.18 and 17.19). Data are seen as one of the three systemic issues (in Goal 17) for implementing Sustainable Development Goals, alongside policies and partnerships. This paper reviews the surveillance priorities in the context of the Sustainable Development Goals and highlights the shift from periodic measurement towards sustainable disaggregated, real-time, case, and patient data, which are used routinely to improve programs. Finally, the key directions in developing person-centered monitoring systems are assessed with country examples. The directions contribute to the Sustainable Development Goal focus on people-centered development applied to data. ©Daniel Low-Beer, Mary Mahy, Francoise Renaud, Txema Calleja. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 24.04.2018.

  12. Tenaga Nasional Berhad dam safety and surveillance program

    International Nuclear Information System (INIS)

    Jansen Luis; Zulkhairi Abd Talib

    2006-01-01

    This paper discusses the current practice of dam surveillance, which includes dam monitoring which is a process of visual inspections, measuring, processing, compiling and analyzing dam instrumentation data to determine the performance of a dam. The prime objective of the dam surveillance system is to ensure that any occurrence and development of safety deficiencies and problems are quickly detected, identified, analyzed and the required remedial actions are determined and consequently carried out in due time. In brief, the section is responsible to ensure that the dam monitoring and surveillance works are implemented as per scheduled and in accordance with the requirement and guidelines prepared by the dam designers and in accordance with international commission on large dams, ICOLD. The paper also illustrates and recommends an alternative approach for dam surveillance program using risk management approach, which is currently being actively adopted by some countries like USA, Canada, Australia and etc, towards improving the dam safety management and the decision making process. The approach provides a wider area of opportunity, improvements and benefits particular in the evaluation and modifications to the dam performance and safety. The process provides an effective and efficient tool for the decision makers and engineers through a comprehensive evaluation and a good understanding of the hazards, risks and consequences in relation to dam safety investigations. (Author)

  13. Monitoring activities review of the Radiological Environmental Surveillance Program

    International Nuclear Information System (INIS)

    Ritter, P.D.

    1992-03-01

    The 1992 Monitoring Activities Review (MAR) is directed at the Radiological Environment Surveillance Program (RESP) activities at the Radioactive Waste Management Complex (RWMC) of Idaho Engineering Laboratory (INEL). MAR panelists studied RESP documents and discussed their concerns with Environmental Monitoring Unit (EMU) staff and other panel members. These concerns were subsequently consolidated into a collection of recommendations with supporting discussions. Recommendations focus on specific monitoring activities, as well as the overall program. The MAR report also contains pertinent comments that should not require further action

  14. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology.

    Science.gov (United States)

    Bühler, Klaus; Naether, Olaf G J; Bilger, Wilma

    2014-01-14

    Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) both have a role to play in follicular development during the natural menstrual cycle. LH supplementation during controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is used for patients with hypogonadotropic hypogonadism. However, the use of exogenous LH in COS in normogonadotropic women undergoing ART is the subject of debate. The aim of this study was to investigate characteristics of infertile women who received the 2:1 formulation of follitropin alfa and lutropin alfa (indicated for stimulation of follicular development in women with severe LH and FSH deficiency) in German clinical practice. A 3-year, multicentre, open-label, observational/non-interventional, post-marketing surveillance study of women (21-45 years) undergoing ART. Primary endpoint: reason for prescribing the 2:1 formulation of follitropin alfa and lutropin alfa. Secondary variables included: COS duration/dose; oocytes retrieved; fertilization; clinical pregnancy; ovarian hyperstimulation syndrome (OHSS). In total, 2220 cycles were assessed; at least one reason for prescribing the 2:1 formulation was given in 1834/2220 (82.6%) cycles. Most common reasons were: poor ovarian response (POR) (39.4%), low baseline LH (17.8%), and age (13.8%). COS: mean dose of the 2:1 formulation on first day, 183.1/91.5 IU; mean duration, 10.8 days. In 2173/2220 (97.9%) cycles, human chorionic gonadotrophin was administered. Oocyte pick-up (OPU) was attempted in 2108/2220 (95.0%) cycles; mean (standard deviation) 8.0 (5.4) oocytes retrieved/OPU cycle. Fertilization (≥1 oocyte fertilized) rates: in vitro fertilization (IVF), 391/439 (89.1%) cycles; intracytoplasmic sperm injection (ICSI)/IVF + ICSI, 1524/1613 (94.5%) cycles. Clinical pregnancy rate: all cycles, 25.9%; embryo transfer cycles, 31.3%. OHSS: hospitalization for OHSS, 8 (0.36%) cycles, Grade 2, 60 (2.7%), and Grade 3, 1 (0.05%). In German routine clinical

  15. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

    Science.gov (United States)

    Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L; Baux, Ana Cebrian; Džavík, Vladimír; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen

    2011-03-29

    The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  16. Surveillance and in-service inspection (SISI) program at FFTF

    International Nuclear Information System (INIS)

    Conrads, T.J.

    1980-01-01

    Assurance of the integrity of the sodium coolant pressure boundaries of the Fast Flux Test Facility systems and components is essential for safe operation. A program has been developed to monitor the integrity of the coolant boundaries and certain plant conditions. Specific equipment and features have been designed into the plant for monitoring. The purpose of SISI is to prevent failures or minimize their consequences through early detection. The program which administers the requirements for monitoring applicable plant conditions whose integrity is necessary to protect public health and safety is known as the Surveillance and In-service Inspection (SISI) Program. The SISI program utilizes a wide range of monitoring techniques to ensure that material degradation or structural deficiencies will not result in the loss of the ability to shut down the reactor, cool the reactor core, or cause the release of radioactive material to the environment

  17. Regional surveillance program for the detection of fatal infant abuse

    International Nuclear Information System (INIS)

    Kleinman, P.K.; Blackbourne, B.D.; Marks, S.C.; Adams, V.I.; Karellas, A.

    1987-01-01

    From 1984 to 1986, a regional surveillance program for the detection of infant abuse was carried out. Infants dying of uncertain cause were studied with a protocol designed to identify possible cases of infant abuse. At autopsy, resection of selected osseous material was performed, followed by meticulous specimen radiography and histopathologic analysis. Characteristic injuries involving the metaphyses, posterior rib arcs and spine, as well as less specific fractures of the long bone shafts and clavicles, were identified in eight abused infants. The authors believe that this multidisciplinary approach to unexplained infant death enhances detection of abuse and provides valuable documentary evidence for criminal prosecution

  18. N-CDAD in Canada: Results of the Canadian Nosocomial Infection Surveillance Program 1997 N-CDAD Prevalence Surveillance Project

    Directory of Open Access Journals (Sweden)

    Meaghen Hyland

    2001-01-01

    Full Text Available BACKGROUND: A 1996 preproject survey among Canadian Hospital Epidemiology Committee (CHEC sites revealed variations in the prevention, detection, management and surveillance of Clostridium difficile-associated diarrhea (CDAD. Facilities wanted to establish national rates of nosocomially acquired CDAD (N-CDAD to understand the impact of control or prevention measures, and the burden of N-CDAD on health care resources. The CHEC, in collaboration with the Laboratory Centre for Disease Control (Health Canada and under the Canadian Nosocomial Infection Surveillance Program, undertook a prevalence surveillance project among selected hospitals throughout Canada.

  19. SRS environmental air surveillance program 1954-2015: General trends

    Energy Technology Data Exchange (ETDEWEB)

    Abbott, K. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL); Jannik, T. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

    2016-06-02

    The radiological monitoring program at SRS was established under the DuPont Company in June 1951 and was used as a measurement of the effectiveness of plant controls and as an authoritative record of environmental conditions surrounding the plant. It also served as a method of demonstrating compliance with applicable federal regulations and guidance. This document serves as a general summary of changes made specifically to the environmental air monitoring program since its inception, and a discussion of the general trends seen in the air monitoring program at SRS from 1954 to 2015. Initially, the environmental air surveillance program focused not only on releases from SRS but also on fallout from various weapons testing performed through the end of 1978. Flypaper was used to measure the amount of fallout in the atmosphere during this period, and was present at each of the 10 monitoring stations. By 1959, all site stacks were included in the air monitoring program to determine their contribution to the airborne radioactivity onsite, and the number of air surveillance samplers rose to 18. This trend of an increased number of sampling locations continued to a peak of 35 sampling locations before shifting to a downward trend in the mid-1990s. In 1962, 4 outer-range samplers were placed in Savannah and Macon, GA, and in Greenville and Columbia, SC. Until 1976, air samplers were simply placed around the perimeter of the various operation locations (after 1959, this included stacks to determine their contribution to the airborne radioactivity), with the intent of creating as representative a distribution as possible of the air surrounding operations.

  20. Registries in European post-marketing surveillance

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim

    2017-01-01

    at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. METHODS: European Public Assessment Reports were consulted to identify products for which a request...

  1. An evaluation of the Australian Rotavirus Surveillance Program.

    Science.gov (United States)

    Roberts-Witteveen, April R; Patel, Mahomed S; Roche, Paul W

    2008-09-01

    The Australian Rotavirus Serotyping Program (ARSP) serotypes rotavirus isolates obtained from stool samples sent from Australian laboratories. In collaboration with ARSP the Australian Government Department of Health and Ageing evaluated the program for its utility and capacity to monitor effectiveness of the rotavirus vaccines recently introduced into the Australian National Immunisation Program. The system was described using ARSP annual reports and staff interviews. The attributes of the system were assessed by adapting standard guidelines for evaluating a surveillance system. Email surveys or face to face interviews were conducted with staff of ARSP, participating laboratories, rotavirus vaccine manufacturing companies and representatives of the Communicable Diseases Network Australia. The ability of the ARSP to monitor changes in rotavirus serotype epidemiology was assessed. ARSP serotypes rotavirus isolates received from participating laboratories at least bi-annually, with results being reported at least as often. Serotype analyses have informed formulation of rotavirus vaccines and contributed to forecasting the extent of outbreaks caused by novel serotypes. The ARSP will be able to monitor changes in rotavirus serotype epidemiology and identify probable vaccination failures. Enhancement of the representativeness and sensitivity of the system are needed for the data to remain useful in the public health context. Methods for transferring data between the program and state and territory health departments need to be developed.

  2. Regulatory standards applicable or relevant to the independent Hanford environmental surveillance and oversight program

    International Nuclear Information System (INIS)

    King, S.E.; Hendrickson, P.L.; Siegel, M.R.; Woodruff, M.G.; Belfiglio, J.; Elliott, R.W.

    1990-03-01

    The authors reviewed federal and state statutes and regulations, as well as Department of Energy (DOE) orders and other guidance material, for potential applicability to the environmental surveillance program conducted for the Hanford site by the Pacific Northwest Laboratory (PNL). There are no federal or state statutes or regulations which are directly applicable to the environmental surveillance program. However, other regulatory schemes, while not directly applicable to the environmental surveillance program, are important insofar as they are indicative of regulatory concern and direction. Because of the evolving nature of environmental regulations, this area needs to be closely monitored for future impact on environmental surveillance activities. 9 refs.,

  3. Decision support methods for the detection of adverse events in post-marketing data.

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  4. 2003 Long-Term Surveillance and Maintenance Program Report

    International Nuclear Information System (INIS)

    2004-01-01

    are part of long-term site management. In response to post-closure care requirements set forth in UMTRCA, DOE Headquarters established the Long-Term Surveillance and Maintenance (LTS&M) Program in 1988 at the DOE office in Grand Junction, Colorado. The program assumed long-term management responsibility for sites remediated under UMTRCA and other programs. Since its inception, the LTS&M Program has evolved in response to changing stakeholder needs, improvements in technology, and the addition of more DOE sites as remediation is completed. The mission of the LTS&M Program was to fulfill DOE's responsibility to implement all activities necessary to ensure regulatory compliance and to protect the public and the environment from long-lived wastes associated with the nation's nuclear energy, weapons, and research activities. Key components of the LTS&M Program included stakeholder participation, site monitoring and maintenance, records and information management, and research and technology transfer. This report presents summaries of activities conducted in 2003 in fulfillment of the LTS&M Program mission. On December 15, 2003, DOE established the Office of Legacy Management (LM) to allow for optimum management of DOE's legacy responsibilities. Offices are located in Washington, DC, Grand Junction, Colorado, Morgantown, West Virginia, and Pittsburgh, Pennsylvania, to perform long-term site management, land management, site transition support, records management, and other related tasks. All activities formerly conducted under the LTS&M Program have been incorporated into the Office of Land and Site Management (LM-50), as well as management of remedies involving ground water and surface water contaminated by former processing activities

  5. 2003 Long-Term Surveillance and Maintenance Program Report

    Energy Technology Data Exchange (ETDEWEB)

    None

    2004-07-01

    are part of long-term site management. In response to post-closure care requirements set forth in UMTRCA, DOE Headquarters established the Long-Term Surveillance and Maintenance (LTS&M) Program in 1988 at the DOE office in Grand Junction, Colorado. The program assumed long-term management responsibility for sites remediated under UMTRCA and other programs. Since its inception, the LTS&M Program has evolved in response to changing stakeholder needs, improvements in technology, and the addition of more DOE sites as remediation is completed. The mission of the LTS&M Program was to fulfill DOE’s responsibility to implement all activities necessary to ensure regulatory compliance and to protect the public and the environment from long-lived wastes associated with the nation’s nuclear energy, weapons, and research activities. Key components of the LTS&M Program included stakeholder participation, site monitoring and maintenance, records and information management, and research and technology transfer. This report presents summaries of activities conducted in 2003 in fulfillment of the LTS&M Program mission. On December 15, 2003, DOE established the Office of Legacy Management (LM) to allow for optimum management of DOE’s legacy responsibilities. Offices are located in Washington, DC, Grand Junction, Colorado, Morgantown, West Virginia, and Pittsburgh, Pennsylvania, to perform long-term site management, land management, site transition support, records management, and other related tasks. All activities formerly conducted under the LTS&M Program have been incorporated into the Office of Land and Site Management (LM–50), as well as management of remedies involving ground water and surface water contaminated by former processing activities.

  6. Impact of a surgical site infection (SSI) surveillance program in orthopedics and traumatology.

    Science.gov (United States)

    Mabit, C; Marcheix, P S; Mounier, M; Dijoux, P; Pestourie, N; Bonnevialle, P; Bonnomet, F

    2012-10-01

    Surveillance of surgical site infections (SSI) is a priority. One of the fundamental principles for the surveillance of SSI is based on receiving effective field feedback (retro-information). The aim of this study was to report the results of a program of SSI surveillance and validate the hypothesis that there is a correlation between creating a SSI surveillance program and a reduction in SSI. The protocol was based on the weekly collection of surveillance data obtained directly from the different information systems in different departments. A delay of 3 months was established before extraction and analysis of data and information from the surgical teams. The NNIS index (National Nosocomial Infections Surveillance System) developed by the American surveillance system and the reduction of length of hospital stay index Journées d'hospitalisation évitées (JHE). Since the end of 2009, 7156 surgical procedures were evaluated (rate of inclusion 97.3%), and 84 SSI were registered with a significant decrease over time from 1.86% to 0.66%. A total of 418 days of hospitalization have been saved since the beginning of the surveillance system. Our surveillance system has three strong points: follow-up is continuous, specifically adapted to orthopedic traumatology and nearly exhaustive. The extraction of data directly from hospital information systems effectively improves the collection of data on surgical procedures. The implementation of a SSI surveillance protocol reduces SSI. Level III. Prospective study. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  7. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

    Science.gov (United States)

    Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

    2016-05-01

    Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

  8. Environmental surveillance program. Quarterly progress report, July--September, 1993

    International Nuclear Information System (INIS)

    Walker, D.W.; Hall, L.F.; Downs, J.

    1996-01-01

    This report contains data developed from monitoring site measurements and laboratory analyses of environmental samples that were collected during the period of July-September, 1993. Because some laboratory procedures are lengthy and could adversely affect the desired timeliness of reports, results of some analyses from this time period will be included in the next quarterly report. Quarterly reports, then, will be routine periodic documents that present continually updated information concerning the potential presence of environmental contaminants in the vicinity of the Idaho National Engineering Laboratory (INEL). During the third calendar quarter of 1993, Environmental Surveillance Program (ESP) measurements did not reveal unexpected levels of contaminants in any environmental samples measured or analyzed. Most of the results reported in this document are related to off-site air and ground water measurements. Future reports will include results of monitoring at additional locations and for additional environmental materials. Annual reports from the ESP will contain data generated during the previous four calendar quarters, and will display measurement trends for various combinations of locations, contaminants and environmental media. The annual report will also include more interpretive material and discussions than will normally be found in quarterly reports

  9. Outcomes of an Enhanced Surveillance Program for Carbapenem-Resistant Enterobacteriaceae

    OpenAIRE

    Fitzpatrick, Margaret; Zembower, Teresa; Malczynski, Michael; Qi, Chao; Bolon, Maureen K.

    2014-01-01

    Optimal surveillance strategies for identifying patients colonized with and at risk for transmitting carbapenem-resistant Enterobacteriaceae (CRE) are urgently needed. We instituted an enhanced surveillance program for CRE that identified unrecognized CRE-colonized patients but failed to identify possible CRE transmissions. We also identified risk factors associated with transmitting CRE.

  10. 21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What are my responsibilities once I am notified that I am required to conduct postmarket surveillance? 822.24 Section 822.24 Food and Drugs FOOD AND... SURVEILLANCE Responsibilities of Manufacturers § 822.24 What are my responsibilities once I am notified that I...

  11. Linezolid Surveillance Results for the United States (LEADER Surveillance Program 2014).

    Science.gov (United States)

    Flamm, Robert K; Mendes, Rodrigo E; Hogan, Patricia A; Streit, Jennifer M; Ross, James E; Jones, Ronald N

    2016-04-01

    Thelinezolidexperience andaccuratedetermination ofresistance (LEADER) surveillance program has monitored linezolid activity, spectrum, and resistance since 2004. In 2014, a total of 6,865 Gram-positive pathogens from 60 medical centers from 36 states were submitted. The organism groups evaluated wereStaphylococcus aureus(3,106), coagulase-negative staphylococci (CoNS; 797), enterococci (855),Streptococcus pneumoniae(874), viridans group streptococci (359), and beta-hemolytic streptococci (874). Susceptibility testing was performed by reference broth microdilution at the monitoring laboratory. Linezolid-resistant isolates were confirmed by repeat testing. PCR and sequencing were performed to detect mutations in 23S rRNA, L3, L4, and L22 proteins and acquired genes (cfrandoptrA). The MIC50/90forStaphylococcus aureuswas 1/1 μg/ml, with 47.2% of isolates being methicillin-resistantStaphylococcus aureus Linezolid was active against allStreptococcus pneumoniaestrains and beta-hemolytic streptococci with a MIC50/90of 1/1 μg/ml and against viridans group streptococci with a MIC50/90of 0.5/1 μg/ml. Among the linezolid-nonsusceptible MRSA strains, one strain harboredcfronly (MIC, 4 μg/ml), one harbored G2576T (MIC, 8 μg/ml), and one containedcfrand G2576T with L3 changes (MIC, ≥8 μg/ml). Among CoNS, 0.75% (six isolates) of all strains demonstrated linezolid MIC results of ≥4 μg/ml. Five of these were identified asStaphylococcus epidermidis, four of which containedcfrin addition to the presence of mutations in the ribosomal proteins L3 and L4, alone or in combination with 23S rRNA (G2576T) mutations. Six enterococci (0.7%) were linezolid nonsusceptible (≥4 μg/ml; five with G2576T mutations, including one with an additionalcfrgene, and one strain withoptrAonly). Linezolid demonstrated excellent activity and a sustained susceptibility rate of 99.78% overall. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  12. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

    Science.gov (United States)

    Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

    2015-01-01

    Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

  13. [A review on the advancement of internet-based public health surveillance program].

    Science.gov (United States)

    Zhao, Y Q; Ma, W J

    2017-02-10

    Internet data is introduced into public health arena under the features of fast updating and tremendous volume. Mining and analyzing internet data, researchers can model the internet-based surveillance system to assess the distribution of health-related events. There are two main types of internet-based surveillance systems, i.e. active and passive, which are distinguished by the sources of information. Through passive surveillance system, information is collected from search engine and social media while the active system gathers information through provision of the volunteers. Except for serving as a real-time and convenient complementary approach to traditional disease, food safety and adverse drug reaction surveillance program, Internet-based surveillance system can also play a role in health-related behavior surveillance and policy evaluation. Although several techniques have been applied to filter information, the accuracy of internet-based surveillance system is still bothered by the false positive information. In this article, we have summarized the development and application of internet-based surveillance system in public health to provide reference for a better surveillance program in China.

  14. Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

    OpenAIRE

    Hund, Lauren; Pagano, Marcello

    2014-01-01

    Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than ...

  15. Active epidemiological surveillance in the program of poliomyelitis eradication in Serbia

    Directory of Open Access Journals (Sweden)

    Jevremović Ivana

    2002-01-01

    Full Text Available The main strategy of the worldwide Program of Poliomyelitis Eradication is based on immunization with oral poliovirus vaccine and active epidemiological surveillance aimed to demonstrate the absence of wild poliovirus circulation. The specification of the surveillance in the program, reporting and investigation of certain syndrome – the acute flaccid paralysis - as a specific feature of surveillance of poliomyelitis, is a new experience both for clinicians and epidemiologists. Along with the achieved results, problems in conducting the active epidemiological surveillance in Serbia, applied measures, and suggestions for improving its quality were presented. This experience might help in implementing the active surveillance for some other diseases that could be prevented by vaccine immunization.

  16. Identifying risk factors for brain metastasis in breast cancer patients: Implication for a vigorous surveillance program

    Directory of Open Access Journals (Sweden)

    Lorraine Chow

    2015-10-01

    Conclusion: Chinese breast cancer patients with brain metastasis were more likely to have high-grade tumors and negative estrogen receptor status. A more vigorous surveillance program for the central nervous system should be considered for this group of patients.

  17. Process Evaluation of a Workers' Health Surveillance Program for Meat Processing Workers

    NARCIS (Netherlands)

    van Holland, Berry J; Brouwer, Sandra; de Boer, Michiel R; Reneman, Michiel F; Soer, Remko

    2017-01-01

    Objective To evaluate the implementation process of a workers' health surveillance (WHS) program in a Dutch meat processing company. Methods Workers from five plants were eligible to participate in the WHS program. The program consisted of four evaluative components and an intervention component.

  18. Process Evaluation of a Workers' Health Surveillance Program for Meat Processing Workers

    NARCIS (Netherlands)

    van Holland, Berry; Brouwer, Sandra; de Boer, Michiel R; Reneman, Michiel F; Soer, Remko

    Objective To evaluate the implementation process of a workers' health surveillance (WHS) program in a Dutch meat processing company. Methods Workers from five plants were eligible to participate in the WHS program. The program consisted of four evaluative components and an intervention component.

  19. State of the reactor vessel surveillance programs in Korea and foreign countries

    International Nuclear Information System (INIS)

    Kim, Jeong Kyu; Hwang, Jong Keun; Park, Keon Woo; Kim, Bum Sik; Jeong, Kyung Hoon

    1996-06-01

    ASTM standards are dominating all over the world in the field of the reactor vessel surveillance program. They are mainly used directly or that the national standards in use correspond quite well with ASTM. According to, however, increasing concerns about the protection of environment and safety of nuclear plant, various approaches to establish and reinforce the national standards are made actively in Europe. In addition, some methods to share the nuclear data by integrating the existing test, analysis procedures and units system are considered. For nuclear plants in Korea, MOST Notice No. 92-20 should be applied for all PWRs after UCN units 3 and 4 since it was promulgated at Dec. 1992. The notice almost reflects the contents of ASTM E 185. But, the notice has much to be desired to provide the technical back-ground for reactor vessel surveillance program because it is not a standard such as ASTM or ASME code but regulation such as CFR or RG. Several Korean Standards are also used in limited area of the surveillance program. Therefore, practical requirements and rules for surveillance program are in accordance with the ASTM and CFR. In this report, the state of application of the standards to the surveillance program in Korea and Europe are reviewed and their national standards re compared with US standards or regulations. Current level and the future prospect of surveillance technology for PWR vessel are discussed at this point of view. 15 tabs., 12 figs., 38 refs. (Author)

  20. FINAL REPORT FORMER RADIATION WORKER MEDICAL SURVEILLANCE PROGRAM AT ROCKY FLATS For Department of Energy Programs

    Energy Technology Data Exchange (ETDEWEB)

    Joe M. Aldrich

    2004-11-01

    The Former Radiation Worker Medical Surveillance Program at Rocky Flats was conducted in Arvada, CO, by Oak Ridge Associated Universities through the Oak Ridge Institute for Science and Education under DOE Contract DE-AC05-00OR22750. Objectives of the program were to obtain information on the value of medical surveillance among at-risk former radiation workers and to provide long-term internal radiation dosimetry information to the scientific community. This program provided the former radiation workers of the Rocky Flats Environmental Technology Site (formerly Rocky Flats Plant) an opportunity to receive follow-up medical monitoring and a re-evaluation of their internal radiation dose. The former Rocky Flats radiation worker population is distinctive because it was a reasonably stable work force that received occupational exposures, at times substantial, over several decades. This report reflects the summation of health outcomes, statistical analyses, and dose assessment information on former Rocky Flats radiation workers to the date of study termination as of March 2004.

  1. FINAL REPORT. FORMER RADIATION WORKER MEDICAL SURVEILLANCE PROGRAM AT ROCKY FLATS For Department of Energy Programs

    International Nuclear Information System (INIS)

    Aldrich, Joe M.

    2004-01-01

    The Former Radiation Worker Medical Surveillance Program at Rocky Flats was conducted in Arvada, CO, by Oak Ridge Associated Universities through the Oak Ridge Institute for Science and Education under DOE Contract DE-AC--05-00OR22750. Objectives of the program were to obtain information on the value of medical surveillance among at-risk former radiation workers and to provide long-term internal radiation dosimetry information to the scientific community. This program provided the former radiation workers of the Rocky Flats Environmental Technology Site (formerly Rocky Flats Plant) an opportunity to receive follow-up medical monitoring and a re-evaluation of their internal radiation dose. The former Rocky Flats radiation worker population is distinctive because it was a reasonably stable work force that received occupational exposures, at times substantial, over several decades. This report reflects the summation of health outcomes, statistical analyses, and dose assessment information on former Rocky Flats radiation workers to the date of study termination as of March 2004

  2. LWR surveillance dosimetry improvement program: PSF metallurgical blind test results

    International Nuclear Information System (INIS)

    Kam, F.B.K.; Stallmann, F.W.; Guthrie, G.; McElroy, W.N.

    1985-01-01

    The ORR-PSF benchmark experiment was designed to simulate the surveillance capsule-pressure vessel configuration in power reactors and to test the validity of procedures which determine the radiation damage in the vessel from test results in the surveillance capsule. The PSF metallurgical blind test was initiated to give participants an opportunity to test their current embrittlement prediction methodologies. Experimental results were withheld from the participants except for the type of information which is normally contained in surveillance reports. Preliminary analysis of the PSF metallurgical blind test results shows that: (1) current prediction methodologies, as used by the PSF Blind Test participants, are adequate, falling within +- 20 0 C of the measured values for Δ NDT. None of the different methods is clearly superior; (2) the proposed revision of Reg. Guide 1.99 (Rev. 2) gives a better representation of the fluence and chemistry dependency of Δ NDT than the current version (Rev. 1); and (3) fluence rate effects can be seen but not quantified. Fluence spectral effects are too small to be detectable in this experiment. (orig.)

  3. Surveillance in Programming Plagiarism beyond Techniques: An Incentive-Based Fishbone Model

    Science.gov (United States)

    Wang, Yanqing; Chen, Min; Liang, Yaowen; Jiang, Yu

    2013-01-01

    Lots of researches have showed that plagiarism becomes a severe problem in higher education around the world, especially in programming learning for its essence. Therefore, an effective strategy for plagiarism surveillance in program learning is much essential. Some literature focus on code similarity algorithm and the related tools can help to…

  4. Arthropod Surveillance Programs: Basic Components, Strategies, and Analysis

    Science.gov (United States)

    2012-01-01

    CA. 9 NAMRU-3, US Navy, Cairo, Egypt . inferences from trap capture data. The following is a review of the three arthropod surveillance compo- nents...by thigmotaxis. Fig. 1. The two traps used for stored product insects, A) the commonly used Dome trap (Trècè) and B) the newly developed pyramid ...trap. The pyramid trap is made up of two elements: a cover (1) and a base (2) with a center pitfall (3). (Online Þgure in color.) 140 ANNALS OF THE

  5. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study.

    Science.gov (United States)

    Yahno, Nikolay N; Fedotova, Anastasia V

    2017-01-01

    In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant ( P 85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment ( P effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials.

  6. Summary report of the state surveillance program on the transportation of radioactive materials

    International Nuclear Information System (INIS)

    1977-11-01

    From 1973 to 1976, a surveillance program was conducted in New Jersey, Oregon, Missouri, New York, Illinois, Texas, Louisiana, South Carolina, Minnesota, and New York City to provide training support for State radiation personnel and to determine actual radiation exposure conditions and radioactive material package handling practices through the terminals of air carriers and freight forwarders. NRC and DOT along with the participating States, developed the surveillance program. In general, the results did not indicate a public health or safety problem due to the transportation of radioactive materials. Some employees of several freight forwarders, are, however, receiving annual exposures in excess of 500 mrem. Recommendations are given

  7. Evaluation of the surveillance program of Streptococcus agalactiae in Danish dairy herds

    DEFF Research Database (Denmark)

    Andersen, H. J.; Pedersen, L. H.; Aarestrup, Frank Møller

    2003-01-01

    The aim of this study was to evaluate the Danish surveillance program of Streptococcus agalactiae in dairy herds with respect to 1) fluctuation over time of the presence of S. agalactiae in bulk tank milk, 2) sensitivity and specificity of the bacteriological method used, and 3) contamination...... the isolates. Streptococcus agalactiae was found in eight of 96 herds in which S. agalactiae had never previously been found during the surveillance program. Streptococcus agalactiae was not found in all seven sampling rounds in any of the eight herds. Comparing the approved method with supplemental findings...

  8. Strengthening Acute Flaccid Paralysis Surveillance through the Village Polio Volunteers Program in Somalia.

    Science.gov (United States)

    Mbaeyi, Chukwuma; Mohamed, Abdinoor; Owino, Brian Ogola; Mengistu, Kumlachew F; Ehrhardt, Derek; Elsayed, Eltayeb Ahmed

    2018-03-02

    Surveillance for cases of acute flaccid paralysis (AFP) is a key strategy adopted for the eradication of polio. Detection of poliovirus circulation is often predicated on the ability to identify AFP cases and test their stool specimens for poliovirus infection in a timely manner. The Village Polio Volunteers (VPV) program was established in 2013 in a bid to strengthen polio eradication activities in Somalia, including AFP surveillance, given the country's vulnerability to polio outbreaks. To assess the impact of the VPV program on AFP surveillance, we determined case counts, case-reporting sources, and non-polio AFP rates in the years before and after program introduction, i.e., 2011-2016. We also compared the stool adequacy and timeliness of cases reported by VPVs to those reported by other sources. In the years following program introduction, VPVs accounted for a high proportion of AFP cases reported in Somalia. AFP case counts rose from 148 cases in 2012, the year before program introduction, to 279 cases in 2015, during which VPVs accounted for 40% of reported cases. Further, the non-polio AFP rate improved from 2.8 cases in 2012 to 4.8 cases per 100,000 persons Somalia, similar community-based programs could play a crucial role in enhancing surveillance activities in countries with limited healthcare infrastructure.

  9. ORNL Surplus Facilities Management Program maintenance and surveillance plan for fiscal year 1984

    International Nuclear Information System (INIS)

    Coobs, J.H.; Myrick, T.E.

    1986-10-01

    The Surplus Facilities Management Program (SFMP) at Oak Ridge National Laboratory (ORNL) is part of the Department of Energy's (DOE) National SFMP, administered by the Richland Operations Office. The purpose and objectives of the national program are set forth in the current SFMP Program Plan and include (1) the maintenance and surveillance of facilities awaiting decommissioning, (2) planning for the orderly decommissioning of these facilities, and (3) implementation of a program to accomplish the facility disposition in a safe, cost-effective, and timely manner. As outlined in the national program plan, participating SFMP contractors are required to prepare a formal plan that documents the maintenance and surveillance (M and S) programs established for each site. This report has been prepared to provide this documentation for those facilties included in the ORNL SFMP

  10. LWR surveillance dosimetry improvement program: PSF metallurgical blind test results

    International Nuclear Information System (INIS)

    Kam, F.B.K.; Maerker, R.E.; Stallmann, F.W.

    1984-01-01

    The metallurgical irradiation experiment at the Oak Ridge Research Reactor Poolside Facility (ORR-PSF) was designed as a benchmark to test the accuracy of radiation embrittlement predictions in the pressure vessel wall of light water reactors on the basis of results from surveillance capsules. The PSF metallurgical Blind Test is concerned with the simulated surveillance capsule (SSC) and the simulated pressure vessel capsule (SPVC). The data from the ORR-PSF benchmark experiment are the basis for comparison with the predictions made by participants of the metallurgical ''Blind Test''. The Blind Test required the participants to predict the embrittlement of the irradiated specimen based only on dosimetry and metallurgical data from the SSC1 capsule. This exercise included both the prediction of damage fluence and the prediction of embrittlement based on the predicted fluence. A variety of prediction methodologies was used by the participants. No glaring biases or other deficiencies were found, but neither were any of the methods clearly superior to the others. Closer analysis shows a rather complex and poorly understood relation between fluence and material damage. Many prediction formulas can give an adequate approximation, but further improvement of the prediction methodology is unlikely at this time given the many unknown factors. Instead, attention should be focused on determining realistic uncertainties for the predicted material changes. The Blind Test comparisons provide some clues for the size of these uncertainties. In particular, higher uncertainties must be assigned to materials whose chemical composition lies outside the data set for which the prediction formula was obtained. 16 references, 14 figures, 5 tables

  11. Establishment of a Canine Rabies Burden in Haiti through the Implementation of a Novel Surveillance Program

    Science.gov (United States)

    Wallace, Ryan M; Reses, Hannah; Franka, Richard; Dilius, Pierre; Fenelon, Natael; Orciari, Lillian; Etheart, Melissa; Destine, Apollon; Crowdis, Kelly; Blanton, Jesse D; Francisco, Calvin; Ludder, Fleurinord; Del Rio Vilas, Victor; Haim, Joseph; Millien, Max

    2015-01-01

    The Republic of Haiti is one of only several countries in the Western Hemisphere in which canine rabies is still endemic. Estimation methods have predicted that 130 human deaths occur per year, yet existing surveillance mechanisms have detected few of these rabies cases. Likewise, canine rabies surveillance capacity has had only limited capacity, detecting only two rabid dogs per year, on average. In 2013, Haiti initiated a community-based animal rabies surveillance program comprised of two components: active community bite investigation and passive animal rabies investigation. From January 2013 –December 2014, 778 rabies suspect animals were reported for investigation. Rabies was laboratory-confirmed in 70 animals (9%) and an additional 36 cases were identified based on clinical diagnosis (5%), representing an 18-fold increase in reporting of rabid animals compared to the three years before the program was implemented. Dogs were the most frequent rabid animal (90%). Testing and observation ruled out rabies in 61% of animals investigated. A total of 639 bite victims were reported to the program and an additional 364 bite victims who had not sought medical care were identified during the course of investigations. Only 31% of people with likely rabies exposures had initiated rabies post-exposure prophylaxis prior to the investigation. Rabies is a neglected disease in-part due to a lack of surveillance and understanding about the burden. The surveillance methods employed by this program established a much higher burden of canine rabies in Haiti than previously recognized. The active, community-based bite investigations identified numerous additional rabies exposures and bite victims were referred for appropriate medical care, averting potential human rabies deaths. The use of community-based rabies surveillance programs such as HARSP should be considered in canine rabies endemic countries. PMID:26600437

  12. Development of a supplemental surveillance program for reactor pressure vessel thermal annealing

    International Nuclear Information System (INIS)

    Server, W.L.; Rosinski, S.T.

    1997-01-01

    The technical decision to thermally anneal a nuclear reactor pressure vessel (RPV) depends upon the level of embrittlement in the RPV steels, the amount of recovery of fracture toughness properties expected from the anneal, and the rate of re-embrittlement after the vessel is placed back into service. The recovery of Charpy impact toughness properties after annealing can be estimated initially by using a recovery model developed using experimental measurements of recovery (such as that developed by Eason et al. for U.S. vessel materials). However, actual validation measurements on plant-specific archived vessel materials (hopefully in the existing surveillance program) are needed; otherwise, irradiated surrogate materials, essentially the same as the RPV steels or bounding in expected behavior, must be utilized. The efficient use of any of these materials requires a supplemental surveillance program focused at both recovery and reirradiation embrittlement. Reconstituted Charpy specimens and new surveillance capsules will most likely be needed as part of this supplemental surveillance program. A new version of ASTM E 509 has recently been approved which provides guidance on thermal annealing in general and specifically for the development of an annealing supplemental surveillance program. The post-anneal re-embrittlement properties are crucial for continued plant operation, and the use of a re-embrittlement model, such as the lateral shift approach, may be overly conservative. This paper illustrates the new ASTM E 509 Standard Guide methodology for an annealing supplemental surveillance program. As an example, the proposed program for the Palisades RPV beltline steels is presented which covers the time from annealing to the end of operating license and beyond, if license renewal is pursued. The Palisades nuclear power plant RPV was planned to be annealed in 1998, but that plant is currently being re-evaluated. The proposed anneal was planned to be conducted at a

  13. The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.

    Science.gov (United States)

    Carnovale, Carla; Brusadelli, Tatiana; Zuccotti, GianVincenzo; Beretta, Silvia; Sullo, Maria Giuseppa; Capuano, Annalisa; Rossi, Francesco; Moschini, Martina; Mugelli, Alessandro; Vannacci, Alfredo; Laterza, Marcella; Clementi, Emilio; Radice, Sonia

    2014-09-01

    To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use. We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization. The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.

  14. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

    Directory of Open Access Journals (Sweden)

    Yahno NN

    2017-11-01

    Full Text Available Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197, fluvoxamine (50–300 mg/day for 90 days was effective for the treatment of depression in 299 adult patients (age ≥18 years with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively, global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale. The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296 was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001 improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85% recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200 experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both. No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine

  15. Detection of imminent vein graft occlusion: what is the optimal surveillance program?

    Science.gov (United States)

    Tinder, Chelsey N; Bandyk, Dennis F

    2009-12-01

    The prediction of infrainguinal vein bypass failure remains an inexact judgment. Patient demographics, technical factors, and vascular laboratory graft surveillance testing are helpful in identifying a high-risk graft cohort. The optimal surveillance program to detect the bypass at risk for imminent occlusion continues to be developed, but required elements are known and include clinical assessment for new or changes in limb ischemia symptoms, measurement of ankle and/or toe systolic pressure, and duplex ultrasound imaging of the bypass graft. Duplex ultrasound assessment of bypass hemodynamics may be the most accurate method to detect imminent vein graft occlusion. The finding of low graft flow during intraoperative assessment or at a scheduled surveillance study predicts failure; and if associated with an occlusive lesion, a graft revision can prolong patency. The most common abnormality producing graft failure is conduit stenosis caused by myointimal hyperplasia; and the majority can be repaired by an endovascular intervention. Frequency of testing to detect the failing bypass should be individualized to the patient, the type of arterial bypass, and prior duplex ultrasound scan findings. The focus of surveillance is on identification of the low-flow arterial bypass and timely repair of detected critical stenosis defined by duplex velocity spectra criteria of a peak systolic velocity 300 cm/s and peak systolic velocity ratio across the stenosis >3.5-correlating with >70% diameter-reducing stenosis. When conducted appropriately, a graft surveillance program should result in an unexpected graft failure rate of <3% per year.

  16. Feasibility and acceptability of a workers' health surveillance program for hospital physicians

    NARCIS (Netherlands)

    Ruitenburg, Martijn M.; Plat, Marie-Christine J.; Frings-Dresen, Monique H. W.; Sluiter, Judith K.

    2015-01-01

    A Workers' Health Surveillance (WHS) program is an occupational health strategy used to detect and address the health of individual workers to improve their ability to work. This study aims to investigate the feasibility and acceptability of a new job-specific WHS for hospital physicians. All

  17. Detection capacity, information gaps and the design of surveillance programs for invasive forest pests

    Science.gov (United States)

    Denys Yemshanov; Frank Koch; Yakov Ben-Haim; William Smith

    2010-01-01

    Integrated pest risk maps and their underlying assessments provide broad guidance for establishing surveillance programs for invasive species, but they rarely account for knowledge gaps regarding the pest of interest or how these can be reduced. In this study we demonstrate how the somewhat competing notions of robustness to uncertainty and potential knowledge gains...

  18. 10 CFR Appendix H to Part 50 - Reactor Vessel Material Surveillance Program Requirements

    Science.gov (United States)

    2010-01-01

    ... arrangement for data sharing between plants. d. There must be a contingency plan to assure that the... Requirements I. Introduction II. Definitions III. Surveillance Program Criteria IV. Report of Test Results I..., Rockville, MD 20852-2738. II. Definitions All terms used in this appendix have the same meaning as in...

  19. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Science.gov (United States)

    2010-01-01

    ... low pathogenic avian influenza. 145.15 Section 145.15 Animals and Animal Products ANIMAL AND PLANT... pathogenic avian influenza. (a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the...

  20. [Training programs for staff at local Infectious Disease Surveillance Centers: the needs and usefulness].

    Science.gov (United States)

    Suzuki, Tomoyuki; Kamiya, Nobuyuki; Yahata, Yuichiro; Ozeki, Yukie; Kishimoto, Tsuyoshi; Nadaoka, Yoko; Nakanishi, Yoshiko; Yoshimura, Takesumi; Shimada, Tomoe; Tada, Yuki; Shirabe, Komei; Kozawa, Kunihisa

    2013-03-01

    The objective of this study was to assess the need for and usefulness of training programs for Local Infectious Disease Surveillance Center (LIDSC) staff. A structured questionnaire survey was conducted to assess the needs and usefulness of training programs. The subjects of the survey were participants of a workshop held after an annual conference for the LIDSC staff. Data on demographic information, the necessity of training programs for LIDSC staff, the themes and contents of the training program, self-assessment of knowledge on epidemiology and statistics were covered by the questionnaire. A total of 55 local government officials responded to the questionnaire (response rate: 100%). Among these, 95% of participants believed that the training program for the LIDSC staff was necessary. Basic statistical analysis (85%), descriptive epidemiology (65%), outline of epidemiology (60%), interpretation of surveillance data (65%), background and objectives of national infectious disease surveillance in Japan (60%), methods of field epidemiology (60%), and methods of analysis data (51%) were selected by over half of the respondents as suitable themes for training programs. A total of 34 LIDSC staff answered the self-assessment question on knowledge of epidemiology. A majority of respondents selected "a little" or "none" for all questions about knowledge. Only a few respondents had received education in epidemiology. The results of this study indicate that LIDSC staff have basic demands for fundamental and specialized education to improve their work. Considering the current situation regarding the capacity of LIDSC staff, these training programs should be started immediately.

  1. A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras

    Directory of Open Access Journals (Sweden)

    Gustavo A Fontecha

    2014-07-01

    Full Text Available Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt “CVMNK” genotype in codons 72-76.

  2. A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras.

    Science.gov (United States)

    Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

    2014-07-01

    Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt "CVMNK" genotype in codons 72-76.

  3. Master schedule for CY-1984 Hanford environmental surveillance routine sampling program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Price, K.R.; Eddy, P.A.; Carlile, J.M.V.

    1983-12-01

    This report provides the current schedule of data collection for the routine Hanford environmental surveillance and ground-water Monitoring Programs at the Hanford Site. The purpose is to evaluate and report the levels of radioactive and nonradioactive pollutants in the Hanford environs. The routine sampling schedule provided herein does not include samples that are planned to be collected during FY-1984 in support of special studies, special contractor support programs, or for quality control purposes

  4. The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies.

    Science.gov (United States)

    von Kalckreuth, Vera; Konings, Frank; Aaby, Peter; Adu-Sarkodie, Yaw; Ali, Mohammad; Aseffa, Abraham; Baker, Stephen; Breiman, Robert F; Bjerregaard-Andersen, Morten; Clemens, John D; Crump, John A; Cruz Espinoza, Ligia Maria; Deerin, Jessica Fung; Gasmelseed, Nagla; Sow, Amy Gassama; Im, Justin; Keddy, Karen H; Cosmas, Leonard; May, Jürgen; Meyer, Christian G; Mintz, Eric D; Montgomery, Joel M; Olack, Beatrice; Pak, Gi Deok; Panzner, Ursula; Park, Se Eun; Rakotozandrindrainy, Raphaël; Schütt-Gerowitt, Heidi; Soura, Abdramane Bassiahi; Warren, Michelle R; Wierzba, Thomas F; Marks, Florian

    2016-03-15

    New immunization programs are dependent on data from surveillance networks and disease burden estimates to prioritize target areas and risk groups. Data regarding invasive Salmonella disease in sub-Saharan Africa are currently limited, thus hindering the implementation of preventive measures. The Typhoid Fever Surveillance in Africa Program (TSAP) was established by the International Vaccine Institute to obtain comparable incidence data on typhoid fever and invasive nontyphoidal Salmonella (iNTS) disease in sub-Saharan Africa through standardized surveillance in multiple countries. Standardized procedures were developed and deployed across sites for study site selection, patient enrolment, laboratory procedures, quality control and quality assurance, assessment of healthcare utilization and incidence calculations. Passive surveillance for bloodstream infections among febrile patients was initiated at thirteen sentinel sites in ten countries (Burkina Faso, Ethiopia, Ghana, Guinea-Bissau, Kenya, Madagascar, Senegal, South Africa, Sudan, and Tanzania). Each TSAP site conducted case detection using these standardized methods to isolate and identify aerobic bacteria from the bloodstream of febrile patients. Healthcare utilization surveys were conducted to adjust population denominators in incidence calculations for differing healthcare utilization patterns and improve comparability of incidence rates across sites. By providing standardized data on the incidence of typhoid fever and iNTS disease in sub-Saharan Africa, TSAP will provide vital input for targeted typhoid fever prevention programs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  5. Mark of the reconstitution process of the surveillance program of the CLV

    International Nuclear Information System (INIS)

    Romero, J.; Hernandez, R.; Fernandez, F.

    2006-01-01

    The surveillance program of the reactor vessel of the nucleo electric central of Mexico it evaluates the mechanical state of the vessel, for it are had surveillance capsules with a series of witness test tubes, subjected to a similar or major neutron flux to that of the vessel. The objective is to evaluate in advance the embrittlement grade of the vessel in its design life. However the number of capsules with the witness test tubes it is only for the design life of the plant and at the moment the nucleo electric plants negotiate an extension of life of these, until for 20 years or more, of there the importance of this witness material that stores the information of the damage accumulated by irradiation. This material requires to be taken advantage after being rehearsed and the normative one settles down as obligatory to qualify the rebuilding process to obtain other 'new' Charpy test tubes that are again introduced in the reactor, reusing this material, as much for the surveillance program as for the extension of the plant life. In this work the qualification of the welding process by 'Stud Welding' for the rebuilding of Charpy test tubes of the surveillance program of the BWR reactor Unit 2 of the Laguna Verde Nucleo electric plant, Veracruz, Mexico is described. (Author)

  6. Verifying Elimination Programs with a Special Emphasis on Cysticercosis Endpoints and Postelimination Surveillance

    Directory of Open Access Journals (Sweden)

    Sukwan Handali

    2012-01-01

    Full Text Available Methods are needed for determining program endpoints or postprogram surveillance for any elimination program. Cysticercosis has the necessary effective strategies and diagnostic tools for establishing an elimination program; however, tools to verify program endpoints have not been determined. Using a statistical approach, the present study proposed that taeniasis and porcine cysticercosis antibody assays could be used to determine with a high statistical confidence whether an area is free of disease. Confidence would be improved by using secondary tests such as the taeniasis coproantigen assay and necropsy of the sentinel pigs.

  7. Portsmouth Gaseous Diffusion Plant Decontamination and Decommissioning Program surveillance and maintenance plan, FY 1993--2002

    International Nuclear Information System (INIS)

    Schloesslin, W.

    1992-11-01

    The Decontamination and Decommissioning (D ampersand D) Program at the Portsmouth Gaseous Diffusion Plant (PORTS) is part of the Environmental Restoration (ER) and Waste Management (WM) Programs (ERWM). The objective of the ER Program is to provide PORTS the capability to meet applicable environmental regulations through facility development activities and site remedial actions. The WM Program supports the ER Program. The D ampersand D Program provides collective management of the sites within the plant which require decontamination and decommissioning, prioritizes those areas in terms of health, safety and environmental concerns, and implements the appropriate level of remedial action. The D ampersand D Program provides support to facilities which formerly served one or more of the many Plant functions. Program activities include (1) surveillance and maintenance of facilities awaiting decommissioning; (2) planning safe and orderly facility decommissioning; and (3) implementing a program to accomplish facility disposition in a safe, cost effective, and timely manner. In order to achieve the first objective, a formal plan which documents the surveillance and maintenance needs for each inactive facility has been prepared. This report provides this documentation for the PORTS facilities currently included in the D ampersand D Program and includes projected resource requirements for the planning period of FY 1993 through FY 2002

  8. The Lawrence Livermore National Laboratory DOE-STD-3013 Surveillance Program for the Storage of Plutonium Packages

    International Nuclear Information System (INIS)

    Riley, D

    2005-01-01

    This document presents a site-specific DOE-STD-3013 (3013) surveillance program for 3013 material stored at Lawrence Livermore National Laboratory (LLNL) in the B332 Plutonium Facility. The 3013 standard requires the development of a surveillance program to assure the long-term safety of plutonium storage in 3013 compliant containers. A complex-wide Integrated Surveillance Program in Support of Long-Term Storage of Plutonium-Bearing Materials (ISP)(LA-UR-00-3246, Revision 1, March 2001) has been developed to give guidance on an acceptable surveillance approach and to set up a mechanism to integrate surveillance activities and facilitate the sharing of lessons learned. This LLNL 3013 surveillance program has been developed following guidelines established for Storage Sites in the ISP and is sufficient for the storage in the LLNL Plutonium Facility. The LLNL 3013 surveillance program must be coupled with the DOE complex wide Materials Identification and Surveillance (MIS) program and the ISP led by Savannah River Site (SRS). These programs support the technical basis for continuing safe storage of plutonium packages and provide the technical basis for the limited scope of the site-specific LLNL 3013 surveillance program. The LLNL 3013 surveillance program calls for surveillance of 3013 packages to begin approximately three years after packaging of the first oxide. One percent of the stored packages per year will be randomly selected and nondestructively examined (NDE) by LLNL per the guidelines of the ISP. Additional packages may be selected for NDE if recommended by the ISP Steering Committee and agreed upon by the MIS Working Group. One selected package will be shipped to SRS for destructive analysis each year starting when SRS can receive them. This is expected to be in FY2007. We expect to store a maximum of 400 3013 packages. This would result in an expected maximum of 4 surveillances per year. The activities outlined in the program evolved from the current

  9. Safety experience with bosentan in 146 children 2-11 years old with pulmonary arterial hypertension: results from the European Postmarketing Surveillance program

    DEFF Research Database (Denmark)

    Beghetti, M.; Hoeper, M.M.; Kiely, D.G.

    2008-01-01

    captured in the database. Predominant etiologies in children were idiopathic PAH (40.4%) and PAH related to congenital heart disease (45.2%). The majority of children were in New York Heart Association functional class II (28.1%) or III (50.7%), and median exposure to bosentan was 29.1 wk. Elevated...

  10. Characteristics of national and statewide health care-associated infection surveillance programs: A qualitative study.

    Science.gov (United States)

    Russo, Philip L; Havers, Sally M; Cheng, Allen C; Richards, Michael; Graves, Nicholas; Hall, Lisa

    2016-12-01

    There are many well-established national health care-associated infection surveillance programs (HAISPs). Although validation studies have described data quality, there is little research describing important characteristics of large HAISPs. The aim of this study was to broaden our understanding and identify key characteristics of large HAISPs. Semi-structured interviews were conducted with purposively selected leaders from national and state-based HAISPs. Interview data were analyzed following an interpretive description process. Seven semi-structured interviews were conducted over a 6-month period during 2014-2015. Analysis of the data generated 5 distinct characteristics of large HAISPs: (1) triggers: surveillance was initiated by government or a cooperative of like-minded people, (2) purpose: a clear purpose is needed and determines other surveillance mechanisms, (3) data measures: consistency is more important than accuracy, (4) processes: a balance exists between the volume of data collected and resources, and (5) implementation and maintenance: a central coordinating body is crucial for uniformity and support. National HAISPs are complex and affect a broad range of stakeholders. Although the overall goal of health care-associated infection surveillance is to reduce the incidence of health care-associated infection, there are many crucial factors to be considered in attaining this goal. The findings from this study will assist the development of new HAISPs and could be used as an adjunct to evaluate existing programs. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  11. Master schedule for CY-1983 Hanford environmental surveillance routine sampling program

    International Nuclear Information System (INIS)

    Blumer, P.J.; Sula, M.J.; Eddy, P.A.; Dirkes, R.L.

    1982-12-01

    The current schedule of data collection for the routine Hanford environmental surveillance and ground-water monitoring programs at the Hanford Site is presented. The purpose of the programs is to evaluate and report the levels of radioactive and nonradioactive pollutants in the Hanford environs. Radiological monitoring data are reported for air (particulate filter and gases/vapor), Columbia River water, sanitary water, onsite pond water, foodstuffs (whole milk, leafy vegetables, fruit, wheat/alfalfa, beef, poultry/eggs), wildlife, soil and vegetation, and direct radiation. Information is also given for on site radiation control audit surveys (roadway, railway, aerial, and waste disposal sites, and the Hanford ground-water monitoring program

  12. Cost-effectiveness of surveillance programs for families at high and moderate risk of hereditary non-polyposis colorectal cancer

    DEFF Research Database (Denmark)

    Olsen, Kim R.; Bojesen, Stig E.; Gerdes, Anne-Marie M.

    2007-01-01

    for the group at high risk. The aim of the present study is to determine cost-effectiveness of surveillance programs where families at both high and moderate risk of HNPCC participate. METHODS: A decision analytic model (Markov model) is developed to assess surveillance programs where families at high......OBJECTIVES: Surveillance programs are recommended to both families at high risk (Amsterdam-positive families with known- and unknown mutation) and moderate risk (families not fulfilling all Amsterdam criteria) of colorectal cancer (CRC). Cost-effectiveness has so far only been estimated...

  13. Safety, Efficacy, and Persistence of Long-Term Mirabegron Treatment for Overactive Bladder in the Daily Clinical Setting: Interim (1-Year) Report from a Japanese Post-Marketing Surveillance Study.

    Science.gov (United States)

    Kato, Daisuke; Tabuchi, Hiromi; Uno, Satoshi

    2017-08-01

    To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis. Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3 months, 6 months, and 1 year, or at discontinuation (P similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032). Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years. © 2017 John Wiley & Sons Australia, Ltd.

  14. Analysis of participation in the federally mandated coal workers' health-surveillance program

    International Nuclear Information System (INIS)

    Nickolaus, M.E.

    1987-01-01

    The Federal Coal Mine Health and Safety Act of 1969 required that periodic chest radiographs be offered to underground coal miners to protect the miners from the development of Coal Workers' Pneumoconiosis (CWP) and progression of the disease to progressive massive fibrosis (PMF). These examinations are administered by the National Institute for Occupational Safety and Health (NIOSH) through the Coal Workers' Health Surveillance Program (CWHSP). This study developed rates of participation for each of 558 West Virginia underground coal mines who submitted or had NIOSH assigned plans for making chest radiographs available during the third round, July 1978 through December 1980. These rates were analyzed in relation to desired levels of participation and to reinforcing, predisposing and enabling factors presumed to affect rates of participation in disease prevention and surveillance programs

  15. Application of advanced irradiation analysis methods to light water reactor pressure vessel test and surveillance programs

    International Nuclear Information System (INIS)

    Odette, R.; Dudey, N.; McElroy, W.; Wullaert, R.; Fabry, A.

    1977-01-01

    Inaccurate characterization and inappropriate application of neutron irradiation exposure variables contribute a substantial amount of uncertainty to embrittlement analysis of light water reactor pressure vessels. Damage analysis involves characterization of the irradiation environment (dosimetry), correlation of test and surveillance metallurgical and dosimetry data, and projection of such data to service conditions. Errors in available test and surveillance dosimetry data are estimated to contribute a factor of approximately 2 to the data scatter. Non-physical (empirical) correlation procedures and the need to extrapolate to the vessel may add further error. Substantial reductions in these uncertainties in future programs can be obtained from a more complete application of available damage analysis tools which have been developed for the fast reactor program. An approach to reducing embrittlement analysis errors is described, and specific examples of potential applications are given. The approach is based on damage analysis techniques validated and calibrated in benchmark environments

  16. Surveillance and Maintenance Plan for the ORNL Decontamination and Decommissioning Program FY 1993--2002

    International Nuclear Information System (INIS)

    Ford, M.K.; Holder, L. Jr.

    1992-07-01

    The Decontamination and Decommissioning (D ampersand D) Program at the Oak Ridge National Laboratory (ORNL) is part of the Department of Energy (DOE) Environmental Restoration D ampersand D program. The purpose and objectivesof this program include: (1) surveillance and maintenance (S ampersand M) of facilities awaiting decommissioning; (2) planning for the orderly decommissioning of these facilities; and (3) implementation of a program to accomplish facility disposition in a safe, cost-effective, and timely manner. Participating D ampersand D contractors are required to prepare formal plans that document the S ampersand M programs established for each site. This report has been prepared to provide this documentation for those facilities included in the ORNL D ampersand D Program

  17. Establishment of a health surveillance program for reintroduction of the Eurasian beaver (Castor fiber) into Scotland.

    Science.gov (United States)

    Goodman, Gidona; Girling, Simon; Pizzi, Romain; Meredith, Anna; Rosell, Frank; Campbell-Palmer, Roisin

    2012-10-01

    In 2009 and 2010 16 Norwegian Eurasian beavers (Castor fiber) were reintroduced to Knapdale, Scotland as part of a 5-yr reintroduction trial (Scottish Beaver Trial). Despite numerous reintroduction programs throughout Europe there is no published information concerning recommended health surveillance during beaver reintroduction and only one publication describing causes of mortality. We describe the establishment of a health surveillance program based on International Union of Conservation of Nature (IUCN) and governmental guidelines, and report preliminary results based on the fecal and blood samples following the completion of the first stage of reintroduction. Animals underwent at least one general anesthetic to allow collection of fecal and blood samples and a thorough clinical examination. No bacterial enteric pathogens such as Salmonella spp., Campylobacter spp., or Yersinia pseudotuberculosis were isolated, nor were Giardia spp. or Cryptosporidium spp. However, numerous helminths including Travassosius rufus and Stichorchis subtriquetrus were detected. Five animals were positive for Leptospira antibodies. This included Leptospira saxkoebing, Leptospira canicola, Leptospira copenhageni, Leptospira icterohaemorrhagiae, Leptospira autumnalis, and Leptospira javanica. The highest loss of animals (20%) was during the statutory 6-mo rabies quarantine period. No common cause of death was determined. The rabies quarantine conditions were waived for four remaining animals, three of which were introduced to the wild successfully. The authors recommend the shortest possible quarantine period when introducing beavers, but allowing for the minimum recommended IUCN 35 days to allow for implementation of the initial stage of the health surveillance program, examination of animals, sample collection, and processing.

  18. Standard Practice for Design of Surveillance Programs for Light-Water Moderated Nuclear Power Reactor Vessels

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This practice covers procedures for designing a surveillance program for monitoring the radiation-induced changes in the mechanical properties of ferritic materials in light-water moderated nuclear power reactor vessels. This practice includes the minimum requirements for the design of a surveillance program, selection of vessel material to be included, and the initial schedule for evaluation of materials. 1.2 This practice was developed for all light-water moderated nuclear power reactor vessels for which the predicted maximum fast neutron fluence (E > 1 MeV) at the end of license (EOL) exceeds 1 × 1021 neutrons/m2 (1 × 1017 n/cm2) at the inside surface of the reactor vessel. 1.3 This practice applies only to the planning and design of surveillance programs for reactor vessels designed and built after the effective date of this practice. Previous versions of Practice E185 apply to earlier reactor vessels. 1.4 This practice does not provide specific procedures for monitoring the radiation induced cha...

  19. Northeast Regional Cancer Institute's Cancer Surveillance and Risk Factor Program

    Energy Technology Data Exchange (ETDEWEB)

    Lesko, Samuel M.

    2007-07-31

    OBJECTIVES The Northeast Regional Cancer Institute is conducting a program of ongoing epidemiologic research to address cancer disparities in northeast Pennsylvania. Of particular concern are disparities in the incidence of, stage at diagnosis, and mortality from colorectal cancer. In northeast Pennsylvania, age-adjusted incidence and mortality rates for colorectal cancer are higher, and a significantly smaller proportion of new colorectal cancer cases are diagnosed with local stage disease than is observed in comparable national data. Further, estimates of the prevalence of colorectal cancer screening in northeast Pennsylvania are lower than the US average. The Northeast Regional Cancer Institute’s research program supports surveillance of common cancers, investigations of cancer risk factors and screening behaviors, and the development of resources to further cancer research in this community. This project has the following specific objectives: I. To conduct cancer surveillance in northeast Pennsylvania. a. To monitor incidence and mortality for all common cancers, and colorectal cancer, in particular, and b. To document changes in the stage at diagnosis of colorectal cancer in this high-risk, underserved community. II. To conduct a population-based study of cancer risk factors and screening behavior in a six county region of northeast Pennsylvania. a. To monitor and document changes in colorectal cancer screening rates, and b. To document the prevalence of cancer risk factors (especially factors that increase the risk of colorectal cancer) and to identify those risk factors that are unusually common in this community. APPROACH Cancer surveillance was conducted using data from the Northeast Regional Cancer Institute’s population-based Regional Cancer Registry, the Pennsylvania Cancer Registry, and NCI’s SEER program. For common cancers, incidence and mortality were examined by county within the region and compared to data for similar populations in the US

  20. Re-utilization by '' Stud Welding'' of capsules charpy-V belonged to surveillance programs

    International Nuclear Information System (INIS)

    Lapena, J.; Perosanz, F. J.; Gachuz, M.

    1998-01-01

    The perspectives of nuclear plants life extension that are approximating to their end of design life compels to make new surveillance programs. The re-utilization of specimens belonging to surveillance capsules already tested in these new surveillance programs seems be a solution worldwide accepted. The two possible re-utilization processes of this irradiated material are: Subsized specimens and Reconstitution. While the first alternative (Subsized specimens) outlines serious problems for apply the results, the reconstitution eliminates this problem, since the resulting specimens after of the reconstruction procedure would be of the same dimensions that the original. The reconstruction process involves welds, and therefore it has associated the specific problems of this type of joints. Furthermore, by be tried to material irradiated with certain degree of internal damage, that is the variable to evaluate, requires that the heat contribution to the piece not originate local thermal treatments that alter its mechanical qualities. In this work has been followed the evolution by the variables of the weld process and their influence on the quality by the union from metallographic al point of view as well as mechanical for a weld procedure by Stud Welding. The principal objective is to optimize said parameters to assure a good mechanical continuity, without detriment of the microstructural characteristics of the original material. To verify this last have been accomplished with metallographical tests, temperature profile, hardness and will be carried out also Charpy tests. (Author)

  1. Sheen surveillance: An environmental monitoring program subsequent to the 1989 Exxon Valdez shoreline cleanup

    International Nuclear Information System (INIS)

    Taft, D.G.; Egging, D.E.; Kuhn, H.A.

    1995-01-01

    In the fall of 1989, an aerial surveillance program was implemented to locate oil sheens (or slicks) originating from shorelines affected by the Exxon Valdez spill. The objectives of the program were to identify any oil on the water that warranted response and to identify those sections of shoreline that would be priority candidates for further cleanup in 1990. The program initially surveyed the entire affected area, but, because proportionally fewer sheens were spotted in the Gulf of Alaska, the program was refocused on Prince Williams Sound in early 1990. The surveillance program consisted of frequent low-altitude flights with trained observers in a deHavilland Twin otter outfitted with observation ports and communication equipment. The primary surveillance technique used was direct visual observation. Other techniques, including photography, were tested but proved less effective. The flights targeted all shorelines of concern, particularly those near fishing, subsistence, and recreational areas.the observers attempted to locate all sheens, estimate their size and color, ad identify the source of the oil found in the sheen. Size and color were used to estimate the volume of oil in each sheen. Samples were collected whenever possible during the summer of 1990 using a floating Teflon trademark sampling device that was developed for easy deployment from a boat or the pontoon of a float plane. Forty four samples were analyzed by UV-fluorescence spectroscopy. Eleven of these samples were also analyzed by GC/MS. In general, the analyses confirmed the observers' judgment of source. 16 refs., 9 figs., 2 tabs

  2. Process Evaluation of a Workers' Health Surveillance Program for Meat Processing Workers.

    Science.gov (United States)

    van Holland, Berry J; Brouwer, Sandra; de Boer, Michiel R; Reneman, Michiel F; Soer, Remko

    2017-09-01

    Objective To evaluate the implementation process of a workers' health surveillance (WHS) program in a Dutch meat processing company. Methods Workers from five plants were eligible to participate in the WHS program. The program consisted of four evaluative components and an intervention component. Qualitative and quantitative methods were used to evaluate seven process aspects. Data were gathered by interviews with stakeholders, participant questionnaires, and from registries of the company and occupational health service. Results Two recruitment strategies were used: open invitation or automatic participation. Of the 986 eligible workers, 305 participated in the program. Average reach was 53 %. Two out of five program components could not be assessed on dose delivered, dose received and fidelity. If components were assessable, 85-100 % of the components was delivered, 66-100 % of the components was received by participants, and fidelity was 100 %. Participants were satisfied with the WHS program (mean score 7.6). Contextual factors that facilitated implementation were among others societal developments and management support. Factors that formed barriers were program novelty and delayed follow-up. Conclusion The WHS program was well received by participants. Not all participants were offered the same number of program components, and not all components were performed according to protocol. Deviation from protocol is an indication of program failure and may affect program effectiveness.

  3. Extension of the RPV irradiation surveillance program of NPP GKN II by T0 approach

    International Nuclear Information System (INIS)

    Barthelmes, J.; Keim, E.; Hein, H.; Koenig, G.

    2015-01-01

    The nuclear power plant (NPP) Neckarwestheim II (GKN II) started operation in 1989 and was designed for 40 years of operation. During the plant life time the reactor pressure vessel (RPV) integrity is a main aspect for nuclear safety since the RPV is exposed to neutron irradiation affecting the mechanical material properties, in particular toughness. In this context the ductile to brittle transition reference temperature of the RPV materials can be determined either indirectly according to the RT(NDT) concept by means of comparative examinations of irradiated and unirradiated notched-bar impact specimens or directly according to the Master Curve concept by means of examination of irradiated fracture mechanic specimens and determination of an alternative reference temperature RT(T0). With the implementation and evaluation of the first irradiation surveillance program consisting of three sets, one unirradiated reference set (set 1) and two irradiated sets (set 2 and 3), the RPV safety could be proven for the assessment fluence (AF) of 8*10 18 cm -2 (E > 1 MeV) using the RT(NDT) concept. Against the background of a possible long term operation and the state-of-the-art of science and technology in 1998 the NPP GKN II initiated a supplemental irradiation surveillance program with two irradiation sets (set 4 and 5) containing fracture mechanic specimens for complementary proof of safety according to the Master Curve concept. The results of the first irradiated set 4 are presented and assessed by means of the reference temperatures according to the Master Curve concept and compared to the results of the irradiation sets 1 to 3 of the conventional irradiation surveillance program. As an important outcome the existing RPV integrity assessment could be ensured by the Master Curve results. The applied approach adapts to the state-of-the-art of science and technology and is best practice to ensure the safe operation of RPV supplementary. (authors)

  4. Fast neutron fluence calculations as support for a BWR pressure vessel and internals surveillance program

    International Nuclear Information System (INIS)

    Lucatero, Marco A.; Palacios-Hernandez, Javier C.; Ortiz-Villafuerte, Javier; Xolocostli-Munguia, J. Vicente; Gomez-Torres, Armando M.

    2010-01-01

    Materials surveillance programs are required to detect and prevent degradation of safety-related structures and components of a nuclear power reactor. In this work, following the directions in the Regulatory Guide 1.190, a calculational methodology is implemented as additional support for a reactor pressure vessel and internals surveillance program for a BWR. The choice of the neutronic methods employed was based on the premise of being able of performing all the expected future survey calculations in relatively short times, but without compromising accuracy. First, a geometrical model of a typical BWR was developed, from the core to the primary containment, including jet pumps and all other structures. The methodology uses the Synthesis Method to compute the three-dimensional neutron flux distribution. In the methodology, the code CORE-MASTER-PRESTO is used as the three-dimensional core simulator; SCALE is used to generate the fine-group flux spectra of the components of the model and also used to generate a 47 energy-groups job cross section library, collapsed from the 199-fine-group master library VITAMIN-B6; ORIGEN2 was used to compute the isotopic densities of uranium and plutonium; and, finally, DORT was used to calculate the two-dimensional and one-dimensional neutron flux distributions required to compute the synthesized three-dimensional neutron flux. Then, the calculation of fast neutron fluence was performed using the effective full power time periods through six operational fuel cycles of two BWR Units and until the 13th cycle for Unit 1. The results showed a maximum relative difference between the calculated-by-synthesis fast neutron fluxes and fluences and those measured by Fe, Cu and Ni dosimeters less than 7%. The dosimeters were originally located adjacent to the pressure vessel wall, as part of the surveillance program. Results from the computations of peak fast fluence on pressure vessel wall and specific weld locations on the core shroud are

  5. Clinical, Bacteriologic, and Geographic Stratification of Melioidosis Emerges from the Sri Lankan National Surveillance Program.

    Science.gov (United States)

    Sathkumara, Harindra D; Merritt, Adam J; Corea, Enoka M; Krishnananthasivam, Shivankari; Natesan, Mohan; Inglis, Timothy J J; De Silva, Aruna Dharshan

    2018-02-01

    Melioidosis, a potentially fatal tropical infection, is said to be underdiagnosed in low-income countries. An increase in melioidosis cases in Sri Lanka allowed us to analyze the relationship among clinical outcome, bacteriology, epidemiology, and geography in the first 108 laboratory-confirmed cases of melioidosis from a nationwide surveillance program. The additional 76 cases of laboratory-confirmed melioidosis confirmed further associations between Burkholderia pseudomallei multilocus sequence typing (MLST) and infection phenotype; ST1137/unifocal bacteremic infection (χ 2 = 3.86, P national genotyping-supported melioidosis registry will improve melioidosis diagnosis, treatment, and prevention where underdiagnosis and mortality rates remain high.

  6. Post-marketing surveillance of quinolones 1988-1990.

    Science.gov (United States)

    Davey, P G; McDonald, T; Lindsay, G

    1991-04-01

    It has been much easier to obtain original data on adverse drug reactions (ADR) of quinolones from the pharmaceutical industry than it was two years ago. This is to be welcomed and, as anticipated, the new data continue to suggest that the new 4-quinolones have an ADR profile which is very similar to that of other antimicrobials. Visual disturbance is not a prominent feature, in contrast to the ADR profile of nalidixic acid. Better definition of quinolone ADRs requires prospective study, and the results of a newly completed prescription event monitoring study are awaited with interest. The potential use of computerised databases and record linkage is examined, but at present the number of quinolone prescriptions is too small to assess documentation of serious but rare events such as convulsions. Physicians need to be aware of the limitations of current data on suspected ADRs. Further investment in computerised databases is required to satisfy the requirements for attributing causality of an event to a drug.

  7. Utilization of Healthcare in the Typhoid Fever Surveillance in Africa Program.

    Science.gov (United States)

    Panzner, Ursula; Pak, Gi Deok; Aaby, Peter; Adu-Sarkodie, Yaw; Ali, Mohammad; Aseffa, Abraham; Baker, Stephen; Bjerregaard-Andersen, Morten; Crump, John A; Deerin, Jessica; Cruz Espinoza, Ligia Maria; Gasmelseed, Nagla; Heriniaina, Jean Noël; Hertz, Julian T; Im, Justin; von Kalckreuth, Vera; Keddy, Karen H; Lankoande, Bruno; Løfberg, Sandra; Meyer, Christian G; Oresto, Michael Munishi; Park, Jin Kyung; Park, Se Eun; Rakotozandrindrainy, Raphaël; Sarpong, Nimako; Soura, Abdramane Bassiahi; Gassama Sow, Amy; Tall, Adama; Teferi, Mekonnen; Worku, Alemayehu; Yeshitela, Biruk; Wierzba, Thomas F; Marks, Florian

    2016-03-15

    Assessing healthcare utilization is important to identify weaknesses of healthcare systems, to outline action points for preventive measures and interventions, and to more accurately estimate the disease burden in a population. A healthcare utilization survey was developed for the Typhoid Fever Surveillance in Africa Program (TSAP) to adjust incidences of salmonellosis determined through passive, healthcare facility-based surveillance. This cross-sectional survey was conducted at 11 sites in 9 sub-Saharan African countries. Demographic data and healthcare-seeking behavior were assessed at selected households. Overall and age-stratified percentages of each study population that sought healthcare at a TSAP healthcare facility and elsewhere were determined. Overall, 88% (1007/1145) and 81% (1811/2238) of the population in Polesgo and Nioko 2, Burkina Faso, respectively, and 63% (1636/2590) in Butajira, Ethiopia, sought healthcare for fever at any TSAP healthcare facility. A far smaller proportion-namely, 20%-45% of the population in Bissau, Guinea-Bissau (1743/3885), Pikine, Senegal (1473/4659), Wad-Medani, Sudan (861/3169), and Pietermaritzburg, South Africa (667/2819); 18% (483/2622) and 9% (197/2293) in Imerintsiatosika and Isotry, Madagascar, respectively; and 4% (127/3089) in Moshi, Tanzania-sought healthcare at a TSAP healthcare facility. Patients with fever preferred to visit pharmacies in Imerintsiatosika and Isotry, and favored self-management of fever in Moshi. Age-dependent differences in healthcare utilization were also observed within and across sites. Healthcare utilization for fever varied greatly across sites, and revealed that not all studied populations were under optimal surveillance. This demonstrates the importance of assessing healthcare utilization. Survey data were pivotal for the adjustment of the program's estimates of salmonellosis and other conditions associated with fever. © The Author 2016. Published by Oxford University Press for the

  8. Guidance for implementing the UMTRA Project long-term surveillance program

    International Nuclear Information System (INIS)

    1992-09-01

    The US Nuclear Regulatory Commission (NRC) has issued a general license for the custody and long-term care of US Department of Energy (DOE) Uranium Mill Tailings Remedial Action (UMTRA) Project permanent disposal sites. The purpose of this general license is to ensure that the UMTRA disposal sites will be cared for in such a manner as to protect the public health and safety and the environment upon completion of remedial actions. The general license will be in effect for a disposal site when NRC accepts the disposal site long-term surveillance plan (LTSP) that meets the requirements of 10 CFR 40.27. The site LTSP describes in detail the long-term surveillance program, including any monitoring, maintenance, and emergency measures necessary to fulfill the conditions of the general license. This guidance document provides (1) instructions for preparing the disposal site LTSPs and (2) instructions for carrying out the UMTRA Project long-term surveillance program, including any monitoring that may be required. The information provided in this document also is in accordance with the regulatory requirements set forth in 40 CFR 192. On January 5, 1985, the US Tenth Circuit Court of Appeals remanded the groundwater standards, 40 CFR 192.02. Proposed groundwater standards were issued for comment on September 24, 1987 (52 FR 3600). When the groundwater standards become final, this document will be revised, as appropriate. This document also will be updated in response to any changes to 10 CFR 40, or in response to changes in the manner in which the long-term care of the licensed disposal sites is carried out

  9. Continuous high-temperature surveillance instrumentation for Dresden-2 hydrogen water chemistry program

    International Nuclear Information System (INIS)

    Fleming, M.F.; Mitchell, R.A.; Nelson, J.L.

    1987-01-01

    The objective of this program (under EPRI Contract RP1930-11) is to install and operate a high-temperature surveillance instrumentation system capable of monitoring the length of cracks in boiling water reactor (BWR) piping during plant operation. The ability to measure crack growth in BWR power plant piping welds is important to rapidly identify the effectiveness of repairs (such as the Hydrogen Water Chemistry Program). The feasibility of a system capable of continuous ultrasonic instrumentation at 600 0 F (288 0 C) was successfully demonstrated at the Dresden-2 suction line known as N1B. This intergranular stress corrosion cracking (IGSCC) surveillance instrumentation is sound in principal, because it survived on N1B for a time period of more than nine months from April 1985 to January 1986 (the last time data were recorded). The redesigned low-profile transducer system used for this system operated successfully for the same nine-month time period. This low profile transducer fits in the two-inch space normally occupied by insulation. As a result of poor routing of the coaxial cables running from the low-profile transducer to the electrical feed-throughs between the drywell and containment, these cables melted. Other instrument cables nearby were not damaged

  10. Environmental Restoration Program pollution prevention checklist guide for the surveillance and maintenance project phase

    International Nuclear Information System (INIS)

    1993-09-01

    DOE Order 5820.2 mandates that a surveillance and maintenance program be established in all shut-down facilities to ensure adequate containment of contamination, provide physical safety and security, and reduce potential public and environmental hazards. A key consideration in this process is the prevention of any waste to be generated from these activities. The purpose of this checklist guide is to assist the user with incorporating pollution prevention/waste minimization (PP/WM) in all Surveillance and Maintenance (S ampersand M) phase projects of the Environmental Restoration (ER) Program. This guide will help users document their PP/WM activities for technology transfer and reporting requirements. Automated computer screens will be created from the checklist data to assist users with implementing and evaluating waste reduction. Users can then establish numerical performance measures to measure progress in planning, training, self-assessments, field implementation, documentation, and technology transfer. Cost savings result as users train and assess themselves and perform preliminary waste assessments

  11. A reliability program for emergency diesel generators at nuclear power plants: Maintenance, surveillance, and condition monitoring

    International Nuclear Information System (INIS)

    Lofgren, E.V.; Henderson, W.; Burghardt, D.; Kripps, L.; Rothleder, B.

    1988-12-01

    This report is a companion report on NUREG/CR-5078, Volume 1, ''A Reliability Program for Emergency Diesel Generators at Nuclear Power Plants: Program Structure.'' The purpose of this report is to provide technical findings and insights related to: failure evaluation, troubleshooting, maintenance, surveillance, and condition monitoring. Examples and recommendations are provided for each of these areas based on actual emergency diesel generator (EDG) operating experience and the opinions of diesel generator experts. This report expands the more general guidance provided in Volume 1. In addition, a discussion of EDG interactions with other plant systems (e.g., instrument, air, service water, dc power) is provided since experience has shown that these support systems and their operation can adversely affect EDG reliability. Portions of this report have been designed for use by onsite personnel for evaluating operational characteristics of EDGs. 5 refs., 8 figs., 7 tabs

  12. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    Science.gov (United States)

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  13. A focused ethnographic study of Alberta cattle veterinarians' decision making about diagnostic laboratory submissions and perceptions of surveillance programs.

    Directory of Open Access Journals (Sweden)

    Kate Sawford

    Full Text Available The animal and public health communities need to address the challenge posed by zoonotic emerging infectious diseases. To minimize the impacts of future events, animal disease surveillance will need to enable prompt event detection and response. Diagnostic laboratory-based surveillance systems targeting domestic animals depend in large part on private veterinarians to submit samples from cases to a laboratory. In contexts where pre-diagnostic laboratory surveillance systems have been implemented, this group of veterinarians is often asked to input data. This scenario holds true in Alberta where private cattle veterinarians have been asked to participate in the Alberta Veterinary Surveillance Network-Veterinary Practice Surveillance, a platform to which pre-diagnostic disease and non-disease case data are submitted. Consequently, understanding the factors that influence these veterinarians to submit cases to a laboratory and the complex of factors that affect their participation in surveillance programs is foundational to interpreting disease patterns reported by laboratories and engaging veterinarians in surveillance. A focused ethnographic study was conducted with ten cattle veterinarians in Alberta. Individual in-depth interviews with participants were recorded and transcribed to enable thematic analysis. Laboratory submissions were biased toward outbreaks of unknown cause, cases with unusual mortality rates, and issues with potential herd-level implications. Decreasing cattle value and government support for laboratory testing have contributed to fewer submissions over time. Participants were willing participants in surveillance, though government support and collaboration were necessary. Changes in the beef industry and veterinary profession, as well as cattle producers themselves, present both challenges and opportunities in surveillance.

  14. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    Science.gov (United States)

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

  15. The US Support Program to IAEA Safeguards Priority of Containment and Surveillance

    Energy Technology Data Exchange (ETDEWEB)

    Diaz,R.A.

    2008-06-13

    The United States Support Program (USSP) priority for containment and surveillance (US) focuses on maintaining or improving the reliability and cost-effectiveness of C/S systems for IAEA safeguards, expanding the number of systems that are unattended and remotely monitored, and developing verification methods that help streamline the on-site inspection process. Existing IAEA C/S systems have evolved to become complex, integrated systems, which may include active seals, nondestructive assay (NDA) instruments, video cameras, and other sensors. These systems operate autonomously. They send analytical data to IAEA headquarters where it can be reviewed. These systems present challenges to the goals of improved system performance, standardization, reliability, maintainability, documentation, and cost effectiveness. One critical lesson from past experiences is the need for cooperation and common objectives among the IAEA, the developer, and the facility operator, to create a successful, cost effective system. Recent USSP C/S activities include Rokkasho Reprocessing Plant safeguard systems, production of a new shift register, numerous vulnerability assessments of C/S systems, a conduit monitoring system which identifies tampering of IAEA conduit deployed in the field, fiber optic seal upgrades, unattended monitoring system software upgrades, next generation surveillance system which will upgrade existing camera systems, and support of the IAEA's development of the universal nondestructive assay data acquisition platform.

  16. Minutes of the 13th light water reactor pressure vessel surveillance dosimetry improvement program (LWR-PV-SDIP) meeting

    International Nuclear Information System (INIS)

    1984-04-01

    Information is presented concerning ASTM LWR standards and program documentation; trend curves, PSF, and other test reactor metallurgical programs; PSF dosimetry and metallurgical capsule neutron and gamma environment characterization and metallurgical studies; PVS characterization program; other neutron fields; surveillance dosimetry measurement facility (SDMF) and perturbation studies; transport theory calculations; gamma field benchmarks and photo-reaction studies; and fission and non-fission sensor inventories and quality assurance

  17. Establishment of a High Canine Rabies Burden in Haiti through the Implementation of a Novel Surveillance Program [corrected].

    Directory of Open Access Journals (Sweden)

    Ryan M Wallace

    2015-11-01

    Full Text Available The Republic of Haiti is one of only several countries in the Western Hemisphere in which canine rabies is still endemic. Estimation methods have predicted that 130 human deaths occur per year, yet existing surveillance mechanisms have detected few of these rabies cases. Likewise, canine rabies surveillance capacity has had only limited capacity, detecting only two rabid dogs per year, on average. In 2013, Haiti initiated a community-based animal rabies surveillance program comprised of two components: active community bite investigation and passive animal rabies investigation. From January 2013 -December 2014, 778 rabies suspect animals were reported for investigation. Rabies was laboratory-confirmed in 70 animals (9% and an additional 36 cases were identified based on clinical diagnosis (5%, representing an 18-fold increase in reporting of rabid animals compared to the three years before the program was implemented. Dogs were the most frequent rabid animal (90%. Testing and observation ruled out rabies in 61% of animals investigated. A total of 639 bite victims were reported to the program and an additional 364 bite victims who had not sought medical care were identified during the course of investigations. Only 31% of people with likely rabies exposures had initiated rabies post-exposure prophylaxis prior to the investigation. Rabies is a neglected disease in-part due to a lack of surveillance and understanding about the burden. The surveillance methods employed by this program established a much higher burden of canine rabies in Haiti than previously recognized. The active, community-based bite investigations identified numerous additional rabies exposures and bite victims were referred for appropriate medical care, averting potential human rabies deaths. The use of community-based rabies surveillance programs such as HARSP should be considered in canine rabies endemic countries.

  18. What Have We Learned From the Typhoid Fever Surveillance in Africa Program?

    Science.gov (United States)

    Baker, Stephen; Hombach, Joachim; Marks, Florian

    2016-03-15

    The Typhoid Fever Surveillance in Africa Program (TSAP) was established in 2009 to fill the data void concerning invasive Salmonella disease in sub-Saharan Africa, and to specifically estimate the burden of bloodstream infections caused by the key pathogen, Salmonella enterica serovar Typhi. TSAP has achieved this ambitious target, finding high incidences of typhoid fever in both rural and urban populations in several countries in sub-Saharan Africa. The results of TSAP will undoubtedly dictate the direction of future typhoid fever research in Africa, and at last provides a key piece of the disease burden jigsaw puzzle. With the dawn of new Vi conjugate vaccines against Salmonella Typhi, the next priority for the typhoid community must be providing the required data on these vaccines so they can be licensed and provided to those in high-risk groups and locations across sub-Saharan Africa. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

  19. Economic evaluation and budget impact analysis of the surveillance program for hepatocellular carcinoma in Thai chronic hepatitis B patients.

    Science.gov (United States)

    Sangmala, Pannapa; Chaikledkaew, Usa; Tanwandee, Tawesak; Pongchareonsuk, Petcharat

    2014-01-01

    The incidence rate and the treatment costs of hepatocellular carcinoma (HCC) are high, especially in Thailand. Previous studies indicated that early detection by a surveillance program could help by down-staging. This study aimed to compare the costs and health outcomes associated with the introduction of a HCC surveillance program with no program and to estimate the budget impact if the HCC surveillance program were implemented. A cost utility analysis using a decision tree and Markov models was used to compare costs and outcomes during the lifetime period based on a societal perspective between alternative HCC surveillance strategies with no program. Costs included direct medical, direct non-medical, and indirect costs. Health outcomes were measured as life years (LYs), and quality adjusted life years (QALYs). The results were presented in terms of the incremental cost-effectiveness ratio (ICER) in Thai THB per QALY gained. One- way and probabilistic sensitivity analyses were applied to investigate parameter uncertainties. Budget impact analysis (BIA) was performed based on the governmental perspective. Semi-annual ultrasonography (US) and semi-annual ultrasonography plus alpha-fetoprotein (US plus AFP) as the first screening for HCC surveillance would be cost-effective options at the willingness to pay (WTP) threshold of 160,000 THB per QALY gained compared with no surveillance program (ICER=118,796 and ICER=123,451 THB/QALY), respectively. The semi-annual US plus AFP yielded more net monetary benefit, but caused a substantially higher budget (237 to 502 million THB) than semi-annual US (81 to 201 million THB) during the next ten fiscal years. Our results suggested that a semi-annual US program should be used as the first screening for HCC surveillance and included in the benefit package of Thai health insurance schemes for both chronic hepatitis B males and females aged between 40-50 years. In addition, policy makers considered the program could be feasible

  20. Experience gained with the development of a performance test program for the monitoring and surveillance systems in the Embalse nuclear power plant

    International Nuclear Information System (INIS)

    Arestin, M.L.

    1988-01-01

    The monitoring and surveillance system for Embalse nuclear power plant are presented. The reactor, the nuclear fuel management, the equipments from monitoring and surveillance system, the activities developed by the AIEA experts in each mission of this test program and the management of the components for this test program in Argentine are described. (E.G.) [pt

  1. Effectiveness and Cost-benefit Evaluation of a Comprehensive Workers' Health Surveillance Program for Sustainable Employability of Meat Processing Workers

    NARCIS (Netherlands)

    Holland, van Berry J.; Reneman, Michiel F; Soer, Remko; Brouwer, Sandra; de Boer, Michiel R

    Objective To evaluate the effectiveness of a comprehensive workers' health surveillance (WHS) program on aspects of sustainable employability and cost-benefit. Methods A cluster randomized stepped wedge trial was performed in a Dutch meat processing company from february 2012 until march 2015. In

  2. Effectiveness and Cost-benefit Evaluation of a Comprehensive Workers' Health Surveillance Program for Sustainable Employability of Meat Processing Workers

    NARCIS (Netherlands)

    van Holland, Berry J; Reneman, Michiel F; Soer, Remko; Brouwer, Sandra; de Boer, Michiel R

    2017-01-01

    Objective To evaluate the effectiveness of a comprehensive workers' health surveillance (WHS) program on aspects of sustainable employability and cost-benefit. Methods A cluster randomized stepped wedge trial was performed in a Dutch meat processing company from february 2012 until march 2015. In

  3. 9 CFR 146.14 - Diagnostic surveillance program for H5/H7 low pathogenic avian influenza.

    Science.gov (United States)

    2010-01-01

    .../H7 low pathogenic avian influenza. 146.14 Section 146.14 Animals and Animal Products ANIMAL AND PLANT... pathogenic avian influenza. (a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the...

  4. Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection.

    Science.gov (United States)

    North, Barbara B; Oldham, Michael J

    2011-02-01

    Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services.

  5. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    Science.gov (United States)

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  6. 8 x 8 fuel surveillance program at Monticello site - end of Cycle 6: fourth post-irradiation inspection, October 1978

    International Nuclear Information System (INIS)

    Skarshaug, N.H.

    1980-09-01

    A fuel surveillance program for a lead 8 x 8 reload fuel assembly was implemented at the Monticello Nuclear Power Station in May 1974 prior to Reactor Cycle 3. Inspection results of the fourth post-irradiation inspection performed on this surveillance fuel assembly in October 1978 at EOC 6, after a bundle average exposure of 25,900 MWd/MT, are presented. The measurement techniques, results obtained and comparisons to previous measurements are discussed. The bundle and individual rods examined exhibited characteristics of normal operation and were approved for continued irradiation during Monticello operating Cycle 7

  7. Program of environmental radiological surveillance of the radioactive wastes storage center of Maquixco in the period January-December 1991

    International Nuclear Information System (INIS)

    Gaso P, M.I.

    1991-12-01

    The primary objective of all program of environmental radiological surveillance (PVRA), it is to follow the evolution of the radioactive content of the links of the chains that constitute the different ways of transfer of the radioactivity toward the man, with the purpose of making a realistic evaluation of the environmental impact produced by the installation under surveillance. In the CADER in Mexico, only accidents or escapes of radioactivity of slow evolution can be detected. At the moment the radioactive wastes in this installation are not treated. In this report the results obtained during the year 1991 are presented. (Author)

  8. European surveillance network for influenza in pigs: surveillance programs, diagnostic tools and Swine influenza virus subtypes identified in 14 European countries from 2010 to 2013.

    Directory of Open Access Journals (Sweden)

    Gaëlle Simon

    Full Text Available Swine influenza causes concern for global veterinary and public health officials. In continuing two previous networks that initiated the surveillance of swine influenza viruses (SIVs circulating in European pigs between 2001 and 2008, a third European Surveillance Network for Influenza in Pigs (ESNIP3, 2010-2013 aimed to expand widely the knowledge of the epidemiology of European SIVs. ESNIP3 stimulated programs of harmonized SIV surveillance in European countries and supported the coordination of appropriate diagnostic tools and subtyping methods. Thus, an extensive virological monitoring, mainly conducted through passive surveillance programs, resulted in the examination of more than 9 000 herds in 17 countries. Influenza A viruses were detected in 31% of herds examined from which 1887 viruses were preliminary characterized. The dominating subtypes were the three European enzootic SIVs: avian-like swine H1N1 (53.6%, human-like reassortant swine H1N2 (13% and human-like reassortant swine H3N2 (9.1%, as well as pandemic A/H1N1 2009 (H1N1pdm virus (10.3%. Viruses from these four lineages co-circulated in several countries but with very different relative levels of incidence. For instance, the H3N2 subtype was not detected at all in some geographic areas whereas it was still prevalent in other parts of Europe. Interestingly, H3N2-free areas were those that exhibited highest frequencies of circulating H1N2 viruses. H1N1pdm viruses were isolated at an increasing incidence in some countries from 2010 to 2013, indicating that this subtype has become established in the European pig population. Finally, 13.9% of the viruses represented reassortants between these four lineages, especially between previous enzootic SIVs and H1N1pdm. These novel viruses were detected at the same time in several countries, with increasing prevalence. Some of them might become established in pig herds, causing implications for zoonotic infections.

  9. Factors influencing moisture analysis in the 3013 destructive examination surveillance program

    Energy Technology Data Exchange (ETDEWEB)

    Scogin, J. H. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

    2017-10-24

    Thermogravimetric analysis of a solid sample with mass spectrometry (TGA-MS) of the evolved gas is used in the destructive examination (DE) portion of the Integrated Surveillance Program to quantify the moisture content of the material stored in a 3013 container. As with any measurement determined from a small sample, the collection, storage, transportation, and handling of the sample can affect its ability to represent the properties of the bulk material. During the course of the DE program, questions have periodically arisen concerning the ability of the moisture sample to reflect reliably the actual moisture content of the entire material stored in the 3013 container. Most concerns are related to the ability to collect a representative sample and to preserve the moisture content of the sample between collection and analysis. Recent delays in analysis caused by maintenance issues with the TGA-MS instrument presented a unique opportunity to document and quantify the effects various factors have on the TGA-MS moisture measurement. This report will use recent data to document the effects that current sample collection and handling practices have on the TGA-MS moisture measurement. Some suggestions will be made which could improve the current sample collection and handling practices for the TGA-MS moisture measurement so that the analytical results more accurately reflect the moisture content of the material stored in the 3013 container.

  10. Overview of a comprehensive environmental monitoring and surveillance program: The role of fish and wildlife

    International Nuclear Information System (INIS)

    Gray, R.H.

    1988-05-01

    Concern about the effects of potential releases from nuclear and non-nuclear activities on the US Department of Energy's Hanford Site in southeastern Washington has evolved over four decades into a comprehensive environmental monitoring and surveillance program. The program includes field sampling, and chemical and physical analyses of air, surface and ground water, fish and wildlife, soil, foodstuffs, and natural vegetation. In addition to monitoring radioactivity in fish and wildlife, population numbers of key species are determined, usually during the breeding season. Data from monitoring efforts are used to assess the environmental impacts of Hanford operations and calculate the overall radiological dose to humans onsite, at the Site perimeter, or residing in nearby communities. Chinook salmon spawning in the Columbia River at Hanford has increased in recent years with a concomitant increase in winter nesting activity of bald eagles (Haliaeetus leucocephalus). An elk (Cervus elaphus) herd, established by immigration in 1972, is also increasing. Nesting Canada goose (Branta canadensis) and great blue heron (Ardea herodias), and various other animals, e.g., mule deer (Odocoileus hemionus) and coyotes (Canis latrans) are common. Measured exposure to penetrating radiation and calculated radiation doses to the public are well below applicable regulatory limits

  11. Factors influencing moisture analysis in the 3013 destructive examination surveillance program

    International Nuclear Information System (INIS)

    Scogin, J. H.

    2017-01-01

    Thermogravimetric analysis of a solid sample with mass spectrometry (TGA-MS) of the evolved gas is used in the destructive examination (DE) portion of the Integrated Surveillance Program to quantify the moisture content of the material stored in a 3013 container. As with any measurement determined from a small sample, the collection, storage, transportation, and handling of the sample can affect its ability to represent the properties of the bulk material. During the course of the DE program, questions have periodically arisen concerning the ability of the moisture sample to reflect reliably the actual moisture content of the entire material stored in the 3013 container. Most concerns are related to the ability to collect a representative sample and to preserve the moisture content of the sample between collection and analysis. Recent delays in analysis caused by maintenance issues with the TGA-MS instrument presented a unique opportunity to document and quantify the effects various factors have on the TGA-MS moisture measurement. This report will use recent data to document the effects that current sample collection and handling practices have on the TGA-MS moisture measurement. Some suggestions will be made which could improve the current sample collection and handling practices for the TGA-MS moisture measurement so that the analytical results more accurately reflect the moisture content of the material stored in the 3013 container.

  12. Electronic surveillance systems in infection prevention: organizational support, program characteristics, and user satisfaction.

    Science.gov (United States)

    Grota, Patti G; Stone, Patricia W; Jordan, Sarah; Pogorzelska, Monika; Larson, Elaine

    2010-09-01

    The use of electronic surveillance systems (ESSs) is gradually increasing in infection prevention and control programs. Little is known about the characteristics of hospitals that have a ESS, user satisfaction with ESSs, and organizational support for implementation of ESSs. A total of 350 acute care hospitals in California were invited to participate in a Web-based survey; 207 hospitals (59%) agreed to participate. The survey included a description of infection prevention and control department staff, where and how they spent their time, a measure of organizational support for infection prevention and control, and reported experience with ESSs. Only 23% (44/192) of responding infection prevention and control departments had an ESS. No statistically significant difference was seen in how and where infection preventionists (IPs) who used an ESS and those who did not spend their time. The 2 significant predictors of whether an ESS was present were score on the Organizational Support Scale (odds ratio [OR], 1.10; 95% confidence interval [CI], 1.02-1.18) and hospital bed size (OR, 1.004; 95% CI, 1.00-1.007). Organizational support also was positively correlated with IP satisfaction with the ESS, as measured on the Computer Usability Scale (P = .02). Despite evidence that such systems may improve efficiency of data collection and potentially improve patient outcomes, ESSs remain relatively uncommon in infection prevention and control programs. Based on our findings, organizational support appears to be a major predictor of the presence, use, and satisfaction with ESSs in infection prevention and control programs.

  13. Electronic surveillance systems in infection prevention: Organizational support, program characteristics, and user satisfaction

    Science.gov (United States)

    Grota, Patti G.; Stone, Patricia W.; Jordan, Sarah; Pogorzelska, Monika; Larson, Elaine

    2012-01-01

    Background The use of electronic surveillance systems (ESSs) is gradually increasing in infection prevention and control programs. Little is known about the characteristics of hospitals that have a ESS, user satisfaction with ESSs, and organizational support for implementation of ESSs. Methods A total of 350 acute care hospitals in California were invited to participate in a Web-based survey; 207 hospitals (59%) agreed to participate. The survey included a description of infection prevention and control department staff, where and how they spent their time, a measure of organizational support for infection prevention and control, and reported experience with ESSs. Results Only 23% (44/192) of responding infection prevention and control departments had an ESS. No statistically significant difference was seen in how and where infection preventionists (IPs) who used an ESS and those who did not spend their time. The 2 significant predictors of whether an ESS was present were score on the Organizational Support Scale (odds ratio [OR], 1.10; 95% confidence interval [CI], 1.02-1.18) and hospital bed size (OR, 1.004; 95% CI, 1.00-1.007). Organizational support also was positively correlated with IP satisfaction with the ESS, as measured on the Computer Usability Scale (P = .02). Conclusion Despite evidence that such systems may improve efficiency of data collection and potentially improve patient outcomes, ESSs remain relatively uncommon in infection prevention and control programs. Based on our findings, organizational support appears to be a major predictor of the presence, use, and satisfaction with ESSs in infection prevention and control programs. PMID:20176411

  14. The Department of Defense Global, Laboratory-Based Influenza Surveillance Program: Technical Report on Program Methods for the 2012-2013 Influenza Season

    Science.gov (United States)

    2013-10-01

    PNL (EPI)” in AHLTA/CHCS, where available To request col lection kits, use the current ve rsion of the “Supply Orde r Form ” avai lable (under...Influenza Surveillance Program Sentinel Sites • Order the “RESPIRATORY CULTURE PNL (EPI)” in AHLTA/CHCS, where available • Submit 6-10 specimens

  15. Surveillance programs in Denmark has revealed the circulation of novel reassortant influenza A viruses in swine

    DEFF Research Database (Denmark)

    Larsen, Lars Erik; Hjulsager, Charlotte Kristiane; Trebbien, Ramona

    2014-01-01

    avH1N1 and H3N2 which is different from the dominating European H1N2 subtype (1). The prevalence of the H1N1pdm09 virus in swine has increased since 2009 in some countries including Denmark. Here we present the results of the national passive surveillance program on influenza in swine performed from...... by the combination of the gene segments hemagglutinin (HA) and neuraminidase (NA). In most European countries, the avian-like (av)H1N1, the 2009 pandemic variant (H1N1pdm09), H1N2 and H3N2 subtypes have constituted the dominating SIV subtypes during recent years. In Denmark, the H1N2 subtype is a reassortant between......Swine influenza is a respiratory disease caused by multiple subtypes of influenza A virus. Swine influenza virus (SIV) is enzootic in swine populations in Europe, Asia, North and South America. The influenza A virus genome consist of eight distinct gene segments and SIV subtypes are defined...

  16. Minutes of the Twelfth LWR pressure vessel surveillance dosimtery improvement program meeting

    International Nuclear Information System (INIS)

    1989-01-01

    The 1983 Twelfth Light Water Reactor Pressure Vessel Surveillance Dosimetry Improvement Program (LWR-PV-SDIP) Meeting, which was held October 24-28, 1983. Sections 1 through 14 of this report provide documentation of agreements, commitments, and reports that are subject to the approval and concurrence of the participating laboratories and supporting agencies and organizations. Attachment No. 1 provides information on the preparation of a number of NUREG publications that will document the results of various aspects of the LWR-PV-SDIP. For each NUREG publication, a tentative ''Table of Contents'' is provided in addition to suggested interlaboratory writing assignments and camera-ready copy contribution due dates, as appropriate. Attachment No. 2 provides information on planning for the Fifth ASTM-EURATOM Symposium. Attachment No. 3 provides information on an ASTM press release about an MPC-6 meeting and dpa and E > 1 MeV exposure parameters. Attachments No. 4 and 5 provide copies of two LWR-PV-SDIP related papers presented at the Eleventh WRSR Information Meeting, October 24-28, 1983

  17. Corrosion surveillance program of aluminum spent fuel elements in wet storage sites

    International Nuclear Information System (INIS)

    Linardi, E; Haddad, R

    2012-01-01

    Due to different degradation issues observed in aluminum-clad spent fuel during long term storage in water, the IAEA implemented in 1996 a Coordinated Research Project (CRP) and a Regional Project for Latin America, on Corrosion of Research Reactor Aluminum Clad Spent Fuel in Water. Argentine has been among the participant countries of these projects, carrying out spent fuel corrosion surveillance activities in its storage facilities. As a result of the research a large database on corrosion of aluminum-clad fuel has been generated. It was determined that the main types of corrosion affecting the spent fuel are pitting and galvanic corrosion due to contact with stainless steel. It was concluded that the quality of the water is the critical factor to control in a spent fuel storage facility. Another phase of the program is being conducted currently, which began in 2011 with the immersion of test racks in the RA1 reactor pool, and in the Research Reactor Spent Fuel Storage Facility (FACIRI), located in Ezeiza Atomic Center. This paper presents the results of the chemical analysis of the water performed so far, and its relationship with the examination of the coupons extracted from the sites (author)

  18. The EBR-II materials-surveillance program. 4: Results of SURV-4 and SURV-6

    International Nuclear Information System (INIS)

    Ruther, W.E.; Hayner, G.O.; Carlson, B.G.; Ebersole, E.R.; Allen, T.R.

    1998-01-01

    In March of 1965, a set of surveillance (SURV) samples was placed in the EBR-II reactor to determine the effect of irradiation, thermal aging, and sodium corrosion on reactor materials. Eight subassemblies were placed into row 12 positions of EBR-II to determine the effect of irradiation at 370 C. Two subassemblies were placed into the primary sodium basket to determine the effect of thermal aging at 370 C. For both the irradiated and thermally aged samples, one half of all samples were exposed to primary system sodium while one half were sealed in capsules with a helium atmosphere. Fifteen different structural materials were tested in the SURV program. In addition to the fifteen types of metal samples, graphite blocks were irradiated in the SURV subassemblies to determine the effect of irradiation on the graphite neutron shield. In this report, the properties of these materials irradiated at 370 C to a total fluence of 2.2 x 10 22 n/cm 2 (over 2,994 days) are compared with those of similar specimens thermally aged at 370 C for 2,994 days in the storage basket of the reactor. The properties analyzed were weight, density, microstructure, hardness, tensile and yield strength, impact strength, and creep

  19. [Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-12-01

    Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

  20. NASA Astronaut Occupational Surveillance Program and Lifetime Surveillance of Astronaut Health, LSAH, Astronaut Exposures and Risk in the Terrestrial and Spaceflight Environment

    Science.gov (United States)

    Keprta, Sean R.; Tarver, William; Van Baalen, Mary; McCoy, Torin

    2015-01-01

    United States Astronauts have a very unique occupational exposure profile. In order to understand these risks and properly address them, the National Aeronautics and Atmospheric Administration, NASA, originally created the Longitudinal Study of Astronaut Health, LSAH. The first LSAH was designed to address a variety of needs regarding astronaut health and included a 3 to 1 terrestrial control population in order to compare United States "earth normal" disease and aging to that of a microgravity exposed astronaut. Over the years that program has been modified, now termed Lifetime Surveillance of Astronaut Health, still LSAH. Astronaut spaceflight exposures have also changed, with the move from short duration shuttle flights to long duration stays on international space station and considerable terrestrial training activities. This new LSAH incorporates more of an occupational health and medicine model to the study of occupationally exposed astronauts. The presentation outlines the baseline exposures and monitoring of the astronaut population to exposures, both terrestrial, and in space.

  1. The EBR-II materials-surveillance program. 5: Results of SURV-5

    International Nuclear Information System (INIS)

    Ruther, W.E.; Staffon, J.D.; Carlson, B.G.; Allen, T.R.

    1998-01-01

    In March of 1965, a set of surveillance (SURV) samples was placed in the EBR-II reactor to determine the effect of irradiation, thermal aging, and sodium corrosion on reactor materials. Eight subassemblies were placed into row 12 positions of EBR-II to determine the effect of irradiation at 370 C. Two subassemblies were placed into the primary sodium basket to determine the effect of thermal aging at 370 C. One half of all samples were exposed to primary system sodium while one half were sealed in capsules with a helium atmosphere. Fifteen different structural materials were tested in the SURV program. In this work, the properties of these materials irradiated at 370 C to a total fluence of 3.2 x 10 22 n/cm 2 were determined. These materials are the fifth set of irradiated subassemblies to be examined as part of the SURV program (SURV-5). The properties analyzed were weight, density, microstructure, hardness, tensile and yield strength, and fracture resistance. Of all the alloys examined in SURV-5, only Berylco-25 showed any significant weight loss. Stainless steel (both 304 and 347) had the largest density decrease, although the density decrease from irradiation for all alloys was less than 0.4 percent. The microstructure of both Berylco-25 and the aluminum-bronze alloy was altered significantly. Iron- and nickel-base alloys showed little change in microstructure. Austenitic steels (304 and 347) harden with irradiation. The hardness of Inconel X750 did not change significantly with irradiation. The ultimate tensile strength of Inconel X750, 304 stainless steel, 420 stainless steel and welded 304 changed little due to a fluence increase from 2.2 x 10 22 n/cm 2 (the maximum fluence of the SURV-4 samples) to 3.2 x 10 22 n/cm 2

  2. Annual summary report on the surveillance and maintenance activities for the Oak Rige National Laboratory Environmental Restoration Program for fiscal year 1995

    International Nuclear Information System (INIS)

    1995-11-01

    This Annual Summary Report on the Surveillance and Maintenance Activities for the Oak Ridge National Laboratory Environmental Restoration Program for Fiscal Year 1995 was prepared to communicate the accomplishments of the Program during fiscal year 1995. This work was performed under work breakdown structure element 1.4.12.6.1.14.20 (activity data sheet 3314, ''Remedial Action Surveillance and Maintenance''). Publication of this document meets the Life Cycle Baseline milestone date of November 30, 1995. This document provides the accomplishments for both the Remedial Action and Decontamination and Decommissioning Surveillance and Maintenance programs

  3. Annual summary report of the Decontamination and Decommissioning Surveillance and Maintenance Program at Oak Ridge National Laboratory for period ending September 30, 1994

    International Nuclear Information System (INIS)

    Anderson, L.A.; Burwinkle, T.W.; Ford, M.K.; Gaddis, H.R.; Holder, L. Jr.; Mandry, G.J.; Nelson, T.R.; Patton, B.D.

    1995-03-01

    The Surplus Facilities Management Program (SFMP) was established at Oak Ridge National Laboratory (ORNL) in 1976 to provide collective management of all surplus sites under ORNL's control on the Oak Ridge Reservation. Presently, over 50 facilities, grouped into projects, are currently managed by the Decontamination and Decommissioning Program, the successor program to the SFMP. Support includes (1) surveillance and maintenance planning; (2) routine surveillance and maintenance; and (3) special maintenance projects. This report documents routine surveillance and maintenance, special projects, and special maintenance performed on these facilities for the period of October 1993 through September 1994

  4. Studies and research concerning BNFP: process monitoring and process surveillance demonstration program

    Energy Technology Data Exchange (ETDEWEB)

    Kight, H R

    1979-11-01

    Computerized methods of monitoring process functions and alarming off-standard conditions were implemented and demonstrated during the FY 1979 Uranium Run. In addition, prototype applications of instruments for the purpose of tamper indication and surveillance were tested.

  5. Surveillance programs for detection and characterization of emergent pathogens and antimicrobial resistance: results from the Division of Infectious Diseases, UNIFESP.

    Science.gov (United States)

    Colombo, Arnaldo L; Janini, Mario; Salomão, Reinaldo; Medeiros, Eduardo A S; Wey, Sergio B; Pignatari, Antonio C C

    2009-09-01

    Several epidemiological changes have occurred in the pattern of nosocomial and community acquired infectious diseases during the past 25 years. Social and demographic changes possibly related to this phenomenon include a rapid population growth, the increase in urban migration and movement across international borders by tourists and immigrants, alterations in the habitats of animals and arthropods that transmit disease, as well as the raise of patients with impaired host defense abilities. Continuous surveillance programs of emergent pathogens and antimicrobial resistance are warranted for detecting in real time new pathogens, as well as to characterize molecular mechanisms of resistance. In order to become more effective, surveillance programs of emergent pathogens should be organized as a multicenter laboratory network connected to the main public and private infection control centers. Microbiological data should be integrated to guide therapy, adapting therapy to local ecology and resistance patterns. This paper presents an overview of data generated by the Division of Infectious Diseases, Federal University of São Paulo, along with its participation in different surveillance programs of nosocomial and community acquired infectious diseases.

  6. Facility Decontamination and Decommissioning Program Surveillance and Maintenance Plan, Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Poderis, Reed J. [NSTec; King, Rebecca A. [NSTec

    2013-09-30

    This Surveillance and Maintenance (S&M) Plan describes the activities performed between deactivation and final decommissioning of the following facilities located on the Nevada National Security Site, as documented in the Federal Facility Agreement and Consent Order under the Industrial Sites program as decontamination and decommissioning sites: ? Engine Maintenance, Assembly, and Disassembly (EMAD) Facility: o EMAD Building (Building 25-3900) o Locomotive Storage Shed (Building 25-3901) ? Test Cell C (TCC) Facility: o Equipment Building (Building 25-3220) o Motor Drive Building (Building 25-3230) o Pump Shop (Building 25-3231) o Cryogenic Lab (Building 25-3232) o Ancillary Structures (e.g., dewars, water tower, piping, tanks) These facilities have been declared excess and are in various stages of deactivation (low-risk, long-term stewardship disposition state). This S&M Plan establishes and implements a solid, cost-effective, and balanced S&M program consistent with federal, state, and regulatory requirements. A graded approach is used to plan and conduct S&M activities. The goal is to maintain the facilities in a safe condition in a cost-effective manner until their final end state is achieved. This plan accomplishes the following: ? Establishes S&M objectives and framework ? Identifies programmatic guidance for S&M activities to be conducted by National Security Technologies, LLC, for the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) ? Provides present facility condition information and identifies hazards ? Identifies facility-specific S&M activities to be performed and their frequency ? Identifies regulatory drivers, NNSA/NFO policies and procedures, and best management practices that necessitate implementation of S&M activities ? Provides criteria and frequencies for revisions and updates ? Establishes the process for identifying and dispositioning a condition that has not been previously identified or

  7. The AFHSC-Division of GEIS Operations Predictive Surveillance Program: a multidisciplinary approach for the early detection and response to disease outbreaks.

    Science.gov (United States)

    Witt, Clara J; Richards, Allen L; Masuoka, Penny M; Foley, Desmond H; Buczak, Anna L; Musila, Lillian A; Richardson, Jason H; Colacicco-Mayhugh, Michelle G; Rueda, Leopoldo M; Klein, Terry A; Anyamba, Assaf; Small, Jennifer; Pavlin, Julie A; Fukuda, Mark M; Gaydos, Joel; Russell, Kevin L; Wilkerson, Richard C; Gibbons, Robert V; Jarman, Richard G; Myint, Khin S; Pendergast, Brian; Lewis, Sheri; Pinzon, Jorge E; Collins, Kathrine; Smith, Matthew; Pak, Edwin; Tucker, Compton; Linthicum, Kenneth; Myers, Todd; Mansour, Moustafa; Earhart, Ken; Kim, Heung Chul; Jiang, Ju; Schnabel, Dave; Clark, Jeffrey W; Sang, Rosemary C; Kioko, Elizabeth; Abuom, David C; Grieco, John P; Richards, Erin E; Tobias, Steven; Kasper, Matthew R; Montgomery, Joel M; Florin, Dave; Chretien, Jean-Paul; Philip, Trudy L

    2011-03-04

    The Armed Forces Health Surveillance Center, Division of Global Emerging Infections Surveillance and Response System Operations (AFHSC-GEIS) initiated a coordinated, multidisciplinary program to link data sets and information derived from eco-climatic remote sensing activities, ecologic niche modeling, arthropod vector, animal disease-host/reservoir, and human disease surveillance for febrile illnesses, into a predictive surveillance program that generates advisories and alerts on emerging infectious disease outbreaks. The program's ultimate goal is pro-active public health practice through pre-event preparedness, prevention and control, and response decision-making and prioritization. This multidisciplinary program is rooted in over 10 years experience in predictive surveillance for Rift Valley fever outbreaks in Eastern Africa. The AFHSC-GEIS Rift Valley fever project is based on the identification and use of disease-emergence critical detection points as reliable signals for increased outbreak risk. The AFHSC-GEIS predictive surveillance program has formalized the Rift Valley fever project into a structured template for extending predictive surveillance capability to other Department of Defense (DoD)-priority vector- and water-borne, and zoonotic diseases and geographic areas. These include leishmaniasis, malaria, and Crimea-Congo and other viral hemorrhagic fevers in Central Asia and Africa, dengue fever in Asia and the Americas, Japanese encephalitis (JE) and chikungunya fever in Asia, and rickettsial and other tick-borne infections in the U.S., Africa and Asia.

  8. Incidence, treatment and survival of patients with craniopharyngioma in the surveillance, epidemiology and end results program

    Science.gov (United States)

    Zacharia, Brad E.; Bruce, Samuel S.; Goldstein, Hannah; Malone, Hani R.; Neugut, Alfred I.; Bruce, Jeffrey N.

    2012-01-01

    Craniopharyngioma is a rare primary central nervous system neoplasm. Our objective was to determine factors associated with incidence, treatment, and survival of craniopharyngiomas in the United States. We used the surveillance, epidemiology and end results program (SEER) database to identify patients who received a diagnosis of craniopharyngioma during 2004–2008. We analyzed clinical and demographic information, including age, race, sex, tumor histology, and treatment. Age-adjusted incidence rates and age, sex, and race-adjusted expected survival rates were calculated. We used Cox proportional hazards models to determine the association between covariates and overall survival. We identified 644 patients with a diagnosis of craniopharyngioma. Black race was associated with an age-adjusted relative risk for craniopharyngioma of 1.26 (95% confidence interval [CI], 0.98–1.59), compared with white race. One- and 3-year survival rates of 91.5% (95% CI, 88.9%–93.5%), and 86.2% (95% CI, 82.7%–89.0%) were observed for the cohort; relative survival rates were 92.1% (95% CI, 89.5%–94.0%) and 87.6% (95% CI, 84.1%–90.4%) for 1- and 3-years, respectively. In the multivariable model, factors associated with prolonged survival included younger age, smaller tumor size, subtotal resection, and radiation therapy. Black race, on the other hand, was associated with worse overall survival in the final model. We demonstrated that >85% of patients survived 3 years after diagnosis and that subtotal resection and radiation therapy were associated with prolonged survival. We also noted a higher incidence rate and worse 1- and 3-year survival rates in the black population. Future investigations should examine these racial disparities and focus on evaluating the efficacy of emerging treatment paradigms. PMID:22735773

  9. Feasibility and acceptability of a workers' health surveillance program for hospital physicians.

    Science.gov (United States)

    Ruitenburg, Martijn M; Plat, Marie-Christine J; Frings-Dresen, Monique H W; Sluiter, Judith K

    2015-01-01

    A Workers' Health Surveillance (WHS) program is an occupational health strategy used to detect and address the health of individual workers to improve their ability to work. This study aims to investigate the feasibility and acceptability of a new job-specific WHS for hospital physicians. All hospital physicians of the general surgery, radiotherapy and obstetrics and gynecology departments from 1 academic hospital were invited to participate in the WHS by the in-company occupational health service. An occupational physician and a medical assistant were trained to use the protocol. Feasibility was operationalized as the received and delivered dose, observed success factors and potential obstacles. Acceptability was assessed by asking whether the WHS was desirable and feasible for future use and by estimating the effects on health and work ability. Written questions and semi-structured interviews were conducted with the participating physicians, 5 department managers and the 2 occupational health professionals involved in the study. One-third of the hospital physicians (34%) participated in every part of the WHS. The delivered dose was 77/84 (92%). Almost all hospital physicians who received recommendations expected to adhere to this advice. The study participants appreciated the organization of the WHS. This WHS was positively graded (8 out of 10 max) in terms of acceptability. Positive effects of the WHS on health, work functioning and long-term work ability were perceived by 2/3 of the physicians. The new job-specific WHS for hospital physicians showed good feasibility and acceptability among participating hospital physicians, occupational health professionals and medical managers. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  10. Feasibility and acceptability of a workers’ health surveillance program for hospital physicians

    Directory of Open Access Journals (Sweden)

    Martijn M. Ruitenburg

    2015-08-01

    Full Text Available Objectives: A Workers’ Health Surveillance (WHS program is an occupational health strategy used to detect and address the health of individual workers to improve their ability to work. This study aims to investigate the feasibility and acceptability of a new job-specific WHS for hospital physicians. Material and Methods: All hospital physicians of the general surgery, radiotherapy and obstetrics and gynecology departments from 1 academic hospital were invited to participate in the WHS by the in-company occupational health service. An occupational physician and a medical assistant were trained to use the protocol. Feasibility was operationalized as the received and delivered dose, observed success factors and potential obstacles. Acceptability was assessed by asking whether the WHS was desirable and feasible for future use and by estimating the effects on health and work ability. Written questions and semi-structured interviews were conducted with the participating physicians, 5 department managers and the 2 occupational health professionals involved in the study. Results: One-third of the hospital physicians (34% participated in every part of the WHS. The delivered dose was 77/84 (92%. Almost all hospital physicians who received recommendations expected to adhere to this advice. The study participants appreciated the organization of the WHS. This WHS was positively graded (8 out of 10 max in terms of acceptability. Positive effects of the WHS on health, work functioning and long-term work ability were perceived by 2/3 of the physicians. Conclusions: The new job-specific WHS for hospital physicians showed good feasibility and acceptability among participating hospital physicians, occupational health professionals and medical managers.

  11. Lawrence Livermore National Laboratory (LLNL) Oxide Material Representation in the Material Identification and Surveillance (MIS) Program, Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Riley, D C; Dodson, K

    2004-06-30

    The Materials Identification and Surveillance (MIS) program was established within the 94-1 R&D Program to confirm the suitability of plutonium-bearing materials for stabilization, packaging, and long-term storage under DOE-STD-3013-2000. Oxide materials from different sites were chemically and physically characterized. The adequacy of the stabilization process parameters of temperature and duration at temperature (950 C and 2 hours) for eliminating chemical reactivity and reducing the moisture content to less than 0.5 weight percent were validated. Studies also include surveillance monitoring to determine the behavior of the oxides and packaging materials under storage conditions. Materials selected for this program were assumed to be representative of the overall inventory for DOE sites. The Quality Assurance section of the DOE-STD-3013-2000 required that each site be responsible for assuring that oxides packaged according to this standard are represented by items in the MIS characterization program. The purpose of this document is to define the path for determining if an individual item is ''represented'' in the MIS Program and to show that oxides being packaged at Lawrence Livermore National Laboratory (LLNL) are considered represented in the MIS program. The methodology outlined in the MIS Representation Document (LA-14016-MS) for demonstrating representation requires concurrence of the MIS working Group (MIS-WG). The signature page on this document provides for the MIS-WG concurrence.

  12. Airborne Video Surveillance

    National Research Council Canada - National Science Library

    Blask, Steven

    2002-01-01

    The DARPA Airborne Video Surveillance (AVS) program was established to develop and promote technologies to make airborne video more useful, providing capabilities that achieve a UAV force multiplier...

  13. DVT surveillance program in the ICU: analysis of cost-effectiveness.

    Directory of Open Access Journals (Sweden)

    Ajai K Malhotra

    Full Text Available BACKGROUND: Venous Thrombo-embolism (VTE--Deep venous thrombosis (DVT and/or pulmonary embolism (PE--in traumatized patients causes significant morbidity and mortality. The current study evaluates the effectiveness of DVT surveillance in reducing PE, and performs a cost-effectiveness analysis. METHODS: All traumatized patients admitted to the adult ICU underwent twice weekly DVT surveillance by bilateral lower extremity venous Duplex examination (48-month surveillance period--SP. The rates of DVT and PE were recorded and compared to the rates observed in the 36-month pre-surveillance period (PSP. All patients in both periods received mechanical and pharmacologic prophylaxis unless contraindicated. Total costs--diagnostic, therapeutic and surveillance--for both periods were recorded and the incremental cost for each Quality Adjusted Life Year (QALY gained was calculated. RESULTS: 4234 patients were eligible (PSP--1422 and SP--2812. Rate of DVT in SP (2.8% was significantly higher than in PSP (1.3% - p<0.05, and rate of PE in SP (0.7% was significantly lower than that in PSP (1.5% - p<0.05. Logistic regression demonstrated that surveillance was an independent predictor of increased DVT detection (OR: 2.53 - CI: 1.462-4.378 and decreased PE incidence (OR: 0.487 - CI: 0.262-0.904. The incremental cost was $509,091/life saved in the base case, translating to $29,102/QALY gained. A sensitivity analysis over four of the parameters used in the model indicated that the incremental cost ranged from $18,661 to $48,821/QALY gained. CONCLUSIONS: Surveillance of traumatized ICU patients increases DVT detection and reduces PE incidence. Costs in terms of QALY gained compares favorably with other interventions accepted by society.

  14. Study of operational conditions in medical radiodiagnostic services - ionizing radiation surveillance program in Sao Paulo State, Brazil

    International Nuclear Information System (INIS)

    Aldred, Marta Aurelia; Eduardo, Maria Bernardete de Paula; Carvalho, Marisa Lima

    1996-01-01

    A radiation surveillance program was created in Sao Paulo State (Brazil) in 1994 to identify the risks in health care services. A total number of 259 centres were visited and 411 radiodiagnostic rooms were inspected. During the survey an 'inspection form' of 32 items was filled in. Analysis of the answers classified 24% of services as high risk, 22% of rooms showed irregular installations, 25% of X-ray equipment presented problems and 22% of personnel used inadequate procedures. Additional and regular surveys were programmed for the services considered of high risk in order to reduce it

  15. The new classification system for slaughter-pig herds in the Danish Salmonella surveillance-and-control program

    DEFF Research Database (Denmark)

    Alban, L.; Stege, Helle; Dahl, J.

    2002-01-01

    the Danish Salmonella Database including all herds in 2000. The classification scheme has been adjusted on the following points. (1) The sampling has been simplified into 60, 75, or 100 samples per herd per year depending on herd size. This means more-precise estimates for the seroprevalence among smaller......The Danish surveillance-and-control program for Salmonella in slaughter pigs was introduced in 1995. The key element of the program is a quick and correct identification of herds with high seroprevalence. After 5 years, the classification scheme was evaluated-and a revision was made. Data from two...

  16. The AFHSC-Division of GEIS Operations Predictive Surveillance Program: a multidisciplinary approach for the early detection and response to disease outbreaks

    Science.gov (United States)

    2011-01-01

    The Armed Forces Health Surveillance Center, Division of Global Emerging Infections Surveillance and Response System Operations (AFHSC-GEIS) initiated a coordinated, multidisciplinary program to link data sets and information derived from eco-climatic remote sensing activities, ecologic niche modeling, arthropod vector, animal disease-host/reservoir, and human disease surveillance for febrile illnesses, into a predictive surveillance program that generates advisories and alerts on emerging infectious disease outbreaks. The program’s ultimate goal is pro-active public health practice through pre-event preparedness, prevention and control, and response decision-making and prioritization. This multidisciplinary program is rooted in over 10 years experience in predictive surveillance for Rift Valley fever outbreaks in Eastern Africa. The AFHSC-GEIS Rift Valley fever project is based on the identification and use of disease-emergence critical detection points as reliable signals for increased outbreak risk. The AFHSC-GEIS predictive surveillance program has formalized the Rift Valley fever project into a structured template for extending predictive surveillance capability to other Department of Defense (DoD)-priority vector- and water-borne, and zoonotic diseases and geographic areas. These include leishmaniasis, malaria, and Crimea-Congo and other viral hemorrhagic fevers in Central Asia and Africa, dengue fever in Asia and the Americas, Japanese encephalitis (JE) and chikungunya fever in Asia, and rickettsial and other tick-borne infections in the U.S., Africa and Asia. PMID:21388561

  17. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  18. Orphan therapies: making best use of postmarket data.

    Science.gov (United States)

    Maro, Judith C; Brown, Jeffrey S; Dal Pan, Gerald J; Li, Lingling

    2014-08-01

    Postmarket surveillance of the comparative safety and efficacy of orphan therapeutics is challenging, particularly when multiple therapeutics are licensed for the same orphan indication. To make best use of product-specific registry data collected to fulfill regulatory requirements, we propose the creation of a distributed electronic health data network among registries. Such a network could support sequential statistical analyses designed to detect early warnings of excess risks. We use a simulated example to explore the circumstances under which a distributed network may prove advantageous. We perform sample size calculations for sequential and non-sequential statistical studies aimed at comparing the incidence of hepatotoxicity following initiation of two newly licensed therapies for homozygous familial hypercholesterolemia. We calculate the sample size savings ratio, or the proportion of sample size saved if one conducted a sequential study as compared to a non-sequential study. Then, using models to describe the adoption and utilization of these therapies, we simulate when these sample sizes are attainable in calendar years. We then calculate the analytic calendar time savings ratio, analogous to the sample size savings ratio. We repeat these analyses for numerous scenarios. Sequential analyses detect effect sizes earlier or at the same time as non-sequential analyses. The most substantial potential savings occur when the market share is more imbalanced (i.e., 90% for therapy A) and the effect size is closest to the null hypothesis. However, due to low exposure prevalence, these savings are difficult to realize within the 30-year time frame of this simulation for scenarios in which the outcome of interest occurs at or more frequently than one event/100 person-years. We illustrate a process to assess whether sequential statistical analyses of registry data performed via distributed networks may prove a worthwhile infrastructure investment for pharmacovigilance.

  19. Opportunities for Enhanced Strategic Use of Surveys, Medical Records, and Program Data for HIV Surveillance of Key Populations: Scoping Review

    Science.gov (United States)

    Baral, Stefan D; Edwards, Jessie K; Zadrozny, Sabrina; Hargreaves, James; Zhao, Jinkou; Sabin, Keith

    2018-01-01

    Background Normative guidelines from the World Health Organization recommend tracking strategic information indicators among key populations. Monitoring progress in the global response to the HIV epidemic uses indicators put forward by the Joint United Nations Programme on HIV/AIDS. These include the 90-90-90 targets that require a realignment of surveillance data, routinely collected program data, and medical record data, which historically have developed separately. Objective The aim of this study was to describe current challenges for monitoring HIV-related strategic information indicators among key populations ((men who have sex with men [MSM], people in prisons and other closed settings, people who inject drugs, sex workers, and transgender people) and identify future opportunities to enhance the use of surveillance data, programmatic data, and medical record data to describe the HIV epidemic among key populations and measure the coverage of HIV prevention, care, and treatment programs. Methods To provide a historical perspective, we completed a scoping review of the expansion of HIV surveillance among key populations over the past three decades. To describe current efforts, we conducted a review of the literature to identify published examples of SI indicator estimates among key populations. To describe anticipated challenges and future opportunities to improve measurement of strategic information indicators, particularly from routine program and health data, we consulted participants of the Third Global HIV Surveillance Meeting in Bangkok, where the 2015 World Health Organization strategic information guidelines were launched. Results There remains suboptimal alignment of surveillance and programmatic data, as well as routinely collected medical records to facilitate the reporting of the 90-90-90 indicators for HIV among key populations. Studies (n=3) with estimates of all three 90-90-90 indicators rely on cross-sectional survey data. Programmatic data and

  20. Status report - The Canadian Hospitals Injury Reporting and Prevention Program: a dynamic and innovative injury surveillance system

    Directory of Open Access Journals (Sweden)

    J. Crain

    2016-06-01

    Full Text Available This status report on the Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP, an emergency department-based injury and poisoning surveillance system, describes the result of migrating from a centralized data entry and coding process to a decentralized process, the web-based eCHIRPP system, in 2011. This secure system is improving the CHIRPP’s overall flexibility and timeliness, which are key attributes of an effective surveillance system. The integrated eCHIRPP platform enables near real-time data entry and access, has user-friendly data management and analysis tools, and allows for easier communication and connectivity across the CHIRPP network through an online collaboration centre. Current pilot testing of automated data monitoring and trend analysis tools—designed to monitor and flag incoming data according to predefined criteria (for example, a new consumer product—is revealing eCHIRPP’s potential for providing early warnings of new hazards, issues and trends.

  1. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    Science.gov (United States)

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  2. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  3. Influence of border disease virus (BDV) on serological surveillance within the bovine virus diarrhea (BVD) eradication program in Switzerland.

    Science.gov (United States)

    Kaiser, V; Nebel, L; Schüpbach-Regula, G; Zanoni, R G; Schweizer, M

    2017-01-13

    In 2008, a program to eradicate bovine virus diarrhea (BVD) in cattle in Switzerland was initiated. After targeted elimination of persistently infected animals that represent the main virus reservoir, the absence of BVD is surveilled serologically since 2012. In view of steadily decreasing pestivirus seroprevalence in the cattle population, the susceptibility for (re-) infection by border disease (BD) virus mainly from small ruminants increases. Due to serological cross-reactivity of pestiviruses, serological surveillance of BVD by ELISA does not distinguish between BVD and BD virus as source of infection. In this work the cross-serum neutralisation test (SNT) procedure was adapted to the epidemiological situation in Switzerland by the use of three pestiviruses, i.e., strains representing the subgenotype BVDV-1a, BVDV-1h and BDSwiss-a, for adequate differentiation between BVDV and BDV. Thereby the BDV-seroprevalence in seropositive cattle in Switzerland was determined for the first time. Out of 1,555 seropositive blood samples taken from cattle in the frame of the surveillance program, a total of 104 samples (6.7%) reacted with significantly higher titers against BDV than BVDV. These samples originated from 65 farms and encompassed 15 different cantons with the highest BDV-seroprevalence found in Central Switzerland. On the base of epidemiological information collected by questionnaire in case- and control farms, common housing of cattle and sheep was identified as the most significant risk factor for BDV infection in cattle by logistic regression. This indicates that pestiviruses from sheep should be considered as a source of infection of domestic cattle and might well impede serological BVD surveillance.

  4. Pediatric post-marketing safety systems in North America: assessment of the current status.

    Science.gov (United States)

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  5. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  6. Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização Vigilancia de eventos adversos post vacunación y seguridad de programas de inmunización Surveillance of adverse effects following vaccination and safety of immunization programs

    Directory of Open Access Journals (Sweden)

    Eliseu Alves Waldman

    2011-02-01

    confiabilidad de los programas de vacunación.The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.

  7. Air surveillance

    International Nuclear Information System (INIS)

    Patton, G.W.

    1995-01-01

    This section of the 1994 Hanford Site Environmental Report summarizes the air surveillance and monitoring programs currently in operation at that Hanford Site. Atmospheric releases of pollutants from Hanford to the surrounding region are a potential source of human exposure. For that reason, both radioactive and nonradioactive materials in air are monitored at a number of locations. The influence of Hanford emissions on local radionuclide concentrations was evaluated by comparing concentrations measured at distant locations within the region to concentrations measured at the Site perimeter. This section discusses sample collection, analytical methods, and the results of the Hanford air surveillance program. A complete listing of all analytical results summarized in this section is reported separately by Bisping (1995)

  8. Air surveillance

    Energy Technology Data Exchange (ETDEWEB)

    Patton, G.W.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the air surveillance and monitoring programs currently in operation at that Hanford Site. Atmospheric releases of pollutants from Hanford to the surrounding region are a potential source of human exposure. For that reason, both radioactive and nonradioactive materials in air are monitored at a number of locations. The influence of Hanford emissions on local radionuclide concentrations was evaluated by comparing concentrations measured at distant locations within the region to concentrations measured at the Site perimeter. This section discusses sample collection, analytical methods, and the results of the Hanford air surveillance program. A complete listing of all analytical results summarized in this section is reported separately by Bisping (1995).

  9. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    NARCIS (Netherlands)

    Boschman, J.S.; van der Molen, H.F.; van Duivenbooden, C.; Sluiter, J.K.; Frings-Dresen, M.H.W.

    2011-01-01

    Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the

  10. Development of containers sealing system like part of surveillance program of the vessel in nuclear power plants

    International Nuclear Information System (INIS)

    Romero C, J.; Hernandez C, R.; Fernandez T, F.; Rocamontes A, M.; Perez R, N.

    2009-10-01

    The owners of nuclear power plants should be demonstrate that the embrittlement effects by neutronic radiation do not commit the structural integrity from the pressure vessel of nuclear reactors, during conditions of routine operation and below postulate accident. For this reason, there are surveillance programs of vessels of nuclear power plants, in which are present surveillance capsules. A surveillance capsule is compound by the support, six containers for test tubes and dosimeters. The containers for test tubes are of two types: rectangular container for test tubes, Charpy V and Cylindrical Container for tension test tubes. These test tubes are subject to a same or bigger neutronic flow to that of vessel, being representative of vessel mechanical conditions. The test tubes are rehearsed to watch over the increase of embrittlement that presents the vessel. This work describes the development of welding system to seal the containers for test tubes, these should be filled with helium of ultra high purity, to a pressure of an atmosphere. In this system the welding process Gas Tungsten Arc Welding is used, a hermetic camera that allows to place the containers with three grades of freedom, a vacuum subsystem and pressure, high technology equipment's like: power source with integrated computer, arc starter of high frequency, helium flow controller, among others. Finally, the advances in the inspection system for the qualification of sealing system are mentioned, system that should measure the internal pressure of containers and the helium purity inside these. (Author)

  11. BAQMAP. Air Quality Monitoring and Surveillance Program for Botswana. Mission 1 Report 4-22 November 1996

    Energy Technology Data Exchange (ETDEWEB)

    Bekkestad, T.; Dreiem, R.; Hermansen, O.; Knudsen, S.

    1996-12-31

    This report is concerned with the start of a joint project between the authorities in Botswana and Norway on the development of an air pollution monitoring and surveillance program for Botswana. NILU will provide assistance in the fields of (1) Siting and establishment of an air pollution monitoring network, (2) Laboratory techniques, methods and routines, (3) Quality control and quality assurance procedures, (4) Emission data bases, (5) Statistical data analysis and reporting, (6) Atmospheric dispersion model estimates for air quality planning and assessment analysis. This is the report of the Norwegian team after their first visit to Botswana. 1 ref., 13 figs., 35 tabs.

  12. BAQMAP. Air Quality Monitoring and Surveillance Program for Botswana. Mission 1 Report 4-22 November 1996

    Energy Technology Data Exchange (ETDEWEB)

    Bekkestad, T; Dreiem, R; Hermansen, O; Knudsen, S

    1997-12-31

    This report is concerned with the start of a joint project between the authorities in Botswana and Norway on the development of an air pollution monitoring and surveillance program for Botswana. NILU will provide assistance in the fields of (1) Siting and establishment of an air pollution monitoring network, (2) Laboratory techniques, methods and routines, (3) Quality control and quality assurance procedures, (4) Emission data bases, (5) Statistical data analysis and reporting, (6) Atmospheric dispersion model estimates for air quality planning and assessment analysis. This is the report of the Norwegian team after their first visit to Botswana. 1 ref., 13 figs., 35 tabs.

  13. Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

    International Nuclear Information System (INIS)

    1996-02-01

    This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1

  14. OPPIDUM surveillance program: 20 years of information on drug abuse in France.

    Science.gov (United States)

    Frauger, Elisabeth; Moracchini, Christophe; Le Boisselier, Reynald; Braunstein, David; Thirion, Xavier; Micallef, Joëlle

    2013-12-01

    It is important to assess drug abuse liability in 'real life' using different surveillance systems. Some are based on specific population surveys, such as individuals with drug abuse or dependence, or under opiate maintenance treatment, because this population is very familiar with drugs and is more likely to divert or abuse them. In France, an original surveillance system based on this specific population and called 'Observation of illegal drugs and misuse of psychotropic medications (OPPIDUM) survey' was set up in 1990 as the first of its kind. The aim of this article is to describe this precursor of French drug abuse surveillance using different examples, to demonstrate its ability to effectively give health authorities and physicians interesting data on drug abuse. OPPIDUM is an annual, cross-sectional survey that anonymously collects information on abuse and dependence observed in patients recruited in specialized care centers dedicated to drug dependence. From 1990 to 2010, a total of 50,734 patients were included with descriptions of 102,631 psychoactive substance consumptions. These data have outlined emergent behaviors such as the misuse of buprenorphine by intravenous or nasal administration. It has contributed to assess abuse liability of emergent drugs such as clonazepam or methylphenidate. This surveillance system was also able to detect the decrease of flunitrazepam abuse following implementation of regulatory measures. OPPIDUM's twenty years of experience clearly demonstrate that collection of valid and useful data on drug abuse is possible and can provide helpful information for physicians and health authorities. © 2013 The Authors Fundamental and Clinical Pharmacology © 2013 Société Française de Pharmacologie et de Thérapeutique.

  15. Trends in Drug Resistance of Acinetobacter baumannii over a 10-year Period: Nationwide Data from the China Surveillance of Antimicrobial Resistance Program

    Directory of Open Access Journals (Sweden)

    Lei Gao

    2017-01-01

    Conclusions: This longitudinal multicenter surveillance program revealed the nationwide emergence of A. baumannii in China and showed a significant increase in prevalence from 2004 to 2014. High levels of bacterial resistance were detected among samples collected from clinical settings in China, with IRAB and XDRAB being especially prevalent. This study will help to guide empirical therapy and identify at-risk groups requiring more intense interventional infection control measures, while also helping to focus surveillance efforts.

  16. Reporting and Surveillance for Norovirus Outbreaks

    Science.gov (United States)

    ... Vaccine Surveillance Network (NVSN) Foodborne Diseases Active Surveillance Network (FoodNet) National Outbreak Reporting System (NORS) Estimates of Foodborne Illness in the United States CDC's Vessel Sanitation Program CDC Feature: Surveillance for Norovirus Outbreaks Top ...

  17. Minutes of the 14th Light Water Reactor Pressure Vessel Surveillance Dosimetry Improvement Program (LWR-PV-SDIP) meeting, October 1-5, 1984

    International Nuclear Information System (INIS)

    1984-01-01

    Topics discussed include: ASTM LWR standards; trend curves, PSF, and other test reactor metallurgical programs; PSF dosimetry and metallurgical capsule neutron and gamma characterization and metallurgical studies; PVS characterization program; other neutron fields; Surveillance Dosimetry Measurement Facility (SDMF) and perturbation studies; transport theory calculations; gamma field benchmarks and photo-reaction studies; and fission and non-fission sensor inventories and quality assurance

  18. FY 1994 annual summary report of the surveillance and maintenance activities for the Oak Ridge National Laboratory Environmental Restoration Program

    International Nuclear Information System (INIS)

    1994-11-01

    The Oak Ridge National Laboratory (ORNL) Environmental Restoration (ER) Surveillance and Maintenance (S and M) Program was initiated to manage former waste management and environmental research sites contaminated with radioactive materials and/or hazardous chemicals. The S and M Program is responsible for managing designated sites/facilities from the end of their operating lives until final disposition or site stabilization. To effectively manage and perform the various S and M Program responsibilities, five summary-level work breakdown structure (WBS) elements have been established: S and M Preliminary Investigations, Special Projects, Routine S and M, Inactive Groundwater Wells, and Project Management. Routine S and M activities were conducted as scheduled throughout fiscal years (FY) 1994 at applicable inactive waste management (WM) and other contaminated areas. Overall, the ER S and M Program maintains 47 facilities, performs vegetation maintenance on approximately 230 acres, maintains 54 inactive tanks, and provides overall site management on over 700 acres. In addition to the routine S and M activities, detailed site inspections were conducted at established frequencies on appropriate sites in the ER S and M Program. This document provides a summary of the FY 1994 ORNL ER S and M Program accomplishments

  19. U.S. Department of Energy Illness, and Injury Surveillance Program, Worker Health At A Glance, 1995-2004

    Energy Technology Data Exchange (ETDEWEB)

    U.S. Department of Energy, Office of Health, Safety and Security, Office of Illness and Injury Prevention Programs

    2007-10-01

    The Department of Energy’s (DOE) Illness and Injury Surveillance Program (IISP) has monitored the health of contractor workers at selected DOE sites since 1990. For the first time, the IISP has sufficient data to describe, in a collective manner, the health trends occurring among workers at a number of DOE sites during a 10-year period. This brief report and the more detailed Worker Health Summary assess illness and injury trends of DOE workers according to gender, age, occupational group, and program office over the 10-year period, 1995 through 2004. During this time, over 137,000 individual contractor workers were employed at the 15 DOE sites participating in the IISP.

  20. BAQMAP Air Quality Monitoring and Surveillance Program for Botswana. Mission 2 Report 27 January - 18 February 1997

    Energy Technology Data Exchange (ETDEWEB)

    Bekkestad, T.

    1997-12-31

    This report is concerned with Mission 2 of a joint project between the authorities in Botswana and Norway on the development of an air pollution monitoring and surveillance program for Botswana. Mission 2 was undertaken as part of the annual meeting on 4 February 1997. Discussions and decision on the air quality program was performed after the annual meeting. Passive samplers for SO{sub 2} and NO{sub 2} were installed in Selebi-Phikwe and Francistown. The samplers measured air pollution from the BCL smelter and traffic, respectively, during the first two weeks of February 1997. The samplers have been analysed and the results are given in this report, which also includes a status report. 13 tabs.

  1. Standardized physics-dosimetry for US pressure vessel cavity surveillance programs

    International Nuclear Information System (INIS)

    Ruddy, F.H.; McElroy, W.N.; Lippincott, E.P.

    1984-01-01

    This paper summarizes the applications of ASTM standard methods, guides and practices to define the selection and deployment of recommended dosimetry sets, the selection of dosimetry capsules and thermal neutron shields, the placement of dosimetry, the methods of measurement of dosimetry sensor reaction products, data analysis procedures, and uncertainty evaluation procedures. It also describes the validation of these standards both by in-reactor testing of advanced PV cavity surveillance physics-dosimetry and by data development. The use of these standards to guide selection and development of advanced dosimetry sets for commercial reactors is also summarized. (Auth.)

  2. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  3. Work-Related Asthma in Korea - Findings from the Korea Work-Related Asthma Surveillance (KOWAS) program, 2004-2009.

    Science.gov (United States)

    Kwon, Soon-Chan; Song, Jaechul; Kim, Yong-Kyu; Calvert, Geoffrey M

    2015-01-01

    To determine the incidence and epidemiological characteristics of work-related asthma in Korea. During 2004-2009, the Korea Work-Related Asthma Surveillance (KOWAS) program collected data on new cases of work-related asthma from occupational physicians, allergy and chest physicians, regional surveillance systems, and workers' compensation schemes. The incidence was calculated on the basis of industry, occupation, sex, age, and region. In addition, the distribution of causal agents was determined. During the study period, 236 cases of work-related asthma were reported, with 77 cases from more than 1 source. A total of 22.0% (n=52) were reported by occupational physicians, 52.5% (n=124) by allergy and chest physicians, 24.2% (n=57) by regional surveillance systems, and 43.2% (n=102) by workers' compensation schemes. The overall average annual incidence was 3.31 cases/million workers, with a rate of 3.78/million among men and 2.58/million among women. The highest incidence was observed in the 50-59-year age group (7.74/million), in the Gyeonggi/Incheon suburb of Seoul (8.50/million), in the furniture and other instrument manufacturing industries (67.62/million), and among craft and related trades workers (17.75/million). The most common causal agents were isocyanates (46.6%), flour/grain (8.5%), metal (5.9%), reactive dyes (5.1%), and solvents (4.2%). The incidence of work-related asthma in Korea was relatively low, and varied according to industry, occupation, gender, age, and region. Data provided by workers' compensation schemes and physician reports have been useful for determining the incidence and causes of work-related asthma.

  4. NRC data base for power reactor surveillance programs and for irradiation experiments results

    International Nuclear Information System (INIS)

    Kam, F.B.K.; Stallmann, F.W.

    1991-01-01

    The radiation damage of pressure vessel materials in nuclear reactors depends on many different factors, primarily fluence, fluence spectrum, fluence rate, irradiation temperature, and chemistry. These factors and, possibly, others such as heat treatment and type of flux used in weldments must be considered to reliably predict the pressure vessel embrittlement and to assure the safe operation of the reactor. Based on embrittlement predictions, decisions must be made concerning operating parameters, low-leakage fuel management, possible life extension, and the need for annealing of the pressure vessel. Large numbers of data obtained from surveillance capsules and test reactor experiments are needed, comprising many different materials and different irradiation conditions, to develop generally applicable damage prediction models that can be used for industry standards and regulatory guides. The US Nuclear Regulatory Agency has, therefore, sponsored a project to construct an Embrittlement Data Base (EDB) for a comprehensive collection of data concerning changes in material properties of pressure vessel steels due to neutron irradiation. A first version containing data from surveillance capsules of commercial power reactors, the Power Reactor Embrittlement Data Base (PR-EDB) Version 1, has been completed and is available to authorized users from the Radiation Shielding Information Center at the Oak Ridge National Laboratory. This document provides a discussion of the features of the current database. 1 fig

  5. Hospital adoption of automated surveillance technology and the implementation of infection prevention and control programs.

    Science.gov (United States)

    Halpin, Helen; Shortell, Stephen M; Milstein, Arnold; Vanneman, Megan

    2011-05-01

    This research analyzes the relationship between hospital use of automated surveillance technology (AST) for identification and control of hospital-acquired infections (HAI) and implementation of evidence-based infection control practices. Our hypothesis is that hospitals that use AST have made more progress implementing infection control practices than hospitals that rely on manual surveillance. A survey of all acute general care hospitals in California was conducted from October 2008 through January 2009. A structured computer-assisted telephone interview was conducted with the quality director of each hospital. The final sample includes 241 general acute care hospitals (response rate, 83%). Approximately one third (32.4%) of California's hospitals use AST for monitoring HAI. Adoption of AST is statistically significant and positively associated with the depth of implementation of evidence-based practices for methicillin-resistant Staphylococcus aureus and ventilator-associated pneumonia and adoption of contact precautions and surgical care infection practices. Use of AST is also statistically significantly associated with the breadth of hospital implementation of evidence-based practices across all 5 targeted HAI. Our findings suggest that hospitals using AST can achieve greater depth and breadth in implementing evidenced-based infection control practices. Copyright © 2011 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  6. Modification of an environmental surveillance program to monitor PCDD/Fs and metals around a municipal solid waste incinerator.

    Science.gov (United States)

    Vilavert, Lolita; Nadal, Martí; Mari, Montse; Schuhmacher, Marta; Domingo, José L

    2009-11-01

    Since the mid-90s, an environmental surveillance program has been on-going to provide information on the levels of PCDD/Fs and various metals in soil and vegetation samples collected in the vicinity of a municipal solid waste incinerator (MSWI) in Tarragona (Catalonia, Spain). However, the presence of other potential sources of pollution in the zone, such as traffic, forest fires, local industries, etc., makes hard to determine the impact concerning the MSWI. Therefore, in 2007 a change in the monitoring program was implemented by collecting additional ambient air samples through active and passive sampling devices. Mean PCDD/F levels in herbage and soil were 0.10 ng I-TEQ/kg dry weight (range: 0.05-0.17 ng I-TEQ/kg dw) and 0.64 ng I-TEQ/kg dw (range: 0.13-2.41 ng I-TEQ/kg dw), respectively. A significant reduction of the PCDD/F concentration in both monitors was observed with respect to our previous surveys. Air mean concentrations of PCDD/Fs were 12.04 and 15.21 fg WHO-TEQ/m(3) in 2007 and 2008, respectively, meaning a non-significant increase of 26%. In addition, a generalized increase of environmental metal levels with respect to our baseline study was not observed. The current concentrations of PCDD/Fs and metals in the vicinity of the MSWI of Tarragona are relatively low in comparison with other areas under the influence of emissions from waste incinerators. This indicates that the environmental impact of the MSWI of Tarragona is not significant. Moreover, the modification of the surveillance program has proven to be successful.

  7. U.S. Department of Energy, Illness and Injury Surveillance Program, Worker Health Summary, 1995-2004

    Energy Technology Data Exchange (ETDEWEB)

    U.S. Department of Energy, Office of Health, Safety and Security, Office of Illness and Injury Prevention Programs

    2007-10-01

    The Department of Energy’s (DOE) Illness and Injury Surveillance Program has created an opportunity to assess illness and injury rates and patterns among workers at participating sites for well over a decade. The Worker Health Summary introduces an additional perspective on worker health with the introduction of analyses comparing the experience of sites in different program offices and a focus on time trends covering a decade of worker illness and injury experience. These analyses by program office suggest that illness and injury patterns among National Nuclear Security Administration (NNSA) workers diverge in many ways from those seen among Environmental Management (EM) and Science workers for reasons not yet understood. These differences will receive further investigation in future special focus studies, as will other findings of interest. With the time depth now available in our data, the Worker Health Summary reveals an additional nuance in worker health trends: changing health patterns in a specialized and skilled but aging work force. Older workers are becoming an increasing percentage of the work force, and their absence rates for diseases such as diabetes and hypertension are increasing as well. The impact of these emerging health issues, if properly addressed, can be managed to maintain or even enhance worker health and productivity. Prevention strategies designed to reduce the toll of these health conditions appear warranted, and this report gives us an indication of where to focus them. The analyses that follow reflect the Illness and Injury Surveillance Program’s continued commitment to apply a public health perspective in protecting the health of DOE’s work force.

  8. Antimicrobial susceptibilities of Proteus mirabilis: a longitudinal nationwide study from the Taiwan surveillance of antimicrobial resistance (TSAR) program.

    Science.gov (United States)

    Wang, Jann-Tay; Chen, Pei-Chen; Chang, Shan-Chwen; Shiau, Yih-Ru; Wang, Hui-Ying; Lai, Jui-Fen; Huang, I-Wen; Tan, Mei-Chen; Lauderdale, Tsai-Ling Yang

    2014-09-05

    Longitudinal nationwide data on antimicrobial susceptibility in Proteus mirabilis from different sources are rare. The effects of the revised Clinical and Laboratory Standards Institute (CLSI) β-lactam breakpoints on susceptibility rates and on detecting extended-spectrum β-lactamase (ESBL) and AmpC β-lactamase-producers in this species are also seldom evaluated. The present study analyzed data from the Taiwan Surveillance of Antimicrobial Resistance program to address these issues. Isolates were collected biennially between 2002 and 2012 from 25 to 28 hospitals in Taiwan. Minimum inhibitory concentrations (MIC) were determined by reference broth microdilution method. All isolates with aztreonam, ceftazidime, or cefotaxime MIC ≥ 2 mg/L were checked for the presence of ESBL by CLSI confirmatory test and subjected to ESBL and AmpC β-lactamases gene detection by PCR. Univariate and multivariate analyses were performed. Between 2002 and 2012, a total of 1157 P. mirabilis were studied. Susceptibility to cefotaxime, ceftazidime, and ciprofloxacin decreased significantly during the past decade, from 92.6% to 81.7%, 100% to 95.2%, and 80.1% to 53.8%, respectively (P mirabilis from Taiwan in the past decade. The prevalence of ESBL remained stable but AmpC β-lactamase-producing P. mirabilis increased significantly. Cefotaxime was a better surrogate than ceftazidime for predicting the presence of these β-lactamases. Continuous surveillance on antimicrobial resistance and associated resistance mechanisms in P. mirabilis is warranted.

  9. Soil and vegetation surveillance

    Energy Technology Data Exchange (ETDEWEB)

    Antonio, E.J.

    1995-06-01

    Soil sampling and analysis evaluates long-term contamination trends and monitors environmental radionuclide inventories. This section of the 1994 Hanford Site Environmental Report summarizes the soil and vegetation surveillance programs which were conducted during 1994. Vegetation surveillance is conducted offsite to monitor atmospheric deposition of radioactive materials in areas not under cultivation and onsite at locations adjacent to potential sources of radioactivity.

  10. Standardized physics-dosimetry for US pressure vessel cavity surveillance programs

    International Nuclear Information System (INIS)

    Ruddy, F.H.; McElroy, W.N.; Lippincott, E.P.

    1984-01-01

    Standardized Physics-Dosimetry procedures and data are being developed and tested for monitoring the neutron doses accumulated by reactor pressure vessels (PV) and their support structures. These procedures and data are governed by a set of 21 ASTM standard practices, guides, and methods for the prediction of neutron-induced changes in light water reactor (LWR) PVs and support structure steels throughout the service life of the PV. This paper summarizes the applications of these standards to define the selection and deployment of recommended dosimetry sets, the selection of dosimetry capsules and thermal neutron shields, the placement of dosimetry, the methods of measurement of dosimetry sensor reaction products, data analysis procedures, and uncertainty evaluation procedures. It also describes the validation of these standards both by in-reactor testing of advanced PV cavity surveillance physics-dosimetry and by data development. The use of these standards to guide selection and deployment of advanced dosimetry sets for commercial reactors is also summarized

  11. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  12. [Surveillance system on drug abuse: Interest of the French national OPPIDUM program of French addictovigilance network].

    Science.gov (United States)

    Frauger, Elisabeth; Pochard, Liselotte; Boucherie, Quentin; Giocanti, Adeline; Chevallier, Cécile; Daveluy, Amélie; Gibaja, Valérie; Caous, Anne-Sylvie; Eiden, Céline; Authier, Nicolas; Le Boisselier, Reynald; Guerlais, Marylène; Jouanjus, Émilie; Lepelley, Marion; Pizzoglio, Véronique; Pain, Stéphanie; Richard, Nathalie; Micallef, Joëlle

    2017-09-01

    It is important to assess drug abuse liability in 'real life' using different surveillance systems. OPPIDUM ('Observation of illegal drugs and misuse of psychotropic medications') surveillance system anonymously collects information on drug abuse and dependence observed in patients recruited in specialized care centers dedicated to drug dependence. The aim of this article is to demonstrate the utility of OPPIDUM system using 2015 data. OPPIDUM is a cross-sectional survey repeated each year since 1995. In 2015, 5003 patients described the modality of use of 10,159 psychoactive drugs. Among them, 77% received an opiate maintenance treatment: 68% methadone (half of them consumed capsule form) and 27% buprenorphine (39% consumed generic form). Brand-name buprenorphine is more often injected than generic buprenorphine (10% vs. 2%) and among methadone consumers 7% of methadone capsule consumers have illegally obtained methadone (vs. 9% for syrup form). The proportion of medications among psychoactive drugs injected is important (42%), with morphine representing 21% of the total psychoactive drugs injected and buprenorphine, 16%. OPPIDUM highlighted emergent behaviors of abuse with some analgesic opioids (like tramadol, oxycodone or fentanyl), pregabalin, or quetiapine. OPPIDUM highlighted variations of drugs use regarding geographic approaches or by drug dependence care centers (like in harm reduction centers). OPPIDUM clearly demonstrated that collection of valid and useful data on drug abuse is possible, these data have an interest at regional, national and international levels. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  13. Effectiveness and Cost-benefit Evaluation of a Comprehensive Workers' Health Surveillance Program for Sustainable Employability of Meat Processing Workers.

    Science.gov (United States)

    van Holland, Berry J; Reneman, Michiel F; Soer, Remko; Brouwer, Sandra; de Boer, Michiel R

    2018-03-01

    Objective To evaluate the effectiveness of a comprehensive workers' health surveillance (WHS) program on aspects of sustainable employability and cost-benefit. Methods A cluster randomized stepped wedge trial was performed in a Dutch meat processing company from february 2012 until march 2015. In total 305 workers participated in the trial. Outcomes were retrieved during a WHS program, by multiple questionnaires, and from company registries. Primary outcomes were sickness absence, work ability, and productivity. Secondary outcomes were health, vitality, and psychosocial workload. Data were analyzed with linear and logistic multilevel models. Cost-benefit analyses from the employer's perspective were performed as well. Results Primary outcomes sickness absence (OR = 1.40), work ability (B = -0.63) and productivity (OR = 0.71) were better in the control condition. Secondary outcomes did not or minimally differ between conditions. Of the 12 secondary outcomes, the only outcome that scored better in the experimental condition was meaning of work (B = 0.18). Controlling for confounders did not or minimally change the results. However, our stepped wedge design did not enable adjustment for confounding in the last two periods of the trial. The WHS program resulted in higher costs for the employer on the short and middle term. Conclusions Primary outcomes did not improve after program implementation and secondary outcomes remained equal after implementation. The program was not cost-beneficial after 1-3 year follow-up. Main limitation that may have contributed to absence of positive effects may be program failure, because interventions were not deployed as intended.

  14. [Role of the National Poliovirus Laboratory for the Program of eradication and poliomyelitis surveillance].

    Science.gov (United States)

    Trallero, Gloria; Cabrerizo, María; Avellón, Ana

    2013-01-01

    The Spanish acute flaccid paralysis surveillance network is coordinated by the National Poliovirus Laboratory (NPL), which, since 1998, carries out polioviruses (PV) and other enteroviruses detected characterization by cell culture and molecular techniques. A total of 110,725 (70046+40679) samples were studied between 1998-2012 and enteroviruses were detected in 8% of these. Among these enteroviruses 241 PV were characterized as PV Sabin-like, except samples belong to an imported poliomyelitis case, all of which were characterised as vaccine derived PV type 2. The NPL has carried out the serotyping and the intratypic differentiation of all the isolated PV in Spain of any syndrome. It is shown that wild PV has not circulated in our country during the 15 years studied and that has led to the signing of the Act of the "eradication of poliomyelitis in Spain" by WHO in 2001, and the /"certification of the eradication of wild PV free for European countries" on 21 June 2002. Currently only 3 countries have endemic transmission of wild PV (Pakistan, Afghanistan and Nigeria). Until a complete worldwide eradication, was achieved, Spain will actively continue to participate in the maintenance of the poliomyelitis eradication infrastructure by monitoring and vaccination as well as the wild PV containment plan to avoid the spread of wild PV.

  15. The effectiveness of a health-surveillance program for caisson saturation divers in a tunnel-boring machine: a microbiological survey

    NARCIS (Netherlands)

    van Rees Vellinga, T. P.; Sterk, W.; van Dijk, F. J. H.

    2010-01-01

    The purpose of this field study is to report and evaluate the implementation of a health surveillance program we developed to monitor the microbiological load for saturation divers, including preventive and therapeutic interventions. We extended the DMAC protocol for Saturation Diving Chamber

  16. Components production and assemble of the irradiation capsule of the Surveillance Program of Materials of the nuclear power plant of Laguna Verde

    International Nuclear Information System (INIS)

    Medrano, A.

    2009-01-01

    To predict the effects of the neutrons radiation and the thermal environment about the mechanical properties of the reactor vessel materials of the nuclear power plant of Laguna Verde, a surveillance program is implemented according to the outlines settled by Astm E185-02 -Standard practice for design of surveillance programs for light-water moderated nuclear power reactor vessels-. This program includes the installation of three irradiation capsules of similar materials to those of the reactor vessels, these samples are test tubes for mechanical practices of impact and tension. In the National Institute of Nuclear Research and due to the infrastructure as well as of the actual human resources of the Pilot Plant of Nuclear Fuel Assembles Production it was possible to realize the materials rebuilding extracted in 2005 of Unit 2 of nuclear power plant of Laguna Verde as well as the production, assemble and reassignment of the irradiation capsule made in 2006. At the present time the surveillance materials extracted in 2008 of Unit 1 of the nuclear power plant of Laguna Verde are reconstituting and the components are manufactured for the assembles of the irradiation capsule that will be reinstalled in the reactor vessel in 2010. The purpose of the present work is to describe the necessary components as well as its disposition during the assembles of the irradiation capsule for the surveillance program of the reactors vessel of the nuclear power plant of Laguna Verde. (Author)

  17. Quality assurance program for surveillance of fast reactor mixed oxide fuel analytical chemistry

    International Nuclear Information System (INIS)

    Rein, J.E.; Zeigler, R.K.; Waterbury, G.R.; McClung, W.E.; Praetorius, P.R.; Delvin, W.L.

    1976-01-01

    An effective quality assurance program for the chemical analysis of nuclear fuel is essential to assure that the fuel will meet the strict chemical specifications required for optimum reactor performance. Such a program has been in operation since 1972 for the fuels manufactured for the Fast Flux Test Facility. This program, through the use of common quality control and calibration standards, has consistently provided high levels of agreement among laboratories in all areas of analysis. The paper presented gives a summary of the chemical specifications for the fuel and source material, an outline of the requirements for laboratory qualifications and the preparation of calibration and quality control materials, general administration details of the plan, and examples where the program has been useful in solving laboratory problems

  18. Waterborne Release Monitoring and Surveillance Programs at the Savannah River Site

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard, A.

    1999-03-26

    This report documents the liquid release environmental compliance programs currently in place at the Savannah river Site (SRS). Included are descriptions of stream monitoring programs, which measure chemical parameters and radionuclides in site streams and the Savannah river and test representative biological communities within the streams for chemical and radiological uptake. This report also explains the field sampling and analytical capabilities that are available at SRS during both normal and emergency conditions.

  19. Waterborne Release Monitoring and Surveillance Programs at the Savannah River Site

    International Nuclear Information System (INIS)

    Blanchard, A.

    1999-01-01

    This report documents the liquid release environmental compliance programs currently in place at the Savannah river Site (SRS). Included are descriptions of stream monitoring programs, which measure chemical parameters and radionuclides in site streams and the Savannah river and test representative biological communities within the streams for chemical and radiological uptake. This report also explains the field sampling and analytical capabilities that are available at SRS during both normal and emergency conditions

  20. A trial of a job-specific workers' health surveillance program for construction workers: study protocol.

    Science.gov (United States)

    Boschman, Julitta S; van der Molen, Henk F; van Duivenbooden, Cor; Sluiter, Judith K; Frings-Dresen, Monique H W

    2011-09-29

    Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job

  1. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS group (n = 206 with that of a control (WHS group (n = 206. The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the

  2. Retinoblastoma incidence patterns in the US Surveillance, Epidemiology, and End Results program.

    Science.gov (United States)

    Wong, Jeannette R; Tucker, Margaret A; Kleinerman, Ruth A; Devesa, Susan S

    2014-04-01

    IMPORTANCE Several studies have found no temporal or demographic differences in the incidence of retinoblastoma except for age at diagnosis, whereas other studies have reported variations in incidence by sex and race/ethnicity. OBJECTIVE To examine updated US retinoblastoma incidence patterns by sex, age at diagnosis, laterality, race/ethnicity, and year of diagnosis. DESIGN, SETTING, AND PARTICIPANTS The Surveillance, Epidemiology, and End Results (SEER) databases were examined for retinoblastoma incidence patterns by demographic and tumor characteristics. We studied 721 children in SEER 18 registries, 659 in SEER 13 registries, and 675 in SEER 9 registries. MAIN OUTCOMES AND MEASURES Incidence rates, incidence rate ratios (IRRs), and annual percent changes in rates. RESULTS During 2000-2009 in SEER 18, there was a significant excess of total retinoblastoma among boys compared with girls (IRR, 1.18; 95% CI, 1.02 to 1.36), in contrast to earlier reports of a female predominance. Bilateral retinoblastoma among white Hispanic boys was significantly elevated relative to white non-Hispanic boys (IRR, 1.81; 95% CI, 1.22 to 2.79) and white Hispanic girls (IRR, 1.75; 95% CI, 1.11 to 2.91) because of less rapid decreases in bilateral rates since the 1990s among white Hispanic boys than among the other groups. Retinoblastoma rates among white non-Hispanics decreased significantly since 1992 among those younger than 1 year and since 1998 among those with bilateral disease. CONCLUSIONS AND RELEVANCE Although changes in the availability of prenatal screening practices for retinoblastoma may have contributed to these incidence patterns, further research is necessary to determine their actual effect on the changing incidence of retinoblastoma in the US population. In addition, consistent with other cancers, an excess of retinoblastoma diagnosed in boys suggests a potential effect of sex on cancer origin.

  3. Prognostic factors for survival in patients with Ewing's sarcoma using the surveillance, epidemiology, and end results (SEER) program database.

    Science.gov (United States)

    Duchman, Kyle R; Gao, Yubo; Miller, Benjamin J

    2015-04-01

    The current study aims to determine cause-specific survival in patients with Ewing's sarcoma while reporting clinical risk factors for survival. The Surveillance, Epidemiology, and End Results (SEER) Program database was used to identify patients with osseous Ewing's sarcoma from 1991 to 2010. Patient, tumor, and socioeconomic variables were analyzed to determine prognostic factors for survival. There were 1163 patients with Ewing's sarcoma identified in the SEER Program database. The 10-year cause-specific survival for patients with non-metastatic disease at diagnosis was 66.8% and 28.1% for patients with metastatic disease. Black patients demonstrated reduced survival at 10 years with an increased frequency of metastatic disease at diagnosis as compared to patients of other race, while Hispanic patients more frequently presented with tumor size>10cm. Univariate analysis revealed that metastatic disease at presentation, tumor size>10cm, axial tumor location, patient age≥20 years, black race, and male sex were associated with decreased cause-specific survival at 10 years. Metastatic disease at presentation, axial tumor location, tumor size>10cm, and age≥20 years remained significant in the multivariate analysis. Patients with Ewing's sarcoma have decreased cause-specific survival at 10 years when metastatic at presentation, axial tumor location, tumor size>10cm, and patient age≥20 years. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Mark of the reconstitution process of the surveillance program of the CLV; Calificacion del proceso de reconstitucion del programa de vigilancia de CLV

    Energy Technology Data Exchange (ETDEWEB)

    Romero, J.; Hernandez, R.; Fernandez, F. [ININ, 52045 Ocoyoacac, Estado de Mexico (Mexico)]. e-mail: jrc@nuclear.inin.mx

    2006-07-01

    surveillance program of the reactor vessel of the nucleo electric central of Mexico it evaluates the mechanical state of the vessel, for it are had surveillance capsules with a series of witness test tubes, subjected to a similar or major neutron flux to that of the vessel. The objective is to evaluate in advance the embrittlement grade of the vessel in its design life. However the number of capsules with the witness test tubes it is only for the design life of the plant and at the moment the nucleo electric plants negotiate an extension of life of these, until for 20 years or more, of there the importance of this witness material that stores the information of the damage accumulated by irradiation. This material requires to be taken advantage after being rehearsed and the normative one settles down as obligatory to qualify the rebuilding process to obtain other 'new' Charpy test tubes that are again introduced in the reactor, reusing this material, as much for the surveillance program as for the extension of the plant life. In this work the qualification of the welding process by 'Stud Welding' for the rebuilding of Charpy test tubes of the surveillance program of the BWR reactor Unit 2 of the Laguna Verde Nucleo electric plant, Veracruz, Mexico is described. (Author)

  5. Site surveillance and maintenance program for Palos Park: Report for 1987

    International Nuclear Information System (INIS)

    Golchert, N.W.

    1988-04-01

    The results of the environmental monitoring program conducted at Site A/Plot M in the Palos Park Forest Preserve area for CY 1987 are presented. The monitoring program is the ongoing remedial action that resulted from the original radiological characterization of the site. This study had determined that hydrogen-3 (as tritiated water) migrated from the burial ground and was present in two nearby hand-pumped picnic wells. The current program consists of sample collection and analysis of air, surface and subsurface water, and bottom sediment. The results of the analyses are used to (1) determine the migration pathway of water from the burial ground (Plot M) to hand-pumped picnic wells, (2) establish if buried radionuclides other than hydrogen-3 have migrated, and (3) generally characterize the radiological environment of the area. The program was designed to study the migration of non-radiological hazardous waste constituents that may have been buried with the radioactive waste. This was done by analyzing borehole water samples for selected heavy metals and organic compounds and analyzing quarterly water samples from the Red Gate Woods picnic well for inorganic constituents. Hydrogen-3 in the Red Gate Woods picnic well continued to show the same pattern of elevated levels in the winter and low concentrations in the summer, but the magnitude of the current winter peak was significantly less than in earlier years. 16 refs., 6 figs., 15 tabs

  6. Head Injury Secondary to Suspected Child Maltreatment: Results of a Prospective Canadian National Surveillance Program

    Science.gov (United States)

    Bennett, Susan; Ward, Michelle; Moreau, Katherine; Fortin, Gilles; King, Jim; MacKay, Morag; Plint, Amy

    2011-01-01

    Objective: We sought to determine the incidence, clinical features, and demographic profile of head injury secondary to suspected child maltreatment (abuse or neglect) in Canada to help inform the development and evaluation of prevention programs for abusive head injuries. Methods: From March 1, 2005 to February 28, 2008, an average of 2,545…

  7. European Surveillance Network for Influenza in Pigs: Surveillance Programs, Diagnostic Tools and Swine Influenza Virus Subtypes Identified in 14 European Countries from 2010 to 2013

    DEFF Research Database (Denmark)

    Simon, Gaelle; Larsen, Lars Erik; Duerrwald, Ralf

    2014-01-01

    : avian-like swine H1N1 (53.6%), human-like reassortant swine H1N2 (13%) and human-like reassortant swine H3N2 (9.1%), as well as pandemic A/H1N1 2009 (H1N1pdm) virus (10.3%). Viruses from these four lineages co-circulated in several countries but with very different relative levels of incidence....... For instance, the H3N2 subtype was not detected at all in some geographic areas whereas it was still prevalent in other parts of Europe. Interestingly, H3N2-free areas were those that exhibited highest frequencies of circulating H1N2 viruses. H1N1pdm viruses were isolated at an increasing incidence in some......Swine influenza causes concern for global veterinary and public health officials. In continuing two previous networks that initiated the surveillance of swine influenza viruses (SIVs) circulating in European pigs between 2001 and 2008, a third European Surveillance Network for Influenza in Pigs...

  8. Recommendations to the NRC for review criteria for alternative methods of low-level radioactive waste disposal: Environmental monitoring and surveillance programs

    International Nuclear Information System (INIS)

    Denham, D.H.; Stenner, R.D.; Eddy, P.A.; Jaquish, R.E.; Ramsdell, J.V. Jr.

    1988-07-01

    Licensing of a facility for low-level radioactive waste disposal requires the review of the environmental monitoring and surveillance programs. A set of review criteria is recommended for the US Nuclear Regulatory Commission (NRC) staff to use in each monitoring phase---preoperational, operational, and post operational---for evaluating radiological and selected nonradiological parameters in proposed environmental monitoring and surveillance programs at low-level waste disposal facilities. Applicable regulations, industry standards, and technical guidance on low-level radioactive waste are noted throughout the document. In the preoperational phase, the applicant must demonstrate that the environmental monitoring program identifies radiation levels and radionuclide concentrations at the site and also provides adequate basic data on the disposal site. Data recording and statistical analyses for this phase are addressed

  9. [Thought on several problems of clinical revaluation of post-marketing herb research].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

  10. Ski and snowboard school programs: Injury surveillance and risk factors for grade-specific injury.

    Science.gov (United States)

    Sran, R; Djerboua, M; Romanow, N; Mitra, T; Russell, K; White, K; Goulet, C; Emery, C; Hagel, B

    2018-05-01

    The objective of our study was to evaluate incidence rates and profile of school program ski and snowboard-related injuries by school grade group using a historical cohort design. Injuries were identified via Accident Report Forms completed by ski patrollers. Severe injury was defined as those with ambulance evacuation or recommending patient transport to hospital. Poisson regression analysis was used to examine the school grade group-specific injury rates adjusting for risk factors (sex, activity, ability, and socioeconomic status) and accounting for the effect of clustering by school. Forty of 107 (37%) injuries reported were severe. Adolescents (grades 7-12) had higher crude injury rates (91 of 10 000 student-days) than children (grades 1-3: 25 of 10 000 student-days; grades 4-6: 65 of 10 000 student-days). Those in grades 1-3 had no severe injuries. Although the rate of injury was lower in grades 1-3, there were no statistically significant grade group differences in adjusted analyses. Snowboarders had a higher rate of injury compared with skiers, while higher ability level was protective. Participants in grades 1-3 had the lowest crude and adjusted injury rates. Students in grades 7-12 had the highest rate of overall and severe injuries. These results will inform evidence-based guidelines for school ski/snowboard program participation by school-aged children. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. National and Regional Representativeness of Hospital Emergency Department Visit Data in the National Syndromic Surveillance Program, United States, 2014

    Science.gov (United States)

    Coates, Ralph J.; Pérez, Alejandro; Baer, Atar; Zhou, Hong; English, Roseanne; Coletta, Michael; Dey, Achintya

    2016-01-01

    Objective We examined the representativeness of the nonfederal hospital emergency department (ED) visit data in the National Syndromic Surveillance Program (NSSP). Methods We used the 2012 American Hospital Association Annual Survey Database, other databases, and information from state and local health departments participating in the NSSP about which hospitals submitted data to the NSSP in October 2014. We compared ED visits for hospitals submitting 15 data with all ED visits in all 50 states and Washington, DC. Results Approximately 60.4 million of 134.6 million ED visits nationwide (~45%) were reported to have been submitted to the NSSP. ED visits in 5 of 10 regions and the majority of the states were substantially underrepresented in the NSSP. The NSSP ED visits were similar to national ED visits in terms of many of the characteristics of hospitals and their service areas. However, visits in hospitals with the fewest annual ED visits, in rural trauma centers, and in hospitals serving populations with high percentages of Hispanics and Asians were underrepresented. Conclusions NSSP nonfederal hospital ED visit data were representative for many hospital characteristics and in some geographic areas but were not very representative nationally and in many locations. Representativeness could be improved by increasing participation in more states and among specific types of hospitals. PMID:26883318

  12. A distinctive avian assemblage (Aves: Passeriformes in Western Darién, Panama is uncovered through a disease surveillance program

    Directory of Open Access Journals (Sweden)

    Matthew J. Miller

    2014-08-01

    Full Text Available Basic knowledge about the distribution of flora and fauna is lacking for most tropical areas. Improving our knowledge of the tropical biota will help address contemporary global problems, including emerging tropical diseases. Less appreciated is the role that applied studies can have in improving our understanding of basic biological patterns and processes in the tropics. Here, I describe a novel avifauna assemblage uncovered in Western Darién province in the Republic of Panama that was uncovered during a vector-borne disease surveillance program. I compared the passerine bird species composition at 16 sites using records from recent ornithological expeditions sponsored by the Smithsonian Tropical Research Institute in Central and Eastern Panama. Based on the results of a Mantel test, geographic distance did not correlate with pairwise distinctiveness of sites. Instead, based on an index of distinctiveness modified from the Chao-Jaccard index, most sites were more or less similarly distinctive, with one site, Aruza Abajo, significantly more distinctive than the rest. I found that the distinctiveness of this site was due not only to the presence of several rare and range-restricted taxa, but also to the absence of taxa that are common elsewhere. This finding provides more evidence of high species composition turnover (beta-diversity in the Panamanian biota, which appears to be driven by a combination of soil and climate differences over narrow distances. Rev. Biol. Trop. 62 (2: 711-717. Epub 2014 June 01.

  13. Gas generation over plutonium oxides in the 94-1 shelf-life surveillance program

    International Nuclear Information System (INIS)

    Berg, J.M.; Harradine, D.M.; Hill, D.D.; McFarlan, James T.; Padilla, D.D.; Prenger, F. Coyne; Veirs, D.K.; Worl, L.A.

    2002-01-01

    The Department of Energy (DOE) is embarking upon a program to store large quantities of plutonium-bearing materials for up to fifty years. The Los Alamos National Laboratory Shelf Life Project was established to bound the behavior of plutonium-bearing material meeting the DOE 3013 Standard. The shelf life study monitors temperature, pressure and gas composition over oxide materials in a limited number of large-scale 3013 inner containers and in many small-scale containers. For the large-scale study, baseline plutonium oxides, oxides exposed to high-humidity atmospheres, and oxides containing chloride salt impurities are planned. The first large-scale container represents a baseline and contains dry plutonium oxide prepared according to the 3013 Standard. This container has been observed for pressure, temperature and gas compositional changes for less than a year. Results indicate that no detectable changes in pressure and gas composition are observed.

  14. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    Science.gov (United States)

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-12-01

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  15. Annual summary report of the decontamination and decommissioning surveillance and maintenance program at Oak Ridge National Laboratory for period ending September 30, 1991

    International Nuclear Information System (INIS)

    Ford, M.K.; Holder, L. Jr.

    1991-09-01

    The Surplus Facilities Management Program and Defense Facilities Decommissioning Program were established at Oak Ridge National Laboratory (ORNL) in 1976 in order to provide collective management of all surplus sites under ORNL control on the Oak Ridge Reservation. Some 34 facilities, classified into 3 civilian-related and 8 defense-related projects, are currently managed by the recently integrated Decontamination and Decommissioning Program. Support includes (1) surveillance and maintenance (S ampersand M) planning, (2) routine S ampersand M, and (3) special maintenance projects. This report documents routine S ampersand M, special projects, and special maintenance performed on these facilities for the period of October 1990 through September 1991

  16. Surveillance program for former PCB-exposed workers of a transformer and capacitor recycling company, family members, employees of surrounding companies, and area residents--executive summary.

    Science.gov (United States)

    Kraus, Thomas; Gube, Monika; Lang, Jessica; Esser, Andre; Sturm, Walter; Fimm, Bruno; Willmes, Klaus; Neulen, Joseph; Baron, Jens Malte; Merk, Hans; Schettgen, Thomas; Konrad, Kerstin; Deisz, Sabine; Rink, Lothar; Hagmann, Michael; Fillies, Birgit; Zschiesche, Wolfgang; Wittsiepe, Jürgen; Wilhelm, Michael

    2012-01-01

    In a German company polychlorinated biphenyls (PCB)-containing transformers and capacitors were recycled on a large scale. Human biomonitoring revealed a high PCB body burden in workers of the recycling company, in surrounding locations of this plant, in companies in the neighborhood of this plant, and in family members of these employees. In order to clarify whether possible adverse health effects occurred or may occur in the future, a prospective surveillance program was initiated. After an extensive literature search, an interdisciplinary group of experts developed a surveillance program based on current knowledge with respect to possible adverse health effects that might occur in the recycling process of transformers and capacitors. Exposure to various hazardous substances (PCB, polychlorinated dibenzo-p-dioxins and dibenzo-furans [PCDD/F], metals, solvents) was considered. Criteria derived from human biomonitoring results of PCB were used for admission to the program. Participants in the surveillance program are first informed about risks and aims of the program. Subsequently, physicians started a detailed documentation of participants' general and occupational history, with their complaints, diseases, and nutritional habits, as well as information regarding their living areas, by means of a standardized questionnaire. In addition, separate examinations were performed to detect possible neurological, immunological, (neuro)psychological, hormonal, and skin effects. Moreover, DNA exposure as assessed by the comet assay and antioxidative status were determined. The program will be offered at yearly intervals for 3 years, and then at 5 and 10 years after program onset. Until now the program has proved to be feasible, and acceptance among workers and their families has been high. Based on the results, criteria will be developed to define adverse health effects that might be attributable to a hazardous substance exposure.

  17. Using data from a nationally representative nutrition surveillance system to assess trends and influence nutrition programs and policy

    Directory of Open Access Journals (Sweden)

    Nasima Akhter

    2010-02-01

    Full Text Available The Nutritional Surveillance Project (NSP* of Helen Keller International (HKI, Bangladesh, implemented in partnership with the Government of Bangladesh’s (GOB Institute of Public Health Nutrition (IPHN from 1990 until 2006, is among the longest running surveillance systems; and was implemented with an overall goal to monitor nutrition and health status of children and mothers in Bangladesh. From 1990-1997, NSP data collection included rural and urban poor populations of disaster prone areas of Bangladesh. Since 1998, it evolved into a nationally representative nutrition surveillance system in rural Bangladesh and also continued assessing trends of malnutrition in urban poor areas. Over the 16 year period, the NSP produced plethora of information that was packaged and shared as bulletins, in peer reviewed journal articles, as presentations at conferences, seminars, workshops. The NSP had a flexible framework that allowed it to assess trends and underlying factors of malnutrition, monitor and evaluate selected programs and conduct special studies related to current and emerging issues. NSP findings were available to contribute to program development and supported policy discussions in-country and internationally. The NSP continuously highlighted the importance of monitoring, which is not only an indispensible element for a successful program, but also helps prioritization and decision making to maximize utilization of limited resources for developing countries burdened with numerous problems to address. The NSP provides an example of a technically sound surveillance system with rapid turnover of data and findings, which is imperative to successful program planning, policy formulation and tracking progress toward developmental goals.Le projet Nutritional Surveillance Project (NSP* de l’association Helen Keller International (HKI, mis en œuvre au Bangladesh en partenariat avec l’Institute of Public Health Nutrition (IPHN,

  18. The Establishment of the Colombian Integrated Program for Antimicrobial Resistance Surveillance (COIPARS): A Pilot Project on Poultry Farms, Slaughterhouses and Retail Market.

    Science.gov (United States)

    Donado-Godoy, P; Castellanos, R; León, M; Arevalo, A; Clavijo, V; Bernal, J; León, D; Tafur, M A; Byrne, B A; Smith, W A; Perez-Gutierrez, E

    2015-04-01

    The development of antimicrobial resistance among bacteria (AMR) is currently one of the world's most pressing public health problems. The use of antimicrobial agents in humans and animals has resulted in AMR which has narrowed the potential use of antibiotics for the treatment of infections in humans. To monitor AMR and to develop control measures, some countries, such as the USA, Canada and Denmark, have established national integrated surveillance systems (FDA, , CIPARS, 2007, DANMAP,2002). The components of these programs monitor changes in susceptibility/resistance to antimicrobial agents of selected zoonotic pathogens and commensal organisms recovered from animals, retail meats and humans. The rapid development of Colombia's animal production industry has raised food safety issues including the emergence of antibiotic resistance. The Colombian Integrated Surveillance Program for Antimicrobial Resistance (COIPARS) was established as a pilot project to monitor AMR on poultry farms, slaughter houses and retail markets. © 2015 Blackwell Verlag GmbH.

  19. Multicenter evaluation of resistance patterns of Klebsiella pneumoniae, Escherichia coli, Salmonella spp and Shigella spp isolated from clinical specimens in Brazil: RESISTNET surveillance program

    Directory of Open Access Journals (Sweden)

    Carmen Paz Oplustil

    Full Text Available Surveillance programs are essential to detect the increase of antimicrobial resistance, and several different programs are being conducted in many countries. The RESISTNET is a surveillance program for bacterial resistance against several antimicrobial agents initiated in 1998 among Latin American countries. In Brazil, several centers were invited to join this surveillance and a total of 11 centers (6 from São Paulo and 5 from other states participated in the study. All results were analyzed using the WHONET program. A total of 894 Escherichia coli, 386 Klebsiella pneumoniae, 70 Shigella spp and 57 Salmonella spp strains were analyzed in this study from April, 1998, to April, 1999. Susceptibility testing was performed by the disk diffusion method using NCCLS 1998 guidelines for several different drugs. For all strains, imipenem was the most effective drug (100% of the strains were susceptible. Klebsiella pneumoniae presented a high resistance rate to ampicillin (96.4%. The rate of probable ESBL producers among K. pneumoniae strains was 36.3%, most of them being isolated from catheters (58.8%. Among all Escherichia coli strains analyzed, the highest resistance rate was found for trimethoprim/sulfamethoxazole (46.9% and the majority of the resistant strains were isolated from urine samples (47.8%. Among Salmonella spp, the resistance rates were low for all antibiotics tested. For Shigella spp strains there was a high resistance to trimethoprim/sulfamethoxazole (80.0%. No resistance to ceftriaxone was observed in these strains. Surveillance of antimicrobial resistance is critical for the successful management of infectious diseases. The results of this survey show significant resistance rates among these bacteria which are responsible for several types of human infections.

  20. Building a structured monitoring and evaluating system of postmarketing drug use in Shanghai.

    Science.gov (United States)

    Du, Wenmin; Levine, Mitchell; Wang, Longxing; Zhang, Yaohua; Yi, Chengdong; Wang, Hongmin; Wang, Xiaoyu; Xie, Hongjuan; Xu, Jianglong; Jin, Huilin; Wang, Tongchun; Huang, Gan; Wu, Ye

    2007-01-01

    In order to understand a drug's full profile in the post-marketing environment, information is needed regarding utilization patterns, beneficial effects, ADRs and economic value. China, the most populated country in the world, has the largest number of people who are taking medications. To begin to appreciate the impact of these medications, a multifunctional evaluation and surveillance system was developed, the Shanghai Drug Monitoring and Evaluative System (SDMES). Set up by the Shanghai Center for Adverse Drug Reaction Monitoring in 2001, the SDMES contains three databases: a population health data base of middle aged and elderly persons; hospital patient medical records; and a spontaneous ADR reporting database. Each person has a unique identification and Medicare number, which permits record-linkage within and between these three databases. After more than three years in development, the population health database has comprehensive data for more than 320,000 residents. The hospital database has two years of inpatient medical records from five major hospitals, and will be increasing to 10 hospitals in 2007. The spontaneous reporting ADR database has collected 20,205 cases since 2001 from approximately 295 sources, including hospitals, pharmaceutical companies, drug wholesalers and pharmacies. The SDMES has the potential to become an important national and international pharmacoepidemiology resource for drug evaluation.

  1. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

    Full Text Available Post-market environmental monitoring (PMEM of genetically modified (GM crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

  2. Introduction to surveillance studies

    CERN Document Server

    Petersen, JK

    2012-01-01

    Introduction & OverviewIntroduction Brief History of Surveillance Technologies & TechniquesOptical SurveillanceAerial Surveillance Audio Surveillance Radio-Wave SurveillanceGlobal Positioning Systems Sensors Computers & the Internet Data Cards Biochemical Surveillance Animal Surveillance Biometrics Genetics Practical ConsiderationsPrevalence of Surveillance Effectiveness of Surveillance Freedom & Privacy IssuesConstitutional Freedoms Privacy Safeguards & Intrusions ResourcesReferences Glossary Index

  3. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU

    NARCIS (Netherlands)

    Hoekman, Jarno; Klamer, Thea T.; Mantel-Teeuwisse, Aukje K.; Leufkens, Hubert G M; De Bruin, Marie L.

    2016-01-01

    Aim: The aim of the present study was to provide an insight into the characteristics and follow-up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). Methods: We compiled a list of all postmarketing studies attached as specific obligations to the

  4. Mono- and combination drug therapies in hospitalized patients with bipolar depression. Data from the European drug surveillance program AMSP

    Directory of Open Access Journals (Sweden)

    Haeberle Anne

    2012-09-01

    Full Text Available Abstract Background For the pharmacological treatment of bipolar depression several guidelines exist. It is largely unknown, to what extent the prescriptions in daily clinical routine correspond to these evidence based recommendations and which combinations of psychotropic drugs are frequently used. Methods The prescriptions of psychotropic drugs were investigated of all in-patients with bipolar depression (n = 2246; time period 1994–2009 from hospitals participating in the drug surveillance program AMSP. For the drug use in 2010, 221 cases were analysed additionally. Results From 1994 to 2009, 85% of all patients received more than one class of psychotropic substances: 74% received antidepressants in combination therapy, 55% antipsychotics, 48% anticonvulsants and 33% lithium. When given in combination, lithium is the most often prescribed substance for bipolar depression (33%, followed by valproic acid (23%, mirtazapine and venlafaxine (16% each, quetiapine (15%, lamotrigine (14% and olanzapine (13%. Both, lithium and valproic acid are often combined with selective serotonin reuptake inhibitors (SSRI, but also with mirtazapine und venlafaxine. Combinations of more than one antidepressant occur quite often, whereby combinations with bupropion, paroxetine, fluoxetine or fluvoxamine are very rare. In 2010, quetiapine (alone and combined was the most frequently prescribed drug (39%; aripiprazole was administered in 10%. Conclusion Combinations of antidepressants (SSRI, mirtazapine, venlafaxine with mood stabilizers (lithium, valproic acid, lamotrigine and / or atypical antipsychotics (quetiapine, olanzapine are common. Of most of those combinations the efficacy has not been studied. The use of aripiprazole and the concomitant use of two or three antidepressants contrast the guidelines.

  5. Carbapenem non-susceptible enterobacteriaceae in Quebec, Canada: results of a laboratory surveillance program (2010-2012.

    Directory of Open Access Journals (Sweden)

    Brigitte Lefebvre

    Full Text Available The emergence and spread of carbapenemase-producing Enterobacteriaceae (CPE represent a major public health concern because these bacteria are usually extensively resistant to most antibiotics. In order to evaluate their dissemination in Quebec, a surveillance program was introduced in 2010. We report the molecular and epidemiological profiles of CPE isolates collected. Between August 2010 and December 2012, a total of 742 non-duplicate isolates non-susceptible to carbapenems were analysed. AmpC β-lactamase and metallo-β-lactamase production were detected by Etest and carbapenemase production by the modified Hodge test (MHT. Antibiotic susceptibility profiles were determined using broth microdilution or Etest. Clonality of Klebsiella pneumoniae carbapenemase (KPC strains was analyzed by pulsed-field gel electrophoresis (PFGE. The presence of genes encoding carbapenemases as well as other β-lactamases was detected using PCR. Of the 742 isolates tested, 169 (22.8% were CPE. Of these 169 isolates, 151 (89.3% harboured a blaKPC gene while the remaining isolates carried blaSME (n = 9, blaOXA-48 (n = 5, blaNDM (n = 3, and blaNMC (n = 1 genes. Among the 93 KPC strains presenting with a unique pattern (unique PFGE pattern and/or unique antibiotics susceptibility profile, 99% were resistant to ertapenem, 95% to imipenem, 87% to meropenem, 97% to aztreonam, 31% to colistin and 2% to tigecycline. In 19 patients, 2 to 5 KPC strains from different species or with a different PFGE pattern were isolated. CPE strains were present in the province of Quebec with the majority of strains harbouring KPC. Alternately, SME, OXA-48 and NMC containing strains were rarely found.

  6. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  7. Surveillance Culture

    DEFF Research Database (Denmark)

    2017-01-01

    What does it mean to live in a world full of surveillance? In this documentary film, we take a look at everyday life in Denmark and how surveillance technologies and practices influence our norms and social behaviour. Researched and directed by Btihaj Ajana and Anders Albrechtslund....

  8. GEIS Surveillance Network Program

    Science.gov (United States)

    2013-10-01

    influenza-like illness in Kenya, determine etiologies of diarrheal illnesses and the antimicrobial resistance patterns of bacterial causes, determine ...of the blood sample. These drugs include Arteether, Pyronaridine, Primaquine, Artesunate, Proguanil, Trimethoprim , Sulfamethoxazole, Pyrimethamine...that are controlled with Trimethoprim /sulfamethoxazole (TMP/SMZ). Use of TMP/SMZ prophylaxis however might put populations at risk of developing

  9. Analysis to evaluate predictors of fiberboard aging to guide surveillance sampling for the 9975 life extension program

    Energy Technology Data Exchange (ETDEWEB)

    Kelly, Elizabeth J. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Daugherty, William L. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL); Hackney, Elizabeth R. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

    2016-05-09

    During surveillance of the 9975 shipping package at the Savannah River Site K-Area Complex, several package dimensions are recorded. The analysis described in this report shows that, based on the current data analysis, two of these measurements, Upper Assembly Outer Diameter (UAOD) and Upper Assembly Inside Height (UAIH), do not have statistically significant aging trends regardless of wattage levels. In contrast, this analysis indicates that the measurement of Air Shield Gap (ASGap) does show a significant increase with age. It appears that the increase is greater for high wattage containers, but this result is dominated by two measurements from high-wattage containers. For all three indicators, additional high-wattage, older containers need to be examined before any definitive conclusions can be reached. In addition, the current analysis indicates that ASGap measurements for low and medium wattage containers are increasing slowly over time. To reduce uncertainties and better capture the aging trend for these containers, additional low and medium wattage older containers should also be examined. Based on this analysis, surveillance guidance is to augment surveillance containers resulting from 3013 surveillance with 9975-focused sampling that targets older, high wattage containers and also includes some older, low and medium wattage containers. This focused sampling began in 2015 and will continue in 2016. The UAOD, UAIH and ASGap data are highly variable. It is possible that additional factors such as seasonal variation and packaging site location might reduce variability and be useful for focusing surveillance and predicting aging.

  10. Trends in Drug Resistance of Acinetobacter baumannii over a 10-year Period: Nationwide Data from the China Surveillance of Antimicrobial Resistance Program.

    Science.gov (United States)

    Gao, Lei; Lyu, Yuan; Li, Yun

    2017-03-20

    Acinetobacter baumannii has emerged as an important pathogen causing a variety of infections. Using data from the China Surveillance of Antimicrobial Resistance Program conducted biennially, we investigated the secular changes in the resistance of 2917 isolates of A. baumannii from 2004 to 2014 to differ antimicrobial agents. Pathogen samples were collected from 17 to 20 hospitals located in the eastern, central, and western regions of China. Minimum inhibitory concentrations (MICs) were determined by a 2-fold agar dilution method, and antimicrobial susceptibility was established using the 2014 Clinical Laboratory Standards Institute-approved breakpoints. Isolates not susceptible to all the tested aminoglycosides, fluoroquinolones, β-lactams, β-lactam/β-lactam inhibitors and carbapenems were defined as extensively drug resistant. The rates of nonsusceptibility to common antimicrobial agents remained high (>65%) over the years with some fluctuations to certain agents. The prevalence of imipenem-resistant A. baumannii (IRAB) increased from 13.3% in 2004 to 70.5% in 2014 and that of extensively drug-resistant A. baumannii (XDRAB) increased from 11.1% in 2004 to 60.4% in 2014. The activity of tigecycline was stable with MIC90 ≤4 mg/L against A. baumannii from 2009 to 2014. Susceptibility to colistin remained high (97.0%) from 2009 to 2014. The prevalence of XDRAB increased in all the three surveillance regions over the years and was significantly higher in Intensive Care Unit (ICU) wards than non-ICU wards. This longitudinal multicenter surveillance program revealed the nationwide emergence of A. baumannii in China and showed a significant increase in prevalence from 2004 to 2014. High levels of bacterial resistance were detected among samples collected from clinical settings in China, with IRAB and XDRAB being especially prevalent. This study will help to guide empirical therapy and identify at-risk groups requiring more intense interventional infection control

  11. Rethinking Research Ethics: The Case of Postmarketing Trials

    Science.gov (United States)

    London, Alex John; Carlisle, Benjamin

    2015-01-01

    Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237

  12. The Incidence and Prevalence of Systemic Lupus Erythematosus in New York County (Manhattan), New York: The Manhattan Lupus Surveillance Program.

    Science.gov (United States)

    Izmirly, Peter M; Wan, Isabella; Sahl, Sara; Buyon, Jill P; Belmont, H Michael; Salmon, Jane E; Askanase, Anca; Bathon, Joan M; Geraldino-Pardilla, Laura; Ali, Yousaf; Ginzler, Ellen M; Putterman, Chaim; Gordon, Caroline; Helmick, Charles G; Parton, Hilary

    2017-10-01

    The Manhattan Lupus Surveillance Program (MLSP) is a population-based registry designed to determine the prevalence of systemic lupus erythematosus (SLE) in 2007 and the incidence from 2007 to 2009 among residents of New York County (Manhattan), New York, and to characterize cases by race/ethnicity, including Asians and Hispanics, for whom data are lacking. We identified possible SLE cases from hospital records, rheumatologist records, and administrative databases. Cases were defined according to the American College of Rheumatology (ACR) classification criteria, the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria, or the treating rheumatologist's diagnosis. Rates among Manhattan residents were age-standardized, and capture-recapture analyses were conducted to assess case underascertainment. By the ACR definition, the age-standardized prevalence and incidence rates of SLE were 62.2 and 4.6 per 100,000 person-years, respectively. Rates were ∼9 times higher in women than in men for prevalence (107.4 versus 12.5) and incidence (7.9 versus 1.0). Compared with non-Hispanic white women (64.3), prevalence was higher among non-Hispanic black (210.9), Hispanic (138.3), and non-Hispanic Asian (91.2) women. Incidence rates were higher among non-Hispanic black women (15.7) compared with non-Hispanic Asian (6.6), Hispanic (6.5), and non-Hispanic white (6.5) women. Capture-recapture adjustment increased the prevalence and incidence rates (75.9 and 6.0, respectively). Alternate SLE definitions without capture-recapture adjustment revealed higher age-standardized prevalence and incidence rates (73.8 and 6.2, respectively, by the SLICC definition and 72.6 and 5.0 by the rheumatologist definition) than the ACR definition, with similar patterns by sex and race/ethnicity. The MLSP confirms findings from other registries on disparities by sex and race/ethnicity, provides new estimates among Asians and Hispanics, and provides estimates using the

  13. Active SMS-based influenza vaccine safety surveillance in Australian children.

    Science.gov (United States)

    Pillsbury, Alexis; Quinn, Helen; Cashman, Patrick; Leeb, Alan; Macartney, Kristine

    2017-12-18

    Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p safety profile between brands. Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Surveillance Pleasures

    DEFF Research Database (Denmark)

    Albrechtslund, Anders

    The notorious intensification and digitalization of surveillance technologies and practices in today’s society has brought about numerous changes. These changes have been widely noticed, described and discussed across many academic disciplines. However, the contexts of entertainment, play...

  15. Studies and development of essential systems in the surveillance program, life extension potential of the vessel and master curve in nuclear power plants

    International Nuclear Information System (INIS)

    Romero C, J.; Hernandez C, R.; Rocamontes A, M.; Perez R, N.

    2010-01-01

    The nuclear power plants owners should demonstrate that the effects of the embrittlement by neutronic radiation do not commit the structural integrity of the pressure vessel of the nuclear reactors, so much under conditions of routine operation as below an accident postulate. In consequence, in Mexico surveillance programs of the vessels of the nuclear power plant of Laguna Verde exist, in which three surveillance capsules are have by reactor. A surveillance capsule is composed by a support and between six and eight containers for test tubes and dosemeters. The containers for test tubes are of two types: rectangular container for Charpy V test tubes and cylindrical container for tension test tubes. These test tubes are subject to a same or bigger neutronic flow that of the vessel, being representative witness of the mechanical conditions of the vessel. The objective of to assay the test tubes to impact is to evaluate the embrittlement grade of the vessel beforehand during its useful life of operation, as well as to determinate the running of the ductile-fragile transition temperature in function of the time. (Author)

  16. Surface Environmental Surveillance Procedures Manual

    International Nuclear Information System (INIS)

    Hanf, Robert W.; Poston, Ted M.

    2000-01-01

    Shows and explains certain procedures needed for surface environmental surveillance. Hanford Site environmental surveillance is conducted by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy (DOE) under the Surface Environmental Surveillance Project (SESP). The basic requirements for site surveillance are set fourth in DOE Order 5400.1, General Environmental Protection Program Requirements. Guidance for the SESP is provided in DOE Order 5484.1, Environmental Protection, Safety, and Health Protection Information Reporting Requirements and DOE Order 5400.5, Radiation Protection of the Public and Environment. Guidelines for environmental surveillance activities are provided in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance. An environmental monitoring plan for the Hanford Site is outlined in DOE/RL 91-50 Rev. 2, Environmental Monitoring Plan, United States Department of Energy, Richland Operations Office. Environmental surveillance data are used in assessing the impact of current and past site operations on human health and the environment, demonstrating compliance with applicable local, state, and federal environmental regulations, and verifying the adequacy of containment and effluent controls. SESP sampling schedules are reviewed, revised, and published each calendar year in the Hanford Site Environmental Surveillance Master Sampling Schedule. Environmental samples are collected by SESP staff in accordance with the approved sample collection procedures documented in this manual. Personnel training requirements are documented in SESP-TP-01 Rev.2, Surface Environmental Surveillance Project Training Program.

  17. Designing a risk-based surveillance program for Mycobacterium avium ssp. paratuberculosis in Norwegian dairy herds using multivariate statistical process control analysis.

    Science.gov (United States)

    Whist, A C; Liland, K H; Jonsson, M E; Sæbø, S; Sviland, S; Østerås, O; Norström, M; Hopp, P

    2014-11-01

    Surveillance programs for animal diseases are critical to early disease detection and risk estimation and to documenting a population's disease status at a given time. The aim of this study was to describe a risk-based surveillance program for detecting Mycobacterium avium ssp. paratuberculosis (MAP) infection in Norwegian dairy cattle. The included risk factors for detecting MAP were purchase of cattle, combined cattle and goat farming, and location of the cattle farm in counties containing goats with MAP. The risk indicators included production data [culling of animals >3 yr of age, carcass conformation of animals >3 yr of age, milk production decrease in older lactating cows (lactations 3, 4, and 5)], and clinical data (diarrhea, enteritis, or both, in animals >3 yr of age). Except for combined cattle and goat farming and cattle farm location, all data were collected at the cow level and summarized at the herd level. Predefined risk factors and risk indicators were extracted from different national databases and combined in a multivariate statistical process control to obtain a risk assessment for each herd. The ordinary Hotelling's T(2) statistic was applied as a multivariate, standardized measure of difference between the current observed state and the average state of the risk factors for a given herd. To make the analysis more robust and adapt it to the slowly developing nature of MAP, monthly risk calculations were based on data accumulated during a 24-mo period. Monitoring of these variables was performed to identify outliers that may indicate deviance in one or more of the underlying processes. The highest-ranked herds were scattered all over Norway and clustered in high-density dairy cattle farm areas. The resulting rankings of herds are being used in the national surveillance program for MAP in 2014 to increase the sensitivity of the ongoing surveillance program in which 5 fecal samples for bacteriological examination are collected from 25 dairy herds

  18. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  19. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

  20. Post-marketing surveillance of chemicals: organisations and databases : Workshop report

    NARCIS (Netherlands)

    Bouwmeester M; van Drongelen A; Graven C; Hernandez L; Herremans J; de Kaste D; Razenberg L; Vandebriel R; Piersma A; VTS; GZB

    2018-01-01

    The safety evaluation of chemicals is in general performed by the government, importer or manufacturer before marketing, and is based on (inter)national legislation. Less is known about the exact products in which chemicals are processed. Even though multiple institutions in the Netherlands are

  1. Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction

    Science.gov (United States)

    2017-12-19

    Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Functional Deformities; Pseudoarthrosis; Revision of Endoprosthesis-treated Hips; Fracture, Proximal Humeral; Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies); Femur Fracture; Pseudarthrosis; Trochanteric Fractures; Bridging of Large Bone Defects; Revisions

  2. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Science.gov (United States)

    2011-07-21

    ... limited and, therefore, FDA may limit the number of participants from each organization. If time and space... with device interoperability. 15. The current and future state of MMIS and RTLS systems to support safe.... Any lessons learned that can be applied from documenting medication use. 24. How the documentation of...

  3. 77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...

    Science.gov (United States)

    2012-08-30

    ... structure of registries; (6) business models for sustainable efforts; and (7) strategies and priorities for... a problem or disease; and to examine trends of disease, treatment, or product use over time. To be...

  4. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    OpenAIRE

    Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.

    2012-01-01

    Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Admini...

  5. Integrated cardiac safety: assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance

    National Research Council Canada - National Science Library

    Turner, J. Rick; Durham, Todd A

    2009-01-01

    ... PROTEOMICS AND TRANSCRIPTOMICS 2.8 GENE EXPRESSION 2.9 PROTEINS 2.10 CELLS 2.11 CELL MEMBRANES 2.12 PROTEINS IN CELL MEMBRANES 2.13 ION CHANNELS 2.14 RECEPTORS ADVERSE DRUG REACTIONS MELANOGASTER 25 ...

  6. Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance data.

    Science.gov (United States)

    DuMouchel, William; Smith, Eric T; Beasley, Richard; Nelson, Harold; Yang, Xionghu; Fram, David; Almenoff, June S

    2004-07-01

    Churg-Strauss syndrome (CSS), also known as allergic granulomatous angiitis (AGA), is a rare vasculitis that occurs in patients with bronchial asthma. The nature of the association of CSS with various asthma therapies is unclear. This study investigated the associations of different multidrug asthma therapy regimens and the reporting of AGA (the preferred code for CSS in the coding dictionary for the Adverse Event Reporting System [AERS]) by applying an iterative method of disproportionally analysis to th AERS database maintained by the US Food and Drug Administration. The public-release version of the AERS database was used to identify reports of AGA in patients receiving asthma therapy. Reporting of AGA was examined using iterative disproportionality methods in patients receiving > or =1 of the following drug classes: inhaled corticosteroid (ICS), leukotriene receptor antagonist (LTRA), short-acting beta(2)-agonist (SABA), or long-acting beta(2)-agonist (LABA). The Bayesian data-mining algorithm known as the multi-item gamma poisson shrinker was used to determine the relative reporting rates by calculation of the empirical Bayes geometric mean (EBGM) and its 90% CI (EB05 = lower limit and EB95 = upper limit) for each drug. Subset analyses were performed for each drug with different medication combinations to differentiate the relative reporting of AGA for each. A strong association was found between LTRA use and AGA (EBGM = 104.0, EB05 = 95.0, EB95 = 113.8) that persisted with all combinations of therapy studied. AGA was also associated with the ICS, SABA and LABA classes (EBGM values of 27.8, 14.6 and 40.4, respectively). However, the latter associations were mostly dependent on the presence of concurrent LTRA and, to a lesser extemt, oral corticosteroid therapy and became negligible (ie, EB05 < 2) for patients who were not receiving these concurrent treatments. Differences based on relative reporting were observed in the patterns of association of AGA with LTRA, ICS, and beta(2)-agonist therapies. A strong association between LTRA use and AGA was present regardless of the use of other asthma drugs.

  7. Validación de un programa de vigilancia de infecciones nosocomiales Validation of a nosocomial infections surveillance program

    Directory of Open Access Journals (Sweden)

    M. Sigfrido Rangel-Frausto

    1999-01-01

    Full Text Available OBJETIVO. Validar el programa de vigilancia de infecciones nosocomiales y conocer la morbilidad y la mortalidad. MATERIAL Y MÉTODOS. Un médico especialmente capacitado, realizó vigilancia intensiva de todos los pacientes admitidos en el hospital. Los casos de infección fueron discutidos con otros dos médicos y el resultado se comparó con la vigilancia rutinaria. Se incluyó a todos los pacientes hospitalizados del 11 de julio al 12 de agosto de 1995, que no tenían un proceso infeccioso activo o que no manifestaban un periodo de incubación a su ingreso. Se siguieron diariamente y se registraron datos de: edad, sexo y padecimiento de ingreso. Se recabó información sobre tratamiento antimicrobiano, microrganismo aislado y susceptibilidad. Se evaluó el estado clínico final y se estimó el tiempo de estancia hospitalaria. RESULTADOS. De 429 pacientes, 45 desarrollaron infección nosocomial (casos y 384 no lo hicieron (controles. La incidencia de infecciones nosocomiales fue de 10.48/100. La sensibilidad y la especificidad del programa fueron de 93.3 y 98.7%, respectivamente. La mortalidad en los infectados fue de 11.11%, y en el grupo de los no infectados, de 2.4%. El promedio de estancia hospitalaria fue de 20 y 11 días, para infectados y no infectados, respectivamente (pOBJECTIVES. To validate the nosocomial infections surveillance system, establish its impact in morbi-mortality. MATERIAL AND METHODS. Surveillance of every single patient admited during a one month period was done by one of us (DMG. Each posibile case was discussed with two other hospital epidemiologists (SPLR, MSRF. This intensive surveillance was compared against the routinely surveillance performed by the nurses. We included all hospitalized patients between 11th July and 12th of August according to CDC (Atlanta, GA nosocomial infections definitions. Patients were followed everyday and information about age, gender, underlying diagnosis, microorganisms responsible

  8. 76 FR 23825 - Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshop

    Science.gov (United States)

    2011-04-28

    ... understanding of the performance of diagnostics at the postmarket settings. II. Who is the target audience for... interested parties. The target audience is professionals in the scientific community with experience in...

  9. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Science.gov (United States)

    2012-02-24

    ... organizational unit responsible for adverse event reporting compliance when these conditions exist and when the...'s current thinking on postmarketing adverse event reporting for medical products and dietary...

  10. The effectiveness of a health-surveillance program for caisson saturation divers in a tunnel-boring machine: a microbiological survey.

    Science.gov (United States)

    Van Rees Vellinga, T P; Sterk, W; Van Dijk, F J H

    2010-01-01

    The purpose of this field study is to report and evaluate the implementation of a health surveillance program we developed to monitor the microbiological load for saturation divers, including preventive and therapeutic interventions. We extended the DMAC protocol for Saturation Diving Chamber Hygiene and added some components: ear inspections, swabs and environmental swabs every third day. The implementation was evaluated by analyzing the results of the activities. In a pre-saturation dive check we examined a total of 17 divers. Here we present the data from all seven saturation phases, collected over a period of 1.5 years. In every saturation phase we have found pathogenic bacteria or fungi in divers and in the environment, but more in some periods than in others. We did not observe any serious infection that required a diver to abort his stay in the living chamber. This health surveillance program has demonstrated the potential value of an early warning system to prevent problems. The bacterial load found in divers and in the environment was clearly visible. Prevention could be improved by more consistent implementation of the protocol. Fortunately, the infections had no serious consequences for the health of the workers or for the continuation of the work process.

  11. Public involvement in environmental surveillance at Hanford

    International Nuclear Information System (INIS)

    Hanf, R.W. Jr.; Patton, G.W.; Woodruff, R.K.; Poston, T.M.

    1994-08-01

    Environmental surveillance at the Hanford Site began during the mid-1940s following the construction and start-up of the nation's first plutonium production reactor. Over the past approximately 45 years, surveillance operations on and off the Site have continued, with virtually all sampling being conducted by Hanford Site workers. Recently, the US Department of Energy Richland Operations Office directed that public involvement in Hanford environmental surveillance operations be initiated. Accordingly, three special radiological air monitoring stations were constructed offsite, near hanford's perimeter. Each station is managed and operated by two local school teaches. These three stations are the beginning of a community-operated environmental surveillance program that will ultimately involve the public in most surveillance operations around the Site. The program was designed to stimulate interest in Hanford environmental surveillance operations, and to help the public better understand surveillance results. The program has also been used to enhance educational opportunities at local schools

  12. Annual summary report on surveillance and maintenance activities of the surplus contaminated facilities program at Oak Ridge National Laboratory for period ending September 30, 1991

    International Nuclear Information System (INIS)

    Cannon, T.R.; Ford, M.K.; Holder, L. Jr.

    1991-09-01

    The Surplus Contaminated Facilities Program (SCFP) was established at the Oak Ridge National Laboratory (ORNL) in 1985 to provide support for inactive contaminated facilities that were largely abandoned by the programs which they formerly served. This support provides for routine surveillance and maintenance (S ampersand M) and special projects beyond a routine nature when such actions are needed to ensure adequate protection of personnel or the environment. The facilities included in the program had been used for research, technology development, isotope production and processing, and waste management. Support for facilities in the SCFP has previously been provided by the Department of Energy's (DOE's) Office of Energy Research: Multiprogram Energy Laboratories -- Facilities Support (ERKG) because of multiprogram use of the facilities or because of the landlord responsibility of Energy Research. Recently, an integrated Decontamination and Decommissioning (D ampersand D) program within the DOE Office of Environmental Restoration and Waste Management has been established to collectively manage the former Surplus Facilities Management Program, Defense D ampersand D Program, and the KG-funded, ORNL-originated SCFP. This report gives an overview of the S ampersand M planning, routine S ampersand M, and special maintenance project activities which have occurred at the SCFP facilities during the 1991 Fiscal Year

  13. Annual summary report of the Decontamination and Decommissioning surveillance and maintenance program at Oak Ridge National Laboratory for period ending September 30, 1992

    International Nuclear Information System (INIS)

    Ford, M.K.; Holder, L. Jr.

    1992-09-01

    The Oak Ridge National Laboratory (ORNL) Decontamination and Decommissioning (D ampersand D) Program is part of the Department of Energy (DOE) Environmental Restoration D ampersand D Program and has continued to provide surveillance and maintenance (S ampersand M) support for 34 surplus facilities. The objectives are (1) to ensure adequate containment of residual radioactive materials remaining in the facilities, (2) to provide safety and security controls to minimize the potential hazards to on-site personnel and to the general public, and (3) to manage the facilities in the most cost-effective manner while awaiting decommissioning. This support has included work in three principal areas: (1) S ampersand M planning, (2) routine S ampersand M, and (3) special projects designed to correct serious facility deficiencies beyond the scope of routine maintenance

  14. The results of the surveillance specimen program performed in the RPVs NPP V-2 in Jaslovske Bohunice

    Energy Technology Data Exchange (ETDEWEB)

    Kupca, L; Beno, P [Vyskumny Ustav Jadrovych Elektrarni, Trnava (Slovakia); Cepeek, S [Atomova Elektraren Bohunice, Jaslovske Bohunice (Slovakia); Tomasich, M [Slovak Nuclear Society, Bratislava (Slovakia)

    1994-12-31

    After a description of the mechanical and chemical characteristics of the materials (steels, welded joints) used in the pressure vessels of the WWER-440 V-213 type, the present status of the Bohunice NPP Unit 3 and 4 pressure vessel embrittlement assessment programme is presented: neutron flux monitoring and calculations, detector accuracy, irradiation temperature monitoring, reactor core fuel loading calculation, materials, number and types of surveillance specimens, specimen testing. Results are given for 5 years of irradiation: mechanical properties, transition temperatures, lifetime evaluation. 4 refs., 13 figs., 6 tabs.

  15. Influenza surveillance

    Directory of Open Access Journals (Sweden)

    Karolina Bednarska

    2016-04-01

    Full Text Available Influenza surveillance was established in 1947. From this moment WHO (World Health Organization has been coordinating international cooperation, with a goal of monitoring influenza virus activity, effective diagnostic of the circulating viruses and informing society about epidemics or pandemics, as well as about emergence of new subtypes of influenza virus type A. Influenza surveillance is an important task, because it enables people to prepare themselves for battle with the virus that is constantly mutating, what leads to circulation of new and often more virulent strains of influenza in human population. As vaccination is the most effective method of fighting the virus, one of the major tasks of GISRS is developing an optimal antigenic composition of the vaccine for the current epidemic season. European Influenza Surveillance Network (EISN has also developed over the years. EISN is running integrated epidemiological and virological influenza surveillance, to provide appropriate data to public health experts in member countries, to enable them undertaking relevant activities based on the current information about influenza activity. In close cooperation with GISRS and EISN are National Influenza Centres - national institutions designated by the Ministry of Health in each country.

  16. Surveillance Angels

    NARCIS (Netherlands)

    Rothkrantz, L.J.M.

    2014-01-01

    The use of sensor networks has been proposed for military surveillance and environmental monitoring applications. Those systems are composed of a heterogeneous set of sensors to observe the environment. In centralised systems the observed data will be conveyed to the control room to process the

  17. Break-even analysis of costs for controlling Toxoplasma gondii infections in slaughter pigs via a serological surveillance program in the Netherlands.

    Science.gov (United States)

    van Asseldonk, M; van Wagenberg, C P A; Wisselink, H J

    2017-03-01

    Toxoplasma gondii (T. gondii) is a food safety hazard which causes a substantial human disease burden and cost-of-illness. Infected pig meat is a common source of toxoplasmosis. A break-even analysis was conducted to estimate the point for which the intervention cost at fattening pig farms equaled the cost of averted human disease burden and cost-of-illness minus the costs of a T. gondii surveillance program. The surveillance program comprised serological testing of blood samples taken at slaughter. Break-even points were determined given alternative levels of the effectiveness of the intervention program (10% up to 90% in steps of 10%), the value of an averted DALY (20,000, 50,000 and 80,000 Euro), and threshold of sample prevalence for a farm to be under intervention (5% up to 50% out of 20 samples in steps of 5%). Since test characteristics are a determining factor in the break-even analysis, and literature is inconclusive concerning sensitivity (se) and specificity (sp) of the serological test kit used, two alternative sets of assumptions were analysed. The estimated maximum costs of an intervention if only benefits for domestic consumers were accounted amounted approximately 2981 Euro (se=98.9% and sp=92.7%) versus 4389 Euro (se=65.2% and sp=97.4%) per year per fattening pig farm under intervention assuming an effectiveness of 50%, 50,000 Euro per averted DALY and threshold T. gondii sample prevalence of 5% for a farm to be under intervention. Since almost 80% of the gross domestic production is exported corresponding break-even values increased up to 12,034 Euro and 18,366 Euro if benefits for consumers abroad were included as well. Empirical research to strengthen the knowledge about the efficacy of a farm intervention measures is recommended. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Crypto and empire: the contradictions of counter-surveillance advocacy

    NARCIS (Netherlands)

    Gürses, S.; Kundnani, A.; Van Hoboken, J.

    2016-01-01

    Since Edward Snowden’s revelations of US and UK surveillance programs, privacy advocates, progressive security engineers, and policy makers have been seeking to win majority support for countering surveillance. The problem is framed as the replacement of targeted surveillance with mass surveillance

  19. Rinderpest surveillance

    International Nuclear Information System (INIS)

    2003-01-01

    Rinderpest is probably the most lethal virus disease of cattle and buffalo and can destroy whole populations; damaging economies; undermining food security and ruining the livelihood of farmers and pastoralists. The disease can be eradicated by vaccination and control of livestock movement. The Department of Technical Co-operation is sponsoring a programme, with technical support from the Joint FAO/IAEA Division to provide advice, training and materials to thirteen states through the 'Support for Rinderpest Surveillance in West Asia' project. (IAEA)

  20. Health surveillance

    International Nuclear Information System (INIS)

    1981-01-01

    The Code includes a number of requirements for the health surveillance of employees associated with the mining and milling of radioactive ores. This guideline is particularly directed at determining the level of fitness of employees and prospective employees, detecting any symptom which might contraindicate exposure to the environment encountered in mine/mill situations, examination of any employee who may have been exposed to radiation in excess of defined limits and the accumulation and provision of data on the health of employees

  1. Annual summary report of the Decontamination and Decommissioning Surveillance and Maintenance Program at Oak Ridge National Laboratory for period ending September 30, 1993

    International Nuclear Information System (INIS)

    1993-11-01

    The Oak Ridge National Laboratory (ORNL) Decontamination and Decommissioning (D ampersand D) Program has continued to provide surveillance and maintenance (S ampersand M) support for 34 surplus facilities. The objectives are to (1) ensure adequate containment of residual radioactive materials remaining in the facilities, (2) provide safety and security controls to minimize the potential hazards to on-site personnel and the general public, and (3) manage the facilities in the most cost-effective manner while awaiting decommissioning. This support has included work in three principal areas: (1) S ampersand M planning, (2) routine S ampersand M, and (3) special projects designed to correct serious facility deficiencies beyond the scope of routine maintenance

  2. Impact of a change in surveillance definition on performance assessment of a catheter-associated urinary tract infection prevention program at a tertiary care medical center.

    Science.gov (United States)

    Sopirala, Madhuri M; Syed, Asma; Jandarov, Roman; Lewis, Margaret

    2018-03-16

    In January 2015, the Centers for Disease Control and Prevention (CDC)/National Health Safety Network (NHSN) changed the definition of catheter-associated urinary tract infection (CAUTI). We evaluated the outcomes of a robust CAUTI prevention program when we performed surveillance using the old definition (before 2015) versus the new definition (after 2015). This is the first study to evaluate how the change in CDC/NHSN definitions affected the outcomes of a CAUTI reduction program. Baseline was from January 2012 to September 2014; the intervention period was from October 2014 to February 2016. Staff nurses were trained to be liaisons of infection prevention (Link Nurses) with clearly defined CAUTI prevention goals and with ongoing monthly activities. CAUTI incidence per 1000 catheter days was compared between the baseline and intervention periods, using the 2 definitions. With the new definition, CAUTIs decreased by 33%, from 2.69 to 1.81 cases per 1000 catheter days (incidence rate ratio [IRR] = 0.67; 95% confidence interval [CI]: 0.48-0.93; P definition, CAUTIs increased by 12%, from 3.38 to 3.80 cases per 1000 catheter days (IRR = 1.12; 95% CI: 0.88-1.43; P = .348). We aggressively targeted CAUTI prevention, but a reduction was observed only with the new definition. Our findings stress the importance of having a reasonably accurate surveillance definition to monitor infection prevention initiatives. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  3. Adherence to the breast cancer surveillance program for women at risk for familial breast and ovarian cancer versus overscreening: a monocenter study in Germany.

    Science.gov (United States)

    Vetter, Lisa; Keller, Monika; Bruckner, Thomas; Golatta, Michael; Eismann, Sabine; Evers, Christina; Dikow, Nicola; Sohn, Christof; Heil, Jörg; Schott, Sarah

    2016-04-01

    Breast cancer (BC) is the leading cancer among women worldwide and in 5-10 % of cases is of hereditary origin, mainly due to BRCA1/2 mutations. Therefore, the German Consortium for Familial Breast and Ovarian Cancer (HBOC) with its 15 specialized academic centers offers families at high risk for familial/hereditary cancer a multimodal breast cancer surveillance program (MBCS) with regular breast MRI, mammography, ultrasound, and palpation. So far, we know a lot about the psychological effects of genetic testing, but we know little about risk-correlated adherence to MBCS or prophylactic surgery over time. The aim of this study was to investigate counselees' adherence to recommendations for MBCS in order to adjust the care supply and define predictors for incompliance. All counselees, who attended HBOC consultation at the University Hospital Heidelberg between July 01, 2009 and July 01, 2011 were eligible to participate. A tripartite questionnaire containing sociodemographic information, psychological parameters, behavioral questions, and medical data collection from the German consortium were used. A high participation rate was achieved among the study population, with 72 % returning the questionnaire. This study showed a rate of 59 % of full-adherers to the MBCS. Significant predictors for partial or full adherence were having children (p = 0.0221), younger daughters (p = 0.01795), a higher awareness of the topic HBOC (p = 0.01795, p breast cancer risk (p breast cancer surveillance program for women at risk for familial breast and ovarian cancer versus overscreening-a monocenter study in Germany.

  4. Elements of quality assurance in environmental surveillance

    International Nuclear Information System (INIS)

    Johnson, L.J.

    1975-01-01

    Qualities of an environmental surveillance program requiring control or assurance are reviewed. Requirements of accuracy, reproducibility, sensitivity, acceptability, and time and cost effectiveness are qualities discussed. The controls applicable to sample collection, handling, chemical analysis, measurement and data presentation are identified and discussed as they pertain to environmental monitoring. Quality assurance program recommendations for developing and reporting environmental surveillance data are provided

  5. Multiparametric Magnetic-Resonance to Confirm Eligibility to an Active Surveillance Program for Low-Risk Prostate Cancer: Intermediate Time Results of a Third Referral High Volume Centre Active Surveillance Protocol.

    Science.gov (United States)

    Luzzago, Stefano; Musi, Gennaro; Catellani, Michele; Russo, Andrea; Di Trapani, Ettore; Mistretta, Francesco Alessandro; Bianchi, Roberto; Cozzi, Gabriele; Conti, Andrea; Pricolo, Paola; Ferro, Matteo; Matei, Deliu-Victor; Mirone, Vincenzo; Petralia, Giuseppe; de Cobelli, Ottavio

    2018-05-07

    To evaluate the role of confirmatory multiparametric magnetic resonance imaging (mpMRI) of the prostate at the time of Active Surveillance (AS) enrollment to reduce disease misclassification. From 2012 to 2016, 383 patients with low-risk disease respecting Prostate Cancer Research International AS criteria underwent confirmatory 1.5-T mpMRI. AS was proposed to patients with Prostate Imaging and Report and Data System (PI-RADS) score ≤3 and no extraprostatic extension (EPE), whereas patients with PI-RADS score ≥4 and/or EPE were treated actively. Kaplan-Meier analyses quantified progression-free survival (PFS) in patients enrolled in the AS program. Logistic regression analyses tested the association between confirmatory mpMRI and clinically significant prostate cancer (csPCa) at radical prostatectomy (RP). Diagnostic performance of mpMRI was calculated in patients submitted to immediate RP. PFS rate was 99, 90 and 86% at 1, 2 and 3 years respectively. At multivariable analysis, PI-RADS 3, PI-RADS 4, PI-RADS 5 and EPE increased the probability of having csPCa at immediate RP (PI-RADS 3 [OR] 1.2, p = 0.26; PI-RADS 4 [OR] 5.1, p = 0.02; PI-RADS 5 [OR] 6.7; p = 0.009; EPE [OR] 11.8, p < 0.001). Confirmatory mpMRI showed sensibility, specificity, positive predictive value and negative predictive value of 85, 55, 68 and 76% respectively. MpMRI at the time of AS enrollment reduces the misclassification rate of csPCa. We suggest to perform target biopsies in patients with PI-RADS score 3 and 4 lesions. © 2018 S. Karger AG, Basel.

  6. Visual interface for the automation of the instrumented pendulum of Charpy tests used in the surveillance program of reactors vessel of nuclear power plants

    International Nuclear Information System (INIS)

    Rojas S, A.S.; Sainz M, E.; Ruiz E, J.A.

    2004-01-01

    Inside the Programs of Surveillance of the nuclear power stations periodic information is required on the state that keep the materials with those that builds the vessel of the reactor. This information is obtained through some samples or test tubes that are introduced inside the core of the reactor and it is observed if its physical characteristics remain after having been subjected to the radiation changes and temperature. The rehearsal with the instrumented Charpy pendulum offers information on the behavior of fracture dynamics of a material. In the National Institute of Nuclear Research (ININ) it has an instrumented Charpy pendulum. The operation of this instrument is manual, having inconveniences to carry out rehearsals with radioactive material, handling of high and low temperatures, to fulfill the normative ones for the realization of the rehearsals, etc. In this work the development of a computational program is presented (virtual instrument), for the automation of the instrumented pendulum. The system has modules like: Card of data acquisition, signal processing, positioning system, tempered system, pneumatic system, compute programs like it is the visual interface for the operation of the instrumented Charpy pendulum and the acquisition of impact signals. This system shows that given the characteristics of the nuclear industry with radioactive environments, the virtual instrumentation and the automation of processes can contribute to diminish the risks to the personnel occupationally exposed. (Author)

  7. Development of the plant life management technology for RPV steels [ - Current status of surveillance test specimen reconstitution program -

    International Nuclear Information System (INIS)

    Kazunobu, Sakamoto; Eliichiro, Otsuka; Yoshiaki, Oka; Kosei, Taguchi; Michiyoshi, Yamamoto

    2001-01-01

    In order to develop the reconstitution technology to standardize surveillance test specimen reconstitution practices to deal with the extended service life of reactor pressure vessels, the Japan Power Engineering and Inspection Corporation (JAPEIC) has been carried out the project entrusted by the Ministry of International Trade and Industry (MITI). We focus on a correlation between the reduction of absorbed energy and the interaction of the heat affected zone (HAZ) and the plastic zone, to establish applicable reconstitution conditions for Charpy specimens. The relationship between the plastic zone width and the absorbed energy has been obtained by estimating the plastic zone width from the hardness distribution of the Charpy specimens. Impact tests of reconstituted specimens with 10 mm-length insert using the surface activated joining method were performed and the test results were compared to those obtained by the standard specimens. By comparing the length of insert material to the sum of HAZ width and plastic zone width, it is clear that the interaction causes the reduction of the absorbed energy. Hence, the applicable conditions of reconstituted Charpy specimens could be assessed by comparing the insert length to the sum of HAZ width and plastic zone width. Moreover the effects of the possible deviations from the standard shape and size specimens for the reconstituted specimens were studied. (authors)

  8. Analysis of the particular spill characteristics observed by the Belgian aerial surveillance program during the Tricolor incident

    International Nuclear Information System (INIS)

    Price, M.

    2004-01-01

    This presentation described the Tricolor oil spill incident, the remote sensing equipment used to monitor the spill, the observed spill characteristics and the flight data assessment. The spill occurred on December 14, 2002 following a collision between the carrier Tricolor and the container vessel Kariba in French waters in the Zone of Joint Responsibility, close to the Belgian and English borders. The Tricolor sank and 3 more vessels collided with the wreck in the five weeks following the collision, spilling several 100 tons of mostly heavy fuel oil into the sea. The remote sensing equipment aboard Belgian surveillance aircraft noted that freshly spilled oil formed a network of widespread dark oil trails surrounded by light oil fractions. The spill volumes were estimated to be high because of the large extent of the polluted area. Nine months following the spill, the emulsified oil trails had a density close to that of seawater. It was assumed that a cold and thick emulsion had formed and became trapped inside the wreck. Upon release, the emulsion could submerse and resurface. The incident demonstrated that early stage oil sample analysis could help interpret slick behaviour by means of remote sensing. 9 refs., 3 tabs., 1 fig

  9. Nutritional surveillance.

    Science.gov (United States)

    Mason, J B; Mitchell, J T

    1983-01-01

    The concept of nutritional surveillance is derived from disease surveillance, and means "to watch over nutrition, in order to make decisions that lead to improvements in nutrition in populations". Three distinct objectives have been defined for surveillance systems, primarily in relation to problems of malnutrition in developing countries: to aid long-term planning in health and development; to provide input for programme management and evaluation; and to give timely warning of the need for intervention to prevent critical deteriorations in food consumption. Decisions affecting nutrition are made at various administrative levels, and the uses of different types of nutritional surveillance information can be related to national policies, development programmes, public health and nutrition programmes, and timely warning and intervention programmes. The information should answer specific questions, for example concerning the nutritional status and trends of particular population groups.Defining the uses and users of the information is the first essential step in designing a system; this is illustrated with reference to agricultural and rural development planning, the health sector, and nutrition and social welfare programmes. The most usual data outputs are nutritional outcome indicators (e.g., prevalence of malnutrition among preschool children), disaggregated by descriptive or classifying variables, of which the commonest is simply administrative area. Often, additional "status" indicators, such as quality of housing or water supply, are presented at the same time. On the other hand, timely warning requires earlier indicators of the possibility of nutritional deterioration, and agricultural indicators are often the most appropriate.DATA COME FROM TWO MAIN TYPES OF SOURCE: administrative (e.g., clinics and schools) and household sample surveys. Each source has its own advantages and disadvantages: for example, administrative data often already exist, and can be

  10. The impact of state-level nutrition-education program funding on BMI: evidence from the behavioral risk factor surveillance system.

    Science.gov (United States)

    McGeary, Kerry Anne

    2013-04-01

    Currently, there is insufficient evidence regarding which policies will improve nutrition, reduce BMI levels and the prevalence of obesity and overweight nationwide. This preliminary study investigates the impact of a nutrition-education policy relative to price policy as a means to reduce BMI in the United States (US). Model estimations use pooled cross-sectional data at the individual-level from the Centers for Disease Control's (CDC), Behavioral Risk Factor Surveillance System (BRFSS), state-level food prices from the American Chamber of Commerce Research Association (ACCRA) and funding for state-specific nutrition-education programs from the United States Department of Agriculture (USDA) from 1992 to 2006. The total number of observations for the study is 2,249,713 over 15 years. During this period, federal funding for state-specific nutrition-education programs rose from approximately $660 thousand for seven states to nearly $248 million for all fifty-two states. In 2011, federal funding for nutrition-education programs reached $375 million. After controlling for state-fixed effects, year effects and state specific linear and quadratic time trends, we find that nutrition education spending has the intended effect on BMI, obese and overweight in aggregate. However, we find heterogeneity as individuals from certain, but not all, income and education levels respond to nutrition-education funding. The results regarding nutrition-education programs suggest that large scale funding of nutrition-education programs may improve BMI levels and reduce obesity and overweight. However, more study is required to determine if these funds are able make the requisite dietary improvements that may ultimately improve BMI for individuals from low income and education-levels. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Decrease in Staphylococcus aureus colonization and hospital-acquired infection in a medical intensive care unit after institution of an active surveillance and decolonization program.

    Science.gov (United States)

    Fraser, Thomas G; Fatica, Cynthia; Scarpelli, Michele; Arroliga, Alejandro C; Guzman, Jorge; Shrestha, Nabin K; Hixson, Eric; Rosenblatt, Miriam; Gordon, Steven M; Procop, Gary W

    2010-08-01

    To evaluate the effects of an active surveillance program for Staphylococcus aureus linked to a decolonization protocol on the incidence of healthcare-associated infection and new nasal colonization due to S. aureus. Retrospective quasi-experimental study. An 18-bed medical intensive care unit at a tertiary care center in Cleveland, Ohio. From January 1, 2006, through December 31, 2007, all patients in the medical intensive care unit were screened for S. aureus nasal carriage at admission and weekly thereafter. During the preintervention period, January 1 through September 30, 2006, only surveillance occurred. During the intervention period, January 1 through December 31, 2007, S. aureus carriers received mupirocin intranasally. Beginning in February 2007, carriers also received chlorhexidine gluconate baths. During the preintervention period, 604 (73.7%) of 819 patients were screened for S. aureus nasal carriage, yielding 248 prevalent carriers (30.3%). During the intervention period, 752 (78.3%) of 960 patients were screened, yielding 276 carriers (28.8%). The incidence of S. aureus carriage decreased from 25 cases in 3,982 patient-days (6.28 cases per 1,000 patient-days) before intervention to 18 cases in 5,415 patient-days (3.32 cases per 1,000 patient-days) (P=.04; relative risk [RR], 0.53 [95% confidence interval {CI}, 0.28-0.97]) and from 9.57 to 4.77 cases per 1,000 at-risk patient-days (P=.02; RR, 0.50 [95% CI, 0.27-0.91]). The incidence of S. aureus hospital-acquired bloodstream infection during the 2 periods was 2.01 and 1.11 cases per 1,000 patient-days, respectively (P=.28). The incidence of S. aureus ventilator-associated pneumonia decreased from 1.51 to 0.18 cases per 1,000 patient-days (P=.03; RR, 0.12 [95% CI, 0.01-0.83]). The total incidence of S. aureus hospital-acquired infection decreased from 3.52 to 1.29 cases per 1,000 patient-days (P=.03; RR, 0.37 [95% CI, 0.14-0.90]). Active surveillance for S. aureus nasal carriage combined with

  12. Scale up of a Plasmodium falciparum elimination program and surveillance system in Kayin State, Myanmar [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daniel M. Parker

    2017-10-01

    Full Text Available Background: Myanmar has one of the largest malaria burdens in Southeast Asia. Along the border with Thailand, Plasmodium falciparum parasites are increasingly showing reduced sensitivity to artemisinin combination therapies. Given that there are no current alternative treatment therapies, one proposed solution to the threat of untreatable P. falciparum malaria is to eliminate the parasite from the region. Several small-scale elimination projects have been piloted along the Myanmar-Thailand border. Following their success, this operational research aimed to scale up the elimination to a broad area of Eastern Kayin State, Myanmar. Methods: The project relied on geographic reconnaissance and a geographic information system, community engagement, generalized access to community-based early diagnosis and treatment, near real-time epidemiological surveillance, cross sectional malaria prevalence surveys and targeted mass drug administration in villages with high prevalence of P. falciparum malaria. Molecular markers of drug resistance were also monitored in individuals with symptomatic and asymptomatic infections. Discussion: This project illustrates the establishment of an elimination project and operational research in a remote, rural area encompassing several armed groups, multiple political organizations and a near-absent health care infrastructure. The establishment of the project relied on a strong rapport with the target community, on-the-ground knowledge (through geographic surveys and community engagement, rapid decision making and an approach that was flexible enough to quickly adapt to a complex landscape. The elimination project is ongoing, now over three years in operation, and assessment of the impact of this operational research will follow. This project has relevance not only for other malaria elimination projects but also for operational research aimed at eliminating other diseases.

  13. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    Science.gov (United States)

    Wang, S F; Zhan, S Y

    2016-07-01

    Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China.

  14. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  15. Rapid surveillance for health events following a mass meningococcal B vaccine program in a university setting: A Canadian Immunization Research Network study.

    Science.gov (United States)

    Langley, J M; MacDougall, D M; Halperin, B A; Swain, A; Halperin, S A; Top, K A; McNeil, S A; MacKinnon-Cameron, D; Marty, K; De Serres, G; Dubé, E; Bettinger, J A

    2016-07-25

    An outbreak of Neisseria meningitidis serotype B infection occurred at a small residential university; public health announced an organizational vaccination program with the 4-component Meningococcal B (4CMenB) vaccine (Bexsero(TM), Novartis/GlaxoSmithKline Inc.) several days later. Since there were limited published data on reactogenicity of 4CMenB in persons over 17years of age, this study sought to conduct rapid surveillance of health events in vaccinees and controls using an online survey. Vaccine uptake was 84.7% for dose 1 (2967/3500) and 70% (2456/3500) for dose 2; the survey response rates were 33.0% (987/2967) and 18.7% (459/2456) in dose 1 and dose 1 recipients respectively, and 12% in unvaccinated individuals (63/533). Most students were 20-29years of age (vaccinees, 64.0%; controls, 74.0). A new health problem or worsening of an existing health problem was reported by 30.0% and 30.3% of vaccine recipients after doses 1 and 2 respectively; and by 15.9% of controls. These health problems interfered with the ability to perform normal activities in most vaccinees reporting these events (74.7% post dose 1; 62.6% post dose 2), and in 60% of controls. The health problems led to a health care provider visit (including emergency room) in 12.8% and 14.4% of vaccinees post doses 1 and 2, respectively and in 40% of controls. The most common reactions in vaccinees were injection site reactions (20.6% post dose 1, 16.1% post dose 20 and non-specific systemic complaints (22.6% post dose 1, 17.6% post dose 2). No hospitalizations were reported. An online surveillance program during an emergency meningococcal B vaccine program was successfully implemented, and detected higher rates of health events in vaccinees compared to controls, and high rates of both vaccinees and controls seeking medical attention. The types of adverse events reported by young adult vaccinees were consistent with those previously. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Health surveillance of radiological work

    International Nuclear Information System (INIS)

    Pauw, H.; Vliet, J.V.D.; Zuidema, H.

    1988-01-01

    Shielding x-ray devices and issuing film badges to radiological workers in 1936 can be considered the start of radiological protection in the Philips enterprises in the Netherlands. Shielding and equipment were constantly improved based upon the dosimetry results of the filmbadges. The problem of radioactive waste led to the foundation of a central Philips committee for radiological protection in 1956, which in 1960 also issued an internal license system in order to regulate the proper precautions to be taken : workplace design and layout, technological provisions and working procedures. An evaluation of all radiological work in 1971 learnt that a stricter health surveillance program was needed to follow up the precautions issued by the license. On one hand a health surveillance program was established and on the other hand all types of radiological work were classified. In this way an obligatory and optimal health surveillance program was issued for each type of radiological work

  17. Special Supplemental Nutrition Program for Women, Infants, and Children participation and infants' growth and health: a multisite surveillance study.

    Science.gov (United States)

    Black, Maureen M; Cutts, Diana B; Frank, Deborah A; Geppert, Joni; Skalicky, Anne; Levenson, Suzette; Casey, Patrick H; Berkowitz, Carol; Zaldivar, Nieves; Cook, John T; Meyers, Alan F; Herren, Tim

    2004-07-01

    The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is the largest food supplement program in the United States, serving almost 7 500 000 participants in 2002. Because the program is a grant program, rather than an entitlement program, Congress is not mandated to allocate funds to serve all eligible participants. Little is known about the effects of WIC on infant growth, health, and food security. To examine associations between WIC participation and indicators of underweight, overweight, length, caregiver-perceived health, and household food security among infants 95th percentile, varied from 7% to 9% and did not differ among the 3 groups but were higher than the 5% expected from national growth charts. Rates of food insecurity were consistent with national data for minority households with children. Families that did not receive WIC assistance because of access problems had higher rates of food insecurity (28%) than did WIC participants (23%), although differences were not significant after covariate control. Caregivers who did not perceive a need for WIC services had more economic and personal resources than did WIC participants and were less likely to be food-insecure, but there were no differences in infants' weight-for-age, perceived health, or overweight between families that did not perceive a need for WIC services and those that received WIC assistance. Infants participation. Health care providers should promote WIC utilization for eligible families and advocate that WIC receive support to reduce waiting lists and eliminate barriers that interfere with access.

  18. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

    Science.gov (United States)

    Hoekman, Jarno; Klamer, Thea T; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; De Bruin, Marie L

    2016-07-01

    The aim of the present study was to provide an insight into the characteristics and follow-up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). We compiled a list of all postmarketing studies attached as specific obligations to the licence of medicines that were granted conditional marketing authorization from January 2006 to April 2014. Studies were characterized based on their objective, design, status upon marketing authorization (MA) and due data set by authorities. They were linked to online study registrations (Clinicaltrials.gov, ENCePP) to determine completion date. We described and associated characteristics of studies and medicines, and determined whether studies were completed on time. A total of 59 postmarketing studies were requested for 21 conditionally authorized medicines. Most studies had an interventional study design (73%), were ongoing upon MA (61%) and aimed to provide additional data on efficacy (45%). Interventional studies were more often ongoing and providing efficacy data, while observational and other studies were more often new and providing safety data. Frequent grounds for requesting postmarketing studies were 'long-term follow-up' and 'increase data on subpopulations'. Of the 34 studies eligible for follow-up analysis, 26 (76%) were completed and 17 (50%) completed on time. Actual completion time took a median (interquartile range) of 274 (-121 to 556) days longer than expected. Our results indicated that most postmarketing studies attached to a conditional marketing authorization were eventually completed but that half were completed with a substantial delay. The observations suggest caution when broadening the use of postmarketing studies for resolving uncertainties about benefits and risks after MA. © 2016 The British Pharmacological Society.

  19. Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU

    Science.gov (United States)

    Klamer, Thea T.; Mantel‐Teeuwisse, Aukje K.; Leufkens, Hubert G. M.; De Bruin, Marie L.

    2016-01-01

    Aim The aim of the present study was to provide an insight into the characteristics and follow‐up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). Methods We compiled a list of all postmarketing studies attached as specific obligations to the licence of medicines that were granted conditional marketing authorization from January 2006 to April 2014. Studies were characterized based on their objective, design, status upon marketing authorization (MA) and due data set by authorities. They were linked to online study registrations (Clinicaltrials.gov, ENCePP) to determine completion date. We described and associated characteristics of studies and medicines, and determined whether studies were completed on time. Results A total of 59 postmarketing studies were requested for 21 conditionally authorized medicines. Most studies had an interventional study design (73%), were ongoing upon MA (61%) and aimed to provide additional data on efficacy (45%). Interventional studies were more often ongoing and providing efficacy data, while observational and other studies were more often new and providing safety data. Frequent grounds for requesting postmarketing studies were ‘long‐term follow‐up’ and ‘increase data on subpopulations’. Of the 34 studies eligible for follow‐up analysis, 26 (76%) were completed and 17 (50%) completed on time. Actual completion time took a median (interquartile range) of 274 (−121 to 556) days longer than expected. Conclusions Our results indicated that most postmarketing studies attached to a conditional marketing authorization were eventually completed but that half were completed with a substantial delay. The observations suggest caution when broadening the use of postmarketing studies for resolving uncertainties about benefits and risks after MA. PMID:26992001

  20. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  1. Surveillance and Critical Theory

    Directory of Open Access Journals (Sweden)

    Christian Fuchs

    2015-09-01

    Full Text Available In this comment, the author reflects on surveillance from a critical theory approach, his involvement in surveillance research and projects, and the status of the study of surveillance. The comment ascertains a lack of critical thinking about surveillance, questions the existence of something called “surveillance studies” as opposed to a critical theory of society, and reflects on issues such as Edward Snowden’s revelations, and Foucault and Marx in the context of surveillance.

  2. SAVY-4000 Field Surveillance Plan Update for 2017

    Energy Technology Data Exchange (ETDEWEB)

    Kelly, Elizabeth J. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Stone, Timothy Amos [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Smith, Paul Herrick [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Reeves, Kirk Patrick [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Veirs, Douglas Kirk [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Prochnow, David Adrian [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-03-20

    The Packaging Surveillance Program section of the Department of Energy (DOE) Manual 441.1-­1, Nuclear Material Packaging Manual (DOE 2008), requires DOE contractors to “ensure that a surveillance program is established and implemented to ensure the nuclear material storage package continues to meet its design criteria.”This 2017 update reflects changes to the surveillance plan resulting from surveillance findings as documented in Reeves et al. 2016. These findings include observations of corrosion in SAVY and Hagan containers and the indication (in one SAVY container) of possible filter membrane thermal degradation. This surveillance plan update documents the rationale for selecting surveillance containers, specifies the containers for 2017 surveillance, and identifies a minimum set of containers for 2018 surveillance. This update contains important changes to the previous surveillance plans.

  3. Ball-Contact Injuries in 11 National Collegiate Athletic Association Sports: The Injury Surveillance Program, 2009-2010 Through 2014-2015.

    Science.gov (United States)

    Fraser, Melissa A; Grooms, Dustin R; Guskiewicz, Kevin M; Kerr, Zachary Y

    2017-07-01

    Surveillance data regarding injuries caused by ball contact in collegiate athletes have not been well examined and are mostly limited to discussions of concussions and catastrophic injuries.   To describe the epidemiology of ball-contact injuries in 11 National Collegiate Athletic Association (NCAA) sports during the 2009-2010 through 2014-2015 academic years.   Descriptive epidemiology study.   Convenience sample of NCAA programs in 11 sports (men's football, women's field hockey, women's volleyball, men's baseball, women's softball, men's and women's basketball, men's and women's lacrosse, and men's and women's soccer) during the 2009-2010 through 2014-2015 academic years.   Collegiate student-athletes participating in 11 sports.   Ball-contact-injury rates, proportions, rate ratios, and proportion ratios with 95% confidence intervals were based on data from the NCAA Injury Surveillance Program during the 2009-2010 through 2014-2015 academic years.   During the 2009-2010 through 2014-2015 academic years, 1123 ball-contact injuries were reported, for an overall rate of 3.54/10 000 AEs. The sports with the highest rates were women's softball (8.82/10 000 AEs), women's field hockey (7.71/10 000 AEs), and men's baseball (7.20/10 000 AEs). Most ball-contact injuries were to the hand/wrist (32.7%) and head/face (27.0%) and were diagnosed as contusions (30.5%), sprains (23.1%), and concussions (16.1%). Among sex-comparable sports (ie, baseball/softball, basketball, and soccer), women had a larger proportion of ball-contact injuries diagnosed as concussions than men (injury proportion ratio = 2.33; 95% confidence interval = 1.63, 3.33). More than half (51.0%) of ball-contact injuries were non-time loss (ie, participation-restriction time common severe ball-contact injuries were concussions (n = 18) and finger fractures (n = 10).   Ball-contact-injury rates were the highest in women's softball, women's field hockey, and men's baseball. Although

  4. Coding completeness and quality of relative survival-related variables in the National Program of Cancer Registries Cancer Surveillance System, 1995-2008.

    Science.gov (United States)

    Wilson, Reda J; O'Neil, M E; Ntekop, E; Zhang, Kevin; Ren, Y

    2014-01-01

    Calculating accurate estimates of cancer survival is important for various analyses of cancer patient care and prognosis. Current US survival rates are estimated based on data from the National Cancer Institute's (NCI's) Surveillance, Epidemiology, and End RESULTS (SEER) program, covering approximately 28 percent of the US population. The National Program of Cancer Registries (NPCR) covers about 96 percent of the US population. Using a population-based database with greater US population coverage to calculate survival rates at the national, state, and regional levels can further enhance the effective monitoring of cancer patient care and prognosis in the United States. The first step is to establish the coding completeness and coding quality of the NPCR data needed for calculating survival rates and conducting related validation analyses. Using data from the NPCR-Cancer Surveillance System (CSS) from 1995 through 2008, we assessed coding completeness and quality on 26 data elements that are needed to calculate cancer relative survival estimates and conduct related analyses. Data elements evaluated consisted of demographic, follow-up, prognostic, and cancer identification variables. Analyses were performed showing trends of these variables by diagnostic year, state of residence at diagnosis, and cancer site. Mean overall percent coding completeness by each NPCR central cancer registry averaged across all data elements and diagnosis years ranged from 92.3 percent to 100 percent. RESULTS showing the mean percent coding completeness for the relative survival-related variables in NPCR data are presented. All data elements but 1 have a mean coding completeness greater than 90 percent as was the mean completeness by data item group type. Statistically significant differences in coding completeness were found in the ICD revision number, cause of death, vital status, and date of last contact variables when comparing diagnosis years. The majority of data items had a coding

  5. Registro e tecnovigilância de implantes dentários: panorama atual nos EUA, na União Europeia, no Brasil e sugestões de aprimoramento desses sistemas | Registry and surveillance of dental implants: current panorama in the USA, European Union, Brazil and suggestions for improved systems

    Directory of Open Access Journals (Sweden)

    Diana Ribeiro do Espírito Santo Jacomo

    2016-05-01

    reporting, as well as a long time between problems identification and the action (due to the extension of the administrative process. In the European Union the few identified studies suggested that the regulatory system provides risks to patients related to the lack of transparency among notifying organs and to the difficulty in articulating the post-marketing surveillance among countries. In Brazil, the post-marketing surveillance is centralized, and is still in its infancy, having the “sentinel” hospitals and “Notivisa” as its main initiatives. Population ageing promotes strong demand for patients’ oral rehabilitation, especially the needy included in the “Smiling Brazil” program. The service demand may offer a market expansion opportunity, but it also poses a risk of low-quality products entry. In this context, the improvement of post-market surveillance activities of dental implants becomes a priority.

  6. GSFC Supplier Surveillance

    Science.gov (United States)

    Kelly, Michael P.

    2011-01-01

    Topics covered include: Develop Program/Project Quality Assurance Surveillance Plans The work activities performed by the developer and/or his suppliers are subject to evaluation and audit by government-designated representatives. CSO supports project by selecting on-site supplier representative s by one of several methods: (1) a Defense Contract Management Agency (DCMA) person via a Letter Of Delegation (LOD), (2) an independent assurance contractor (IAC) via a contract Audits, Assessments, and Assurance (A3) Contract Code 300 Mission Assurance Support Contract (MASC)

  7. Use of a simplified pathways model to improve the environmental surveillance program at the radioactive waste management complex of the Idaho National Engineering Laboratory (INEL)

    International Nuclear Information System (INIS)

    Case, M.J.; Rope, S.K.

    1985-01-01

    Systems analysis, including a simple pathways model based on first-order kinetics, is a useful way to design or improve environmental monitoring networks. This method allows investigators and administrators to consider interactions that may be occurring in the system and provides guidance in determining the need to collect data on various system components and processes. A simplified pathways model of radionuclide movement from low-level waste and transuranic waste buried at the Radioactive Waste Management Complex was developed (1) to identify critical pathways that should be monitored and (2) to identify key input parameters that need investigation by special studies. The model was modified from the Savannah River Laboratory DOSTOMAN code. Site-specific data were used in the model, if available. Physical and biological pathways include airborne and waterborne transport of surface soil, subsurface migration to the aquifer, waste container degradation, plant uptake, small mammal burrowing, and a few simplified food chain pathways. The model was run using a set of radionuclides determined to be significant in terms of relative hazard. Critical transport pathways which should be monitored were selected based on relative influence on model results. Key input parameters were identified for possible special studies by evaluating the sensitivity of model response to the parameters used to define transport pathways. A description of the approaches used and the guidance recommended to improve the environmental surveillance program are presented in this paper. 5 references, 1 figure, 2 tables

  8. Instrumentation of a Charpy-pendulum. Additional data obtained from it and its application to nuclear reactor pressure vessels surveillance programs

    International Nuclear Information System (INIS)

    Chomik, Enrique P.; Dhers, Horacio; Iorio, Antonio F.; Ciriani, Dario F.

    1999-01-01

    Charpy test gives information about a material dynamic fracture behavior. In a plain Charpy test, this information is the absorbed energy during fracture of the specimen, lateral deformation and the percentage of ductile fracture of the specimen. These parameters can then be used for the determination of the material response to a dynamic applied load, and are used at present to determine the brittle-ductile transition temperature of a material. However, there is a lot of additional information that can be obtained from a Charpy test, which is vital for the case of surveillance programs of nuclear power plants, where it is necessary to get the most available information from the specimens to be tested, because each one of them was irradiated for many years under temperature and neutronic flux conditions similar to that of the internal surface of the reactor pressure vessel, which converts these specimens in unique and very expensive ones. This additional information can be obtained from the curve that determines the evolution of the applied force to the specimen throughout the time involved in its fracture. It was possible to instrument a Charpy pendulum at a fraction of the cost necessary to buy an instrumentation package like the ones available in the market, and since the instrumentation equipment obtained is easy to transport. It has the additional advantage that can be used to instrument any other pendulum replacing only the hammer of the pendulum with a instrumented one for that pendulum. (author)

  9. Risk of leukemia associated with the first course of cancer treatment: an analysis of the Surveillance, Epidemiology, and End Results Program experience

    International Nuclear Information System (INIS)

    Curtis, R.E.; Hankey, B.F.; Myers, M.H.; Young, J.L. Jr.

    1984-01-01

    The risk of leukemia associated with the first course of cancer treatment was evaluated in over 440,000 patients diagnosed during 1973-80 (average follow-up . 1.91 yr) from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. Although the reporting of the first course of therapy probably was incomplete, 34 acute nonlymphocytic leukemias (ANLL) developed compared with 7.6 expected among 70,674 patients known to receive initial chemotherapy [relative risk (RR) . 4.5, 95% confidence interval (Cl) . 3.1-6.3]. Significant ANLL excesses were observed following chemotherapy for breast cancer (RR . 8.1), ovarian cancer (RR . 22.2), and multiple myeloma (RR . 9.5). Patients initially treated with radiation (with no record of chemotherapy) also had a significantly increased ANLL risk; 45 leukemias occurred versus 17.9 expected (RR . 2.5, 95% Cl . 1.8-3.4). In this group, excess ANLL were found following irradiation for uterine corpus cancer (RR . 4.0). Kidney and renal pelvis cancer patients had a twofold leukemia risk (all types) that was unrelated to treatment (RR . 2.2)

  10. Surveillance of the North-Eastern Atlantic dumpsite for low-level radioactive waste. The Swiss oceanographic research program 'PROSPER'. Progress report

    International Nuclear Information System (INIS)

    Nyffeler, F.; Ruch, P.; Hanselmann, K.

    1984-08-01

    This report describes the results of the research undertaken within the CRESP program by the Swiss group PROSPER, for the surveillance of the current dumpsite for low-level radioactive waste in the North-Eastern Atlantic. About 100 nephelometric profiles obtained during three cruises in the vicinity of the site provide a sound basis for the description of the benthic nepheloid layer structure. Statistical analyses show that the last 1000 m of water above the bottom are influenced by resuspension processes or by lateral advection of particles detached from the surrounding relief. A mapping performed over a large area (200 x 200 km) confirms the accumulation of particles in topographic lows. Geochemical analysis of suspended matter and surficial sediment has been carried out in order to compare their elemental composition, and to determine the classes of particles which are more likely to be resuspended. The discrepancy between BNL and local sediment composition suggests that advective transport or resuspension of older bottom sediment, exposed following slumping from the hill slopes, could act in addition to the local resuspension of recent sediment. (author)

  11. The incidence of nosocomial infection in the Intensive Care Unit, Hospital Universiti Kebangsaan Malaysia: ICU-acquired nosocomial infection surveillance program 1998-1999.

    Science.gov (United States)

    Rozaidi, S W; Sukro, J; Dan, A

    2001-06-01

    CU-acquired nosocomial infection (NI) remains one of the major causes of ICU mortality. This study presents the incidence of ICU-acquired nosocomial infection in ICU HUKM for the years 1998 and 1999, as part of the ongoing ICU-acquired nosocomial infection surveillance program. The overall incidence was 23%. The main types of NI was lower respiratory tract infection (15.3%), primary bacteraemia (8.1%), ventilator associated pneumonia (5.4%), urinary tract infection (2.0%), skin infection (1.6%) central venous catheter sepsis (1.2%) and surgical skin infection (0.8%). The overall culture positive nosocomial infection rate was only 12.1%, majority from the lungs (12.6%), blood (7.3%), skin swabs (2.0%), and urine (1.6%). The main gram-negative organism cultured was Acinetobacter sp. (19%) and Staph. aureus (8.5%) was the gram-positive organism. The overall ICU mortality rate was 27.5% of which 60.9% of patients who died were attributed directly to sepsis.

  12. Participant-centred active surveillance of adverse events following immunisation: a narrative review.

    Science.gov (United States)

    Cashman, Patrick; Macartney, Kristine; Khandaker, Gulam; King, Catherine; Gold, Michael; Durrheim, David N

    2017-05-01

    The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified. Most countries had a single system: Ghana, Japan, China, Korea, Netherlands, Singapore, Brazil, Cambodia, Sri Lanka, Turkey and Cameroon except the USA (2), Canada (4) and Australia (6). Data were collected from participants with and without AEFI in all studies reviewed with denominator data enabling AEFI rate calculations. All studies considered either a single vaccine or specified vaccines or were time limited except one Australian system, which provides continuous automated participant-centred active surveillance of all vaccines. Post-marketing surveillance systems using solicited patient feedback are emerging as a novel AEFI monitoring tool. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in low and middle income countries deserves further investigation. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

  13. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  14. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  15. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption.

    Science.gov (United States)

    Miller, Larry E; Reckling, W Carlton; Block, Jon E

    2013-01-01

    The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery. Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts. Complaints were reported in 204 (3.8%) patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%), with nerve impingement (n = 48, 0.9%) and recurrent sacroiliac joint pain (n = 43, 0.8%) most frequently cited. All other clinical complaints were rare (≤0.2%). Ninety-six revision surgeries were performed in 94 (1.8%) patients at a median follow-up of four (range 0-30) months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9%) or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%). Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6%) or for continued pain of undetermined etiology (n = 6, 0.1%). Analysis of a postmarket product complaints database demonstrates an overall low risk of complaints with the iFuse SI Joint Fusion System in patients with degenerative sacroiliitis or sacroiliac joint disruption.

  16. Assessment of Tapentadol API Abuse Liability With the Researched Abuse, Diversion and Addiction-Related Surveillance System.

    Science.gov (United States)

    Vosburg, Suzanne K; Severtson, S Geoffrey; Dart, Richard C; Cicero, Theodore J; Kurtz, Steven P; Parrino, Mark W; Green, Jody L

    2018-04-01

    Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine reuptake inhibition, is used for the management of moderate to severe acute and chronic pain. Its dual mechanism of action is thought to reduce opioid-related side effects that can complicate pain management. Since approval, tapentadol has been tracked across multiple outcomes suggesting abuse liability, and a pattern of relatively low, although not absent, abuse liability has been found. This retrospective cohort study further details the abuse liability of tapentadol as an active pharmaceutical ingredient (API) when immediate-release as well as extended-release formulations were on the market together (fourth quarter of 2011 to second quarter of 2016). Tapentadol (API) was compared with tramadol, hydrocodone, morphine, oxycodone, hydromorphone, and oxymorphone across Poison Center, Drug Diversion, and Treatment Center Programs Combined data streams from the Researched Abuse, Diversion and Addiction-Related Surveillance system. Findings suggest the public health burden related to tapentadol to date is low, but present. Event rates of abuse per population-level denominators were significantly lower than all other opioids examined. However, when adjusted for drug availability, event rates of abuse were lower than most Schedule II opioids studied, but were not the lowest. Disentangling these 2 sets of findings further by examining various opioid formulations, such as extended-release and the role of abuse-deterrent formulations, is warranted. This article presents the results from an examination of tapentadol API across the Researched Abuse, Diversion and Addiction-Related Surveillance System: a broad and carefully designed postmarketing mosaic. Data to date from Poison Center, Drug Diversion, and Treatment Centers combined suggest a low, but present public health burden related to tapentadol. Copyright © 2018. Published by Elsevier Inc.

  17. Prevalence of rotavirus genotypes in children younger than 5 years of age before the introduction of a universal rotavirus vaccination program: report of rotavirus surveillance in Turkey.

    Directory of Open Access Journals (Sweden)

    Riza Durmaz

    Full Text Available BACKGROUND: Group A rotaviruses are the most common causative agent of acute gastroenteritis among children less than 5 years of age throughout the world. This sentinel surveillance study was aimed to obtain baseline data on the rotavirus G and P genotypes across Turkey before the introduction of a universal rotavirus vaccination program. METHODS: Rotavirus antigen-positive samples were collected from 2102 children less than 5 years of age who attended hospitals participating in the Turkish Rotavirus Surveillance Network. Rotavirus antigen was detected in the laboratories of participating hospitals by commercial serological tests such as latex agglutination, immunochromatographic test or enzyme immunoassay. Rotavirus G and P genotypes were determined by reverse transcription polymerase chain reaction (RT-PCR using consensus primers detecting the VP7 and VP4 genes, followed by semi-nested type-specific multiplex PCR. RESULTS: RT-PCR found rotavirus RNA in 1644 (78.2% of the samples tested. The highest rate of rotavirus positivity (38.7% was observed among children in the 13 to 24 month age group, followed by children in the age group of 25 to 36 months (28.3%. A total of eight different G types, six different P types, and 42 different G-P combinations were obtained. Four common G types (G1, G2, G3, and G9 and two common P types (P[8] and P[4] accounted for 95.1% and 98.8% of the strains, respectively. G9P[8] was the most common G/P combination found in 40.5% of the strains followed by G1P[8] (21.6%, G2P[8] (9.3%, G2P[4] (6.5%, G3P[8] (3.5%, and finally, G4P[8] (3.4%. These six common genotypes included 83.7% of the strains tested in this study. The rate of uncommon genotypes was 14%. CONCLUSION: The majority of the strains analyzed belonged to the G1-G4 and G9 genotypes, suggesting high coverage of current rotavirus vaccines. This study also demonstrates a dramatic increase in G9 genotype across the country.

  18. Prevalence of Rotavirus Genotypes in Children Younger than 5 Years of Age before the Introduction of a Universal Rotavirus Vaccination Program: Report of Rotavirus Surveillance in Turkey

    Science.gov (United States)

    Durmaz, Riza; Kalaycioglu, Atila Taner; Acar, Sumeyra; Bakkaloglu, Zekiye; Karagoz, Alper; Korukluoglu, Gulay; Ertek, Mustafa; Torunoglu, Mehmet Ali

    2014-01-01

    Background Group A rotaviruses are the most common causative agent of acute gastroenteritis among children less than 5 years of age throughout the world. This sentinel surveillance study was aimed to obtain baseline data on the rotavirus G and P genotypes across Turkey before the introduction of a universal rotavirus vaccination program. Methods Rotavirus antigen-positive samples were collected from 2102 children less than 5 years of age who attended hospitals participating in the Turkish Rotavirus Surveillance Network. Rotavirus antigen was detected in the laboratories of participating hospitals by commercial serological tests such as latex agglutination, immunochromatographic test or enzyme immunoassay. Rotavirus G and P genotypes were determined by reverse transcription polymerase chain reaction (RT-PCR) using consensus primers detecting the VP7 and VP4 genes, followed by semi-nested type-specific multiplex PCR. Results RT-PCR found rotavirus RNA in 1644 (78.2%) of the samples tested. The highest rate of rotavirus positivity (38.7%) was observed among children in the 13 to 24 month age group, followed by children in the age group of 25 to 36 months (28.3%). A total of eight different G types, six different P types, and 42 different G–P combinations were obtained. Four common G types (G1, G2, G3, and G9) and two common P types (P[8] and P[4]) accounted for 95.1% and 98.8% of the strains, respectively. G9P[8] was the most common G/P combination found in 40.5% of the strains followed by G1P[8] (21.6%), G2P[8] (9.3%), G2P[4] (6.5%), G3P[8] (3.5%), and finally, G4P[8] (3.4%). These six common genotypes included 83.7% of the strains tested in this study. The rate of uncommon genotypes was 14%. Conclusion The majority of the strains analyzed belonged to the G1–G4 and G9 genotypes, suggesting high coverage of current rotavirus vaccines. This study also demonstrates a dramatic increase in G9 genotype across the country. PMID:25437502

  19. Who is Surveilling Whom?

    DEFF Research Database (Denmark)

    Mortensen, Mette

    2014-01-01

    This article concerns the particular form of counter-surveillance termed “sousveillance”, which aims to turn surveillance at the institutions responsible for surveillance. Drawing on the theoretical perspectives “mediatization” and “aerial surveillance,” the article studies WikiLeaks’ publication...

  20. Results from 15years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes.

    Science.gov (United States)

    Shephard, Mark; Shephard, Anne; McAteer, Bridgit; Regnier, Tamika; Barancek, Kristina

    2017-12-01

    Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  1. Containment and Surveillance Equipment Compendium

    International Nuclear Information System (INIS)

    Luetters, F.O.

    1980-02-01

    The Containment and Surveillance Equipment Compendium contains information sections describing the application and status of seals, optical surveillance systems, and monitors for international safeguards systems. The Compendium is a collection of information on equipment in use (generally by the IAEA) or under development in the US in diverse programs being conducted at numerous facilities under different sponsors. The Compendium establishes a baseline for the status and applications of C/S equipment and is a tool to assist in the planning of future C/S hardware development activities. The Appendix contains design concepts which can be developed to meet future goals

  2. The out-of-focus bias in drug surveillance.

    Science.gov (United States)

    Gnädinger, Markus; Mellinghoff, Hans-Ulrich

    2013-03-01

    Existing drug safety systems with phase II and III studies and post-marketing surveillance by principle do not allow for the recognition of an important class of adverse drug reactions (ADRs). ADRs that are resistant to being detected reliably may a) appear as if they are age-related chronic diseases, which also manifest themselves in a high degree without drug treatment, b) arise in "old" drugs, c) arise during long-term application, and d) arise with the administration to frail and aged populations. "Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist.

  3. Aiding surveillance

    International Development Research Centre (IDRC) Digital Library (Canada)

    arashid

    8 See, for example, the work of the Center for Global Development, ..... toward social protection, cash transfer, or social safety net programs as effective tools for .... that the [MIS] will fit within the users' work environment and be useful to them.

  4. Ideology, Critique and Surveillance

    Directory of Open Access Journals (Sweden)

    Heidi Herzogenrath-Amelung

    2013-11-01

    Full Text Available The 2013 revelations concerning global surveillance programmes demonstrate in unprecedented clarity the need for Critical Theory of information and communication technologies (ICTs to address the mechanisms and implications of increasingly global, ubiquitous surveillance. This is all the more urgent because of the dominance of the “surveillance ideology” (the promise of security through surveillance that supports the political economy of surveillance. This paper asks which theoretical arguments and concepts can be useful for philosophically grounding a critique of this surveillance ideology. It begins by examining how the surveillance ideology works through language and introduces the concept of the ‘ideological packaging’ of ICTs to show how rhetoric surrounding the implementation of surveillance technologies reinforces the surveillance ideology. It then raises the problem of how ideology-critique can work if it relies on language itself and argues that Martin Heidegger’s philosophy can make a useful contribution to existing critical approaches to language.

  5. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    Science.gov (United States)

    Liao, Xing; Robinson, Nicola

    2013-07-01

    Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

  6. Antifungal susceptibilities of Candida, Cryptococcus neoformans and Aspergillus fumigatus from the Asia and Western Pacific region: data from the SENTRY antifungal surveillance program (2010-2012).

    Science.gov (United States)

    Pfaller, Michael A; Messer, Shawn A; Jones, Ronald N; Castanheira, Mariana

    2015-09-01

    The SENTRY Antifungal Surveillance Program monitors global susceptibility rates of newer and established antifungal agents. We report the in vitro activity of seven antifungal agents against 496 contemporary clinical isolates of yeasts and molds. The isolates were obtained from 20 laboratories in the Asia-Western Pacific (APAC) region during 2010 through 2012. Anidulafungin, caspofungin, micafungin, fluconazole, itraconazole, posaconazole and voriconazole were susceptibility tested using CLSI methods and species-specific interpretive criteria. Sequencing of fks hot spots was performed for echinocandin-resistant strains. Isolates included 13 species of Candida (n=460), 5 species of non-Candida yeasts (21), 5 species of Aspergillus (11) and 4 other molds. Echinocandin resistance was uncommon among eight species of Candida and was only detected in three isolates of Candida glabrata, two from Australia harboring mutations in fks1 (F625S) and fks2 (S663P). Resistance to the azoles was much more common and was observed among all species with the exception of Candida dubliniensis. Fluconazole resistance rates observed with C. glabrata (6.8%) was comparable to that seen with Candida parapsilosis (5.7%) and Candida tropicalis (3.6%). Cross resistance among the triazoles was seen with each of these three species. The mold-active azoles and the echinocandins were all active against isolates of Aspergillus fumigatus. Azole resistance was not detected among the isolates of Cryptococcus neoformans. Antifungal resistance is uncommon among isolates of fungi causing invasive fungal infections in the APAC region. As in other regions of the world, emerging resistance to the echinocandins among invasive isolates of C. glabrata bears close monitoring.

  7. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  8. Wallops Ship Surveillance System

    Science.gov (United States)

    Smith, Donna C.

    2011-01-01

    Approved as a Wallops control center backup system, the Wallops Ship Surveillance Software is a day-of-launch risk analysis tool for spaceport activities. The system calculates impact probabilities and displays ship locations relative to boundary lines. It enables rapid analysis of possible flight paths to preclude the need to cancel launches and allow execution of launches in a timely manner. Its design is based on low-cost, large-customer- base elements including personal computers, the Windows operating system, C/C++ object-oriented software, and network interfaces. In conformance with the NASA software safety standard, the system is designed to ensure that it does not falsely report a safe-for-launch condition. To improve the current ship surveillance method, the system is designed to prevent delay of launch under a safe-for-launch condition. A single workstation is designated the controller of the official ship information and the official risk analysis. Copies of this information are shared with other networked workstations. The program design is divided into five subsystems areas: 1. Communication Link -- threads that control the networking of workstations; 2. Contact List -- a thread that controls a list of protected item (ocean vessel) information; 3. Hazard List -- threads that control a list of hazardous item (debris) information and associated risk calculation information; 4. Display -- threads that control operator inputs and screen display outputs; and 5. Archive -- a thread that controls archive file read and write access. Currently, most of the hazard list thread and parts of other threads are being reused as part of a new ship surveillance system, under the SureTrak project.

  9. Army's drinking water surveillance program

    International Nuclear Information System (INIS)

    Sneeringer, P.V.; Belkin, F.; Straffon, N.; Costick, S.A.

    1977-01-01

    In 1976 a total of 827 water sources from Army installations throughout the world were sampled and analyzed for 53 chemical constituents and physical parameters. Medically significant contaminants included radiation measurements, heavy metals, fluoride, nitrate, and pesticides. Radiological activity appeared to vary with geographic location; a majority being from water sources in the western part of the U.S. No results for tritium were found to exceed the health-reference limit. Confirmatory analyses for radium-226 identified 3 groundwater sources as exceeding the limit; one was attributed to natural activity and the other sources are currently being investigated. Of the metals considered to be medically significant, mercury, chromium, lead, cadmium, silver, barium and arsenic were found in amounts within health level limits. Nitrate levels exceeding the health limit were confirmed for 2 drinking water sources

  10. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Kazuo Iijima

    Full Text Available Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data.Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies from PubMed (MEDLINE, Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07-8.76] vs. postmarketing: 1.48 [0.81-2.69]. The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2 increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%. The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease.Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the

  11. Tuberculosis en trabajadores de la salud: importancia de los programas de vigilancia y control Tuberculosis in healthcare workers: importance of surveillance and control programs

    Directory of Open Access Journals (Sweden)

    Luis Ostrosky-Zeichner

    2000-02-01

    follow-up were analyzed. Statistical analysis was performed with odds ratios, p-values, and 95% confidence intervals. Subgroup analysis were done with chi². Kaplan-Meier estimates were used to analyze times to conversion. RESULTS: Surveillance was done in 1617 workers (68% female and 32% male. Mean age was 26.9±7.6(15-68 years. Job positions were 30.5% nurses, 14.6% residents and 14.1% interns. Place of origin was Mexico City in 65.8%. BCG vaccination was present in 71.6% and 15.1% had previous PPD. Admission PPD was positive in 39.6%, negative in 48.3% and 12.1% were lost to follow-up. On negatives, 483 booster shots were applied, and 49 additional positives were found. Follow-up was done in 231 workers, of which 100 (43.3% converted. The mean time for conversion was 22.8±12.4 months. The conversion rate at twelve months was 20%. Fifty workers received/accepted isoniazid prophylaxis. CONCLUSIONS: A high percentage of workers were PPD-positive; booster shots allowed the detection of an additional 10%. A high conversion rate underscores the need to organize tuberculosis control programs in Mexico.

  12. Environmental surveillance master sampling schedule

    International Nuclear Information System (INIS)

    Bisping, L.E.

    1995-02-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the U.S. Department of Energy (DOE). This document contains the planned 1994 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP), Drinking Water Project, and Ground-Water Surveillance Project. Samples are routinely collected for the SESP and analyzed to determine the quality of air, surface water, soil, sediment, wildlife, vegetation, foodstuffs, and farm products at Hanford Site and surrounding communities. The responsibility for monitoring onsite drinking water falls outside the scope of the SESP. PNL conducts the drinking water monitoring project concurrent with the SESP to promote efficiency and consistency, utilize expertise developed over the years, and reduce costs associated with management, procedure development, data management, quality control, and reporting. The ground-water sampling schedule identifies ground-water sampling .events used by PNL for environmental surveillance of the Hanford Site. Sampling is indicated as annual, semi-annual, quarterly, or monthly in the sampling schedule. Some samples are collected and analyzed as part of ground-water monitoring and characterization programs at Hanford (e.g. Resources Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or Operational). The number of samples planned by other programs are identified in the sampling schedule by a number in the analysis column and a project designation in the Cosample column. Well sampling events may be merged to avoid redundancy in cases where sampling is planned by both-environmental surveillance and another program

  13. Environmental surveillance master sampling schedule

    Energy Technology Data Exchange (ETDEWEB)

    Bisping, L.E.

    1995-02-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the U.S. Department of Energy (DOE). This document contains the planned 1994 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP), Drinking Water Project, and Ground-Water Surveillance Project. Samples are routinely collected for the SESP and analyzed to determine the quality of air, surface water, soil, sediment, wildlife, vegetation, foodstuffs, and farm products at Hanford Site and surrounding communities. The responsibility for monitoring onsite drinking water falls outside the scope of the SESP. PNL conducts the drinking water monitoring project concurrent with the SESP to promote efficiency and consistency, utilize expertise developed over the years, and reduce costs associated with management, procedure development, data management, quality control, and reporting. The ground-water sampling schedule identifies ground-water sampling .events used by PNL for environmental surveillance of the Hanford Site. Sampling is indicated as annual, semi-annual, quarterly, or monthly in the sampling schedule. Some samples are collected and analyzed as part of ground-water monitoring and characterization programs at Hanford (e.g. Resources Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or Operational). The number of samples planned by other programs are identified in the sampling schedule by a number in the analysis column and a project designation in the Cosample column. Well sampling events may be merged to avoid redundancy in cases where sampling is planned by both-environmental surveillance and another program.

  14. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  15. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  16. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  17. SOA-surveillance Nederland

    NARCIS (Netherlands)

    Rijlaarsdam J; Bosman A; Laar MJW van de; CIE

    2000-01-01

    In May 1999 a working group was started to evaluate the current surveillance systems for sexually transmitted diseases (STD) and to make suggestions for a renewed effective and efficient STD surveillance system in the Netherlands. The surveillance system has to provide insight into the prevalence

  18. Containment and surveillance devices

    International Nuclear Information System (INIS)

    Campbell, J.W.; Johnson, C.S.; Stieff, L.R.

    The growing acceptance of containment and surveillance as a means to increase safeguards effectiveness has provided impetus to the development of improved surveillance and containment devices. Five recently developed devices are described. The devices include one photographic and two television surveillance systems and two high security seals that can be verified while installed

  19. Groundwater surveillance plan for the Oak Ridge Reservation

    International Nuclear Information System (INIS)

    Forstrom, J.M.; Smith, E.D.; Winters, S.L.; McMaster, W.M.

    1994-07-01

    US Department of Energy (DOE) Order 5400.1 requires the preparation of environmental monitoring plans and implementation of environmental monitoring programs for all DOE facilities. The order identifies two distinct components of environmental monitoring, namely effluent monitoring and environmental surveillance. In general, effluent monitoring has the objectives of characterizing contaminants and demonstrating compliance with applicable standards and permit requirements, whereas environmental surveillance has the broader objective of monitoring the effects of DOE activities on on- and off-site environmental and natural resources. The purpose of this document is to support the Environmental Monitoring Plan for the Oak Ridge Reservation (ORR) by describing the groundwater component of the environmental surveillance program for the DOE facilities on the ORR. The distinctions between groundwater effluent monitoring and groundwater surveillance have been defined in the Martin Marietta Energy Systems, Inc., Groundwater Surveillance Strategy. As defined in the strategy, a groundwater surveillance program consists of two parts, plant perimeter surveillance and off-site water well surveillance. This document identifies the sampling locations, parameters, and monitoring frequencies for both of these activities on and around the ORR and describes the rationale for the program design. The program was developed to meet the objectives of DOE Order 5400.1 and related requirements in DOE Order 5400.5 and to conform with DOE guidance on environmental surveillance and the Energy Systems Groundwater Surveillance Strategy

  20. Children aged 12–59 months missed through the National Vitamin A Capsule Distribution Program in Bangladesh: findings of the Nutritional Surveillance Project

    Directory of Open Access Journals (Sweden)

    N. Akhter

    2009-07-01

    Full Text Available From January 1990 to December 2006, Helen Keller International implemented the Nutritional Surveillance Project (NSP in Bangladesh, which has been used to conduct regular surveillance and special surveys to provide information on health and nutritional status of children and mothers, and report on the coverage and impact of nutrition and health programs in Bangladesh. The Government of Bangladesh (GOB distributes vitamin A Capsule (VAC among children aged 12–59 months biannually. The NSP data was analyzed to assess VAC coverage and to explore which children were less likely to receive a VAC in order to help GOB identify necessary modifications aimed at higher coverage of VAC among all eligible children. Results showed that coverage among girls and boys was not different (P=0.970. However, coverage was consistently lower among children aged 12-23 months compared to older children (24–59 months (P≤0.001 in each of the distribution rounds. Coverage among children from poorer households was lower than among children from wealthiest households (P<0.001, with the extent of this difference varying by round. Coverage was significantly higher if households had had contact with a government health assistant in the last month (P<0.001; and among households who owned a radio or a TV compared to those who did not. The VAC distribution campaign needs to be strengthened to cover the children who are currently not reached; especially younger children, children living in underserved regions, children from poorer households and from households with less contact with health service providers or mass media.De janvier 1990 à décembre 2006, l’ONG Helen Keller International a mis en oeuvre le projet Nutritional Surveillance Project (NSP au Bangladesh. Ce projet a permis de réaliser une surveillance régulière et des études ciblées afin de recueillir des informations sur l’état de santé et l’état nutritionnel des mères et des enfants, et de

  1. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  2. Problems with radiological surveillance instrumentation

    International Nuclear Information System (INIS)

    Swinth, K.L.; Tanner, J.E.; Fleming, D.M.

    1984-09-01

    Many radiological surveillance instruments are in use at DOE facilities throughout the country. These instruments are an essential part of all health physics programs, and poor instrument performance can increase program costs or compromise program effectiveness. Generic data from simple tests on newly purchased instruments shows that many instruments will not meet requirements due to manufacturing defects. In other cases, lack of consideration of instrument use has resulted in poor acceptance of instruments and poor reliability. The performance of instruments is highly variable for electronic and mechanical performance, radiation response, susceptibility to interferences and response to environmental factors. Poor instrument performance in these areas can lead to errors or poor accuracy in measurements

  3. Problems with radiological surveillance instrumentation

    International Nuclear Information System (INIS)

    Swinth, K.L.; Tanner, J.E.; Fleming, D.M.

    1985-01-01

    Many radiological surveillance instruments are in use at DOE facilities throughout the country. These instruments are an essential part of all health physics programs, and poor instrument performance can increase program costs or compromise program effectiveness. Generic data from simple tests on newly purchased instruments shows that many instruments will not meet requirements due to manufacturing defects. In other cases, lack of consideration of instrument use has resulted in poor acceptance of instruments and poor reliability. The performance of instruments is highly variable for electronic and mechanical performance, radiation response, susceptibility to interferences and response to environmental factors. Poor instrument performance in these areas can lead to errors or poor accuracy in measurements

  4. In Vitro Activity of Imipenem against Carbapenemase-Positive Enterobacteriaceae Isolates Collected by the SMART Global Surveillance Program from 2008 to 2014.

    Science.gov (United States)

    Karlowsky, James A; Lob, Sibylle H; Kazmierczak, Krystyna M; Badal, Robert E; Young, Katherine; Motyl, Mary R; Sahm, Daniel F

    2017-06-01

    The Study for Monitoring Antimicrobial Resistance Trends (SMART) global surveillance program collected 103,960 isolates of Enterobacteriaceae from 2008 to 2014. From this isolate collection, all ertapenem-nonsusceptible isolates (MIC, ≥1 μg/ml; n = 3,428) and 9,371 isolates of Escherichia coli , Klebsiella pneumoniae , Klebsiella oxytoca , and Proteus mirabilis with an ertapenem-susceptible extended-spectrum-β-lactamase (ESBL)-positive phenotype were assessed for the presence of common carbapenemase genes using a Check-MDR CT101 microarray (Check-Points, Wageningen, the Netherlands) and published multiplex PCR assays. Testing identified 1,493 isolates that harbored a carbapenemase gene (1,485 ertapenem-nonsusceptible isolates and 8 ertapenem-susceptible ESBL-positive isolates) and accounted for 1.4% (1,493/103,960) of all isolates of Enterobacteriaceae The most frequently identified carbapenemase genes were the KPC ( n = 794), OXA-48-like ( n = 300), and NDM ( n = 290) genes. Carbapenemase genes were most frequently identified in Klebsiella pneumoniae ( n = 1,127), Escherichia coli ( n = 149), and Enterobacter cloacae ( n = 110). Among the carbapenemase-positive isolates, 66.7% (2/3), 37.0% (111/300), 20.0% (8/40), 3.3% (3/92), 2.3% (18/794), and 0% (0/290) of the isolates with genes for GES, OXA-48-like, IMP, VIM, KPC, and NDM, respectively, were susceptible to imipenem (MIC, ≤1 μg/ml). Isolates that tested as susceptible to imipenem were not uncommon among carbapenemase-positive isolates (9.4%, 141/1,493) and most frequently carried OXA-48-like enzymes (78.7%; 111/141); however, overall, these isolates remained rare (0.1%, 141/103,960). The practice of screening clinical isolates of Enterobacteriaceae that test as susceptible to carbapenems in vitro for the presence of carbapenemase genes remains controversial and requires further study. Copyright © 2017 American Society for Microbiology.

  5. The relationship between prostate volume and prostate-specific antigen variability: data from the Baltimore Longitudinal Study of Aging and the Johns Hopkins Active Surveillance Program.

    Science.gov (United States)

    Nichols, John H; Loeb, Stacy; Metter, E Jeffrey; Ferrucci, Luigi; Carter, H Ballentine

    2012-05-01

    Study Type--Prognostic (cohort). Level of Evidence 2b. What's known on the subject? And what does the study add? Previous studies have attempted to characterize the normal biological variability in PSA among men without prostate cancer. These reports suggest that PSA variability is unrelated to age, but there are conflicting data on its association with the baseline PSA level. There are limited published data regarding the effects of prostate volume on PSA variability. A prior study assessing whether prostate volume changes would confound the use of PSA velocity in clinical practice reported that prostate volume changes were not significantly related to PSA changes. This study did not directly address the effect of baseline prostate volume on serial PSA variability. The objective of the current study was to further examine the relationship between prostate volume and PSA variability. Our hypothesis was that larger baseline prostate volume would be associated with increased PSA variability in men without known prostate cancer and in those with suspected small-volume disease. The results of the study suggest that baseline PSA, not prostate volume, is the primary driver of PSA variability in these populations. • To clarify the relationship between serial prostate-specific antigen (PSA) variability and prostate volume in both cancer-free participants from the Baltimore Longitudinal Study of Aging (BLSA) and patients with low-risk prostate cancer from the Johns Hopkins Active Surveillance Program (AS). • In all, 287 men from the BLSA and 131 patients from the AS were included in the analysis, all with at least two PSA measurements and concurrent prostate volume measurements. • PSA variability was calculated in ng/mL per year, and a linear mixed-effects model was used to determine the relative effects of prostate volume, baseline PSA and age on PSA change over time. • In a model with prostate volume, age and baseline PSA, there was no significant relationship

  6. Prevalence of Obesity and Overweight and Its Associated Factors in Urban Adults from West Azerbaijan, Iran: The National Food and Nutritional Surveillance Program (NFNSP

    Directory of Open Access Journals (Sweden)

    Bahareh Nikooyeh

    2016-04-01

    Full Text Available Background and Objectives: Globally, the prevalence of overweight/obesity is increasing at an alarming rate. According to the World Health Organization (WHO, about 1.9 billion adults worldwide are overweight, and of these, over 600 million are obese. The purpose of this study was to determine the prevalence of overweight and obesity in West Azerbaijan, Iran, in 2014. Materials and Methods: Data were collected as part of the National Food and Nutritional Surveillance Program (NFNSP. A total of 249 men and women aged 20–60 from West Azerbaijan were included in the survey conducted in 2014. Body height and weight were measured with light clothing and no footwear after overnight fasting. Results: Mean age of the participants was 38.5 ±7.8 yrs. Mean BMI was 28.0±4.9 kg/m2 (men: 26.8±4.2 vs. women: 29.0±5.3, p<0.001. The prevalence of overweight and obesity was 36.5% (men: 38.6 % vs. women: 34.8%, p: 0.439 and 33.3% (men: 25.4 vs. women: 40.0 %, p: 0.016, respectively. Women were more likely to be overweight or obese than males (P=0.038. Multiple logistic regression revealed that gender (women vs. men (OR, 2.05; CI, 1.15-3.65; p,0.014 and age (OR, 1.06; CI, 1.01-1.1; p,0.004 increased the risk of becoming overweight or obese. Women who were housewives were five times more at risk of becoming overweight or obese (OR: 4.93; CI: 1.9-12.3; p<0.001 even after adjusting for age and educational level. Conclusions: The high prevalence of weight problems in West Azerbaijan is a serious health concern, especially in women. The lifestyle of housewives is a potential risk factor for weight gain in women. Keywords: Obesity, Prevalence, Azerbaijan, Adults

  7. A retrospective analysis of the infectious bovine rhinotracheitis (bovine herpes virus-1) surveillance program in Norway using Monte Carlo simulation models

    DEFF Research Database (Denmark)

    Paisley, Larry; Tharaldsen, J.; Jarp, J.

    2001-01-01

    Serological surveillance for antibodies against bovine herpes virus type I (BHV-1) which causes infectious bovine rhinotracheitis and infectious pustular vulvovaginitis has been carried out since 1992 in Norway. Since 1993 (when a single infected herd was detected) all bulk-milk and pooled...

  8. 2003 Nevada Test Site Annual Illness and Injury Surveillance Report

    Energy Technology Data Exchange (ETDEWEB)

    U.S. Department of Energy, Office of Health, Safety and Security, Office of Illness and Injury Prevention Programs

    2007-05-23

    Annual Illness and Injury Surveillance Program report for 2003 for the Nevada Test Site. The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of epidemiologic surveillance activities that provide an early warning system for health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence of workdays, occupational injuries and illnesses, and disabilities and deaths among current workers.

  9. Development of containers sealing system like part of surveillance program of the vessel in nuclear power plants; Desarrollo del sistema de sellado de contenedores como parte del programa de vigilancia de la vasija en nucleoelectricas

    Energy Technology Data Exchange (ETDEWEB)

    Romero C, J.; Hernandez C, R.; Fernandez T, F.; Rocamontes A, M.; Perez R, N. [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico)], e-mail: jesus.romero@inin.gob.mx

    2009-10-15

    The owners of nuclear power plants should be demonstrate that the embrittlement effects by neutronic radiation do not commit the structural integrity from the pressure vessel of nuclear reactors, during conditions of routine operation and below postulate accident. For this reason, there are surveillance programs of vessels of nuclear power plants, in which are present surveillance capsules. A surveillance capsule is compound by the support, six containers for test tubes and dosimeters. The containers for test tubes are of two types: rectangular container for test tubes, Charpy V and Cylindrical Container for tension test tubes. These test tubes are subject to a same or bigger neutronic flow to that of vessel, being representative of vessel mechanical conditions. The test tubes are rehearsed to watch over the increase of embrittlement that presents the vessel. This work describes the development of welding system to seal the containers for test tubes, these should be filled with helium of ultra high purity, to a pressure of an atmosphere. In this system the welding process Gas Tungsten Arc Welding is used, a hermetic camera that allows to place the containers with three grades of freedom, a vacuum subsystem and pressure, high technology equipment's like: power source with integrated computer, arc starter of high frequency, helium flow controller, among others. Finally, the advances in the inspection system for the qualification of sealing system are mentioned, system that should measure the internal pressure of containers and the helium purity inside these. (Author)

  10. Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US

    Directory of Open Access Journals (Sweden)

    Jara M

    2013-03-01

    Full Text Available Michele Jara,1 Graham Barker,2 Herbert R Henney 3rd1 1Acorda Therapeutics, Inc, Ardsley, NY, USA; 2Biogen Idec, Inc, Maidenhead, Berkshire, UK Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine in some countries were approved in the US to improve walking in patients with multiple sclerosis, as demonstrated by improvement in walking speed. Postmarketing safety experience is available from exposure of approximately 46,000 patients in the US from product approval through March 2011. Objective: To provide a descriptive analysis of all spontaneously reported postmarketing adverse events (AEs for dalfampridine-ER since product launch. Methods: AE data were extracted from the safety database from product launch through March 31, 2011; AEs were classified using the Medical Dictionary for Regulatory Activities. Seizure cases were reviewed for patient demographics, time to event from treatment onset, and presence of additional risk factors. Results: The most frequently reported postmarketing AEs were similar to those reported during clinical development: dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, asthenia, and back pain (all included in US product labeling. New clinically significant findings are related to lack of efficacy and inappropriate dosing. Of the approximately 46,000 patients exposed, 85 seizures were reported (~5.4/1000 patient-years, of which 82 were reported or confirmed by a health care practitioner (~5.2/1000 patient-years. Beyond the intrinsic multiple sclerosis-related seizure risk, more than half of the 85 cases (62% had an additional potential risk factor for seizure including a previous history of convulsions, renal impairment, incorrect dosing, or use of concurrent medications with a labeled seizure risk. Duration of treatment prior to the seizure ranged from one dose to 365 days; 26/85 (31% patients suffered a seizure

  11. Post-marketing safety surveillance for inactivated and live-attenuated Japanese encephalitis vaccines in China, 2008-2013.

    Science.gov (United States)

    Wu, Wendi; Liu, Dawei; Li, Keli; Nuorti, J Pekka; Nohynek, Hanna M; Xu, Disha; Ye, Jiakai; Zheng, Jingshan; Wang, Huaqing

    2017-06-22

    Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008-2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008-2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates. We also used disproportionality reporting analysis between JE-I and JE-L to assess potential safety signals. A total of 34,879 AEFIs related with JE-I and JE-L were reported, with a ratio of male to female as 1.3:1; 361 (1.0%) cases were classified as serious. JE vaccines were administered concurrently with one or more other vaccines in 13,592 (39.0%) of cases. The overall AEFI reporting rates were 214.4 per million vaccination doses for JE-L and 176.9 for JE-I (rate ratio [RR]: 1.2, 95% confidence interval [CI]: 1.1-1.3) in 2010-2013. Febrile convulsions (FC) following JE-I was found as a signal of disproportionate reporting (SDR). However, there was no significant difference between the reporting rates of FC of JE-I and JE-L (0.3 per million vaccination doses for JE-L, 0.4 for JE-I, p=0.05). While our analysis did not find apparent safety concern of JE vaccines in China, further study should consider JE-I vaccines and febrile convulsion, and taking more sensitive methods to detect signals. Copyright © 2017. Published by Elsevier Ltd.

  12. Safety and patient comfort with iodixanol: a postmarketing surveillance study in 9515 patients undergoing diagnostic CT examinations

    Energy Technology Data Exchange (ETDEWEB)

    Haeussler, Marc D. (Gemeinschaftspraxis fuer Radiologie und Neurologie, Praxis Mosbach, Mosbach (Germany)), e-mail: info@praxis-mosbach.de

    2010-10-15

    Background: Iodinated radiographic contrast media are considered safe diagnostic drugs with a low incidence of adverse drug reactions. Purpose: To determine prospectively the incidence and nature of immediate and delayed adverse drug reactions occurring after administration of iodixanol for contrast-enhanced computed tomography (CT) in routine practice in nonselected patients, and to assess patient comfort (pain and sensations of heat or coldness). Material and Methods: Patient characteristics (including demographics, risk factors, indication for CT, and status of the vein used to administer iodixanol) and aspects of iodixanol administration (including dose and volume) were documented on a standardized case report form. Patients were asked to report immediate (during the visit) or delayed (occurring up to 7 days after administration of iodixanol) adverse reactions; those deemed related or possibly related to iodixanol were documented on a standardized adverse drug reaction form. Discomfort was rated by patients on a scale of 0-10 for pain, heat, and coldness; individual scores were combined into a composite score (0-30). Results: Evaluable documentation was provided for 9515 patients in 77 centers across Germany. Adverse drug reactions were reported in 70 patients (0.74%), including hypersensitivity reactions in 55 patients. Thirty patients experienced immediate reactions and 40 experienced delayed reactions. Serious adverse drug reactions were evident in five patients (0.05%). Patients with allergic diathesis appeared to be at increased risk of immediate and delayed adverse drug reactions. Discomfort was generally mild, with 72% of patients reporting a composite score of 0-3. Conclusion: In the outpatient setting, where it is often difficult to properly assess patients for specific risk factors, it was reassuring that iodixanol demonstrated an excellent safety profile in over 9500 patients undergoing diagnostic CT examinations. There were no unexpected serious adverse drug reactions, and patient discomfort during administration was mild or absent in most patients

  13. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study).

    Science.gov (United States)

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-Niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients' demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs.

  14. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study.

    Directory of Open Access Journals (Sweden)

    Ying-Ying Yan

    Full Text Available Salvia Miltiorrhiza Depside Salt for Infusion (SMDS is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed.To investigate the safety issues, including adverse events (AEs, adverse events related to SMDS (ADEs, and adverse drug reactions (ADRs of the SMDS in the real world clinical practice.This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting. Consecutive patients prescribed with SMDS were all included in 36 sites. Pharmacists were well trained to standardized collect the patients information, including demographics, medical history, prescribing patterns of SMDS, combined medications, adverse events, laboratory investigations, outcomes of the treatment when discharge, and interventions by pharmacists. Adverse events and adverse drug reactions were collected in details. Multivariate possion regression analysis was applied to identify risk factors associated with ADEs using the significance level (α 0.05. ClinicalTrials.gov Identifier: NCT01872520.Thirty six hospitals were participated in the study and 30180 consecutive inpatients were included. The median age was 62 (interquartile range [IQR], 50-73 years, and male was 17384 (57.60% among the 30180 patients. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. There were 9 kinds of new ADEs which were not on the approved label found in the present study. According to the multivariate analysis, male (RR = 1.381, P = 0.009, 95%CI [1.085~1.759], more concomitant medications (RR = 1.049, P<0.001, 95%CI [1.041~1.057], longer duration of SMDS therapy (RR = 1.027, P<0.001, 95%CI [1.013~1.041], higher drug concentration (RR = 1.003, P = 0.014, 95%CI [1.001~1.006], and resolvent unapproved (RR = 1.900, P = 0.002, 95%CI [1.260~2.866] were the independent risk factors of the ADEs. Moreover, following the approved indication (RR = 0.655, P<0.001, 95%CI [0.532~0.807] was associated with lower incidence of ADEs.SMDS was well tolerated in the general population. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. Several risk factors of its ADEs have been identified. It is recommended to follow the instructions when prescribing and administrating SMDS in the real world clinical practice.

  15. Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis.

    Science.gov (United States)

    Menter, Alan; Thaçi, Diamant; Papp, Kim A; Wu, Jashin J; Bereswill, Mareike; Teixeira, Henrique D; Rubant, Simone; Williams, David A

    2015-09-01

    ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis. Initial 5-year results are reported. Two populations were analyzed: the "all-treated" population received 1 or more adalimumab doses in registry, continuing adalimumab treatment from a current prescription or previous study participation, and included the "new-prescription" population initiating adalimumab 4 weeks or earlier preregistry entry. Data were collected from September 26, 2008, through November 30, 2013, for all-treated (n = 6059), which included new-prescription (n = 2580, 42.6%); median registry exposure was 765 and 677 days, respectively. In all-treated, rate (events per 100 patient-years of total adalimumab exposure [E/100PY]) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.3 E/100PY, serious infection 1.0 E/100PY, malignancies 0.9 E/100PY (nonmelanoma skin cancers 0.6 E/100PY; melanomas <0.1 E/100PY). Standardized mortality ratio was 0.30 (95% confidence interval 0.19-0.44). Physician Global Assessment clear or minimal (effectiveness parameter) was achieved by 57.0% at 12 months and 64.7% at 60 months of treatment. Observational data are subject to outcome-reporting bias. No new safety signals were observed with adalimumab treatment during this initial 5-year registry review. Observed number of deaths was below expected. As-observed effectiveness remained stable through 60 months. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  16. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

    Science.gov (United States)

    Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

    2018-04-01

    Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

  17. Safety and patient comfort with iodixanol: a postmarketing surveillance study in 9515 patients undergoing diagnostic CT examinations

    International Nuclear Information System (INIS)

    Haeussler, Marc D.

    2010-01-01

    Background: Iodinated radiographic contrast media are considered safe diagnostic drugs with a low incidence of adverse drug reactions. Purpose: To determine prospectively the incidence and nature of immediate and delayed adverse drug reactions occurring after administration of iodixanol for contrast-enhanced computed tomography (CT) in routine practice in nonselected patients, and to assess patient comfort (pain and sensations of heat or coldness). Material and Methods: Patient characteristics (including demographics, risk factors, indication for CT, and status of the vein used to administer iodixanol) and aspects of iodixanol administration (including dose and volume) were documented on a standardized case report form. Patients were asked to report immediate (during the visit) or delayed (occurring up to 7 days after administration of iodixanol) adverse reactions; those deemed related or possibly related to iodixanol were documented on a standardized adverse drug reaction form. Discomfort was rated by patients on a scale of 0-10 for pain, heat, and coldness; individual scores were combined into a composite score (0-30). Results: Evaluable documentation was provided for 9515 patients in 77 centers across Germany. Adverse drug reactions were reported in 70 patients (0.74%), including hypersensitivity reactions in 55 patients. Thirty patients experienced immediate reactions and 40 experienced delayed reactions. Serious adverse drug reactions were evident in five patients (0.05%). Patients with allergic diathesis appeared to be at increased risk of immediate and delayed adverse drug reactions. Discomfort was generally mild, with 72% of patients reporting a composite score of 0-3. Conclusion: In the outpatient setting, where it is often difficult to properly assess patients for specific risk factors, it was reassuring that iodixanol demonstrated an excellent safety profile in over 9500 patients undergoing diagnostic CT examinations. There were no unexpected serious adverse drug reactions, and patient discomfort during administration was mild or absent in most patients

  18. Methods for molecular surveillance of influenza

    OpenAIRE

    Wang, Ruixue; Taubenberger, Jeffery K

    2010-01-01

    Molecular-based techniques for detecting influenza viruses have become an integral component of human and animal surveillance programs in the last two decades. The recent pandemic of the swine-origin influenza A virus (H1N1) and the continuing circulation of highly pathogenic avian influenza A virus (H5N1) further stress the need for rapid and accurate identification and subtyping of influenza viruses for surveillance, outbreak management, diagnosis and treatment. There has been remarkable pr...

  19. Evaluation of risk factors associated with congenital malformations in the surveillance program of birth defects based on the methodology ECLAMC in Bogotá during the period 2001 to 2010

    OpenAIRE

    Zarate, Ana María; Pontificia Universidad Javeriana; García, Gloria; Secretaría Distrital de Salud; Zarante, Ignacio; Pontificia Universidad Javeriana

    2016-01-01

    Introduction: Birth defects are a cause of morbidity and mortality in our country, so the Institute of Human Genetics and the Health Secretary of Bogotá developed a surveillance program based on the methodology of the Latin American Collaborative Study of Congenital Malformations (ECLAMC).Methods: We collected data on births monitored in the case-control and monitor modes. Maternal and newborn risk factors were evaluated.Results: 121,674 births were monitored, 1,81% had congenital malformatio...

  20. The surveillance error grid.

    Science.gov (United States)

    Klonoff, David C; Lias, Courtney; Vigersky, Robert; Clarke, William; Parkes, Joan Lee; Sacks, David B; Kirkman, M Sue; Kovatchev, Boris

    2014-07-01

    the data plotted on the CEG and PEG produced risk estimates that were more granular and reflective of a continuously increasing risk scale. The SEG is a modern metric for clinical risk assessments of BG monitor errors that assigns a unique risk score to each monitor data point when compared to a reference value. The SEG allows the clinical accuracy of a BG monitor to be portrayed in many ways, including as the percentages of data points falling into custom-defined risk zones. For modeled data the SEG, compared with the CEG and PEG, allows greater precision for quantifying risk, especially when the risks are low. This tool will be useful to allow regulators and manufacturers to monitor and evaluate glucose monitor performance in their surveillance programs. © 2014 Diabetes Technology Society.

  1. Secure surveillance videotapes

    International Nuclear Information System (INIS)

    Resnik, W.M.; Kadner, S.P.; Olsen, R.; Chitumbo, K.; Pepper, S.

    1995-01-01

    With assistance from the US Program for Technical Assistance to IAEA Safeguards (POTAS), Aquila Technologies Group developed the Tamper-Resistant Analog Media (TRAM-1000) system to provide standard VHS surveillance video tapes with an enhanced tamper-indicating capability. This project represents further implementation of the partnership approach in facilities including light water reactors with MOX facilities. These facilities use Uniplex Digiquad system video tapes. The partnership approach ensures that one organization can exchange the tapes in a machine without the presence of the other, without losing continuity of information. The TRAM-1000 system development project was accomplished in two stages. In the first stage of the project, the original system delivered to the IAEA, consists of three parts: (1) the tamper detection unit, (2) a specially augmented VHS video tape, and (3) an HP-95 reader. The tamper detection unit houses a VACOSS active fiber-optic seal and an electronic identification tag (E-TAG) reader. In the second stage of the project, the original TRAM-1000 was modified to its current design based on agency input. After delivery of the original TRAM-1000 system to the IAEA, it was reviewed by inspectors. The inspectors felt that the initial system's tape storage/transport method could be simplified. Rather than threading the fiber through the tape spindles, the inspectors suggested that the tape be placed in a bag capable of being sealed. Also, a more flexible fiber-optic cable was recommended. As a result of these suggestions, Aquila developed a tamper-proof bag specifically for holding a surveillance video tape and sealable with a VACOSS fiber optical seal

  2. Redefining syndromic surveillance

    Directory of Open Access Journals (Sweden)

    Rebecca Katz

    2011-12-01

    Full Text Available With growing concerns about international spread of disease and expanding use of early disease detection surveillance methods, the field of syndromic surveillance has received increased attention over the last decade. The purpose of this article is to clarify the various meanings that have been assigned to the term syndromic surveillance and to propose a refined categorization of the characteristics of these systems. Existing literature and conference proceedings were examined on syndromic surveillance from 1998 to 2010, focusing on low- and middle-income settings. Based on the 36 unique definitions of syndromic surveillance found in the literature, five commonly accepted principles of syndromic surveillance systems were identified, as well as two fundamental categories: specific and non-specific disease detection. Ultimately, the proposed categorization of syndromic surveillance distinguishes between systems that focus on detecting defined syndromes or outcomes of interest and those that aim to uncover non-specific trends that suggest an outbreak may be occurring. By providing an accurate and comprehensive picture of this field’s capabilities, and differentiating among system types, a unified understanding of the syndromic surveillance field can be developed, encouraging the adoption, investment in, and implementation of these systems in settings that need bolstered surveillance capacity, particularly low- and middle-income countries.

  3. Handbook of surveillance technologies

    CERN Document Server

    Petersen, JK

    2012-01-01

    From officially sanctioned, high-tech operations to budget spy cameras and cell phone video, this updated and expanded edition of a bestselling handbook reflects the rapid and significant growth of the surveillance industry. The Handbook of Surveillance Technologies, Third Edition is the only comprehensive work to chronicle the background and current applications of the full-range of surveillance technologies--offering the latest in surveillance and privacy issues.Cutting-Edge--updates its bestselling predecessor with discussions on social media, GPS circuits in cell phones and PDAs, new GIS s

  4. Surveillance extension experience at WWER-440 type reactors

    International Nuclear Information System (INIS)

    Gillemot, F.; Uri, G.; Oszwald, F.; Trampus, P.

    1993-01-01

    In WWER-440 reactors, the surveillance specimens are located in accelerated irradiation positions. After 5 years, all specimens are withdrawn and the operational changes are not monitored. At Paks NPP a new surveillance program extension has been settled in order to avoid these original program disadvantages and generate further data for plant lifetime management. This paper includes: research performed to prepare the surveillance extension programme, the evaluation method for the surveillance extension, and first results (Charpy and tensile tests). (authors). 6 refs., 12 figs., 3 tabs

  5. Surveillance extension experience at WWER-440 type reactors

    Energy Technology Data Exchange (ETDEWEB)

    Gillemot, F; Uri, G [Budapesti Mueszaki Egyetem, Budapest (Hungary); Oszwald, F; Trampus, P

    1994-12-31

    In WWER-440 reactors, the surveillance specimens are located in accelerated irradiation positions. After 5 years, all specimens are withdrawn and the operational changes are not monitored. At Paks NPP a new surveillance program extension has been settled in order to avoid these original program disadvantages and generate further data for plant lifetime management. This paper includes: research performed to prepare the surveillance extension programme, the evaluation method for the surveillance extension, and first results (Charpy and tensile tests). (authors). 6 refs., 12 figs., 3 tabs.

  6. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  7. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  8. Environmental surveillance master sampling schedule

    International Nuclear Information System (INIS)

    Bisping, L.E.

    1997-01-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest National Laboratory (PNNL)(a) for the US Department of Energy (DOE). This document contains the planned 1997 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP) and Drinking Water Monitoring Project. In addition, Section 3.0, Biota, also reflects a rotating collection schedule identifying the year a specific sample is scheduled for collection. The purpose of these monitoring projects is to evaluate levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in DOE Order 5400.1, General Environmental Protection Program, and DOE Order 5400.5, Radiation Protection of the Public and the Environment. The sampling methods will be the same as those described in the Environmental Monitoring Plan, US Department of Energy, Richland Operations Office, DOE/RL91-50, Rev. 1, US Department of Energy, Richland, Washington

  9. Creating a bridge between data collection and program planning: a technical assistance model to maximize the use of HIV/AIDS surveillance and service utilization data for planning purposes.

    Science.gov (United States)

    Logan, Jennifer A; Beatty, Maile; Woliver, Renee; Rubinstein, Eric P; Averbach, Abigail R

    2005-12-01

    Over time, improvements in HIV/AIDS surveillance and service utilization data have increased their usefulness for planning programs, targeting resources, and otherwise informing HIV/AIDS policy. However, community planning groups, service providers, and health department staff often have difficulty in interpreting and applying the wide array of data now available. We describe the development of the Bridging Model, a technical assistance model for overcoming barriers to the use of data for program planning. Through the use of an iterative feedback loop in the model, HIV/AIDS data products constantly are evolving to better inform the decision-making tasks of their multiple users. Implementation of this model has led to improved data quality and data products and to a greater willingness and ability among stakeholders to use the data for planning purposes.

  10. Are hepatocellular carcinoma surveillance programs effective at improving the therapeutic options?: ¿mejoran las opciones terapéuticas de estos pacientes? Eficacia de los programas de cribado de hepatocarcinoma

    Directory of Open Access Journals (Sweden)

    E. Zapata

    2010-08-01

    Full Text Available Aim: to evaluate whether the current surveillance programs (ultrasonography and alpha-fetoprotein testing every six months are successful in detecting patients in the early stages. Material and methods: the health records of all patients diagnosed with hepatocellular carcinoma in Donostia Hospital between 2003 and 2005 were reviewed retrospectively. Eighty-five patients (11 women and 74 men were included in the study and demographic data, risk factors and clinical data were obtained. Patients were split into two groups according to whether or not they had been included in a surveillance program. Results: seventy per cent of patients of the surveillance group is diagnosed in early stage opposite to 26.7% of patients in no surveillance group (p Objetivo: determinar si la utilización en nuestro medio del programa de cribado de HCC establecido -alfa-fetoproteína (AFP y ecografia semestral- en pacientes con hepatopatía crónica permite detectar pacientes en estadios precoces de la enfermedad. Material y métodos: Diseño experimental: estudio retrospectivo. Criterios diagnósticos de HCC: 2 o más técnicas de imagen con lesión hipervascular mayor de 2 cm o 1 técnica de imagen con lesión hipervascular mayor de 2 cm asociado a AFP mayor de 400 ng/ml. Pacientes: 85 pacientes diagnosticados de HCC en el Hospital Donostia entre los años 2003 y 2005. Datos analizados: información demográfica (sexo, edad, factores de riesgo (alcohol, virus de hepatitis, hemocromatosis, otras enfermedades asociadas, e información clínica (etiología de la hepatopatía, estadio de Child-Pugh, determinación de AFP, hallazgos radiológicos, criterios de resecabilidad, tratamiento recibido, evolución. Se divide la muestra en dos grupos según hubieran seguido o no un programa de cribado. Resultados: el 70% de los pacientes del grupo de cribado se diagnostican en estadio precoz frente al 26,7% del grupo de no cribado (p < 0,05. Trece pacientes no pueden recibir

  11. Between visibility and surveillance

    DEFF Research Database (Denmark)

    Uldam, Julie

    As activists move from alternative media platforms to commercial social media platforms they face increasing challenges in protecting their online security and privacy. While government surveillance of activists is well-documented in both scholarly research and the media, corporate surveillance...

  12. Reassembling Surveillance Creep

    DEFF Research Database (Denmark)

    Bøge, Ask Risom; Lauritsen, Peter

    2017-01-01

    We live in societies in which surveillance technologies are constantly introduced, are transformed, and spread to new practices for new purposes. How and why does this happen? In other words, why does surveillance “creep”? This question has received little attention either in theoretical developm......We live in societies in which surveillance technologies are constantly introduced, are transformed, and spread to new practices for new purposes. How and why does this happen? In other words, why does surveillance “creep”? This question has received little attention either in theoretical...... development or in empirical analyses. Accordingly, this article contributes to this special issue on the usefulness of Actor-Network Theory (ANT) by suggesting that ANT can advance our understanding of ‘surveillance creep’. Based on ANT’s model of translation and a historical study of the Danish DNA database......, we argue that surveillance creep involves reassembling the relations in surveillance networks between heterogeneous actors such as the watchers, the watched, laws, and technologies. Second, surveillance creeps only when these heterogeneous actors are adequately interested and aligned. However...

  13. Designing Surveillance of Healthcare-Associated Infections in the Era of Automation and Reporting Mandates

    NARCIS (Netherlands)

    van Mourik, Maaike S M; Perencevich, Eli N; Gastmeier, Petra; Bonten, Marc J M

    2018-01-01

    Surveillance and feedback of infection rates to clinicians and other stakeholders is a cornerstone of healthcare-associated infection (HAI) prevention programs. In addition, HAIs are increasingly included in public reporting and payment mandates. Conventional manual surveillance methods are resource

  14. Designing Surveillance of Healthcare-Associated Infections in the Era of Automation and Reporting Mandates.

    NARCIS (Netherlands)

    van Mourik, Maaike S M; Perencevich, Eli N; Gastmeier, Petra; Bonten, Marc J M

    2018-01-01

    Surveillance and feedback of infection rates to clinicians and other stakeholders is a cornerstone of healthcare-associated infection (HAI) prevention programs. In addition, HAIs are increasingly included in public reporting and payment mandates. Conventional manual surveillance methods are resource

  15. Internal Audits and Quality Assurance Surveillance in NPP Krsko

    International Nuclear Information System (INIS)

    Cavajda, M.; Bracic, I.

    1996-01-01

    This paper is describing establishment of the requirements for the development and execution of the Internal Audit and Quality Assurance Surveillance Program in the NPP Krsko, to identify relevant regulatory commitment and other documents, and to exhibit different functional areas, levels and work categories and factors that impact selecting and scheduling an audit or surveillance. It is not intention of this paper to explain how and by whom an audit or surveillance has to be done. (author)

  16. Second Generation of HIV Surveillance System: A Pattern for Iran

    OpenAIRE

    Nematollahi, M; Khalesi, N; Moghaddasi, H; Askarian, M

    2012-01-01

    Background For the purpose of minimizing the HIV/AIDS epidemic effects, one of the programs is the promotion of scientific methods and setting of the suitable surveillance systems. The present research was conducted to design the HIV/AIDS surveillance system in Iran applying WHO recommendations and the experience of some countries. Methods In 2009, based on the country's requirements, the HIV/AIDS surveillance system was proposed and designed for Iran. The Delphi technique was utilized to fin...

  17. Quality surveillance at nuclear power plants

    International Nuclear Information System (INIS)

    Deviney, D.E.

    1990-01-01

    Quality surveillance (QS) of nuclear power plants has been occurring for a number of years and is growing in importance as a management tool for assuring that power plants are operated and maintained safely. Quality surveillance can be identified by many terms, such as monitoring, assessment, technical audits, and others. The name given to the function is not important. Quality surveillance at nuclear power plants developed out of a need. Historically, audits were performed to verify compliance to quality program requirements. Verification of day-to-day implementation of activities was not being performed. This left a void in verification activities since inspections were mainly directed at hardware verification. Quality surveillance, therefore, was born out of a need to fill this void in verification. This paper discusses quality surveillance definition; objectives of QS, activities considered for QS, personnel performing QS. As in any human endeavor, people and the attitudes of those people make a program succeed or fail. In the case of QS this is even more critical because of the overview and exposure given to the nuclear industry. Properly trained and experienced personnel performing QS combined with the right attitude contribute to the successful performance of a QS. This is only one side of the success equation, however; acceptance of and actions taken by plant management establish the total success of a QS program

  18. Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

    Science.gov (United States)

    Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs.

  19. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  20. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    Science.gov (United States)

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  1. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    Science.gov (United States)

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  3. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  4. Determinants of persistence in hypertensive patients treated with irbesartan: results of a postmarketing survey

    Directory of Open Access Journals (Sweden)

    Greminger Peter

    2005-06-01

    Full Text Available Abstract Background Persistence is a key factor for long-term blood pressure control, which is of high prognostic importance for patients at increased cardiovascular risk. Here we present the results of a post-marketing survey including 4769 hypertensive patients treated with irbesartan in 886 general practices in Switzerland. The goal of this survey was to evaluate the tolerance and the blood pressure lowering effect of irbesartan as well as the factors affecting persistence in a large unselected population. Methods Prospective observational survey conducted in general practices in all regions of Switzerland. Previously untreated and uncontrolled pre-treated patients were started with a daily dose of 150 mg irbesartan and followed up to 6 months. Results After an observation time slightly exceeding 4 months, the average reduction in systolic and diastolic blood pressure was 20 (95% confidence interval (CI -19.6 to -20.7 mmHg and 12 mmHg (95% CI -11.4 to -12.1 mmHg, respectively. At this time, 26% of patients had a blood pressure Conclusion The results of this survey confirm that irbesartan is effective, well tolerated and well accepted by patients, as indicated by the good persistence. This post-marketing survey also emphasizes the importance of the tolerability profile and of achieving an early control of blood pressure as positive predictors of persistence.

  5. Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

    Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  7. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  8. Antimicrobial resistance in Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and group A beta-haemolytic streptococci in 2002-2003. Results of the multinational GRASP Surveillance Program

    DEFF Research Database (Denmark)

    Beekmann, Susan E; Heilmann, Kris P; Richter, Sandra S

    2005-01-01

    A multinational surveillance study, GRASP, was conducted between November 2002 and April 2003 with the aim of assessing rates of antimicrobial resistance among 2656 isolates of Streptococcus pneumoniae, 2486 isolates of group A beta-haemolytic streptococci, 1358 isolates of Haemophilus influenzae...... and 1047 of Moraxella catarrhalis from 20 countries in Europe, eastern Asia and southern Africa. Conspicuous differences between various countries were noted in the S. pneumoniae resistance rates observed for penicillin (0-79.2%) and erythromycin (4-66%), along with other antimicrobials. The percentage...... of MDR strains was above 25% in 8 of the 20 countries studied. Group A streptococcal macrolide resistance rates ranged from 0% to 35% by country, while rates of beta-lactamase production ranged from 0% to 39% for H. influenzae and 80-100% for M. catarrhalis. Antibiotic resistance in S. pneumoniae remains...

  9. Effects of Experimenter Surveillance on Reactive Self-Monitoring.

    Science.gov (United States)

    Belfiore, Phillip J.; And Others

    1989-01-01

    Worker reactivity patterns were examined in a study of two women with mild and moderate mental retardation who self-monitored their work productivity with and without external surveillance. Findings suggest that surveillance is a setting event that may be important in achieving and maintaining self-management program benefits. (MSE)

  10. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    Science.gov (United States)

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  11. A GIS-driven integrated real-time surveillance pilot system for national West Nile virus dead bird surveillance in Canada

    Directory of Open Access Journals (Sweden)

    Aramini Jeff

    2006-04-01

    Full Text Available Abstract Background An extensive West Nile virus surveillance program of dead birds, mosquitoes, horses, and human infection has been launched as a result of West Nile virus first being reported in Canada in 2001. Some desktop and web GIS have been applied to West Nile virus dead bird surveillance. There have been urgent needs for a comprehensive GIS services and real-time surveillance. Results A pilot system was developed to integrate real-time surveillance, real-time GIS, and Open GIS technology in order to enhance West Nile virus dead bird surveillance in Canada. Driven and linked by the newly developed real-time web GIS technology, this integrated real-time surveillance system includes conventional real-time web-based surveillance components, integrated real-time GIS components, and integrated Open GIS components. The pilot system identified the major GIS functions and capacities that may be important to public health surveillance. The six web GIS clients provide a wide range of GIS tools for public health surveillance. The pilot system has been serving Canadian national West Nile virus dead bird surveillance since 2005 and is adaptable to serve other disease surveillance. Conclusion This pilot system has streamlined, enriched and enhanced national West Nile virus dead bird surveillance in Canada, improved productivity, and reduced operation cost. Its real-time GIS technology, static map technology, WMS integration, and its integration with non-GIS real-time surveillance system made this pilot system unique in surveillance and public health GIS.

  12. The Copyright Surveillance Industry

    Directory of Open Access Journals (Sweden)

    Mike Zajko

    2015-09-01

    Full Text Available Creative works are now increasingly distributed as digital “content” through the internet, and copyright law has created powerful incentives to monitor and control these flows. This paper analyzes the surveillance industry that has emerged as a result. Copyright surveillance systems identify copyright infringement online and identify persons to hold responsible for infringing acts. These practices have raised fundamental questions about the nature of identification and attribution on the internet, as well as the increasing use of algorithms to make legal distinctions. New technologies have threatened the profits of some media industries through copyright infringement, but also enabled profitable forms of mass copyright surveillance and enforcement. Rather than a system of perfect control, copyright enforcement continues to be selective and uneven, but its broad reach results in systemic harm and provides opportunities for exploitation. It is only by scrutinizing copyright surveillance practices and copyright enforcement measures that we can evaluate these consequences.

  13. Deployment Health Surveillance

    National Research Council Canada - National Science Library

    DeNicola, Anthony D

    2004-01-01

    ... of stress in causing chronic illness. The lack of comprehensive deployment health surveillance has made it difficult to determine possible causes of adverse health effects reported by Gulf War veterans...

  14. Sanitary surveillance and bioethics

    Directory of Open Access Journals (Sweden)

    Volnei Garrafa

    2017-08-01

    Full Text Available Regulatory practices in the field of health surveillance are indispensable. The aim of this study is to show ‒ taking the Brazilian National Surveillance Agency, governing body of sanitary surveillance in Brazil as a reference ‒ that bioethics provides public bodies a series of theoretical tools from the field of applied ethics for the proper exercise and control of these practices. To that end, the work uses two references of bioethics for the development of a comparative and supportive analysis to regulatory activities in the field of health surveillance: the Universal Declaration on Bioethics and Human Rights of Unesco and the theory of intervention bioethics. We conclude that organizations and staff working with regulatory activities can take advantage of the principles and frameworks proposed by bioethics, especially those related to the Declaration and the theory of intervention bioethics, the latter being set by the observation and use of the principles of prudence, precaution, protection and prevention.

  15. HIV surveillance in complex emergencies.

    Science.gov (United States)

    Salama, P; Dondero, T J

    2001-04-01

    Many studies have shown a positive association between both migration and temporary expatriation and HIV risk. This association is likely to be similar or even more pronounced for forced migrants. In general, HIV transmission in host-migrant or host-forced-migrant interactions depends on the maturity of the HIV epidemic in both the host and the migrant population, the relative seroprevalence of HIV in the host and the migrant population, the prevalence of other sexually transmitted infections (STIs) that may facilitate transmission, and the level of sexual interaction between the two communities. Complex emergencies are the major cause of mass population movement today. In complex emergencies, additional factors such as sexual interaction between forced-migrant populations and the military; sexual violence; increasing commercial sex work; psychological trauma; and disruption of preventive and curative health services may increase the risk for HIV transmission. Despite recent success in preventing HIV infection in stable populations in selected developing countries, internally displaced persons and refugees (or forced migrants) have not been systematically included in HIV surveillance systems, nor consequently in prevention activities. Standard surveillance systems that rely on functioning health services may not provide useful data in many complex emergency settings. Secondary sources can provide some information in these settings. Little attempt has been made, however, to develop innovative HIV surveillance systems in countries affected by complex emergencies. Consequently, data on the HIV epidemic in these countries are scarce and HIV prevention programs are either not implemented or interventions are not effectively targeted. Second generation surveillance methods such as cross-sectional, population-based surveys can provide rapid information on HIV, STIs, and sexual behavior. The risks for stigmatization and breaches of confidentiality must be recognized

  16. Hanford Site surface environmental surveillance

    International Nuclear Information System (INIS)

    Dirkes, R.L.

    1998-01-01

    Environmental surveillance of the Hanford Site and the surrounding region is conducted to demonstrate compliance with environmental regulations, confirm adherence to US Department of Energy (DOE) environmental protection policies, support DOE environmental management decisions, and provide information to the public. The Surface Environmental Surveillance Project (SESP) is a multimedia environmental monitoring program conducted to measure the concentrations of radionuclides and chemical contaminants in the environment and assess the integrated effects of these contaminants on the environment and the public. The monitoring program includes sampling air, surface water, sediments, soil, natural vegetation, agricultural products, fish, and wildlife. Functional elements inherent in the operation of the SESP include project management, quality assurance/control, training, records management, environmental sampling network design and implementation, sample collection, sample analysis, data management, data review and evaluation, exposure assessment, and reporting. The SESP focuses on those contaminant/media combinations calculated to have the highest potential for contributing to off-site exposure. Results of the SESP indicate that contaminant concentrations in the Hanford environs are very low, generally below environmental standards, at or below analytical detection levels, and indicative of environmental levels. However, areas of elevated contaminant concentrations have been identified at Hanford. The extent of these areas is generally limited to past operating areas and waste disposal sites

  17. Incidence and prevalence of systemic lupus erythematosus among Arab and Chaldean Americans in southeastern Michigan: the Michigan Lupus Epidemiology and Surveillance Program.

    Science.gov (United States)

    Housey, Michelle; DeGuire, Peter; Lyon-Callo, Sarah; Wang, Lu; Marder, Wendy; McCune, W Joseph; Helmick, Charles G; Gordon, Caroline; Dhar, J Patricia; Leisen, James; Somers, Emily C

    2015-05-01

    We assessed the burden of systemic lupus erythematosus (SLE) among Arab and Chaldean Americans residing in southeast Michigan. For those meeting SLE criteria from the Michigan Lupus Epidemiology and Surveillance Registry, we determined Arab or Chaldean ethnicity by links with demographic data from birth certificates and with a database of Arab and Chaldean names. We compared prevalence and incidence of SLE for Arab and Chaldean Americans with estimates for non-Arab and non-Chaldean American Whites and Blacks. We classified 54 individuals with SLE as Arab and Chaldean Americans. The age-adjusted incidence and prevalence estimates for Arab and Chaldean Americans were 7.6 and 62.6 per 100 000, respectively. Arab and Chaldean Americans had a 2.1-fold excess SLE incidence compared with non-Arab and non-Chaldean American Whites. Arab and Chaldean American women had both significantly higher incidence rates (5.0-fold increase) and prevalence estimates (7.4-fold increase) than did Arab and Chaldean American men. Recognizing that Arab and Chaldean Americans experience different disease burdens from Whites is a first step toward earlier diagnosis and designing targeted interventions. Better methods of assigning ethnicity would improve research in this population.

  18. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

    Science.gov (United States)

    Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2017-07-01

    This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

  19. Surveillance of irradiation embrittlement of nuclear reactor pressure vessels

    International Nuclear Information System (INIS)

    Najzer, M.

    1982-01-01

    Surveillance of irradiation embrittlement of nuclear reactor pressure vessels is briefly discussed. The experimental techniques and computer programs available for this work at the J. Stefan Institute are described. (author)

  20. Development and implementation of a quality assurance program for a hormonal contraceptive implant.

    Science.gov (United States)

    Owen, Derek H; Jenkins, David; Cancel, Aida; Carter, Eli; Dorflinger, Laneta; Spieler, Jeff; Steiner, Markus J

    2013-04-01

    The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  1. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    Science.gov (United States)

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the qua