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

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.

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.

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.

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.

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

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.

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.

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

[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.

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.

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.

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.

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

Science.gov (United States)

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.

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.

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

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.

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

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.

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.

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.

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.

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

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...

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.

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.

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.

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...

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.

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

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

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

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

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.

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

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.

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.

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

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.

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...

[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.

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...

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.

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

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.

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.

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.

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.

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.

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

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.

[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.

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.

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.

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

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.

[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.

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)

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

Directory of Open Access Journals (Sweden)

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.

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.)

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

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.

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.

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.

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...

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).

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

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

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

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

[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.

[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.

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.

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

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.

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.

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

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

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

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

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;

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.

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

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)

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

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

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.

[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.

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.

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.

[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.

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

[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.

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)

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

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.

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

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.

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.

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.

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

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.,

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

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.

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

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.

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.

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.

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.

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.

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

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.

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.

Adverse Event Reporting System (AERS)

Data.gov (United States)

U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

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.

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.

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

[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.

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.

[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.

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

A theoretical study of solvent effects on the characteristics of the ...

Indian Academy of Sciences (India)

adrenaline).25 Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier (BBB).25. Data from clinical studies and post-marketing surveil- lance programs conducted in Japan show that the.

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...

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.

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.

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.

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

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.

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

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.

[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.

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)

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

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)

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.

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

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…

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

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

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.

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.

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

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.

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

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.

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...

[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.

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

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

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.

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.

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

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

77 FR 45927 - Implementation of Device Registration and Listing Requirements Enacted in the Public Health...

Science.gov (United States)

2012-08-02

... would also assist us in our fundamental regulatory activities, such as planning and scheduling... of labeling (or the label and package insert) and, in some cases, advertising. Section 510(j)(2) of... postmarketing surveillance programs, help ensure the safety of imported devices, improve the scheduling and...

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...

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

[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.

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

[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.

[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.

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

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.

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.

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.

[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.

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.

[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.

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

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.

[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

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

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

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

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

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.

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.

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

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

[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.

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.

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

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

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...

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

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.

[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.

[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

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

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.

An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

Science.gov (United States)

Komparic, Ana; Smith, Maxwell J; Thompson, Alison

2016-04-01

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

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

[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.

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...

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.

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 ...

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.

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...

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

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.

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

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.

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)

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

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.

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).

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)

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.

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

[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.

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.

[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.

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

Evaluation of surveillance of dengue fever cases in the public health centre of Putat Jaya based on attribute surveillance

Directory of Open Access Journals (Sweden)

Zumaroh Zumaroh

2015-01-01

Full Text Available Dengue Hemorrhagic Fever (DHF is a public health problem in the village of Putat Jaya which is an endemic area. Surveilans activity in DHF control program is the most important activity in controlling and monitoring disease progression. The program is expected to achieve incidence rate 55/100.000 population. This study aimed to evaluate the implementation of case surveilans in health centre of putat jaya based on attribute surveillance. Attribute surveillance is an indicator that describes the characteristics of the surveillance system. This research was an evaluation research with descriptive study design. As informants were clinic staff who deal specifically with cases of dengue hemorrhagic fever and laboratory workers. The techniques of data collection by interviews and document study. The variables of this study were simplicity, flexibility, acceptability, sensitivity, positive predictive value, representativeness, timeliness, data quality and data stability. It could be seen from Incidence Rate in 2013 has reached 133/100.00 population. The activity of surveilance in the village of Putat Jaya reviewed from disease contol program management was not succeed into decrease incidence rate of DHF. Therefore, dengue control programs in health centers Putat Jaya need to do cross-sector cooperation and cross-program cooperation, strengthening the case reporting system by way increasing in the utilization of information and communication technology electromedia. Keywords: case surveillance, dengue hemorrhagic fever, evaluation, attribute surveillance, Putat Jaya

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.

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.

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

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

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.

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...

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

Science.gov (United States)

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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.

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

Science.gov (United States)

Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

2017-10-01

This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

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.

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.

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.

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...

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

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.

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.

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

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

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

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...

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

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.

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

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

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.

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

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.

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

[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.

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

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.

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.

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

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)

Surveillance strategy for an extended operating cycle in commercial nuclear reactors

International Nuclear Information System (INIS)

McHenry, R.S.; Moore, T.J.; Maurer, J.H.; Todreas, N.E.

1997-01-01

The impetus for improved economic performance of commercial nuclear power plants can be partially satisfied by increasing plant capacity factors through operating cycle extension. One aspect of an operating cycle extension effort is the modification of plant surveillance programs to complete required regulatory and investment protection surveillance activities within the extended planned outage schedule. The goal of this paper is to introduce a general strategy for existing power plants to transition their surveillance programs to an extended operating cycle up to 48 months in length, and to test the feasibility of this strategy through the complete analysis of the surveillance programs at operating BWR and PWR case study plants. The reconciliation of surveillances at these plants demonstrates that surveillance performance will not preclude 48 month operating cycles. Those surveillance activities that could not be resolved to an extended cycle are identified for further study. Finally, a number of general issues are presented that should be considered before implementing a cycle extension effort

Surveillance strategy for an extended operating cycle in commercial nuclear reactors

International Nuclear Information System (INIS)

McHenry, R.S.; Moore, T.J.; Maurer, J.H.; Todreas, N.E.

1997-01-01

The impetus for improved economic performance of commercial nuclear power plants can be partially satisfied by increasing plant capacity factors through operating cycle extension. One aspect of an operating cycle extension effort is the modification of plant surveillance programs to complete required regulatory and investment protection surveillance activities within the extended planned outage schedule. The goal is to introduce a general strategy for existing power plants to transition their surveillance programs to an extended operating cycle up to 48 months in length, and to test the feasibility of this strategy through the complete analysis of the surveillance programs at operating BWR and PWR case study plants. The reconciliation of surveillances at these plants demonstrates that surveillance performance will not preclude 48 month operating cycles. Those surveillance activities that could not be resolved to an extended cycle are identified for further study. Finally, a number of general issues are presented that should be considered before implementing a cycle extension effort

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.

[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

Science.gov (United States)

Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

2012-03-01

Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

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

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

Energy Technology Data Exchange (ETDEWEB)

Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

2015-11-15

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

Science.gov (United States)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

International Nuclear Information System (INIS)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

2015-01-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

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.

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...

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.

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.

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

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.

Surveillance of the exposure to ionizing radiations of the University health staff

International Nuclear Information System (INIS)

Tomasina, F.; Sponton, F.; Pintado, C.; Laborde, A.; Blanco, D.; Stolovas, N.; Satragno, N.

2011-01-01

Introduction The surveillance program for the workers exposed to ionizing radiations involves personal dosemeters of exposed workers, and their assessment and comparison with the reference values, which allow prioritizing and taking effective preventive action. Objectives To present the occupational health surveillance program for university workers exposed to ionizing radiations during the 2003-2006 period.Methods Longitudinal and descriptive study. Dosimetric data were obtained from secondary source, on the basis of the dosimetric surveillance program in the University of the Republic. The exposure was evaluated through film dosimetry. The personal dosimetric value records were analyzed within the surveillance program in 2003, 2004, 2005 and 2006.Results It was observed that the dosimetric values did not exceed the reference values accepted as annual maximum figures. The annual maximum dose received was 15,72 milisieverts in the diagnosis and specialized treatment areas of the university hospital. Conclusions Surveillance of exposure to radiations allowed directing the specific systematic medical check-ups as well as stretching the taking of radioprotective measures. In this regard, the Department of Occupational Health is carrying out educational tasks and disseminating the surveillance program in order to reinforce preventive measures.

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)

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

The utility industry and reactor surveillance

International Nuclear Information System (INIS)

Jenkins, R.B.

1983-01-01

Every commercial nuclear power reactor pressure vessel (RPV) is required to have a reactor vessel surveillance program at the time of plant licensing. The program is part of a continuing structural integrity assessment of the RPV. As such, the surveillance program supplements Section III of the American Society of Mechanical Engineers (ASME) Code (1), which is the design basis for nuclear power plant component pressure boundaries. The Code assumes that the materials of construction are ductile in the evaluation and design of all components. The surveillance program for each RPV is intended to provide assurance of continued applicability of the ASME Code, Appendix G, assessment of that RPV's operating limits. This assessment ensures that the RPV is always in a condition which precludes the unstable propagation of flaws in the vessel wall material. The potential presence of flaws and the desire to ensure ductility are significant considerations in ferritic steels such as those used to fabricate nuclear reactor pressure vessels. These materials are known to exhibit transition from ductile-to-brittle fracture behavior over a determined temperature range. Neutron irradiation tends to shift this ductile-to-brittle behavior transition zone to a temperature higher than unirradiated materials

[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.

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.

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

[Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

Science.gov (United States)

Xiao, Ying; Zhao, Yubin; Xie, Yanming

2011-10-01

The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

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.

State surveillance of radioactive material transportation. Final report

International Nuclear Information System (INIS)

Salomon, S.N.

1984-02-01

The main objective of this final report on the state surveillance of the transportation of radioactive material (RAM) is to suggest the most cost-effective inspection areas where enforcement actions might be taken by the states during their participation in the State Hazardous Materials Enforcement Development (SHMED) Program. On the basis of the lessons learned from the surveillance program, these actions are enforcement at low-level radioactive burial sites by means of civil penalties and site use suspension; enforcement at airports and at terminals that forward freight; and enforcement of courier companies. More effective and efficient enforcement can be achieved through instrumented police patrol cars and remote surveillance because they require the least amount of time of enforcement personnel. In addition, there is a strong relationship between effective emergency response and enforcement because the appropriate shipping papers, placarding and knowledge of appropriate emergency response procedures lead to improved emergency response. These lessons originate from a ten-state surveillance program from 1977 through 1981 jointly sponsored by the US Nuclear Regulatory Commission (NRC) and DOT. The states give recommendations in the categories of education, training, expanded surveillance, coordination and enforcement. The topics of special interest covered include low-level radioactive waste disposal sites, airports, cargo terminals, highways, ports, and accidents and incidents. The three most common problems in compliance with RAM transportation regulations reported by the states are incorrect package labeling; improper shipping papers; and incorrect or missing placards. Other common problems reported by the states are summarized. The relationship to other studies, the status of the SHMED Program, a synopsis of state RAM surveillance reports, and NRC/DOT expenditures are given

Converging requirements and emerging challenges to public health diseases surveillance and bio surveillance

International Nuclear Information System (INIS)

Rao, V.; Abel, T.

2009-01-01

Disease surveillance systems are a critical component of an early warning system for public health agencies to prepare and respond to major public health catastrophes. With a growing emphasis for more robust early indicator and warning systems to track emerging and dangerous diseases of suspicious nature, considerable emphasis is now placed on deployment of more expanded electronic disease surveillance systems. The architectural considerations for bio surveillance information system are based on collection, analysis and dissemination of human, veterinary and agricultural related disease surveillance to broader regional areas likely to be affected in the event of an emerging disease, or due to bioterrorism and better coordinate plans, preparations and response by governmental agencies and multilateral forums. The diseases surveillance systems architectures by intent and design could as well support biological threat monitoring and threat reduction initiatives. As an illustrative sample set, this paper will describe the comparative informatics requirements for a disease surveillance systems developed by CSC for the US Centers for Diseases Control and Prevention (CDC) currently operational nationwide, and biological weapons threat assessment developed as part of the Threat Agent Detection and Response (TADR) Network under the US Biological Threat Reduction Program and deployed at Uzbekistan, Kazakhstan, Georgia, and Azerbaijan.(author)

Selection of 3013 Containers for Field Surveillance. Fiscal Year 2016 Update

Energy Technology Data Exchange (ETDEWEB)

Kelly, Elizabeth J. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Berg, John M. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Cheadle, Jesse [Savannah River Nuclear Solutions, LLC, (SRNS), Aiken, SC (United States); McClard, James [Project Services Group LLC, Suwanee, GA (United States); Veirs, Douglas Kirk [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2016-04-19

This update is the eighth in a series of reports that document the binning and sample selection of 3013 containers for the Field Surveillance program as part of the Integrated Surveillance Program. This report documents changes made to both the container binning assignments and the sample selection approach. Binning changes documented in this update are a result of changes to the prompt gamma calibration curves and the reassignment of a small number of Hanford items from the Pressure bin to the Pressure and Corrosion (P&C) bin. Field Surveillance sample selection changes are primarily a result of focusing future destructive examinations (DEs) on the potential for stress corrosion cracking in higher moisture containers in the P&C bin. The decision to focus the Field Surveillance program on higher moisture items is based on findings from both the Shelf-life testing program and DEs.

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)

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.

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.

Quality surveillance at Duke Power operating nuclear stations

International Nuclear Information System (INIS)

Bradley, W.H.

1985-01-01

The Duke Power quality assurance (QA) program originally had three levels of QA audits that reported results to different levels of management and in different time frames. It soon became obvious that although problems were being identified, considerable confusion was being created by reporting them to different levels. Additionally, it was recognized that all audits were dealing in history: events that had already occurred and therefore could not be averted. What was needed was a problem identification system focused on current activities. The Duke quality surveillance program was created by dropping the first level of audits and replacing it with an on-the-scene review system to identify current problems. The quality surveillance program is a success and will be even more so after surveillance personnel acquire additional technical expertise. To that end, a training program has been initiated that will stop just short of operator licensing in the operations area and will also include other areas such as health physics and chemistry

Surveillance - filling the gap between audits and inspection

International Nuclear Information System (INIS)

Coulombe, C.T.

1987-01-01

Historically, two major verification activities are accomplished at nuclear plants: audits and inspections. Both have their roots firmly planted in regulation. They are required elements of a quality assurance (QA) program. Inspection, focused on hardware, verifies that equipment meets its specified requirements. Auditing, focused on documentation, verifies, through objective evidence, that the QA program is being effectively implemented. Quality surveillance, focused on performance, verifies effective use of the plant's procedures and quality program. The surveillance concept provides a method to assure that the gap between the inspection function and the audit function is filled in

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.

The pharmacist and adverse drug reaction reporting.

Science.gov (United States)

Pearson, K

1982-08-01

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

LLNL Livermore site Groundwater Surveillance Plan

International Nuclear Information System (INIS)

1992-04-01

Department of Energy (DOE) Order 5400.1 establishes environ-mental protection program requirements, authorities, and responsibilities for DOE operations to assume compliance with federal, state, and local environmental protection laws and regulations; Federal Executive Orders; and internal DOE policies. ne DOE Order contains requirements and guidance for environmental monitoring programs, the objectives of which are to demonstrate compliance with legal and regulatory requirements imposed by federal, state, and local agencies; confirm adherence to DOE environmental protection polices; and support environmental management decisions. The environmental monitoring programs consist of two major activities: (1) measurement and monitoring of effluents from DOE operations, and (2) surveillance through measurement, monitoring, and calculation of the effects of those operations on the environment and public health. The latter concern, that of assessing the effects, if any, of Lawrence Livermore National Laboratory (LLNL) operations and activities on on-site and off-site surface waters and groundwaters is addressed by an Environmental Surveillance Program being developed by LLNL. The Groundwater Surveillance Plan presented here has been developed on a sitespecific basis, taking into consideration facility characteristics, applicable regulations, hazard potential, quantities and concentrations of materials released, the extent and use of local water resources, and specific local public interest and concerns

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)

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.

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

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

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

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...

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.

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...

2003 Oak Ridge National Laboratory 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 ORNL. 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.

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.

Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

International Nuclear Information System (INIS)

Zhu, Xiao; Kruhlak, Naomi L.

2014-01-01

Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

Science.gov (United States)

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

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.

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 ...

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

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.

2003 East Tennessee Technology Park 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 East Tennessee Technology Park (K-25).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.

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.

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)

[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.

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.

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.

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

2004 Hanford Site Annual Illness and Injury Surveillance Report, Revised October 2007

Energy Technology Data Exchange (ETDEWEB)

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

2007-10-24

Annual Illness and Injury Surveillance Program for 2004 for the Hanford 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.

[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.

[Surveillance of susceptibility of clinical isolates to cefmetazole between 2000 and 2003].

Science.gov (United States)

Sato, Yuki; Abe, Tomomi; Koga, Tetsufumi; Ito, Kazuyoshi; Tochikawa, Yuko

2005-06-01

For the post-marketing surveillance of cefmetazole (CMZ, Cefmetazon), MICs of injectable beta-lactam antibacterials including CMZ against clinical isolates from 15 medical institutions all over Japan are measured yearly and the incidence rates of resistance in various species are also evaluated. In the first surveillance from June 2000 to March 2001, 574 isolates of 13 species were tested, 548 isolates of the same 13 species were tested in the second surveillance from April 2001 to March 2002, and 654 isolates of the same 13 species were tested in the third surveillance from April 2002 to March 2003. No remarkable changes in the activity of CMZ were observed in these surveillances spanning three years. The activity of CMZ in this study was comparable to that in the studies conducted before Cefmetazon was launched. This result suggests that CMZ still maintains potent activity. Changes in percent resistance of each species to CMZ (MIC of CMZ > or = 32 microg/ml) were as follows: methicillin-susceptible Staphylococcus aureus (MSSA, 0.0% --> 0.0% --> 0.0%), methicillin-resistant Staphylococcus aureus (MRSA, 72.9% --> 87.2% --> 88.7%), Staphylococcus epidermidis (18.5% --> 31.6% --> 14.3%), coagulase-negative Staphylococcus spp. (CNS, 13.3% --> 18.2% --> 21.4%), Escherichia coli (3.6% --> 0.8% --> 2.1%), Klebsiella pneumoniae (3.4% --> 3.8% --> 2.1%), Klebsiella oxytoca (0.0% --> 0.0% --> 0.0%), Proteus mirabilis (2.3% --> 2.1% --> 0.0%), Proteus vulgaris (13.6% --> 6.7% --> 0.0%), Morganella morganii (7.3% --> 0.0% --> 14.0%), Providencia spp. (12.5% --> 0.0% --> 18.2%), Peptostreptococcus spp. (0.0% --> 0.0% --> 0.0%), Bacteroides fragilis (10.3% --> 10.8% --> 17.1%), Bacteroides spp. (78.6% --> 87.5% --> 62.5%). The Change in percent resistance of MRSA, other CNS, and B. flagiris tended to increase. It is necessary to pay much attention to trends observed in these species. Compared to other drugs tested, against MSSA, the activity of CMZ was inferior to that of CEZ

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

1995 annual epidemiologic surveillance report for Hanford Site

International Nuclear Information System (INIS)

1995-01-01

The US 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. A number of DOE sites participate in the Epidemiologic Surveillance Program. This program monitors illnesses and health conditions that result in an absence of five or more consecutive workdays, occupational injuries and illnesses, disabilities and deaths among current workers. This report provides a summary of epidemiologic surveillance data collected from the Hanford Site from January 1, 1995 through December 31, 1995. The data were collected by a coordinator at Hanford and submitted to the Epidemiologic Surveillance Data Center, located at Oak Ridge Institute for Science and Education, where quality control procedures and data analyses were carried out. The information in the main body of the report provides a descriptive analysis of the data collected from the site, and the appendices provides additional detail. The report also contains an expanded Glossary and an Explanation of Diagnostic Categories which gives examples of health conditions in each of the diagnostic categories

1995 annual epidemiologic surveillance report for Hanford Site

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-12-31

The US 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. A number of DOE sites participate in the Epidemiologic Surveillance Program. This program monitors illnesses and health conditions that result in an absence of five or more consecutive workdays, occupational injuries and illnesses, disabilities and deaths among current workers. This report provides a summary of epidemiologic surveillance data collected from the Hanford Site from January 1, 1995 through December 31, 1995. The data were collected by a coordinator at Hanford and submitted to the Epidemiologic Surveillance Data Center, located at Oak Ridge Institute for Science and Education, where quality control procedures and data analyses were carried out. The information in the main body of the report provides a descriptive analysis of the data collected from the site, and the appendices provides additional detail. The report also contains an expanded Glossary and an Explanation of Diagnostic Categories which gives examples of health conditions in each of the diagnostic categories.

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...

1995 annual epidemiologic surveillance report for Fernald Environmental Management Project

International Nuclear Information System (INIS)

1995-01-01

The US 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. During the past several years, a number of DOE sites have participated in the Epidemiologic Surveillance Program. This program monitors illnesses and health conditions that result in an absence of five or more consecutive workdays, occupational injuries and illnesses, and disabilities and deaths among current workers. This report provides a summary of epidemiologic surveillance data collected from the Fernald Environmental Management Project (FEMP) from January 1, 1995 through December 31, 1995. The data were collected by a coordinator at FEMP and submitted to the Epidemiologic Surveillance Data Center, located at Oak Ridge Institute for Science and Education, where quality control procedures and data analyses were carried out

1995 annual epidemiologic surveillance report for Fernald Environmental Management Project

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-12-31

The US 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. During the past several years, a number of DOE sites have participated in the Epidemiologic Surveillance Program. This program monitors illnesses and health conditions that result in an absence of five or more consecutive workdays, occupational injuries and illnesses, and disabilities and deaths among current workers. This report provides a summary of epidemiologic surveillance data collected from the Fernald Environmental Management Project (FEMP) from January 1, 1995 through December 31, 1995. The data were collected by a coordinator at FEMP and submitted to the Epidemiologic Surveillance Data Center, located at Oak Ridge Institute for Science and Education, where quality control procedures and data analyses were carried out.

Monitoring Device Safety in Interventional Cardiology

OpenAIRE

Matheny, Michael E.; Ohno-Machado, Lucila; Resnic, Frederic S.

2006-01-01

Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.

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.

Surveillance specimen programmes for WWER reactor vessels in the Czech Republic

International Nuclear Information System (INIS)

Brynda, J.; Hogel, J.; Brumovsky, M.

2003-01-01

The present state of materials degradation in WWER reactor pressure vessels manufactured in the Czech Republic is highlighted. The standard surveillance program for WWER-440/V-213 type reactors is described and its deficiencies together with the main results obtained are discussed. A new supplementary surveillance program meeting all requirements for PWR type reactors has been developed and launched. An entirely new design was chosen for the surveillance programme for WWER-1000/V-320 type reactor pressure vessels. Materials selection, container design and location as well as the withdrawal plan connected with ex-vessel fluence monitoring are described

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

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)

History and evolution of surveillance in public health

Directory of Open Access Journals (Sweden)

Varun Kumar

2014-01-01

Full Text Available The modern concept of surveillance has evolved over the centuries. Public health surveillance provides the scientific database essential for decision making and appropriate public health action. It is considered as the best public health tool to prevent the occurrence of epidemics and is the backbone of public health programs and provides information so that effective action can be taken in controlling and preventing diseases of public health importance. This article reviews the history of evolution of public health surveillance from historical perspective: from Hippocrates, Black Death and quarantine, recording of vital events for the first time, first field investigation, legislations that were developed over time and modern concepts in public health surveillance. Eradication of small pox is an important achievement in public health surveillance but the recent Severe Acute Respiratory Syndrome (SARS and Influenza pandemics suggest still there is a room for improvement. Recently new global disease surveillance networks like FluNet and DengueNet were developed as internet sites for monitoring influenza and dengue information. In spite of these developments, global public health surveillance still remains unevenly distributed. There is a need for increased international cooperation to address the global needs of public health surveillance.

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

2003 Idaho National Engineering and Environmental Laboratory 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 Idaho National Lab. 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.

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.)

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

Surveillance of Site A and Plot M

International Nuclear Information System (INIS)

Golchert, N.W.

1991-05-01

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for CY 1990 are presented. The surveillance program is the ongoing remedial action that resulted from the 1976-1978 radiological characterization of the site. That study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were 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 determine the migration pathway of water from the burial ground (plot M) to the hand-pumped picnic wells, establish if buries radionuclides other than hydrogen-3 have migrated, and generally characterize the radiological environment of the area. Tritiated water continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continues to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site or those living in the vicinity. 20 refs., 7 figs., 15 tabs

[Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

Science.gov (United States)

Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

2011-10-01

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

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

Neuroprotective effect of apocynin nitrone in oxygen glucose ...

African Journals Online (AJOL)

(DOAJ), African Journal Online, Bioline International, Open-J-Gate and Pharmacy Abstracts ..... Sun K, Fan J, Han J. Ameliorating effects of traditional. Chinese ... Edaravone reported during post-marketing surveillance. ... Comparison of the.

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.

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.

Corrosion surveillance in spent fuel storage pools

International Nuclear Information System (INIS)

Howell, J.P.

1996-01-01

In mid-1991, corrosion of aluminum-clad spent nuclear fuel was observed in the light-water filled basins at the Savannah River site. A corrosion surveillance program was initiated in the P, K, L-Reactor basins and in the Receiving Basin for Offsite Fuels (RBOF). This program verified the aggressive nature of the pitting corrosion and provided recommendations for changes in basin operations to permit extended longer term interim storage. The changes were implemented during 1994--1996 and have resulted in significantly improved basin water quality with conductivity in the 1--3 microS/cm range. Under these improved conditions, no new pitting has been observed over the last three years. This paper describes the corrosion surveillance program at SRS and what has been learned about the corrosion of aluminum-clad in spent fuel storage pools

Information Systems to Support Surveillance for Malaria Elimination

Science.gov (United States)

Ohrt, Colin; Roberts, Kathryn W.; Sturrock, Hugh J. W.; Wegbreit, Jennifer; Lee, Bruce Y.; Gosling, Roly D.

2015-01-01

Robust and responsive surveillance systems are critical for malaria elimination. The ideal information system that supports malaria elimination includes: rapid and complete case reporting, incorporation of related data, such as census or health survey information, central data storage and management, automated and expert data analysis, and customized outputs and feedback that lead to timely and targeted responses. Spatial information enhances such a system, ensuring cases are tracked and mapped over time. Data sharing and coordination across borders are vital and new technologies can improve data speed, accuracy, and quality. Parts of this ideal information system exist and are in use, but have yet to be linked together coherently. Malaria elimination programs should support the implementation and refinement of information systems to support surveillance and response and ensure political and financial commitment to maintain the systems and the human resources needed to run them. National malaria programs should strive to improve the access and utility of these information systems and establish cross-border data sharing mechanisms through the use of standard indicators for malaria surveillance. Ultimately, investment in the information technologies that support a timely and targeted surveillance and response system is essential for malaria elimination. PMID:26013378

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.

2009 Pantex Plant Annual Illness and Injury Surveillance

Energy Technology Data Exchange (ETDEWEB)

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

2010-12-15

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.

Long-term surveillance plan for the Lowman, Idaho, disposal site

International Nuclear Information System (INIS)

1993-09-01

The long-term surveillance plan (LTSP) for the Lowman, Idaho, Uranium Mill Tailings Remedial Action (UMTRA) Project disposal site describes the surveillance activities for the Lowman disposal cell. The US Department of Energy (DOE) will carry out these activities to ensure that the disposal cell continues to function as designed. This preliminary final LTSP is being submitted to the US Nuclear Regulatory Commission (NRC) as a requirement for issuance of a general license for custody and long-term care for the disposal site. The general license requires that the disposal cell be cared for in accordance with the provisions of this LTSP. The LTSP documents whether the land and interests are owned by the United States or an Indian tribe, and describes, in detail, how the long-term care of the disposal site will be carried out through the UMTRA Project long-term surveillance program. The Lowman, Idaho, LTSP is based on the DOE's Guidance for Implementing the UMTRA Project Long-term Surveillance Program, (DOE, 1992)

Surveillance dosimetry of operating power plants

International Nuclear Information System (INIS)

McElroy, W.N.; Davis, A.I.; Gold, R.

1981-01-01

The main focus of the research efforts presently underway is the LWR power reactor surveillance program in which metallurgical test specimens of the reactor PV and dosimetry sensors are placed in three or more surveillance capsules at or near the reactor PV inner wall. They are then irradiated in a temperature and neutron flux-spectrum environment as similar as possible to the PV itself for periods of about 1.5 to 15 effective full-power years (EFPY), with removal of the last capsule at a fluence corresponding to the 30- to 40-year plant end-of-life (EOL) fluence. Because the neutron flux level at the surveillance position is greater than at the vessel, the test is accelerated wit respect to the vessel exposure, allowing early assessment of EOL conditions

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.

The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study.

Science.gov (United States)

Meijer, Willemijn M; Cornel, Martina C; Dolk, Helen; de Walle, Hermien E K; Armstrong, Nicola C; de Jong-van den Berg, Lolkje T W

2006-09-01

European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than 1 million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology and drug safety surveillance. The 34 full members and 6 associate members of the EUROCAT network were sent a questionnaire about their data sources on drug exposure and on drug coding. Available data on drug exposure during the first trimester available in the central EUROCAT database for the years 1996-2000 was summarised for 15 out of 25 responding full members. Of the 40 registries, 29 returned questionnaires (25 full and 4 associate members). Four of these registries do not collect data on maternal drug use. Of the full members, 15 registries use the EUROCAT drug code, 4 use the international ATC drug code, 3 registries use another coding system and 7 use a combination of these coding systems. Obstetric records are the most frequently used sources of drug information for the registries, followed by interviews with the mother. Only one registry uses pharmacy data. Percentages of cases with drug exposure (excluding vitamins/minerals) varied from 4.4% to 26.0% among different registries. The categories of drugs recorded varied widely between registries. Practices vary widely between registries regarding recording drug exposure information. EUROCAT has the potential to be an effective collaborative framework to contribute to post-marketing drug surveillance in relation to teratogenic effects, but work is needed to implement ATC drug coding more widely, and to diversify the sources of information used to determine drug exposure in each registry.

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.

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.

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.

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.

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...

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.

R and D study on on-line criticality surveillance system (V)

International Nuclear Information System (INIS)

Yamada, Sumasu

2001-02-01

In view of necessity and importance of criticality surveillance systems for ensuring the safety of nuclear fuel manufacturing and reprocessing plants, 5-year basic studies and 4 year R and D studies on an on-line criticality surveillance system were carried out since 1991. This report is a summary of these series of studies. Noticing that the signal from a neutron detector is random in principle, these series of studies aimed to accumulate knowledge for developing an inexpensive criticality surveillance system with quick response based on the Auto-Regressive Moving Average (ARMA) model identification algorithm. During five-year basic studies on criticality surveillance system since 1991, we obtained knowledge required for developing a criticality surveillance system based on the ARMA model identification algorithm through 1) studies on recursive ARMA model identification algorithms most appropriate for estimating subcriticality form time series data under a steady state condition, 2) studies on pre-processing of signal from neutron detectors, 3) developing a new recursive ARMA model identification algorithm with small time delay to estimate time-dependent subcriticality, 4) proposing a basic concept for the elements required for an on-line criticality surveillance system, and 5) numerical analysis of data from the DCA experiments. During next four-year R and D studies on a criticality surveillance system since 1996, we 1) proposed modules required for a no-line criticality surveillance system, 2) revealed effectiveness of a adaptive digital filter (ADF) algorithm, as an important redundancy to the recursive ARMA model identification algorithm to be used in the signal processing module through numerical analysis of real data, 3) proposed a module of the Feynman-α method over γ ray signal and a fast signal processing module for γ ray signal, 4) developed a line-noise removal filter(Notch filter) and revealed its effectiveness for the DCA data corrupted with power

75 FR 65490 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information...

Science.gov (United States)

2010-10-25

...; marketing practices; effectiveness of marketing practices; and health, toxicological, behavioral, and... the manufacture, marketing, and distribution of tobacco products to protect the public health..., focus groups, surveys, experimental clinical studies, post-marketing surveillance, toxicological and...

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.

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.

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.

Surveillance system using the CCTV at the fuel transfer pond in the Tokai reprocessing plant

International Nuclear Information System (INIS)

Hayakawa, T.; Fukuhara, J.; Ochiai, K.; Ohnishi, T.; Ogata, Y.; Okamoto, H.

1991-01-01

The Fuel Transfer Pond (FTP) in the Tokai Reprocessing Plant (TRP) is a strategic point for safeguards. Spent fuels, therefore, in the FTP have been surveyed by the surveillance system using the underwater CCTV. This system was developed through the improvement of devices composed of cameras and VCRs and the provision of tamper resistance function as one of the JASPAS (Japan Support Program for Agency Safeguards) program. The purpose of this program is to realize the continuous surveillance of the slanted tunnel through which the spent fuel on the conveyor is moved from the FTP to the Mechanical Processing Cell (MPC). This paper reports that, when this surveillance system is applied to an inspection device, the following requirements are needed: To have the ability of continuous and unattended surveillance of the spent fuel on the conveyor path from the FTP to the MPC; To have the tamper resistance function for continuous and unattended surveillance of the spent fuel

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....

Information systems to support surveillance for malaria elimination.

Science.gov (United States)

Ohrt, Colin; Roberts, Kathryn W; Sturrock, Hugh J W; Wegbreit, Jennifer; Lee, Bruce Y; Gosling, Roly D

2015-07-01

Robust and responsive surveillance systems are critical for malaria elimination. The ideal information system that supports malaria elimination includes: rapid and complete case reporting, incorporation of related data, such as census or health survey information, central data storage and management, automated and expert data analysis, and customized outputs and feedback that lead to timely and targeted responses. Spatial information enhances such a system, ensuring cases are tracked and mapped over time. Data sharing and coordination across borders are vital and new technologies can improve data speed, accuracy, and quality. Parts of this ideal information system exist and are in use, but have yet to be linked together coherently. Malaria elimination programs should support the implementation and refinement of information systems to support surveillance and response and ensure political and financial commitment to maintain the systems and the human resources needed to run them. National malaria programs should strive to improve the access and utility of these information systems and establish cross-border data sharing mechanisms through the use of standard indicators for malaria surveillance. Ultimately, investment in the information technologies that support a timely and targeted surveillance and response system is essential for malaria elimination. © The American Society of Tropical Medicine and Hygiene.

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.

Emerging infectious diseases in free-ranging wildlife-Australian zoo based wildlife hospitals contribute to national surveillance.

Directory of Open Access Journals (Sweden)

Keren Cox-Witton

Full Text Available Emerging infectious diseases are increasingly originating from wildlife. Many of these diseases have significant impacts on human health, domestic animal health, and biodiversity. Surveillance is the key to early detection of emerging diseases. A zoo based wildlife disease surveillance program developed in Australia incorporates disease information from free-ranging wildlife into the existing national wildlife health information system. This program uses a collaborative approach and provides a strong model for a disease surveillance program for free-ranging wildlife that enhances the national capacity for early detection of emerging diseases.

Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.

Science.gov (United States)

Casey, Christine; Vellozzi, Claudia; Mootrey, Gina T; Chapman, Louisa E; McCauley, Mary; Roper, Martha H; Damon, Inger; Swerdlow, David L

2006-02-03

CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal vaccinia; generalized vaccinia; accidental autoinoculation, nonocular; ocular vaccinia; progressive vaccinia; erythema multiforme major; postvaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox vaccine surveillance case

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.

Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States

Directory of Open Access Journals (Sweden)

Jara M

2015-12-01

Full Text Available Michele Jara, Thomas Aquilina, Peter Aupperle, Adrian L Rabinowicz Acorda Therapeutics, Inc., Ardsley, NY, USA Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine outside the US, 10 mg twice daily, was approved by the US Food and Drug Administration (FDA in January 2010 to improve walking in people with multiple sclerosis, as determined by an increase in walking speed. Objective: To provide a descriptive analysis of reported adverse events (AEs for commercially available dalfampridine-ER from March 2010 through March 31, 2015. Methods: Five-year postmarketing data for dalfampridine-ER were available from the exposure of approximately 107,000 patients in the US (103,700 patient-years. Commonly reported AEs (≥2% of all reported AEs and serious AEs were determined. The incidence of reported seizures was determined and the events were further investigated. Results: Among the 107,000 patients exposed to dalfampridine-ER (70% female; mean age 52.1, the most common AEs were dizziness (3.7%, insomnia (3.2%, balance disorder (3%, fall (2.4%, headache (2.4%, nausea (2.1%, and urinary tract infection (2%. Other common AEs were drug ineffectiveness (5.8%, gait disturbance (4.6%, and inappropriate dosing (3.1%. Serious AEs included rare anaphylactic reactions (five cases and drug hypersensitivity reactions (eight cases. A total of 657 seizure cases were reported (6.3/1,000 patient-years; of these, 324 were medically confirmed (3.1/1,000 patient-years. Incidence of reported seizures was stable over time. Duration of treatment prior to a seizure ranged from a single dose to >4 years; 12% of the seizures occurred within a week of starting treatment. Conclusion: The 5-year US postmarketing safety data of dalfampridine-ER is consistent with the safety profile observed in clinical trials. Incidence of reported seizures remained stable over time. Since commercial availability in March 2010, a

Converting Mosquito Surveillance to Arbovirus Surveillance with Honey-Baited Nucleic Acid Preservation Cards.

Science.gov (United States)

Flies, Emily J; Toi, Cheryl; Weinstein, Philip; Doggett, Stephen L; Williams, Craig R

2015-07-01

Spatially and temporally accurate information about infectious mosquito distribution allows for pre-emptive public health interventions that can reduce the burden of mosquito-borne infections on human populations. However, the labile nature of arboviruses, the low prevalence of infection in mosquitoes, the expensive labor costs for mosquito identification and sorting, and the specialized equipment required for arbovirus testing can obstruct arbovirus surveillance efforts. The recently developed techniques of testing mosquito expectorate using honey-baited nucleic acid preservation cards or sugar bait stations allows a sensitive method of testing for infectious, rather than infected, mosquito vectors. Here we report the results from the first large-scale incorporation of honey-baited cards into an existing mosquito surveillance program. During 4 months of the peak virus season (January-April, 2014) for a total of 577 trap nights, we set CO2-baited encephalitis vector survey (EVS) light traps at 88 locations in South Australia. The collection container for the EVS trap was modified to allow for the placement of a honey-baited nucleic acid preservation card (FTA™ card) inside. After collection, mosquitoes were maintained in a humid environment and allowed access to the cards for 1 week. Cards were then analyzed for common endemic Australian arboviruses using a nested RT-PCR. Eighteen virus detections, including 11 Ross River virus, four Barmah Forest virus, and three Stratford virus (not previously reported from South Australia) were obtained. Our findings suggest that adding FTA cards to an existing mosquito surveillance program is a rapid and efficient way of detecting infectious mosquitoes with high spatial resolution.

A qualitative assessment of factors influencing acceptance of a new rotavirus vaccine among health care providers and consumers

Energy Technology Data Exchange (ETDEWEB)

Manish M Patel, Alan P Janssen, Richard Tardif, Mark Herring, Umesh Parashar

2007-10-18

In 2006, a new rotavirus vaccine (RotaTeq) was licensed in the US and recommended for routine immunization of all US infants. Because a previously licensed vaccine (Rotashield) was withdrawn from the US for safety concerns, identifying barriers to uptake of RotaTeq will help develop strategies to broaden vaccine coverage. Our qualitative assessment provides complementary data to recent quantitative surveys and suggests that physicians and parents are likely to adopt the newly licensed rotavirus vaccine. Increasing parental awareness of the rotavirus disease burden and providing physicians with timely post-marketing surveillance data will be integral to a successful vaccination program.

2010 Pantex Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-06-29

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2009 Hanford 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 Health and Safety, Office of Illness and Injury Prevention Programs

2010-12-01

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.

2007 Hanford Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, Office of Health, Safety, and Security

2009-07-16

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2006 Pantex Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-05-19

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2006 Hanford Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-05-14

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2010 Hanford Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-10-05

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Pantex Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-07-31

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

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)

Hazelwood Interim Storage Site environmental surveillance report for calendar year 1993

International Nuclear Information System (INIS)

1994-06-01

This report summarizes the results of environmental surveillance activities conducted at the Hazelwood Interim Storage Site (HISS) during calendar year 1993. It includes an overview of site operations, the basis for monitoring for radioactive and non-radioactive parameters, summaries of environmental program at HISS, a summary of the results, and the calculated hypothetical radiation dose to the offsite population. Environmental surveillance activities were conducted in accordance with the site environmental monitoring plan, which describes the rationale and design criteria for the surveillance program, the frequency of sampling and analysis, specific sampling and analysis procedures, and quality assurance requirements. The US Department of Energy (DOE) began environmental monitoring of HISS in 1984, when the site was assigned to DOE by Congress through the energy and Water Development Appropriations Act and subsequent to DOE's Formerly Utilized Sites Remediation Action Program (FUSRAP). Contamination at HISS originated from uranium processing work conducted at Mallinckrodt Chemical Works at the St. Louis Downtown Site (SLDS) from 1942 through 1957

Typhoid Fever surveillance and vaccine use - South-East Asia and Western Pacific regions, 2009-2013.

Science.gov (United States)

Date, Kashmira A; Bentsi-Enchill, Adwoa D; Fox, Kimberley K; Abeysinghe, Nihal; Mintz, Eric D; Khan, M Imran; Sahastrabuddhe, Sushant; Hyde, Terri B

2014-10-03

Typhoid fever is a serious, systemic infection resulting in nearly 22 million cases and 216,500 deaths annually, primarily in Asia. Safe water, adequate sanitation, appropriate personal and food hygiene, and vaccination are the most effective strategies for prevention and control. In 2008, the World Health Organization (WHO) recommended use of available typhoid vaccines to control endemic disease and outbreaks and strengthening of typhoid surveillance to improve disease estimates and identify high-risk populations (e.g., persons without access to potable water and adequate sanitation). This report summarizes the status of typhoid surveillance and vaccination programs in the WHO South-East Asia (SEAR) and Western Pacific regions (WPR) during 2009-2013, after the revised WHO recommendations. Data were obtained from the WHO/United Nations Children's Fund (UNICEF) Joint Reporting Form on Immunization, a supplemental survey of surveillance and immunization program managers, and published literature. During 2009-2013, 23 (48%) of 48 countries and areas of SEAR (11) and WPR (37) collected surveillance or notifiable disease data on typhoid cases, with most surveillance activities established before 2008. Nine (19%) countries reported implementation of typhoid vaccination programs or recommended vaccine use during 2009-2013. Despite the high incidence, typhoid surveillance is weak in these two regions, and vaccination efforts have been limited. Further progress toward typhoid fever prevention and control in SEAR and WPR will require country commitment and international support for enhanced surveillance, targeted use of existing vaccines and availability of newer vaccines integrated within routine immunization programs, and integration of vaccination with safe water, sanitation, and hygiene measures.

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

U.S. Department of Energy Office of Occupational Medicine and Medical Surveillance 1995--1997 triannual report

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-08-01

From 1995 through 1997 the Office of Occupational Medicine and Medical Surveillance (EH-61) has made numerous achievements that have enhanced the performance of the office and more importantly, the Department of Energy (DOE). This report provides specific information about program activities and accomplishments, as well as individual contacts for each program. The mission of EH-61 is the prevention of worker illness by fostering outstanding occupational medicine and medical surveillance programs within the DOE complex. This mission is being realized as a result of efforts in four main business lines: (1) Surveillance; (2) Research, (3) Policy/Technical Support; and (4) Information/Communication.

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

Selection of 3013 Containers for Field Surveillance

International Nuclear Information System (INIS)

Larry Peppers; Elizabeth Kelly; James McClard; Gary Friday; Theodore Venetz; Jerry Stakebade

2007-01-01

This report revises and combines three earlier reports dealing with the binning, statistical sampling, and sample selection of 3013 containers for field surveillance. It includes changes to the binning specification resulting from completion of the Savannah River Site packaging campaign and new information from the shelf-life program and field surveillance activities. The revised bin assignments result in changes to the random sample specification. These changes are necessary to meet the statistical requirements of the surveillance program. This report will be reviewed regularly and revised as needed. Section 1 of this report summarizes the results of an extensive effort to assign all of the current and projected 3013 containers in the Department of Energy (DOE) inventory to one of three bins (Innocuous, Pressure and Corrosion, or Pressure) based on potential failure mechanisms. Grouping containers into bins provides a framework to make a statistical selection of individual containers from the entire population for destructive and nondestructive field surveillance. The binning process consisted of three main steps. First, the packaged containers were binned using information in the Integrated Surveillance Program database and a decision tree. The second task was to assign those containers that could not be binned using the decision tree to a specific bin using container-by-container engineering review. The final task was to evaluate containers not yet packaged and assign them to bins using process knowledge. The technical basis for the decisions made during the binning process is included in Section 1. A composite decision tree and a summary table show all of the containers projected to be in the DOE inventory at the conclusion of packaging at all sites. Decision trees that provide an overview of the binning process and logic are included for each site. Section 2 of this report describes the approach to the statistical selection of containers for surveillance and

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.

Scoping review on search queries and social media for disease surveillance: a chronology of innovation.

Science.gov (United States)

Bernardo, Theresa Marie; Rajic, Andrijana; Young, Ian; Robiadek, Katie; Pham, Mai T; Funk, Julie A

2013-07-18

The threat of a global pandemic posed by outbreaks of influenza H5N1 (1997) and Severe Acute Respiratory Syndrome (SARS, 2002), both diseases of zoonotic origin, provoked interest in improving early warning systems and reinforced the need for combining data from different sources. It led to the use of search query data from search engines such as Google and Yahoo! as an indicator of when and where influenza was occurring. This methodology has subsequently been extended to other diseases and has led to experimentation with new types of social media for disease surveillance. The objective of this scoping review was to formally assess the current state of knowledge regarding the use of search queries and social media for disease surveillance in order to inform future work on early detection and more effective mitigation of the effects of foodborne illness. Structured scoping review methods were used to identify, characterize, and evaluate all published primary research, expert review, and commentary articles regarding the use of social media in surveillance of infectious diseases from 2002-2011. Thirty-two primary research articles and 19 reviews and case studies were identified as relevant. Most relevant citations were peer-reviewed journal articles (29/32, 91%) published in 2010-11 (28/32, 88%) and reported use of a Google program for surveillance of influenza. Only four primary research articles investigated social media in the context of foodborne disease or gastroenteritis. Most authors (21/32 articles, 66%) reported that social media-based surveillance had comparable performance when compared to an existing surveillance program. The most commonly reported strengths of social media surveillance programs included their effectiveness (21/32, 66%) and rapid detection of disease (21/32, 66%). The most commonly reported weaknesses were the potential for false positive (16/32, 50%) and false negative (11/32, 34%) results. Most authors (24/32, 75%) recommended that

Surveillance of Site A and Plot M, Report for 2008.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W.

2009-05-07

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2008 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby hand pumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to (1) monitor the migration pathway of hydrogen-3 contaminated water from the burial ground (Plot M) to the hand-pumped picnic wells, (2) establish if other buried radionuclides have migrated, and (3) monitor for the presence of radioactive materials in the environment of the area. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

Surveillance of Site A and Plot M, Report for 2009.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W.

2010-04-21

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2009 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby hand-pumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to monitor the migration pathway of hydrogen-3 contaminated water from the burial ground (Plot M) to the hand-pumped picnic wells and monitor for the presence of radioactive materials in the environment of the area. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

Surveillance of Site A and Plot M report for 2010.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W. (ESQ)

2011-05-31

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2010 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby hand-pumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to monitor the migration pathway of hydrogen-3 contaminated water from the burial ground (Plot M) to the hand-pumped picnic wells and monitor for the presence of radioactive materials in the environment of the area. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

Surveillance of site A and plot M, report for 2007.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W.; ESH/QA Oversight

2008-03-25

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2007 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby hand pumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to: (1) monitor the migration pathway of water from the burial ground (Plot M) to the hand-pumped picnic wells, (2) establish if other buried radionuclides have migrated, and (3) monitor the presence of radioactive materials in the environment of the area. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

Surveillance of Site A and Plot M - Report for 2006.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W.; ESH/QA Oversight

2007-05-07

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2006 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby hand-pumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to (1) monitor the migration pathway of water from the burial ground (PlotM) to the hand pumped picnic wells, (2) establish if buried radionuclides other than hydrogen-3 have migrated, and (3) monitor the presence of radioactive and chemically hazardous materials in the environment of the area. Hydrogen-3 in the Red GateWoods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

Surveillance of Site A and Plot M - Report for 2005.

Energy Technology Data Exchange (ETDEWEB)

Golchert, N. W.; ESH/QA Oversight

2006-04-10

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for Calendar Year 2005 are presented. Based on the results of the 1976-1978 radiological characterization of the site, a determination was made that a surveillance program be established. The characterization study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were present in two nearby handpumped picnic wells. The current surveillance program began in 1980 and consists of sample collection and analysis of surface and subsurface water. The results of the analyses are used to (1) monitor the migration pathway of water from the burial ground (Plot M) to the handpumped picnic wells, (2) establish if buried radionuclides other than hydrogen-3 have migrated, and (3) monitor the presence of radioactive and chemically hazardous materials in the environment of the area. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Hydrogen-3 continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity.

[The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

Science.gov (United States)

Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

2017-01-01

In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data

NARCIS (Netherlands)

Witjes, J.A.; Gomella, L.G.; Stenzl, A.; Chang, S.S.; Zaak, D.; Grossman, H.B.

2014-01-01

OBJECTIVE: To detail and put into perspective, safety of hexaminolevulinate blue light cystoscopy (HAL-BLC), including repeated use, based on combined data of controlled trials used for registration of HAL and postmarketing experience. METHODS: Safety data of 2 randomized comparative studies (group

Guidelines for submitting adverse event reports for publication

NARCIS (Netherlands)

Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

2009-01-01

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these

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.

EVMS Self-Surveillance of Remote Handled Low Level Waste (RHLLW) Project

Energy Technology Data Exchange (ETDEWEB)

Nelson, Michael L. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Case, Kimberly [Idaho National Lab. (INL), Idaho Falls, ID (United States); Hergesheimer, Linda [Idaho National Lab. (INL), Idaho Falls, ID (United States); Johnson, Maxine [Idaho National Lab. (INL), Idaho Falls, ID (United States); Parker, Doug [Idaho National Lab. (INL), Idaho Falls, ID (United States); Staten, Rick [Idaho National Lab. (INL), Idaho Falls, ID (United States); Taylor, Scott [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2013-07-01

DOE G 413.3-10A, Section 3.a states: “The Contractor has primary responsibility for implementing and maintaining a surveillance program to ensure continued compliance of the system with ANSI/EIA-748B. DOE O 413.3B requires the FPD to ensure the contractor conducts a Self-Surveillance annually. This annual Self-Surveillance,…should cover all 32 guidelines of the ANSI/EIA748B. Documentation of the Self-Surveillance is sent to the CO and the PMSO (copy to OECM) confirming the continued compliance of their EVMS ANSI/EIA748B...” This review, and the associated report, is deemed to satisfy this requirement.

Distributed data processing for public health surveillance

Directory of Open Access Journals (Sweden)

Yih Katherine

2006-09-01

Full Text Available Abstract Background Many systems for routine public health surveillance rely on centralized collection of potentially identifiable, individual, identifiable personal health information (PHI records. Although individual, identifiable patient records are essential for conditions for which there is mandated reporting, such as tuberculosis or sexually transmitted diseases, they are not routinely required for effective syndromic surveillance. Public concern about the routine collection of large quantities of PHI to support non-traditional public health functions may make alternative surveillance methods that do not rely on centralized identifiable PHI databases increasingly desirable. Methods The National Bioterrorism Syndromic Surveillance Demonstration Program (NDP is an example of one alternative model. All PHI in this system is initially processed within the secured infrastructure of the health care provider that collects and holds the data, using uniform software distributed and supported by the NDP. Only highly aggregated count data is transferred to the datacenter for statistical processing and display. Results Detailed, patient level information is readily available to the health care provider to elucidate signals observed in the aggregated data, or for ad hoc queries. We briefly describe the benefits and disadvantages associated with this distributed processing model for routine automated syndromic surveillance. Conclusion For well-defined surveillance requirements, the model can be successfully deployed with very low risk of inadvertent disclosure of PHI – a feature that may make participation in surveillance systems more feasible for organizations and more appealing to the individuals whose PHI they hold. It is possible to design and implement distributed systems to support non-routine public health needs if required.

Use of carabids for the post-market environmental monitoring of genetically modified crops

Czech Academy of Sciences Publication Activity Database

Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

2017-01-01

Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

1995 Annual epidemiologic surveillance report for Brookhaven National Laboratory

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-12-31

The US Department of Energy`s (DOE) conduct of epidemiologic surveillance provides an early warning system for health problems among workers. This program monitors illnesses and health conditions that result in an absence of five or more consecutive workdays, occupational injuries and illnesses, and disabilities and deaths among current workers. This report summarizes epidemiologic surveillance data collected from Brookhaven National Laboratory (BNL) from January 1, 1995 through December 31, 1995. The data were collected by a coordinator at BNL and submitted to the Epidemiologic Surveillance Data Center, located at Oak Ridge Institute for Science and Education, where quality control procedures and data analyses were carried out.

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)

Safety issues with bisphosphonate therapy for osteoporosis

DEFF Research Database (Denmark)

Suresh, Ernest; Pazianas, Michael; Abrahamsen, Bo

2014-01-01

Randomized controlled trials have demonstrated the efficacy of bisphosphonates (BP) in improving BMD and reducing fracture risk. Various safety issues that were not noted in clinical trials have, however, now emerged with post-marketing surveillance and increasing clinical experience. The risk...

Is Dysguesia Going to be a Rare or a Common Side‑effect of ...

African Journals Online (AJOL)

amlodipine are peripheral edema (8.3%), fatigue (4.5%), dizziness, palpitations, myalgia, stomachache, headache, dyspepsia, nausea, blood disorders, gynecomastia, .... Coulter DM. Eye pain with nifedipine and disturbance of taste with captopril: A mutually controlled study showing a method of postmarketing surveillance.

gmo

African Journals Online (AJOL)

2014-06-01

Jun 1, 2014 ... fied some of the advantages of GMOs and also the health concerns. It is clear ... GMO products and post-marketing surveillance for possible negative ... Use of technology for Gene therapy - direct use of. DNA to treat disease.

In vivo recovery and safety of human factor VIII product AAFACT in patients with haemophilia A

NARCIS (Netherlands)

Vossebeld, P. J. M.; Tissing, M. H.; van den Berg, H. M.; Leebeek, F. W. G.; de Goede-Bolder, A.; Novakova, I. R. O.; Gerrits, W. B. J.; Peters, M.; Koopman, M. M. W.; Faber, A.; Hiemstra, H.; Grob, P.; Strengers, P. F. W.

2003-01-01

AAFACT, a monoclonal purified, solvent/detergent treated human plasma-derived coagulation factor VIII concentrate obtained from plasma of voluntary, non-remunerated blood donors, is manufactured and marketed in the Netherlands by Sanquin Plasma Products since 1995. In a postmarketing surveillance

78 FR 46588 - Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and...

Science.gov (United States)

2013-08-01

... NVAC was also asked to make recommendations on how to best communicate this information to decision... a series of teleconferences and electronic communications, the NVAC Global Immunizations working... Vaccine Safety Monitoring and Post-Marketing Surveillance 4. Building Global Immunization Research and...

Haematological Indices, Blood glucose levels and lipid profile of rats ...

African Journals Online (AJOL)

Arun Kumar Agnihotri

2015-11-11

Nov 11, 2015 ... Short Communication. Imafidon et al. ... one of the most commonly used food colourant. A food additive is only approved for ... Post-marketing surveillance of its effects ... value permitted in alcoholic beverages, up to 100 mg/kg ...

Using Deep Learning Algorithm to Enhance Image-review Software for Surveillance Cameras

Energy Technology Data Exchange (ETDEWEB)

Cui, Yonggang

2018-05-07

We propose the development of proven deep learning algorithms to flag objects and events of interest in Next Generation Surveillance System (NGSS) surveillance to make IAEA image review more efficient. Video surveillance is one of the core monitoring technologies used by the IAEA Department of Safeguards when implementing safeguards at nuclear facilities worldwide. The current image review software GARS has limited automated functions, such as scene-change detection, black image detection and missing scene analysis, but struggles with highly cluttered backgrounds. A cutting-edge algorithm to be developed in this project will enable efficient and effective searches in images and video streams by identifying and tracking safeguards relevant objects and detect anomalies in their vicinity. In this project, we will develop the algorithm, test it with the IAEA surveillance cameras and data sets collected at simulated nuclear facilities at BNL and SNL, and implement it in a software program for potential integration into the IAEA’s IRAP (Integrated Review and Analysis Program).

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.

Improvements to Technical Specifications surveillance requirements

International Nuclear Information System (INIS)

Lobel, R.; Tjader, T.R.

1992-12-01

In August 1983 an NRC task group was formed to investigate problems with surveillance testing required by Technical Specifications, and to recommend approaches to effect improvements. NUREG-1024 (''Technical Specifications-Enhancing Safety Impact'') resulted, and it contained recommendations to review the basis for test frequencies; to ensure that the tests promote safety and do not degrade equipment; and to review surveillance tests so that they do not unnecessarily burden personnel. The Technical Specifications Improvement Program (TSIP) was established in December 1984 to provide the framework for rewriting and improving the Technical Specifications. As an element of the TSIP, all Technical Specifications surveillance requirements were comprehensively examined as recommended in NUREG-1024. The results of that effort are presented in this report. The study found that while some testing at power is essential to verify equipment and system operability, safety can be improved, equipment degradation decreased, and unnecessary personnel burden relaxed by reducing the amount of testing at power

Infectious diseases: Surveillance, genetic modification and simulation

Science.gov (United States)

Koh, H. L.; Teh, S.Y.; De Angelis, D. L.; Jiang, J.

2011-01-01

Infectious diseases such as influenza and dengue have the potential of becoming a worldwide pandemic that may exert immense pressures on existing medical infrastructures. Careful surveillance of these diseases, supported by consistent model simulations, provides a means for tracking the disease evolution. The integrated surveillance and simulation program is essential in devising effective early warning systems and in implementing efficient emergency preparedness and control measures. This paper presents a summary of simulation analysis on influenza A (H1N1) 2009 in Malaysia. This simulation analysis provides insightful lessons regarding how disease surveillance and simulation should be performed in the future. This paper briefly discusses the controversy over the experimental field release of genetically modified (GM) Aedes aegypti mosquito in Malaysia. Model simulations indicate that the proposed release of GM mosquitoes is neither a viable nor a sustainable control strategy. ?? 2011 WIT Press.

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

2007 Idaho National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-05-04

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2006 Brookhaven National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-03-06

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Brookhaven National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-07-31

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2010 Idaho National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-09-26

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Sandia National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-02-04

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.

2006 Kansas City Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-06-13

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2010 Savannah River Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-09-12

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Kansas City Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-07-13

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.

2009 Brookhaven National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2010-11-24

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.

2008 Brookhaven National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-12-10

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.

2006 Savannah River Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-08-20

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Savannah River Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-05-05

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.

2008 Kansas City Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-09-22

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.

2008 Savannah River Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-09-29

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.

2010 Sandia National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-10-26

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2007 Nevada Test Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-06-30

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.

2008 Idaho National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2010-11-23

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.

2006 Nevada Test Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2008-04-24

The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2010 Kansas City Plant Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-06-20

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2009 Argonne National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2010-08-19

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.

2008 Sandia National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-09-17

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.

2010 Brookhaven National Laboratory Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2011-08-16

The U.S. Department of Energy's (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

2008 Nevada Test Site Annual Illness and Injury Surveillance Report

Energy Technology Data Exchange (ETDEWEB)

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

2009-10-05

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.

Attaching Hollywood to a Surveillant Assemblage: Normalizing Discourses of Video Surveillance

Directory of Open Access Journals (Sweden)

Randy K Lippert

2015-10-01

Full Text Available This article examines video surveillance images in Hollywood film. It moves beyond previous accounts of video surveillance in relation to film by theoretically situating the use of these surveillance images in a broader “surveillant assemblage”. To this end, scenes from a sample of thirty-five (35 films of several genres are examined to discern dominant discourses and how they lend themselves to normalization of video surveillance. Four discourses are discovered and elaborated by providing examples from Hollywood films. While the films provide video surveillance with a positive associative association it is not without nuance and limitations. Thus, it is found that some forms of resistance to video surveillance are shown while its deterrent effect is not. It is ultimately argued that Hollywood film is becoming attached to a video surveillant assemblage discursively through these normalizing discourses as well as structurally to the extent actual video surveillance technology to produce the images is used.

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.

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.

Optimal surveillance strategy for invasive species management when surveys stop after detection.

Science.gov (United States)

Guillera-Arroita, Gurutzeta; Hauser, Cindy E; McCarthy, Michael A

2014-05-01

Invasive species are a cause for concern in natural and economic systems and require both monitoring and management. There is a trade-off between the amount of resources spent on surveying for the species and conducting early management of occupied sites, and the resources that are ultimately spent in delayed management at sites where the species was present but undetected. Previous work addressed this optimal resource allocation problem assuming that surveys continue despite detection until the initially planned survey effort is consumed. However, a more realistic scenario is often that surveys stop after detection (i.e., follow a "removal" sampling design) and then management begins. Such an approach will indicate a different optimal survey design and can be expected to be more efficient. We analyze this case and compare the expected efficiency of invasive species management programs under both survey methods. We also evaluate the impact of mis-specifying the type of sampling approach during the program design phase. We derive analytical expressions that optimize resource allocation between monitoring and management in surveillance programs when surveys stop after detection. We do this under a scenario of unconstrained resources and scenarios where survey budget is constrained. The efficiency of surveillance programs is greater if a "removal survey" design is used, with larger gains obtained when savings from early detection are high, occupancy is high, and survey costs are not much lower than early management costs at a site. Designing a surveillance program disregarding that surveys stop after detection can result in an efficiency loss. Our results help guide the design of future surveillance programs for invasive species. Addressing program design within a decision-theoretic framework can lead to a better use of available resources. We show how species prevalence, its detectability, and the benefits derived from early detection can be considered.

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

Surveillance for stage I nonseminoma testicular cancer

DEFF Research Database (Denmark)

Daugaard, Gedske; Gundgaard, Maria Gry; Mortensen, Mette Saksø

2014-01-01

PURPOSE: To describe treatment results in a large cohort with stage I nonseminoma germ cell cancer (NSGCC) treated in a surveillance program. PATIENTS AND METHODS: From January 1, 1984, to December 31, 2007, 1,226 patients with stage I NSGCC, including high-risk patients with vascular invasion......, were observed in a surveillance program. RESULTS: The relapse rate after orchiectomy alone was 30.6% at 5 years. Presence of vascular invasion together with embryonal carcinoma and rete testis invasion in the testicular primary identified a group with a relapse risk of 50%. Without risk factors....... Relapses after 5 years were seen in 0.5% of the whole cohort or in 1.6% of relapsing patients. The majority of relapses (94.4%) belonged to the good prognostic group according to the International Germ Cell Cancer Collaborative Group classification. The disease-specific survival at 15 years was 99...

76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

Science.gov (United States)

2011-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

NARCIS (Netherlands)

Dellicour, S.O.M.C.

2014-01-01

Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries.

1998 annual report Office of Occupational Medicine and Medical Surveillance

International Nuclear Information System (INIS)

Gebus, George R.

1999-01-01

the mission of EH-61 is the prevention of worker illness by fostering outstanding occupational medicine and medical surveillance programs within the DOE complex. The EH-61 annual report for 1998 describes our major activities and achievements as we have worked toward realizing this mission through our main program lines (1) Surveillance; (2) policy(Field SUppOti; (3) Information/Communication; and (4) Research. Some of our major 1998 accomplishments are highlighted below for more details, please consult the corresponding sections of this report. The FORMER BERYLLIUM WORKERS MEDICAL SURVEILLANCE PROGRAM identifies and locates former employees exposed to beryllium and provides enhanced medical monitoring for early identification of chronic beryllium disease (CBD). Over Z0,000 current and former workers have been contacted to date, and there have been about 8,8oo responders. More than 100 cases of CBD have been detected. The DOE FORMER WORKERS PROGRAM (FWP) is targeted primarily to former workers who have either retired or left DOE facilities. In FY 1998, there were 10 pilot projects operating at 9 sites. These pilots will validate approaches for medical screening of former employees and health risk communication efforts. When completed in FY 2002, the information gained from the pilots will serve as a basis for projecting funding and resources needed for the FWP in the years ahead. We have helped develop health-related POLICIES/GUIDANCE, that will promote the health of the contractor workforce by addressing current and emerging issues related to occupational health. The RADIATION EMERGENCY ASSISTANCE CENTER/TRAINING SITE (REAC/TS) is supported by EH-61 and assists DOE by maintaining state-of-the-art expertise in radiation medicine and biodosimetry. This support provides DOE with a national and international 24-hour response capability for evaluating and managing victims of radiation accidents occurring at its facilities or among the general public. In collaboration

Surveillance as a complement to irradiation embrittlement studies: Status and needs

International Nuclear Information System (INIS)

Steele, L.E.

1977-01-01

The history of the study of radiation embrittlement of reactor pressure vessel steels has gone through three stages in the USA. 1) A scientific curiosity. 2) Empirical or laboratory evaluation of typical steels, and 3) Integration of the scientific and empirical to advance status and evolve standard techniques. The current stage is one in which surveillance data compliments the laboratory studies which characterized Stage 3. The early USA surveillance programs were generally analyzed by the same people who were the primary laboratory investigators. An effort must be made to continue this type of collaboration as a useful two-way learning procedure though it will become more and more difficult as nuclear power is broadly commercialized. The current status of both types of USA programs will be presented to encourage the most advantageous use of data from both sources. At this time about 25 USA nuclear power reactors have operated long enough to have provided initial surveillance or dosimetry results. An effort will be made to summarize the general status of these in order to: 1) Provide complimentary data to laboratory studies. 2) Assess directions in handling the problems of radiation embrittlement. 3) Note lessons learned for improving surveillance efforts in the future. 4) Identify possible research tasks for the future to support in-service surveillance and other measures. 5) Justify facts advancing surveillance requirements to status of national codes and standards. 6) Justify facts requiring changes in current national codes and standards. A plan will be presented along with an introduction of each member of the USA delegation for systematic presentation of the status of reactor vessel surveillance in the USA. (author)

Long-term surveillance plan for the Burro Canyon disposal cell, Slick Rock, Colorado

International Nuclear Information System (INIS)

1996-11-01

This long-term surveillance plant (LTSP) describes the US Department of energy's (DOE) long-term care program for the Uranium Mill Tailings Remediation Action (UMTRA) Project's burro Canyon disposal cell in San Miguel County, Colorado. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Burro Canyon disposal cell performs as designed. The program is based on site inspections to identify threats to disposal cell integrity. No ground water monitoring will be required at the Burro Canyon disposal cell because the ground water protection strategy is supplemental standards based on low-yield from the upper-most aquifer

Surveillance of Site A and Plot M

International Nuclear Information System (INIS)

Golchert, N.W.

1993-05-01

The results of the environmental surveillance program conducted at Site A/Plot M in the Palos Forest Preserve area for CY 1992 are presented. The surveillance program is the ongoing remedial action that resulted from the 1976--1978 radiological characterization of the site. That study determined that very low levels of hydrogen-3 (as tritiated water) had migrated from the burial ground and were 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 the 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. Hydrogen-3 in the Red Gate Woods picnic wells was still detected this year, but the average and maximum concentrations were significantly less than found earlier. Tritiated water continues to be detected in a number of wells, boreholes, dolomite holes, and a surface stream. For many years it was the only radionuclide found to have migrated in measurable quantities. Analyses since 1984 have indicated the presence of low levels of strontium-90 in water from a number of boreholes next to Plot M. The available data does not allow a firm conclusion as to whether the presence of this nuclide represents recent migration or movement that may have occurred before Plot M was capped. The results of the surveillance program continue to indicate that the radioactivity remaining at Site A/Plot M does not endanger the health or safety of the public visiting the site, using the picnic area, or living in the vicinity

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

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

R and D study on on-line criticality surveillance system (IV)

International Nuclear Information System (INIS)

Yamada, Sumasu

2000-02-01

Developing an inexpensive on-line criticality surveillance system is required for ensuring the safety of nuclear fuel reprocessing plants. Based on the series of researches for five years, R and D study on On-line Criticality Surveillance system has been carried out since 1996. The concept of this Criticality Surveillance System is based on the Auto-Regressive Moving Average (ARMA) model identification algorithms to the time series of signal fluctuation of a neutron detector. We have proposed several new ideas of modification to the original design of the Criticality Surveillance System, and also reported some results of numerical analysis over the DCA experiments. In those days, DOS/V personal computers with Microsoft Windows have came into wide use instead of those based on the MS-DOS, which have been popular in Japan. NEC, a major maker of MS-DOS computers, stopped the production of MS-DOS computers and changed their management policy toward production of DOS/V personal computers. Our researches have been developed using MS-DOS computers. For the effective use of these important results, it became an urgent theme to transplant all programs developed on MS-DOS computers into computers with the OS, which is not easily affected by commercialism. Since the design concept should be based on high reliability, electromagnetic disturbance-free and high expandability, and also computers have achieved remarkably high performance as well as low price in these days, these computers should be used not only as a simple signal processing unit but also a totally integrated signal analyzing system along with conventional signal analyzing software in stead of IC chips with analyzing soft wares. This configuration enables us to easily introduce newly developed techniques and to provide supplement information. Then, this approach can enhance the reliability of the Criticality Surveillance System without addition of any special devices, and also provide the flexibility of the system

How reliable are national surveillance data? Findings from an audit of Canadian methicillin-resistant Staphylococcus aureus surveillance data.

Science.gov (United States)

Forrester, Leslie; Collet, Jun Chen; Mitchell, Robyn; Pelude, Linda; Henderson, Elizabeth; Vayalumkal, Joseph; Leduc, Stephanie; Ghahreman, Saeed; Weir, Christine; Gravel, Denise

2012-03-01

The Canadian Nosocomial Infection Surveillance Program (CNISP) has conducted surveillance for incident cases of methicillin-resistant Staphylococcus aureus (MRSA) in sentinel hospitals since 1995. In 2007, a reliability audit of the 2005 data was conducted. In 2005, 5,652 cases were submitted to the CNISP from 43 hospitals. A proportional sample of submitted forms (up to 25) from each site were randomly selected. Stratified random sampling was used to obtain the comparison data. The original data were compared with the reabstracted data for congruence on 7 preselected variables. Reabstracted data were received from 30 out of 43 hospitals (70%), providing 443 of the 598 case forms requested (74%). Of these, 397 (90%) had matching case identification numbers. Overall, the percentage of discordant responses was 7.0%, ranging from 3.5% for sex and up to 23.7% for less well-defined variables (eg, where MRSA was acquired). Our findings suggest that, in general, the 2005 MRSA data are reliable. However to improve reliability a data quality framework with quality assurance practices, including ongoing auditing should be integrated into the CNISP's surveillance programs. Providing training to data collectors and standard definitions with practical examples may help to improve data quality, especially for those variables that require clinical judgment. Crown Copyright © 2012. Published by Mosby, Inc. All rights reserved.

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.

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

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)

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

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

Long-term surveillance plan for the Maybell, Colorado Disposal Site

International Nuclear Information System (INIS)