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

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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

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

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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.

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

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Joseph R Egger

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

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

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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.

European surveillance network for influenza in pigs

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Simon, Gaëlle; Larsen, Lars E.; Dürrwald, Ralf; Foni, Emanuela; Harder, Timm; Reeth, Van Kristien; Markowska-Daniel, Iwona; Reid, Scott M.; Dan, Adam; Maldonado, Jaime; Huovilainen, Anita; Billinis, Charalambos; Davidson, Irit; Agüero, Montserrat; Vila, Thaïs; Hervé, Séverine; Breum, Solvej Østergaard; Chiapponi, Chiara; Urbaniak, Kinga; Kyriakis, Constantinos S.; Brown, Ian H.; Loeffen, Willie; Meulen, Van der Karen; Schlegel, Michael; Bublot, Michel; Kellam, Paul; Watson, Simon; Lewis, Nicola S.; Pybus, Oliver G.; Webby, Richard; Chen, Hualan; Vincent, Amy L.

2014-01-01

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

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

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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

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

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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.

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

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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.

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.

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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

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

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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.

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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.

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

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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.

Risk management and post-marketing surveillance of CNS drugs.

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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.

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

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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.

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

2014-01-01

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

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

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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.

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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

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

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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.

Survey of surveillance systems and select prevention activities for hepatitis B and C, European Union/European Economic Area, 2009.

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Duffell, E F; van de Laar, M J

2015-04-02

Hepatitis B and C viral infections are leading causes of hepatic cirrhosis and cancer. The incidence and prevalence of both hepatitis B and C varies across European countries. European wide surveillance data help to understand the dynamic epidemiology of hepatitis B and C, which is important for the implementation and effectiveness of prevention and control activities.Comparison of surveillance data between countries in Europe is hampered by the differences in national healthcare and reporting systems. This report presents the results of a survey in 2009 which was undertaken to collect baseline information on surveillance systems and core prevention programmes for hepatitis B and C in individual European Union/ European Economic Area countries. The results provide key information to aid the interpretation of surveillance data, and while indicating heterogeneity in national surveillance systems and programmes, they highlight the potential of these systems. This resource has supported the implementation of a standardised European enhanced surveillance programme.

Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU

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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

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

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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.

Surveillance perspective on Lyme borreliosis across the European Union and European Economic Area.

Science.gov (United States)

van den Wijngaard, Cees C; Hofhuis, Agnetha; Simões, Mariana; Rood, Ente; van Pelt, Wilfrid; Zeller, Herve; Van Bortel, Wim

2017-07-06

Lyme borreliosis (LB) is the most prevalent tick-borne disease in Europe. Erythema migrans (EM), an early, localised skin rash, is its most common presentation. Dissemination of the bacteria can lead to more severe manifestations including skin, neurological, cardiac, musculoskeletal and ocular manifestations. Comparison of LB incidence rates in the European Union (EU)/European Economic Area (EEA) and Balkan countries are difficult in the absence of standardised surveillance and reporting procedures. We explored six surveillance scenarios for LB surveillance in the EU/EEA, based on the following key indicators: (i) erythema migrans, (ii) neuroborreliosis, (iii) all human LB manifestations, (iv) seroprevalence, (v) tick bites, and (vi) infected ticks and reservoir hosts. In our opinion, neuroborreliosis seems most feasible and useful as the standard key indicator, being one of the most frequent severe LB manifestations, with the possibility of a specific case definition. Additional surveillance with erythema migrans as key indicator would add value to the surveillance of neuroborreliosis and lead to a more complete picture of LB epidemiology in the EU/EEA. The other scenarios have less value as a basis for EU-level surveillance, but can be considered periodically and locally, as they could supply complementary insights. This article is copyright of The Authors, 2017.

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.

Surveillance and laboratory detection for non-polio enteroviruses in the European Union/European Economic Area, 2016

Science.gov (United States)

Harvala, Heli; Jasir, Aftab; Penttinen, Pasi; Pastore Celentano, Lucia; Greco, Donato; Broberg, Eeva

2017-01-01

Enteroviruses (EVs) cause severe outbreaks of respiratory and neurological disease as illustrated by EV-D68 and EV-A71 outbreaks, respectively. We have mapped European laboratory capacity for identification and characterisation of non-polio EVs to improve preparedness to respond to (re)-emerging EVs linked to severe disease. An online questionnaire on non-polio EV surveillance and laboratory detection was submitted to all 30 European Union (EU)/European Economic Area (EEA) countries. Twenty-nine countries responded; 26 conducted laboratory-based non-polio EV surveillance, and 24 included neurological infections in their surveillance. Eleven countries have established specific surveillance for EV-D68 via sentinel influenza surveillance (n = 7), typing EV-positive respiratory samples (n = 10) and/or acute flaccid paralysis surveillance (n = 5). Of 26 countries performing non-polio EV characterisation/typing, 10 further characterised culture-positive EV isolates, whereas the remainder typed PCR-positive but culture-negative samples. Although 19 countries have introduced sequence-based EV typing, seven still rely entirely on virus isolation. Based on 2015 data, six countries typed over 300 specimens mostly by sequencing, whereas 11 countries characterised under 50 EV-positive samples. EV surveillance activity varied between EU/EEA countries, and did not always specifically target patients with neurological and/or respiratory infections. Introduction of sequence-based typing methods is needed throughout the EU/EEA to enhance laboratory capacity for the detection of EVs. PMID:29162204

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

The European standard series in 9 European countries, 2002/2003 - First results of the European Surveillance System on Contact Allergies

NARCIS (Netherlands)

Uter, W; Hegewald, J; Aberer, W; Ayala, F; Bircher, AJ; Brasch, J; Coenraads, PJ; Schuttelaar, Marielouise; Elsner, P; Fartasch, M; Mahler, V.; Fortina, AB; Frosch, PJ; Fuchs, T; Johansen, JD; Menne, T; Jolanki, R; Krecisz, B; Kiec-Swierczynska, M; Larese, F; Orton, D; Peserico, A; Rantanen, T; Schnuch, A

Since January 2001, the European Surveillance System on Contact Allergies (ESSCA), supported by European Union funding (contract QLK4-CT-2001-00343), has started to collect patch-test data. This comprises a standardized clinical history and the patch-test results using the European standard series,

The European standard series in 9 European countries, 2002/2003 -- first results of the European Surveillance System on Contact Allergies

DEFF Research Database (Denmark)

Uter, W; Hegewald, J; Aberer, W

2005-01-01

Since January 2001, the European Surveillance System on Contact Allergies (ESSCA), supported by European Union funding (contract QLK4-CT-2001-00343), has started to collect patch-test data. This comprises a standardized clinical history and the patch-test results using the European standard series...... observed. The prevalence of contact allergy to Myroxylon pereirae resin (balsam of Peru) (5.8%) is coming close to the frequency found with the fragrance mix (6.4%). Regarding contact allergy to chromium compounds, different frequencies were noted in the 2 centres focused on occupational dermatitis (2......-marketing surveillance in the field of contact allergy, ESSCA will meet its objective of increased consumer safety across Europe....

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.

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.

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.

The Need for European Surveillance of CDI.

Science.gov (United States)

Wiuff, Camilla; Banks, A-Lan; Fitzpatrick, Fidelma; Cottom, Laura

2018-01-01

Since the turn of the millennium, the epidemiology of Clostridium difficile infection (CDI) has continued to challenge. Over the last decade there has been a growing awareness that improvements to surveillance are needed. The increasing rate of CDI and emergence of ribotype 027 precipitated the implementation of mandatory national surveillance of CDI in the UK. Changes in clinical presentation, severity of disease, descriptions of new risk factors and the occurrence of outbreaks all emphasised the importance of early diagnosis and surveillance.However a lack of consensus on case definitions, clinical guidelines and optimal laboratory diagnostics across Europe has lead to the underestimation of CDI and impeded comparison between countries. These inconsistencies have prevented the true burden of disease from being appreciated.Acceptance that a multi-country surveillance programme and optimised diagnostic strategies are required not only to detect and control CDI in Europe, but for a better understanding of the epidemiology, has built the foundations for a more robust, unified surveillance. The concerted efforts of the European Centre for Disease Prevention and Control (ECDC) CDI networks, has lead to the development of an over-arching long-term CDI surveillance strategy for 2014-2020. Fulfilment of the ECDC priorities and targets will no doubt be challenging and will require significant investment however the hope is that both a national and Europe-wide picture of CDI will finally be realised.

The European Gonococcal Antimicrobial Surveillance Programme (Euro-GASP)--a sentinel approach in the European Union (EU)/European Economic Area (EEA).

Science.gov (United States)

Spiteri, Gianfranco; Cole, Michelle; Unemo, Magnus; Hoffmann, Steen; Ison, Catherine; van de Laar, Marita

2013-12-01

Antimicrobial resistance in Neisseria gonorrhoeae is monitored in the European Union/European Economic Area through the European Gonococcal Antimicrobial Surveillance Programme (Euro-GASP) coordinated by the European Centre for Disease Prevention and Control. Euro-GASP includes a sentinel surveillance programme which aims to detect in a timely manner changes in resistance patterns and inform treatment guidelines. The programme aims to test a representative number of isolates from each European Union/European Economic Area member state per year for a range of therapeutically relevant antimicrobials through a biannual hybrid centralised/decentralised system. Testing is supported by an External Quality Assurance programme and a laboratory training programme. Participation in the programme has increased to 21 countries in 2012. Euro-GASP has been able to detect the rapid spread of isolates with decreased susceptibility to cefixime across Europe in 2010 and 2011. Results from the programme have informed changes in European treatment guidelines for gonorrhoea and led to the development of the 'Response plan to control and manage the threat of multidrug resistant gonorrhoea in Europe'. Future challenges for Euro-GASP include supporting countries to participate in Euro-GASP through decentralised testing, improving timeliness and epidemiological data quality, and increasing participation from Eastern Europe.

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.

Assessment of HIV molecular surveillance capacity in the European Union, 2016.

Science.gov (United States)

Keating, Patrick; Pharris, Anastasia; Leitmeyer, Katrin; De Angelis, Stefania; Wensing, Annemarie; Amato-Gauci, Andrew J; Broberg, Eeva

2017-12-01

IntroductionExpanding access to HIV antiretroviral treatment is expected to decrease HIV incidence and acquired immunodeficiency syndrome (AIDS) mortality. However, this may also result in increased HIV drug resistance (DR). Better monitoring and surveillance of HIV DR is required to inform treatment regimens and maintain the long term effectiveness of antiretroviral drugs. As there is currently no formal European Union (EU)-wide collection of HIV DR data, this study aimed to assess the current HIV molecular surveillance capacity in EU/European Economic Area (EEA) countries in order to inform the planning of HIV DR monitoring at EU level. Methods: Thirty EU/EEA countries were invited to participate in a survey on HIV molecular surveillance capacity, which also included laboratory aspects. Results: Among 21 responding countries, 13 reported using HIV sequence data (subtype and/or DR) for surveillance purposes at national level. Of those, nine stated that clinical, epidemiological and sequence data were routinely linked for analysis. Discussion/conclusion : We identified similarities between existing HIV molecular surveillance systems, but also found important challenges including human resources, data ownership and legal issues that would need to be addressed.Information on capacities should allow better planning of the phased introduction of HIV DR surveillance at EU/EEA level.

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

European human rights, criminal surveillance, and intelligence surveillance : Towards “good enough” oversight, preferably but not necessarily by judges

NARCIS (Netherlands)

Malgieri, G.; de Hert, Paul; Gray, David C.; Henderson, Stephen

2017-01-01

The two European Courts (the European Court of Human Rights, ECtHR and, to a lesser degree, the European Union Court of Justice, EUCJ) have contributed greatly to the development of a legal framework for surveillance by either law enforcement agencies in the criminal law area or by secret services.

European Surveillance System on Contact Allergies (ESSCA)

DEFF Research Database (Denmark)

Uter, W; Amario-Hita, J C; Balato, A

2017-01-01

BACKGROUND: Contact allergy is a common condition and can severely interfere with daily life or professional activities. Due to changes in exposures, such as introduction of new substances, new products or formulations and regulatory intervention, the spectrum of contact sensitization changes....... OBJECTIVE: To evaluate the current spectrum of contact allergy to allergens present in the European baseline series (EBS) across Europe. METHODS: Retrospective analysis of data collected by the European Surveillance System on Contact Allergies (ESSCA, www.essca-dc.org) in consecutively patch-tested patients......, 2013/14, in 46 departments in 12 European countries. RESULTS: Altogether, 31 689 patients were included in the analysis. Compared to a similar analysis in 2004, the prevalence of contact allergy to methylisothiazolinone went up to around 20% in several departments. In comparison, contact allergy...

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.

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

Full Text Available O objetivo do presente trabalho foi comparar e analisar os requisitos necessários para registro e as ações de tecnovigilância para implantes dentários nos EUA, na União Europeia e no Brasil. Após análise da literatura e das principais normas em vigor, observou-se a preocupação com o controle de riscos e a prevenção de falhas no uso dos implantes dentários. Nos EUA, o sistema de registro e tecnovigilância é centralizado e se verificam problemas de subnotificação e falhas na análise dos relatórios de notificação, bem como um intervalo de tempo longo entre a identificação dos problemas e a ação devido à extensão do processo administrativo. Na União Europeia, os poucos estudos identificados sugerem que o sistema regulatório oferece riscos aos pacientes devido à ausência de transparência entre os Órgãos Notificadores e à dificuldade em se articular a tecnovigilância entre os países. No Brasil, a tecnovigilância é centralizada, porém ainda é incipiente. O envelhecimento da população promove forte demanda por reabilitação oral dos pacientes, sobretudo os carentes, prevista no programa Brasil Sorridente. A demanda pelo serviço oferece uma oportunidade de expansão do mercado, mas detecta-se risco de entrada de produtos de baixa qualidade. Neste contexto, o aprimoramento das atividades de tecnovigilância de implantes dentários é necessário. -------------------------------------------------------------------------------------------- This study compared and analyzed, after reviewing the literature and the main legal regulations, the requirements for registration and the post-marketing surveillance activities of dental implants in the USA, the European Union and in Brazil. The legal regulations studied showed a concern for risk control and for prevention of failures in the use of dental implants. In the US, the system is centralized, which produces underreporting problems and flaws in the analysis of

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

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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

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.

Standardised surveillance of Clostridium difficile infection in European acute care hospitals: a pilot study, 2013.

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van Dorp, Sofie M; Kinross, Pete; Gastmeier, Petra; Behnke, Michael; Kola, Axel; Delmée, Michel; Pavelkovich, Anastasia; Mentula, Silja; Barbut, Frédéric; Hajdu, Agnes; Ingebretsen, André; Pituch, Hanna; Macovei, Ioana S; Jovanović, Milica; Wiuff, Camilla; Schmid, Daniela; Olsen, Katharina Ep; Wilcox, Mark H; Suetens, Carl; Kuijper, Ed J

2016-07-21

Clostridium difficile infection (CDI) remains poorly controlled in many European countries, of which several have not yet implemented national CDI surveillance. In 2013, experts from the European CDI Surveillance Network project and from the European Centre for Disease Prevention and Control developed a protocol with three options of CDI surveillance for acute care hospitals: a 'minimal' option (aggregated hospital data), a 'light' option (including patient data for CDI cases) and an 'enhanced' option (including microbiological data on the first 10 CDI episodes per hospital). A total of 37 hospitals in 14 European countries tested these options for a three-month period (between 13 May and 1 November 2013). All 37 hospitals successfully completed the minimal surveillance option (for 1,152 patients). Clinical data were submitted for 94% (1,078/1,152) of the patients in the light option; information on CDI origin and outcome was complete for 94% (1,016/1,078) and 98% (294/300) of the patients in the light and enhanced options, respectively. The workload of the options was 1.1, 2.0 and 3.0 person-days per 10,000 hospital discharges, respectively. Enhanced surveillance was tested and was successful in 32 of the hospitals, showing that C. difficile PCR ribotype 027 was predominant (30% (79/267)). This study showed that standardised multicountry surveillance, with the option of integrating clinical and molecular data, is a feasible strategy for monitoring CDI in Europe. This article is copyright of The Authors, 2016.

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

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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.

Vector-borne disease surveillance in livestock populations: a critical review of literature recommendations and implemented surveillance (BTV-8) in five European countries

DEFF Research Database (Denmark)

Dórea, Fernanda C.; Elbers, Armin R.W.; Hendrikx, Pascal

2016-01-01

Preparedness against vector-borne threats depends on the existence of a long-term, sustainable surveillance of vector-borne disease and their relevant vectors. This work reviewed the availability of such surveillance systems in five European countries (Denmark, France, The Netherlands, Sweden and...

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

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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.

Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

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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

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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

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...

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

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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.

European surveillance network for influenza in pigs 3 (ESNIP 3)

DEFF Research Database (Denmark)

Simon, G.; Reid, S. M.; Larsen, Lars Erik

and seeks to strengthen formal interactions with human and avian surveillance networks. Materials and Methods: The project consortium comprises 24 participants, contributing a variety of specialism’s and skills ensuring multi-disciplinary cutting-edge outputs. Most partners are actively working with swine...... influenza virus (SIV) experimentally and in the field. Three work packages aim to increase knowledge of the epidemiology and evolution of SIV in European pigs to inform changes in disease trends and variation in contemporary viruses through organised field surveillance programmes. Results: An inventory...... of the programmes that are currently active in fifteen of the partners showed that passive surveillance was primarily used. Detected virus strains will be characterised by antigenic cartography (informing better evidence-based approaches for selection of vaccine strains) and genetically through full genome...

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

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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.

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

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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.

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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.

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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.

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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.

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

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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.

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

DEFF Research Database (Denmark)

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

2014-01-01

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

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

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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.

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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.

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.

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.

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.

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

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.

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.

Surveillance for European bat lyssavirus in Swiss bats.

Science.gov (United States)

Megali, A; Yannic, G; Zahno, M-L; Brügger, D; Bertoni, G; Christe, P; Zanoni, R

2010-10-01

Most countries in Western Europe are currently free of rabies in terrestrial mammals. Nevertheless, rabies remains a residual risk to public health due to the natural circulation of bat-specific viruses, such as European bat lyssaviruses (EBLVs). European bat lyssavirus types 1 and 2 (EBLV-1 and EBLV-2) are widely distributed throughout Europe, but little is known of their true prevalence and epidemiology. We report that only three out of 837 brains taken from bats submitted to the Swiss Rabies Centre between 1976 and 2009 were found by immunofluorescence (FAT) to be positive for EBLVs. All three positive cases were in Myotis daubentoni, from 1992, 1993 and 2002. In addition to this passive surveillance, we undertook a targeted survey in 2009, aimed at detecting lyssaviruses in live bats in Switzerland. A total of 237 bats of the species M. daubentoni, Myotis myotis, Eptesicus serotinus and Nyctalus noctula were captured at different sites in western Switzerland. Oropharyngeal swabs and blood from each individual were analysed by RT-PCR and rapid fluorescent focus inhibition test (RFFIT), respectively. RNA corresponding to EBLV-2 was detected from oropharyngeal swabs of a single M. daubentoni bat, but no infectious virus was found. Molecular phylogenetic analysis revealed that the corresponding sequence was closely related to the other EBLV-2 sequences identified in previous rabies isolates from Swiss bats (particularly to that found at Geneva in 2002). Three M. daubentoni bats were found to be seropositive by RFFIT. In conclusion, even though the prevalence is low in Switzerland, continuous management and surveillance are required to assess the potential risk to public health.

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).

Gonorrhoea and gonococcal antimicrobial resistance surveillance networks in the WHO European Region, including the independent countries of the former Soviet Union.

Science.gov (United States)

Unemo, Magnus; Ison, Catherine A; Cole, Michelle; Spiteri, Gianfranco; van de Laar, Marita; Khotenashvili, Lali

2013-12-01

Antimicrobial resistance (AMR) in Neisseria gonorrhoeae has emerged for essentially all antimicrobials following their introduction into clinical practice. During the latest decade, susceptibility to the last remaining options for antimicrobial monotherapy, the extended-spectrum cephalosporins (ESC), has markedly decreased internationally and treatment failures with these ESCs have been verified. In response to this developing situation, WHO and the European Centre for Disease Prevention and Control (ECDC) have published global and region-specific response plans, respectively. One main component of these action/response plans is to enhance the surveillance of AMR and treatment failures. This paper describes the perspectives from the diverse WHO European Region (53 countries), including the independent countries of the former Soviet Union, regarding gonococcal AMR surveillance networks. The WHO European Region has a high prevalence of resistance to all previously recommended antimicrobials, and most of the first strictly verified treatment failures with cefixime and ceftriaxone were also reported from Europe. In the European Union/European Economic Area (EU/EEA), the European gonococcal antimicrobial surveillance programme (Euro-GASP) funded by the ECDC is running. In 2011, the Euro-GASP included 21/31 (68%) EU/EEA countries, and the programme is further strengthened annually. However, in the non-EU/EEA countries, internationally reported and quality assured gonococcal AMR data are lacking in 87% of the countries and, worryingly, appropriate support for establishment of a GASP is still lacking. Accordingly, national and international support, including political and financial commitment, for gonococcal AMR surveillance in the non-EU/EEA countries of the WHO European Region is essential.

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

Community incidence of pathogen-specific gastroenteritis: reconstructing the surveillance pyramid for seven pathogens in seven European Union member states

DEFF Research Database (Denmark)

Haagsma, J. A.; Geenen, P. L.; Ethelberg, S.

2013-01-01

By building reconstruction models for a case of gastroenteritis in the general population moving through different steps of the surveillance pyramid we estimated that millions of illnesses occur annually in the European population, leading to thousands of hospitalizations. We used data on the hea......By building reconstruction models for a case of gastroenteritis in the general population moving through different steps of the surveillance pyramid we estimated that millions of illnesses occur annually in the European population, leading to thousands of hospitalizations. We used data...

[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.

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

NARCIS (Netherlands)

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

Background European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than I million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for

[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.

The EUVAC-NET survey: national pertussis surveillance systems in the European Union, Switzerland, Norway, and Iceland.

Science.gov (United States)

Schmidt, J E; Tozzi, A E; Rava, L; Glismann, S

2001-06-01

A questionnaire was mailed out to member states of the European Union (EU) plus Switzerland, Norway, and Iceland, to inquire about the type of information routinely recorded in national pertussis surveillance systems. Information was requested on surveillance methods, type of information recorded for cases of pertussis, vaccination schedule, type of vaccine used, and methods for estimating vaccination coverage. Local surveillance methods, vaccination strategies, and methods to estimate vaccination coverage were found to differ widely across the participating countries. The results of the questionnaire survey show, however, that there are comparable subsets of variables common to many countries. Future activities of the EUVAC-NET project will include defining the homogeneous elements in national systems and to group appropriately those countries with common surveillance features.

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.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

Science.gov (United States)

Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

2011-07-01

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

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

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.

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

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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.

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

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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.

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

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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.

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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].

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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.

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

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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.

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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

Infectious diseases prioritisation for event-based surveillance at the European Union level for the 2012 Olympic and Paralympic Games.

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Economopoulou, A; Kinross, P; Domanovic, D; Coulombier, D

2014-04-17

In 2012, London hosted the Olympic and Paralympic Games (the Games), with events occurring throughout the United Kingdom (UK) between 27 July and 9 September 2012. Public health surveillance was performed by the Health Protection Agency (HPA). Collaboration between the HPA and the European Centre for Disease Prevention and Control (ECDC) was established for the detection and assessment of significant infectious disease events (SIDEs) occurring outside the UK during the time of the Games. Additionally, ECDC undertook an internal prioritisation exercise to facilitate ECDC’s decisions on which SIDEs should have preferentially enhanced monitoring through epidemic intelligence activities for detection and reporting in daily surveillance in the European Union (EU). A team of ECDC experts evaluated potential public health risks to the Games, selecting and prioritising SIDEs for event-based surveillance with regard to their potential for importation to the Games, occurrence during the Games or export to the EU/European Economic Area from the Games. The team opted for a multilevel approach including comprehensive disease selection, development and use of a qualitative matrix scoring system and a Delphi method for disease prioritisation. The experts selected 71 infectious diseases to enter the prioritisation exercise of which 27 were considered as priority for epidemic intelligence activities by ECDC for the EU for the Games.

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

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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.

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

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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.

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

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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.

Molecular surveillance of measles and rubella in the WHO European Region: new challenges in the elimination phase.

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Santibanez, S; Hübschen, J M; Ben Mamou, M C; Muscat, M; Brown, K E; Myers, R; Donoso Mantke, O; Zeichhardt, H; Brockmann, D; Shulga, S V; Muller, C P; O'Connor, P M; Mulders, M N; Mankertz, A

2017-08-01

The WHO European Region (EUR) has adopted the goal of eliminating measles and rubella but individual countries perform differently in achieving this goal. Measles virus spread across the EUR by mobile groups has recently led to large outbreaks in the insufficiently vaccinated resident population. As an instrument for monitoring the elimination process and verifying the interruption of endemic virus transmission, molecular surveillance has to provide valid and representative data. Irrespective of the country's specific situation, it is required to ensure the functionality of the laboratory surveillance that is supported by the WHO Global Measles and Rubella Laboratory Network. To investigate whether the molecular surveillance in the EUR is adequate for the challenges in the elimination phase, we addressed the quality assurance of molecular data, the continuity and intensity of molecular monitoring, and the analysis of transmission chains. Published articles, the molecular External Quality Assessment Programme of the WHO, the Centralized Information System for Infectious Diseases of the WHO EUR and the WHO Measles and Rubella Nucleotide Surveillance databases served as information sources. Molecular proficiency testing conducted by the WHO in 2016 has shown that the expertise for measles and rubella virus genotyping exists in all parts of the EUR. The analysis of surveillance data reported nationally to the WHO in 2013-2016 has revealed some countries with outbreaks but not sufficiently representative molecular data. Long-lasting supranational MV transmission chains were identified. A more systematic molecular monitoring and recording of the transmission pattern for the whole EUR could help to create a meaningful picture of the elimination process. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Survey of Clostridium difficile infection surveillance systems in Europe, 2011.

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Kola, Axel; Wiuff, Camilla; Akerlund, Thomas; van Benthem, Birgit H; Coignard, Bruno; Lyytikäinen, Outi; Weitzel-Kage, Doris; Suetens, Carl; Wilcox, Mark H; Kuijper, Ed J; Gastmeier, Petra

2016-07-21

To develop a European surveillance protocol for Clostridium difficile infection (CDI), existing national CDI surveillance systems were assessed in 2011. A web-based electronic form was provided for all national coordinators of the European CDI Surveillance Network (ECDIS-Net). Of 35 national coordinators approached, 33 from 31 European countries replied. Surveillance of CDI was in place in 14 of the 31 countries, comprising 18 different nationwide systems. Three of 14 countries with CDI surveillance used public health notification of cases as the route of reporting, and in another three, reporting was limited to public health notification of cases of severe CDI. The CDI definitions published by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the European Centre for Disease Prevention and Control (ECDC) were widely used, but there were differing definitions to distinguish between community- and healthcare-associated cases. All CDI surveillance systems except one reported annual national CDI rates (calculated as number of cases per patient-days). Only four surveillance systems regularly integrated microbiological data (typing and susceptibility testing results). Surveillance methods varied considerably between countries, which emphasises the need for a harmonised European protocol to allow consistent monitoring of the CDI epidemiology at European level. The results of this survey were used to develop a harmonised EU-wide hospital-based CDI surveillance protocol. This article is copyright of The Authors, 2016.

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

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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.

Zonisamide and renal calculi in patients with epilepsy: how big an issue?

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Wroe, Stephen

2007-08-01

To determine the prevalence of renal calculi in patients treated with zonisamide during randomized, controlled and open-label clinical trials, and from post-marketing surveillance data. Reports of renal calculi from four placebo-controlled double-blind trials of zonisamide, their long-term open-label treatment extension phases, and the US/European zonisamide clinical trial programme were reviewed. One double-blind study and its extension included routine ultrasound screening to identify asymptomatic calculi. Post-marketing surveillance data were also investigated, as was concomitant treatment with topiramate. No symptomatic renal calculi were reported during four randomized double-blind, placebo-controlled trials involving 848 subjects (including 498 zonisamide recipients) treated for up to 3 months. In long-term extension studies with treatment for up to 24 months, symptomatic renal calculi were reported in 9/626 (1.4%) patients. Pooled safety data from all US/European clinical trials identified 15/1296 (1.2%) patients with symptomatic renal calculi during treatment for up to 8.7 years. Post-marketing surveillance revealed nine cases from 59 667 patient-years of exposure in the USA, and 14 from 709 294 patient-years of exposure in Japan; only one case occurred during concomitant topiramate and zonisamide treatment. No imbalance in electrolyte levels was found from 35 patients receiving such co-treatment in clinical trials. The available data suggest that the risk of developing renal calculi during zonisamide treatment is low. Data are insufficient to determine whether concomitant treatment with topiramate increases the risk of renal stones.

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.

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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.

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

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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.

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

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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.

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

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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

Reliable surveillance of tick-borne encephalitis in European countries is necessary to improve the quality of vaccine recommendations.

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Stefanoff, Pawel; Polkowska, Aleksandra; Giambi, Cristina; Levy-Bruhl, Daniel; O'Flanagan, Darina; Dematte, Luca; Lopalco, Pier Luigi; Mereckiene, Jolita; Johansen, Kari; D'Ancona, Fortunato

2011-02-01

In July-November 2009, 26 European Union (EU) Member States (MSs), Norway and Iceland, participated in a survey seeking information on national tick-borne encephalitis (TBE) vaccination recommendations. Information on TBE surveillance, methods used to ascertain endemic areas, vaccination recommendations, vaccine coverage and methods of monitoring of vaccine coverage were obtained. Sixteen countries (57%) reported presence of TBE endemic areas on their territory. Vaccination against TBE was recommended for the general population in 8 (28%) countries, for occupational risk groups - in 13 (46%) countries, and for tourists going abroad - in 22 (78%) countries. Although vaccination recommendations for country residents, and for tourists always referred to endemic areas, there was no uniform, standardized method used to define endemic areas. For this reason, clear recommendations for tourists need to be developed, and standardized surveillance directed to efficient assessment of TBE risk need to be implemented in European countries. Copyright © 2010 Elsevier Ltd. All rights reserved.

[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.

Community incidence of pathogen-specific gastroenteritis: reconstructing the surveillance pyramid for seven pathogens in seven European Union member states.

Science.gov (United States)

Haagsma, J A; Geenen, P L; Ethelberg, S; Fetsch, A; Hansdotter, F; Jansen, A; Korsgaard, H; O'Brien, S J; Scavia, G; Spitznagel, H; Stefanoff, P; Tam, C C; Havelaar, A H

2013-08-01

By building reconstruction models for a case of gastroenteritis in the general population moving through different steps of the surveillance pyramid we estimated that millions of illnesses occur annually in the European population, leading to thousands of hospitalizations. We used data on the healthcare system in seven European Union member states in relation to pathogen characteristics that influence healthcare seeking. Data on healthcare usage were obtained by harmonized cross-sectional surveys. The degree of under-diagnosis and underreporting varied by pathogen and country. Overall, underreporting and under-diagnosis were estimated to be lowest for Germany and Sweden, followed by Denmark, The Netherlands, UK, Italy and Poland. Across all countries, the incidence rate was highest for Campylobacter spp. and Salmonella spp. Incidence estimates resulting from the pyramid reconstruction approach are adjusted for biases due to different surveillance systems and are therefore a better basis for international comparisons than reported data.

WHO European Childhood Obesity Surveillance Initiative 2008: weight, height and body mass index in 6-9-year-old children.

LENUS (Irish Health Repository)

Wijnhoven, T M A

2012-09-21

What is already known about this subject Overweight and obesity prevalence estimates among children based on International Obesity Task Force definitions are substantially lower than estimates based on World Health Organization definitions. Presence of a north-south gradient with the highest level of overweight found in southern European countries. Intercountry comparisons of overweight and obesity in primary-school children in Europe based on measured data lack a similar data collection protocol. What this study adds Unique dataset on overweight and obesity based on measured weights and heights in 6-9-year-old children from 12 European countries using a harmonized surveillance methodology. Because of the use of a consistent data collection protocol, it is possible to perform valid multiple comparisons between countries. It demonstrates wide variations in overweight and obesity prevalence estimates among primary-school children between European countries and regions. BACKGROUND: Nutritional surveillance in school-age children, using measured weight and height, is not common in the European Region of the World Health Organization (WHO). The WHO Regional Office for Europe has therefore initiated the WHO European Childhood Obesity Surveillance Initiative. OBJECTIVE: To present the anthropometric results of data collected in 2007\\/2008 and to investigate whether there exist differences across countries and between the sexes. METHODS: Weight and height were measured in 6-9-year-old children in 12 countries. Prevalence of overweight, obesity, stunting, thinness and underweight as well as mean Z-scores of anthropometric indices of height, weight and body mass index were calculated. RESULTS: A total of 168 832 children were included in the analyses and a school participation rate of more than 95% was obtained in 8 out of 12 countries. Stunting, underweight and thinness were rarely prevalent. However, 19.3-49.0% of boys and 18.4-42.5% of girls were overweight (including

Socioeconomic inequalities in childhood overweight: heterogeneity across five countries in the WHO European Childhood Obesity Surveillance Initiative (COSI-2008).

Science.gov (United States)

Lissner, L; Wijnhoven, T M A; Mehlig, K; Sjöberg, A; Kunesova, M; Yngve, A; Petrauskiene, A; Duleva, V; Rito, A I; Breda, J

2016-05-01

Excess risk of childhood overweight and obesity occurring in socioeconomically disadvantaged families has been demonstrated in numerous studies from high-income regions, including Europe. It is well known that socioeconomic characteristics such as parental education, income and occupation are etiologically relevant to childhood obesity. However, in the pan-European setting, there is reason to believe that inequalities in childhood weight status may vary among countries as a function of differing degrees of socioeconomic development and equity. In this cross-sectional study, we have examined socioeconomic differences in childhood obesity in different parts of the European region using nationally representative data from Bulgaria, the Czech Republic, Lithuania, Portugal and Sweden that were collected in 2008 during the first round of the World Health Organization (WHO) European Childhood Obesity Surveillance Initiative. Heterogeneity in the association between parental socioeconomic indicators and childhood overweight or obesity was clearly observed across the five countries studied. Positive as well as negative associations were observed between parental socioeconomic indicators and childhood overweight, with statistically significant interactions between country and parental indicators. These findings have public health implications for the WHO European Region and underscore the necessity to continue documenting socioeconomic inequalities in obesity in all countries through international surveillance efforts in countries with diverse geographic, social and economic environments. This is a prerequisite for universal as well as targeted preventive actions.

Contact allergy to ingredients of topical medications : results of the European Surveillance System on Contact Allergies (ESSCA), 2009-2012

NARCIS (Netherlands)

Uter, Wolfgang; Spiewak, Radoslaw; Cooper, Susan M.; Wilkinson, Mark; Sanchez Perez, Javier; Schnuch, Axel; Schuttelaar, Marie-Louise

2016-01-01

PurposeThe aim of this study was to give an overview of the prevalence of contact allergy to active ingredients and excipients of topical medications across Europe. MethodsRetrospective analysis of data collected by the European Surveillance System on Contact Allergies () with substances applied to

[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

Survey on the Use of Whole-Genome Sequencing for Infectious Diseases Surveillance: Rapid Expansion of European National Capacities, 2015–2016

Directory of Open Access Journals (Sweden)

Joana Revez

2017-12-01

Full Text Available Whole-genome sequencing (WGS has become an essential tool for public health surveillance and molecular epidemiology of infectious diseases and antimicrobial drug resistance. It provides precise geographical delineation of spread and enables incidence monitoring of pathogens at genotype level. Coupled with epidemiological and environmental investigations, it delivers ultimate resolution for tracing sources of epidemic infections. To ascertain the level of implementation of WGS-based typing for national public health surveillance and investigation of prioritized diseases in the European Union (EU/European Economic Area (EEA, two surveys were conducted in 2015 and 2016. The surveys were designed to determine the national public health reference laboratories’ access to WGS and operational WGS-based typing capacity for national surveillance of selected foodborne pathogens, antimicrobial-resistant pathogens, and vaccine-preventable diseases identified as priorities for European genomic surveillance. Twenty-eight and twenty-nine out of the 30 EU/EEA countries participated in the survey in 2015 and 2016, respectively. National public health reference laboratories in 22 and 25 countries had access to WGS-based typing for public health applications in 2015 and 2016, respectively. Reported reasons for limited or no access were lack of funding, staff, and expertise. Illumina technology was the most frequently used followed by Ion Torrent technology. The access to bioinformatics expertise and competence for routine WGS data analysis was limited. By mid-2016, half of the EU/EEA countries were using WGS analysis either as first- or second-line typing method for surveillance of the pathogens and antibiotic resistance issues identified as EU priorities. The sampling frame as well as bioinformatics analysis varied by pathogen/resistance issue and country. Core genome multilocus allelic profiling, also called cgMLST, was the most frequently used annotation

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.

Guidelines for surveillance of individuals with constitutional mismatch repair-deficiency proposed by the European Consortium "Care for CMMR-D" (C4CMMR-D).

Science.gov (United States)

Vasen, H F A; Ghorbanoghli, Z; Bourdeaut, F; Cabaret, O; Caron, O; Duval, A; Entz-Werle, N; Goldberg, Y; Ilencikova, D; Kratz, C P; Lavoine, N; Loeffen, J; Menko, F H; Muleris, M; Sebille, G; Colas, C; Burkhardt, B; Brugieres, L; Wimmer, K

2014-05-01

Lynch syndrome (LS) is an autosomal dominant disorder caused by a defect in one of the DNA mismatch repair genes: MLH1, MSH2, MSH6 and PMS2. In the last 15 years, an increasing number of patients have been described with biallelic mismatch repair gene mutations causing a syndrome referred to as 'constitutional mismatch repair-deficiency' (CMMR-D). The spectrum of cancers observed in this syndrome differs from that found in LS, as about half develop brain tumours, around half develop digestive tract cancers and a third develop haematological malignancies. Brain tumours and haematological malignancies are mainly diagnosed in the first decade of life, and colorectal cancer (CRC) and small bowel cancer in the second and third decades of life. Surveillance for CRC in patients with LS is very effective. Therefore, an important question is whether surveillance for the most common CMMR-D-associated cancers will also be effective. Recently, a new European consortium was established with the aim of improving care for patients with CMMR-D. At a workshop of this group held in Paris in June 2013, one of the issues addressed was the development of surveillance guidelines. In 1968, criteria were proposed by WHO that should be met prior to the implementation of screening programmes. These criteria were used to assess surveillance in CMMR-D. The evaluation showed that surveillance for CRC is the only part of the programme that largely complies with the WHO criteria. The values of all other suggested screening protocols are unknown. In particular, it is questionable whether surveillance for haematological malignancies improves the already favourable outcome for patients with these tumours. Based on the available knowledge and the discussions at the workshop, the European consortium proposed a surveillance protocol. Prospective collection of all results of the surveillance is needed to evaluate the effectiveness of the programme.

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.

Future directions for the European influenza reference laboratory network in influenza surveillance.

Science.gov (United States)

Goddard, N; Rebelo-de-Andrade, H; Meijer, A; McCauley, J; Daniels, R; Zambon, M

2015-07-30

By defining strategic objectives for the network of influenza laboratories that have national influenza centre status or national function within European Union Member States, Iceland and Norway, it is possible to align their priorities in undertaking virological surveillance of influenza. This will help maintain and develop the network to meet and adapt to new challenges over the next 3-5 years and underpin a longer-term strategy over 5-10 years. We analysed the key activities undertaken by influenza reference laboratories in Europe and categorised them into a framework of four key strategic objectives areas: enhancing laboratory capability, ensuring laboratory capacity, providing emergency response and translating laboratory data into information for public health action. We make recommendations on the priority areas for future development.

Cybersecurity in European Union and In Mercosur: Big Data and Surveillance Versus Privacy and Data Protection On the Internet

Directory of Open Access Journals (Sweden)

Rafaela Bolson Dalla Favera

2016-12-01

Full Text Available This paper aims to discuss the surveillance practices, with the help of big data, especially after the revelations of Edward Snowden in 2013. It aims to analyze the acting of European Union in relation to the cybersecurity, besides to expose and discuss any existing strategies in Mercosur to face these problems, which will culminate with the analysis of the Internet Civil Mark in Brazil. It was found the need for the same block members act of transnational and cooperative manner, as recommended by the European Union Policies, betting on collaborative cybersecurity strategies, in favor of human and fundamental rights.

Characteristics of patients patch tested in the European Surveillance System on Contact Allergies (ESSCA) network, 2009-2012

DEFF Research Database (Denmark)

Uter, Wolfgang; Gefeller, Olaf; Giménez-Arnau, Ana

2015-01-01

from 63 530 consultations collected by 53 departments from 12 countries participating in the European Surveillance System on Contact Allergies (ESSCA) ( www.essca-dc.org) between 2009 and 2012. RESULTS: Considerable variation in the prevalence of the MOAHLFA factors between departments was found...... one department per country give valuable insights into the spectrum of contact allergy prevalence rates in that country, but are not as representative as national data pooled from several departments....

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.

[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.

Indicators of alcohol consumption and attributable harm for monitoring and surveillance in European Union countries.

Science.gov (United States)

Rehm, Jürgen; Scafato, Emanuele

2011-03-01

Alcohol is a major risk factor for burden of disease and injury in Europe, and contributes markedly to between region differences in life expectancy. Monitoring and surveillance systems have shown to be a key factor in implementing effective policies. The aim of this paper is to propose a system of indicators for alcohol consumption and attributable harm which can be used as an over-time monitoring tool at the country level as well as for comparisons between countries. A systematic research in electronic data bases was conducted but most of the information was derived from ongoing international efforts to establish alcohol monitoring and surveillance systems. European Union. Countries. Exposure to alcohol, mortality, burden of disease. Adult per capita alcohol consumption, prevalence of abstention, and frequency of drinking more than 60 g pure alcohol in one occasion are proposed as a minimal set of alcohol exposure indicators, which can quickly be implemented in all EU countries. With respect to health harm indicators, the best minimal choice which can be implemented quickly in all countries of the EU would be alcohol-attributable years of life lost due to premature death. In addition, country specific indicators could be added, when alcohol places specific burden on specific diseases. National and European Union-wide monitoring systems for alcohol exposure and attributable harm to inform public health-related policy decisions could be implemented easily. The establishement of such monitoring systems would follow the recent World Assembly resolution for a global strategy to reduce alcohol-related harm. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

The European Narcolepsy Network (EU-NN) database

DEFF Research Database (Denmark)

Khatami, Ramin; Luca, Gianina; Baumann, Christian R

2016-01-01

Narcolepsy with cataplexy is a rare disease with an estimated prevalence of 0.02% in European populations. Narcolepsy shares many features of rare disorders, in particular the lack of awareness of the disease with serious consequences for healthcare supply. Similar to other rare diseases, only a ......, identification of post-marketing medication side-effects, and will contribute to improve clinical trial designs and provide facilities to further develop phase III trials....... Narcolepsy Network is introduced. The database structure, standardization of data acquisition and quality control procedures are described, and an overview provided of the first 1079 patients from 18 European specialized centres. Due to its standardization this continuously increasing data pool is most...

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

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

Surveillance of Food- and Smear-Transmitted Pathogens in European Soldiers with Diarrhea on Deployment in the Tropics: Experience from the European Union Training Mission (EUTM Mali

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Hagen Frickmann

2015-01-01

Full Text Available Introduction. Since 2013, European soldiers have been deployed on the European Union Training Mission (EUTM in Mali. From the beginning, diarrhea has been among the most “urgent” concerns. Diarrhea surveillance based on deployable real-time PCR equipment was conducted between December 2013 and August 2014. Material and Methods. In total, 53 stool samples were obtained from 51 soldiers with acute diarrhea. Multiplex PCR panels comprised enteroinvasive bacteria, diarrhea-associated Escherichia coli (EPEC, ETEC, EAEC, and EIEC, enteropathogenic viruses, and protozoa. Noroviruses were characterized by sequencing. Cultural screening for Enterobacteriaceae with extended-spectrum beta-lactamases (ESBL with subsequent repetitive sequence-based PCR (rep-PCR typing was performed. Clinical information was assessed. Results. Positive PCR results for diarrhea-associated pathogens were detected in 43/53 samples, comprising EPEC (n=21, ETEC (n=19, EAEC (n=15, Norovirus (n=10, Shigella spp./EIEC (n=6, Cryptosporidium parvum (n=3, Giardia duodenalis (n=2, Salmonella spp. (n=1, Astrovirus (n=1, Rotavirus (n=1, and Sapovirus (n=1. ESBL-positive Enterobacteriaceae were grown from 13 out of 48 samples. Simultaneous infections with several enteropathogenic agents were observed in 23 instances. Symptoms were mild to moderate. There were hints of autochthonous transmission. Conclusions. Multiplex real-time PCR proved to be suitable for diarrhea surveillance on deployment. Etiological attribution is challenging in cases of detection of multiple pathogens.

European Surveillance of Antimicrobial Consumption (ESAC): outpatient penicillin use in Europe (1997-2009).

Science.gov (United States)

Versporten, Ann; Coenen, Samuel; Adriaenssens, Niels; Muller, Arno; Minalu, Girma; Faes, Christel; Vankerckhoven, Vanessa; Aerts, Marc; Hens, Niel; Molenberghs, Geert; Goossens, Herman

2011-12-01

Data on 13 years (1997-2009) of outpatient penicillin use were collected from 33 European countries within the European Surveillance of Antimicrobial Consumption (ESAC) project and analysed in detail. For the period 1997-2009, data on outpatient use of systemic penicillins aggregated at the level of the active substance were collected using the Anatomical Therapeutic Chemical (ATC)/defined daily dose (DDD) method (WHO, version 2011) and expressed in DDD per 1000 inhabitants per day (DID). For detailed analysis of trends over time, seasonal variation and composition of outpatient penicillin use in 33 European countries, we distinguished between narrow-spectrum penicillins (NSP), broad-spectrum penicillins (BSP), penicillinase-resistant penicillins (PRP) and combinations with β-lactamase inhibitors (COP). Total outpatient penicillin (ATC group J01C) use in 2009 varied by a factor of 3.8 between the countries with the highest (16.08 DID in France) and lowest (4.23 DID in the Russian Federation) use. COP represented 45.8%, BSP 40.7%, NSP 10.8% and PRP 2.6% of total European outpatient penicillin use. Total outpatient penicillin use significantly increased over time by 1.53 (SD 0.71) DID between 1997 and 2009. COP (mainly co-amoxiclav) increased by 2.17 (SD 0.40) DID, which was the result of its absolute increase as well as the observed shift from NSP and BSP towards COP. This increase exceeded 10% in 20 countries, where it coincided with a similar decrease in either BSP (15 countries) or NSP (5 countries). Penicillins represented the most widely used antibiotic subgroup in all 33 participating countries, albeit with considerable variation in their use patterns. For Europe, a continuous increase in overall penicillin use and of COP use was observed during the period 1997-2009.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

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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.

[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.

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.

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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?

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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].

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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.

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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].

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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.

[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

Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US

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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

European active surveillance study of women taking HRT (EURAS-HRT: study protocol [NCT00214903

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Heinemann Lothar AJ

2006-01-01

Full Text Available Abstract Background The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor. Methods/design The primary objective of the study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes - in particular venous and arterial thromboembolism - and other serious adverse events (SAEs in new HRT users over a period of several years. One product under surveillance is Angeliq®, which contains the novel progestagen drospirenone (DRSP combined with estradiol. In addition, all other oral combined HRT products with a novel progestagen or estrogen that will be newly marketed during the study period will be studied. These new HRT products will be compared with established HRT products. The combined cohort will include at least 30,000 women recruited in several European countries. At least 90,000 years of observation are expected from the field work which started in early 2002 and will end around 2008. The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes occurring during the observational period will be evaluated. Discussion A complete lifetime medical history, individually validated SAEs over time, and a low loss to follow-up rate are essential for a robust safety assessment. Therefore

Influenza surveillance

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Karolina Bednarska

2016-04-01

Full Text Available Influenza surveillance was established in 1947. From this moment WHO (World Health Organization has been coordinating international cooperation, with a goal of monitoring influenza virus activity, effective diagnostic of the circulating viruses and informing society about epidemics or pandemics, as well as about emergence of new subtypes of influenza virus type A. Influenza surveillance is an important task, because it enables people to prepare themselves for battle with the virus that is constantly mutating, what leads to circulation of new and often more virulent strains of influenza in human population. As vaccination is the most effective method of fighting the virus, one of the major tasks of GISRS is developing an optimal antigenic composition of the vaccine for the current epidemic season. European Influenza Surveillance Network (EISN has also developed over the years. EISN is running integrated epidemiological and virological influenza surveillance, to provide appropriate data to public health experts in member countries, to enable them undertaking relevant activities based on the current information about influenza activity. In close cooperation with GISRS and EISN are National Influenza Centres - national institutions designated by the Ministry of Health in each country.

Priorities for antibiotic resistance surveillance in Europe

DEFF Research Database (Denmark)

Fluit, A. C.; van der Bruggen, J. T.; Aarestrup, Frank Møller

2006-01-01

Antibiotic resistance is an increasing global problem. Surveillance studies are needed to monitor resistance development, to guide local empirical therapy, and to implement timely and adequate countermeasures. To achieve this, surveillance studies must have standardised methodologies, be longitud......Antibiotic resistance is an increasing global problem. Surveillance studies are needed to monitor resistance development, to guide local empirical therapy, and to implement timely and adequate countermeasures. To achieve this, surveillance studies must have standardised methodologies...... to the various reservoirs of antibiotic-resistant bacteria, such as hospitalised patients, nursing homes, the community, animals and food. Two studies that could serve as examples of tailored programmes are the European Antimicrobial Resistance Surveillance System (EARSS), which collects resistance data during...... of antibiotic resistance....

Cybersecurity in European Union and In Mercosur: Big Data and Surveillance Versus Privacy and Data Protection On the Internet

OpenAIRE

Favera, Rafaela Bolson Dalla; Silva, Rosane Leal da

2016-01-01

This paper aims to discuss the surveillance practices, with the help of big data, especially after the revelations of Edward Snowden in 2013. It aims to analyze the acting of European Union in relation to the cybersecurity, besides to expose and discuss any existing strategies in Mercosur to face these problems, which will culminate with the analysis of the Internet Civil Mark in Brazil. It was found the need for the same block members act of transnational and cooperative manner, as recommend...

Meeting the International Health Regulations (2005) surveillance core capacity requirements at the subnational level in Europe

DEFF Research Database (Denmark)

Ziemann, Alexandra; Rosenkötter, Nicole; Riesgo, Luis Garcia-Castrillo

2015-01-01

BACKGROUND: The revised World Health Organization's International Health Regulations (2005) request a timely and all-hazard approach towards surveillance, especially at the subnational level. We discuss three questions of syndromic surveillance application in the European context for assessing...... public health emergencies of international concern: (i) can syndromic surveillance support countries, especially the subnational level, to meet the International Health Regulations (2005) core surveillance capacity requirements, (ii) are European syndromic surveillance systems comparable to enable cross...... effect of different types of public health emergencies in a timely manner as required by the International Health Regulations (2005)....

[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.

Mapping HIV/STI behavioural surveillance in Europe

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Lert France

2010-10-01

Full Text Available Abstract Background Used in conjunction with biological surveillance, behavioural surveillance provides data allowing for a more precise definition of HIV/STI prevention strategies. In 2008, mapping of behavioural surveillance in EU/EFTA countries was performed on behalf of the European Centre for Disease prevention and Control. Method Nine questionnaires were sent to all 31 member States and EEE/EFTA countries requesting data on the overall behavioural and second generation surveillance system and on surveillance in the general population, youth, men having sex with men (MSM, injecting drug users (IDU, sex workers (SW, migrants, people living with HIV/AIDS (PLWHA, and sexually transmitted infection (STI clinics patients. Requested data included information on system organisation (e.g. sustainability, funding, institutionalisation, topics covered in surveys and main indicators. Results Twenty-eight of the 31 countries contacted supplied data. Sixteen countries reported an established behavioural surveillance system, and 13 a second generation surveillance system (combination of biological surveillance of HIV/AIDS and STI with behavioural surveillance. There were wide differences as regards the year of survey initiation, number of populations surveyed, data collection methods used, organisation of surveillance and coordination with biological surveillance. The populations most regularly surveyed are the general population, youth, MSM and IDU. SW, patients of STI clinics and PLWHA are surveyed less regularly and in only a small number of countries, and few countries have undertaken behavioural surveys among migrant or ethnic minorities populations. In many cases, the identification of populations with risk behaviour and the selection of populations to be included in a BS system have not been formally conducted, or are incomplete. Topics most frequently covered are similar across countries, although many different indicators are used. In most

Antifungal therapy in European hospitals

DEFF Research Database (Denmark)

Zarb, P; Amadeo, B; Muller, A

2012-01-01

The study aimed to identify targets for quality improvement in antifungal use in European hospitals and determine the variability of such prescribing. Hospitals that participated in the European Surveillance of Antimicrobial Consumption Point Prevalence Surveys (ESAC-PPS) were included. The WHO...

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

Active animal health surveillance in European Union Member States: gaps and opportunities.

Science.gov (United States)

Bisdorff, B; Schauer, B; Taylor, N; Rodríguez-Prieto, V; Comin, A; Brouwer, A; Dórea, F; Drewe, J; Hoinville, L; Lindberg, A; Martinez Avilés, M; Martínez-López, B; Peyre, M; Pinto Ferreira, J; Rushton, J; VAN Schaik, G; Stärk, K D C; Staubach, C; Vicente-Rubiano, M; Witteveen, G; Pfeiffer, D; Häsler, B

2017-03-01

Animal health surveillance enables the detection and control of animal diseases including zoonoses. Under the EU-FP7 project RISKSUR, a survey was conducted in 11 EU Member States and Switzerland to describe active surveillance components in 2011 managed by the public or private sector and identify gaps and opportunities. Information was collected about hazard, target population, geographical focus, legal obligation, management, surveillance design, risk-based sampling, and multi-hazard surveillance. Two countries were excluded due to incompleteness of data. Most of the 664 components targeted cattle (26·7%), pigs (17·5%) or poultry (16·0%). The most common surveillance objectives were demonstrating freedom from disease (43·8%) and case detection (26·8%). Over half of components applied risk-based sampling (57·1%), but mainly focused on a single population stratum (targeted risk-based) rather than differentiating between risk levels of different strata (stratified risk-based). About a third of components were multi-hazard (37·3%). Both risk-based sampling and multi-hazard surveillance were used more frequently in privately funded components. The study identified several gaps (e.g. lack of systematic documentation, inconsistent application of terminology) and opportunities (e.g. stratified risk-based sampling). The greater flexibility provided by the new EU Animal Health Law means that systematic evaluation of surveillance alternatives will be required to optimize cost-effectiveness.

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.

Patch test results of the European baseline series among patients with occupational contact dermatitis across Europe - analyses of the European Surveillance System on Contact Allergy network, 2002-2010.

Science.gov (United States)

Pesonen, Maria; Jolanki, Riitta; Larese Filon, Francesca; Wilkinson, Mark; Kręcisz, Beata; Kieć-Świerczyńska, Marta; Bauer, Andrea; Mahler, Vera; John, Swen M; Schnuch, Axel; Uter, Wolfgang

2015-03-01

Occupational contact dermatitis is one of the most common occupational diseases in Europe. In order to develop effective preventive measures, detailed and up-to-date data on the incidence, main causes and professions at risk of occupational contact dermatitis are needed. To describe the pattern of patch test reactivity to allergens in the European baseline series of patients with occupational contact dermatitis in different occupations. We analysed data collected by the European Surveillance System on Contact Allergy (ESSCA) network from 2002 to 2010, from 11 European countries. Allergens in the European baseline series associated with an at least doubled risk of occupational contact dermatitis include: thiuram rubber chemical accelerators, epoxy resin, and the antimicrobials methylchloroisothiazolinone/methylisothiazolinone, methyldibromo glutaronitrile, and formaldehyde. The highest risk of occupational contact dermatitis was found in occupations classified as 'other personal services workers', which includes hairdressers, nursing and other healthcare professionals, precision workers in metal and related materials, and blacksmiths, tool-makers and related trades workers. In the planning and implementation of measures aimed at preventing occupational contact dermatitis, the focus should be on the identified high-risk occupational groups and the most common occupational allergies. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[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...

Bat Rabies Surveillance in Europe

DEFF Research Database (Denmark)

Schatz, J.; Fooks, A. R.; McElhinney, L.

2013-01-01

Rabies is the oldest known zoonotic disease and was also the first recognized bat associated infection in humans. To date, four different lyssavirus species are the causative agents of rabies in European bats: the European Bat Lyssaviruses type 1 and 2 (EBLV-1, EBLV-2), the recently discovered...... putative new lyssavirus species Bokeloh Bat Lyssavirus (BBLV) and the West Caucasian Bat Virus (WCBV). Unlike in the new world, bat rabies cases in Europe are comparatively less frequent, possibly as a result of varying intensity of surveillance. Thus, the objective was to provide an assessment of the bat...... rabies surveillance data in Europe, taking both reported data to the WHO Rabies Bulletin Europe and published results into account. In Europe, 959 bat rabies cases were reported to the RBE in the time period 1977–2010 with the vast majority characterized as EBLV-1, frequently isolated in the Netherlands...

WHO European Childhood Obesity Surveillance Initiative in Serbia: a prevalence of overweight and obesity among 6-9-year-old school children.

Science.gov (United States)

Djordjic, Visnja; Radisavljevic, Snezana; Milanovic, Ivana; Bozic, Predrag; Grbic, Miljana; Jorga, Jagoda; Ostojic, Sergej M

2016-09-01

The World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) is a public health program established in order to understand the progress of the obesity epidemic in young populations and gain inter-country comparisons within the European region, yet the data from a number of East European countries, including Serbia, were not available then. Therefore, the main aim of this cross-sectional study was to collect data about the prevalence of overweight and obesity among 6-9-year-old school children in Serbia according to the standardized protocol during the Fourth COSI Implementation Round. From September 2015 to November 2015, 5102 first- and second-grade primary-school children (age 7.7±0.6 years) were assessed for weight, height, and body mass index (BMI) in 14 Serbian school districts. The prevalence rates of obesity, as calculated using the International Obesity Task Force (IOTF) cut-off points, vary across different age groups, with the lowest obesity rates reported in 7-year-old boys (6.2%), while the highest obesity prevalence rates were observed in 6-year-old boys (9.7%). In addition, being overweight was strongly associated with poor local community development and lower level of urbanization. The overall prevalence of overweight (23.1%, including obesity) and obesity (6.9%) in Serbian primary-school children seem to be comparable to rather high rates previously reported in other countries participating in the COSI program, indicating an obesity epidemic in Serbian children. This surveillance system should be regularly implemented throughout Europe, providing comparable data on rates of overweight/obesity in primary schools that might drive prudent actions to reverse the pandemic trend of childhood obesity.

Tick-borne encephalitis vaccines: past and present.

Science.gov (United States)

Zent, Olaf; Bröker, Michael

2005-10-01

Vaccines to protect against tick-borne encephalitis (TBE) are produced by two manufacturers and are widely used in European and Asian countries, where TBE virus is endemic. General trends in vaccine development during recent decades and extensive postmarketing experience resulted in several modifications to their formulations and practical implications for use. Modifications were made to the production process, such as the change of the virus master bank from mouse brain to primary cells; to the excipients, especially the stabilizers and preservative; and to include formulations for children. Additionally, a rapid vaccination schedule has been developed for persons who require a fast onset of protection. Recent data from clinical studies and postmarketing surveillance indicate that both vaccines are safe, efficacious and interchangeable. Further (major) changes to formulation or alternative targets for vaccine development are not anticipated in the next 5 years. Recent serologic studies indicate that the persistence of protective immunity was longer than expected. Thus, recommendations for prolongation of TBE booster intervals have been made in several European countries, and a harmonization for booster recommendations is predicted within the European Union. Based on epidemiologic trends, the use of TBE vaccines will continue to increase in all age groups, including children.

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.

Colorectal Cancer Surveillance after Index Colonoscopy: Guidance from the Canadian Association of Gastroenterology

Directory of Open Access Journals (Sweden)

Desmond Leddin

2013-01-01

Full Text Available BACKGROUND: Differences between American (United States [US] and European guidelines for colonoscopy surveillance may create confusion for the practicing clinician. Under- or overutilization of surveillance colonoscopy can impact patient care.

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.

Patch test results with fragrance markers of the baseline series - analysis of the European Surveillance System on Contact Allergies (ESSCA) network 2009-2012

DEFF Research Database (Denmark)

Frosch, Peter J; Duus Johansen, Jeanne; Schuttelaar, Marie-Louise A

2015-01-01

BACKGROUND: Contact allergy to fragrances is common, and impairs quality of life, particularly in young women. OBJECTIVE: To provide current results on the prevalences of sensitization to fragrance allergens used as markers in the baseline series of most European countries. METHODS: Data of patie......BACKGROUND: Contact allergy to fragrances is common, and impairs quality of life, particularly in young women. OBJECTIVE: To provide current results on the prevalences of sensitization to fragrance allergens used as markers in the baseline series of most European countries. METHODS: Data...... of patients consecutively patch tested between 2009 and 2012 in 12 European countries with fragrance allergens contained in the baseline series were collected by the European Surveillance System on Contact Allergies network and descriptively analysed. Four departments used the TRUE Test(®) system. RESULTS......: Contact allergy to fragrances is common throughout Europe, with regional variation probably being explained by patch test technique, and differences in exposure and referral patterns. The current basic markers of fragrance sensitivity in the baseline series should be supplemented with additional fragrance...

[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.

[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.

Workers' health surveillance: implementation of the Directive 89/391/EEC in Europe

NARCIS (Netherlands)

Colosio, C.; Mandic-Rajcevic, S.; Godderis, L.; van der Laan, G.; Hulshof, C.; van Dijk, F.

2017-01-01

Background European Union (EU) Directive 89/391 addressed occupational health surveillance, which recommends to provide workers with `access to health surveillance at regular intervals', aiming to prevent work-related and occupational diseases. Aims To investigate how EU countries adopted this

Internet and Surveillance

DEFF Research Database (Denmark)

The Internet has been transformed in the past years from a system primarily oriented on information provision into a medium for communication and community-building. The notion of “Web 2.0”, social software, and social networking sites such as Facebook, Twitter and MySpace have emerged in this co......The Internet has been transformed in the past years from a system primarily oriented on information provision into a medium for communication and community-building. The notion of “Web 2.0”, social software, and social networking sites such as Facebook, Twitter and MySpace have emerged...... institutions have a growing interest in accessing this personal data. Here, contributors explore this changing landscape by addressing topics such as commercial data collection by advertising, consumer sites and interactive media; self-disclosure in the social web; surveillance of file-sharers; privacy...... in the age of the internet; civil watch-surveillance on social networking sites; and networked interactive surveillance in transnational space. This book is a result of a research action launched by the intergovernmental network COST (European Cooperation in Science and Technology)....

[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.

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.

Surveillance of the environmental radioactivity

International Nuclear Information System (INIS)

Schneider, Th.; Gitzinger, C.; Jaunet, P.; Eberbach, F.; Clavel, B.; Hemidy, P.Y.; Perrier, G.; Kiper, Ch.; Peres, J.M.; Josset, M.; Calvez, M.; Leclerc, M.; Leclerc, E.; Aubert, C.; Levelut, M.N.; Debayle, Ch.; Mayer, St.; Renaud, Ph.; Leprieur, F.; Petitfrere, M.; Catelinois, O.; Monfort, M.; Baron, Y.; Target, A.

2008-01-01

The objective of these days was to present the organisation of the surveillance of the environmental radioactivity and to allow an experience sharing and a dialog on this subject between the different actors of the radiation protection in france. The different presentations were as follow: evolution and stakes of the surveillance of radioactivity in environment; the part of the European commission, regulatory aspects; the implementation of the surveillance: the case of Germany; Strategy and logic of environmental surveillance around the EDF national centers of energy production; environmental surveillance: F.B.F.C. site of Romans on Isere; steps of the implementation 'analysis for release decree at the F.B.F.C./C.E.R.C.A. laboratory of Romans; I.R.S.N. and the environmental surveillance: situation and perspectives; the part of a non institutional actor, the citizenship surveillance done by A.C.R.O.; harmonization of sampling methods: the results of inter operators G.T. sampling; sustainable observatory of environment: data traceability and samples conservation; inter laboratories tests of radioactivity measurements; national network of environmental radioactivity measurement: laboratories agreements; the networks of environmental radioactivity telemetry: modernization positioning; programme of observation and surveillance of surface environment and installations of the H.A.-M.A.V.L. project (high activity and long life medium activity); Evolution of radionuclides concentration in environment and adaptation of measurements techniques to the surveillance needs; the national network of radioactivity measurement in environment; modes of data restoration of surveillance: the results of the Loire environment pilot action; method of sanitary impacts estimation in the area of ionizing radiations; the radiological impact of atmospheric nuclear tests in French Polynesia; validation of models by the measure; network of measurement and alert management of the atmospheric

Surveillance, Privacy and Trans-Atlantic Relations

DEFF Research Database (Denmark)

Recent revelations, by Edward Snowden and others, of the vast network of government spying enabled by modern technology have raised major concerns both in the European Union and the United States on how to protect privacy in the face of increasing governmental surveillance. This book brings...

Success Factors of European Syndromic Surveillance Systems: A Worked Example of Applying Qualitative Comparative Analysis.

Science.gov (United States)

Ziemann, Alexandra; Fouillet, Anne; Brand, Helmut; Krafft, Thomas

2016-01-01

Syndromic surveillance aims at augmenting traditional public health surveillance with timely information. To gain a head start, it mainly analyses existing data such as from web searches or patient records. Despite the setup of many syndromic surveillance systems, there is still much doubt about the benefit of the approach. There are diverse interactions between performance indicators such as timeliness and various system characteristics. This makes the performance assessment of syndromic surveillance systems a complex endeavour. We assessed if the comparison of several syndromic surveillance systems through Qualitative Comparative Analysis helps to evaluate performance and identify key success factors. We compiled case-based, mixed data on performance and characteristics of 19 syndromic surveillance systems in Europe from scientific and grey literature and from site visits. We identified success factors by applying crisp-set Qualitative Comparative Analysis. We focused on two main areas of syndromic surveillance application: seasonal influenza surveillance and situational awareness during different types of potentially health threatening events. We found that syndromic surveillance systems might detect the onset or peak of seasonal influenza earlier if they analyse non-clinical data sources. Timely situational awareness during different types of events is supported by an automated syndromic surveillance system capable of analysing multiple syndromes. To our surprise, the analysis of multiple data sources was no key success factor for situational awareness. We suggest to consider these key success factors when designing or further developing syndromic surveillance systems. Qualitative Comparative Analysis helped interpreting complex, mixed data on small-N cases and resulted in concrete and practically relevant findings.

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.

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...

Protecting personal data in camera surveillance practices

NARCIS (Netherlands)

Dubbeld, L.

2005-01-01

This paper explores in which ways privacy (in particular, data protection principles) comes to the fore in the day-to-day operation of a public video surveillance system. Starting from current European legal perspectives on data protection, and building on an empirical case study, the meanings and

Epidemiological models to support animal disease surveillance activities

DEFF Research Database (Denmark)

Willeberg, Preben; Paisley, Larry; Lind, Peter

2011-01-01

and models for interpreting surveillance data as part of ongoing control or eradication programmes. Two Danish examples are outlined. The first illustrates how models were used in documenting country freedom from disease (trichinellosis) and the second demonstrates how models were of assistance in predicting...... the risk of future cases, detected and undetected, of a waning infection of bovine spongiform encephalopathy. Both studies were successful in advancing European policy changes to reduce the cost of surveillance to appropriate levels given the magnitude of the respective hazards....

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

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

Reaction kinetic analysis of reactor surveillance data

Energy Technology Data Exchange (ETDEWEB)

Yoshiie, T., E-mail: yoshiie@rri.kyoto-u.ac.jp [Research Reactor Institute, Kyoto University, Kumatori-cho, Sennan-gun, Osaka-fu 590-0494 (Japan); Kinomura, A. [Research Reactor Institute, Kyoto University, Kumatori-cho, Sennan-gun, Osaka-fu 590-0494 (Japan); Nagai, Y. [The Oarai Center, Institute for Materials Research, Tohoku University, Oarai, Ibaraki 311-1313 (Japan)

2017-02-15

In the reactor pressure vessel surveillance data of a European-type pressurized water reactor (low-Cu steel), it was found that the concentration of matrix defects was very high, and a large number of precipitates existed. In this study, defect structure evolution obtained from surveillance data was simulated by reaction kinetic analysis using 15 rate equations. The saturation of precipitation and the growth of loops were simulated, but it was not possible to explain the increase in DBTT on the basis of the defect structures. The sub-grain boundary segregation of solutes was discussed for the origin of the DBTT increase.

Approaches to passive mosquito surveillance in the EU

NARCIS (Netherlands)

Kampen, H.; Medlock, J.M.; Vaux, A.G.C.; Koenraadt, C.J.M.; Vliet, van A.J.H.; Bartumeus, F.; Oltra, A.; Sousa, C.A.; Chouin, S.; Werner, D.

2015-01-01

The recent emergence in Europe of invasive mosquitoes and mosquito-borne disease associated with both invasive and native mosquito species has prompted intensified mosquito vector research in most European countries. Central to the efforts are mosquito monitoring and surveillance activities in order

[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.

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

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.

[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

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.)

Effects of surveillance on the rule of law, due process and the presumption of innocence

NARCIS (Netherlands)

Galetta, Antonella; de Hert, Paul; Wright, D.; Kreissl, R.

2015-01-01

This contribution focuses on the impact of surveillance on the rule of law, due process and the presumption of innocence, key values and principles of a democratic order. It illustrates how they are implemented and enforced in contemporary surveillance societies, while referring to European law and

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.

Childhood multidrug-resistant tuberculosis in the European Union and European Economic Area: an analysis of tuberculosis surveillance data from 2007 to 2015.

Science.gov (United States)

Ködmön, Csaba; van den Boom, Martin; Zucs, Phillip; van der Werf, Marieke Johanna

2017-11-01

BackgroundConfirming tuberculosis (TB) in children and obtaining information on drug susceptibility is essential to ensure adequate treatment. We assessed whether there are gaps in diagnosis and treatment of multidrug-resistant (MDR) TB in children in the European Union and European Economic Area (EU/EEA), quantified the burden of MDR TB in children and characterised cases. Methods : We analysed surveillance data from 2007 to 2015 for paediatric cases younger than 15 years. Results : In that period, 26 EU/EEA countries reported 18,826 paediatric TB cases of whom 4,129 (21.9%) were laboratory-confirmed. Drug susceptibility testing results were available for 3,378 (17.9%), representing 81.8% of the confirmed cases. The majority (n = 2,967; 87.8%) had drug-sensitive TB, 249 (7.4%) mono-resistant TB, 64 (1.9%) poly-resistant TB, 90 (2.7%) MDR TB and eight (0.2%) had extensively drug-resistant (XDR) TB. MDR TB was more frequently reported among paediatric cases with foreign background (adjusted odds ratio (aOR) = 1.73; 95% confidence interval (95% CI): 1.12-2.67) or previous TB treatment (aOR: 6.42; 95% CI: 3.24-12.75). Successful treatment outcome was reported for 58 of 74 paediatric MDR TB cases with outcome reported from 2007 to 2013; only the group of 5-9 years-olds was significantly associated with unsuccessful treatment outcome (crude odds ratio (cOR) = 11.45; 95% CI: 1.24-106.04). Conclusions : The burden of MDR TB in children in the EU/EEA appears low, but may be underestimated owing to challenges in laboratory confirmation. Diagnostic improvements are needed for early detection and adequate treatment of MDR TB. Children previously treated for TB or of foreign origin may warrant higher attention.

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.

[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.

What are the benefits of medical screening and surveillance?

NARCIS (Netherlands)

Wilken, D.; Baur, X.; Barbinova, L.; Preisser, A.; Meijer, E.; Rooyackers, J.M.; Heederik, D.J.J.

2012-01-01

Pre-employment examination is considered to be an important practice and is commonly performed in several countries within the European Union. The benefits of medical surveillance programmes are not generally accepted and their structure is often inconsistent. The aim of this review was to evaluate,

[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.

WHO European Childhood Obesity Surveillance Initiative: impact of type of clothing worn during anthropometric measurements and timing of the survey on weight and body mass index outcome measures in 6–9-year-old children

NARCIS (Netherlands)

Wijnhoven, T.M.A.; Raaij, van J.M.A.; Spinelli, A.; Yngve, Agneta; Lissner, L.; Spiroski, I.; Farrugia Sant Angelo, V.; Pérez-Farinós, Napoleon; Martos, E.; Heinen, M.; Kunesova, M.; Rito, A.I.; Hovengen, R.; Starc, G.; Duleva, Vesselka; Pudule, I.; Petrauskiene, Ausra; Braeckevelt, L.; Hassapidou, M.; Breda, João; Veer, van 't P.

2016-01-01

The World Health Organization European Childhood Obesity Surveillance Initiative (COSI) conducted examinations in 6–9-year-old children from 16 countries in the first two rounds of data collection. Allowing participating countries to adhere to their local legal requirements or adapt to other

WORKPLACE SURVEILLANCE: BIG BROTHER IS WATCHING YOU?

Directory of Open Access Journals (Sweden)

Corneliu BÎRSAN

2018-05-01

Full Text Available Only recently workplace surveillance has become a real concern of the international community. Very often we hear about employers who monitor and record the actions of their employees, in order to check for any breaches of company policies or procedures, to ensure that appropriate behaviour standards are being met and that company property, confidential information and intellectual property is not being damaged. Surveillance at workplace may include inter alia monitoring of telephone and internet use, opening of personal files stored on a professional computer, video surveillance. But what if this monitoring or recording breaches human rights? In order to give practical examples for these means, we shall proceed to a chronological analysis of the most relevant cases dealt by the European Court of Human Rights along the time, in which the Strasbourg judges decided that the measures taken by the employers exceed the limits given by Article 8 of the Convention. After providing the most relevant examples from the Court’s case-law in this field, we shall analyse the outcome of the recent Grand Chamber Barbulescu v. Romania judgment. The purpose of this study is to offer to the interested legal professionals and to the domestic authorities of the Member States the information in order to adequately protect the right of each individual to respect for his or her private life and correspondence under the European Convention on Human Rights.

Livestock-associated meticillin-resistant Staphylococcus aureus (MRSA) among human MRSA isolates, European Union/European Economic Area countries, 2013.

Science.gov (United States)

Kinross, Pete; Petersen, Andreas; Skov, Robert; Van Hauwermeiren, Evelyn; Pantosti, Annalisa; Laurent, Frédéric; Voss, Andreas; Kluytmans, Jan; Struelens, Marc J; Heuer, Ole; Monnet, Dominique L

2017-11-01

Currently, surveillance of livestock-associated meticillin-resistant Staphylococcus aureus (LA-MRSA) in humans in Europe is not systematic but mainly event-based. In September 2014, the European Centre for Disease Prevention and Control (ECDC) initiated a questionnaire to collect data on the number of LA-MRSA from human samples (one isolate per patient) from national/regional reference laboratories in European Union/European Economic Area (EU/EEA) countries in 2013. Identification of LA-MRSA as clonal complex (CC) 398 by multilocus sequence typing (MLST) was preferred, although surrogate methods such as spa -typing were also accepted. The questionnaire was returned by 28 laboratories in 27 EU/EEA countries. Overall, LA-MRSA represented 3.9% of 13,756 typed MRSA human isolates, but it represented ≥ 10% in five countries (Belgium, Denmark, Spain, the Netherlands and Slovenia). Seven of the reference laboratories did not type MRSA isolates in 2013. To monitor the dispersion of LA-MRSA and facilitate targeted control measures, we advocate periodic systematic surveys or integrated multi-sectorial surveillance.

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.

The Humanitarian Drone and the Borders: Unveiling the Rationales Underlying the Deployment of Drones in Border Surveillance

NARCIS (Netherlands)

Marin, Luisa; Custers, Bart

2016-01-01

In these days economic and political pressures push for the deployment of drones’ technology in civil and commercial domains. This chapter focuses in particular on the deployment of drones in the context of border surveillance. Border surveillance is a shared competence between the European Union,

Energy regulation at EU level. The role of the European Commission and ACER in the context of REMIT

International Nuclear Information System (INIS)

Konar, Selma

2015-01-01

The regulatory act of promulgating REMIT, the Regulation on Wholesale Market Integrity and Transparency, has highlighted the commanding position of both the European Commission and ACER, the Agency for the Cooperation of Energy Regulators, in the regulation of energy affairs in the European Union. Furthermore it has led to major changes in how surveillance is organized at the national level. The first part of this publication is dedicated to the organization of market surveillance following the promulgation of REMIT. It depicts the tasks of the European Commission and ACER in this context. The Regulation has accorded the authorities a central role in managing the European Union's responsibilities with regard to energy wholesale trade. The act of delegating such far-reaching competence to the authorities deserves careful review however. The article shows how, given ACER's lack of practical experience in market surveillance, as well as its lack of human resources, the task of surveilling the European energy wholesale market confronts the agency with a significant challenge. How successfully the EU energy agency will master this challenge will depend on a number of different factors. Stringent requirements will be needed for the data registration offices in order to ensure optimal data processing. National authorities and supervisory bodies should be made to participate in the data monitoring process. ACER's efficiency in surveilling the market will furthermore depend decisively on its IT infrastructure.

Food and water radioactivity surveillance system in Romania

International Nuclear Information System (INIS)

Cucu, A.; Gheorghe, R.; May, C.; Barbu, R.

2008-01-01

Full text: Justification: Food and water radioactivity content are closely related both to natural radioactivity and also generated by contamination due to anthropic nuclear activities. Consequently, in accordance with the European Union acquis and World Health Organization recommendation, surveillance systems were operationalized in many European countries. According to the national Romanian derived legislation the public health authorities are responsible for organizing and coordination of the national surveillance system for water and food radioactivity and their health related effects. Objectives: Description of the levels and type of radioactivity of drinking water and main foodstuffs and their contribution to the Romanian population exposure in order to elaborate appropriate public health interventions. Method: The gross parameters, alpha and beta, have been used for screening surveillance of drinking water sources indeed for potable purposes in order to identify those that could exceed the total indicative dose of 0.1 mSv/year. The food surveillance was focused on the main foodstuffs including milk, meat, fish, eggs, bread, potatoes, root vegetables (mainly carrots), leafy vegetables (mainly cabbage), fruits, and canteen menu, controlled for presence and level of radioactivity for 137 Cs, 90 Sr, 226 Ra, 210 Po and 40 K. Nuclear facility related monitoring for areas as nuclear power plant Cernavoda (type HWR-CANDU) and for regions with activities of extraction and fabrication of uranium fuel includes monitoring of radioactivity for: environmental deposit levels, surface waters, spontaneous vegetation, drinking water and foodstuffs. Results: 1) The water radioactivity surveillance results, mapped by administrative borders of the national territory, reveal that parameters of drinking water complies both with Drinking Water Directive 98/83 EC and WHO recommandation/2004; 2) For food stuff radioactivity: a) Mean registered values fully comply with reference for

High heterogeneity in methods used for the laboratory confirmation of pertussis diagnosis among European countries, 2010: integration of epidemiological and laboratory surveillance must include standardisation of methodologies and quality assurance.

Science.gov (United States)

He, Q; Barkoff, A M; Mertsola, J; Glismann, S; Bacci, S

2012-08-09

Despite extensive childhood immunisation, pertussis remains one of the world’s leading causes of vaccine preventable deaths. The current methods used for laboratory diagnosis of pertussis include bacterial culture, polymerase chain reaction (PCR) and enzyme linked immunosorbent assay (ELISA) serology. We conducted a questionnaire survey to identify variations in the laboratory methods and protocols used among participating countries included in the European surveillance network for vaccine-preventable diseases(EUVAC.NET). In February 2010, we performed the survey using a web-based questionnaire and sent it to the country experts of 25 European Union countries,and two European Economic Area (EEA) countries,Norway and Iceland. The questionnaire consisted of 37 questions which covered both general information on surveillance methods and detailed laboratory methods used. A descriptive analysis was performed.Questionnaires were answered by all 27 contacted countries. Nineteen countries had pertussis reference laboratories at the national level; their functions varied from performing diagnosis to providing technical advice for routine microbiology laboratories. Culture,PCR and serology were used in 17, 18 and 20 countries,respectively. For PCR, nine laboratories used insertion sequence IS481 as the target gene, which is present in multiple copies in the Bordetella pertussis genome and thus has a greater sensitivity over single copy targets, but has been proved not to be specific for B.pertussis. Antibodies directed against pertussis toxin(PT) are specific for B. pertussis infections. For ELISA serology, only 13 countries’ laboratories used purified PT as coating antigen and 10 included World Health Organization (WHO) or Food and Drug Administration (FDA) reference sera in their tests. This present survey shows that methods used for laboratory confirmation of pertussis differ widely among European countries and that there is a great heterogeneity of the reference

Surveillance of environmental radiation in Finland. Annual Report 2000

International Nuclear Information System (INIS)

Mustonen, R.

2001-01-01

The main goal of the surveillance of environmental radioactivity is to be always aware of levels of radiation to which the public is exposed. Another goal is to detect all remarkable changes in levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of the health of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on the national and the European Communities' legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air, water and soil in the Member States. In Finland, also the Finnish Meteorological Institute (FMI) and the Defence Forces are monitoring environmental radiation at their own stations. This report summarises the results of environmental radiation surveillance in 2000. The report also contains some comparisons with results from the previous years. The results are collected from monitoring programmes of STUK, FMI and the Defence Forces Research Institute of Technology. Nuclear power plant licensees are responsible for environmental surveillance in the vicinity of nuclear power plants in Finland. Those results are reported elsewhere. STUK's partners in surveillance of environmental radioactivity are collecting and delivering samples for laboratory analyses, or are participating in whole-body counting. STUK would like to express its gratitude to the following institutions for the successful co-operation: Defence Forces

Surveillance of environmental radiation in Finland. Annual Report 2001

International Nuclear Information System (INIS)

Mustonen, R.

2002-01-01

The main goal of the surveillance of environmental radioactivity is to be always aware of levels of radiation to which the public is exposed. Another goal is to detect all remarkable changes in levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of health of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on the national and the European Communities' legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air, water and soil in the Member States. In Finland, also the Finnish Meteorological Institute (FMI) and the Defence Forces are monitoring environmental radiation at their own stations. This report summarises the results of environmental radiation surveillance in 2001. The report also contains some comparisons with results from the previous years. The results are collected from monitoring programmes of STUK, FMI and the Defence Forces Research Institute of Technology. Nuclear power plant licensees are responsible for environmental surveillance in the vicinity of nuclear power plants in Finland. Those results are reported elsewhere. STUK's partners in surveillance of environmental radioactivity are collecting and delivering environmental samples for laboratory analyses, or are participating in whole-body counting. STUK would like to express its gratitude to the following institutions for the successful co-operation: Defence

Surveillance of extensively drug-resistant tuberculosis in Europe, 2003-2007.

NARCIS (Netherlands)

Devaux, I.; Manissero, D.; Fernandez de la Hoz, K.; Kremer, K.; Soolingen, D. van

2010-01-01

This paper describes the results of second-line drug (SLD) susceptibility tests among multidrug-resistant tuberculosis (MDR TB) cases reported in 20 European countries aiming to identify extensively drug-resistant tuberculosis (XDR TB) cases. A project on molecular surveillance of MDR TB cases was

Security clouds: Towards an ethical governance of surveillance in Europe

NARCIS (Netherlands)

den Boer, M.G.W.; van Buuren, J.

2012-01-01

Within the European Union (EU), several instruments have been created at local, national and international level to monitor the movements of persons, goods and systems. The political justification of this vast expansion of surveillance instruments is based on the supposed need for security actors to

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.

WHO European Childhood Obesity Surveillance Initiative: School nutrition environment and body mass index in primary schools.

Science.gov (United States)

Wijnhoven, Trudy M A; van Raaij, Joop M A; Sjöberg, Agneta; Eldin, Nazih; Yngve, Agneta; Kunešová, Marie; Starc, Gregor; Rito, Ana I; Duleva, Vesselka; Hassapidou, Maria; Martos, Eva; Pudule, Iveta; Petrauskiene, Ausra; Sant'Angelo, Victoria Farrugia; Hovengen, Ragnhild; Breda, João

2014-10-30

Schools are important settings for the promotion of a healthy diet and sufficient physical activity and thus overweight prevention. To assess differences in school nutrition environment and body mass index (BMI) in primary schools between and within 12 European countries. Data from the World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) were used (1831 and 2045 schools in 2007/2008 and 2009/2010, respectively). School personnel provided information on 18 school environmental characteristics on nutrition and physical activity. A school nutrition environment score was calculated using five nutrition-related characteristics whereby higher scores correspond to higher support for a healthy school nutrition environment. Trained field workers measured children's weight and height; BMI-for-age (BMI/A) Z-scores were computed using the 2007 WHO growth reference and, for each school, the mean of the children's BMI/A Z-scores was calculated. Large between-country differences were found in the availability of food items on the premises (e.g., fresh fruit could be obtained in 12%-95% of schools) and school nutrition environment scores (range: 0.30-0.93). Low-score countries (Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania) graded less than three characteristics as supportive. High-score (≥0.70) countries were Ireland, Malta, Norway, Portugal, Slovenia and Sweden. The combined absence of cold drinks containing sugar, sweet snacks and salted snacks were more observed in high-score countries than in low-score countries. Largest within-country school nutrition environment scores were found in Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania. All country-level BMI/A Z-scores were positive (range: 0.20-1.02), indicating higher BMI values than the 2007 WHO growth reference. With the exception of Norway and Sweden, a country-specific association between the school nutrition environment score and the school BMI/A Z

Evaluation of a Surveillance Review Software based on Automatic Image Summaries

International Nuclear Information System (INIS)

Rocchi, S.; Hadfi, G.; John, M.; Moeslinger, M.; Murray, J.; Juengling, K.; Sequeira, V.; Versino, C.; )

2015-01-01

Surveillance streams from safeguards instruments contain thousands of images. Inspectors review them in order to find safeguards-relevant events. Statistically a very small fraction of the images is expected to be safeguards-relevant. For this reason inspectors need a tool which helps them to focus their attention directly to the relevant parts of the surveillance stream. The current approach for surveillance review makes use of scene change detection within areas of interest (AOIs). The data reduction provided can be effective for the review of regular processes, and requires specific knowledge of the process/environment under review for the proper setting of the AOIs. The VideoZoom approach, developed by the European Commission Joint Research Centre-Institute for Transuranium Elements (JRC-ITU), detects scene changes on the whole image plane. Changes are then summarized and rendered at different levels of abstraction in four layers of summaries, each one revealing more information about the image changes. By means of a zooming interface, the reviewer is able to navigate the summary layers and decide which are to be examined with full photographic detail or skipped because they are clearly not safeguards-relevant. In this way reviewers can make best use of their time by investigating what really requires their attention. VideoZoom was evaluated by a group of IAEA inspectors on a benchmark of image reviews, with promising results in terms of identification of safeguards-relevant events, efficiency and usability. Following the positive results collected during the preliminary benchmark, the IAEA initiated a task under the European Commission Support Programme (EC SP), aimed at the research, development, and evaluation of surveillance review software based on VideoZoom and compatible with surveillance streams produced by NGSS cameras, the current safeguards surveillance technology deployed by the IAEA. This paper provides a description of the VideoZoom approach to

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.

Patch test results with fragrance markers of the baseline series - analysis of the European Surveillance System on Contact Allergies (ESSCA) network 2009-2012.

Science.gov (United States)

Frosch, Peter J; Duus Johansen, Jeanne; Schuttelaar, Marie-Louise A; Silvestre, Juan F; Sánchez-Pérez, Javier; Weisshaar, Elke; Uter, Wolfgang

2015-09-01

Contact allergy to fragrances is common, and impairs quality of life, particularly in young women. To provide current results on the prevalences of sensitization to fragrance allergens used as markers in the baseline series of most European countries. Data of patients consecutively patch tested between 2009 and 2012 in 12 European countries with fragrance allergens contained in the baseline series were collected by the European Surveillance System on Contact Allergies network and descriptively analysed. Four departments used the TRUE Test(®) system. The 'basic markers' were tested on 51 477 [fragrance mix II (FM II)] to 57 123 [Myroxylon pereirae, balsam of Peru] patients, and yielded positive reactions as follows: fragrance mix I 6.9%, Myroxylon pereirae 5.4%, FM II 3.8%, colophonium 2.6%, and hydroxyisohexyl 3-cyclohexene carboxaldehyde 1.7%, with some regional differences. Prevalences with TRUE Test(®) allergens were lower. Additional fragrances were tested on 3643 (trimethylbenzenepropanol) to 14 071 (oil of turpentine) patients, and yielded between 2.6% (Cananga odorata) and 0.7% (trimethylbenzenepropanol) positive reactions. Contact allergy to fragrances is common throughout Europe, with regional variation probably being explained by patch test technique, and differences in exposure and referral patterns. The current basic markers of fragrance sensitivity in the baseline series should be supplemented with additional fragrance allergens. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[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.

What are the benefits of medical screening and surveillance?

Directory of Open Access Journals (Sweden)

D. Wilken

2012-06-01

Full Text Available Pre-employment examination is considered to be an important practice and is commonly performed in several countries within the European Union. The benefits of medical surveillance programmes are not generally accepted and their structure is often inconsistent. The aim of this review was to evaluate, on the basis of the available literature, the usefulness of medical screening and surveillance. MEDLINE was searched from its inception up to March 2010. Retrieved literature was evaluated in a peer-review process and relevant data was collected following a systematic extraction schema. Pre-placement screening identifies subjects who are at an increased risk for developing work-related allergic disease, but pre-employment screening is too low to be used as exclusion criteria. Medical surveillance programmes can identify workers who have, or who are developing, work-related asthma. These programmes can also be used to avoid worsening of symptoms by implementing preventive measures. A combination of different tools within the surveillance programme, adjusted for the risk of the individual worker, improves the predictive value. Medical surveillance programmes provide medical as well as socioeconomic benefits. However, pre-employment screening cannot be used to exclude workers. They may act as a starting point for surveillance strategies. A stratified approach can increase the effectiveness and reduce the costs for such programmes.

Hepatocellular Carcinoma Surveillance Among Cirrhotic Patients With Commercial Health Insurance.

Science.gov (United States)

Goldberg, David S; Valderrama, Adriana; Kamalakar, Rajesh; Sansgiry, Sujit S; Babajanyan, Svetlana; Lewis, James D

2016-03-01

To evaluate hepatocellular carcinoma (HCC) surveillance rates among commercially insured patients, and evaluate factors associated with compliance with surveillance recommendations. Most HCC occurs in patients with cirrhosis. American Association for the Study of Liver Diseases and European Association for the Study of the Liver guidelines each recommend biannual HCC surveillance for cirrhotic patients to diagnose HCC at an early, curable stage. However, compliance with these guidelines in commercially insured patients is unknown. We used the Truven Health Analytics databases from 2006 to 2010, using January 1, 2006 as the anchor date for evaluating outcomes. The primary outcome was continuous surveillance measure, defined as the proportion of time "up-to-date" with surveillance (PTUDS), with the 6-month interval immediately following each ultrasound categorized as "up-to-date." During a median follow-up of 22.9 (interquartile range, 16.3 to 33.9) months among 8916 cirrhotic patients, the mean PTUDS was 0.34 (SD, 0.29), and the median was 0.31 (interquartile range, 0.03 to 0.52). These values increased only modestly with inclusion of serum alpha-fetoprotein testing, contrast-enhanced abdominal computed tomographic scans or magnetic resonance imagings, and/or extension of up-to-date time to 12 months. Being diagnosed by a nongastroenterology provider and increasing age were significantly associated with decreased HCC surveillance (Psurveillance (Psurveillance rates remained low. HCC surveillance rates in commercially insured at-risk patients remain poor despite formalized guidelines, highlighting the need to develop interventions to improve surveillance rates.

Surveillance of environmental radiation in Finland. Annual Report 2004

International Nuclear Information System (INIS)

Mustonen, R.

2005-07-01

The main goal of the surveillance of environmental radioactivity is to be always aware of levels of artificial radiation in the environment to which the public is exposed. Another goal is to detect all remarkable changes in levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of health of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. Surveillance of environmental radiation contains surveillance of artificial radiation and artificial radioactive elements in the environment. Natural radiation and natural radioactive elements are not associated with the surveillance programme, although the greater part of the public exposure to radiation is caused by natural radiation. Exposure to natural radiation is controlled separately if there is reason to suspect that natural radioactive elements cause unusual high exposure to the public (e.g. indoor radon and natural radionuclides in drinking water). Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on the national and the European Communities' legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air, water and soil in the Member States. In Finland, also the Finnish Meteorological Institute (FMI) and the Defence Forces are monitoring environmental radiation at their own stations. This report summarises the results of environmental radiation surveillance in 2004. The report also contains some comparisons with results from the

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.

[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

Concordance between European and US case definitions of healthcare-associated infections

Science.gov (United States)

2012-01-01

Background Surveillance of healthcare-associated infections (HAI) is a valuable measure to decrease infection rates. Across Europe, inter-country comparisons of HAI rates seem limited because some countries use US definitions from the US Centers for Disease Control and Prevention (CDC/NHSN) while other countries use European definitions from the Hospitals in Europe Link for Infection Control through Surveillance (HELICS/IPSE) project. In this study, we analyzed the concordance between US and European definitions of HAI. Methods An international working group of experts from seven European countries was set up to identify differences between US and European definitions and then conduct surveillance using both sets of definitions during a three-month period (March 1st -May 31st, 2010). Concordance between case definitions was estimated with Cohen’s kappa statistic (κ). Results Differences in HAI definitions were found for bloodstream infection (BSI), pneumonia (PN), urinary tract infection (UTI) and the two key terms “intensive care unit (ICU)-acquired infection” and “mechanical ventilation”. Concordance was analyzed for these definitions and key terms with the exception of UTI. Surveillance was performed in 47 ICUs and 6,506 patients were assessed. One hundred and eighty PN and 123 BSI cases were identified. When all PN cases were considered, concordance for PN was κ = 0.99 [CI 95%: 0.98-1.00]. When PN cases were divided into subgroups, concordance was κ = 0.90 (CI 95%: 0.86-0.94) for clinically defined PN and κ = 0.72 (CI 95%: 0.63-0.82) for microbiologically defined PN. Concordance for BSI was κ = 0.73 [CI 95%: 0.66-0.80]. However, BSI cases secondary to another infection site (42% of all BSI cases) are excluded when using US definitions and concordance for BSI was κ = 1.00 when only primary BSI cases, i.e. Europe-defined BSI with ”catheter” or “unknown” origin and US-defined laboratory-confirmed BSI (LCBI), were

Concordance between European and US case definitions of healthcare-associated infections

Directory of Open Access Journals (Sweden)

Hansen Sonja

2012-08-01

Full Text Available Abstract Background Surveillance of healthcare-associated infections (HAI is a valuable measure to decrease infection rates. Across Europe, inter-country comparisons of HAI rates seem limited because some countries use US definitions from the US Centers for Disease Control and Prevention (CDC/NHSN while other countries use European definitions from the Hospitals in Europe Link for Infection Control through Surveillance (HELICS/IPSE project. In this study, we analyzed the concordance between US and European definitions of HAI. Methods An international working group of experts from seven European countries was set up to identify differences between US and European definitions and then conduct surveillance using both sets of definitions during a three-month period (March 1st -May 31st, 2010. Concordance between case definitions was estimated with Cohen’s kappa statistic (κ. Results Differences in HAI definitions were found for bloodstream infection (BSI, pneumonia (PN, urinary tract infection (UTI and the two key terms “intensive care unit (ICU-acquired infection” and “mechanical ventilation”. Concordance was analyzed for these definitions and key terms with the exception of UTI. Surveillance was performed in 47 ICUs and 6,506 patients were assessed. One hundred and eighty PN and 123 BSI cases were identified. When all PN cases were considered, concordance for PN was κ = 0.99 [CI 95%: 0.98-1.00]. When PN cases were divided into subgroups, concordance was κ = 0.90 (CI 95%: 0.86-0.94 for clinically defined PN and κ = 0.72 (CI 95%: 0.63-0.82 for microbiologically defined PN. Concordance for BSI was κ = 0.73 [CI 95%: 0.66-0.80]. However, BSI cases secondary to another infection site (42% of all BSI cases are excluded when using US definitions and concordance for BSI was κ = 1.00 when only primary BSI cases, i.e. Europe-defined BSI with ”catheter” or “unknown” origin and US-defined laboratory-confirmed BSI

Complementing the surveillance law principles of the Court of Strasbourg with its environmental law principles. An integrated technology approach to a human rights framework for surveillance

NARCIS (Netherlands)

de Hert, P.J.A.; Galetta, Antonella

2014-01-01

If one looks at the case law of the European Court of Human Rights on surveillance matters, a well mature set of principles emerge, namely: legality, legitimacy, proportionality (the standard check) and, if the Court is "on it", also necessity and subsidiarity (the closer scrutiny check). We pass

Fiscal policy surveillance in the enlarged European Union: Procedural checks or simple arithmetic?

NARCIS (Netherlands)

Groenendijk, Nico; Batten, Jonathan A.; Kearney, Colm

2006-01-01

In its recommendation on the 2004 update of the Broad Economic Policy Guidelines (BEPGs), the European Commission (2004) issued country-specific recommendations for fiscal policy in the Central and Eastern European (CEE) countries that have recently joined the European Union (EU) (henceforth the

A hard lesson for Europeans: the ASEAN CDC.

Science.gov (United States)

Tibayrenc, Michel

2005-06-01

Despite the growing threat of major pandemics, the European Union is planning no more than a meager surveillance agency staffed with 70 people on the 2007 horizon: the new European Centre for Disease Control. I argue that an effective structure should be much larger and include a strong research activity. Asian countries, inspired by the US CDC, are now taking this concept in hand and creating an ASEAN Center For Disease Control, with sophisticated laboratory facilities to be included. This is a tough lesson for us Europeans, and our avarice in this domain could have tragic consequences in the future.

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.

Surveillance report 2015-2016. Functioning of the wholesale electricity, CO_2 and natural gas markets

International Nuclear Information System (INIS)

2016-01-01

After a presentation of some key figures regarding the electric power and natural gas markets, this reports, illustrated by many data tables, discusses the integration of wholesale market surveillance in the European system: a complete and operational framework, constitution of a European register of participants, data reporting at the European level, link with financial regulation, and surveillance of wholesale agents. In the second part, it gives an overview of the context of the energy markets: drop in raw material prices, temperatures above normal with a particularly mild winter, sharp drop in the price of emission allowances. The third section proposes an analysis of wholesale electricity markets: fundamentals (evolutions of production and consumption, of production sources, D-7 nuclear availability), wholesale prices, major growth in exchanged volumes. The last section addresses wholesale natural gas markets: review of the gas system (evolution of demand and supply), evolution of gas prices, evolution of trading (global deliveries, spot and forward market)

WHO European Childhood Obesity Surveillance Initiative: School Nutrition Environment and Body Mass Index in Primary Schools

Directory of Open Access Journals (Sweden)

Trudy M.A. Wijnhoven

2014-10-01

Full Text Available Background: Schools are important settings for the promotion of a healthy diet and sufficient physical activity and thus overweight prevention. Objective: To assess differences in school nutrition environment and body mass index (BMI in primary schools between and within 12 European countries. Methods: Data from the World Health Organization (WHO European Childhood Obesity Surveillance Initiative (COSI were used (1831 and 2045 schools in 2007/2008 and 2009/2010, respectively. School personnel provided information on 18 school environmental characteristics on nutrition and physical activity. A school nutrition environment score was calculated using five nutrition-related characteristics whereby higher scores correspond to higher support for a healthy school nutrition environment. Trained field workers measured children’s weight and height; BMI-for-age (BMI/A Z-scores were computed using the 2007 WHO growth reference and, for each school, the mean of the children’s BMI/A Z-scores was calculated. Results: Large between-country differences were found in the availability of food items on the premises (e.g., fresh fruit could be obtained in 12%-95% of schools and school nutrition environment scores (range: 0.30-0.93. Low-score countries (Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania graded less than three characteristics as supportive. High-score (≥0.70 countries were Ireland, Malta, Norway, Portugal, Slovenia and Sweden. The combined absence of cold drinks containing sugar, sweet snacks and salted snacks were more observed in high-score countries than in low-score countries. Largest within-country school nutrition environment scores were found in Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania. All country-level BMI/A Z-scores were positive (range: 0.20-1.02, indicating higher BMI values than the 2007 WHO growth reference. With the exception of Norway and Sweden, a country-specific association between the

WHO European Childhood Obesity Surveillance Initiative: School Nutrition Environment and Body Mass Index in Primary Schools

Science.gov (United States)

Wijnhoven, Trudy M.A.; van Raaij, Joop M.A.; Sjöberg, Agneta; Eldin, Nazih; Yngve, Agneta; Kunešová, Marie; Starc, Gregor; Rito, Ana I.; Duleva, Vesselka; Hassapidou, Maria; Martos, Éva; Pudule, Iveta; Petrauskiene, Ausra; Farrugia Sant’Angelo, Victoria; Hovengen, Ragnhild; Breda, João

2014-01-01

Background: Schools are important settings for the promotion of a healthy diet and sufficient physical activity and thus overweight prevention. Objective: To assess differences in school nutrition environment and body mass index (BMI) in primary schools between and within 12 European countries. Methods: Data from the World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) were used (1831 and 2045 schools in 2007/2008 and 2009/2010, respectively). School personnel provided information on 18 school environmental characteristics on nutrition and physical activity. A school nutrition environment score was calculated using five nutrition-related characteristics whereby higher scores correspond to higher support for a healthy school nutrition environment. Trained field workers measured children’s weight and height; BMI-for-age (BMI/A) Z-scores were computed using the 2007 WHO growth reference and, for each school, the mean of the children’s BMI/A Z-scores was calculated. Results: Large between-country differences were found in the availability of food items on the premises (e.g., fresh fruit could be obtained in 12%−95% of schools) and school nutrition environment scores (range: 0.30−0.93). Low-score countries (Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania) graded less than three characteristics as supportive. High-score (≥0.70) countries were Ireland, Malta, Norway, Portugal, Slovenia and Sweden. The combined absence of cold drinks containing sugar, sweet snacks and salted snacks were more observed in high-score countries than in low-score countries. Largest within-country school nutrition environment scores were found in Bulgaria, Czech Republic, Greece, Hungary, Latvia and Lithuania. All country-level BMI/A Z-scores were positive (range: 0.20−1.02), indicating higher BMI values than the 2007 WHO growth reference. With the exception of Norway and Sweden, a country-specific association between the school

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.

Euratom multi-camera optical surveillance system (EMOSS) - a digital solution

International Nuclear Information System (INIS)

Otto, P.; Wagner, H.G.; Taillade, B.; Pryck, C. de.

1991-01-01

In 1989 the Euratom Safeguards Directorate of the Commission of the European Communities drew up functional and draft technical specifications for a new fully digital multi-camera optical surveillance system. HYMATOM of Castries designed and built a prototype unit for laboratory and field tests. This paper reports and system design and first test results

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...

[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.

Using European travellers as an early alert to detect emerging pathogens in countries with limited laboratory resources

Directory of Open Access Journals (Sweden)

Grais Rebecca

2007-01-01

Full Text Available Abstract Background The volume, extent and speed of travel have dramatically increased in the past decades, providing the potential for an infectious disease to spread through the transportation network. By collecting information on the suspected place of infection, existing surveillance systems in industrialized countries may provide timely information for areas of the world without adequate surveillance currently in place. We present the results of a case study using reported cases of Shigella dysenteriae serotype 1 (Sd1 in European travellers to detect "events" of Sd1, related to either epidemic cases or endemic cases in developing countries. Methods We identified papers from a Medline search for reported events of Sd1 from 1940 to 2002. We requested data on shigella infections reported to the responsible surveillance entities in 17 European countries. Reports of Sd1 from the published literature were then compared with Sd1 notified cases among European travellers from 1990 to 2002. Results Prior to a large epidemic in 1999–2000, no cases of Sd1 had been identified in West Africa. However, if travellers had been used as an early warning, Sd1 could have been identified in this region as earlier as 1992. Conclusion This project demonstrates that tracking diseases in European travellers could be used to detect emerging disease in developing countries. This approach should be further tested with a view to the continuous improvement of national health surveillance systems and existing European networks, and may play a significant role in aiding the international public health community to improve infectious disease control.

Control of Infectious Diseases in the Era of European Clinical Microbiology Laboratory Consolidation: New Challenges and Opportunities for the Patient and for Public Health Surveillance

Directory of Open Access Journals (Sweden)

Olivier Vandenberg

2018-02-01

Full Text Available Many new innovative diagnostic approaches have been made available during the last 10 years with major impact on patient care and public health surveillance. In parallel, to enhance the cost-effectiveness of the clinical microbiology laboratories (CMLs, European laboratory professionals have streamlined their organization leading to amalgamation of activities and restructuring of their professional relationships with clinicians and public health specialists. Through this consolidation process, an operational model has emerged that combines large centralized clinical laboratories performing most tests on one high-throughput analytical platform connected to several distal laboratories dealing locally with urgent analyses at near point of care. The centralization of diagnostic services over a large geographical region has given rise to the concept of regional-scale “microbiology laboratories network.” Although the volume-driven cost savings associated with such laboratory networks seem self-evident, the consequence(s for the quality of patient care and infectious disease surveillance and control remain less obvious. In this article, we describe the range of opportunities that the changing landscape of CMLs in Europe can contribute toward improving the quality of patient care but also the early detection and enhanced surveillance of public health threats caused by infectious diseases. The success of this transformation of health services is reliant on the appropriate preparation in terms of staff, skills, and processes that would be inclusive of stakeholders. In addition, rigorous metrics are needed to set out more concrete laboratory service performance objectives and assess the expected benefits to society in terms of saving lives and preventing diseases.

Control of Infectious Diseases in the Era of European Clinical Microbiology Laboratory Consolidation: New Challenges and Opportunities for the Patient and for Public Health Surveillance.

Science.gov (United States)

Vandenberg, Olivier; Kozlakidis, Zisis; Schrenzel, Jacques; Struelens, Marc Jean; Breuer, Judith

2018-01-01

Many new innovative diagnostic approaches have been made available during the last 10 years with major impact on patient care and public health surveillance. In parallel, to enhance the cost-effectiveness of the clinical microbiology laboratories (CMLs), European laboratory professionals have streamlined their organization leading to amalgamation of activities and restructuring of their professional relationships with clinicians and public health specialists. Through this consolidation process, an operational model has emerged that combines large centralized clinical laboratories performing most tests on one high-throughput analytical platform connected to several distal laboratories dealing locally with urgent analyses at near point of care. The centralization of diagnostic services over a large geographical region has given rise to the concept of regional-scale "microbiology laboratories network." Although the volume-driven cost savings associated with such laboratory networks seem self-evident, the consequence(s) for the quality of patient care and infectious disease surveillance and control remain less obvious. In this article, we describe the range of opportunities that the changing landscape of CMLs in Europe can contribute toward improving the quality of patient care but also the early detection and enhanced surveillance of public health threats caused by infectious diseases. The success of this transformation of health services is reliant on the appropriate preparation in terms of staff, skills, and processes that would be inclusive of stakeholders. In addition, rigorous metrics are needed to set out more concrete laboratory service performance objectives and assess the expected benefits to society in terms of saving lives and preventing diseases.

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.

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.

Towards a standardised surveillance for Trichinella in the European Union

DEFF Research Database (Denmark)

Alban, L.; Pozio, E.; Boes, J.

2011-01-01

a specified design prevalence which we set to 1 per million pigs. A simple and transparent method is proposed to estimate this confidence, based on the sensitivity of the surveillance system, taking into account the sensitivity of testing and the design prevalence. The probability of detecting a positive case......, if present, must be high (>95 or >99%) to ensure that there is a low or negligible risk of transmission to humans through the food chain. In MS where the probability of a positive pig is demonstrated to be negligible, testing of fattening pigs from a sub-population consisting of pigs from controlled housing...

A review of occupational disease surveillance systems in Modernet countries.

Science.gov (United States)

Carder, M; Bensefa-Colas, L; Mattioli, S; Noone, P; Stikova, E; Valenty, M; Telle-Lamberton, M

2015-11-01

To improve occupational health public policies and to facilitate coordinated research within the European Union to reduce the incidence of occupational diseases (ODs), it is important to know what OD surveillance systems exist and how they compare. Monitoring trends in occupational diseases and tracing new and emerging risks in a network (Modernet) participants are well placed to provide this information as most either contribute data to and/or are involved in the management of OD systems. To identify and describe OD surveillance systems in Modernet countries with the longer-term objective of identifying a core template to be used on a large scale. A questionnaire sent to Modernet participants, seeking structured information about the OD surveillance system(s) in their country. Overall 14 countries (70%) provided information for 33 OD systems, among them 11 compensation-based (CB) systems. Six countries provided information for non-CB systems reporting for any type of OD. The other systems reported either only ODs from a prescribed list, or specific diagnoses or diagnostic groups, with reports to most schemes being physician-based. Data collected varied but all systems collected diagnosis, age, gender, date reported and occupation (and/or industry) and most collected information on exposure. This review provides information beneficial to both policy makers and researchers by identifying data sources useable to measure OD trends in European countries and opening the way to future work, both on trend comparisons within Europe and on the definition of a core template to extend OD surveillance on a larger scale. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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.

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.

Physical activity surveillance in the European Union: reliability and validity of the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ).

Science.gov (United States)

Baumeister, Sebastian E; Ricci, Cristian; Kohler, Simone; Fischer, Beate; Töpfer, Christine; Finger, Jonas D; Leitzmann, Michael F

2016-05-23

The current study examined the reliability and validity of the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ), a novel questionnaire for the surveillance of physical activity (PA) during work, transportation, leisure time, sports, health-enhancing and muscle-strengthening activities over a typical week. Reliability was assessed by administering the 8-item questionnaire twice to a population-based sample of 123 participants aged 15-79 years at a 30-day interval. Concurrent (inter-method) validity was examined in 140 participants by comparisons with self-report (International Physical Activity Questionnaire-Long Form (IPAQ-LF), 7-day Physical Activity Record (PAR), and objective criterion measures (GT3X+ accelerometer, physical work capacity at 75% (PWC(75%)) from submaximal cycle ergometer test, hand grip strength). The EHIS-PAQ showed acceptable reliability, with a median intraclass correlation coefficient across PA domains of 0.55 (range 0.43-0.73). Compared to the GT3X+ (counts/minutes/day), the EHIS-PAQ underestimated moderate-to-vigorous PA (median difference -11.7, p-value = 0.054). Spearman correlation coefficients (ρ) for validity were moderate-to-strong (ρ's > 0.41) for work-related PA (IPAQ = 0.64, GT3X + =0.43, grip strength = 0.48), transportation-related PA (IPAQ = 0.62, GT3X + =0.43), walking (IPAQ = 0.58), and health-enhancing PA (IPAQ = 0.58, PAR = 0.64, GT3X + =0.44, PWC(75%) = 0.48), and fair-to-poor (ρ's PAQ showed good evidence for reliability and validity for the measurement of PA levels at work, during transportation and health-enhancing PA.

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...

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.

Risk indicators affecting honeybee colony survival in Europe: one year of surveillance

DEFF Research Database (Denmark)

Jacques, Antoine; Laurent, Marion; Bougeard, Stéphanie

2016-01-01

The first pan-European harmonized active epidemiological surveillance program on honeybee colony mortality (EPILOBEE) was set up across 17 European Member States to estimate honeybee colony mortality over winter and during the beekeeping season. In nine Member States, overwinter losses were higher...... and statistically different from the empirical level of 10 % under which the level of overwinter mortality was considered as acceptable with usual beekeeping conditions. In four other countries, these losses were lower. Using multivariable Poisson regression models, it was showed that the size of the operation...

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....

Rationale and methods of the European Food Consumption Validation (EFCOVAL) Project

DEFF Research Database (Denmark)

de Boer, E. J.; Slimani, N.; van 't Veer, P.

2011-01-01

dietary recalls (24-HDRs) in the European Prospective Investigation into Cancer and Nutrition (EPIC) Study) was reprogrammed and adapted according to prioritized specifications, resulting in a software program working under the Windows operating system. In parallel of the EPIC-Soft development...... questionnaire and modeling of usual intake is a suitable method for pan-European surveillance of nutritional adequacy and food safety among healthy adults and maybe in children aged 7 years and older. European Journal of Clinical Nutrition (2011) 65, S1-S4; doi:10.1038/ejcn.2011.82...

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.

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.

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

Lessons learnt to keep Europe polio-free: a review of outbreaks in the European Union, European Economic Area, and candidate countries, 1973 to 2013.

Science.gov (United States)

Derrough, Tarik; Salekeen, Alexandra

2016-04-21

Between 1973 and 2013, 12 outbreaks of paralytic poliomyelitis with a cumulative total of 660 cases were reported in the European Union, European Economic Area and candidate countries. Outbreaks lasted seven to 90 weeks (median: 24 weeks) and were identified through the diagnosis of cases of acute flaccid paralysis, for which infection with wild poliovirus was subsequently identified. In two countries, environmental surveillance was in place before the outbreaks, but did not detect any wild strain before the occurrence of clinical cases. This surveillance nonetheless provided useful information to monitor the outbreaks and their geographical spread. Outbreaks were predominantly caused by poliovirus type 1 and typically involved unvaccinated or inadequately vaccinated groups within highly immunised communities. Oral polio vaccine was primarily used to respond to the outbreaks with catch-up campaigns implemented either nationwide or in restricted geographical areas or age groups. The introduction of supplementary immunisation contained the outbreaks. In 2002, the European region of the World Health Organization was declared polio-free and it has maintained this status since. However, as long as there are non-vaccinated or under-vaccinated groups in European countries and poliomyelitis is not eradicated, countries remain continuously at risk of reintroduction and establishment of the virus. Continued efforts to reach these groups are needed in order to ensure a uniform and high vaccination coverage.

Design and development of correlation techniques to maintain a space surveillance system catalogue

Science.gov (United States)

Olmedo, E.; Sánchez Ortiz, Noelia; Lerate, Mercedes; Belló-Mora, Miguel; Klinkrad, H.

2009-10-01

A growing interest exists in a future, autonomous European Space Surveillance System (ESSS). Currently, most of the knowledge about Earth-orbiting space objects is based on information provided by the USASPACECOM. This paper presents the required initial orbit determination (IOD) and correlation techniques to process optical measurements. Former studies were focused on the handling of radar measurements, which are summarised with the aim of describing a global procedure for processing hybrid measurement types (combination of radar and optic data for catalogue maintenance). The introduction of manoeuvres are presented due to their importance in the space object catalogue maintenance. The detection of uncatalogued objects and the successful correlation of already catalogued objects involve two different tasks for telescopes: survey and tasking. Assumptions for both strategies are developed on the basis of the previous work developed at the University of Berne (see [T. Flohrer, T. Schildknecht, R. Musci, E. Stöveken, Performance estimation for GEO space surveillance, Advances in Space Research 35 (2005). [1]; T. Flohrer, T. Schildknecht, R. Musci, Proposed strategies for optical observations in a future European Space Surveillance Network, presented in the 36th COSPAR Scientific Assembly (2006). [2]; R. Musci, T. Schildknecht, M. Ploner, Orbit improvement for GEO objects using follow-up observations, Advances in Space Research 34 (2004). [3]; R. Musci, T. Schildknecht, M. Ploner, G. Beutler, Orbit improvement for GTO objects using follow-up observations, Advances in Space Research 35 (2005). [4]; R. Musci, T. Schildknecht, T. Flohrer, G. Beutler, Concept for a catalogue of space debris in GEO, Proceedings of the Fourth European Conference on Space Debris, (ESA SP-587, 2005). [5

The surveillance of the electricity wholesale market and emission trading market

International Nuclear Information System (INIS)

Luedemann, Volker

2015-01-01

The Regulation on Wholesale Market Integrity and Transparency (REMIT) and the German Law on the Establishment of a Market Transparency Office for Wholesale Trade in Electricity and Gas (MTS-G) have fundamentally changed the surveillance of electricity wholesale trade in Germany. From now on the Federal Network Agency and the Federal Cartel Office will be jointly responsible for monitoring the electricity wholesale trade for suspicious market phenomena and abusive behaviour. The REMIT specifies that the electricity trade must be surveilled ''with due consideration to interactions'' with the emission trade system. However, occurrences observed in recent years have shown that the emission trading system is in need of reform. This has also been recognised and has prompted extensive corrective action by the regulatory authorities of the European Union. These changes have yet to be transposed into the national surveillance regimes. The present article explains why the new role accorded to the Federal Network Agency under the REMIT fails to eliminate the structural shortcomings of the old surveillance system. At least the decision to put the collection and evaluation of data exclusively in the hands of the market transparency office and the cooperation this will prompt between the supervisory authorities responsible will make the task of surveilling the energy wholesale trading market a lot easier for the authorities. The energy transition and its exigencies will yet lead to further changes in the market and its surveillance regime.

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

A European study on the relationship between antimicrobial use and antimicrobial resistance

NARCIS (Netherlands)

Bronzwaer, SLAM; Cars, O; Buchholz, U; Molstad, S; Goettsch, W; Veldhuijzen, IK; Kool, JL; Sprenger, MJW; Degener, JE

In Europe, antimicrobial resistance has been monitored since 1998 by the European Antimicrobial Resistance Surveillance System (EARSS). We examined the relationship between penicillin nonsusceptibility of invasive isolates of Streptococcus pneumoniae and antibiotic sales. Information was collected

[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

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

Migration-related tuberculosis: epidemiology and characteristics of tuberculosis cases originating outside the European Union and European Economic Area, 2007 to 2013.

Science.gov (United States)

Ködmön, Csaba; Zucs, Phillip; van der Werf, Marieke J

2016-01-01

Migrants arriving from high tuberculosis (TB)-incidence countries may pose a significant challenge to TB control programmes in the host country. TB surveillance data for 2007-2013 submitted to the European Surveillance System were analysed. Notified TB cases were stratified by origin and reporting country. The contribution of migrant TB cases to the TB epidemiology in EU/EEA countries was analysed. Migrant TB cases accounted for 17.4% (n = 92,039) of all TB cases reported in the EU/EEA in 2007-2013, continuously increasing from 13.6% in 2007 to 21.8% in 2013. Of 91,925 migrant cases with known country of origin, 29.3% were from the Eastern Mediterranean, 23.0% from south-east Asia, 21.4% from Africa, 13.4% from the World Health Organization European Region (excluding EU/EEA), and 12.9% from other regions. Of 46,499 migrant cases with known drug-susceptibility test results, 2.9% had multidrug-resistant TB, mainly (51.7%) originating from the European Region. The increasing contribution of TB in migrants from outside the EU/EEA to the TB burden in the EU/EEA is mainly due to a decrease in native TB cases. Especially in countries with a high proportion of TB cases in non-EU/EEA migrants, targeted prevention and control initiatives may be needed to progress towards TB elimination.

How can cardiothoracic and vascular medical devices stay in the market?

Science.gov (United States)

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Rule-based versus probabilistic selection for active surveillance using three definitions of insignificant prostate cancer

NARCIS (Netherlands)

L.D.F. Venderbos (Lionne); M.J. Roobol-Bouts (Monique); C.H. Bangma (Chris); R.C.N. van den Bergh (Roderick); L.P. Bokhorst (Leonard); D. Nieboer (Daan); Godtman, R; J. Hugosson (Jonas); van der Kwast, T; E.W. Steyerberg (Ewout)

2016-01-01

textabstractTo study whether probabilistic selection by the use of a nomogram could improve patient selection for active surveillance (AS) compared to the various sets of rule-based AS inclusion criteria currently used. We studied Dutch and Swedish patients participating in the European Randomized

General Surveillance of the soil ecosystem: An approach to monitoring unexpected adverse effects of GMO's

NARCIS (Netherlands)

Smit, E.; Bakker, P.A.H.M.; Bergmans, H.; Bloem, J.; Griffiths, B.; Rutgers, M.

2012-01-01

The commercial cultivation of genetically modified (GM) crops in the European Union (EU) necessitates, according to EU legislation, the setting up of a General Surveillance (GS) system that should be able to detect unanticipated effects of GM crops on the environment. Although the applicant is

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 ...

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

Science.gov (United States)

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Paper 5: Surveillance of multiple congenital anomalies: implementation of a computer algorithm in European registers for classification of cases

DEFF Research Database (Denmark)

Garne, Ester; Dolk, Helen; Loane, Maria

2011-01-01

Surveillance of multiple congenital anomalies is considered to be more sensitive for the detection of new teratogens than surveillance of all or isolated congenital anomalies. Current literature proposes the manual review of all cases for classification into isolated or multiple congenital anomal...

The Rise of a European Healthcare Union

DEFF Research Database (Denmark)

Vollaard, Hans; Martinsen, Dorte Sindbjerg

2017-01-01

Healthcare has only slowly appeared on the European Union’s (EU) policy agenda. EU involvement in policies concerning the organization, financing and the provision of diagnosis, care and cures to ill people developed along three fragmented tracks: (a) EU public health policies concerning the well......-being of all people; (b) the application of the free movement principle to national healthcare systems in particular by the EU’s Court of Justice (CJEU); and (c) the austerity packages and the stricter EU surveillance of national budgets since the debt crises. The key questions of this special issue...... are whether this fragmented EU involvement has now developed into a distinct European healthcare union, and if so what its driving forces have been. Thus, it explores how European integration in healthcare has moved forward despite widespread reluctance. It also examines the underexplored political dynamics...

Improving antimicrobial prescribing in Irish primary care through electronic data collection and surveillance: a feasibility study.

Science.gov (United States)

Galvin, Sandra; Callan, Aoife; Cormican, Martin; Duane, Sinead; Bennett, Kathleen; Murphy, Andrew W; Vellinga, Akke

2015-07-02

The increase in the spread of antimicrobial resistance (AMR) in bacterial pathogens and limited availability of new antimicrobials places immense pressure on general practitioners (GPs) to prescribe appropriately. Currently, electronic antimicrobial prescribing data is not routinely collected from GPs in Ireland for surveillance purposes to assess regional specific fluctuations or trends in antimicrobial prescribing. The current study aimed to address this issue by assessing the feasibility of remotely extracting antimicrobial prescribing data from primary care practices in Ireland, for the purpose of assessing prescribing quality using the European Surveillance of Antimicrobial Consumption (ESAC) drug specific quality indicators. Participating practices (n = 30) uploaded data to the Irish Primary Care Research Network (IPCRN). The IPCRN data extraction facility is integrated within the practice patient management software system and permitted the extraction of anonymised patient prescriptions for a one year period, from October 2012 to October 2013. The quality of antimicrobial prescribing was evaluated using the twelve ESAC drug specific quality indicators using the defined daily dose (DDD) per 1,000 inhabitants per day (DID) methodology. National and European prescribing surveillance data (based on total pharmacy sales) was obtained for a comparative analysis. Antimicrobial prescriptions (n = 57,079) for 27,043 patients were obtained from the thirty study practices for a one year period. On average, study practices prescribed a greater proportion of quinolones (37 % increase), in summer compared with winter months, a variation which was not observed in national and European data. In comparison with national data, study practices prescribed higher proportions of β-lactamase-sensitive penicillins (4.98 % vs. 4.3 %) and a greater use of broad spectrum compared to narrow-spectrum antimicrobials (ratio = 9.98 vs. 6.26) was observed. Study practices exceeded the

Tuberculosis among migrant populations in the European Union and the European Economic Area.

Science.gov (United States)

Odone, Anna; Tillmann, Taavi; Sandgren, Andreas; Williams, Gemma; Rechel, Bernd; Ingleby, David; Noori, Teymur; Mladovsky, Philipa; McKee, Martin

2015-06-01

Although tuberculosis (TB) incidence has been decreasing in the European Union/European Economic Area (EU/EEA) in the last decades, specific subgroups of the population, such as migrants, remain at high risk of TB. This study is based on the report 'Key Infectious Diseases in Migrant Populations in the EU/EEA' commissioned by The European Centre for Disease Prevention and Control. We collected, critically appraised and summarized the available evidence on the TB burden in migrants in the EU/EEA. Data were collected through: (i) a comprehensive literature review; (ii) analysis of data from The European Surveillance System (TESSy) and (iii) evidence provided by TB experts during an infectious disease workshop in 2012. In 2010, of the 73,996 TB cases notified in the EU/EEA, 25% were of foreign origin. The overall decrease of TB cases observed in recent years has not been reflected in migrant populations. Foreign-born people with TB exhibit different socioeconomic and clinical characteristics than native sufferers. This is one of the first studies to use multiple data sources, including the largest available European database on infectious disease notifications, to assess the burden and provide a comprehensive description and analysis of specific TB features in migrants in the EU/EEA. Strengthened information about health determinants and factors for migrants' vulnerability is needed to plan, implement and evaluate targeted TB care and control interventions for migrants in the EU/EEA. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association.

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.

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

Science.gov (United States)

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

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.

European surveillance study on antimicrobial susceptibility of Gram-positive anaerobic cocci

DEFF Research Database (Denmark)

Brazier, J; Chmelar, D; Dubreuil, L

2008-01-01

Gram-positive anaerobic cocci (GPAC) are a heterogeneous group of microorganisms frequently isolated from local and systemic infections. In this study, the antimicrobial susceptibilities of clinical strains isolated in 10 European countries were investigated. After identification of 299 GPAC...

Assessment of zoonotic potential of four European swine influenza viruses in the ferret model

DEFF Research Database (Denmark)

Fobian, Kristina; P. Fabrizio, Thomas; Yoon, Sun-Woo

herds and enhanced focus on risk assessment of these new viruses. In this study, four European swine influenza viruses were assessed for their zoonotic potential. Of the four viruses, two were enzootic viruses of subtype H1N2 (with avian-like H1) and H3N2 and two were new reassortants, one with avian......The reverse zoonotic events that introduced the 2009 pandemic influenza virus into swine herds have drastically increased the diversity of reassortants throughout Europe. The pandemic potential of these novel reassortments is unknown, hence necessitating enhanced surveillance of European swine...... to neuraminidase inhibitors. These findings suggest that the investigated viruses have the potential to infect humans and further underline the need for continued surveillance as well as pandemic and zoonotic assessment of new influenza reassortants....

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

Hepatitis B and C surveillance and screening programmes in the non-EU/EEA Member States of the WHO European Region

DEFF Research Database (Denmark)

Mozalevskis, Antons; Eramova, Irina; Safreed-Harmon, Kelly

2016-01-01

The hepatitis B virus (HBV) and hepatitis C virus (HCV) epidemics warrant a comprehensive response based on reliable population-level information about transmission, disease progression and disease burden, with national surveillance systems playing a major role. In order to shed light on the status...... surveillance, passive case-finding and the reporting of both acute and chronic HBV and HCV. Only some countries had surveillance systems that incorporated the tracking of associated conditions and outcomes such as cirrhosis and liver transplantation. Screening programmes for some key populations appeared...... to be in place in many countries, but there may be gaps in relation to screening programmes for people who inject drugs, prisoners, sex workers and men who have sex with men. Nonetheless, important components of a surveillance structure are in place in the responding study countries. It is advisable to build...

The European Union and armed drones: framing the debate

DEFF Research Database (Denmark)

Martins, Bruno Oliveira

2015-01-01

Armed drones are an issue extremely relevant for the EU. The recent emergence of targeted killings as a common counter-terrorism technique, the existence of several EU member states using armed and surveillance drones in military scenarios, the presence of member states troops in areas where armed...... drones have been active, the US use of European-originated intelligence to execute targeted killings, and the broader status of international law, are developments that illustrate the importance of the topic. Yet, the EU still does not have an official position on armed drones. In 2014 the European...... Parliament recognized that this is problematic, adopting a Resolution that expressed “grave concern over the use of armed drones outside the international legal framework” and that urged the EU to “develop an appropriate policy response at both European and global level”. This Forum answers to the European...

Reassembling Surveillance Creep

DEFF Research Database (Denmark)

Bøge, Ask Risom; Lauritsen, Peter

2017-01-01

We live in societies in which surveillance technologies are constantly introduced, are transformed, and spread to new practices for new purposes. How and why does this happen? In other words, why does surveillance “creep”? This question has received little attention either in theoretical developm......We live in societies in which surveillance technologies are constantly introduced, are transformed, and spread to new practices for new purposes. How and why does this happen? In other words, why does surveillance “creep”? This question has received little attention either in theoretical...... development or in empirical analyses. Accordingly, this article contributes to this special issue on the usefulness of Actor-Network Theory (ANT) by suggesting that ANT can advance our understanding of ‘surveillance creep’. Based on ANT’s model of translation and a historical study of the Danish DNA database......, we argue that surveillance creep involves reassembling the relations in surveillance networks between heterogeneous actors such as the watchers, the watched, laws, and technologies. Second, surveillance creeps only when these heterogeneous actors are adequately interested and aligned. However...

Using Acute Flaccid Paralysis Surveillance as a Platform for Vaccine-Preventable Disease Surveillance.

Science.gov (United States)

Wassilak, Steven G F; Williams, Cheryl L; Murrill, Christopher S; Dahl, Benjamin A; Ohuabunwo, Chima; Tangermann, Rudolf H

2017-07-01

Surveillance for acute flaccid paralysis (AFP) is a fundamental cornerstone of the global polio eradication initiative (GPEI). Active surveillance (with visits to health facilities) is a critical strategy of AFP surveillance systems for highly sensitive and timely detection of cases. Because of the extensive resources devoted to AFP surveillance, multiple opportunities exist for additional diseases to be added using GPEI assets, particularly because there is generally 1 district officer responsible for all disease surveillance. For this reason, integrated surveillance has become a standard practice in many countries, ranging from adding surveillance for measles and rubella to integrated disease surveillance for outbreak-prone diseases (integrated disease surveillance and response). This report outlines the current level of disease surveillance integration in 3 countries (Nepal, India, and Nigeria) and proposes that resources continue for long-term maintenance in resource-poor countries of AFP surveillance as a platform for surveillance of vaccine-preventable diseases and other outbreak-prone diseases. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Redefining syndromic surveillance

Directory of Open Access Journals (Sweden)

Rebecca Katz

2011-12-01

Full Text Available With growing concerns about international spread of disease and expanding use of early disease detection surveillance methods, the field of syndromic surveillance has received increased attention over the last decade. The purpose of this article is to clarify the various meanings that have been assigned to the term syndromic surveillance and to propose a refined categorization of the characteristics of these systems. Existing literature and conference proceedings were examined on syndromic surveillance from 1998 to 2010, focusing on low- and middle-income settings. Based on the 36 unique definitions of syndromic surveillance found in the literature, five commonly accepted principles of syndromic surveillance systems were identified, as well as two fundamental categories: specific and non-specific disease detection. Ultimately, the proposed categorization of syndromic surveillance distinguishes between systems that focus on detecting defined syndromes or outcomes of interest and those that aim to uncover non-specific trends that suggest an outbreak may be occurring. By providing an accurate and comprehensive picture of this field’s capabilities, and differentiating among system types, a unified understanding of the syndromic surveillance field can be developed, encouraging the adoption, investment in, and implementation of these systems in settings that need bolstered surveillance capacity, particularly low- and middle-income countries.

Safe ageing management of nuclear power plants: An European synthesis

International Nuclear Information System (INIS)

Grandemange, J.M.

2002-01-01

Ageing of nuclear power plants means evolution of material or equipment properties on one side, and evolution of personnel skill and procedure adequacy on the other side, both of which, after a certain time, may not be compatible with the required safety provisions, or with an economic operation of the plant. Repair or replacement of components, as well as change in service conditions for a better compatibility with component reduced capabilities can be used to mitigate ageing effects. The paper summarises the results of a study conducted in this field with the support of the European Commission. It presents: the synthesis of the work done under international auspices, and in the European context; the comparison of ageing management approaches used in several European countries with international recommendations; the summary of the various potential phenomena and their governing parameters, the methods of in-service ageing identification and possible mitigation methods; illustrative ageing management practices, taking material ageing aspects as examples. Concerning the first topic, the European report identifies 56 OECD and IAEA reports on ageing management issues, 35 being summarised in an appendix to the report. It also identifies numerous European and international studies covering topics of interest to ageing and Plant Life management. ageing management approaches have been considered from the regulatory point of view and from the utilities management point of view. Contributors to the study have identified a general consensus in Europe, with no limited time operating authorisation, the safety being a utility responsibility under continuous surveillance by the regulatory authority. Practical ageing management methods include: periodic safety reviews (PSR), a ten years periodicity being a common practice, completed by continuous ageing management taking into account safety and industrial anticipation needs; the implementation of life-time management programmes

Energy regulation at EU level. The role of the European Commission and ACER in the context of REMIT; Energieregulierung auf Unionsebene. Die Rolle der Europaeischen Kommission und der ACER nach der REMIT-VO

Energy Technology Data Exchange (ETDEWEB)

Konar, Selma [Sozietaet Becker Buettner Held, Muenchen (Germany). Energie- und Infrastrukturrecht

2015-03-15

The regulatory act of promulgating REMIT, the Regulation on Wholesale Market Integrity and Transparency, has highlighted the commanding position of both the European Commission and ACER, the Agency for the Cooperation of Energy Regulators, in the regulation of energy affairs in the European Union. Furthermore it has led to major changes in how surveillance is organized at the national level. The first part of this publication is dedicated to the organization of market surveillance following the promulgation of REMIT. It depicts the tasks of the European Commission and ACER in this context. The Regulation has accorded the authorities a central role in managing the European Union's responsibilities with regard to energy wholesale trade. The act of delegating such far-reaching competence to the authorities deserves careful review however. The article shows how, given ACER's lack of practical experience in market surveillance, as well as its lack of human resources, the task of surveilling the European energy wholesale market confronts the agency with a significant challenge. How successfully the EU energy agency will master this challenge will depend on a number of different factors. Stringent requirements will be needed for the data registration offices in order to ensure optimal data processing. National authorities and supervisory bodies should be made to participate in the data monitoring process. ACER's efficiency in surveilling the market will furthermore depend decisively on its IT infrastructure.

Schistosomiasis in european travelers and migrants

DEFF Research Database (Denmark)

Lingscheid, Tilman; Kurth, Florian; Clerinx, Jan

2017-01-01

Schistosomiasis remains one of the most prevalent parasitic diseases worldwide and the infection is frequently found in travelers and migrants. The European Network for Tropical Medicine and Travel Health conducted a sentinel surveillance study on imported schistosomiasis between 1997 and 2010...... or antigen testing. Schistosomiasis remains a frequent infection in travelers and migrants to Europe. Travelers should be made aware of the risk of schistosomiasis infection when traveling to sub-Saharan Africa. Posttravel consultations particularly for returning expatriates are useful given the high...

The plays and arts of surveillance: studying surveillance as entertainment

NARCIS (Netherlands)

Albrechtslund, Anders; Dubbeld, L.

2006-01-01

This paper suggests a direction in the development of Surveillance Studies that goes beyond current attention for the caring, productive and enabling aspects of surveillance practices. That is, surveillance could be considered not just as positively protective, but even as a comical, playful,

gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease--sub-analysis of the Japan TAXUS Express2 post-marketing survey.

Science.gov (United States)

Okura, Hiroyuki; Nakamura, Masato; Kotani, Jun-Ichi; Kozuma, Ken

2013-01-01

 Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome.  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, Ptarget lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05).  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year. 

Surveillance and Critical Theory

Directory of Open Access Journals (Sweden)

Christian Fuchs

2015-09-01

Full Text Available In this comment, the author reflects on surveillance from a critical theory approach, his involvement in surveillance research and projects, and the status of the study of surveillance. The comment ascertains a lack of critical thinking about surveillance, questions the existence of something called “surveillance studies” as opposed to a critical theory of society, and reflects on issues such as Edward Snowden’s revelations, and Foucault and Marx in the context of surveillance.

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...

Information management and ante-mortem inspection procedures for the emerging diseases control: Experiences acquired in the epidemiological surveillance of bluetongue and lumpy skin disease.

Science.gov (United States)

Corradini, Alessandra; Trevisani, Marcello; Dosa, Geremia; Padovani, Anna

2018-03-31

The spread of exotic, emerging and reemerging diseases, has become, in the last years, one of the most important threats to the animal productions and public health, representing a new challenge for the European Community. In a global-market framework, where trade and contacts between countries are simplified, effective and well-developed surveillance systems are necessary. Multiple factors are, in fact, associated with the emergence of new, known or exotic diseases in this new economic panorama and for these reasons controls on animal imports, traceability and timeliness detection of infected animals should be considered the basis of a sound surveillance. In this work, we focused our attention on the management of Bluetongue and on the risk of introduction of the Lumpy Skin Disease in Italy, in order to describe the national and European surveillance systems for these diseases. In particular, we underlined the crucial role of information that reach the Official Veterinarian at the slaughterhouse concerning the epidemiological situation of the sending countries. Information that are important for the management of the ante-mortem inspection and for increasing the awareness of the Veterinary Inspectors of their role in the surveillance.

Information management and ante-mortem inspection procedures for the emerging diseases control: Experiences acquired in the epidemiological surveillance of bluetongue and lumpy skin disease

Directory of Open Access Journals (Sweden)

Alessandra Corradini

2018-03-01

Full Text Available The spread of exotic, emerging and reemerging diseases, has become, in the last years, one of the most important threats to the animal productions and public health, representing a new challenge for the European Community. In a global-market framework, where trade and contacts between countries are simplified, effective and well-developed surveillance systems are necessary. Multiple factors are, in fact, associated with the emergence of new, known or exotic diseases in this new economic panorama and for these reasons controls on animal imports, traceability and timeliness detection of infected animals should be considered the basis of a sound surveillance. In this work, we focused our attention on the management of Bluetongue and on the risk of introduction of the Lumpy Skin Disease in Italy, in order to describe the national and European surveillance systems for these diseases. In particular, we underlined the crucial role of information that reach the Official Veterinarian at the slaughterhouse concerning the epidemiological situation of the sending countries. Information that are important for the management of the ante-mortem inspection and for increasing the awareness of the Veterinary Inspectors of their role in the surveillance.

Ideology, Critique and Surveillance

Directory of Open Access Journals (Sweden)

Heidi Herzogenrath-Amelung

2013-11-01

Full Text Available The 2013 revelations concerning global surveillance programmes demonstrate in unprecedented clarity the need for Critical Theory of information and communication technologies (ICTs to address the mechanisms and implications of increasingly global, ubiquitous surveillance. This is all the more urgent because of the dominance of the “surveillance ideology” (the promise of security through surveillance that supports the political economy of surveillance. This paper asks which theoretical arguments and concepts can be useful for philosophically grounding a critique of this surveillance ideology. It begins by examining how the surveillance ideology works through language and introduces the concept of the ‘ideological packaging’ of ICTs to show how rhetoric surrounding the implementation of surveillance technologies reinforces the surveillance ideology. It then raises the problem of how ideology-critique can work if it relies on language itself and argues that Martin Heidegger’s philosophy can make a useful contribution to existing critical approaches to language.

Challenges of maintaining polio-free status of the European Region.

Science.gov (United States)

Khetsuriani, Nino; Pfeifer, Dina; Deshevoi, Sergei; Gavrilin, Eugene; Shefer, Abigail; Butler, Robb; Jankovic, Dragan; Spataru, Roman; Emiroglu, Nedret; Martin, Rebecca

2014-11-01

The European region, certified as polio free in 2002, had recent wild poliovirus (WPV) introductions, resulting in a major outbreak in Central Asian countries and Russia in 2010 and in current widespread WPV type 1 circulation in Israel, which endangered the polio-free status of the region. We assessed the data on the major determinants of poliovirus transmission risk (population immunity, surveillance, and outbreak preparedness) and reviewed current threats and measures implemented in response to recent WPV introductions. Despite high regional vaccination coverage and functioning surveillance, several countries in the region are at high or intermediate risk of poliovirus transmission. Coverage remains suboptimal in some countries, subnational geographic areas, and population groups, and surveillance (acute flaccid paralysis, enterovirus, and environmental) needs further strengthening. Supplementary immunization activities, which were instrumental in the rapid interruption of WPV1 circulation in 2010, should be implemented in high-risk countries to close population immunity gaps. National polio outbreak preparedness plans need strengthening. Immunization efforts to interrupt WPV transmission in Israel should continue. The European region has successfully maintained its polio-free status since 2002, but numerous challenges remain. Staying polio free will require continued coordinated efforts, political commitment and financial support from all countries. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Who is Surveilling Whom?

DEFF Research Database (Denmark)

Mortensen, Mette

2014-01-01

This article concerns the particular form of counter-surveillance termed “sousveillance”, which aims to turn surveillance at the institutions responsible for surveillance. Drawing on the theoretical perspectives “mediatization” and “aerial surveillance,” the article studies WikiLeaks’ publication...

SOA-surveillance Nederland

NARCIS (Netherlands)

Rijlaarsdam J; Bosman A; Laar MJW van de; CIE

2000-01-01

In May 1999 a working group was started to evaluate the current surveillance systems for sexually transmitted diseases (STD) and to make suggestions for a renewed effective and efficient STD surveillance system in the Netherlands. The surveillance system has to provide insight into the prevalence

The nationwide case-cohort study in pharmacoepidemiology: a study of iatrogenic anaphylaxis and agranulocytosis

NARCIS (Netherlands)

M.M. van der Klauw (Melanie)

1997-01-01

textabstractDrug safety is an important palt of postmarketing surveillance. In ancient times, people were already aware of the fact that drugs could have side effects. The oldest drugs were mainly of plant and animal origin, but also mercury, arsenic and antimony were used, the toxic effects of

Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

Science.gov (United States)

Sakoulas, G

2009-12-01

The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

Science.gov (United States)

Bollaerts, Kaatje; De Smedt, Tom; Donegan, Katherine; Titievsky, Lina; Bauchau, Vincent

2018-03-26

New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact. With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines. We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit-risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines. The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed. The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data.

Attributing foodborne salmonellosis in humans to animal reservoirs in the European Union using a multi-country stochastic model

DEFF Research Database (Denmark)

de Knegt, Leonardo; Pires, Sara Monteiro; Hald, Tine

2015-01-01

A Bayesian modelling approach comparing the occurrence of Salmonella serovars in animals and humans was used to attribute salmonellosis cases to broilers, turkeys, pigs, laying hens, travel and outbreaks in 24 European Union countries. Salmonella data for animals and humans, covering the period f......, highlighting differences in the epidemiology of Salmonella, surveillance focus and eating habits across the European Union....

Second European multi-disciplinary conference of national strategies for Chlamydia trach. and human papillomavirus NSCP conf. in Berlin, 2013 enhanced detection, management and surveillance of sexually transmitted infections in Europe are essential!

Science.gov (United States)

Ozolins, D; D' Elios, M M; Ripa, T; Bailey, R; Timms, P; Spiteri, G; Haar, K; Unemo, M

2013-01-01

There is a need for updated guidance on detection, management and surveillance of sexually transmitted infections (STIs). Chlamydia, gonorrhoea and syphilisreporting needs to be mandatory in more European countries to aid collection of data. More widespread Chlamydia screening is needed in many countries as this is the only way to reduce complications. The role of Human Papillomavirus (HPV) screening in a situation where the prevalence of HPV infection has dropped significantly was also discussed in the context of the high cost of screening, the need for a relatively complex infrastructure, particularly in developing countries, and falling vaccination costs. An integrated HPV vaccination and screening policy could be the most appropriate with vaccination at 9-13 years as recommended by WHO and a single HPV screen at 35-39 years, possibly repeated thereafter every 10 years. Female and male HPV vaccination programmes could lead to near elimination of genital warts in both females and males. Surveillance of STIsshould be intensified where needed; additional or better quality data should be collected including reasons for testing, denominator data to estimate positivity rates, diagnostic methods, concurrent STIs, sexual orientation and country of acquisition; more analytical rather than descriptive epidemiology is needed.

Hallucinatory Side Effects of ADHD Drugs

Directory of Open Access Journals (Sweden)

J Gordon Millichap

2009-04-01

Full Text Available Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug Administration, and Department of Health and Human Services, Maryland.

Overweight and obesity in primary-school children: a surveillance system for policy-making in Europe from 2007 onwards

NARCIS (Netherlands)

Wijnhoven, T.M.A.

2015-01-01

Trudy M.A. Wijnhoven

Overweight and obesity in primary-school children: a surveillance system for policy-making in Europe from 2007 onwards.

Background

As a follow-up to the European Ministerial Conference on

Surveillance of environmental radiation in Finland. Annual Report 2002

International Nuclear Information System (INIS)

Mustonen, R.

2003-01-01

The main goal of the surveillance of environmental radioactivity is to be always aware of the levels of radiation to which the public is exposed. Another goal is to detect all remarkable changes in the levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on a continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on both national and EU legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for the surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air, water and soil in the Member States. In Finland, the Finnish Meteorological Institute (FMI) and the Defence Forces also monitor environmental radiation at their own stations. This report summarises the results of environmental radiation surveillance in 2002. The report also contains some comparisons with results from the previous years. The results are obtained from the monitoring programmes of STUK, FMI and the Defence Forces Research Institute of Technology. Nuclear power plant licensees are responsible for environmental surveillance in the vicinity of nuclear power plants in Finland. These results are reported elsewhere. STUK's partners in the surveillance of environmental radioactivity collect and deliver environmental samples for laboratory analyses, or participate in whole-body counting. STUK would like to express its gratitude to the following institutions for successful co-operation: The Finnish Defence Forces, the Finnish

Surveillance of environmental radiation in Finland. Annual Report 2003

International Nuclear Information System (INIS)

Mustonen, R.

2004-01-01

The main goal of the surveillance of environmental radioactivity is to be always aware of the levels of radiation to which the public is exposed. Another goal is to detect all remarkable changes in the levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on a continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on both national and EU legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for the surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air, water and soil in the Member States. In Finland, the Finnish Meteorological Institute (FMI) and the Defence Forces also monitor environmental radiation at their own stations. This report summarises the results of environmental radiation surveillance in 2003. The report also contains some comparisons with results from the previous years. The results are obtained from the monitoring programmes of STUK, FMI and the Defence Forces Research Institute of Technology. Nuclear power plant licensees are responsible for environmental surveillance in the vicinity of nuclear power plants in Finland. These results are reported elsewhere. STUK's partners in the surveillance of environmental radioactivity collect and deliver environmental samples for laboratory analyses, or participate in whole-body counting. STUK would like to express its gratitude to the following institutions for successful co- operation: The Finnish Defence Forces, the Finnish

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.

Surveillance of environmental radiation in Finland. Annual report 2011; Ympaeristoen saeteilyvalvonta Suomessa. Vuosiraportti 2011

Energy Technology Data Exchange (ETDEWEB)

Mustonen, R. (ed.)

2012-08-15

The main goal of the surveillance of environmental radioactivity is to be always aware of levels of artificial radiation in the environment to which the public is exposed. Another goal is to detect all remarkable changes in levels of environmental radiation and radioactivity. Compliance with the basic safety standards laid down for protection of health of the general public against dangers arising from ionising radiation can be ensured with environmental radiation surveillance. Running of surveillance programmes on continuous basis also maintains and develops competence and readiness to respond to radiological emergencies. This report summarises the results of environmental radiation surveillance in 2011. The report also contains some comparisons with results from the previous years. Surveillance of environmental radiation contains surveillance of artificial radiation and artificial radioactive elements in the environment. Natural radiation and natural radioactive elements are not associated with the surveillance programme, although the greater part of the public exposure to radiation is caused by natural radiation. Exposure to natural radiation is controlled separately if there is reason to suspect, that natural radioactive elements cause unusual high exposure to the public (e.g. indoor radon and natural radionuclides in drinking water). Nuclear power plant licensees are responsible for environmental surveillance in the vicinity of nuclear power plants in Finland. Those results are reported elsewhere. Surveillance of environmental radioactivity in Finland is one of the official obligations of the Radiation and Nuclear Safety Authority (STUK). This obligation is based on the national and the European Communities' legislation. The Finnish radiation protection legislation appoints STUK as the national authority responsible for surveillance of environmental radioactivity, and the Euratom Treaty assumes continuous monitoring of levels of radioactivity in the air

European Medicines Agency initiatives and perspectives on pharmacogenomics

Science.gov (United States)

Ehmann, Falk; Caneva, Laura; Papaluca, Marisa

2014-01-01

Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to support further the implementation of pharmacogenomics in drug development and surveillance so that patients and the public can benefit from advances in genomic science and technology. PMID:24433361

Evaluation of the cost-effectiveness of bovine brucellosis surveillance in a disease-free country using stochastic scenario tree modelling.

Directory of Open Access Journals (Sweden)

Viviane Hénaux

Full Text Available Surveillance systems of exotic infectious diseases aim to ensure transparency about the country-specific animal disease situation (i.e. demonstrate disease freedom and to identify any introductions. In a context of decreasing resources, evaluation of surveillance efficiency is essential to help stakeholders make relevant decisions about prioritization of measures and funding allocation. This study evaluated the efficiency (sensitivity related to cost of the French bovine brucellosis surveillance system using stochastic scenario tree models. Cattle herds were categorized into three risk groups based on the annual number of purchases, given that trading is considered as the main route of brucellosis introduction in cattle herds. The sensitivity in detecting the disease and the costs of the current surveillance system, which includes clinical (abortion surveillance, programmed serological testing and introduction controls, were compared to those of 19 alternative surveillance scenarios. Surveillance costs included veterinary fees and laboratory analyses. The sensitivity over a year of the current surveillance system was predicted to be 91±7% at a design prevalence of 0.01% for a total cost of 14.9±1.8 million €. Several alternative surveillance scenarios, based on clinical surveillance and random or risk-based serological screening in a sample (20% of the population, were predicted to be at least as sensitive but for a lower cost. Such changes would reduce whole surveillance costs by 20 to 61% annually, and the costs for farmers only would be decreased from about 12.0 million € presently to 5.3-9.0 million € (i.e. 25-56% decrease. Besides, fostering the evolution of the surveillance system in one of these directions would be in agreement with the European regulations and farmers perceptions on brucellosis risk and surveillance.

Evaluation of the cost-effectiveness of bovine brucellosis surveillance in a disease-free country using stochastic scenario tree modelling.

Science.gov (United States)

Hénaux, Viviane; Calavas, Didier

2017-01-01

Surveillance systems of exotic infectious diseases aim to ensure transparency about the country-specific animal disease situation (i.e. demonstrate disease freedom) and to identify any introductions. In a context of decreasing resources, evaluation of surveillance efficiency is essential to help stakeholders make relevant decisions about prioritization of measures and funding allocation. This study evaluated the efficiency (sensitivity related to cost) of the French bovine brucellosis surveillance system using stochastic scenario tree models. Cattle herds were categorized into three risk groups based on the annual number of purchases, given that trading is considered as the main route of brucellosis introduction in cattle herds. The sensitivity in detecting the disease and the costs of the current surveillance system, which includes clinical (abortion) surveillance, programmed serological testing and introduction controls, were compared to those of 19 alternative surveillance scenarios. Surveillance costs included veterinary fees and laboratory analyses. The sensitivity over a year of the current surveillance system was predicted to be 91±7% at a design prevalence of 0.01% for a total cost of 14.9±1.8 million €. Several alternative surveillance scenarios, based on clinical surveillance and random or risk-based serological screening in a sample (20%) of the population, were predicted to be at least as sensitive but for a lower cost. Such changes would reduce whole surveillance costs by 20 to 61% annually, and the costs for farmers only would be decreased from about 12.0 million € presently to 5.3-9.0 million € (i.e. 25-56% decrease). Besides, fostering the evolution of the surveillance system in one of these directions would be in agreement with the European regulations and farmers perceptions on brucellosis risk and surveillance.

European surveillance for enterovirus D68 during the emerging North-American outbreak in 2014

DEFF Research Database (Denmark)

Poelman, Randy; Schuffenecker, Isabelle; Van Leer-Buter, Coretta

2015-01-01

BACKGROUND: In August and September 2014, unexpected clusters of enterovirus-D68 (EV-D68) infections associated with severe respiratory disease emerged from North-America. In September, the European Centre for Disease Prevention and Control (ECDC) asked European countries to strengthen respiratory...... sample screening for enterovirus detection and typing in cases with severe respiratory presentations. OBJECTIVES: To provide a detailed picture of EV-D68 epidemiology in Europe by conducting a retrospective and prospective laboratory analysis of clinical specimens. STUDY DESIGN: An initiative supported...

The French surveillance network of Creutzfeldt-Jakob disease. Epidemiological data in France and worldwide.

Science.gov (United States)

Brandel, J-P; Peckeu, L; Haïk, S

2013-09-01

France, involved for a long time in the epidemiological surveillance of transmissible spongiform encephalopathy (TSE), created a national network of surveillance in 1991, because of the description of the first cases of Creutzfeldt-Jakob disease (CJD) linked to a treatment by growth hormone of human origin and the observation of cases of cats infected with the agent of the bovine spongiform encephalopathy in the United Kingdom (UK). The French surveillance network is integrated into the European network of surveillance since its creation in 1993. As in other countries, sporadic CJD is the most frequent form of TSE in France with an annual mortality rate of 1.44 per million. Genetic forms are most often associated with a mutation at codon 200. Among the cases of iatrogenic CJD, 13 cases of CJD after duramater grafts were observed and 119 related to treatment with growth hormone. France is the country worst affected in Europe and the world by this latter form, before the USA and UK. Since 1996, 27 cases of variant of CJD (vCJD) has been observed, making France the second country in the world most affected after the UK. No cases of transfusion-associated vCJD have been observed. Copyright © 2013. Published by Elsevier SAS.

21 CFR 822.17 - How long will your review of my submission take?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How long will your review of my submission take... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA Review and Action § 822.17 How long will your review of my submission take? We will review your submission within 60 days of receipt. ...

Surveillance Culture

DEFF Research Database (Denmark)

2017-01-01

What does it mean to live in a world full of surveillance? In this documentary film, we take a look at everyday life in Denmark and how surveillance technologies and practices influence our norms and social behaviour. Researched and directed by Btihaj Ajana and Anders Albrechtslund....

The Nigerian health care system: Need for integrating adequate medical intelligence and surveillance systems

Directory of Open Access Journals (Sweden)

Menizibeya Osain Welcome

2011-01-01

Full Text Available Objectives : As an important element of national security, public health not only functions to provide adequate and timely medical care but also track, monitor, and control disease outbreak. The Nigerian health care had suffered several infectious disease outbreaks year after year. Hence, there is need to tackle the problem. This study aims to review the state of the Nigerian health care system and to provide possible recommendations to the worsening state of health care in the country. To give up-to-date recommendations for the Nigerian health care system, this study also aims at reviewing the dynamics of health care in the United States, Britain, and Europe with regards to methods of medical intelligence/surveillance. Materials and Methods : Databases were searched for relevant literatures using the following keywords: Nigerian health care, Nigerian health care system, and Nigerian primary health care system. Additional keywords used in the search were as follows: United States (OR Europe health care dynamics, Medical Intelligence, Medical Intelligence systems, Public health surveillance systems, Nigerian medical intelligence, Nigerian surveillance systems, and Nigerian health information system. Literatures were searched in scientific databases Pubmed and African Journals OnLine. Internet searches were based on Google and Search Nigeria. Results : Medical intelligence and surveillance represent a very useful component in the health care system and control diseases outbreak, bioattack, etc. There is increasing role of automated-based medical intelligence and surveillance systems, in addition to the traditional manual pattern of document retrieval in advanced medical setting such as those in western and European countries. Conclusion : The Nigerian health care system is poorly developed. No adequate and functional surveillance systems are developed. To achieve success in health care in this modern era, a system well grounded in routine

Overview of the Disease Situation and Surveillance in Europe In 2011

DEFF Research Database (Denmark)

Olesen, Niels Jørgen; Nicolajsen, Nicole

2012-01-01

with focus on the listed diseases but also including other diseases of interest. 3. Laboratory data from the NRLs and other laboratories, including number of samples examined, diagnoses of fish diseases made. A new part was included for 2011 as a deliverable for the EFSA project CFP/EFSA/AHAW/2011/03: Risk...... categorisation for Aquatic Animal Health Surveillance: 4. Status on implementation of the new fish health surveillance legislation. The data on the European aquaculture production were obtained from the FIGIS database. Unfortunately this database does not include information on the number and size of fish farms......, which are epidemiologically important data. The production in 2010 is almost the same as in 2009 and has for the sixth time in row raised from the previous year and has now passed 2 million ton (Figur 1) Data from 2011 is not yet available. The farm sizes vary a lot between countries, e.g. the majority...

[Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

Science.gov (United States)

Li, Yuanyuan; Xie, Yanming

2011-10-01

The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

Workers' health surveillance: implementation of the Directive 89/391/EEC in Europe.

Science.gov (United States)

Colosio, C; Mandic-Rajcevic, S; Godderis, L; van der Laan, G; Hulshof, C; van Dijk, F

2017-10-01

European Union (EU) Directive 89/391 addressed occupational health surveillance, which recommends to provide workers with 'access to health surveillance at regular intervals', aiming to prevent work-related and occupational diseases. To investigate how EU countries adopted this Directive. We invited one selected representative per member state to complete a questionnaire. All 28 EU countries implemented the Directive in some form. Workers' health surveillance (WHS) is available to all workers in 15 countries, while in 12, only specific subgroups have access. In 21 countries, workers' participation is mandatory, and in 22, the employer covers the cost. In 13 countries, access to WHS is not available to all workers but depends on exposure to specific risk factors, size of the enterprise or belonging to vulnerable groups. In 26 countries, the employer appoints and revokes the physician in charge of WHS. Twelve countries have no recent figures, reports or cost-benefit analyses of their WHS programmes. In 15 countries where reports exist, they are often in the native language. Coverage and quality of occupational health surveillance should be evaluated to facilitate learning from good practice and from scientific studies. We propose a serious debate in the EU with the aim of protecting workers more effectively, including the use of evidence-based WHS programmes. © The Author 2017. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com

21 CFR 822.2 - What is the purpose of this part?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What is the purpose of this part? 822.2 Section 822.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE General Provisions § 822.2 What is the purpose of this part? The...

21 CFR 822.16 - What will you consider in the review of my submission?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What will you consider in the review of my submission? 822.16 Section 822.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA Review and Action § 822.16 What will you...

Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED)

Science.gov (United States)

Dinis-Ribeiro, M.; Areia, M.; de Vries, A. C.; Marcos-Pinto, R.; Monteiro-Soares, M.; O'Connor, A.; Pereira, C.; Pimentel-Nunes, P.; Correia, R.; Ensari, A.; Dumonceau, J. M.; Machado, J. C.; Macedo, G.; Malfertheiner, P.; Matysiak-Budnik, T.; Megraud, F.; Miki, K.; O'Morain, C.; Peek, R. M.; Ponchon, T.; Ristimaki, A.; Rembacken, B.; Carneiro, F.; Kuipers, E. J.

2012-01-01

Atrophic gastritis, intestinal metaplasia, and epithelial dysplasia of the stomach are common and are associated with an increased risk for gastric cancer. In the absence of guidelines, there is wide disparity in the management of patients with these premalignant conditions. The European Society of Gastrointestinal Endoscopy (ESGE), the European Helicobacter Study Group (EHSG), the European Society of Pathology (ESP) and the Sociedade Portuguesa de Endoscopia Digestiva (SPED) have therefore combined efforts to develop evidence-based guidelines on the management of patients with precancerous conditions and lesions of the stomach (termed MAPS). A multidisciplinary group of 63 experts from 24 countries developed these recommendations by means of repeat online voting and a meeting in June 2011 in Porto, Portugal. The recommendations emphasize the increased cancer risk in patients with gastric atrophy and metaplasia, and the need for adequate staging in the case of high grade dysplasia, and they focus on treatment and surveillance indications and methods. PMID:22198778

A proposal to create an extension to the European baseline series.

Science.gov (United States)

Wilkinson, Mark; Gallo, Rosella; Goossens, An; Johansen, Jeanne D; Rustemeyer, Thomas; Sánchez-Pérez, Javier; Schuttelaar, Marie L; Uter, Wolfgang

2018-02-01

The current European baseline series consists of 30 allergens, and was last updated in 2015. To use data from the European Surveillance System on Contact Allergies (ESSCA) to propose an extension to the European baseline series in response to changes in environmental exposures. Data from departmental and national extensions to the baseline series, together with some temporary additions from departments contributing to the ESSCA, were collated during 2013-2014. In total, 31689 patients were patch tested in 46 European departments. Many departments and national groups already consider the current European baseline series to be a suboptimal screen, and use their own extensions to it. The haptens tested are heterogeneous, although there are some consistent themes. Potential haptens to include in an extension to the European baseline series comprise sodium metabisulfite, formaldehyde-releasing preservatives, additional markers of fragrance allergy, propolis, Compositae mix, and 2-hydroxyethyl methacrylate. In combination with other published work from the ESSCA, changes to the current European baseline series are proposed for discussion. As well as addition of the allergens listed above, it is suggested that primin and clioquinol should be deleted from the series, owing to reduced environmental exposure. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Limits on surveillance: frictions, fragilities and failures in the operation of camera surveillance.

NARCIS (Netherlands)

Dubbeld, L.

2004-01-01

Public video surveillance tends to be discussed in either utopian or dystopian terms: proponents maintain that camera surveillance is the perfect tool in the fight against crime, while critics argue that the use of security cameras is central to the development of a panoptic, Orwellian surveillance

The surveillance of the electricity wholesale market and emission trading market; Die Ueberwachung von Stromgrosshandelsmarkt und Emissionshandelsmarkt

Energy Technology Data Exchange (ETDEWEB)

Luedemann, Volker [Hochschule Osnabrueck (Germany). Forschungszentrum Energiewirtschaft/Energierecht (fee); Hochschule Osnabrueck (Germany). Wirtschafts- und Wettbewerbsrecht; Konar, Selma [Sozietaet Becker Buettner Held, Muenchen (Germany)

2015-05-15

The Regulation on Wholesale Market Integrity and Transparency (REMIT) and the German Law on the Establishment of a Market Transparency Office for Wholesale Trade in Electricity and Gas (MTS-G) have fundamentally changed the surveillance of electricity wholesale trade in Germany. From now on the Federal Network Agency and the Federal Cartel Office will be jointly responsible for monitoring the electricity wholesale trade for suspicious market phenomena and abusive behaviour. The REMIT specifies that the electricity trade must be surveilled ''with due consideration to interactions'' with the emission trade system. However, occurrences observed in recent years have shown that the emission trading system is in need of reform. This has also been recognised and has prompted extensive corrective action by the regulatory authorities of the European Union. These changes have yet to be transposed into the national surveillance regimes. The present article explains why the new role accorded to the Federal Network Agency under the REMIT fails to eliminate the structural shortcomings of the old surveillance system. At least the decision to put the collection and evaluation of data exclusively in the hands of the market transparency office and the cooperation this will prompt between the supervisory authorities responsible will make the task of surveilling the energy wholesale trading market a lot easier for the authorities. The energy transition and its exigencies will yet lead to further changes in the market and its surveillance regime.

Handbook of surveillance technologies

CERN Document Server

Petersen, JK

2012-01-01

From officially sanctioned, high-tech operations to budget spy cameras and cell phone video, this updated and expanded edition of a bestselling handbook reflects the rapid and significant growth of the surveillance industry. The Handbook of Surveillance Technologies, Third Edition is the only comprehensive work to chronicle the background and current applications of the full-range of surveillance technologies--offering the latest in surveillance and privacy issues.Cutting-Edge--updates its bestselling predecessor with discussions on social media, GPS circuits in cell phones and PDAs, new GIS s

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

Science.gov (United States)

Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2017-07-01

This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

Containment and surveillance devices

International Nuclear Information System (INIS)

Campbell, J.W.; Johnson, C.S.; Stieff, L.R.

The growing acceptance of containment and surveillance as a means to increase safeguards effectiveness has provided impetus to the development of improved surveillance and containment devices. Five recently developed devices are described. The devices include one photographic and two television surveillance systems and two high security seals that can be verified while installed

A concept for routine emergency-care data-based syndromic surveillance in Europe.

Science.gov (United States)

Ziemann, A; Rosenkötter, N; Garcia-Castrillo Riesgo, L; Schrell, S; Kauhl, B; Vergeiner, G; Fischer, M; Lippert, F K; Krämer, A; Brand, H; Krafft, T

2014-11-01

We developed a syndromic surveillance (SyS) concept using emergency dispatch, ambulance and emergency-department data from different European countries. Based on an inventory of sub-national emergency data availability in 12 countries, we propose framework definitions for specific syndromes and a SyS system design. We tested the concept by retrospectively applying cumulative sum and spatio-temporal cluster analyses for the detection of local gastrointestinal outbreaks in four countries and comparing the results with notifiable disease reporting. Routine emergency data was available daily and electronically in 11 regions, following a common structure. We identified two gastrointestinal outbreaks in two countries; one was confirmed as a norovirus outbreak. We detected 1/147 notified outbreaks. Emergency-care data-based SyS can supplement local surveillance with near real-time information on gastrointestinal patients, especially in special circumstances, e.g. foreign tourists. It most likely cannot detect the majority of local gastrointestinal outbreaks with few, mild or dispersed cases.

An integrated national mortality surveillance system for death registration and mortality surveillance, China.

Science.gov (United States)

Liu, Shiwei; Wu, Xiaoling; Lopez, Alan D; Wang, Lijun; Cai, Yue; Page, Andrew; Yin, Peng; Liu, Yunning; Li, Yichong; Liu, Jiangmei; You, Jinling; Zhou, Maigeng

2016-01-01

In China, sample-based mortality surveillance systems, such as the Chinese Center for Disease Control and Prevention's disease surveillance points system and the Ministry of Health's vital registration system, have been used for decades to provide nationally representative data on health status for health-care decision-making and performance evaluation. However, neither system provided representative mortality and cause-of-death data at the provincial level to inform regional health service needs and policy priorities. Moreover, the systems overlapped to a considerable extent, thereby entailing a duplication of effort. In 2013, the Chinese Government combined these two systems into an integrated national mortality surveillance system to provide a provincially representative picture of total and cause-specific mortality and to accelerate the development of a comprehensive vital registration and mortality surveillance system for the whole country. This new system increased the surveillance population from 6 to 24% of the Chinese population. The number of surveillance points, each of which covered a district or county, increased from 161 to 605. To ensure representativeness at the provincial level, the 605 surveillance points were selected to cover China's 31 provinces using an iterative method involving multistage stratification that took into account the sociodemographic characteristics of the population. This paper describes the development and operation of the new national mortality surveillance system, which is expected to yield representative provincial estimates of mortality in China for the first time.

Digital dashboard design using multiple data streams for disease surveillance with influenza surveillance as an example.

Science.gov (United States)

Cheng, Calvin K Y; Ip, Dennis K M; Cowling, Benjamin J; Ho, Lai Ming; Leung, Gabriel M; Lau, Eric H Y

2011-10-14

Great strides have been made exploring and exploiting new and different sources of disease surveillance data and developing robust statistical methods for analyzing the collected data. However, there has been less research in the area of dissemination. Proper dissemination of surveillance data can facilitate the end user's taking of appropriate actions, thus maximizing the utility of effort taken from upstream of the surveillance-to-action loop. The aims of the study were to develop a generic framework for a digital dashboard incorporating features of efficient dashboard design and to demonstrate this framework by specific application to influenza surveillance in Hong Kong. Based on the merits of the national websites and principles of efficient dashboard design, we designed an automated influenza surveillance digital dashboard as a demonstration of efficient dissemination of surveillance data. We developed the system to synthesize and display multiple sources of influenza surveillance data streams in the dashboard. Different algorithms can be implemented in the dashboard for incorporating all surveillance data streams to describe the overall influenza activity. We designed and implemented an influenza surveillance dashboard that utilized self-explanatory figures to display multiple surveillance data streams in panels. Indicators for individual data streams as well as for overall influenza activity were summarized in the main page, which can be read at a glance. Data retrieval function was also incorporated to allow data sharing in standard format. The influenza surveillance dashboard serves as a template to illustrate the efficient synthesization and dissemination of multiple-source surveillance data, which may also be applied to other diseases. Surveillance data from multiple sources can be disseminated efficiently using a dashboard design that facilitates the translation of surveillance information to public health actions.

Mass Processing of Sentinel-1 Images for Maritime Surveillance

Directory of Open Access Journals (Sweden)

Carlos Santamaria

2017-07-01

Full Text Available The free, full and open data policy of the EU’s Copernicus programme has vastly increased the amount of remotely sensed data available to both operational and research activities. However, this huge amount of data calls for new ways of accessing and processing such “big data”. This paper focuses on the use of Copernicus’s Sentinel-1 radar satellite for maritime surveillance. It presents a study in which ship positions have been automatically extracted from more than 11,500 Sentinel-1A images collected over the Mediterranean Sea, and compared with ship position reports from the Automatic Identification System (AIS. These images account for almost all the Sentinel-1A acquisitions taken over the area during the two-year period from the start of the operational phase in October 2014 until September 2016. A number of tools and platforms developed at the European Commission’s Joint Research Centre (JRC that have been used in the study are described in the paper. They are: (1 Search for Unidentified Maritime Objects (SUMO, a tool for ship detection in Synthetic Aperture Radar (SAR images; (2 the JRC Earth Observation Data and Processing Platform (JEODPP, a platform for efficient storage and processing of large amounts of satellite images; and (3 Blue Hub, a maritime surveillance GIS and data fusion platform. The paper presents the methodology and results of the study, giving insights into the new maritime surveillance knowledge that can be gained by analysing such a large dataset, and the lessons learnt in terms of handling and processing the big dataset.

Validation of an electronic surveillance system for acute lung injury.

Science.gov (United States)

Herasevich, Vitaly; Yilmaz, Murat; Khan, Hasrat; Hubmayr, Rolf D; Gajic, Ognjen

2009-06-01

Early detection of acute lung injury (ALI) is essential for timely implementation of evidence-based therapies and enrollment into clinical trials. We aimed to determine the accuracy of computerized syndrome surveillance for detection of ALI in hospitalized patients and compare it with routine clinical assessment. Using a near-real time copy of the electronic medical records, we developed and validated a custom ALI electronic alert (ALI "sniffer") based on the European-American Consensus Conference Definition and compared its performance against provider-derived documentation. A total of 3,795 consecutive critically ill patients admitted to nine multidisciplinary intensive care units (ICUs) of a tertiary care teaching institution were included. ALI developed in 325 patients and was recognized by bedside clinicians in only 86 (26.5%). Under-recognition of ALI was associated with not implementing protective mechanical ventilation (median tidal volumes of 9.2 vs. 8.0 ml/kg predicted body weight, P sniffer" demonstrated excellent sensitivity of 96% (95% CI 94-98) and moderate specificity of 89% (95% CI 88-90) with a positive predictive value ranging from 24% (95% CI 13-40) in the heart-lung transplant ICU to 64% (95% CI 55-71) in the medical ICU. The computerized surveillance system accurately identifies critically ill patients who develop ALI syndrome. Since the lack of ALI recognition is a barrier to the timely implementation of best practices and enrollment into research studies, computerized syndrome surveillance could be a useful tool to enhance patient safety and clinical research.

Harmonisation of the acute respiratory infection reporting system in the Czech Republic with the European community networks.

NARCIS (Netherlands)

Kyncl, J.; Paget, W.J.; Havlickova, M.; Kriz, B.

2005-01-01

Respiratory virus activity is detected in Europe each winter, yet the precise timing and size of this activity is highly unpredictable. The impact of influenza infection and/or acute respiratory infection in European countries is continuously monitored through a variety of surveillance systems. All

Conditional Risk of Relapse in Surveillance for Clinical Stage I Testicular Cancer.

Science.gov (United States)

Nayan, Madhur; Jewett, Michael A S; Hosni, Ali; Anson-Cartwright, Lynn; Bedard, Philippe L; Moore, Malcolm; Hansen, Aaron R; Chung, Peter; Warde, Padraig; Sweet, Joan; O'Malley, Martin; Atenafu, Eshetu G; Hamilton, Robert J

2017-01-01

Patients on surveillance for clinical stage I (CSI) testicular cancer are counseled regarding their baseline risk of relapse. The conditional risk of relapse (cRR), which provides prognostic information on patients who have survived for a period of time without relapse, have not been determined for CSI testicular cancer. To determine cRR in CSI testicular cancer. We reviewed 1239 patients with CSI testicular cancer managed with surveillance at a tertiary academic centre between 1980 and 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: cRR estimates were calculated using the Kaplan-Meier method. We stratified patients according to validated risk factors for relapse. We used linear regression to determine cRR trends over time. At orchiectomy, the risk of relapse within 5 yr was 42.4%, 17.3%, 20.3%, and 12.2% among patients with high-risk nonseminomatous germ cell tumor (NSGCT), low-risk NSGCT, seminoma with tumor size ≥3cm, and seminoma with tumor size testicular cancer is very low. Consideration should be given to adapting surveillance protocols to individualized risk of relapse based on cRR as opposed to static protocols based on baseline factors. This strategy could reduce the intensity of follow-up for the majority of patients. Our study is the first to provide data on the future risk of relapse during surveillance for clinical stage I testicular cancer, given a patient has been without relapse for a specified period of time. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Prevention of meticillin-resistant Staphylococcus aureus bloodstream infections in European hospitals: moving beyond policies.

Science.gov (United States)

Borg, M A; Hulscher, M; Scicluna, E A; Richards, J; Azanowsky, J-M; Xuereb, D; Huis, A; Moro, M L; Maltezou, H C; Frank, U

2014-08-01

There is evidence that meticillin-resistant Staphylococcus aureus (MRSA) bacteraemia can be reduced with improved infection control and antibiotic stewardship. To survey infection control and antibiotic stewardship practices within European hospitals and to identify initiatives that correlate with reduced MRSA prevalence. Online questionnaires were sent to European hospitals about their surveillance, hand hygiene, intravenous device management, admission screening, isolation, antibiotic prescribing, hospital demographics and MRSA blood culture isolates during 2010. In all, 269 replies were received from hospitals in 29 European countries. Lower MRSA prevalence showed significant association with presence of incidence surveillance, performance of root cause analysis, mandatory training requirements for hand hygiene, accountability measures for persistent non-compliance, and multi-stakeholder teamwork in antibiotic prescribing. Presence of policies on intravenous catheter insertion and management showed no variation between different MRSA prevalence groups. However, low-prevalence hospitals reported more competency assessment programmes in insertion and maintenance of peripheral and central venous catheters. Hospitals from the UK and Ireland reported the highest uptake of infection control and antibiotic stewardship practices that were significantly associated with low MRSA prevalence, whereas Southern European hospitals exhibited the lowest. In multiple regression analysis, isolation of high-risk patients, performance of root cause analysis, obligatory training for nurses in hand hygiene, and undertaking joint ward rounds including microbiologists and infectious disease physicians remained significantly associated with lower MRSA prevalence. Proactive infection control and antibiotic stewardship initiatives that instilled accountability, ownership, teamwork, and validated competence among healthcare workers were associated with improved MRSA outcomes. Copyright �

Introduction of African swine fever into the European Union through illegal importation of pork and pork products.

Science.gov (United States)

Costard, Solenne; Jones, Bryony Anne; Martínez-López, Beatriz; Mur, Lina; de la Torre, Ana; Martínez, Marta; Sánchez-Vizcaíno, Fernando; Sánchez-Vizcaíno, Jose-Manuel; Pfeiffer, Dirk Udo; Wieland, Barbara

2013-01-01

Transboundary animal diseases can have very severe socio-economic impacts when introduced into new regions. The history of disease incursions into the European Union suggests that initial outbreaks were often initiated by illegal importation of meat and derived products. The European Union would benefit from decision-support tools to evaluate the risk of disease introduction caused by illegal imports in order to inform its surveillance strategy. However, due to the difficulty in quantifying illegal movements of animal products, very few studies of this type have been conducted. Using African swine fever as an example, this work presents a novel risk assessment framework for disease introduction into the European Union through illegal importation of meat and products. It uses a semi-quantitative approach based on factors that likely influence the likelihood of release of contaminated smuggled meat and products, and subsequent exposure of the susceptible population. The results suggest that the European Union is at non-negligible risk of African swine fever introduction through illegal importation of pork and products. On a relative risk scale with six categories from negligible to very high, five European Union countries were estimated at high (France, Germany, Italy and United Kingdom) or moderate (Spain) risk of African swine fever release, five countries were at high risk of exposure if African swine fever were released (France, Italy, Poland, Romania and Spain) and ten countries had a moderate exposure risk (Austria, Bulgaria, Germany, Greece, Hungary, Latvia, Lithuania, Portugal, Sweden and United Kingdom). The approach presented here and results obtained for African swine fever provide a basis for the enhancement of risk-based surveillance systems and disease prevention programmes in the European Union.

Regional Disease Surveillance Meeting - Final Paper

Energy Technology Data Exchange (ETDEWEB)

Lesperance, Ann M.; Mahy, Heidi A.

2006-08-08

On June 1, 2006, public health officials working in surveillance, epidemiological modeling, and information technology communities from the Seattle/Tacoma area and State of Washington met with members of the Pacific Northwest National Laboratory (PNNL) to discuss the current state of disease surveillance and gaps and needs to improve the current systems. The meeting also included a discussion of PNNL initiatives that might be appropriate to enhance disease surveillance and the current tools being used for disease surveillance. Participants broke out into two groups to identify critical gaps and needs for improving a surveillance system, and discuss the requirements for developing improved surveillance. Each group developed a list of key priorities summarizing the requirements for improved surveillance. The objective of this meeting was to work towards the development of an improved disease surveillance system.

A review of zoonotic disease surveillance supported by the Armed Forces Health Surveillance Center.

Science.gov (United States)

Burke, R L; Kronmann, K C; Daniels, C C; Meyers, M; Byarugaba, D K; Dueger, E; Klein, T A; Evans, B P; Vest, K G

2012-05-01

The Armed Forces Health Surveillance Center (AFHSC), Division of Global Emerging Infections Surveillance and Response System conducts disease surveillance through a global network of US Department of Defense research laboratories and partnerships with foreign ministries of agriculture, health and livestock development in over 90 countries worldwide. In 2010, AFHSC supported zoonosis survey efforts were organized into four main categories: (i) development of field assays for animal disease surveillance during deployments and in resource limited environments, (ii) determining zoonotic disease prevalence in high-contact species which may serve as important reservoirs of diseases and sources of transmission, (iii) surveillance in high-risk human populations which are more likely to become exposed and subsequently infected with zoonotic pathogens and (iv) surveillance at the human-animal interface examining zoonotic disease prevalence and transmission within and between human and animal populations. These efforts have aided in the detection, identification and quantification of the burden of zoonotic diseases such as anthrax, brucellosis, Crimean Congo haemorrhagic fever, dengue fever, Hantaan virus, influenza, Lassa fever, leptospirosis, melioidosis, Q fever, Rift Valley fever, sandfly fever Sicilian virus, sandfly fever Naples virus, tuberculosis and West Nile virus, which are of military and public health importance. Future zoonotic surveillance efforts will seek to develop local capacity for zoonotic surveillance focusing on high risk populations at the human-animal interface. © 2011 Blackwell Verlag GmbH.

Query Health: standards-based, cross-platform population health surveillance.

Science.gov (United States)

Klann, Jeffrey G; Buck, Michael D; Brown, Jeffrey; Hadley, Marc; Elmore, Richard; Weber, Griffin M; Murphy, Shawn N

2014-01-01

Understanding population-level health trends is essential to effectively monitor and improve public health. The Office of the National Coordinator for Health Information Technology (ONC) Query Health initiative is a collaboration to develop a national architecture for distributed, population-level health queries across diverse clinical systems with disparate data models. Here we review Query Health activities, including a standards-based methodology, an open-source reference implementation, and three pilot projects. Query Health defined a standards-based approach for distributed population health queries, using an ontology based on the Quality Data Model and Consolidated Clinical Document Architecture, Health Quality Measures Format (HQMF) as the query language, the Query Envelope as the secure transport layer, and the Quality Reporting Document Architecture as the result language. We implemented this approach using Informatics for Integrating Biology and the Bedside (i2b2) and hQuery for data analytics and PopMedNet for access control, secure query distribution, and response. We deployed the reference implementation at three pilot sites: two public health departments (New York City and Massachusetts) and one pilot designed to support Food and Drug Administration post-market safety surveillance activities. The pilots were successful, although improved cross-platform data normalization is needed. This initiative resulted in a standards-based methodology for population health queries, a reference implementation, and revision of the HQMF standard. It also informed future directions regarding interoperability and data access for ONC's Data Access Framework initiative. Query Health was a test of the learning health system that supplied a functional methodology and reference implementation for distributed population health queries that has been validated at three sites. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under

Surveillance indicators and their use in implementation of the Marine Strategy Framework Directive

DEFF Research Database (Denmark)

Shephard, Samuel; Greenstreet, Simon P. R.; Piet, GerJan J.

2015-01-01

The European Union Marine Strategy Framework Directive (MSFD) uses indicators to track ecosystem state in relation to Good Environmental Status (GES). These indicators were initially expected to be “operational”, i.e. to have well-understood relationships between state and specified anthropogenic...... pressure(s), and to have defined targets. Recent discussion on MSFD implementation has highlighted an additional class of “surveillance” indicators. Surveillance indicators monitor key aspects of the ecosystem for which there is: first, insufficient evidence to define targets and support formal state...

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.

Critical Surveillance Studies in the Information Society

Directory of Open Access Journals (Sweden)

Thomas Allmer

2011-11-01

Full Text Available The overall aim of this paper is to clarify how we can theorize and systemize economic surveillance. Surveillance studies scholars like David Lyon stress that economic surveillance such as monitoring consumers or the workplace are central aspects of surveillance societies. The approach that is advanced in this work recognizes the importance of the role of the economy in contemporary surveillance societies. The paper at hand constructs theoretically founded typologies in order to systemize the existing literature of surveillance studies and to analyze examples of surveillance. Therefore, it mainly is a theoretical approach combined with illustrative examples. This contribution contains a systematic discussion of the state of the art of surveillance and clarifies how different notions treat economic aspects of surveillance. In this work it is argued that the existing literature is insufficient for studying economic surveillance. In contrast, a typology of surveillance in the modern economy, which is based on foundations of a political economy approach, allows providing a systematic analysis of economic surveillance on the basis of current developments on the Internet. Finally, some political recommendations are drawn in order to overcome economic surveillance. This contribution can be fruitful for scholars who want to undertake a systematic analysis of surveillance in the modern economy and who want to study the field of surveillance critically.

World Alliance for Risk Factor Surveillance White Paper on Surveillance and Health Promotion

Directory of Open Access Journals (Sweden)

Stefano Campostrini

2015-02-01

Full Text Available This is not a research paper on risk factor surveillance. It is an effort by a key group of researchers and practitioners of risk factor surveillance to define the current state of the art and to identify the key issues involved in the current practice of behavioral risk factor surveillance. Those of us who are the principal authors have worked and carried out research in this area for some three decades. As a result of a series of global meetings beginning in 1999 and continuing every two years since then, a collective working group of the International Union of Health Promotion and Education (IUHPE was formed under the name World Alliance of Risk Factor Surveillance (WARFS. Under this banner the organization sought to write a comprehensive statement on the importance of surveillance to health promotion and public health. This paper, which has been revised and reviewed by established peers in the field, is the result. It provides the reader with a clear summary of the major issues that need to be considered by any and all seeking to carry out behavioral risk factor surveillance.

ONTOLOGY MAPPING IN THE RESILIENCE STUDY: THE ORGANIZATIONAL PERSPECTIVE FOR EUROPEAN UNION CASE

Directory of Open Access Journals (Sweden)

Tiberiu-Tudor SALANŢIU

2017-12-01

Full Text Available The ontology mapping in resilience surveillance on organization level can found utilization in analysis of association between idiosyncrasies and structure adaptability. Starting from the data regarding the economic trends for European Union members from 2014 to 2016 the aim of the research is to analyse the European Union resilience through interpretation of the link between members behaviour and structure convergence. The members positioned in European Union was analysed after organization clusterization of the twenty-eight state members. Two different structures are included into analysis for the studied periods: a structure which incorporates just the state members, and other which also take into account the eurozone blue-chips. In order to analyse the members’ relation in structure a gravity model has been developed, the obtained results for each state members pair are contained in a skew matrix. The values are interpreted through a knowledge-base to highlight the European Union resilience degree.

A One Health approach to antimicrobial resistance surveillance: is there a business case for it?

Science.gov (United States)

Queenan, Kevin; Häsler, Barbara; Rushton, Jonathan

2016-10-01

Antimicrobial resistance is a global problem of complex epidemiology, suited to a broad, integrated One Health approach. Resistant organisms exist in humans, animals, food and the environment, and the main driver of this resistance is antimicrobial usage. A One Health conceptual framework for surveillance is presented to include all of these aspects. Global and European (regional and national) surveillance systems are described, highlighting shortcomings compared with the framework. Policy decisions rely on economic and scientific evidence, so the business case for a fully integrated system is presented. The costs of integrated surveillance are offset by the costs of unchecked resistance and the benefits arising from interventions and outcomes. Current estimates focus on costs and benefits of human health outcomes. A One Health assessment includes wider societal costs of lost labour, changes in health-seeking behaviour, impacts on animal health and welfare, higher costs of animal-origin food production, and reduced consumer confidence in safety and international trade of such food. Benefits of surveillance may take years to realise and are dependent on effective and accepted interventions. Benefits, including the less tangible, such as improved synergies and efficiencies in service delivery and more timely and accurate risk identification, should also be recognised. By including these less tangible benefits to society, animal welfare, ecosystem health and resilience, together with the savings and efficiencies through shared resources and social capital-building, a stronger business case for a One Health approach to surveillance can be made. Copyright © 2016 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

[Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

Science.gov (United States)

Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

2014-09-01

Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

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.

Measles and respiratory failure: Case report and review of the last European outbreaks

Directory of Open Access Journals (Sweden)

Leonel Lagunes

2015-08-01

Full Text Available Measles is an preventable acute viral illness, with the potential for severe and fatal complications. According to the European Centre for Disease Prevention and Control in the last surveillance report, a total of 10 271 cases of measles were reported from January to December 2013. And 127 of those were reported in Spain with a 2.7/1 million habitants rate. In 2010, the World Health Organization European Region made a new commitment to eradicate measles by 2015 in the zone, however, measles cases and outbreaks are still occurring in many countries. We present the last 2 cases with severe measles-associated respiratory failure and a review of the literature of the last European outbreaks. Two young adults were admitted in the intensive care unit due to respiratory failure with a confirmed measles infection. Both treated with high flow nasal cannula during 3 to 5 days; one had a pneumococcal pneumonia coinfection. An incomplete vaccination schedule was documented in one of them while the other did not remember his. Within 10 days of admission, both were discharged from intensive care unit and the hospital with no complications. Measles can present with a variety of symptoms in adults and is responsible for a high morbidity especially during outbreaks. Pneumonia is a severe complication of measles infection, commonly reported. Surveillance and vaccination programs should be strengthened in order to achieve measles elimination.

Inappropriate colonoscopic surveillance of hyperplastic polyps.

LENUS (Irish Health Repository)

Keane, R A

2011-11-15

Colonoscopic surveillance of hyperplastic polyps alone is controversial and may be inappropriate. The colonoscopy surveillance register at a university teaching hospital was audited to determine the extent of such hyperplastic polyp surveillance. The surveillance endoscopy records were reviewed, those patients with hyperplastic polyps were identified, their clinical records were examined and contact was made with each patient. Of the 483 patients undergoing surveillance for colonic polyps 113 (23%) had hyperplastic polyps alone on last colonoscopy. 104 patients remained after exclusion of those under appropriate surveillance. 87 of the 104 patients (84%) were successfully contacted. 37 patients (8%) were under appropriate colonoscopic surveillance for a significant family history of colorectal carcinoma. 50 (10%) patients with hyperplastic polyps alone and no other clinical indication for colonoscopic surveillance were booked for follow up colonoscopy. This represents not only a budgetary but more importantly a clinical opportunity cost the removal of which could liberate valuable colonoscopy time for more appropriate indications.

Evidence for more cost-effective surveillance options for bovine spongiform encephalopathy (BSE) and scrapie in Great Britain.

Science.gov (United States)

Wall, Ben A; Arnold, Mark E; Radia, Devi; Gilbert, Will; Ortiz-Pelaez, Angel; Stärk, Katharina Dc; Van Klink, Ed; Guitian, Javier

2017-08-10

Transmissible spongiform encephalopathies (TSEs) are an important public health concern. Since the emergence of bovine spongiform encephalopathy (BSE) during the 1980s and its link with human Creutzfeldt-Jakob disease, active surveillance has been a key element of the European Union's TSE control strategy. Success of this strategy means that now, very few cases are detected compared with the number of animals tested. Refining surveillance strategies would enable resources to be redirected towards other public health priorities. Cost-effectiveness analysis was performed on several alternative strategies involving reducing the number of animals tested for BSE and scrapie in Great Britain and, for scrapie, varying the ratio of sheep sampled in the abattoir to fallen stock (which died on the farm). The most cost-effective strategy modelled for BSE involved reducing the proportion of fallen stock tested from 100% to 75%, producing a cost saving of ca GBP 700,000 per annum. If 50% of fallen stock were tested, a saving of ca GBP 1.4 million per annum could be achieved. However, these reductions are predicted to increase the period before surveillance can detect an outbreak. For scrapie, reducing the proportion of abattoir samples was the most cost-effective strategy modelled, with limited impact on surveillance effectiveness. This article is copyright of The Authors, 2017.

Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

Science.gov (United States)

Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

2017-09-12

A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

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)

Surveillance of antibiotic resistance

Science.gov (United States)

Johnson, Alan P.

2015-01-01

Surveillance involves the collection and analysis of data for the detection and monitoring of threats to public health. Surveillance should also inform as to the epidemiology of the threat and its burden in the population. A further key component of surveillance is the timely feedback of data to stakeholders with a view to generating action aimed at reducing or preventing the public health threat being monitored. Surveillance of antibiotic resistance involves the collection of antibiotic susceptibility test results undertaken by microbiology laboratories on bacteria isolated from clinical samples sent for investigation. Correlation of these data with demographic and clinical data for the patient populations from whom the pathogens were isolated gives insight into the underlying epidemiology and facilitates the formulation of rational interventions aimed at reducing the burden of resistance. This article describes a range of surveillance activities that have been undertaken in the UK over a number of years, together with current interventions being implemented. These activities are not only of national importance but form part of the international response to the global threat posed by antibiotic resistance. PMID:25918439

A Global Cancer Surveillance Framework Within Noncommunicable Disease Surveillance: Making the Case for Population-Based Cancer Registries.

Science.gov (United States)

Piñeros, Marion; Znaor, Ariana; Mery, Les; Bray, Freddie

2017-01-01

The growing burden of cancer among several major noncommunicable diseases (NCDs) requires national implementation of tailored public health surveillance. For many emerging economies where emphasis has traditionally been placed on the surveillance of communicable diseases, it is critical to understand the specificities of NCD surveillance and, within it, of cancer surveillance. We propose a general framework for cancer surveillance that permits monitoring the core components of cancer control. We examine communalities in approaches to the surveillance of other major NCDs as well as communicable diseases, illustrating key differences in the function, coverage, and reporting in each system. Although risk factor surveys and vital statistics registration are the foundation of surveillance of NCDs, population-based cancer registries play a unique fundamental role specific to cancer surveillance, providing indicators of population-based incidence and survival. With an onus now placed on governments to collect these data as part of the monitoring of NCD targets, the integration of cancer registries into existing and future NCD surveillance strategies is a vital requirement in all countries worldwide. The Global Initiative for Cancer Registry Development, endorsed by the World Health Organization, provides a means to enhance cancer surveillance capacity in low- and middle-income countries. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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.

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

Full Text Available O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, selecionados nas bases Medline/PubMed, com as palavras-chave: "adverse events following vaccine", "adverse events following vaccine surveillance", "post-marketing surveillance" e "safety vaccine" e "Phase IV clinical trials", e excluídos aqueles com foco em tipos específicos desses eventos. Foram apontados os principais aspectos que justificam a importância dos eventos adversos pós-vacina em saúde pública, os instrumentos que garantem a segurança das vacinas e as finalidades, atributos, tipos, interpretações de dados, limitações e novos desafios da vigilância de eventos adversos pós-vacina, bem como estratégias para aumentar sua sensibilidade. A revisão é concluída com desafios para os próximos anos, visando à segurança e confiabilidade dos programas de vacinação.El objetivo de la revisión fue analizar aspectos conceptuales y operacionales de sistemas de vigilancia de eventos adversos post vacuna. Fueron incluidos artículos disponibles en formato electrónico, publicados entre 1985 y 2009, seleccionados en las bases PubMed/Medline, con las palabras clave: "vigilancia de eventos adversos post vacuna", "vigilancia post comercialización", "seguridad de vacunas" y "estudios de Fase IV", y excluidos aquellos con foco en tipos específicos de tales eventos. Se señalaron los principales aspectos que justifican la importancia de los eventos adversos post vacuna en salud pública, los instrumentos que garantizan la seguridad de las vacunas y las finalidades, atributos, tipos, interpretaciones de datos, limitaciones y nuevos desafíos de la vigilancia de eventos adversos post vacuna, así como estrategias para aumentar su sensibilidad. Se concluye con desafíos para los próximos años, buscando seguridad y

Surveillance of Zika virus infection in the EU/EEA, June 2015 to January 2017.

Science.gov (United States)

Spiteri, G; Sudre, B; Septfons, A; Beauté, J

2017-10-01

Surveillance of Zika virus (ZIKV) infection in the European Union/European Economic Area (EU/EEA) was implemented in 2016 in response to the large outbreak reported in the Americas in 2015 associated with an increased number of infants born with microcephaly. Between June 2015 and January 2017, 21 EU/EEA countries reported 2,133 confirmed cases of ZIKV infection, of whom 106 were pregnant women. Cases infected in the Caribbean constituted 71% of reported cases. Almost all cases (99%) were most probably infected by mosquito bite during travel outside continental Europe, while only 1% were transmitted sexually. Considering that 584 imported cases were reported between May and October 2016 among residents of areas with established presence of Aedes albopictus , the absence of autochthonous vector-borne cases suggests that Ae. albopictus is not an efficient vector for ZIKV infection.

Issues ignored in laboratory quality surveillance

International Nuclear Information System (INIS)

Zeng Jing; Li Xingyuan; Zhang Tingsheng

2008-01-01

According to the work requirement of the related laboratory quality surveillance in ISO17025, this paper analyzed and discussed the issued ignored in the laboratory quality surveillance. In order to solve the present problem, it is required to understand the work responsibility in the quality surveillance correctly, to establish the effective working routine in the quality surveillance, and to conduct, the quality surveillance work. The object in the quality surveillance shall be 'the operator' who engaged in the examination/calibration directly in the laboratory, especially the personnel in training (who is engaged in the examination/calibration). The quality supervisors shall be fully authorized, so that they can correctly understand the work responsibility in quality surveillance, and are with the rights for 'full supervision'. The laboratory also shall arrange necessary training to the quality supervisor, so that they can obtain sufficient guide in time and are with required qualification or occupation prerequisites. (authors)

Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis: Text mining of the Japanese postmarketing adverse event-reporting database.

Science.gov (United States)

Atsumi, Tatsuya; Ando, Yoshiaki; Matsuda, Shinichi; Tomizawa, Shiho; Tanaka, Riwa; Takagi, Nobuhiro; Nakasone, Ayako

2018-05-01

To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients. Individual case safety reports, including structured (age, sex, adverse event [AE]) and unstructured (clinical narratives) data, were analyzed by automated text mining from a Japanese post-marketing AE-reporting database (16 April 2008-10 April 2015) assuming the following: treated in Japan; TCZ RA treatment; ≥1 SI; unable to exclude causality between TCZ and SIs. The database included 7653 RA patients; 1221 reports met four criteria, encompassing 1591 SIs. Frequent SIs were pneumonia (15.9%), cellulitis (9.9%), and sepsis (5.0%). Reports for 782 patients included SI onset date; 60.7% of patients had signs/symptoms ≤28 days before SI diagnosis, 32.7% had signs/symptoms with date unidentified, 1.7% were asymptomatic, and 4.9% had unknown signs/symptoms. The most frequent signs/symptoms were for skin (swelling and pain) and respiratory (cough and pyrexia) infections. Among 68 patients who had normal laboratory results for C-reactive protein, body temperature, and white blood cell count, 94.1% had signs or symptoms of infection. This study identified prodromal signs and symptoms of SIs in RA patients receiving TCZ. Data mining clinical narratives from post-marketing AE databases may be beneficial in characterizing SIs.

Adoption Space and the Idea-to-Market Process of Health Technologies.

Science.gov (United States)

Saranummi, Niilo; Beuscart, Regis; Black, Norman; Maglaveras, Nicos; Strano, Chiara; Karavidopoulou, Youla

2016-01-01

Although Europe 'produces' excellent science, it has not been equally successful in translating scientific results into commercially successful companies in spite of European and national efforts invested in supporting the translation process. The Idea-to-Market process is highly complex due to the large number of actors and stakeholders. ITECH was launched to propose recommendations which would accelerate the Idea-to-Market process of health technologies leading to improvements in the competitiveness of the European health technology industry in the global markets. The project went through the following steps: defining the Idea-to-Market process model; collection and analysis of funding opportunities; identification of 12 gaps and barriers in the Idea-to-Market process; a detailed analysis of these supported by interviews; a prioritization process to select the most important issues; construction of roadmaps for the prioritized issues; and finally generating recommendations and associated action plans. Seven issues were classified as in need of actions. Three of these are part of the ongoing Medical Device Directive Reform (MDR), namely health technology assessment, post-market surveillance and regulatory process, and therefore not within the scope of ITECH. Recommendations were made for eHealth taxonomy; Education and training; Clinical trials and Adoption space and Human Factors Engineering (HFE).

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

Science.gov (United States)

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Surviving Surveillance: How Pregnant Women and Mothers Living With HIV Respond to Medical and Social Surveillance.

Science.gov (United States)

Greene, Saara; Ion, Allyson; Kwaramba, Gladys; Lazarus, Lisa; Loutfy, Mona

2017-12-01

Pregnant women and mothers living with HIV are under surveillance of service providers, family members, and the community at large. Surveillance occurs throughout the medical management of their HIV during pregnancy, preventing HIV transmission to their baby, infant feeding practices, and as part of assessments related to their ability to mother. Enacted and anticipatory HIV-related stigma can exacerbate the negative impact that being under surveillance has on mothers living with HIV as they move through their pregnancy, birthing, and mothering experiences. In response, women living with HIV find ways to manage their experiences of surveillance through engaging in acts of distancing, planning, and resisting at different points in time, and sometimes enacting all three practices at once. Positioning the narratives of pregnant women and mothers living with HIV in relation to their experiences of surveillance illuminates the relationship between the surveillance of mothers living with HIV and HIV-related stigma.

The EUVAC-NET project: creation and operation of a surveillance community network for vaccine preventable infectious diseases.

Science.gov (United States)

Glismann, S; Rønne, T; Tozzi, A

2001-06-01

The EUVAC-NET network is in charge of the epidemiological surveillance and control of vaccine preventable diseases. It is coordinated by the SSI in Denmark, in collaboration with the ISS in Italy. The two main diseases targeted by the network are measles and pertussis. A collaboration is planned with the PHLS for the monitoring of Haemophilus influenzae b. EUVAC-NET includes the Member States of the European Union, and Iceland, Norway and Switzerland.

Assessment of different surveillance systems for avian influenza in commercial poultry in Catalonia (North-Eastern Spain).

Science.gov (United States)

Alba, A; Casal, J; Napp, S; Martin, P A J

2010-11-01

Compulsory surveillance programmes for avian influenza (AI) have been implemented in domestic poultry and wild birds in all the European Member States since 2005. The implementation of these programmes is complex and requires a close evaluation. A good indicator to assess their efficacy is the sensitivity (Se) of the surveillance system. In this study, the sensitivities for different sampling designs proposed by the Spanish authorities for the commercial poultry population of Catalonia were assessed, using the scenario tree model methodology. These samplings were stratified throughout the territory of Spain and took into account the species, the types of production and their specific risks. The probabilities of detecting infection at different prevalences at both individual and holding level were estimated. Furthermore, those subpopulations that contributed more to the Se of the system were identified. The model estimated that all the designs met the requirements of the European Commission. The probability of detecting AI circulating in Catalonian poultry did not change significantly when the within-holding design prevalence varied from 30% to 10%. In contrast, when the among-holding design prevalence decreased from 5% to 1%, the probability of detecting AI was drastically reduced. The sampling of duck and goose holdings, and to a lesser extent the sampling of turkey and game bird holdings, increased the Se substantially. The Se of passive surveillance in chickens for highly pathogenic avian influenza (HPAI) and low pathogenicity avian influenza (LPAI) were also assessed. The probability of the infected birds manifesting apparent clinical signs and the awareness of veterinarians and farmers had great influence on the probability of detecting AI. In order to increase the probability of an early detection of HPAI in chicken, the probability of performing AI specific tests when AI is suspected would need to be increased. Copyright © 2010 Elsevier B.V. All rights

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 ...

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.

Bat rabies surveillance in France: first report of unusual mortality among serotine bats.

Science.gov (United States)

Picard-Meyer, Evelyne; Servat, Alexandre; Wasniewski, Marine; Gaillard, Matthieu; Borel, Christophe; Cliquet, Florence

2017-12-13

Rabies is a fatal viral encephalitic disease that is caused by lyssaviruses which can affect all mammals, including human and bats. In Europe, bat rabies cases are attributed to five different lyssavirus species, the majority of rabid bats being attributed to European bat 1 lyssavirus (EBLV-1), circulating mainly in serotine bats (Eptesicus serotinus). In France, rabies in bats is under surveillance since 1989, with 77 positive cases reported between 1989 and 2016. In the frame of the bat rabies surveillance, an unusual mortality of serotine bats was reported in 2009 in a village in North-East France. Six juvenile bats from an E. serotinus maternity colony counting ~200 individuals were found to be infected with EBLV-1. The active surveillance of the colony by capture sessions of bats from July to September 2009 showed a high detection rate of neutralising EBLV-1 antibodies (≈ 50%) in the colony. Moreover, one out of 111 animals tested was found to shed viable virus in saliva, while lyssavirus RNA was detected by RT-PCR for five individuals. This study demonstrated that the lyssavirus infection in the serotine maternity colony was followed by a high rate of bat rabies immunity after circulation of the virus in the colony. The ratio of seropositive bats is probably indicative of an efficient virus transmission coupled to a rapid circulation of EBLV-1 in the colony.

Between visibility and surveillance

DEFF Research Database (Denmark)

Uldam, Julie

As activists move from alternative media platforms to commercial social media platforms they face increasing challenges in protecting their online security and privacy. While government surveillance of activists is well-documented in both scholarly research and the media, corporate surveillance...

A post-marketing study of gadodiamide hydrate in patients with cerebral infarction

International Nuclear Information System (INIS)

Ono, Yuko; Aoki, Shigeki

2003-01-01

We evaluated the efficacy and safety of gadodiamide hydrate (GH: Omuniscan) in patients with cerebral infarction in a multicenter post-marketing study. A total of 122 patients enrolled in this study at 16 institutions in throughout Japan. We administrated GH to patients intravenously at 0.2 mL/kg, an approved usage and dosage for head MRI. Efficacy was evaluated by comparing contrast intensity and diagnostic improvement on T1WI before and after the administration of GH and diagnostic significance was investigated. Moreover, clinical data thus obtained were compared with those of phase III studies of GH and other contrast agents with respect to general evaluation of diagnostic improvement. The effects of contrast enhancement on the detection and extent of lesions as well as image quality were judged in terms of improving general evaluation and diagnosis, which was observed in 93.3% of the patients. No serious adverse event were associated with GH administration. The efficacy of GH in this clinical trial was higher, than historical data, with respect to general evaluation and diagnostic improvement. Contrast enhanced MRI with GH in cerebral infarction was confirmed to be of diagnostic value. (author)

Travel-associated infection presenting in Europe (2008-12): an analysis of EuroTravNet longitudinal, surveillance data, and evaluation of the effect of the pre-travel consultation

NARCIS (Netherlands)

Schlagenhauf, Patricia; Weld, Leisa; Goorhuis, Abraham; Gautret, Philippe; Weber, Rainer; von Sonnenburg, Frank; Lopez-Vélez, Rogelio; Jensenius, Mogens; Cramer, Jakob P.; Field, Vanessa K.; Odolini, Silvia; Gkrania-Klotsas, Effrossyni; Chappuis, Francois; Malvy, Denis; van Genderen, Perry J. J.; Mockenhaupt, Frank; Jauréguiberry, Stéphane; Smith, Catherine; Beeching, Nicholas J.; Ursing, Johan; Parola, Philippe; Grobusch, Martin P.

2015-01-01

Travel is important in the acquisition and dissemination of infection. We aimed to assess European surveillance data for travel-related illness to profile imported infections, track trends, identify risk groups, and assess the usefulness of pre-travel advice. We analysed travel-associated morbidity

Privacy Implications of Surveillance Systems

DEFF Research Database (Denmark)

Thommesen, Jacob; Andersen, Henning Boje

2009-01-01

This paper presents a model for assessing the privacy „cost‟ of a surveillance system. Surveillance systems collect and provide personal information or observations of people by means of surveillance technologies such as databases, video or location tracking. Such systems can be designed for vari......This paper presents a model for assessing the privacy „cost‟ of a surveillance system. Surveillance systems collect and provide personal information or observations of people by means of surveillance technologies such as databases, video or location tracking. Such systems can be designed...... for various purposes, even as a service for those being observed, but in any case they will to some degree invade their privacy. The model provided here can indicate how invasive any particular system may be – and be used to compare the invasiveness of different systems. Applying a functional approach......, the model is established by first considering the social function of privacy in everyday life, which in turn lets us determine which different domains will be considered as private, and finally identify the different types of privacy invasion. This underlying model (function – domain – invasion) then serves...

Remote container monitoring and surveillance systems

International Nuclear Information System (INIS)

Resnik, W.M.; Kadner, S.P.

1995-01-01

Aquila Technologies Group is developing a monitoring and surveillance system to monitor containers of nuclear materials. The system will both visually and physically monitor the containers. The system is based on the combination of Aquila's Gemini All-Digital Surveillance System and on Aquila's AssetLAN trademark asset tracking technology. This paper discusses the Gemini Digital Surveillance system as well as AssetLAN technology. The Gemini architecture with emphasis on anti-tamper security features is also described. The importance of all-digital surveillance versus other surveillance methods is also discussed. AssetLAN trademark technology is described, emphasizing the ability to continually track containers (as assets) by location utilizing touch memory technology. Touch memory technology provides unique container identification, as well as the ability to store and retrieve digital information on the container. This information may relate to container maintenance, inspection schedules, and other information. Finally, this paper describes the combination of the Gemini system with AssetLAN technology, yielding a self contained, container monitoring and area/container surveillance system. Secure container fixture design considerations are discussed. Basic surveillance review functions are also discussed

Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: The CoreValve prospective, international, post-market ADVANCE-II study

NARCIS (Netherlands)

A.S. Petronio (Anna); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); J. Bosmans (Johan); F. Bedogni (Francesco); M. Branny (Marian); K. Stangl (Karl); J. Kovac (Jan); M. Schiltgen (Molly); S. Kraus (Stacia); P.P.T. de Jaegere (Peter)

2015-01-01

textabstractObjectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis,

Microbiological Food Safety Surveillance in China

Directory of Open Access Journals (Sweden)

Xiaoyan Pei

2015-08-01

Full Text Available Microbiological food safety surveillance is a system that collects data regarding food contamination by foodborne pathogens, parasites, viruses, and other harmful microbiological factors. It helps to understand the spectrum of food safety, timely detect food safety hazards, and provide relevant data for food safety supervision, risk assessment, and standards-setting. The study discusses the microbiological surveillance of food safety in China, and introduces the policies and history of the national microbiological surveillance system. In addition, the function and duties of different organizations and institutions are provided in this work, as well as the generation and content of the surveillance plan, quality control, database, and achievement of the microbiological surveillance of food safety in China.

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.

The Copyright Surveillance Industry

Directory of Open Access Journals (Sweden)

Mike Zajko

2015-09-01

Full Text Available Creative works are now increasingly distributed as digital “content” through the internet, and copyright law has created powerful incentives to monitor and control these flows. This paper analyzes the surveillance industry that has emerged as a result. Copyright surveillance systems identify copyright infringement online and identify persons to hold responsible for infringing acts. These practices have raised fundamental questions about the nature of identification and attribution on the internet, as well as the increasing use of algorithms to make legal distinctions. New technologies have threatened the profits of some media industries through copyright infringement, but also enabled profitable forms of mass copyright surveillance and enforcement. Rather than a system of perfect control, copyright enforcement continues to be selective and uneven, but its broad reach results in systemic harm and provides opportunities for exploitation. It is only by scrutinizing copyright surveillance practices and copyright enforcement measures that we can evaluate these consequences.

Sanitary surveillance and bioethics

Directory of Open Access Journals (Sweden)

Volnei Garrafa

2017-08-01

Full Text Available Regulatory practices in the field of health surveillance are indispensable. The aim of this study is to show ‒ taking the Brazilian National Surveillance Agency, governing body of sanitary surveillance in Brazil as a reference ‒ that bioethics provides public bodies a series of theoretical tools from the field of applied ethics for the proper exercise and control of these practices. To that end, the work uses two references of bioethics for the development of a comparative and supportive analysis to regulatory activities in the field of health surveillance: the Universal Declaration on Bioethics and Human Rights of Unesco and the theory of intervention bioethics. We conclude that organizations and staff working with regulatory activities can take advantage of the principles and frameworks proposed by bioethics, especially those related to the Declaration and the theory of intervention bioethics, the latter being set by the observation and use of the principles of prudence, precaution, protection and prevention.

Congenital rubella syndrome surveillance as a platform for surveillance of other congenital infections, Peru, 2004-2007.

Science.gov (United States)

Whittembury, Alvaro; Galdos, Jorge; Lugo, María; Suárez-Ognio, Luis; Ortiz, Ana; Cabezudo, Edwin; Martínez, Mario; Castillo-Solórzano, Carlos; Andrus, Jon Kim

2011-09-01

Rubella during pregnancy can cause serious fetal abnormalities and death. Peru has had integrated measles/rubella surveillance since 2000 but did not implement congenital rubella syndrome (CRS) surveillance until 2004, in accordance with the Pan American Health Organization recommendations for rubella elimination. The article describes the experience from the CRS sentinel surveillance system in Peru. Peru has maintained a national sentinel surveillance system for reporting confirmed and suspected CRS cases since 2004. A surveillance protocol was implemented with standardized case definitions and instruments in the selected sentinel sites. Each sentinel site completes their case investigations and report forms and sends the reports to the Health Region Epidemiology Department, which forwards the data to the national Epidemiology Department. CRS surveillance data were analyzed for the period 2004-2007. During the period 2004-2007, 16 health facilities, which are located in 9 of the 33 health regions, representing the 3 main geographical areas (coast, mountain, and jungle), were included as sentinel sites for the CRS surveillance. A total of 2061 suspected CRS cases were reported to the system. Of these, 11 were classified as CRS and 23 as congenital rubella infection. Factors significantly associated with rubella vertical transmission were: (1) in the mother, maternal history of rash during pregnancy (odds ratio [OR], 12.0; 95% confidence interval [CI], 3.8-37.8); (2) and in the infant, pigmentary retinopathy (OR, 18.4; 95% CI, 3.2-104.6), purpura (OR, 14.7; 95% CI, 2.8-78.3), and developmental delay (OR, 4.4; 95% CI, 1.75-11.1). The surveillance system has been able to identify rubella vertical transmission, reinforcing the evidence that rubella was a public health problem in Peru. This system may serve as a platform to implement surveillance for other congenital infections in Peru.

The role of supplementary environmental surveillance to complement acute flaccid paralysis surveillance for wild poliovirus in Pakistan - 2011-2013.

Directory of Open Access Journals (Sweden)

Tori L Cowger

Full Text Available More than 99% of poliovirus infections are non-paralytic and therefore, not detected by acute flaccid paralysis (AFP surveillance. Environmental surveillance (ES can detect circulating polioviruses from sewage without relying on clinical presentation. With extensive ES and continued circulation of polioviruses, Pakistan presents a unique opportunity to quantify the impact of ES as a supplement to AFP surveillance on overall completeness and timeliness of poliovirus detection.Genetic, geographic and temporal data were obtained for all wild poliovirus (WPV isolates detected in Pakistan from January 2011 through December 2013. We used viral genetics to assess gaps in AFP surveillance and ES as measured by detection of 'orphan viruses' (≥1.5% different in VP1 capsid nucleotide sequence. We compared preceding detection of closely related circulating isolates (≥99% identity detected by AFP surveillance or ES to determine which surveillance system first detected circulation before the presentation of each polio case.A total of 1,127 WPV isolates were detected by AFP surveillance and ES in Pakistan from 2011-2013. AFP surveillance and ES combined exhibited fewer gaps (i.e., % orphan viruses in detection than AFP surveillance alone (3.3% vs. 7.7%, respectively. ES detected circulation before AFP surveillance in nearly 60% of polio cases (200 of 346. For polio cases reported from provinces conducting ES, ES detected circulation nearly four months sooner on average (117.6 days than did AFP surveillance.Our findings suggest ES in Pakistan is providing earlier, more sensitive detection of wild polioviruses than AFP surveillance alone. Overall, targeted ES through strategic selection of sites has important implications in the eradication endgame strategy.

Risk based surveillance for vector borne diseases

DEFF Research Database (Denmark)

Bødker, Rene

of samples and hence early detection of outbreaks. Models for vector borne diseases in Denmark have demonstrated dramatic variation in outbreak risk during the season and between years. The Danish VetMap project aims to make these risk based surveillance estimates available on the veterinarians smart phones...... in Northern Europe. This model approach may be used as a basis for risk based surveillance. In risk based surveillance limited resources for surveillance are targeted at geographical areas most at risk and only when the risk is high. This makes risk based surveillance a cost effective alternative...... sample to a diagnostic laboratory. Risk based surveillance models may reduce this delay. An important feature of risk based surveillance models is their ability to continuously communicate the level of risk to veterinarians and hence increase awareness when risk is high. This is essential for submission...

Educational inequalities in self-rated health across US states and European countries.

Science.gov (United States)

Präg, Patrick; Subramanian, S V

2017-07-01

The US shows a distinct health disadvantage when compared to other high-income nations. A potential lever to reduce this disadvantage is to improve the health situation of lower socioeconomic groups. Our objective is to explore how the considerable within-US variation in health inequalities compares to the health inequalities across other Western countries. Representative survey data from 44 European countries and the US federal states were obtained from the fourth wave of the European Values Study (EVS) and the 2008 wave of the Behavioral Risk Factor Surveillance System. Using binary logistic regression, we analyze different forms of educational inequalities in self-rated health (SRH), adjusted for age and sex. The extent of educational inequalities in SRH varies considerably over European countries and US states; with US states in general showing greater inequality, however, differences between US states and European countries are less clear than commonly assumed. The US has considerable differences in educational inequalities in SRH across geographic locations. To understand the reasons for the US health disadvantage, comparative research has to take into account the vast variation in health inequalities within the US.

Optimizing outcomes with polymethylmethacrylate fillers.

Science.gov (United States)

Gold, Michael H; Sadick, Neil S

2018-03-30

The ideal filler should be long-lasting, biocompatible, chemically inert, soft and easy to use, and have a long history of safety. This review focuses on the evolution and development of the PMMA-collagen gel, Bellafill, and the 10 years of postmarketing experience of Bellafill since it received premarket approval (PMA) from the FDA as Artefill in 2006. Artefill was rebranded to Bellafill in 2015. The authors conducted a literature search on PubMed for key articles describing the steps in which Arteplast, a PMMA filler developed in 1989, led to the development of Bellafill, the only PMMA filler approved by the US FDA for the treatment of nasolabial folds and acne scar correction. The factors governing efficacy and safety were also evaluated for the major PMMA fillers available in the world. The process of manufacturing and purifying PMMA has played a major role in minimizing adverse events for Bellafill. Postmarketing surveillance data for the 2007-2016 period show that for more than 530 000 Bellafill syringes distributed worldwide, 11 confirmed granulomas (excluding clinical trial data) (0.002% of syringes sold) have been reported. Data on other PMMA fillers are limited and inconsistent. The authors suggest that adverse events are often attributable to lack of proficiency in treatment technique and other factors. Bellafill has demonstrated an excellent safety and effectiveness profile in multiple clinical studies, customer feedback, and 10 years of postmarketing surveillance experience. Adverse events occur with all fillers for a variety of reasons. In addition to quality of the product, injector skill and technique are critical to ensuring good clinical outcomes. © 2018 Wiley Periodicals, Inc.

Post-marketing surveillance of chemicals: organisations and databases : Workshop report

NARCIS (Netherlands)

Bouwmeester M; van Drongelen A; Graven C; Hernandez L; Herremans J; de Kaste D; Razenberg L; Vandebriel R; Piersma A; VTS; GZB

2018-01-01

The safety evaluation of chemicals is in general performed by the government, importer or manufacturer before marketing, and is based on (inter)national legislation. Less is known about the exact products in which chemicals are processed. Even though multiple institutions in the Netherlands are

Appropriateness of endoscopic surveillance recommendations in organised colorectal cancer screening programmes based on the faecal immunochemical test.

Science.gov (United States)

Zorzi, Manuel; Senore, Carlo; Turrin, Anna; Mantellini, Paola; Visioli, Carmen Beatriz; Naldoni, Carlo; Sassoli De' Bianchi, Priscilla; Fedato, Chiara; Anghinoni, Emanuela; Zappa, Marco; Hassan, Cesare

2016-11-01

To assess the appropriateness of recommendations for endoscopic surveillance in organised colorectal cancer (CRC) screening programmes based on the faecal immunochemical test (FIT). 74 Italian CRC screening programmes provided aggregated data on the recommendations given after FIT-positive colonoscopies in 2011 and 2013. Index colonoscopies were divided into negative/no adenoma and low- risk, intermediate-risk and high-risk adenomas. Postcolonoscopy recommendations included a return to screening (FIT after 2 years or 5 years), an endoscopic surveillance after 6 months or after 1 year, 3 years or 5 years, surgery or other. We assessed the deviation from the postcolonoscopy recommendations of the European Guidelines in 2011 and 2013 and the correlation between overuse of endoscopic surveillance in 2011 and the process indicators associated with the endoscopic workload in 2013. 49 704 postcolonoscopy recommendations were analysed. High-risk, intermediate-risk and low-risk adenomas, and no adenomas were reported in 5.9%, 19.3%, 15.3% and 51.5% of the cases, respectively. Endoscopic surveillance was inappropriately recommended in 67.4% and 7%, respectively, of cases with low-risk and no adenoma. Overall, 37% of all endoscopic surveillance recommendations were inappropriate (6696/17 860). Overuse of endoscopic surveillance was positively correlated with the extension of invitations (correlation coefficient (cc) 0.29; p value 0.03) and with compliance with post-FIT+ colonoscopy (cc 0.25; p value 0.05), while it was negatively correlated with total colonoscopy waiting times longer than 60 days (cc -0.26; p value 0.05). In organised screening programmes, a high rate of inappropriate recommendations for patients with low risk or no adenomas occurs, affecting the demand for endoscopic surveillance by a third. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Towards One Health disease surveillance: The Southern African Centre for Infectious Disease Surveillance approach

Directory of Open Access Journals (Sweden)

Esron D. Karimuribo

2012-06-01

Full Text Available Africa has the highest burden of infectious diseases in the world and yet the least capacity for its risk management. It has therefore become increasingly important to search for ‘fit-for- purpose’ approaches to infectious disease surveillance and thereby targeted disease control. The fact that the majority of human infectious diseases are originally of animal origin means we have to consider One Health (OH approaches which require inter-sectoral collaboration for custom-made infectious disease surveillance in the endemic settings of Africa. A baseline survey was conducted to assess the current status and performance of human and animal health surveillance systems and subsequently a strategy towards OH surveillance system was developed. The strategy focused on assessing the combination of participatory epidemiological approaches and the deployment of mobile technologies to enhance the effectiveness of disease alerts and surveillance at the point of occurrence, which often lies in remote areas. We selected three study sites, namely the Ngorongoro, Kagera River basin and Zambezi River basin ecosystems. We have piloted and introduced the next-generation Android mobile phones running the EpiCollect application developed by Imperial College to aid geo-spatial and clinical data capture and transmission of this data from the field to the remote Information Technology (IT servers at the research hubs for storage, analysis, feedback and reporting. We expect that the combination of participatory epidemiology and technology will significantly improve OH disease surveillance in southern Africa.

Towards one health disease surveillance: the Southern African Centre for Infectious Disease Surveillance approach.

Science.gov (United States)

Karimuribo, Esron D; Sayalel, Kuya; Beda, Eric; Short, Nick; Wambura, Philemon; Mboera, Leonard G; Kusiluka, Lughano J M; Rweyemamu, Mark M

2012-06-20

Africa has the highest burden of infectious diseases in the world and yet the least capacity for its risk management. It has therefore become increasingly important to search for 'fit-for- purpose' approaches to infectious disease surveillance and thereby targeted disease control. The fact that the majority of human infectious diseases are originally of animal origin means we have to consider One Health (OH) approaches which require inter-sectoral collaboration for custom-made infectious disease surveillance in the endemic settings of Africa. A baseline survey was conducted to assess the current status and performance of human and animal health surveillance systems and subsequently a strategy towards OH surveillance system was developed. The strategy focused on assessing the combination of participatory epidemiological approaches and the deployment of mobile technologies to enhance the effectiveness of disease alerts and surveillance at the point of occurrence, which often lies in remote areas. We selected three study sites, namely the Ngorongoro, Kagera River basin and Zambezi River basin ecosystems. We have piloted and introduced the next-generation Android mobile phones running the EpiCollect application developed by Imperial College to aid geo-spatial and clinical data capture and transmission of this data from the field to the remote Information Technology (IT) servers at the research hubs for storage, analysis, feedback and reporting. We expect that the combination of participatory epidemiology and technology will significantly improve OH disease surveillance in southern Africa.

HIV Infection in Migrant Populations in the European Union and European Economic Area in 2007-2012: An Epidemic on the Move.

Science.gov (United States)

Hernando, Victoria; Alvárez-del Arco, Débora; Alejos, Belén; Monge, Susana; Amato-Gauci, Andrew J; Noori, Teymur; Pharris, Anastasia; del Amo, Julia

2015-10-01

Migrants are considered a key group at risk for HIV infection. This study describes the epidemiology of HIV and the distribution of late HIV presentation among migrants within the European Union/European Economic Area during 2007-2012. HIV cases reported to European Surveillance System (TESSy) were analyzed. Migrants were defined as people whose geographical origin was different than the reporting country. Multiple logistic regression was used to model late HIV presentation. Overall, 156,817 HIV cases were reported, of which 60,446 (38%) were migrants. Of these, 53% were from Sub-Saharan Africa, 12% from Latin America, 9% from Western Europe, 7% from Central Europe, 5% from South and Southeast Asia, 4% from East Europe, 4% from Caribbean, and 3% from North Africa and Middle East. Male and female migrants from Sub-Saharan Africa and Latin America had higher odds of late HIV presentation than native men and women. Migrants accounted for 40% of all HIV notifications in 2007 versus 35% in 2012. HIV cases in women from Sub-Saharan Africa decreased from 3725 in 2007 to 2354 in 2012. The number of HIV cases from Latin America peaked in 2010 to decrease thereafter. HIV diagnoses in migrant men who have sex with men increased from 1927 in 2007 to 2459 in 2012. Migrants represent two-fifths of the HIV cases reported and had higher late HIV presentation. HIV epidemic in migrant populations in European Union/European Economic Area member states is changing, probably reflecting the global changes in the HIV pandemic, the impact of large-scale ART implementation, and migration fluctuations secondary to the economic crisis in Europe.

Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women.

Science.gov (United States)

Levy, Delphine P; Jager, Martine; Kapp, Nathalie; Abitbol, Jean-Louis

2014-05-01

To describe the safety of ulipristal acetate in emergency contraception. Postmarketing pharmacovigilance data collection. A total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing. No safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials. Use of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events. Copyright © 2014 Elsevier Inc. All rights reserved.

Cancer Registries and Monitoring the Impact of Prophylactic Human Papillomavirus Vaccines: The Potential Role

OpenAIRE

Saraiya, Mona; Goodman, Marc T.; Datta, S. Deblina; Chen, Vivien W.; Wingo, Phyllis A.

2008-01-01

The recent US Food and Drug Administration licensure of a prophylactic vaccine against oncogenic human papillomavirus (HPV) types 16 and 18, the first of its kind, poses unique challenges in postmarketing vaccine surveillance, especially in measuring vaccine effectiveness against biologic endpoints of HPV infection. Historically, the national system of population-based cancer registries in the US has provided high-quality data on cancer incidence and mortality for the most important biologic ...

Guidelines for Whole-Body Vibration Health Surveillance

Science.gov (United States)

POPE, M.; MAGNUSSON, M.; LUNDSTRÖM, R.; HULSHOF, C.; VERBEEK, J.; BOVENZI, M.

2002-05-01

examination, which includes recording any change in exposure to WBV. The findings for the individual should be compared with previous examinations. Group data should also be compiled periodically. Medical removal may be considered along with re-placement in working practices without exposure to WBV. This paper presents opinions on health surveillance for whole-body vibration developed within a working group of partners funded on a European Community Network (BIOMED2 concerted action BMH4-CT98-3251: Research network on detection and prevention of injuries due to occupational vibration exposures). The health surveillance protocol and the draft questionnaire with explanation comments are presented for wider consideration by the science community and others before being considered appropriate for implementation.

Participatory Surveillance and Photo Sharing Practices

DEFF Research Database (Denmark)

Albrechtslund, Anders; Damkjaer, Maja Sonne; Bøge, Ask Risom

2019-01-01

-material perspective on photo-sharing practices. Information, Communication & Society, 19(4), 475–488. Sontag, S. (1977). On Photography. Picador. Steeves, V., & Jones, O. (2010). Editorial: Surveillance, Children and Childhood. Surveillance & Society, 7(3/4), 187–191....... that parents do not generally plan to store or organize their photos, and even less their children’s photos. This seems to indicate a shift from a pre-digital perception of photos as objects to be packaged, accumulated, framed etc. which can age and disappear (see Sontag, 1977) to something perceived less....... References: Albrechtslund, A. (2008). Online Social Networking as Participatory Surveillance. First Monday, 13(3). Fotel, T., & Thomsen, T. U. (2002). The Surveillance of Children’s Mobility. Surveillance & Society, 1(4), 535-554. Lobinger, K. (2016). Photographs as things–photographs of things. A texto...

Cost effectiveness of surveillance for GI cancers.

Science.gov (United States)

Omidvari, Amir-Houshang; Meester, Reinier G S; Lansdorp-Vogelaar, Iris

2016-12-01

Gastrointestinal (GI) diseases are among the leading causes of death in the world. To reduce the burden of GI diseases, surveillance is recommended for some diseases, including for patients with inflammatory bowel diseases, Barrett's oesophagus, precancerous gastric lesions, colorectal adenoma, and pancreatic neoplasms. This review aims to provide an overview of the evidence on cost-effectiveness of surveillance of individuals with GI conditions predisposing them to cancer, specifically focussing on the aforementioned conditions. We searched the literature and reviewed 21 studies. Despite heterogeneity of studies in terms of settings, study populations, surveillance strategies and outcomes, most reviewed studies suggested at least some surveillance of patients with these GI conditions to be cost-effective. For some high-risk conditions frequent surveillance with 3-month intervals was warranted, while for other conditions, surveillance may only be cost-effective every 10 years. Further studies based on more robust effectiveness evidence are needed to inform and optimise surveillance programmes for GI cancers. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Environmental surveillance master sampling schedule

Energy Technology Data Exchange (ETDEWEB)

Bisping, L.E.

1993-01-01

Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the US Department of Energy (DOE). Samples are routinely collected and analyzed to determine the quality of air, surface water, ground water, soil, sediment, wildlife, vegetation, foodstuffs, and farm products at Hanford Site and surrounding communities. This document contains the planned schedule for routine sample collection for the Surface Environmental Surveillance Project (SESP) and Drinking Water Project, and Ground-Water Surveillance Project.

Elementary Surveillance (ELS) and Enhanced Surveillance (EHS) Validation via Mode S Secondary Radar Surveillance

National Research Council Canada - National Science Library

Grappel, Robert D; Harris, Garrett S; Kozar, Mark J; Wiken, Randall T

2008-01-01

...) and Enhanced Surveillance (ERS) data link applications. The intended audience for this report is an engineering staff assigned the task of implementing a monitoring system used to determine ELS and EHS compliance...

Laser surveillance system (LASSY)

International Nuclear Information System (INIS)

Boeck, H.

1991-09-01

Laser Surveillance System (LASSY) is a beam of laser light which scans a plane above the water or under-water in a spent-fuel pond. The system can detect different objects and estimates its coordinates and distance as well. LASSY can operate in stand-alone configuration or in combination with a video surveillance to trigger signal to a videorecorder. The recorded information on LASSY computer's disk comprises date, time, start and stop angle of detected alarm, the size of the disturbance indicated in number of deviated points and some other information. The information given by the laser system cannot be fully substituted by TV camera pictures since the scanning beam creates a horizontal surveillance plan. The engineered prototype laser system long-term field test has been carried out in Soluggia (Italy) and has shown its feasibility and reliability under the conditions of real spent fuel storage pond. The verification of the alarm table on the LASSY computer with the recorded video pictures of TV surveillance system confirmed that all alarm situations have been detected. 5 refs

Measles in Italy, laboratory surveillance activity during 2010

Directory of Open Access Journals (Sweden)

Claudia Fortuna

2014-12-01

Full Text Available INTRODUCTION: The European Regional Office of the World Health Organization (WHO/Europe developed a strategic approach to stop the indigenous transmission of measles in its 53 Member States by 2015. This study describes the measles laboratory surveillance activity performed by the National Reference Laboratory for Measles and Rubella at the Italian National Institute of Health (Istituto Superiore di Sanità during 2010. METHODS: Urine, oral fluid and capillary blood samples from 211 suspected measles cases arrived to the NRL from different regions of Italy for confirmation of the clinical diagnosis. Serological and/or molecular assays were performed; after molecular detection, positive samples were sequenced and genotyped. RESULTS AND DISCUSSION: 85% (180/211 of the specimens were confirmed as measles cases and 139 of these were analyzed phylogenetically. The phylogenetic analysis revealed a co-circulation of D4 and D8 genotypes for the reviewed period.

Safety learning from drugs of the same class

DEFF Research Database (Denmark)

Stefansdottir, G; Knol, M J; Arnardottir, A H

2012-01-01

This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs......) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were...... present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country...

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)

A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

Directory of Open Access Journals (Sweden)

Masakazu Fujiwara

Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

Project Surveillance and Maintenance Plan

International Nuclear Information System (INIS)

1985-09-01

The Project Surveillance and Maintenance Plan (PSMP) describes the procedures that will be used by the US Department of Energy (DOE), or other agency as designated by the President to verify that inactive uranium tailings disposal facilities remain in compliance with licensing requirements and US Environmental Protection Agency (EPA) standards for remedial actions. The PSMP will be used as a guide for the development of individual Site Surveillance and Maintenance Plans (part of a license application) for each of the UMTRA Project sites. The PSMP is not intended to provide minimum requirements but rather to provide guidance in the selection of surveillance measures. For example, the plan acknowledges that ground-water monitoring may or may not be required and provides the [guidance] to make this decision. The Site Surveillance and Maintenance Plans (SSMPs) will form the basis for the licensing of the long-term surveillance and maintenance of each UMTRA Project site by the NRC. Therefore, the PSMP is a key milestone in the licensing process of all UMTRA Project sites. The Project Licensing Plan (DOE, 1984a) describes the licensing process. 11 refs., 22 figs., 8 tabs

Integrated health outcomes research strategies in drug or medical device development, pre- and postmarketing: time for change.

Science.gov (United States)

Badía, Xavier; Guyver, Alice; Magaz, Sol; Bigorra, Juan

2002-06-01

The implementation of health outcomes research as a healthcare decision-making tool has expanded rapidly in the last decade. Drugs and medical devices are increasingly being required to demonstrate not only their efficacy and safety characteristics, but also their performance in at least three core dimensions of health outcomes research: clinical effectiveness, patient-reported outcomes and economic outcomes. However, the current integration of health outcomes research lacks coordination and communication and as a result, money and time is being spent on the generation of health outcomes research data which can be both insufficient and fail to satisfy the information demands of all the relevant stakeholders. In response to this, a new paradigm is evolving which involves the implementation of health outcomes research strategies that encompass the development, pre- and postmarketing stages of a drug or medical device.

Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

Science.gov (United States)

Ma, Handong; Weng, Chunhua

2016-04-01

-term BBW acquisition events without compromising prediction accuracy. This study contributes a method for post-marketing pharmacovigilance using Convergent Focus Shift (CFS) patterns in clinical trial study populations mined from linked public data resources. These signals are otherwise unavailable from individual data resources. We demonstrated the added value of linked public data and the feasibility of integrating ClinicalTrials.gov summaries and drug safety labels for post-marketing surveillance. Future research is needed to ensure better accessibility and linkage of heterogeneous drug safety data for efficient pharmacovigilance. Copyright © 2016 Elsevier Inc. All rights reserved.

Ebola Surveillance - Guinea, Liberia, and Sierra Leone.

Science.gov (United States)

McNamara, Lucy A; Schafer, Ilana J; Nolen, Leisha D; Gorina, Yelena; Redd, John T; Lo, Terrence; Ervin, Elizabeth; Henao, Olga; Dahl, Benjamin A; Morgan, Oliver; Hersey, Sara; Knust, Barbara

2016-07-08

Developing a surveillance system during a public health emergency is always challenging but is especially so in countries with limited public health infrastructure. Surveillance for Ebola virus disease (Ebola) in the West African countries heavily affected by Ebola (Guinea, Liberia, and Sierra Leone) faced numerous impediments, including insufficient numbers of trained staff, community reticence to report cases and contacts, limited information technology resources, limited telephone and Internet service, and overwhelming numbers of infected persons. Through the work of CDC and numerous partners, including the countries' ministries of health, the World Health Organization, and other government and nongovernment organizations, functional Ebola surveillance was established and maintained in these countries. CDC staff were heavily involved in implementing case-based surveillance systems, sustaining case surveillance and contact tracing, and interpreting surveillance data. In addition to helping the ministries of health and other partners understand and manage the epidemic, CDC's activities strengthened epidemiologic and data management capacity to improve routine surveillance in the countries affected, even after the Ebola epidemic ended, and enhanced local capacity to respond quickly to future public health emergencies. However, the many obstacles overcome during development of these Ebola surveillance systems highlight the need to have strong public health, surveillance, and information technology infrastructure in place before a public health emergency occurs. Intense, long-term focus on strengthening public health surveillance systems in developing countries, as described in the Global Health Security Agenda, is needed.The activities summarized in this report would not have been possible without collaboration with many U.S and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

Science.gov (United States)

Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

2018-03-06

To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

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.

Privacy preserving surveillance and the tracking-paradox

OpenAIRE

Greiner, S.; Birnstill, Pascal; Krempel, Erik; Beckert, B.; Beyerer, Jürgen

2013-01-01

Increasing capabilities of intelligent video surveillance systems impose new threats to privacy while, at the same time, offering opportunities for reducing the privacy invasiveness of surveillance measures as well as their selectivity. We show that aggregating more data about observed people does not necessarily lead to less privacy, but can increase the selectivity of surveillance measures. In case of video surveillance in a company environment, if we enable the system to authenticate emplo...

Surveillance theory and its implications for law

NARCIS (Netherlands)

Timan, Tjerk; Galic, Masa; Koops, Bert-Jaap; Brownsword, Roger; Scotford, Eloise; Yeung, Karen

2017-01-01

This chapter provides an overview of key surveillance theories and their implications for law and regulation. It presents three stages of theories that characterise changes in thinking about surveillance in society and the disciplining, controlling, and entertaining functions of surveillance.

Medical surveillance of occupationally exposed workers

International Nuclear Information System (INIS)

2007-05-01

The guide covers medical surveillance of workers engaged in radiation work and their fitness for this work, protection of the foetus and infant during the worker's pregnancy or breastfeeding, and medical surveillance measures to be taken when the dose limit has been exceeded. The guide also covers recognition of practitioners responsible for medical surveillance of category A workers, medical certificates to be issued to workers, and preservation and transfer of medical records. The medical surveillance requirements specified in this Guide cover the use of radiation and nuclear energy. The guide also applies to exposure to natural radiation in accordance with section 28 of the Finnish Radiation Decree

Negotiating privacy in surveillant welfare relations

DEFF Research Database (Denmark)

Andersen, Lars Bo; Lauritsen, Peter; Bøge, Ask Risom

. However, while privacy is central to debates of surveillance, it has proven less productive as an analytical resource for studying surveillance in practice. Consequently, this paper reviews different conceptualisations of privacy in relation to welfare and surveillance and argues for strengthening...... the analytical capacity of the concept by rendering it a situated and relational concept. The argument is developed through a research and design project called Teledialogue meant to improve the relation between case managers and children placed at institutions or in foster families. Privacy in Teledialogue...... notion of privacy are discussed in relation to both research- and public debates on surveillance in a welfare setting....

Medical surveillance of occupationally exposed workers

Energy Technology Data Exchange (ETDEWEB)

2007-05-15

The guide covers medical surveillance of workers engaged in radiation work and their fitness for this work, protection of the foetus and infant during the worker's pregnancy or breastfeeding, and medical surveillance measures to be taken when the dose limit has been exceeded. The guide also covers recognition of practitioners responsible for medical surveillance of category A workers, medical certificates to be issued to workers, and preservation and transfer of medical records. The medical surveillance requirements specified in this Guide cover the use of radiation and nuclear energy. The guide also applies to exposure to natural radiation in accordance with section 28 of the Finnish Radiation Decree

Systematic review of electronic surveillance of infectious diseases with emphasis on antimicrobial resistance surveillance in resource-limited settings.

Science.gov (United States)

Rattanaumpawan, Pinyo; Boonyasiri, Adhiratha; Vong, Sirenda; Thamlikitkul, Visanu

2018-02-01

Electronic surveillance of infectious diseases involves rapidly collecting, collating, and analyzing vast amounts of data from interrelated multiple databases. Although many developed countries have invested in electronic surveillance for infectious diseases, the system still presents a challenge for resource-limited health care settings. We conducted a systematic review by performing a comprehensive literature search on MEDLINE (January 2000-December 2015) to identify studies relevant to electronic surveillance of infectious diseases. Study characteristics and results were extracted and systematically reviewed by 3 infectious disease physicians. A total of 110 studies were included. Most surveillance systems were developed and implemented in high-income countries; less than one-quarter were conducted in low-or middle-income countries. Information technologies can be used to facilitate the process of obtaining laboratory, clinical, and pharmacologic data for the surveillance of infectious diseases, including antimicrobial resistance (AMR) infections. These novel systems require greater resources; however, we found that using electronic surveillance systems could result in shorter times to detect targeted infectious diseases and improvement of data collection. This study highlights a lack of resources in areas where an effective, rapid surveillance system is most needed. The availability of information technology for the electronic surveillance of infectious diseases, including AMR infections, will facilitate the prevention and containment of such emerging infectious diseases. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Surveillance and threat detection prevention versus mitigation

CERN Document Server

Kirchner, Richard

2014-01-01

Surveillance and Threat Detection offers readers a complete understanding of the terrorist/criminal cycle, and how to interrupt that cycle to prevent an attack. Terrorists and criminals often rely on pre-attack and pre-operational planning and surveillance activities that can last a period of weeks, months, or even years. Identifying and disrupting this surveillance is key to prevention of attacks. The systematic capture of suspicious events and the correlation of those events can reveal terrorist or criminal surveillance, allowing security professionals to employ appropriate countermeasures and identify the steps needed to apprehend the perpetrators. The results will dramatically increase the probability of prevention while streamlining protection assets and costs. Readers of Surveillance and Threat Detection will draw from real-world case studies that apply to their real-world security responsibilities. Ultimately, readers will come away with an understanding of how surveillance detection at a high-value, f...

Surveillance of nuclear power reactors

International Nuclear Information System (INIS)

Marini, J.

1983-01-01

Surveillance of nuclear power reactors is now a necessity imposed by such regulatory documents as USNRC Regulatory Guide 1.133. In addition to regulatory requirements, however, nuclear reactor surveillance offers plant operators significant economic advantages insofar as a single day's outage is very costly. The economic worth of a reactor surveillance system can be stated in terms of the improved plant availability provided through its capability to detect incidents before they occur and cause serious damage. Furthermore, the TMI accident has demonstrated the need for monitoring certain components to provide operators with clear information on their functional status. In response to the above considerations, Framatome has developed a line of products which includes: pressure vessel leakage detection systems, loose part detection systems, component vibration monitoring systems, and, crack detection and monitoring systems. Some of the surveillance systems developed by Framatome are described in this paper

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

Microprocessor-based integrated LMFBR core surveillance

International Nuclear Information System (INIS)

Gmeiner, L.

1984-06-01

This report results from a joint study of KfK and INTERATOM. The aim of this study is to explore the advantages of microprocessors and microelectronics for a more sophisticated core surveillance, which is based on the integration of separate surveillance techniques. Due to new developments in microelectronics and related software an approach to LMFBR core surveillance can be conceived that combines a number of measurements into a more intelligent decision-making data processing system. The following techniques are considered to contribute essentially to an integrated core surveillance system: - subassembly state and thermal hydraulics performance monitoring, - temperature noise analysis, - acoustic core surveillance, - failure characterization and failure prediction based on DND- and cover gas signals, and - flux tilting techniques. Starting from a description of these techniques it is shown that by combination and correlation of these individual techniques a higher degree of cost-effectiveness, reliability and accuracy can be achieved. (orig./GL) [de

Active prospective surveillance study with post-discharge surveillance of surgical site infections in Cambodia

Directory of Open Access Journals (Sweden)

José Guerra

2015-05-01

Full Text Available Summary: Barriers to the implementation of the Centers for Disease Control and Prevention (CDC guidelines for surgical site infection (SSI surveillance have been described in resource-limited settings. This study aimed to estimate the SSI incidence rate in a Cambodian hospital and to compare different modalities of SSI surveillance. We performed an active prospective study with post-discharge surveillance. During the hospital stay, trained surveyors collected the CDC criteria to identify SSI by direct examination of the surgical site. After discharge, a card was given to each included patient to be presented to all practitioners examining the surgical site. Among 167 patients, direct examination of the surgical site identified a cumulative incidence rate of 14 infections per 100 patients. An independent review of medical charts presented a sensitivity of 16%. The sensitivity of the purulent drainage criterion to detect SSIs was 83%. After hospital discharge, 87% of the patients provided follow-up data, and nine purulent drainages were reported by a practitioner (cumulative incidence rate: 20%. Overall, the incidence rate was dependent on the surveillance modalities. The review of medical charts to identify SSIs during hospitalization was not effective; the use of a follow-up card with phone calls for post-discharge surveillance was effective. Keywords: Surgical wound infection, Cambodia, Infection control, Developing countries, Follow-up studies, Feasibility studies

[The eradication of the poliomyelitis in the European Region of the World Health Organization].

Science.gov (United States)

Limia Sánchez, Aurora

2013-01-01

Poliomyelitis was considered an important event for the public health since the end of XIX century when this disease became epidemic. As soon as vaccines were available member states of the World Health Organization (WHO) in the European Region started to implement vaccination programmes against polio with an important impact in the incidence in this disease. In May 1988, the World Health Assembly resolution for the global eradication of poliomyelitis was adopted and the mechanisms to oversee the progress in the different WHO Regions were established. This article briefly reviews the history of polio in the WHO European Region, the process for certification and maintenance, the strategies for eradication and the current situation in the European Region and globally. The European Region was certified polio-free in 2002. Nevertheless, there are still three endemic countries in the world, some others use live attenuated vaccines as well as countries in the Horn of Africa are recently suffering the reintroduction of wild poliovirus. Considering these circumstances, the risk of reintroduction of poliovirus and the generation of outbreaks in the European Region exists, therefore high vaccination coverage against polio and good quality surveillance systems are needed to be guaranteed in every member state.

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

First detection of European bat lyssavirus type 2 (EBLV-2) in Norway.

Science.gov (United States)

Moldal, Torfinn; Vikøren, Turid; Cliquet, Florence; Marston, Denise A; van der Kooij, Jeroen; Madslien, Knut; Ørpetveit, Irene

2017-07-11

In Europe, bat rabies is primarily attributed to European bat lyssavirus type 1 (EBLV-1) and European bat lyssavirus type 2 (EBLV-2) which are both strongly host-specific. Approximately thirty cases of infection with EBLV-2 in Daubenton's bats (Myotis daubentonii) and pond bats (M. dasycneme) have been reported. Two human cases of rabies caused by EBLV-2 have also been confirmed during the last thirty years, while natural spill-over to other non-flying mammals has never been reported. Rabies has never been diagnosed in mainland Norway previously. In late September 2015, a subadult male Daubenton's bat was found in a poor condition 800 m above sea level in the southern part of Norway. The bat was brought to the national Bat Care Centre where it eventually displayed signs of neurological disease and died after two days. EBLV-2 was detected in brain tissues by polymerase chain reaction (PCR) followed by sequencing of a part of the nucleoprotein gene, and lyssavirus was isolated in neuroblastoma cells. The detection of EBLV-2 in a bat in Norway broadens the knowledge on the occurrence of this zoonotic agent. Since Norway is considered free of rabies, adequate information to the general public regarding the possibility of human cases of bat-associated rabies should be given. No extensive surveillance of lyssavirus infections in bats has been conducted in the country, and a passive surveillance network to assess rabies prevalence and bat epidemiology is highly desired.

Twitter Influenza Surveillance: Quantifying Seasonal Misdiagnosis Patterns and their Impact on Surveillance Estimates.

Science.gov (United States)

Mowery, Jared

2016-01-01

Influenza (flu) surveillance using Twitter data can potentially save lives and increase efficiency by providing governments and healthcare organizations with greater situational awareness. However, research is needed to determine the impact of Twitter users' misdiagnoses on surveillance estimates. This study establishes the importance of Twitter users' misdiagnoses by showing that Twitter flu surveillance in the United States failed during the 2011-2012 flu season, estimates the extent of misdiagnoses, and tests several methods for reducing the adverse effects of misdiagnoses. Metrics representing flu prevalence, seasonal misdiagnosis patterns, diagnosis uncertainty, flu symptoms, and noise were produced using Twitter data in conjunction with OpenSextant for geo-inferencing, and a maximum entropy classifier for identifying tweets related to illness. These metrics were tested for correlations with World Health Organization (WHO) positive specimen counts of flu from 2011 to 2014. Twitter flu surveillance erroneously indicated a typical flu season during 2011-2012, even though the flu season peaked three months late, and erroneously indicated plateaus of flu tweets before the 2012-2013 and 2013-2014 flu seasons. Enhancements based on estimates of misdiagnoses removed the erroneous plateaus and increased the Pearson correlation coefficients by .04 and .23, but failed to correct the 2011-2012 flu season estimate. A rough estimate indicates that approximately 40% of flu tweets reflected misdiagnoses. Further research into factors affecting Twitter users' misdiagnoses, in conjunction with data from additional atypical flu seasons, is needed to enable Twitter flu surveillance systems to produce reliable estimates during atypical flu seasons.

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...

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

Science.gov (United States)

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

The value of information: Current challenges in surveillance implementation.

Science.gov (United States)

Stärk, Katharina D C; Häsler, Barbara

2015-11-01

Animal health surveillance is a complex activity that involves multiple stakeholders and provides decision support across sectors. Despite progress in the design of surveillance systems, some technical challenges remain, specifically for emerging hazards. Surveillance can also be impacted by political interests and costly consequences of case reporting, particularly in relation to international trade. Constraints on surveillance can therefore be of technical, economic and political nature. From an economic perspective, both surveillance and intervention are resource-using activities that are part of a mitigation strategy. Surveillance provides information for intervention decisions and thereby helps to offset negative effects of animal disease and to reduce the decision uncertainty associated with choices on disease control. It thus creates monetary and non-monetary benefits, both of which may be challenging to quantify. The technical relationships between surveillance, intervention and loss avoidance have not been established for most hazards despite being important consideration for investment decisions. Therefore, surveillance cannot just be maximised to minimise intervention costs. Economic appraisals of surveillance need to be done on a case by case basis for any hazard considering both surveillance and intervention performance, the losses avoided and the values attached to them. This can be achieved by using an evaluation approach which provides a systematic investigation of the worth or merit of surveillance activities. Evaluation is driven by a specific evaluation question which for surveillance systems commonly considers effectiveness, efficiency, implementation and/or compliance issues. More work is needed to provide guidance on the appropriate selection of evaluation attributes and general good practice in surveillance evaluation. Due to technical challenges, economic constraints and variable levels of capacity, the implementation of surveillance systems

TU-AB-204-01: Device Approval Process

International Nuclear Information System (INIS)

Delfino, J.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-02: Device Adverse Events and Compliance

International Nuclear Information System (INIS)

Gonzales, S.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-03: Research Activities in Medical Physics

International Nuclear Information System (INIS)

Badano, A.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-04: Partnerships

International Nuclear Information System (INIS)

Ochs, R.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-02: Device Adverse Events and Compliance

Energy Technology Data Exchange (ETDEWEB)

Gonzales, S. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-04: Partnerships

Energy Technology Data Exchange (ETDEWEB)

Ochs, R. [Food & Drug Administration Center for Devices and Radiological Health (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-03: Research Activities in Medical Physics

Energy Technology Data Exchange (ETDEWEB)

Badano, A. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-01: Device Approval Process

Energy Technology Data Exchange (ETDEWEB)

Delfino, J. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

Sibutramine usage in New Zealand: an analysis of prescription data by the Intensive Medicines Monitoring Programme.

Science.gov (United States)

Hill, Geraldine R; Ashton, Janelle; Harrison-Woolrych, Mira

2007-11-01

To describe patterns of sibutramine usage in New Zealand during the first 3 years of marketing using data acquired during post-marketing safety surveillance. Demographic and prescription data were examined from a nationwide cohort of 17 298 patients prescribed sibutramine between 1 February 2001 and 31 March 2004. Outcome measures were age and sex distribution of the cohort; period prevalence of sibutramine usage for each ethnic group; duration of treatment and reasons for cessation of therapy. Limited BMI data were also examined. About 0.5% of the NZ population were prescribed sibutramine in the period studied. Overwhelmingly, the highest users of sibutramine were NZ European women aged 30-59 years. Maori and Pacific Peoples were under-represented in the cohort, despite the higher prevalence of obesity among these populations. Sibutramine usage was predominantly short-term: 59% of the cohort used sibutramine for 90 days or less, half of whom used it for only 1 month. There has been extensive use of sibutramine in New Zealand. Sibutramine has been relatively under-utilised by Maori and Pacific ethnic groups, compared to New Zealand Europeans, despite their higher prevalence of obesity. A number of factors may have contributed to the predominantly short-term use of this medicine, including the cost of the medicine to the consumer, weight loss not meeting expectations and adverse effects of the medicine.

2012 Sexually Transmitted Diseases Surveillance

Science.gov (United States)

... Data Appendix Tables A1 - A4 STD Surveillance Case Definitions Contributors Related Links STD Home STD Data & Statistics NCHHSTP Atlas Interactive STD Data - 1996-2013 STD Health Equity HIV/AIDS Surveillance & Statistics Follow STD STD on Twitter STD on Facebook File Formats Help: How do I view different ...

Weighing in on Surveillance: Perception of the Impact of Surveillance on Female Ballet Dancers' Health

Science.gov (United States)

Dryburgh, Anne; Fortin, Sylvie

2010-01-01

The aim of this qualitative study was to investigate professional ballet dancers' perceptions of the impact of surveillance on their psychological and physical health. The theoretical framework was inspired by Foucault's writing, particularly his concepts of surveillance, power, discipline and docile bodies. Fifteen professional ballet dancers…

DengueTools: innovative tools and strategies for the surveillance and control of dengue

Directory of Open Access Journals (Sweden)

Annelies Wilder-Smith

2012-03-01

Full Text Available Dengue fever is a mosquito-borne viral disease estimated to cause about 230 million infections worldwide every year, of which 25,000 are fatal. Global incidence has risen rapidly in recent decades with some 3.6 billion people, over half of the world's population, now at risk, mainly in urban centres of the tropics and subtropics. Demographic and societal changes, in particular urbanization, globalization, and increased international travel, are major contributors to the rise in incidence and geographic expansion of dengue infections. Major research gaps continue to hamper the control of dengue. The European Commission launched a call under the 7th Framework Programme with the title of ‘Comprehensive control of Dengue fever under changing climatic conditions’. Fourteen partners from several countries in Europe, Asia, and South America formed a consortium named ‘DengueTools’ to respond to the call to achieve better diagnosis, surveillance, prevention, and predictive models and improve our understanding of the spread of dengue to previously uninfected regions (including Europe in the context of globalization and climate change.The consortium comprises 12 work packages to address a set of research questions in three areas: Research area 1: Develop a comprehensive early warning and surveillance system that has predictive capability for epidemic dengue and benefits from novel tools for laboratory diagnosis and vector monitoring. Research area 2: Develop novel strategies to prevent dengue in children. Research area 3: Understand and predict the risk of global spread of dengue, in particular the risk of introduction and establishment in Europe, within the context of parameters of vectorial capacity, global mobility, and climate change.In this paper, we report on the rationale and specific study objectives of ‘DengueTools’. DengueTools is funded under the Health theme of the Seventh Framework Programme of the European Community, Grant

DengueTools: innovative tools and strategies for the surveillance and control of dengue.

Science.gov (United States)

Wilder-Smith, Annelies; Renhorn, Karl-Erik; Tissera, Hasitha; Abu Bakar, Sazaly; Alphey, Luke; Kittayapong, Pattamaporn; Lindsay, Steve; Logan, James; Hatz, Christoph; Reiter, Paul; Rocklöv, Joacim; Byass, Peter; Louis, Valérie R; Tozan, Yesim; Massad, Eduardo; Tenorio, Antonio; Lagneau, Christophe; L'Ambert, Grégory; Brooks, David; Wegerdt, Johannah; Gubler, Duane

2012-01-01

Dengue fever is a mosquito-borne viral disease estimated to cause about 230 million infections worldwide every year, of which 25,000 are fatal. Global incidence has risen rapidly in recent decades with some 3.6 billion people, over half of the world's population, now at risk, mainly in urban centres of the tropics and subtropics. Demographic and societal changes, in particular urbanization, globalization, and increased international travel, are major contributors to the rise in incidence and geographic expansion of dengue infections. Major research gaps continue to hamper the control of dengue. The European Commission launched a call under the 7th Framework Programme with the title of 'Comprehensive control of Dengue fever under changing climatic conditions'. Fourteen partners from several countries in Europe, Asia, and South America formed a consortium named 'DengueTools' to respond to the call to achieve better diagnosis, surveillance, prevention, and predictive models and improve our understanding of the spread of dengue to previously uninfected regions (including Europe) in the context of globalization and climate change.The consortium comprises 12 work packages to address a set of research questions in three areas:Research area 1: Develop a comprehensive early warning and surveillance system that has predictive capability for epidemic dengue and benefits from novel tools for laboratory diagnosis and vector monitoring.Research area 2: Develop novel strategies to prevent dengue in children.Research area 3: Understand and predict the risk of global spread of dengue, in particular the risk of introduction and establishment in Europe, within the context of parameters of vectorial capacity, global mobility, and climate change.In this paper, we report on the rationale and specific study objectives of 'DengueTools'. DengueTools is funded under the Health theme of the Seventh Framework Programme of the European Community, Grant Agreement Number: 282589 Dengue Tools.

Surveillance of WWER-440 fuel performance

International Nuclear Information System (INIS)

Simko, J.; Urban, P.

1999-01-01

In this lecture next problems of surveillance of WWER-440 fuel performance are presented: surveillance of WWER-440 fuel performance at Mochovce NPP; basic data of WWER-440 reactor; in-core reactor measuring system 'SVRK'; basic level of SVRK; information output of basic level of SVRK; surveillance of fuel performance; table of permissible operation conditions of the reactor; limitation of the unit 1 power at the beginning of the operation; cyclic changes of power; future perspectives

An Institutional Approach to Bordering in Islands: The Canary Islands on the African-European Migration Routes

Directory of Open Access Journals (Sweden)

Dirk Godenau

2012-05-01

Full Text Available Islands play a significant role in international irregular maritime migration. Frequently they are part of maritime interstitial spaces between states, and their location, combined with institutional membership, makes them part of international migration routes and subject to border management strategies. In this paper borders are analysed as social institutions used for regulating relative permeability through rules of entry and exit for persons, goods and capital. Borders institutionalize territoriality and are politically implemented by states. They are selective, also in migration, and irregular border transit is not always indicative of an inability to control. The Canary Islands are used as an illustrative example of how border management at the southern edge of the European Union has evolved towards more coercive deterrence and tighter surveillance. The Canary Islands experienced irregular maritime immigration from the west African coasts during the first decade of the 21st century and most of these migrants intended to use the islands as transit space towards the European continent. Increasing surveillance in countries of origin, enforcement of border controls and stricter return policies were used to stop flows. The so-called “cayuco crisis” in 2006 induced institutional change in border management and forced the active involvement of the EU through FRONTEX.

[Surveillance Plan on Recent Outbreak of Measles and Rubella in Catalonia, Spain].

Science.gov (United States)

Jané, Mireia; Torner, Nuria; Vidal, Ma José

2015-01-01

Measles and rubella are two immuno-preventive illnesses. In Catalonia, since 1988 all children are given two doses of measles and rubella vaccine with high levels of vaccination coverage. The measles elimination programme has been carried out since 1990 in Catalonia. This programme includes achieving and keeping high immunization levels among population with high vaccination coverage, intense epidemiological surveillance and an immediate response to the appearance of a case or outbreak. In 2014, the measles incidence rate was 1.9 cases/ 100,000 inhabitants. There were 4 recent outbreaks in 2006, 2011, 2013 and 2014 that affected 381, 289, 31 and 124 people respectively. All outbreaks were triggered by an imported case. In 2011 and 2014 measles outbreaks, 6% and 5.5% of affected people were health care workers. All outbreaks presented a great variety of measles genotypes. Concerning rubella elimination programme, since 2002, 68 cases of postnatal rubella and 5 cases of congenital rubella were confirmed. Regarding measles and rubella surveillance and control, in addition to strengthen vaccination coverage, it is essential immediate notification, within the first 24 hours since suspicion and laboratory confirmation. In addition there is a need to enforce vaccination among health care workers as well as in other susceptible and unvaccinated people. It is recommended to vaccinate all people who were born after 1966 and who have not been vaccinated with two doses of trivalent measles-mumps-rubella vaccine. Furthermore, we have to emphasize that the progress concerning genotypes study allows identifying various imported cases from other European countries with active outbreaks, aspect that makes easier the surveillance of these illnesses.

A new era of European Integration?

DEFF Research Database (Denmark)

de la Porte, Caroline; Heins, Elke

2015-01-01

. On this basis, we show first that new instruments - the Six-Pack, Fiscal Compact and Two-Pack - have been layered onto the existing institutional framework governing the Economic and Monetary Union (EMU). Furthermore, we show that the instruments strengthening budgetary discipline to improve the functioning...... of European Monetary Union have become more explicit in terms of policy objectives, particularly specifying new benchmarks to obtain fiscal discipline. They are also stricter in terms of surveillance and enforcement. Second, we show that there are initiatives to address and improve the social dimension...... of the EU - Europe 2020, the Social Investment Package and the Youth Guarantee - and that these have also emerged through a process of institutional layering. However, the aims around Europe 2020 and Social Investment continue to be based on the voluntary Open Method of Coordination, with comparatively weak...

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.

EU Law and Mass Internet Metadata Surveillance in the Post-Snowden Era

Directory of Open Access Journals (Sweden)

Nora Ni Loideain

2015-09-01

Full Text Available Legal frameworks exist within democracies to prevent the misuse and abuse of personal data that law enforcement authorities obtain from private communication service providers. The fundamental rights to respect for private life and the protection of personal data underpin this framework within the European Union. Accordingly, the protection of the principles and safeguards required by these rights is key to ensuring that the oversight of State surveillance powers is robust and transparent. Furthermore, without the robust scrutiny of independent judicial review, the principles and safeguards guaranteed by these rights may become more illusory than real. Following the Edward Snowden revelations, major concerns have been raised worldwide regarding the legality, necessity and proportionality standards governing these laws. In 2014, the highest court in the EU struck down the legal framework that imposed a mandatory duty on communication service providers to undertake the mass retention of metadata for secret intelligence and law enforcement authorities across the EU. This article considers the influence of the Snowden revelations on this landmark judgment. Subsequently, the analysis explores the significance of this ruling for the future reform of EU law governing metadata surveillance and its contribution to the worldwide debate on indiscriminate and covert monitoring in the post-Snowden era.

Tuberculosis treatment outcome monitoring in European Union countries: systematic review

Science.gov (United States)

van Hest, Rob; Ködmön, Csaba; Verver, Suzanne; Erkens, Connie G.M.; Straetemans, Masja; Manissero, Davide; de Vries, Gerard

2013-01-01

Treatment success measured by treatment outcome monitoring (TOM) is a key programmatic output of tuberculosis (TB) control programmes. We performed a systematic literature review on national-level TOM in the 30 European Union (EU)/European Economic Areas (EEA) countries to summarise methods used to collect and report data on TOM. Online reference bibliographic databases PubMed/MEDLINE and EMBASE were searched to identify relevant indexed and non-indexed literature published between January 2000 and August 2010. The search strategy resulted in 615 potentially relevant indexed citations, of which 27 full-text national studies (79 data sets) were included for final analysis. The selected studies were performed in 10 EU/EEA countries and gave a fragmented impression of TOM in the EU/EEA. Publication year, study period, sample size, databases, definitions, variables, patient and outcome categories, and population subgroups varied widely, portraying a very heterogeneous picture. This review confirmed previous reports of considerable heterogeneity in publications of TOM results across EU/EEA countries. PubMed/MEDLINE and EMBASE indexed studies are not a suitable instrument to measure representative TOM results for the 30 EU/EEA countries. Uniform and complete reporting to the centralised European Surveillance System will produce the most timely and reliable results of TB treatment outcomes in the EU/EEA. PMID:22790913

Liberal luxury: Decentering Snowden, surveillance and privilege

Directory of Open Access Journals (Sweden)

Piro Rexhepi

2016-11-01

Full Text Available This paper reflects on the continued potency of veillance theories to traverse beyond the taxonomies of surveillance inside liberal democracies. It provides a commentary on the ability of sousveillance to destabilise and disrupt suer/violence by shifting its focus from the centre to the periphery, where Big Data surveillance is tantamount to sur/violence. In these peripheral political spaces, surveillance is not framed by concerns over privacy, democracy and civil society; rather, it is a matter of life and death, a technique of both biopolitical and thanatopolitical power. I argue that the universalist, and universalizing, debates over surveillance cannot be mapped through the anxieties of privileged middle classes as they would neither transcend nor make possible alternative ways of tackling the intersection of surveillance and violence so long as they are couched in the liberal concerns for democracy. I call this phenomenon “liberal luxury,” whereby debates over surveillance have over-emphasised liberal proclivities at the expense of disengaging those peripheral populations most severely affected by sur/violence.

Reviewing surveillance activities in nuclear power plants

International Nuclear Information System (INIS)

1989-03-01

This document provides guidance to Operational Safety Review Teams (OSARTs) for reviewing surveillance activities at a nuclear power plant. In addition, the document contains reference material to support the review of surveillance activities, to assist within the Technical Support area and to ensure consistency between individual reviews. Drafts of the document have already been used on several OSART missions and found to be useful. The document first considers the objectives of an excellent surveillance programme. Investigations to determine the quality of the surveillance programme are then discussed. The attributes of an excellent surveillance programme are listed. Advice follows on how to phrase questions so as to obtain an informative response on surveillance features. Finally, specific equipment is mentioned that should be considered when reviewing functional tests. Four annexes provide examples drawn from operating nuclear power plants. They were selected to supplement the main text of the document with the best international practices as found in OSART reviews. They should in no way limit the acceptance and development of alternative approaches that lead to equivalent or better results. Refs, figs and tabs