Science.gov

Sample records for product surveillance postmarketing

  1. Postmarketing Surveillance for “Modified-Risk” Tobacco Products

    PubMed Central

    2012-01-01

    Introduction: The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have “modified-risk” for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of marketing. Method: A narrative review approach was taken. The author searched and integrated publicly accessible literature on tobacco product surveillance as well as drug and medical device postmarket activities currently performed by FDA. Results: FDA relies on active and passive methods for postmarket surveillance and can require specific studies and risk evaluation and mitigation strategies for certain products, including those with abuse liability. Past efforts at examining the individual and population effects of reduced harm tobacco products provide an example of integrating different data streams. Discussion: Postmarket surveillance can be viewed in terms of the Agent–Host–Vector–Environment model, and concepts from diffusion of innovations are relevant to understanding factors associated with the adoption of new products by the population. Given that active and passive surveillance approaches have different strengths and weaknesses, multiple approaches may be necessary to evaluate population-level effects. Assuring that required studies are properly conducted and reported and that data indicating significant public health harms are quickly recognized will be important going forward. Conclusions: The advent of broad regulatory authority over tobacco provides opportunities for policy evaluation research. The research community can provide FDA with the independent science it needs to evaluate the public health impact of novel tobacco products. PMID:21330282

  2. Postmarket surveillance. Final rule.

    PubMed

    2002-06-01

    The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health. PMID:12053947

  3. [Post-marketing surveillance studies].

    PubMed

    Pigeot, I; Windeler, J

    2005-05-01

    Approval of a drug on the market is typically considered as the successful endpoint of a long development phase. This often leads to reduced interest in further research for the indication approved, while in contrast the patient's as well as physician's interest in further research increases. This paper discusses the main areas of effectiveness, safety and post-marketing practice regarding sensible study types for the specific area and the potential gain of knowledge. PMID:15887069

  4. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.8 When, where, and how must I submit my postmarket surveillance plan? You must submit your plan...

  5. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order)...

  6. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order)...

  7. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I must conduct postmarket surveillance? We will send you a letter (the postmarket surveillance order)...

  8. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... conduct postmarket surveillance? 822.30 Section 822.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and Exemptions § 822.30 May I request exemption from the requirement to conduct postmarket surveillance? You...

  9. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... conduct postmarket surveillance? 822.30 Section 822.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and Exemptions § 822.30 May I request exemption from the requirement to conduct postmarket surveillance? You...

  10. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conduct postmarket surveillance? 822.30 Section 822.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and Exemptions § 822.30 May I request exemption from the requirement to conduct postmarket surveillance? You...

  11. 77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... iterative nature of product development, the learning curve associated with technology adoption, and the... intensity. CDRH believes that registry development in targeted product areas will both provide needed... Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle AGENCY: Food and...

  12. ABCDXXX: The obscenity of postmarketing surveillance for teratogenic effects.

    PubMed

    Friedman, Jan M

    2012-08-01

    Our current system of postmarketing surveillance, which is based on voluntary reporting of suspected teratogenic effects, is a failure. Postmarketing surveillance should, at a minimum, provide reassurance that every approved drug treatment does not produce a teratogenic effect as great as thalidomide embryopathy or fetal alcohol syndrome. This means that postmarketing surveillance should be able to detect a twofold or greater increase in the frequency of major congenital anomalies, a fivefold or greater increase in the frequency of intellectual disability, or a characteristic pattern of minor anomalies and functional abnormalities that occurs with a frequency of at least 10% among the children of women who were treated with the drug during pregnancy. Effective surveillance for teratogenic effects could be accomplished through a complementary set of mechanisms that includes pregnancy exposure registries or cohorts as well as direct examination of a small subset of infants whose mothers received the treatment during various periods of pregnancy. If this routine surveillance reveals a "signal" (i.e., an indication suggesting a possible teratogenic effect), further study would be needed to establish whether the observed effect is real and causal. Once a signal of possible teratogenicity in humans has been recognized, validating or refuting it would become an urgent matter. PMID:22786781

  13. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

    PubMed Central

    Sinaci, A. Anil; Laleci Erturkmen, Gokce B.; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H. Alper; Cicekli, Nihan Kesim

    2015-01-01

    Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

  14. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies.

    PubMed

    Sinaci, A Anil; Laleci Erturkmen, Gokce B; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H Alper; Cicekli, Nihan Kesim

    2015-01-01

    Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

  15. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket...

  16. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket...

  17. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket...

  18. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket...

  19. Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices

    PubMed Central

    Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B.; Brennan, Troyen A; Liang, Matthew H

    2008-01-01

    Objective To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA’s post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Results Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Conclusion Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures. PMID:19088864

  20. Efficacy and tolerability of almotriptan in postmarketing surveillance studies.

    PubMed

    Pascual, Julio

    2005-01-01

    While randomized, double-blind, placebo-controlled trials are considered the gold standard of clinical evidence, they are limited by patient numbers, duration of patient exposure, and restricted patient populations. Data from controlled trials may not be generalizable to all individuals likely to take the drug under investigation. Postmarketing surveillance studies are designed to measure efficacy and safety in larger and more diverse populations, allowing them to detect less common and delayed adverse events. However, postmarketing surveillance studies are limited by their lack of randomization, open-label design that can result in patient and physician bias, incomplete follow-up, less than rigorous outcome measurement, and lack of a contemporaneous control group. With regard to acute treatment of migraine, clinical trials using per protocol primary endpoints do not reflect the more favorable experience with triptans in general practice. Postmarketing surveillance studies have been performed to determine whether the high levels of efficacy and tolerability of almotriptan reported in controlled clinical trials can been reproduced in routine practice. An observational study conducted in Spain with 2,074 migraine sufferers (4,183 attacks) reported a 2-hour pain-relief rate of 86.9%, a 2-hour pain-free rate of 51.5%, and a sustained pain-free rate of 46.0%; 1.1% of patients reported adverse reactions. A German postmarketing study in 899 patients (2,131 attacks) with acute migraine treated with almotriptan 12.5 mg reported 2-hour pain relief in 84.5% of attacks and 2-hour pain free in 41.4%; 1.1% of patients reported adverse reactions. The consistency of response (at least two out of three attacks successfully treated) with almotriptan 12.5 mg was 87.3%. Regarding satisfaction, 88.5% of patients were satisfied or very satisfied and 80.3% of patients stated that almotriptan was better compared to their prior therapy; 92% of physicians indicated that they would continue

  1. 77 FR 9256 - Design and Methodology for Postmarket Surveillance Studies Under Section 522 of the Federal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-16

    ... HUMAN SERVICES Food and Drug Administration Design and Methodology for Postmarket Surveillance Studies... announcing a public workshop entitled ``Design and Methodology for Postmarket Surveillance Studies under... stakeholders with experience in epidemiology, statistics, and biomedical research to advance the design...

  2. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How will I know if I must conduct postmarket surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I...

  3. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false How will I know if I must conduct postmarket surveillance? 822.5 Section 822.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.5 How will I know if I...

  4. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will...

  5. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will...

  6. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will...

  7. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will...

  8. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... conduct postmarket surveillance? 822.6 Section 822.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.6 When will you notify me that I am required to conduct postmarket surveillance? We will...

  9. Signal detection in post-marketing surveillance for controlled substances.

    PubMed

    Dasgupta, Nabarun; Schnoll, Sidney H

    2009-12-01

    Signal detection for pharmaceutical controlled substances presents unique challenges compared to other pharmacovigilance programs because risks are present in the patient and non-patient populations. Defining signals for controlled substances has been difficult because no specific empirical criteria have been established through regulatory actions or guidances. We start with a review of data sources available for decision making to regulators and industry. In this paper we present a framework for processing signals received during post-marketing surveillance: signal identification, verification and assessment, followed by intervention and evaluation. Signal identification involves processing qualitative and quantitative information in order to generate hypotheses describing concerns with controlled substances. Integration of heterogeneous data sources makes this process difficult and we describe multiple approaches utilized in practice today. Signal verification currently relies heavily on telephone interviews with stakeholders in local communities. Once information on a potential signal has been gathered signal assessment is a higher order process conducted with an eye towards broader societal expectations and the ability to intervene or further study the problem. Intervention and evaluation complete the cycle of signal assessment and triage. This paper is intended as a primer of the current practice of signal assessment in the post-marketing surveillance for controlled substances. PMID:19616902

  10. Quality of alcohol-based hand disinfectants and their regulatory status. Production, sales and post-marketing surveillance.

    PubMed

    Michelsen, Klaus

    2008-10-01

    A high standard of hand hygiene is achieved by developing, producing and distributing hand disinfectants compliant with the German law for medicinal products. This ensures optimal protection of patients and staff from infections. In addition all local requirements are automatically fulfilled independent of the place within which the product is being used. It is shown that continuous improvement can be stimulated by intensive cooperation between the customer and supplier to ensure that customer expectations are met. PMID:18994683

  11. Japanese Physicians’ Views on Drug Post-Marketing Surveillance

    PubMed Central

    Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

    2015-01-01

    Background Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians’ views on PMS with the aim of conducting PMS more effectively. Methods We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians’ attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Results Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Conclusions Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure. PMID:26566409

  12. 21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has...

  13. 21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has...

  14. 21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has...

  15. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false If I stop marketing the device subject to... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved...

  16. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false If I stop marketing the device subject to... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved...

  17. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false If I stop marketing the device subject to... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved...

  18. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false If I stop marketing the device subject to... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved...

  19. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false If I stop marketing the device subject to... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved...

  20. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Radiological Health's (CDRH') Web site...

  1. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Radiological Health's (CDRH') Web site (www.fda.gov/cdrh/ombudsman/). The 36-month period refers to...

  2. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Radiological Health's (CDRH') Web site...

  3. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Radiological Health's (CDRH') Web site (www.fda.gov/cdrh/ombudsman/). The 36-month period refers to...

  4. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Radiological Health's (CDRH') Web site (www.fda.gov/cdrh/ombudsman/). The 36-month period refers to...

  5. Monitoring product safety in the postmarketing environment

    PubMed Central

    Dieck, Gretchen S

    2013-01-01

    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. PMID:25114782

  6. Strategies for Postmarketing Surveillance of Drugs and Devices in Patients with ESRD Undergoing Dialysis

    PubMed Central

    Vardi, Moshe; Yeh, Robert W.; Herzog, Charles A.; Winkelmayer, Wolfgang C.; Setoguchi, Soko

    2013-01-01

    Summary The lack of evidence on the effectiveness and safety of interventions in chronic dialysis patients has been a subject of continuing criticism. New technologies are often introduced into the market without having specifically studied or even included patients with advanced kidney disease. Therefore, the need to generate valid effectiveness and safety data in this vulnerable subpopulation is of utmost importance. The US Food and Drug Administration has recently placed an increased focus on safety surveillance, and sponsors must now meet this additional postmarketing commitment. In patients with ESRD, the unique data collection environment in the United States allows for creative and efficient study designs to meet the needs of patients, providers, and sponsors. The purpose of this manuscript is to review the methodological and practical aspects of the different options for postmarketing study design in this field, with critical appraisal of their advantages and disadvantages. PMID:23970129

  7. Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance

    PubMed Central

    Silva, I. R.; Kulldorff, M.

    2016-01-01

    Summary The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post-market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data. PMID:26011024

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

    PubMed

    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. PMID:16758501

  9. Adverse events associated with vitamin K1: results of a worldwide postmarketing surveillance programme.

    PubMed

    Pereira, S P; Williams, R

    1998-05-01

    We compared adverse events associated with a conventional vitamin K(1) preparation, Konakion, with a new mixed micellar formulation, Konakion MM. Data were obtained worldwide from spontaneous reports, clinical trials and postmarketing surveillance. During the period 1974 to July 1995, an estimated 635 million adults and 728 million children were prescribed Konakion or Konakion MM. Of the 404 adverse events in 286 subjects reported, 387 (96%) were associated with Konakion. Konakion MM accounted for 4% (n=17) of the reported adverse events, and 5% of total sales figures. Thirteen of the 17 adverse events (76%) reported for Konakion MM were minor injection site reactions. Overall, 120 of the adverse events were serious, of which 117 (98%) were associated with Konakion. Eighty-five probable anaphylactoid reactions (of which six were fatal) were reported for conventional Konakion, compared with one non-fatal anaphylactoid reaction for Konakion MM. During the last 12 months of postmarketing surveillance, there were 14 serious adverse events reported in an estimated 21 million individuals treated with Konakion, but none in the 13 million who received Konakion MM. These results suggest that the Cremophor EL-solubilized preparations of vitamin K(1) have a higher profile of adverse events, including anaphylactoid reactions, than the newer mixed micellar preparation, Konakion MM. PMID:15073995

  10. Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin.

    PubMed

    Hajak, Göran; Lemme, Kathrin; Zisapel, Nava

    2015-01-01

    Surveillance studies are useful to evaluate how a new medicinal product performs in everyday treatment and how the patient who takes it feels and functions, thereby determining the benefit/risk ratio of the drug under real-life conditions. Prolonged-release melatonin (PRM; Circadin) was approved in Europe for the management of primary insomnia patients age 55 years or older suffering from poor quality of sleep. With traditional hypnotics (e.g. benzodiazepine-receptor agonists), there are concerns about rebound insomnia and/or withdrawal symptoms. We report data from a postmarketing surveillance study in Germany on the effects of 3 weeks of treatment with PRM on sleep in patients with insomnia during treatment and at early (1-2 days) and late (around 2 weeks) withdrawal. In total, 653 patients (597 evaluable) were recruited at 204 sites (mean age 62.7 years, 68% previously treated with hypnotics, 65% women). With PRM treatment, the mean sleep quality (on a scale of 1-5 on which 1 is very good and 5 is very bad) improved from 4.2 to 2.6 and morning alertness improved from 4.0 to 2.5. The improvements persisted over the post-treatment observation period. Rebound insomnia, defined as a one-point deterioration in sleep quality below baseline values, was found in 3.2% (early withdrawal) and 2.0% (late withdrawal). Most of the patients (77%) who used traditional hypnotics before PRM treatment had stopped using them and only 5.6% of naive patients started such drugs after PRM discontinuation. PRM was well tolerated during treatment and the most frequently reported adverse events were nausea (10 patients, 1.5%), dizziness, restlessness and headache (five patients each, <1%). There were no serious adverse events and no adverse events were reported after discontinuation. The persisting treatment effect and very low rebound rate suggest a beneficial role of sleep-wake cycle stabilization with PRM in the treatment of insomnia. PMID:25054634

  11. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Radiological Health's (CDRH's) Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsand... 21 Food and Drugs 8 2013-04-01 2013-04-01 false What should I do if I do not agree that postmarket surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT...

  12. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Radiological Health's (CDRH's) Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsand... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What should I do if I do not agree that postmarket surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT...

  13. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false What should I do if I do not agree that postmarket surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Radiological Health's (CDRH's) Web site (http://www.fda.gov/cdrh/ombudsman/dispute.html)....

  14. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What should I do if I do not agree that postmarket surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Radiological Health's (CDRH's) Web site (http://www.fda.gov/cdrh/ombudsman/dispute.html)....

  15. 21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What should I do if I do not agree that postmarket surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Radiological Health's (CDRH's) Web site (http://www.fda.gov/cdrh/ombudsman/dispute.html)....

  16. A Distributed, Collaborative Intelligent Agent System Approach for Proactive Postmarketing Drug Safety Surveillance

    PubMed Central

    Ji, Yanqing; Ying, Hao; Farber, Margo S.; Yen, John; Dews, Peter; Miller, Richard E.; Massanari, R. Michael

    2014-01-01

    Discovering unknown adverse drug reactions (ADRs) in postmarketing surveillance as early as possible is of great importance. The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (<10% reporting rate), latency, and inconsistent reporting. We propose a novel team-based intelligent agent software system approach for proactively monitoring and detecting potential ADRs of interest using electronic patient records. We designed such a system and named it ADRMonitor. The intelligent agents, operating on computers located in different places, are capable of continuously and autonomously collaborating with each other and assisting the human users (e.g., the food and drug administration (FDA), drug safety professionals, and physicians). The agents should enhance current systems and accelerate early ADR identification. To evaluate the performance of the ADRMonitor with respect to the current spontaneous reporting approach, we conducted simulation experiments on identification of ADR signal pairs (i.e., potential links between drugs and apparent adverse reactions) under various conditions. The experiments involved over 275 000 simulated patients created on the basis of more than 1000 real patients treated by the drug cisapride that was on the market for seven years until its withdrawal by the FDA in 2000 due to serious ADRs. Healthcare professionals utilizing the spontaneous reporting approach and the ADRMonitor were separately simulated by decision-making models derived from a general cognitive decision model called fuzzy recognition-primed decision (RPD) model that we recently developed. The quantitative simulation results show that 1) the number of true ADR signal pairs detected by the ADRMonitor is 6.6 times higher than that by the spontaneous reporting strategy; 2) the ADR detection rate of the ADRMonitor agents with even moderate decision-making skills is five

  17. A distributed, collaborative intelligent agent system approach for proactive postmarketing drug safety surveillance.

    PubMed

    Ji, Yanqing; Ying, Hao; Farber, Margo S; Yen, John; Dews, Peter; Miller, Richard E; Massanari, R Michael

    2010-05-01

    Discovering unknown adverse drug reactions (ADRs) in postmarketing surveillance as early as possible is of great importance. The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (<10% reporting rate), latency, and inconsistent reporting. We propose a novel team-based intelligent agent software system approach for proactively monitoring and detecting potential ADRs of interest using electronic patient records. We designed such a system and named it ADRMonitor. The intelligent agents, operating on computers located in different places, are capable of continuously and autonomously collaborating with each other and assisting the human users (e.g., the food and drug administration (FDA), drug safety professionals, and physicians). The agents should enhance current systems and accelerate early ADR identification. To evaluate the performance of the ADRMonitor with respect to the current spontaneous reporting approach, we conducted simulation experiments on identification of ADR signal pairs (i.e., potential links between drugs and apparent adverse reactions) under various conditions. The experiments involved over 275,000 simulated patients created on the basis of more than 1000 real patients treated by the drug cisapride that was on the market for seven years until its withdrawal by the FDA in 2000 due to serious ADRs. Healthcare professionals utilizing the spontaneous reporting approach and the ADRMonitor were separately simulated by decision-making models derived from a general cognitive decision model called fuzzy recognition-primed decision (RPD) model that we recently developed. The quantitative simulation results show that 1) the number of true ADR signal pairs detected by the ADRMonitor is 6.6 times higher than that by the spontaneous reporting strategy; 2) the ADR detection rate of the ADRMonitor agents with even moderate decision-making skills is five

  18. Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

    PubMed

    Silva, Ivair R

    2016-04-30

    Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper introduces a valid method for a true management of the alpha spending at each one of a sequence of Monte Carlo tests. The method also enables the use of a sequential simulation strategy for each Monte Carlo test, which is useful for saving computational execution time. Thus, the proposed procedure allows for sequential Monte Carlo test in sequential analysis, and this is the reason that it is called 'composite sequential' test. An upper bound for the potential power losses from the proposed method is deduced. The composite sequential design is illustrated through an application for post-market vaccine safety surveillance data. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26561330

  19. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... Review and Action § 822.21 What must I do if I want to make changes to my postmarket surveillance...

  20. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... Review and Action § 822.21 What must I do if I want to make changes to my postmarket surveillance...

  1. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... Review and Action § 822.21 What must I do if I want to make changes to my postmarket surveillance...

  2. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... Review and Action § 822.21 What must I do if I want to make changes to my postmarket surveillance...

  3. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... Review and Action § 822.21 What must I do if I want to make changes to my postmarket surveillance...

  4. [Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].

    PubMed

    Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

    2015-10-01

    The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases. PMID:26742284

  5. Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis

    PubMed Central

    Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Mimori, Tsuneyo; Ryu, Junnosuke; Takei, Syuji; Takeuchi, Tsutomu; Tanaka, Yoshiya; Takasaki, Yoshinari; Yamanaka, Hisashi; Watanabe, Masahiko; Tamada, Hiroshi; Koike, Takao

    2016-01-01

    Abstract Objective: To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA). Methods: Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations. Results: Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept. Conclusions: Abatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected. PMID:26635183

  6. A team agent approach to postmarketing surveillance of adverse drug reactions.

    PubMed

    Ji, Yanqing; Ying, Hao; Barth-Jones, Daniel; Yen, John; Zhu, Shizhou; Miller, Richard; Michael Massanari, R

    2005-01-01

    Current postmarketing surveillance methods largely rely on spontaneous reports which suffer from serious underreporting, latency, and inconsistent reporting. Thus they are not ideal for rapidly identifying rare adverse drug reactions (ADRs). We propose an active, multi-agent computer software system, where each agent is empowered with teamwork capabilities such as anticipating information needs, identifying relevant ADR information, and continuously monitoring and proactively sharing such information in a collaborative fashion with other agents. The main purpose of this system is to help regulatory authorities (e.g., FDA in the U.S.) find previously unrecognized ADRs as early as possible. Another objective is to promote increased filing of on-line ADR reports thereby, addressing the severe underreporting problem with the current system. The proposed system has the potential to significantly accelerate the process of ADR discovery and response by utilizing electronic patient data distributed across many different sources and locations more effectively. Our preliminary system design is presented and some issues related to it are discussed. PMID:17281878

  7. 21 CFR 822.20 - What are the consequences if I fail to submit a postmarket surveillance plan, my plan is...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan? 822.20 Section 822.20 Food and Drugs FOOD AND...

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

    PubMed Central

    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

  9. EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study.

    PubMed

    Faruqui, Arif A

    2007-05-01

    The objective of EVOLVE [nebivolol (nevol) evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73 +/- 14.16 mm Hg which dropped to 135.13 +/- 11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p < 0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21 +/- 8.25 mm Hg that dropped to 83.69 +/- 6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p < 0.001). The heart rate in this study showed a significant decrease from 86.13 +/- 9.35 at basal to 75.09 +/- 7.42 at the end of the study (p < 0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n = 22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by

  10. 21 CFR 822.20 - What are the consequences if I fail to submit a postmarket surveillance plan, my plan is...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan? 822.20 Section 822.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH...

  11. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary......

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

    PubMed Central

    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

  13. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... 10.115). The guidance represents the Agency's current thinking on postmarketing adverse event... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Adverse Event... announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting...

  14. Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example.

    PubMed

    Pascual, Julio; Diener, Hans-Christoph; Massiou, Hélène

    2006-02-01

    Randomised controlled trials cannot collect all the data relevant for use in everyday clinical practice because drug exposure is limited, endpoints are restricted and some patient populations are excluded. Postmarketing surveillance (PS) studies can add important information for real-world clinical practice. Acute migraine therapy with almotriptan 12.5 mg was evaluated in 4 PS studies, 2 conducted in Spain, 1 in Germany and 1 in France. Almotriptan was associated with a high rate of treatment response and was well tolerated in all 4 studies. In the Spanish and German studies, 2-hour pain-relief, 2-hour pain-free, and sustained painfree rates were enhanced when patients treated mild pain. Patient satisfaction with almotriptan, assessed in the German and French studies, was high and the majority of patients preferred almotriptan to their previous acute migraine therapy. In conclusion, PS studies augment our knowledge of antimigraine therapy, giving a more complete picture of how such agents work in the general population. PMID:16440139

  15. Semiparametric Bayesian commensurate survival model for post-market medical device surveillance with non-exchangeable historical data.

    PubMed

    Murray, Thomas A; Hobbs, Brian P; Lystig, Theodore C; Carlin, Bradley P

    2014-03-01

    Trial investigators often have a primary interest in the estimation of the survival curve in a population for which there exists acceptable historical information from which to borrow strength. However, borrowing strength from a historical trial that is non-exchangeable with the current trial can result in biased conclusions. In this article we propose a fully Bayesian semiparametric method for the purpose of attenuating bias and increasing efficiency when jointly modeling time-to-event data from two possibly non-exchangeable sources of information. We illustrate the mechanics of our methods by applying them to a pair of post-market surveillance datasets regarding adverse events in persons on dialysis that had either a bare metal or drug-eluting stent implanted during a cardiac revascularization surgery. We finish with a discussion of the advantages and limitations of this approach to evidence synthesis, as well as directions for future work in this area. The article's Supplementary Materials offer simulations to show our procedure's bias, mean squared error, and coverage probability properties in a variety of settings. PMID:24308779

  16. Sucrose-Formulated Recombinant Factor VIII Dosing Flexibility in Prophylaxis Regimens: Experience from Postmarketing Surveillance Studies

    PubMed Central

    Humphries, Thomas J.; Rauchensteiner, Stephan; Tückmantel, Claudia; Pieper, Alexander; Maas Enriquez, Monika; Mathew, Prasad

    2015-01-01

    Objectives. Prophylaxis regimens for severe hemophilia A allowing more flexible dosing while maintaining efficacy may improve adherence and decrease the cost of prophylaxis. Here, we compared the clinical effectiveness of once- or twice-weekly versus ≥3-times-weekly prophylaxis with sucrose-formulated recombinant factor VIII (rFVIII-FS) in a “real-world” practice setting. Methods. Data from 3 postmarketing studies were pooled. Patients with severe hemophilia A receiving ≥1 prophylaxis infusion/wk of rFVIII-FS for ≥80% of a prophylaxis observation period (≥5 months) were included. Patients were categorized based on physician-assigned treatment regimens of 1-2 prophylaxis injections/wk (n = 63) or ≥3 prophylaxis injections/wk (n = 76). Descriptive statistics were determined for annualized bleeding rates (ABRs). Results. Median (quartile 1; quartile 3) ABR for all bleeds was 2.0 (0; 4.0) in the 1-2 prophylaxis injections/wk group and 3.9 (1.5; 9.3) in the ≥3 prophylaxis injections/wk group. Median ABRs for joint, spontaneous, and trauma-related bleeds were numerically lower with 1-2 prophylaxis injections/wk. As an estimate of prophylaxis success, 63% (≥3 prophylaxis injections/wk) to 84% of patients (1-2 prophylaxis injections/wk) had ≤4 annualized joint bleeds. Conclusions. Dosing flexibility and successful prophylaxis with rFVIII-FS were demonstrated. Very good bleeding control was achieved with both once-twice-weekly and ≥3-times-weekly prophylaxis dosing regimens. PMID:26356675

  17. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the Center for Devices and......

  18. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the Center for Devices and......

  19. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the Center for Devices and......

  20. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the Center for Devices and......

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

    PubMed Central

    2013-01-01

    Background 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. Methods 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. Results 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. Conclusions 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. PMID:24112460

  2. Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance.

    PubMed

    Noah, B A; Brushwood, D B

    2000-01-01

    In the last three years, the Food and Drug Administration has withdrawn seven prescription drugs from the market, and it has required intensified warnings for a number of others, all due to the discovery of previously unforeseen side effects associated with their use. Adverse drug reactions are a leading cause of death in the United States. For a variety of physiological and socio-medical reasons, the elderly are particularly susceptible to adverse drug reactions. Because the pre-approval process cannot expose all potential risks associated with a drug, the authors assert that policymakers should consider implementing a more extensive, and more integrated, post-approval surveillance and testing system. They conclude that the recent cluster of drug withdrawals due to safety problems raises legitimate questions about the rigor and effectiveness of the post-approval monitoring system for new drugs, and these questions extend beyond the obvious difficulties associated with the collection and analysis of risk data. Traditionally viewed as a regulatory problem for the FDA, the problem of adverse drug reactions implicates patient welfare and the provision of medical care more broadly, and a purely regulatory mind set unnecessarily constrains thinking about possible approaches to improving drug safety. Possible solutions to the problem ought to contemplate more formalized involvement of the medical community, pharmacists, and patients. This Article introduces a proposed systems approach to detecting and preventing adverse drug reactions, and discusses several other incremental reforms to existing systems that may help the medical community to improve the overall safety of prescription drug therapy for the elderly, and ultimately for all patients. PMID:11184355

  3. Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices

    PubMed Central

    Zhang, B-C; Hou, L; Lv, B

    2014-01-01

    Objective: To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. Methods: A total of 20 185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. Results: The overall rate of ADRs was 1.52%, of which 0.58% was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p < 0.001), in those receiving pre-heated iodixanol vs non-heating (p < 0.001), in those aged 70 years or younger (p < 0.001), in those in whom a power injector was used for contrast delivery (p < 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥80 kg, age less than 65 years, contrast flow rate ≥4 ml s−1 and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0–3. Conclusion: The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. Advances in knowledge: The major strength of this study is that it included 20 185 patients enrolled in various types of imaging examinations. The

  4. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance

    PubMed Central

    Inoue, Hiroshi; Uchiyama, Shinichiro; Atarashi, Hirotsugu; Okumura, Ken; Koretsune, Yukihiro; Yasaka, Masahiro; Yamashita, Takeshi; Ohnishi, Makiko; Yagi, Nobutaka; Fukaya, Taku

    2016-01-01

    Background/aim A post-marketing surveillance (PMS) study is being conducted to investigate the safety and effectiveness of the long-term use of dabigatran etexilate (dabigatran) in Japanese patients with nonvalvular atrial fibrillation (NVAF). Results of an interim analysis of this prospective cohort study including patient characteristics and adverse drug reactions (ADRs) collected up to September 17, 2014 are reported here. Methods Patients with NVAF who began to receive dabigatran for the first time from December 2011 to November 2013 were enrolled at 1042 study sites in Japan. Clinical parameters included patient characteristics, dabigatran dose strength, concomitant medications and outcome events. All outcome events were collected as serious and non-serious adverse events (AEs). ADRs were evaluated in this report. Pre-defined safety events of special interest for intensive survey were serious and non-serious outcome events such as myocardial infarction, as well as the total number of hemorrhage and gastrointestinal disorders. Results A total of 6772 patients were registered. The safety analysis set included 6148 patients; mean age was 70.8±9.9 (SD) years: 2323 patients (37.8%) were aged 75 years or older. Males accounted for 66.8% of the patients. Mean CHADS2 score was 1.8±1.3; the CHADS2 score was 0 in 13.6%, 1 in 31.3%, 2 in 25.9%, 3 in 14.9%, and 4 to 6 in 11.1% of the patients. Of the 6148 patients, 1701 patients (27.7%) were switchers from warfarin and 4407 patients (71.7%) were non-switchers (OAC naïve patients). Treatment adherence was assessed for the first 3 months from the start of treatment for this analysis. Total 5656 patients (92.0%) reported taking dabigatran twice daily (bid) every day according to the label recommendation. During the follow up period [mean duration of follow up: 498±259 days (corresponding to 8386 patient-years)], pre-defined safety events of special interest for intensive survey (reported as serious ADRs) were: myocardial

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

    PubMed

    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

  6. Efficacy, safety and tolerability of recombinant factor VIII (REFACTO) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and Austria.

    PubMed

    Pollmann, H; Externest, D; Ganser, A; Eifrig, B; Kreuz, W; Lenk, H; Pabinger, I; Schramm, W; Schwarz, T F; Zimmermann, R; Zavazava, N; Oldenburg, J; Klamroth, R

    2007-03-01

    An open-label, multicentre, postmarketing surveillance study conducted in Germany and Austria with recombinant factor VIII (REFACTO) has enrolled 217 patients (mean age 26.3 years) from 38 haemophilia centres during the first 4.8 years. Most patients (188/217; 86.6%) had severe to moderately severe haemophilia A, of whom 153 completed sufficient diary information for the main efficacy analysis. These 153 patients experienced a median of 6.6 (interquartile range 1.4-18.6) bleeding episodes per year. Patients treated with prophylaxis experienced a median of 4.4 (1.1-9.3) bleeds per year, while patients treated on-demand experienced a median of 22.8 (11.3-29.0) bleeds per year. Overall, most physicians (41/43 [95.3%]) were 'very satisfied' or 'satisfied' with the efficacy of REFACTO in the treatment of bleeding episodes. A total of 137 non-serious adverse events have been reported in 52/217 patients (24.0%) to date. In addition, 129 serious adverse events in 87 patients (40%) were reported, including 41 cases of 'less than expected therapeutic effect' (LETE). Of these, 39 LETE cases were reported in one centre; however, patients in this centre experienced considerably fewer bleeding episodes per year than patients outside this centre. Overall, six patients (2.8%) have developed de novo inhibitors, three of which were considered high titre. Four of these patients were at high risk (0-50 exposure days [ED]) of inhibitor formation, one was at intermediate risk (51-100 ED) and one was at low risk (>100 ED). These results emphasize the benefit of postmarketing surveillance and, overall, this study confirms the efficacy, safety and tolerability of REFACTO in the treatment of patients with haemophilia A. PMID:17286765

  7. 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

    PubMed Central

    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

  8. Post-marketing surveillance of adverse events following immunization with inactivated quadrivalent and trivalent influenza vaccine in health care providers in Western Australia.

    PubMed

    Regan, Annette K; Tracey, Lauren; Gibbs, Robyn

    2015-11-17

    In 2015, inactivated quadrivalent influenza vaccine (QIV) was first introduced into the Australian market. A routine vaccine safety surveillance system in Western Australia was used to conduct post-licensure surveillance of adverse events following immunization with inactivated QIV and trivalent influenza vaccines (TIV) in a sample of 1685 healthcare providers (HCPs). A similar percentage of HCPs who received QIV reported having any reaction seven days post-vaccination as HCPs who received TIV (13.6 vs. 12.8%, respectively; p=0.66). However, a slightly higher percentage of HCPs who received QIV reported pain or swelling at the injection site as compared to HCPs who received TIV (6.9% vs. 4.2%, respectively; p=0.02). No serious vaccine-associated adverse events were detected during follow-up of either vaccine. Acknowledging the study limitations, the results of this post-marketing surveillance support the safety of QIV, suggesting there is little difference in the reactogenicity of QIV as compared to TIV. PMID:26476362

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

    PubMed Central

    Okada, Kenya; Sudo, Yohei; Itoh, Hiromichi; Yoshida, Hisao; Kuroda, Tatsuhiko

    2014-01-01

    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. PMID:26770729

  10. Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers

    PubMed Central

    2013-01-01

    Background After several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice. Methods A prospective, post-marketing active pharmacosurveillance was conducted in 41 hospitals and 19 primary care polyclinics. Patients with DFU received hrEGF, 25 or 75 μg, intralesionally 3 times per week until complete granulation of the ulcer or 8 weeks maximum, adjuvant to standard wound care. Outcomes measured were complete granulation, amputations, and adverse events (AE) during treatment; complete lesion re-epithelization and relapses in follow-up (median: 1.2; maximum 4.2 years). Results The study included 1788 patients with 1835 DFU (81% Wagner’s grades 3 or 4; 43% ischemic) treated from May 2007 to April 2010. Complete granulation was observed in 76% of the ulcers in 5 weeks (median). Ulcer non-ischemic etiology (OR: 3.6; 95% CI: 2.8-4.7) and age (1.02; 1.01-1.03, for each younger year) were the main variables with influence on this outcome. During treatment, 220 (12%) amputations (171 major) were required in 214 patients, mostly in ischemic or Wagner’s grade 3 to 5 ulcers. Re-epithelization was documented in 61% of the 1659 followed-up cases; 5% relapsed per year. AE (4171) were reported in 47% of the subjects. Mild or moderate local pain and burning sensation, shivering and chills, were 87% of the events. Serious events, not related to treatment, occurred in 1.7% of the patients. Conclusions The favorable benefit/risk balance, confirms the beneficial clinical profile of intralesional hrEGF in the treatment of DFUs. PMID:24004460

  11. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

    PubMed Central

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade “2”/”3” solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade “2”/”3” solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India. PMID:25424932

  12. 21 CFR 314.540 - Postmarketing safety reporting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.540 Section... New Drugs for Serious or Life-Threatening Illnesses § 314.540 Postmarketing safety reporting. Drug products approved under this program are subject to the postmarketing recordkeeping and safety...

  13. 21 CFR 314.630 - Postmarketing safety reporting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.630 Section... Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety...

  14. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan...

  15. Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression

    PubMed Central

    Kato, Masaki; Kimura, Toshifumi; Kimura, Takeshi; Hara, Terufumi

    2015-01-01

    Objective Selective serotonin reuptake inhibitors are commonly used in the pharmacotherapy of depression. However, adverse events can lead to their early discontinuation. This study evaluated the safety and effectiveness of paroxetine controlled-release (CR) tablets in Japanese patients with depression/depressive state (hereafter referred to as depression) in routine clinical practice in Japan. Patients and methods This was an open-label, noninterventional, prospective, postmarketing surveillance study. A total of 3,213 patients aged 12–92 years with depression were prescribed paroxetine CR for 8 weeks at the physician’s discretion. Safety was evaluated on the basis of the reporting of adverse drug reactions. Effectiveness was evaluated on the basis of the physician’s assessment using the Clinical Global Impression-Global Improvement (CGI-GI) and the Clinical Global Impression-Severity of Illness (CGI-SI) scales, as well as on the basis of the patients’ self-reported satisfaction. The primary effectiveness outcome was the improvement rate based on the physician’s assessment using the CGI-GI. Results The incidence of adverse drug reactions was 11.2% (359/3,213; 95% confidence interval [CI]: 10.1%–12.3%). The common adverse drug reactions that accounted for 1.0% or more of the incidence were nausea (3.5%) and somnolence (2.7%). The proportion of patients who continued paroxetine CR at week 8 was 80.2% (2,577/3,213; 95% CI: 78.8%–81.6%). The improvement rate at week 8 (last observation carried forward) was 72.8% (2,132/2,927; 95% CI: 71.2%–74.4%). The proportion of patients with CGI-SI scores of moderately or severely ill decreased from 63.6% at baseline to 17.9% at week 8. The proportion of patients who were satisfied with paroxetine CR treatment was 69.8% (2,040/2,921; 95% CI: 68.1%–71.5%). Conclusion The results of this study suggest that paroxetine CR is a well-tolerated and efficacious treatment for depression in routine clinical practice. PMID

  16. 21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 am required to conduct postmarket surveillance? You must submit your plan to conduct...

  17. 21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 am required to conduct postmarket surveillance? You must submit your plan to conduct...

  18. 21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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 am required to conduct postmarket surveillance? You must submit your plan to conduct...

  19. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. PMID:26704926

  20. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  1. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  2. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  3. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  4. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... scientific and medical journals either as case reports or as the result of a formal clinical trial. (2) As... experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies... adverse drug experiences that occurred in clinical trials if they were previously submitted as part of...

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

    PubMed Central

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

    2015-01-01

    Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

  6. Safety and effectiveness of switching from infliximab to etanercept in patients with rheumatoid arthritis: results from a large Japanese postmarketing surveillance study.

    PubMed

    Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio

    2012-06-01

    Finding an effective treatment strategy for rheumatoid arthritis (RA) patients who have not benefited from previous tumor necrosis factor-α antagonist treatment is important for minimizing RA disease activity and improving patient outcomes. The aim of this study was to compare the safety and effectiveness of etanercept in patients with and without infliximab (IFX) treatment experience. Patients (n = 7,099) from a large postmarketing observational study of etanercept use in Japan were divided into 2 cohorts based on previous IFX use (pre-IFX and non-IFX). Baseline characteristics were assessed in each cohort. Adverse events (AEs) and European League Against Rheumatism (EULAR) responses were monitored every 4 weeks for 24 weeks. At baseline, pre-IFX patients were younger and had fewer comorbidities and a shorter RA duration than non-IFX patients. During the study, pre-IFX patients received concomitant methotrexate more often than non-IFX patients. The incidence of AEs and serious AEs were significantly lower in pre-IFX patients, as was the percentage of patients who discontinued treatment. Both cohorts had significant improvement (P < 0.001) in EULAR responses at the end of the treatment period. This study demonstrated that etanercept was effective and well tolerated in active RA patients with and without prior IFX treatment. PMID:21331576

  7. Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis.

    PubMed

    Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio

    2012-06-01

    The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2-5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs. PMID:21327436

  8. Postmarketing analysis of medicines: methodology and value of the spanish case-control study and surveillance system in preventing birth defects.

    PubMed

    Martínez-Frías, María Luisa

    2007-01-01

    There are many surveillance systems of congenital defects all over the world; several of them have developed specific approaches to generate and test selected hypotheses regarding human teratogens. However, to the best of our knowledge, none of them have a permanent and systematised programme for the study of the risk and safety of drugs. The aim of this article is to describe the research programme on the potential effects of drugs in pregnancy followed by the Spanish Collaborative Study of Congenital Malformations (ECEMC), which is a permanent ongoing case-control study and surveillance system. The programme to analyse drugs includes a continuous and systematic study on the potential effects of medicines used during pregnancy. This programme has several characteristics that make it different from other current systems: (i) the collection of numerous datapoints (up to 312 per infant) in a case-control design; (ii) the use of a versatile and specific coding of birth defects; (iii) a specific programme for the continuous analysis of the potential effects of each type of drugs used during pregnancy that has been developed specifically for the ECEMC methodology, including its dysmorphological coding system. The description of the ECEMC's approach to surveillance of the effects of drug use during pregnancy may help researches in this area, particularly those using data from birth defects registries. PMID:17408307

  9. A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance

    PubMed Central

    Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

    2015-01-01

    Objective Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. Methods All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Results Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand–foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7–8.1), and the overall survival rate at 1 year was 75.4% (73.5–77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis. Conclusions Sorafenib for the treatment of advanced renal cell carcinoma under the labeled dose was feasible in daily medical practice, for its acceptable toxicity profile and favorable clinical benefit that were consistent with those in clinical trials. PMID:26206897

  10. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false What must I include in my surveillance plan? 822... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.10 What must I include in my surveillance plan? Your surveillance plan must include a discussion of: (a)...

  11. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What must I include in my surveillance plan? 822... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.10 What must I include in my surveillance plan? Your surveillance plan must include a discussion of: (a)...

  12. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What must I include in my surveillance plan? 822... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.10 What must I include in my surveillance plan? Your surveillance plan must include a discussion of: (a)...

  13. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What must I include in my surveillance plan? 822... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.10 What must I include in my surveillance plan? Your surveillance plan must include a discussion of: (a)...

  14. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false What must I include in my surveillance plan? 822... SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.10 What must I include in my surveillance plan? Your surveillance plan must include a discussion of: (a)...

  15. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD... prepare my submission or design my postmarket surveillance plan? Guidance documents that discuss...

  16. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD... prepare my submission or design my postmarket surveillance plan? Guidance documents that discuss...

  17. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD... prepare my submission or design my postmarket surveillance plan? Guidance documents that discuss...

  18. Manufacturer's drug interaction and postmarketing adverse event data: what are appropriate uses?

    PubMed

    Kraft, W K; Waldman, S A

    2001-01-01

    Governmental agencies overseeing pharmaceutical products use a risk/benefit approach to analyse data and make regulatory decisions. Comprehensive public dissemination of the safety profile of pharmaceutical products is part of an overall strategy for reducing risk associated with the use of any medical product. In the US, reports of postmarketing surveillance of approved drugs are in the public domain. Some, but not all, of the information in drug interaction studies is available to the public through the Freedom of Information Act (FOIA). However, there are concerns over the misuse of these data for commercial or other gain. The need to protect intellectual property and foster innovation in drug development, and concerns of legal liability are often cited as reasons to limit full public access to data from drug development studies. In contrast, intellectual freedom. public safety, and a mandate for transparent decision-making processes by regulatory agencies are issues that support open access to these data. Ultimately. concern for the public safety justifies open access to postmarketing surveillance data, and to a lesser degree, data regarding drug interactions in marketed products, and should outweigh the potential loss of competitive advantage by pharmaceutical companies. PMID:11522118

  19. Design and analysis of post-marketing research.

    PubMed

    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. PMID:23818199

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

    PubMed Central

    Moro, Pedro L.; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W.; Cano, Maria

    2016-01-01

    Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. PMID:27410239

  1. Tocilizumab in systemic juvenile idiopathic arthritis in a real-world clinical setting: results from 1 year of postmarketing surveillance follow-up of 417 patients in Japan

    PubMed Central

    Yokota, Shumpei; Itoh, Yasuhiko; Morio, Tomohiro; Origasa, Hideki; Sumitomo, Naokata; Tomobe, Minako; Tanaka, Kunihiko; Minota, Seiji

    2016-01-01

    Objectives To evaluate the safety and effectiveness of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA) in real-world clinical settings in Japan. Methods Paediatric patients with sJIA initiating TCZ between April 2008 and February 2012 and those previously enrolled in clinical trials who initiated TCZ before April 2008 were enrolled in a Japanese registry surveillance programme. Safety and effectiveness parameters were collected for 52 weeks. Results Of 417 patients enrolled, mean age was 11.2 years and 48.0% were female. TCZ exposure was 407.0 patient-years (PYs). Baseline corticosteroid use was higher than in clinical trials. Rates of total adverse events (AEs) and serious AEs (SAEs) were 224.3/100 PYs and 54.5/100 PYs, respectively, with SAEs higher than previously reported. The most frequent AEs and SAEs were infections and infestations (69.8/100 PYs and 18.2/100 PYs, respectively). 74 serious infections occurred in 55 patients (18.2/100 PYs); higher than previously reported. 26 macrophage activation syndrome events were reported in 24 patients (6.4/100 PYs). Fever and rash symptoms improved from baseline to week 52 (54.6% to 5.6% and 43.0% to 5.6%, respectively). At 4 weeks, 8 weeks and 52 weeks, 90.5%, 96.2% and 99.0% of patients achieved normal C reactive protein levels (<0.3 mg/dL), respectively. Conclusions These first real-world data demonstrated that TCZ was well tolerated, with acceptable safety and effectiveness in patients with sJIA. Higher incidences of SAEs and serious infections may be due to differences, such as corticosteroid use and concomitant diseases, between patient populations enrolled in previously reported clinical trials and this study. PMID:26644233

  2. Influenza Virus Surveillance in Coordinated Swine Production Systems, United States.

    PubMed

    Kaplan, Bryan S; DeBeauchamp, Jennifer; Stigger-Rosser, Evelyn; Franks, John; Crumpton, Jeri Carol; Turner, Jasmine; Darnell, Daniel; Jeevan, Trushar; Kayali, Ghazi; Harding, Abbey; Webby, Richard J; Lowe, James F

    2015-10-01

    To clarify the epidemiology of influenza A viruses in coordinated swine production systems to which no animals from outside the system are introduced, we conducted virologic surveillance during September 2012-September 2013. Animal age, geographic location, and farm type were found to affect the prevalence of these viruses. PMID:26402228

  3. Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events.

    PubMed

    Kotarek, Joseph; Stuart, Christine; De Paoli, Silvia H; Simak, Jan; Lin, Tsai-Lien; Gao, Yamei; Ovanesov, Mikhail; Liang, Yideng; Scott, Dorothy; Brown, Janice; Bai, Yun; Metcalfe, Dean D; Marszal, Ewa; Ragheb, Jack A

    2016-03-01

    Peginesatide (Omontys(®); Affymax, Inc., Cupertino, CA) was voluntarily withdrawn from the market less than a year after the product launch. Although clinical trials had demonstrated the drug to be safe and efficacious, 49 cases of anaphylaxis, including 7 fatalities, were reported not long after market introduction. Commercialization was initiated with a multiuse vial presentation, which differs in formulation from the single-use vial presentation used in phase 3 studies. Standard physical and chemical testing did not indicate any deviation from product specifications in either formulation. However, an analysis of subvisible particulates using nanoparticle tracking analysis and flow imaging revealed a significantly higher concentration of subvisible particles in the multiuse vial presentation linked to the hypersensitivity cases. Although it is unknown whether the elevated particulate content is causally related to these serious adverse events, this report illustrates the utility of characterizing subvisible particulates not captured by conventional light obscuration. PMID:26886324

  4. 21 CFR 601.44 - Postmarketing safety reporting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Postmarketing safety reporting. 601.44 Section 601.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Accelerated Approval of Biological Products for Serious or Life-Threatening...

  5. 78 FR 28853 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... require a manufacturers to conduct postmarket surveillance (PS) of any device that meets the criteria set... for a device 80 1 80 8 640 that is no longer marketed (Sec. 822.28) Waiver (Sec. 822.29) 1 1 1 40 40... document is based on the data available in FDA's internal tracking system. Sections 822.26, 822.27, and...

  6. Postmarket policy considerations for biosimilar oncology drugs.

    PubMed

    Renwick, Matthew J; Smolina, Kate; Gladstone, Emilie J; Weymann, Deirdre; Morgan, Steven G

    2016-01-01

    Oncology biological products are some of the most expensive drugs on the market and are a growing financial burden on patients and health-care systems. By 2020, numerous major biological cancer drugs will lose their patent protection allowing follow-on competitors, known as biosimilars, to enter the market. Clinical and regulatory considerations for biosimilars have begun to harmonise in Europe and the USA to help to define and streamline the pathway for biosimilar market authorisation. Yet, substantial international variation still exists in the pricing and market uptake of approved biosimilar oncology drugs. Differences in national postmarket policies for biosimilars might explain these disparities in pricing and uptake. In this Policy Review, policy approaches to competition between biosimilars and originators used by seven European countries--Belgium, France, Germany, Italy, the Netherlands, Norway, and the UK--and the USA are discussed, chosen because these countries represent a variety of postmarket policies and build on conclusions from previous work. We discuss these policies within the context of interchangeability, physician prescribing, substitutability, pharmacist dispensing, hospital financing and tendering, and pricing. PMID:26758759

  7. [Literature review on premarketing and postmarketing evidence of xiyanping injection].

    PubMed

    Wang, Zhi-Fei; Chen, Xiao; Zhang, Wen; Xie, Yan-Ming

    2014-09-01

    This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection. PMID:25532411

  8. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.

    PubMed

    Roller, Sarah Taylor; Pippins, Raqiyyah R; Ngai, Jennifer W

    2009-01-01

    This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment. PMID:19999646

  9. Population based mortality surveillance in carbon products manufacturing plants.

    PubMed Central

    Teta, M J; Ott, M G; Schnatter, A R

    1987-01-01

    The utility of a population based, corporate wide mortality surveillance system was evaluated after a 10 year observation period of one of the company's divisions. The subject population, 2219 white male, long term employees from Union Carbide Corporation's carbon based electrode and specialty products operations, was followed up for mortality from 1974 to 1983. External comparisons with the United States male population were supplemented with internal comparisons among subgroups of the study population, defined by broad job categories and time related variables, adjusting for important correlates of the healthy worker effect. Significant deficits of deaths were observed for all causes and the major non-cancer causes of death. The numbers of deaths due to malignant neoplasms and respiratory cancer were less than, but not statistically different from, expected. There was a non-significant excess of deaths from lymphopoietic cancer, occurring predominantly among salaried employees. When specific locations were examined, operations with potential exposure to coal tar products exhibited a mortality pattern similar to that of the total cohort. The risk for lung cancer was significantly raised (five observed, 1.4 expected) in one small, but older, location which did not involve coal tar products during the period of employment of these individuals, but which historically used asbestos materials for several unique applications. Although these findings are limited by small numbers and a short observation period, the population based surveillance strategy has provided valuable information regarding the mortality experience of the population, directions for future research, and the allocation of epidemiological resources. PMID:3593661

  10. Magnetic Resonance Based Diagnostics for Polymer Production and Surveillance

    SciTech Connect

    Chinn, S; Herberg, J; Gjersing, E; Cook, A; Sawvel, A M; Maxwell, R; Wheeler, H; Wilson, M

    2006-09-27

    In an effort to develop a magnetic resonance based diagnostic tool to be used for polymer production and surveillance, we have investigated the use of magnetic resonance imaging (MRI) and unilateral relaxometry. MRI provides a spatial map of the polymer, which can be correlated to the structure heterogeneity. Though highly detailed information can be obtained with MRI, the high equipment cost and expertise required to operate the system makes it a poor choice for a production setting. Unilateral relaxometry via the NMR MOUSE provides rapid, inexpensive polymer screening, useful in the development in new polymer parts or to identify potentially defective components. The NMR ProFiler (originally called the NMR MOUSE) was procured by Kansas City originally for production support of the W80 LEP with future applications as a surveillance diagnostic. A robotic autosampler has been designed allowing the detection of several components without the need for any human interaction. A summary of the qualification experiments and results to date from the ProFiler and the robotic unit will be presented.

  11. [Post-marketing drug safety measures for the attainment of safer and more effective use of drug].

    PubMed

    Kurokawa, Tatsuo

    2011-01-01

    In contrast with the 20th century's dramatic improvements in the direct and/or hazardous toxicity of drugs, indirect toxicity and/or long-term safety concerns such as relation of cancer risk and TNF-alpha receptor blockers have caused significant complexity in post-marketing surveillance (PMS) scenery. The post-marketing phase of drugs and their safety measures now appear to be much more complicated and heavier than decades ago. The spontaneous adverse drug reaction (ADR) reporting system which has been one of the main pillars of PMS measures for almost 50 years may have to be reviewed in terms of its effectiveness, and may need augmentation from medical data bases. Only a pharmaco-epidemiological analysis and integration of the output with a conventional spontaneous reporting approach offers a chance to satisfy the current complex safety issues. Today's tendency toward practical saturation at medical/pharmaceutical frontiers, by regulatory authorities and safety divisions of pharmaceutical companies with ever-increasing day-to-day safety information can also be pointed out. Such phenomena may actually reduce the productivity of safety measures and also jeopardize the maintenance of an acceptable risk/benefit drug ratio. To alleviate these potential negative implications, establishment of a consortium to act as a sentinel that would gather up-to-date and essential safety information, including epidemiological data, from all sources and provide it plus recommendations to all stakeholders can be suggested. Through such activities, we could expect significant improvement of drug safety measures in post-marketing phase which would effectively cover not only new drugs but also generic and bio-simulated drugs. PMID:21628973

  12. Review of Transporter-Related Postmarketing Requirement or Postmarketing Commitment Studies.

    PubMed

    Fan, Ying; Sun, Bo; Agarwal, Sheetal; Zhang, Lei

    2016-07-01

    The objectives of this report are to summarize the content and status of transporter-related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results on labeling to guide the optimal use of the drugs. Multiple data sources were searched to collect information on transporter-related PMR/PMC studies between January 1999 and May 2015. A total of 40 transporter-related PMR/PMC study requests were issued for 35 NDAs. Among these PMR/PMC studies, 27 requested studies related to P-glycoprotein. As of May 31, 2015, 34 transporter-related PMR/PMC studies (85%) are considered "fulfilled" (per the FDA's PMR/PMC website), and 22 (65%) resulted in labeling updates. The majority of the PMR/PMC studies are for drugs in the therapeutic areas of anti-infectives, oncology, and neurology. The results from PMR/PMC studies are important for dosing optimization and are often included in the updated labeling. Because a significant lag time is anticipated between drug approval and PMR/PMC fulfillment, NDA applicants are encouraged to include transporter-related assessments in clinical drug development programs for drug products. PMID:27385175

  13. Guideline for postmarketing Chinese medicine pharmacoeconomic evaluation.

    PubMed

    Wang, Xin; Wang, Zhi-Fei; Xie, Yan-Ming; Zhang, Wen; Liao, Xing; Chang, Yan-Peng

    2015-06-01

    Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation. PMID:24671571

  14. Surveillance methods for identifying, characterizing, and monitoring tobacco products: potential reduced exposure products as an example

    PubMed Central

    O’Connor, Richard J.; Cummings, K. Michael; Rees, Vaughan W.; Connolly, Gregory N.; Norton, Kaila J.; Sweanor, David; Parascandola, Mark; Hatsukami, Dorothy K.; Shields, Peter G.

    2015-01-01

    Tobacco products are widely sold and marketed, yet integrated data systems for identifying, tracking, and characterizing products are lacking. Tobacco manufacturers recently have developed potential reduction exposure products (PREPs) with implied or explicit health claims. Currently, a systematic approach for identifying, defining, and evaluating PREPs sold at the local, state or national levels in the US has not been developed. Identifying, characterizing, and monitoring new tobacco products could be greatly enhanced with a responsive surveillance system. This paper critically reviews available surveillance data sources for identifying and tracking tobacco products, including PREPs, evaluating strengths and weaknesses of potential data sources in light of their reliability and validity. Absent regulations mandating disclosure of product-specific information, it is likely that public health officials will need to rely on a variety of imperfect data sources to help identify, characterize, and monitor tobacco products, including PREPs. PMID:19959680

  15. A conceptual framework for economic optimization of single hazard surveillance in livestock production chains.

    PubMed

    Guo, Xuezhen; Claassen, G D H; Oude Lansink, A G J M; Saatkamp, H W

    2014-06-01

    Economic analysis of hazard surveillance in livestock production chains is essential for surveillance organizations (such as food safety authorities) when making scientifically based decisions on optimization of resource allocation. To enable this, quantitative decision support tools are required at two levels of analysis: (1) single-hazard surveillance system and (2) surveillance portfolio. This paper addresses the first level by presenting a conceptual approach for the economic analysis of single-hazard surveillance systems. The concept includes objective and subjective aspects of single-hazard surveillance system analysis: (1) a simulation part to derive an efficient set of surveillance setups based on the technical surveillance performance parameters (TSPPs) and the corresponding surveillance costs, i.e., objective analysis, and (2) a multi-criteria decision making model to evaluate the impacts of the hazard surveillance, i.e., subjective analysis. The conceptual approach was checked for (1) conceptual validity and (2) data validity. Issues regarding the practical use of the approach, particularly the data requirement, were discussed. We concluded that the conceptual approach is scientifically credible for economic analysis of single-hazard surveillance systems and that the practicability of the approach depends on data availability. PMID:24630402

  16. The application of post-market monitoring to novel foods.

    PubMed

    Hepburn, P; Howlett, J; Boeing, H; Cockburn, A; Constable, A; Davi, A; de Jong, N; Moseley, B; Oberdörfer, R; Robertson, C; Wal, J M; Samuels, F

    2008-01-01

    The role of post-market monitoring (PMM) in the safety assessment of novel foods is critically discussed in order to derive guidelines as to in which situations the application of PMM might be warranted. Available data sources on food consumption and health status, and the methodologies for generating such data are reviewed. The paper suggests improvements to make them more applicable for PMM purposes. It is concluded that any PMM programme must be a hypothesis-driven scientific exercise. PMM can have a role as a complement to, but not as a replacement for, a comprehensive pre-market safety assessment. Its use may be appropriate to confirm that product use is as predicted in the pre-market assessment; to provide reassurance that effects observed in the pre-market assessment occur with no greater frequency or intensity in the post-market phase than anticipated; and to investigate the significance of any adverse effects reported by consumers after market-launch. However PMM is insufficiently powerful to test the hypothesis that any effects seen in the pre-market assessment are absent in the post-market phase. Current methodologies place limitations on what PMM can achieve. PMM should only be used when triggered by or when the focus is on specific evidence-based questions. PMID:17950974

  17. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.

    PubMed

    Ball, R; Robb, M; Anderson, S A; Dal Pan, G

    2016-03-01

    In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products. PMID:26667601

  18. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China.

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-07-01

    This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers. PMID:23818198

  19. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... reports or as the result of a formal clinical trial. (2) As with all reports submitted under paragraph (c... derived from commercial marketing experience, postmarketing clinical investigations, postmarketing... adverse experience obtained from a postmarketing clinical study (whether or not conducted under...

  20. 21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Annual reports of postmarketing pediatric studies... pediatric studies. Sponsors of licensed biological products shall submit the following information each year... labeling supplements for pediatric use have been submitted and whether new studies in the...

  1. 21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Annual reports of postmarketing pediatric studies... pediatric studies. Sponsors of licensed biological products shall submit the following information each year... labeling supplements for pediatric use have been submitted and whether new studies in the...

  2. 21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Annual reports of postmarketing pediatric studies... pediatric studies. Sponsors of licensed biological products shall submit the following information each year... labeling supplements for pediatric use have been submitted and whether new studies in the...

  3. 21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Annual reports of postmarketing pediatric studies... pediatric studies. Sponsors of licensed biological products shall submit the following information each year... labeling supplements for pediatric use have been submitted and whether new studies in the...

  4. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.50 Alert system and exchange of... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Alert system and exchange of postmarket...

  5. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.50 Alert system and exchange of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Alert system and exchange of postmarket...

  6. 76 FR 52669 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ...The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. The August 4, 2011, notice is the......

  7. 75 FR 68802 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ...Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and......

  8. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD... plan are available on the Center for Devices and Radiological Health's Web site and from the Center...

  9. Strategies for postmarketing surveillance of drugs for rare diseases.

    PubMed

    Kesselheim, A S; Gagne, J J

    2014-03-01

    Rare diseases are an important part of the public health, affecting 6-8% of the population, and drugs intended for rare diseases comprise the fastest growing subcategory of new drug approvals in the United States. However, clinical study of therapeutics in these populations is limited by the low prevalence of these diseases, and the natural history or pathogenesis of the disease may be poorly described. In addition, commonly used strategies for evaluation of postapproval safety and effectiveness, such as meta-analyses and review of spontaneous adverse event reports, may not be applicable. Alternative methodological approaches, including natural history studies, adaptive clinical trial designs, and epidemiological studies using patient-organized registries, show substantial promise for the study of rare disease therapeutics. Bayesian trials and distributed networks of large electronic databases are the most promising strategies for active and prospective monitoring of clinical interventions for rare diseases. PMID:24193169

  10. Preclinical, Clinical, and Over-the-Counter Postmarketing Experience with a New Vaginal Cup: Menstrual Collection

    PubMed Central

    North, Barbara B.

    2011-01-01

    Abstract Background 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. Methods 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. Results 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. Conclusions 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. PMID

  11. Postmarketing Trials and Pediatric Device Approvals

    PubMed Central

    Hwang, Thomas J.; Kesselheim, Aaron S.

    2014-01-01

    BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described. METHODS: We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)–mandated postmarketing trials. RESULTS: Twenty-two devices were approved for use in children via the premarket approval pathway and 3 via the humanitarian device exemption pathway. Twenty-two (88%) qualified as pediatric despite minimum approval ages of ≥18 years (the FDA Center for Devices and Radiologic Health considers patients 18–21 years old as pediatric). Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (86%). Overall, 21 (84%) devices were not studied in any patients <18 years of age. Postmarketing studies were mandated by the FDA for 19 (76%) devices, although only 3 (18%) required enrollment of pediatric patients. CONCLUSIONS: Most high-risk pediatric devices are approved on the basis of trials in patients ≥18 years old, with few pediatric patients exposed to the devices before market availability. Few postmarketing studies require additional study in pediatric patients. PMID:24733871

  12. The New Product Watch: Successes and Challenges of Crowdsourcing as a Method of Surveillance.

    PubMed

    Nyman, Amy L; Biener, Lois

    2016-01-01

    New smokeless tobacco (eg, snus and dissolvable tobacco products) and nontobacco nicotine products (eg, e-cigarettes) have emerged in recent years amid widespread speculation about locations of test marketing, toxic constituents, and consumer targeting. The New Product Watch was a pilot online monitoring system aimed at filling these information gaps by using a form of crowdsourcing: recruiting volunteers to visit local retailers and report their findings. With very little funding, the New Product Watch gathered county-specific data on new product availability in 19 states as well as trend data on product marketing and demand, and completed 2 rounds of product purchases and subsequent toxic constituent analyses. Data were collected over a 2-year period, between 2009 and 2011. Despite the successes, we found that this small-scale, volunteer effort was not a sustainable method for ensuring continuous, systematic surveillance of new product availability, marketing, and toxicity. PMID:24335713

  13. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  14. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption

    PubMed Central

    Miller, Larry E; Reckling, W Carlton; Block, Jon E

    2013-01-01

    Background 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. Methods 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. Results 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%). Conclusion 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

  15. Postmarket Drug Safety Information for Patients and Providers

    MedlinePlus

    ... Information for Patients and Providers Postmarket Drug Safety Information for Patients and Providers Share Tweet Linkedin Pin ... communication to patients and healthcare providers. Latest Safety Information Index to Drug-Specific Information For patients, consumers, ...

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

    PubMed Central

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-01-01

    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. PMID:26167249

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

    PubMed

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-01

    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. PMID:26167249

  18. Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study

    PubMed Central

    Lexchin, Joel

    2014-01-01

    Objectives Examine the probability of new active substances (NASs) approved in Canada between 1 January 1997 and 31 March 2012 acquiring a serious postmarket safety warning. Design Cohort study. Data sources Annual reports of the Therapeutic Products Directorate and the Biologic and Genetic Therapies Directorate; evaluations of therapeutic innovation from the Patented Medicine Prices Review Board and Prescrire International; MedEffect Canada website. Interventions Postmarket regulatory safety warning or withdrawal from market due to safety reasons. Primary and secondary outcome measures Compare the probability of acquiring a postmarket safety warning in Canada in four different groups of drugs: (1) traditional medications versus biologics; (2) medications that offer significant new therapeutic benefits versus those that do not. Determine how well the type of review that an NAS received from Health Canada predicted the product's postmarket therapeutic value. Results The probability of a traditional NAS acquiring a serious safety warning and/or being withdrawn was 29.9% (95% CI 21.8% to 40.2%) vs 27.3% (95% CI 18.2% to 39.7%) for an NAS of biological origin (p=0.47, log-rank test). For medications that were significant therapeutic advances the probability was 40.2% (95% CI 24.5% to 60.9%) vs 33.9% (95% CI 26.4% to 42.7%) for those that were not (p=0.18, log-rank test). Health Canada was 77.4% accurate in predicting the therapeutic importance of an NAS. Conclusions There was no difference in postmarket regulatory safety action between traditional medications and biologics and no difference between drugs with significant therapeutic benefits and those without. Although these results draw on Canadian data, they are likely to be relevant internationally. Further research should assess whether the current level of premarket safety evaluation is acceptable. PMID:24549164

  19. Post-marketing experience with an opioid nasal spray for migraine: lessons for the future.

    PubMed

    Loder, E

    2006-02-01

    In 1992 a nasal spray formulation of butorphanol, an opioid medication intended for pain relief, was marketed in the USA on an unscheduled basis. Only a few years later, amid widespread reports of abuse and dependence, primarily in migraine patients, its manufacturer voluntarily requested the Food and Drug Administration to reschedule the drug as a Schedule IV narcotic. The events surrounding this episode are reviewed, and four problem areas that might have contributed are identified: (i) inadequate review of previous experience with other formulations of butorphanol; (ii) failure to consider the impact of disease state and drug formulation on the risk of adverse events; (iii) the limited scope of clinical trials prior to approval; and (iv) aggressive marketing efforts. The implications of these lessons for future drug development and post-marketing surveillance in the migraine field are considered. PMID:16426261

  20. Regulatory considerations for determining postmarketing study commitments.

    PubMed

    Meyer, R J

    2007-08-01

    Postmarketing Study Commitments (PMCs) are, most commonly, agreements made by pharmaceutical companies at the time of an FDA approval to perform a study or studies to elucidate further characteristics of the drug under consideration. The role of PMCs in drug regulation has come under considerable scrutiny in recent years, particularly as discussions of drug safety have intensified. Although these agreed-upon PMCs are described in FDA regulations, such PMCs are not sought by FDA with every approval, and completion of the agreed-upon studies is not a requirement for the drug's sponsor (there are required PMCs under certain regulatory provisions and these are discussed below). Requests by FDA at the time of regulatory approval for studies under PMCs have been a common practice for many years. When made, PMCs are described in the approval letters and are therefore publicly available. Concerns over whether PMCs were being duly performed, reported, and reviewed by FDA were addressed in the FDA Modernization Act of 1997, which required more detailed reporting by manufactures on their progress in meeting the PMCs and required FDA to report certain information publicly. PMID:17538552

  1. 21 CFR 822.32 - What records are the investigators in my surveillance plan required to keep?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What records are the investigators in my surveillance plan required to keep? 822.32 Section 822.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Records and Reports § 822.32 What records are the...

  2. 21 CFR 601.70 - Annual progress reports of postmarketing studies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Annual progress reports of postmarketing studies. 601.70 Section 601.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Postmarketing Studies § 601.70 Annual progress reports of postmarketing studies. (a) General requirements....

  3. Potential metal impurities in active pharmaceutical substances and finished medicinal products - A market surveillance study.

    PubMed

    Wollein, Uwe; Bauer, Bettina; Habernegg, Renate; Schramek, Nicholas

    2015-09-18

    A market surveillance study has been established by using different atomic spectrometric methods for the determination of selected elemental impurities of particular interest, to gain an overview about the quality of presently marketed drug products and their bulk drug substances. The limit tests were carried out with respect to the existing EMA guideline on the specification limits for residuals of metal catalysts or metal reagents. Also attention was given to the future implementation of two new chapters of the United States Pharmacopoeia (USP) stating limit concentrations of elemental impurities. The methods used for determination of metal residues were inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-optical emission spectrometry (ICP-OES), and atomic absorption spectrometry technologies (GFAAS, CVAAS, HGAAS). This article presents the development and validation of the methods used for the determination of 21 selected metals in 113 samples from drug products and their active pharmaceutical ingredients. PMID:26036232

  4. Surveillance indicators for potential reduced exposure products (PREPs): developing survey items to measure awareness

    PubMed Central

    Bogen, Karen; Biener, Lois; Garrett, Catherine A; Allen, Jane; Cummings, K Michael; Hartman, Anne; Marcus, Stephen; McNeill, Ann; O'Connor, Richard J; Parascandola, Mark; Pederson, Linda

    2009-01-01

    Background Over the past decade, tobacco companies have introduced cigarettes and smokeless tobacco products (known as Potential Reduced Exposure Products, PREPs) with purportedly lower levels of some toxins than conventional cigarettes and smokeless products. It is essential that public health agencies monitor awareness, interest, use, and perceptions of these products so that their impact on population health can be detected at the earliest stages. Methods This paper reviews and critiques existing strategies for measuring awareness of PREPs from 16 published and unpublished studies. From these measures, we developed new surveillance items and subjected them to two rounds of cognitive testing, a common and accepted method for evaluating questionnaire wording. Results Our review suggests that high levels of awareness of PREPs reported in some studies are likely to be inaccurate. Two likely sources of inaccuracy in awareness measures were identified: 1) the tendency of respondents to misclassify "no additive" and "natural" cigarettes as PREPs and 2) the tendency of respondents to mistakenly report awareness as a result of confusion between PREPs brands and similarly named familiar products, for example, Eclipse chewing gum and Accord automobiles. Conclusion After evaluating new measures with cognitive interviews, we conclude that as of winter 2006, awareness of reduced exposure products among U.S. smokers was likely to be between 1% and 8%, with the higher estimates for some products occurring in test markets. Recommended measurement strategies for future surveys are presented. PMID:19840394

  5. Drug approval and surveillance.

    PubMed

    Potts, M

    1980-01-01

    This article argues that current regulations governing the licensing of drugs, particularly in the U.S., need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use. In terms of research and development of new forms of contraception, this proposal would have great impact. It is believed that the U.S./Food and Drug Administration (FDA) requirements--animal experiments and Phase 1 and 2 clinical trials--not only put an unacceptable financial burden on any institution attempting to develop new contraceptives, but do not demonstrably contribute to the reduction of risks. The author questions whether even if oral contraceptives introduced prior to new U.S./FDA regulations had been subject to these current regulations that convincing evidence would have been found to alert anyone to the now-known rare adverse effects, such as risk of thromboembolism. It is pointed out that these sorts of rare risks were uncovered by continuous screening processes which are not now a part of the FDA drug regulation requirements. The author also questions the politics of "conpulsory safety," such as might be legislated for regulated car safety belt use. Citing a partnership already established between government and private industry in high-risk/low cost ventures in the aerospace industry, the author sees no reason why such a relationship could not evolve in the pharmaceutical industry. In Britain, proposals have been made to establish a fund to compensate patients adversely affected by drugs which pharmaceutical companies would reimburse if proved negligent; such a fund may work in the U.S. under new regulations which stress postmarketing surveillance. PMID:6110574

  6. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    PubMed

    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. PMID:23818200

  7. 21 CFR 314.630 - Postmarketing safety reporting.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Postmarketing safety reporting. 314.630 Section 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical...

  8. 21 CFR 314.540 - Postmarketing safety reporting.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Postmarketing safety reporting. 314.540 Section 314.540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Accelerated Approval of New Drugs for Serious or Life-Threatening...

  9. Surveillance of tobacco industry retail marketing activities of reduced harm products.

    PubMed

    Slater, Sandy; Giovino, Gary; Chaloupka, Frank

    2008-01-01

    With the introduction of potential reduced exposure products (PREPs) and the interest in studying tobacco harm reduction, sound research and surveillance are needed to examine and understand the distribution and availability of PREPs in communities, as well as the tobacco industry's marketing practices surrounding these products. We examined the availability and marketing of PREPs in a national sample of tobacco retail stores. We also compared the price of PREPs to those of premium brand cigarettes and examined the distribution of PREPs in comparison with premium brand cigarettes by store type, urbanization, region, and race/ethnicity. We found that PREPs are not widely available, are priced similarly to leading cigarette brands, and have few promotional offers. We also found some significant differences in the distribution of PREPs and cigarettes, as well as in the distribution of Ariva and Omni, by store type and community demographics. The fact that this study used data collected nationally emphasizes the importance of these findings and helps shed some light on the tobacco industry's PREP marketing strategies. This study's national sample provides a unique perspective that needs to be replicated if and when other PREPs are widely marketed. PMID:18188759

  10. Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

    PubMed

    Sekine, S; Pinnow, E E; Wu, E; Kurtzig, R; Hall, M; Dal Pan, G J

    2016-07-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  11. Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

    PubMed Central

    Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

    2016-01-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  12. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Classifying Significant Postmarket Drug Safety Issues.'' This draft guidance describes FDA's current approach to classifying a significant postmarket drug safety issue as a ``priority'' tracked safety issue (TSI) or a ``standard'' TSI, with the capability of elevating some priority TSIs to an......

  13. 76 FR 47211 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... a postmarketing study or clinical trial that an applicant has been required to, or has agreed to... postmarketing study/clinical trial. This report must also include reasons, if any, for failure to complete the study/clinical trial. These studies and clinical trials are intended to further define the...

  14. 77 FR 13339 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... monitor the progress of a postmarketing study or clinical trial that an applicant has been required to, or... the status of the postmarketing study/clinical trial. This report must also include reasons, if any, for failure to complete the study/clinical trial. These studies and clinical trials are intended...

  15. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  16. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  17. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  18. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  19. The use of existing environmental networks for the post-market monitoring of GM crop cultivation in the EU.

    PubMed

    Smets, G; Alcalde, E; Andres, D; Carron, D; Delzenne, P; Heise, A; Legris, G; Martinez Parrilla, M; Verhaert, J; Wandelt, C; Ilegems, M; Rüdelsheim, P

    2014-07-01

    The European Union (EU) Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment requires that both Case-Specific Monitoring (CSM) and General Surveillance (GS) are considered as post-market implementing measures. Whereas CSM is directed to monitor potential adverse effects of GMOs or their use identified in the environmental risk assessment, GS aims to detect un-intended adverse effects of GMOs or their use on human and animal health or the environment. Guidance documents on the monitoring of genetically modified (GM) plants from the Commission and EFSA clarify that, as appropriate, GS can make use of established routine surveillance practices. Networks involved in routine surveillance offer recognised expertise in a particular domain and are designed to collect information on important environmental aspects over a large geographical area. However, as the suitability of existing monitoring networks to provide relevant data for monitoring impacts of GMOs is not known, plant biotechnology companies developed an approach to describe the processes and criteria that will be used for selecting and evaluating existing monitoring systems. In this paper, the availability of existing monitoring networks for this purpose is evaluated. By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information. PMID:24836113

  20. Rethinking Research Ethics: The Case of Postmarketing Trials

    PubMed Central

    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

  1. Systems pharmacology augments drug safety surveillance.

    PubMed

    Lorberbaum, T; Nasir, M; Keiser, M J; Vilar, S; Hripcsak, G; Tatonetti, N P

    2015-02-01

    Small molecule drugs are the foundation of modern medical practice, yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on postmarketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology-the integration of systems biology and chemical genomics-can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

  2. SURVEILLANCE REPORTS

    EPA Science Inventory

    Surveillance reports are designed to provide useful data to researchers, planners, policymakers, and other professionals interested in alcohol abuse and its associated illnesses and mortality. Other surveillance report topics include apparent per capita consumption of alcoholic b...

  3. RNA cleavage products generated by antisense oligonucleotides and siRNAs are processed by the RNA surveillance machinery

    PubMed Central

    Lima, Walt F.; De Hoyos, Cheryl L.; Liang, Xue-hai; Crooke, Stanley T.

    2016-01-01

    DNA-based antisense oligonucleotides (ASOs) elicit cleavage of the targeted RNA by the endoribonuclease RNase H1, whereas siRNAs mediate cleavage through the RNAi pathway. To determine the fates of the cleaved RNA in cells, we lowered the levels of the factors involved in RNA surveillance prior to treating cells with ASOs or siRNA and analyzed cleavage products by RACE. The cytoplasmic 5′ to 3′ exoribonuclease XRN1 was responsible for the degradation of the downstream cleavage products generated by ASOs or siRNA targeting mRNAs. In contrast, downstream cleavage products generated by ASOs targeting nuclear long non-coding RNA Malat 1 and pre-mRNA were degraded by nuclear XRN2. The downstream cleavage products did not appear to be degraded in the 3′ to 5′ direction as the majority of these products contained intact poly(A) tails and were bound by the poly(A) binding protein. The upstream cleavage products of Malat1 were degraded in the 3′ to 5′ direction by the exosome complex containing the nuclear exoribonuclease Dis3. The exosome complex containing Dis3 or cytoplasmic Dis3L1 degraded mRNA upstream cleavage products, which were not bound by the 5′-cap binding complex and, consequently, were susceptible to degradation in the 5′ to 3′ direction by the XRN exoribonucleases. PMID:26843429

  4. RNA cleavage products generated by antisense oligonucleotides and siRNAs are processed by the RNA surveillance machinery.

    PubMed

    Lima, Walt F; De Hoyos, Cheryl L; Liang, Xue-Hai; Crooke, Stanley T

    2016-04-20

    DNA-based antisense oligonucleotides (ASOs) elicit cleavage of the targeted RNA by the endoribonuclease RNase H1, whereas siRNAs mediate cleavage through the RNAi pathway. To determine the fates of the cleaved RNA in cells, we lowered the levels of the factors involved in RNA surveillance prior to treating cells with ASOs or siRNA and analyzed cleavage products by RACE. The cytoplasmic 5' to 3' exoribonuclease XRN1 was responsible for the degradation of the downstream cleavage products generated by ASOs or siRNA targeting mRNAs. In contrast, downstream cleavage products generated by ASOs targeting nuclear long non-coding RNA Malat 1 and pre-mRNA were degraded by nuclear XRN2. The downstream cleavage products did not appear to be degraded in the 3' to 5' direction as the majority of these products contained intact poly(A) tails and were bound by the poly(A) binding protein. The upstream cleavage products of Malat1 were degraded in the 3' to 5' direction by the exosome complex containing the nuclear exoribonuclease Dis3. The exosome complex containing Dis3 or cytoplasmic Dis3L1 degraded mRNA upstream cleavage products, which were not bound by the 5'-cap binding complex and, consequently, were susceptible to degradation in the 5' to 3' direction by the XRN exoribonucleases. PMID:26843429

  5. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    PubMed Central

    D’Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D’Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Background Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50μg, placebo (both delivered via the Breezhaler® device), or tiotropium 18 μg (delivered via the HandiHaler® device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. Results The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. Conclusion The overall safety profile of glycopyrronium was

  6. Hazards of Illicit Methamphetamine Production and Efforts at Reduction: Data from the Hazardous Substances Emergency Events Surveillance System

    PubMed Central

    Melnikova, Natalia; Welles, Wanda Lizak; Wilburn, Rebecca E.; Rice, Nancy; Wu, Jennifer; Stanbury, Martha

    2011-01-01

    Objectives. Methamphetamine (meth) is a highly addictive drug of abuse that can easily be made in small illegal laboratories from household chemicals that are highly toxic and dangerous. Meth labs have been found in locations such as homes, outbuildings, motels, and cars. Its production endangers the “cook,” neighbors, responders, and the environment. This article describes surveillance data used to examine the emergence and public health impacts of illicit clandestine meth labs, as well as two states' efforts to thwart lab operations and prevent responder injuries. Methods. We analyzed data collected from 2001 to 2008 by 18 states participating in the Agency for Toxic Substances and Disease Registry's Hazardous Substances Emergency Events Surveillance (HSEES) Program to examine the occurrence and public health impacts of clandestine meth production. Results. HSEES data indicate that the majority of clandestine meth lab events occurred in residential areas. About 15% of meth lab events required evacuation. Nearly one-fourth of these events resulted in injuries, with 902 reported victims. Most victims (61%) were official responders, and one-third were members of the general public. Since 2004, with the implementation of local and federal laws and prevention activities, the number of meth lab events has declined. Increased education and training of first responders has led to decreased injuries among police officers, firefighters, and emergency medical personnel. Conclusions. HSEES data provided a good data source for monitoring the emergence of domestic clandestine meth production, the associated public health effects, and the results of state and federal efforts to promote actions to address the problem. PMID:21563719

  7. Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

    PubMed Central

    Lee, Hye Jin; Son, Jeong Min; Mun, Jihee; Kim, Dong Wook

    2015-01-01

    Background and Purpose: Zonisamide (ZNS) is one of new antiepileptic drug, which is known to inhibit seizure through multiple mechanisms of action. In Korea, ZNS was approved as an antiepileptic drug in 1992 and has been used for epilepsy patients with partial and generalized seizures. The objective of this study was to investigate the efficacy and tolerability of ZNS in patients with epilepsy and to identify the incidence of adverse events in real clinical setting. Methods: This study was carried out in patients who received ZNS for epilepsy. Patients who were observed for at least 12 weeks after treatment with ZNS were included as evaluable subjects. Information regarding the status and type of adverse events occurring during the course of treatment with ZNS was obtained regardless of causal relationship to ZNS and efficacy was assessed by the study physicians and patients at 12 weeks post dose of ZNS. Results: A total of 1,948 patients were included in the study, and ZNS efficacy was evaluated in 1,744 patients. ZNS was used as a monotherapy in 1,095 patients and as an adjunctive drug in 853 patients. Of the total patients, 1,345 (69.1%) patients had partial seizure, 563 patients had generalized seizure, and 40 patients were undetermined. Adverse events were reported in 65 patients (3.34%) including 1 case of Stevens-Johnson syndrome, but no incidence of serious unexpected adverse drug reactions were reported. 755 patients (43.29%) became seizure free with ZNS treatment, and additional 322 patients (18.41%) experienced marked improvement with ZNS treatment. Conclusions: Our study shows the safety and tolerability of ZNS treatment in patients with epilepsy in real clinical setting. In addition, ZNS was found to be an effective option as a monotherapy or in patients with generalized seizure. PMID:26819941

  8. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ...-mail, and telephone number. For those without Internet access, please contact Jay Crowley (see Contact..., information about lodging, and other relevant information on the Internet at http://www.fda.gov/UDI . Comments... Sentinel Initiative, on the Internet at...

  9. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061... Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www... accessible at http://www.regulations.gov . It may be viewed at the Division of Dockets Management...

  10. A Mobile Sensing Approach for Regional Surveillance of Fugitive Methane Emissions in Oil and Gas Production.

    PubMed

    Albertson, John D; Harvey, Tierney; Foderaro, Greg; Zhu, Pingping; Zhou, Xiaochi; Ferrari, Silvia; Amin, M Shahrooz; Modrak, Mark; Brantley, Halley; Thoma, Eben D

    2016-03-01

    This paper addresses the need for surveillance of fugitive methane emissions over broad geographical regions. Most existing techniques suffer from being either extensive (but qualitative) or quantitative (but intensive with poor scalability). A total of two novel advancements are made here. First, a recursive Bayesian method is presented for probabilistically characterizing fugitive point-sources from mobile sensor data. This approach is made possible by a new cross-plume integrated dispersion formulation that overcomes much of the need for time-averaging concentration data. The method is tested here against a limited data set of controlled methane release and shown to perform well. We then present an information-theoretic approach to plan the paths of the sensor-equipped vehicle, where the path is chosen so as to maximize expected reduction in integrated target source rate uncertainty in the region, subject to given starting and ending positions and prevailing meteorological conditions. The information-driven sensor path planning algorithm is tested and shown to provide robust results across a wide range of conditions. An overall system concept is presented for optionally piggybacking of these techniques onto normal industry maintenance operations using sensor-equipped work trucks. PMID:26807713

  11. Application of syndromic surveillance on routinely collected cattle reproduction and milk production data for the early detection of outbreaks of Bluetongue and Schmallenberg viruses.

    PubMed

    Veldhuis, Anouk; Brouwer-Middelesch, Henriëtte; Marceau, Alexis; Madouasse, Aurélien; Van der Stede, Yves; Fourichon, Christine; Welby, Sarah; Wever, Paul; van Schaik, Gerdien

    2016-02-01

    This study aimed to evaluate the use of routinely collected reproductive and milk production data for the early detection of emerging vector-borne diseases in cattle in the Netherlands and the Flanders region of Belgium (i.e., the northern part of Belgium). Prospective space-time cluster analyses on residuals from a model on milk production were carried out to detect clusters of reduced milk yield. A CUSUM algorithm was used to detect temporal aberrations in model residuals of reproductive performance models on two indicators of gestation length. The Bluetongue serotype-8 (BTV-8) epidemics of 2006 and 2007 and the Schmallenberg virus (SBV) epidemic of 2011 were used as case studies to evaluate the sensitivity and timeliness of these methods. The methods investigated in this study did not result in a more timely detection of BTV-8 and SBV in the Netherlands and BTV-8 in Belgium given the surveillance systems in place when these viruses emerged. This could be due to (i) the large geographical units used in the analyses (country, region and province level), and (ii) the high level of sensitivity of the surveillance systems in place when these viruses emerged. Nevertheless, it might be worthwhile to use a syndromic surveillance system based on non-specific animal health data in real-time alongside regular surveillance, to increase the sense of urgency and to provide valuable quantitative information for decision makers in the initial phase of an emerging disease outbreak. PMID:26732291

  12. Environmental surveillance master sampling schedule

    SciTech Connect

    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.

  13. Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

    PubMed

    Edwards, Brian; Hugman, Bruce; Tobin, Mary; Whalen, Matthew

    2012-04-01

    Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees' concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products. PMID:22339507

  14. Interactions between Natural Health Products and Oral Anticoagulants: Spontaneous Reports in the Italian Surveillance System of Natural Health Products

    PubMed Central

    Paoletti, Angelica; Gallo, Eugenia; Benemei, Silvia; Vietri, Michele; Lapi, Francesco; Volpi, Roberta; Menniti-Ippolito, Francesca; Gori, Luigi; Mugelli, Alessandro; Firenzuoli, Fabio; Vannacci, Alfredo

    2011-01-01

    Introduction. The safety of vitamin K antagonists (VKA) use can be compromised by many popular herbal supplements taken by individuals. The literature reports that 30% of warfarin-treated patients self-medicates with herbs. Possible interactions represent an health risk. We aimed to identify all herbs-oral anticoagulants interactions collected in the Italian database of suspected adverse reactions to “natural health” products. Methods. The Italian database of spontaneous reports of suspected adverse reactions to natural products was analyzed to address herb-VKAs interactions. Results. From 2002 to 2009, we identified 12 reports with 7 cases of INR reduction in patients treated with warfarin (n = 3) and acenocoumarol (n = 4), and 5 cases of INR increase (all warfarin associated). It was reported 8 different herbal products as possibly interacting. Discussion. Our study confirms the risk of interactions, highlighting the difficulty to characterize them and their mechanisms and, finally, prevent their onset. The reported data underline the urgent need of healthcare providers being aware of the possible interaction between natural products and VKA, also because of the critical clinical conditions affecting patients. This is the first step to have the best approach to understand possible INR alterations linked to herb-VKA interaction and to rightly educate patients in treatment with VKA. PMID:21274401

  15. Poliomyelitis surveillance.

    PubMed

    1998-04-01

    Attention to the 4 poliomyelitis surveillance indicators approved by the International Commission for the Certification of Poliomyelitis Eradication (ICCPE) in 1994, has deteriorated since the Americas were declared free from wild poliovirus. The indicators are designed to measure the performance of health services and the sensitivity of the surveillance system to detect wild poliovirus circulating in the community. Sensitivity is the most important characteristic of the poliomyelitis surveillance system and it is measured by the rate of acute flaccid paralysis (AFP) per 100,000 under age 15 years. As of March 21, 1998, the AFP rate reached its lowest level yet in the Americas, with only Bolivia, Chile, and Honduras presenting an acceptable rate (the analysis does not include the US and Canada). The other countries in the Caribbean region and Latin America had rates under 1 AFP case per 100,000 children under age 15. It follows that only 6% of children under age 15 in the region are currently protected by a sensitive AFP surveillance system. Poliovirus may therefore be circulating silently in the region. Renewed attention must be given to the AFP surveillance indicators. PMID:12321498

  16. Surface Environmental Surveillance Project: Locations Manual Volume 1 – Air and Water Volume 2 – Farm Products, Soil & Vegetation, and Wildlife

    SciTech Connect

    Fritz, Brad G.; Patton, Gregory W.; Stegen, Amanda; Poston, Ted M.

    2009-01-01

    This report describes all environmental monitoring locations associated with the Surface Environmental Surveillance Project. Environmental surveillance of the Hanford site and surrounding areas is conducted by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy (DOE). Sampling is conducted to evaluate levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in DOE Order 450.1, Environmental Protection Program, and DOE Order 5400.5, Radiation Protection of the Public and the Environment. The environmental surveillance sampling design is described in the Hanford Site Environmental Monitoring Plan, United States Department of Energy, Richland Operation Office (DOE/RL-91-50). This document contains the locations of sites used to collect samples for the Surface Environmental Surveillance Project (SESP). Each section includes directions, maps, and pictures of the locations. A general knowledge of roads and highways on and around the Hanford Site is necessary to successfully use this manual. Supplemental information (Maps, Gazetteer, etc.) may be necessary if user is unfamiliar with local routes. The SESP is a multimedia environmental surveillance effort to measure the concentrations of radionuclides and chemicals in environmental media to demonstrate compliance with applicable environmental quality standards and public exposure limits, and assessing environmental impacts. Project personnel annually collect selected samples of ambient air, surface water, agricultural products, fish, wildlife, and sediments. Soil and vegetation samples are collected approximately every 5 years. Analytical capabilities include the measurement of radionuclides at very low environmental concentrations and, in selected media, nonradiological chemicals including metals, anions, volatile organic compounds, and total organic carbon.

  17. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Surveillance requirements... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The contract administration office determines the extent...

  18. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Surveillance requirements... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The contract administration office determines the extent...

  19. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Surveillance requirements... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The contract administration office determines the extent...

  20. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Surveillance requirements... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The contract administration office determines the extent...

  1. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Surveillance requirements... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The contract administration office determines the extent...

  2. Surveillance Metrics Sensitivity Study

    SciTech Connect

    Bierbaum, R; Hamada, M; Robertson, A

    2011-11-01

    In September of 2009, a Tri-Lab team was formed to develop a set of metrics relating to the NNSA nuclear weapon surveillance program. The purpose of the metrics was to develop a more quantitative and/or qualitative metric(s) describing the results of realized or non-realized surveillance activities on our confidence in reporting reliability and assessing the stockpile. As a part of this effort, a statistical sub-team investigated various techniques and developed a complementary set of statistical metrics that could serve as a foundation for characterizing aspects of meeting the surveillance program objectives. The metrics are a combination of tolerance limit calculations and power calculations, intending to answer level-of-confidence type questions with respect to the ability to detect certain undesirable behaviors (catastrophic defects, margin insufficiency defects, and deviations from a model). Note that the metrics are not intended to gauge product performance but instead the adequacy of surveillance. This report gives a short description of four metrics types that were explored and the results of a sensitivity study conducted to investigate their behavior for various inputs. The results of the sensitivity study can be used to set the risk parameters that specify the level of stockpile problem that the surveillance program should be addressing.

  3. Surveillance metrics sensitivity study.

    SciTech Connect

    Hamada, Michael S.; Bierbaum, Rene Lynn; Robertson, Alix A.

    2011-09-01

    In September of 2009, a Tri-Lab team was formed to develop a set of metrics relating to the NNSA nuclear weapon surveillance program. The purpose of the metrics was to develop a more quantitative and/or qualitative metric(s) describing the results of realized or non-realized surveillance activities on our confidence in reporting reliability and assessing the stockpile. As a part of this effort, a statistical sub-team investigated various techniques and developed a complementary set of statistical metrics that could serve as a foundation for characterizing aspects of meeting the surveillance program objectives. The metrics are a combination of tolerance limit calculations and power calculations, intending to answer level-of-confidence type questions with respect to the ability to detect certain undesirable behaviors (catastrophic defects, margin insufficiency defects, and deviations from a model). Note that the metrics are not intended to gauge product performance but instead the adequacy of surveillance. This report gives a short description of four metrics types that were explored and the results of a sensitivity study conducted to investigate their behavior for various inputs. The results of the sensitivity study can be used to set the risk parameters that specify the level of stockpile problem that the surveillance program should be addressing.

  4. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    PubMed

    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. PMID:22292397

  5. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Alert system and exchange of postmarket vigilance reports. 26.50 Section 26.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  6. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Alert system and exchange of postmarket vigilance reports. 26.50 Section 26.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  7. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Alert system and exchange of postmarket vigilance reports. 26.50 Section 26.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  8. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International......

  9. [Influenza surveillance].

    PubMed

    Bednarska, Karolina; Hallmann-Szelińska, Ewelina; Kondratiuk, Katarzyna; Brydak, Lidia B

    2016-01-01

    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. PMID:27117107

  10. Air surveillance

    SciTech Connect

    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).

  11. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    PubMed

    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. PMID:27453095

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

    PubMed

    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. PMID:25532372

  13. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis

    PubMed Central

    Iijima, Kazuo; Umezu, Mitsuo; Iwasaki, Kiyotaka

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be

  14. Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse, Misuse, Dependence, and Diversion

    PubMed Central

    Wang, Y. Grace; Swick, Todd J.; Carter, Lawrence P.; Thorpy, Michael J.; Benowitz, Neal L.

    2009-01-01

    Study Objectives: This study reviewed the cumulative postmarketing and clinical safety experience with sodium oxybate (Xyrem®), a treatment approved for cataplexy and excessive daytime sleepiness in narcolepsy. Study objectives were to investigate the occurrence of abuse/misuse of sodium oxybate since first market introduction in 2002, classify cases using DSM-IV criteria for substance abuse and dependence, and describe specific characteristics of these cases. Methods: We retrospectively reviewed postmarketing spontaneous adverse event (AE) reports from 15 countries for all cases containing reporting terminology related to abuse/misuse to determine its occurrence. All death cases independent of causality were reviewed to identify associated risk factors. Results: Approximately 26,000 patients worldwide received sodium oxybate from first market introduction in 2002 through March 2008. Of those 26,000 patients, 0.2% reported ≥ 1 of the events studied. These included 10 cases (0.039%) meeting DSM-IV abuse criteria, 4 cases (0.016%) meeting DSM-IV dependence criteria, 8 cases (0.031%, including 3 of the previous 4) with withdrawal symptoms reported after discontinuation of sodium oxybate, 2 confirmed cases (0.008%) of sodium oxybate–facilitated sexual assault, 8 cases (0.031%) of overdose with suicidal intent, 21 deaths (0.08%) in patients receiving sodium oxybate treatment with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. During this period, approximately 600,000 bottles of sodium oxybate were distributed, and 5 incidents (0.0009%) of diversion were reported. Conclusion: Cumulative postmarketing and clinical experience indicates a very low risk of abuse/misuse of sodium oxybate. Citation: Wang YG; Swick TJ; Carter LP; Thorpy MJ; Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (xyrem): abuse, misuse, dependence, and diversion. J Clin Sleep

  15. Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation.

    PubMed

    Babiskin, Andrew H; Zhang, Xinyuan

    2015-09-01

    Amphetamine (AMP) salts-based extended-release (ER) drug products are widely used for the treatment of attention deficit hyperactivity disorder. We developed physiologically based absorption models for mixed AMP salts ER capsules and dextroamphetamine sulfate ER capsules to address specific questions raised during generic drug postmarketing surveillance and bioequivalence (BE) guidance development. The models were verified against several data sets. Virtual BE simulations were conducted to assess BE in various populations other than normal healthy subjects where BE studies are generally conducted for approval. The models were also used to predict pharmacokinetics (PK) for hypothetical formulations having dissolution profiles falling within specification after the development of in vitro-in vivo relation. Finally, we demonstrated how to use the models to test sensitivity of PK metrics to the changes in formulation variables. PMID:25973928

  16. Information surveillance

    NASA Astrophysics Data System (ADS)

    Seiders, Barbara; McQuerry, Dennis; Ferryman, Thomas A.; Whitney, Paul D.; Rybka, Anthony

    2002-07-01

    Biological weapons are within reach of individuals, small groups, terrorist organizations, as well as nations. With pervasive integration of civilian and military populations worldwide, the ill winds of biological warfare stand to affect military troops and civilians alike. A variety of technologies are emerging - such as pathogen detection devices, streaming internet characterization tools, information exploitation techniques, automated feature extraction, and ubiquitous wireless communication - that can help. These technologies, if taken together within an integrated analytical framework, could make possible the monitoring of diverse parameters that may indicate a change in the state of health of a given population - either the emergence of a naturally occurring disease or the outbreak of a disease as a result of hostile intent. This presentation will discuss the application of new information surveillance tools and technologies as they apply to health and disease monitoring, particularly within the context of potential terrorist or hostile nation use of biological warfare. Although discussed within the specific context of health surveillance, the tools and processes described here are generally applicable within other domains of subject matter expertise.

  17. Information surveillance

    SciTech Connect

    Seiders, Barbara AB; McQuerry, Dennis L.; Ferryman, Thomas A.; Whitney, Paul D.; Rybka, Anthony J.

    2002-07-15

    Biological weapons are within reach of individuals, small groups, terrorist organizations, as well as nations. With pervasive integration of civilian and military populations worldwide, the ill winds of biological warfare stand to affect military troops and civilians alike. A variety of technologies are emerging - such as pathogen detection devices, streaming internet characterization tools, information exploitation techniques, automated feature extraction, and ubiquitous wireless communication - that can help. These technologies, if taken together within an integrated analytical framework, could make possible the monitoring of diverse parameters that may indicate a change in the state of health of a given population - either the emergence of a naturally occurring disease or the outbreak of a disease as a result of hostile intent. This presentation will discuss the application of new information surveillance tools and technologies as they apply to health and disease monitoring, particularly within the context of potential terrorist or hostile nation use of biological warfare. Although discussed within the specific context of health surveillance, the tools and processes described here are generally applicable within other domains of subject matter expertise.

  18. Public involvement in environmental surveillance at Hanford

    SciTech Connect

    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.

  19. 48 CFR 242.1104 - Surveillance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... production surveillance is required, shall— (A) Conduct a periodic risk assessment of the contractor to... risk assessment shall consider information provided by the contractor and the contracting officer; (B) Develop a production surveillance plan based on the risk level determined during a risk assessment;...

  20. 48 CFR 242.1104 - Surveillance requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... production surveillance is required, shall— (A) Conduct a periodic risk assessment of the contractor to... risk assessment shall consider information provided by the contractor and the contracting officer; (B) Develop a production surveillance plan based on the risk level determined during a risk assessment;...

  1. 48 CFR 242.1104 - Surveillance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... production surveillance is required, shall— (A) Conduct a periodic risk assessment of the contractor to... risk assessment shall consider information provided by the contractor and the contracting officer; (B) Develop a production surveillance plan based on the risk level determined during a risk assessment;...

  2. 48 CFR 242.1104 - Surveillance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... production surveillance is required, shall— (A) Conduct a periodic risk assessment of the contractor to... risk assessment shall consider information provided by the contractor and the contracting officer; (B) Develop a production surveillance plan based on the risk level determined during a risk assessment;...

  3. 48 CFR 242.1104 - Surveillance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... production surveillance is required, shall— (A) Conduct a periodic risk assessment of the contractor to... risk assessment shall consider information provided by the contractor and the contracting officer; (B) Develop a production surveillance plan based on the risk level determined during a risk assessment;...

  4. Concern, but not with surveillance.

    PubMed

    Ivinson, A J

    2000-01-01

    According to Brian Ward, vaccines are probably the most efficacious and cost-effective medical interventions ever invented. He notes that surveillance of vaccine-related adverse events is important, and resources should be made available for monitoring vaccine safety at a time of increasing vaccine activity. However, in an environment of limited resources, there is a dispute over the level of resources devoted to vaccine surveillance versus vaccine deployment. In an examination of the balance of risk versus benefit, several arguments are given. Nevertheless, no tangible evidence supports the claim that the increased use of new vaccines will be more trouble than it is worth. Ward offers a more worthy argument against the use of vaccines aimed at maintaining productivity rather than securing personal health and well-being. Overall, the author upholds the importance of good vaccine surveillance but opposes the notion of shifting resources from vaccine development to vaccine surveillance. PMID:10743292

  5. The surveillant assemblage.

    PubMed

    Haggerty, K D; Ericson, R V

    2000-12-01

    George Orwell's 'Big Brother' and Michel Foucault's 'panopticon' have dominated discussion of contemporary developments in surveillance. While such metaphors draw our attention to important attributes of surveillance, they also miss some recent dynamics in its operation. The work of Gilles Deleuze and Felix Guattari is used to analyse the convergence of once discrete surveillance systems. The resultant 'surveillant assemblage' operates by abstracting human bodies from their territorial settings, and separating them into a series of discrete flows. These flows are then reassembled in different locations as discrete and virtual 'data doubles'. The surveillant assemblage transforms the purposes of surveillance and the hierarchies of surveillance, as well as the institution of privacy. PMID:11140886

  6. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

    PubMed

    Begier, Elizabeth M; Burwen, Dale R; Haber, Penina; Ball, Robert

    2004-03-15

    Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis. PMID:14999618

  7. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    PubMed

    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. PMID:22292395

  8. Public participation in radiological surveillance.

    PubMed

    Hanf, R W; Schreckhise, R G; Patton, G W; Poston, T M; Jaquish, R E

    1997-10-01

    In 1989, Pacific Northwest National Laboratory developed a program, for the U.S. Department of Energy, to involve local citizens in environmental surveillance at the Hanford Site. The Community-Operated Environmental Surveillance Program was patterned after similar community-involvement efforts at the Nevada Test Site and the Three Mile Island nuclear facility. Its purpose is to increase the flow of information to the public, thereby enhancing the public's awareness and understanding of surveillance activities. The program consists of two components: radiological air monitoring at nine offsite locations and agricultural product sampling at selected locations near the site. At each air-monitoring station, two local school teachers collect air particulate samples and operate equipment to monitor ambient radiation levels. Atmospheric tritium samples (as water vapor) are also collected at some locations. Four of the air-monitoring stations include large, colorful informational displays for public viewing. These displays provide details on station equipment, sample types, and sampling purposes. Instruments in the displays also monitor, record, and show real-time ambient radiation readings (measured with a pressurized ionization chamber) and meteorological conditions. Agricultural products, grown primarily by middle-school-aged students, are obtained from areas downwind of the site. Following analysis of these samples, environmental surveillance staff visit the schools to discuss the results with the students and their teachers. The data collected by these air and agricultural sampling efforts are summarized with other routinely collected sitewide surveillance data and reported annually in the Hanford Site environmental report. PMID:9314235

  9. Market surveillance on non-halal additives incorporated in surimi based products using polymerase chain reaction (PCR)-southern hybridization analysis

    NASA Astrophysics Data System (ADS)

    Aravindran, S.; Sahilah, A. M.; Aminah, A.

    2014-09-01

    Halal surveillance on halal ingredients incorporated in surimi based products were studied using polymerase chain reaction (PCR)-southern hybridization on chip analysis. The primers used in this technique were targeted on mitochondria DNA (mtDNA) of cytochrome b (cyt b) gene sequence which able to differentiate 7 type (beef, chicken, duck, goat, buffalo, lamb and pork) of species on a single chip. 17 (n = 17*3) different brands of surimi-based product were purchased randomly from Selangor local market in January 2013. Of 17 brands, 3 (n = 3*3) brands were positive for chicken DNA, 1 (n = 1*3) brand was positive for goat DNA, and the remainder 13 brands (n = 13*3) have no DNA species detected. The sensitivity of PCR-southern hybridization primers to detect each meat species was 0.1 ng. In the present study, it is evidence that PCR-Southern Hybridization analysis offered a reliable result due to its highly specific and sensitive properties in detecting non-halal additive such as plasma protein incorporation in surimi-based product.

  10. Community pharmacist surveillance of hypertension in pregnancy

    PubMed Central

    Tsao, Nicole W.; Lynd, Larry D.; Thomas, Jamie M.; Ferreira, Ema

    2014-01-01

    Background: Hypertensive disorders of pregnancy (HDP) are associated with serious maternal and perinatal complications. For nonsevere hypertension, there is a lack of consensus regarding treatment during pregnancy and while breastfeeding. Further, there is considerable variability in guidelines for antihypertensive drug choices. As part of a Drug Safety and Effectiveness Network (DSEN)–funded project, we piloted a novel surveillance strategy in which community pharmacists recruited pregnant and breastfeeding women to monitor their blood pressure and medication use and to provide education on HDP. Methods: Participating pharmacists were required to complete a certified training program, identify and recruit patients who were pregnant or breastfeeding, obtain informed consent, administer a patient questionnaire and complete an initial case report form for enrolled patients. Study outcomes included the feasibility of community pharmacists to enroll patients and carry out study-related documentation and follow-up. The criteria for success in this pilot study included the ability of pharmacists to recruit 10 participants per pharmacy. Results: 178 community pharmacies across British Columbia agreed to participate in this feasibility study, of which 63 pharmacists completed the study training. Of these, only 21 pharmacists recruited at least 1 patient and 1 pharmacist met the success criteria. Overall, 51 patients were enrolled, 2 withdrew from the study and 7 patients were diagnosed with HDP. Antihypertensive medications used by patients included methyldopa and labetalol. Conclusions: While postmarketing surveillance is an important tool for the assessment of drug safety in the pregnant and breastfeeding patient population, the feasibility of community pharmacists taking on this role was not successfully demonstrated. PMID:25364340

  11. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    PubMed

    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. PMID:26983223

  12. Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers

    PubMed Central

    Del Tacca, Mario; Pasqualetti, Giuseppe; Di Paolo, Antonello; Virdis, Agostino; Massimetti, Gabriele; Gori, Giovanni; Versari, Daniele; Taddei, Stefano; Blandizzi, Corrado

    2009-01-01

    AIMS There are concerns about the quality of generic drugs in the postmarketing setting. The aim was to establish whether two generic formulations of amoxicillin, available on the Italian market, fulfil the criteria for clinical pharmacokinetic bioequivalence vs. the branded drug. METHODS Two generic amoxicillin products (generic A and B) were selected among four fast-release tablet formulations available on the Italian market. Twenty-four healthy adult volunteers of either sex participated to a single-dose, randomized, three-treatment, crossover, single-blind bioequivalence study designed to compare generic A and B with branded amoxicillin. Plasma samples were collected at preset times for 24 h after dosing, and assayed for amoxicillin levels by high-performance liquid chromatography. RESULTS Ninety percent confidence intervals of AUC ratios were 0.8238, 1.0502 (ratio 0.9302) and 0.8116, 1.1007 (ratio 0.9452) for generic A and B vs. branded amoxicillin, respectively. Ninety percent confidence intervals of Cmax ratios were 0.7921, 1.0134 (ratio 0.8960) and 0.8246, 1.1199 (ratio 0.9610) for generic A and B vs. branded amoxicillin, respectively. The mean pharmacokinetic profiles showed that the AUC value of branded amoxicillin was 8.5 and 5.4% greater than that estimated for generic A and B, respectively. Few adverse events were recorded; these were not serious and occurred without apparent relationship to any specific amoxicillin formulation. CONCLUSIONS These results indicate that one of the two marketed amoxicillin generics analysed in the present study is not bioequivalent to the brand leader product for Cmax on the basis of single-dose pharmacokinetic assessment. PMID:19660001

  13. General Medical Surveillance Program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background on the General Medical Surveillance Program at LeRC is presented. The purpose of the General Medical Surveillance Program at LeRC is outlined, and the specifics of the program are discussed.

  14. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    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. PMID:26591543

  15. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    PubMed

    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. PMID:27220799

  16. Residues of veterinary medicinal products and coccidiostats in eggs--causes, control and results of surveillance program in Poland.

    PubMed

    Piatkowska, M; Jedziniak, P; Zmudzki, J

    2012-01-01

    The use of veterinary medicinal products in food producing animals for a variety of purposes causes that their residues may be presented in edible tissues. As a result, in concern of public health, European Union Countries establish each year monitoring plans and they control the levels of harmful substances in food of animal origin. This paper presents survey of residues of veterinary medicinal products and coccidiostats in eggs for Poland and European Union in years 2007-2010. Despite the decrease in reported non-compliant results for coccidiostats, the numbers were still higher than those for veterinary medicines. The most often determined coccidiostats were: nicarbazin, dinitrocarbanilide, salinomycin and lasalocid, and the most often reported non-compliant results for veterinary medicines were: antimicrobials, enrofloxacin and doxycycline. PMID:23390776

  17. USE OF MAILBOX APPROACH, VIDEO SURVEILLANCE, AND SHORT-NOTICE RANDOM INSPECTIONS TO ENHANCE DETECTION OF UNDECLARED LEU PRODUCTION AT GAS CENTRIFUGE ENRICHMENT PLANTS.

    SciTech Connect

    BOYER, B.D.; GORDON, D.M.; JO, J.

    2006-07-16

    Current safeguards approaches used by the IAEA at gas centrifuge enrichment plants (GCEPs) need enhancement in order to detect undeclared LEU production with adequate detection probability. ''Mailbox'' declarations have been used in the last two decades to verify receipts, production, and shipments at some bulk-handling facilities (e.g., fuel-fabrication plants). The operator declares the status of his plant to the IAEA on a daily basis using a secure ''Mailbox'' system such as a secure tamper-resistant computer. The operator agrees to hold receipts and shipments for a specified period of time, along with a specified number of annual inspections, to enable inspector access to a statistically large enough population of UF{sub 6} cylinders and fuel assemblies to achieve the desired detection probability. The inspectors can access the ''Mailbox'' during randomly timed inspections and then verify the operator's declarations for that day. Previously, this type of inspection regime was considered mainly for verifying the material balance at fuel-fabrication, enrichment, and conversion plants. Brookhaven National Laboratory has expanded the ''Mailbox'' concept with short-notice random inspections (SNRIs), coupled with enhanced video surveillance, to include declaration and verification of UF{sub 6} cylinder operational data to detect activities associated with undeclared LEU production at GCEPs. Since the ''Mailbox'' declarations would also include data relevant to material-balance verification, these randomized inspections would replace the scheduled monthly interim inspections for material-balance purposes; in addition, the inspectors could simultaneously perform the required number of Limited-Frequency Unannounced Access (LFUA) inspections used for HEU detection. This approach would provide improved detection capabilities for a wider range of diversion activities with not much more inspection effort than at present.

  18. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea.

    PubMed

    Choi, Minjoung; Han, Euiri; Lee, Sunmi; Kim, Taegyun; Shin, Won

    2015-01-01

    The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases. To facilitate development of safe and effective products and provide more opportunities to patients suffering from severe diseases, several regulatory programs, such as the use of investigational products for emergency situations, fast-track approval, prereview of application packages, and intensive regulatory consultation, can be applied to these products. The regulatory approach for these innovative products is case by case and founded on science-based review that is flexible and balances the risks and benefits. PMID:26374218

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

    PubMed

    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. PMID:22400144

  20. The future of population-based postmarket drug risk assessment: a regulator's perspective.

    PubMed

    Hammad, T A; Neyarapally, G A; Iyasu, S; Staffa, J A; Dal Pan, G

    2013-09-01

    The US Food and Drug Administration emphasizes the role of regulatory science in the fulfillment of its mission to promote and protect public health and foster innovation. With respect to the evaluation of drug effects in the real world, regulatory science plays an important role in drug risk assessment and management. This article discusses opportunities and challenges with population-based drug risk assessment as well as related regulatory science knowledge gaps in the following areas: (i) population-based data sources and methods to evaluate drug safety issues; (ii) evidence-based thresholds to account for uncertainty in postmarket data; (iii) approaches to optimize the integration and interpretation of evidence from different sources; and (iv) approaches to evaluate the real-world impact of regulatory decisions. Regulators should continue the ongoing dialogue with multiple stakeholders to strengthen regulatory safety science and address these and other critical knowledge gaps. PMID:23739537

  1. Technical success from endovascular aneurysm repair in the post-marketing era: a multicenter prospective trial.

    PubMed

    Naslund, Thomas C; Becker, Stacey Y

    2003-01-01

    Evaluation of post-marketing success with the Ancure Endovascular Graft (AEG) was accomplished by review of a multicenter, prospective trial involving 46 centers and 163 patients. A second cohort of patients (n = 350) treated with the AEG under a controlled-use interval prior to the prospective trial was simultaneously evaluated. Technical success in both groups of patients (96.9% and 97.4%, respectively) was similar to what was reported in pre-market clinical trials. Operative implantation complications unique to the AEG included graft limb stenosis/occlusion in 35.6 and 31.4%, contralateral pull wire being caught on hooks in 33.7 and 28%, failure to seal (type I endoleak) in 17.2 and 18.3%, jacket guard being stuck in 12.9 and 11%, contralateral wire being stuck in 6.8 and 7.1%, high jacket retraction force in 16 and 8.5%, and inability to retract jacket in 1.8 and 0.5% of patients involved in the multicenter trial and controlled-use interval, respectively. One of four patients undergoing conversion in the prospective trial had graft misdeployment as a mode of failure. Three were converted for access failure. The 30-day mortality rate in the prospective trial was 3.7%. Interventions to resolve implantation-related events included stenting, guide catheter manipulations, wire exchanges, and delivery catheter disassembly. These interventions were successful in virtually every case. Open surgical procedures were not needed to correct these operative problems. Results from this study demonstrate excellent technical success with the AEG in the post-market era. Interventions to resolve implantation complications, when utilized, are highly successful in facilitating AEG implantation and providing technical success. PMID:12522699

  2. Analyzing search behavior of healthcare professionals for drug safety surveillance.

    PubMed

    Odgers, David J; Harpaz, Rave; Callahan, Alison; Stiglic, Gregor; Shah, Nigam H

    2015-01-01

    Post-market drug safety surveillance is hugely important and is a significant challenge despite the existence of adverse event (AE) reporting systems. Here we describe a preliminary analysis of search logs from healthcare professionals as a source for detecting adverse drug events. We annotate search log query terms with biomedical terminologies for drugs and events, and then perform a statistical analysis to identify associations among drugs and events within search sessions. We evaluate our approach using two different types of reference standards consisting of known adverse drug events (ADEs) and negative controls. Our approach achieves a discrimination accuracy of 0.85 in terms of the area under the receiver operator curve (AUC) for the reference set of well-established ADEs and an AUC of 0.68 for the reference set of recently labeled ADEs. We also find that the majority of associations in the reference sets have support in the search log data. Despite these promising results additional research is required to better understand users' search behavior, biasing factors, and the overall utility of analyzing healthcare professional search logs for drug safety surveillance. PMID:25592591

  3. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

    PubMed Central

    2014-01-01

    Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

  4. Respiratory health surveillance in a toluene di-isocyanate production unit, 1967-97: clinical observations and lung function analyses

    PubMed Central

    Ott, M; Klees, J.; Poche, S.

    2000-01-01

    OBJECTIVES—To characterise irritant and allergic airway responses and assess changes in forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) relative to exposure to toluene di-isocyanate (TDI).
METHODS—Employees (n=313) ever assigned to a TDI production unit for ⩾3 months (1967-92) were identified from personnel records along with 158 frequency matched referents without known exposure to TDI. Reports made during visits to the occupational clinic of incidents related to exposure to TDI and annual periodic examination results (questionnaire, physical findings, and spirometry) were abstracted and assessed relative to industrial hygiene estimates of exposure to TDI.
RESULTS—Mean 8 hour time weighted average estimates of TDI concentrations ranged from 9.9 ppb in jobs with potentially high exposure during the early years of plant operations to 0.5 ppb in jobs with potentially low exposure in more recent years. The corresponding rates of visits to the clinic due to incidents of exposure to TDI (including both irritant and allergic airway responses) declined from 20.5 to 1.0 visits per 100 years of employment at the unit. The annual incidence of asthma induced by TDI declined from 1.8% before 1980 to 0.7% afterwards. Neither cross sectional nor longitudinal analyses of FVC and FEV1 showed significant dose-response findings relative to exposure to TDI across the total exposed population. Among cases of occupational asthma there was an apparent initial decline in FEV1 within 2 years of first reporting symptoms, but not an accelerated rate of decline in follow up tests from 4-30 years after induction of asthma.
CONCLUSIONS—Occurrences of both asthma induced by TDI and irritant airway responses due to exposure to TDI were found in this cohort, but there was no relation between cumulative exposure to TDI and irreversible airflow obstruction as assessed by spirometry.


Keywords: toluene di-isocyanate; lung function

  5. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L E

    1992-01-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the US Department of Energy (DOE). This document contains the planned schedule for routine sample collection for the Surface Environmental Surveillance Project (SESP) and Ground-Water Monitoring Project. Samples for radiological analyses include Air-Particulate Filter, gases and vapor; Water/Columbia River, Onsite Pond, Spring, Irrigation, and Drinking; Foodstuffs/Animal Products including Whole Milk, Poultry and Eggs, and Beef; Foodstuffs/Produce including Leafy Vegetables, Vegetables, and Fruit; Foodstuffs/Farm Products including Wine, Wheat and Alfalfa; Wildlife; Soil; Vegetation; and Sediment. Direct Radiation Measurements include Terrestrial Locations, Columbia River Shoreline Locations, and Onsite Roadway, Railway and Aerial, Radiation Surveys.

  6. Autonomous surveillance for biosecurity.

    PubMed

    Jurdak, Raja; Elfes, Alberto; Kusy, Branislav; Tews, Ashley; Hu, Wen; Hernandez, Emili; Kottege, Navinda; Sikka, Pavan

    2015-04-01

    The global movement of people and goods has increased the risk of biosecurity threats and their potential to incur large economic, social, and environmental costs. Conventional manual biosecurity surveillance methods are limited by their scalability in space and time. This article focuses on autonomous surveillance systems, comprising sensor networks, robots, and intelligent algorithms, and their applicability to biosecurity threats. We discuss the spatial and temporal attributes of autonomous surveillance technologies and map them to three broad categories of biosecurity threat: (i) vector-borne diseases; (ii) plant pests; and (iii) aquatic pests. Our discussion reveals a broad range of opportunities to serve biosecurity needs through autonomous surveillance. PMID:25744760

  7. Food and farm products surveillance

    SciTech Connect

    Poston, T.M.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the radiological analyses performed on food and farm samples collected during 1994. The food and farm sampling design addresses the potential influence of Hanford Site releases. Details of the sampling design and radionuclides analyzed are included in this section.

  8. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L.E.

    1995-02-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the U.S. Department of Energy (DOE). This document contains the planned 1994 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP), Drinking Water Project, and Ground-Water Surveillance Project. Samples are routinely collected for the SESP and analyzed to determine the quality of air, surface water, soil, sediment, wildlife, vegetation, foodstuffs, and farm products at Hanford Site and surrounding communities. The responsibility for monitoring onsite drinking water falls outside the scope of the SESP. PNL conducts the drinking water monitoring project concurrent with the SESP to promote efficiency and consistency, utilize expertise developed over the years, and reduce costs associated with management, procedure development, data management, quality control, and reporting. The ground-water sampling schedule identifies ground-water sampling .events used by PNL for environmental surveillance of the Hanford Site. Sampling is indicated as annual, semi-annual, quarterly, or monthly in the sampling schedule. Some samples are collected and analyzed as part of ground-water monitoring and characterization programs at Hanford (e.g. Resources Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or Operational). The number of samples planned by other programs are identified in the sampling schedule by a number in the analysis column and a project designation in the Cosample column. Well sampling events may be merged to avoid redundancy in cases where sampling is planned by both-environmental surveillance and another program.

  9. Mercury Surveillance Program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background on mercury exposure is presented including forms, sources, permissible exposure limits, and physiological effects. The purpose of the Mercury Surveillance Program at LeRC is outlined, and the specifics of the Medical Surveillance Program for Mercury Exposure at LeRC are discussed.

  10. Soil and vegetation surveillance

    SciTech Connect

    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.

  11. Arsenic surveillance program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background information about arsenic is presented including forms, common sources, and clinical symptoms of arsenic exposure. The purpose of the Arsenic Surveillance Program and LeRC is outlined, and the specifics of the Medical Surveillance Program for Arsenic Exposure at LeRC are discussed.

  12. Asbestos Surveillance Program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background on asbestos is presented including the different types and the important medical distinctions between those different types. The four diseases associated with asbestos exposure are discussed: mesothelioma, lung cancer, asbestosis, and benign pleural disorders. The purpose of the LeRC Asbestos Surveillance Program is outlined, and the specifics of the Medical Surveillance Program for Asbestos Monitoring at LeRC are discussed.

  13. Lead Surveillance Program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background on lead exposure is presented including forms of lead, sources, hematologic effects, neurologic effects, endocrine effects, renal effects, and reproductive and developmental effects. The purpose of the Lead Surveillance Program at LeRC is outlined, and the specifics of the Medical Surveillance Program for Lead Exposure at LeRC are discussed.

  14. Economic Analysis of Classical Swine Fever Surveillance in the Netherlands.

    PubMed

    Guo, X; Claassen, G D H; Oude Lansink, A G J M; Loeffen, W; Saatkamp, H W

    2016-06-01

    Classical swine fever (CSF) is a highly contagious pig disease that causes economic losses and impaired animal welfare. Improving the surveillance system for CSF can help to ensure early detection of the virus, thereby providing a better initial situation for controlling the disease. Economic analysis is required to compare the benefits of improved surveillance with the costs of implementing a more intensive system. This study presents a comprehensive economic analysis of CSF surveillance in the Netherlands, taking into account the specialized structure of Dutch pig production, differences in virulence of CSF strains and a complete list of possible surveillance activities. The starting point of the analysis is the current Dutch surveillance system (i.e. the default surveillance-setup scenario), including the surveillance activities 'daily clinical observation by the farmer', 'veterinarian inspection after a call', 'routine veterinarian inspection', 'pathology in AHS', 'PCR on tonsil in AHS', 'PCR on grouped animals in CVI' and 'confirmatory PCR by NVWA'. Alternative surveillance-setup scenarios were proposed by adding 'routine serology in slaughterhouses', 'routine serology on sow farms' and 'PCR on rendered animals'. The costs and benefits for applying the alternative surveillance-setup scenarios were evaluated by comparing the annual mitigated economic losses because of intensified CSF surveillance with the annual additional surveillance costs. The results of the cost-effectiveness analysis show that the alternative surveillance-setup scenarios with 'PCR on rendered animals' are effective for the moderately virulent CSF strain, whereas the scenarios with 'routine serology in slaughterhouses' or 'routine serology on sow farms' are effective for the low virulent strain. Moreover, the current CSF surveillance system in the Netherlands is cost-effective for both moderately virulent and low virulent CSF strains. The results of the cost-benefit analysis for the

  15. Performance of health product risk management and surveillance conducted by health personnel at sub-district health promotion hospitals in the northeast region of Thailand

    PubMed Central

    Kanjanarach, Tipaporn; Jaisa-ard, Raksaworn; Poonaovarat, Nantawan

    2014-01-01

    Background Health personnel at sub-district health promotion hospitals (SD-HPHs) are assigned to take responsibility for 15 activities related to health product risk management and surveillance (HP-RM&S). This cross-sectional survey aimed to identify factors that determined their job performance and to record their expressed needs to support HP-RM&S operation. In this study, job performance was defined as completion of all 15 activities. Methods Self-administered postal questionnaires were used to collect data from 380 randomly selected health personnel who were in charge of HP-RM&S at SD-HPHs in the northeast of Thailand. Results Thirty-six point one percent (n=137) of the respondents were able to perform all 15 of the HP-RM&S activities assigned to SD-HPHs. A logistic regression model identified three factors that statistically significantly determined the completion of all 15 HP-RM&S activities. These were: receiving a high or very high level of support from the community (adjusted odds ratio [OR]: 2.5; 95% confidence interval [CI]: 1.5, 4.1), the responsible persons for HP-RM&S did not hold an administrative position (adjusted OR: 1.7; 95% CI: 1.1, 2.7), and having at least one training session related to HP-RM&S per year (adjusted OR: 1.7; 95% CI 1.1, 2.6). There were 1,536 expressed needs which can be classified into four major categories, ie, training needs (41.6%, n=639), resource support (28.3%, n=435), mechanisms that facilitate HP-RM&S operation (24.1%, n=370) and adjusting of the scope of HP-RM&S (6.0%, n=92). The topics most frequently referred to in training needs were drug law, food law, and cosmetics law. Conclusion A strategy for improvement of the job performance in HP-RM&S of health personnel in SD-HPHs should target identifying schemes to encourage the community to proactively participate in HP-RM&S. The district health office as the organization directly controlling and supervising SD-HPHs should also regularly update knowledge base and skills

  16. Unattended optical surveillance equipment

    NASA Astrophysics Data System (ADS)

    Mangan, D. L.; Johnson, C. S.; Schneider, S. L.

    In many security situations, it is necessary to utilize unattended optical surveillance systems. Sandia National Laboratories has developed three optical surveillance systems which operate in the unattended surveillance mode. The first of these systems is known as the Modular Integrated Video System (MIVS). The MIVS is a microprocessor controlled video system which records scenes at selectable intervals. Each scene consists of six to ten frames recorded on a 8 mm videotape. A MIVS video recorder has the capacity to record approximately 26,000 scenes. Scenes can be recorded at intervals ranging from 1 to 99 minutes between recordings. The unit has been designed for permanent installation with facility power. The camera can be located up to 30 m from the recording module with the authentication technology protecting the cable connecting the camera to the recording unit. The Portable Surveillance unit (PSU) is a second system which has been designed for unattended operation. The PSU is designed for situations where quick set up of an optical surveillance device is required. The PSU operates in a manner similar to the MIVS and can be operated off of facility power for long time periods, or from an internal battery pack for short term surveillance applications. The Video Surveillance Unit (VSU) provides similar capabilities for permanent rack mounted installations. This paper describes the MIVS, the PSU, and the VSU, and discusses potential applications for the system. Equipment for reviewing the videotapes produced by the systems is also described.

  17. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L.E.

    1994-02-01

    This document contains the planned 1994 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP), Drinking Water Project, and Ground-Water Surveillance Project. Samples are routinely collected for the SESP and analyzed to determine the quality of air, surface water, soil, sediment, wildlife, vegetation, foodstuffs, and farm products at Hanford Site and surrounding communities. The responsibility for monitoring the onsite drinking water falls outside the scope of the SESP. The Hanford Environmental Health Foundation is responsible for monitoring the nonradiological parameters as defined in the National Drinking Water Standards while PNL conducts the radiological monitoring of the onsite drinking water. PNL conducts the drinking water monitoring project concurrent with the SESP to promote efficiency and consistency, utilize the expertise developed over the years, and reduce costs associated with management, procedure development, data management, quality control and reporting. The ground-water sampling schedule identifies ground-water sampling events used by PNL for environmental surveillance of the Hanford Site.

  18. Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality

    PubMed Central

    Necyk, Candace; Tsuyuki, Ross T; Boon, Heather; Foster, Brian C; LeGatt, Don; Cembrowski, George; Murty, Mano; Barnes, Joanne; Charrois, Theresa L; Arnason, John T; Ware, Mark A; Rosychuk, Rhonda J; Vohra, Sunita

    2014-01-01

    Objectives To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies. Design Cross-sectional study of screened patients. Setting 10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011. Participants The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications. Primary outcome measures Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality. Results Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE. Conclusions A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a

  19. Circuits of Surveillance

    PubMed Central

    Williams, Robin; Johnson, Paul

    2005-01-01

    This paper examines the increasing police use of DNA profiling and databasing as a developing instrumentality of modern state surveillance. It briefly notes previously published work on a variety of surveillance technologies and their role in the governance of social action and social order. It then argues that there are important differences amongst the ways in which several such technologies construct and use identificatory artefacts, their orientations to human subjectivity, and their role in the governmentality of citizens and others. The paper then describes the novel and powerful form of bio-surveillance offered by DNA profiling and illustrates this by reference to an ongoing empirical study of the police uses of the UK National DNA Database for the investigation of crime. It is argued that DNA profiling and databasing enable the construction of a ‘closed circuit’ of surveillance of a defined population. PMID:16467920

  20. DIALYSIS SURVEILLANCE NETWORK

    EPA Science Inventory

    A voluntary national surveillance system monitoring bloodstream and vascular infections. This is a yearly survey, done in collaboration with the Centers for Medicare and Medicaid Services (CMS) that collects data on infection control practices, and the frequency of certain dialys...

  1. IMPROVING WATERBORNE DISEASE SURVEILLANCE

    EPA Science Inventory

    Public health surveillance has played a key role in controlling the spread of communicable disease and identifying the need for specific publich health practices, such as the filteration and chlorination of drinking water supplies. However, the characteristics of waterborne ou...

  2. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

    PubMed

    Cameron, D M; Donahue, D A; Costin, G-E; Kaufman, L E; Avalos, J; Downey, M E; Billhimer, W L; Gilpin, S; Wilt, N; Simion, F A

    2013-12-01

    Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product. PMID:24064305

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

    PubMed

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-01

    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. PMID:24721472

  4. Preliminary Results From the C-Pulse® OPTIONS HF European Multicenter Post-Market Study

    PubMed Central

    Schulz, Antonia; Krabatsch, Thomas; Schmitto, Jan D.; Hetzer, Roland; Seidel, Mirko; Dohmen, Pascal M.; Hotz, Holger

    2016-01-01

    Background The C-Pulse® System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. Material/Methods We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. Results Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support. Conclusions The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time. PMID:26887528

  5. A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program

    PubMed Central

    Tong, Kenneth; Nicandro, Jean Paul; Shringarpure, Reshma; Chuang, Emil

    2013-01-01

    Objectives: Adverse events (AEs) of ischemic colitis (IC) and complications of constipation (CoC) associated with alosetron are rare and have been adjudicated during the first 5.5 years of the risk management program (RMP); however, changes in incidence rates relative to reductions in AE reports and increases in alosetron prescriptions over the 9-year RMP have not been evaluated. The authors aim to evaluate temporal trends in alosetron postmarketing safety over the 9-year RMP. Methods: The alosetron safety database was searched to identify cases of IC, CoC, and related AEs from 20 November 2002 to 31 December 2011. Adjudication of IC and CoC cases were based on US Food and Drug Administration-defined criteria. Incidence rates were calculated using the number of AEs and alosetron prescriptions (expressed as cases/1000 patient-years exposure). Results: A total of 29 cases were adjudicated as probable/possible IC and 7 cases were adjudicated as CoC. Cumulative adjudicated incidence rate of IC (1.03 cases/1000 patient-years) is low and stable, while that of CoC (0.25 cases/1000 patient-years) is low, declining progressively over time. Decreases in the incidence rates of potential symptoms of IC (abdominal pain with bloody diarrhea/hematochezia) and CoC (constipation) were also observed. Conclusions: Over the 9-year RMP period, incidence rates of IC and CoC remain rare. Substantial reductions over time were observed in the incidence of CoC and in symptoms suggestive of IC or CoC, while IC incidence has been stable at approximately 1.0 case/1000 patient-years. Decreases in AEs and serious outcomes associated with IC and CoC since the reintroduction of alosetron are likely attributable to the RMP. PMID:24003335

  6. Geospatial Intelligence (GEOINT) and Intelligence Surveillance and Reconnaissance (ISR) convergence

    NASA Astrophysics Data System (ADS)

    Lee, Michael G.

    2013-05-01

    An examination of the potentialities, benefits and challenges of the confluence, integration and operation of Geospatial Intelligence (GEOINT) capabilities, products and techniques within the larger context of the Intelligence, Surveillance and Reconnaissance (ISR) arena, particularly in regards to persistent surveillance and Full Motion Video (FMV).

  7. Surveillance of antibiotic resistance

    PubMed Central

    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

  8. [Worker's Health Surveillance

    PubMed

    Machado

    1997-01-01

    This paper is part of a broader discussion on the need for more in-depth study of workers' health surveillance practices, which are most often developed empirically, without well-defined theoretical or technical foundations. The paper presents a concept of surveillance in workers' health as a fulcrum for actions in the relationship between the work process and health. It emphasizes the exposure-based perspective involved in the epidemiological approach. Risk situations and effects are placed in spatial and technological context. The model provides an interdisciplinary approach with a technological, social, and epidemiological basis in a three-dimensional structure. A matrix for planning actions in workers' health surveillance is also presented, focusing on the connections between effects, risks, territory, and activities. PMID:10886936

  9. Global health surveillance.

    PubMed

    St Louis, Michael

    2012-07-27

    Awareness of the importance of global health surveillance increased in the latter part of the 20th century with the global emergence of human immunodeficiency virus and novel strains of influenza. In the first decade of the 21st century, several events further highlighted global shared interests in and vulnerability to infectious diseases. Bioterrorist use of anthrax spores in 2001 raised awareness of the value of public health surveillance for national security. The epidemic of severe acute respiratory syndrome (SARS) in 2003, re-emergence of a panzootic of avian influenza A H5N1 in 2005, and the sudden emergence of pandemic H1N1 in North America in 2009 all highlighted the importance of shared global responsibility for surveillance and disease control. In particular, in 2003, SARS precipitated changes in awareness of the world's collective economic vulnerability to epidemic shocks. PMID:22832992

  10. Viral surveillance and discovery

    PubMed Central

    Lipkin, Walter Ian; Firth, Cadhla

    2014-01-01

    The field of virus discovery has burgeoned with the advent of high throughput sequencing platforms and bioinformatics programs that enable rapid identification and molecular characterization of known and novel agents, investments in global microbial surveillance that include wildlife and domestic animals as well as humans, and recognition that viruses may be implicated in chronic as well as acute diseases. Here we review methods for viral surveillance and discovery, strategies and pitfalls in linking discoveries to disease, and identify opportunities for improvements in sequencing instrumentation and analysis, the use of social media and medical informatics that will further advance clinical medicine and public health. PMID:23602435

  11. 78 FR 55723 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... their products. In the Federal Register of May 16, 2013 (78 FR 28853), FDA published a 60-day notice... Office of Management and Budget Review; Comment Request; Postmarket Surveillance AGENCY: Food and Drug... following proposed collection of information to OMB for review and clearance. Postmarket...

  12. Light armored vehicle reconnaissance and surveillance system

    NASA Astrophysics Data System (ADS)

    Barbeau, Nicolas R.

    1994-10-01

    The Canadian Department of National Defence (DND) has established a requirement for a fleet of reconnaissance vehicles equipped with a modern surveillance system to be used in a wide variety of scenarios. This includes conventional operations within NATO, contingency operations in troubled areas as well as UN peacekeeping missions. As such, the Light Armored Vehicles Reconnaissance and Surveillance System will be the first 24 hour all- weather reconnaissance system integrated into a combat vehicle. This paper intends to describe how the operational requirements defined by DND were translated into sensor and system requirements. After a summary of the current configuration, it focuses on product pre-planned improvements and future needs.

  13. MARGINAL EXPENSE OIL WELL WIRELESS SURVEILLANCE MEOWS

    SciTech Connect

    Mason M. Medizade; John R. Ridgely; Donald G. Nelson

    2004-11-01

    A marginal expense oil well wireless surveillance system to monitor system performance and production from rod-pumped wells in real time from wells operated by Vaquero Energy in the Edison Field, Main Area of Kern County in California has been successfully designed and field tested. The surveillance system includes a proprietary flow sensor, a programmable transmitting unit, a base receiver and receiving antenna, and a base station computer equipped with software to interpret the data. First, the system design is presented. Second, field data obtained from three wells is shown. Results of the study show that an effective, cost competitive, real-time wireless surveillance system can be introduced to oil fields across the United States and the world.

  14. GONOCOCCAL SURVEILLANCE ISOLATE PROJECT (GSIP)

    EPA Science Inventory

    The Gonococcal Isolate Surveillance Project (GISP) is a collaborative project to monitor antimicrobial resistance in Neisseria gonorrhoeae in the United States. The database is a sentinel surveillance system of 26 clinics for sexually transmitted diseases (STDs) and 5 regional la...

  15. Youth Risk Behavior Surveillance System

    MedlinePlus

    ... What's this? Submit Button Youth Risk Behavior Surveillance System (YRBSS) Recommend on Facebook Tweet Share Compartir New ... Minority Data Released! The Youth Risk Behavior Surveillance System (YRBSS) monitors six types of health-risk behaviors ...

  16. Diagnostics and surveillance methods

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Detection and diagnosis of influenza A virus (IAV) infection in animals requires a laboratory test since disease from IAV presents no pathognomonic signs. Diagnosis and surveillance of animal influenza focuses on the detection of virus or type specific antibodies. Whether one targets the virus or ...

  17. TUBERCULOSIS SURVEILLANCE REPORTS

    EPA Science Inventory

    The TB Surveillance Reports contain tabular and graphic information about reported TB cases collected from 59 reporting areas (the 50 states, the District of Columbia, New York City, U.S. dependencies and possessions, and independent nations in free association with the United St...

  18. Mortar launched surveillance system

    NASA Astrophysics Data System (ADS)

    Lewis, Carl E.; Carlton, Lindley A.

    2001-02-01

    Accurate Automation Corporation has completed the conceptual design of a mortar launched air vehicle system to perform close range or over-the-horizon surveillance missions. Law enforcement and military units require an organic capability to obtain real time intelligence information of time critical targets. Our design will permit law enforcement to detect, classify, locate and track these time critical targets. The surveillance system is a simple, unmanned fixed-winged aircraft deployed via a conventional mortar tube. The aircraft's flight surfaces are deployed following mortar launch to permit maximum range and time over target. The aircraft and sensor system are field retrievable. The aircraft can be configured with an engine to permit extended time over target or range. The aircraft has an integrated surveillance sensor system; a programmable CMOS sensor array. The integrated RF transmitted to capable of down- linking real-time video over line-of-sight distances exceeding 10 kilometers. The major benefit of the modular design is the ability to provide surveillance or tracking quickly at a low cost. Vehicle operational radius and sensor field coverage as well as design trade results of vehicle range and endurance performance and payload capacity at operational range are presented for various mortar configurations.

  19. A Population Health Surveillance Theory

    PubMed Central

    Bigras-Poulin, Michel; Michel, Pascal; Ravel, André

    2012-01-01

    OBJECTIVES Despite its extensive use, the term "Surveillance" often takes on various meanings in the scientific literature pertinent to public health and animal health. A critical appraisal of this literature also reveals ambiguities relating to the scope and necessary structural components underpinning the surveillance process. The authors hypothesized that these inconsistencies translate to real or perceived deficiencies in the conceptual framework of population health surveillance. This paper presents a population health surveillance theory framed upon an explicit conceptual system relative to health surveillance performed in human and animal populations. METHODS The population health surveillance theory reflects the authors' system of thinking and was based on a creative process. RESULTS Population health surveillance includes two broad components: one relating to the human organization (which includes expertise and the administrative program), and one relating to the system per se (which includes elements of design and method) and which can be viewed as a process. The population health surveillance process is made of five sequential interrelated steps: 1) a trigger or need, 2) problem formulation, 3) surveillance planning, 4) surveillance implementation, and 5) information communication and audit. CONCLUSIONS The population health surveillance theory provides a systematic way of understanding, organizing and evaluating the population health surveillance process. PMID:23251837

  20. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L.E.

    1996-02-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest National Laboratory (PNNL) for the US Department of Energy (DOE). This document contains the planned 1996 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP), Drinking Water Project, and Ground-Water Surveillance Project.

  1. Outbreaks of H5N1 in poultry in Thailand: the relative role of poultry production types in sustaining transmission and the impact of active surveillance in control

    PubMed Central

    Walker, Patrick; Cauchemez, Simon; Hartemink, Nienke; Tiensin, Thanawat; Ghani, Azra C.

    2012-01-01

    H5N1, highly pathogenic avian influenza, continues to pose a public health risk in the countries of southeast Asia where it has become endemic. However, in Thailand, which experienced two of the largest recorded epidemics in 2004–2005, the disease has been successfully reduced to very low levels. We fitted a spatio-temporal model of the spread of infection to outbreak data collected during the second wave of outbreaks to assess the extent to which different poultry types were responsible for propagating infection. Our estimates suggest that the wave of outbreaks would not have been possible without the contribution of backyard flocks to the susceptibility of a sub-district. However, we also estimated that outbreaks involving commercial poultry, a much larger sector in Thailand than in neighbouring countries, were disproportionately infectious, a factor which was also crucial in sustaining the wave. As a result, implemented measures that aim to reduce the role of commercial farms in the spread of infection, such as the drive to bring aspects of the supply chain ‘in house’, may help to explain the subsequent success in controlling H5N1 in Thailand. We also found that periods of active surveillance substantially improved the rate of outbreak detection. PMID:22356818

  2. Outbreaks of H5N1 in poultry in Thailand: the relative role of poultry production types in sustaining transmission and the impact of active surveillance in control.

    PubMed

    Walker, Patrick; Cauchemez, Simon; Hartemink, Nienke; Tiensin, Thanawat; Ghani, Azra C

    2012-08-01

    H5N1, highly pathogenic avian influenza, continues to pose a public health risk in the countries of southeast Asia where it has become endemic. However, in Thailand, which experienced two of the largest recorded epidemics in 2004-2005, the disease has been successfully reduced to very low levels. We fitted a spatio-temporal model of the spread of infection to outbreak data collected during the second wave of outbreaks to assess the extent to which different poultry types were responsible for propagating infection. Our estimates suggest that the wave of outbreaks would not have been possible without the contribution of backyard flocks to the susceptibility of a sub-district. However, we also estimated that outbreaks involving commercial poultry, a much larger sector in Thailand than in neighbouring countries, were disproportionately infectious, a factor which was also crucial in sustaining the wave. As a result, implemented measures that aim to reduce the role of commercial farms in the spread of infection, such as the drive to bring aspects of the supply chain 'in house', may help to explain the subsequent success in controlling H5N1 in Thailand. We also found that periods of active surveillance substantially improved the rate of outbreak detection. PMID:22356818

  3. Surface-water surveillance

    SciTech Connect

    Saldi, K.A.; Dirkes, R.L.; Blanton, M.L.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the Surface water on and near the Hanford Site is monitored to determine the potential effects of Hanford operations. Surface water at Hanford includes the Columbia River, riverbank springs, ponds located on the Hanford Site, and offsite water systems directly east and across the Columbia River from the Hanford Site, and offsite water systems directly east and across the Columbia River from the Hanford Site. Columbia River sediments are also included in this discussion. Tables 5.3.1 and 5.3.2 summarize the sampling locations, sample types, sampling frequencies, and sample analyses included in surface-water surveillance activities during 1994. Sample locations are also identified in Figure 5.3.1. This section describes the surveillance effort and summarizes the results for these aquatic environments. Detailed analytical results are reported by Bisping (1995).

  4. Small animal disease surveillance.

    PubMed

    Sánchez-Vizcaíno, Fernando; Jones, Philip H; Menacere, Tarek; Heayns, Bethaney; Wardeh, Maya; Newman, Jenny; Radford, Alan D; Dawson, Susan; Gaskell, Rosalind; Noble, Peter J M; Everitt, Sally; Day, Michael J; McConnell, Katie

    2015-12-12

    This is the first UK small animal disease surveillance report from SAVSNET. Future reports will expand to other syndromes and diseases. As data are collected for longer, the estimates of changes in disease burden will become more refined, allowing more targeted local and perhaps national interventions. Anonymised data can be accessed for research purposes by contacting the authors. SAVSNET welcomes feedback on this report. PMID:26667432

  5. Companion animal disease surveillance: a new solution to an old problem?

    PubMed

    Ward, M P; Kelman, M

    2011-09-01

    Infectious disease surveillance in companion animals has a long history. However, it has mostly taken the form of ad hoc surveys, or has focused on adverse reactions to pharmaceuticals. In 2006 a Blue Ribbon Panel was convened by the U.S. White House Office of Science and Technology Policy to discuss the potential utility of a national companion animal health surveillance system. Such a system could provide fundamental information about disease occurrence, transmission and risk factors; and could facilitate industry-supported pharmaco-epidemiological studies and post-market surveillance. Disease WatchDog, a prospective national disease surveillance project, was officially launched in January 2010 to capture data on diseases in dogs and cats throughout Australia. Participation is encouraged by providing registrants real-time disease maps and material for improved communication between veterinarians and clients. From January to mid-November 2010, an estimated 31% of veterinary clinics Australia-wide joined the project. Over 1300 disease cases - including Canine Parvovirus (CPV), Canine Distemper, Canine Hepatitis, Feline Calicivirus, Feline Herpesvirus, and Tick Paralysis - were reported. In New South Wales alone, 552 CPV cases in dogs were reported from 89 postcode locations. New South Wales data was scanned using the space-time permutation test. Up to 24 clusters (P<0.01) were identified, occurring in all months except March. The greatest number of clusters (n=6) were identified in April. The most likely cluster was identified in western Sydney, where 36 cases of CPV were reported from a postcode in February. Although the project is still in its infancy, already new information on disease distribution has been produced. Disease information generated could facilitate targeted control and prevention programs. PMID:22748174

  6. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

    PubMed

    Alicino, Cristiano; Merlano, Caterina; Zappettini, Simona; Schiaffino, Sergio; Della Luna, Giovanni; Accardo, Cristina; Gasparini, Roberto; Durando, Paolo; Icardi, Giancarlo

    2015-01-01

    Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate. PMID:25483520

  7. Supportive housing and surveillance.

    PubMed

    Boyd, Jade; Cunningham, David; Anderson, Solanna; Kerr, Thomas

    2016-08-01

    Urban centres in the US, Britain and Canada have responded to identified visible 'social problems' such addiction, mental health and homelessness by providing some supportive housing for the urban poor and marginalized. While some critics have questioned what supportive housing specifically entails in terms of the built environment, what remains under explored, though a growing area of concern, is the relationship between surveillance and supportive housing for urban residents identified as having addiction and mental health problems - a gap addressed in this paper. Drawing upon qualitative ethnographic observational data we examine some of the measures of control and coercion that are encroaching into social housing primarily established for poor and marginalized people with addiction and mental health problems in the urban centre of Vancouver, Canada. We witnessed three modes of regulation and control, that vary widely, among the residencies observed: physical surveillance technologies; site-specific modes of coercion; police presence and staff surveillance, which all together impact the everyday lives of residents living in low-income and supportive housing. We argue that supportive housing has the potential to provide its intended commitment - safe and secure affordable housing. However, owing to an (over)emphasis on 'security', the supportive housing we observed were also sites of social control. PMID:27453148

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

    PubMed

    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. PMID:25532370

  9. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety. PMID:27245017

  10. Active surveillance for prostate cancer.

    PubMed

    Romero-Otero, Javier; García-Gómez, Borja; Duarte-Ojeda, José M; Rodríguez-Antolín, Alfredo; Vilaseca, Antoni; Carlsson, Sigrid V; Touijer, Karim A

    2016-03-01

    It is worth distinguishing between the two strategies of expectant management for prostate cancer. Watchful waiting entails administering non-curative androgen deprivation therapy to patients on development of symptomatic progression, whereas active surveillance entails delivering curative treatment on signs of disease progression. The objectives of the two management strategies and the patients enrolled in either are different: (i) to review the role of active surveillance as a management strategy for patients with low-risk prostate cancer; and (ii) review the benefits and pitfalls of active surveillance. We carried out a systematic review of active surveillance for prostate cancer in the literature using the National Center for Biotechnology Information's electronic database, PubMed. We carried out a search in English using the terms: active surveillance, prostate cancer, watchful waiting and conservative management. Selected studies were required to have a comprehensive description of the demographic and disease characteristics of the patients at the time of diagnosis, inclusion criteria for surveillance, and a protocol for the patients' follow up. Review articles were included, but not multiple papers from the same datasets. Active surveillance appears to reduce overtreatment in patients with low-risk prostate cancer without compromising cancer-specific survival at 10 years. Therefore, active surveillance is an option for select patients who want to avoid the side-effects inherent to the different types of immediate treatment. However, inclusion criteria for active surveillance and the most appropriate method of monitoring patients on active surveillance have not yet been standardized. PMID:26621054

  11. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

    PubMed Central

    Lexchin, Joel

    2015-01-01

    Aims Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review. Methods A list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan−Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured. Results Compared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review. Conclusions Possible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely. PMID:25393960

  12. Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor

    PubMed Central

    Komatsu, Yoshito; Ohki, Emiko; Ueno, Naomi; Yoshida, Ai; Toyoshima, Yasuharu; Ueda, Eiji; Houzawa, Hiroyuki; Togo, Kanae; Nishida, Toshirou

    2015-01-01

    Objective This study was conducted to expand the sunitinib safety database in Japanese imatinib-resistant/-intolerant gastrointestinal stromal tumor patients. Retrospective analyses investigated common adverse events as potential prognostic markers. Methods Four hundred and seventy patients who received sunitinib between June 2008 and November 2009 were analyzed for safety, progression-free survival and overall survival; 386 for objective response rate; 88% received sunitinib on Schedule 4/2 starting at 50 mg/day. Results No unexpected safety issues occurred. Grade ≥ 3 adverse events occurred in 70%, most commonly thrombocytopenia (33%), neutropenia (22%) and leukopenia (15%). Objective response rate was 20% (95% confidence interval 16–24). Median progression-free survival was 22.4 weeks (95% confidence interval, 21.7–24.0). The overall survival rate at 24 weeks was 91% (95% confidence interval, 88–94). Higher relative dose intensity (≥70 vs. <70%) during the first 6 weeks and better Eastern Cooperative Oncology Group performance status (0 vs. ≥1) were associated with longer progression-free survival (24.0 vs. 20.1 weeks; P = 0.011; and 24.1 vs. 16.9 weeks; P < 0.001) and higher 24-week overall survival rate (94 vs. 83%; P < 0.001; and 96 vs. 83%; P < 0.001). Increased progression-free survival and overall survival rates were associated with specific adverse events. Cox proportional hazard modeling adjusted for relative dose intensity and performance status established hand–foot syndrome (hazard ratio = 0.636; 95% confidence interval, 0.456–0.888) and leukopenia (hazard ratio = 0.683; 95% confidence interval, 0.492–0.948) occurring within 12 weeks were significantly correlated with increased progression-free survival. Conclusion Sunitinib showed good efficacy and tolerable safety. Factors associated with greater efficacy were relative dose intensity, performance status and specific early adverse events. PMID:26373318

  13. Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance.

    PubMed

    Winthrop, K L; Novosad, S A; Baddley, J W; Calabrese, L; Chiller, T; Polgreen, P; Bartalesi, F; Lipman, M; Mariette, X; Lortholary, O; Weinblatt, M E; Saag, M; Smolen, J

    2015-12-01

    No consensus has previously been formed regarding the types and presentations of infectious pathogens to be considered as 'opportunistic infections' (OIs) within the setting of biologic therapy. We systematically reviewed published literature reporting OIs in the setting of biologic therapy for inflammatory diseases. The review sought to describe the OI definitions used within these studies and the types of OIs reported. These findings informed a consensus committee (infectious diseases and rheumatology specialists) in deliberations regarding the development of a candidate list of infections that should be considered as OIs in the setting of biologic therapy. We reviewed 368 clinical trials (randomised controlled/long-term extension), 195 observational studies and numerous case reports/series. Only 11 observational studies defined OIs within their methods; no consistent OI definition was identified across studies. Across all study formats, the most numerous OIs reported were granulomatous infections. The consensus group developed a working definition for OIs as 'indicator' infections, defined as specific pathogens or presentations of pathogens that 'indicate' the likelihood of an alteration in host immunity in the setting of biologic therapy. Using this framework, consensus was reached upon a list of OIs and case-definitions for their reporting during clinical trials and other studies. Prior studies of OIs in the setting of biologic therapy have used inconsistent definitions. The consensus committee reached agreement upon an OI definition, developed case definitions for reporting of each pathogen, and recommended these be used in future studies to facilitate comparison of infection risk between biologic therapies. PMID:26395500

  14. Innovative Use of Existing Public and Private Data Sources for Postmarketing Surveillance of Central Line-Associated Bloodstream Infections Associated With Intravenous Needleless Connectors.

    PubMed

    Tabak, Ying P; Johannes, Richard S; Sun, Xiaowu; Crosby, Cynthia T; Jarvis, William R

    2016-01-01

    The Centers for Medicare and Medicaid Services (CMS) Hospital Compare central line-associated bloodstream infection (CLABSI) data and private databases containing new-generation intravenous needleless connector (study NC) use at the hospital level were linked. The relative risk (RR) of CLABSI associated with the study NCs was estimated, adjusting for hospital characteristics. Among 3074 eligible hospitals in the 2013 CMS database, 758 (25%) hospitals used the study NCs. The study NC hospitals had a lower unadjusted CLABSI rate (1.03 vs 1.13 CLABSIs per 1000 central line days, P < .0001) compared with comparator hospitals. The adjusted RR for CLABSI was 0.94 (95% confidence interval: 0.86, 1.02; P = .11). PMID:27598072

  15. Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study).

    PubMed

    Kinugawa, Koichiro; Inomata, Takayuki; Sato, Naoki; Yasuda, Moriyoshi; Shimakawa, Toshiyuki; Bando, Kosuke; Mizuguchi, Kazuki

    2015-01-01

    The vasopressin receptor 2 (V2) receptor antagonist tolvaptan is an aquaretic agent that has been found to improve symptoms in patients with congestive heart failure. In this study (SMILE study), we administered tolvaptan to patients aged ≥ 80 years with heart failure accompanied by congestive symptoms and compared its effectiveness and safety profiles in this group with those in patients < 80 years (U-80). The results showed that the effectiveness of tolvaptan in the aged patients was similar to that in U-80 patients. In the safety profile, the incidence rate of thirst was lower in the aged patients than that in U-80 patients (9.6% versus 11.6%, P = 0.0023). Furthermore, the incidence of hypernatremia, defined as ≥ 150 mEq/L in aged patients, was comparable with that in U-80 patients (2.9% versus 3.6%, respectively, P = 0.3657). Based on these findings, tolvaptan has similar effectiveness and safety profiles in aged patients compared with U-80 patients. In addition, we found that a higher starting dose of tolvaptan was markedly associated with the occurrence of hypernatremia exclusively in the aged population; therefore, we recommend that tolvaptan should be started at lower doses in aged patients. PMID:25740389

  16. The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines: a simulation study

    PubMed Central

    2014-01-01

    Background Sequence symmetry analysis (SSA) is a potential tool for rapid detection of adverse drug events (ADRs) associated with newly marketed medicines utilizing computerized claims data. SSA is robust to patient specific confounders but it is sensitive to the underlying utilization trends in the medicines of interest. Methods to adjust for utilisation trends have been developed, however, there has been no systematic investigation to assess the performance of SSA when variable prescribing trends occur. The objective of this study was to evaluate the validity of SSA as a signal detection tool for newly marketed medicines. Methods Randomly simulated prescription supplies for a population of 1 million were generated for two medicines, DrugA (medicine of interest) and DrugB (medicine indicative of an adverse event). Scenarios were created by varying medicine utilization trends for a newly marketed medicine (DrugA). In addition, the magnitude of association between DrugA and DrugB was varied. For each scenario 1000 simulations were generated. Average Adjusted Sequence Ratios (ASR), bootstrapped 95% confidence intervals (CIs), percentage of CI's which covered the expected ASR and percent relative bias were calculated. Results When no association was simulated between DrugA and DrugB, over 95% of SSA CI's covered the expected ASR (ASR = 1) and relative bias was 1% or less irrespective of medicine utilization trends. In scenarios where DrugA and DrugB were associated (ASR = 2), unadjusted SR's were underestimated by between 11.7 and 15.3%. After adjustment for trend, ASR estimates were close to expected with relative bias less than 1%. Power was over 80% in all scenarios except for one scenario in which medicine uptake was gradual and the effect of interest was weak (ASR = 1.2). Conclusions Adjustment for underlying medicine utilization patterns effectively overcomes potential under-ascertainment bias in SSA analyses. SSA may be effectively applied as a safety signal detection tool for newly marketed medicines where sufficiently large health claim data are available. PMID:24886247

  17. Innovative Use of Existing Public and Private Data Sources for Postmarketing Surveillance of Central Line-Associated Bloodstream Infections Associated With Intravenous Needleless Connectors

    PubMed Central

    Tabak, Ying P.; Johannes, Richard S.; Sun, Xiaowu; Crosby, Cynthia T.

    2016-01-01

    The Centers for Medicare and Medicaid Services (CMS) Hospital Compare central line-associated bloodstream infection (CLABSI) data and private databases containing new-generation intravenous needleless connector (study NC) use at the hospital level were linked. The relative risk (RR) of CLABSI associated with the study NCs was estimated, adjusting for hospital characteristics. Among 3074 eligible hospitals in the 2013 CMS database, 758 (25%) hospitals used the study NCs. The study NC hospitals had a lower unadjusted CLABSI rate (1.03 vs 1.13 CLABSIs per 1000 central line days, P < .0001) compared with comparator hospitals. The adjusted RR for CLABSI was 0.94 (95% confidence interval: 0.86, 1.02; P = .11). PMID:27598072

  18. Assessing Natural Product-Drug Interactions: An End-to-End Safety Framework.

    PubMed

    Roe, Amy L; Paine, Mary F; Gurley, Bill J; Brouwer, Kenneth R; Jordan, Scott; Griffiths, James C

    2016-04-01

    The use of natural products (NPs), including herbal medicines and other dietary supplements, by North Americans continues to increase across all age groups. This population has access to conventional medications, with significant polypharmacy observed in older adults. Thus, the safety of the interactions between multi-ingredient NPs and drugs is a topic of paramount importance. Considerations such as history of safe use, literature data from animal toxicity and human clinical studies, and NP constituent characterization would provide guidance on whether to assess NP-drug interactions experimentally. The literature is replete with reports of various NP extracts and constituents as potent inhibitors of drug metabolizing enzymes, and transporters. However, without standard methods for NP characterization or in vitro testing, extrapolating these reports to clinically-relevant NP-drug interactions is difficult. This lack of a clear definition of risk precludes clinicians and consumers from making informed decisions about the safety of taking NPs with conventional medications. A framework is needed that describes an integrated robust approach for assessing NP-drug interactions; and, translation of the data into formulation alterations, dose adjustment, labelling, and/or post-marketing surveillance strategies. A session was held at the 41st Annual Summer Meeting of the Toxicology Forum in Colorado Springs, CO, to highlight the challenges and critical components that should be included in a framework approach. PMID:26776752

  19. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines

    PubMed Central

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-01-01

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. PMID:25444788

  20. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. PMID:25444788

  1. Wallops Ship Surveillance System

    NASA Technical Reports Server (NTRS)

    Smith, Donna C.

    2011-01-01

    Approved as a Wallops control center backup system, the Wallops Ship Surveillance Software is a day-of-launch risk analysis tool for spaceport activities. The system calculates impact probabilities and displays ship locations relative to boundary lines. It enables rapid analysis of possible flight paths to preclude the need to cancel launches and allow execution of launches in a timely manner. Its design is based on low-cost, large-customer- base elements including personal computers, the Windows operating system, C/C++ object-oriented software, and network interfaces. In conformance with the NASA software safety standard, the system is designed to ensure that it does not falsely report a safe-for-launch condition. To improve the current ship surveillance method, the system is designed to prevent delay of launch under a safe-for-launch condition. A single workstation is designated the controller of the official ship information and the official risk analysis. Copies of this information are shared with other networked workstations. The program design is divided into five subsystems areas: 1. Communication Link -- threads that control the networking of workstations; 2. Contact List -- a thread that controls a list of protected item (ocean vessel) information; 3. Hazard List -- threads that control a list of hazardous item (debris) information and associated risk calculation information; 4. Display -- threads that control operator inputs and screen display outputs; and 5. Archive -- a thread that controls archive file read and write access. Currently, most of the hazard list thread and parts of other threads are being reused as part of a new ship surveillance system, under the SureTrak project.

  2. Boston Collaborative Drug Surveillance Program

    Cancer.gov

    The Boston Collaborative Drug Surveillance Program started in 1966 and conducted epidemiologic research to quantify the potential adverse effects of prescription drugs, utilizing in-hospital monitoring.

  3. GSFC Supplier Surveillance

    NASA Technical Reports Server (NTRS)

    Kelly, Michael P.

    2011-01-01

    Topics covered include: Develop Program/Project Quality Assurance Surveillance Plans The work activities performed by the developer and/or his suppliers are subject to evaluation and audit by government-designated representatives. CSO supports project by selecting on-site supplier representative s by one of several methods: (1) a Defense Contract Management Agency (DCMA) person via a Letter Of Delegation (LOD), (2) an independent assurance contractor (IAC) via a contract Audits, Assessments, and Assurance (A3) Contract Code 300 Mission Assurance Support Contract (MASC)

  4. Systems for persistent surveillance

    NASA Astrophysics Data System (ADS)

    Lewis, Keith

    2011-09-01

    The requirements for a persistent wide-area surveillance system are discussed in the context of evolving military operations. Significant emphasis has been placed on the development of new sensing technologies to meet the challenges posed by asymmetric threats. Within the UK, the Electro-Magnetic Remote Sensing Defence Technology Centre (EMRS DTC) has supported the research and development of new capabilities including radio-frequency (RF) and electro-optic (EO) systems, as well as work on sensor exploitation, with a goal of developing solutions for enhancing situational awareness. This activity has been supported by field trials to determine the efficacy of competing technologies in relation to realistic threat scenarios.

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

    PubMed

    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. PMID:22292377

  6. Sonoma Persistent Surveillance System

    SciTech Connect

    Pennington, D M

    2006-03-24

    Sonoma offers the first cost-effective, broad-area, high-resolution, real-time motion imagery system for surveillance applications. Sonoma is unique in its ability to provide continuous, real-time video imagery of an area the size of a small city with resolutions sufficient to track 8,000 moving objects in the field of view. At higher resolutions and over smaller areas, Sonoma can even track the movement of individual people. The visual impact of the data available from Sonoma is already causing a paradigm shift in the architecture and operation of other surveillance systems. Sonoma is expected to cost just one-tenth the price of comparably sized sensor systems. Cameras mounted on an airborne platform constantly monitor an area, feeding data to the ground for real-time analysis. Sonoma was designed to provide real-time data for actionable intelligence in situations such as monitoring traffic, special events, border security, and harbors. If a Sonoma system had been available in the aftermath of the Katrina and Rita hurricanes, emergency responders would have had real-time information on roads, water levels, and traffic conditions, perhaps saving many lives.

  7. Intelligent route surveillance

    NASA Astrophysics Data System (ADS)

    Schoemaker, Robin; Sandbrink, Rody; van Voorthuijsen, Graeme

    2009-05-01

    Intelligence on abnormal and suspicious behaviour along roads in operational domains is extremely valuable for countering the IED (Improvised Explosive Device) threat. Local sensor networks at strategic spots can gather data for continuous monitoring of daily vehicle activity. Unattended intelligent ground sensor networks use simple sensing nodes, e.g. seismic, magnetic, radar, or acoustic, or combinations of these in one housing. The nodes deliver rudimentary data at any time to be processed with software that filters out the required information. At TNO (Netherlands Organisation for Applied Scientific Research) research has started on how to equip a sensor network with data analysis software to determine whether behaviour is suspicious or not. Furthermore, the nodes should be expendable, if necessary, and be small in size such that they are hard to detect by adversaries. The network should be self-configuring and self-sustaining and should be reliable, efficient, and effective during operational tasks - especially route surveillance - as well as robust in time and space. If data from these networks are combined with data from other remote sensing devices (e.g. UAVs (Unmanned Aerial Vehicles)/aerostats), an even more accurate assessment of the tactical situation is possible. This paper shall focus on the concepts of operation towards a working intelligent route surveillance (IRS) research demonstrator network for monitoring suspicious behaviour in IED sensitive domains.

  8. Sexually Transmitted Diseases Surveillance, 2012: Gonorrhea

    MedlinePlus

    ... and 44.1% among women. Gonococcal Isolate Surveillance Project Antimicrobial resistance remains an important consideration in the ... 4–9 In 1986, the Gonococcal Isolate Surveillance Project (GISP), a national sentinel surveillance system, was established ...

  9. DEFENSE MEDICAL SURVEILLANCE MONTHLY REPORT (MSMR)

    EPA Science Inventory

    The Medical Surveillance Monthly Report (MSMR) is the Army Medical Surveillance Activity's (AMSA) principal vehicle for disseminating medical surveillance information of broad interest. It routinely publishes summaries of notifiable diseases, trends of illnesses of special survei...

  10. NATIONAL ELECTRONIC DISEASE SURVEILLANCE SYSTEM (NEDSS)

    EPA Science Inventory

    The National Electronic Disease Surveillance System (NEDSS) project is a public health initiative to provide a standard-based, integrated approach to disease surveillance and to connect public health surveillance to the burgeoning clinical information systems infrastructure. NEDS...

  11. Equine Disease Surveillance: Quarterly Summary.

    PubMed

    2016-01-23

    West Nile virus in Europe and the USA. Evidence that the spread of vesicular stomatitis in the USA is beginning to slow. Summary of UK surveillance testing, July to September 2015 These are among matters discussed in the most recent quarterly equine disease surveillance report, prepared by Defra, the Animal Health Trust and the British Equine Veterinary Association. PMID:26795859

  12. PEDIATRIC NUTRITION SURVEILLANCE SYSTEM (PEDNSS)

    EPA Science Inventory

    The Pediatric Nutrition Surveillance System (PedNSS) is a program-based surveillance system designed to monitor the growth, anemia, and breast-feeding status of low-income U.S. children who participate in federally funded maternal and child health nutritional programs. The system...

  13. BORDER INFECTIOUS DISEASES SURVEILLANCE PROJECT

    EPA Science Inventory

    In 1997, the Centers for Disease Control and Prevention, the Mexican Secretariat of Health, and border health officials began the development of the Border Infectious Disease Surveillance (BIDS) project, a surveillance system for infectious diseases along the U.S.-Mexico border. ...

  14. PREGNANCY NUTRITION SURVEILLANCE SYSTEM (PNSS)

    EPA Science Inventory

    The Pregnancy Nutrition Surveillance System (PNSS) is a program based surveillance system developed in order to assist health professionals in achieving of the goals of identifying and reducing pregnancy-related health risks that contribute to adverse pregnancy outcomes. Its purp...

  15. Equine disease surveillance: quarterly summary.

    PubMed

    2016-07-30

    National and international disease outbreaksAfrican horse sickness in South AfricaRising EHV-1 abortion cases in the UKSummary of surveillance testing, January to March 2016 These are among matters discussed in the most recent quarterly equine disease surveillance report, prepared by Defra, the Animal Health Trust and the British Equine Veterinary Association. PMID:27474057

  16. [Entomological surveillance in Mauritius].

    PubMed

    Gopaul, R

    1995-01-01

    The entomological surveillance is an essential link in the fight against malaria in Mauritius. Because of the large number of malaria-infected travellers in Mauritius and the presence of the vector Anopheles arabiensis, the risk of local transmission is very real. The medical entomology division together with the malaria control unit and the health appointees exert a rigorous entomological surveillance of malaria. Field agents make entomological investigations of pilot villages and around the harbor and airport, where there have been cases of malaria, in addition to a few randomly chosen regions. All of the inhabited regions are accessible because of a good highway infrastructure, which enables a complete coverage for the entomological prospectives. Entomological controls are also conducted in the airplanes and the ships. All of the captured mosquitos and the harvested larva are transferred to a laboratory for identification, dissection or sensibility tests, etc. The larva of A. arabiensis have not yet developed resistance to Temephos and the adults are still sensitive to DDT. Thus, the larval habitats are treated with Temephos and DDT is sprayed in the residences where there have been native cases of malaria. The entomology division studies the ecology and the evolution of the larval habitats, as well as the impact of the anti-larval fight on the anophelene density. In addition to the chemical fight, a biological control is being tried with larva-eating fish such as Lebistes and Tilapia. In general, the anophelene density in Mauritius is low, but after the big summer rains, especially during a period of cyclones, there is a considerable increase of larval habitats and consequently a higher number of A. arabiensis. Therefore during this season, it is necessary to make an even more rigorous entomological surveillance. A. arabiensis has a strong exophile tendency even if it is endophage and exophage. This mosquito is zoophile, mostly towards cattle, and the

  17. Smart sensing surveillance system

    NASA Astrophysics Data System (ADS)

    Hsu, Charles; Chu, Kai-Dee; O'Looney, James; Blake, Michael; Rutar, Colleen

    2010-04-01

    An effective public safety sensor system for heavily-populated applications requires sophisticated and geographically-distributed infrastructures, centralized supervision, and deployment of large-scale security and surveillance networks. Artificial intelligence in sensor systems is a critical design to raise awareness levels, improve the performance of the system and adapt to a changing scenario and environment. In this paper, a highly-distributed, fault-tolerant, and energy-efficient Smart Sensing Surveillance System (S4) is presented to efficiently provide a 24/7 and all weather security operation in crowded environments or restricted areas. Technically, the S4 consists of a number of distributed sensor nodes integrated with specific passive sensors to rapidly collect, process, and disseminate heterogeneous sensor data from near omni-directions. These distributed sensor nodes can cooperatively work to send immediate security information when new objects appear. When the new objects are detected, the S4 will smartly select the available node with a Pan- Tilt- Zoom- (PTZ) Electro-Optics EO/IR camera to track the objects and capture associated imagery. The S4 provides applicable advanced on-board digital image processing capabilities to detect and track the specific objects. The imaging detection operations include unattended object detection, human feature and behavior detection, and configurable alert triggers, etc. Other imaging processes can be updated to meet specific requirements and operations. In the S4, all the sensor nodes are connected with a robust, reconfigurable, LPI/LPD (Low Probability of Intercept/ Low Probability of Detect) wireless mesh network using Ultra-wide band (UWB) RF technology. This UWB RF technology can provide an ad-hoc, secure mesh network and capability to relay network information, communicate and pass situational awareness and messages. The Service Oriented Architecture of S4 enables remote applications to interact with the S4

  18. Smart sensing surveillance system

    NASA Astrophysics Data System (ADS)

    Hsu, Charles; Chu, Kai-Dee; O'Looney, James; Blake, Michael; Rutar, Colleen

    2010-04-01

    Unattended ground sensor (UGS) networks have been widely used in remote battlefield and other tactical applications over the last few decades due to the advances of the digital signal processing. The UGS network can be applied in a variety of areas including border surveillance, special force operations, perimeter and building protection, target acquisition, situational awareness, and force protection. In this paper, a highly-distributed, fault-tolerant, and energyefficient Smart Sensing Surveillance System (S4) is presented to efficiently provide 24/7 and all weather security operation in a situation management environment. The S4 is composed of a number of distributed nodes to collect, process, and disseminate heterogeneous sensor data. Nearly all S4 nodes have passive sensors to provide rapid omnidirectional detection. In addition, Pan- Tilt- Zoom- (PTZ) Electro-Optics EO/IR cameras are integrated to selected nodes to track the objects and capture associated imagery. These S4 camera-connected nodes will provide applicable advanced on-board digital image processing capabilities to detect and track the specific objects. The imaging detection operations include unattended object detection, human feature and behavior detection, and configurable alert triggers, etc. In the S4, all the nodes are connected with a robust, reconfigurable, LPI/LPD (Low Probability of Intercept/ Low Probability of Detect) wireless mesh network using Ultra-wide band (UWB) RF technology, which can provide an ad-hoc, secure mesh network and capability to relay network information, communicate and pass situational awareness and messages. The S4 utilizes a Service Oriented Architecture such that remote applications can interact with the S4 network and use the specific presentation methods. The S4 capabilities and technologies have great potential for both military and civilian applications, enabling highly effective security support tools for improving surveillance activities in densely crowded

  19. Getting the Bigger Picture With Digital Surveillance

    NASA Technical Reports Server (NTRS)

    2002-01-01

    Through a Space Act Agreement, Diebold, Inc., acquired the exclusive rights to Glenn Research Center's patented video observation technology, originally designed to accelerate video image analysis for various ongoing and future space applications. Diebold implemented the technology into its AccuTrack digital, color video recorder, a state-of- the-art surveillance product that uses motion detection for around-the- clock monitoring. AccuTrack captures digitally signed images and transaction data in real-time. This process replaces the onerous tasks involved in operating a VCR-based surveillance system, and subsequently eliminates the need for central viewing and tape archiving locations altogether. AccuTrack can monitor an entire bank facility, including four automated teller machines, multiple teller lines, and new account areas, all from one central location.

  20. Surgical wound infection surveillance.

    PubMed

    Lee, J T

    2003-12-01

    Measuring the frequency of a defined outcome flaw for a series of patients undergoing operative procedures generates information for performance evaluation. Such data influence decisions to improve care if used responsibly. Wound infection (WI), bacterial invasion of the incision, is the most common infectious complication of surgical care and WI prevention has value because the complication affects economic, patient satisfaction, and patient functional status outcomes. WI frequency, one kind of surgical outcome flaw rate, is traditionally used to judge one aspect of surgical care quality. At the author's institution, global WI surveillance was conducted without interruption for 20 years. Results for 85,260 consecutive inpatient operations performed during the period showed that secular changes in infection rates occurred but were not necessarily caused by surgical care quality decrements. PMID:14750065

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

    PubMed Central

    Jara, Michele; Aquilina, Thomas; Aupperle, Peter; Rabinowicz, Adrian L

    2015-01-01

    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 warning regarding the risk of anaphylaxis and severe allergic reactions was added to the US prescribing information

  2. Secure surveillance videotapes

    SciTech Connect

    Resnik, W.M.; Kadner, S.P.; Olsen, R.; Chitumbo, K.; Pepper, S.

    1995-12-31

    With assistance from the US Program for Technical Assistance to IAEA Safeguards (POTAS), Aquila Technologies Group developed the Tamper-Resistant Analog Media (TRAM-1000) system to provide standard VHS surveillance video tapes with an enhanced tamper-indicating capability. This project represents further implementation of the partnership approach in facilities including light water reactors with MOX facilities. These facilities use Uniplex Digiquad system video tapes. The partnership approach ensures that one organization can exchange the tapes in a machine without the presence of the other, without losing continuity of information. The TRAM-1000 system development project was accomplished in two stages. In the first stage of the project, the original system delivered to the IAEA, consists of three parts: (1) the tamper detection unit, (2) a specially augmented VHS video tape, and (3) an HP-95 reader. The tamper detection unit houses a VACOSS active fiber-optic seal and an electronic identification tag (E-TAG) reader. In the second stage of the project, the original TRAM-1000 was modified to its current design based on agency input. After delivery of the original TRAM-1000 system to the IAEA, it was reviewed by inspectors. The inspectors felt that the initial system`s tape storage/transport method could be simplified. Rather than threading the fiber through the tape spindles, the inspectors suggested that the tape be placed in a bag capable of being sealed. Also, a more flexible fiber-optic cable was recommended. As a result of these suggestions, Aquila developed a tamper-proof bag specifically for holding a surveillance video tape and sealable with a VACOSS fiber optical seal.

  3. The Development of Surveillance Systems.

    PubMed

    Henderson, D A

    2016-03-01

    Surveillance systems in public health practice have increased in number and sophistication with advances in data collection, analysis, and communication. When the Communicable Disease Center (now the Centers for Disease Control and Prevention) was founded some 70 years ago, surveillance referred to the close observation of individuals with suspected smallpox, plague, or cholera. Alexander Langmuir, head of the Epidemiology Branch, redefined surveillance as the epidemiology-based critical factor in infectious disease control. I joined Langmuir as assistant chief in 1955 and was appointed chief of the Surveillance Section in 1961. In this paper, I describe Langmuir's redefinition of surveillance. Langmuir asserted that its proper use in public health meant the systematic reporting of infectious diseases, the analysis and epidemiologic interpretation of data, and both prompt and widespread dissemination of results. I outline the Communicable Disease Center's first surveillance systems for malaria, poliomyelitis, and influenza. I also discuss the role of surveillance in the global smallpox eradication program, emphasizing that the establishment of systematic reporting systems and prompt action based on results were critical factors of the program. PMID:26928219

  4. The Surveyor Mobile Surveillance System

    SciTech Connect

    Not Available

    1986-07-01

    This paper reports that KLM Technologies, Inc. delivered the Surveyor Mobile Surveillance System to Niagara Mohawk Power Corporation (NMPC) in May 1986 for a long-term test and evaluation program at the Nine Mile Point Nuclear Plant. NMPC is leasing the Surveyor, and KLM personnel will be providing training and support during the test and evaluation program, which will cover various surveillance, inspection, and possible light maintenance tasks in high radiation and contamination areas of the plant. Prior to delivery to NMPC, the surveyor was demonstrated at Detroit Edison Company's Fermi II Nuclear Plant where it was judged to be rugged, compact, and easy to use for surveillance and inspection tasks.

  5. Occupational health surveillance in the chemical industry.

    PubMed

    Flueckiger, A

    2000-08-01

    Health surveillance has its well defined place within occupational health care. Only a few functions are specific to the chemical industry. Occupational health surveillance used to be targeted at the early detection of occupational illnesses (secondary prevention) but other purposes have gained importance in recent years: ensuring the fitness of every worker for his or her job, promoting workers' health in general, contributing to the safety of the plant operation by identifying workers whose behaviour is likely to endanger others, contributing to product quality by assisting in the fulfilment of good manufacturing practice requirements, etc. If the occupational physician wants to maintain his role as key player in protecting workers' health, he must get involved in the important activities of primary prevention contributing directly to workplace improvements. Such improvements can only be based on systematic assessments of the workplaces. These assessments again provide the necessary objective basis to structure health surveillance in a way that takes into account the possible adverse effects coming from the workplace. PMID:11294324

  6. DEFENSE MEDICAL SURVEILLANCE SYSTEM (DMSS)

    EPA Science Inventory

    AMSA operates the Defense Medical Surveillance System (DMSS), an executive information system whose database contains up-to-date and historical data on diseases and medical events (e.g., hospitalizations, ambulatory visits, reportable diseases, HIV tests, acute respiratory diseas...

  7. SEXUALLY TRANSMITTED DISEASES SURVEILLANCE SYSTEM

    EPA Science Inventory

    The Sexually Transmitted Disease Surveillance System presents statistics and trends for sexually transmitted diseases (STDs). Data demonstrate details which provide information about STD morbidity in the United States, STD prevalence with subgroups and populations which are the f...

  8. A new algorithmic approach for the extraction of temporal associations from clinical narratives with an application to medical product safety surveillance reports.

    PubMed

    Wang, Wei; Kreimeyer, Kory; Woo, Emily Jane; Ball, Robert; Foster, Matthew; Pandey, Abhishek; Scott, John; Botsis, Taxiarchis

    2016-08-01

    The sheer volume of textual information that needs to be reviewed and analyzed in many clinical settings requires the automated retrieval of key clinical and temporal information. The existing natural language processing systems are often challenged by the low quality of clinical texts and do not demonstrate the required performance. In this study, we focus on medical product safety report narratives and investigate the association of the clinical events with appropriate time information. We developed a novel algorithm for tagging and extracting temporal information from the narratives, and associating it with related events. The proposed algorithm minimizes the performance dependency on text quality by relying only on shallow syntactic information and primitive properties of the extracted event and time entities. We demonstrated the effectiveness of the proposed algorithm by evaluating its tagging and time assignment capabilities on 140 randomly selected reports from the US Vaccine Adverse Event Reporting System (VAERS) and the FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS). We compared the performance of our tagger with the SUTime and HeidelTime taggers, and our algorithm's event-time associations with the Temporal Awareness and Reasoning Systems for Question Interpretation (TARSQI). We further evaluated the ability of our algorithm to correctly identify the time information for the events in the 2012 Informatics for Integrating Biology and the Bedside (i2b2) Challenge corpus. For the time tagging task, our algorithm performed better than the SUTime and the HeidelTime taggers (F-measure in VAERS and FAERS: Our algorithm: 0.86 and 0.88, SUTime: 0.77 and 0.74, and HeidelTime 0.75 and 0.42, respectively). In the event-time association task, our algorithm assigned an inappropriate timestamp for 25% of the events, while the TARSQI toolkit demonstrated a considerably lower performance, assigning inappropriate timestamps in 61.5% of the same

  9. Hallam environmental radiation surveillance

    SciTech Connect

    Not Available

    1988-01-01

    An environmental surveillance report is presented for decommissioned Hallam power plant. Statistical analysis shows that the spring data mean is significantly greater than the fall data mean for all water sources. The spring variation is also significantly greater than the fall variation. The water sources demonstrate homogeneity for spring and fall sub-surface sources. Surface water has significantly more radiation than sub-surface water. This may be attributed to increased tritium content in surface water due to atmospheric leaching. Finally, the surface water samples are in close proximity to Sheldon Station, a coal fired plant, and increased coal particulate matter may be increasing the environmental radioactivity. A linear regression model suggests spring readings are decreasing and fall readings significantly increasing from 1975 to 1987. The spring recharge water probably contains natural and man-made radioactivity leached from the atmosphere, as well as natural radioactivity leached from the soil and rocks. The lower mean and less variance for the fall data may better characterize the aquifer. 7 figs.

  10. Collaborative space surveillance

    NASA Astrophysics Data System (ADS)

    Lin, Ching-Fang; Pham, Khanh D.

    2009-05-01

    This paper presents a space-based, space-surveillance study wherein the goal is to demonstrate the feasibility and scalability of the modeling and simulation of a distributed multi-agent multiple satellites tracking and prediction system. A flexible and modular system architecture that enables collaborative and efficient teaming among distributed agents is delineated. Hierarchical objective methodology is deployed to align the mission objectives with the diverse agents' capabilities and resources. A set of satellite platform and sensor configuration/models is considered. Detailed mathematical models of the satellite orbits including the mutual visibility function are simulated for combinations of GEO and LEO orbits. An Unscented Kalman Filter (UKF)/Distributed Unscented Information Filter (DUIF) for high-accuracy orbital determination and tracking is demonstrated to show that the LEO orbit estimation from the GEO satellite with only angle measurements based on UKF is an excellent approach. Simulation studies show that the rate of filter convergence depends on sample time period, initial error, process error, measurement errors as well as the relative geometry of the LEO and GEO satellite orbits.

  11. Breast cancer surveillance.

    PubMed

    Rachetta, Eleonora; Osano, Silvia; Astegiano, Francesco; Martincich, Laura

    2016-10-01

    Since several studies have demonstrated the inadequate diagnostic performance of mammography in high risk women, over the past two decades, different breast imaging tests have been evaluated as additional diagnostic methods to mammography, and the most relevant ones are the techniques that do not imply the use of X-rays, considering the young age of these patients and the higher radio-sensitivity. Breast dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) has risen growing interest not only because of the absence of use of X-rays, but also because it provides morpho-functional features, which may depict biological characteristics of breast tissues, including invasive and in situ cancers. Different multicenter non-randomized prospective studies aimed to evaluate breast DCE-MRI as an integral part of surveillance programs, agreed about the evidence that in high risk women screening with DCE-MRI is more effective than either mammography and/or ultrasound. Moreover, this modality leads to the identifications of cancers at a more favorable stage, allowing a real advantage in terms of tumor size and nodal involvement. The medical community is evaluating to suggest DCE-MRI alone as screening modality in high-risk women, as it was reported that in these cases the sensitivity of MRI plus conventional imaging was not significantly higher than that of MRI alone. Breast MRI is now recommended as part of screening program for high risk women by both European and American guidelines. PMID:26924173

  12. Public Health Disease Surveillance Networks.

    PubMed

    Morse, Stephen S

    2014-02-01

    Zoonotic infections are important sources of human disease; most known emerging infections are zoonotic (e.g., HIV, Ebola virus, severe acute respiratory syndrome, Nipah virus, and enteropathogenic Escherichia coli) and originated as natural infections of other species that acquired opportunities to come in contact with humans. There are also serious infectious diseases classically considered zoonotic, such as influenza, rabies, bubonic plague, brucellosis, and leptospirosis. More recently, it has been recognized that wildlife constitutes a particularly important source of novel zoonoses. With all this microbial movement, surveillance is considered the first line of public health defense. The zoonotic origin of many human and livestock infections argues strongly for the synergistic value of a One Health approach, which provides the capability to identify pathogens crossing into new species and could provide earlier warning of potential epidemics. This article discusses public health surveillance and major recent surveillance initiatives and reviews progress toward implementing a One Health surveillance framework. Networks discussed include global intergovernmental organizations and recent combined efforts of these organizations; Web-based nongovernmental systems (e.g., ProMED, the Program for Monitoring Emerging Diseases); and networks of bilateral or multilateral government programs (e.g., the CDC's Global Disease Detection [GDD] platform; the U.S. Department of Defense's Global Emerging Infections Surveillance and Response System [GEIS]; regional and subregional networks; and the U.S. Agency for International Development's Emerging Pandemic Threats [EPT] program and its surveillance component, PREDICT). Syndromic surveillance also has potential to complement existing systems. New technologies are enabling revolutionary capabilities for global surveillance, but in addition to serious technical needs, both sustainability and data-sharing mechanisms remain

  13. Occupational Surveillance for Spaceflight Exposures

    NASA Technical Reports Server (NTRS)

    Tarver, William J.

    2010-01-01

    This slide presentation reviews the importance of longterm occupational health surveillance of astronauts after exposure to the possible hazards of spaceflight. Because there is not much information about long term effects of spaceflight on human health, it is important to identify some of the possible results of exposure to the many possible factors that can influence longterm health impacts. This surveillance also allows for NASA to meet the obligation to care for the astronauts for their lifetime.

  14. Surface Environmental Surveillance Procedures Manual

    SciTech Connect

    RW Hanf; TM Poston

    2000-09-20

    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.

  15. Was the French clinical surveillance system of bovine brucellosis influenced by the occurrence and surveillance of other abortive diseases?

    PubMed

    Bronner, Anne; Morignat, Eric; Touratier, Anne; Gache, Kristel; Sala, Carole; Calavas, Didier

    2015-03-01

    The bovine brucellosis clinical surveillance system implemented in France aims to detect early any case of bovine brucellosis, a disease of which the country has been declared free since 2005. It relies on the mandatory notification of every bovine abortion. Following the spread of the Schmallenberg virus (SBV) in France in 2012 and 2013, and the implementation in 2012 of a clinical surveillance programme of Q fever based on abortion notifications in ten pilot départements, our objective was to study whether these two events influenced the brucellosis clinical surveillance system. The proportion of notifying farmers was analyzed over each semester from June 1, 2009 to June 30, 2013 according to the size and production type of herds, SBV status of départements and the implementation of the Q fever surveillance. Our analysis showed a slight increase in the proportion of notifying farmers as départements became infected by SBV, and after the implementation of Q fever surveillance (during the first semester of 2013). These variations might be explained by an increase in abortion occurrence (congenital deformities in newborns, due to SBV) and/or by an increase in farmers' and veterinarians' awareness (due to the spread of SBV and the implementation of the Q fever surveillance). These results highlight the difficulties in interpreting variations in the proportion of notifying farmers as a consequence of an increase in abortion occurrence. As bovine abortion surveillance can play an important role in the early warning for several diseases, there is a need to explore other ways to monitor abortions in cattle, such as syndromic surveillance using the dates of artificial insemination or calving data. PMID:25617916

  16. Rosuvastatin safety: lessons from the FDA review and post-approval surveillance.

    PubMed

    Davidson, Michael H

    2004-11-01

    Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use. In this database, rosuvastatin had a similar safety profile to other approved statins up to the highest approval dose of 40 mg. As with all statins, there is a marked increase in adverse effects when the dose is titrated from 40 to 80 mg, and rosuvastatin demonstrates a similar dose/toxicity relationship. In the pre-approval data trials on 80 mg, there was a 1.0% (n = 16) incidence of myopathy and 7 patients developed rhabdomyolysis. However the post-marketing surveillance for rosuvastatin, there have been reports of rhabdomyolysis, but the incidence rate, when corrected for prescription utilisation, is similar to other statins following initial approval. PMID:15500414

  17. 10 CFR Appendix H to Part 50 - Reactor Vessel Material Surveillance Program Requirements

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Reactor Vessel Material Surveillance Program Requirements H Appendix H to Part 50 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. H Appendix H to Part 50—Reactor Vessel Material Surveillance Program Requirements I. Introduction II....

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Reactor Vessel Material Surveillance Program Requirements H Appendix H to Part 50 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. H Appendix H to Part 50—Reactor Vessel Material Surveillance Program Requirements I. Introduction II....

  19. 10 CFR Appendix H to Part 50 - Reactor Vessel Material Surveillance Program Requirements

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Reactor Vessel Material Surveillance Program Requirements H Appendix H to Part 50 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. H Appendix H to Part 50—Reactor Vessel Material Surveillance Program Requirements I. Introduction II....

  20. 10 CFR Appendix H to Part 50 - Reactor Vessel Material Surveillance Program Requirements

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Reactor Vessel Material Surveillance Program Requirements H Appendix H to Part 50 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. H Appendix H to Part 50—Reactor Vessel Material Surveillance Program Requirements I. Introduction II....

  1. 10 CFR Appendix H to Part 50 - Reactor Vessel Material Surveillance Program Requirements

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Reactor Vessel Material Surveillance Program Requirements H Appendix H to Part 50 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. H Appendix H to Part 50—Reactor Vessel Material Surveillance Program Requirements I. Introduction II....

  2. Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

    PubMed Central

    Giuliano, F; Jackson, G; Montorsi, F; Martin-Morales, A; Raillard, P

    2010-01-01

    Aim: To review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED). Methods: Data were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer’s postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (≥ 65 and ≥ 75 years). Special safety topics included cardiovascular risk, priapism, non-arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and α-blockers) and incorrect use. Results: Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged ≥ 65 years, and in those aged ≥ 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse. Conclusion: This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues. PMID:19900167

  3. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    PubMed

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment". PMID:27220797

  4. Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

    PubMed Central

    Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

    2006-01-01

    For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

  5. National nosocomial infections surveillance system (NNIS): description of surveillance methods.

    PubMed

    Emori, T G; Culver, D H; Horan, T C; Jarvis, W R; White, J W; Olson, D R; Banerjee, S; Edwards, J R; Martone, W J; Gaynes, R P

    1991-02-01

    The National Nosocomial Infections Surveillance System (NNIS) is an ongoing collaborative surveillance system sponsored by the Centers for Disease Control (CDC) to obtain national data on nosocomial infections. The CDC uses the data that are reported voluntarily by participating hospitals to estimate the magnitude of the nosocomial infection problem in the United States and to monitor trends in infections and risk factors. Hospitals collect data by prospectively monitoring specific groups of patients for infections with the use of protocols called surveillance components. The surveillance components used by the NNIS are hospitalwide, intensive care unit, high-risk nursery, and surgical patient. Detailed information including demographic characteristics, infections and related risk factors, pathogens and their antimicrobial susceptibilities, and outcome, is collected on each infected patient. Data on risk factors in the population of patients being monitored are also collected; these permit the calculation of risk-specific rates. An infection risk index, which includes the traditional wound class, is being evaluated as a predictor of the likelihood that an infection will develop after an operation. A major goal of the NNIS is to use surveillance data to develop and evaluate strategies to prevent and control nosocomial infections. The data collected with the use of the surveillance components permit the calculation of risk-specific infection rates, which can be used by individual hospitals as well as national health-care planners to set priorities for their infection control programs and to evaluate the effectiveness of their efforts. The NNIS will continue to evolve in finding more effective and efficient ways to assess the influence of patient risk and changes in the financing of health care on the infection rate. PMID:1850582

  6. Risky Bodies: Health Surveillance and Teachers' Embodiment of Health

    ERIC Educational Resources Information Center

    Webb, Louisa; Quennerstedt, Mikael

    2010-01-01

    In the current climate of health surveillance, governmental measurement and control as well as a focus on individual responsibility for risk are prevalent in school contexts. Physical education is a crucial site for the production and reproduction of health messages and thus is an important location through which health and healthy bodies are…

  7. Surveillance of avian influenza in the Caribbean through the Caribbean Animal Health Network: surveillance tools and epidemiologic studies.

    PubMed

    Lefrançois, T; Hendrikx, P; Ehrhardt, N; Millien, M; Gomez, L; Gouyet, L; Gaidet, N; Gerbier, G; Vachiéry, N; Petitclerc, F; Carasco-Lacombe, C; Pinarello, V; Ahoussou, S; Levesque, A; Gongora, H V; Trotman, M

    2010-03-01

    The Caribbean region is considered to be at risk for avian influenza (AI) due to a large backyard poultry system, an important commercial poultry production system, the presence of migratory birds, and disparities in the surveillance systems. The Caribbean Animal Health Network (CaribVET) has developed tools to implement AI surveillance in the region with the goals to have 1) a regionally harmonized surveillance protocol and specific web pages for AI surveillance on www.caribvet.net, and 2) an active and passive surveillance for AI in domestic and wild birds. A diagnostic network for the Caribbean, including technology transfer and AI virus molecular diagnostic capability in Guadeloupe (real-time reverse transcription-polymerase chain reaction for the AI virus matrix gene), was developed. Between 2006 and 2009, 627 samples from four Caribbean countries were tested for three circumstances: importation purposes, following a clinical suspicion of AI, or through an active survey of wild birds (mainly waders) during the southward and northward migration periods in Guadeloupe. None of the samples tested were positive, suggesting a limited role of these species in the AI virus ecology in the Caribbean. Following low pathogenic H5N2 outbreaks in the Dominican Republic in 2007, a questionnaire was developed to collect data for a risk analysis of AI spread in the region through fighting cocks. The infection pathway of the Martinique commercial poultry sector by AI, through introduction of infected cocks, was designed, and recommendations were provided to the Caribbean Veterinary Services to improve cock movement control and biosecurity measures. The CaribVET and its organization allowed interaction between diagnostic and surveillance tools on the one hand and epidemiologic studies on the other, both of them developed in congruence with regional strategies. Together, these CaribVET activities contribute to strengthening surveillance of avian influenza virus (AIV) in the

  8. Pan-European Chikungunya surveillance: designing risk stratified surveillance zones.

    PubMed

    Tilston, Natasha; Skelly, Chris; Weinstein, Phil

    2009-01-01

    The first documented transmission of Chikungunya within Europe took place in Italy during the summer of 2007. Chikungunya, a viral infection affecting millions of people across Africa and Asia, can be debilitating and no prophylactic treatment exists. Although imported cases are reported frequently across Europe, 2007 was the first confirmed European outbreak and available evidence suggests that Aedes albopictus was the vector responsible and the index case was a visitor from India. This paper proposed pan-European surveillance zones for Chikungunya, based on the climatic conditions necessary for vector activity and viral transmission. Pan-European surveillance provides the best hope for an early-warning of outbreaks, because national boundaries do not play a role in defining the risk of this new vector borne disease threat. A review of climates, where Chikungunya has been active, was used to inform the delineation of three pan-European surveillance zones. These vary in size each month across the June-September period of greatest risk. The zones stretch across southern Europe from Portugal to Turkey. Although the focus of this study was to define the geography of potential surveillance zones based on the climatic limits on the vector and virus, a preliminary examination of inward bound airline passengers was also undertaken. This indicated that France and Italy are likely to be at greater risk due to the number of visitors they receive from Chikungunya active regions, principally viraemic visitors from India. Therefore this study represents a first attempt at creating risk stratified surveillance zones, which we believe could be usefully refined with the use of higher resolution climate data and more complete air travel data. PMID:19878588

  9. Medical surveillance for the emerging occupational and environmental respiratory diseases

    PubMed Central

    Weissman, David N.

    2016-01-01

    Purpose of review To highlight the important issues to consider in deciding whether to pursue and how to conduct medical surveillance for the emerging occupational and environmental respiratory diseases. It provides several recent examples illustrating implementation and usefulness of medical surveillance and the lessons learned from these experiences. Recent findings Medical surveillance conducted after sentinel outbreaks of constrictive bronchiolitis in microwave popcorn and flavoring production plants have shown the usefulness of this approach in documenting the burden of disease, identifying particular problem areas as targets for preventive interventions, and in tracking the progress. They have also identified the usefulness of longitudinal spirometry, which allows comparison of the individuals’ results to their own previous tests. The importance of recognizing a sentinel outbreak needing greater investigation is demonstrated by the cluster of cases of constrictive bronchiolitis recognized in military veterans returning from Iraq and Afghanistan. The World Trade Center disaster has demonstrated the importance of having baseline lung function data for future comparison and the importance of rapidly identifying exposed populations at greatest risk for health effects, and thus potentially having the greatest benefit from medical surveillance. Summary When used appropriately, medical surveillance is a useful tool in addressing the emerging occupational and environmental respiratory diseases by facilitating improvements in primary prevention and enabling interventions to help individuals through secondary prevention. PMID:24500294

  10. Exploring the Usefulness of Occupational Exposure Registries for Surveillance

    PubMed Central

    Genesove, Leon; Moore, Kris; Del Bianco, Ann; Kramer, Desre

    2014-01-01

    Objective: The ongoing presence of asbestos in products used across workplaces in Canada reinforces the importance of occupational exposure surveillance. This study evaluates the usefulness of the Ontario Asbestos Workers Registry. Methods: The study includes 30,829 workers aged 15 to 80 years. Researchers reported on the data quality and analyzed the proportions of workers exposed by industry, and standardized rates by geographic areas and over time. Results: The incidence of exposure started to decrease around 1990; but about 2000 workers were still exposed annually until 2006. Results showed large geographical disparities. Unexpectedly, workers from industries other than construction reported exposure. Conclusions: The Ontario Asbestos Workers Registry is a useful but challenging source of information for the surveillance of asbestos exposure in Ontario. The registry could benefit from well-defined surveillance objectives, a clear exposure definition, systematic enforcement, regular data analyses, and results dissemination. PMID:25162835

  11. Regional Disease Surveillance Meeting - Final Paper

    SciTech Connect

    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.

  12. SETI radio spectrum surveillance system

    NASA Technical Reports Server (NTRS)

    Crow, B.; Lokshin, A.; Marina, M.; Ching, L.

    1985-01-01

    The SETI Radio Spectrum Surveillance System (SRSSS) will provide a data base for assessing the radio frequency interference (RFI) environment for SETI and minimizing RFI disruptions during the search. The system's hardware and software are described and the sensitivity of the system is discussed.

  13. Instrumental Surveillance of Water Quality.

    ERIC Educational Resources Information Center

    Miller, J. A.; And Others

    The role analytical instrumentation performs in the surveillance and control of the quality of water resources is reviewed. Commonly performed analyses may range from simple tests for physical parameters to more highly sophisticated radiological or spectrophotometric methods. This publication explores many of these types of water quality analyses…

  14. Privacy-protecting video surveillance

    NASA Astrophysics Data System (ADS)

    Wickramasuriya, Jehan; Alhazzazi, Mohanned; Datt, Mahesh; Mehrotra, Sharad; Venkatasubramanian, Nalini

    2005-02-01

    Forms of surveillance are very quickly becoming an integral part of crime control policy, crisis management, social control theory and community consciousness. In turn, it has been used as a simple and effective solution to many of these problems. However, privacy-related concerns have been expressed over the development and deployment of this technology. Used properly, video cameras help expose wrongdoing but typically come at the cost of privacy to those not involved in any maleficent activity. This work describes the design and implementation of a real-time, privacy-protecting video surveillance infrastructure that fuses additional sensor information (e.g. Radio-frequency Identification) with video streams and an access control framework in order to make decisions about how and when to display the individuals under surveillance. This video surveillance system is a particular instance of a more general paradigm of privacy-protecting data collection. In this paper we describe in detail the video processing techniques used in order to achieve real-time tracking of users in pervasive spaces while utilizing the additional sensor data provided by various instrumented sensors. In particular, we discuss background modeling techniques, object tracking and implementation techniques that pertain to the overall development of this system.

  15. Video surveillance with speckle imaging

    DOEpatents

    Carrano, Carmen J.; Brase, James M.

    2007-07-17

    A surveillance system looks through the atmosphere along a horizontal or slant path. Turbulence along the path causes blurring. The blurring is corrected by speckle processing short exposure images recorded with a camera. The exposures are short enough to effectively freeze the atmospheric turbulence. Speckle processing is used to recover a better quality image of the scene.

  16. Mortar-launched surveillance system

    NASA Astrophysics Data System (ADS)

    Lewis, Carl E.; Cooper, Steve; Carlton, Lindley A.

    2001-09-01

    Accurate Automation Corporation has completed the conceptual design of a mortar launched air vehicle system to perform close range or over-the-horizon surveillance missions. Law enforcement and military units require an organic capability to obtain real time intelligence information of time critical targets. Our design will permit law enforcement to detect, classify, locate and track these time critical targets. The surveillance system is a simple, unmanned fixed-winged aircraft deployed via a conventional mortar tube. The aircraft's flight surfaces are deployed following mortar launch to permit maximum range and time over target. The aircraft and sensor system are field retrievable. The aircraft can be configured with an engine to permit extended time over target or range. The aircraft has an integrated surveillance sensor system; a programmable CMOS sensor array. The integrated RF transmitter is capable of down- linking real-time video over line-of-sight distances exceeding 10 kilometers. The major benefit of the modular design is the ability to provide surveillance or tracking quickly at a low cost. Vehicle operational radius and sensor field coverage as well as design trade results of vehicle range and endurance performance and payload capacity at operational range are presented for various mortar configurations.

  17. HAEMOPHILUS INFLUENZA DISEASES SURVEILLANCE SYSTEM

    EPA Science Inventory

    The Haemophilus Influenzae System at NIP compiles information on all U.S. Haemophilus influenzae invasive disease cases reported to CDC via NETSS since 1991 (managed by EPO and NIP), or via active surveillance in several locales since 1989 (managed by NCIP). Information collected...

  18. Nutrition Surveillance. Annual Summary 1982.

    ERIC Educational Resources Information Center

    Centers for Disease Control (DHHS/PHS), Atlanta, GA.

    This report summarizes information, including selected indices of nutritional status, as reported from 28 states and the District of Columbia to the Nutritional Status Surveillance System. This system has two components, one addressing nutritional status among high-risk pediatric populations, and the other addressing nutritional status among…

  19. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  20. Student Resistance to the Surveillance Curriculum

    ERIC Educational Resources Information Center

    Hope, Andrew

    2010-01-01

    The growth of surveillance in UK schools in recent years has resulted in the development of what can be labelled as the surveillance curriculum. Operating through the overt and hidden curricula, contemporary surveillance practices and technologies not only engage students in a discourse of control, but also increasingly socialise them into a…

  1. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  2. Surveillance Cameras in Schools: An Ethical Analysis

    ERIC Educational Resources Information Center

    Warnick, Bryan R.

    2007-01-01

    In this essay, Bryan R. Warnick responds to the increasing use of surveillance cameras in public schools by examining the ethical questions raised by their use. He explores the extent of a student's right to privacy in schools, stipulates how video surveillance is similar to and different from commonly accepted in-person surveillance practices,…

  3. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  4. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  5. 48 CFR 44.304 - Surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively...

  6. 48 CFR 44.304 - Surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively...

  7. 40 CFR 52.12 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Source surveillance. 52.12 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS General Provisions § 52.12 Source surveillance. (a) Each subpart identifies the plan provisions for source surveillance which are disapproved, and sets forth...

  8. 48 CFR 44.304 - Surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively...

  9. 40 CFR 52.12 - Source surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Source surveillance. 52.12 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS General Provisions § 52.12 Source surveillance. (a) Each subpart identifies the plan provisions for source surveillance which are disapproved, and sets forth...

  10. 48 CFR 44.304 - Surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively...

  11. 48 CFR 44.304 - Surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively...

  12. 40 CFR 52.12 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Source surveillance. 52.12 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS General Provisions § 52.12 Source surveillance. (a) Each subpart identifies the plan provisions for source surveillance which are disapproved, and sets forth...

  13. NATIONAL WEST NILE VIRUS SURVEILLANCE SYSTEM

    EPA Science Inventory

    In order to understand the implications of WN viruses introduction into the United States the Centers of Disease Control and the U.S. Department of Agriculture created a system of active bird surveillance, active mosquito surveillance, enhanced passive veterinary surveillance, an...

  14. Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.

    PubMed

    McNicholas, Anne; Galloway, Yvonne; Stehr-Green, Paul; Reid, Stewart; Radke, Sarah; Sexton, Kerry; Kieft, Charlotte; Macdonald, Claire; Neutze, Jocelyn; Drake, Ross; Isaac, Dorothy; O'Donnell, Mary; Tatley, Michael; Oster, Philipp; O'Hallahan, Jane

    2007-01-01

    New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety. PMID:17660718

  15. Integrated monitoring and surveillance system demonstration project

    SciTech Connect

    Aumeier, S.E.; Walters, G.; Kotter, D.; Walrath, W.M.; Zamecnik, R.J.

    1997-07-01

    We present a summary of efforts associated with the installation of an integrated system for the surveillance and monitoring of stabilized plutonium metals and oxides in long-term storage. The product of this effort will include a Pu storage requirements document, baseline integrated monitoring and surveillance system (IMSS) prototype and test bed that will be installed in the Fuel Manufacturing Facility (FMF) nuclear material vault at Argonne National Laboratory - West (ANL-W), and a Pu tracking database including data analysis capabilities. The prototype will be based on a minimal set of vault and package monitoring requirements as derived from applicable DOE documentation and guidelines, detailed in the requirements document, including DOE-STD-3013-96. The use of standardized requirements will aid individual sites in the selection of sensors that best suit their needs while the prototype IMSS, located at ANL-W, will be used as a test bed to compare and contrast sensor performance against a baseline integrated system (the IMSS), demonstrate system capabilities, evaluate potential technology gaps, and test new hardware and software designs using various storage configurations. With efforts currently underway to repackage and store a substantial quantity of plutonium and plutonium-bearing material within the DOE complex, this is an opportune time to undertake such a project. 4 refs.

  16. A conceptual framework for economic optimization of an animal health surveillance portfolio.

    PubMed

    Guo, X; Claassen, G D H; Oude Lansink, A G J M; Saatkamp, H W

    2016-04-01

    Decision making on hazard surveillance in livestock product chains is a multi-hazard, multi-stakeholder, and multi-criteria process that includes a variety of decision alternatives. The multi-hazard aspect means that the allocation of the scarce resource for surveillance should be optimized from the point of view of a surveillance portfolio (SP) rather than a single hazard. In this paper, we present a novel conceptual approach for economic optimization of a SP to address the resource allocation problem for a surveillance organization from a theoretical perspective. This approach uses multi-criteria techniques to evaluate the performances of different settings of a SP, taking cost-benefit aspects of surveillance and stakeholders' preferences into account. The credibility of the approach has also been checked for conceptual validity, data needs and operational validity; the application potentials of the approach are also discussed. PMID:26415763

  17. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  18. The Sharper Image for Surveillance

    SciTech Connect

    Hazi, A

    2006-01-13

    A technique adapted by Livermore scientists to take the twinkle out of stars is now being used to improve the resolution of long-range surveillance systems trained on earthbound objects. The speckle-imaging technique involves taking tens to hundreds of pictures with short-exposure times and reconstructing a single, sharp image using image-processing software. The technique drew the interest of Livermore engineer Carmen Carrano. She developed a prototype remote-surveillance system that can produce a detailed image of a face from a couple of kilometers away. The system also helps identify vehicles tens of kilometers away and improves the viewing of large structures more than 60 kilometers away.

  19. Multisensor/multimission surveillance aircraft

    NASA Astrophysics Data System (ADS)

    Jobe, John T.

    1994-10-01

    The realignment of international powers, and the formation of new nations has resulted in increasing worldwide concern over border security, an expanding refugee problem, protection of fishery and mineral areas, and smuggling of all types. The focus on military services, to protect or defend against these threats of vital, national interest, is shifting to other government agencies and even commercial contractors to apply innovative and cost effective solutions. Previously, airborne surveillance and reconnaissance platforms have been large, mission dedicated military aircraft. The time has arrived for a smaller, more efficient, and more effective airborne capability. This paper briefly outlines a system of systems approach that smaller nations can afford to incorporate in their budgets, while greatly expanding their surveillance capability. The characteristics of specific cameras and sensors are purposely not addressed, so the emphasis can be placed on the integration of multiple sensors and capabilities.

  20. Mining Surveillance and Maintenance Dollars

    SciTech Connect

    MARTINEZ, R.

    2000-02-01

    Accelerating site cleanup to reduce facility risks to the workers, the public and the environment during a time of declining federal budgets represents a significant technical and economic challenge to U.S. Department of Energy (DOE) Operations Offices and their respective contractors. A significant portion of a facility's recurring annual expenses are associated with routine, long-term surveillance and maintenance (S&M) activities. However, ongoing S&M activities do nothing to reduce risks and basically spend money that could be reallocated towards facility deactivation. This paper discusses the background around DOE efforts to reduce surveillance and maintenance costs, one approach used to perform cost reviews, lessons learned from field implementation and what assistance is available to assist DOE sites in performing these evaluations.

  1. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L.E.

    1997-01-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest National Laboratory (PNNL)(a) for the US Department of Energy (DOE). This document contains the planned 1997 schedules for routine collection of samples for the Surface Environmental Surveillance Project (SESP) and Drinking Water Monitoring Project. In addition, Section 3.0, Biota, also reflects a rotating collection schedule identifying the year a specific sample is scheduled for collection. The purpose of these monitoring projects is to evaluate levels of radioactive and nonradioactive pollutants in the Hanford environs, as required in DOE Order 5400.1, General Environmental Protection Program, and DOE Order 5400.5, Radiation Protection of the Public and the Environment. The sampling methods will be the same as those described in the Environmental Monitoring Plan, US Department of Energy, Richland Operations Office, DOE/RL91-50, Rev. 1, US Department of Energy, Richland, Washington.

  2. Mobile Surveillance and Monitoring Robots

    SciTech Connect

    Kimberly, Howard R.; Shipers, Larry R.

    1999-07-14

    Long-term nuclear material storage will require in-vault data verification, sensor testing, error and alarm response, inventory, and maintenance operations. System concept development efforts for a comprehensive nuclear material management system have identified the use of a small flexible mobile automation platform to perform these surveillance and maintenance operations. In order to have near-term wide-range application in the Complex, a mobile surveillance system must be small, flexible, and adaptable enough to allow retrofit into existing special nuclear material facilities. The objective of the Mobile Surveillance and Monitoring Robot project is to satisfy these needs by development of a human scale mobile robot to monitor the state of health, physical security and safety of items in storage and process; recognize and respond to alarms, threats, and off-normal operating conditions; and perform material handling and maintenance operations. The system will integrate a tool kit of onboard sensors and monitors, maintenance equipment and capability, and SNL developed non-lethal threat response technology with the intelligence to identify threats and develop and implement first response strategies for abnormal signals and alarm conditions. System versatility will be enhanced by incorporating a robot arm, vision and force sensing, robust obstacle avoidance, and appropriate monitoring and sensing equipment.

  3. Tissue damage detection by osmotic surveillance

    PubMed Central

    Enyedi, Balázs; Kala, Snigdha; Nikolich-Zugich, Tijana; Niethammer, Philipp

    2013-01-01

    How tissue damage is detected to induce inflammatory responses is unclear. Most studies have focused on damage signals released by cell breakage and necrosis1. Whether tissues utilize other cues besides cell lysis to detect that they are damaged is unknown. We find that osmolarity differences between interstitial fluid and the external environment mediate rapid leukocyte recruitment to sites of tissue damage in zebrafish by activating cytosolic phospholipase a2 (cPLA2) at injury sites. cPLA2 initiates the production of non-canonical arachidonate metabolites that mediate leukocyte chemotaxis via a 5-oxo-ETE receptor (OXE-R). Thus, tissues can detect damage through direct surveillance of barrier integrity. By this mechanism, cell-swelling likely functions as a pro-inflammatory intermediate. PMID:23934216

  4. Tissue damage detection by osmotic surveillance.

    PubMed

    Enyedi, Balázs; Kala, Snigdha; Nikolich-Zugich, Tijana; Niethammer, Philipp

    2013-09-01

    How tissue damage is detected to induce inflammatory responses is unclear. Most studies have focused on damage signals released by cell breakage and necrosis. Whether tissues use other cues in addition to cell lysis to detect that they are damaged is unknown. We find that osmolarity differences between interstitial fluid and the external environment mediate rapid leukocyte recruitment to sites of tissue damage in zebrafish by activating cytosolic phospholipase a2 (cPLA2) at injury sites. cPLA2 initiates the production of non-canonical arachidonate metabolites that mediate leukocyte chemotaxis through a 5-oxo-ETE receptor (OXE-R). Thus, tissues can detect damage through direct surveillance of barrier integrity, with cell swelling probably functioning as a pro-inflammatory intermediate in the process. PMID:23934216

  5. HIV surveillance in complex emergencies.

    PubMed

    Salama, P; Dondero, T J

    2001-04-01

    Many studies have shown a positive association between both migration and temporary expatriation and HIV risk. This association is likely to be similar or even more pronounced for forced migrants. In general, HIV transmission in host-migrant or host-forced-migrant interactions depends on the maturity of the HIV epidemic in both the host and the migrant population, the relative seroprevalence of HIV in the host and the migrant population, the prevalence of other sexually transmitted infections (STIs) that may facilitate transmission, and the level of sexual interaction between the two communities. Complex emergencies are the major cause of mass population movement today. In complex emergencies, additional factors such as sexual interaction between forced-migrant populations and the military; sexual violence; increasing commercial sex work; psychological trauma; and disruption of preventive and curative health services may increase the risk for HIV transmission. Despite recent success in preventing HIV infection in stable populations in selected developing countries, internally displaced persons and refugees (or forced migrants) have not been systematically included in HIV surveillance systems, nor consequently in prevention activities. Standard surveillance systems that rely on functioning health services may not provide useful data in many complex emergency settings. Secondary sources can provide some information in these settings. Little attempt has been made, however, to develop innovative HIV surveillance systems in countries affected by complex emergencies. Consequently, data on the HIV epidemic in these countries are scarce and HIV prevention programs are either not implemented or interventions are not effectively targeted. Second generation surveillance methods such as cross-sectional, population-based surveys can provide rapid information on HIV, STIs, and sexual behavior. The risks for stigmatization and breaches of confidentiality must be recognized

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

    PubMed Central

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  7. Postmarket safety of drugs approved by Health Canada on the basis of clinical and surrogate outcomes: a cohort study

    PubMed Central

    Ahmed, Tareq

    2015-01-01

    Background Health Canada approves drugs on the basis of evidence from clinical trials using clinical or surrogate outcomes. This study compares the postmarket safety of these 2 groups of drugs. Methods Information about whether clinical or surrogate outcomes were used and the date of market approval were obtained from Health Canada’s Summary Basis of Decision documents issued from Jan. 1, 2005, to Dec. 31, 2014. Safety warnings and the dates they were issued were identified through advisories on the MedEffect Canada website. Kaplan–Meier survival curves were calculated to determine the likelihood that drugs in the clinical and surrogate outcome groups would receive a serious safety warning. The time from market authorization to first serious safety warning was compared for the 2 groups of drugs. Results A total of 124 drugs were approved by Health Canada using clinical outcomes and 114 using surrogate outcomes. Kaplan–Meier curves did not differ between the 2 groups (p < 0.9). The median time from market authorization to first serious safety warning was 722 days in the clinical outcome group and 818 days in the surrogate outcome group (difference 96 days, 95% confidence interval –295 to 425). Interpretation We found no statistically significant difference in postmarket safety between drugs approved using clinical outcomes and those approved using surrogate outcomes. Because drugs in the surrogate outcome group are approved before their benefit:harm ratio is fully established, these drugs should be used with caution until their clinical benefits are better understood. PMID:26442227

  8. Measles surveillance in Victoria, Australia.

    PubMed Central

    Wang, Yung-Hsuan J.; Andrews, Ross M.; Lambert, Stephen B.

    2006-01-01

    OBJECTIVE: Many countries are implementing measles elimination strategies. In Australia, the State of Victoria has conducted enhanced measles surveillance since 1997 using case interviews and home-based specimen collection for laboratory confirmation. We attempted to identify features of notified cases that would better target surveillance resources. METHODS: We retrospectively classified notifications received from 1998 to 2003 as having been received in an epidemic (one or more laboratory-confirmed cases) or an interepidemic period (no laboratory-confirmed cases). We labelled the first case notified in any epidemic period that was not laboratory-confirmed at the time of notification as a "sentinel case". To maximize detection of sentinel cases while minimizing the follow-up of eventually discarded notifications, we generated algorithms using sentinel cases and interepidemic notifications. FINDINGS: We identified 10 sentinel cases with 422 interepidemic notifications from 1281 Victorian notifications. Sentinel cases were more likely to report fever at rash onset (odds ratio (OR) 15.7, 95% confidence interval (CI) CI: 2.1-688.9), cough (OR 10.4, 95% CI: 1.4-456.7), conjunctivitis (OR 7.9, 95% CI: 1.8-39.1), or year of birth between 1968 and 1981 (OR 31.8, 95% CI: 6.7-162.3). Prospective application of an algorithm consisting of fever at rash onset or born between 1968 and 1981 in the review period would have detected all sentinel cases and avoided the need for enhanced follow-up of 162 of the 422 eventually discarded notifications. CONCLUSION: Elimination strategies should be refined to suit regional and local priorities. The prospective application of an algorithm in Victoria is likely to reduce enhanced measles surveillance resource use in interepidemic periods, while still detecting early cases during measles outbreaks. PMID:16501727

  9. Norovirus Surveillance: An Epidemiological Perspective.

    PubMed

    Harris, John P

    2016-02-01

    Surveillance for norovirus is challenging because the nature of illness due to norovirus is such that the majority of people who are infected will not have any contact with medical services and are highly unlikely to have a sample collected for diagnosis. Public health advice urges people to not visit hospitals or their family physicians, to prevent the risk further spread. The recognition of the importance of this pathogen was quickly established following the introduction of surveillance of outbreaks of gastrointestinal infection in England and Wales in 1992. This period saw >1800 outbreaks of norovirus infection reported in hospitals in England, affecting >45 000 patients and staff. A new system for reporting outbreaks of norovirus infection in hospitals, the Hospital Norovirus outbreak Reporting Scheme (HNORS), began in January 2009. Summary information on outbreaks is provided by infection control staff at hospitals and includes questions on the date the first and last person in the outbreak became symptomatic and whether closure of a bay or ward was needed. In the first 3 years (2009-2011) of the HNORS surveillance scheme, 4000 outbreaks were reported, affecting 40 000 patients and 10 000 staff. Over the last 3 years, these outbreaks have been associated with an average of 13 000 patients and 3400 staff becoming ill, with 15 000 lost bed-days annually. With the possible introduction of a vaccine on the horizon, targeted research with a more integrated approach to laboratory testing and outbreak reporting is essential to a greater understanding of the epidemiology of norovirus. PMID:26744431

  10. Optimal Colonoscopy Surveillance Interval after Polypectomy

    PubMed Central

    Kim, Tae Oh

    2016-01-01

    The detection and removal of adenomatous polyps and postpolypectomy surveillance are considered important for the control of colorectal cancer (CRC). Surveillance using colonoscopy is an effective tool for preventing CRC after colorectal polypectomy, especially if compliance is good. In current practice, the intervals between colonoscopies after polypectomy are variable. Different recommendations for recognizing at risk groups and defining surveillance intervals after an initial finding of colorectal adenomas have been published. However, high-grade dysplasia and the number and size of adenomas are known major cancer predictors. Based on this, a subgroup of patients that may benefit from intensive surveillance colonoscopy can be identified. PMID:27484812

  11. Remotely piloted LTA vehicle for surveillance

    NASA Technical Reports Server (NTRS)

    Seemann, G. R.; Harris, G. L.; Brown, G. J.

    1975-01-01

    Various aspects of a remotely piloted mini-LTA vehicle for surveillance, monitoring and measurement for civilian and military applications are considered. Applications, operations and economics are discussed.

  12. Anomaly detection for internet surveillance

    NASA Astrophysics Data System (ADS)

    Bouma, Henri; Raaijmakers, Stephan; Halma, Arvid; Wedemeijer, Harry

    2012-06-01

    Many threats in the real world can be related to activity of persons on the internet. Internet surveillance aims to predict and prevent attacks and to assist in finding suspects based on information from the web. However, the amount of data on the internet rapidly increases and it is time consuming to monitor many websites. In this paper, we present a novel method to automatically monitor trends and find anomalies on the internet. The system was tested on Twitter data. The results showed that it can successfully recognize abnormal changes in activity or emotion.

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

    PubMed Central

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

    2014-01-01

    Objective 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. Materials and methods 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. Results 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. Discussions 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. Conclusions 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. PMID:24699371

  14. Zoonotic foodborne parasites and their surveillance.

    PubMed

    Murrell, K D

    2013-08-01

    Humans suffer from several foodborne helminth zoonotic diseases, some of which can be deadly (e.g., trichinellosis, cerebral cysticercosis) while others are chronic and cause only mild illness (e.g., intestinal taeniosis). The route of infection is normally consumption of the parasite's natural host as a human food item (e.g., meat). The risk for infection with these parasites is highest wherever people have an inadequate knowledge of infection and hygiene, poor animal husbandry practices, and unsafe management and disposal of human and animal waste products. The design of surveillance and control strategies for the various foodborne parasite species, and the involvement of veterinary and public health agencies, vary considerably because of the different life cycles of these parasites, and epidemiological features. Trichinella spiralis, which causes most human trichinellosis, is acquired from the consumption of pork, although increasingly cases occur from eating wild game. For cysticercosis, however, the only sources for human infection are pork (Taenia solium) or beef (T. saginata). The chief risk factor for infection of humans with these parasites is the consumption of meat that has been inadequately prepared. For the pig or cow, however, the risk factors are quite different between Trichinella and Taenia. For T. spiralis the major source of infection of pigs is exposure to infected animal meat (which carries the infective larval stage), while for both Taenia species it is human faecal material contaminated with parasite eggs shed by the adult intestinal stage of the tapeworm. Consequently, the means for preventing exposure of pigs and cattle to infective stages of T. spiralis, T. solium, and T. saginata vary markedly, especially the requirements for ensuring the biosecurity of these animals at the farm. The surveillance strategies and methods required for these parasites in livestock are discussed, including the required policy-level actions and the necessary

  15. LANL surveillance requirements management and surveillance requirements from NA-12 tasking memo

    SciTech Connect

    Hills, Charles R

    2011-01-25

    Surveillance briefing to NNSA to support a tasking memo from NA-12 on Surveillance requirements. This talk presents the process for developing surveillance requirements, discusses the LANL requirements that were issued as part of that tasking memo, and presents recommendations on Component Evaluation and Planning Committee activities for FY11.

  16. Environmental surveillance master sampling schedule

    SciTech Connect

    Bisping, L.E.

    1991-01-01

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by the Pacific Northwest Laboratory (PNL) for the US Department of Energy (DOE). This document contains the planned schedule for routine sample collection for the Surface Environmental Surveillance Project (SESP) and Ground-Water Monitoring Project. The routine sampling plan for the SESP has been revised this year to reflect changing site operations and priorities. Some sampling previously performed at least annually has been reduced in frequency, and some new sampling to be performed at a less than annual frequency has been added. Therefore, the SESP schedule reflects sampling to be conducted in calendar year 1991 as well as future years. The ground-water sampling schedule is for 1991. This schedule is subject to modification during the year in response to changes in Site operation, program requirements, and the nature of the observed results. Operational limitations such as weather, mechanical failures, sample availability, etc., may also require schedule modifications. Changes will be documented in the respective project files, but this plan will not be reissued. The purpose of these monitoring projects is to evaluate levels of radioactive and nonradioactive pollutants in the Hanford evirons.

  17. Rocky Flats Beryllium Health Surveillance.

    PubMed

    Stange, A W; Furman, F J; Hilmas, D E

    1996-10-01

    The Rocky Flats Beryllium Health Surveillance Program (BHSP), initiated in June 1991, was designed to provide medical surveillance for current and former employees exposed to beryllium. The BHSP identifies individuals who have developed beryllium sensitivity using the beryllium lymphocyte proliferation test (BeLPT). A detailed medical evaluation to determine the prevalence of chronic beryllium disease (CBD) is offered to individuals identified as beryllium sensitized or to those who have chest X-ray changes suggestive of CBD. The BHSP has identified 27 cases of CBD and another 74 cases of beryllium sensitization out of 4268 individuals tested. The distribution of BeLPT values for normal, sensitized, and CBD-identified individuals is described. Based on the information collected during the first 3 1/3 years of the BHSP, the BeLPT is the most effective means for the early identification of beryllium-sensitized individuals and to identify individuals who may have CBD. The need for BeLPT retesting is demonstrated through the identification of beryllium sensitization in individuals who previously tested normal. Posterior/anterior chest X-rays were not effective in the identification of CBD. PMID:8933045

  18. Cyber surveillance for flood disasters.

    PubMed

    Lo, Shi-Wei; Wu, Jyh-Horng; Lin, Fang-Pang; Hsu, Ching-Han

    2015-01-01

    Regional heavy rainfall is usually caused by the influence of extreme weather conditions. Instant heavy rainfall often results in the flooding of rivers and the neighboring low-lying areas, which is responsible for a large number of casualties and considerable property loss. The existing precipitation forecast systems mostly focus on the analysis and forecast of large-scale areas but do not provide precise instant automatic monitoring and alert feedback for individual river areas and sections. Therefore, in this paper, we propose an easy method to automatically monitor the flood object of a specific area, based on the currently widely used remote cyber surveillance systems and image processing methods, in order to obtain instant flooding and waterlogging event feedback. The intrusion detection mode of these surveillance systems is used in this study, wherein a flood is considered a possible invasion object. Through the detection and verification of flood objects, automatic flood risk-level monitoring of specific individual river segments, as well as the automatic urban inundation detection, has become possible. The proposed method can better meet the practical needs of disaster prevention than the method of large-area forecasting. It also has several other advantages, such as flexibility in location selection, no requirement of a standard water-level ruler, and a relatively large field of view, when compared with the traditional water-level measurements using video screens. The results can offer prompt reference for appropriate disaster warning actions in small areas, making them more accurate and effective. PMID:25621609

  19. Rocky Flats beryllium health surveillance

    SciTech Connect

    Stange, A.W.; Furman, F.J.; Hilmas, D.E.

    1996-10-01

    The Rocky Flats Beryllium Health Surveillance Program (BHSP), initiated in June 1991, was designed to provide medical surveillance for current and former employees exposed to beryllium. The BHSP identifies individuals who have developed beryllium sensitivity using the beryllium lymphocyte proliferation test (BeLPT). A detailed medical evaluation to determine the prevalence of chronic beryllium disease (CBD) is offered to individuals identified as beryllium sensitized or to those who have chest X-ray changes suggestive of CBD. The BHSP has identified 27 cases of CBD and another 74 cases of beryllium sensitization out of 4268 individuals tested. The distribution of BeLPT values for normal, sensitized, and CBD-identified individuals is described. Based on the information collected during the first 3 1/3 years of the BHSP, the BeLPT is the most effective means for the early identification of beryllium-sensitized individuals and to identify individuals who may have CBD. The need for BeLPT retesting is demonstrated through the identification of beryllium sensitization in individuals who previously tested normal. Posterior/anterior chest X-rays were not effective in the identification of CBD. 12 refs., 8 tabs.

  20. Cyber Surveillance for Flood Disasters

    PubMed Central

    Lo, Shi-Wei; Wu, Jyh-Horng; Lin, Fang-Pang; Hsu, Ching-Han

    2015-01-01

    Regional heavy rainfall is usually caused by the influence of extreme weather conditions. Instant heavy rainfall often results in the flooding of rivers and the neighboring low-lying areas, which is responsible for a large number of casualties and considerable property loss. The existing precipitation forecast systems mostly focus on the analysis and forecast of large-scale areas but do not provide precise instant automatic monitoring and alert feedback for individual river areas and sections. Therefore, in this paper, we propose an easy method to automatically monitor the flood object of a specific area, based on the currently widely used remote cyber surveillance systems and image processing methods, in order to obtain instant flooding and waterlogging event feedback. The intrusion detection mode of these surveillance systems is used in this study, wherein a flood is considered a possible invasion object. Through the detection and verification of flood objects, automatic flood risk-level monitoring of specific individual river segments, as well as the automatic urban inundation detection, has become possible. The proposed method can better meet the practical needs of disaster prevention than the method of large-area forecasting. It also has several other advantages, such as flexibility in location selection, no requirement of a standard water-level ruler, and a relatively large field of view, when compared with the traditional water-level measurements using video screens. The results can offer prompt reference for appropriate disaster warning actions in small areas, making them more accurate and effective. PMID:25621609

  1. Drugs and other product choices.

    PubMed

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature. PMID:19453345

  2. Corporation-induced Diseases, Upstream Epidemiologic Surveillance, and Urban Health

    PubMed Central

    2008-01-01

    Corporation-induced diseases are defined as diseases of consumers, workers, or community residents who have been exposed to disease agents contained in corporate products. To study the epidemiology and to guide expanded surveillance of these diseases, a new analytical framework is proposed. This framework is based on the agent–host–environment model and the upstream multilevel epidemiologic approach and posits an epidemiologic cascade starting with government-sanctioned corporate profit making and ending in a social cost, i.e., harm to population health. Each of the framework’s levels addresses a specific level of analysis, including government, corporations, corporate conduits, the environment of the host, and the host. The explained variable at one level is also the explanatory variable at the next lower level. In this way, a causal chain can be followed along the epidemiologic cascade from the site of societal power down to the host. The framework thus describes the pathways by which corporate decisions filter down to disease production in the host and identifies opportunities for epidemiologic surveillance. Since the environment of city dwellers is strongly shaped by corporations that are far upstream and several levels away, the framework has relevance for the study of urban health. Corporations that influence the health of urban populations include developers and financial corporations that determine growth or decay of urban neighborhoods, as well as companies that use strategies based on neighborhood characteristics to sell products that harm consumer health. Epidemiological inquiry and surveillance are necessary at all levels to provide the knowledge needed for action to protect the health of the population. To achieve optimal inquiry and surveillance at the uppermost levels, epidemiologists will have to work with political scientists and other social scientists and to utilize novel sources of information. PMID:18437580

  3. Citizen Science and Wildlife Disease Surveillance.

    PubMed

    Lawson, Becki; Petrovan, Silviu O; Cunningham, Andrew A

    2015-12-01

    Achieving effective wildlife disease surveillance is challenging. The incorporation of citizen science (CS) in wildlife health surveillance can be beneficial, particularly where resources are limited and cost-effectiveness is paramount. Reports of wildlife morbidity and mortality from the public facilitate large-scale surveillance, both in time and space, which would otherwise be financially infeasible, and raise awareness of incidents occurring on privately owned land. CS wildlife disease surveillance schemes benefit scientists, the participating public and wildlife alike. CS has been employed for targeted, scanning and syndromic surveillance of wildlife disease. Whilst opportunistic surveillance is most common, systematic observations enable the standardisation of observer effort and, combined with wildlife population monitoring schemes, can allow evaluation of disease impacts at the population level. Near-universal access to digital media has revolutionised reporting modalities and facilitated rapid and economical means of sharing feedback with participants. Here we review CS schemes for wildlife disease surveillance and highlight their scope, benefits, logistical considerations, financial implications and potential limitations. The need to adopt a collaborative and multidisciplinary approach to wildlife health surveillance is increasingly recognised and the general public can make a significant contribution through CS. PMID:26318592

  4. Video Surveillance: All Eyes Turn to IP

    ERIC Educational Resources Information Center

    Raths, David

    2011-01-01

    Many university officials recognize the need to upgrade their older analog video surveillance systems. In a 2010 survey by "Campus Safety" magazine, half of university respondents expressed dissatisfaction with the quality and coverage of their current video surveillance systems. Among the limitations of analog closed-circuit television (CCTV)…

  5. 40 CFR 52.1077 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Source surveillance. 52.1077 Section 52.1077 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1077 Source surveillance....

  6. 40 CFR 52.2684 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Source surveillance. 52.2684 Section 52.2684 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Guam § 52.2684 Source surveillance. (a)...

  7. 48 CFR 244.304 - Surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Surveillance. 244.304 Section 244.304 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT... Reviews 244.304 Surveillance. (b) The ACO, or the purchasing system analyst (PSA) with the concurrence...

  8. 40 CFR 52.2684 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 5 2012-07-01 2012-07-01 false Source surveillance. 52.2684 Section 52.2684 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Guam § 52.2684 Source surveillance. (a)...

  9. 40 CFR 52.1077 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Source surveillance. 52.1077 Section 52.1077 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1077 Source surveillance....

  10. 40 CFR 52.1077 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Source surveillance. 52.1077 Section 52.1077 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1077 Source surveillance....

  11. 40 CFR 52.2684 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Source surveillance. 52.2684 Section 52.2684 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Guam § 52.2684 Source surveillance. (a)...

  12. 40 CFR 52.1479 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Source surveillance. 52.1479 Section 52.1479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1479 Source surveillance. (a)...

  13. 40 CFR 52.2684 - Source surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 5 2014-07-01 2014-07-01 false Source surveillance. 52.2684 Section 52.2684 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Guam § 52.2684 Source surveillance. (a)...

  14. 40 CFR 52.479 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Source surveillance. 52.479 Section 52.479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.479 Source surveillance. (a)...

  15. 40 CFR 52.1479 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Source surveillance. 52.1479 Section 52.1479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1479 Source surveillance. (a)...

  16. 40 CFR 52.130 - Source surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ....130, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Source surveillance. 52.130 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Arizona § 52.130 Source surveillance. (a)...

  17. 40 CFR 52.479 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Source surveillance. 52.479 Section 52.479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.479 Source surveillance. (a)...

  18. 40 CFR 52.130 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....130, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Source surveillance. 52.130 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Arizona § 52.130 Source surveillance. (a)...

  19. 40 CFR 52.2684 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 5 2013-07-01 2013-07-01 false Source surveillance. 52.2684 Section 52.2684 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Guam § 52.2684 Source surveillance. (a)...

  20. 17 CFR 38.604 - Financial surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Financial surveillance. 38.604 Section 38.604 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION DESIGNATED CONTRACT MARKETS Financial Integrity of Transactions § 38.604 Financial surveillance. A designated contract...

  1. 40 CFR 52.479 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Source surveillance. 52.479 Section 52.479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.479 Source surveillance. (a)...

  2. 40 CFR 52.1077 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Source surveillance. 52.1077 Section 52.1077 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1077 Source surveillance....

  3. 40 CFR 52.479 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Source surveillance. 52.479 Section 52.479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.479 Source surveillance....

  4. 40 CFR 52.130 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....130, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Source surveillance. 52.130 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Arizona § 52.130 Source surveillance. (a)...

  5. 40 CFR 52.1479 - Source surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 4 2014-07-01 2014-07-01 false Source surveillance. 52.1479 Section 52.1479 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1479 Source surveillance. (a)...

  6. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Surveillance. 34.51 Section 34.51 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic operation the radiographer, or the other...

  7. GLOBAL EMERGING INFECTIONS SURVEILLANCE AND RESPONSE SYSTEM

    EPA Science Inventory

    Department of Defense (DoD) Gonococcal Isolate Surveillance Project (GISP). The DoD Global Emerging Infections Surveillance and Response System (DoD-GEIS) partners with the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) in the global surv...

  8. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41...

  9. Geographical Information Systems for Dengue Surveillance

    PubMed Central

    Duncombe, Jennifer; Clements, Archie; Hu, Wenbiao; Weinstein, Philip; Ritchie, Scott; Espino, Fe Esperanza

    2012-01-01

    This review provides details on the role of Geographical Information Systems (GIS) in current dengue surveillance systems and focuses on the application of open access GIS technology to emphasize its importance in developing countries, where the dengue burden is greatest. It also advocates for increased international collaboration in transboundary disease surveillance to confront the emerging global challenge of dengue. PMID:22556070

  10. Obesity Assemblages and Surveillance in Schools

    ERIC Educational Resources Information Center

    Rich, Emma

    2010-01-01

    In this paper, I draw on the growing body of work in surveillance studies, to examine the increasing propensity in recent years towards the monitoring and collection of information about children's weight and health within school contexts. Applying Haggerty and Ericson's concept of the surveillant assemblage within school contexts, the paper…

  11. 17 CFR 38.604 - Financial surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MARKETS Financial Integrity of Transactions § 38.604 Financial surveillance. A designated contract market must monitor members' compliance with the designated contract market's minimum financial standards and... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Financial surveillance....

  12. 40 CFR 52.1479 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Source surveillance. 52.1479 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1479 Source surveillance. (a) The... records of, and periodically report, information on the nature and amount of emissions. (b)...

  13. 40 CFR 52.1479 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Source surveillance. 52.1479 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1479 Source surveillance. (a) The... records of, and periodically report, information on the nature and amount of emissions. (b)...

  14. 40 CFR 52.12 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... exclusive use, of any credible evidence or information, relevant to whether a source would have been in... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Source surveillance. 52.12 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS General Provisions § 52.12 Source surveillance. (a)...

  15. 40 CFR 52.2075 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Source surveillance. 52.2075 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Rhode Island § 52.2075 Source surveillance... report information as may be necessary to enable the state to determine whether such sources are...

  16. 40 CFR 52.2075 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Source surveillance. 52.2075 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Rhode Island § 52.2075 Source surveillance... report information as may be necessary to enable the state to determine whether such sources are...

  17. 40 CFR 52.12 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... exclusive use, of any credible evidence or information, relevant to whether a source would have been in... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Source surveillance. 52.12 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS General Provisions § 52.12 Source surveillance. (a)...

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

    PubMed

    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

  19. Bluetongue virus surveillance in a newly infected area.

    PubMed

    Giovannini, A; Calistri, P; Conte, A; Savini, L; Nannini, D; Patta, C; Santucci, U; Caporale, V

    2004-01-01

    The occurrence of bluetongue virus (BTV) in areas in which intensive animal production is practised and where there is extensive movement of animals may have a substantial impact on both animal trade and husbandry. This situation occurred in Italy after the detection of bluetongue (BT) in August 2000. In such situations, surveillance can be used to delineate with precision those areas in which the virus is circulating and, consequently, to enforce the appropriate animal movement restrictions. Furthermore, surveillance can provide the data required to assess the risk associated with animal movement and trade. A structured surveillance system for the detection of BTV has been in place in Italy since August 2001. The system is based on the periodical testing of unvaccinated sentinel cattle that are uniformly scattered throughout Italy in a grid of 400 km(2) cells. The initial number of sentinel sites and sentinel animals, together with the width of the restricted area generated by the finding of a single seroconversion in a sentinel animal, were based on conservative criteria. Animal movement was restricted in a 20 km radius buffer zone around any positive serological result. This buffer area extends about 1,257 km(2), equivalent to the area of three grid cells. After the commencement of the BT vaccination campaign in Italy, the sentinel surveillance system was the only way in which the effectiveness of vaccination and the incidence of infection in the non-immunised strata of ruminant animals could be estimated. Data collected over two years was used to assess the risks posed by the adoption of less conservative criteria for the delineation of infected areas and by the progressive relaxation of movement restrictions of vaccinated animals. In regard to the delineation of restricted areas, a new approach was tested and validated in the field, based on a Bayesian analysis of the positive and negative results obtained by the testing of sentinel animals from defined

  20. Safety surveillance in haemophilia and allied disorders.

    PubMed

    Lassila, R; Makris, M

    2016-06-01

    The introduction of clotting factor concentrates has transformed the lives of persons with inherited bleeding disorders. With the use of prophylactic treatment, it is now possible to prevent bleeding in these individuals. The early concentrates were contaminated with the HIV and hepatitis C viruses (HCV) and resulted in major morbidity and mortality in the recipients. Current products are much safer, especially in terms of infectious agents, but other adverse events such as alloantibodies (inhibitors), allergic reactions and thrombotic risks remain of concern. Approximately 30% of previously untreated patients with severe haemophilia A develop inhibitors, making this the most important issue in haemophilia care today. Recently, it was suggested that one of the most commonly used concentrates was associated with a higher inhibitor risk, but this was not supported by the evidence from all studies. Good safety surveillance systems are essential for all diseases and products but are particularly so in the group of individuals with inherited bleeding disorders treated with clotting factor concentrates who have suffered disproportionately from the adverse effects of their treatment. National and multinational systems are now in place to allow reporting of adverse events in patients with inherited bleeding disorders. All clinicians treating individuals with inherited bleeding disorders should prospectively report adverse events to treatment even if they are believed to be common and well recognized. PMID:27001233

  1. Microbiological Food Safety Surveillance in China

    PubMed Central

    Pei, Xiaoyan; Li, Ning; Guo, Yunchang; Liu, Xiumei; Yan, Lin; Li, Ying; Yang, Shuran; Hu, Jing; Zhu, Jianghui; Yang, Dajin

    2015-01-01

    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. PMID:26343705

  2. Wireless sensor network for mobile surveillance systems

    NASA Astrophysics Data System (ADS)

    van Dijk, Gert J. A.; Maris, Marinus G.

    2004-11-01

    Guarding safety and security within industrial, commercial and military areas is an important issue nowadays. A specific challenge lies in the design of portable surveillance systems that can be rapidly deployed, installed and easily operated. Conventional surveillance systems typically employ stand alone sensors that transmit their data to a central control station for data-processing. One of the disadvantages of these kinds of systems is that they generate a lot of data that may induce processing or storage problems. Moreover, data from the sensors must be constantly observed and assessed by human operators. In this paper, a surveillance concept based on distributed intelligence in wireless sensor networks is proposed. In this concept, surveillance is automatically performed by means of many small sensing devices including cameras. The requirements for such surveillance systems are investigated. Experiments with a demonstration system were conducted to verify some of the claims made throughout this paper.

  3. Optimizing Provider Recruitment for Influenza Surveillance Networks

    PubMed Central

    Scarpino, Samuel V.; Dimitrov, Nedialko B.; Meyers, Lauren Ancel

    2012-01-01

    The increasingly complex and rapid transmission dynamics of many infectious diseases necessitates the use of new, more advanced methods for surveillance, early detection, and decision-making. Here, we demonstrate that a new method for optimizing surveillance networks can improve the quality of epidemiological information produced by typical provider-based networks. Using past surveillance and Internet search data, it determines the precise locations where providers should be enrolled. When applied to redesigning the provider-based, influenza-like-illness surveillance network (ILINet) for the state of Texas, the method identifies networks that are expected to significantly outperform the existing network with far fewer providers. This optimized network avoids informational redundancies and is thereby more effective than networks designed by conventional methods and a recently published algorithm based on maximizing population coverage. We show further that Google Flu Trends data, when incorporated into a network as a virtual provider, can enhance but not replace traditional surveillance methods. PMID:22511860

  4. Improved Global Capacity for Influenza Surveillance.

    PubMed

    Polansky, Lauren S; Outin-Blenman, Sajata; Moen, Ann C

    2016-06-01

    During 2004-2009, the Centers for Disease Control and Prevention (CDC) partnered with 39 national governments to strengthen global influenza surveillance. Using World Health Organization data and program evaluation indicators collected by CDC in 2013, we retrospectively evaluated progress made 4-9 years after the start of influenza surveillance capacity strengthening in the countries. Our results showed substantial increases in laboratory and sentinel surveillance capacities, which are essential for knowing which influenza strains circulate globally, detecting emergence of novel influenza, identifying viruses for vaccine selection, and determining the epidemiology of respiratory illness. Twenty-eight of 35 countries responding to a 2013 questionnaire indicated that they have leveraged routine influenza surveillance platforms to detect other pathogens. This additional surveillance illustrates increased health-system strengthening. Furthermore, 34 countries reported an increased ability to use data in decision making; data-driven decisions are critical for improving local prevention and control of influenza around the world. PMID:27192395

  5. Improved Global Capacity for Influenza Surveillance

    PubMed Central

    Outin-Blenman, Sajata; Moen, Ann C.

    2016-01-01

    During 2004–2009, the Centers for Disease Control and Prevention (CDC) partnered with 39 national governments to strengthen global influenza surveillance. Using World Health Organization data and program evaluation indicators collected by CDC in 2013, we retrospectively evaluated progress made 4–9 years after the start of influenza surveillance capacity strengthening in the countries. Our results showed substantial increases in laboratory and sentinel surveillance capacities, which are essential for knowing which influenza strains circulate globally, detecting emergence of novel influenza, identifying viruses for vaccine selection, and determining the epidemiology of respiratory illness. Twenty-eight of 35 countries responding to a 2013 questionnaire indicated that they have leveraged routine influenza surveillance platforms to detect other pathogens. This additional surveillance illustrates increased health-system strengthening. Furthermore, 34 countries reported an increased ability to use data in decision making; data-driven decisions are critical for improving local prevention and control of influenza around the world. PMID:27192395

  6. Surveillance strategies for foot and mouth disease to prove absence of disease and absence of viral circulation.

    PubMed

    Caporale, V; Giovannini, A; Zepeda, C

    2012-12-01

    Free trade of animals and their products is based on the international or bilateral recognition of the health status of the animal populations being traded. This recognition is based on documentation of their health status by the exporting country, based on the results of continuing surveillance. According to the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), this may be based on various methods of surveillance, such as: documenting non-specific surveillance (clinical surveillance, passive notification of suspect cases, etc.); documenting activities that increase the sensitivity of non-specific surveillance (training activities, rewards/sanctions for notification/failure to notify, etc.); documenting all specific surveillance and its results (random surveys, targeted and risk-based surveillance, convenience-testing activities, etc.). Usually, the infection is the subject of the declaration of freedom. While clinical and passive surveillance can provide a high level of confidence that foot and mouth disease (FMD) infection is absent, this is not the case in vaccinated populations. In these populations, specific surveillance becomes much more important than non-specific clinical surveillance. Specific surveillance is severely restricted by the performance of the test(s) employed. The imperfect specificity of any serological test is further complicated when techniques to differentiate infected from vaccinated animals (DIVA) are used, because imperfect purification of the antigen used for vaccination may foster the production of undesired antibodies in the vaccinated animals. The authors discuss various approaches to overcome this problem; their merits and flaws in documenting the absence of infection or virus circulation for animal diseases in general, and for FMD in particular. Particular attention is paid to finding methods that can be applied in a variety of epidemiological conditions and organisational structures, since these

  7. Ebola Surveillance - Guinea, Liberia, and Sierra Leone.

    PubMed

    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

    2016-01-01

    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). PMID:27389614

  8. Digital Dashboard Design Using Multiple Data Streams for Disease Surveillance With Influenza Surveillance as an Example

    PubMed Central

    Cheng, Calvin KY; Ip, Dennis KM; Cowling, Benjamin J; Ho, Lai Ming; Leung, Gabriel M

    2011-01-01

    Background 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. Objective 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. Methods 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. Results 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. Conclusions 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

  9. Respiratory disease surveillance in Hungary

    SciTech Connect

    Agocs, M.M.; Rudnai, P.; Etzel, R.A. )

    1992-08-28

    In October 1989, the Hungarian National Institute of Hygiene initiated the Children's Acute Respiratory Morbidity (CHARM) Surveillance System to assess the association between nine reportable respiratory diseases and air pollution. The weekly number of physician-diagnosed, reportable respiratory diseases among four age groups of children (less than 1, 1-2, 3-5, and 6-14 years) was tabulated for Sopron, a city with 60,000 residents. We calculated the proportion of diseases occurring during weeks with low, moderate, and high sulfur dioxide (SO2) and nitrogen dioxide (NO2) concentrations. The weekly averages of the 24-hour median SO2 concentrations were divided into thirds at less than or equal to 17.6, greater than 17.6 to less than or equal to 26.3, and greater than 26.3 micrograms/m3 (range: 0.9-79.6 micrograms/m3), and the NO2 concentrations at less than or equal to 29.8, greater than 29.8 to less than or equal to 44.1, and greater than 44.1 micrograms/m3 (range: 4.2-90.1 micrograms/m3). During 1990, 11,474 respiratory disease cases occurred among the 4,020 children less than 15 years of age living in Sopron and monitored by the CHARM system. The two most frequently reported disease categories were rhinitis/tonsillitis/pharyngitis (71.5%) and acute bronchitis (8.5%). Sixty-seven percent of pneumonia cases occurred when SO2 concentrations were highest. We found no association between levels of NO2 and respiratory diseases. The CHARM Surveillance System may characterize more fully which groups of children develop particular respiratory diseases following exposure to air pollution.

  10. [Ethical problems in health surveillance].

    PubMed

    Toffoletto, F; Briatico Vangosa, G; Panizza, C

    2000-01-01

    Surveillance of workers' health in the field of occupational medicine poses substantial ethical problems in view of occupational medicine's complex responsibilities towards workers and employers, preventive and protection services, workers' representatives, public healthcare and preventive medicine facilities, controlling agencies and judicial authorities. Potentially conflicting rights and duties often come into play in this sector. In the last few years various international and national bodies have drawn up codes of ethics or guidelines for the conduct of physicians in occupational medicine, three of which are of particular importance: 1) The International Ethical Code of the International Commission on Occupational Health (ICOH, 1992); 2) The Code of Conduct of the National Association of Company Doctors (ANMA, 1997); 3) The Technical and Ethical Guidelines for workers' health (ILO, 1998). The chief purpose of all these documents is to safeguard the health of workers and to guarantee the safety of the workplace by defining programmes of health supervision to match specific risks. The methods should be non-invasive and should allow for a check or efficiency. The physician is expected to have a high degree of professionalism and up-to-date skills; to be independent and impartial; to be reserved and capable of inter-disciplinary co-operation. On the basis of the above documents, a number of problematic aspects may be appraised concerning the relationship between the occupational health physician responsible for the surveillance activities of the local health authority and the relative company physician. The documents stress the importance of keeping up to date and of quality, fields in which the dominant role played by Scientific Societies is underlined. Finally it is recommended that health supervision be arranged in such a manner as to foster the professionalism and responsibility of the physician in charge rather than the formal implementation of health

  11. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    PubMed

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  12. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    PubMed

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  13. Standardized rendering from IR surveillance motion imagery

    NASA Astrophysics Data System (ADS)

    Prokoski, F. J.

    2014-06-01

    Government agencies, including defense and law enforcement, increasingly make use of video from surveillance systems and camera phones owned by non-government entities.Making advanced and standardized motion imaging technology available to private and commercial users at cost-effective prices would benefit all parties. In particular, incorporating thermal infrared into commercial surveillance systems offers substantial benefits beyond night vision capability. Face rendering is a process to facilitate exploitation of thermal infrared surveillance imagery from the general area of a crime scene, to assist investigations with and without cooperating eyewitnesses. Face rendering automatically generates greyscale representations similar to police artist sketches for faces in surveillance imagery collected from proximate locations and times to a crime under investigation. Near-realtime generation of face renderings can provide law enforcement with an investigation tool to assess witness memory and credibility, and integrate reports from multiple eyewitnesses, Renderings can be quickly disseminated through social media to warn of a person who may pose an immediate threat, and to solicit the public's help in identifying possible suspects and witnesses. Renderings are pose-standardized so as to not divulge the presence and location of eyewitnesses and surveillance cameras. Incorporation of thermal infrared imaging into commercial surveillance systems will significantly improve system performance, and reduce manual review times, at an incremental cost that will continue to decrease. Benefits to criminal justice would include improved reliability of eyewitness testimony and improved accuracy of distinguishing among minority groups in eyewitness and surveillance identifications.

  14. Modernization of existing VVER-1000 surveillance programs

    SciTech Connect

    Kochkin, V.; Erak, D.; Makhotin, D.

    2011-07-01

    According to generally accepted world practice, evaluation of the reactor pressure vessel (RPV) material behavior during operation is carried out using tests of surveillance specimens. The main objective of the surveillance program consists in insurance of safe RPV operation during the design lifetime and lifetime-extension period. At present, the approaches of pressure vessels residual life validation based on the test results of their surveillance specimens have been developed and introduced in Russia and are under consideration in other countries where vodo-vodyanoi energetichesky reactors- (VVER-) 1000 are in operation. In this case, it is necessary to ensure leading irradiation of surveillance specimens (as compared to the pressure vessel wall) and to provide uniformly irradiated specimen groups for mechanical testing. Standard surveillance program of VVER-1000 has several significant shortcomings and does not meet these requirements. Taking into account program of lifetime extension of VVER-1000 operating in Russia, it is necessary to carry out upgrading of the VVER-1000 surveillance program. This paper studies the conditions of a surveillance specimen's irradiation and upgrading of existing sets to provide monitoring and prognosis of RPV material properties for extension of the reactor's lifetime up to 60 years or more. (authors)

  15. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Diagnostic surveillance program for low pathogenic avian influenza. 145.15 Section 145.15 Animals and Animal Products ANIMAL AND PLANT... antigen detection test. Memoranda of understanding or other means must be used to establish testing...

  16. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Diagnostic surveillance program for low pathogenic avian influenza. 145.15 Section 145.15 Animals and Animal Products ANIMAL AND PLANT... antigen detection test. Memoranda of understanding or other means must be used to establish testing...

  17. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Diagnostic surveillance program for low pathogenic avian influenza. 145.15 Section 145.15 Animals and Animal Products ANIMAL AND PLANT... antigen detection test. Memoranda of understanding or other means must be used to establish testing...

  18. Sustaining surveillance: Evaluating syndromic surveillance in the Pacific

    PubMed Central

    Paterson, Beverley J.; Kool, Jacob L.; Durrheim, David N.; Pavlin, Boris

    2012-01-01

    Prior to the 2009 H1N1 pandemic, the Pacific Island Countries and Territories (PICTs) had agreed to develop a standardised, simple syndromic surveillance system to ensure compliance with International Health Regulations requirements (rapid outbreak detection, information sharing and response to outbreaks). In October 2010, the new system was introduced and over the next 12 months implemented in 20 of 22 PICTs. An evaluation was conducted to identify strengths and weaknesses of the system, ease of use and possible points for improvement. An in-country quantitative and qualitative evaluation in five PICTs identified that the most important determinants of the system's success were: simplicity of the system; support from all levels of government; clearly defined roles and responsibilities; feedback to those who collect the data; harmonisation of case definitions; integration of data collection tools into existing health information systems; and availability of clinical and epidemiological advice from external agencies such as the World Health Organization and the Secretariat of the Pacific Community. Regional reporting of alerts, outbreaks and outbreak updates has dramatically increased since implementation of the system. This syndromic system will assist PICTs to detect future influenza pandemics and other emerging infectious diseases and to rapidly contain outbreaks in the Pacific. PMID:22817479

  19. Sustaining surveillance: evaluating syndromic surveillance in the Pacific.

    PubMed

    Paterson, Beverley J; Kool, Jacob L; Durrheim, David N; Pavlin, Boris

    2012-01-01

    Prior to the 2009 H1N1 pandemic, the Pacific Island Countries and Territories (PICTs) had agreed to develop a standardised, simple syndromic surveillance system to ensure compliance with International Health Regulations requirements (rapid outbreak detection, information sharing and response to outbreaks). In October 2010, the new system was introduced and over the next 12 months implemented in 20 of 22 PICTs. An evaluation was conducted to identify strengths and weaknesses of the system, ease of use and possible points for improvement. An in-country quantitative and qualitative evaluation in five PICTs identified that the most important determinants of the system's success were: simplicity of the system; support from all levels of government; clearly defined roles and responsibilities; feedback to those who collect the data; harmonisation of case definitions; integration of data collection tools into existing health information systems; and availability of clinical and epidemiological advice from external agencies such as the World Health Organization and the Secretariat of the Pacific Community. Regional reporting of alerts, outbreaks and outbreak updates has dramatically increased since implementation of the system. This syndromic system will assist PICTs to detect future influenza pandemics and other emerging infectious diseases and to rapidly contain outbreaks in the Pacific. PMID:22817479

  20. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media. PMID:27220801

  1. Observational postmarketing study on efficacy and safety of novel generic risperidone risset(r) in patients with acute or chronic schizophrenic or other related psychosis.

    PubMed

    Kucukalić, Abdulah; Srkalović, Azijada Pasicek; Oremus, Marijana; Rustempasić, Edhem

    2004-06-01

    Objective. The aim of this study was to establish the effectiveness and safety of risperidone (Risset(R) - PLIVA) in patients with acute or chronic schizophrenic or other related psychosis. Study was designed as postmarketing, 4-week, open-label, flexible-dose observational study. Subjects and Methods. 30 patients, both genders, aged 18-70 years, with diagnosed various types of schizophrenic psychosis were enrolled in the study as outpatient and inpatient setting. The patients had to have a total score >/=40 on Positive and Negative scale - two parts of the Positive and Negative Syndrome Scale (PANSS), and to be able to discontinue current antipsychotic and antiparkinsonian medications. The primary efficacy parameter was the percent of score difference between baseline and week 4 of therapy on two above-mentioned PANSS subscales. The difference was considered as significant improvement if decrease from the baseline was 20% or more. The safety of risperidone was evaluated on the basis of reported adverse events. Results. All 30 enrolled patients completed the study. After the 4 weeks of treatment, 23/30 patients (76.67%) had clinically significant improvement of 20% or more decreased total PANSS score (Positive and Negative subscale). In 4/30 patients (13.33%) clinical improvement was also reported with <20% decreased total PANSS score. No serious adverse event was observed. Conclusions. Overall, collected data indicate that in this specific population (70% patients were resistant to previous anti-psychotic therapy), Risset(R) has shown very good effectiveness and safety. PMID:19114946

  2. The U.S.-Mexico Border Infectious Disease Surveillance Project: Establishing Binational Border Surveillance

    PubMed Central

    Waterman, Stephen; Lucas, Carlos Alvarez; Falcon, Veronica Carrion; Morales, Pablo Kuri; Lopez, Luis Anaya; Peter, Chris; Gutiérrez, Alejandro Escobar; Gonzalez, Ernesto Ramirez; Flisser, Ana; Bryan, Ralph; Valle, Enrique Navarro; Rodriguez, Alfonso; Hernandez, Gerardo Alvarez; Rosales, Cecilia; Ortiz, Javier Arias; Landen, Michael; Vilchis, Hugo; Rawlings, Julie; Leal, Francisco Lopez; Ortega, Luis; Flagg, Elaine; Conyer, Roberto Tapia; Cetron, Martin

    2003-01-01

    In 1997, the Centers for Disease Control and Prevention, the Mexican Secretariat of Health, and border health officials began the development of the Border Infectious Disease Surveillance (BIDS) project, a surveillance system for infectious diseases along the U.S.-Mexico border. During a 3-year period, a binational team implemented an active, sentinel surveillance system for hepatitis and febrile exanthems at 13 clinical sites. The network developed surveillance protocols, trained nine surveillance coordinators, established serologic testing at four Mexican border laboratories, and created agreements for data sharing and notification of selected diseases and outbreaks. BIDS facilitated investigations of dengue fever in Texas-Tamaulipas and measles in California–Baja California. BIDS demonstrates that a binational effort with local, state, and federal participation can create a regional surveillance system that crosses an international border. Reducing administrative, infrastructure, and political barriers to cross-border public health collaboration will enhance the effectiveness of disease prevention projects such as BIDS. PMID:12533288

  3. Space Surveillance Catalog growth during SBIRS low deployment.

    NASA Astrophysics Data System (ADS)

    Hoult, C. P.; Wright, R. P.

    The Space Surveillance Catalog is a database of all Resident Space Objects (RSOs) on Earth orbit. It is expected to grow in the future as more RSOs accumulate on orbit. Potentially still more dramatic growth could follow the deployment of the Space Based Infrared System Low Earth Orbit Component (SBTRS Low). SBIRS Low, currently about to enter development, offers the potential to detect and acquire much smaller debris RSOs than can be seen by the current ground-based Space Surveillance Network (SSN). SBIRS Low will host multicolor infrared/visible sensors on each satellite in a proliferated constellation on low Earth orbit, and if appropriately tasked, these sensors could provide significant space surveillance capability. Catalog growth during SBIRS Low deployment was analyzed using a highly aggregated code that numerically integrates the Markov equations governing the state transitions of RSOs from uncataloged to cataloged, and back again. It was assumed that all newly observed debris RSOs will be detected as by-products of routine Catalog maintenance, not including any post breakup searches, and if sufficient sensor resources are available, be acquired into the Catalog. Debris over the entire low to high altitude regime were considered.

  4. Disease surveillance in England and Wales, June 2016.

    PubMed

    2016-07-01

    Targeted surveillance for bluetongue virus beginsHighlights from the scanning surveillance networkUpdate on international disease threatsMonitoring of colistin resistance in pigs in scanning surveillance submissions These are among matters discussed in the Animal and Plant Health Agency's (APHA's) June disease surveillance report. PMID:27365239

  5. Cyber-Surveillance: A Case Study in Policy and Development

    ERIC Educational Resources Information Center

    Kim, Richard S. Y.

    2010-01-01

    The dissertation examines the historical development of surveillance, electronic surveillance, and cyber-surveillance from colonial times in the United States to the present. It presents the surveillance laws, technologies and policies as a balance between national security and privacy. To examine more recent developments, the dissertation…

  6. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan...

  7. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan...

  8. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan...

  9. 48 CFR 237.172 - Service Contracts Surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Surveillance. 237.172 Section 237.172 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS...-General 237.172 Service Contracts Surveillance. Ensure that quality assurance surveillance plans are....) Retain quality assurance surveillance plans in the official contract file. See https://sam.dau.mil,...

  10. 48 CFR 237.172 - Service Contracts Surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Surveillance. 237.172 Section 237.172 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS...-General 237.172 Service Contracts Surveillance. Ensure that quality assurance surveillance plans are....) Retain quality assurance surveillance plans in the official contract file. See https://sam.dau.mil,...

  11. 48 CFR 237.172 - Service Contracts Surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Surveillance. 237.172 Section 237.172 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS...-General 237.172 Service Contracts Surveillance. Ensure that quality assurance surveillance plans are....) Retain quality assurance surveillance plans in the official contract file. See https://sam.dau.mil,...

  12. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan...

  13. 48 CFR 237.172 - Service Contracts Surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Surveillance. 237.172 Section 237.172 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS...-General 237.172 Service Contracts Surveillance. Ensure that quality assurance surveillance plans are....) Retain quality assurance surveillance plans in the official contract file. See https://sam.dau.mil,...

  14. 48 CFR 237.172 - Service Contracts Surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Surveillance. 237.172 Section 237.172 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS...-General 237.172 Service Contracts Surveillance. Ensure that quality assurance surveillance plans are....) Retain quality assurance surveillance plans in the official contract file. See https://sam.dau.mil,...

  15. Evaluation of historical dry well surveillance logs

    SciTech Connect

    Price, R.K.

    1996-09-09

    Several dry well surveillance logs from 1975 through 1995 for the SX Tank Farm have been examined to identify potential subsurface zones of radioactive contaminant migration. Several dynamic conditions of the gamma-ray emitting radioactive contaminant shave been identified.

  16. NATIONAL RESPIRATORY AND ENTERIC VIRUS SURVEILLANCE SYSTEM

    EPA Science Inventory

    The National Respiratory and Enteric Virus Surveillance System is a lab based system which monitors temporal and geographic patterns associated with the detection of respiratory syncytial virus (RSV), human parainfluenza viruses (HPIV), respiratory and enteric adenoviruses, and r...

  17. Surveillance, Epidemiology, and End Results Program

    Cancer.gov

    A premier source for cancer statistics in the US. We collect incidence, prevalence and survival data and publish reports on these and cancer mortality. For those interested in cancer statistics and surveillance methods.

  18. Hanford Site Environmental Surveillance Master Sampling Schedule

    SciTech Connect

    Bisping, Lynn E.

    2000-01-27

    This document contains the CY2000 schedules for the routine collection of samples for the Surface Environmental Surveillance Project (SESP) and Drinking Water Monitoring Project. Each section includes sampling locations, sample types, and analyses to be performed.

  19. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic installations... RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic...

  20. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic installations... RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic...

  1. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic installations... RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic...

  2. [Health surveillance: foundations, interfaces and tendencies].

    PubMed

    Arreaza, Antonio Luis Vicente; de Moraes, José Cássio

    2010-07-01

    The present article rescues initially the forms, content and operational projection of the epidemiological surveillance as indispensable tool for the knowledge field and public health practices. After that, we verify that the health surveillance model establishes an enlargement of this operational concept of surveillance by integrating the collectives and individuals practices in different health necessities dimensions, which includes beyond of the risks and damages control also the eco-socials determinants. In the sequence, we search to dimension the distinct levels of actuation of this sanitary practice articulated to the interventions of promotion, protection and recovery under a located and integrated logic of the unique system of Brazilian health. Finally, we argue that all the conceptual-operational model framework of public health surveillance itself constitutes as a politics and sanitary base for the consolidation of the health promotion paradigm in the collective health field. PMID:20694344

  3. NATIONAL NOSOCOMIAL INFECTIONS SURVEILLANCE SYSTEM (NNIS)

    EPA Science Inventory

    The National Nosocomial Infections Surveillance (NNIS) System is a cooperative effort that began in 1970 between the Centers for Disease Control and Prevention (CDC) and participating hospitals to create a national nosocomial infections database. The database is used to describe ...

  4. Surveillance and Monitoring of Dialysis Access

    PubMed Central

    Kumbar, Lalathaksha; Karim, Jariatul; Besarab, Anatole

    2012-01-01

    Vascular access is the lifeline of a hemodialysis patient. Currently arteriovenous fistula and graft are considered the permanent options for vascular access. Monitoring and surveillance of vascular access are an integral part of the care of hemodialysis patient. Although different techniques and methods are available for identifying access dysfunction, the scientific evidence for the optimal methodology is lacking. A small number of randomized controlled trials have been performed evaluating different surveillance techniques. We performed a study of the recent literature published in the PUBMED, to review the scientific evidence on different methodologies currently being used for surveillance and monitoring and their impact on the care of the dialysis access. The limited randomized studies especially involving fistulae and small sample size of the published studies with conflicting results highlight the need for a larger multicentered randomized study with hard clinical end points to evaluate the optimal surveillance strategy for both fistula and graft. PMID:22164333

  5. TRAUMATIC BRAIN INJURY SURVEILLANCE SYSTEM (TBISS)

    EPA Science Inventory

    The National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC) had developed and maintains a surveillance system to understand the magnitude and characteristics of hospitalized and fatal traumatic brain injuries in the United State...

  6. Medical Surveillance Requirements For Nonionizing Radiation Workers

    NASA Astrophysics Data System (ADS)

    Hathaway, James A.

    1980-10-01

    The potential value of medical surveillance examinations for laser workers and other workers potentially exposed to high intensity optical radiation is evaluated. A review of the known adverse biological effects leads to the conclusion that most effects are related to acute and subacute exposures which do not lend themselves to effective medical surveillance. In addition, surveys of thousands of laser workers conducted since 1965 demonstrated that routine periodic medical surveillance has been unnecessary and/or impractical using currently available ophthalmic screening methods. Examination techniques to detect early changes in cataract formation or retinal degeneration (two potential chronic effects of optical radiation) are not sufficiently reliable or specific to be of value as routine screening tests. Epidemiologic studies of large worker groups are suggested to evaluate the potential for these chronic conditions to develop as the result of job exposure; however, specific recommendations for routine medical surveillance are limited to preplacement and termination examinations with appropriate evaluation of individuals following acute injury.

  7. Immune surveillance for ERAAP dysfunction.

    PubMed

    Nagarajan, Niranjana A; Shastri, Nilabh

    2013-09-01

    The ER aminopeptidase associated with antigen processing, ERAAP (or ERAP1), is essential for trimming peptides that are presented by MHC class I molecules. ERAP1 is inhibited by human cytomegalovirus, and ERAP1 polymorphisms are associated with autoimmune diseases. How the immune system detects ERAAP dysfunction, however, is unknown. We have shown previously that ERAAP-deficient cells present an immunogenic pMHC I repertoire, that elicits CD8+ T cell response in WT mice. Additionally, we discovered that the WT CD8+ T cells recognized novel peptides presented by non-classical, or MHC class Ib, molecules on ERAAP-deficient cells. The MHC Ib restricted WT CD8 T cells eliminated ERAAP-deficient cells in vitro and in vivo. We identified the FL9 peptide, presented by Qa-1(b), a MHC class Ib molecule exclusively on ERAAP-deficient cells. Remarkably, T cells specific for the FL9-Qa-1(b) complex were frequent in naïve WT mice, and had an antigen-experienced phenotype. Thus, novel non-classical pQa-1(b) complexes direct cytotoxic T cells to target cells with defective peptide processing in the endoplasmic reticulum. Here, we discuss the implications of our findings, and the possible roles of pMHC Ib-specific T cells in immune surveillance for ERAAP dysfunction. PMID:23433779

  8. Malaria elimination: surveillance and response

    PubMed Central

    Bridges, Daniel J; Winters, Anna M; Hamer, Davidson H

    2012-01-01

    In the last decade, substantial progress has been made in reducing malaria-associated morbidity and mortality across the globe. Nevertheless, sustained malaria control is essential to continue this downward trend. In some countries, where aggressive malaria control has reduced malaria to a low burden level, elimination, either nationally or subnationally, is now the aim. As countries or areas with a low malaria burden move towards elimination, there is a transition away from programs of universal coverage towards a strategy of localized detection and response to individual malaria cases. To do so and succeed, it is imperative that a strong surveillance and response system is supported, that community cadres are trained to provide appropriate diagnostics and treatment, and that field diagnostics are further developed such that their sensitivity allows for the detection and subsequent treatment of malaria reservoirs in low prevalence environments. To be certain, there are big challenges on the road to elimination, notably the development of drug and insecticide resistance. Nevertheless, countries like Zambia are making great strides towards implementing systems that support malaria elimination in target areas. Continued development of new diagnostics and antimalarial therapies is needed to support progress in malaria control and elimination. PMID:23265423

  9. Hanford Site Environmental Surveillance Master Sampling Schedule

    SciTech Connect

    Bisping, Lynn E.

    2002-01-16

    Environmental surveillance of the Hanford Site and surrounding areas is conducted by Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy (DOE). Sampling is conducted to evaluate levels of radioactive and nonradioactive pollutants in the Hanford environs. The document contains the CY 2002 schedules for the routine collection of samples for the Surface Environmental Surveillance Project (SESP) and Drinking Water Monitoring Project.

  10. Tank Farm Operations Surveillance Automation Analysis

    SciTech Connect

    MARQUEZ, D.L.

    2000-12-21

    The Nuclear Operations Project Services identified the need to improve manual tank farm surveillance data collection, review, distribution and storage practices often referred to as Operator Rounds. This document provides the analysis in terms of feasibility to improve the manual data collection methods by using handheld computer units, barcode technology, a database for storage and acquisitions, associated software, and operational procedures to increase the efficiency of Operator Rounds associated with surveillance activities.

  11. Enhanced surveillance program FY1998 accomplishments

    SciTech Connect

    Kass, J

    1998-10-01

    This report highlights the accomplishments of the Enhanced Surveillance Program (ESP), the highest-priority research and development effort in stockpile management today. This is volume one of eleven, the unclassified summary of selected program highlights. These highlights fall into the following focus areas: pits, high explosives, organics, dynamics, diagnostics, systems, secondaries, materials-aging models, non-nuclear components, and routine surveillance testing system upgrades. Principal investigators from around the DOE complex contributed to this report.

  12. Public health surveillance and infectious disease detection.

    PubMed

    Morse, Stephen S

    2012-03-01

    Emerging infectious diseases, such as HIV/AIDS, SARS, and pandemic influenza, and the anthrax attacks of 2001, have demonstrated that we remain vulnerable to health threats caused by infectious diseases. The importance of strengthening global public health surveillance to provide early warning has been the primary recommendation of expert groups for at least the past 2 decades. However, despite improvements in the past decade, public health surveillance capabilities remain limited and fragmented, with uneven global coverage. Recent initiatives provide hope of addressing this issue, and new technological and conceptual advances could, for the first time, place capability for global surveillance within reach. Such advances include the revised International Health Regulations (IHR 2005) and the use of new data sources and methods to improve global coverage, sensitivity, and timeliness, which show promise for providing capabilities to extend and complement the existing infrastructure. One example is syndromic surveillance, using nontraditional and often automated data sources. Over the past 20 years, other initiatives, including ProMED-mail, GPHIN, and HealthMap, have demonstrated new mechanisms for acquiring surveillance data. In 2009 the U.S. Agency for International Development (USAID) began the Emerging Pandemic Threats (EPT) program, which includes the PREDICT project, to build global capacity for surveillance of novel infections that have pandemic potential (originating in wildlife and at the animal-human interface) and to develop a framework for risk assessment. Improved understanding of factors driving infectious disease emergence and new technological capabilities in modeling, diagnostics and pathogen identification, and communications, such as using the increasing global coverage of cellphones for public health surveillance, can further enhance global surveillance. PMID:22455675

  13. Surveillance and Diagnosis of Hepatocellular Carcinoma

    PubMed Central

    Fitzmorris, Paul

    2015-01-01

    Hepatocellular carcinoma (HCC) is an important cause of cancer-related death worldwide. If the disease is detected early, the treatment is more likely to be curative. This article discusses the current evidence regarding the surveillance and diagnosis of HCC, focusing on recent articles and the recommendations of the American Association for the Study of Liver Diseases (AASLD), which are briefly compared with the recommendations of other liver disease organizations. HCC surveillance aims to detect disease at an early stage in order to augment the likelihood of curative treatment. According to AASLD recommendations, patients who have cirrhosis and those who do not have cirrhosis but are at high risk for HCC should be screened. Ultrasonogra-phy (USG) at 6-month intervals is recommended. The available serologic markers, including serum alpha-fetoprotein, are inadequate for surveillance, even when combined with USG. Despite achievements in HCC management, physicians continue to underutilize surveillance. Quadruple-phase, contrast-enhanced computed tomography scans or magnetic resonance images with characteristic radiologic findings are commonly used to diagnose HCC in suspicious cases. The available surveillance and diagnostic tests effectively identify HCC at an early stage, and as a result, the chances of cure are increased. Physicians caring for patients who have cirrhosis and chronic liver disease should be familiar with HCC surveillance recommendations and the prognostic importance of early diagnosis. PMID:27099571

  14. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

  15. Surveillance test bed for SDIO

    NASA Astrophysics Data System (ADS)

    Wesley, Michael; Osterheld, Robert; Kyser, Jeff; Farr, Michele; Vandergriff, Linda J.

    1991-08-01

    The Surveillance Test Bed (STB) is a program under development for the Strategic Defense Initiative Organization (SDIO). Its most salient features are (1) the integration of high fidelity backgrounds and optical signal processing models with algorithms for sensor tasking, bulk filtering, track/correlation and discrimination and (2) the integration of radar and optical estimates for track and discrimination. Backgrounds include induced environments such as nuclear events, fragments and debris, and natural environments, such as earth limb, zodiacal light, stars, sun and moon. At the highest level of fidelity, optical emulation hardware combines environmental information with threat information to produce detector samples for signal processing algorithms/hardware under test. Simulation of visible sensors and radars model measurement degradation due to the various environmental effects. The modeled threat is composed of multiple object classes. The number of discrimination classes are further increased by inclusion of fragments, debris and stars. High fidelity measurements will be used to drive bulk filtering algorithms that seek to reject fragments and debris and, in the case of optical sensors, stars. The output of the bulk filters will be used to drive track/correlation algorithms. Track algorithm output will include sequences of measurements that have been degraded by backgrounds, closely spaced objects (CSOs), signal processing errors, bulk filtering errors and miscorrelations; these measurements will be presented as input to the discrimination algorithms. The STB will implement baseline IR track file editing and IR and radar feature extraction and classification algorithms. The baseline will also include data fusion algorithms which will allow the combination of discrimination estimates from multiple sensors, including IR and radar; alternative discrimination algorithms may be substituted for the baseline after STB completion.

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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. PMID:26769996

  18. Using Poison Center Data for Postdisaster Surveillance

    PubMed Central

    Wolkin, Amy; Schnall, Amy H.; Law, Royal; Schier, Joshua

    2015-01-01

    The role of public health surveillance in disaster response continues to expand as timely, accurate information is needed to mitigate the impact of disasters. Health surveillance after a disaster involves the rapid assessment of the distribution and determinants of disaster-related deaths, illnesses, and injuries in the affected population. Public health disaster surveillance is one mechanism that can provide information to identify health problems faced by the affected population, establish priorities for decision makers, and target interventions to meet specific needs. Public health surveillance traditionally relies on a wide variety of data sources and methods. Poison center (PC) data can serve as data sources of chemical exposures and poisonings during a disaster. In the US, a system of 57 regional PCs serves the entire population. Poison centers respond to poison-related questions from the public, health care professionals, and public health agencies. The Centers for Disease Control and Prevention (CDC) uses PC data during disasters for surveillance of disaster-related toxic exposures and associated illnesses to enhance situational awareness during disaster response and recovery. Poison center data can also be leveraged during a disaster by local and state public health to supplement existing surveillance systems. Augmenting traditional surveillance data (ie, emergency room visits and death records) with other data sources, such as PCs, allows for better characterization of disaster-related morbidity and mortality. Poison center data can be used during a disaster to detect outbreaks, monitor trends, track particular exposures, and characterize the epidemiology of the event. This timely and accurate information can be used to inform public health decision making during a disaster and mitigate future disaster-related morbidity and mortality. PMID:25205009

  19. Factor XI replacement for inherited factor XI deficiency in routine clinical practice: results of the HEMOLEVEN prospective 3-year postmarketing study

    PubMed Central

    Bauduer, F; de Raucourt, E; Boyer-Neumann, C; Trossaert, M; Beurrier, P; Faradji, A; Peynet, J; Borg, J-Y; Chamouni, P; Chatelanaz, C; Henriet, C; Bridey, F; Goudemand, J

    2015-01-01

    Factor XI (FXI)-deficient patients may develop excessive bleeding after trauma or surgery. Replacement therapy should be considered in high-risk situations, especially when FXI levels are below 20 IU dL−1. HEMOLEVEN is a human plasma-derived factor XI concentrate available in France since 1992, but there are few data regarding its use by physicians. This prospective study assessed the use, efficacy and safety of HEMOLEVEN in common clinical practice. HEMOLEVEN was evaluated in FXI-deficient patients in 13 French centres in a 3-year postmarketing study. Forty-four patients (30 females, 14 males) received 67 treatments. The median age was 37 years (8 months–91 years). Basal FXI levels were <1 to 51 IU dL−1 (median: 5.5); 29 patients were severely FXI-deficient (<20 IU dL−1). FXI was administered prophylactically before 43 surgical procedures, 10 invasive procedures, 8 vaginal deliveries, or as curative treatment for six bleeds. The efficacy was assessed as excellent/good in 63, moderate in two and undetermined in two treatments. Seven patients experienced seven adverse effects, including two rated as serious: one sudden massive pulmonary embolism with fatal outcome and one case of inhibitor to FXI. HEMOLEVEN is effective for bleeding prevention in FXI deficiency. However, considering the benefit/risk ratio observed in relation to dosage in this study; firstly, it should be used sparingly due to its potential prothrombotic effect; secondly, new prescription procedures should be defined to adapt the dosage, especially in patients with intrinsic and/or acquired risk factors for thrombosis. PMID:25817556

  20. Radiation surveillance using an unmanned aerial vehicle.

    PubMed

    Pöllänen, Roy; Toivonen, Harri; Peräjärvi, Kari; Karhunen, Tero; Ilander, Tarja; Lehtinen, Jukka; Rintala, Kimmo; Katajainen, Tuure; Niemelä, Jarkko; Juusela, Marko

    2009-02-01

    Radiation surveillance equipment was mounted in a small unmanned aerial vehicle. The equipment consists of a commercial CsI detector for count rate measurement and a specially designed sampling unit for airborne radioactive particles. Field and flight tests were performed for the CsI detector in the area where (137)Cs fallout from the Chernobyl accident is 23-45 kBq m(-2). A 3-GBq (137)Cs point source could be detected at the altitude of 50 m using a flight speed of 70 km h(-1) and data acquisition interval of 1s. Respective response for (192)Ir point source is 1 GBq. During the flight, the detector reacts fast to ambient external dose rate rise of 0.1 microSv h(-1), which gives for the activity concentration of (131)I less than 1 kB qm(-3). Operation of the sampler equipped with different type of filters was investigated using wind-tunnel experiments and field tests with the aid of radon progeny. Air flow rate through the sampler is 0.2-0.7 m(3)h(-1) at a flight speed of 70 km h(-1) depending on the filter type in question. The tests showed that the sampler is able to collect airborne radioactive particles. Minimum detectable concentration for transuranium nuclides, such as (239)Pu, is of the order of 0.2 Bq m(-3) or less when alpha spectrometry with no radiochemical sample processing is used for activity determination immediately after the flight. When a gamma-ray spectrometer is used, minimum detectable concentrations for several fission products such as (137)Cs and (131)I are of the order of 1 Bq m(-3). PMID:19046635