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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. Postmarketing surveillance for drug abuse.

    PubMed

    Arfken, Cynthia L; Cicero, Theodore J

    2003-06-01

    Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested. The two specific surveillance systems are compared with limitations highlighted. Postmarketing surveillance is in its infancy and requires more research on ways to improve its validity without inducing illicit experimentation. Information on comparator medications is highly recommended both to validate the system and to place the results in context.

  3. Postmarketing surveillance of food additives.

    PubMed

    Butchko, H H; Tschanz, C; Kotsonis, F N

    1994-08-01

    Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the acceptable daily intake of a food additive. Surveillance of anecdotal reports of adverse health effects is used to determine the presence of infrequent idiosyncratic responses that may not be predictable from premarket evaluations. The high-intensity sweetner, aspartame, is a food additive that has been the subject of extensive evaluation during the postmarketing period and is thus used as an example to discuss postmarketing surveillance.

  4. Development, production, and postmarketing surveillance of hepatitis A vaccines in China.

    PubMed

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

    2014-01-01

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

  5. New horizons in post-marketing surveillance.

    PubMed

    Waller, P; Wood, S

    1993-01-01

    Post-marketing surveillance is the process of monitoring and evaluating the safety of marketed medicines using a variety of methods. However, many doctors believe that post-marketing surveillance has a more limited meaning, ie an observational study of a new medicine sponsored by a pharmaceutical company. Although such studies were performed extensively in the United Kingdom during the 1980s, few have been published. Their purpose was to study large populations of users in ordinary practice with the aim of identifying hazards that had been missed, because clinical trials were too small, too short or did not always reflect real life. To some extent these studies have now fallen into disrepute, both on scientific grounds and because they have often been thought to be a thinly-disguised promotional exercise. The purpose of this article is to examine some of the previous problems with post-marketing surveillance and to propose new directions for the future.

  6. 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

    ... Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle AGENCY: Food and Drug... Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle... relatively short, product life-cycle. For these reasons, FDA's Center for Devices and Radiological...

  7. Role of postmarketing surveillance in contemporary medicine.

    PubMed

    Woodcock, Janet; Behrman, Rachel E; Dal Pan, Gerald J

    2011-01-01

    Contemporary medicine is a large and complex system involving many participants, all of whom play a critical role in managing the risks intrinsic to medical product use. Despite the robust premarket review and approval process of the U.S. Food and Drug Administration (FDA), new information will inevitably be learned in the postmarketing period about the safety of medicines and how they are and should be used. For much of this information, FDA relies on public reports about possible adverse events. In turn, the public depends on FDA to communicate the most up-to-date safety information on medical products to better inform treatment decisions. Expanding the scope and strengthening the capabilities of the drug safety surveillance system are among key FDA projects designed to reduce avoidable injury and death from medication use. Although improving drug safety is our goal and obligation to the public, FDA cannot protect the public adequately without the active involvement of all participants in healthcare. PMID:20809798

  8. Postmarketing surveillance of abuse liability of sibutramine.

    PubMed

    Arfken, Cynthia L; Schuster, Charles R; Johanson, Chris-Ellyn

    2003-03-01

    The abuse liability of medications is a growing concern as the number of newly approved psychoactive medications increases. Postmarketing surveillance can assist in determining abuse liability, but strategies are not well-defined for medications believed to be at low abuse risk. Using a newly approved medication (sibutramine--an anorectic drug), a novel approach to postmarketing abuse surveillance was introduced. A one-page anonymous questionnaire covering sibutramine, a scheduled anorectic drug (phentermine), and a fabricated name was added to the intake process of 58 treatment programs. From the 8780 completed questionnaires, 8.8% had heard of sibutramine and phentermine. For continued use to get high (a proxy for abuse), the rate for sibutramine was lower than for phentermine (0.6 vs. 2.2%, McNemar's chi(2) = 110.45, P < 0.001) but was higher than for the fabricated name (0.6 vs. 0.3%, McNemar's chi(2) = 11.86, P < 0.001). These results suggest the risk of abuse associated with sibutramine was lower than that associated with a known abused drug, one that itself is considered low risk despite decades of population exposure. The relatively high rate of hearing of sibutramine may be due to the direct-to-consumer advertisement. This approach is only one indicator in a surveillance framework but appears promising and validates findings from laboratory-based abuse liability studies that also indicate low abuse liability for sibutramine.

  9. Postmarketing surveillance of quinolones, 1990 to 1992.

    PubMed

    Davey, P; McDonald, T

    1993-01-01

    During the last 2 years, the major event in the postmarketing surveillance of quinolones has been the worldwide withdrawal of temafloxacin after only 15 weeks on the USA market. The Adverse Drug Reaction (ADR) reports that led to the withdrawal have been reviewed and show that the frequency and type of ADR and serious ADR were highly unusual in comparison with other quinolones marketed in the USA (ciprofloxacin, norfloxacin and ofloxacin). The difficulty in establishing causality between drugs and ADRs is discussed. Prescription event monitoring and computerised databases are beginning to reach the size required to pick up rare ADRs but, even so, they can only establish association rather than causality. Perhaps a more important question is the issue of acceptable risk. This requires better definition in order to apply decision analysis to the options available for the treatment of bacterial infections. PMID:7689451

  10. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false When, where, and how must I submit my postmarket 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 §...

  11. 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 AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance...

  12. 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

  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. The rationale for a post-marketing surveillance.

    PubMed

    Westerholm, B

    1987-01-01

    Post-marketing surveillance is essential in order to protect patients against avoidable risks from medication. Complete assessment of a drug cannot, for practical reasons, be made before marketing. There are several methods which can be used in post-marketing surveillance. Spontaneous reporting on adverse drug reactions is a quick method, but underreporting is a problem. Intensive monitoring gives high quality data but is expensive. Health registers can be used to trace cases for case-control studies but diagnoses are sometimes incorrect. Prospective studies is an informative way to obtain results but they take time. Data on drug utilization are also valuable because they give an estimate of the size of the population using a particular drug. They also reveal whether warnings about adverse drug reactions have had any effect on the prescribing pattern.

  15. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...The Food and Drug Administration (FDA) is announcing the following public meeting entitled ``Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance system in the United...

  16. Patient-initiated postmarketing surveillance: a validation study.

    PubMed

    Fisher, S; Bryant, S G; Solovitz, B L; Kluge, R M

    1987-11-01

    A new patient-initiated, pharmacy-based postmarketing surveillance system is described. At the time a new prescription for a targeted drug was filled, 2705 outpatients (experimentals) randomly assigned to the new system had a printed notice attached to their medication bags: the information requested them to report any "new or unusual symptoms" during the next 2 weeks by a toll-free telephone number to a trained nonprofessional who conducted a standardized adverse drug reaction (ADR) interview. To help validate the new system, another sample of 1109 patients (controls) did not receive a request for self-monitoring but were interviewed by telephone 2 weeks later. Target drugs were chosen from two classes for which side effect profiles are well identified: oral antibiotics and tricyclic antidepressants. Results show that within both drug classes, all patient-initiated reports closely matched those obtained from controls; the experimental and control groups also reported predictably high relative frequencies for the most commonly expected ADRs. Additional analyses suggest that a patient-initiated monitoring system could prove to be a promising complement to existing physician-based surveillance systems. PMID:3429691

  17. 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 postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION... surveillance or modify your postmarket surveillance because you no longer market the device. We will make...

  18. 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 postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION... surveillance or modify your postmarket surveillance because you no longer market the device. We will make...

  19. Postmarketing drug surveillance by record linkage in Tayside.

    PubMed

    Crombie, I K; Brown, S V; Hamley, J G

    1984-09-01

    The feasibility of conducting postmarketing drug surveillance by record linkage in Tayside was assessed. The key feature of the method is that all hospital discharge data are already computerised by the area health board and may be accessed through the unique community health number (CHNo) which has been allocated to all Tayside residents. The 12 861 prescriptions for cimetidine dispensed in Tayside over a nine month period were collected and the CHNo identified for 76%. These corresponded to 3802 individuals and their discharge data, together with those for an equal number of controls matched by age, sex, and general practitioner were retrieved from the computer. The expected excess of those diseases for which cimetidine is prescribed (peptic ulcer and oesophagitis) was observed. Other drug-disease associations were observed but may have been due to confounding and emphasise the inadequacy of community based controls. The major advantages of record linkage are, firstly, the low cost of the method, the present study costing just over pounds 12 000, and, secondly, the duration of patient follow up which may may be extended for as many years as required simply by rerunning the computer programs. To assemble large patient cohorts the study would have to be extended to other area health boards that are currently developing similar computer systems. Record linkage may provide a cost effective method for the follow up of patients to identify serious adverse drug reactions, particularly those that take several years to develop.

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

    PubMed

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

    2013-09-01

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

  1. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

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

  2. 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

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What should I consider when designing my plan to conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE...

  3. 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

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What should I consider when designing my plan to conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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

  9. Electronic Health Data for Postmarket Surveillance: A Vision Not Realized.

    PubMed

    Moore, Thomas J; Furberg, Curt D

    2015-07-01

    What has been learned about electronic health data as a primary data source for regulatory decisions regarding the harms of drugs? Observational studies with electronic health data for postmarket risk assessment can now be conducted in Europe and the US in patient populations numbering in the tens of millions compared with a few hundred patients in a typical clinical trial. With standard protocols, results can be obtained in a few months; however, extensive research published by scores of investigators has illuminated the many obstacles that prevent obtaining robust, reproducible results that are reliable enough to be a primary source for drug safety decisions involving the health and safety of millions of patients. The most widely used terminology for coding patient interactions with medical providers for payment has proved ill-suited to identifying the adverse effects of drugs. Directly conflicting results were reported in otherwise similar patient health databases, even using identical event definitions and research methods. Evaluation of some accepted statistical methods revealed systematic bias, while others appeared to be unreliable. When electronic health data studies detected no drug risk, there were no robust and accepted standards to judge whether the drug was unlikely to cause the adverse effect or whether the study was incapable of detecting it. Substantial investment and careful thinking is needed to improve the reliability of risk assessments based on electronic health data, and current limitations need to be fully understood. PMID:26025018

  10. 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

  11. 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... notify you that you may stop your surveillance study....

  12. 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... notify you that you may stop your surveillance study....

  13. 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... notify you that you may stop your surveillance study....

  14. 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

  15. Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

    PubMed

    Silva, I R; Kulldorff, M

    2015-09-01

    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.

  16. [The problem of post-marketing surveillance planning on drugs for infectious disease].

    PubMed

    Sato, J

    2001-12-01

    In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health, Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them. It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.

  17. The ethics of post-marketing surveillance of therapeutic agents.

    PubMed

    Beran, R G

    2001-01-01

    Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection.

  18. The ethics of post-marketing surveillance of therapeutic agents.

    PubMed

    Beran, R G

    2001-01-01

    Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection. PMID:11817390

  19. 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.

  20. Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases.

    PubMed

    Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

    2015-01-01

    Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.

  1. Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

    PubMed Central

    Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

    2015-01-01

    Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved. PMID:26508981

  2. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

    PubMed

    Trifirò, G; Coloma, P M; Rijnbeek, P R; Romio, S; Mosseveld, B; Weibel, D; Bonhoeffer, J; Schuemie, M; van der Lei, J; Sturkenboom, M

    2014-06-01

    A growing number of international initiatives (e.g. EU-ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety. The motivation behind combining multiple healthcare databases is the earlier detection and validation, and hence earlier management, of potential safety issues. Overall, the combination of multiple healthcare databases increases statistical sample size and heterogeneity of exposure for postmarketing drug and vaccine safety surveillance, despite posing several technical challenges. Healthcare databases generally differ by underlying healthcare systems, type of information collected, drug/vaccine and medical event coding systems and language. Therefore, harmonization of medical data extraction through homogeneous coding algorithms across highly different databases is necessary. Although no standard procedure is currently available to achieve this, several approaches have been developed in recent projects. Another main challenge involves choosing the work models for data management and analyses whilst respecting country-specific regulations in terms of data privacy and anonymization. Dedicated software (e.g. Jerboa) has been produced to deal with privacy issues by sharing only anonymized and aggregated data using a common data model. Finally, storage and safe access to the data from different databases requires the development of a proper remote research environment. The aim of this review is to provide a summary of the potential, disadvantages, methodological issues and possible solutions concerning the conduct of postmarketing multidatabase drug and vaccine safety studies, as demonstrated by several international initiatives.

  3. 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

    ... 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 OF... Radiological Health's (CDRH's) Web site...

  4. 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)....

  5. 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)....

  6. 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

    ... 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 OF... Radiological Health's (CDRH's) Web site...

  7. 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)....

  8. 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.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. [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.

  15. 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

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

    PubMed

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

    2013-06-01

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

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

    PubMed

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

    2011-01-01

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

  18. 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

  19. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  20. 75 FR 6036 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... of information technology. Postmarket Surveillance--21 CFR Part 822 (OMB Control Number 0910- 0449... Collection; Comment Request; Postmarket Surveillance AGENCY: Food and Drug Administration, HHS. ACTION... on information collection requirements for Postmarket Surveillance. DATES: Submit written...

  1. 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

  2. Post-marketing surveillance of immediate allergic reactions: polygeline-based versus polygeline-free pediatric TBE vaccine.

    PubMed

    Zent, Olaf; Hennig, Renald

    2004-12-16

    Scattered cases of immediate allergic reactions occurred in the nineties after widespread use of the original (polygeline-based) pediatric tick-borne encephalitis (TBE) vaccine and were reported to Pharmacovigilance, Chiron Vaccines. Although, still indicating a very rare frequency of about two cases per 100,000 doses sold, the benefit/risk assessment resulted in its withdrawal from the market in early 1998. An intensive evaluation revealed that polygeline used as a vaccine stabilizer was the most probable cause of the reported allergic reactions. Consequently, an improved pediatric TBE vaccine, free of polygeline and other protein-derived vaccine stabilizers, was developed. A post-marketing surveillance analysis covering the first two vaccination seasons after the introduction of this new pediatric TBE vaccine in early 2002 reveals a very low reporting rate of immediate allergic reactions post immunization (within the range as noted for other widely used vaccines for childhood immunization), i.e., 0.08-0.24 cases per 100,000 doses sold depending on case definition and medical assessment. In conclusion, this analysis provides post-marketing surveillance evidence that the change in the vaccine formulation, with regards to the potential risk of immediate allergic reactions, has led to an intended improvement in the vaccine's safety profile.

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

    PubMed Central

    Zaid, Abdel Naser; Ghanem, Masshour; Shweiki, Dua’a; Shtewi, Hala; Shaheen, Raja’; Al Helaly, Sondos; Khayyat, Zeina; Al Ramahi, Rowa’a; Zyoud, Sa’ed H

    2016-01-01

    Objectives The objectives of this study were to evaluate the general quality of the most prescribed products of valsartan (VL; alone or in combination) and to evaluate their efficacy and safety among Palestinian population through in vivo postmarketing surveillance. Patients and methods The first part was pharmacopeial quality control assay, including dissolution, disintegration, friability, and weight uniformity for VL. The second part was a 3-month cardiology clinics, observational, postmarketing surveillance pilot study that included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as monotherapy or combination therapy. The end points were reduction in blood pressure (BP) and the rate of incidence of adverse effects (AEs) at weeks 4 and 8. Results According to our quality control tests, all VL products showed high-quality standards according to the international guidelines. A reduction in BP was observed at weeks 4 and 8, and no significant difference was observed between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of the AEs were of mild-to-moderate intensity. In general, the most frequently reported AEs included headache (17.5%), dizziness (11.75%), and weakness (11.7%). No serious AEs or death cases were reported during the study period. Conclusion High quality of VL tablet products was used; hence, the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension. PMID:27703364

  4. Postmarketing surveillance of rabeprazole in upper gastrointestinal peptic lesions in Japanese patients with coexisting hepatic disorders

    PubMed Central

    Makino, Isao; Nakamura, Kimihide; Sato, Yoichi; Sato, Yuzuru; Sezai, Shuichi; Ikeda, Yusei; Shinmura, Wahei; Watahiki, Hajime; Yamamoto, Hideaki; Hioki, Yayuki; Suzuki, Masao; Kumada, Takashi; Honda, Takashi; Rikitoku, Tomoo; Hisanaga, Yasuhiro; Fukui, Hiroshi; Yamao, Junichi; Kawasaki, Hironaka; Hosoda, Akihide; Onji, Morikazu; Matsui, Hidetaka; Sata, Michio; Torimura, Takuji; Oho, Kazuhiko; Maekawa, Ryuichiro; Takagi, Yoshiyuki; Shakado, Satoshi; Nakayama, Masafumi; Gondo, Kazuhisa; Fukushima, Hirofumi; Kusaba, Taku; Tsubouchi, Hirohito; Hayashi, Katsuhiro; Hori, Takeshi; Iida, Yozo; Yutoku, Kouki; Maetani, Noboru; Kubo, Yoshitsugu; Miyata, Yoshifumi

    2006-01-01

    Background: Many Japanese patients with hepatic disorders confirmed on diagnostic imaging and coexisting upper gastrointestinal (GI) peptic lesions receive treatment with proton pump inhibitors. Some pharmacotherapies used to treat peptic ulcers have been associated with adverse drug reactions (ADRs), including elevated liver enzyme levels. Objective: The aim of this study was to determine the tolerability and effectiveness of rabeprazole sodium in treating peptic lesions in patients with coexisting hepatic disorders. Methods: This open-label, practice-based, postmarketing surveillance investigation was conducted at 15 centers across Japan. Male and female patients aged ≥18 years with peptic lesions confirmed on upper GI endoscopy and with underlying hepatic disease were enrolled. Patients were randomly assigned to receive rabeprazole 10 or 20 mg PO (tablet) QD after a meal for up to 8 weeks. Tolerability was assessed using monitoring of the incidence of ADRs determined by direct patient questioning, spontaneous reporting, and laboratory assessment. All patients who received at least 1 dose of study drug were included in the tolerability assessment. Effectiveness was assessed at baseline and study end using the rates of achievement of improvement on endoscopy, relief of subjective/objective symptoms (rates of improvement in epigastric pain and heartburn), and global improvement. The effectiveness analysis included all patients with complete data before and after treatment. Subanalyses were conducted to determine the effectiveness of drug by identification of the proportion of patients with coexisting hepatic disorders (cirrhosis, chronic hepatitis, and other hepatic diseases [eg, alcoholic hepatitis, fatty liver]) and by peptic lesion (gastric ulcer, duodenal ulcer, stomal ulcer, and reflux esophagitis) who achieved improvement. Results: A total of 114 patients were enrolled; 108 patients were included in the tolerability analysis (81 men, 27 women; mean age, 59

  5. 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

  6. Post-market surveillance of GM foods: applicability and limitations of schemes used with pharmaceuticals and some non-GM novel foods.

    PubMed

    Wal, J-M; Hepburn, P A; Lea, L J; Crevel, R W R

    2003-08-01

    Post-market surveillance (PMS) is increasingly required by some regulatory authorities for the marketing approval of GM-Novel Foods. This requirement, in addition to a complete conventional safety assessment, aims to show that unexpected (adverse) effects do not occur after long-term everyday exposure. Large food manufacturers have systems to obtain feedback from consumers on their products. We show that such systems can be enhanced to collect information on possible health effects of specific products and relate these to intake in specific groups of consumers. The term post-launch monitoring (PLM) is proposed to distinguish the process from that used for pharmaceuticals. GM foods differ from branded products to which existing systems have been applied. The paper discusses whether and how such systems could be applied to GM foods and what additional elements would need to be incorporated in them. A PLM system should define and organize the flow of information between the different stakeholders. We conclude that because such data will be generated from a range of sources and will need to be collated, verified, and integrated, an independent agency will be essential to undertake this activity in order to balance the interests of all stakeholders and ensure public trust.

  7. A postmarket surveillance study on electro-neuro-adaptive-regulator therapy.

    PubMed

    Bonello, Rod P; Cohen, Marc; Reece, John; Aggarwal, Arun; Rigney, Curtis

    2014-01-01

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

  8. 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

  9. 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.

  10. Postmarket Drug Surveillance Without Trial Costs: Discovery of Adverse Drug Reactions Through Large-Scale Analysis of Web Search Queries

    PubMed Central

    Gabrilovich, Evgeniy

    2013-01-01

    Background Postmarket drug safety surveillance largely depends on spontaneous reports by patients and health care providers; hence, less common adverse drug reactions—especially those caused by long-term exposure, multidrug treatments, or those specific to special populations—often elude discovery. Objective Here we propose a low cost, fully automated method for continuous monitoring of adverse drug reactions in single drugs and in combinations thereof, and demonstrate the discovery of heretofore-unknown ones. Methods We used aggregated search data of large populations of Internet users to extract information related to drugs and adverse reactions to them, and correlated these data over time. We further extended our method to identify adverse reactions to combinations of drugs. Results We validated our method by showing high correlations of our findings with known adverse drug reactions (ADRs). However, although acute early-onset drug reactions are more likely to be reported to regulatory agencies, we show that less acute later-onset ones are better captured in Web search queries. Conclusions Our method is advantageous in identifying previously unknown adverse drug reactions. These ADRs should be considered as candidates for further scrutiny by medical regulatory authorities, for example, through phase 4 trials. PMID:23778053

  11. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients.

    PubMed

    Koike, Takao; Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Takei, Shuji; Takeuchi, Tsutomu; Yamanaka, Hisashi; Tanaka, Yoshiya

    2012-08-01

    This interim analysis of postmarketing surveillance data for adalimumab-treated rheumatoid arthritis (RA) patients summarizes safety and effectiveness during the first 24 weeks of therapy for the first 3,000 patients treated in Japan (June 2008-December 2009). Patient eligibility for antitumor necrosis factor therapy was based on the Japanese College of Rheumatology treatment guidelines and Japanese labeling. All patients were screened for tuberculosis. Approximately 50% of the population was biologic naïve, 66% received concomitant methotrexate (MTX), and 72% received concomitant glucocorticoids. The overall incidence rate of adverse events was 31% (5.5% serious) and that of adverse drug reactions (ADRs) was 27% (4.1% serious). Incidence rates of ADRs and serious ADRs were similar regardless of prior biologic therapy or concomitant MTX use but were significantly higher in patients receiving glucocorticoids compared with those not receiving glucocorticoids. Bacterial/bronchial pneumonia occurred in 1.2% of patients; interstitial pneumonia, 0.6%; Pneumocystis jirovecii pneumonia, 0.3%; tuberculosis, 0.13%; and administration-site reactions, 6.1%. Mean 28-joint Disease Activity Scores decreased significantly after 24 weeks from 5.29 to 3.91. All subgroups showed significant improvement, particularly the biologic-naïve patients receiving concomitant MTX. No new safety concerns were identified. ADR Incidence rates were similar to those of other biologic agents approved for RA.

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

    PubMed Central

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

    2013-01-01

    Summary 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 paper 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 paper’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

  13. [Planning, realization and evaluation of post-marketing surveillance studies. Recommendations of the Society for Phytotherapy].

    PubMed

    Kraft, K; Loew, D; Schneider, B; Kemper, F H

    1997-08-01

    Post-marketing-surveillance studies with herbal drugs usually are prospective prescription-epidemiological studies, which should allow statements on quality, efficacy and safety. Until now neither laws nor concrete normative guidelines for the methodology and the evaluation of post-marketing-surveillance studies are existing which could be used for pharmacovigilance. In the present paper guidelines for planning, realisation and evaluation are presented which should allow studies of high quality. The essential components required for the investigational plan are focussed. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally statistical methods which allow the evaluation of the therapeutic efficacy are presented.

  14. The safety of quetiapine: results of a post-marketing surveillance study on 1728 patients in England.

    PubMed

    Twaites, Beverley R; Wilton, Lynda V; Shakir, Saad A W

    2007-06-01

    The safety of the atypical antipsychotic quetiapine as used in general practice in England was examined by prescription-event monitoring (PEM). Patients were identified from dispensed National Health Service (NHS) prescriptions issued by general practitioners (GPs) for quetiapine between October 1997 and July 1999. The outcome data were event reports obtained by sending questionnaires ('green forms') to the prescribing doctor at Least 6 months after the first prescription for an individual patient. Green forms with clinically useful information on 1728 patients (median age 39 years (IQR 30-56); 53% female) were received. The most frequently reported event during the first month of treatment was 'drowsiness/sedation' (47; 3% cohort). This was also the most frequently reported specified adverse drug reaction (ADR) to quetiapine (7; 11% of 65 reported ADRs) and the highest reported clinical reason for stopping quetiapine (51; 6% of the 734 reported reasons for stopping). There was a low incidence of extrapyramidal disease (21 during treatment, 1% of cohort) and hyperprolactinaemia (three during treatment, 0.2%) in this study. Three cases of diabetes mellitus in this cohort were reported to be a new diagnosis. Six pregnancies were reported during treatment with quetiapine, five of which were exposed during the first trimester only. There were four Live births with no reported congenital abnormaLities. Fifty-six deaths were reported during this study (3% cohort). The most frequently reported causes of death reLated to the cardiovascular (18) and respiratory (15) systems. The results of this post-marketing surveillance study demonstrated that quetiapine is generally well-tolerated when used in general practice. PMID:17656426

  15. [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

    2002-02-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, monobactams, and carbapenems. Changes in CZOP susceptibility for the bacteria were also evaluated with the bacterial resistance ratio calculated with the breakpoint MIC. Twenty-five species (3,362 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2000, and consisted of Moraxella (Branhamella) catarrhalis (n = 136), Haemophilus influenzae (n = 289), Escherichia coli (n = 276), Klebsiella pneumoniae (n = 192), Klebsiella oxytoca (n = 157), Enterobacter cloacae (n = 189), Enterobacter aerogenes (n = 93), Serratia marcescens (n = 172), Serratia liquefaciens (n = 24), Citrobacter freundii (n = 177), Citrobacter koseri (n = 70), Proteus mirabilis (n = 113), Proteus vulgaris (n = 89), Morganella morganii (n = 116), Providencia spp. (n = 41), Pseudomonas aeruginosa (n = 290), Pseudomonas fluorescens (n = 56), Pseudomonas putida (n = 63), Acinetobacter baumannii (n = 146), Acinetobacter lwoffii (n = 34), Burkholderia cepacia (n = 101), Stenotrophomonas maltophilia (n = 169), Bacteroides fragilis group (n = 196), and Prevotella/Porphyromonas (n = 173). An antibacterial activity of CZOP against E. coli, K. pneumoniae, K. oxytoca, and S. marcescens was potent and consistent with or more preferable than the study results obtained until the new drug application approval. MIC90 of CZOP against M.(B.) catarrhalis, C. koseri, and P. aeruginosa was not considerably changed and consistent with the study results obtained until the new drug application approval. MIC90 of CZOP against E. cloacae, E. aerogenes, and P. mirabilis increased year by year. The increase in MIC90 of CZOP against E. aerogenes and P. mirabilis, however, was not considered to be an obvious decline in susceptibility. In

  16. 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

  17. 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

  18. 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

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

    PubMed Central

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

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

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

    PubMed

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

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings. PMID:24743364

  1. 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

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

    PubMed

    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.

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

    PubMed

    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

  4. 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... POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.12 Do you have any information that will help...

  5. 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

  6. 21 CFR 26.33 - Product coverage.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY... surveillance/postmarket and initial/preapproval inspection reports and European Community (EC)-type...

  7. 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

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... Medical Products and Dietary Supplements During an Influenza Pandemic.'' The guidance discusses FDA's... devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations...

  8. 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

    ... Influenza Pandemic.'' In the Federal Register of December 16, 2008 (73 FR 76364), FDA published notice of... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft...

  9. A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac (®) ) in India.

    PubMed

    Kulkarni, Prasad S; Raut, Sidram K; Dhere, Rajeev M

    2013-01-01

    A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (³ 3 years) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 days. Among 7565 individuals (3 - 85 years), a total of 81 solicited adverse reactions (1%) were reported in 49 subjects (0.65%). The reactions included mild to moderate respiratory symptoms. No H1N1 case was encountered during one year postvaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.

  10. 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...

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. Aspartame: scientific evaluation in the postmarketing period.

    PubMed

    Butchko, H H; Stargel, W W

    2001-12-01

    Prior to marketing, the safety of the high-intensity sweetener aspartame for its intended uses as a sweetener and flavor enhancer was demonstrated by the results of over 100 scientific studies in animals and humans. In the postmarketing period, the safety of aspartame was further evaluated through extensive monitoring of intake, postmarketing surveillance of anecdotal reports of alleged health effects, and additional research to evaluate these anecdotal reports and other scientific issues. The results of the extensive intake evaluation in the United States, which was done over an 8-year period, and the results of studies done in other countries demonstrated intakes which were well below the acceptable daily intakes set by the FDA and regulatory bodies in other countries, as well as the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of the anecdotal reports of adverse health effects, the first such system for a food additive, revealed that the reported effects were generally mild and also common in the general population and that there was no consistent or unique pattern of symptoms that could be causally linked to consumption of aspartame. Finally, the results of the extensive scientific research done to evaluate these allegations did not show a causal relationship between aspartame and adverse effects. Thus, the weight of scientific evidence confirms that, even in amounts many times what people typically consume, aspartame is safe for its intended uses as a sweetener and flavor enhancer.

  16. 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

    ... studies and clinical trials that applicants have agreed to, or are required to, conduct. FOR FURTHER... postmarketing studies, including clinical trials, for human drug and biological products (section 506B of the FD... monitor the progress of a postmarketing study or clinical trial that an applicant has been required to,...

  17. Methods for observational post-licensure medical product safety surveillance.

    PubMed

    Nelson, Jennifer C; Cook, Andrea J; Yu, Onchee; Zhao, Shanshan; Jackson, Lisa A; Psaty, Bruce M

    2015-04-01

    Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

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

    PubMed Central

    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.

    2015-01-01

    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

  19. 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

  20. 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

  1. 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.

  2. 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

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

    PubMed

    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

    2009-12-01

    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 reduced exposure products (PREP) 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 United States has not been developed. Identifying, characterizing, and monitoring new tobacco products could be greatly enhanced with a responsive surveillance system. This article 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. With the absence of 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.

  4. 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

  5. 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.

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

    PubMed Central

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

    2015-01-01

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

  7. 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

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What are my responsibilities once I am notified that I am required to conduct postmarket surveillance? 822.24 Section 822.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...

  8. 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.

  9. 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

  10. Global Tobacco Surveillance System (GTSS): purpose, production, and potential.

    PubMed

    2005-01-01

    The World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Canadian Public Health Association (CPHA) developed the Global Tobacco Surveillance System (GTSS) to assist all 192 WHO Member States in collecting data on youth and adult tobacco use. The flexible GTSS system includes common data items but allows countries to include important unique information at their discretion. It uses a common survey methodology, similar field procedures for data collection, and similar data management and processing techniques. The GTSS includes collection of data through three surveys: the Global Youth Tobacco Survey (GYTS) for youth, and the Global School Personnel Survey (GSPS) and the Global Health Professional Survey (GHPS) for adults. GTSS data potentially can be applied in four ways. First, countries and research partners can disseminate data through publications, presentations, and an active GTSS web site. Second, countries can use GTSS data to inform politicians about the tobacco problem in their country, leading to new policy decisions to prevent and control tobacco use. Third, GTSS can provide countries with valuable feedback to evaluate and improve Country National Action Plans or develop new plans. Fourth, in response to the WHO FCTC call for countries to use consistent methods and procedures in their surveillance efforts, GTSS offers such consistency in sampling procedures, core questionnaire items, training infield procedures, and analysis of data across all survey sites. The GTSS represents the most comprehensive tobacco surveillance system ever developed and implemented. As an example, this paper describes development of the GYTS and discusses potential uses of the data. Sample data were drawn from 38 sites in 24 countries in the African Region, 82 sites in 35 countries in the Americas Region, 20 sites in 17 countries and the Gaza Strip/West Bank region in the Eastern Mediterranean Region, 25 sites in 22 countries in the European

  11. 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...

  12. 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...

  13. 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...

  14. 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

    ... studies and clinical trials that applicants have agreed to, or are required to, conduct. FOR FURTHER..., including clinical trials, for human drug and biological products (section 506B of the FD&C Act (21 U.S.C... a postmarketing study or clinical trial that an applicant has been required to, or has agreed...

  15. 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

    ... studies and clinical trials that applicants have agreed to or are required to conduct. FOR FURTHER..., including clinical trials, for human drug and biological products (section 506B of the FD&C Act (21 U.S.C... a postmarketing study or clinical trial that an applicant has been required to or has agreed...

  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, 2012 CFR

    2012-04-01

    ... plan are available on the Center for Devices and Radiological Health's Web site and from the Food and... 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...

  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, 2013 CFR

    2013-04-01

    ... plan are available on the Center for Devices and Radiological Health's Web site and from the Food and... 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...

  18. 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

    ... plan are available on the Center for Devices and Radiological Health's Web site and from the Food and... 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...

  19. A comprehensive post-market review of studies on a probiotic product containing Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011.

    PubMed

    Foster, L M; Tompkins, T A; Dahl, W J

    2011-12-01

    The probiotic preparation Lacidofil® has been commercially available in Europe, Asia and North America since 1995. This product is a combination of two strains, Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011. The strains have been evaluated for safety, identity and mechanisms of probiotic action in vitro, in animal models and human clinical trials. The strains adhered to human epithelial cells, helped to maintain the barrier function and blocked the adhesion of a number of pathogens, allowing them to be cleared from the intestine. The strains also elicited an anti-inflammatory response by down-regulating IL-1β, IL-8 and TNF-α. In various stress models, the probiotic combination facilitated better coping and outcomes which may be through the maintenance of barrier function and suppressing inflammation. Overall, pre-clinical studies suggest a potential anti-infectious role for the strains and the combination. Clinical studies, primarily in children, have identified Lacidofil as an effective supplement for various gastrointestinal diseases such as antibiotic-associated diarrhoea and acute gastroenteritis. Recent research has also indicated that Lacidofil may be beneficial for individuals with atopic dermatitis or vaginal dysbacteriosis.

  20. 21 CFR 314.540 - Postmarketing safety reporting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses § 314.540 Postmarketing safety reporting. Drug... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.540...

  1. 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

  2. Understanding productivity, a key to Aedes aegypti surveillance.

    PubMed

    Tun-Lin, W; Kay, B H; Barnes, A

    1995-12-01

    The objective of this work was to define criteria that could be applied to achieve faster, more economical, and accurate assessment of vector populations for control of dengue viruses. During 1989-1990, 1,349 premises were surveyed in Townsville, Charters Towers and Mingela/Ravenswood, Queensland, Australia. In each locality, 1.9-8.4% of premises contained three or more containers with Aedes aegypti immature forms and were designated as key premises. Comparison of surveys in Townsville from 1989 to 1990 indicated that positive premises (i.e., those with at least one container with Ae. aegypti present) were 3.22 times more likely to remain positive than negative houses to become positive the following year. The Ae. aegypti population in Townsville was seen to be totally associated with garden receptacles, discarded household items, and trash but one well and one rainwater tank were responsible for 28% of all immature forms recorded in the 1,349 premises inspected. These breeding sites of high productivity were designated as key containers. At Charters Towers, Mingela, and Ravenswood, rainwater tanks were seen as the most important key container because although they constituted 13-29% of positive containers, they supported 60-63% of the immature forms. This study demonstrates that there is a certain degree of stability with regard to positive premises and that some of these, or some container types, contribute disproportionately to the Ae. aegypti population. Control programs could be made more efficient if efforts were concentrated on these sites of key vector productivity.

  3. 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.

  4. 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

  5. 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.

  6. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The... clinical trials for prescription drugs approved under the FD&C Act and biological products approved under... of the new provisions and a description of the types of postmarketing studies and clinical...

  7. 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, ...

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 21 CFR 822.32 - What records are the investigators in my surveillance plan required to keep?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  16. 21 CFR 601.70 - Annual progress reports of postmarketing studies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false 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....

  17. 21 CFR 601.70 - Annual progress reports of postmarketing studies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false 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....

  18. 21 CFR 601.70 - Annual progress reports of postmarketing studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false 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....

  19. 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.

  20. 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 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...

  1. 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.

  2. In-line milk filter analysis: Escherichia coli O157 surveillance of milk production holdings.

    PubMed

    Murphy, Brenda P; Murphy, Mary; Buckley, James F; Gilroy, Deirdre; Rowe, Michael T; McCleery, David; Fanning, Séamus

    2005-01-01

    Escherichia coli O157 is a major etiological agent of food-borne illness. Bovine animals are recognized reservoirs for this organism and represent a significant source from where these pathogens can enter the food chain. Food products derived from these animals are convenient vehicles, and are often the focal point(s) of infection. As a useful strategy to provide herd-level surveillance and to investigate for the presence of this pathogen in a population of Irish dairy cattle, milk filters from 97 farms were analysed by conventional culture and other methods. Five hundred and thirty-six milk filters were evaluated over a 2-year period. Filters from 12 of the 97 farms (12%) were found to contain E. coli O157, based on culture methods. Sixteen verocytotoxigenic E. coli O157 organisms were recovered and characterized in detail. The farm families in each case were consuming raw milk from their respective herds. The potential risk to public health associated with the detection of E. coli O157 and the local consumption of raw milk are discussed.

  3. A conceptual framework for the design of environmental post-market monitoring of genetically modified plants.

    PubMed

    Sanvido, Olivier; Widmer, Franco; Winzeler, Michael; Bigler, Franz

    2005-01-01

    Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.

  4. 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

  5. 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.

  6. 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

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

    PubMed

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

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

  8. 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.

  9. 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

  10. A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data

    PubMed Central

    Nelson, Jennifer C.; Wellman, Robert; Yu, Onchee; Cook, Andrea J.; Maro, Judith C.; Ouellet-Hellstrom, Rita; Boudreau, Denise; Floyd, James S.; Heckbert, Susan R.; Pinheiro, Simone; Reichman, Marsha; Shoaibi, Azadeh

    2016-01-01

    Introduction: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings. Existing Methods: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects—two national observational electronic health care database safety monitoring programs. Future Surveillance Planning: Based on this examination, we suggest three steps for future surveillance planning in health care databases: (1) prespecify the sequential design and analysis plan, using available feasibility data to reduce assumptions and minimize later changes to initial plans; (2) assess existing drug or vaccine uptake, to determine if there is adequate information to proceed with surveillance, before conducting more resource-intensive planning; and (3) statistically evaluate and clearly communicate the sequential design with all those designing and interpreting the safety-surveillance results prior to implementation. Plans should also be flexible enough to accommodate dynamic and often unpredictable changes to the database information made by the health plans for administrative purposes. Conclusions: This paper is intended to encourage dialogue about establishing a more systematic, scalable, and transparent sequential design-planning process for medical-product safety-surveillance systems utilizing observational electronic health care databases. Creating such a framework could yield improvements over existing practices, such as designs with increased power to assess serious adverse events. PMID:27713904

  11. 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

  12. 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.

  13. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs.

    PubMed

    Vray, Muriel; Hamelin, Bernard; Jaillon, Patrice

    2005-01-01

    The respective roles of controlled clinical trials and observational studies (cohort or case-control studies) in evaluating the efficacy, safety and usefulness of a drug were analysed. A randomised, controlled, double-blind study is the best method of estimating the efficacy of a treatment. It provides the least biased and most robust estimate of the causal relationship. In certain situations and on the basis of certain criteria, observational studies can have a proof-of-efficacy value. Randomised, controlled, pre- and postmarketing authorisation (MA) clinical studies identify the rarer adverse effects and compare them with those resulting from the reference treatment. Before the MA, the pooled safety data from different controlled trials can provide an estimation of relatively frequent adverse events and subjects at risk. However, an observational study is the most appropriate method of evaluating the safety of a drug in the currently used conditions. By definition, a drug influences the health of a population if it directly or indirectly improves its health. A drug would have a major role in public health if it reduced mortality or morbidity related to a particular disease or if it improved the quality of life of patients with this disease. Prior to marketing a product, modelling is the approach of choice to quantify the expected effect. Pragmatic, postmarketing trials and observational studies are the reference methods used to define the population affected, the efficacy and safety of the drug in a real situation and its usefulness for public health. In conclusion, randomised clinical trials remain the reference approach for evaluating efficacy, while observational studies have a confirmatory value. Observational studies are the most appropriate way of evaluating safety in the currently used conditions, as the clinical trial has limited indications. In the interests of public health, modelling is the pre-marketing approach of choice, while pragmatic trials and

  14. Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health Product and Prescription Drug Use in Community Pharmacies

    PubMed Central

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

    2012-01-01

    Background Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use. Methodology/Principal Findings Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use. Conclusions/Significance Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms. PMID:23028841

  15. 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

  16. 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

  17. [Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators].

    PubMed

    Fauchier, L; de Bouët du Portal, H; Giraudeau, C; Froger, S; Cosnay, P; Babuty, D

    2005-01-01

    This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.

  18. [A postmarketing surveillance study on 31,724 patients using Dengzhan Xixin injection in hospital].

    PubMed

    Li, Yuan-yuan; Lei, Lei; Xie, Yan-ming

    2015-12-01

    Aim to explore the adverse drug reactions (ADR) characteristic and calculate the ADR incidence of Dengzhan Xixin injection (DZXX). A multicenter, large sample, and prospective cohort study was conducted from August 2012 to December 2014. A total of 31 724 patients using DZXX were observed. A total of 31 724 patients with 15 ADR cases among 31 724 patients, accounting for 0.06% , were reported. There were 8 male patients ADRs and 7 female patients with ADRs. ADRs included skin rashes, itching, headache, red face, abdominal pain, etc. 1 case with rhubarb radix scutellariae allergies. These ADRs happened from 5 min to within 0.5 h after DZXX were used to treat patients. ADR patients discontinued treatment, of which 2 patients used promethazine for recovery and improvement. There were 2 cases with different DZXX concentration, out of the normal range. DZXX injection could cause some ADRs. Users must not ignore these and be careful of its related side effects. This study was a cohort with large sample, which should produce strong evidence for clinical practice. However, there was still weak evidence to conclude that it was a safe Chinese medicine injection in clinical practice. PMID:27245018

  19. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain... electronic and written comments by October 13, 2011. Location: The public workshop will be held at the... 20903, 301-980-1936, e-mail: jay.crowley@fda.hhs.gov Registration: Registration is free and will be on...

  20. Alert systems for post-marketing surveillance of adverse drug reactions.

    PubMed

    Praus, M; Schindel, F; Fescharek, R; Schwarz, S

    1993-12-30

    When monitoring spontaneous reports of adverse reactions to registered drugs, it is important to detect any change in the number of reported adverse reactions in the course of time. Sales adjusted adverse drug reaction rates are usually compared in order to be able to take drug exposure into account. Here we review the so-called arithmetic and some statistical procedures which could form the basis for an alert system. The advantages and disadvantages of each of these methods are discussed. The importance of data requirements and the problems which arise when using an alert system are pointed out and then clarified with the help of the example of diphtheria/tetanus vaccine. PMID:8134741

  1. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... that a sponsor conduct a safety-related postmarket clinical trial or observational epidemiological... TSIs has been handled informally and on a case-by-case basis, without an agreed upon framework...

  2. 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

  3. 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.

  4. Effects of Directiveness of Instructions and Surveillance on the Production and Persistence of Children's Donations.

    ERIC Educational Resources Information Center

    Israel, Allen C.; Brown, Margary S.

    1979-01-01

    Examines the contribution of two variables, directiveness of instructions and presence of a socializing agent, upon the production and persistence of modeled donating. Subjects were 112 second and third graders. (MP)

  5. 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.

  6. 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.

  7. 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

  8. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... use of any reliable contractor production control or data management systems. (d) In performing... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting...

  9. 48 CFR 42.1104 - Surveillance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... use of any reliable contractor production control or data management systems. (d) In performing... CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting...

  10. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    PubMed

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  11. 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

  12. 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

  13. 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.

  14. 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. 42.1104 Section 42.1104 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT CONTRACT ADMINISTRATION AND AUDIT SERVICES Production Surveillance and Reporting 42.1104 Surveillance requirements. (a) The...

  15. 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.

  16. 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.

  17. [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

  18. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  19. 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...

  20. 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...

  1. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 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...

  2. 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...

  3. Defining 'surveillance' in drug safety.

    PubMed

    Aronson, Jeffrey K; Hauben, Manfred; Bate, Andrew

    2012-05-01

    The concept of surveillance in pharmacovigilance and pharmacoepidemiology has evolved from the concept of surveillance in epidemiology, particularly of infectious diseases. We have surveyed the etymology, usages, and previous definitions of 'surveillance' and its modifiers, such as 'active' and 'passive'. The following essential definitional features of surveillance emerge: (i) surveillance and monitoring are different--surveillance involves populations, while monitoring involves individuals; (ii) surveillance can be performed repeatedly and at any time during the lifetime of a medicinal product or device; (iii) although itself non-interventional, it can adduce any types of evidence (interventional, observational, or anecdotal, potentially at different times); (iv) it encompasses data collection, management, analysis, and interpretation; (v) it includes actions to be taken after signal detection, including initial evaluation and communication; and (vi) it should contribute to the classification of adverse reactions and their prevention or mitigation and/or to the harnessing of beneficial effects. We conclude that qualifiers add ambiguity and uncertainty without enhancing the idea of surveillance. We propose the following definition of surveillance of health-care products, which embraces all the surveyed ideas and reflects real-world pharmacovigilance processes: 'a form of non-interventional public health research, consisting of a set of processes for the continued systematic collection, compilation, interrogation, analysis, and interpretation of data on benefits and harms (including relevant spontaneous reports, electronic medical records, and experimental data).' As a codicil, we note that the purposes of surveillance are to identify, evaluate, understand, and communicate previously unknown effects of health-care products, or new aspects of known effects, in order to harness such effects (if beneficial) or prevent or mitigate them (if harmful).

  4. 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).

  5. [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

  6. [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.

  7. A comparison of active adverse event surveillance systems worldwide.

    PubMed

    Huang, Yu-Lin; Moon, Jinhee; Segal, Jodi B

    2014-08-01

    Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based-the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK-the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances. PMID:25022829

  8. Continuous sequential boundaries for vaccine safety surveillance.

    PubMed

    Li, Rongxia; Stewart, Brock; Weintraub, Eric; McNeil, Michael M

    2014-08-30

    Various recently developed sequential methods have been used to detect signals for post-marketing surveillance in drug and vaccine safety. Among these, the maximized sequential probability ratio test (MaxSPRT) has been used to detect elevated risks of adverse events following vaccination using large healthcare databases. However, a limitation of MaxSPRT is that it only provides a time-invariant flat boundary. In this study, we propose the use of time-varying boundaries for controlling how type I error is distributed throughout the surveillance period. This is especially useful in two scenarios: (i) when we desire generally larger sample sizes before a signal is generated, for example, when early adopters are not representative of the larger population; and (ii) when it is desired for a signal to be generated as early as possible, for example, when the adverse event is considered rare but serious. We consider four specific time-varying boundaries (which we call critical value functions), and we study their statistical power and average time to signal detection. The methodology we present here can be viewed as a generalization or flexible extension of MaxSPRT. PMID:24691986

  9. [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.

  10. 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

  11. 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

  12. 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;...

  13. 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;...

  14. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation.

    PubMed

    Tompkins, T A; Xu, X; Ahmarani, J

    2010-03-01

    Probiotics as dietary supplements have been readily accepted by Asian populations. Use of certain probiotic preparations is widespread and the number of clinical trials undertaken with such products is unparalleled in western scientific literature. One such preparation, containing a combination of Enterococcus faecium R0026 and Bacillus subtilis R0179, has 23 publications on post-market clinical studies involving over 1,800 adults. The majority of these publications are printed in Chinese and Korean journals. This review examines the clinical findings with this probiotic combination. As mono-therapy, it has been used to overcome symptoms associated with chronic diarrhoea and irritable bowel syndrome. It has been used as co-adjuvant therapy with sulfasalazine and mesalazine to improve remission times in mild to moderate Ulcerative Colitis and to improve compliance with conventional triple therapy for Helicobacter pylori eradication. While the much of the data is preliminary and the study designs require refinement, the contribution of these trials should not be ignored. The information derived in this review will provide practitioners with practical information on appropriate applications for probiotic supplements, expected outcomes, dosing regimes, safety and reported adverse events. Furthermore, identification of problems in these trials should help researchers design better clinical trials when investigating probiotic products.

  15. 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

  16. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)

    PubMed Central

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. PMID:27799968

  17. 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

    ... Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Public Workshop AGENCY: Food and Drug... Section 522 of the Federal Food, Drug and Cosmetic Act''. The purpose of the public workshop is to provide... the Federal Register.) Background: Under section 522(a) of the Federal Food, Drug and Cosmetic Act...

  18. Safety of Japanese encephalitis live attenuated vaccination in post-marketing surveillance in Guangdong, China, 2005-2012.

    PubMed

    Liu, Yu; Lin, Hualiang; Zhu, Qi; Wu, Chenggang; Zhao, Zhanjie; Zheng, Huizhen

    2014-03-26

    We reviewed the adverse events following immunization of live attenuated Japanese encephalitis vaccine in Guangdong Province, China. During the period of 2005-2012, 23 million doses of live attenuated Japanese encephalitis vaccine were used and 1426 adverse events were reported (61.24 per million doses); of which, 570 (40%) were classified as allergic reactions (24.48 per million doses), 31 (2%) were neurologic events (1.33 per million doses), and 36 (2.5%) were diagnosed as serious adverse events (1.55 per million doses). This study suggests that the JEV-L has a reasonable safety profile, most adverse events are relatively mild, with relatively rare neurologic events being observed. PMID:24503272

  19. ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease

    ClinicalTrials.gov

    2013-03-20

    Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis; Heart Diseases; Coronary Stenosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

  20. Correlation of β-Lactamase Production and Colistin Resistance among Enterobacteriaceae Isolates from a Global Surveillance Program

    PubMed Central

    Bradford, Patricia A.; Biedenbach, Douglas J.; Wise, Mark G.; Hackel, Meredith; Sahm, Daniel F.

    2015-01-01

    The increasing use of carbapenems for treating multidrug-resistant (MDR) Gram-negative bacterial infections has contributed to the global dissemination of carbapenem-resistant Enterobacteriaceae (CRE). Serine and metallo-β-lactamases (MBLs) that hydrolyze carbapenems have become prevalent and endemic in some countries, necessitating the use of older classes of agents, such as colistin. A total of 19,719 isolates of Enterobacteriaceae (excluding Proteeae and Serratia spp., which have innate resistance to colistin) were collected from infected patients during 2012 and 2013 in a global surveillance program and tested for antimicrobial susceptibility using CLSI methods. Isolates of CRE were characterized for carbapenemases and extended-spectrum β-lactamases (ESBLs) by PCR and sequencing. Using EUCAST breakpoints, the rate of colistin susceptibility was 98.4% overall, but it was reduced to 88.0% among 482 carbapenemase-positive isolates. Colistin susceptibility was higher among MBL-positive isolates (92.6%) than those positive for a KPC (87.9%) or OXA-48 (84.2%). Of the agents tested, only tigecycline (MIC90, 2 to 4 μg/ml) and aztreonam-avibactam (MIC90, 0.5 to 1 μg/ml) consistently tested with low MIC values against colistin-resistant, ESBL-positive, and carbapenemase-positive isolates. Among the 309 (1.6%) colistin-resistant isolates from 10 species collected in 38 countries, 58 carried a carbapenemase that included KPCs (38 isolates), MBLs (6 isolates), and OXA-48 (12 isolates). These isolates were distributed globally (16 countries), and 95% were Klebsiella pneumoniae. Thirty-nine (67.2%) isolates carried additional ESBL variants of CTX-M, SHV, and VEB. This sample of Enterobacteriaceae demonstrated a low prevalence of colistin resistance overall. However, the wide geographic dispersion of colistin resistance within diverse genus and species groups and the higher incidence observed among carbapenemase-producing MDR pathogens are concerning. PMID:26666920

  1. [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

  2. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  3. 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

  4. 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.

  5. 21 CFR 314.81 - Other postmarketing reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., Center for Drug Evaluation and Research, Office of New Drug Quality Assessment, Bldg. 21, rm. 2562, 10903... in which they were implemented, or if no changes, a statement of that fact. (iv) Chemistry... of the drug product in medical practice, papers and abstracts in which the drug is used as a...

  6. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... products to the Center for Biologics Evaluation and Research (HFM-210), or to the Center for Drug... Consolidated Forms and Publications Distribution Center, 3222 Hubbard Rd., Landover, MD 20785. Supplies of the VAERS form may be obtained from VAERS by calling 1-800-822-7967. (g) Multiple reports. A...

  7. 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

  8. 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.

  9. Post-marketing management of the use of non-narcotic analgesics.

    PubMed

    Miettinen, O S

    1986-01-01

    While the use of non-narcotic analgesics is of considerable health benefit to people everywhere, they also represent a health problem. This problem has to do more with the risks associated with individual courses of treatment than with the commonality of those treatments. The public health challenge in post-marketing management of non-narcotic analgesic use, is to promote a pattern of use such that the risks are justifiable by the benefits and are the lowest that can be attained. To achieve such goals it is essential to have scientific knowledge about the benefits and risks and to be able to determine the quality of use in the population as to how proper it is. Current post-marketing management programmes focus largely on regulation, overlooking other equally important basic methods of public health intervention, namely education and service. If it is accepted that mass education is the key element in the proper management of non-narcotic analgesic use, the present emphasis on regulation needs amendment. Such changes will take time, but it is conceivable that ultimately the management goal can be achieved with minimal regulatory intervention.

  10. [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

  11. 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.

  12. [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

  13. [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.

  14. 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

  15. 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

  16. A statistical methodology for drug-drug interaction surveillance.

    PubMed

    Norén, G Niklas; Sundberg, Rolf; Bate, Andrew; Edwards, I Ralph

    2008-07-20

    Interaction between drug substances may yield excessive risk of adverse drug reactions (ADRs) when two drugs are taken in combination. Collections of individual case safety reports (ICSRs) related to suspected ADR incidents in clinical practice have proven to be very useful in post-marketing surveillance for pairwise drug--ADR associations, but have yet to reach their full potential for drug-drug interaction surveillance. In this paper, we implement and evaluate a shrinkage observed-to-expected ratio for exploratory analysis of suspected drug-drug interaction in ICSR data, based on comparison with an additive risk model. We argue that the limited success of previously proposed methods for drug-drug interaction detection based on ICSR data may be due to an underlying assumption that the absence of interaction is equivalent to having multiplicative risk factors. We provide empirical examples of established drug-drug interaction highlighted with our proposed approach that go undetected with logistic regression. A database wide screen for suspected drug-drug interaction in the entire WHO database is carried out to demonstrate the feasibility of the proposed approach. As always in the analysis of ICSRs, the clinical validity of hypotheses raised with the proposed method must be further reviewed and evaluated by subject matter experts. PMID:18344185

  17. 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.

  18. 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

  19. 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.

  20. The surveillance error grid.

    PubMed

    Klonoff, David C; Lias, Courtney; Vigersky, Robert; Clarke, William; Parkes, Joan Lee; Sacks, David B; Kirkman, M Sue; Kovatchev, Boris

    2014-07-01

    Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. A total of 206 diabetes clinicians were surveyed about the clinical risk of errors of measured BG levels by a monitor. The impact of such errors on 4 patient scenarios was surveyed. Each monitor/reference data pair was scored and color-coded on a graph per its average risk rating. Using modeled data representative of the accuracy of contemporary meters, the relationships between clinical risk and monitor error were calculated for the Clarke error grid (CEG), Parkes error grid (PEG), and SEG. SEG action boundaries were consistent across scenarios, regardless of whether the patient was type 1 or type 2 or using insulin or not. No significant differences were noted between responses of adult/pediatric or 4 types of clinicians. Although small specific differences in risk boundaries between US and non-US clinicians were noted, the panel felt they did not justify separate grids for these 2 types of clinicians. The data points of the SEG were classified in 15 zones according to their assigned level of risk, which allowed for comparisons with the classic CEG and PEG. Modeled glucose monitor data with realistic self-monitoring of blood glucose errors derived from meter testing experiments plotted on the SEG when compared to

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. Efficacy and safety of recombinant factor VIII products in patients with hemophilia A.

    PubMed

    Musso, Robert

    2008-10-01

    The introduction of recombinant factor VIII (rFVIII) clotting factor concentrates nearly 20 years ago represented a significant advance in the treatment of hemophilia A. The major advantage of rFVIII products compared with plasma-derived FVIII products is related to product safety, with rFVIII products virtually eliminating bloodborne pathogen transmission. The most challenging aspect of hemophilia A management today is the development of FVIII inhibitors; previously untreated patients are at the highest risk for inhibitor formation. Presented in this article are results of clinical trials in previously treated and untreated patients and postmarketing surveillance studies for the four commercially available rFVIII products (Recombinate, ReFacto, Kogenate FS/Kogenate Bayer and Advate). Recombinant FVIII therapies are highly efficacious when used ondemand and prophylactically, and they have excellent safety profiles; there have been no reports of viral- or prion-based disease transmission associated with rFVIII administration. The incidence rate of inhibitors in previously untreated patients ranges from 15% to approximately 30%. Because rFVIII concentrates have proven efficacy and safety profiles, a number of hemophilia treatment groups recommend rFVIII products as first-line therapy in the management of hemophilia A.

  13. 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

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

    PubMed

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients. PMID:19917022

  15. 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.

  16. 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...

  17. A GIS-driven integrated real-time surveillance pilot system for national West Nile virus dead bird surveillance in Canada

    PubMed Central

    Shuai, Jiangping; Buck, Peter; Sockett, Paul; Aramini, Jeff; Pollari, Frank

    2006-01-01

    Background An extensive West Nile virus surveillance program of dead birds, mosquitoes, horses, and human infection has been launched as a result of West Nile virus first being reported in Canada in 2001. Some desktop and web GIS have been applied to West Nile virus dead bird surveillance. There have been urgent needs for a comprehensive GIS services and real-time surveillance. Results A pilot system was developed to integrate real-time surveillance, real-time GIS, and Open GIS technology in order to enhance West Nile virus dead bird surveillance in Canada. Driven and linked by the newly developed real-time web GIS technology, this integrated real-time surveillance system includes conventional real-time web-based surveillance components, integrated real-time GIS components, and integrated Open GIS components. The pilot system identified the major GIS functions and capacities that may be important to public health surveillance. The six web GIS clients provide a wide range of GIS tools for public health surveillance. The pilot system has been serving Canadian national West Nile virus dead bird surveillance since 2005 and is adaptable to serve other disease surveillance. Conclusion This pilot system has streamlined, enriched and enhanced national West Nile virus dead bird surveillance in Canada, improved productivity, and reduced operation cost. Its real-time GIS technology, static map technology, WMS integration, and its integration with non-GIS real-time surveillance system made this pilot system unique in surveillance and public health GIS. PMID:16626490

  18. 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.

  19. 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

  20. Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies.

    PubMed

    O'Neill, R T

    This paper deals with a conceptual discussion of a variety of statistical concepts, methods and strategies that are relevant to the quantitative assessment of risk derived from safety data collected during the pre- and post-marketing phase of a new drug's life cycle. A call is made for the use of more standard approaches to the analysis of safety data that are statistically and epidemiologically rigorous and for attempts to link the strategies for pre-market safety assessment with strategies for post-market safety evaluation. This link may be facilitated by recognizing the limitations and complementary roles played by pre- and post-market safety data collection schemes and by linking the quantitative analyses utilized for either exploratory or confirmatory purposes of risk assessment in each phase of safety data collection. Examples are provided of studies specifically designed to evaluate risk in a post approval setting and several available guidelines intended to improve the quality of these studies are discussed.

  1. 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.

  2. 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

  3. 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

  4. [To explore evidence evaluation for harm: establishing the body of evidence for harm for postmarketing traditional Chinese medicine].

    PubMed

    Liao, Xing; Xie, Yan-ming; Wang, Yong-yan; Nicola, Robinson

    2015-12-01

    There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.

  5. [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.

  6. [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

  7. [Results of the Russian EKSPERT program: post-marketing supervision over efficacy and influence of the preparation Ekvator on quality of life at out-patients with arterial hypertension].

    PubMed

    Glezer, M G; Vygodin, V A; Avakian, A A; Prokof'eva, E B

    2014-01-01

    Results of an open multicenter prospective postmarketing observational program EKSPERT (post-marketing surveillance of the effectiveness and impact of the EKVATOR treatment on quality of life in patients with arterial hypertension in ambulatory practice). Observation of 10 000 patients conducted in 300 medical center in various regions of the Russian Federation in 1005 doctors. Selected for the final analysis 4954 registration cards. It is shown that in patients with initially insufficient effective antihypertensive treatment has a large number of risk factors: men older than 55 years--56.5%, women older than 65 years--27.8%, unfavorable family history of arterial hypertension (AH)--87.9%, diabetes mellitus (DM)--13.4%, smoking--of patients 18.6%, obesity--35%, angina--35.59%, heart failure--41.3% with a history of myocardial infarction--10.9%, stroke--4.5%, renal disease--11.8%, hypercholesterolemia > 5.0 mmol/l--76.7%. Initially drug antihypertensive treatment was performed in 76.6% of patients, while 43.9% were treated regularly. Prior studies angiotensin converting enzyme inhibitors (ACE) afforded 60.56%, sartans--11% of patients, beta-blockers--41.9%, duretics--41.46%, calcium antagonists used in 21.42% of the patients. After the cancellation of previously used other ACE inhibitors, calcium antagonists and sartans patients were switched to therapy with the EKVATOR (amlodipine and lisinopril). Intensity reduction in systolic and diastolic blood pressure (SBP and DBP) did not depend on sex of the patients, the presence of angina, diabetes. Greater reduction in blood pressure in hypertensive duration more than 5 years, in the presence of congestive heart failure due to more frequent initiation of therapy with full-dose combination (amlodipine 10 mg and lisinopril 20 mg). After 1 months of starting therapy changes uorvney target blood pressure (< 140 and 90 mmHg) reached 51.5% of patients. Target SBP reached 59.7% of patients, the target level of DBP--69.4%. It is

  8. 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

  9. 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.

  10. Intussusception in southern India: comparison of retrospective analysis and active surveillance.

    PubMed

    Jehangir, Susan; John, Jacob; Rajkumar, Sangeeth; Mani, Betty; Srinivasan, Rajan; Kang, Gagandeep

    2014-08-11

    through active monitoring in the trial. The WHO recommendation of sentinel hospital based surveillance for post-marketing surveillance after rotavirus vaccine introduction is likely to a better approach than active surveillance. PMID:25091689

  11. 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 ...

  12. 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.

  13. The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

    PubMed

    Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

    2010-02-01

    The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

  14. 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.

  15. 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.

  16. Mobile security surveillance system

    NASA Astrophysics Data System (ADS)

    Sokolnikov, Andre

    2006-05-01

    The necessity to control certain areas from outside intrusion or, vice versa, preventing subjects/objects (e.g. prisoners) from leaving a controlled area has brought to life numerous designs of surveillance systems for the above-mentioned tasks. Fibers, laser beams, microwaves, etc have been used for decades to provide an alarm signal, should anyone or anything cross a light, radio beam or break a fiber. However, it is difficult to distinguish a stray animal from a human being, or even a snow ball from the first two using the conventional surveillance designs. False alarms render practically useless the above means, especially for field applications. It is possible, nonetheless, to set up an automatic system that discriminates objects/subjects crossing the control line/perimeter - a statistical approach which includes time series analysis is proposed as a solution for the problem.

  17. 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).

  18. [Health surveillance of workers].

    PubMed

    Alessio, L; Curti, R; Rivolta, G

    1987-01-01

    The paper deals with the concepts of environmental monitoring and health surveillance, which include the following tasks: biological monitoring, health information, pre-employment and periodical medical examinations. Biological monitoring permits evaluation of the degree of exposure and its early effects. The early effects can be detected with specific tests exploring initial biological alterations while the organism is still capable of compensating such changes. Application of biological monitoring requires a profound knowledge of toxicology and health surveillance in general terms requires a solid basis of occupational medicine in order to set objectives and make judgements concerning fitness for specific jobs. Details are given of the measures the occupational health physician must take and when he must take them in the case of development of an occupational disease. Particular attention is given to the removal of the subject from exposure, the first certificate of occupational disease, the notification to the Local Health Unit and the diagnosis.

  19. Surveillance for gastrointestinal malignancies

    PubMed Central

    Tiwari, Ashish K; Laird-Fick, Heather S; Wali, Ramesh K; Roy, Hemant K

    2012-01-01

    Gastrointestinal (GI) malignancies are notorious for frequently progressing to advanced stages even in the absence of serious symptoms, thus leading to delayed diagnoses and dismal prognoses. Secondary prevention of GI malignancies through early detection and treatment of cancer-precursor/premalignant lesions, therefore, is recognized as an effective cancer prevention strategy. In order to efficiently detect these lesions, systemic application of screening tests (surveillance) is needed. However, most of the currently used non-invasive screening tests for GI malignancies (for example, serum markers such as alpha-fetoprotein for hepatocellular carcinoma, and fecal occult blood test, for colon cancer) are only modestly effective necessitating the use of highly invasive endoscopy-based procedures, such as esophagogastroduodenoscopy and colonoscopy for screening purposes. Even for hepatocellular carcinoma where non-invasive imaging (ultrasonography) has become a standard screening tool, the need for repeated liver biopsies of suspicious liver nodules for histopathological confirmation can’t be avoided. The invasive nature and high-cost associated with these screening tools hinders implementation of GI cancer screening programs. Moreover, only a small fraction of general population is truly predisposed to developing GI malignancies, and indeed needs surveillance. To spare the average-risk individuals from superfluous invasive procedures and achieve an economically viable model of cancer prevention, it’s important to identify cohorts in general population that are at substantially high risk of developing GI malignancies (risk-stratification), and select suitable screening tests for surveillance in these cohorts. We herein provide a brief overview of such high-risk cohorts for different GI malignancies, and the screening strategies that have commonly been employed for surveillance purpose in them. PMID:22969223

  20. Adaptive maritime video surveillance

    NASA Astrophysics Data System (ADS)

    Gupta, Kalyan Moy; Aha, David W.; Hartley, Ralph; Moore, Philip G.

    2009-05-01

    Maritime assets such as ports, harbors, and vessels are vulnerable to a variety of near-shore threats such as small-boat attacks. Currently, such vulnerabilities are addressed predominantly by watchstanders and manual video surveillance, which is manpower intensive. Automatic maritime video surveillance techniques are being introduced to reduce manpower costs, but they have limited functionality and performance. For example, they only detect simple events such as perimeter breaches and cannot predict emerging threats. They also generate too many false alerts and cannot explain their reasoning. To overcome these limitations, we are developing the Maritime Activity Analysis Workbench (MAAW), which will be a mixed-initiative real-time maritime video surveillance tool that uses an integrated supervised machine learning approach to label independent and coordinated maritime activities. It uses the same information to predict anomalous behavior and explain its reasoning; this is an important capability for watchstander training and for collecting performance feedback. In this paper, we describe MAAW's functional architecture, which includes the following pipeline of components: (1) a video acquisition and preprocessing component that detects and tracks vessels in video images, (2) a vessel categorization and activity labeling component that uses standard and relational supervised machine learning methods to label maritime activities, and (3) an ontology-guided vessel and maritime activity annotator to enable subject matter experts (e.g., watchstanders) to provide feedback and supervision to the system. We report our findings from a preliminary system evaluation on river traffic video.

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  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. 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

  11. 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.

  12. 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.

  13. Bodygraphic Injury Surveillance System

    NASA Astrophysics Data System (ADS)

    Tsuboi, Toshiki; Kitamura, Koji; Nishida, Yoshihumi; Motomura, Yoichi; Takano, Tachio; Yamanaka, Tatsuhiro; Mizoguchi, Hiroshi

    This paper proposes a new technology,``a bodygraphic injury surveillance system (BISS)'' that not only accumulates accident situation data but also represents injury data based on a human body coordinate system in a standardized and multilayered way. Standardized and multilayered representation of injury enables accumulation, retrieval, sharing, statistical analysis, and modeling causalities of injury across different fields such as medicine, engineering, and industry. To confirm the effectiveness of the developed system, the authors collected 3,685 children's injury data in cooperation with a hospital. As new analyses based on the developed BISS, this paper shows bodygraphically statistical analysis and childhood injury modeling using the developed BISS and Bayesian network technology.

  14. 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.

  15. 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)

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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 ...

  3. 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

  4. 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

  5. Video surveillance at night

    NASA Astrophysics Data System (ADS)

    Stevens, Mark R.; Pollak, Joshua B.; Ralph, Scott; Snorrason, Magnus S.

    2005-05-01

    The interpretation of video imagery is the quintessential goal of computer vision. The ability to group moving pixels into regions and then associate those regions with semantic labels has long been studied by the vision community. In urban nighttime scenarios, the difficulty of this task is simultaneously alleviated and compounded. At night there is typically less movement in the scene, which makes the detection of relevant motion easier. However, the poor quality of the imagery makes it more difficult to interpret actions from these motions. In this paper, we present a system capable of detecting moving objects in outdoor nighttime video. We focus on visible-and-near-infrared (VNIR) cameras, since they offer low cost and very high resolution compared to alternatives such as thermal infrared. We present empirical results demonstrating system performance on a parking lot surveillance scenario. We also compare our results to a thermal infrared sensor viewing the same scene.

  6. 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.

  7. National Retail Data Monitor for public health surveillance.

    PubMed

    Wagner, Michael M; Tsui, F C; Espino, J; Hogan, W; Hutman, J; Hersh, J; Neill, D; Moore, A; Parks, G; Lewis, C; Aller, R

    2004-09-24

    The National Retail Data Monitor (NRDM) is a public health surveillance tool that collects and analyzes daily sales data for over-the-counter (OTC) health-care products. NRDM collects sales data for selected OTC health-care products in near real time from >15,000 retail stores and makes them available to public health officials. NRDM is one of the first examples of a national data utility for public health surveillance that collects, redistributes, and analyzes daily sales-volume data of selected health-care products, thereby reducing the effort for both data providers and health departments.

  8. Post-marketing survey on clinical response to interferon beta in relapsing multiple sclerosis: the Roman experience.

    PubMed

    Pozzilli, C; Prosperini, L; Sbardella, E; De Giglio, L; Onesti, E; Tomassini, V

    2005-12-01

    Safety, tolerability and efficacy profiles of interferon beta (IFNbeta) therapy in relapsing multiple sclerosis (MS) has been widely verified both in trial settings and in daily clinical practice. However, for a variable percentage of treated patients, it remains only partially effective. In this study, we reported the post-marketing experience of the efficacy of IFNbeta therapy for a large cohort of MS patients regularly attending the MS Outpatient Clinic of "La Sapienza University" in Rome. In this cohort we also sought clinical and paraclinical variables responsible for the clinical course of MS during IFNbeta therapy. Patients that received treatment with one of the IFNbeta formulations for at least 1 year were included. Clinical outcomes (i. e., relapses and disability score) were monitored throughout the entire study period. Magnetic resonance imaging (MRI) scans were performed twice for each subject: at baseline and after 1 year of therapy. The occurrence of more than one relapse during the study period or a sustained disability progression in the Expanded Disability Status Scale (EDSS) score were considered as criteria for the definition of suboptimal clinical response to IFNbeta therapy. During IFNbeta therapy (number of patients 242, mean length of treatment 4.3+/-2.3 years) a reduction in the annualised relapse rate of 59% (p<0.001) was observed. Eighty-six patients (35%) fulfilled the criterion for defining "suboptimal responder" on the basis of relapses, and 69 (28.5%) did the same on the basis of EDSS sustained progression. Twenty-seven (11.1%) patients showed both an EDSS progression and two or more relapses. The presence of T1-enhancing lesions and new T2 hyperintense lesions on the scan performed after the first year of therapy were the best MRI features associated with both the occurrence of relapses during the treatment period (OR for enhancing lesions and relapses 3.6; OR for new T2 lesion and relapses 2.8). The present post-marketing experience

  9. 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

  10. Review of Australia's polio surveillance.

    PubMed

    Paterson, Beverley J; Durrheim, David N

    2013-06-01

    With eradication almost within reach, the importance of detecting every poliomyelitis case has taken on additional significance. The selected surveillance strategy must be effective and efficient. A review of polio surveillance in Australia was conducted to consider whether current strategies were optimal. Document review and semi-structured key informant interviews were used to conduct the review. Interviews were recorded, transcribed and thematically analysed. The review was an iterative process with feedback on the findings sought from interviewees. Since Western Pacific Regional polio-elimination status was certified, one imported adult case was detected in 2007 in Australia, with no evidence of further transmission, and no Australian paediatric cases identified. Respondents reported that: it was not possible to prevent importations; paediatric cases were more likely to be identified than adult cases; and there may be a low level of suspicion among clinicians. Case detection and outbreak mitigation were considered key reasons to undertake polio surveillance. While Australia has not achieved one of the key World Health Organization (WHO) surveillance targets, this did not compromise Australias polio-free status. Identified issues with polio surveillance were the potential for an importation with high attendant investigation and containment costs, low stool sample collection rates, and the opportunity to improve safeguards around the importation and laboratory storage of biological samples containing poliovirus. The review found strong support for ongoing polio surveillance, particularly to detect imported cases and to demonstrate commitment to maintaining a polio-free region. Existing polio surveillance strategies were considered appropriate for Australia. PMID:24168089

  11. 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.

  12. 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.

  13. Autonomous wildfire surveillance

    NASA Astrophysics Data System (ADS)

    de Vries, Jan S.

    1993-11-01

    Until recently, problems resulting from fires in forests and natural areas were solved on a national rather than international level. This resulted in duplicating research efforts. The Commission of the European Communities (CEC) tries to enhance the cooperation between European countries to stimulate research on the causes and the technological developments for wildfire prevention, detection, and fighting. One result of these efforts has been the start of an international project on the development of a demonstration system that will be used to aid wild land managers and fire fighters in preventing and fighting wild fires. The system will consist of a decision support system and an autonomous wild fire detection system. The basic information that is used by the decision support system is on the one hand a database system with historical, topographical, logistic, meteorological and geographic information and on the other hand `real-time' data from automated cameras and weather sensors. Also, in other large countries outside Europe, such as Canada, the United States and Australia, technological approaches are being developed to reduce hazards as a result of wild fires. In this paper a summary is given on the various problems and solutions in the area of autonomous wild fire detection and surveillance in the CEC and some other parts of the world.

  14. Surveillance in Barrett esophagus.

    PubMed

    Gindea, C; Birla, R; Hoara, P; Caragui, A; Constantinoiu, S

    2014-01-01

    The only known precursor of the esophageal adenocarcinoma (EAC) is represented by the Barrett's esophagus (BE). EAC incidence has increased sharply in the last 4 decades. The annual conversion rate of BE to cancer is small but significant; therefore the identification of patients at a higher risk of cancer represents a dilemma. The endoscopic surveillance of BE aims to detect dysplasia and in particular high-grade dysplasia and intramucosal cancers that can be endoscopically treated before progressing to invasive cancer with lymph node metastases. Using standard white light endoscopy (WLE), these high-risk lesions are often subtle and hard to detect. In addition to high-definition standard endoscopy, chromoendoscopy (CE), virtual chromoendoscopy (e.g. narrow band imaging), and confocal laser endomicroscopy might increase the diagnostic efficiency for the detection of dysplastic lesions and can also increase the diagnostic efficiency for the detection of BE dysplasia or cancer. This ability to detect subtle mucosal abnormalities that harbor high-grade dysplasia (HGD) or intramucosal carcinoma might enable endoscopists skilled in the assessment of BE to perform targeted rather than random biopsies. The standard protocol will remain the careful examination by using conventional high-resolution endoscopes, combined with a longer inspection time, which is associated with an increased detection of dysplasia until these modalities have been demonstrated to enhance efficiency or be cost effective. Many of the limitations of the current clinical standard may be overcome in the future by the use of multi-modal imaging combined with molecular information. PMID:25870698

  15. 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

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. Alberta Congenital Anomalies Surveillance System.

    PubMed Central

    Lowry, R B; Thunem, N Y; Anderson-Redick, S

    1989-01-01

    The Alberta Congenital Anomalies Surveillance System was started in 1966 in response to the thalidomide tragedy earlier in the decade. It was one of four provincial surveillance systems on which the federal government relied for baseline statistics of congenital anomalies. The government now collects data from six provinces and one territory. The Alberta Congenital Anomaly Surveillance System originally depended on three types of notification to the Division of Vital Statistics, Department of Health, Government of Alberta: birth notice and certificates of death and stillbirth; increased sources of ascertainment have greatly improved data quality. We present the data for 1980-86 and compare the prevalence rates of selected anomalies with the rates from three other surveillance systems. Surveillance systems do not guarantee that a new teratogen will be detected, but they are extremely valuable for testing hypotheses regarding causation. At the very least they provide baseline data with which to compare any deviation or trend. For many, if not most, congenital anomalies total prevention is not possible; however, surveillance systems can be used to measure progress in prevention. PMID:2819634

  1. [Measles surveillance in Germany. From sentinel to mandatory surveillance].

    PubMed

    Siedler, A; Grüber, A; Mankertz, A

    2013-09-01

    From September 1999 to March 2011, sentinel surveillance of measles was conducted by a self-selected sample of private physicians in Germany. From 2001, when mandatory surveillance for measles was established, two surveillance systems worked in parallel. The aim of this article is to summarize the strengths and limitations of sentinel versus mandatory surveillance. Active monthly reporting included case-based questionnaires on patients with (suspected) measles or zeroreporting. For confirmation of measles, the diagnostic patient specimens were sent to regional laboratories for serological tests or to the National Reference Laboratory (NRC). In the NRC in addition to serological tests measles-virus (MV) detection by PCR in urine, throat swabs, and oral fluid (since 2003) as well as MVgenotyping was offered. From January 2000 to December 2010, 934 out of 1,488 participating sentinel-practices did not see any measles case, while 554 reported 3,573 suspected cases. Measles was confirmed by laboratory testing in 801 cases, excluded in 473 cases, and the diagnosis remained uncertain in 215 cases. Of 3,100 analyzed cases, 2,712 (87 %) were unvaccinated, 217 (7 %) and 32 (1 %) were vaccinated with one or two doses, respectively, and for 139 (4 %) cases the vaccination status was unknown. The main reason for not being vaccinated against measles was refusal (n = 1,383). The confirmation rate was lower in the vaccinated than in the unvaccinated patients (19 % vs. 63 %). Since 2006, sentinel-cases have differed from notified cases by region and age. The proportion of sentinel cases from all NRC-investigated cases decreased from more than  50 % (2002) to less than  5 % (since 2007). Sentinel surveillance allowed for the detection of trends, delivered additional information for measles prevention, and played a major role in measles diagnostics. Since mandatory surveillance was established and sentinel surveillance no longer reflected the epidemiologic

  2. 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.

  3. 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

  4. Post-marketing observational study on 5% intravenous immunoglobulin therapy in patients with secondary immunodeficiency and recurrent serious bacterial infections.

    PubMed

    Günther, Georg; Dreger, Bettina

    2013-07-01

    Secondary hypogammaglobulinemia is one of the factors responsible for the increased susceptibility to infection in patients with chronic lymphocytic leukemia (CLL). This study assessed the therapeutic results, concomitant medication and tolerance of administering 5% intravenous immunoglobulin, secondary immunodeficiency and recurrent serious bacterial infections. A single center, post-marketing, observational clinical study was performed on 10 patients with a variety of hematological malignancies (CLL, follicular non-Hodgkin lymphoma, IgM-secreting immunocytoma, IgA plasmacytoma and myelodysplastic syndrome/non-Hodgkin lymphoma) who had been infused with IVIG from June 1994 to May 2009. The clinical benefit of IVIG was assessed by comparing the incidence of bacterial infections before and after starting this therapy. Plasma immunoglobulin concentrations and relevant hematological variables were recorded. For safety assessment, adverse events were monitored. The standard IVIG dosage was approximately 0.35 g/kg body weight every 3-4 weeks. Most patients had normal IgG trough values of >600 mg/dL during the IVIG treatment period. The rate of bacterial infections was reduced from 2.4 per patient in the 3 months before IVIG to 0.7 (0-1.5) per patient per year during IVIG treatment. All patients received concomitant medication, mainly anticancer and anti-anemia therapy (100%). No serious adverse events related to IVIG were observed. The frequency of at least one minor adverse reaction was 1.44% (8/556 infusions). In conclusion, the investigated IVIG preparation was well tolerated and clinically beneficial in reducing the long term rate of serious bacterial infections in patients receiving concomitant treatment for malignant diseases.

  5. [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".

  6. [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

  7. [Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].

    PubMed

    Zhong, Cheng-Liang; Hu, Si-Yuan; Xie, Yan-Ming; Wang, Yong-Yan

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.

  8. 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.

  9. 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…

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

    PubMed Central

    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

  11. 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

  12. 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.

  13. 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

  14. 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…

  15. Smart sensing surveillance video system

    NASA Astrophysics Data System (ADS)

    Hsu, Charles; Szu, Harold

    2016-05-01

    An intelligent video surveillance system is able to detect and identify abnormal and alarming situations by analyzing object movement. The Smart Sensing Surveillance Video (S3V) System is proposed to minimize video processing and transmission, thus allowing a fixed number of cameras to be connected on the system, and making it suitable for its applications in remote battlefield, tactical, and civilian applications including border surveillance, special force operations, airfield protection, perimeter and building protection, and etc. The S3V System would be more effective if equipped with visual understanding capabilities to detect, analyze, and recognize objects, track motions, and predict intentions. In addition, alarm detection is performed on the basis of parameters of the moving objects and their trajectories, and is performed using semantic reasoning and ontologies. The S3V System 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 environments. It would be directly applicable to solutions for emergency response personnel, law enforcement, and other homeland security missions, as well as in applications requiring the interoperation of sensor networks with handheld or body-worn interface devices.

  16. 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.

  17. 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…

  18. Innovative Uses for Syndromic Surveillance

    PubMed Central

    Zhang, Guoyan; Leguen, Fermin; Llau, Anthoni; Rico, Edhelene

    2010-01-01

    To determine if expanded queries can be used to identify specific reportable diseases/conditions not detected by using automated syndrome categories, we developed new categories to use with the Electronic Surveillance System for the Early Notification of Community Based Epidemics. Results suggest innovative queries can enhance clinicians’ compliance with reportable disease requirements. PMID:20350382

  19. 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.

  20. Innovative uses for syndromic surveillance.

    PubMed

    O'Connell, Erin K; Zhang, Guoyan; Leguen, Fermin; Llau, Anthoni; Rico, Edhelene

    2010-04-01

    To determine if expanded queries can be used to identify specific reportable diseases/conditions not detected by using automated syndrome categories, we developed new categories to use with the Electronic Surveillance System for the Early Notification of Community Based Epidemics. Results suggest innovative queries can enhance clinicians' compliance with reportable disease requirements.

  1. The use of consumption data to assess exposure to biotechnology-derived foods and the feasibility of identifying effects on human health through post-market monitoring.

    PubMed

    Hlywka, J J; Reid, J E; Munro, I C

    2003-10-01

    The pre-market safety assessment of foods derived through biotechnology provides a scientific basis for concluding reasonable certainty of no harm and ensuring safety. At a minimum, the outcome of such an assessment provides sufficient information to estimate the likelihood of adverse effects on consumers, generally precluding the need for post-market monitoring. Post-market monitoring (PMM) may be appropriate under certain conditions where a better estimate of dietary exposure and/or nutritional consequence of a biotechnology-derived food is required, when a potential safety issue, such as allergenicity, cannot be adequately addressed through pre-market studies, or to corroborate dietary intakes of a nutritionally improved food with beneficial effects on human health. Monitoring programs must be hypothesis-driven, and are dependent upon the availability of accurate consumption data. Exposure assessment methods include both deterministic and probabilistic estimates of intakes using food supply data, individual dietary surveys, household surveys, or total diet studies. In the development of a monitoring approach, resource allocation should be dependent upon both the desired level of conservatism and the endpoint of interest. However, the cost of monitoring varies substantially, and the potential to determine causation may be limited.

  2. 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…

  3. 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,…

  4. 40 CFR 52.12 - 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. 52.12 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...

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. Influenza virus surveillance, vaccine strain selection, and manufacture.

    PubMed

    Stöhr, Klaus; Bucher, Doris; Colgate, Tony; Wood, John

    2012-01-01

    As outlined in other chapters, the influenza virus, existing laboratory diagnostic abilities, and disease epidemiology have several peculiarities that impact on the timing and processes for the annual production of influenza vaccines. The chapter provides an overview on the key biological and other factors that influence vaccine production. They are the reason for an "annual circle race" beginning with global influenza surveillance during the influenza season in a given year to the eventual supply of vaccines 12 months later in time before the next seasonal outbreak and so on. As influenza vaccines are needed for the Northern and Southern Hemisphere outbreaks in fall and spring, respectively, global surveillance and vaccine production has become a year round business. Its highlights are the WHO recommendations on vaccine strains in February and September and the eventual delivery of vaccine doses in time before the coming influenza season. In between continues vaccine strain and epidemiological surveillance, preparation of new high growth reassortments, vaccine seed strain preparation and development of standardizing reagents, vaccine bulk production, fill-finishing and vaccine release, and in some regions, clinical trials for regulatory approval.

  15. The value of population pharmacokinetics and simulation for postmarketing safety evaluation of dosing guidelines for drugs with a narrow therapeutic index: buflomedil as a case study.

    PubMed

    Bourguignon, Laurent; Ducher, Michel; Matanza, David; Bleyzac, Nathalie; Uhart, Mathieu; Odouard, Emmanuel; Maire, Pascal; Goutelle, Sylvain

    2012-04-01

    Population pharmacokinetics and simulation techniques currently play an important role in new drug development. This paper illustrates the potential value of those methods in postmarketing safety assessment, using buflomedil in elderly patients as an example. We retrospectively assessed the risk of buflomedil overdosing associated with the latest dosing recommendations of the French Drug Agency (AFSSAPS). First, buflomedil concentrations measured in 24 elderly patients were analysed with a nonparametric population approach. Then, the pharmacokinetic model was used to perform a 1000-patient Monte Carlo simulation for the two recommended buflomedil dosage regimens. The maximum concentrations calculated after 10 days of therapy were compared with levels observed in reported cases of toxicity to assess the probability of overdosing. A three-compartment model best fit concentration data. Population predictions showed little bias (-0.14 mg/L) and good precision (8.73 mg(2) /L(2)). Overall results of the simulation study showed that the application of the two recommended dosage regimens of buflomedil was associated with overdosing (C(max) > 10 mg/L) and potential toxicity in 2.9% of geriatric patients. In patients with mild renal impairment, who may receive the higher-dosage regimen by therapeutic error, the probability of overdosing was 6.2%. Despite specific dosing recommendations in case of renal impairment, this study shows that the use of buflomedil could be associated with significant risk of overdosing in geriatric patients. Such results might have enhanced decision-making when buflomedil safety was reassessed by AFSSAPS in 2006. The retrospective case of buflomedil illustrates how these methods may be valuable in postmarketing safety evaluation of potentially toxic drugs.

  16. 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

  17. 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

  18. Surveillance for dengue and dengue hemorrhagic fever.

    PubMed

    Gubler, D J

    1989-01-01

    Dengue and dengue hemorrhagic fever are emerging as major public health problems in most tropical countries. Effective prevention and control programs will depend on improved surveillance designed to provide early warning of dengue epidemics. This article outlines a reasonable approach to dengue surveillance of this kind. Virologic surveillance should be considered the most important element in any such early warning system. Dengue virus transmission should be monitored to determine which serotypes are present, their distribution, and the type of illnesses associated with each. Other key components of an active surveillance system should include monitoring of fever activity and clinical surveillance for cases of severe and fatal disease associated with viral syndromes. Collectively, these three surveillance components can provide an early warning capability permitting emergency mosquito control measures to be implemented and major epidemics to be averted.

  19. Surveillance Imaging Following Endovascular Aneurysm Repair

    PubMed Central

    Pandey, Nirnimesh; Litt, Harold I.

    2015-01-01

    There is a significant risk of complication following endovascular abdominal repair (EVAR), including endoleak, graft translocation, thrombosis, and infection. Surveillance imaging is important for detecting EVAR complication. Surveillance modalities include conventional X-ray, computed tomography, magnetic resonance imaging, ultrasound, and conventional angiography, with inherent advantages and drawbacks to each modality. The authors present common complications following EVAR, and recent advances in the key modalities for surveillance. PMID:26327742

  20. 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

  1. Skunk rabies surveillance in Illinois.

    PubMed

    Barllett, P C; Martin, R J

    1982-06-15

    Surveillance data indicated that an increased incidence of skunk rabies in Illinois during 1979-1980 was not attributable to increased reporting or submission of skunks to the state laboratories for rabies examination. Available road-kill data suggested that the skunk population increased prior to the increase in skunk rabies incidence. An increased skunk population was hypothesized to have caused the increased incidence by facilitating transmission of the virus through increased skunk density. Analysis of the temporal distribution of skunk rabies revealed a bimodal seasonal cycle, with peak occurrence in the spring and fall, and the possible beginning of a secular cycle, with peak incidence every 6 to 8 years.

  2. 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.

  3. The value of HAZWOPER medical surveillance.

    PubMed

    Huss, R Gail; Williamson, Kristen N; Alvis, Kimberly L; Hewitt, David J

    2011-11-01

    Medical surveillance is mandated for workers with potential exposure to hazardous materials. However, little guidance is provided regarding the components of a medical surveillance testing program for these individuals. This article describes the medical surveillance program for a group of 72 employees who respond to hazardous material releases throughout the United States. Conditions related to chemical exposures were not identified in this group. However, several non-occupational health conditions were identified, including a relatively high prevalence of one or more signs of metabolic syndrome. Medical surveillance may provide valuable information regarding an individual's underlying health status and non-occupational health conditions to be addressed at an early stage. PMID:22045009

  4. 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

  5. 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.

  6. 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

  7. Surveying the surveillance: surgical site infections excluded by the January 2013 updated surveillance definitions.

    PubMed

    Dicks, Kristen V; Lewis, Sarah S; Durkin, Michael J; Baker, Arthur W; Moehring, Rebekah W; Chen, Luke F; Sexton, Daniel J; Anderson, Deverick J

    2014-05-01

    The updated 2013 Centers for Disease Control and Prevention/National Healthcare Safety Network definitions for surgical site infections (SSIs) reduced the duration of prolonged surveillance from 1 year to 90 days and defined which procedure types require prolonged surveillance. Applying the updated 2013 SSI definitions to cases analyzed using the pre-2013 surveillance definitions excluded 10% of previously identified SSIs.

  8. Dengue surveillance in the French armed forces: a dengue sentinel surveillance system in countries without efficient local epidemiological surveillance.

    PubMed

    de Laval, Franck; Dia, Aissata; Plumet, Sébastien; Decam, Christophe; Leparc Goffart, Isabelle; Deparis, Xavier

    2013-01-01

    Surveillance of travel-acquired dengue could improve dengue risk estimation in countries without ability. Surveillance in the French army in 2010 to 2011 highlighted 330 dengue cases, mainly in French West Indies and Guiana: DENV-1 circulated in Guadeloupe, Martinique, French Guiana, New Caledonia, Djibouti; DENV-3 in Mayotte and Djibouti; and DENV-4 in French Guiana.

  9. Dengue surveillance in the French armed forces: a dengue sentinel surveillance system in countries without efficient local epidemiological surveillance.

    PubMed

    de Laval, Franck; Dia, Aissata; Plumet, Sébastien; Decam, Christophe; Leparc Goffart, Isabelle; Deparis, Xavier

    2013-01-01

    Surveillance of travel-acquired dengue could improve dengue risk estimation in countries without ability. Surveillance in the French army in 2010 to 2011 highlighted 330 dengue cases, mainly in French West Indies and Guiana: DENV-1 circulated in Guadeloupe, Martinique, French Guiana, New Caledonia, Djibouti; DENV-3 in Mayotte and Djibouti; and DENV-4 in French Guiana. PMID:23809078

  10. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which 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 medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  11. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which 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 medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  12. Battlefield Optical Surveillance System (BOSS)

    NASA Astrophysics Data System (ADS)

    Ireland, Robert J.

    1997-02-01

    The battlefield optical surveillance system (BOSS) was developed for DARPA by the U.S. Air Force's Phillips Laboratory. BOSS is a HMMWV mounted laser surveillance and deterrence system. It is intended to be used to detect and to deter potentially hostile individuals, snipers and groups of agitators. The BOSS integrates the following: (1) a thermal camera (8-12 micrometer FLIR), that detects and cues to possible targets, (2) a 45 watt, 808 nm (near IR), air- cooled laser which provides covert illumination and designation for a day/night camera to acquire said target and attain a high-resolution image using night vision equipment, and (3) a 1 watt, 532 nm (green) laser that overtly illuminates and designates the target. It also has significant deterring effects both physiological and psychological on individuals and crowds. BOSS offers the potential capability to detect snipers before the first shot is fired. Detection of optical augmentations and the thermal characteristics of a sniper allows for this early detection. The integration of BOSS with acoustic sniper detection systems are being explored.

  13. 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.

  14. 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

  15. Volcano surveillance using infrared cameras

    NASA Astrophysics Data System (ADS)

    Spampinato, Letizia; Calvari, Sonia; Oppenheimer, Clive; Boschi, Enzo

    2011-05-01

    Volcanic eruptions are commonly preceded, accompanied, and followed by variations of a number of detectable geophysical and geochemical manifestations. Many remote sensing techniques have been applied to tracking anomalies and eruptive precursors, and monitoring ongoing volcanic eruptions, offering obvious advantages over in situ techniques especially during hazardous activity. Whilst spaceborne instruments provide a distinct advantage for collecting data remotely in this regard, they still cannot match the spatial detail or time resolution achievable using portable imagers on the ground or aircraft. Hand-held infrared camera technology has advanced significantly over the last decade, resulting in a proliferation of commercially available instruments, such that volcano observatories are increasingly implementing them in monitoring efforts. Improved thermal surveillance of active volcanoes has not only enhanced hazard assessment but it has contributed substantially to understanding a variety of volcanic processes. Drawing on over a decade of operational volcano surveillance in Italy, we provide here a critical review of the application of infrared thermal cameras to volcano monitoring. Following a summary of key physical principles, instrument capabilities, and the practicalities and methods of data collection, we discuss the types of information that can be retrieved from thermal imagery and what they have contributed to hazard assessment and risk management, and to physical volcanology. With continued developments in thermal imager technology and lower instrument costs, there will be increasing opportunity to gather valuable observations of volcanoes. It is thus timely to review the state of the art and we hope thereby to stimulate further research and innovation in this area.

  16. 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

  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. Surveillance for emerging respiratory viruses.

    PubMed

    Al-Tawfiq, Jaffar A; Zumla, Alimuddin; Gautret, Philippe; Gray, Gregory C; Hui, David S; Al-Rabeeah, Abdullah A; Memish, Ziad A

    2014-10-01

    Several new viral respiratory tract infectious diseases with epidemic potential that threaten global health security have emerged in the past 15 years. In 2003, WHO issued a worldwide alert for an unknown emerging illness, later named severe acute respiratory syndrome (SARS). The disease caused by a novel coronavirus (SARS-CoV) rapidly spread worldwide, causing more than 8000 cases and 800 deaths in more than 30 countries with a substantial economic impact. Since then, we have witnessed the emergence of several other viral respiratory pathogens including influenza viruses (avian influenza H5N1, H7N9, and H10N8; variant influenza A H3N2 virus), human adenovirus-14, and Middle East respiratory syndrome coronavirus (MERS-CoV). In response, various surveillance systems have been developed to monitor the emergence of respiratory-tract infections. These include systems based on identification of syndromes, web-based systems, systems that gather health data from health facilities (such as emergency departments and family doctors), and systems that rely on self-reporting by patients. More effective national, regional, and international surveillance systems are required to enable rapid identification of emerging respiratory epidemics, diseases with epidemic potential, their specific microbial cause, origin, mode of acquisition, and transmission dynamics. PMID:25189347

  19. 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

  20. 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...

  1. 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 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...

  2. 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 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...

  3. 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 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...

  4. 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 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...

  5. 40 CFR 52.794 - 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. 52.794 Section 52...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Indiana § 52.794 Source surveillance. (a) The... County sources specifically listed in Table 2 of 325 IAC 6-1-10.2 (§ 52.770(c)(57)); for pushing...

  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. 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...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1077 Source surveillance. (a... procedures for stationary sources to be periodically tested....

  8. 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)...

  9. 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... adequate legally enforceable procedures for requiring owners or operators of stationary sources to...

  10. 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)…

  11. 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.

  12. 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....

  13. 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....

  14. 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....

  15. Microbiological Food Safety Surveillance in China.

    PubMed

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

    2015-09-01

    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.

  16. 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

  17. 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

  18. 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

  19. Bovine tuberculosis surveillance alternatives in Belgium.

    PubMed

    Welby, S; Govaerts, M; Vanholme, L; Hooyberghs, J; Mennens, K; Maes, L; Van Der Stede, Y

    2012-09-15

    Belgium obtained the bovine tuberculosis (bTB) officially free status in 2003 (EC Decision 2003/467/EC). This study was carried out to evaluate the components of the current bTB surveillance program in Belgium and to determine the sensitivity of this program. Secondly, alternatives to optimize the bTB surveillance in accordance with European legislation (Council Directive 64/432/EEC) were evaluated. Separate scenario trees were designed for each active surveillance component of the bTB surveillance program. Data from 2005 to 2009 regarding cattle population, movement and surveillance were collected to feed the stochastic scenario tree simulation model. A total of 7,403,826 cattle movement history records were obtained for the 2,678,020 cattle from 36,059 cattle herds still active in 2009. The current surveillance program sensitivity as well as the impact of alternative surveillance protocols was simulated in a stochastic model using 10,000 iterations per simulation. The median (50% percentile) of the component sensitivities across 10,000 iterations was 0.83, 0.85, 0.99, 0.99, respectively, for (i) testing the cattle only during the winter screening, (ii) testing only imported cattle, (iii) testing only purchased cattle and (iv) testing only all slaughtered cattle. The sensitivity analysis showed that the most influential input parameter explaining the variability around the output came from the uncertainty distribution around the sensitivity of the diagnostic tests used within the bTB surveillance. Providing all animals are inspected and post mortem inspection is highly sensitive, slaughterhouse surveillance was the most effective surveillance component. If these conditions were not met, the uncertainty around the mean sensitivity of this component was important. Using an antibody ELISA at purchase and an interferon gamma test during winter screening and at import would increase greatly the sensitivity and the confidence level of Belgium's freedom from b

  20. 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

  1. System for maritime surveillance aid

    NASA Astrophysics Data System (ADS)

    Yamamoto, Kazuo; Yamada, Kimio; Kiriya, Nobuo

    1997-02-01

    A system to aid maritime surveillance is being studied to search for small floating objects like a life raft or to detect oil spill more reliably and efficiently. The system consists of sensors, an image processor and a display so as to reject unnecessary noise in the sea surface images, and then to detect and identify the objects to be searched. This paper describes the optical sensor system with an infrared camera and a TV camera. The infrared camera detects 3-5 micrometers waveband by 512 by 512 solid state sensing elements. The systems was used to gather images on different sea areas in summer and winter by aircraft and on the ground. Typical images are presented to demonstrate the validity of the sensor system to search for small flowing objects. The influences of air and water temperature, weather and observation altitude upon the images are discussed. Image processing techniques like filtering or image superposition are also described to suppress noise.

  2. 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

  3. [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

  4. Epidemic salmonellosis from cheddar cheese: surveillance and prevention.

    PubMed

    Fontaine, R E; Cohen, M L; Martin, W T; Vernon, T M

    1980-02-01

    On August 3, 1976, ongoing Salmonella surveillance in Colorado first detected an epidemic of Salmonella heidelberg infections that eventually totaled 339 isolates. The majority of the cases occurred between July 23 and August 12 in two widely separated cities: Denver and Pueblo. Epidemiologic investigation successively incriminated 1) recent dining at Mexican-style restaurants (p less than 0.001), 2) eating foods containing cheese in these restaurants (p = 0.029), and 3) consumption of cheddar cheese from a single shipment of a single manufacturer (p less than 0.01). The prompt investigation enabled an embargo of 2087 kg (41%) of the contaminated cheese. S. heidelberg was isolated from seven production lots of the incriminated cheese. Surveillance and the epidemiologic investigation may have resulted in prevention of 25,000 diarrheal illnesses.

  5. 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.

  6. 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)

  7. ["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

  8. ["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

  9. Utilization of Surveillance Colonoscopy in Community Practice

    PubMed Central

    Schoen, Robert E.; Pinsky, Paul F.; Weissfeld, Joel L.; Yokochi, Lance A.; Reding, Doug J.; Hayes, Richard B.; Church, Timothy; Yurgalevich, Susan; Doria-Rose, V. Paul; Hickey, Tom; Riley, Thomas; Berg, Christine D.

    2009-01-01

    Background and Aims The recommended timing of surveillance colonoscopy for individuals with adenomatous polyps is based on adenoma histology, size, and number. The burden and cost of surveillance colonoscopy are significant. The aim of this study was to examine the utilization of surveillance colonoscopy on a community wide basis. Methods We retrospectively queried participants in the Prostate, Lung, Colorectal, and Ovarian Cancer screening trial in nine U.S. communities about use of surveillance colonoscopy. Subjects whose initial colonoscopy demonstrated advanced adenoma (AA), non-advanced adenoma (NAA), or non-adenomatous findings (NA) were included. Colonoscopy exams were confirmed by reviewing colonoscopy reports. Results Of 3,876 subjects selected for inquiry, 3,627 (93.6%) responded. The cumulative probability of a surveillance colonoscopy within 5 years was 58.4% (N=1342) in the AA group, 57.5% in those with ≥3 NAA (N=117), 46.7% in those with 1-2 NAA (N=905), and 26.5% (N=1263) in subjects without an adenoma. Within 7 years, 33.2% of subjects with advanced adenoma received ≥ 2 surveillance exams versus 26.9% for those with ≥3 NAA, 18.2% for those with 1 or 2 NAA, and 10.4% for those with non-adenomatous findings. Incomplete colonoscopy, family history of colorectal cancer, or interval adenomatous findings could explain only a minority of surveillance colonoscopy in low risk subjects. Conclusions In community practice there is substantial over utilization of surveillance colonoscopy among low risk subjects and under utilization among subjects with advanced adenoma. Interventions to better align surveillance colonoscopy use with risk for advanced lesions is needed. PMID:19818779

  10. 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

  11. Application of IR microbolometers in border surveillance

    NASA Astrophysics Data System (ADS)

    Breakfield, David K.; Norton, Peter; Plemons, Dan; Rodriguez, Christian; Sustare, Dennis

    2007-04-01

    BAE Systems led a collaborative study with New Mexico State University to investigate a series of ground based persistent surveillance solutions for potential use along the Southwest border of the United States. This study considered a wide range of system options for mobile and fixed site applications. This paper summarizes the findings of the study including the central role of the imaging subsystems in mobile ground based surveillance solutions and the suitability of uncooled IR Microbolometers within this subsystem. The paper also provides a discussion of the benefits of real time decision support applications when fielding a persistent surveillance solution.

  12. 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...

  13. 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...

  14. Systematic Review of Cerebral Palsy Registries/Surveillance Groups: Relationships between Registry Characteristics and Knowledge Dissemination

    PubMed Central

    Hurley, Donna S; Sukal-Moulton, Theresa; Gaebler-Spira, Deborah; Krosschell, Kristin J; Pavone, Larissa; Mutlu, Akmer; Dewald, Julius PA; Msall, Michael E

    2016-01-01

    The aims of this study were to provide a comprehensive summary of the body of research disseminated by Cerebral Palsy (CP) registries and surveillance programs from January 2009 through May 2014 in order to describe the influence their results have on our overall understanding of CP. Secondly, registries/surveillance programs and the work they produced were evaluated and grouped using standardized definitions and classification systems. Method A systematic review search in PubMed, CINAH and Embase for original articles published from 1 January 2009 to 20 May 2014 originating from or supported by population based CP registries and surveillance programs or population based national registries including CP were included. Articles were grouped by 2009 World CP Registry Congress aim, registry/surveillance program classification, geographical region, and the International Classification of Function, Disability and Health (ICF) domain. Registry variables were assessed using the ICF-CY classification. Results Literature searches returned 177 articles meeting inclusion criteria. The majority (69%) of registry/surveillance program productivity was related to contributions as a Resource for CP Research. Prevention (23%) and Surveillance (22%) articles were other areas of achievement, but fewer articles were published in the areas of Planning (17%) and Raising the Profile of CP (2%). There was a range of registry/surveillance program classifications contributing to this productivity, and representation from multiple areas of the globe, although most of the articles originated in Europe, Australia, and Canada. The domains of the ICF that were primarily covered included body structures and function at the early stages of life. Encouragingly, a variety of CP registry/surveillance program initiatives included additional ICF domains of participation and environmental and personal factors. Interpretation CP registries and surveillance programs, including novel non-traditional ones

  15. 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

  16. The U.S.-Mexico Border Infectious Disease Surveillance project: establishing bi-national border surveillance.

    PubMed

    Weinberg, Michelle; 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.

  17. The U.S.-Mexico Border Infectious Disease Surveillance project: establishing bi-national border surveillance.

    PubMed

    Weinberg, Michelle; 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

  18. Active Surveillance of Candidemia, Australia

    PubMed Central

    Slavin, Monica; Nguyen, Quoc; Marriott, Deborah; Playford, E. Geoffrey; Ellis, David; Sorrell, Tania

    2006-01-01

    Population-based surveillance for candidemia in Australia from 2001 to 2004 identified 1,095 cases. Annual overall and hospital-specific incidences were 1.81/100,000 and 0.21/1,000 separations (completed admissions), respectively. Predisposing factors included malignancy (32.1%), indwelling vascular catheters (72.6%), use of antimicrobial agents (77%), and surgery (37.1%). Of 919 episodes, 81.5% were inpatient healthcare associated (IHCA), 11.6% were outpatient healthcare associated (OHCA), and 6.9% were community acquired (CA). Concomitant illnesses and risk factors were similar in IHCA and OHCA candidemia. IHCA candidemia was associated with sepsis at diagnosis (p<0.001), death <30 days after infection (p<0.001), and prolonged hospital admission (p<0.001). Non–Candida albicans species (52.7%) caused 60.5% of cases acquired outside hospitals and 49.9% of IHCA candidemia (p = 0.02). The 30-day death rate was 27.7% in those >65 years of age. Adult critical care stay, sepsis syndrome, and corticosteroid therapy were associated with the greatest risk for death. Systematic epidemiologic studies that use standardized definitions for IHCA, OHCA, and CA candidemia are indicated. PMID:17176564

  19. 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

  20. 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.

  1. 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.

  2. 40 CFR 52.479 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS District of Columbia § 52.479 Source surveillance. (a) (b) The requirements of § 51.213 are not met with respect to the strategies for carpool locator...

  3. 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.

  4. Dengue surveillance in the Pacific Islands.

    PubMed

    Condon, R; Taleo, G; Stewart, T; Sweeney, T; Kiedrzynski, T

    2000-09-01

    Adequate monitoring of dengue activity can be achieved using a combination of mosquito vector surveillance, fever surveillance, sentinel clinicians and laboratory screening. An apparent increase in fever cases or clinically suspected DF should prompt a careful clinical and laboratory investigation. If an outbreak of dengue is confirmed, health authorities will need to implement emergency community-wide control strategies. Laboratories will quickly feel the burden of clinical monitoring of cases admitted with DHF/DSS. Surveillance can change to clinical case definitions as health workers become familiar with the presenting features of DF and DHF/DSS. Criteria for hospital referral and admission must be well understood. Routine laboratory and sentinel surveillance may resume as the epidemic wanes, and should then continue indefinitely to monitor any resurgence of dengue activity.

  5. ATIVS: analytical tool for influenza virus surveillance.

    PubMed

    Liao, Yu-Chieh; Ko, Chin-Yu; Tsai, Ming-Hsin; Lee, Min-Shi; Hsiung, Chao A

    2009-07-01

    The WHO Global Influenza Surveillance Network has routinely performed genetic and antigenic analyses of human influenza viruses to monitor influenza activity. Although these analyses provide supporting data for the selection of vaccine strains, it seems desirable to have user-friendly tools to visualize the antigenic evolution of influenza viruses for the purpose of surveillance. To meet this need, we have developed a web server, ATIVS (Analytical Tool for Influenza Virus Surveillance), for analyzing serological data of all influenza viruses and hemagglutinin sequence data of human influenza A/H3N2 viruses so as to generate antigenic maps for influenza surveillance and vaccine strain selection. Functionalities are described and examples are provided to illustrate its usefulness and performance. The ATIVS web server is available at http://influenza.nhri.org.tw/ATIVS/.

  6. 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…

  7. [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.

  8. [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

  9. Evaluation of safety and efficacy of ketoconazole 2% and zinc pyrithione 1% shampoo in patients with moderate to severe dandruff--a postmarketing study.

    PubMed

    Saple, D G; Ravichandran, G; Desai, A

    2000-12-01

    A postmarketing study was conducted on 236 patients from 23 centres suffering from moderate to severe dandruff with a combination of ketoconazole and zinc pyrithione (1%) for a duration of 4 weeks with 2 weeks further follow-up. Scoring of dandruff was done on a 0-10 scale for each of the 6 regions of scalp at each week up to 6 weeks. The results indicate that there was a consistent improvement in dandruff scores over the treatment period and a reduction of > 90% was seen for all areas of scalp individually as well as collectively as compared to baseline. The treatment also showed significant improvement in other signs and symptoms such as erythema and itching, with a highly favourable adverse event profile. The overall assessment for global improvement by investigators showed good-excellent results with high acceptability amongst the patient population for the treatment. A combination shampoo of ketoconazole (2%) and zinc pyrithione (1%) offers a safe and effective option in the treatment of dandruff.

  10. Beyond traditional surveillance: applying syndromic surveillance to developing settings – opportunities and challenges

    PubMed Central

    May, Larissa; Chretien, Jean-Paul; Pavlin, Julie A

    2009-01-01

    Background All countries need effective disease surveillance systems for early detection of outbreaks. The revised International Health Regulations [IHR], which entered into force for all 194 World Health Organization member states in 2007, have expanded traditional infectious disease notification to include surveillance for public health events of potential international importance, even if the causative agent is not yet known. However, there are no clearly established guidelines for how countries should conduct this surveillance, which types of emerging disease syndromes should be reported, nor any means for enforcement. Discussion The commonly established concept of syndromic surveillance in developed regions encompasses the use of pre-diagnostic information in a near real time fashion for further investigation for public health action. Syndromic surveillance is widely used in North America and Europe, and is typically thought of as a highly complex, technology driven automated tool for early detection of outbreaks. Nonetheless, low technology applications of syndromic surveillance are being used worldwide to augment traditional surveillance. Summary In this paper, we review examples of these novel applications in the detection of vector-borne diseases, foodborne illness, and sexually transmitted infections. We hope to demonstrate that syndromic surveillance in its basic version is a feasible and effective tool for surveillance in developing countries and may facilitate compliance with the new IHR guidelines. PMID:19607669

  11. 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.

  12. 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.

  13. 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.

  14. Data requirements for electronic surveillance of healthcare-associated infections.

    PubMed

    Woeltje, Keith F; Lin, Michael Y; Klompas, Michael; Wright, Marc Oliver; Zuccotti, Gianna; Trick, William E

    2014-09-01

    Electronic surveillance for healthcare-associated infections (HAIs) is increasingly widespread. This is driven by multiple factors: a greater burden on hospitals to provide surveillance data to state and national agencies, financial pressures to be more efficient with HAI surveillance, the desire for more objective comparisons between healthcare facilities, and the increasing amount of patient data available electronically. Optimal implementation of electronic surveillance requires that specific information be available to the surveillance systems. This white paper reviews different approaches to electronic surveillance, discusses the specific data elements required for performing surveillance, and considers important issues of data validation.

  15. HIV surveillance among injecting drug users.

    PubMed

    Des Jarlais, D C; Dehne, K; Casabona, J

    2001-04-01

    Injecting drug users (IDUs) should be considered a 'partially hidden population' at high risk for HIV infection. In almost all locations it should be possible to locate and conduct research with IDUs, but it will probably never be possible to enumerate or draw random samples from an IDU population. Surveillance research studies with IDUs should include risk behaviors, as surveillance of HIV infection only will not be sufficiently time sensitive, and be used to develop and refine HIV prevention programming for the population. Contacts with IDUs can be developed at multiple settings, including voluntary treatment programs, law enforcement settings, and through 'street outreach.' Each type of setting has different advantages, disadvantages and ethical concerns. HIV testing as part of surveillance also raises additional important ethical concerns. The primary risk behaviors that should be included in surveillance studies are 'sharing' of drug injection equipment, the potential for rapid partner change among risk partners, and sexual risk behavior. Additional important objectives for surveillance research include: (1) the size of the local IDU population, (2) patterns of drug use, (3) availability injection equipment, (4) participation in prevention activities, and (5) access to and use of anti-retroviral treatments. HIV incidence is an ultimate objective for surveillance research, but there are no currently available cost-efficient methods for studying HIV incidence, so estimation from indirect measurements is usually required. PMID:11421178

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

    PubMed Central

    Hyland, Meaghen; Ofner-Agostini, Marianna; Miller, Mark; Paton, Shirley; Gourdeau, Marie; Ishak, Magued

    2001-01-01

    BACKGROUND: A 1996 preproject survey among Canadian Hospital Epidemiology Committee (CHEC) sites revealed variations in the prevention, detection, management and surveillance of Clostridium difficile-associated diarrhea (CDAD). Facilities wanted to establish national rates of nosocomially acquired CDAD (N-CDAD) to understand the impact of control or prevention measures, and the burden of N-CDAD on health care resources. The CHEC, in collaboration with the Laboratory Centre for Disease Control (Health Canada) and under the Canadian Nosocomial Infection Surveillance Program, undertook a prevalence surveillance project among selected hospitals throughout Canada. OBJECTIVE: To establish national prevalence rates of N-CDAD. METHODS: For six weeks in 1997, selected CHEC sites tested all diarrheal stools from inpatients for either C difficile toxin or C difficile bacteria with evidence of toxin production. Questionnaires were completed for patients with positive stool assays who met the case definitions. RESULTS: Nineteen health care facilities in eight provinces participated in the project. The overall prevalence of N-CDAD was 13.0% (95% CI 9.5% to 16.5%). The mean number of N-CDAD cases were 66.3 cases/100,000 patient days (95% CI 37.5 to 95.1) and 5.9 cases/1000 patient admissions (95% CI 3.4 to 8.4). N-CDAD was found most frequently in older patients and those who had been hospitalized for longer than two weeks in medical or surgical wards. CONCLUSIONS: This national prevalence surveillance project, which established N-CDAD rates, is useful as 'benchmark' data for Canadian health care facilities, and in understanding the patterns and impact of N-CDAD. PMID:18159321

  17. 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.

  18. Olestra consumption does not predict serum concentrations of carotenoids and fat-soluble vitamins in free-living humans: early results from the sentinel site of the olestra post-marketing surveillance study.

    PubMed

    Thornquist, M D; Kristal, A R; Patterson, R E; Neuhouser, M L; Rock, C L; Neumark-Sztainer, D; Cheskin, L J

    2000-07-01

    In 1996, the U.S. Food and Drug Administration approved olestra, a fat substitute, for use in snack foods. Previous studies had shown that olestra consumption could reduce absorption of carotenoids and fat-soluble vitamins. To determine the association between consumption of olestra-containing snack foods and serum concentrations of carotenoids and fat-soluble vitamins in a free-living population, we interviewed independent population-based cross-sectional samples of 1043 adults before olestra was available and 933 adults 9 mo after olestra snacks were introduced into the marketplace in Marion County, IN, the first major test market for olestra. A cohort composed of 403 adults from the first survey, oversampling those most frequently reporting olestra consumption during follow-up telephone interviews, completed a second survey. We assessed diet, lifestyle factors and olestra consumption, and collected blood for assays for the serum concentrations of six carotenoids, four fat-soluble vitamins and lipids. Nine months after the introduction of olestra into the marketplace, 15.5% of Marion County residents reported consuming an olestra-containing snack in the previous month, with a median frequency among consumers of 3.0 times per month. There were no significant associations or consistent trends for decreased serum carotenoids or fat-soluble vitamins associated with olestra consumption, although cohort members consuming >/=2 g/d of olestra had adjusted total serum carotenoids 15% lower compared with baseline. There were increases in serum vitamin K concentrations associated with olestra consumption (P = 0.03 in the cross section and P = 0.06 in the cohort). In summary, there was no statistically significant evidence in this free-living population of associations between olestra consumption and decreased serum concentrations of carotenoids and fat-soluble vitamins. PMID:10867041

  19. 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

  20. Using poison center data for postdisaster surveillance.

    PubMed

    Wolkin, Amy; Schnall, Amy H; Law, Royal; Schier, Joshua

    2014-10-01

    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.

  1. 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…

  2. 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.

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

    PubMed

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

    2012-05-01

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

  4. 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

  5. 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

  6. Rotavirus vaccination and intussusception – Science, surveillance, and safety: A review of evidence and recommendations for future research priorities in low and middle income countries

    PubMed Central

    Yen, Catherine; Healy, Kelly; Tate, Jacqueline E.; Parashar, Umesh D.; Bines, Julie; Neuzil, Kathleen; Santosham, Mathuram; Steele, A. Duncan

    2016-01-01

    ABSTRACT As of January 2016, 80 countries have introduced rotavirus vaccines into their national immunization programs. Many have documented significant declines in rotavirus-specific and all-cause diarrheal illnesses following vaccine introduction. Two globally licensed rotavirus vaccines have been associated with a low risk of intussusception in several studies. In July 2014, the Rotavirus Organization of Technical Allies Council convened a meeting of research and advocacy organizations, public health experts, funders, and vaccine manufacturers to discuss post-marketing intussusception surveillance and rotavirus vaccine impact data. Meeting objectives were to evaluate updated data, identify and prioritize research gaps, discuss best practices for intussusception monitoring in lower-income settings and risk communication, and provide insight to country-level stakeholders on best practices for intussusception monitoring and communication. Meeting participants agreed with statements from expert bodies that the benefits of vaccination with currently available rotavirus vaccines outweigh the low risk of vaccination-associated intussusception. However, further research is needed to better understand the relationship of intussusception to wild-type rotavirus and rotavirus vaccines and delineate potential etiologies and mechanisms of intussusception. Additionally, evidence from research and post-licensure evaluations should be presented with evidence of the benefits of vaccination to best inform policymakers deciding on vaccine introduction or vaccination program sustainability. PMID:27322835

  7. Surveillance issues in inflammatory bowel disease: ulcerative colitis.

    PubMed

    Provenzale, D; Onken, J

    2001-02-01

    This review article on the surveillance of patients with ulcerative colitis provides an overview of the criteria for evaluating screening and surveillance programs and applies the criteria to the available evidence to determine the effectiveness of the surveillance of patients with ulcerative colitis. We examine the clinical outcomes associated with surveillance, the additional clinical time required to confirm the diagnosis of dysplasia and cancer, compliance with surveillance and follow-up, and the effectiveness of the individual components of a surveillance program, including colonoscopy and pathologist's interpretation. The disability associated with colectomy is considered, as are the cost and acceptability of surveillance programs. Patients with long-standing ulcerative colitis are at risk for developing colorectal cancer. Recommended surveillance colonoscopy should be supported. New endoscopic and histopathologic techniques to improve the identification of high-risk patients may enhance the effectiveness and cost-effectiveness of surveillance practices.

  8. Project Surveillance and Maintenance Plan. [UMTRA Project

    SciTech Connect

    Not Available

    1985-09-01

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

  9. Active surveillance for nonmuscle invasive bladder cancer.

    PubMed

    Miyake, Makito; Fujimoto, Kiyohide; Hirao, Yoshihiko

    2016-06-01

    Nonmuscle invasive bladder cancer (NMIBC) is known to be a heterogeneous malignancy that requires varying treatment modalities and follow-up schedules. Low-grade Ta papillary tumors are categorized as low-risk NMIBC because of their favorable prognosis. There is an expanding movement that overdiagnosis and overtreatment should be avoided considering the economic impact and the patients' quality of life. It has been over 10 years since the initial assessment of active surveillance for low-risk NMIBC suggested its feasibility and safety. However, urologists are still unfamiliar with this treatment option, which can be ideal in appropriately selected patients. In this review article, we focus on active surveillance for low-risk NMIBC and discuss the evidence and rationale for this treatment option. There are several issues to resolve in order to advocate active surveillance as a standard option in selected patients. A specific follow-up protocol including intervals of cystoscopy, urine cytology, urine markers, and other radiographic examinations need to be optimized and validated. Finally, we integrate the available data into the follow-up strategy and propose a new surveillance protocol for active surveillance of recurrent low-risk bladder cancer. PMID:27326406

  10. Moving object detection for video surveillance.

    PubMed

    Kalirajan, K; Sudha, M

    2015-01-01

    The emergence of video surveillance is the most promising solution for people living independently in their home. Recently several contributions for video surveillance have been proposed. However, a robust video surveillance algorithm is still a challenging task because of illumination changes, rapid variations in target appearance, similar nontarget objects in background, and occlusions. In this paper, a novel approach of object detection for video surveillance is presented. The proposed algorithm consists of various steps including video compression, object detection, and object localization. In video compression, the input video frames are compressed with the help of two-dimensional discrete cosine transform (2D DCT) to achieve less storage requirements. In object detection, key feature points are detected by computing the statistical correlation and the matching feature points are classified into foreground and background based on the Bayesian rule. Finally, the foreground feature points are localized in successive video frames by embedding the maximum likelihood feature points over the input video frames. Various frame based surveillance metrics are employed to evaluate the proposed approach. Experimental results and comparative study clearly depict the effectiveness of the proposed approach. PMID:25861686

  11. Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012.

    PubMed

    Bettinger, J A; Rouleau, I; Gariepy, M C; Bowie, W R; Valiquette, L; Vanderkooi, O G; Kellner, J D; Coleman, B L; McNeil, S A; McCarthy, A; De Serres, G

    2015-01-01

    In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015. PMID:26227369

  12. [Asymptomatic kidney stones: active surveillance vs. treatment].

    PubMed

    Neisius, A; Thomas, C; Roos, F C; Hampel, C; Fritsche, H-M; Bach, T; Thüroff, J W; Knoll, T

    2015-09-01

    The prevalence of kidney stones is increasing worldwide. Asymptomatic non-obstructing kidney stones are increasingly detected as an incidental finding on radiologic imaging, which has been performed more frequently over the last decades. Beside the current interventional treatment modalities such as extracorporeal shockwave lithotripsy (ESWL), ureterorenoscopy (URS) and percutaneous nephrolithotomy (PNL), active surveillance of asymptomatic kidney stones has been a focus of discussion lately, not only for attending physicians, but even more so for patients. The current German and European guidelines recommend active surveillance for patients with asymptomatic kidney stones if no interventional therapy is mandatory because of pain or medical factors. Herein we review the current literature on risks and benefits of active surveillance of asymptomatic non-obstructing kidney stones.

  13. [The epidemiological surveillance of dengue in Mexico].

    PubMed

    Montesano-Castellanos, R; Ruiz-Matus, C

    1995-01-01

    The clinical behavior of dengue fever in Mexico has changed, now with the occurrence of hemorrhagic cases. In response to the emergence of such cases, a specific epidemiologic surveillance system has been designed and implemented. This system includes the means to monitor the factors involved in the evolution of the disease. The identification and analysis of these factors is necessary to implement prevention and control measures. This paper presents the main components and procedures of the epidemiologic surveillance system for common and hemorrhagic dengue fever in Mexico, emphasizing the usefulness of the risk approach to predict the pattern of this disease. The model includes the collaboration of a multidisciplinary group. The Epidemiologic Surveillance State Committee, coordinated by the National Health System, participates in the collection and analysis of epidemiologic data, particularly data related to the population, the individual, the vector, the viruses and the environment. PMID:8599150

  14. Infectious diseases: Surveillance, genetic modification and simulation

    USGS Publications Warehouse

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

    2011-01-01

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

  15. [Asymptomatic kidney stones: active surveillance vs. treatment].

    PubMed

    Neisius, A; Thomas, C; Roos, F C; Hampel, C; Fritsche, H-M; Bach, T; Thüroff, J W; Knoll, T

    2015-09-01

    The prevalence of kidney stones is increasing worldwide. Asymptomatic non-obstructing kidney stones are increasingly detected as an incidental finding on radiologic imaging, which has been performed more frequently over the last decades. Beside the current interventional treatment modalities such as extracorporeal shockwave lithotripsy (ESWL), ureterorenoscopy (URS) and percutaneous nephrolithotomy (PNL), active surveillance of asymptomatic kidney stones has been a focus of discussion lately, not only for attending physicians, but even more so for patients. The current German and European guidelines recommend active surveillance for patients with asymptomatic kidney stones if no interventional therapy is mandatory because of pain or medical factors. Herein we review the current literature on risks and benefits of active surveillance of asymptomatic non-obstructing kidney stones. PMID:26378390

  16. System For Surveillance Of Spectral Signals

    DOEpatents

    Gross, Kenneth C.; Wegerich, Stephan; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

    2003-04-22

    A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

  17. System for surveillance of spectral signals

    DOEpatents

    Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

    2006-02-14

    A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test ("SPRT") methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

  18. System for surveillance of spectral signals

    DOEpatents

    Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

    2001-01-01

    A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a SPRT sequential probability ratio test methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

  19. System For Surveillance Of Spectral Signals

    DOEpatents

    Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

    2004-10-12

    A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test ("SPRT") methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

  20. Enhanced Video Surveillance (EVS) with speckle imaging

    SciTech Connect

    Carrano, C J

    2004-01-13

    Enhanced Video Surveillance (EVS) with Speckle Imaging is a high-resolution imaging system that substantially improves resolution and contrast in images acquired over long distances. This technology will increase image resolution up to an order of magnitude or greater for video surveillance systems. The system's hardware components are all commercially available and consist of a telescope or large-aperture lens assembly, a high-performance digital camera, and a personal computer. The system's software, developed at LLNL, extends standard speckle-image-processing methods (used in the astronomical community) to solve the atmospheric blurring problem associated with imaging over medium to long distances (hundreds of meters to tens of kilometers) through horizontal or slant-path turbulence. This novel imaging technology will not only enhance national security but also will benefit law enforcement, security contractors, and any private or public entity that uses video surveillance to protect their assets.

  1. [The epidemiological surveillance of dengue in Mexico].

    PubMed

    Montesano-Castellanos, R; Ruiz-Matus, C

    1995-01-01

    The clinical behavior of dengue fever in Mexico has changed, now with the occurrence of hemorrhagic cases. In response to the emergence of such cases, a specific epidemiologic surveillance system has been designed and implemented. This system includes the means to monitor the factors involved in the evolution of the disease. The identification and analysis of these factors is necessary to implement prevention and control measures. This paper presents the main components and procedures of the epidemiologic surveillance system for common and hemorrhagic dengue fever in Mexico, emphasizing the usefulness of the risk approach to predict the pattern of this disease. The model includes the collaboration of a multidisciplinary group. The Epidemiologic Surveillance State Committee, coordinated by the National Health System, participates in the collection and analysis of epidemiologic data, particularly data related to the population, the individual, the vector, the viruses and the environment.

  2. Laser Surveillance System for Spent Fuel

    SciTech Connect

    Fiarman, S.; Zucker, M. S.; Bieber, Jr., A. M.

    1980-01-01

    A laser surveillance system installed at spent fuel storage pools (SFSP's) will provide the safeguard inspector with specific knowledge of spent fuel movement that cannot be obtained with current surveillance systems. The laser system will allow for the division of the pool's spent fuel inventory into two populations - those assemblies which have been moved and those which haven't - which is essential for maximizing the efficiency and effectiveness of the inspection effort. We have designed, constructed, and tested a full size laser system operating in air and have used an array of 6 zircaloy BWR tubes to simulate an assembly. The reflective signal from the zircaloy rods is a strong function of position of the assembly, but in all cases is easily discernable from the reference scan of the background with no assembly. A design for a SFSP laser surveillance system incorporating laser ranging is discussed. 10 figures.

  3. Surveillance for fetal alcohol syndrome in Colorado.

    PubMed Central

    Miller, L A; Shaikh, T; Stanton, C; Montgomery, A; Rickard, R; Keefer, S; Hoffman, R

    1995-01-01

    The authors performed surveillance for fetal alcohol syndrome with an existing birth defects registry. Fetal alcohol syndrome cases were identified from multiple sources using passive surveillance and from two selected medical sites using enhanced surveillance. Between May 1992 and March 1994, a total of 173 cases were identified, and the medical records of the cases were reviewed to determine whether the cases met a surveillance case definition for fetal alcohol syndrome. Of these cases, 37 (21 percent) met either definite (28) or probable (9) criteria for fetal alcohol syndrome, 76 met possible criteria (44 percent), and 60 (35 percent) were defined as not fetal alcohol syndrome. Enhanced surveillance had the highest sensitivity for definite or probable cases, 31 of 37 (84 percent), followed by hospital discharge data, 14 of 37 (38 percent). The authors also compared birth certificate information for 22 definite or probable cases in children born between 1989 and 1992 to birth certificate information for all Colorado births for that period. The proportion of mothers of children with fetal alcohol syndrome was statistically significantly greater (as determined by exact binomial 95 percent confidence limits) than the proportion of all mothers for the following characteristics: black race (0.23 versus 0.05), unmarried (0.55 versus 0.22), not employed during pregnancy (0.86 versus 0.43), and started prenatal care in the third trimester (0.18 versus 0.04). Surveillance for fetal alcohol syndrome can be accomplished with an existing registry system in combination with additional case finding and verification activities. Through followup investigation of reported cases, data can be gathered on the mothers of children with fetal alcohol syndrome. These data could be used to target fetal alcohol syndrome prevention programs. PMID:8570819

  4. Creating a global dialogue on infectious disease surveillance: connecting organizations for regional disease surveillance (CORDS).

    PubMed

    Gresham, Louise S; Smolinski, Mark S; Suphanchaimat, Rapeepong; Kimball, Ann Marie; Wibulpolprasert, Suwit

    2013-01-01

    Connecting Organizations for Regional Disease Surveillance (CORDS) is an international non-governmental organization focused on information exchange between disease surveillance networks in different areas of the world. By linking regional disease surveillance networks, CORDS builds a trust-based social fabric of experts who share best practices, surveillance tools and strategies, training courses, and innovations. CORDS exemplifies the shifting patterns of international collaboration needed to prevent, detect, and counter all types of biological dangers - not just naturally occurring infectious diseases, but also terrorist threats. Representing a network-of-networks approach, the mission of CORDS is to link regional disease surveillance networks to improve global capacity to respond to infectious diseases. CORDS is an informal governance cooperative with six founding regional disease surveillance networks, with plans to expand; it works in complement and cooperatively with the World Health Organization (WHO), the World Organization for Animal Health (OIE), and the Food and Animal Organization of the United Nations (FAO). As described in detail elsewhere in this special issue of Emerging Health Threats, each regional network is an alliance of a small number of neighboring countries working across national borders to tackle emerging infectious diseases that require unified regional efforts. Here we describe the history, culture and commitment of CORDS; and the novel and necessary role that CORDS serves in the existing international infectious disease surveillance framework.

  5. Creating a Global Dialogue on Infectious Disease Surveillance: Connecting Organizations for Regional Disease Surveillance (CORDS)

    PubMed Central

    Gresham, Louise S.; Smolinski, Mark S.; Suphanchaimat, Rapeepong; Kimball, Ann Marie; Wibulpolprasert, Suwit

    2013-01-01

    Connecting Organizations for Regional Disease Surveillance (CORDS) is an international non-governmental organization focused on information exchange between disease surveillance networks in different areas of the world. By linking regional disease surveillance networks, CORDS builds a trust-based social fabric of experts who share best practices, surveillance tools and strategies, training courses, and innovations. CORDS exemplifies the shifting patterns of international collaboration needed to prevent, detect, and counter all types of biological dangers – not just naturally occurring infectious diseases, but also terrorist threats. Representing a network-of-networks approach, the mission of CORDS is to link regional disease surveillance networks to improve global capacity to respond to infectious diseases. CORDS is an informal governance cooperative with six founding regional disease surveillance networks, with plans to expand; it works in complement and cooperatively with the World Health Organization (WHO), the World Organization for Animal Health (OIE), and the Food and Animal Organization of the United Nations (FAO). As described in detail elsewhere in this special issue of Emerging Health Threats, each regional network is an alliance of a small number of neighboring countries working across national borders to tackle emerging infectious diseases that require unified regional efforts. Here we describe the history, culture and commitment of CORDS; and the novel and necessary role that CORDS serves in the existing international infectious disease surveillance framework. PMID:23362412

  6. Creating a global dialogue on infectious disease surveillance: connecting organizations for regional disease surveillance (CORDS).

    PubMed

    Gresham, Louise S; Smolinski, Mark S; Suphanchaimat, Rapeepong; Kimball, Ann Marie; Wibulpolprasert, Suwit

    2013-01-01

    Connecting Organizations for Regional Disease Surveillance (CORDS) is an international non-governmental organization focused on information exchange between disease surveillance networks in different areas of the world. By linking regional disease surveillance networks, CORDS builds a trust-based social fabric of experts who share best practices, surveillance tools and strategies, training courses, and innovations. CORDS exemplifies the shifting patterns of international collaboration needed to prevent, detect, and counter all types of biological dangers - not just naturally occurring infectious diseases, but also terrorist threats. Representing a network-of-networks approach, the mission of CORDS is to link regional disease surveillance networks to improve global capacity to respond to infectious diseases. CORDS is an informal governance cooperative with six founding regional disease surveillance networks, with plans to expand; it works in complement and cooperatively with the World Health Organization (WHO), the World Organization for Animal Health (OIE), and the Food and Animal Organization of the United Nations (FAO). As described in detail elsewhere in this special issue of Emerging Health Threats, each regional network is an alliance of a small number of neighboring countries working across national borders to tackle emerging infectious diseases that require unified regional efforts. Here we describe the history, culture and commitment of CORDS; and the novel and necessary role that CORDS serves in the existing international infectious disease surveillance framework. PMID:23362412

  7. An emergency response UAV Surveillance System.

    PubMed

    Rodriguez, Pedro A; Geckle, William J; Barton, Jeffrey D; Samsundar, John; Gao, Tia; Brown, Myron Z; Martin, Sean R

    2006-01-01

    A system using Unmanned Air Vehicles (UAVs), equipped for real time telemetry of video imagery, sensor support data, and GPS/INS navigation, is being developed to provide situational awareness (SA) to the central command of mass casualty incident response. UAVs provide an inexpensive and safe means of acquiring video surveillance in chaotic disaster scenes, while being durable and non-intrusive. The system provides autonomous surveillance of defined perimeters, video tracking and active following of targets of interest, and real time cueing to other imaging UAVs.

  8. Avian influenza surveillance of wild birds

    USGS Publications Warehouse

    Slota, Paul

    2007-01-01

    The President's National Strategy for Pandemic Influenza directs federal agencies to expand the surveillance of United States domestic livestock and wildlife to ensure early warning of hightly pathogenic avian influenza (HPAI) in the U.S. The immediate concern is a potential introduction of HPAI H5N1 virus into the U.S. The presidential directive resulted in the U.S. Interagency Strategic Plan for Early Detection of H5N1 Highly Pathogenic Avian Influenza in Wild Migratory Birds (referred to as the Wild Bird Surveillance Plan or the Plan).

  9. Centralized surveillance and control of satellite networks

    NASA Astrophysics Data System (ADS)

    Rzewnicki, S. E.; McBeath, J. W.; Brostrup-Jensen, P.

    Satellite based services and networks are increasing in number. This paper describes how such networks can be operated efficiently using software based systems to do satellite transmission surveillance and remote earth station status, alarm and control monitoring at a centralized operations control center. Arrangements are available to accomplish real time, customer controlled configuration of space segments and earth station equipment. Application of the system elements satellite transmission surveillance, alarm and control central, earth station remote, and customer control terminals - to a number of typical networks is described.

  10. Self tuning system for industrial surveillance

    DOEpatents

    Stephan, Wegerich W; Jarman, Kristin K.; Gross, Kenneth C.

    2000-01-01

    A method and system for automatically establishing operational parameters of a statistical surveillance system. The method and system performs a frequency domain transition on time dependent data, a first Fourier composite is formed, serial correlation is removed, a series of Gaussian whiteness tests are performed along with an autocorrelation test, Fourier coefficients are stored and a second Fourier composite is formed. Pseudorandom noise is added, a Monte Carlo simulation is performed to establish SPRT missed alarm probabilities and tested with a synthesized signal. A false alarm test is then emperically evaluated and if less than a desired target value, then SPRT probabilities are used for performing surveillance.

  11. Comparison of carbohydrate sources in yeast-fermentation CO2 generators for mosquito surveillance

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Mosquito surveillance in remote areas with limited access to canisters of CO2 or dry ice will benefit from an effective alternative CO2 source, such as the natural production of CO2 from yeast fermentation of several carbohydrate sources. In this study, we document the differences in mosquito and n...

  12. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  13. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  14. 9 CFR 145.15 - Diagnostic surveillance program for low pathogenic avian influenza.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  15. Improving the Effect and Efficiency of FMD Control by Enlarging Protection or Surveillance Zones

    PubMed Central

    Halasa, Tariq; Toft, Nils; Boklund, Anette

    2015-01-01

    An epidemic of foot-and-mouth disease (FMD) in a FMD-free country with large exports of livestock and livestock products would result in profound economic damage. This could be reduced by rapid and efficient control of the disease spread. The objectives of this study were to estimate the economic impact of a hypothetical FMD outbreak in Denmark based on changes to the economic assumptions of the model, and to investigate whether the control of an FMD epidemic can be improved by combining the enlargement of protection or surveillance zones with pre-emptive depopulation or emergency vaccination. The stochastic spatial simulation model DTU-DADS was used to simulate the spread of FMD in Denmark. The control strategies were the basic EU and Danish strategy, pre-emptive depopulation, suppressive or protective vaccination, enlarging protection or surveillance zones, and a combination of pre-emptive depopulation or emergency vaccination with enlarged protection or surveillance zones. Herds are detected either based on basic detection through the appearance of clinical signs, or as a result of surveillance in the control zones. The economic analyses consisted of direct costs and export losses. Sensitivity analysis was performed on uncertain and potentially influential input parameters. Enlarging the surveillance zones from 10 to 15 km, combined with pre-emptive depopulation over a 1-km radius around detected herds resulted in the lowest total costs. This was still the case even when the different input parameters were changed in the sensitivity analysis. Changing the resources for clinical surveillance did not affect the epidemic consequences. In conclusion, an FMD epidemic in Denmark would have a larger economic impact on the agricultural sector than previously anticipated. Furthermore, the control of a potential FMD outbreak in Denmark may be improved by combining pre-emptive depopulation with an enlarged protection or surveillance zone. PMID:26664996

  16. Which surveillance systems were operational after Typhoon Haiyan?

    PubMed Central

    Villa, Eireen; Pacho, Agnes; Galvan, Maria Adona; Corpuz, Aura

    2015-01-01

    Introduction Effective disease surveillance is vital for a successful disaster response. This study assessed the functionality of the three disease surveillance systems used post-Haiyan: Philippine Integrated Disease Surveillance and Response (PIDSR), Event-based Surveillance and Response (ESR) and Surveillance in Post Extreme Emergencies and Disasters (SPEED). Methods A survey of 45 government health officers from affected areas was conducted in March 2014. The survey documented when each of the systems was operational and included questions that ranked the functionality of the three surveillance systems and whether they complemented each other. Results Two of 11 (18%) surveillance units had an operational SPEED system pre-event. PIDSR and ESR remained operational in five of 11 (45%) surveillance units without interruption of reporting. Ten surveillance units (91%) rated PIDSR as functional post-Typhoon; eight (72.7%) considered ESR functional. SPEED was rated as functional by three (27%) surveillance units. Seven of 11 (63.6%) surveillance units rated the three systems as being complementary to each other. Discussion In most of the areas affected by Typhoon Haiyan, the routine surveillance systems (PIDSR and ESR) were not disrupted; although, in Leyte it took seven weeks for these to be operational. Although SPEED is recommended for activation within 48 hours after a disaster, this did not occur in most of the surveyed areas. Most of the surveillance units rated PIDSR, ESR and SPEED to be complementary to each other. PMID:26767139

  17. Conceptual evaluation of population health surveillance programs: method and example.

    PubMed

    El Allaki, Farouk; Bigras-Poulin, Michel; Ravel, André

    2013-03-01

    Veterinary and public health surveillance programs can be evaluated to assess and improve the planning, implementation and effectiveness of these programs. Guidelines, protocols and methods have been developed for such evaluation. In general, they focus on a limited set of attributes (e.g., sensitivity and simplicity), that are assessed quantitatively whenever possible, otherwise qualitatively. Despite efforts at standardization, replication by different evaluators is difficult, making evaluation outcomes open to interpretation. This ultimately limits the usefulness of surveillance evaluations. At the same time, the growing demand to prove freedom from disease or pathogen, and the Sanitary and Phytosanitary Agreement and the International Health Regulations require stronger surveillance programs. We developed a method for evaluating veterinary and public health surveillance programs that is detailed, structured, transparent and based on surveillance concepts that are part of all types of surveillance programs. The proposed conceptual evaluation method comprises four steps: (1) text analysis, (2) extraction of the surveillance conceptual model, (3) comparison of the extracted surveillance conceptual model to a theoretical standard, and (4) validation interview with a surveillance program designer. This conceptual evaluation method was applied in 2005 to C-EnterNet, a new Canadian zoonotic disease surveillance program that encompasses laboratory based surveillance of enteric diseases in humans and active surveillance of the pathogens in food, water, and livestock. The theoretical standard used for evaluating C-EnterNet was a relevant existing structure called the "Population Health Surveillance Theory". Five out of 152 surveillance concepts were absent in the design of C-EnterNet. However, all of the surveillance concept relationships found in C-EnterNet were valid. The proposed method can be used to improve the design and documentation of surveillance programs. It

  18. Plutonium Surveillance Destructive Examination Requirements at Savannah River National Laboratory for K-Area Interim Surveillance

    SciTech Connect

    Stefek, T. M.

    2005-09-29

    The DOE 3013 storage standard requires nested, welded 300 series stainless steel containers to store plutonium-bearing materials for up to 50 years. Packaged contents include stabilized plutonium-bearing residues that contain chloride salts and a low (< 0.5 weight %) water content. The DOE 3013 STD requires surveillance of the packages over the 50 year lifetime. These surveillance requirements have been further defined by the Integrated Surveillance Program to include both non-destructive examination (NDE) and destructive examination (DE) of the 3013 container. The DE portion of surveillance involves examining the 3013 nested containers, analyzing the head space gas, and evaluating the plutonium oxide chemistry. At SRS, the stored 3013 containers will undergo preparation for the DE surveillance activities in facilities located in K-Area. The actual DE surveillance will be performed in SRNL. This report provides preliminary functional requirements for the destructive examination (DE) of plutonium-bearing oxide materials and containers in support of K-Area Interim Surveillance (KIS). The KIS project will install interim facilities to prepare the samples for analysis in SRNL. This document covers the requirements for the interim period beginning in 2007, and lasting until the Container Storage and Surveillance Capability (CSSC) project provides the permanent facilities in K-Area to perform sampling and repackaging operations associated with the 3013 container storage and surveillance program. Initial requirements for the CSSC project have been previously defined in WSRC-TR-2004-00584 ''Plutonium Surveillance Destructive Examination Requirements at Savannah River National Laboratory''. As part of the Plutonium Surveillance Program of 3013 Containers at the Savannah River Site (SRS), the Savannah River National Laboratory (SRNL) will receive the emptied 3013 container components, plutonium oxide samples and headspace gas samples from K-Area. The DE program scope

  19. NASA Low Visibility Landing and Surface Operations (LVLASO) Atlanta Demonstration: Surveillance Systems Performance Analysis

    NASA Technical Reports Server (NTRS)

    Cassell, Rick; Evers, Carl; Hicok, Dan; Lee, Derrick

    1999-01-01

    NASA conducted a series of flight experiments at Hartsfield Atlanta International Airport as part of the Low Visibility Landing and Surface Operations (LVLASO) Program. LVLASO is one of the subelements of the NASA Terminal Area Productivity (TAP) Program, which is focused on providing technology and operating procedures for achieving clear-weather airport capacity in instrument-weather conditions, while also improving safety. LVLASO is investigating various technologies to be applied to airport surface operations, including advanced flight deck displays and surveillance systems. The purpose of this report is to document the performance of the surveillance systems tested as part of the LVLASO flight experiment. There were three surveillance sensors tested: primary radar using Airport Surface Detection Equipment (ASDE-3) and the Airport Movement Area Safety System (AMASS), Multilateration using the Airport Surface Target Identification System (ATIDS), and Automatic Dependent Surveillance - Broadcast (ADS-B) operating at 1090 MHz. The performance was compared to the draft requirements of the ICAO Advanced Surface Movement Guidance and Control System (A-SMGCS). Performance parameters evaluated included coverage, position accuracy, and update rate. Each of the sensors was evaluated as a stand alone surveillance system.

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

    PubMed

    Queenan, Kevin; Häsler, Barbara; Rushton, Jonathan

    2016-10-01

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

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

    PubMed

    Queenan, Kevin; Häsler, Barbara; Rushton, Jonathan

    2016-10-01

    Antimicrobial resistance is a global problem of complex epidemiology, suited to a broad, integrated One Health approach. Resistant organisms exist in humans, animals, food and the environment, and the main driver of this resistance is antimicrobial usage. A One Health conceptual framework for surveillance is presented to include all of these aspects. Global and European (regional and national) surveillance systems are described, highlighting shortcomings compared with the framework. Policy decisions rely on economic and scientific evidence, so the business case for a fully integrated system is presented. The costs of integrated surveillance are offset by the costs of unchecked resistance and the benefits arising from interventions and outcomes. Current estimates focus on costs and benefits of human health outcomes. A One Health assessment includes wider societal costs of lost labour, changes in health-seeking behaviour, impacts on animal health and welfare, higher costs of animal-origin food production, and reduced consumer confidence in safety and international trade of such food. Benefits of surveillance may take years to realise and are dependent on effective and accepted interventions. Benefits, including the less tangible, such as improved synergies and efficiencies in service delivery and more timely and accurate risk identification, should also be recognised. By including these less tangible benefits to society, animal welfare, ecosystem health and resilience, together with the savings and efficiencies through shared resources and social capital-building, a stronger business case for a One Health approach to surveillance can be made. PMID:27496533

  2. Policy-driven development of cost-effective, risk-based surveillance strategies.

    PubMed

    Reist, M; Jemmi, T; Stärk, K D C

    2012-07-01

    Animal health and residue surveillance verifies the good health status of the animal population, thereby supporting international free trade of animals and animal products. However, active surveillance is costly and time-consuming. The development of cost-effective tools for animal health and food hazard surveillance is therefore a priority for decision-makers in the field of veterinary public health. The assumption of this paper is that outcome-based formulation of standards, legislation leaving room for risk-based approaches and close collaboration and a mutual understanding and exchange between scientists and policy makers are essential for cost-effective surveillance. We illustrate this using the following examples: (i) a risk-based sample size calculation for surveys to substantiate freedom from diseases/infection, (ii) a cost-effective national surveillance system for Bluetongue using scenario tree modelling and (iii) a framework for risk-based residue monitoring. Surveys to substantiate freedom from infectious bovine rhinotracheitis and enzootic bovine leucosis between 2002 and 2009 saved over 6 million € by applying a risk-based sample size calculation approach, and by taking into account prior information from repeated surveys. An open, progressive policy making process stimulates research and science to develop risk-based and cost-efficient survey methodologies. Early involvement of policy makers in scientific developments facilitates implementation of new findings and full exploitation of benefits for producers and consumers. PMID:22265642

  3. The end of the BSE saga: do we still need surveillance for human prion diseases?

    PubMed

    Budka, Herbert; Will, Robert G

    2015-01-01

    The epidemics of classical bovine spongiform encephalopathy (BSE) and variant Creutzfeldt-Jakob disease (vCJD) related to BSE-infected food are coming to an end. The decline in concern about these diseases may invite complacency and questions whether surveillance for human prion diseases is still necessary. This article reviews the main points of surveillance and why it is still needed: animal sources for human prion infection other than BSE cannot be excluded; the potentially increasing circulation of prions between humans by blood, blood products and medical procedures; the prevalence of vCJD prion carriers in the UK; and the scientific study of prion diseases as paradigm for other neurodegenerative diseases with "prion-like" spread of pathological proteins. We conclude that continuation of detailed surveillance of human prion disorders would be prudent in view of all these points that deserve clarification. PMID:26715203

  4. Contribution of Meat Inspection to the surveillance of poultry health and welfare in the European Union.

    PubMed

    Huneau-Salaün, A; Stärk, K D C; Mateus, A; Lupo, C; Lindberg, A; LE Bouquin-Leneveu, S

    2015-08-01

    In the European Union, Meat Inspection (MI) aims to protect public health by ensuring that minimal hazardous material enters in the food chain. It also contributes to the detection and monitoring of animal diseases and welfare problems but its utility for animal surveillance has been assessed partially for some diseases only. Using the example of poultry production, we propose a complete assessment of MI as a health surveillance system. MI allows a long-term syndromic surveillance of poultry health but its contribution is lowered by a lack of data standardization, analysis and reporting. In addition, the probability of case detection for 20 diseases and welfare conditions was quantified using a scenario tree modelling approach, with input data based on literature and expert opinion. The sensitivity of MI appeared to be very high to detect most of the conditions studied because MI is performed at batch level and applied to a high number of birds per batch.

  5. Governmental Surveillance of Three Progressive Educators.

    ERIC Educational Resources Information Center

    Nelson, Murry R.; Singleton, H. Wells

    Governmental interference with academic freedom is illustrated by F.B.I. surveillance of and unauthorized distribution of information about progressive educators John Dewey, George Counts, and Harold Rugg. These three educators attracted the attention of governmental agencies and special interest groups during the 1930s and 1940s because they…

  6. Surveillance and Conformity in Competitive Youth Swimming

    ERIC Educational Resources Information Center

    Lang, Melanie

    2010-01-01

    Underpinned by a Foucauldian analysis of sporting practices, this paper identifies the disciplinary mechanism of surveillance at work in competitive youth swimming. It highlights the ways in which swimmers and their coaches are subject to and apply this mechanism to produce embodied conformity to normative behaviour and obedient, docile bodies.…

  7. Marginal Expense Oil Well Wireless Surveillance (MEOWWS)

    SciTech Connect

    Nelson, Donald G.

    2002-03-11

    The objective of this study was to identify and field test a new, low cost, wireless oil well surveillance system. A variety of suppliers and technologies were considered. One supplier and system was chosen that was low cost, new to the oil field, and successfully field tested.

  8. Tracking Vehicles in traffic Surveillance Video

    SciTech Connect

    Maire, M; Kamath, C

    2005-08-12

    We present a system for detecting and tracking vehicles in surveillance video. Our algorithm uses a simple motion model to determine salient regions in a sequence of video frames. Similar regions are associated between frames and clustered to yield coherent final tracks. The entire process is automatic and uses computation time that scales according to the size of the input video sequence.

  9. Syndromic Surveillance Using Ambulatory Electronic Health Records

    PubMed Central

    Hripcsak, George; Soulakis, Nicholas D.; Li, Li; Morrison, Frances P.; Lai, Albert M.; Friedman, Carol; Calman, Neil S.; Mostashari, Farzad

    2009-01-01

    Objective To assess the performance of electronic health record data for syndromic surveillance and to assess the feasibility of broadly distributed surveillance. Design Two systems were developed to identify influenza-like illness and gastrointestinal infectious disease in ambulatory electronic health record data from a network of community health centers. The first system used queries on structured data and was designed for this specific electronic health record. The second used natural language processing of narrative data, but its queries were developed independently from this health record. Both were compared to influenza isolates and to a verified emergency department chief complaint surveillance system. Measurements Lagged cross-correlation and graphs of the three time series. Results For influenza-like illness, both the structured and narrative data correlated well with the influenza isolates and with the emergency department data, achieving cross-correlations of 0.89 (structured) and 0.84 (narrative) for isolates and 0.93 and 0.89 for emergency department data, and having similar peaks during influenza season. For gastrointestinal infectious disease, the structured data correlated fairly well with the emergency department data (0.81) with a similar peak, but the narrative data correlated less well (0.47). Conclusions It is feasible to use electronic health records for syndromic surveillance. The structured data performed best but required knowledge engineering to match the health record data to the queries. The narrative data illustrated the potential performance of a broadly disseminated system and achieved mixed results. PMID:19261941

  10. Space Surveillance: United States, Russia, and China

    NASA Astrophysics Data System (ADS)

    Seidelmann, P. K.

    2012-06-01

    With the launch of Sputnik, the United States and Russia began the process of tracking artificial satellites. This led to developments for observations, orbit determination, and catalog maintenance. The two countries followed somewhat different approaches to the same problem based on the available hardware and theoretical developments. As more sophisticated hardware and theories have been developed, progress has been made. However, new problems have developed because of debris, collision possibilities, and reentering objects. In addition, the range of spacecraft has increased to include geosynchronous orbits. In more recent times the European Space Agency (ESA) and China have become involved in various aspects of Space Surveillance. In 1994, the first meeting between United States and Russian experts in the field of space surveillance was held. Since then, seven more US Russia Space Surveillance Workshops have been held, with the addition of participants from ESA. Terry Alfriend has been the US Technical Chairman for many of these workshops. In 2009 a US China Space Surveillance Technical Interchange was held in Shanghai, China, and Terry was the US Technical Chairman.

  11. 40 CFR 52.2030 - 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. 52.2030 Section 52.2030 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Pennsylvania § 52.2030 Source...

  12. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic operation... area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic...

  13. 10 CFR 34.51 - Surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.51 Surveillance. During each radiographic operation... area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic...

  14. Imported infectious diseases and surveillance in Japan.

    PubMed

    Taniguchi, Kiyosu; Yoshida, Makiko; Sunagawa, Tomimasa; Tada, Yuki; Okabe, Nobuhiko

    2008-11-01

    Surveillance of imported infectious diseases is important because of the need for early detection of outbreaks of international concern as well as information of risk to the travelers. This paper attempts to review how the Japanese surveillance system deals with imported infectious diseases and reviews the trend of these diseases. The cases of acquired infection overseas were extracted from the surveillance data in 1999-2008. The incidence and rate of imported cases of a series of infectious diseases with more than one imported case were observed by the year of diagnosis and place of acquired infection. During the period 10,030 cases that could be considered to be imported infectious diseases were identified. Shigellosis ranked as the most common imported disease, followed by amebiasis, malaria, enterohemorrhagic Escherichia coli infection and the acquired immunodeficiency syndrome, typhoid fever, dengue fever, hepatitis A, giardiasis, cholera, and paratyphoid fever. The annual trends of these diseases always fluctuated but not every change was investigated. The study reveals that the situation of imported infectious diseases can be identified in the current Japanese surveillance system with epidemiologic features of both temporal and geographic distribution of cases of imported infectious diseases. However, further timely investigation for unusual increase in infectious diseases is needed. PMID:18984479

  15. 46 CFR 197.560 - Medical surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... GENERAL PROVISIONS Benzene § 197.560 Medical surveillance. (a) General. (1) The employer must provide, and... permitted to enter or continue working in a workplace in which they will be or may be exposed to benzene: (i) Employees who were exposed to more than 10 ppm of benzene as an eight-hour TWA on at least 30 calendar...

  16. 46 CFR 197.560 - Medical surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... GENERAL PROVISIONS Benzene § 197.560 Medical surveillance. (a) General. (1) The employer must provide, and... permitted to enter or continue working in a workplace in which they will be or may be exposed to benzene: (i) Employees who were exposed to more than 10 ppm of benzene as an eight-hour TWA on at least 30 calendar...

  17. 46 CFR 197.560 - Medical surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... GENERAL PROVISIONS Benzene § 197.560 Medical surveillance. (a) General. (1) The employer must provide, and... permitted to enter or continue working in a workplace in which they will be or may be exposed to benzene: (i) Employees who were exposed to more than 10 ppm of benzene as an eight-hour TWA on at least 30 calendar...

  18. 46 CFR 197.560 - Medical surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... GENERAL PROVISIONS Benzene § 197.560 Medical surveillance. (a) General. (1) The employer must provide, and... permitted to enter or continue working in a workplace in which they will be or may be exposed to benzene: (i) Employees who were exposed to more than 10 ppm of benzene as an eight-hour TWA on at least 30 calendar...

  19. 46 CFR 197.560 - Medical surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... GENERAL PROVISIONS Benzene § 197.560 Medical surveillance. (a) General. (1) The employer must provide, and... permitted to enter or continue working in a workplace in which they will be or may be exposed to benzene: (i) Employees who were exposed to more than 10 ppm of benzene as an eight-hour TWA on at least 30 calendar...

  20. Community-Operated Environmental Surveillance Program

    SciTech Connect

    1995-06-01

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

  1. Enhanced surveillance of maternal mortality in Texas.

    PubMed

    Estes, Larissa J; Lloyd, Linda E; Selwyn, Beatrice J

    2012-12-01

    Maternal mortality is often used to measure health and well-being for women. Improved surveillance efforts can improve maternal mortality estimates and inform the development of strategies to address the needs of maternal and child health populations. The purpose of this study was to provide better estimates of maternal mortality in Texas by using enhanced surveillance methods. Results from our analyses of fetal death and live birth records in Texas from 2000 through 2006 were then linked to pregnancy-related death records and death records of women of childbearing age (15-44 years) in Texas from 2001 through 2006. Enhanced surveillance identified almost 3.5 times as many deaths that might be associated with pregnancy than do current methods and confirmed a persistent race/ethnicity trend in maternal mortality. The leading cause of these 2001-2006 pregnancy-associated deaths was accidents. Enhanced surveillance allows the identification of additional deaths possibly associated with pregnancy and provides a stable foundation to investigate trends further and to review maternal mortality cases systematically.

  2. Privacy information management for video surveillance

    NASA Astrophysics Data System (ADS)

    Luo, Ying; Cheung, Sen-ching S.

    2013-05-01

    The widespread deployment of surveillance cameras has raised serious privacy concerns. Many privacy-enhancing schemes have been proposed to automatically redact images of trusted individuals in the surveillance video. To identify these individuals for protection, the most reliable approach is to use biometric signals such as iris patterns as they are immutable and highly discriminative. In this paper, we propose a privacy data management system to be used in a privacy-aware video surveillance system. The privacy status of a subject is anonymously determined based on her iris pattern. For a trusted subject, the surveillance video is redacted and the original imagery is considered to be the privacy information. Our proposed system allows a subject to access her privacy information via the same biometric signal for privacy status determination. Two secure protocols, one for privacy information encryption and the other for privacy information retrieval are proposed. Error control coding is used to cope with the variability in iris patterns and efficient implementation is achieved using surrogate data records. Experimental results on a public iris biometric database demonstrate the validity of our framework.

  3. 40 CFR 52.2427 - Source surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... transportation sources. (1) This section is applicable to the Commonwealth of Virginia. (2) In order to assure...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2427 Source surveillance. (a... procedures for determining actual emission reductions achieved as a result of implementing the...

  4. 40 CFR 52.2427 - Source surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... transportation sources. (1) This section is applicable to the Commonwealth of Virginia. (2) In order to assure...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2427 Source surveillance. (a... procedures for determining actual emission reductions achieved as a result of implementing the...

  5. 40 CFR 52.2427 - Source surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... transportation sources. (1) This section is applicable to the Commonwealth of Virginia. (2) In order to assure...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2427 Source surveillance. (a... procedures for determining actual emission reductions achieved as a result of implementing the...

  6. 40 CFR 52.2427 - Source surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... transportation sources. (1) This section is applicable to the Commonwealth of Virginia. (2) In order to assure...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2427 Source surveillance. (a... procedures for determining actual emission reductions achieved as a result of implementing the...

  7. Role of access surveillance and preemptive intervention.

    PubMed

    Work, Jack

    2011-06-01

    Vascular access dysfunction continues to be a major cause of morbidity and mortality in the end-stage renal patient. Thrombosis is the primary cause of prosthetic arteriovenous access (ie, graft) failure caused by the progressive development of neointimal hyperplasia, which eventually leads to a stenosis, usually at the venous anastomosis. More than 20 years ago, observational studies using a variety of surveillance techniques, coupled with preemptive angioplasty, convincingly demonstrated the ability to detect venous stenosis, and elective treatment of stenoses significantly decreased both thrombosis and access loss. Although multiple observational studies have shown a benefit from surveillance, these studies generally had no control population, used historical controls, or used incorrect statistical analysis. However, five randomized controlled trials that evaluated the effect of graft surveillance coupled with preemptive angioplasty have failed to demonstrate a benefit on graft outcomes, including prolongation of graft survival. This review will examine the role of access surveillance and preemptive angioplasty in achieving the goal of reducing vascular access thrombosis and prolonging access survival.

  8. Semantic-based surveillance video retrieval.

    PubMed

    Hu, Weiming; Xie, Dan; Fu, Zhouyu; Zeng, Wenrong; Maybank, Steve

    2007-04-01

    Visual surveillance produces large amounts of video data. Effective indexing and retrieval from surveillance video databases are very important. Although there are many ways to represent the content of video clips in current video retrieval algorithms, there still exists a semantic gap between users and retrieval systems. Visual surveillance systems supply a platform for investigating semantic-based video retrieval. In this paper, a semantic-based video retrieval framework for visual surveillance is proposed. A cluster-based tracking algorithm is developed to acquire motion trajectories. The trajectories are then clustered hierarchically using the spatial and temporal information, to learn activity models. A hierarchical structure of semantic indexing and retrieval of object activities, where each individual activity automatically inherits all the semantic descriptions of the activity model to which it belongs, is proposed for accessing video clips and individual objects at the semantic level. The proposed retrieval framework supports various queries including queries by keywords, multiple object queries, and queries by sketch. For multiple object queries, succession and simultaneity restrictions, together with depth and breadth first orders, are considered. For sketch-based queries, a method for matching trajectories drawn by users to spatial trajectories is proposed. The effectiveness and efficiency of our framework are tested in a crowded traffic scene. PMID:17405446

  9. Imported infectious diseases and surveillance in Japan.

    PubMed

    Taniguchi, Kiyosu; Yoshida, Makiko; Sunagawa, Tomimasa; Tada, Yuki; Okabe, Nobuhiko

    2008-11-01

    Surveillance of imported infectious diseases is important because of the need for early detection of outbreaks of international concern as well as information of risk to the travelers. This paper attempts to review how the Japanese surveillance system deals with imported infectious diseases and reviews the trend of these diseases. The cases of acquired infection overseas were extracted from the surveillance data in 1999-2008. The incidence and rate of imported cases of a series of infectious diseases with more than one imported case were observed by the year of diagnosis and place of acquired infection. During the period 10,030 cases that could be considered to be imported infectious diseases were identified. Shigellosis ranked as the most common imported disease, followed by amebiasis, malaria, enterohemorrhagic Escherichia coli infection and the acquired immunodeficiency syndrome, typhoid fever, dengue fever, hepatitis A, giardiasis, cholera, and paratyphoid fever. The annual trends of these diseases always fluctuated but not every change was investigated. The study reveals that the situation of imported infectious diseases can be identified in the current Japanese surveillance system with epidemiologic features of both temporal and geographic distribution of cases of imported infectious diseases. However, further timely investigation for unusual increase in infectious diseases is needed.

  10. Remote, wireless stakeout surveillance for law enforcement

    NASA Astrophysics Data System (ADS)

    Ford, Mike; Klein, Allen; Smith, Stan; Jones, John Paul

    2005-05-01

    Inflation combined with the added burden of homeland security requirements, is increasing pressure on local law enforcement budgets and manpower resources. The problem is: how can law enforcement agencies fulfill all of their requirements? How can they respond to these requirements, including homeland security, with limited manpower? Civil Rights considerations also place constraints on law enforcement. One possible solution is the Remote Law Enforcement Surveillance System (RLESS) concept. RLESS makes more efficient use of existing manpower while avoiding infringement on civil liberties. RLESS provides the capability for unattended stakeout and surveillance. Many stakeout or surveillance operations are conducted by vice, homicide, organized crime or other task forces. Lasting from days to weeks. Many large drug stings last months involving many persons of interest. A single surveillance mission usually involves a minimum of two persons X 3 shifts per day conducting active observation, equating to 48 man-hours per day. Their tasks include watching, listening, and documenting with photography. Recent military developments have included new technologies and techniques that enable remote unattended observation of areas or points of interest. This capability is now available to support law enforcement stakeouts, thereby significantly minimizes the stresses on manpower.

  11. The value of information: Current challenges in surveillance implementation.

    PubMed

    Stärk, Katharina D C; Häsler, Barbara

    2015-11-01

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

  12. Safety Surveillance of Traditional Chinese Medicine: Current and Future

    PubMed Central

    Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli

    2015-01-01

    Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. PMID:25647717

  13. Safety surveillance of traditional Chinese medicine: current and future.

    PubMed

    Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli; Cheng, Yung-Chi

    2015-02-01

    Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed.

  14. Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use

    PubMed Central

    Atemnkeng, Magnus A; De Cock, Katelijne; Plaizier-Vercammen, Jacqueline

    2007-01-01

    Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET) following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP), propylparahydroxybenzoate (PP), benzoic acid and sorbic acid. MP and PP were identified in Artesiane® (artemether 300 mg/100 ml), Alaxin® (dihydroartemisinin 160 mg/80 ml) andGvither ® (artemether 300 mg/100 ml) respectively. Sorbic acid was presentin Artenam® (artemether 180 mg/60 ml) while benzoic acid was identified in Santecxin® (dihydroartemisinin 160 mg/80 ml) andArtexin® (dihydroartemisinin 160 mg/80 ml) respectively. Cotecxin® (dihydroartemisinin 160 mg/80 ml) did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6) of the products did not completely dissolve and the PET results revealed that only Artenam® and Gvither® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both the active

  15. 14 CFR 135.431 - Continuing analysis and surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Continuing analysis and surveillance. 135... Maintenance, Preventive Maintenance, and Alterations § 135.431 Continuing analysis and surveillance. (a) Each certificate holder shall establish and maintain a system for the continuing analysis and surveillance of...

  16. 14 CFR 121.373 - Continuing analysis and surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Continuing analysis and surveillance. 121... Alterations § 121.373 Continuing analysis and surveillance. (a) Each certificate holder shall establish and maintain a system for the continuing analysis and surveillance of the performance and effectiveness of...

  17. HIV surveillance systems in the Asia Pacific region.

    PubMed

    Loo, Virginia; Saidel, Tobi; Reddy, Amala; Htin, Khin Cho Win; Shwe, Ye Yu; Verbruggen, Bob

    2012-07-01

    In 2011, the United Nations Joint Programme on HIV/AIDS (UNAIDS) Regional Support Team for Asia-Pacific conducted a stock-taking process of available strategic information in the Asia Pacific region. This paper summarizes the progress of HIV surveillance for 20 countries in the region, covering population size estimates of key populations at higher risk, HIV case reporting, HIV sentinel surveillance and probability surveys of behavioural and biological markers. Information on surveillance activities was obtained from publically available surveillance reports and protocols, supplemented by personal communication with the UNAIDS monitoring and evaluation advisers and surveillance experts in country. Key findings include substantial efforts in broadening the number and types of HIV surveillance components included in national HIV surveillance systems and adopting approaches to make surveillance more cost-efficient, such as integrating routine programme monitoring data and passive surveillance case reporting systems. More investment in regularly analysing and applying surveillance data to programme strengthening at the subnational level is needed but will require additional capacity-building and resources. The ability to triangulate multiple sources of surveillance data into a more comprehensive view of the HIV epidemic will be enhanced if more investment is made in better documentation and dissemination of surveillance activities and findings. PMID:23908915

  18. 17 CFR 38.156 - Automated trade surveillance system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Automated trade surveillance... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.156 Automated trade surveillance system. A designated contract market must maintain an automated trade surveillance system capable of detecting and...

  19. 17 CFR 38.156 - Automated trade surveillance system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Automated trade surveillance... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.156 Automated trade surveillance system. A designated contract market must maintain an automated trade surveillance system capable of detecting and...

  20. Comparison between active and passive surveillance within the network of epidemiological surveillance of animal diseases in Chad.

    PubMed

    Ouagal, Mahamat; Hendrikx, Pascal; Saegerman, Claude; Berkvens, Dirk

    2010-11-01

    A comparative study between passive and active surveillance based on herd visits (villages) was conducted over a period of 24 months. It included 106 surveillance stations of the animal disease epidemiological surveillance network in Chad distributed randomly into 52 stations of active surveillance and 54 stations of passive surveillance. Nine diseases of various vaccination and expected prevalence status were monitored. The active surveillance stations carried out four herd visits monthly to look for the diseases under surveillance and organised four farmers awareness-raising meetings to stimulate them to make disease notifications. The passive surveillance stations held each month four farmer awareness-raising meetings. The suspicions recorded by the stations were consigned to a suspicion form specific to each disease, indicating whether a call from the farmer, a visit to the herd or a awareness-raising meeting was the source. The results showed that, irrespective of surveillance type, all diseases under surveillance, except the rare diseases (Rinderpest and Rift Valley Fever) were reported by the surveillance agents. However, suspicions recorded following farmer calls are significantly more important than suspicions carried out during herd visits or meetings. Nevertheless, a considerable number of suspicions is recorded during awareness-raising meetings. Finally approximately 83% of the herd visits realised by the active surveillance stations showed negative results (no suspicion identified). Passive surveillance stimulated by awareness-raising meetings appears to be better adapted to Chads conditions and less expensive for the surveillance of existing diseases. However, for the rare diseases, other methods of specific active surveillance (such as for example sentinel herds) remain important to complete passive surveillance.