Science.gov

Sample records for collaborative drug surveillance

  1. 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.

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2010-05-01

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

  4. 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.

  5. Drug approval and surveillance.

    PubMed

    Potts, M

    1980-01-01

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

  6. 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

  7. Recent advances in distributed collaborative surveillance

    NASA Astrophysics Data System (ADS)

    Saptharishi, Mahesh; Bhat, K.; Diehl, Christopher P.; Oliver, C. S.; Savvides, Marios; Soto, Alvaro; Dolan, John M.; Khosla, Pradeep K.

    2000-07-01

    In Carnegie Mellon University's CyberScout project, we are developing mobile and stationary sentries capable of autonomous reconnaissance and surveillance. In this paper, we describe recent advances in the areas of efficient perception algorithms (detection, classification, and correspondence) and mission planning. In detection, we have achieved improved rejection of camera jitter and environmental variations (e.g., lighting, moving foliage) through multi-modal filtering, and we have implemented panoramic backgrounding through pseudo-real-time mosaicing. In classification, we present methods for discriminating between individual, groups of individuals, and vehicles, and between individuals with and without backpacks. In correspondence, we describe an accurate multi-hypothesis approach based on both motion and appearance. Finally, in mission planning, we describe mapbuilding using multiple sensory cues and a computationally efficient decentralized planner for multiple platforms.

  8. The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study

    PubMed Central

    de Bie, Sandra; Coloma, Preciosa M; Ferrajolo, Carmen; Verhamme, Katia M C; Trifirò, Gianluca; Schuemie, Martijn J; Straus, Sabine M J M; Gini, Rosa; Herings, Ron; Mazzaglia, Giampiero; Picelli, Gino; Ghirardi, Arianna; Pedersen, Lars; Stricker, Bruno H C; van der Lei, Johan; Sturkenboom, Miriam C J M

    2015-01-01

    Aim Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0–18 years). Methods Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996–2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events. Results The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock. Conclusion Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance. PMID:25683723

  9. Epidemiology of the Viral Hepatitis-HIV Syndemic in San Francisco: A Collaborative Surveillance Approach

    PubMed Central

    Scheer, Susan; Shallow, Sue; Pipkin, Sharon; Huang, Sandra

    2014-01-01

    Objectives To describe the epidemiology of people coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV) and HIV in San Francisco, the San Francisco Department of Public Health's Communicable Disease Control and Prevention Section and the HIV Epidemiology Section collaborated to link their registries. Methods In San Francisco, hepatitis reporting is primarily through passive laboratory-based surveillance, and HIV/AIDS reporting is primarily through laboratory-initiated active surveillance. We conducted the registry linkage in 2010 using a sequential algorithm. Results The registry match included 31,997 HBV-infected people who were reported starting in 1984; 10,121 HCV-infected people who were reported starting in 2001; and 34,551 HIV/AIDS cases reported beginning in 1981. Of the HBV and HCV cases, 6.3% and 12.6% were coinfected with HIV, respectively. The majority of cases were white males; however, black people were disproportionately affected. For more than 90% of the HBV/HIV cases, male-to-male sexual contact (men who have sex with men [MSM]) was the risk factor for HIV infection. Injection drug use was the most frequent risk factor for HIV infection among the HCV/HIV cases; however, 35.6% of the HCV/HIV coinfected males were MSM but not injection drug users. Conclusions By linking the two registries, we found new ways to foster collaborative work and expand our programmatic flexibility. This analysis identified particular populations at risk for coinfection, which can be used by viral hepatitis and HIV screening, prevention, and treatment programs to integrate, enhance, target, and prioritize prevention services and clinical care within the community to maximize health outcomes. PMID:24385655

  10. Collaboration for rare disease drug discovery research

    PubMed Central

    Litterman, Nadia K.; Rhee, Michele; Swinney, David C.; Ekins, Sean

    2014-01-01

    Rare disease research has reached a tipping point, with the confluence of scientific and technologic developments that if appropriately harnessed, could lead to key breakthroughs and treatments for this set of devastating disorders. Industry-wide trends have revealed that the traditional drug discovery research and development (R&D) model is no longer viable, and drug companies are evolving their approach. Rather than only pursue blockbuster therapeutics for heterogeneous, common diseases, drug companies have increasingly begun to shift their focus to rare diseases. In academia, advances in genetics analyses and disease mechanisms have allowed scientific understanding to mature, but the lack of funding and translational capability severely limits the rare disease research that leads to clinical trials. Simultaneously, there is a movement towards increased research collaboration, more data sharing, and heightened engagement and active involvement by patients, advocates, and foundations. The growth in networks and social networking tools presents an opportunity to help reach other patients but also find researchers and build collaborations. The growth of collaborative software that can enable researchers to share their data could also enable rare disease patients and foundations to manage their portfolio of funded projects for developing new therapeutics and suggest drug repurposing opportunities. Still there are many thousands of diseases without treatments and with only fragmented research efforts. We will describe some recent progress in several rare diseases used as examples and propose how collaborations could be facilitated. We propose that the development of a center of excellence that integrates and shares informatics resources for rare diseases sponsored by all of the stakeholders would help foster these initiatives. PMID:25685324

  11. Respect versus Surveillance: Drug Testing Our Students

    ERIC Educational Resources Information Center

    Brendtro, Larry K.; Martin, Gordon A., Jr.

    2006-01-01

    This launches a new periodic feature in Reclaiming Children and Youth. "Justice Alerts" examines current laws and policies against the twofold standards of solid science and moral values. This inaugural article explores the legal issues and political rhetoric surrounding random drug testing in schools and describes how science is being skewed to…

  12. Surveillance for Antimicrobial Drug Resistance in Under-Resourced Countries

    PubMed Central

    Mary, Catherine; Altmann, Dany M.; Doumbo, Ogobara; Morpeth, Susan; Bhutta, Zulfiqar A.; Klugman, Keith P.

    2014-01-01

    Antimicrobial drug resistance is usually not monitored in under-resourced countries because they lack surveillance networks, laboratory capacity, and appropriate diagnostics. This accelerating problem accounts for substantial number of excess deaths, especially among infants. Infections particularly affected by antimicrobial drug resistance include tuberculosis, malaria, severe acute respiratory infections, and sepsis caused by gram-negative bacteria. Nonetheless, mapping antimicrobial drug resistance is feasible in under-resourced countries, and lessons can be learned from previous successful efforts. Specimen shipping conditions, data standardization, absence of contamination, and adequate diagnostics must be ensured. As a first step toward solving this problem, we propose that a road map be created at the international level to strengthen antimicrobial resistance surveillance in under-resourced countries. This effort should include a research agenda; a map of existing networks and recommendations to unite them; and a communication plan for national, regional, and international organizations and funding agencies. PMID:24564906

  13. 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

  14. When Collaborative Is Not Collaborative: Supporting Student Learning through Self-Surveillance

    ERIC Educational Resources Information Center

    Kotsopoulos, Donna

    2010-01-01

    Collaborative learning has been widely endorsed in education. This qualitative research examines instances of collaborative learning during mathematics that were seen to be predominantly non-collaborative despite the pedagogical efforts and intentions of the teacher and the task. In an effort to disrupt the non-collaborative learning, small groups…

  15. TickNET—A Collaborative Public Health Approach to Tickborne Disease Surveillance and Research

    PubMed Central

    Hinckley, Alison; Hook, Sarah; Beard, C. Ben

    2015-01-01

    TickNET, a public health network, was created in 2007 to foster greater collaboration between state health departments, academic centers, and the Centers for Disease Control and Prevention on surveillance and prevention of tickborne diseases. Research activities are conducted through the Emerging Infections Program and include laboratory surveys, high-quality prevention trials, and pathogen discovery. PMID:26291549

  16. Distributed and Mobile Collaboration for Real Time Epidemiological Surveillance during Forces Deployments.

    PubMed

    Chaudet, Hervé; Meynard, Jean-Baptiste; Texier, Gaëtan; Tournebize, Olivier; Pellegrin, Liliane; Queyriaux, Benjamin; Boutin, Jean-Paul

    2005-01-01

    This paper presents a pilot project of a real time syndromic surveillance system in French armed forces for early warning of biological attack by mass destruction weapons. For simulating the situation of a theatre of operations and its organisation, an electronic syndromic surveillance system covering all branches of service in French Guiana (about 3,000 persons) has been deployed and connected to a surveillance centre in France. This system has been design taking in account a collaborative view of epidemiological surveillance and the mobility of forces in extreme conditions. Several kinds of hardware, from rugged personal digital assistant to desktop computer, and several telecommunication links, from PSTN to satellite data links, are used. This system allows a quick report of cases, which are georeferenced. In the first results, some problems associated with the human and the technical aspects have been reported, in association with some immediate advantages. PMID:16160386

  17. A Binational Model of Collaboration for Enhancing Cross-border ID Surveillance

    PubMed Central

    Ortwine, Kristine; Ferran, Karen; Iniguez-Stevens, Esmeralda

    2013-01-01

    Objective The purpose of this demonstration is to describe the cross-border collaborative processes used for the development of a transparent methodology to identify and prioritize zoonotic infectious disease agents in the California-Baja California border region. Introduction International borders present unique challenges for the surveillance of infectious disease. Border communities represent locations with vast differences in cultures and languages, governing institutions, healthcare access, and priorities for the collection and surveillance of disease data. Pathogens and the health and security risks they create do not respect geographical and political boundaries. However, the organizations responsible for the surveillance and control of these agents must function within the borders of their respective governments. One Border One Health (OBOH) is a binational, multidisciplinary initiative aimed at engaging partners in the US and Mexico to identify and implement methods for successful communication and collaboration to enhance health capacity and disease surveillance within the border region. The advancements of international initiatives such as OBOH will help to develop the types of multi-country networks necessary for the effective monitoring of disease patterns and risks. Methods One Border One Health Surveillance Committee participants represent multi-disciplinary professionals working together for the advancement of One Health principles in the California/Baja California border region. This showcase documents the identification and prioritization of zoonotic infectious disease agents along the US-Mexico border, by use of a transparent methodology which engaged public and private partners from both countries. Preliminary research and input from collaborators in government, academic, and private sectors in the US and Mexico allowed for review and discussion of current methodologies available for prioritizing infectious agents. The DISCONTOOLS Work Package 2

  18. Drug abuse treatment in the context of correctional surveillance.

    PubMed

    Nurco, D N; Hanlon, T E; Bateman, R W; Kinlock, T W

    1995-01-01

    Evaluating drug abuse treatment within a correctional framework presents unique issues and challenges. Given their respective emphases on rehabilitation and incapacitation, treatment and corrections approaches to incarcerated drug abusers often differ in methods aimed at reducing deviant behavior. Although this results in problems in planning integrative drug abuse intervention strategies, the two approaches are not always incompatible. Corrections can help identify those individuals in need of treatment, and for some of these, treatment can lessen the need for incapacitation. Understandably, gaining a drug-abusing offender's cooperation in monitoring routines and engendering trust in the confidentiality of treatment conducted in criminal justice systems settings, while still ensuring public safety, are not easy tasks. Nevertheless, there are decided advantages, in terms of compliance and retention, to the increased surveillance exercised by the criminal justice system in community-based treatment efforts. In these efforts, therapy coupled with urine monitoring appears particularly promising. Along with the presentation of descriptive and preliminary outcome information, this report provides a discussion of treatment/corrections issues within the framework of an ongoing treatment evaluation study involving drug-abusing parolees in Baltimore City. PMID:7752293

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

    PubMed Central

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

    2015-01-01

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

  20. Preventing Prescription Drug Abuse in Adolescence: A Collaborative Approach

    ERIC Educational Resources Information Center

    Jones, Beth A.; Fullwood, Harry; Hawthorn, Melissa

    2012-01-01

    With the growing awareness of adolescent prescription drug abuse, communities and schools are beginning to explore prevention and intervention strategies which are appropriate for their youth. This article provides a framework for developing a collaborative approach to prescription drug abuse prevention--called the Prevention Awareness Team--that…

  1. The completeness of AIDS case reporting, 1988: a multisite collaborative surveillance project.

    PubMed Central

    Rosenblum, L; Buehler, J W; Morgan, M W; Costa, S; Hidalgo, J; Holmes, R; Lieb, L; Shields, A; Whyte, B M

    1992-01-01

    OBJECTIVES. The purpose of this study was to evaluate the completeness of acquired immunodeficiency syndrome (AIDS) case reporting. METHODS. Statewide or hospital-specific 1988 medical records were linked with AIDS surveillance in six sites. Medical records were reviewed for persons who had diagnoses suggesting human immunodeficiency virus (HIV) infection or AIDS but were not reported to AIDS surveillance by September 1989. RESULTS. Among 4500 hospitalized persons diagnosed with AIDS through 1988 in the six sites, completeness of reporting was 92% (95% CI = 89%, 96%; range across sites = 89% to 97%). Completeness of reporting was high in males (92%), females (95%), Whites (95%), Blacks (90%), Hispanics (92%), men reporting sexual contact with men (92%), persons reporting injecting-drug use (91%), and persons exposed to HIV through heterosexual contact (99%). In Medicaid enrollees (two states), completeness of reporting was 99% (95% CI = 95%, 99%) in inpatients and 90% (95% CI = 79%, 90%) in outpatients. Of previously reported persons with AIDS, 82% were reported within 5 months of diagnosis. CONCLUSIONS. Completeness of AIDS reporting was high, overall and in each major demographic and HIV exposure group. These results demonstrate that current surveillance data in these six sites provide timely and accurate information regarding persons with AIDS. PMID:1443299

  2. Drug-Induced Liver Injury during Antidepressant Treatment: Results of AMSP, a Drug Surveillance Program

    PubMed Central

    Friedrich, Michaela-Elena; Akimova, Elena; Huf, Wolfgang; Konstantinidis, Anastasios; Papageorgiou, Konstantinos; Winkler, Dietmar; Toto, Sermin; Greil, Waldemar; Grohmann, Renate; Kasper, Siegfried

    2016-01-01

    Background: Drug-induced liver injury is a common cause of liver damage and the most frequent reason for withdrawal of a drug in the United States. The symptoms of drug-induced liver damage are extremely diverse, with some patients remaining asymptomatic. Methods: This observational study is based on data of Arzneimittelsicherheit in der Psychiatrie, a multicenter drug surveillance program in German-speaking countries (Austria, Germany, and Switzerland) recording severe drug reactions in psychiatric inpatients. Of 184234 psychiatric inpatients treated with antidepressants between 1993 and 2011 in 80 psychiatric hospitals, 149 cases of drug-induced liver injury (0.08%) were reported. Results: The study revealed that incidence rates of drug-induced liver injury were highest during treatment with mianserine (0.36%), agomelatine (0.33%), and clomipramine (0.23%). The lowest probability of drug-induced liver injury occurred during treatment with selective serotonin reuptake inhibitors ([0.03%), especially escitalopram [0.01%], citalopram [0.02%], and fluoxetine [0.02%]). The most common clinical symptoms were nausea, fatigue, loss of appetite, and abdominal pain. In contrast to previous findings, the dosage at the timepoint when DILI occurred was higher in 7 of 9 substances than the median overall dosage. Regarding liver enzymes, duloxetine and clomipramine were associated with increased glutamat-pyruvat-transaminase and glutamat-oxalat-transaminase values, while mirtazapine hardly increased enzyme values. By contrast, duloxetine performed best in terms of gamma-glutamyl-transferase values, and trimipramine, clomipramine, and venlafaxine performed worst. Conclusions: Our findings suggest that selective serotonin reuptake inhibitors are less likely than the other antidepressants, examined in this study, to precipitate drug-induced liver injury, especially in patients with preknown liver dysfunction. PMID:26721950

  3. Collaborative virtual organisation and infrastructure for drug discovery.

    PubMed

    Hardy, Barry; Affentranger, Roman

    2013-07-01

    A virtual organisation approach was applied to collaborative drug discovery integrating experimental and computational design approaches. Scientists Against Malaria was formed with the goal of designing novel antimalarial drug candidates. The collaboration of nine founding partners carried out computational and laboratory work that produced significant volumes of data and metadata, the interpretation for the analysis of which, as well as the related decision making, was challenging. During the first phase the partners developed this 'green-field' project from initiation through to target selection and modelling, computational screening, biological materials and assay preparation, culminating in the completion of initial experimental testing. A support infrastructure involving a semantic collaborative laboratory framework, interoperating with a cloud of web services through an ontology describing the virtual and experimental screening data, was designed and tested. PMID:23416145

  4. Collaborative drug therapy management and its application to pharmaceutical compounding.

    PubMed

    Anderson, Derick

    2007-01-01

    Patient care within the US healthcare system is changing constantly, as are the roles of healthcare practitioners, including pharmacists. For over 30 years, pharmacists have promoted the concept of clinical pharmacy, which places pharmacists in a central role in patient medication management. The goal is to allow the pharmacist to become a vital part of treatment planning by individualizing patients' therapeutic regimens. The Collaborative Drug Therapy Management agreement is a step toward that goal. The combination of drug therapy management and compounding pharmacy can be powerful in meeting patients' specific needs. PMID:23974486

  5. 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

  6. Collaborative drug therapy management and comprehensive medication management-2015.

    PubMed

    McBane, Sarah E; Dopp, Anna L; Abe, Andrew; Benavides, Sandra; Chester, Elizabeth A; Dixon, Dave L; Dunn, Michaelia; Johnson, Melissa D; Nigro, Sarah J; Rothrock-Christian, Tracie; Schwartz, Amy H; Thrasher, Kim; Walker, Scot

    2015-04-01

    The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes. PMID:25884536

  7. Improving Post-Approval Drug Safety Surveillance: Getting Better Information Sooner

    PubMed Central

    Hennessy, Sean; Strom, Brian L.

    2015-01-01

    Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include establishment of government-sponsored networks of population databases, use of data mining approaches, and formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks, allowing earlier identification of risks as well as reassurance about the absence of specific risks. PMID:25292435

  8. Open source drug discovery--a new paradigm of collaborative research in tuberculosis drug development.

    PubMed

    Bhardwaj, Anshu; Scaria, Vinod; Raghava, Gajendra Pal Singh; Lynn, Andrew Michael; Chandra, Nagasuma; Banerjee, Sulagna; Raghunandanan, Muthukurussi V; Pandey, Vikas; Taneja, Bhupesh; Yadav, Jyoti; Dash, Debasis; Bhattacharya, Jaijit; Misra, Amit; Kumar, Anil; Ramachandran, Srinivasan; Thomas, Zakir; Brahmachari, Samir K

    2011-09-01

    It is being realized that the traditional closed-door and market driven approaches for drug discovery may not be the best suited model for the diseases of the developing world such as tuberculosis and malaria, because most patients suffering from these diseases have poor paying capacity. To ensure that new drugs are created for patients suffering from these diseases, it is necessary to formulate an alternate paradigm of drug discovery process. The current model constrained by limitations for collaboration and for sharing of resources with confidentiality hampers the opportunities for bringing expertise from diverse fields. These limitations hinder the possibilities of lowering the cost of drug discovery. The Open Source Drug Discovery project initiated by Council of Scientific and Industrial Research, India has adopted an open source model to power wide participation across geographical borders. Open Source Drug Discovery emphasizes integrative science through collaboration, open-sharing, taking up multi-faceted approaches and accruing benefits from advances on different fronts of new drug discovery. Because the open source model is based on community participation, it has the potential to self-sustain continuous development by generating a storehouse of alternatives towards continued pursuit for new drug discovery. Since the inventions are community generated, the new chemical entities developed by Open Source Drug Discovery will be taken up for clinical trial in a non-exclusive manner by participation of multiple companies with majority funding from Open Source Drug Discovery. This will ensure availability of drugs through a lower cost community driven drug discovery process for diseases afflicting people with poor paying capacity. Hopefully what LINUX the World Wide Web have done for the information technology, Open Source Drug Discovery will do for drug discovery. PMID:21782516

  9. The temporal relationship between drug supply indicators: an audit of international government surveillance systems

    PubMed Central

    Werb, Dan; Kerr, Thomas; Nosyk, Bohdan; Strathdee, Steffanie; Montaner, Julio; Wood, Evan

    2013-01-01

    Objectives Illegal drug use continues to be a major threat to community health and safety. We used international drug surveillance databases to assess the relationship between multiple long-term estimates of illegal drug price and purity. Design We systematically searched for longitudinal measures of illegal drug supply indicators to assess the long-term impact of enforcement-based supply reduction interventions. Setting Data from identified illegal drug surveillance systems were analysed using an a priori defined protocol in which we sought to present annual estimates beginning in 1990. Data were then subjected to trend analyses. Main outcome measures Data were obtained from government surveillance systems assessing price, purity and/or seizure quantities of illegal drugs; systems with at least 10 years of longitudinal data assessing price, purity/potency or seizures were included. Results We identified seven regional/international metasurveillance systems with longitudinal measures of price or purity/potency that met eligibility criteria. In the USA, the average inflation-adjusted and purity-adjusted prices of heroin, cocaine and cannabis decreased by 81%, 80% and 86%, respectively, between 1990 and 2007, whereas average purity increased by 60%, 11% and 161%, respectively. Similar trends were observed in Europe, where during the same period the average inflation-adjusted price of opiates and cocaine decreased by 74% and 51%, respectively. In Australia, the average inflation-adjusted price of cocaine decreased 14%, while the inflation-adjusted price of heroin and cannabis both decreased 49% between 2000 and 2010. During this time, seizures of these drugs in major production regions and major domestic markets generally increased. Conclusions With few exceptions and despite increasing investments in enforcement-based supply reduction efforts aimed at disrupting global drug supply, illegal drug prices have generally decreased while drug purity has generally

  10. Using a Clinical Surveillance System to Detect Drug-Associated Hypoglycemia in Nursing Home Residents

    PubMed Central

    Culley, Colleen M.; Perera, Subashan; Marcum, Zachary A.; Kane-Gill, Sandra L.; Handler, Steven M.

    2016-01-01

    Background/Objectives Hypoglycemia is a common adverse drug event (ADE) frequently associated with temporary harm in the nursing home (NH) setting. Reports from the Office of the Inspector General and the U.S. Department of Health and Human Services recommend the need for increased surveillance of drug-associated hypoglycemia events. The objective of this study was to test if a clinical surveillance system could be used to detect drug-associated hypoglycemia events and determine their incidence in NH residents Design Retrospective cohort Setting Four NHs in Western Pennsylvania Participants Computer-generated alerts detecting potential drug-associated hypoglycemia in residents with glucose ≤ 70 mg/dL and ordered a medication(s) associated with hypoglycemia over a 6-month period were included. Measurements Descriptive statistics were used to summarize all variables, including the frequency and distribution of alert type by glucose threshold. Analyses were conducted per numbers of alerts and per distinct residents. The frequency of medications associated with the alerts was determined. Additional calculations included the time to drug-associated hypoglycemic event alert from date of admission and frequency of events associated with post-acute/short-stay (≤ 35 days) admissions. Results Total of 772 alerts involving 141 unique residents were detected. Ninety (63.8%) residents had a glucose ≤ 55 mg/dL, and 42 (29.8%) had a glucose ≤ 40 mg/dL alert. Insulin orders were associated with 762 (98.7%) alerts. Overall incidence of drug-associated hypoglycemia events was 9.5 per 1000 resident-days. Conclusion Hypoglycemia can be detected using a clinical surveillance system. Our evaluation found a high incidence of drug-associated hypoglycemia in a general NH population. Future studies are needed to determine the potential benefits of use of a surveillance system in real-time detection and management of hypoglycemia in the NH. PMID:26456318

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

    PubMed

    Kesselheim, A S; Gagne, J J

    2014-03-01

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

  12. The collaborative experience of creating the National Capital Region Disease Surveillance Network.

    PubMed

    Lewis, Sheri H; Holtry, Rekha S; Loschen, Wayne A; Wojcik, Richard; Hung, Lang; Lombardo, Joseph

    2011-01-01

    The Johns Hopkins University Applied Physics Laboratory (JHU/APL) implemented state and district surveillance nodes in a central aggregated node in the National Capital Region (NCR). Within this network, de-identified health information is integrated with other indicator data and is made available to local and state health departments for enhanced disease surveillance. Aggregated data made available to the central node enable public health practitioners to observe abnormal behavior of health indicators spanning jurisdictions and view geographical spread of outbreaks across regions.Forming a steering committee, the NCR Enhanced Surveillance Operating Group (ESOG), was key to overcoming several data-sharing issues. The committee was composed of epidemiologists and key public health practitioners from the 3 jurisdictions. The ESOG facilitated early system development and signing of the cross-jurisdictional data-sharing agreement. This agreement was the first of its kind at the time and provided the legal foundation for sharing aggregated health information across state/district boundaries for electronic disease surveillance.Electronic surveillance system for the early notification of community-based epidemics provides NCR users with a comprehensive regional view to ascertain the spread of disease, estimate resource needs, and implement control measures. This article aims to describe the creation of the NCR Disease Surveillance Network as an exceptional example of cooperation and potential that exists for regional surveillance activities. PMID:21464687

  13. Handling Temporality of Clinical Events for Drug Safety Surveillance

    PubMed Central

    Zhao, Jing; Henriksson, Aron; Kvist, Maria; Asker, Lars; Boström, Henrik

    2015-01-01

    Using longitudinal data in electronic health records (EHRs) for post-marketing adverse drug event (ADE) detection allows for monitoring patients throughout their medical history. Machine learning methods have been shown to be efficient and effective in screening health records and detecting ADEs. How best to exploit historical data, as encoded by clinical events in EHRs is, however, not very well understood. In this study, three strategies for handling temporality of clinical events are proposed and evaluated using an EHR database from Stockholm, Sweden. The random forest learning algorithm is applied to predict fourteen ADEs using clinical events collected from different lengths of patient history. The results show that, in general, including longer patient history leads to improved predictive performance, and that assigning weights to events according to time distance from the ADE yields the biggest improvement. PMID:26958278

  14. Surveillance of anti-tuberculosis drug resistance in the world: an updated analysis, 2007–2010

    PubMed Central

    van Gemert, Wayne; Falzon, Dennis; Sismanidis, Charalambos; Glaziou, Philippe; Floyd, Katherine; Raviglione, Mario

    2012-01-01

    Abstract Objective To present a global update of drug-resistant tuberculosis (TB) and explore trends in 1994–2010. Methods Data on drug resistance among new and previously treated TB patients, as reported by countries to the World Health Organization, were analysed. Such data are collected through surveys of a representative sample of TB patients or surveillance systems based on routine drug susceptibility testing. Associations between multidrug-resistant TB (MDR-TB) and human immunodeficiency virus (HIV) infection and sex were explored through logistic regression. Findings In 2007–2010, 80 countries and 8 territories reported surveillance data. MDR-TB among new and previously treated cases was highest in the Russian Federation (Murmansk oblast, 28.9%) and the Republic of Moldova (65.1%), respectively. In three former Soviet Union countries and South Africa, more than 10% of the cases of MDR-TB were extensively drug-resistant. Globally, in 1994 to 2010 multidrug resistance was observed in 3.4% (95% confidence interval, CI: 1.9–5.0) of all new TB cases and in 19.8% (95% CI: 14.4–25.1) of previously treated TB cases. No overall associations between MDR-TB and HIV infection (odds ratio, OR: 1.4; 95% CI: 0.7–3.0) or sex (OR: 1.1; 95% CI: 0.8–1.4) were found. Between 1994 and 2010, MDR-TB rates in the general population increased in Botswana, Peru, the Republic of Korea and declined in Estonia, Latvia and the United States of America. Conclusion The highest global rates of MDR-TB ever reported were documented in 2009 and 2010. Trends in MDR-TB are still unclear in most settings. Better surveillance or survey data are required, especially from Africa and India. PMID:22423162

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

    PubMed

    Noah, B A; Brushwood, D B

    2000-01-01

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

  16. 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

  17. [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

  18. Mono- and combination drug therapies in hospitalized patients with bipolar depression. Data from the European drug surveillance program AMSP

    PubMed Central

    2012-01-01

    Background For the pharmacological treatment of bipolar depression several guidelines exist. It is largely unknown, to what extent the prescriptions in daily clinical routine correspond to these evidence based recommendations and which combinations of psychotropic drugs are frequently used. Methods The prescriptions of psychotropic drugs were investigated of all in-patients with bipolar depression (n = 2246; time period 1994–2009) from hospitals participating in the drug surveillance program AMSP. For the drug use in 2010, 221 cases were analysed additionally. Results From 1994 to 2009, 85% of all patients received more than one class of psychotropic substances: 74% received antidepressants in combination therapy, 55% antipsychotics, 48% anticonvulsants and 33% lithium. When given in combination, lithium is the most often prescribed substance for bipolar depression (33%), followed by valproic acid (23%), mirtazapine and venlafaxine (16% each), quetiapine (15%), lamotrigine (14%) and olanzapine (13%). Both, lithium and valproic acid are often combined with selective serotonin reuptake inhibitors (SSRI), but also with mirtazapine und venlafaxine. Combinations of more than one antidepressant occur quite often, whereby combinations with bupropion, paroxetine, fluoxetine or fluvoxamine are very rare. In 2010, quetiapine (alone and combined) was the most frequently prescribed drug (39%); aripiprazole was administered in 10%. Conclusion Combinations of antidepressants (SSRI, mirtazapine, venlafaxine) with mood stabilizers (lithium, valproic acid, lamotrigine) and / or atypical antipsychotics (quetiapine, olanzapine) are common. Of most of those combinations the efficacy has not been studied. The use of aripiprazole and the concomitant use of two or three antidepressants contrast the guidelines. PMID:22998655

  19. Naturally surveilled space: the design of a male drug rehabilitation center

    NASA Astrophysics Data System (ADS)

    Permana, A. R.; Aryanti, T.; Rahmanullah, F.

    2016-04-01

    The increase of drug addicts in Indonesia has not been supported by adequate facilities, both quantitatively and qualitatively. Despite being treated in a rehabilitation center, drug addicts may still use drugs surreptitiously and put themselves in danger. Architectural design may contribute to this either positively or negatively. This article elaborates a therapeutic design of a male rehabilitation center in the borderland of Bandung city, Indonesia. Employing the notion of natural surveillance, the rehabilitation center is designed to allow continual control over attendees without them feeling suppressed. The center design uses the behavioral approach to consider both attendees’ physical and psychological comforts, as well as their security. Building masses are designed in a way that forms an inward orientation and are laid out circularly according to the therapy processes that attendees must undertake. Moreover, rooms are planned differently in response to attendees’ unique conditions and restrictive physical requirements, such as their restriction on lighting and requirement of water for treatment. The landscape uses shady trees and vegetations as natural borders to demarcate the private zone, where attendees live, from the public area, where visitors may enter. The design is intended to provide a model for a responsive drug rehabilitation center that facilitates drug addicts’ recovery.

  20. Drug induced immune haemolytic anaemia in the Berlin Case-Control Surveillance Study.

    PubMed

    Garbe, Edeltraut; Andersohn, Frank; Bronder, Elisabeth; Klimpel, Andreas; Thomae, Michael; Schrezenmeier, Hubert; Hildebrandt, Martin; Späth-Schwalbe, Ernst; Grüneisen, Andreas; Mayer, Beate; Salama, Abdulgabar; Kurtal, Hanife

    2011-09-01

    Drug-induced immune haemolytic anaemia is a rare but serious condition. This study investigated the possibility of drug aetiology of immune haemolytic anaemia (IHA) in 134 patients with new onset of IHA who were identified in the Berlin Case-Control Surveillance Study between 2000 and 2009. Single drugs related to IHA in three or more patients and assessed more than once as a certain or probable cause of IHA in a standardized causality assessment included diclofenac, fludarabine, oxaliplatin, ceftriaxone and piperacillin. In a case-control study including all 124 IHA cases developed in outpatient care and 731 controls, significantly increased odds ratios (OR) were observed for beta-lactam antibiotics (OR=8·8; 95% confidence interval [CI] 3·2-25·2), cotrimoxazole (OR=6·5; CI 1·1-37·9), ciprofloxacin (OR=6·9, CI 1·3-38·5), fludarabine (OR=22·2; CI: 2·8-454·5) and lorazepam (OR=5·3; CI: 1·2-21·2). Excluding new onset cases with a chronic IHA disease course, an increased risk became also apparent for diclofenac with an OR of 3·1 (CI 1·3-7·0). This is the first case-control study investigating drugs as risk factors for IHA. It corroborates an increased risk for several drugs that have been implicated as a cause of IHA in the standardized causality assessment of individual cases. PMID:21749359

  1. A Radar-Enabled Collaborative Sensor Network Integrating COTS Technology for Surveillance and Tracking

    PubMed Central

    Kozma, Robert; Wang, Lan; Iftekharuddin, Khan; McCracken, Ernest; Khan, Muhammad; Islam, Khandakar; Bhurtel, Sushil R.; Demirer, R. Murat

    2012-01-01

    The feasibility of using Commercial Off-The-Shelf (COTS) sensor nodes is studied in a distributed network, aiming at dynamic surveillance and tracking of ground targets. Data acquisition by low-cost (<$50 US) miniature low-power radar through a wireless mote is described. We demonstrate the detection, ranging and velocity estimation, classification and tracking capabilities of the mini-radar, and compare results to simulations and manual measurements. Furthermore, we supplement the radar output with other sensor modalities, such as acoustic and vibration sensors. This method provides innovative solutions for detecting, identifying, and tracking vehicles and dismounts over a wide area in noisy conditions. This study presents a step towards distributed intelligent decision support and demonstrates effectiveness of small cheap sensors, which can complement advanced technologies in certain real-life scenarios. PMID:22438713

  2. A radar-enabled collaborative sensor network integrating COTS technology for surveillance and tracking.

    PubMed

    Kozma, Robert; Wang, Lan; Iftekharuddin, Khan; McCracken, Ernest; Khan, Muhammad; Islam, Khandakar; Bhurtel, Sushil R; Demirer, R Murat

    2012-01-01

    The feasibility of using Commercial Off-The-Shelf (COTS) sensor nodes is studied in a distributed network, aiming at dynamic surveillance and tracking of ground targets. Data acquisition by low-cost (<$50 US) miniature low-power radar through a wireless mote is described. We demonstrate the detection, ranging and velocity estimation, classification and tracking capabilities of the mini-radar, and compare results to simulations and manual measurements. Furthermore, we supplement the radar output with other sensor modalities, such as acoustic and vibration sensors. This method provides innovative solutions for detecting, identifying, and tracking vehicles and dismounts over a wide area in noisy conditions. This study presents a step towards distributed intelligent decision support and demonstrates effectiveness of small cheap sensors, which can complement advanced technologies in certain real-life scenarios. PMID:22438713

  3. The Spanish Protocol for radiological surveillance of metal recycling: a collaboration of government and industry.

    PubMed

    Cadierno, Juan Pedro García; Renedo, J I Serrano; Lopez, E Gil

    2006-11-01

    The presence of radioactive materials in scrap metal has been detected relatively often in recent years. As a result of an accidental melting of a 137Cs source in a Spanish steel mill (Acerinox) in 1998, the national authorities, the involved private companies, and the main trade unions drafted a protocol for prevention of and responding to such events ("Spanish Protocol"). The Protocol was signed in 1999. The number of subscribing companies is 90. The Protocol is a voluntary agreement defining the radiological surveillance of scrap metal and its products and the duties and rights of the signatories. From the effective date of the Protocol to December 2004, 461 pieces of ferric scrap were detected including sources of radiation and contaminated metal. Four melting incidents have happened in different companies. PMID:17033458

  4. Decentralized closed-loop collaborative surveillance and tracking performance sensitivity to communications connectivity

    NASA Astrophysics Data System (ADS)

    DeSena, Jonathan T.; Martin, Sean R.; Clarke, Jesse C.; Dutrow, Daniel A.; Kohan, Brian C.; Newman, Andrew J.

    2013-05-01

    As the number and diversity of sensing assets available for intelligence, surveillance and reconnaissance (ISR) operations continues to expand, the limited ability of human operators to effectively manage, control and exploit the ISR ensemble is exceeded, leading to reduced operational effectiveness. Our approach is to apply the principles of feedback control to ISR operations, "closing the loop" from the sensor collections through automated processing to ISR asset control. Previous work by the authors demonstrated closed-loop control, involving both platform routing and sensor pointing, of a multi-sensor, multi-platform ISR ensemble tasked with providing situational awareness and performing search, track and classification of multiple targets. The multi-asset control used a joint optimization of routes and schedules in a centralized architecture, requiring a fully-connected communications network. This paper presents an extension of the previous work to a decentralized architecture that relaxes the communications requirements. The decentralized approach achieves a solution equivalent to the centralized system when the network allows full communications and gracefully degrades ISR performance as communications links degrade. The decentralized closedloop ISR system has been exercised via a simulation test bed against a scenario in the Afghanistan theater under a variety of network conditions, from full to poor connectivity. Simulation experiment results are presented.

  5. 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

  6. Pregnancy Risk Assessment Monitoring System and the W.K. Kellogg Foundation joint project to enhance maternal and child health surveillance: focus on collaboration.

    PubMed

    Ahluwalia, Indu B; Harrison, Leslie; Simpson, Patrick; Wako, Etobssie; Helms Shealy, Kristen; Kapaya, Martha; Williams, Tanya; Williams, Letitia; D'Angelo, Denise

    2015-04-01

    Maternal and child health (MCH) surveillance data are important for understanding gaps in services and disparities in burden of disease, access to care, risk behaviors, and health outcomes. However, national and state surveillance systems are not always designed to gather sufficient data for calculating reliable estimates of the health conditions among high-risk or underrepresented population subgroups living in smaller geographic areas. The Centers for Disease Control and Prevention's Pregnancy Risk Assessment Monitoring System (PRAMS) has conducted surveillance for over 25 years in collaboration with state and city health departments. In 2012, PRAMS embarked on a multiyear collaboration with the W.K. Kellogg Foundation (WKKF) to include oversampling of minority and low-income women in selected geographic areas in four states (Louisiana, Michigan, Mississippi, and New Mexico) where the WKKF funded extensive place-based initiatives are located. The PRAMS-WKKF collaboration has broad implications for promoting meaningful collaboration between public, private, local, state, and federal organizations to address MCH data gaps on disparities, and for improving the availability of information needed for MCH programs, policy makers, and women. PMID:25860106

  7. Proportion of drug-related serious rare blood dyscrasias: estimates from the Berlin Case-Control Surveillance Study.

    PubMed

    Andersohn, Frank; Bronder, Elisabeth; Klimpel, Andreas; Garbe, Edeltraut

    2004-11-01

    Drugs are an important cause of serious rare blood dyscrasias. To estimate the proportion of drug-related cases, we used data from the ongoing Berlin Case-Control Surveillance Study. The analysis included a total of 171 cases. The number of cases in which a drug etiology was assessed as at least "possible" was n = 29 (97%) for acute agranulocytosis, n = 4 (0.21%) for aplastic anemia, n = 8 (26%) for immune hemolytic anemia, n = 20 (25%) for immune thrombocytopenia, and n = 2 (20%) for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Our analysis suggests that a substantial fraction of blood dyscrasias may be attributable to drug therapy. PMID:15495238

  8. Collaboration

    ERIC Educational Resources Information Center

    King, Michelle L.

    2010-01-01

    This article explores collaboration between library media educators and regular classroom teachers. The article focuses on the context of the issue, positions on the issue, the impact of collaboration, and how to implement effective collaboration into the school system. Various books and professional journals are used to support conclusions…

  9. Examining intensity and types of interagency collaboration between child welfare and drug and alcohol service providers.

    PubMed

    He, Amy S

    2015-08-01

    The co-occurrence of child maltreatment and caregiver substance use disorders (SUDs) is a pervasive problem, with an estimated two thirds of child welfare (CW) systems cases involving SUDs. Interagency collaboration between CW and drug and alcohol service (DAS) providers shows promise in improving connections to and delivery of SUD services for CW-involved families. However, interagency collaboration between CW and DAS providers continues to be difficult to achieve and little is known about organizational characteristics and contexts that influence collaboration between these two entities. Using data from the second cohort of families from the National Survey of Child and Adolescent Well-Being, this study examined national trends in interagency collaboration between CW and DAS providers and organizational factors that influence the nature and intensity of interagency collaboration. Results indicated that collaboration intensity was greater for CW agencies that reported increased caseloads and those located in more populated counties. However, collaboration intensity decreased for CW agencies located in counties with higher child poverty. Study findings have implications for policy leaders and directors of CW agencies throughout the United States, especially because collaborating with DAS providers may increase CW agencies' organizational capacity and relieve job stress related to high caseloads. Development of strategies that spur engagement in more intense and multiple types of collaboration between CW agencies and DAS providers has the potential to relieve service burden on CW staffs and expedite service delivery to CW-involved families dealing with SUDs. PMID:26188423

  10. Drug-Endangered Children Need a Collaborative Community Response

    ERIC Educational Resources Information Center

    Altshuler, Sandra J.

    2005-01-01

    The United States is facing an epidemic of the use of methamphetamine drugs. Child welfare has not yet addressed the needs of the children living in so-called "meth homes." These children are endangered not only from the chemicals involved, but also from parental abuse and neglect. Communities are recognizing the need for interagency collaboration…

  11. Pioneering government-sponsored drug repositioning collaborations: progress and learning.

    PubMed

    Frail, Donald E; Brady, Madeleine; Escott, K Jane; Holt, Alison; Sanganee, Hitesh J; Pangalos, Menelas N; Watkins, Chris; Wegner, Craig D

    2015-12-01

    A new model for translational research and drug repositioning has recently been established based on three-way partnerships between public funders, the pharmaceutical industry and academic investigators. Through two pioneering initiatives - one involving the Medical Research Council in the United Kingdom and one involving the National Center for Advancing Translational Sciences of the National Institutes of Health in the United States - new investigations of highly characterized investigational compounds have been funded and are leading to the exploration of known mechanisms in new disease areas. This model has been extended beyond these first two initiatives. Here, we discuss the progress to date and the unique requirements and challenges for this model. PMID:26585533

  12. Collaborate!

    ERIC Educational Resources Information Center

    Villano, Matt

    2007-01-01

    This article explores different approaches that facilitate online collaboration. The newest efforts in collaboration revolve around wikis. These websites allow visitors to add, remove, edit, and change content directly online. Another fairly affordable approach involves open source, a programming language that is, in many ways, collaborative…

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  15. Recovery Poetry 101: The Use of Collaborative Poetry in a Dual-Diagnosis Drug and Alcohol Treatment Program.

    ERIC Educational Resources Information Center

    Gillispie, Charles

    2001-01-01

    Presents a practice report that profiles the use of collaborative writing techniques in a dual-diagnosis drug and alcohol treatment program. Provides examples of typical patient-generated collaborative poems. Concludes that collaborative group poetry, when effectively facilitated, can generate a meaningful process-discussion toward values…

  16. Open Drug Discovery Teams: A Chemistry Mobile App for Collaboration.

    PubMed

    Ekins, Sean; Clark, Alex M; Williams, Antony J

    2012-08-01

    The Open Drug Discovery Teams (ODDT) project provides a mobile app primarily intended as a research topic aggregator of predominantly open science data collected from various sources on the internet. It exists to facilitate interdisciplinary teamwork and to relieve the user from data overload, delivering access to information that is highly relevant and focused on their topic areas of interest. Research topics include areas of chemistry and adjacent molecule-oriented biomedical sciences, with an emphasis on those which are most amenable to open research at present. These include rare and neglected diseases, and precompetitive and public-good initiatives such as green chemistry. The ODDT project uses a free mobile app as user entry point. The app has a magazine-like interface, and server-side infrastructure for hosting chemistry-related data as well as value added services. The project is open to participation from anyone and provides the ability for users to make annotations and assertions, thereby contributing to the collective value of the data to the engaged community. Much of the content is derived from public sources, but the platform is also amenable to commercial data input. The technology could also be readily used in-house by organizations as a research aggregator that could integrate internal and external science and discussion. The infrastructure for the app is currently based upon the Twitter API as a useful proof of concept for a real time source of publicly generated content. This could be extended further by accessing other APIs providing news and data feeds of relevance to a particular area of interest. As the project evolves, social networking features will be developed for organizing participants into teams, with various forms of communication and content management possible. PMID:23198003

  17. Open Drug Discovery Teams: A Chemistry Mobile App for Collaboration

    PubMed Central

    Ekins, Sean; Clark, Alex M; Williams, Antony J

    2012-01-01

    Abstract The Open Drug Discovery Teams (ODDT) project provides a mobile app primarily intended as a research topic aggregator of predominantly open science data collected from various sources on the internet. It exists to facilitate interdisciplinary teamwork and to relieve the user from data overload, delivering access to information that is highly relevant and focused on their topic areas of interest. Research topics include areas of chemistry and adjacent molecule-oriented biomedical sciences, with an emphasis on those which are most amenable to open research at present. These include rare and neglected diseases, and precompetitive and public-good initiatives such as green chemistry. The ODDT project uses a free mobile app as user entry point. The app has a magazine-like interface, and server-side infrastructure for hosting chemistry-related data as well as value added services. The project is open to participation from anyone and provides the ability for users to make annotations and assertions, thereby contributing to the collective value of the data to the engaged community. Much of the content is derived from public sources, but the platform is also amenable to commercial data input. The technology could also be readily used in-house by organizations as a research aggregator that could integrate internal and external science and discussion. The infrastructure for the app is currently based upon the Twitter API as a useful proof of concept for a real time source of publicly generated content. This could be extended further by accessing other APIs providing news and data feeds of relevance to a particular area of interest. As the project evolves, social networking features will be developed for organizing participants into teams, with various forms of communication and content management possible. PMID:23198003

  18. Surveillance of infection status of drug resistant Staphylococcus aureus in an Indian teaching hospital

    PubMed Central

    Dubey, Debasmita; Rath, Shakti; Sahu, Mahesh C.; Pattnaik, Lolly; Debata, Nagen K.; Padhy, Rabindra N.

    2013-01-01

    Objective To access nosocomial and community accounts of multidrug resistant strains of Staphylococcus aureus (S. aureus) isolated by surveillance in a teaching hospital, over a period of 30 months. Methods Clinical samples from nosocomial sources, i.e., wards and cabins, intensive care unit (ICU) and neonatal intensive care unit (NICU) sources, as well as community or outpatient department (OPD) sources of a hospital were used for isolating strains of S. aureus resistant to methicillin/oxacillin and vancomycin, over a period, November 2009-April 2012. Results Of a total of 1 507 S. aureus isolates, 485 strains from community and 1 022 isolates were from nosocomial sources; Out of 485 (100%) OPD S. aureus isolates, 390 (80.41%) were MRSA strains. Similarly, from wards and cabins of 564 (100%) isolates, 461 (81.73%) strains were MRSA; whereas of 458 (100%) isolates obtained from ICU and NICU, 363 (79.25%) strains were MRSA. It was ascertained with χ2-tests of independence that MRSA strains were equally distributed in “community” or “wards and cabins” or “ICU and NICU” sources, alike rest other drug-resistant S. aureus strains. Antibiotic sensitivity patterns of isolated strains with 16 antibiotics were ascertained. Out of 390 (100%) MRSA strains isolated from OPD, 80 (20.51%) were vancomycin resistant (VRSA) and 173 (44.35%) strains were moderately sensitive to vancomycin or called, vancomycin intermediate strains (VISA). Similarly, from nosocomial sources, out of 461 (100%) MRSA isolates obtained from wards and cabins, 110 (23.86%) strains were VRSA and 208 (45.11%) were VISA strains, whereas out of 363 MRSA isolates obtained from ICU and NICU, 61 (16.8%) VRSA strains and 164 (45.17%) VISA strains were found. A progressive increase of percent values of drug resistance to 16 antibiotics used for antibiotic profiling revealed its subtle infection dynamics. Conclusions This study revealed the appalling state of occurrence of MRSA and VRSA in a

  19. Drug-induced liver injury: results from the hospital-based Berlin Case–Control Surveillance Study

    PubMed Central

    Douros, Antonios; Bronder, Elisabeth; Andersohn, Frank; Klimpel, Andreas; Thomae, Michael; Sarganas, Giselle; Kreutz, Reinhold; Garbe, Edeltraut

    2015-01-01

    Aim Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case–control study to determine the hepatotoxic risk of a wide range of drugs. Methods The Berlin Case–Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network. Between 2002 and 2011, 198 patients with acute idiopathic hepatitis, 377 inpatient controls and 708 outpatient controls were ascertained. Case patients were thoroughly validated using anamnestic, clinical, laboratory and histological data. Drug exposure was obtained in a face-to-face interview. A possible drug aetiology was assessed in individual patients by applying the updated Council for International Organizations of Medical Sciences (CIOMS) scale. Drug risks were further quantified [odds ratios (OR) with 95% confidence intervals (CI)] in a case–control design with unconditional logistic regression analysis. Drug intake in the last 28 days before index date was considered for the analysis. Results The study corroborated hepatotoxic risks for a number of drugs, including phenprocoumon (OR 3.3, 95% CI 1.5, 6.7), amiodarone (OR 5.5, 95% CI 1.3, 21.2), clozapine (OR 34.6, 95% CI 2.8, 824.9) and flupirtine (OR 40.2, 95% CI 5.5, 856.9). Increased risks were also suggested for less commonly reported substances such as angiotensin II receptor blockers, atypical antipsychotics and for biperiden, a drug never before reported to be hepatotoxic. Conclusions Our study identified a large number of drugs as possible causes of hepatotoxicity. The observed risk for seldom reported substances highlights the need for further post-authorization safety studies not exclusively focusing on drugs already labelled as potentially hepatotoxic. PMID:25444550

  20. [Strategy and collaboration between medicinal chemists and pharmaceutical scientists for drug delivery systems].

    PubMed

    Mano, Takashi

    2013-01-01

    In order to successfully apply drug delivery systems (DDS) to new chemical entities (NCEs), collaboration between medicinal chemists and formulation scientists is critical for efficient drug discovery. Formulation scientists have to use 'language' that medicinal chemists understand to help promote mutual understanding, and medicinal chemists and formulation scientists have to set up strategies to use suitable DDS technologies at the discovery phase of the programmes to ensure successful transfer into the development phase. In this review, strategies of solubilisation formulation for oral delivery, inhalation delivery, nasal delivery and bioconjugation are all discussed. For example, for oral drug delivery, multiple initiatives can be proposed to improve the process to select an optimal delivery option for an NCE. From a technical perspective, formulation scientists have to explain the scope and limitations of formulations as some DDS technologies might be applicable only to limited chemical spaces. Other limitations could be the administered dose and, cost, time and resources for formulation development and manufacturing. Since DDS selection is best placed as part of lead-optimisation, formulation scientists need to be involved in discovery projects at lead selection and optimisation stages. The key to success in their collaboration is to facilitate communication between these two areas of expertise at both a strategic and scientific level. Also, it would be beneficial for medicinal chemists and formulation scientists to set common goals to improve the process of collaboration and build long term partnerships to improve DDS. PMID:23292022

  1. An update of the Near-Earth Asteroid Tracking/Maui Space Surveillance System (NEAT/MSSS) collaboration

    NASA Technical Reports Server (NTRS)

    Bambery, R. J.; Helin, E. F.; Pravdo, S. H.; Lawrence, K. J.; Hicks, M. D.

    2002-01-01

    Jet Propulsion Laboratory's (JPL) Near-Earth Asteroid Tracking (NEAT) program has two simultaneously-operating, autonomous search systems on two geographically-separated 1.2-m telescopes; one at the Maui Space Surveillance System (NEAT/MSSS) and the other on the Palomar Observatory's Oschin telescope (NEAT/Palomar). This paper will focus exclusively on the NEAT/MSSS system.

  2. Drug Development Value Chain Constructed by Collaboration Between The SOSHO Project and The NPO BIOGRID

    NASA Astrophysics Data System (ADS)

    Inoue, Tsuyoshi; Kado, Yuji; Tokuoka, Keiji; Matsumura, Hiroyoshi; Kai, Yasushi; Mori, Yusuke; Adachi, Hiroaki; Takano, Kazufumi; Murakami, Satoshi; Fukunishi, Yoshifumi; Nakamura, Haruki; Kinoshita, Takayoshi; Nakanishi, Isao; Okuno, Yasushi; Minakata, Seiji; Sakata, Tsuneaki

    2007-03-01

    We recently established a drug development value chain collaborated by The SOSHO project (http://www.sosho.jp) and The BioGrid Project (http://www.biogrid.jp/) to accelerate new drug development. The SOSHO project provides new crystal growth methods including handling of protein crystals, and The BioGrid Project their developing software necessary for the in silico screening of promising drugs and the simulation of biological responses to proteins. We selected the two target enzymes; human hematopoietic prostaglandin D synthase (H-PGDS) and orotidine 5'-monophosphate decarboxylase from human malaria parasite plasmodium falciparum (PfOMPDC). The optimizing of HQL-79, the inhibitor for human H-PGDS and the screening of a lead compound for PfOMPDC by using in silico method are in study.

  3. 77 FR 71211 - Request for Information: Establish a Public-Private Collaboration, “Drug Development Initiative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF VETERANS AFFAIRS Request for Information: Establish a Public-Private Collaboration, ``Drug Development Initiative'' (DDI), for New Pharmacological Treatments for Post-Traumatic Stress Disorder (PTSD) AGENCY: Office...

  4. Building a Collaboration One Day at a Time: Integrating Infant Mental Health into a Residential Drug Treatment Program

    ERIC Educational Resources Information Center

    Heffron, Mary Claire; Purcell, Arlene; Schalit, Jackie

    2007-01-01

    Families In Recovery Staying Together (FIRST) is a team from Children's Hospital and Research Center at Oakland that has joined in collaboration with two local perinatal residential drug treatment programs to create early childhood mental health services at those sites. The authors highlight the collaboration strategies and challenges the partners…

  5. GONOCOCCAL SURVEILLANCE ISOLATE PROJECT (GSIP)

    EPA Science Inventory

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

  6. Bigger Data, Collaborative Tools and the Future of Predictive Drug Discovery

    PubMed Central

    Clark, Alex M.; Swamidass, S. Joshua; Litterman, Nadia; Williams, Antony J.

    2014-01-01

    Over the past decade we have seen a growth in the provision of chemistry data and cheminformatics tools as either free websites or software as a service (SaaS) commercial offerings. These have transformed how we find molecule-related data and use such tools in our research. There have also been efforts to improve collaboration between researchers either openly or through secure transactions using commercial tools. A major challenge in the future will be how such databases and software approaches handle larger amounts of data as it accumulates from high throughput screening and enables the user to draw insights, enable predictions and move projects forward. We now discuss how information from some drug discovery datasets can be made more accessible and how privacy of data should not overwhelm the desire to share it at an appropriate time with collaborators. We also discuss additional software tools that could be made available and provide our thoughts on the future of predictive drug discovery in this age of big data. We use some examples from our own research on neglected diseases, collaborations, mobile apps and algorithm development to illustrate these ideas. PMID:24943138

  7. Analyzing collaboration networks and developmental patterns of nano-enabled drug delivery (NEDD) for brain cancer

    PubMed Central

    Huang, Ying; Ma, Jing; Kwon, Seokbeom; Zhu, Donghua

    2015-01-01

    Summary The rapid development of new and emerging science & technologies (NESTs) brings unprecedented challenges, but also opportunities. In this paper, we use bibliometric and social network analyses, at country, institution, and individual levels, to explore the patterns of scientific networking for a key nano area – nano-enabled drug delivery (NEDD). NEDD has successfully been used clinically to modulate drug release and to target particular diseased tissues. The data for this research come from a global compilation of research publication information on NEDD directed at brain cancer. We derive a family of indicators that address multiple facets of research collaboration and knowledge transfer patterns. Results show that: (1) international cooperation is increasing, but networking characteristics change over time; (2) highly productive institutions also lead in influence, as measured by citation to their work, with American institutes leading; (3) research collaboration is dominated by local relationships, with interesting information available from authorship patterns that go well beyond journal impact factors. Results offer useful technical intelligence to help researchers identify potential collaborators and to help inform R&D management and science & innovation policy for such nanotechnologies. PMID:26425417

  8. Bigger data, collaborative tools and the future of predictive drug discovery.

    PubMed

    Ekins, Sean; Clark, Alex M; Swamidass, S Joshua; Litterman, Nadia; Williams, Antony J

    2014-10-01

    Over the past decade we have seen a growth in the provision of chemistry data and cheminformatics tools as either free websites or software as a service commercial offerings. These have transformed how we find molecule-related data and use such tools in our research. There have also been efforts to improve collaboration between researchers either openly or through secure transactions using commercial tools. A major challenge in the future will be how such databases and software approaches handle larger amounts of data as it accumulates from high throughput screening and enables the user to draw insights, enable predictions and move projects forward. We now discuss how information from some drug discovery datasets can be made more accessible and how privacy of data should not overwhelm the desire to share it at an appropriate time with collaborators. We also discuss additional software tools that could be made available and provide our thoughts on the future of predictive drug discovery in this age of big data. We use some examples from our own research on neglected diseases, collaborations, mobile apps and algorithm development to illustrate these ideas. PMID:24943138

  9. Collaborative drug therapy management: case studies of three community-based models of care.

    PubMed

    Snyder, Margie E; Earl, Tara R; Gilchrist, Siobhan; Greenberg, Michael; Heisler, Holly; Revels, Michelle; Matson-Koffman, Dyann

    2015-01-01

    Collaborative drug therapy management agreements are a strategy for expanding the role of pharmacists in team-based care with other providers. However, these agreements have not been widely implemented. This study describes the features of existing provider-pharmacist collaborative drug therapy management practices and identifies the facilitators and barriers to implementing such services in community settings. We conducted in-depth, qualitative interviews in 2012 in a federally qualified health center, an independent pharmacy, and a retail pharmacy chain. Facilitators included 1) ensuring pharmacists were adequately trained; 2) obtaining stakeholder (eg, physician) buy-in; and 3) leveraging academic partners. Barriers included 1) lack of pharmacist compensation; 2) hesitation among providers to trust pharmacists; 3) lack of time and resources; and 4) existing informal collaborations that resulted in reduced interest in formal agreements. The models described in this study could be used to strengthen clinical-community linkages through team-based care, particularly for chronic disease prevention and management. PMID:25811494

  10. Analyzing collaboration networks and developmental patterns of nano-enabled drug delivery (NEDD) for brain cancer.

    PubMed

    Huang, Ying; Ma, Jing; Porter, Alan L; Kwon, Seokbeom; Zhu, Donghua

    2015-01-01

    The rapid development of new and emerging science & technologies (NESTs) brings unprecedented challenges, but also opportunities. In this paper, we use bibliometric and social network analyses, at country, institution, and individual levels, to explore the patterns of scientific networking for a key nano area - nano-enabled drug delivery (NEDD). NEDD has successfully been used clinically to modulate drug release and to target particular diseased tissues. The data for this research come from a global compilation of research publication information on NEDD directed at brain cancer. We derive a family of indicators that address multiple facets of research collaboration and knowledge transfer patterns. Results show that: (1) international cooperation is increasing, but networking characteristics change over time; (2) highly productive institutions also lead in influence, as measured by citation to their work, with American institutes leading; (3) research collaboration is dominated by local relationships, with interesting information available from authorship patterns that go well beyond journal impact factors. Results offer useful technical intelligence to help researchers identify potential collaborators and to help inform R&D management and science & innovation policy for such nanotechnologies. PMID:26425417

  11. Utilizing harmonization and common surveillance methods to consolidate 4 cohorts: the Western Alaska Tribal Collaborative for Health (WATCH) study

    PubMed Central

    Koller, Kathryn R.; Wolfe, Abbie W.; Metzger, Jesse S.; Austin, Melissa A.; Hopkins, Scarlett E.; Kaufmann, Cristiane; Jolly, Stacey E.; Ebbesson, Sven O.E.; Umans, Jason G.; Howard, Barbara V.; Boyer, Bert B.

    2013-01-01

    Background According to health status reports, chronic disease prevalence appears to be rising in western Alaska Native (AN) people, and accurate population-based data are needed. Four cohort studies of western AN people were conducted in the Norton Sound and Yukon-Kuskokwim regions, but none have been large enough to allow reliable estimates of rates of chronic diseases and evaluate their risk factors. Objective In this article, the methods used to combine 4 major cohort studies of rural western AN people are described and the benefits and challenges encountered in combining data and standardizing surveillance methods for these studies are discussed. Design Tribal permission was obtained for each cohort study and the consolidated study. Data from baseline exams were directly combined or harmonized into new variables. Common surveillance methods were developed and implemented to identify incidence and risk factors for cardiovascular disease (CVD) events and type 2 diabetes. Results A cohort of 4,569 western AN participants (2,116 men and 2,453 women), aged 18–95 years, was established to study CVD and diabetes prevalence. Prospective surveillance data over an average 6.7-year follow-up can now be used to study CVD and diabetes incidence and associated risk factors in a subset of 2,754 western AN participants (1,218 men and 1,536 women) who consented to initial surveillance. Conclusions The combined cohort provides statistical power to examine incidence rates and risk factors for CVD and diabetes and allows for analyses by geographic region. The data can be used to develop intervention programmes in these populations and others. PMID:23671836

  12. US Food and Drug Administration international collaborations for cellular therapy product regulation

    PubMed Central

    2012-01-01

    Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend this to the cellular therapy field. The US FDA and its global regulatory counterparts are engaged in collaborations focused on the convergence of scientific and regulatory approaches, and the education of scientists, clinicians, regulators, and the public at large on the development of cellular therapies. PMID:23021082

  13. A Network-Based Model of Oncogenic Collaboration for Prediction of Drug Sensitivity

    PubMed Central

    Laderas, Ted G.; Heiser, Laura M.; Sönmez, Kemal

    2015-01-01

    Tumorigenesis is a multi-step process, involving the acquisition of multiple oncogenic mutations that transform cells, resulting in systemic dysregulation that enables proliferation, invasion, and other cancer hallmarks. The goal of precision medicine is to identify therapeutically-actionable mutations from large-scale omic datasets. However, the multiplicity of oncogenes required for transformation, known as oncogenic collaboration, makes assigning effective treatments difficult. Motivated by this observation, we propose a new type of oncogenic collaboration where mutations in genes that interact with an oncogene may contribute to the oncogene’s deleterious potential, a new genomic feature that we term “surrogate oncogenes.” Surrogate oncogenes are representatives of these mutated subnetworks that interact with oncogenes. By mapping mutations to a protein–protein interaction network, we determine the significance of the observed distribution using permutation-based methods. For a panel of 38 breast cancer cell lines, we identified a significant number of surrogate oncogenes in known oncogenes such as BRCA1 and ESR1, lending credence to this approach. In addition, using Random Forest Classifiers, we show that these significant surrogate oncogenes predict drug sensitivity for 74 drugs in the breast cancer cell lines with a mean error rate of 30.9%. Additionally, we show that surrogate oncogenes are predictive of survival in patients. The surrogate oncogene framework incorporates unique or rare mutations from a single sample, and therefore has the potential to integrate patient-unique mutations into drug sensitivity predictions, suggesting a new direction in precision medicine and drug development. Additionally, we show the prevalence of significant surrogate oncogenes in multiple cancers from The Cancer Genome Atlas, suggesting that surrogate oncogenes may be a useful genomic feature for guiding pancancer analyses and assigning therapies across many tissue

  14. Barriers to community-based drug dependence treatment: implications for police roles, collaborations and performance indicators

    PubMed Central

    Ma, Yi; Du, Chunhua; Cai, Thomas; Han, Qingfeng; Yuan, Huanhuan; Luo, Tingyan; Ren, Guoliang; Mburu, Gitau; Wang, Bangyuan; Golichenko, Olga; Zhang, Chaoxiong

    2016-01-01

    Introduction Worldwide, people who use drugs (PWUD) are among the populations at highest risk for HIV infection. In China, PWUD are primarily sentenced to compulsory detainment centres, in which access to healthcare, including HIV treatment and prevention services, is limited or non-existent. In 2008, China's 2008 Anti-Drug Law encouraged the development and use of community-based drug dependence rehabilitation, yet there is limited evidence evaluating the efficacy and challenges of this model in China. In this study, we explore these challenges and describe how cooperation between law enforcement and health departments can meet the needs of PWUD. Methods In 2015, we conducted semi-structured, in-depth interviews with all four staff members and 16 clients of the Ping An Centre No. 1 for community-based drug treatment, three local police officers and three officials from the local Centre for Disease Control. Interviews explored obstacles in implementing community-based drug dependence treatment and efforts to resolve these difficulties. Transcripts were coded and analyzed with qualitative data analysis software (MAXQDA 11). Results We identified three challenges to community-based drug treatment at the Ping An Centre No. 1: (1) suboptimal coordination among parties involved, (2) a divergence in attitudes towards PWUD and harm reduction between law enforcement and health officials and (3) conflicting performance targets for police and health officials that undermine the shared goal of treatment. We also identified the take-home methadone maintenance treatment model at the Ping An Centre No. 1 as an example of an early successful collaboration between the police, the health department and PWUD. Conclusions To overcome barriers to effective community-based drug treatment, we recommend aligning the goals of law enforcement and public health agencies towards health-based performance indicators. Furthermore, tensions between PWUD and police need to be addressed and trust

  15. Les liaisons dangereuses: resource surveillance, uranium diplomacy and secret French-American collaboration in 1950s Morocco.

    PubMed

    Adamson, Matthew

    2016-03-01

    This study explores the origins and consequences of a unique, secret, French-American collaboration to prospect for uranium in 1950s Morocco. This collaboration permitted mediation between the United States and France. The appearance of France in an American-supported project for raw nuclear materials signalled American willingness to accept a new nuclear global order in which the French assumed a new, higher position as regional nuclear ally as opposed to suspicious rival. This collaboration also permitted France and the United States to agree tacitly to the same geopolitical status for the French Moroccan Protectorate, a status under dispute both in Morocco and outside it. The secret scientific effort reassured the French that, whatever the Americans might say publicly, they stood behind the maintenance of French hegemony in the centuries-old kingdom. But Moroccan independence proved impossible to deny. With its foreseeable arrival, the collaboration went from seductive to dangerous, and the priority of American and French geologists shifted from finding a major uranium lode to making sure that nothing was readily available to whatever post-independence interests might prove most powerful. Ultimately, the Kingdom of Morocco took a page out of the French book, using uranium exploration to assert sovereignty over a different disputed territory, its de facto colony of the Western Sahara. PMID:26563833

  16. DIALYSIS SURVEILLANCE NETWORK

    EPA Science Inventory

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

  17. Conjoined Twins: A Worldwide Collaborative Epidemiological Study of the International Clearinghouse for Birth Defects Surveillance and Research

    PubMed Central

    MUTCHINICK, OSVALDO M.; LUNA-MUÑOZ, LEONORA; AMAR, EMMANUELLE; BAKKER, MARIAN K.; CLEMENTI, MAURIZIO; COCCHI, GUIDO; DUTRA, MARIA DA GRAÇA; FELDKAMP, MARCIA L.; LANDAU, DANIELLE; LEONCINI, EMANUELE; LI, ZHU; LOWRY, BRIAN; MARENGO, LISA K.; MARTÍNEZ-FRÍAS, MARÍA-LUISA; MASTROIACOVO, PIERPAOLO; MÉTNEKI, JULIA; MORGAN, MARGERY; PIERINI, ANNA; RISSMAN, ANKE; RITVANEN, ANNUKKA; SCARANO, GIOACCHINO; SIFFEL, CSABA; SZABOVA, ELENA; ARTEAGA-VÁZQUEZ, JAZMÍN

    2015-01-01

    Conjoined twins (CT) are a very rare developmental accident of uncertain etiology. Prevalence has been previously estimated to be 1 in 50,000 to 1 in 100,000 births. The process by which monozygotic twins do not fully separate but form CT is not well understood. The purpose of the present study was to analyze diverse epidemiological aspects of CT, including the different variables listed in the Introduction Section of this issue of the Journal. The study was made possible using the International Clearinghouse for Birth Defects Surveillance and Research (ICBDSR) structure. This multicenter worldwide research includes the largest sample of CT ever studied. A total of 383 carefully reviewed sets of CT obtained from 26,138,837 births reported by 21 Clearinghouse Surveillance Programs (SP) were included in the analysis. Total prevalence was 1.47 per 100,000 births (95% CI: 1.32–1.62). Salient findings including an evident variation in prevalence among SPs: a marked variation in the type of pregnancy outcome, a similarity in the proportion of CT types among programs: a significant female predominance in CT: particularly of the thoracopagus type and a significant male predominance in parapagus and parasitic types: significant differences in prevalence by ethnicity and an apparent increasing prevalence trend in South American countries. No genetic, environmental or demographic significant associated factors were identified. Further work in epidemiology and molecular research is necessary to understand the etiology and pathogenesis involved in the development of this fascinating phenomenon of nature. PMID:22002822

  18. Drug-Induced Acute Myocardial Infarction: Identifying ‘Prime Suspects’ from Electronic Healthcare Records-Based Surveillance System

    PubMed Central

    Coloma, Preciosa M.; Schuemie, Martijn J.; Trifirò, Gianluca; Furlong, Laura; van Mulligen, Erik; Bauer-Mehren, Anna; Avillach, Paul; Kors, Jan; Sanz, Ferran; Mestres, Jordi; Oliveira, José Luis; Boyer, Scott; Helgee, Ernst Ahlberg; Molokhia, Mariam; Matthews, Justin; Prieto-Merino, David; Gini, Rosa; Herings, Ron; Mazzaglia, Giampiero; Picelli, Gino; Scotti, Lorenza; Pedersen, Lars; van der Lei, Johan; Sturkenboom, Miriam

    2013-01-01

    Background Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in ‘real-world’ settings. Objective To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network. Methods Post-marketing safety surveillance was conducted in seven population-based healthcare databases in three countries (Denmark, Italy, and the Netherlands) using anonymised demographic, clinical, and prescription/dispensing data representing 21,171,291 individuals with 154,474,063 person-years of follow-up in the period 1996–2010. Primary care physicians’ medical records and administrative claims containing reimbursements for filled prescriptions, laboratory tests, and hospitalisations were evaluated using a three-tier triage system of detection, filtering, and substantiation that generated a list of drugs potentially associated with AMI. Outcome of interest was statistically significant increased risk of AMI during drug exposure that has not been previously described in current literature and is biologically plausible. Results Overall, 163 drugs were identified to be associated with increased risk of AMI during preliminary screening. Of these, 124 drugs were eliminated after adjustment for possible bias and confounding. With subsequent application of criteria for novelty and biological plausibility, association with AMI remained for nine drugs (‘prime suspects’): azithromycin; erythromycin; roxithromycin; metoclopramide; cisapride; domperidone; betamethasone; fluconazole; and megestrol acetate. Limitations Although global health status, co-morbidities, and time-invariant factors were adjusted for, residual confounding cannot be ruled out. Conclusion A strategy to identify potentially drug-induced AMI from electronic healthcare data has

  19. Characterization of Adolescent Prescription Drug Abuse and Misuse Using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R]) System

    ERIC Educational Resources Information Center

    Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick

    2013-01-01

    Objective: To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R])) System. Method: Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all…

  20. Wastewater testing compared to random urinalyses for the surveillance of illicit drug use in prisons

    PubMed Central

    Brewer, Alex J.; Banta-Green, Caleb J.; Ort, Christoph; Robel, Alix E.

    2015-01-01

    Introduction and Aims Illicit drug use is known to occur among inmate populations of correctional (prison) facilities. Conventional approaches to monitor illicit drug use in prisons include random urinalyses (RUAs). Conventional approaches are expected to be prone to bias because prisoners may be aware of which days of the week RUAs are conducted. Therefore, we wanted to compare wastewater loads for methamphetamine and cocaine during days with RUA testing and without. Design and Methods We collected daily 24-hour composite samples of wastewater by continuous sampling, computed daily loads for one month and compared the frequency of illicit drug detection to the number of positive RUAs. Diurnal data also were collected for three days in order to determine within-day patterns of illicit drugs excretion. Results Methamphetamine was observed in each sample of prison wastewater with no significant difference in daily mass loads between RUA testing and non-testing days. Cocaine and its major metabolite, benzoylecgonine, were observed only at levels below quantification in prison wastewater. Six RUAs were positive for methamphetamine during the month while none were positive for cocaine out of the 243 RUAs conducted. Discussion and Conclusions Wastewater analyses offer data regarding the frequency of illicit drug excretion inside the prison that RUAs alone could not detect. PMID:25100044

  1. Increasing HIV-1 Drug Resistance Between 2010 and 2012 in Adults Participating in Population-Based HIV Surveillance in Rural KwaZulu-Natal, South Africa.

    PubMed

    Manasa, Justen; Danaviah, Siva; Lessells, Richard; Elshareef, Muna; Tanser, Frank; Wilkinson, Eduan; Pillay, Sureshnee; Mthiyane, Hloniphile; Mwambi, Henry; Pillay, Deenan; de Oliveira, Tulio

    2016-08-01

    As more human immunodeficiency virus (HIV)-infected patients access combination antiretroviral therapy (cART), higher proportions of newly infected patients may be infected with drug-resistant viruses. Regular surveillance of transmitted drug resistance (TDR) is required in southern Africa where high rates of transmission persist despite rapid expansion of ART. Dried blood spot samples from cART-naive participants from two rounds of an annual population-based HIV surveillance program in rural KwaZulu-Natal were tested for HIV RNA, and samples with HIV RNA >10,000 copies/ml were genotyped for drug resistance. The 2009 surveillance of drug resistance mutation (SDRM) list was used for drug resistance interpretation. The data were added to previously published data from the same program, and the χ(2) test for trend was used to test for trend in estimated prevalence of any TDR. Seven hundred and one participants' data were analyzed: 67 (2010), 381 (2011), and 253 (2012). No TDR was detected in 2010. Years 2011 and 2012 had 18 participants with SDRMs 4.7% and 7.1%, respectively (p = .02, χ(2) test for trend). The nonnucleoside reverse transcriptase inhibitor mutation, K103N, was the most common mutation, occurring in 27 (3.8%) of the participants, while nucleoside reverse transcriptase inhibitor (NRTI) SDRMs were detected in 10 (1.4%) of the participants, of whom eight had only a single NRTI SDRM. The increase in levels of drug resistance observed in this population could be a signal of increasing transmission of drug-resistant HIV. Thus, continued surveillance is critical to inform public health policies around HIV treatment and prevention. PMID:27002368

  2. Increasing HIV-1 Drug Resistance Between 2010 and 2012 in Adults Participating in Population-Based HIV Surveillance in Rural KwaZulu-Natal, South Africa

    PubMed Central

    Danaviah, Siva; Lessells, Richard; Elshareef, Muna; Tanser, Frank; Wilkinson, Eduan; Pillay, Sureshnee; Mthiyane, Hloniphile; Mwambi, Henry; Pillay, Deenan; de Oliveira, Tulio

    2016-01-01

    Abstract As more human immunodeficiency virus (HIV)–infected patients access combination antiretroviral therapy (cART), higher proportions of newly infected patients may be infected with drug-resistant viruses. Regular surveillance of transmitted drug resistance (TDR) is required in southern Africa where high rates of transmission persist despite rapid expansion of ART. Dried blood spot samples from cART-naive participants from two rounds of an annual population-based HIV surveillance program in rural KwaZulu-Natal were tested for HIV RNA, and samples with HIV RNA >10,000 copies/ml were genotyped for drug resistance. The 2009 surveillance of drug resistance mutation (SDRM) list was used for drug resistance interpretation. The data were added to previously published data from the same program, and the χ2 test for trend was used to test for trend in estimated prevalence of any TDR. Seven hundred and one participants' data were analyzed: 67 (2010), 381 (2011), and 253 (2012). No TDR was detected in 2010. Years 2011 and 2012 had 18 participants with SDRMs 4.7% and 7.1%, respectively (p = .02, χ2 test for trend). The nonnucleoside reverse transcriptase inhibitor mutation, K103N, was the most common mutation, occurring in 27 (3.8%) of the participants, while nucleoside reverse transcriptase inhibitor (NRTI) SDRMs were detected in 10 (1.4%) of the participants, of whom eight had only a single NRTI SDRM. The increase in levels of drug resistance observed in this population could be a signal of increasing transmission of drug-resistant HIV. Thus, continued surveillance is critical to inform public health policies around HIV treatment and prevention. PMID:27002368

  3. Tracking Ecstasy Trends in the United States with Data from Three National Drug Surveillance Systems

    ERIC Educational Resources Information Center

    Yacoubian, George S., Jr.

    2003-01-01

    Anecdotal reports have suggested that the use of 3,4-methylenedioxymeth-amphetamine (MDMA or "ecstasy") is a prodigious problem across the United States. Unfortunately, no longitudinal evidence exists to support this contention. In the current study, data from the Drug Abuse Warning Network (DAWN), Monitoring the Future (MTF), and National…

  4. Personalized ovarian cancer disease surveillance and detection of candidate therapeutic drug target in circulating tumor DNA.

    PubMed

    Martignetti, John A; Camacho-Vanegas, Olga; Priedigkeit, Nolan; Camacho, Catalina; Pereira, Elena; Lin, Li; Garnar-Wortzel, Leopold; Miller, Dagny; Losic, Bojan; Shah, Hardik; Liao, Jun; Ma, Jian; Lahiri, Pratik; Chee, Mark; Schadt, Eric; Dottino, Peter

    2014-01-01

    Retrospective studies have demonstrated that nearly 50% of patients with ovarian cancer with normal cancer antigen 125 (CA125) levels have persistent disease; however, prospectively distinguishing between patients is currently impossible. Here, we demonstrate that for one patient, with the first reported fibroblast growth factor receptor 2 (FGFR2) fusion transcript in ovarian cancer, circulating tumor DNA (ctDNA) is a more sensitive and specific biomarker than CA125, and it can also inform on a candidate therapeutic. For a 4-year period, during which the patient underwent primary debulking surgery and chemotherapy, tumor recurrences, and multiple chemotherapeutic regimens, blood samples were longitudinally collected and stored. Whereas postsurgical CA125 levels were elevated only three times for 28 measurements, the FGFR2 fusion ctDNA biomarker was readily detectable by quantitative real-time reverse transcription-polymerase chain reaction (PCR) in all of these same blood samples and in the tumor recurrences. Given the persistence of the FGFR2 fusion, we treated tumor cells derived from this patient and others with the FGFR2 inhibitor BGJ398. Only tumor cells derived from this patient were sensitive to FGFR2 inhibitor treatment. Using the same methodologic approach, we demonstrate in a second patient with a different fusion that PCR and agarose gel electrophoresis can also be used to identify tumor-specific DNA in the circulation. Taken together, we demonstrate that a relatively inexpensive, PCR-based ctDNA surveillance assay can outperform CA125 in identifying occult disease. PMID:24563622

  5. Surveillance of lymphatic filariasis 5 years after stopping mass drug administration in Menoufiya Governorate, Egypt.

    PubMed

    Moustafa, M A; Thabet, H S; Saad, G A; El-Setouhy, M; Mehrez, M; Hamdy, D M

    2014-05-01

    The World Health Organization recommends that before lymphatic filariasis elimination in an area can be confirmed, an additional survey should be performed at least 5 years after stopping mass drug administration. The current study aimed to determine the status of lymphatic filariasis 5 years after cessation ofthe mass drug administration in 3 sentinel Egyptian villages in Menoufiya Governorate. The rapid immunochromatographic card test (ICT) and a new commercial antibody detection kit (CELISA®) were used. All 1321 primary-school children aged 6-7 years old were ICT negative but 27 children were antibody positive. All households surveyed in one village with the highest antibody prevalence were ICT negative, indicating an absence of lymphatic filariasis. The CELISA antibody kit needs more standardization and development to be useful under field conditions. We conclude that lymphatic filariasis is no longer a public health problem in these villages and other villages with similar epidemiological conditions. PMID:24952286

  6. The broken "Off" switch in cancer signaling: PP2A as a regulator of tumorigenesis, drug resistance, and immune surveillance.

    PubMed

    Ruvolo, Peter P

    2016-12-01

    Aberrant activation of signal transduction pathways can transform a normal cell to a malignant one and can impart survival properties that render cancer cells resistant to therapy. A diverse set of cascades have been implicated in various cancers including those mediated by serine/threonine kinases such RAS, PI3K/AKT, and PKC. Signal transduction is a dynamic process involving both "On" and "Off" switches. Activating mutations of RAS or PI3K can be viewed as the switch being stuck in the "On" position resulting in continued signaling by a survival and/or proliferation pathway. On the other hand, inactivation of protein phosphatases such as the PP2A family can be seen as the defective "Off" switch that similarly can activate these pathways. A problem for therapeutic targeting of PP2A is that the enzyme is a hetero-trimer and thus drug targeting involves complex structures. More importantly, since PP2A isoforms generally act as tumor suppressors one would want to activate these enzymes rather than suppress them. The elucidation of the role of cellular inhibitors like SET and CIP2A in cancer suggests that targeting these proteins can have therapeutic efficacy by mechanisms involving PP2A activation. Furthermore, drugs such as FTY-720 can activate PP2A isoforms directly. This review will cover the current state of knowledge of PP2A role as a tumor suppressor in cancer cells and as a mediator of processes that can impact drug resistance and immune surveillance. PMID:27556014

  7. Molecular surveillance of antimalarial drug resistance related genes in Plasmodium falciparum isolates from Eritrea.

    PubMed

    Menegon, Michela; Nurahmed, Abduselam M; Talha, Albadawi A; Nour, Bakri Y M; Severini, Carlo

    2016-05-01

    The introduction of artemisinin-based combination therapy has led to extraordinary results in malaria control, however the recent emergence of partial resistance to artemisinin therapy in Southeast Asia jeopardizes these successes. This study aimed at investigating resistance to the antimalarial drugs by evaluating the polymorphisms in the PfK13, Pfcrt and Pfmdr1 genes in Plasmodium falciparum isolates obtained from patients in Eritrea. PMID:26875763

  8. Analyzing Information Seeking and Drug-Safety Alert Response by Health Care Professionals as New Methods for Surveillance

    PubMed Central

    Pernek, Igor; Stiglic, Gregor; Leskovec, Jure; Strasberg, Howard R; Shah, Nigam Haresh

    2015-01-01

    Background Patterns in general consumer online search logs have been used to monitor health conditions and to predict health-related activities, but the multiple contexts within which consumers perform online searches make significant associations difficult to interpret. Physician information-seeking behavior has typically been analyzed through survey-based approaches and literature reviews. Activity logs from health care professionals using online medical information resources are thus a valuable yet relatively untapped resource for large-scale medical surveillance. Objective To analyze health care professionals’ information-seeking behavior and assess the feasibility of measuring drug-safety alert response from the usage logs of an online medical information resource. Methods Using two years (2011-2012) of usage logs from UpToDate, we measured the volume of searches related to medical conditions with significant burden in the United States, as well as the seasonal distribution of those searches. We quantified the relationship between searches and resulting page views. Using a large collection of online mainstream media articles and Web log posts we also characterized the uptake of a Food and Drug Administration (FDA) alert via changes in UpToDate search activity compared with general online media activity related to the subject of the alert. Results Diseases and symptoms dominate UpToDate searches. Some searches result in page views of only short duration, while others consistently result in longer-than-average page views. The response to an FDA alert for Celexa, characterized by a change in UpToDate search activity, differed considerably from general online media activity. Changes in search activity appeared later and persisted longer in UpToDate logs. The volume of searches and page view durations related to Celexa before the alert also differed from those after the alert. Conclusions Understanding the information-seeking behavior associated with online

  9. HIV Drug Resistance Surveillance in Honduras after a Decade of Widespread Antiretroviral Therapy

    PubMed Central

    Tapia-Trejo, Daniela; Meza, Rita I.; Nuñez, Sandra M.; Parham, Leda; Flores, Norma A.; Valladares, Diana; Pineda, Luisa M.; Flores, Dixiana; Motiño, Roxana; Umanzor, Víctor; Carbajal, Candy; Murillo, Wendy; Lorenzana, Ivette; Palou, Elsa Y.; Reyes-Terán, Gustavo

    2015-01-01

    Introduction We assessed HIV drug resistance (DR) in individuals failing ART (acquired DR, ADR) and in ART-naïve individuals (pre-ART DR, PDR) in Honduras, after 10 years of widespread availability of ART. Methods 365 HIV-infected, ART-naïve, and 381 ART-experienced Honduran individuals were enrolled in 5 reference centres in Tegucigalpa, San Pedro Sula, La Ceiba, and Choluteca between April 2013 and April 2015. Plasma HIV protease-RT sequences were obtained. HIVDR was assessed using the WHO HIVDR mutation list and the Stanford algorithm. Recently infected (RI) individuals were identified using a multi-assay algorithm. Results PDR to any ARV drug was 11.5% (95% CI 8.4–15.2%). NNRTI PDR prevalence (8.2%) was higher than NRTI (2.2%) and PI (1.9%, p<0.0001). No significant trends in time were observed when comparing 2013 and 2014, when using a moving average approach along the study period or when comparing individuals with >500 vs. <350 CD4+ T cells/μL. PDR in recently infected individuals was 13.6%, showing no significant difference with PDR in individuals with longstanding infection (10.7%). The most prevalent PDR mutations were M46IL (1.4%), T215 revertants (0.5%), and K103NS (5.5%). The overall ADR prevalence in individuals with <48 months on ART was 87.8% and for the ≥48 months on ART group 81.3%. ADR to three drug families increased in individuals with longer time on ART (p = 0.0343). M184V and K103N were the most frequent ADR mutations. PDR mutation frequency correlated with ADR mutation frequency for PI and NNRTI (p<0.01), but not for NRTI. Clusters of viruses were observed suggesting transmission of HIVDR both from ART-experienced to ART-naïve individuals and between ART-naïve individuals. Conclusions The global PDR prevalence in Honduras remains at the intermediate level, after 10 years of widespread availability of ART. Evidence of ADR influencing the presence of PDR was observed by phylogenetic analyses and ADR/PDR mutation frequency correlations

  10. The importance of pharmacist surveillance in a unit dose drug distribution system.

    PubMed

    Jarosinski, P F

    1978-09-01

    A study was conducted at a Public Health Service Hospital to determine if the pharmacist could provide important services to patient care while simultaneously performing the repetitious acts involved in unit dose drug distribution. During two five-week periods, the pharmacist actively questioned requests by the nursing staff for additional doses of medication to determine why these additional doses were needed. Also, during these periods the pharmacy actively questioned all doses returned in the dose medication carts which, according to doctor's orders, should have been administered to the patient. Results of these studies included the detection of some potentially dangerous deviations from accepted medication administration times (i.e., "twice" a day order given only four hours apart) as well as other problems, such as missed orders, medication "borrowing" which sometimes magnified errors, and underdosing. The conclusions from the studies are that the pharmacist can provide essential services while simultaneously performing the repetitious tasks of filling, checking, and exchanging unit dose medication cassettes. PMID:10238815

  11. Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

    PubMed Central

    Süsskind, M.; Thürmann, P. A.; Lüke, C.; Jeschke, E.; Tabali, M.; Matthes, H.; Ostermann, T.

    2012-01-01

    Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3 n = 191, 90.5%, CTCAE grade 4/5 n = 20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2). Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms. PMID:22315630

  12. Cross-sector sponsorship of research in eosinophilic esophagitis: a collaborative model for rational drug development in rare diseases.

    PubMed

    Fiorentino, Robert; Liu, Gumei; Pariser, Anne R; Mulberg, Andrew E

    2012-09-01

    Like many rare diseases, eosinophilic esophagitis (EoE) is a poorly understood disorder, and assessment tools to accurately determine disease activity, remission, and natural history have long been inadequate. Clinical outcome end points able to assess the effectiveness of candidate therapeutic agents in clinical trials have been a particular deficiency and are urgently needed. With no approved therapy available to patients and with the prevalence of EoE on the increase, collaborative approaches to drug development are becoming ever more important. We describe a collaborative effort mobilized across institutions, including both the public and private sectors, that was initiated within the past 18 months expressly to address the need for further clinical research into the cause and treatment of EoE. Collaborators include the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition; the International Gastrointestinal Eosinophilic Researchers; and the US Food and Drug Administration. This effort has resulted in the elucidation of several parameters essential for effective EoE registration trials, including the need for clinically meaningful end points that measure changes in clinical symptoms in addition to the assessment of intraepithelial mucosal eosinophilia. The development and use of biomarkers, particularly in early-phase drug development, have become an important focus for investigations that might reduce clinical reliance on serial invasive monitoring. The concerted efforts described here to develop rational therapeutics and drug development paradigms in EoE also appear to provide a model for effective collaboration in the context of drug development for rare diseases and perhaps more generally for public health initiatives. PMID:22857796

  13. Changes in Incidence and Antifungal Drug Resistance in Candidemia: Results From Population-Based Laboratory Surveillance in Atlanta and Baltimore, 2008–2011

    PubMed Central

    Cleveland, Angela Ahlquist; Farley, Monica M.; Harrison, Lee H.; Stein, Betsy; Hollick, Rosemary; Lockhart, Shawn R.; Magill, Shelley S.; Derado, Gordana; Park, Benjamin J.; Chiller, Tom M.

    2015-01-01

    Background Candidemia is common and associated with high morbidity and mortality; changes in population-based incidence rates have not been reported. Methods We conducted active, population-based surveillance in metropolitan Atlanta, Georgia, and Baltimore City/County, Maryland (combined population 5.2 million), during 2008–2011. We calculated candidemia incidence and antifungal drug resistance compared with prior surveillance (Atlanta, 1992–1993; Baltimore, 1998–2000). Results We identified 2675 cases of candidemia with 2329 isolates during 3 years of surveillance. Mean annual crude incidence per 100 000 person-years was 13.3 in Atlanta and 26.2 in Baltimore. Rates were highest among adults aged ≥65 years (Atlanta, 59.1; Baltimore, 72.4) and infants (aged <1 year; Atlanta, 34.3; Baltimore, 46.2). In both locations compared with prior surveillance, adjusted incidence significantly declined for infants of both black and white race (Atlanta: black risk ratio [RR], 0.26 [95% confidence interval {CI}, .17–.38]; white RR: 0.19 [95% CI, .12–.29]; Baltimore: black RR, 0.38 [95% CI, .22–.64]; white RR: 0.51 [95% CI: .29–.90]). Prevalence of fluconazole resistance (7%) was unchanged compared with prior surveillance; 32 (1%) isolates were echinocandin-resistant, and 9 (8 Candida glabrata) were multidrug resistant to both fluconazole and an echinocandin. Conclusions We describe marked shifts in candidemia epidemiology over the past 2 decades. Adults aged ≥65 years replaced infants as the highest incidence group; adjusted incidence has declined significantly in infants. Use of antifungal prophylaxis, improvements in infection control, or changes in catheter insertion practices may be contributing to these declines. Further surveillance for antifungal resistance and efforts to determine effective prevention strategies are needed. PMID:22893576

  14. Effects of a Rural Family Drug Treatment Court Collaborative on Child Welfare Outcomes: Comparison Using Propensity Score Analysis.

    PubMed

    Pollock, McLean D; Green, Sherri L

    2015-01-01

    Previous studies that have examined the impact of family drug treatment courts (FDTCs) on child welfare outcomes have produced mixed results. This study evaluates the impact of a rural, FDTC collaborative on child welfare outcomes using propensity score analysis. Findings from the study show that children in the treatment group had longer stays in child welfare custody but were substantially less likely to experience future incidents of maltreatment than those in families with parental substance use disorders without these services. PMID:26827480

  15. Surveillance of Transmitted HIV Drug Resistance Using Matched Plasma and Dried Blood Spot Specimens From Voluntary Counseling and Testing Sites in Ho Chi Minh City, Vietnam, 2007–2008

    PubMed Central

    Hien, Bui Thu; Wagar, Nick; Tram, Tran Hong; Giang, Le Truong; Yang, Chunfu; Wolfe, Mitchell I.; Hien, Nguyen Tran; Tuan, Nguyen Anh

    2012-01-01

    During 2007–2008, surveillance of transmitted human immunodeficiency virus (HIV) drug resistance (TDR) was performed following World Health Organization guidance among clients with newly diagnosed HIV infection attending voluntary counseling and testing (VCT) sites in Ho Chi Minh City (HCMC), Vietnam. Moderate (5%–15%) TDR to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) was observed among VCT clients aged 18–21 years. Follow-up surveillance of TDR in HCMC and other geographic regions of Vietnam is warranted. Data generated will guide the national HIV drug resistance surveillance strategy and support selection of current and future first-line antiretroviral therapy and HIV prevention programs. PMID:22544201

  16. Transmitted HIV drug resistance at the Thai Red Cross Anonymous Clinic in Bangkok: results from three consecutive years of annual surveillance

    PubMed Central

    Sirivichayakul, Sunee; Kantor, Rami; DeLong, Allison K.; Wongkunya, Rapeeporn; Mekprasan, Suwanna; Ruxrungtham, Kiat; Sohn, Annette H.; Phanuphak, Praphan

    2015-01-01

    Objectives The aim of this study was to prospectively survey transmitted drug resistance (TDR) among recently infected individuals (mostly MSM). Methods TDR was determined in prospective annual cohorts of recently HIV-1-infected individuals consecutively recruited from 2008 to 2010. Resistance interpretation was carried out using Stanford Database tools and the WHO surveillance drug resistance mutation list. Kruskal–Wallis and Fisher's exact tests were used to compare demographic and laboratory outcomes. Results A total of 299 subjects were enrolled, with 89% MSM. Median viral load was significantly higher in 2010 than in 2008 (P = 0.004). Of the 284 analysable reverse transcriptase/protease sequences, TDR to any drug was found in 14/284 (4.9%); 4.0% in 2008, 5.9% in 2009 and 5.3% in 2010, with an increasing trend of TDR to NRTIs and NNRTIs from 2008 to 2010 (P = 0.07). Good correlation was found between our data and the WHO threshold surveillance method. Only rilpivirine had significantly higher (P < 0.05) predicted resistance in 2010 than in 2008 and 2009. Conclusions A trend towards an increase in TDR in Thailand where the major epidemic is among MSM was observed, but did not reach the WHO-defined high-level threshold (>15%). Attention to prevent the development and spread of drug resistance is needed. PMID:25525199

  17. Adverse drug events resulting from use of drugs with sulphonamide-containing anti-malarials and artemisinin-based ingredients: findings on incidence and household costs from three districts with routine demographic surveillance systems in rural Tanzania

    PubMed Central

    2013-01-01

    Background Anti-malarial regimens containing sulphonamide or artemisinin ingredients are widely used in malaria-endemic countries. However, evidence of the incidence of adverse drug reactions (ADR) to these drugs is limited, especially in Africa, and there is a complete absence of information on the economic burden such ADR place on patients. This study aimed to document ADR incidence and associated household costs in three high malaria transmission districts in rural Tanzania covered by demographic surveillance systems. Methods Active and passive surveillance methods were used to identify ADR from sulphadoxine-pyrimethamine (SP) and artemisinin (AS) use. ADR were identified by trained clinicians at health facilities (passive surveillance) and through cross-sectional household surveys (active surveillance). Potential cases were followed up at home, where a complete history and physical examination was undertaken, and household cost data collected. Patients were classified as having ‘possible’ or ‘probable’ ADR by a physician. Results A total of 95 suspected ADR were identified during a two-year period, of which 79 were traced, and 67 reported use of SP and/or AS prior to ADR onset. Thirty-four cases were classified as ‘probable’ and 33 as ‘possible’ ADRs. Most (53) cases were associated with SP monotherapy, 13 with the AS/SP combination (available in one of the two areas only), and one with AS monotherapy. Annual ADR incidence per 100,000 exposures was estimated based on ‘probable’ ADR only at 5.6 for AS/SP in combination, and 25.0 and 11.6 for SP monotherapy. Median ADR treatment costs per episode ranged from US$2.23 for those making a single provider visit to US$146.93 for patients with four visits. Seventy-three per cent of patients used out-of-pocket funds or sold part of their farm harvests to pay for treatment, and 19% borrowed money. Conclusion Both passive and active surveillance methods proved feasible methods for anti-malarial ADR

  18. Surveillance of HIV Transmitted Drug Resistance in Latin America and the Caribbean: A Systematic Review and Meta-Analysis

    PubMed Central

    Avila-Rios, Santiago; Sued, Omar; Rhee, Soo-Yon; Shafer, Robert W.; Reyes-Teran, Gustavo; Ravasi, Giovanni

    2016-01-01

    Background HIV transmitted drug resistance (TDR) remains at moderate level in Latin America and the Caribbean (LAC). However, different epidemiologic scenarios could influence national and sub-regional TDR levels and trends. Methods and Findings We performed a systematic review of currently available publications on TDR in antiretroviral treatment-naïve adults in LAC. Ninety-eight studies published between January 2000 and June 2015 were included according to critical appraisal criteria and classified by sub-region: Brazil (50), Mesoamerica (17), Southern Cone (16), Andean (8) and Caribbean (7). From these, 81 studies encompassing 11,441 individuals with data on DR mutation frequency were included in a meta-analysis. Overall TDR prevalence in LAC was 7.7% (95% CI: 7.2%-8.2%). An increasing trend was observed for overall TDR when comparing 2000–2005 (6.0%) and 2006–2015 (8.2%) (p<0.0001), which was associated with significant NNRTI TDR increase (p<0.0001). NRTI TDR decreased (4.5% vs. 2.3%, p<0.0001). NNRTI TDR increase was associated mainly with K101E, K103N and G190A. NRTI TDR decrease was associated mainly with M184V, K70R and T215Y. All sub-regions reached moderate overall TDR levels. The rapid increase in TDR to all antiretroviral classes in the Caribbean is notable, as well as the significant increase in NNRTI TDR reaching moderate levels in the Southern Cone. NRTI TDR was dominant in 2000–2005, mainly in the Caribbean, Mesoamerica and Brazil. This dominance was lost in 2006–2015 in all sub-regions, with the Southern Cone and the Caribbean switching to NNRTI dominance. PI TDR remained mostly constant with a significant increase only observed in the Caribbean. Conclusions Given the high conceptual and methodological heterogeneity of HIV TDR studies, implementation of surveys with standardized methodology and national representativeness is warranted to generate reliable to inform public health policies. The observed increasing trend in NNRTI TDR

  19. An Analysis of Sponsors/Collaborators of 69,160 Drug Trials Registered with ClinicalTrials.gov

    PubMed Central

    Keezhupalat, Shruthi Muralidharan; Naik, Ankeet; Gupta, Saurabh; Srivatsan, Raghunathan; Saberwal, Gayatri

    2016-01-01

    Background Clinical trials have been criticized on various counts. Any attempt to improve how trials are conducted or reported requires—amongst other things—an understanding of the number, the nature and the location of those that sponsor them or collaborate on them. Here we sought to identify the nature and location of each sponsor/collaborator. Methods and Findings We examined the 'sponsor/collaborator' field for the 69,160 drug trials that were registered with ClinicalTrials.gov over a 9-year period (2005–2014). Of the 12,823 unique sponsors, 56% had sponsored only one and 27% had sponsored 2–5 trials each. Just 18% were involved with six or more trials each, and we have (arbitrarily) labeled these organizations as 'more experienced' in sponsoring/collaborating on trials. These 18% (2,266 sponsors/collaborators) were analyzed further: (a) 951 were corporate organizations and (b) 1,145 were non-corporates (including 31 individuals) with (c) 170 unclassified. Further, we identified the location of each organization in (a) and (b). Conclusions Clinical trials are an important part of a nation's research endeavors, and ultimately contribute to the health of its people. Thus, understanding the clinical trial landscape—including the number and nature of sponsors, and how active they are—is important for every country. We believe that policy makers in particular should be interested in this study to understand the current situation, and to use the numbers as a baseline for the evolving landscape, to assess the impact of their strategies in future. PMID:26886868

  20. Microbial receptor assay for rapid detection and identification of seven families of antimicrobial drugs in milk: collaborative study.

    PubMed

    Charm, S E; Chi, R

    1988-01-01

    A microbial competitive receptor assay for detecting residues of antibiotic families in milk was studied collaboratively by 13 laboratories. The drugs and levels (ppb) tested in this study include penicillin G, 4.8; cephapirin, 5.0; cloxacillin, 100; tetracycline, 2000; chlortetracycline, 2000; oxytetracycline, 2000; erythromycin, 200; lincomycin, 400; clindamycin, 400; sulfamethazine, 75; sulfamethoxazole, 50; sulfisoxazole, 50; streptomycin, 1000; novobiocin, 50; and chloramphenicol, 800. In this method, microbial cells added to a milk sample provide specific binding sites for which 14C or 3H labeled drug competes with drug residues in the sample. The 14C or 3H binding to the specific binding sites is measured in a scintillation counter and compared with a zero standard milk. If the sample is statistically different from the zero standard, it is positive. The assay takes about 15 min. The binding reaction occurs between the receptor site and the drug functional group, so all members of a drug family are detected. In this case, beta-lactams, tetracyclines, macrolides, aminoglycosides, novobiocin, chloramphenicol, and sulfonamides, including p-aminobenzoic acid (PABA) and its other analogs, are detectable. The incidence of false negative determinations among samples is about 1%; the incidence of false positives is about 3%. For negative cases, the relative standard deviations for repeatability ranged from 0 to 5% and for reproducibility from 0 to 6%. For positive cases, relative standard deviations ranged from 0 to 13% for repeatability and from 0 to 14% for reproducibility. The method has been adopted official first action. PMID:3260233

  1. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  2. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  3. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  4. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  5. Antiarrhythmic drugs and polyneuropathy. The Collaborative Group for the Study of Polyneuropathy.

    PubMed Central

    1994-01-01

    A total of 151 patients on chronic treatment with amiodarone and other antiarrhythmic drugs were subjected to standard clinical and electrophysiological investigation to assess the prevalence and specificity of polyneuropathy. Twenty two untreated patients with cardiac disorders and 246 normal subjects served as controls. Abnormal electrophysiological findings supporting the diagnosis of polyneuropathy were present in 38 subjects (25%) given antiarrhythmic drugs, with even distribution among drugs, and four untreated patients (18%). Concurrent clinical abnormalities were present in five treated patients (one each with amiodarone, propafenone, and flecainide, and two with multiple drugs). Therefore, electrophysiological abnormalities are a common, although non-specific, feature in patients taking antiarrhythmic drugs. Amiodarone users do not seem at higher risk of polyneuropathy than subjects treated with other drugs or even untreated patients with cardiac disorders. PMID:8158183

  6. Mapping HIV/STI behavioural surveillance in Europe

    PubMed Central

    2010-01-01

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

  7. Collaboration of School Social Workers and Drug Prevention Staff in the Schools

    ERIC Educational Resources Information Center

    Nemes, Helen

    2009-01-01

    This study examined the factors that are related to collaboration between high school social workers and substance abuse prevention/intervention counselors in New York State high schools (except for New York City high schools). Constructs that were analyzed were high school social workers' perceived adequacy in working with high school students'…

  8. A Collaborative Assessment Among 11 Pharmaceutical Companies of Misinformation in Commonly Used Online Drug Information Compendia

    PubMed Central

    Randhawa, Amarita S.; Babalola, Olakiitan; Henney, Zachary; Miller, Michele; Nelson, Tanya; Oza, Meerat; Patel, Chandni; Randhawa, Anupma S.; Riley, Joyce; Snyder, Scott; So, Sherri

    2016-01-01

    Background: Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. Objective: Evaluate drug summaries within ODIC for accuracy and completeness and identify product-specific misinformation. Methods: Between August 2014 and January 2015, medical information (MI) specialists from 11 pharmaceutical/biotechnology companies systematically evaluated 270 drug summaries within 5 commonly used ODIC for misinformation. Using a standardized approach, errors were identified; classified as inaccurate, incomplete, or omitted; and categorized per sections of the Full Prescribing Information (FPI). On review of each drug summary, content-correction requests were proposed and supported by the respective product’s FPI. Results: Across the 270 drug summaries reviewed within the 5 compendia, the median of the total number of errors identified was 782, with the greatest number of errors occurring in the categories of Dosage and Administration, Patient Education, and Warnings and Precautions. The majority of errors were classified as incomplete, followed by inaccurate and omitted. Conclusion: This analysis demonstrates that ODIC may contain misinformation. HCPs and consumers should be aware of the potential for misinformation and consider more than 1 drug information resource, including the FPI and Medication Guide as well as pharmaceutical/biotechnology companies’ MI departments, to obtain unbiased, accurate, and complete product-specific drug information to help support the safe and effective use of prescription drug products. PMID:26917822

  9. Evaluating Alcoholism and Drug Abuse Knowledge in Medical Education: A Collaborative Project.

    ERIC Educational Resources Information Center

    Griffin, John B., Jr.

    1983-01-01

    Medical students performed less well on examinations about drug abuse problems and patient management than on traditional medical board examinations. The best knowledge was of pharmacology of drug abuse, Alcoholics Anonymous, and treatment of delirium tremens. Students knew less about metabolic and biochemical areas, emergency-room treatment, and…

  10. Epidemiological Surveillance of HIV-1 Transmitted Drug Resistance in Spain in 2004-2012: Relevance of Transmission Clusters in the Propagation of Resistance Mutations

    PubMed Central

    Vega, Yolanda; Delgado, Elena; Fernández-García, Aurora; Cuevas, Maria Teresa; Thomson, Michael M.; Montero, Vanessa; Sánchez, Monica; Sánchez, Ana Maria; Pérez-Álvarez, Lucia

    2015-01-01

    Our objectives were to carry out an epidemiological surveillance study on transmitted drug resistance (TDR) among individuals newly diagnosed of HIV-1 infection during a nine year period in Spain and to assess the role of transmission clusters (TC) in the propagation of resistant strains. An overall of 1614 newly diagnosed individuals were included in the study from January 2004 through December 2012. Individuals come from two different Spanish regions: Galicia and the Basque Country. Resistance mutations to reverse transcriptase inhibitors (RTI) and protease inhibitors (PI) were analyzed according to mutations included in the surveillance drug-resistance mutations list updated in 2009. TC were defined as those comprising viruses from five or more individuals whose sequences clustered in maximum likelihood phylogenetic trees with a bootstrap value ≥90%. The overall prevalence of TDR to any drug was 9.9%: 4.9% to nucleoside RTIs (NRTIs), 3.6% to non-nucleoside RTIs (NNRTIs), and 2.7% to PIs. A significant decrease of TDR to NRTIs over time was observed [from 10% in 2004 to 2% in 2012 (p=0.01)]. Sixty eight (42.2%) of 161 sequences with TDR were included in 25 TC composed of 5 or more individuals. Of them, 9 clusters harbored TDR associated with high level resistance to antiretroviral drugs. T215D revertant mutation was transmitted in a large cluster comprising 25 individuals. The impact of epidemiological networks on TDR frequency may explain its persistence in newly diagnosed individuals. The knowledge of the populations involved in TC would facilitate the design of prevention programs and public health interventions. PMID:26010948

  11. In Vitro and Molecular Surveillance for Antimalarial Drug Resistance in Plasmodium falciparum Parasites in Western Kenya Reveals Sustained Artemisinin Sensitivity and Increased Chloroquine Sensitivity

    PubMed Central

    Komino, Franklin; Okoth, Sheila Akinyi; Goldman, Ira; Onyona, Philip; Wiegand, Ryan E.; Juma, Elizabeth; Shi, Ya Ping; Barnwell, John W.; Udhayakumar, Venkatachalam; Kariuki, Simon

    2015-01-01

    Malaria control is hindered by the evolution and spread of resistance to antimalarials, necessitating multiple changes to drug policies over time. A comprehensive antimalarial drug resistance surveillance program is vital for detecting the potential emergence of resistance to antimalarials, including current artemisinin-based combination therapies. An antimalarial drug resistance surveillance study involving 203 Plasmodium falciparum malaria-positive children was conducted in western Kenya between 2010 and 2013. Specimens from enrolled children were analyzed in vitro for sensitivity to chloroquine (CQ), amodiaquine (AQ), mefloquine (MQ), lumefantrine, and artemisinin derivatives (artesunate and dihydroartemisinin) and for drug resistance allele polymorphisms in P. falciparum crt (Pfcrt), Pfmdr-1, and the K13 propeller domain (K13). We observed a significant increase in the proportion of samples with the Pfcrt wild-type (CVMNK) genotype, from 61.2% in 2010 to 93.0% in 2013 (P < 0.0001), and higher proportions of parasites with elevated sensitivity to CQ in vitro. The majority of isolates harbored the wild-type N allele in Pfmdr-1 codon 86 (93.5%), with only 7 (3.50%) samples with the N86Y mutant allele (the mutant nucleotide is underlined). Likewise, most isolates harbored the wild-type Pfmdr-1 D1246 allele (79.8%), with only 12 (6.38%) specimens with the D1246Y mutant allele and 26 (13.8%) with mixed alleles. All the samples had a single copy of the Pfmdr-1 gene (mean of 0.907 ± 0.141 copies). None of the sequenced parasites had mutations in K13. Our results suggest that artemisinin is likely to remain highly efficacious and that CQ sensitivity appears to be on the rise in western Kenya. PMID:26392510

  12. In Vitro and Molecular Surveillance for Antimalarial Drug Resistance in Plasmodium falciparum Parasites in Western Kenya Reveals Sustained Artemisinin Sensitivity and Increased Chloroquine Sensitivity.

    PubMed

    Lucchi, Naomi W; Komino, Franklin; Okoth, Sheila Akinyi; Goldman, Ira; Onyona, Philip; Wiegand, Ryan E; Juma, Elizabeth; Shi, Ya Ping; Barnwell, John W; Udhayakumar, Venkatachalam; Kariuki, Simon

    2015-12-01

    Malaria control is hindered by the evolution and spread of resistance to antimalarials, necessitating multiple changes to drug policies over time. A comprehensive antimalarial drug resistance surveillance program is vital for detecting the potential emergence of resistance to antimalarials, including current artemisinin-based combination therapies. An antimalarial drug resistance surveillance study involving 203 Plasmodium falciparum malaria-positive children was conducted in western Kenya between 2010 and 2013. Specimens from enrolled children were analyzed in vitro for sensitivity to chloroquine (CQ), amodiaquine (AQ), mefloquine (MQ), lumefantrine, and artemisinin derivatives (artesunate and dihydroartemisinin) and for drug resistance allele polymorphisms in P. falciparum crt (Pfcrt), Pfmdr-1, and the K13 propeller domain (K13). We observed a significant increase in the proportion of samples with the Pfcrt wild-type (CVMNK) genotype, from 61.2% in 2010 to 93.0% in 2013 (P < 0.0001), and higher proportions of parasites with elevated sensitivity to CQ in vitro. The majority of isolates harbored the wild-type N allele in Pfmdr-1 codon 86 (93.5%), with only 7 (3.50%) samples with the N86Y mutant allele (the mutant nucleotide is underlined). Likewise, most isolates harbored the wild-type Pfmdr-1 D1246 allele (79.8%), with only 12 (6.38%) specimens with the D1246Y mutant allele and 26 (13.8%) with mixed alleles. All the samples had a single copy of the Pfmdr-1 gene (mean of 0.907 ± 0.141 copies). None of the sequenced parasites had mutations in K13. Our results suggest that artemisinin is likely to remain highly efficacious and that CQ sensitivity appears to be on the rise in western Kenya. PMID:26392510

  13. Interprofessional collaborative practice incorporating training for alcohol and drug use screening for healthcare providers in rural areas.

    PubMed

    Puskar, Kathy; Mitchell, Ann M; Albrecht, Susan A; Frank, Linda R; Kane, Irene; Hagle, Holly; Lindsay, Dawn; Lee, Heeyoung; Fioravanti, Marie; Talcott, Kimberly S

    2016-07-01

    Interprofessional collaborative practice expands resources in rural and underserved communities. This article explores the impact of an online education programme on the perceptions of healthcare providers about interprofessional care within alcohol and drug use screening for rural residents. Nurses, behavioural health counsellors, and public health professionals participated in an evidence-based practice (screening, brief intervention, and referral to treatment-SBIRT) model that targets individuals who use alcohol and other drugs in a risky manner. SBIRT is recommended by the United States Preventive Services Task Force as a universal, evidence-based screening tool. Online modules, case simulation practice, and interprofessional dialogues are used to deliver practice-based learning experiences. A quasi-experimental method with pre-tests and post-tests was utilised. Results indicate increased perceptions of professional competence, need for cooperation, actual cooperation, and role values pre-to-post training. Implications suggest that online interprofessional education is useful but the added component of professional dialogues regarding patient cases offers promise in promoting collaborative practice. PMID:27295396

  14. Postmarket surveillance. Final rule.

    PubMed

    2002-06-01

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

  15. SURVEILLANCE REPORTS

    EPA Science Inventory

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

  16. Collaboration with Pharma Will Introduce Nanotechnologies in Early Stage Drug Development | Poster

    Cancer.gov

    The Frederick National Lab has begun to assist several major pharmaceutical companies in adopting nanotechnologies in early stage drug development, when the approach is most efficient and cost-effective.

  17. Southern African Treatment Resistance Network (SATuRN) RegaDB HIV drug resistance and clinical management database: supporting patient management, surveillance and research in southern Africa.

    PubMed

    Manasa, Justen; Lessells, Richard; Rossouw, Theresa; Naidu, Kevindra; Van Vuuren, Cloete; Goedhals, Dominique; van Zyl, Gert; Bester, Armand; Skingsley, Andrew; Stott, Katharine; Danaviah, Siva; Chetty, Terusha; Singh, Lavanya; Moodley, Pravi; Iwuji, Collins; McGrath, Nuala; Seebregts, Christopher J; de Oliveira, Tulio

    2014-01-01

    Substantial amounts of data have been generated from patient management and academic exercises designed to better understand the human immunodeficiency virus (HIV) epidemic and design interventions to control it. A number of specialized databases have been designed to manage huge data sets from HIV cohort, vaccine, host genomic and drug resistance studies. Besides databases from cohort studies, most of the online databases contain limited curated data and are thus sequence repositories. HIV drug resistance has been shown to have a great potential to derail the progress made thus far through antiretroviral therapy. Thus, a lot of resources have been invested in generating drug resistance data for patient management and surveillance purposes. Unfortunately, most of the data currently available relate to subtype B even though >60% of the epidemic is caused by HIV-1 subtype C. A consortium of clinicians, scientists, public health experts and policy markers working in southern Africa came together and formed a network, the Southern African Treatment and Resistance Network (SATuRN), with the aim of increasing curated HIV-1 subtype C and tuberculosis drug resistance data. This article describes the HIV-1 data curation process using the SATuRN Rega database. The data curation is a manual and time-consuming process done by clinical, laboratory and data curation specialists. Access to the highly curated data sets is through applications that are reviewed by the SATuRN executive committee. Examples of research outputs from the analysis of the curated data include trends in the level of transmitted drug resistance in South Africa, analysis of the levels of acquired resistance among patients failing therapy and factors associated with the absence of genotypic evidence of drug resistance among patients failing therapy. All these studies have been important for informing first- and second-line therapy. This database is a free password-protected open source database available on

  18. Expansion of chemical space for collaborative lead generation and drug discovery: the European Lead Factory Perspective.

    PubMed

    Karawajczyk, Anna; Giordanetto, Fabrizio; Benningshof, Jorg; Hamza, Daniel; Kalliokoski, Tuomo; Pouwer, Kees; Morgentin, Remy; Nelson, Adam; Müller, Gerhard; Piechot, Alexander; Tzalis, Dimitrios

    2015-11-01

    High-throughput screening (HTS) represents a major cornerstone of drug discovery. The availability of an innovative, relevant and high-quality compound collection to be screened often dictates the final fate of a drug discovery campaign. Given that the chemical space to be sampled in research programs is practically infinite and sparsely populated, significant efforts and resources need to be invested in the generation and maintenance of a competitive compound collection. The European Lead Factory (ELF) project is addressing this challenge by leveraging the diverse experience and know-how of academic groups and small and medium enterprises (SMEs) engaged in synthetic and/or medicinal chemistry. Here, we describe the novelty, diversity, structural complexity, physicochemical characteristics and overall attractiveness of this first batch of ELF compounds for HTS purposes. PMID:26429298

  19. Animal NARMS Surveillance Data

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

  20. Chemical & RNAi screening at MSKCC: a collaborative platform to discover & repurpose drugs to fight disease

    PubMed Central

    Bhinder, Bhavneet; Antczak, Christophe; Shum, David; Radu, Constantin; Mahida, Jeni P.; Liu-Sullivan, Nancy; Ibáñez, Glorymar; Raja, Balajee Somalinga; Calder, Paul A.; Djaballah, Hakim

    2014-01-01

    Memorial Sloan-Kettering Cancer Center (MSKCC) has implemented the creation of a full service state-of-the-art High-throughput Screening Core Facility (HTSCF) equipped with modern robotics and custom-built screening data management resources to rapidly store and query chemical and RNAi screening data outputs. The mission of the facility is to provide oncology clinicians and researchers alike with access to cost-effective HTS solutions for both chemical and RNAi screening, with an ultimate goal of novel target identification and drug discovery. HTSCF was established in 2003 to support the institution’s commitment to growth in molecular pharmacology and in the realm of therapeutic agents to fight chronic diseases such as cancer. This endeavor required broad range of expertise in technology development to establish robust and innovative assays, large collections of diverse chemical and RNAi duplexes to probe specific cellular events, sophisticated compound and data handling capabilities, and a profound knowledge in assay development, hit validation, and characterization. Our goal has been to strive for constant innovation, and we strongly believe in shifting the paradigm from traditional drug discovery towards translational research now, making allowance for unmet clinical needs in patients. Our efforts towards repurposing FDA-approved drugs fructified when digoxin, identified through primary HTS, was administered in the clinic for treatment of stage Vb retinoblastoma. In summary, the overall aim of our facility is to identify novel chemical probes, to study cellular processes relevant to investigator’s research interest in chemical biology and functional genomics, and to be instrumental in accelerating the process of drug discovery in academia. PMID:24661215

  1. Quali-quantitative analysis of best selling drugs from pharmacy, street market and traditional herbal medicine: a pilot study of market surveillance in Senegal.

    PubMed

    Pichini, Simona; Rotolo, Maria Concetta; Bellotti, Pasquale; Minutillo, Adele; Mastrobattista, Luisa; Pacifici, Roberta

    2015-02-01

    A pilot study of market surveillance in Senegal has been performed analyzing best selling drugs from an official pharmacy and a street market in two principal cities of Senegal and some traditional preparations from herbal medicine from the same market. A simple and rapid gas chromatography method with mass spectrometry detection has been applied after a liquid-liquid extraction of pharmaceutical products and traditional preparations at acidic, neutral and basic pH with chloroform-isopropanol (9:1, v/v). The assay was validated in the range from 10mg to 250 mg/g powder preparations with good determination coefficients (r(2)≥ 0.99) for the calibration curves. At three concentrations spanning the linear dynamic ranges of the calibration curves, mean recoveries of substances under investigation were always higher than 90% and intra-assay and inter-assay precision and accuracy were always better than 15%. The four best selling drugs purchased from a Dakar local pharmacy exactly contained the amount of active principles reported in the respective labels while the best selling drugs freely purchased from Kaolack market contained an amount of active ingredients lower than that declared on the label. No pharmacological active compound, but salicylic acid was found in one of the traditional herbal preparations. This pilot study showed that whereas official drugs sold in pharmacies at prices accessible for a very few portion of the population contained the amount of active principles as reported in the labels, those from street market bought by the majority of population contained an amount of active ingredients lower than that declared on the label and finally traditional herbal preparations seldom contain pharmacological active principles. PMID:25481086

  2. HIV-1 Genetic Diversity and Transmitted Drug Resistance Among Recently Infected Individuals at Men Who Have Sex with Men Sentinel Surveillance Points in Hebei Province, China.

    PubMed

    Lu, Xinli; Kang, Xianjiang; Chen, Suliang; Zhao, Hongru; Liu, Yongjian; Zhao, Cuiying; Zhang, Yuqi; Li, Jingyun; Cui, Ze; Wang, Xianfeng

    2015-10-01

    For this study, 50 HIV-1 plasma samples of recently infected men who have sex with men (MSM) were amplified and sequenced. Multiple subtypes were identified by phylogenetic analyses of HIV-1 gag, env, and pol gene regions, including CRF01_AE (56.0%), CRF07_BC (30.0%), subtype B (12.0%), and unique recombinant forms (URFs, 6.0%). CRF01_AE was the most frequent genotype in the epidemic. Three recombination patterns of URFs were identified: 01BC, 01B, and 01C. The rate of HIV-1 transmitted drug resistance (TDR) mutation (M46L) was 2.08% (1/48). URFs and TDR first identified in this study suggest that HIV-1 prevalence is more and more complicated, and HIV-1 drug-resistant strains have begun to spread among at risk populations in Hebei. Our findings can provide vital information for an efficient surveillance system and strategic HIV prevention and control measures in China by revealing the evolutionary status and HIV-1 TDR of HIV-1 strains among recently infected MSM in Hebei Province. PMID:26200883

  3. Surveillance of in vivo resistance of Plasmodium falciparum to antimalarial drugs from 1992 to 1999 in Malabo (Equatorial Guinea).

    PubMed

    Roche, Jesús; Guerra-Neira, Ana; Raso, José; Benito, Agustîn

    2003-05-01

    From 1992-1999, we have assessed the therapeutic efficacy of three malaria treatment regimens (chloroquine 25 mg/kg over three days, pyrimethamine/sulfadoxine 1.25/25 mg/kg in one dose, and quinine 25-30 mg/kg daily in three oral doses over a four-, five-, or seven-day period) in 1,189 children under age 10 at Malabo Regional Hospital in Equatorial Guinea. Of those children, 958 were followed up clinically and parasitologically for 14 days. With chloroquine, the failure rate varied from 55% in 1996 to 40% in 1999; the early treatment failure rate increased progressively over the years, from 6% in 1992 to 30% in 1999. With pyrimethamine/sulfadoxine, the failure rate varied from 0% in 1996 to 16% in 1995. The short quinine treatment regimens used in 1992 and 1993 (4 and 5 days, respectively) resulted in significantly higher failure rates (19% and 22%, respectively) than the 7d regimen (3-5.5%). We conclude that: a) failure rates for chloroquine are in the change period (> 25%), and urgent action is needed; b) pyrimethamine/ sulfadoxine failure rates are in the alert period (6-15%), and surveillance must be continued; and c) quinine failure rates are in the grace period (< 6%), so quinine can be recommended. PMID:12812353

  4. HIV Drug Resistance Surveillance Among Jamaican Men Who Have Sex with Men Should Be Prioritized for Reducing HIV Transmission.

    PubMed

    Collins-Fairclough, Aneisha M; Dennis, Ann M; Nelson, Julie A E; Weir, Sharon S; Figueroa, J Peter

    2015-08-01

    The prevalence of human immunodeficiency virus type 1 (HIV-1) is highest among men who have sex with men (MSM) in Jamaica but no genotypic data are available on the virus strains that are responsible for the epidemic among this key population. HIV-1 polymerase (pol) genes from 65 MSM were sequenced and used to predict drug resistance mutations. An HIV drug resistance prevalence of 28% (minimum 13%) was observed among this cohort, with the most frequent mutations conferring resistance to efavirenz, nevirapine, and lamivudine. Phylogenetic analysis of the sequences revealed 10 times the number of linked HIV infections among this cohort than respondent reporting. HIV treatment and prevention efforts in Jamaica could benefit significantly from Pol genotyping of the HIV strains infecting socially vulnerable MSM prior to initiating antiretroviral therapy (ART), as this would guide suppressive ART and unearth HIV transmission clusters to enable more effective delivery of treatment and prevention programs. PMID:26133540

  5. HIV Drug Resistance Surveillance Among Jamaican Men Who Have Sex with Men Should Be Prioritized for Reducing HIV Transmission

    PubMed Central

    Dennis, Ann M.; Nelson, Julie A.E.; Weir, Sharon S.; Figueroa, J. Peter

    2015-01-01

    Abstract The prevalence of human immunodeficiency virus type 1 (HIV-1) is highest among men who have sex with men (MSM) in Jamaica but no genotypic data are available on the virus strains that are responsible for the epidemic among this key population. HIV-1 polymerase (pol) genes from 65 MSM were sequenced and used to predict drug resistance mutations. An HIV drug resistance prevalence of 28% (minimum 13%) was observed among this cohort, with the most frequent mutations conferring resistance to efavirenz, nevirapine, and lamivudine. Phylogenetic analysis of the sequences revealed 10 times the number of linked HIV infections among this cohort than respondent reporting. HIV treatment and prevention efforts in Jamaica could benefit significantly from Pol genotyping of the HIV strains infecting socially vulnerable MSM prior to initiating antiretroviral therapy (ART), as this would guide suppressive ART and unearth HIV transmission clusters to enable more effective delivery of treatment and prevention programs. PMID:26133540

  6. Geographical Information Systems for Dengue Surveillance

    PubMed Central

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

    2012-01-01

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

  7. 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...

  8. Assessment of Assistance in Smoking Cessation Therapy by Pharmacies in Collaboration with Medical Institutions- Implementation of a Collaborative Drug Therapy Management Protocol Based on a Written Agreement between Physicians and Pharmacists.

    PubMed

    Watanabe, Fumiyuki; Shinohara, Kuniko; Dobashi, Akira; Amagai, Kenji; Hara, Kazuo; Kurata, Kaori; Iizima, Hideo; Shimakawa, Kiyoshi; Shimada, Masahiko; Abe, Sakurako; Takei, Keiji; Kamei, Miwako

    2016-01-01

    This study built a protocol for drug therapy management (hereinafter "the protocol") that would enable continuous support from the decision making of smoking cessation therapy to the completion of therapy through the collaboration of physicians and community pharmacists, after which we evaluated whether the use of this protocol would be helpful to smoking cessation therapy. This study utilized the "On the Promotion of Team-Based Medical Care", a Notification by the Health Policy Bureau as one of the resources for judgment, and referred to collaborative drug therapy management (CDTM) in the United States. After the implementation of this protocol, the success rate of smoking cessation at the participating medical institutions rose to approximately 70%, approximately 28-point improvement compared to the rate before the implementation. In addition to the benefits of the standard smoking cessation program, this result may have been affected by the intervention of pharmacists, who assisted in continuing cessation by advising to reduce drug dosage as necessary approximately one week after the smoking cessation, when side effects and the urge to smoke tend to occur. Additionally, the awareness survey for the intervention group revealed that all respondents, including patients who failed to quit smoking, answered that they were satisfied to the question on general satisfaction. The question about the reason for successful cessation revealed that the support by pharmacists was as important as, or more important than, that by physicians and nurses. This infers that the pharmacists' active engagement in drug therapy for individual patients was favorably acknowledged. PMID:27592827

  9. Evaluation of data quality in a laboratory-based surveillance of M. tuberculosis drug resistance and impact on the prevalence of resistance: France, 2004

    PubMed Central

    KHUÊ, P. M.; MALLET, A.; VEZIRIS, N.; JARLIER, V.; ROBERT, J.

    2008-01-01

    SUMMARY In France, surveillance of anti-tuberculosis drug resistance is performed by the Azay-Mycobacteria network, representing 30% of all culture-positive cases. We sought to validate administrative and clinical data gathered by the network in 2004 and to produce corrected resistance rates accounting for the observed misclassification. We reviewed a 10% sample of patients' records diagnosed in 2004 and measured the agreement between controlled data and data collected by the network by using the kappa (κ) statistic. A re-sampling bootstrap-based method was used to investigate the impact of bias found on resistance rates. Most of data collected by the network, such as demographic data, and country of birth had an excellent agreement (κ>0·8) with controlled data. The concordance was good (κ>0·6) for HIV status and tuberculosis site. The only variable slightly discordant with controlled data was prior history of treatment (κ=0·52). However, after correcting crude resistance rates for the observed misclassification, all estimated rates were within confidence intervals based on reported rates. This validation study is in favour of a good quality of data produced by the network, even though corrected rates are slightly different from observed rates. Therefore, data collected through the network may be used for policy making and tuberculosis programme evaluation. However, improvement in data collection regarding prior history of treatment should be considered. PMID:18028573

  10. Evaluation of data quality in a laboratory-based surveillance of M. tuberculosis drug resistance and impact on the prevalence of resistance: France, 2004.

    PubMed

    Khuê, P M; Mallet, A; Veziris, N; Jarlier, V; Robert, J

    2008-09-01

    In France, surveillance of anti-tuberculosis drug resistance is performed by the Azay-Mycobacteria network, representing 30% of all culture-positive cases. We sought to validate administrative and clinical data gathered by the network in 2004 and to produce corrected resistance rates accounting for the observed misclassification. We reviewed a 10% sample of patients' records diagnosed in 2004 and measured the agreement between controlled data and data collected by the network by using the kappa (kappa) statistic. A re-sampling bootstrap-based method was used to investigate the impact of bias found on resistance rates. Most of data collected by the network, such as demographic data, and country of birth had an excellent agreement (kappa>0.8) with controlled data. The concordance was good (kappa>0.6) for HIV status and tuberculosis site. The only variable slightly discordant with controlled data was prior history of treatment (kappa=0.52). However, after correcting crude resistance rates for the observed misclassification, all estimated rates were within confidence intervals based on reported rates. This validation study is in favour of a good quality of data produced by the network, even though corrected rates are slightly different from observed rates. Therefore, data collected through the network may be used for policy making and tuberculosis programme evaluation. However, improvement in data collection regarding prior history of treatment should be considered. PMID:18028573

  11. 28 CFR 550.42 - Procedures for urine surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Procedures for urine surveillance. 550.42... DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.42 Procedures for urine surveillance. (a) Contractor authorized personnel of the same sex as...

  12. Spread of drug-resistant Streptococcus pneumoniae in Asian countries: Asian Network for Surveillance of Resistant Pathogens (ANSORP) Study.

    PubMed

    Song, J H; Lee, N Y; Ichiyama, S; Yoshida, R; Hirakata, Y; Fu, W; Chongthaleong, A; Aswapokee, N; Chiu, C H; Lalitha, M K; Thomas, K; Perera, J; Yee, T T; Jamal, F; Warsa, U C; Vinh, B X; Jacobs, M R; Appelbaum, P C; Pai, C H

    1999-06-01

    Antimicrobial susceptibility of 996 isolates of Streptococcus pneumoniae from clinical specimens was investigated in 11 Asian countries from September 1996 to June 1997. Korea had the greatest frequency of nonsusceptible strains to penicillin with 79.7%, followed by Japan (65.3%), Vietnam (60.8%), Thailand (57.9%), Sri Lanka (41.2%), Taiwan (38.7%), Singapore (23.1%), Indonesia (21.0%), China (9.8%), Malaysia (9.0%), and India (3.8%). Serotypes 23F and 19F were the most common. Pulsed-field gel electrophoresis (PFGE) of 154 isolates from Asian countries showed several major PFGE patterns. The serotype 23F Spanish clone shared the same PFGE pattern with strains from Korea, Japan, Singapore, Taiwan, Thailand, and Malaysia. Fingerprinting analysis of pbp1a, pbp2x, and pbp2b genes of 12 strains from six countries also showed identical fingerprints of penicillin-binding protein genes in most strains. These data suggest the possible introduction and spread of international epidemic clones into Asian countries and the increasing problems of pneumococcal drug resistance in Asian countries for the first time. PMID:10451154

  13. 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

  14. Cardiovascular Adverse Reactions During Antidepressant Treatment: A Drug Surveillance Report of German-Speaking Countries Between 1993 and 2010

    PubMed Central

    Spindelegger, Christoph Josef; Papageorgiou, Konstantinos; Grohmann, Renate; Engel, Rolf; Greil, Waldemar; Konstantinidis, Anastasios; Agelink, Marcus Willy; Bleich, Stefan; Ruether, Eckart; Toto, Sermin

    2015-01-01

    Background: Antidepressants (ADs) are known to have the potential to cause various cardiovascular adverse drug reactions (ADRs). The tricyclic antidepressants (TCAs) were first revealed to be a possible source of cardiovascular ADRs. In recent years, newer classes of ADs were also suggested to have a higher risk of cardiovascular adverse effects. In particular, the selective serotonin reuptake inhibitors (SSRIs) were suspected to have the potential to induce QTc interval prolongation, and therefore increase the risk of ventricular arrhythmia. This descriptive study is based on the continuous pharmacovigilance program of German-speaking countries (Austria, Germany, and Switzerland), the Arzneimittelsicherheit in der Psychiatrie (AMSP), which assesses severe ADRs occurring in clinical routine situations. Methods: Of 169 278 psychiatric inpatients treated with ADs between 1993 and 2010, 198 cases of cardiovascular ADRs (0.12%) were analyzed. Results: Our study showed that the incidence rates of cardiovascular ADRs were highest during treatment with monoamine oxidase inhibitors (0.27%), TCAs (0.15%), and serotonin noradrenaline reuptake inhibitors (0.14%); the risk of occurring during treatment with SSRIs (0.08%) was significantly lower. The noradrenergic and specific serotonergic AD mirtazapine (0.07%) had a significantly lower risk of cardiovascular ADRs than all other ADs. Severe hypotension was the most frequent ADR, followed by hypertension, arrhythmia, and in some rare cases heart failure. Conclusions: Despite certain limitations due to the AMSP study design, our observations on cardiovascular ADRs can contribute to a better knowledge of the cardiovascular risk profiles of antidepressants in the clinical routine setting. However, prospective studies are needed to verify our findings. PMID:25522416

  15. The prevalence of transmitted drug resistance in newly diagnosed HIV-infected individuals in Croatia: the role of transmission clusters of men who have sex with men carrying the T215S surveillance drug resistance mutation.

    PubMed

    Grgic, Ivana; Lepej, Snjezana Zidovec; Lunar, Maja M; Poljak, Mario; Vince, Adriana; Vrakela, Ivana Baca; Planinic, Ana; Seme, Katja; Begovac, Josip

    2013-02-01

    The aim of this study was to determine the prevalence of transmitted drug resistance (TDR) in newly diagnosed and treatment-naive HIV-infected patients from Croatia and evaluate a possible contribution of transmission clusters to the spread of resistant virus. The study enrolled treatment-naive HIV-infected patients that entered clinical care at the Croatian Reference Center for HIV/AIDS between 2006 and 2008. The protease gene and a part of the reverse transcriptase gene of the HIV-1 genome were sequenced by using the Trugene HIV-1 Genotyping System. The prevalence of transmitted drug resistance was analyzed by using the surveillance drug resistance mutations (SDRM) list recommended by the WHO in 2009. We report findings for 118 of 180 eligible patients (65.6% coverage). SDRM were detected in 26 of 118 patients (22.0%) who were infected with subtype B and belonged mostly to the men having sex with men (MSM). The majority of patients with primary resistance carried SDRM associated with resistance to nucleoside analogues reverse transcriptase inhibitors (NRTIs, 23 of 118 patients, 19.5%). The most frequently found NRTI SDRM was T215S (17 of 118 patients, 14.4%). SDRM associated with resistance to nonnucleoside reverse transcriptase inhibitors were detected in three (2.5%) patients and primary resistance to protease inhibitors was not detected. Non-B subtypes were detected in 13/118 patients (11%). A total of 12 transmission pairs and eight distinct transmission clusters were identified with the largest cluster harboring sequences from 19 patients; among them all but two were carrying the T215S mutation. This study showed a high prevalence of TDR in newly diagnosed MSM from Croatia and is an important contribution concerning the relationship between local transmission clusters and the spread of resistant virus. PMID:22906365

  16. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  17. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  18. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  19. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 822.10 - What must I include in my surveillance plan?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  1. [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

  2. Short Communication: Population-Based Surveillance of HIV-1 Drug Resistance in Cameroonian Adults Initiating Antiretroviral Therapy According to the World Health Organization Guidelines.

    PubMed

    Fokam, Joseph; Takou, Désiré; Santoro, Maria Mercedes; Akonie, Haniel Ze; Kouanfack, Charles; Ceccherini-Silberstein, Francesca; Colizzi, Vittorio; Perno, Carlo-Federico; Ndjolo, Alexis

    2016-04-01

    With ongoing earlier enrollment on and rapid scale-up of antiretroviral therapy (ART) in Cameroon, there are increasing risks of transmitted HIV drug resistance (HIVDR) at population levels. We, therefore, evaluated the threshold of HIVDR in a population initiating ART, to inform on the effectiveness of first-line regimens, considering HIV-1 diversity, plasma viral load (PVL), and CD4-based disease progression. A total of 53 adults [median (interquartile range, IQR) CD4: 162 cell/mm(3) (48-284); median (IQR) PVL: 5.34 log10 RNA (4.17-6.42) copies/ml] initiating ART in 2014 at the Yaoundé Central Hospital were enrolled for HIV-1 protease-reverse transcriptase sequencing. Drug resistance mutations (DRMs) were interpreted using the 2009 World Health Organization (WHO) list versus the Stanford HIVdb algorithm version 7.0. Level of DRMs was low (3.77%) versus moderate (7.55%), respectively, following the WHO list (T69D, K103N) versus Stanford HIVdb (T69D, A98G, K103N, K238T), respectively. Prevailing clade was CRF02_AG (71.70%). Based on Stanford HIVdb, a slightly higher proportion of patients with DRMs were found among ones infected with CRF02_AG than in those non-CRF02_AG infected (7.89% vs. 6.67%, p = 1.000), with lower PVL (7.69% <5.5 vs. 0% ≥5.5 log10 RNA copies/ml, p = .488) and with higher CD4 counts (9.52% CD4 ≥200 vs. 3.33% CD4 <200 cells/mm(3), p = .749). Thresholds of DRMs suggest that standard first-line regimens currently used in Cameroon may remain effective at population levels, despite scale-up of ART in the country, pending adherence, and closed virological monitoring. With an intent-to-diagnose approach, the discrepant levels of DRMs support using Stanford HIVdb to evaluate initial ART, while revising the WHO list for surveillance. PMID:26602836

  3. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  4. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  7. 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).

  8. Collaborating miniature drones for surveillance and reconnaissance

    NASA Astrophysics Data System (ADS)

    Bürkle, Axel

    2009-09-01

    The use of miniature Unmanned Aerial Vehicles (UAVs), e.g. quadrocopters, has gained great popularity over the last years. Some complex application scenarios for micro UAVs call for the formation of swarms of multiple drones. In this paper a platform for the creation of such swarms is presented. It consists of commercial quadrocopters enhanced with on-board processing and communication units enabling autonomy of individual drones. Furthermore, a generic ground control station has been realized. Different co-operation strategies for teams of UAVs are currently evaluated with an agent based simulation tool. Finally, complex application scenarios for multiple micro UAVs are presented.

  9. Drug information resources used by nurse practitioners and collaborating physicians at the point of care in Nova Scotia, Canada: a survey and review of the literature

    PubMed Central

    Murphy, Andrea L; Fleming, Mark; Martin-Misener, Ruth; Sketris, Ingrid S; MacCara, Mary; Gass, David

    2006-01-01

    Background Keeping current with drug therapy information is challenging for health care practitioners. Technologies are often implemented to facilitate access to current and credible drug information sources. In the Canadian province of Nova Scotia, legislation was passed in 2002 to allow nurse practitioners (NPs) to practice collaboratively with physician partners. The purpose of this study was to determine the current utilization patterns of information technologies by these groups of practitioners. Methods Nurse practitioners and their collaborating physician partners in Nova Scotia were sent a survey in February 2005 to determine the frequency of use, usefulness, accessibility, credibility, and current/timeliness of personal digital assistant (PDA), computer, and print drug information resources. Two surveys were developed (one for PDA users and one for computer users) and revised based on a literature search, stakeholder consultation, and pilot-testing results. A second distribution to nonresponders occurred two weeks following the first. Data were entered and analysed with SPSS. Results Twenty-seven (14 NPs and 13 physicians) of 36 (75%) recipients responded. 22% (6) returned personal digital assistant (PDA) surveys. Respondents reported print, health professionals, and online/electronic resources as the most to least preferred means to access drug information, respectively. 37% and 35% of respondents reported using "both print and electronic but print more than electronic" and "print only", respectively, to search monograph-related drug information queries whereas 4% reported using "PDA only". Analysis of respondent ratings for all resources in the categories print, health professionals and other, and online/electronic resources, indicated that the Compendium of Pharmaceuticals and Specialties and pharmacists ranked highly for frequency of use, usefulness, accessibility, credibility, and current/timeliness by both groups of practitioners. Respondents

  10. 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

  11. Information surveillance

    NASA Astrophysics Data System (ADS)

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

    2002-07-01

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

  12. Information surveillance

    SciTech Connect

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

    2002-07-15

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

  13. A Collaboration on Collaboration

    NASA Technical Reports Server (NTRS)

    Cobleigh, Brent

    2004-01-01

    NASA's 2003-2004 Leadership Development Program class recognized that effective collaborations are often the key to achieving mission success. Personal connections and common goals were key elements of their work together and key findings of their collaboration benchmarking within the agency.

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

    PubMed

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

    1991-02-01

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

  15. Citizen Science and Wildlife Disease Surveillance.

    PubMed

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

    2015-12-01

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

  16. 28 CFR 550.42 - Procedures for urine surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for urine surveillance. 550.42 Section 550.42 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract...

  17. The University of Kansas High-Throughput Screening Laboratory. Part II: enabling collaborative drug-discovery partnerships through cutting-edge screening technology

    PubMed Central

    McDonald, Peter R; Roy, Anuradha; Chaguturu, Rathnam

    2011-01-01

    The University of Kansas High-Throughput Screening (KU HTS) core is a state-of-the-art drug-discovery facility with an entrepreneurial open-service policy, which provides centralized resources supporting public- and private-sector research initiatives. The KU HTS core was established in 2002 at the University of Kansas with support from an NIH grant and the state of Kansas. It collaborates with investigators from national and international academic, nonprofit and pharmaceutical organizations in executing HTS-ready assay development and screening of chemical libraries for target validation, probe selection, hit identification and lead optimization. This is part two of a contribution from the KU HTS laboratory. PMID:21806374

  18. The University of Kansas High-Throughput Screening Laboratory. Part II: enabling collaborative drug-discovery partnerships through cutting-edge screening technology.

    PubMed

    McDonald, Peter R; Roy, Anuradha; Chaguturu, Rathnam

    2011-07-01

    The University of Kansas High-Throughput Screening (KU HTS) core is a state-of-the-art drug-discovery facility with an entrepreneurial open-service policy, which provides centralized resources supporting public- and private-sector research initiatives. The KU HTS core was established in 2002 at the University of Kansas with support from an NIH grant and the state of Kansas. It collaborates with investigators from national and international academic, nonprofit and pharmaceutical organizations in executing HTS-ready assay development and screening of chemical libraries for target validation, probe selection, hit identification and lead optimization. This is part two of a contribution from the KU HTS laboratory. PMID:21806374

  19. Perceptions of parental substance use disorders in cross-system collaboration among child welfare, alcohol and other drugs, and dependency court organizations.

    PubMed

    He, Amy S; Traube, Dorian E; Young, Nancy K

    2014-05-01

    Cross-system collaboration among child welfare (CW), alcohol and other drugs (AOD), and court organizations shows promise in addressing the many needs of CW-involved families experiencing parental substance use disorders (SUDs). Research has suggested that differing perceptions of parents with SUDs among staff in these organizations may hinder the collaborative process. Using a sequential explanatory mixed-method approach, this study explored staff perceptions of parental SUDs among CW, AOD, and court organizations. Logistic regression analyses indicated that, compared to CW respondents, AOD respondents were: (a) less likely to believe that parents could provide effective parenting; (b) more likely to believe that abstinence should be a criterion for reunification; (c) more likely to agree that parents should receive jail time as a consequence for noncompliance with court orders; and (d) more likely to believe that parents could succeed in treatment. Thematic analyses of these focal areas identified two core themes (focus on the primary client and mandated time frames for permanency), as well as multiple subthemes, that provided a nuanced understanding of differing perceptions on these matters. Suggestions for the development of anticipatory cross-system training and practices and implications for policy evaluation are discussed. PMID:24268380

  20. 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

  1. FETAL ALCOHOL SYNDROME SURVEILLANCE NETWORK (FASSNET)

    EPA Science Inventory

    CDC, in collaboration with four states, has developed the first state-based program specifically designed to monitor trends in the occurrence of fetal alcohol syndrome (FAS). The program, Fetal Alcohol Syndrome Surveillance Network (FASSNet), reports that many children continue t...

  2. NATIONAL ORAL HEALTH SURVEILLANCE SYSTEM (NOHSS)

    EPA Science Inventory

    National Oral Health Surveillance System (NOHSS) is a collaborative effort between CDC's Division of Oral Health and The Association of State and Territorial Dental Directors (ASTDD). NOHSS is designed to help public health programs monitor the burden of oral disease, use of the ...

  3. Molecular diversity of HIV-1 and surveillance of transmitted drug resistance variants among treatment Naïve patients, 5 years after active introduction of HAART in Kuala Lumpur, Malaysia.

    PubMed

    Ong, Lai Yee; Razak, Siti Nur Humaira; Lee, Yeat Mei; Sri La Sri Ponnampalavanar, Sasheela; Syed Omar, Sharifah Faridah; Azwa, Raja Iskandar; Tee, Kok Keng; Kamarulzaman, Adeeba

    2014-01-01

    Expansion of antiretroviral treatment programs have led to the growing concern for the development of antiretroviral drug resistance. The aims were to assess the prevalence of drug resistant HIV-1 variants and to identify circulating subtypes among HAART-naïve patients. Plasma specimens from N = 100 HIV+ HAART-naïve adult were collected between March 2008 and August 2010 and viral RNA were extracted for nested PCR and sequenced. PR-RT sequences were protein aligned and checked for transmitted drug resistance mutations. Phylogenetic reconstruction and recombination analysis were performed to determine the genotypes. Based on the WHO consensus guidelines, none of the recruited patients had any transmitted drug resistance mutations. When analyzed against the Stanford guidelines, 35% of patients had at least one reported mutation that may reduce drug susceptibility to PI (24%), NRTI (5%), and NNRTI (14%). The commonly detected mutation that may affect current first line therapy was V179D (3%), which may lead to reduced susceptibility to NNRTI. The predominant circulating HIV-1 genotypes were CRF01_AE (51%) and CRF33_01B (17%). The prevalence of unique recombinant forms (URF) was 7%; five distinct recombinant structures involving CRF01_AE and subtype B' were observed, among them a cluster of three isolates that could form a novel circulating recombinant form (CRF) candidate. Transmitted drug resistance prevalence among HAART-naïve patients was low in this cohort of patients in Kuala Lumpur despite introduction of HAART 5 years ago. Owing to the high genetic diversity, continued molecular surveillance can identify the persistent emergence of HIV-1 URF and novel CRF with significant epidemiological impact. PMID:24127302

  4. Collaborative pre-competitive preclinical drug discovery with academics and pharma/biotech partners at Sanford|Burnham: infrastructure, capabilities & operational models.

    PubMed

    Chung, Thomas D Y

    2014-03-01

    competencies of its fully integrated drug discovery expertise, best practices adopted in our day-to-day operations, and finally some of our current funding and collaboration and/or strategic alliance models for pre-competitive drug discovery with other academic/clinical partners, other governmental agencies, and with pharmaceutical and biotechnology companies. PMID:24409951

  5. Multinational Disease Surveillance Programs: Promoting Global Information Exchange for Infectious Diseases.

    PubMed

    Varan, Aiden K; Bruniera-Oliveira, Robson; Peter, Christopher R; Fonseca-Ford, Maureen; Waterman, Stephen H

    2015-09-01

    Cross-border surveillance for emerging diseases such as Ebola and other infectious diseases requires effective international collaboration. We surveyed representatives from 12 multinational disease surveillance programs between January 2013 and April 2014. Our survey identified programmatic similarities despite variation in health priorities, geography, and socioeconomic context, providing a contemporary perspective on infectious disease surveillance networks. PMID:26033019

  6. Evaluation of the Feasibility and Utility of a Pharmacist-Centered Collaborative Drug Therapy Management Program for Oncology-Based Symptom Management.

    PubMed

    Hansen, Elizabeth A; Pietkiewicz, John M; Blum, Bonnie L

    2016-06-01

    Collaborative drug therapy management (CDTM) is a practice agreement between a pharmacist and a physician, which allows the pharmacist to assume responsibility of drug therapy management. There has been limited documentation of CDTM practices in the oncology setting. Therefore, a CDTM program in the gynecology oncology clinic at Roswell Park Cancer Institute (RPCI) was initiated to establish the feasibility and utility of CDTM and its effects on patient care and physician satisfaction. Primarily, 3 symptoms were managed by the CDTM pharmacists, namely chemotherapy-induced nausea and vomiting (CINV), chemotherapy-induced peripheral neuropathy (CIPN), and women's health. The CDTM program showed favorable results after a short 4-month period. The CDTM pharmacists were referred a total of 12 consultations for CDTM purposes; 8 patients enrolled in the CIPN CDTM protocol, 3 in the CINV protocol, and 1 in the women's health protocol. The CDTM pharmacists were able to perform a total of 54 consultations, with a mean time of 16.9 minutes spent with each patient per consultation. Additionally, the CDTM pharmacists made 70 interventions and identified 6 medication-related adverse effects. The patient and physician satisfaction survey demonstrated the value of the CDTM pharmacists, and respondents were supportive of the program. PMID:25510586

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

    PubMed

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

    2016-01-01

    Developing a surveillance system during a public health emergency is always challenging but is especially so in countries with limited public health infrastructure. Surveillance for Ebola virus disease (Ebola) in the West African countries heavily affected by Ebola (Guinea, Liberia, and Sierra Leone) faced numerous impediments, including insufficient numbers of trained staff, community reticence to report cases and contacts, limited information technology resources, limited telephone and Internet service, and overwhelming numbers of infected persons. Through the work of CDC and numerous partners, including the countries' ministries of health, the World Health Organization, and other government and nongovernment organizations, functional Ebola surveillance was established and maintained in these countries. CDC staff were heavily involved in implementing case-based surveillance systems, sustaining case surveillance and contact tracing, and interpreting surveillance data. In addition to helping the ministries of health and other partners understand and manage the epidemic, CDC's activities strengthened epidemiologic and data management capacity to improve routine surveillance in the countries affected, even after the Ebola epidemic ended, and enhanced local capacity to respond quickly to future public health emergencies. However, the many obstacles overcome during development of these Ebola surveillance systems highlight the need to have strong public health, surveillance, and information technology infrastructure in place before a public health emergency occurs. Intense, long-term focus on strengthening public health surveillance systems in developing countries, as described in the Global Health Security Agenda, is needed.The activities summarized in this report would not have been possible without collaboration with many U.S and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html). PMID:27389614

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  11. CDC Periodontal Disease Surveillance Project: background, objectives, and progress report.

    PubMed

    Eke, Paul I; Genco, Robert J

    2007-07-01

    This supplement contains papers presented at the 2006 International Association of Dental Research (IADR) symposium entitled "Development of Self-Reported Measures for Population-Based Surveillance of Periodontitis." These papers highlight activities of an independent periodontal disease surveillance workgroup convened by the Division of Oral Health (DOH), Centers for Disease Control and Prevention (CDC), in collaboration with the American Academy of Periodontology, to examine the feasibility of using self-reported measures for population-based surveillance of periodontal disease in the United States. This workgroup was convened in 2003 as part of a CDC periodontal disease surveillance project. PMID:17610396

  12. Joint collaborative technology experiment

    NASA Astrophysics Data System (ADS)

    Wills, Michael; Ciccimaro, Donny; Yee, See; Denewiler, Thomas; Stroumtsos, Nicholas; Messamore, John; Brown, Rodney; Skibba, Brian; Clapp, Daniel; Wit, Jeff; Shirts, Randy J.; Dion, Gary N.; Anselmo, Gary S.

    2009-05-01

    Use of unmanned systems is rapidly growing within the military and civilian sectors in a variety of roles including reconnaissance, surveillance, explosive ordinance disposal (EOD), and force-protection and perimeter security. As utilization of these systems grows at an ever increasing rate, the need for unmanned systems teaming and inter-system collaboration becomes apparent. Collaboration provides a means of enhancing individual system capabilities through relevant data exchange that contributes to cooperative behaviors between systems and enables new capabilities not possible if the systems operate independently. A collaborative networked approach to development holds the promise of adding mission capability while simultaneously reducing the workload of system operators. The Joint Collaborative Technology Experiment (JCTE) joins individual technology development efforts within the Air Force, Navy, and Army to demonstrate the potential benefits of interoperable multiple system collaboration in a force-protection application. JCTE participants are the Air Force Research Laboratory, Materials and Manufacturing Directorate, Airbase Technologies Division, Force Protection Branch (AFRL/RXQF); the Army Aviation and Missile Research, Development, and Engineering Center Software Engineering Directorate (AMRDEC SED); and the Space and Naval Warfare Systems Center - Pacific (SSC Pacific) Unmanned Systems Branch operating with funding provided by the Joint Ground Robotics Enterprise (JGRE). This paper will describe the efforts to date in system development by the three partner organizations, development of collaborative behaviors and experimentation in the force-protection application, results and lessons learned at a technical demonstration, simulation results, and a path forward for future work.

  13. Trends in antifungal drug susceptibility of Cryptococcus neoformans isolates obtained through population-based surveillance in South Africa in 2002-2003 and 2007-2008.

    PubMed

    Govender, Nelesh P; Patel, Jaymati; van Wyk, Marelize; Chiller, Tom M; Lockhart, Shawn R

    2011-06-01

    Cryptococcus neoformans is the most common cause of meningitis among adult South Africans with HIV infection/AIDS. Widespread use of fluconazole for treatment of cryptococcal meningitis and other HIV-associated opportunistic fungal infections in South Africa may lead to the emergence of isolates with reduced fluconazole susceptibility. MIC testing using a reference broth microdilution method was used to determine if isolates with reduced susceptibility to fluconazole or amphotericin B had emerged among cases of incident disease. Incident isolates were tested from two surveillance periods (2002-2003 and 2007-2008) when population-based surveillance was conducted in Gauteng Province, South Africa. These isolates were also tested for susceptibility to flucytosine, itraconazole, voriconazole, and posaconazole. Serially collected isolate pairs from cases at several large South African hospitals were also tested for susceptibility to fluconazole. Of the 487 incident isolates tested, only 3 (0.6%) demonstrated a fluconazole MIC of ≥ 16 μg/ml; all of these isolates were from 2002-2003. All incident isolates were inhibited by very low concentrations of amphotericin B and exhibited very low MICs to voriconazole and posaconazole. Of 67 cases with serially collected isolate pairs, only 1 case was detected where the isolate collected more than 30 days later had a fluconazole MIC value significantly higher than the MIC of the corresponding incident isolate. Although routine antifungal susceptibility testing of incident isolates is not currently recommended in clinical settings, it is still clearly important for public health to periodically monitor for the emergence of resistance. PMID:21444707

  14. Trends in Antifungal Drug Susceptibility of Cryptococcus neoformans Isolates Obtained through Population-Based Surveillance in South Africa in 2002-2003 and 2007-2008▿

    PubMed Central

    Govender, Nelesh P.; Patel, Jaymati; van Wyk, Marelize; Chiller, Tom M.; Lockhart, Shawn R.

    2011-01-01

    Cryptococcus neoformans is the most common cause of meningitis among adult South Africans with HIV infection/AIDS. Widespread use of fluconazole for treatment of cryptococcal meningitis and other HIV-associated opportunistic fungal infections in South Africa may lead to the emergence of isolates with reduced fluconazole susceptibility. MIC testing using a reference broth microdilution method was used to determine if isolates with reduced susceptibility to fluconazole or amphotericin B had emerged among cases of incident disease. Incident isolates were tested from two surveillance periods (2002-2003 and 2007-2008) when population-based surveillance was conducted in Gauteng Province, South Africa. These isolates were also tested for susceptibility to flucytosine, itraconazole, voriconazole, and posaconazole. Serially collected isolate pairs from cases at several large South African hospitals were also tested for susceptibility to fluconazole. Of the 487 incident isolates tested, only 3 (0.6%) demonstrated a fluconazole MIC of ≥16 μg/ml; all of these isolates were from 2002-2003. All incident isolates were inhibited by very low concentrations of amphotericin B and exhibited very low MICs to voriconazole and posaconazole. Of 67 cases with serially collected isolate pairs, only 1 case was detected where the isolate collected more than 30 days later had a fluconazole MIC value significantly higher than the MIC of the corresponding incident isolate. Although routine antifungal susceptibility testing of incident isolates is not currently recommended in clinical settings, it is still clearly important for public health to periodically monitor for the emergence of resistance. PMID:21444707

  15. 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.

  16. Collaborative Learning.

    ERIC Educational Resources Information Center

    Levy-Reiner, Sherry, Ed.

    1985-01-01

    Descriptions of 10 college programs involving collaborative learning are presented, along with Karen T. Romer's essay, "Collaboration: New Forms of Learning, New Ways of Thinking." The essay identifies various kinds of collaborative learning as well as the benefits of collaborative models. The following programs and schools are described: the…

  17. Molecular surveillance for drug-resistant Plasmodium falciparum in clinical and subclinical populations from three border regions of Burma/Myanmar: cross-sectional data and a systematic review of resistance studies

    PubMed Central

    2012-01-01

    health workers can contribute to molecular surveillance of drug resistance in remote areas of Myanmar. Marginal and displaced populations under-represented among previous resistance investigations can and should be included in resistance surveillance efforts, particularly once genetic markers of artemisinin-delayed parasite clearance are identified. Subclinical infections may contribute to the epidemiology of drug resistance, but determination of gene amplification from desiccated filter samples requires further validation when DNA concentration is low. PMID:22992214

  18. Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

    PubMed

    Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs. PMID:23678729

  19. Battlefield agent collaboration

    NASA Astrophysics Data System (ADS)

    Budulas, Peter P.; Young, Stuart H.; Emmerman, Philip J.

    2001-09-01

    Small air and ground physical agents (robots) will be ubiquitous on the battlefield of the 21st century, principally to lower the exposure to harm of our ground forces in urban and open terrain scenarios. Teams of small collaborating physical agents conducting tasks such as Reconnaissance, Surveillance, and Target Acquisition (RSTA), intelligence, chemical and biological agent detection, logistics, decoy, sentry; and communications relay will have advanced sensors, communications, and mobility characteristics. It is anticipated that there will be many levels of individual and team collaboration between the soldier and robot, robot to robot, and robot to mother ship. This paper presents applications and infrastructure components that illustrate each of these levels. As an example, consider the application where a team of twenty small robots must rapidly explore and define a building complex. Local interactions and decisions require peer to peer collaboration. Global direction and information fusion warrant a central team control provided by a mother ship. The mother ship must effectively deliver/retrieve, service, and control these robots as well as fuse the information gathered by these highly mobile robot teams. Any level of collaboration requires robust communications, specifically a mobile ad hoc network. The application of fixed ground sensors and mobile robots is also included in this paper. This paper discusses on going research at the U.S. Army Research Laboratory that supports the development of multi-robot collaboration. This research includes battlefield visualization, intelligent software agents, adaptive communications, sensor and information fusion, and multi-modal human computer interaction.

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

    PubMed

    Martínez-Frías, María Luisa

    2007-01-01

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

  1. 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

  2. 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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  4. 21 CFR 822.5 - How will I know if I must conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  5. Enhancing Disease Surveillance Event Communication Among Jurisdictions

    PubMed Central

    Tabernero, Nathaniel R.; Loschen, Wayne A.; Jorgensen, Joel; Suereth, Joshua; Coberly, Jacqueline S.; Holtry, Rekha S.; Sikes, Marvin L.; Babin, Steven M.; Lewis, Sheryl L. Happel

    2009-01-01

    Automated disease surveillance systems are becoming widely used by the public health community. However, communication among non-collocated and widely dispersed users still needs improvement. A web-based software tool for enhancing user communications was completely integrated into an existing automated disease surveillance system and was tested during two simulated exercises and operational use involving multiple jurisdictions. Evaluation of this tool was conducted by user meetings, anonymous surveys, and web logs. Public health officials found this tool to be useful, and the tool has been modified further to incorporate features suggested by user responses. Features of the automated disease surveillance system, such as alerts and time series plots, can be specifically referenced by user comments. The user may also indicate the alert response being considered by adding a color indicator to their comment. The web-based event communication tool described in this article provides a common ground for collaboration and communication among public health officials at different locations. PMID:27325909

  6. [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

  7. Trends of Mycobacterium bovis Isolation and First-Line Anti-tuberculosis Drug Susceptibility Profile: A Fifteen-Year Laboratory-Based Surveillance

    PubMed Central

    Bobadilla-del Valle, Miriam; Torres-González, Pedro; Cervera-Hernández, Miguel Enrique; Martínez-Gamboa, Areli; Crabtree-Ramirez, Brenda; Chávez-Mazari, Bárbara; Ortiz-Conchi, Narciso; Rodríguez-Cruz, Luis; Cervantes-Sánchez, Axel; Gudiño-Enríquez, Tomasa; Cinta-Severo, Carmen; Sifuentes-Osornio, José; Ponce de León, Alfredo

    2015-01-01

    Background Mycobacterium tuberculosis causes the majority of tuberculosis (TB) cases in humans; however, in developing countries, human TB caused by M. bovis may be frequent but undetected. Human TB caused by M. bovis is considered a zoonosis; transmission is mainly through consumption of unpasteurized dairy products, and it is less frequently attributed to animal-to-human or human-to-human contact. We describe the trends of M. bovis isolation from human samples and first-line drug susceptibility during a 15-year period in a referral laboratory located in a tertiary care hospital in Mexico City. Methodology/Principal Findings Data on mycobacterial isolates from human clinical samples were retrieved from the laboratory’s database for the 2000–2014 period. Susceptibility to first-line drugs: rifampin, isoniazid, streptomycin (STR) and ethambutol was determined. We identified 1,165 isolates, 73.7% were M. tuberculosis and 26.2%, M. bovis. Among pulmonary samples, 16.6% were M. bovis. The proportion of M. bovis isolates significantly increased from 7.8% in 2000 to 28.4% in 2014 (X2trend, p<0.001). Primary STR resistance was higher among M. bovis compared with M. tuberculosis isolates (10.9% vs.3.4%, p<0.001). Secondary multidrug resistance (MDR) rates were 38.5% and 34.4% for M. bovis and M. tuberculosis, respectively (p = 0.637). A rising trend of primary STR monoresistance was observed for both species (3.4% in 2000–2004 vs. 7.6% in 2010–2014; p = 0.02). Conclusions/Significance There is a high prevalence and a rising trend of M. bovis isolates in our region. The proportion of pulmonary M. bovis isolates is higher than in previous reports. Additionally, we report high rates of primary anti-tuberculosis resistance and secondary MDR in both M. tuberculosis and M. bovis. This is one of the largest reports on drug susceptibility of M. bovis from human samples and shows a significant proportion of first-line anti-tuberculosis drug resistance. PMID:26421930

  8. TA Collaborations

    ERIC Educational Resources Information Center

    Diefendorf, Martha

    2010-01-01

    This paper highlights several current collaborative activities of the National Early Childhood Technical Assistance Center (NECTAC). There are many specific examples of TA (Technical Assistance) collaborations that take place on a regular basis; the seven examples presented here were selected to represent different types of collaboration. The…

  9. Collaborative Arrangements.

    ERIC Educational Resources Information Center

    Cota-Robles, Eugene; Doby, Winston

    Two conference papers describing various collaborative arrangements within the educational community among teachers, students and others are presented in this document. The first paper, "Successful Collaborations" (Eugene Cota-Robles), describes the following projects in California that seek to forge collaborations to improve the education of…

  10. Collaboration Connections

    ERIC Educational Resources Information Center

    Harvey, Carl A., II

    2008-01-01

    Of all the buzz words used in the school library media profession, "collaboration" evokes the strongest feelings--and not all of those feelings are positive. Some library media specialists are not convinced that collaboration is an essential part of their programs, yet collaboration seems to be essential in many other professions. In fact, there…

  11. Collaborative Inquiry

    ERIC Educational Resources Information Center

    David, Jane L.

    2009-01-01

    Teachers can make better use of data when they work together than when they do it alone. Creating the conditions for such collaboration is a tall order. This article describes the idea behind the collaborative inquiry approach. It also mentions several studies that indicate its effectiveness. Tips on how collaborative inquiry can be implemented…

  12. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  19. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  20. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  1. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  2. 21 CFR 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  3. 21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  4. 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

  5. Population-based Surveillance of HIV Drug Resistance Emerging on Treatment and Associated Factors at Sentinel Antiretroviral Therapy Sites in Namibia

    PubMed Central

    Hong, Steven Y.; Jonas, Anna; DeKlerk, Michael; Shiningavamwe, Andreas; Desta, Tiruneh; Badi, Alfons; Morris, Lynn; Hunt, Gillian M.; Ledwaba, Johanna; Sheehan, Heidi B.; Lau, Kiger; Trotter, Andrew; Tang, Alice M.; Wanke, Christine; Jordan, Michael R.

    2015-01-01

    Objective World Health Organization (WHO) prospective surveys of acquired HIV drug resistance (HIVDR) evaluate HIVDR emerging after the first year of antiretroviral therapy (ART) and associated factors. Methods Consecutive ART starters in 2009 were enrolled at three sentinel sites in Namibia. Genotyping was performed at start and after 12 months in patients with HIV viral load (VL) >1000 copies/mL. HIVDR outcomes were: HIVDR Prevention (VL ≤1000 copies/mL), Possible HIVDR (VL>1000 copies/mL without detectable HIVDR or loss to follow-up (LTFU) or ART stop), and HIVDR (VL>1000 copies/mL with detectable HIVDR). Adherence was assessed using medication possession ratio (MPR). Results Of 394 starters, at 12 months 80% were on first-line ART, 1% died, 4% transferred out, 1% stopped ART, <1% switched to second-line and 15% were LTFU. Among patients on first-line, 77% had VL testing. 94% achieved VL ≤1000 copies/mL. At baseline, 7% had HIVDR. After 12 months, among patients with VL testing, 5% had HIVDR. A majority of patients failing therapy had high level resistance to non-nucleoside reverse transcriptase inhibitors but none to protease inhibitors. All sites achieved WHO target of ≥70% HIVDR Prevention. Factors associated with not achieving HIVDR Prevention were: baseline resistance to non-nucleoside reverse transcriptase inhibitors (OR 3.0, p=0.023), WHO stage 3 or 4 at baseline (OR 2.0, p=0.012), and MPR<75% (OR 4.9, p=0.021). Conclusions Earlier ART initiation and removal of barriers to on-time drug pickups may help to prevent HIVDR. These data inform decisions at national and global levels on the effectiveness of first- and second-line regimens. PMID:25564107

  6. Collaborative Attack vs. Collaborative Defense

    NASA Astrophysics Data System (ADS)

    Xu, Shouhuai

    We have witnessed many attacks in the cyberspace. However, most attacks are launched by individual attackers even though an attack may involve many compromised computers. In this paper, we envision what we believe to be the next generation cyber attacks — collaborative attacks. Collaborative attacks can be launched by multiple attackers (i.e., human attackers or criminal organizations), each of which may have some specialized expertise. This is possible because cyber attacks can become very sophisticated and specialization of attack expertise naturally becomes relevant. To counter collaborative attacks, we might need collaborative defense because each “chain” in a collaborative attack may be only adequately dealt with by a different defender. In order to understand collaborative attack and collaborative defense, we present a high-level abstracted framework for evaluating the effectiveness of collaborative defense against collaborative attacks. As a first step towards realizing and instantiating the framework, we explore a characterization of collaborative attacks and collaborative defense from the relevant perspectives.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-16

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

  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. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Rapid Wuchereria bancrofti-Specific Antigen Wb123-Based IgG4 Immunoassays as Tools for Surveillance following Mass Drug Administration Programs on Lymphatic Filariasis

    PubMed Central

    Steel, Cathy; Golden, Allison; Kubofcik, Joseph; LaRue, Nicole; de los Santos, Tala; Domingo, Gonzalo J.

    2013-01-01

    The Global Programme to Eliminate Lymphatic Filariasis has an urgent need for rapid assays to detect ongoing transmission of lymphatic filariasis (LF) following multiple rounds of mass drug administration (MDA). Current WHO guidelines support using the antigen card immunochromatographic test (ICT), which detects active filarial infection but does not detect early exposure to LF. Recent studies found that antibody-based assays better serve this function. In the present study, two tests, a rapid IgG4 enzyme-linked immunosorbent assay (ELISA) and a lateral-flow strip immunoassay, were developed based on the highly sensitive and specific Wuchereria bancrofti antigen Wb123. A comparison of W. bancrofti-infected and -uninfected patients (with or without other helminth infections) demonstrated that both tests had high sensitivities and specificities (93 and 97% [ELISA] and 92 and 96% [strips], respectively). When the W. bancrofti-uninfected group was separated into those with other filarial/helminth infections (i.e., onchocerciasis, loiasis, and strongyloidiasis) and those who were parasite uninfected, the specificities of the assays varied between 91 and 100%. In addition, the geometric mean response by ELISA of W. bancrofti-infected patients was significantly higher than the response of those without W. bancrofti infection (P < 0.0001). Furthermore, the Wb123 ELISA and the lateral-flow strips had high positive and negative predictive values, giving valuable information on the size of survey population needed to be reasonably certain whether or not transmission is ongoing. These highly sensitive and specific IgG4 tests to the W. bancrofti Wb123 protein give every indication that they will serve as useful tools for post-MDA monitoring. PMID:23740923

  14. A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning. Methods/Design The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort), from which we will identify those eligible to participate in a trial of collaborative care for sub-threshold depression (the CASPER trial). We aim to undertake a pragmatic randomised controlled multi-centre trial evaluating the effectiveness and cost-effectiveness of collaborative care; a low intensity psychological intervention in addition to usual general practitioner care versus usual general practitioner care alone. General practitioners from practices based in the North of England will be asked to identify potentially eligible patients over the age of 75 years. Patients will be sent a letter inviting them to participate in the study. We aim to recruit approximately 540 participants for the CASPER trial. A diagnostic interview will be carried out to ascertain trial eligibility with the major depressive episode module of the Mini International Neuropsychiatric Interview (M.I.N.I.), eligible participants randomised to either the intervention or usual care. The primary outcome will be measured with the Patient Health Questionnaire-9 (PHQ-9) and additional quality of life measures will be collected. Data will be collected at baseline, 4 and 12 months for both trial and cohort participants. Trial

  15. SURVEILLANCE FOR WATERBORNE DISEASE AND OUTBREAK ASSOCIATED WITH RECREATIONAL WATER - UNITED STATES 2003-2004

    EPA Science Inventory

    Problem/Condition: Since 1971, the Centers for Disease Control and Prevention (CDC), the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have maintained a collaborative surveillance system for collecting and periodically reporting da...

  16. Surveillance for Waterborne Disease Outbreaks Associated with Drinking Water United States, 2007-2008

    EPA Science Inventory

    Problem/Condition: Since 1971, the Centers for Disease Control and Prevention (CDC), the U.S. Environmental Protection Agency (EPA), and the Council of State and Territorial Epidemiologists have maintained a collaborative Waterborne Disease and Outbreak Surveillance System (WBDOS...

  17. Unattended optical surveillance equipment

    NASA Astrophysics Data System (ADS)

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

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

  18. SOURCES OF DATA FOR IMPROVED SURVEILLANCE OF HIV/AIDS IN CHINA

    PubMed Central

    Jia, Yujiang; Lu, Fan; Sun, Xinhua; Vermund, Sten H

    2009-01-01

    The objective of this paper is to describe the evolution of human immunodeficiency virus/acquired immunodeficiency syndrome surveillance in mainland China, with a focus on reviewing the sources of data being used for improved surveillance of HIV/AIDS. We review the development of HIV/AIDS surveillance and its multiple data sources to monitor the dynamics of HIV/AIDS in China. The surveillance system for HIV/AIDS in China was initiated in 1986. It has evolved in three stages: (1) passive surveillance, (2) HIV sentinel surveillance with coexisting active surveillance and passive surveillance, and (3) comprehensive surveillance. In parallel with the evolution of the surveillance system itself, the HIV epidemic in China has gone through increasing stages of complexity, through an Introduction Phase, a Spreading Phase, and a Rapidy Spreading Phase. More reliable data from improved surveillance suggest that the HIV/AIDS epidemic is expanding in China. HIV infections among 2005 estimates remain concentrated among injection drug users (IDUs), those buying and selling sex, and men who have sex with men. Better HIV/AIDS surveillance synthesizes multiple data sources to provide a more accurate picture of the dynamics of specific HIV/AIDS circumstances in different areas of China. Improved surveillance is meaningful insofar as data are used to implement more effective HIV prevention programs in China. Support for surveillance and strategic analyses can enable policy decision makers to make more effective program choices and mobilize adequate resources to contain HIV. PMID:18613545

  19. Circuits of Surveillance

    PubMed Central

    Williams, Robin; Johnson, Paul

    2005-01-01

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

  20. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  2. ALICE Collaboration

    NASA Astrophysics Data System (ADS)

    Abelev, B.; Adam, J.; Adamová, D.; Aggarwal, M. M.; Aglieri Rinella, G.; Agnello, M.; Agostinelli, A.; Agrawal, N.; Ahammed, Z.; Ahmad, N.; Ahmed, I.; Ahn, S. U.; Ahn, S. A.; Aimo, I.; Aiola, S.; Ajaz, M.; Akindinov, A.; Alam, S. N.; Aleksandrov, D.; Alessandro, B.; Alexandre, D.; Alici, A.; Alkin, A.; Alme, J.; Alt, T.; Altinpinar, S.; Altsybeev, I.; Alves Garcia Prado, C.; Andrei, C.; Andronic, A.; Anguelov, V.; Anielski, J.; Antičić, T.; Antinori, F.; Antonioli, P.; Aphecetche, L.; Appelshäuser, H.; Arcelli, S.; Armesto, N.; Arnaldi, R.; Aronsson, T.; Arsene, I. C.; Arslandok, M.; Augustinus, A.; Averbeck, R.; Awes, T. C.; Azmi, M. D.; Bach, M.; Badalà, A.; Baek, Y. W.; Bagnasco, S.; Bailhache, R.; Bala, R.; Baldisseri, A.; Baltasar Dos Santos Pedrosa, F.; Baral, R. C.; Barbera, R.; Barile, F.; Barnaföldi, G. G.; Barnby, L. S.; Barret, V.; Bartke, J.; Basile, M.; Bastid, N.; Basu, S.; Bathen, B.; Batigne, G.; Batista Camejo, A.; Batyunya, B.; Batzing, P. C.; Baumann, C.; Bearden, I. G.; Beck, H.; Bedda, C.; Behera, N. K.; Belikov, I.; Bellini, F.; Bellwied, R.; Belmont, R.; Belmont-Moreno, E.; Belyaev, V.; Bencedi, G.; Beole, S.; Berceanu, I.; Bercuci, A.; Berdnikov, Y.; Berenyi, D.; Berger, M. E.; Bertens, R. A.; Berzano, D.; Betev, L.; Bhasin, A.; Bhat, I. R.; Bhati, A. K.; Bhattacharjee, B.; Bhom, J.; Bianchi, L.; Bianchi, N.; Bianchin, C.; Bielčík, J.; Bielčíková, J.; Bilandzic, A.; Bjelogrlic, S.; Blanco, F.; Blau, D.; Blume, C.; Bock, F.; Bogdanov, A.; Bøggild, H.; Bogolyubsky, M.; Böhmer, F. V.; Boldizsár, L.; Bombara, M.; Book, J.; Borel, H.; Borissov, A.; Bossú, F.; Botje, M.; Botta, E.; Böttger, S.; Braun-Munzinger, P.; Bregant, M.; Breitner, T.; Broker, T. A.; Browning, T. A.; Broz, M.; Bruna, E.; Bruno, G. E.; Budnikov, D.; Buesching, H.; Bufalino, S.; Buncic, P.; Busch, O.; Buthelezi, Z.; Caffarri, D.; Cai, X.; Caines, H.; Calero Diaz, L.; Caliva, A.; Calvo Villar, E.; Camerini, P.; Carena, F.; Carena, W.; Castillo Castellanos, J.; Casula, E. A. R.; Catanescu, V.; Cavicchioli, C.; Ceballos Sanchez, C.; Cepila, J.; Cerello, P.; Chang, B.; Chapeland, S.; Charvet, J. L.; Chattopadhyay, S.; Chattopadhyay, S.; Chelnokov, V.; Cherney, M.; Cheshkov, C.; Cheynis, B.; Chibante Barroso, V.; Chinellato, D. D.; Chochula, P.; Chojnacki, M.; Choudhury, S.; Christakoglou, P.; Christensen, C. H.; Christiansen, P.; Chujo, T.; Chung, S. U.; Cicalo, C.; Cifarelli, L.; Cindolo, F.; Cleymans, J.; Colamaria, F.; Colella, D.; Collu, A.; Colocci, M.; Conesa Balbastre, G.; Conesa del Valle, Z.; Connors, M. E.; Contreras, J. G.; Cormier, T. M.; Corrales Morales, Y.; Cortese, P.; Cortés Maldonado, I.; Cosentino, M. R.; Costa, F.; Crochet, P.; Cruz Albino, R.; Cuautle, E.; Cunqueiro, L.; Dainese, A.; Danu, A.; Das, D.; Das, I.; Das, K.; Das, S.; Dash, A.; Dash, S.; De, S.; Delagrange, H.; Deloff, A.; Dénes, E.; D'Erasmo, G.; De Caro, A.; de Cataldo, G.; de Cuveland, J.; De Falco, A.; De Gruttola, D.; De Marco, N.; De Pasquale, S.; de Rooij, R.; Diaz Corchero, M. A.; Dietel, T.; Dillenseger, P.; Divià, R.; Di Bari, D.; Di Liberto, S.; Di Mauro, A.; Di Nezza, P.; Djuvsland, Ø.; Dobrin, A.; Dobrowolski, T.; Domenicis Gimenez, D.; Dönigus, B.; Dordic, O.; Dørheim, S.; Dubey, A. K.; Dubla, A.; Ducroux, L.; Dupieux, P.; Dutta Majumdar, A. K.; Hilden, T. E.; Ehlers, R. J.; Elia, D.; Engel, H.; Erazmus, B.; Erdal, H. A.; Eschweiler, D.; Espagnon, B.; Esposito, M.; Estienne, M.; Esumi, S.; Evans, D.; Evdokimov, S.; Fabris, D.; Faivre, J.; Falchieri, D.; Fantoni, A.; Fasel, M.; Fehlker, D.; Feldkamp, L.; Felea, D.; Feliciello, A.; Feofilov, G.; Ferencei, J.; Fernández Téllez, A.; Ferreiro, E. G.; Ferretti, A.; Festanti, A.; Figiel, J.; Figueredo, M. A. S.; Filchagin, S.; Finogeev, D.; Fionda, F. M.; Fiore, E. M.; Floratos, E.; Floris, M.; Foertsch, S.; Foka, P.; Fokin, S.; Fragiacomo, E.; Francescon, A.; Frankenfeld, U.; Fuchs, U.; Furget, C.; Furs, A.; Fusco Girard, M.; Gaardhøje, J. J.; Gagliardi, M.; Gago, A. M.; Gallio, M.; Gangadharan, D. R.; Ganoti, P.; Gao, C.; Garabatos, C.; Garcia-Solis, E.; Gargiulo, C.; Garishvili, I.; Gerhard, J.; Germain, M.; Gheata, A.; Gheata, M.; Ghidini, B.; Ghosh, P.; Ghosh, S. K.; Gianotti, P.; Giubellino, P.; Gladysz-Dziadus, E.; Glässel, P.; Gomez Ramirez, A.; González-Zamora, P.; Gorbunov, S.; Görlich, L.; Gotovac, S.; Graczykowski, L. K.; Grelli, A.; Grigoras, A.; Grigoras, C.; Grigoriev, V.; Grigoryan, A.; Grigoryan, S.; Grinyov, B.; Grion, N.; Grosse-Oetringhaus, J. F.; Grossiord, J.-Y.; Grosso, R.; Guber, F.; Guernane, R.; Guerzoni, B.; Guilbaud, M.; Gulbrandsen, K.; Gulkanyan, H.; Gumbo, M.; Gunji, T.; Gupta, A.; Gupta, R.; Khan, K. H.; Haake, R.; Haaland, Ø.; Hadjidakis, C.; Haiduc, M.; Hamagaki, H.; Hamar, G.

    2014-11-01

    The ALICE Collaboration would like to thank all its engineers and technicians for their invaluable contributions to the construction of the experiment and the CERN accelerator teams for the outstanding performance of the LHC complex.

  3. Approaches to the Surveillance of Foodborne Disease: A Review of the Evidence.

    PubMed

    Ford, Laura; Miller, Megge; Cawthorne, Amy; Fearnley, Emily; Kirk, Martyn

    2015-12-01

    Foodborne disease surveillance aims to reduce the burden of illness due to contaminated food. There are several different types of surveillance systems, including event-based surveillance, indicator-based surveillance, and integrated food chain surveillance. These approaches are not mutually exclusive, have overlapping data sources, require distinct capacities and resources, and can be considered a hierarchy, with each level being more complex and resulting in a greater ability to detect and control foodborne disease. Event-based surveillance is generally the least resource-intensive system and makes use of informal data sources. Indicator-based surveillance is seen as traditional notifiable disease surveillance and consists of routinely collected data. Integrated food chain surveillance is viewed as the optimal practice for conducting continuous risk analysis for foodborne diseases, but also requires significant ongoing resources and greater multisectoral collaboration compared to the other systems. Each country must determine the most appropriate structure for their surveillance system for foodborne diseases based on their available resources. This review explores the evidence on the principles, minimum capabilities, and minimum requirements of each type of surveillance and discusses examples from a range of countries. This review forms the evidence base for the Strengthening the Surveillance and Response for Foodborne Diseases: A Practical Manual. PMID:26554434

  4. Ongoing Surveillance for Lymphatic Filariasis in Togo: Assessment of Alternatives and Nationwide Reassessment of Transmission Status

    PubMed Central

    Budge, Philip J.; Dorkenoo, Ameyo M.; Sodahlon, Yao K.; Fasuyi, Omofolarin B.; Mathieu, Els

    2014-01-01

    Tremendous progress has been made towards the goal of global elimination of lymphatic filariasis (LF) transmission by 2020. The number of endemic countries reducing LF transmission through mass drug administration continues to increase, and therefore, the need for effective post-intervention surveillance also continues to increase. Togo is the first sub-Saharan African country to implement LF surveillance, and it has 6 years of experience with this passive surveillance system. We herein report the results of a recent evaluation of the Togolese LF surveillance system, including an evaluation of blood donors as a surveillance population, and provide updated results of ongoing surveillance, including expansion in remote areas. Since implementation of LF surveillance in 2006, only three cases of positive Wuchereria bancrofti filaremia have been detected, suggesting that interruption of transmission has been sustained. Given the impracticality of validating the surveillance system in the absence of ongoing transmission, we confirmed the lack of transmission through a nationwide reassessment survey. PMID:24189363

  5. Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine’s Workshop Series, “Implementing a National Cancer Clinical Trials System for the 21st Century”

    PubMed Central

    Canetta, Renzo; Nass, Sharyl J.

    2014-01-01

    Since their inception in the 1950s, the National Cancer Institute-funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM’s National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM-ASCO workshops, outlines the progress and remaining challenges of these collaborations. PMID:25326161

  6. 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.

  7. 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.

  8. 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

  9. Collaborative Effort for a Centralized Worldwide Tuberculosis Relational Sequencing Data Platform.

    PubMed

    Starks, Angela M; Avilés, Enrique; Cirillo, Daniela M; Denkinger, Claudia M; Dolinger, David L; Emerson, Claudia; Gallarda, Jim; Hanna, Debra; Kim, Peter S; Liwski, Richard; Miotto, Paolo; Schito, Marco; Zignol, Matteo

    2015-10-15

    Continued progress in addressing challenges associated with detection and management of tuberculosis requires new diagnostic tools. These tools must be able to provide rapid and accurate information for detecting resistance to guide selection of the treatment regimen for each patient. To achieve this goal, globally representative genotypic, phenotypic, and clinical data are needed in a standardized and curated data platform. A global partnership of academic institutions, public health agencies, and nongovernmental organizations has been established to develop a tuberculosis relational sequencing data platform (ReSeqTB) that seeks to increase understanding of the genetic basis of resistance by correlating molecular data with results from drug susceptibility testing and, optimally, associated patient outcomes. These data will inform development of new diagnostics, facilitate clinical decision making, and improve surveillance for drug resistance. ReSeqTB offers an opportunity for collaboration to achieve improved patient outcomes and to advance efforts to prevent and control this devastating disease. PMID:26409275

  10. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis.

    PubMed Central

    Henry, D.; Lim, L. L.; Garcia Rodriguez, L. A.; Perez Gutthann, S.; Carson, J. L.; Griffin, M.; Savage, R.; Logan, R.; Moride, Y.; Hawkey, C.; Hill, S.; Fries, J. T.

    1996-01-01

    OBJECTIVE--To compare the relative risks of serious gastrointestinal complications reported with individual non-steroidal anti-inflammatory drugs. DESIGN--Systematic review of controlled epidemiological studies that found a relation between use of the drugs and admission to hospital for haemorrhage or perforation. SETTING--Hospital and community based case-control and cohort studies. MAIN OUTCOME MEASURES--(a) Estimated relative risks of gastrointestinal complications with use of individual drugs, exposure to ibuprofen being used as reference; (b) a ranking that best summarised the sequence of relative risks observed in the studies. RESULTS--12 studies met the inclusion criteria. 11 provided comparative data on ibuprofen and other drugs. Ibuprofen ranked lowest or equal lowest for risk in 10 of the 11 studies. Pooled relative risks calculated with exposure to ibuprofen used as reference were all significantly greater than 1.0 (interval of point estimates 1.6 to 9.2). Overall, ibuprofen was associated with the lowest relative risk, followed by diclofenac. Azapropazone, tolmetin, ketoprofen, and piroxicam ranked highest for risk and indomethacin, naproxen, sulindac, and aspirin occupied intermediate positions. Higher doses of ibuprofen were associated with relative risks similar to those with naproxen and indomethacin. CONCLUSIONS--The low risk of serious gastrointestinal complications with ibuprofen seems to be attributable mainly to the low doses of the drug used in clinical practice. In higher doses ibuprofen is associated with a similar risk to other non-steroidal anti-inflammatory drugs. Use of low risk drugs in low dosage as first line treatment would substantially reduce the morbidity and mortality due to serious gastrointestinal toxicity from these drugs. PMID:8664664

  11. [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

  12. Global health surveillance.

    PubMed

    St Louis, Michael

    2012-07-27

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

  13. Behavioral surveillance among people at risk for HIV infection in the U.S.: the National HIV Behavioral Surveillance System.

    PubMed

    Gallagher, Kathleen M; Sullivan, Patrick S; Lansky, Amy; Onorato, Ida M

    2007-01-01

    The Centers for Disease Control and Prevention, in collaboration with 25 state and local health departments, began the National HIV Behavioral Surveillance System (NHBS) in 2003. The system focuses on people at risk for HIV infection and surveys the three populations at highest risk for HIV in the United States: men who have sex with men, injecting drug users, and high-risk heterosexuals. The project collects information from these three populations during rotating 12-month cycles. Methods for recruiting participants vary for each at-risk population, but NHBS uses a standardized protocol and core questionnaire for each cycle. Participating health departments tailor their questionnaire to collect information about specific prevention programs offered in their geographic area and to address local data needs. Data collected from NHBS will be used to describe trends in key behavioral risk indicators and evaluate current HIV prevention programs. This information in turn can be used to identify gaps in prevention services and target new prevention activities with the goal of reducing new HIV infections in the United States. PMID:17354525

  14. 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

  15. Collaboration Physics

    ERIC Educational Resources Information Center

    Harlow, Danielle; Otero, Valerie K.

    2005-01-01

    What happens when university curriculum developers are mixed with motivated elementary teachers? ? An awesome learning collaboration that benefits researchers, teachers, and students! That's what the authors discovered when they--university researchers involved in the Physics for Elementary Teachers (PET) project--teamed up with local elementary…

  16. Collaborative Design

    ERIC Educational Resources Information Center

    Broderick, Debora

    2014-01-01

    This practitioner research study investigates the power of multimodal texts within a real-world context and argues that a participatory culture focused on literary arts offers marginalized high school students opportunities for collaborative design and authoring. Additionally, this article invites educators to rethink the at-risk label. This…

  17. Collaborative Spaces

    ERIC Educational Resources Information Center

    Lippman, Peter C.

    2013-01-01

    When architects discuss the educational facilities of the next century and beyond, the conversation turns to collaborative spaces. They envision flexible and fluid spaces that will encourage creative and critical thinking, and free students to communicate clearly about the task at hand. While these are admirable ideals, there are some fundamental…

  18. Collaborative engagement

    NASA Astrophysics Data System (ADS)

    Wade, Robert L.; Reames, Joseph M.

    2004-09-01

    A need exists for United States military forces to perform collaborative engagement operations between unmanned systems. This capability has the potential to contribute significant tactical synergy to the Joint Force operating in the battlespace of the future. Collaborative engagements potentially offer force conservation, perform timely acquisition and dissemination of essential combat information, and can eliminate high value and time critical targets. Collaborative engagements can also add considerably to force survivability by reducing soldier and equipment exposure during critical operations. This paper will address a multiphase U.S. Army Aviation and Missile Research, Development, and Engineering Center (AMRDEC) Joint Technology Center (JTC) Systems Integration Laboratory (SIL) program to assess information requirements, Joint Architecure for Unmanned Systems (JAUS), on-going Science and Technology initiatives, and conduct simulation based experiments to identify and resolve technical risks required to conduct collaborative engagements using unmanned aerial vehicles (UAV) and unmanned ground vehicles (UGV). The schedule outlines an initial effort to expand, update and exercise JAUS, provide early feedback to support user development of Concept of Operations (CONOPs) and Tactics, Techniques and Procedures (TTPs), and develop a Multiple Unified Simulation Environment (MUSE) system with JAUS interfaces necessary to support an unmanned system of systems collaboartive engagement.

  19. Literacy Collaborative.

    ERIC Educational Resources Information Center

    Education Commission of the States, Denver, CO.

    This paper provides an overview of Literacy Collaborative, a comprehensive, schoolwide program designed to provide long-term support to schools working toward successful literacy achievement for every child by the end of 2nd grade. There are currently (year 2000) 390 literacy coordinators or trainers serving 372 schools in 25 states. The…

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  1. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  2. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  3. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 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 ...

  5. Secure Video Surveillance System (SVSS) for unannounced safeguards inspections.

    SciTech Connect

    Galdoz, Erwin G. , Rio de Janeiro, Brazil); Pinkalla, Mark

    2010-09-01

    The Secure Video Surveillance System (SVSS) is a collaborative effort between the U.S. Department of Energy (DOE), Sandia National Laboratories (SNL), and the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC). The joint project addresses specific requirements of redundant surveillance systems installed in two South American nuclear facilities as a tool to support unannounced inspections conducted by ABACC and the International Atomic Energy Agency (IAEA). The surveillance covers the critical time (as much as a few hours) between the notification of an inspection and the access of inspectors to the location in facility where surveillance equipment is installed. ABACC and the IAEA currently use the EURATOM Multiple Optical Surveillance System (EMOSS). This outdated system is no longer available or supported by the manufacturer. The current EMOSS system has met the project objective; however, the lack of available replacement parts and system support has made this system unsustainable and has increased the risk of an inoperable system. A new system that utilizes current technology and is maintainable is required to replace the aging EMOSS system. ABACC intends to replace one of the existing ABACC EMOSS systems by the Secure Video Surveillance System. SVSS utilizes commercial off-the shelf (COTS) technologies for all individual components. Sandia National Laboratories supported the system design for SVSS to meet Safeguards requirements, i.e. tamper indication, data authentication, etc. The SVSS consists of two video surveillance cameras linked securely to a data collection unit. The collection unit is capable of retaining historical surveillance data for at least three hours with picture intervals as short as 1sec. Images in .jpg format are available to inspectors using various software review tools. SNL has delivered two SVSS systems for test and evaluation at the ABACC Safeguards Laboratory. An additional 'proto-type' system remains

  6. 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.

  7. Diagnostics and surveillance methods

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  8. TUBERCULOSIS SURVEILLANCE REPORTS

    EPA Science Inventory

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

  9. Mortar launched surveillance system

    NASA Astrophysics Data System (ADS)

    Lewis, Carl E.; Carlton, Lindley A.

    2001-02-01

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

  10. 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.