Tools for surveillance of anti-malarial drug resistance: an assessment of the current landscape.

PubMed

Nsanzabana, Christian; Djalle, Djibrine; Guérin, Philippe J; Ménard, Didier; González, Iveth J

2018-02-08

To limit the spread and impact of anti-malarial drug resistance and react accordingly, surveillance systems able to detect and track in real-time its emergence and spread need to be strengthened or in some places established. Currently, surveillance of anti-malarial drug resistance is done by any of three approaches: (1) in vivo studies to assess the efficacy of drugs in patients; (2) in vitro/ex vivo studies to evaluate parasite susceptibility to the drugs; and/or (3) molecular assays to detect validated gene mutations and/or gene copy number changes that are associated with drug resistance. These methods are complementary, as they evaluate different aspects of resistance; however, standardization of methods, especially for in vitro/ex vivo and molecular techniques, is lacking. The World Health Organization has developed a standard protocol for evaluating the efficacy of anti-malarial drugs, which is used by National Malaria Control Programmes to conduct their therapeutic efficacy studies. Regional networks, such as the East African Network for Monitoring Antimalarial Treatment and the Amazon Network for the Surveillance of Antimalarial Drug Resistance, have been set up to strengthen regional capacities for monitoring anti-malarial drug resistance. The Worldwide Antimalarial Resistance Network has been established to collate and provide global spatial and temporal trends information on the efficacy of anti-malarial drugs and resistance. While exchange of information across endemic countries is essential for monitoring anti-malarial resistance, sustainable funding for the surveillance and networking activities remains challenging. The technology landscape for molecular assays is progressing quite rapidly, and easy-to-use and affordable new techniques are becoming available. They also offer the advantage of high throughput analysis from a simple blood spots obtained from a finger prick. New technologies combined with the strengthening of national reference

Effectiveness of urine surveillance as an adjunct to outpatient psychotherapy for drug abusers.

PubMed

Milby, J B; Clarke, C; Toro, C; Thornton, S; Rickert, D

1980-10-01

Twenty-nine polydrug abusers were randomly assigned to three out-patient treatment groups after inpatient detoxification. The groups were outpatient psychotherapy (1) with urine surveillance, (2) without surveillance, and (3) waiting list control. Tests were administered before and 3 months after outpatient treatment began. All groups made positive changes during treatment including significant reduction in drugs abused and numbers of subjects reporting less time spent in illegal activity. Notable significant differences were Group 3's reduction in social introversion vs Groups 1 and 2, and Group 1's retaining fewer drug-using friends and showing greatest reduction in barbiturate use frequency vs Groups 2 and 3. Experimenters concluded urine surveillance was somewhat helpful as an adjunct to outpatient psychotherapy but suggested its effect could be amplified by employing more rigorous surveillance procedures, especially if contingency contracting were utilized.

Collaboration for rare disease drug discovery research.

PubMed

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.

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

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

PubMed

Silva, Ivair R

2018-01-15

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

Surveillance of emerging drugs of abuse in Hong Kong: validation of an analytical tool.

PubMed

Tang, Magdalene H Y; Ching, C K; Tse, M L; Ng, Carol; Lee, Caroline; Chong, Y K; Wong, Watson; Mak, Tony W L

2015-04-01

To validate a locally developed chromatography-based method to monitor emerging drugs of abuse whilst performing regular drug testing in abusers. Cross-sectional study. Eleven regional hospitals, seven social service units, and a tertiary level clinical toxicology laboratory in Hong Kong. A total of 972 drug abusers and high-risk individuals were recruited from acute, rehabilitation, and high-risk settings between 1 November 2011 and 31 July 2013. A subset of the participants was of South Asian ethnicity. In total, 2000 urine or hair specimens were collected. Proof of concept that surveillance of emerging drugs of abuse can be performed whilst conducting routine drug of abuse testing in patients. The method was successfully applied to 2000 samples with three emerging drugs of abuse detected in five samples: PMMA (paramethoxymethamphetamine), TFMPP [1-(3-trifluoromethylphenyl)piperazine], and methcathinone. The method also detected conventional drugs of abuse, with codeine, methadone, heroin, methamphetamine, and ketamine being the most frequently detected drugs. Other findings included the observation that South Asians had significantly higher rates of using opiates such as heroin, methadone, and codeine; and that ketamine and cocaine had significantly higher detection rates in acute subjects compared with the rehabilitation population. This locally developed analytical method is a valid tool for simultaneous surveillance of emerging drugs of abuse and routine drug monitoring of patients at minimal additional cost and effort. Continued, proactive surveillance and early identification of emerging drugs will facilitate prompt clinical, social, and legislative management.

Post-marketing surveillance system for drugs in pregnancy--15 years experience of ENTIS.

PubMed

Schaefer, Christof; Hannemann, Doreen; Meister, Reinhard

2005-01-01

Teratology Information Services (TIS) provide the public and health professionals with tailor-made information on drug risks in pregnancy. TIS in Europe, Israel and Latin America collaborate in the European Network of Teratology Information Services (ENTIS) in order to optimise interpretation of risk data, risk communication and risk management as well as recommendations for drug treatment in pregnant women. In addition, efforts are undertaken to enhance and harmonise documentation of exposed pregnancies and their outcomes. These prospectively ascertained data are evaluated like controlled, observational cohort studies, where exposed pregnancies are compared to a non-exposed control group for various outcome variables such as (major) malformations, birth measures and the state of the new-born infant, spontaneous abortion. The prospective methodology minimises recall bias of the studied drugs. Evaluating the data collected according to standardised protocols with appropriate statisticals methods substantially improves risk assessment. The comparison of spontaneous abortions between coumarin exposed pregnancies and controls enrolled in the Berlin TIS demonstrates the benefit of the methodology of survival analysis within the framework of the proportional hazard model. The ENTIS multi-centre approach permits studying large exposed cohorts even with seldomly used medicinal products. In terms of post-marketing surveillance there are no alternatives to TIS data. Data collection by TIS uses an already established risk communication system, and has the advantage of low costs and motivated responders. As a TIS is contacted mainly for insufficiently documented drugs or those suspected of acting as developmental toxicants there is even a selection for products needing research.

Current French system of post-marketing drug surveillance.

PubMed

Albengres, E; Gauthier, F; Tillement, J P

1990-07-01

The French system of drug surveillance is characterized by several original features: thirty regional centres are selected to cover all of France to collect, analyze and enter the adverse drug events in the national data bank. The system is based on a bank of well documented files submitted to a decision of imputation; the report of severe events by prescribers is mandatory; cases are collected either by spontaneous reporting (routine) or by direct request (intensive validation study); the system is being involved in studies of epidemiological type as carried out by the national system of health or a few societies of medicine as well as by the centres themselves in cooperative works on defined populations.

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

PubMed

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

2013-09-30

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. We systematically searched for longitudinal measures of illegal drug supply indicators to assess the long-term impact of enforcement-based supply reduction interventions. 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. 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. 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. 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 increased since 1990. These findings suggest that expanding efforts at

Teach-Discover-Treat (TDT): Collaborative Computational Drug Discovery for Neglected Diseases

PubMed Central

Jansen, Johanna M.; Cornell, Wendy; Tseng, Y. Jane; Amaro, Rommie E.

2012-01-01

Teach – Discover – Treat (TDT) is an initiative to promote the development and sharing of computational tools solicited through a competition with the aim to impact education and collaborative drug discovery for neglected diseases. Collaboration, multidisciplinary integration, and innovation are essential for successful drug discovery. This requires a workforce that is trained in state-of-the-art workflows and equipped with the ability to collaborate on platforms that are accessible and free. The TDT competition solicits high quality computational workflows for neglected disease targets, using freely available, open access tools. PMID:23085175

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…

Documentation forms for monitoring occupational surveillance of healthcare workers who handle cytotoxic drugs.

PubMed

Parillo, V L

1994-01-01

To develop a procedure for medical surveillance of healthcare workers who handle cytotoxic drugs. Literature review and guidelines published by the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. INFORMATION SELECTION: Studies of possible exposure screening tests, congenital defects in offspring, and case studies. Some degree of risk exists in handling cytotoxic drugs, but no reliable screening test for cytotoxic drug exposure has been developed. Reproductive hazards are possible when protective equipment is not used. Areas to be addressed when devising surveillance procedures include who to cover, what baseline data to gather, what periodic monitoring will be necessary (and at what interval it will be conducted), how to handle exposure incidents, and what documentation system will be used. A procedure using a baseline risk factor form and a yearly monitoring questionnaire was devised and implemented. Forms contain documentation of worker teaching. Most often, nurses are the healthcare workers who handle cytotoxic drugs. A consistent approach to monitoring healthcare workers is facilitated by using a defined procedure and standardized forms.

Surveillance of HIV antiretroviral drug resistance in treated individuals in England: 1998-2000.

PubMed

Scott, Paul; Arnold, Eve; Evans, Barry; Pozniak, Anton; Moyle, Graeme; Shahmenesh, Mohsen; White, David; Shirley, Jane; Cane, Patricia; Pillay, Deenan

2004-03-01

To establish a surveillance programme for HIV drug resistance within the UK covering the years from 1998 to 2000, following the introduction of triple combination antiretroviral therapy. Sentinel sites included large, medium sized and small clinical centres. Data were analysed until December 2000. Of nearly 300 samples tested, results from 91, 92 and 92 patients, respectively in 1998, 1999 and 2000, who were receiving HIV therapy with a viral load >2000 copies/mL, the majority had viruses with some degree of drug resistance. Overall, the presence of any resistance increased between 1998 and 1999, and fell again in 2000 (69% versus 88% versus 55%). However, major differences were observed between drug classes, such that non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) resistance rose dramatically over the period studied. We show that this correlated with increased NNRTI prescribing. Furthermore, an overall increase in prevalence of viruses with resistance to one or more drugs within all three available classes was observed. A higher prevalence of drug resistance was observed in patients from smaller clinical centres. This is the first such sentinel surveillance dataset from the UK, and is unique in correlating these data with national antiretroviral prescribing patterns. Our findings are relevant to the increased transmission of HIV drug resistance observed over this period.

Genetic sequencing for surveillance of drug resistance in tuberculosis in highly endemic countries: a multi-country population-based surveillance study.

PubMed

Zignol, Matteo; Cabibbe, Andrea Maurizio; Dean, Anna S; Glaziou, Philippe; Alikhanova, Natavan; Ama, Cecilia; Andres, Sönke; Barbova, Anna; Borbe-Reyes, Angeli; Chin, Daniel P; Cirillo, Daniela Maria; Colvin, Charlotte; Dadu, Andrei; Dreyer, Andries; Driesen, Michèle; Gilpin, Christopher; Hasan, Rumina; Hasan, Zahra; Hoffner, Sven; Hussain, Alamdar; Ismail, Nazir; Kamal, S M Mostofa; Khanzada, Faisal Masood; Kimerling, Michael; Kohl, Thomas Andreas; Mansjö, Mikael; Miotto, Paolo; Mukadi, Ya Diul; Mvusi, Lindiwe; Niemann, Stefan; Omar, Shaheed V; Rigouts, Leen; Schito, Marco; Sela, Ivita; Seyfaddinova, Mehriban; Skenders, Girts; Skrahina, Alena; Tahseen, Sabira; Wells, William A; Zhurilo, Alexander; Weyer, Karin; Floyd, Katherine; Raviglione, Mario C

2018-06-01

In many countries, regular monitoring of the emergence of resistance to anti-tuberculosis drugs is hampered by the limitations of phenotypic testing for drug susceptibility. We therefore evaluated the use of genetic sequencing for surveillance of drug resistance in tuberculosis. Population-level surveys were done in hospitals and clinics in seven countries (Azerbaijan, Bangladesh, Belarus, Pakistan, Philippines, South Africa, and Ukraine) to evaluate the use of genetic sequencing to estimate the resistance of Mycobacterium tuberculosis isolates to rifampicin, isoniazid, ofloxacin, moxifloxacin, pyrazinamide, kanamycin, amikacin, and capreomycin. For each drug, we assessed the accuracy of genetic sequencing by a comparison of the adjusted prevalence of resistance, measured by genetic sequencing, with the true prevalence of resistance, determined by phenotypic testing. Isolates were taken from 7094 patients with tuberculosis who were enrolled in the study between November, 2009, and May, 2014. In all tuberculosis cases, the overall pooled sensitivity values for predicting resistance by genetic sequencing were 91% (95% CI 87-94) for rpoB (rifampicin resistance), 86% (74-93) for katG, inhA, and fabG promoter combined (isoniazid resistance), 54% (39-68) for pncA (pyrazinamide resistance), 85% (77-91) for gyrA and gyrB combined (ofloxacin resistance), and 88% (81-92) for gyrA and gyrB combined (moxifloxacin resistance). For nearly all drugs and in most settings, there was a large overlap in the estimated prevalence of drug resistance by genetic sequencing and the estimated prevalence by phenotypic testing. Genetic sequencing can be a valuable tool for surveillance of drug resistance, providing new opportunities to monitor drug resistance in tuberculosis in resource-poor countries. Before its widespread adoption for surveillance purposes, there is a need to standardise DNA extraction methods, recording and reporting nomenclature, and data interpretation. Bill & Melinda

Surveillance of gastrointestinal disease in France using drug sales data.

PubMed

Pivette, Mathilde; Mueller, Judith E; Crépey, Pascal; Bar-Hen, Avner

2014-09-01

Drug sales data have increasingly been used for disease surveillance during recent years. Our objective was to assess the value of drug sales data as an operational early detection tool for gastroenteritis epidemics at national and regional level in France. For the period 2008-2013, we compared temporal trends of drug sales for the treatment of gastroenteritis with trends of cases reported by a Sentinel Network of general practitioners. We benchmarked detection models to select the one with the best sensitivity, false alert proportion and timeliness, and developed a prospective framework to assess the operational performance of the system. Drug sales data allowed the detection of seasonal gastrointestinal epidemics occurring in winter with a distinction between prescribed and non-prescribed drugs. Sales of non-prescribed drugs allowed epidemic detection on average 2.25 weeks earlier than Sentinel data. These results confirm the value of drug sales data for real-time monitoring of gastroenteritis epidemic activity. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

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. Copyright © 2011 Elsevier Ltd. All rights reserved.

Surveillance and Epidemiology of Drug Resistant Infections Consortium (SEDRIC): Supporting the transition from strategy to action

PubMed Central

Fukuda, Keiji; Limmathurotsakul, Direk; Okeke, Iruka N.; Shetty, Nandini; van Doorn, Rogier; Feasey, Nicholas A.; Chiara, Francesca; Zoubiane, Ghada; Jinks, Tim; Parkhill, Julian; Patel, Jean; Reid, Stuart W.J.; Holmes, Alison H.; Peacock, Sharon J.

2018-01-01

In recognition of the central importance of surveillance and epidemiology in the control of antimicrobial resistance and the need to strengthen surveillance at all levels, Wellcome has brought together a new international expert group SEDRIC (Surveillance and Epidemiology of Drug Resistant Infections Consortium). SEDRIC aims to advance and transform the ways of tracking, sharing and analysing rates of infection and drug resistance, burden of disease, information on antibiotic use, opportunities for preventative measures such as vaccines, and contamination of the environment. SEDRIC will strengthen the availability of information needed to monitor and track risks, including an evaluation of access to, and utility of data generated by pharma and research activities, and will support the translation of surveillance data into interventions, changes in policy and more effective practices. Ways of working will include the provision of independent scientific analysis, advocacy and expert advice to groups, such as the Wellcome Drug Resistant Infection Priority Programme. A priority for SEDRIC’s first Working Group is to review mechanisms to strengthen the generation, collection, collation and dissemination of high quality data, together with the need for creativity in the use of existing data and proxy measures, and linking to existing in-country networking infrastructure. SEDRIC will also promote the translation of technological innovations into public health solutions. PMID:29904730

Ontario family physician readiness to collaborate with community pharmacists on drug therapy management.

PubMed

Pojskic, Nedzad; Mackeigan, Linda; Boon, Heather; Ellison, Philip; Breslin, Curtis

2011-03-01

Empirical evidence suggests that pharmacist-physician collaboration can improve patients' clinical outcomes; however, such collaboration occurs relatively infrequently in the community setting. There has been little research on physicians' perspectives of such collaboration. To ascertain Ontario family physician readiness to collaborate with community pharmacists on drug therapy management. The survey instrument was based on the transtheoretical model of behavior change. It enquired about 3 physician behaviors that represented low-, mid-, and high-level collaboration with pharmacists. The survey was distributed by fax or mail to a random sample of 848 Ontario family physicians and general practitioners, stratified by practice location (urban/rural). The response rate was 36%. Most respondents reported conversing with community pharmacists about a patient's drug therapy management 5 or fewer times per week. Eighty-four percent reported that they regularly took community pharmacists' phone calls, whereas 78% reported that they sometimes sought pharmacists' recommendations regarding their patients' drug therapy. Twenty-eight percent reported that they sometimes referred their patients to community pharmacists for medication reviews, with 44% unaware of such a service. There were no differences in physician readiness to engage in any of the 3 collaborative behaviors in urban versus rural settings. More accurate patient medication lists were perceived as the main advantage (pro) of collaborating with community pharmacists and pharmacists' lack of patient information as the main disadvantage (con). Collectively, perceived pros of collaboration were positive predictors of physician readiness to collaborate on all 3 behaviors, whereas perceived cons were negative predictors for the low- and mid-level behaviors. Female physicians were more likely than males to seek pharmacists' recommendations, whereas more experienced physicians were more likely to refer patients to

Delayed and Unreported Drug-Susceptibility Testing Results in the US National Tuberculosis Surveillance System, 1993-2014.

PubMed

Jones, Jefferson Michael; Armstrong, Lori R

Drug-susceptibility testing (DST) of Mycobacterium tuberculosis is necessary for identifying drug-resistant tuberculosis, administering effective treatment regimens, and preventing the spread of drug-resistant tuberculosis. DST is recommended for all culture-confirmed cases of tuberculosis. We examined trends in delayed and unreported DST results in the Centers for Disease Control and Prevention's National Tuberculosis Surveillance System. We analyzed culture-confirmed tuberculosis cases reported to the National Tuberculosis Surveillance System during 1993-2014 for annual trends in initial DST reporting for first-line antituberculosis drugs and trends in on-time, delayed, and unreported results. We defined on-time reporting as DST results received during the same calendar year in which the patient's case was reported or ≤4 months after the calendar year ended and delayed reporting as DST results received after the calendar year. We compared cases with on-time, delayed, and unreported DST results by patient and tuberculosis program characteristics. The proportion of cases with reported results for all first-line antituberculosis drugs increased during 1993-2011. Reporting of pyrazinamide results was lower than reporting of other drugs. However, during 2000-2012, of 134 787 tuberculosis cases reported to the National Tuberculosis Surveillance System, reporting was on time for 125 855 (93.4%) cases, delayed for 5332 (4.0%) cases, and unreported for 3600 (2.7%) cases. Despite increases in the proportion of cases with on-time DST results, delayed and unreported results persisted. Carefully assessing causes for delayed and unreported DST results should lead to more timely reporting of drug-resistant tuberculosis.

Low-Cost Ultra-Wide Genotyping Using Roche/454 Pyrosequencing for Surveillance of HIV Drug Resistance

PubMed Central

Dudley, Dawn M.; Chin, Emily N.; Bimber, Benjamin N.; Sanabani, Sabri S.; Tarosso, Leandro F.; Costa, Priscilla R.; Sauer, Mariana M.; Kallas, Esper G.; O.’Connor, David H.

2012-01-01

Background Great efforts have been made to increase accessibility of HIV antiretroviral therapy (ART) in low and middle-income countries. The threat of wide-scale emergence of drug resistance could severely hamper ART scale-up efforts. Population-based surveillance of transmitted HIV drug resistance ensures the use of appropriate first-line regimens to maximize efficacy of ART programs where drug options are limited. However, traditional HIV genotyping is extremely expensive, providing a cost barrier to wide-scale and frequent HIV drug resistance surveillance. Methods/Results We have developed a low-cost laboratory-scale next-generation sequencing-based genotyping method to monitor drug resistance. We designed primers specifically to amplify protease and reverse transcriptase from Brazilian HIV subtypes and developed a multiplexing scheme using multiplex identifier tags to minimize cost while providing more robust data than traditional genotyping techniques. Using this approach, we characterized drug resistance from plasma in 81 HIV infected individuals collected in São Paulo, Brazil. We describe the complexities of analyzing next-generation sequencing data and present a simplified open-source workflow to analyze drug resistance data. From this data, we identified drug resistance mutations in 20% of treatment naïve individuals in our cohort, which is similar to frequencies identified using traditional genotyping in Brazilian patient samples. Conclusion The developed ultra-wide sequencing approach described here allows multiplexing of at least 48 patient samples per sequencing run, 4 times more than the current genotyping method. This method is also 4-fold more sensitive (5% minimal detection frequency vs. 20%) at a cost 3–5× less than the traditional Sanger-based genotyping method. Lastly, by using a benchtop next-generation sequencer (Roche/454 GS Junior), this approach can be more easily implemented in low-resource settings. This data provides proof

Enhancing Seasonal Influenza Surveillance: Topic Analysis of Widely Used Medicinal Drugs Using Twitter Data.

PubMed

Kagashe, Ireneus; Yan, Zhijun; Suheryani, Imran

2017-09-12

Uptake of medicinal drugs (preventive or treatment) is among the approaches used to control disease outbreaks, and therefore, it is of vital importance to be aware of the counts or frequencies of most commonly used drugs and trending topics about these drugs from consumers for successful implementation of control measures. Traditional survey methods would have accomplished this study, but they are too costly in terms of resources needed, and they are subject to social desirability bias for topics discovery. Hence, there is a need to use alternative efficient means such as Twitter data and machine learning (ML) techniques. Using Twitter data, the aim of the study was to (1) provide a methodological extension for efficiently extracting widely consumed drugs during seasonal influenza and (2) extract topics from the tweets of these drugs and to infer how the insights provided by these topics can enhance seasonal influenza surveillance. From tweets collected during the 2012-13 flu season, we first identified tweets with mentions of drugs and then constructed an ML classifier using dependency words as features. The classifier was used to extract tweets that evidenced consumption of drugs, out of which we identified the mostly consumed drugs. Finally, we extracted trending topics from each of these widely used drugs' tweets using latent Dirichlet allocation (LDA). Our proposed classifier obtained an F 1 score of 0.82, which significantly outperformed the two benchmark classifiers (ie, P<.001 with the lexicon-based and P=.048 with the 1-gram term frequency [TF]). The classifier extracted 40,428 tweets that evidenced consumption of drugs out of 50,828 tweets with mentions of drugs. The most widely consumed drugs were influenza virus vaccines that had around 76.95% (31,111/40,428) share of the total; other notable drugs were Theraflu, DayQuil, NyQuil, vitamins, acetaminophen, and oseltamivir. The topics of each of these drugs exhibited common themes or experiences from

Enhancing Seasonal Influenza Surveillance: Topic Analysis of Widely Used Medicinal Drugs Using Twitter Data

PubMed Central

Kagashe, Ireneus; Suheryani, Imran

2017-01-01

Background Uptake of medicinal drugs (preventive or treatment) is among the approaches used to control disease outbreaks, and therefore, it is of vital importance to be aware of the counts or frequencies of most commonly used drugs and trending topics about these drugs from consumers for successful implementation of control measures. Traditional survey methods would have accomplished this study, but they are too costly in terms of resources needed, and they are subject to social desirability bias for topics discovery. Hence, there is a need to use alternative efficient means such as Twitter data and machine learning (ML) techniques. Objective Using Twitter data, the aim of the study was to (1) provide a methodological extension for efficiently extracting widely consumed drugs during seasonal influenza and (2) extract topics from the tweets of these drugs and to infer how the insights provided by these topics can enhance seasonal influenza surveillance. Methods From tweets collected during the 2012-13 flu season, we first identified tweets with mentions of drugs and then constructed an ML classifier using dependency words as features. The classifier was used to extract tweets that evidenced consumption of drugs, out of which we identified the mostly consumed drugs. Finally, we extracted trending topics from each of these widely used drugs’ tweets using latent Dirichlet allocation (LDA). Results Our proposed classifier obtained an F1 score of 0.82, which significantly outperformed the two benchmark classifiers (ie, P<.001 with the lexicon-based and P=.048 with the 1-gram term frequency [TF]). The classifier extracted 40,428 tweets that evidenced consumption of drugs out of 50,828 tweets with mentions of drugs. The most widely consumed drugs were influenza virus vaccines that had around 76.95% (31,111/40,428) share of the total; other notable drugs were Theraflu, DayQuil, NyQuil, vitamins, acetaminophen, and oseltamivir. The topics of each of these drugs exhibited

Surveillance of drug resistance for tuberculosis control: why and how?

PubMed

Chaulet, P; Boulahbal, F; Grosset, J

1995-12-01

The resistance of Mycobacterium tuberculosis to antibiotics, which reflects the quality of the chemotherapy applied in the community, is one of the elements of epidemiological surveillance used in national tuberculosis programmes. Measurement of drug resistance poses problems for biologists in standardization of laboratory methods and quality control. The definition of rates of acquired and primary drug resistance also necessitates standardization in the methods used to collect information transmitted by clinicians. Finally, the significance of the rates calculated depends on the choice of the patients sample on which sensitivity tests have been performed. National surveys of drug resistance therefore require multidisciplinary participation in order to select the only useful indicators: rates of primary resistance and of acquired resistance. These indicators, gathered in representative groups of patients over a long period, are a measurement of the impact of modern chemotherapy regimens on bacterial ecology.

Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

PubMed Central

FRIEDMANN, PETER D.; KATZ, ELIZABETH C.; RHODES, ANNE G.; TAXMAN, FAYE S.; O'CONNELL, DANIEL J.; FRISMAN, LINDA K.; BURDON, WILLIAM M.; FLETCHER, BENNETT W.; LITT, MARK D.; CLARKE, JENNIFER; MARTIN, STEVEN S.

2009-01-01

This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment counselors to provide role induction counseling, contract for pro-social behavior, and deliver contingent reinforcement of behaviors consistent with treatment objectives. The Step'n Out study will randomize 450 drug-involved parolees to collaborative behavioral management or usual parole. Follow-up at 3-and 9-months will assess primary outcomes of rearrest, crime and drug use. If collaborative behavioral management is effective, its wider adoption could improve the outcomes of community reentry of drug-involved ex-offenders. PMID:19809591

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…

Integrating animal health and food safety surveillance data from slaughterhouse control.

PubMed

Lynch, J A; Silva, P

2013-08-01

Surveillance at the slaughterhouse level for animal health and food safety purposes encompasses examination for the presence of pathology, pathogens, drug residues, chemical contaminants and antimicrobial resistance. Government, industry and academia are the primary proponents of such surveillance. A variety of policies and policy instruments from voluntary to legislative may be applied to promote or obligate participation. Efforts to integrate data across such diverse organisations encounter significant legal, logistical and financial challenges. Enhancement of policies to encourage effective integration of animal health and food safety surveillance data from slaughterhouse control should promote: a long-term approach; collaboration among government, industry and academia; application of a risk-based scheme; and transparent public access to data, with generation of consumer-oriented communications derived from the data. A strong case can be made that the complementary pursuit of both sustainable animal health and food safety can continue to be aided by surveillance at the slaughterhouse level.

[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.

Surveillance of transmitted HIV drug resistance in antiretroviral-naive patients aged less than 25 years, in Bangkok, Thailand.

PubMed

Sungkanuparph, Somnuek; Pasomsub, Ekawat; Chantratita, Wasun

2014-01-01

Emergence of transmitted HIV drug resistance (TDR) is a concern after global scale-up of antiretroviral therapy (ART). World Health Organization had developed threshold survey method for surveillance of TDR in resource-limited countries. ART in Thailand has been scaling up for >10 years. To evaluate the current TDR in Thailand, a cross-sectional study was conducted among antiretroviral-naive HIV-infected patients aged <25 years who newly visited infectious disease clinic in a university hospital, in 2011. HIV genotypic-resistance test was performed. World Health Organization 2009 surveillance drug-resistance mutations were used to define TDR. Of 50 patients, the prevalence of TDR was 4%. Of 2 patients with TDR, 1 had K103N and the other had Y181C mutations. Transmitted HIV drug resistance is emerging in Thailand after a decade of rapid scale-up of ART. Interventions to prevent TDR at the population level are essentially needed in Thailand. Surveillance for TDR in Thailand has to be regularly performed.

HIV drug resistance surveillance for prioritizing treatment in resource-limited settings

PubMed Central

Walensky, Rochelle P.; Weinstein, Milton C.; Yazdanpanah, Yazdan; Losina, Elena; Mercincavage, Lauren M.; Touré, Siaka; Divi, Nomita; Anglaret, Xavier; Goldie, Sue J.; Freedberg, Kenneth A.

2008-01-01

Background Sentinel testing programs for HIV drug resistance in resource-limited settings can inform policy on antiretroviral therapy (ART) and drug sequencing. Objective To examine the value of resistance surveillance in influencing recommendations toward effective and cost-effective sequencing of ART regimens. Methods A state-transition model of HIV infection was adapted to simulate clinical care in Côte d’Ivoire and evaluate the incremental cost-effectiveness of (1) no ART; (2) ART beginning with a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen followed by a boosted protease inhibitor (PI)-based regimen; and (3) ART beginning with a boosted PI-based regimen followed by an NNRTI-based regimen. Results At a 5% prevalence of NNRTI resistance, a strategy that started with a PI-based regimen had a smaller health benefit and higher cost-effectiveness ratio than a strategy that started with an NNRTI-based regimen (cost-effectiveness ratio $910/year of life saved). Results consistently favored initiation with an NNRTI-based regimen, regardless of the population prevalence of NNRTI resistance (up to 76%) and the efficacy of an NNRTI-based regimen in the setting of resistance. The most influential parameters on the cost-effectiveness of sequencing strategies were boosted PI-based regimen costs and the efficacy of this regimen when used as second-line therapy. Conclusions Drug costs and treatment efficacies, but not NNRTI resistance levels, were most influential in determining optimal HIV drug sequencing in Côte d’Ivoire. Results of surveillance for NNRTI resistance should not be used as a major guide to treatment policy in resource-limited settings. PMID:17457091

Evaluating Behavioral Health Surveillance Systems.

PubMed

Azofeifa, Alejandro; Stroup, Donna F; Lyerla, Rob; Largo, Thomas; Gabella, Barbara A; Smith, C Kay; Truman, Benedict I; Brewer, Robert D; Brener, Nancy D

2018-05-10

In 2015, more than 27 million people in the United States reported that they currently used illicit drugs or misused prescription drugs, and more than 66 million reported binge drinking during the previous month. Data from public health surveillance systems on drug and alcohol abuse are crucial for developing and evaluating interventions to prevent and control such behavior. However, public health surveillance for behavioral health in the United States has been hindered by organizational issues and other factors. For example, existing guidelines for surveillance evaluation do not distinguish between data systems that characterize behavioral health problems and those that assess other public health problems (eg, infectious diseases). To address this gap in behavioral health surveillance, we present a revised framework for evaluating behavioral health surveillance systems. This system framework builds on published frameworks and incorporates additional attributes (informatics capabilities and population coverage) that we deemed necessary for evaluating behavioral health-related surveillance. This revised surveillance evaluation framework can support ongoing improvements to behavioral health surveillance systems and ensure their continued usefulness for detecting, preventing, and managing behavioral health problems.

Evaluating Behavioral Health Surveillance Systems

PubMed Central

Azofeifa, Alejandro; Lyerla, Rob; Largo, Thomas; Gabella, Barbara A.; Smith, C. Kay; Truman, Benedict I.; Brewer, Robert D.; Brener, Nancy D.

2018-01-01

In 2015, more than 27 million people in the United States reported that they currently used illicit drugs or misused prescription drugs, and more than 66 million reported binge drinking during the previous month. Data from public health surveillance systems on drug and alcohol abuse are crucial for developing and evaluating interventions to prevent and control such behavior. However, public health surveillance for behavioral health in the United States has been hindered by organizational issues and other factors. For example, existing guidelines for surveillance evaluation do not distinguish between data systems that characterize behavioral health problems and those that assess other public health problems (eg, infectious diseases). To address this gap in behavioral health surveillance, we present a revised framework for evaluating behavioral health surveillance systems. This system framework builds on published frameworks and incorporates additional attributes (informatics capabilities and population coverage) that we deemed necessary for evaluating behavioral health–related surveillance. This revised surveillance evaluation framework can support ongoing improvements to behavioral health surveillance systems and ensure their continued usefulness for detecting, preventing, and managing behavioral health problems. PMID:29752804

Risk management and post-marketing surveillance of CNS drugs.

PubMed

Henningfield, Jack E; Schuster, Charles R

2009-12-01

Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

Use of whole genome sequencing in surveillance of drug resistant tuberculosis.

PubMed

McNerney, Ruth; Zignol, Matteo; Clark, Taane G

2018-05-01

The threat of resistance to anti-tuberculosis drugs is of global concern. Current efforts to monitor resistance rely on phenotypic testing where cultured bacteria are exposed to critical concentrations of the drugs. Capacity for such testing is low in TB endemic countries. Drug resistance is caused by mutations in the Mycobacterium tuberculosis genome and whole genome sequencing to detect these mutations offers an alternative means of assessing resistance. Areas covered: The challenges of assessing TB drug resistance are discussed. Progress in elucidating the M. tuberculosis resistome and evidence of the accuracy of next generation sequencing for detecting resistance is reviewed. Expert Commentary: There are considerable advantages to using next generation sequencing for TB drug resistance surveillance. Accuracy is high for detecting resistance to the major first-line drugs but is currently lower for the second-line drugs due to our incomplete knowledge regarding resistance causing mutations. With the advances in sequencing technology and the opportunity to replace phenotypic drug susceptibility testing with safer and more cost effective methods it would appear that the question is when to implement. Current bottlenecks are sample extraction to allow whole genome sequencing directly from sputum and the lack of bioinformatics expertise in some TB endemic countries.

Clinical and molecular surveillance of drug resistant vivax malaria in Myanmar (2009-2016).

PubMed

Nyunt, Myat Htut; Han, Jin-Hee; Wang, Bo; Aye, Khin Myo; Aye, Kyin Hla; Lee, Seong-Kyun; Htut, Ye; Kyaw, Myat Phone; Han, Kay Thwe; Han, Eun-Taek

2017-03-16

One of the major challenges for control and elimination of malaria is ongoing spread and emergence of drug resistance. While epidemiology and surveillance of the drug resistance in falciparum malaria is being explored globally, there are few studies on drug resistance vivax malaria. To assess the spread of drug-resistant vivax malaria in Myanmar, a multisite, prospective, longitudinal study with retrospective analysis of previous therapeutic efficacy studies, was conducted. A total of 906 from nine study sites were included in retrospective analysis and 208 from three study sites in prospective study. Uncomplicated vivax mono-infected patients were recruited and monitored with longitudinal follow-up until day 28 after treatment with chloroquine. Amplification and sequence analysis of molecular markers, such as mutations in pvcrt-O, pvmdr1, pvdhps and pvdhfr, were done in day-0 samples in prospective study. Clinical failure cases were found only in Kawthaung, southern Myanmar and western Myanmar sites within 2009-2016. Chloroquine resistance markers, pvcrt-O 'AAG' insertion and pvmdr1 mutation (Y976F) showed higher mutant rate in southern and central Myanmar than western site: 66.7, 72.7 vs 48.3% and 26.7, 17.0 vs 1.7%, respectively. A similar pattern of significantly higher mutant rate of antifolate resistance markers, pvdhps (S382A, K512M, A553G) and pvdhfr (F57L/I, S58R, T61M, S117T/N) were noted. Although clinical failure rate was low, widespread distribution of chloroquine and antifolate resistance molecular makers alert to the emergence and spread of drug resistance vivax malaria in Myanmar. Proper strategy and action plan to eliminate and contain the resistant strain strengthened together with clinical and molecular surveillance on drug resistance vivax is recommended.

Leprosy Drug Resistance Surveillance in Colombia: The Experience of a Sentinel Country

PubMed Central

Beltrán-Alzate, Camilo; López Díaz, Fernando; Romero-Montoya, Marcela; Sakamuri, Rama; Li, Wei; Kimura, Miyako; Brennan, Patrick

2016-01-01

An active search for Mycobacterium leprae drug resistance was carried out, 243 multibacillary patients from endemic regions of Colombia were included from 2004 to 2013 in a surveillance program. This program was a World Health Organization initiative for drug resistance surveillance in leprosy, where Colombia is a sentinel country. M. leprae DNA from slit skin smear and/or skin biopsy samples was amplified and sequenced to identify mutations in the drug resistance determining region (DRDR) in rpoB, folP1, gyrA, and gyrB, the genes responsible for rifampicin, dapsone and ofloxacin drug-resistance, respectively. Three isolates exhibited mutations in the DRDR rpoB gene (Asp441Tyr, Ser456Leu, Ser458Met), two in the DRDR folP1 gene (Thr53Ala, Pro55Leu), and one isolate exhibited mutations in both DRDR rpoB (Ser456Met) and DRDR folP1 (Pro55Leu), suggesting multidrug resistance. One isolate had a double mutation in folP1 (Thr53Ala and Thr88Pro). Also, we detected mutations outside of DRDR that required in vivo evaluation of their association or not with drug resistance: rpoB Arg505Trp, folP1 Asp91His, Arg94Trp, and Thr88Pro, and gyrA Ala107Leu. Seventy percent of M. leprae mutations were related to drug resistance and were isolated from relapsed patients; the likelihood of relapse was significantly associated with the presence of confirmed resistance mutations (OR range 20.1–88.7, p < 0.05). Five of these relapsed patients received dapsone monotherapy as a primary treatment. In summary, the current study calls attention to M. leprae resistance in Colombia, especially the significant association between confirmed resistance mutations and relapse in leprosy patients. A high frequency of DRDR mutations for rifampicin was seen in a region where dapsone monotherapy was used extensively. PMID:27706165

AMR Surveillance in low and middle-income settings - A roadmap for participation in the Global Antimicrobial Surveillance System (GLASS)

PubMed Central

Seale, Anna C.; Gordon, N. Claire; Islam, Jasmin; Peacock, Sharon J.; Scott, J. Anthony G.

2017-01-01

Drug-resistant infections caused by bacteria with increasing antimicrobial resistance (AMR) threaten our ability to treat life-threatening conditions. Tackling AMR requires international collaboration and partnership. An early and leading priority to do this is to strengthen AMR surveillance, particularly in low-income countries where the burden of infectious diseases is highest and where data are most limited. The World Health Organization (WHO) has developed the Global AMR Surveillance System (GLASS) as one of a number of measures designed to tackle the problem of AMR, and WHO member states have been encouraged to produce National Action Plans for AMR by 2017. However, low-income countries are unlikely to have the resources or capacity to implement all the components in the GLASS manual. To facilitate their efforts, we developed a guideline that is aligned to the GLASS procedures, but written specifically for implementation in low-income countries. The guideline allows for flexibility across different systems, but has sufficient standardisation of core protocols to ensure that, if followed, data will be valid and comparable. This will ensure that the surveillance programme can provide health intelligence data to inform evidence-based interventions at local, national and international levels. PMID:29062918

[Surveillance system on drug abuse: Interest of the French national OPPIDUM program of French addictovigilance network].

PubMed

Frauger, Elisabeth; Pochard, Liselotte; Boucherie, Quentin; Giocanti, Adeline; Chevallier, Cécile; Daveluy, Amélie; Gibaja, Valérie; Caous, Anne-Sylvie; Eiden, Céline; Authier, Nicolas; Le Boisselier, Reynald; Guerlais, Marylène; Jouanjus, Émilie; Lepelley, Marion; Pizzoglio, Véronique; Pain, Stéphanie; Richard, Nathalie; Micallef, Joëlle

2017-09-01

It is important to assess drug abuse liability in 'real life' using different surveillance systems. OPPIDUM ('Observation of illegal drugs and misuse of psychotropic medications') surveillance system anonymously collects information on drug abuse and dependence observed in patients recruited in specialized care centers dedicated to drug dependence. The aim of this article is to demonstrate the utility of OPPIDUM system using 2015 data. OPPIDUM is a cross-sectional survey repeated each year since 1995. In 2015, 5003 patients described the modality of use of 10,159 psychoactive drugs. Among them, 77% received an opiate maintenance treatment: 68% methadone (half of them consumed capsule form) and 27% buprenorphine (39% consumed generic form). Brand-name buprenorphine is more often injected than generic buprenorphine (10% vs. 2%) and among methadone consumers 7% of methadone capsule consumers have illegally obtained methadone (vs. 9% for syrup form). The proportion of medications among psychoactive drugs injected is important (42%), with morphine representing 21% of the total psychoactive drugs injected and buprenorphine, 16%. OPPIDUM highlighted emergent behaviors of abuse with some analgesic opioids (like tramadol, oxycodone or fentanyl), pregabalin, or quetiapine. OPPIDUM highlighted variations of drugs use regarding geographic approaches or by drug dependence care centers (like in harm reduction centers). OPPIDUM clearly demonstrated that collection of valid and useful data on drug abuse is possible, these data have an interest at regional, national and international levels. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

ERIC Educational Resources Information Center

Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

2008-01-01

This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

Japanese Physicians' Views on Drug Post-Marketing Surveillance.

PubMed

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

2015-12-01

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. 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. 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. 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.

Linking HIV and antiretroviral drug resistance surveillance in Peru: a model for a third-generation HIV sentinel surveillance.

PubMed

Lama, Javier R; Sanchez, Jorge; Suarez, Luis; Caballero, Patricia; Laguna, Alberto; Sanchez, Jose L; Whittington, William L H; Celum, Connie; Grant, Robert M

2006-08-01

HIV drug resistance surveillance is limited by recruitment and selection bias and by limited information regarding HIV incidence rates, secondary resistance, and treatment prevalence. A second-generation HIV sentinel surveillance among men who have sex with men (MSM), regardless of prior history of HIV screening, serostatus, or treatment, was conducted in Peru in 2002. Recent HIV infection was estimated using sensitive/less sensitive enzyme immunoassay testing. Genotypic resistance testing was performed. HIV prevalence was 13.9% (456 HIV positive of 3280 participants). HIV incidence was estimated to be 5.1 per 100 person-years (95% confidence interval: 3.1-8.3). Among 143 MSM who were aware of their HIV infection before testing, only 20 (14.0%) were receiving antiretrovirals (ARV). Mutations conferring ARV resistance were found in 12 (3.3%) of 359 treatment-naive and 5 (31.3%) of 16 treatment-experienced participants with successful genotyping. One recently infected man from Lima demonstrated 3-class multidrug resistance. The most frequently observed mutations in treatment-naive, chronically infected persons from Lima were M184V (1.7%), D30N (1.3%), L90M (1.3%), and L10I (1.3%). The prevalence of ARV resistance among treatment-naive MSM in Peru is low, reflecting limited access to treatment before 2004, and contrasts with the history of ARV treatment in developed countries, where high levels of nucleoside reverse transcriptase inhibitor resistance occurred before introduction of highly active antiretroviral therapy. Linking ARV resistance and HIV sentinel surveillance in developing settings is feasible and should be considered in third-generation HIV sentinel surveillance programs.

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

PubMed Central

Gabrilovich, Evgeniy

2013-01-01

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

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

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

Lessons learnt from 20 years surveillance of malaria drug resistance prior to the policy change in Burkina Faso.

PubMed

Tinto, Halidou; Valea, Innocent; Ouédraogo, Jean-Bosco; Guiguemdé, Tinga Robert

2016-01-01

The history of drug resistance to the previous antimalarial drugs, and the potential for resistance to evolve to Artemisinin-based combination therapies, demonstrates the necessity to set-up a good surveillance system in order to provide early warning of the development of resistance. Here we report a review summarizing the history of the surveillance of drug resistance that led to the policy change in Burkina Faso. The first Plasmodium falciparum Chloroquine-Resistance strain identified in Burkina Faso was detected by an in vitro test carried out in Koudougou in 1983. Nevertheless, no further cases were reported until 1987, suggesting that resistant strains had been circulating at a low prevalence before the beginning of the systematic surveillance system from 1984. We observed a marked increase of Chloroquine-Resistance in 2002-2003 probably due to the length of follow-up as the follow-up duration was 7 or 14 days before 2002 and 28 days from 2002 onwards. Therefore, pre-2002 studies have probably under-estimated the real prevalence of Chloroquine-Resistance by not detecting the late recrudescence. With a rate of 8.2% treatment failure reported in 2003, Sulfadoxine-Pyrimethamine was still efficacious for the treatment of uncomplicated malaria in Burkina Faso but this rate might rapidly increase as the result of its spreading from neighboring countries and due to its current use for both the Intermittent Preventive Treatment in pregnant women and Seasonal Malaria Chemoprophylaxis. The current strategy for the surveillance of the Artemisinin-based combination treatments resistance should build on lessons learnt under the previous period of 20 years surveillance of Chloroquine and Sulfadoxine-Pyrimethamine resistance (1994-2004). The most important aspect being to extend the number of sentinel sites so that data would be less patchy and could help understanding the dynamic of the resistance.

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.

Postmarketing surveillance in developing countries.

PubMed

Meirik, O

1988-01-01

Authorities in developing countries need to monitor the possible adverse consequences of the increasing use of drugs in their countries. Definite differences exist in the risk-benefit ratios for developed and developing countries, particularly with fertility-regulating drugs. Some physicians believe that the increased risk of thrombosis associated with oral contraceptives (OCs) should not be considered as important in developing countries due to the fact that the background level of venous thrombosis is so low in developing countries that even a 50- or 100-fold increase in relative risk would neither be detectable nor important compared to the risk of unwanted pregnancy. In addition, evidence exists of geographically linked factors in the etiology of some adverse drug reactions (ADRs). Authorities in Brazil, India, Indonesia, Pakistan, the Philippines, Thailand, and Venezuela have established voluntary ADR reporting systems. Several developing countries also actively follow the World Health Organization's International Drug Monitoring Program and have access to its data base. A number of other methodological approaches to postmarketing surveillance are in use in addition to voluntary ADR reporting systems. These include cross-sectional surveys, studies of temporal and geographic correlations of diseases and drug use, and case-control and cohort studies. Each of these approaches offers specific advantages. Postmarketing surveillance should begin at the time new drugs, including contraceptive methods are introduced. Surveillance needs to be an integral part of plans for the introduction of new contraceptive methods in settings where the infrastructure to carry out such surveillance is in place. 3 major public sector agencies, Family Health International, the Population Council, and the World Health Organization, developed a plan to obtain funding for the postmarketing surveillance of a contraceptive implant, Norplant-R. A controlled cohort study will be conducted in

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

PubMed

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

2014-01-01

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

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

NASA Astrophysics Data System (ADS)

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.

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

Influenza sentinel surveillance network: a public health-primary care collaborative action to assess influenza A(H1N1)pmd09 in Catalonia, Spain.

PubMed

Torner, Nuria; Baricot, Maretva; Martínez, Ana; Toledo, Diana; Godoy, Pere; Dominguez, Ángela

2013-03-01

The aim of this study was to evaluate the outcome of a collaborative action between Public Health services and Primary Care in the context of a case-control study on effectiveness of pharmaceutical and non-pharmaceutical measures to prevent hospitalization in a pandemic situation. To carry out this research the collaborative action of the primary care physicians members of the Influenza surveillance network was needed, they had to recall clinical information from influenza A(H1N1)pmd09 confirmed outpatient cases and negative outpatient controls matching their corresponding hospitalized confirmed case.   A survey questionnaire to assess involvement of Influenza Sentinel Surveillance Primary care physicians' Network of Catalonia (PIDIRAC) regarding the outpatient case and control outreach during the pandemic influenza season was performed. A total of 71,1% of completed surveys were received. Perception of pandemic activity was considered to be similar to seasonal influenza activity in 43.8% or higher but not unbearable in 37.5% of the replies. There was no nuisance reported from patients regarding neither the questions nor the surveyor. Collaborative research between Public Health services and Primary Care physicians enhances Public Health actions and research.

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

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 Urine...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

28 CFR 550.41 - Urine surveillance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Urine surveillance. 550.41 Section 550.41 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... clinical trials with the support of the VA Cooperative Studies Program. To identify and test new drug..., ``Drug Development Initiative'' (DDI), for New Pharmacological Treatments for Post-Traumatic Stress... will delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans...

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

Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

PubMed

Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

2017-02-01

Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

Laboratory-Based Surveillance of Extensively Drug-Resistant Tuberculosis in Eastern China.

PubMed

Huang, Yu; Wu, Qingqing; Xu, Shuiyang; Zhong, Jieming; Chen, Songhua; Xu, Jinghang; Zhu, Liping; He, Haibo; Wang, Xiaomeng

2017-03-01

With 25% of the global burden, China has the highest incidence of drug-resistant tuberculosis (TB) in the world. However, surveillance data on extensively drug-resistant TB (XDR-TB) from China are scant. To estimate the prevalence of XDR-TB in Zhejiang, Eastern China, 30 of 90 TB treatment centers in Zhejiang were recruited. Patients with suspected TB who reported to the clinics for diagnosis were requested to undergo a smear sputum test. Positive sputum samples were tested for drug susceptibility. Data on anti-TB drug resistance from 1999 to 2008 were also collected to assess drug resistance trends. A total of 931 cases were recruited for drug susceptibility testing (DST). Among these, 23.6% (95% confidence interval [CI], 18.8-24.4) were resistant to any of the following drugs: isoniazid, rifampin, streptomycin, and ethambutol. Multidrug resistant (MDR) strains were identified in 5.1% of all cases (95% CI, 3.61-6.49). Among MDR-TB cases, 6.4% were XDR (95% CI, 1.7-18.6) and 8.9% (95% CI, 7.0-10.8) of all cases were resistant to either isoniazid or rifampin (but not both). Among MDR-TB cases, 23.4% (95% CI, 12.8-38.4) were resistant to either fluoroquinolones or a second-line anti-TB injectable drug, but not both. From 1999 to 2014, the percentage of MDR cases decreased significantly, from 8.6% to 5.1% (p = 0.00). The Global Fund to Fight TB program showed signs of success in Eastern China. However, drug-resistant TB, MDR-TB, and XDR-TB still pose a challenge for TB control in Eastern China. High-quality directly observed treatment, short-course, and universal DST for TB cases to determine appropriate treatment regimens are urgently needed to prevent acquired drug resistance.

Collaborative Drug Therapy Management: Case Studies of Three Community-Based Models of Care

PubMed Central

Snyder, Margie E.; Earl, Tara R.; 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

Monitoring risk: post marketing surveillance and signal detection.

PubMed

Dart, Richard C

2009-12-01

The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveillance because they are often misused, abused, and diverted. These medications include opioid analgesics, stimulants, sedative-hypnotics, muscle relaxants, anticonvulsants and other drug classes. Their adverse events are difficult to monitor because the perpetrator often attempts to conceal the misuse, abuse and diversion of the product. A postmarketing surveillance system for prescription drugs of abuse in the U.S. should include product specific information that is accurate, immediately available, geographically specific and includes all areas of the country. Most producers of branded opioid analgesic products have created systems that measure abuse from multiple vantage points: criminal justice, treatment professionals, susceptible patient populations and acute health events. In the past, the U.S. government has not established similar requirements for the same products produced by generic manufacturers. However, the Food and Drug Administration Amendments Act of 2007 includes generic opioid analgesic products by requiring that all products containing potent opioid drugs perform rigorous surveillance and risk management. While general risk management guidance has been developed by FDA, more specific analyses and guidance are needed to improve surveillance methodology for drugs which are misused, abused, diverted.

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

PubMed

Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

2018-01-01

Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

Economic evaluation in collaborative hospital drug evaluation reports.

PubMed

Ortega, Ana; Fraga, María Dolores; Marín-Gil, Roberto; Lopez-Briz, Eduardo; Puigventós, Francesc; Dranitsaris, George

2015-09-01

economic evaluation is a fundamental criterion when deciding a drug's place in therapy. The MADRE method (Method for Assistance in making Decisions and Writing Drug Evaluation Reports) is widely used for drug evaluation. This method was developed by the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH), including economic evaluation. We intend to improve the economic aspects of this method. As for the direction to take, we have to first analyze our previous experiences with the current methodology and propose necessary improvements. economic evaluation sections in collaboratively conducted drug evaluation reports (as the scientific society, SEFH) with the MADRE method were reviewed retrospectively. thirty-two reports were reviewed, 87.5% of them included an economic evaluation conducted by authors and 65.6% contained published economic evaluations. In 90.6% of the reports, a Budget impact analysis was conducted. The cost per life year gained or per Quality Adjusted Life Year gained was present in 14 reports. Twenty-three reports received public comments regarding the need to improve the economic aspect. Main difficulties: low quality evidence in the target population, no comparative studies with a relevant comparator, non-final outcomes evaluated, no quality of life data, no fixed drug price available, dosing uncertainty, and different prices for the same drug. proposed improvements: incorporating different forms of aid for non-drug costs, survival estimation and adapting published economic evaluations; establishing criteria for drug price selection, decision-making in conditions of uncertainty and poor quality evidence, dose calculation and cost-effectiveness thresholds depending on different situations. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Epidemiological Surveillance of Birth Defects Compatible with Thalidomide Embryopathy in Brazil

PubMed Central

Vianna, Fernanda Sales Luiz; Lopez-Camelo, Jorge S.; Leite, Júlio César Louguercio; Sanseverino, Maria Teresa Vieira; Dutra, Maria da Graça; Castilla, Eduardo E.; Schüler-Faccini, Lavínia

2011-01-01

The thalidomide tragedy of the 1960s resulted in thousands of children being born with severe limb reduction defects (LRD), among other malformations. In Brazil, there are still babies born with thalidomide embryopathy (TE) because of leprosy prevalence, availability of thalidomide, and deficiencies in the control of drug dispensation. Our objective was to implement a system of proactive surveillance to identify birth defects compatible with TE. Along one year, newborns with LRD were assessed in the Brazilian hospitals participating in the Latin-American Collaborative Study of Congenital Malformations (ECLAMC). A phenotype of LRD called thalidomide embryopathy phenotype (TEP) was established for surveillance. Children with TEP born between the years 2000–2008 were monitored, and during the 2007–2008 period we clinically investigated in greater detail all cases with TEP (proactive period). The period from 1982 to 1999 was defined as the baseline period for the cumulative sum statistics. The frequency of TEP during the surveillance period, at 3.10/10,000 births (CI 95%: 2.50–3.70), was significantly higher than that observed in the baseline period (1.92/10,000 births; CI 95%: 1.60–2.20), and not uniformly distributed across different Brazilian regions. During the proactive surveillance (2007–2008), two cases of suspected TE were identified, although the two mothers had denied the use of the drug during pregnancy. Our results suggest that TEP has probably increased in recent years, which coincides with the period of greater thalidomide availability. Our proactive surveillance identified two newborns with suspected TE, proving to be a sensitive tool to detect TE. The high frequency of leprosy and the large use of thalidomide reinforce the need for a continuous monitoring of TEP across Brazil. PMID:21754997

National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.

PubMed

Butler, Stephen F; Budman, Simon H; Licari, Andrea; Cassidy, Theresa A; Lioy, Katherine; Dickinson, James; Brownstein, John S; Benneyan, James C; Green, Traci Craig; Katz, Nathaniel

2008-12-01

The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. We evaluate population characteristics for data collected through the ASI-MV Connect in 2007 and 2008 and assess the representativeness, geographic coverage, and timeliness of report of the data. Analyses based on 41,923 admissions to 265 treatment centers in 29 states were conducted on product-specific opioid abuse rates, source of drug, and route of administration. ASI-MV Connect data revealed that 11.5% of patients reported abuse of at least one opioid analgesic product in the 30 days prior to entering substance abuse treatment; differences were observed among sub-populations of prescription opioid abusers, among products, and also within various geographic locations. The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs. Copyright (c) 2008 John Wiley & Sons, Ltd.

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 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 CTCs...

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 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 CTCs...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 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 CTCs...

28 CFR 550.42 - Procedures for urine surveillance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 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 CTCs...

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 CTCs...

Collaborative Point Paper on Border Surveillance Technology

DTIC Science & Technology

2007-12-01

including; Unmanned Aerial Vehicles, Airships, and/or Aerostats, (RF, Electro-Optical, Infrared, Video) • Land- based Sensor Systems (Attended...warning. These ground- based systems are primarily short-range, up to around 500 meters. • Observation towers extend surveillance capabilities many...Foreign Companies Applicable Environment(s Foreign Companies Air Land Maritime Technology 25. BAE Systems PLC (BAE Systems Inc. is a US subsidiary

Clinical Relation Extraction Toward Drug Safety Surveillance Using Electronic Health Record Narratives: Classical Learning Versus Deep Learning.

PubMed

Munkhdalai, Tsendsuren; Liu, Feifan; Yu, Hong

2018-04-25

Medication and adverse drug event (ADE) information extracted from electronic health record (EHR) notes can be a rich resource for drug safety surveillance. Existing observational studies have mainly relied on structured EHR data to obtain ADE information; however, ADEs are often buried in the EHR narratives and not recorded in structured data. To unlock ADE-related information from EHR narratives, there is a need to extract relevant entities and identify relations among them. In this study, we focus on relation identification. This study aimed to evaluate natural language processing and machine learning approaches using the expert-annotated medical entities and relations in the context of drug safety surveillance, and investigate how different learning approaches perform under different configurations. We have manually annotated 791 EHR notes with 9 named entities (eg, medication, indication, severity, and ADEs) and 7 different types of relations (eg, medication-dosage, medication-ADE, and severity-ADE). Then, we explored 3 supervised machine learning systems for relation identification: (1) a support vector machines (SVM) system, (2) an end-to-end deep neural network system, and (3) a supervised descriptive rule induction baseline system. For the neural network system, we exploited the state-of-the-art recurrent neural network (RNN) and attention models. We report the performance by macro-averaged precision, recall, and F1-score across the relation types. Our results show that the SVM model achieved the best average F1-score of 89.1% on test data, outperforming the long short-term memory (LSTM) model with attention (F1-score of 65.72%) as well as the rule induction baseline system (F1-score of 7.47%) by a large margin. The bidirectional LSTM model with attention achieved the best performance among different RNN models. With the inclusion of additional features in the LSTM model, its performance can be boosted to an average F1-score of 77.35%. It shows that

Collaborative Point Paper on Border Surveillance Technology

DTIC Science & Technology

2007-06-01

Systems PLC LORHIS (Long Range Hyperspectral Imaging System ) can be configured for either manned or unmanned aircraft to automatically detect and...Airships, and/or Aerostats, (RF, Electro-Optical, Infrared, Video) • Land- based Sensor Systems (Attended/Mobile and Unattended: e.g., CCD, Motion, Acoustic...electronic surveillance technologies for intrusion detection and warning. These ground- based systems are primarily short-range, up to around 500 meters

[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.

Prevention of prescription errors by computerized, on-line, individual patient related surveillance of drug order entry.

PubMed

Oliven, A; Zalman, D; Shilankov, Y; Yeshurun, D; Odeh, M

2002-01-01

Computerized prescription of drugs is expected to reduce the number of many preventable drug ordering errors. In the present study we evaluated the usefullness of a computerized drug order entry (CDOE) system in reducing prescription errors. A department of internal medicine using a comprehensive CDOE, which included also patient-related drug-laboratory, drug-disease and drug-allergy on-line surveillance was compared to a similar department in which drug orders were handwritten. CDOE reduced prescription errors to 25-35%. The causes of errors remained similar, and most errors, on both departments, were associated with abnormal renal function and electrolyte balance. Residual errors remaining on the CDOE-using department were due to handwriting on the typed order, failure to feed patients' diseases, and system failures. The use of CDOE was associated with a significant reduction in mean hospital stay and in the number of changes performed in the prescription. The findings of this study both quantity the impact of comprehensive CDOE on prescription errors and delineate the causes for remaining errors.

Evolutionary ARMS Race: Antimalarial Resistance Molecular Surveillance.

PubMed

Prosser, Christiane; Meyer, Wieland; Ellis, John; Lee, Rogan

2018-04-01

Molecular surveillance of antimalarial drug resistance markers has become an important part of resistance detection and containment. In the current climate of multidrug resistance, including resistance to the global front-line drug artemisinin, there is a consensus to upscale molecular surveillance. The most salient limitation to current surveillance efforts is that skill and infrastructure requirements preclude many regions. This includes sub-Saharan Africa, where Plasmodium falciparum is responsible for most of the global malaria disease burden. New molecular and data technologies have emerged with an emphasis on accessibility. These may allow surveillance to be conducted in broad settings where it is most needed, including at the primary healthcare level in endemic countries, and extending to the village health worker. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

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

2012-05-01

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.

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.

Surveillance of Travellers: An Additional Tool for Tracking Antimalarial Drug Resistance in Endemic Countries

PubMed Central

Gharbi, Myriam; Flegg, Jennifer A.; Pradines, Bruno; Berenger, Ako; Ndiaye, Magatte; Djimdé, Abdoulaye A.; Roper, Cally; Hubert, Véronique; Kendjo, Eric; Venkatesan, Meera; Brasseur, Philippe; Gaye, Oumar; Offianan, André T.; Penali, Louis; Le Bras, Jacques; Guérin, Philippe J.; Study, Members of the French National Reference Center for Imported Malaria

2013-01-01

Introduction There are growing concerns about the emergence of resistance to artemisinin-based combination therapies (ACTs). Since the widespread adoption of ACTs, there has been a decrease in the systematic surveillance of antimalarial drug resistance in many malaria-endemic countries. The aim of this work was to test whether data on travellers returning from Africa with malaria could serve as an additional surveillance system of local information sources for the emergence of drug resistance in endemic-countries. Methodology Data were collected from travellers with symptomatic Plasmodium falciparum malaria returning from Senegal (n = 1,993), Mali (n = 2,372), Cote d’Ivoire (n = 4,778) or Cameroon (n = 3,272) and recorded in the French Malaria Reference Centre during the period 1996–2011. Temporal trends of the proportion of parasite isolates that carried the mutant genotype, pfcrt 76T, a marker of resistance to chloroquine (CQ) and pfdhfr 108N, a marker of resistance to pyrimethamine, were compared for travellers and within-country surveys that were identified through a literature review in PubMed. The in vitro response to CQ was also compared between these two groups for parasites from Senegal. Results The trends in the proportion of parasites that carried pfcrt 76T, and pfdhfr 108N, were compared for parasites from travellers and patients within-country using the slopes of the curves over time; no significant differences in the trends were found for any of the 4 countries. These results were supported by in vitro analysis of parasites from the field in Senegal and travellers returning to France, where the trends were also not significantly different. Conclusion The results have not shown different trends in resistance between parasites derived from travellers or from parasites within-country. This work highlights the value of an international database of drug responses in travellers as an additional tool to assess the emergence of drug

Surveillance of travellers: an additional tool for tracking antimalarial drug resistance in endemic countries.

PubMed

Gharbi, Myriam; Flegg, Jennifer A; Pradines, Bruno; Berenger, Ako; Ndiaye, Magatte; Djimdé, Abdoulaye A; Roper, Cally; Hubert, Véronique; Kendjo, Eric; Venkatesan, Meera; Brasseur, Philippe; Gaye, Oumar; Offianan, André T; Penali, Louis; Le Bras, Jacques; Guérin, Philippe J

2013-01-01

There are growing concerns about the emergence of resistance to artemisinin-based combination therapies (ACTs). Since the widespread adoption of ACTs, there has been a decrease in the systematic surveillance of antimalarial drug resistance in many malaria-endemic countries. The aim of this work was to test whether data on travellers returning from Africa with malaria could serve as an additional surveillance system of local information sources for the emergence of drug resistance in endemic-countries. Data were collected from travellers with symptomatic Plasmodium falciparum malaria returning from Senegal (n = 1,993), Mali (n = 2,372), Cote d'Ivoire (n = 4,778) or Cameroon (n = 3,272) and recorded in the French Malaria Reference Centre during the period 1996-2011. Temporal trends of the proportion of parasite isolates that carried the mutant genotype, pfcrt 76T, a marker of resistance to chloroquine (CQ) and pfdhfr 108N, a marker of resistance to pyrimethamine, were compared for travellers and within-country surveys that were identified through a literature review in PubMed. The in vitro response to CQ was also compared between these two groups for parasites from Senegal. The trends in the proportion of parasites that carried pfcrt 76T, and pfdhfr 108N, were compared for parasites from travellers and patients within-country using the slopes of the curves over time; no significant differences in the trends were found for any of the 4 countries. These results were supported by in vitro analysis of parasites from the field in Senegal and travellers returning to France, where the trends were also not significantly different. The results have not shown different trends in resistance between parasites derived from travellers or from parasites within-country. This work highlights the value of an international database of drug responses in travellers as an additional tool to assess the emergence of drug resistance in endemic areas where information is limited.

Surveillance of drug use among young people attending a music festival in Australia, 2005-2008.

PubMed

Lim, Megan S C; Hellard, Margaret E; Hocking, Jane S; Spelman, Tim D; Aitken, Campbell K

2010-03-01

In order to monitor trends in illicit drug use among youth, surveillance of drug use behaviours among a variety of populations in different settings is required. We monitored drug use among music festival attendees. Cross-sectional studies of young people's reported drug use were performed at a music festival in Melbourne from 2005 to 2008. Self-administered questionnaires collected information on drug use, demographics and other risk behaviour. From 2005 to 2008, over 5000 questionnaires were completed by people aged 16-29; 2273 men and 3011 women. Overall, use of any illicit drug in the past month was reported by 44%. After adjusting for demographic and behavioural characteristics, the prevalence of recent illicit drug use decreased significantly from 46% in 2005 to 43% in 2008 (OR 0.92, 95% CI 0.87-0.97). After adjusting for age and sex the downwards trend was repeated for amphetamines and cannabis, but a significant increase in prevalence was observed in hallucinogen, ecstasy and inhalant use. Drug use was more common among men, older participants and those engaging in high-risk sexual behaviour. Illicit drug use was much more common in this sample than in the National Drug Strategy Household survey, but the direction of trends in drug use were similar; drug use prevalences were much lower than in the Ecstasy and Related Drugs Reporting System, the Illicit Drug Reporting System or National Needle and Syringe Program Survey. Music festival attendees are a potentially useful group for monitoring trends in illicit drug use.

An international survey of cerebral palsy registers and surveillance systems

PubMed Central

Goldsmith, Shona; McIntyre, Sarah; Smithers-Sheedy, Hayley; Blair, Eve; Cans, Christine; Watson, Linda; Yeargin-Allsopp, Marshalyn

2016-01-01

AIM To describe cerebral palsy (CP) surveillance programmes and identify similarities and differences in governance and funding, aims and scope, definition, inclusion/exclusion criteria, ascertainment and data collection, to enhance the potential for research collaboration. METHOD Representatives from 38 CP surveillance programmes were invited to participate in an online survey and submit their data collection forms. Descriptive statistics were used to summarize information submitted. RESULTS Twenty-seven surveillance programmes participated (25 functioning registers, two closed owing to lack of funding). Their aims spanned five domains: resource for CP research, surveillance, aetiology/prevention, service planning, and information provision (in descending order of frequency). Published definitions guided decision making for the definition of CP and case eligibility for most programmes. Consent, case identification, and data collection methods varied widely. Ten key data items were collected by all programmes and a further seven by at least 80% of programmes. All programmes reported an interest in research collaboration. INTERPRETATION Despite variability in methodologies, similarities exist across programmes in terms of their aims, definitions, and data collected. These findings will facilitate harmonization of data and collaborative research efforts, which are so necessary on account of the heterogeneity and relatively low prevalence of CP. PMID:26781543

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. Published by Mosby, Inc.

[Syndromic surveillance in circumstances of bioterrorism threat--the essence, application abilities and superiority over a traditional epidemiological surveillance].

PubMed

Osemek, Paweł; Kocik, Janusz; Paśnik, Krzysztof

2009-12-01

This article provides a short review about trends of developing current syndromic surveillance systems. To improve methods of early detection of natural or bioterrorism-related outbreaks, it has to be established a new way of epidemiological thinking, which uses innovative real-time surveillance systems. Syndromic surveillance has been created for an early detection, to monitor the temporo-spatial spread of an outbreak, and to provide prompt data for immediate analysis and feedback to public health authorities. It supports timely decision making process for countermeasure procedures. Framework of syndromic surveillance system requires a proper electronic infrastructure to be build up. Optimal syndrome definitions and data sources for continuing specific diseases outbreak surveillance have not been determined so far. Systems of interest might enhance collaboration among clinical providers, primary care providers, emergency services, information-systems professionals and public health agencies. However economic scope of this undertakings effectively limits ability to implement it in Polish public health service right now. Besides, syndromic surveillance cannot replace traditional public health surveillance with a post-factum epidemiological investigation and laboratory analysis. It can be a useful supplement.

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) notifying...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 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) notifying...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 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) notifying...

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) notifying...

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) notifying...

Network for Surveillance of Severe Maternal Morbidity: a powerful national collaboration generating data on maternal health outcomes and care.

PubMed

Cecatti, J G; Costa, M L; Haddad, S M; Parpinelli, M A; Souza, J P; Sousa, M H; Surita, F G; Pinto E Silva, J L; Pacagnella, R C; Passini, R

2016-05-01

To identify cases of severe maternal morbidity (SMM) during pregnancy and childbirth, their characteristics, and to test the feasibility of scaling up World Health Organization criteria for identifying women at risk of a worse outcome. Multicentre cross-sectional study. Twenty-seven referral maternity hospitals from all regions of Brazil. Cases of SMM identified among 82 388 delivering women over a 1-year period. Prospective surveillance using the World Health Organization's criteria for potentially life-threatening conditions (PLTC) and maternal near-miss (MNM) identified and assessed cases with severe morbidity or death. Indicators of maternal morbidity and mortality; sociodemographic, clinical and obstetric characteristics; gestational and perinatal outcomes; main causes of morbidity and delays in care. Among 9555 cases of SMM, there were 140 deaths and 770 cases of MNM. The main determining cause of maternal complication was hypertensive disease. Criteria for MNM conditions were more frequent as the severity of the outcome increased, all combined in over 75% of maternal deaths. This study identified around 9.5% of MNM or death among all cases developing any severe maternal complication. Multicentre studies on surveillance of SMM, with organised collaboration and adequate study protocols can be successfully implemented, even in low-income and middle-income settings, generating important information on maternal health and care to be used to implement appropriate health policies and interventions. Surveillance of severe maternal morbidity was proved to be possible in a hospital network in Brazil. © 2015 Royal College of Obstetricians and Gynaecologists.

Clinical Relation Extraction Toward Drug Safety Surveillance Using Electronic Health Record Narratives: Classical Learning Versus Deep Learning

PubMed Central

Munkhdalai, Tsendsuren; Liu, Feifan

2018-01-01

Background Medication and adverse drug event (ADE) information extracted from electronic health record (EHR) notes can be a rich resource for drug safety surveillance. Existing observational studies have mainly relied on structured EHR data to obtain ADE information; however, ADEs are often buried in the EHR narratives and not recorded in structured data. Objective To unlock ADE-related information from EHR narratives, there is a need to extract relevant entities and identify relations among them. In this study, we focus on relation identification. This study aimed to evaluate natural language processing and machine learning approaches using the expert-annotated medical entities and relations in the context of drug safety surveillance, and investigate how different learning approaches perform under different configurations. Methods We have manually annotated 791 EHR notes with 9 named entities (eg, medication, indication, severity, and ADEs) and 7 different types of relations (eg, medication-dosage, medication-ADE, and severity-ADE). Then, we explored 3 supervised machine learning systems for relation identification: (1) a support vector machines (SVM) system, (2) an end-to-end deep neural network system, and (3) a supervised descriptive rule induction baseline system. For the neural network system, we exploited the state-of-the-art recurrent neural network (RNN) and attention models. We report the performance by macro-averaged precision, recall, and F1-score across the relation types. Results Our results show that the SVM model achieved the best average F1-score of 89.1% on test data, outperforming the long short-term memory (LSTM) model with attention (F1-score of 65.72%) as well as the rule induction baseline system (F1-score of 7.47%) by a large margin. The bidirectional LSTM model with attention achieved the best performance among different RNN models. With the inclusion of additional features in the LSTM model, its performance can be boosted to an average F1

NeuroAIDS, drug abuse, and inflammation: building collaborative research activities.

PubMed

Berman, Joan W; Carson, Monica J; Chang, Linda; Cox, Brian M; Fox, Howard S; Gonzalez, R Gilberto; Hanson, Glen R; Hauser, Kurt F; Ho, Wen-Zhe; Hong, Jau-Shyong; Major, Eugene O; Maragos, William F; Masliah, Eliezer; McArthur, Justin C; Miller, Diane B; Nath, Avindra; O'Callaghan, James P; Persidsky, Yuri; Power, Christopher; Rogers, Thomas J; Royal, Walter

2006-12-01

Neurological complications of human immunodeficiency virus (HIV) infection are a public health problem despite the availability of active antiretroviral therapies. The neuropathogenesis of HIV infection revolves around a complex cascade of events that include viral infection and glial immune activation, monocyte-macrophage brain infiltration, and secretion of a host of viral and cellular inflammatory and neurotoxic molecules. Although there is evidence that HIV-infected drug abusers experience more severe neurological disease, the biological basis for this finding is unknown. A scientific workshop organized by the National Institute on Drug Abuse (NIDA) was held on March 23-24, 2006 to address this question. The goal of the meeting was to bring together basic science and clinical researchers who are experts in NeuroAIDS, glial immunity, drugs of abuse, and/or pharmacology in order to find new approaches to understanding interactions between drug abuse and neuroAIDS. The format of the meeting was designed to stimulate open discussion and forge new multidisciplinary research collaborations. This report includes transcripts of active discussions and short presentations from invited participants. The presentations were separated into sections that included: Glial Biology, Inflammation, and HIV; Pharmacology, Neurotoxicology, and Neuroprotection; NeuroAIDS and Virology; and Virus-Drug and Immune-Drug Interactions. Research priorities were identified. Additional information about this meeting is available through links from the NIDA AIDS Research Program website ( http://www.nida.nih.gov/about/organization/arp/arp-websites.htm ).

An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain.

PubMed

Cuomo, Raphael E; Mackey, Tim K

2014-12-02

To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis. A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines. This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30,431 zip codes in the USA. Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication. Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration. This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics

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

PubMed Central

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

2012-01-01

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

Molecular Surveillance as Monitoring Tool for Drug-Resistant Plasmodium falciparum in Suriname

PubMed Central

Adhin, Malti R.; Labadie-Bracho, Mergiory; Bretas, Gustavo

2013-01-01

The aim of this translational study was to show the use of molecular surveillance for polymorphisms and copy number as a monitoring tool to track the emergence and dynamics of Plasmodium falciparum drug resistance. A molecular baseline for Suriname was established in 2005, with P. falciparum chloroquine resistance transporter (pfcrt) and P. falciparum multidrug resistance (pfmdr1) markers and copy number in 40 samples. The baseline results revealed the existence of a uniformly distributed mutated genotype corresponding with the fully mefloquine-sensitive 7G8-like genotype (Y184F, S1034C, N1042D, and D1246Y) and a fixed pfmdr1 N86 haplotype. All samples harbored the pivotal pfcrtK76T mutation, showing that chloroquine reintroduction should not yet be contemplated in Suriname. After 5 years, 40 samples were assessed to trace temporal changes in the status of pfmdr1 polymorphisms and copy number and showed minor genetic alterations in the pfmdr1 gene and no significant changes in copy number, thus providing scientific support for prolongation of the current drug policy in Suriname. PMID:23836573

AACR-FDA-NCI Cancer Biomarkers Collaborative consensus report: advancing the use of biomarkers in cancer drug development.

PubMed

Khleif, Samir N; Doroshow, James H; Hait, William N

2010-07-01

Recent discoveries in cancer biology have greatly increased our understanding of cancer at the molecular and cellular level, but translating this knowledge into safe and effective therapies for cancer patients has proved to be challenging. There is a growing imperative to modernize the drug development process by incorporating new techniques that can predict the safety and effectiveness of new drugs faster, with more certainty, and at lower cost. Biomarkers are central to accelerating the identification and adoption of new therapies, but currently, many barriers impede their use in drug development and clinical practice. In 2007, the AACR-FDA-NCI Cancer Biomarkers Collaborative stepped into the national effort to bring together disparate stakeholders to clearly delineate these barriers, to develop recommendations for integrating biomarkers into the cancer drug development enterprise, and to set in motion the necessary action plans and collaborations to see the promise of biomarkers come to fruition, efficiently delivering quality cancer care to patients.

[Study on the characteristics of serology and sexual behavior among drug users at the HIV sentinel surveillance sites in 2012].

PubMed

Ge, Lin; Cui, Yan; Wang, Lu; Li, Dongmin; Guo, Wei; Ding, Zhengwei; Wang, Lan

2014-02-01

To analyze the serological results and sexual behavior among different types of drug users (DUS) at the HIV sentinel surveillance sites. Sentinel surveillance programs were conducted between April and June annually. DUS were those involved in custodes, living at the communities and those attending the methadone maintenance treatment clinics but with positive urine tests one month before blood sampling collected and questionnaire survey started. 116 279 drug abusers were included in the analysis. The prevalence rates of HIV, Syphilis and HCV among traditional drug (heroin, etc.)users were 5.0%, 4.4% and 49.4%, while the prevalence rates of new narcotic (meth, etc.) users were 0.5%, 4.6%, 15.2%, respectively. The prevalence rates of HIV, syphilis among traditional drug uses were higher than the new narcotic users (P < 0.01). The proportion of sexual behavior in last month and the proportion of sexual behavior with casual and commercial sexual partners were 46.3%, 87.2% and 28.1% among the new narcotic users, respectively, which were higher than those among traditional drug users (40.7% , 82.8% and 22.2%). The proportion of using condom in last sexual contact with casual sexual partner was 33.3% among the new narcotic users which was less than traditional drug users (36.2%). The proportion of condom use in the last commercial sexual contact was 65.1% which was higher than those traditional drug users (62.9%). The proportion of never using condom with casual and commercial sexual partners in the past year was 43.2% and 19.0% among the traditional drug users, which were higher than those among new narcotic users (41.3%, 15.3%). Compared with the traditional drug abusers, the sexual behavior of new narcotic users seemed more active, less engaging in condom use but with higher risk of HIV transmission through sexual contact.

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 ...

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 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 to...

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 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 to...

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 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 to...

Imported malaria in Finland 1995 to 2008: an overview of surveillance, travel trends, and antimalarial drug sales.

PubMed

Guedes, Sandra; Siikamäki, Heli; Kantele, Anu; Lyytikäinen, Outi

2010-01-01

To improve pre-travel advice, we analyzed nationwide population-based surveillance data on malaria cases reported to the National Infectious Disease Register of Finland (population 5.3 million) during 1995 to 2008 and related it to data on traveling and antimalarial drug sales. Surveillance data comprised information on malaria cases reported to the National Infectious Disease Register during 1995 to 2008. Traveling data were obtained from Statistics Finland (SF) and the Association of Finnish Travel Agents (AFTA). SF data included information on overnight leisure trips to malaria-endemic countries during 2000 to 2008. AFTA data included annual number of organized trips during 1999 to 2007. Quarterly numbers of antimalarial drug sales were obtained from the Finnish Medicines Agency. Descriptive and time series analyses were performed. A total of 484 malaria cases (average annual incidence 0.7/100,000 population) were reported; 283 patients were Finnish- and 201 foreign-born. In all, 15% of all cases were children; 72% foreign- and 28% Finnish-born. Malaria infections were mostly acquired in Africa (76%). Among foreign-born cases, 89% of the infections were acquired in the region of birth. The most common species were Plasmodium falciparum (61%) and Plasmodium vivax (22%). Although traveling to malaria-endemic areas increased, no increase occurred in malaria cases, and a decreasing trend was present in antimalarial drug sales. Traveling to malaria-endemic countries and drug sales followed the same seasonal pattern, with peaks in the first and last quarter of the year. More efforts should be focused on disseminating pre-travel advice to immigrants planning to visit friends and relatives and travelers on self-organized trips. © 2010 International Society of Travel Medicine.

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

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.

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 surveillance...

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 surveillance...

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 surveillance...

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 surveillance...

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…

Student Drug Testing and the Surveillance School Economy: An Analysis of Media Representation and Policy Transfer in Australian Schools

ERIC Educational Resources Information Center

Taylor, Emmeline

2018-01-01

Anxieties relating to the health, safety and security of schoolchildren have been met with a variety of surveillance apparatus in schools internationally. Drawing on findings from a content analysis of newspaper reports relating to drug testing in Australian schools, this article seeks to excavate the ways in which the media shapes, informs,…

Epidemiological surveillance of HIV-1 transmitted drug resistance among newly diagnosed individuals in Shijiazhuang, northern China, 2014-2015.

PubMed

Wang, Xianfeng; Liu, Xiaosong; Li, Feng; Zhou, Hong; Li, Jiefang; Wang, Yingying; Liu, Lihua; Liu, Shujun; Feng, Yi; Wang, Ning

2018-01-01

The widespread use of antiretroviral therapy (ART) has led to considerable concerns about the prevalence of transmitted drug resistance (TDR). Sexual contact, particularly men who have sex with men (MSM) was the most prevalent form of HIV transmission in Shijiazhuang. Hence, we conducted an epidemiological surveillance study on TDR among newly diagnosed individuals who infected-HIV through sexual contact in from 2014-2015. Genotypic resistance mutations were defined using the WHO-2009 surveillance list. Potential impact on antiretroviral drug was predicted according to the Stanford HIV db program version 7.0. The role of transmission clusters in drug resistant strains was evaluated by phylogenetic and network analyses. In this study, 589 individuals were recruited and 542 samples were amplified and sequenced successfully. The over prevalence of TDR was 6.1%: 1.8% to nucleoside reverse transcriptase inhibitors (NRTIs), 2.0% to non- NRTIs (NNRTIs) and 2.4% to protease inhibitors (PIs), respectively. We did not find significant differences in the TDR prevalence by demographic and clinical characteristics (p > 0.05). Using network and phylogenetic analysis, almost 60.0% sequences were clustered together. Of these clusters, 2 included at least two individuals carrying the same resistance mutation, accounting for 21.2% (7/33) individuals with TDR. No significant difference was observed in the clustering rate between the individuals with and without TDR. We obtained a moderate level TDR rate in studied region. These findings enhance our understanding of HIV-1 drug resistance prevalence in Shijiazhuang, and may be helpful for the comprehensive prevention and control of HIV-1.

Antimicrobial resistance surveillance in the AFHSC-GEIS network

PubMed Central

2011-01-01

International infectious disease surveillance has been conducted by the United States (U.S.) Department of Defense (DoD) for many years and has been consolidated within the Armed Forces Health Surveillance Center, Division of Global Emerging Infections Surveillance and Response System (AFHSC-GEIS) since 1998. This includes activities that monitor the presence of antimicrobial resistance among pathogens. AFHSC-GEIS partners work within DoD military treatment facilities and collaborate with host-nation civilian and military clinics, hospitals and university systems. The goals of these activities are to foster military force health protection and medical diplomacy. Surveillance activities include both community-acquired and health care-associated infections and have promoted the development of surveillance networks, centers of excellence and referral laboratories. Information technology applications have been utilized increasingly to aid in DoD-wide global surveillance for diseases significant to force health protection and global public health. This section documents the accomplishments and activities of the network through AFHSC-GEIS partners in 2009. PMID:21388568

Antimicrobial resistance surveillance in the AFHSC-GEIS network.

PubMed

Meyer, William G; Pavlin, Julie A; Hospenthal, Duane; Murray, Clinton K; Jerke, Kurt; Hawksworth, Anthony; Metzgar, David; Myers, Todd; Walsh, Douglas; Wu, Max; Ergas, Rosa; Chukwuma, Uzo; Tobias, Steven; Klena, John; Nakhla, Isabelle; Talaat, Maha; Maves, Ryan; Ellis, Michael; Wortmann, Glenn; Blazes, David L; Lindler, Luther

2011-03-04

International infectious disease surveillance has been conducted by the United States (U.S.) Department of Defense (DoD) for many years and has been consolidated within the Armed Forces Health Surveillance Center, Division of Global Emerging Infections Surveillance and Response System (AFHSC-GEIS) since 1998. This includes activities that monitor the presence of antimicrobial resistance among pathogens. AFHSC-GEIS partners work within DoD military treatment facilities and collaborate with host-nation civilian and military clinics, hospitals and university systems. The goals of these activities are to foster military force health protection and medical diplomacy. Surveillance activities include both community-acquired and health care-associated infections and have promoted the development of surveillance networks, centers of excellence and referral laboratories. Information technology applications have been utilized increasingly to aid in DoD-wide global surveillance for diseases significant to force health protection and global public health. This section documents the accomplishments and activities of the network through AFHSC-GEIS partners in 2009.

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…

Severe morbidity after antiretroviral (ART) initiation: active surveillance in HIV care programs, the IeDEA West Africa collaboration.

PubMed

Abo, Yao; Zannou Djimon, Marcel; Messou, Eugène; Balestre, Eric; Kouakou, Martial; Akakpo, Jocelyn; Ahouada, Carin; de Rekeneire, Nathalie; Dabis, François; Lewden, Charlotte; Minga, Albert

2015-04-09

The causes of severe morbidity in health facilities implementing Antiretroviral Treatment (ART) programmes are poorly documented in sub-Saharan Africa. We aimed to describe severe morbidity among HIV-infected patients after ART initiation, based on data from an active surveillance system established within a network of specialized care facilities in West African cities. Within the International epidemiological Database to Evaluate AIDS (IeDEA)--West Africa collaboration, we conducted a prospective, multicenter data collection that involved two facilities in Abidjan, Côte d'Ivoire and one in Cotonou, Benin. Among HIV-infected adults receiving ART, events were recorded using a standardized form. A simple case-definition of severe morbidity (death, hospitalization, fever>38°5C, Karnofsky index<70%) was used at any patient contact point. Then a physician confirmed and classified the event as WHO stage 3 or 4 according to the WHO clinical classification or as degree 3 or 4 of the ANRS scale. From December 2009 to December 2011, 978 adults (71% women, median age 39 years) presented with 1449 severe events. The main diagnoses were: non-AIDS-defining infections (33%), AIDS-defining illnesses (33%), suspected adverse drug reactions (7%), other illnesses (4%) and syndromic diagnoses (16%). The most common specific diagnoses were: malaria (25%), pneumonia (13%) and tuberculosis (8%). The diagnoses were reported as syndromic in one out of five events recorded during this study. This study highlights the ongoing importance of conventional infectious diseases among severe morbid events occurring in patients on ART in ambulatory HIV care facilities in West Africa. Meanwhile, additional studies are needed due to the undiagnosed aspect of severe morbidity in substantial proportion.

A CTD-Pfizer collaboration: manual curation of 88,000 scientific articles text mined for drug-disease and drug-phenotype interactions.

PubMed

Davis, Allan Peter; Wiegers, Thomas C; Roberts, Phoebe M; King, Benjamin L; Lay, Jean M; Lennon-Hopkins, Kelley; Sciaky, Daniela; Johnson, Robin; Keating, Heather; Greene, Nigel; Hernandez, Robert; McConnell, Kevin J; Enayetallah, Ahmed E; Mattingly, Carolyn J

2013-01-01

Improving the prediction of chemical toxicity is a goal common to both environmental health research and pharmaceutical drug development. To improve safety detection assays, it is critical to have a reference set of molecules with well-defined toxicity annotations for training and validation purposes. Here, we describe a collaboration between safety researchers at Pfizer and the research team at the Comparative Toxicogenomics Database (CTD) to text mine and manually review a collection of 88,629 articles relating over 1,200 pharmaceutical drugs to their potential involvement in cardiovascular, neurological, renal and hepatic toxicity. In 1 year, CTD biocurators curated 254,173 toxicogenomic interactions (152,173 chemical-disease, 58,572 chemical-gene, 5,345 gene-disease and 38,083 phenotype interactions). All chemical-gene-disease interactions are fully integrated with public CTD, and phenotype interactions can be downloaded. We describe Pfizer's text-mining process to collate the articles, and CTD's curation strategy, performance metrics, enhanced data content and new module to curate phenotype information. As well, we show how data integration can connect phenotypes to diseases. This curation can be leveraged for information about toxic endpoints important to drug safety and help develop testable hypotheses for drug-disease events. The availability of these detailed, contextualized, high-quality annotations curated from seven decades' worth of the scientific literature should help facilitate new mechanistic screening assays for pharmaceutical compound survival. This unique partnership demonstrates the importance of resource sharing and collaboration between public and private entities and underscores the complementary needs of the environmental health science and pharmaceutical communities. Database URL: http://ctdbase.org/

Economics of zoonoses surveillance in a 'One Health' context: an assessment of Campylobacter surveillance in Switzerland.

PubMed

Babo Martins, S; Rushton, J; Stärk, K D C

2017-04-01

Cross-sectorial surveillance and general collaboration between the animal and the public health sectors are increasingly recognized as needed to better manage the impacts of zoonoses. From 2009, the Swiss established a Campylobacter mitigation system that includes human and poultry surveillance data-sharing within a multi-sectorial platform, in a 'One Health' approach. The objective of this study was to explore the economics of this cross-sectorial approach, including surveillance and triggered interventions. Costs and benefits of the One Health and of the uni-sectorial approach to Campylobacter surveillance were identified using an economic assessment framework developed earlier. Cost information of surveillance activities and interventions was gathered and disability-adjusted life years (DALYs) associated with the disease estimated for 2008 and 2013. In the first 5 years of this One Health approach to Campylobacter mitigation, surveillance contributed with information mainly used to perform risk assessments, monitor trends and shape research efforts on Campylobacter. There was an increase in costs associated with the mitigation activities following integration, due mainly to the allocation of additional resources to research and implementation of poultry surveillance. The overall burden of campylobacteriosis increased by 3·4-8·8% to 1751-2852 DALYs in 2013. In the timing of the analysis, added value associated with this cross-sectorial approach to surveillance of Campylobacter in the country was likely generated through non-measurable benefits such as intellectual capital and social capital.

Translating knowledge from Pakistan's second generation surveillance system to other global contexts.

PubMed

Adrien, Alix; Thompson, Laura H; Archibald, Chris P; Sandstrom, Paul A; Munro, Michelle; Emmanuel, Faran; Blanchard, James F

2013-09-01

From 2004 to 2011, a collaborative project was undertaken to enhance the capacity of the Government of Pakistan to implement an effective second-generation surveillance system for HIV/AIDS, known as the HIV/AIDS Surveillance Project (HASP). In four separate rounds, behavioural questionnaires were administered among injection drug users, and female, male and hijra (transgender) sex workers. Dried blood spots were collected for HIV testing. Through interviews with project staff in Pakistan and Canada, we have undertaken a critical review of the role of HASP in generating, using and translating knowledge, with an emphasis on capacity building within both the donor and recipient countries. We also documented ongoing and future opportunities for the translation of knowledge produced through HASP. Knowledge translation activities have included educational workshops and consultations held in places as diverse as Colombia and Cairo, and the implementation of HASP methodologies in Asia, the Middle East and sub-Saharan Africa. HASP methodologies have been incorporated in multiple WHO reports. Importantly, the donor country, Canada, has benefited in significant ways from this partnership. Operational and logistical lessons from HASP have, in turn, improved how surveillance is performed in Canada. Through this project, significant capacity was built among the staff of HASP, non-governmental organisations which were engaged as implementation partners, data coordination units which were established in each province, and in the laboratory. As is to be expected, different organisations have different agendas and priorities, requiring negotiation, at times, to ensure the success of collaborative activities. Overall, there has been considerable interest in and opportunities made for learning about the methodologies and approaches employed by HASP. Generally, the recognition of the strengths of the approaches and methodologies used by HASP has ensured an appetite for opportunities of

High Prevalence of HIV Drug Resistance Among Newly Diagnosed Infants Aged <18 Months: Results From a Nationwide Surveillance in Nigeria.

PubMed

Inzaule, Seth C; Osi, Samuels J; Akinbiyi, Gbenga; Emeka, Asadu; Khamofu, Hadiza; Mpazanje, Rex; Ilesanmi, Oluwafunke; Ndembi, Nicaise; Odafe, Solomon; Sigaloff, Kim C E; Rinke de Wit, Tobias F; Akanmu, Sulaimon

2018-01-01

WHO recommends protease-inhibitor-based first-line regimen in infants because of risk of drug resistance from failed prophylaxis used in prevention of mother-to-child transmission (PMTCT). However, cost and logistics impede implementation in sub-Saharan Africa, and >75% of children still receive nonnucleoside reverse transcriptase inhibitor-based regimen (NNRTI) used in PMTCT. We assessed the national pretreatment drug resistance prevalence of HIV-infected children aged <18 months in Nigeria, using WHO-recommended HIV drug resistance surveillance protocol. We used remnant dried blood spots collected between June 2014 and July 2015 from 15 early infant diagnosis facilities spread across all the 6 geopolitical regions of Nigeria. Sampling was through a probability proportional-to-size approach. HIV drug resistance was determined by population-based sequencing. Overall, in 48% of infants (205 of 430) drug resistance mutations (DRM) were detected, conferring resistance to predominantly NNRTIs (45%). NRTI and multiclass NRTI/NNRTI resistance were present at 22% and 20%, respectively, while resistance to protease inhibitors was at 2%. Among 204 infants with exposure to drugs for PMTCT, 57% had DRMs, conferring NNRTI resistance in 54% and multiclass NRTI/NNRTI resistance in 29%. DRMs were also detected in 34% of 132 PMTCT unexposed infants. A high frequency of PDR, mainly NNRTI-associated, was observed in a nationwide surveillance among newly diagnosed HIV-infected children in Nigeria. PDR prevalence was equally high in PMTCT-unexposed infants. Our results support the use of protease inhibitor-based first-line regimens in HIV-infected young children regardless of PMTCT history and underscore the need to accelerate implementation of the newly disseminated guideline in Nigeria.

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) The...

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) The...

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) The...

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) The...

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) The...

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 may...

Pharmacovigilance and post-black market surveillance.

PubMed

Langlitz, Nicolas

2009-06-01

Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding and assessment of risks related to the use of drugs in a population, and the prevention of consequential adverse effects. In a narrower sense, the term refers exclusively to postmarket surveillance. This paper briefly outlines how pharmacovigilance has come to play a central role in the regulation of novel pharmaceuticals. However, the focus of the text is on mechanisms emerging in an experimental drug scene that aim at dealing with the risks posed by 'designer drugs' newly introduced to the black market. This discussion of pharmacovigilance and 'post-black market surveillance' is situated in the broader context of the more recent dissemination of vigilance as a key element of government in a world too complex for legal and disciplinary measures alone.

Progress with enhancing veterinary surveillance in the United Kingdom.

PubMed

Lysons, R E; Gibbens, J C; Smith, L H

2007-01-27

The UK has experienced various animal health events that have had national impact in recent years. In response, a ;Veterinary Surveillance Strategy' (VSS) was published in 2003, with the objective of enhancing and coordinating national veterinary surveillance practice in a way that would enable important animal health events to be detected and assessed more rapidly and reliably. The VSS adopts an integrated UK-wide approach, which includes widespread engagement with interested parties both within government and beyond. It proposes enhancing surveillance through improved collaboration; transparent and defensible prioritisation of government resources to surveillance; deriving better value from existing resources, and assuring quality of the surveillance reports and source data. This article describes progress with implementing the VSS, in particular the methodology for developing a functional network and creating an effective, quality-assured, information management system, RADAR.

On the spread and control of MDR-TB epidemics: an examination of trends in anti-tuberculosis drug resistance surveillance data

PubMed Central

Cohen, Ted; Jenkins, Helen E.; Lu, Chunling; McLaughlin, Megan; Floyd, Katherine; Zignol, Matteo

2015-01-01

SUMMARY Background Multidrug resistant tuberculosis (MDR-TB) poses serious challenges for tuberculosis control in many settings, but trends of MDR-TB have been difficult to measure. Methods We analyzed surveillance and population-representative survey data collected worldwide by the World Health Organization between 1993 and 2012. We examined setting-specific patterns associated with linear trends in the estimated per capita rate of MDR-TB among new notified TB cases to generate hypotheses about factors associated with trends in the transmission of highly drug resistant tuberculosis. Results 59 countries and 39 sub-national settings had at least three years of data, but less than 10% of the population in the WHO-designated 27-high MDR-TB burden settings were in areas with sufficient data to track trends. Among settings in which the majority of MDR-TB was autochthonous, we found 10 settings with statistically significant linear trends in per capita rates of MDR-TB among new notified TB cases. Five of these settings had declining trends (Estonia, Latvia, Macao, Hong Kong, and Portugal) ranging from decreases of 3-14% annually, while five had increasing trends (four individual oblasts of the Russian Federation and Botswana) ranging from 14-20% annually. In unadjusted analysis, better surveillance indicators and higher GDP per capita were associated with declining MDR-TB, while a higher existing absolute burden of MDR-TB was associated with an increasing trend. Conclusions Only a small fraction of countries in which the burden of MDR-TB is concentrated currently have sufficient surveillance data to estimate trends in drug-resistant TB. Where trend analysis was possible, smaller absolute burdens of MDR-TB and more robust surveillance systems were associated with declining per capita rates of MDR-TB among new notified cases. PMID:25458783

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 been...

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 been...

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 been...

Medication sales and syndromic surveillance, France.

PubMed

Vergu, Elisabeta; Grais, Rebecca F; Sarter, Hélène; Fagot, Jean-Paul; Lambert, Bruno; Valleron, Alain-Jaques; Flahault, Antoine

2006-03-01

Although syndromic surveillance systems using nonclinical data have been implemented in the United States, the approach has yet to be tested in France. We present the results of the first model based on drug sales that detects the onset of influenza season and forecasts its trend. Using weekly lagged sales of a selected set of medications, we forecast influenzalike illness (ILI) incidence at the national and regional level for 3 epidemic seasons (2000-01, 2001-02, and 2002-03) and validate the model with real-time updating on the fourth (2003-04). For national forecasts 1-3 weeks ahead, the correlation between observed ILI incidence and forecast was 0.85-0.96, an improvement over the current surveillance method in France. Our findings indicate that drug sales are a useful additional tool to syndromic surveillance, a complementary and independent source of information, and a potential improvement for early warning systems for both epidemic and pandemic planning.

Surveillance guidelines for disease elimination: A case study of canine rabies

PubMed Central

Townsend, Sunny E.; Lembo, Tiziana; Cleaveland, Sarah; Meslin, François X.; Miranda, Mary Elizabeth; Putra, Anak Agung Gde; Haydon, Daniel T.; Hampson, Katie

2013-01-01

Surveillance is a critical component of disease control programmes but is often poorly resourced, particularly in developing countries lacking good infrastructure and especially for zoonoses which require combined veterinary and medical capacity and collaboration. Here we examine how successful control, and ultimately disease elimination, depends on effective surveillance. We estimated that detection probabilities of <0.1 are broadly typical of rabies surveillance in endemic countries and areas without a history of rabies. Using outbreak simulation techniques we investigated how the probability of detection affects outbreak spread, and outcomes of response strategies such as time to control an outbreak, probability of elimination, and the certainty of declaring freedom from disease. Assuming realistically poor surveillance (probability of detection <0.1), we show that proactive mass dog vaccination is much more effective at controlling rabies and no more costly than campaigns that vaccinate in response to case detection. Control through proactive vaccination followed by 2 years of continuous monitoring and vaccination should be sufficient to guarantee elimination from an isolated area not subject to repeat introductions. We recommend that rabies control programmes ought to be able to maintain surveillance levels that detect at least 5% (and ideally 10%) of all cases to improve their prospects of eliminating rabies, and this can be achieved through greater intersectoral collaboration. Our approach illustrates how surveillance is critical for the control and elimination of diseases such as canine rabies and can provide minimum surveillance requirements and technical guidance for elimination programmes under a broad-range of circumstances. PMID:23260376

Surveillance guidelines for disease elimination: a case study of canine rabies.

PubMed

Townsend, Sunny E; Lembo, Tiziana; Cleaveland, Sarah; Meslin, François X; Miranda, Mary Elizabeth; Putra, Anak Agung Gde; Haydon, Daniel T; Hampson, Katie

2013-05-01

Surveillance is a critical component of disease control programmes but is often poorly resourced, particularly in developing countries lacking good infrastructure and especially for zoonoses which require combined veterinary and medical capacity and collaboration. Here we examine how successful control, and ultimately disease elimination, depends on effective surveillance. We estimated that detection probabilities of <0.1 are broadly typical of rabies surveillance in endemic countries and areas without a history of rabies. Using outbreak simulation techniques we investigated how the probability of detection affects outbreak spread, and outcomes of response strategies such as time to control an outbreak, probability of elimination, and the certainty of declaring freedom from disease. Assuming realistically poor surveillance (probability of detection <0.1), we show that proactive mass dog vaccination is much more effective at controlling rabies and no more costly than campaigns that vaccinate in response to case detection. Control through proactive vaccination followed by 2 years of continuous monitoring and vaccination should be sufficient to guarantee elimination from an isolated area not subject to repeat introductions. We recommend that rabies control programmes ought to be able to maintain surveillance levels that detect at least 5% (and ideally 10%) of all cases to improve their prospects of eliminating rabies, and this can be achieved through greater intersectoral collaboration. Our approach illustrates how surveillance is critical for the control and elimination of diseases such as canine rabies and can provide minimum surveillance requirements and technical guidance for elimination programmes under a broad-range of circumstances. Copyright © 2012 Elsevier Ltd. All rights reserved.

Economic Assessment of Zoonoses Surveillance in a 'One Health' Context: A Conceptual Framework.

PubMed

Babo Martins, S; Rushton, J; Stärk, K D C

2016-08-01

Collaboration between animal and public health sectors has been highlighted as a means to improve the management of zoonotic threats. This includes surveillance systems for zoonoses, where enhanced cross-sectoral integration and sharing of information are seen as key to improved public health outcomes. Yet, there is a lack of evidence on the economic returns of such collaboration, particularly in the development and implementation of surveillance programmes. The economic assessment of surveillance in this context needs to be underpinned by the understanding of the links between zoonotic disease surveillance in animal populations and the wider public health disease mitigation process and how these relations impact on the costs and benefits of the surveillance activities. This study presents a conceptual framework of these links as a basis for the economic assessment of cross-sectoral zoonoses surveillance with the aim of supporting the prioritization of resource allocation to surveillance. In the proposed framework, monetary, non-monetary and intermediate or intangible cost components and benefit streams of three conceptually distinct stages of zoonotic disease mitigation are identified. In each stage, as the final disease mitigation objective varies so does the use of surveillance information generated in the animal populations for public health decision-making. Consequently, the associated cost components and benefit streams also change. Building on the proposed framework and taking into account these links, practical steps for its application are presented and future challenges are discussed. © 2015 Blackwell Verlag GmbH.

21 CFR 26.18 - Regulatory collaboration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

Beyond counting cases: public health impacts of national Paediatric Surveillance Units

PubMed Central

Grenier, D; Elliott, E J; Zurynski, Y; Pereira, R Rodrigues; Preece, M; Lynn, R; von Kries, R; Zimmermann, H; Dickson, N P; Virella, D

2007-01-01

Paediatric Surveillance Units (PSUs) have been established in 14 countries and facilitate national, prospective, active surveillance for a range of conditions, with monthly reporting by child health specialists. The International Network of Paediatric Surveillance Units (INoPSU) was established in 1998 and facilitates international collaboration among member PSUs and allows for sharing of resources, simultaneous data collection and hence comparison of data from different geographical regions. The impact of data collected by PSUs, both individually and collectively as members of INoPSU, on public health outcomes, clinical care and research is described. PMID:17158859

A mortality index for postmarketing surveillance of new medications.

PubMed

Rose, J C; Unis, A S

2000-03-01

The rate of introduction of new pharmaceuticals is growing as a result of advances in molecular pharmacology and targeted drug development. The Fatal Toxicity Index (FTI) has been proposed as a means for monitoring drug toxicity through post-marketing surveillance. The FTI requires data regarding the general availability of a particular agent in the community which, in the US, is proprietary. The authors propose a Mortality Index as an alternative method for calculating relative lethality that does not rely on proprietary information for postmarketing surveillance. Using data from the Toxic Exposure Surveillance System (TESS) a Mortality Index was calculated from the proportion of deaths occurring among all patients who present to a health care facility with an overdose on the same agent or class of agents. The average Mortality Index for various drugs or drug classes for the years 1989 to 1997 is reported. Because the Mortality Index for desipramine appeared much greater than that for the other tricyclics, a chi-squared analysis was performed. The authors conclude, based on this analysis, that desipramine is significantly more likely to lead to death after overdosage than any other tricyclic antidepressant in the study. Also, the Mortality Index appeared to identify the impact of pediatric formulations on overdose lethality. We conclude that the Mortality Index may be a useful tool for determining the safety of agents during the postmarketing surveillance phase.

SURVEILLANCE FOR WATERBORNE-DISEASE OUTBREAKS-UNITED STATES, 1997-1998

EPA Science Inventory

PROBLEM/CONDITION: Since 1971, CDC and the U.S. Environmental Protection Agency (EPA) have maintained a collaborative surveillance system for collecting and periodically reporting data relating to occurrences and causes of waterborne-disease outbreaks (WBDOs). REPORTING PERIOD CO...

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 notify...

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 notify...

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 notify...

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 notify...

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 notify...

SURVEILLANCE FOR WATERBORNE-DISEASE OUTBREAKS - UNITED STATES, 1999-2000

EPA Science Inventory

PROBLEM/CONDITION: Since 1971, CDC, the U.S. Environmental Protection Agency (EPA), and the Council of State and Territorial Epidemiologists (CSTE) have maintained a collaborative surveillance system for the occurrences and causes of waterborne-disease outbreaks (WBDOs).This surv...

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

2016-07-08

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

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

National Antimicrobial Resistance Monitoring System: Two Decades of Advancing Public Health Through Integrated Surveillance of Antimicrobial Resistance

PubMed Central

Tate, Heather; Plumblee, Jodie R.; Dessai, Uday; Whichard, Jean M.; Thacker, Eileen L.; Hale, Kis Robertson; Wilson, Wanda; Friedman, Cindy R.; Griffin, Patricia M.; McDermott, Patrick F.

2017-01-01

Abstract Drug-resistant bacterial infections pose a serious and growing public health threat globally. In this review, we describe the role of the National Antimicrobial Resistance Monitoring System (NARMS) in providing data that help address the resistance problem and show how such a program can have broad positive impacts on public health. NARMS was formed two decades ago to help assess the consequences to human health arising from the use of antimicrobial drugs in food animal production in the United States. A collaboration among the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the United States Department of Agriculture, and state and local health departments, NARMS uses an integrated “One Health” approach to monitor antimicrobial resistance in enteric bacteria from humans, retail meat, and food animals. NARMS has adapted to changing needs and threats by expanding surveillance catchment areas, examining new isolate sources, adding bacteria, adjusting sampling schemes, and modifying antimicrobial agents tested. NARMS data are not only essential for ensuring that antimicrobial drugs approved for food animals are used in ways that are safe for human health but they also help address broader food safety priorities. NARMS surveillance, applied research studies, and outbreak isolate testing provide data on the emergence of drug-resistant enteric bacteria; genetic mechanisms underlying resistance; movement of bacterial populations among humans, food, and food animals; and sources and outcomes of resistant and susceptible infections. These data can be used to guide and evaluate the impact of science-based policies, regulatory actions, antimicrobial stewardship initiatives, and other public health efforts aimed at preserving drug effectiveness, improving patient outcomes, and preventing infections. Many improvements have been made to NARMS over time and the program will continue to adapt to address emerging resistance threats

National Antimicrobial Resistance Monitoring System: Two Decades of Advancing Public Health Through Integrated Surveillance of Antimicrobial Resistance.

PubMed

Karp, Beth E; Tate, Heather; Plumblee, Jodie R; Dessai, Uday; Whichard, Jean M; Thacker, Eileen L; Hale, Kis Robertson; Wilson, Wanda; Friedman, Cindy R; Griffin, Patricia M; McDermott, Patrick F

2017-10-01

Drug-resistant bacterial infections pose a serious and growing public health threat globally. In this review, we describe the role of the National Antimicrobial Resistance Monitoring System (NARMS) in providing data that help address the resistance problem and show how such a program can have broad positive impacts on public health. NARMS was formed two decades ago to help assess the consequences to human health arising from the use of antimicrobial drugs in food animal production in the United States. A collaboration among the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the United States Department of Agriculture, and state and local health departments, NARMS uses an integrated "One Health" approach to monitor antimicrobial resistance in enteric bacteria from humans, retail meat, and food animals. NARMS has adapted to changing needs and threats by expanding surveillance catchment areas, examining new isolate sources, adding bacteria, adjusting sampling schemes, and modifying antimicrobial agents tested. NARMS data are not only essential for ensuring that antimicrobial drugs approved for food animals are used in ways that are safe for human health but they also help address broader food safety priorities. NARMS surveillance, applied research studies, and outbreak isolate testing provide data on the emergence of drug-resistant enteric bacteria; genetic mechanisms underlying resistance; movement of bacterial populations among humans, food, and food animals; and sources and outcomes of resistant and susceptible infections. These data can be used to guide and evaluate the impact of science-based policies, regulatory actions, antimicrobial stewardship initiatives, and other public health efforts aimed at preserving drug effectiveness, improving patient outcomes, and preventing infections. Many improvements have been made to NARMS over time and the program will continue to adapt to address emerging resistance threats, changes in

Developing Syndromic Surveillance to Monitor and Respond to Adverse Health Events Related to Psychoactive Substance Use: Methods and Applications.

PubMed

Nolan, Michelle L; Kunins, Hillary V; Lall, Ramona; Paone, Denise

Recent increases in drug overdose deaths, both in New York City and nationally, highlight the need for timely data on psychoactive drug-related morbidity. We developed drug syndrome definitions for syndromic surveillance to monitor drug-related emergency department (ED) visits in real time. We used 2012 archived syndromic surveillance data from New York City hospitals to develop definitions for psychoactive drug-related syndromes. The dataset contained ED visit-level information that included patients' chief complaints, dates of visits, ZIP codes of residence, discharge diagnoses, and dispositions. After manually reviewing chief complaints, we developed a classification scheme comprising 3 categories (overdose, drug mention, and drug abuse/misuse), which we used to define 25 psychoactive drug syndromes. From July 2013 through December 2015, the New York City Department of Health and Mental Hygiene performed daily syndromic surveillance of psychoactive drug-related ED visits using the 25 syndrome definitions. Syndromic surveillance triggered 4 public health investigations, supported 8 other public health investigations that had been triggered by other mechanisms, and resulted in the identification of 5 psychoactive drug-related outbreaks. Syndromic surveillance also identified a substantial increase in synthetic cannabinoid-related visits (from an average of 3 per week in January 2014 to >300 per week in July 2015) and an increase in heroin overdose visits (from 80 to 171 in the first 3 quarters of 2012 and 2014, respectively) in a single neighborhood. Syndromic surveillance using these novel definitions enabled monitoring of trends in psychoactive drug-related morbidity, initiation and support of public health investigations, and targeting of interventions. Health departments can refine these definitions for their jurisdictions using the described methods and integrate them into existing syndromic surveillance systems.

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

Drug safety in pregnancy--monitoring congenital anomalies.

PubMed

Morgan, Margery; De Jong-van den Berg, Lolkje T W; Jordan, Sue

2011-04-01

This paper outlines research into the causes of congenital anomalies, and introduces a pan-European study. The potential roles of nurses and midwives in this area are illustrated by a case report. Since the thalidomide disaster, use of drugs in pregnancy has been carefully monitored to prevent anything similar happening again. However, monitoring is incomplete and questions remain unanswered. Many medicines are essential for the health of pregnant women. However, drug use in pregnancy requires surveillance. Methods include spontaneous reporting of adverse events, cohort studies and case control studies. It is hoped that a Europe-wide study, combining data from several congenital anomaly registers, will provide a sufficiently large population to assess the impact of selected drugs on congenital anomalies. However, this work depends on the consistency of reporting by nurses and midwives. Drug safety in pregnancy remains undetermined. Collaboration across Europe has the potential to provide a framework for safety evaluation. Prescribers should consider the possibility of pregnancy in women of child-bearing age. Careful review of maternal drug use in early pregnancy is essential. Midwives and nurses should be aware of adverse event drug reporting systems, including congenital anomaly registers. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How long must I conduct postmarket surveillance of... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.15 How long must I conduct postmarket surveillance of my device? The length of postmarket...

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false How long must I conduct postmarket surveillance of... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.15 How long must I conduct postmarket surveillance of my device? The length of postmarket...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false How long must I conduct postmarket surveillance of... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.15 How long must I conduct postmarket surveillance of my device? The length of postmarket...

Using a Drug Interaction Program (Drug Interactions Advisor™) in a Community Hospital

PubMed Central

Harvey, A. C.; Diehl, G. R.; Finlayson, W. B.

1987-01-01

To test the usefulness of a drugs-interaction program in a community hospital one hundred patients in three medical wards were surveyed with respect to their drug regime. The drugs listed for each patient were entered into Drug Interactions Advisor™ a commercial interactions program running on an Apple IIE. Interacting drugs were listed with the severity of the interaction in each case. Of one hundred patients fifty-one had drugs which could potentially interact and in fifty-one percent of cases a change in therapy would have been advised by Drug Interactions Advisor™. The completeness of the data base was assessed as to its inclusion of drugs actually given and it dealt with eighty-nine percent. The program was tested against ten known interactions and it identified six. Multiple drug therapy is a major problem nowadays and will increase with the aging of the population. Drug interactions programs exploit computer technology to make drug surveillance easier. Without computers such surveillance is difficult if not impossible.

Efficacy and safety of oral CDP-choline. Drug surveillance study in 2817 cases.

PubMed

Lozano Fernández, R

1983-01-01

A drug surveillance study has been carried out with oral cytidine diphosphate choline (CDP-choline, citicoline, Somazina) in 2817 patients of all ages, predominating those between 60 and 80 years old. They were suffering from several neurological processes, mainly the vasculocerebral insufficiency and senile involution. Treatment was carried out for between 15 days and 2 months, the mean dose being 6 ml/d. The efficacy of the treatment was determined on the basis of the disappearance, improvement or worsening of clinical manifestations, most frequently shown by patients. The most benefited clinical manifestations by the treatment were: dizziness disappearing in 48.4% of the cases, and improving in 25.2%, cephalea disappearing in 46.5% and improving in 26.7%, insomnia with 38.6% and 24.9%, respectively; depression with 36.9% and 24.1% and memory shortage with 21.2% and 44.7% respectively. The best results were obtained in chronic cerebrovascular insufficiency, the improvements obtained in dizziness, cephalea, insomnia, fatigue and speech troubles being the most important. The safety of the drug was excellent since side effects were observed only in 5.01% of the patients. Among these effects, the most frequently seen were digestive troubles, observed in 3.6% of the cases.

Changes in incidence and antifungal drug resistance in candidemia: results from population-based laboratory surveillance in Atlanta and Baltimore, 2008-2011.

PubMed

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

2012-11-15

Candidemia is common and associated with high morbidity and mortality; changes in population-based incidence rates have not been reported. 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). 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. 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.

Trends in Drug Resistance of Acinetobacter baumannii over a 10-year Period: Nationwide Data from the China Surveillance of Antimicrobial Resistance Program.

PubMed

Gao, Lei; Lyu, Yuan; Li, Yun

2017-03-20

Acinetobacter baumannii has emerged as an important pathogen causing a variety of infections. Using data from the China Surveillance of Antimicrobial Resistance Program conducted biennially, we investigated the secular changes in the resistance of 2917 isolates of A. baumannii from 2004 to 2014 to differ antimicrobial agents. Pathogen samples were collected from 17 to 20 hospitals located in the eastern, central, and western regions of China. Minimum inhibitory concentrations (MICs) were determined by a 2-fold agar dilution method, and antimicrobial susceptibility was established using the 2014 Clinical Laboratory Standards Institute-approved breakpoints. Isolates not susceptible to all the tested aminoglycosides, fluoroquinolones, β-lactams, β-lactam/β-lactam inhibitors and carbapenems were defined as extensively drug resistant. The rates of nonsusceptibility to common antimicrobial agents remained high (>65%) over the years with some fluctuations to certain agents. The prevalence of imipenem-resistant A. baumannii (IRAB) increased from 13.3% in 2004 to 70.5% in 2014 and that of extensively drug-resistant A. baumannii (XDRAB) increased from 11.1% in 2004 to 60.4% in 2014. The activity of tigecycline was stable with MIC90 ≤4 mg/L against A. baumannii from 2009 to 2014. Susceptibility to colistin remained high (97.0%) from 2009 to 2014. The prevalence of XDRAB increased in all the three surveillance regions over the years and was significantly higher in Intensive Care Unit (ICU) wards than non-ICU wards. This longitudinal multicenter surveillance program revealed the nationwide emergence of A. baumannii in China and showed a significant increase in prevalence from 2004 to 2014. High levels of bacterial resistance were detected among samples collected from clinical settings in China, with IRAB and XDRAB being especially prevalent. This study will help to guide empirical therapy and identify at-risk groups requiring more intense interventional infection control

Adverse drug event monitoring at the Food and Drug Administration.

PubMed

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.

Adverse Drug Event Monitoring at the Food and Drug Administration

PubMed Central

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk. PMID:12534765

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... surveillance is appropriate? 822.7 Section 822.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Notification § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? (a) If you do not agree with...

Surveillance efforts after mass drug administration to validate elimination of lymphatic filariasis as a public health problem in Vanuatu.

PubMed

Taleo, Fasihah; Taleo, George; Graves, Patricia M; Wood, Peter; Kim, Sung Hye; Ozaki, Masayo; Joseph, Hayley; Chu, Brian; Pavluck, Alex; Yajima, Aya; Melrose, Wayne; Ichimori, Kazuyo; Capuano, Corinne

2017-01-01

Vanuatu was formerly highly endemic for lymphatic filariasis (LF), caused by Wuchereria bancrofti and transmitted by Anopheles mosquitoes. After a baseline survey showing 4.8% antigen prevalence in 1998, the country conducted nationwide (in one implementation unit) annual mass drug administration (MDA) with albendazole and diethylcarbamazine citrate from 2000 to 2004 and achieved prevalence of 0.2% by 2006 in a representative nationwide cluster survey among all age groups. Post MDA surveillance was conducted from 2006 to 2012. After MDA, the country was divided for surveillance into three evaluation units (EUs) formed by grouping provinces according to baseline prevalence: EU1: Torba, Sanma and Malampa; EU2: Penama; EU3: Shefa and Tafea. The study compiled all past data and information on surveys in Vanuatu from the country programme. This paper reviews the surveillance activities done after stopping MDA to validate the interruption of transmission and elimination of LF as a public health problem. Post-MDA surveillance consisting of at least three transmission assessment surveys (TAS) in each of the three EUs was conducted between 2006 and 2012. Sentinel and spot check surveys identified a few villages with persistent high prevalence; all antigen positive cases in these sites were treated and additional targeted MDA conducted for 3 years in 13 villages in one area of concern. All three EUs passed all TAS in 2007, 2010 and 2012 respectively, with no positives found except in EU2 (Penama province) in 2012 when 2 children tested positive for circulating filariasis antigen. Assessment of the burden of chronic filariasis morbidity found 95 cases in 2003 and 32 remaining cases in 2007, all aged over 60 years. Vanuatu has achieved validation of elimination of LF as a public health problem. Post-validation surveillance is still recommended especially in formerly highly endemic areas.

SURVEILLANCE FOR DRINKING WATER-ASSOCIATED OUTBREAKS-UNITED STATES, 2001-2002

EPA Science Inventory

Problem/Condition: Since 1971, CDC, the U.S. Environmental Protection
Agency (EPA), and the Council of State and Territorial Epidemiologists CSTE) have maintained a collaborative surveillance system for collecting and periodically reporting data related to occurrences and cau...

Real-Time Surveillance of Infectious Diseases: Taiwan's Experience.

PubMed

Jian, Shu-Wan; Chen, Chiu-Mei; Lee, Cheng-Yi; Liu, Ding-Ping

Integration of multiple surveillance systems advances early warning and supports better decision making during infectious disease events. Taiwan has a comprehensive network of laboratory, epidemiologic, and early warning surveillance systems with nationwide representation. Hospitals and clinical laboratories have deployed automatic reporting mechanisms since 2014 and have effectively improved timeliness of infectious disease and laboratory data reporting. In June 2016, the capacity of real-time surveillance in Taiwan was externally assessed and was found to have a demonstrated and sustainable capability. We describe Taiwan's disease surveillance system and use surveillance efforts for influenza and Zika virus as examples of surveillance capability. Timely and integrated influenza information showed a higher level and extended pattern of influenza activity during the 2015-16 season, which ensured prompt information dissemination and the coordination of response operations. Taiwan also has well-developed disease detection systems and was the first country to report imported cases of Zika virus from Miami Beach and Singapore. This illustrates a high level of awareness and willingness among health workers to report emerging infectious diseases, and highlights the robust and sensitive nature of Taiwan's surveillance system. These 2 examples demonstrate the flexibility of the surveillance systems in Taiwan to adapt to emerging infectious diseases and major communicable diseases. Through participation in the GHSA, Taiwan can more actively collaborate with national counterparts and use its expertise to strengthen global and regional surveillance capacity in the Asia Pacific and in Southeast Asia, in order to advance a world safe and secure from infectious disease.

Real-Time Surveillance of Infectious Diseases: Taiwan's Experience

PubMed Central

Jian, Shu-Wan; Chen, Chiu-Mei; Lee, Cheng-Yi

2017-01-01

Integration of multiple surveillance systems advances early warning and supports better decision making during infectious disease events. Taiwan has a comprehensive network of laboratory, epidemiologic, and early warning surveillance systems with nationwide representation. Hospitals and clinical laboratories have deployed automatic reporting mechanisms since 2014 and have effectively improved timeliness of infectious disease and laboratory data reporting. In June 2016, the capacity of real-time surveillance in Taiwan was externally assessed and was found to have a demonstrated and sustainable capability. We describe Taiwan's disease surveillance system and use surveillance efforts for influenza and Zika virus as examples of surveillance capability. Timely and integrated influenza information showed a higher level and extended pattern of influenza activity during the 2015-16 season, which ensured prompt information dissemination and the coordination of response operations. Taiwan also has well-developed disease detection systems and was the first country to report imported cases of Zika virus from Miami Beach and Singapore. This illustrates a high level of awareness and willingness among health workers to report emerging infectious diseases, and highlights the robust and sensitive nature of Taiwan's surveillance system. These 2 examples demonstrate the flexibility of the surveillance systems in Taiwan to adapt to emerging infectious diseases and major communicable diseases. Through participation in the GHSA, Taiwan can more actively collaborate with national counterparts and use its expertise to strengthen global and regional surveillance capacity in the Asia Pacific and in Southeast Asia, in order to advance a world safe and secure from infectious disease. PMID:28418738

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

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

PubMed

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

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. 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). 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. 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 between them fostered, using community

[Surveillance report of drug-resistant bacteria from 2007 to 2012 in Saga Prefecture, Japan (the second report)].

PubMed

Kiyosuke, Makiko; Nagasawa, Zenzo; Hotta, Taeko; Utsumi, Takashi; Kang, Dongchon; Miyamoto, Hiroshi

2014-06-01

Drug-resistant bacteria are a problematic issue in Japan. Surveillance of drug-resistant bacteria is important because the frequency of isolation and kinds of such bacteria vary between hospitals and local areas. This study summarizes the results of detection of drug-resistant bacteria in Saga Prefecture from July 2007 to June 2012. Data presented in this study were collected through questionnaire survey that was conducted in 12 hospitals. Frequency of drug-resistant bacteria are as follows: 62.5% of Staphylococcus aureus was methicillin-resistant S. aureus (MRSA); 62.2% of Streptococcus pneumoniae was penicillin-intermediate S. pneumoniae (PISP) or penicillin-resistant S. pneumoniae (PRSP); 26.4% of Haemophilus influenzae was beta-lactamase negative ampicillin-resistant H. influenzae (BLNAR); 0.5% of Pseudomonas aeruginosa was metallo-beta-lactamase (MBL) P. aeruginosa; 0.5% of P. aeruginosa was multi-drug resistant P. aeruginosa (MDRP); 12.9% and 5.1% of Escherichia coli and Klebsiella pneumoniae, respectively, were extended-spectrum beta-lactamase (ESBL) producing organisms. While the isolation frequencies of MRSA and PISP/PRSP were unchanged, those of BLNAR, ESBL producing E. coli and ESBL producing K. pneumoniae raised from 15.4% to 34.2%, from 5.7% to 18.4% and from 2.6% to 8.2%, respectively, over the past 5 years. The frequencies of isolation of MDRP and two drug resistant P. aeruginosa declined. This study revealed that the overall trend in the long-term changes of isolation frequency of drug-resistant bacteria in Saga Prefecture is similar to the trend in the national data. It also showed that the frequency and kinds of drug-resistant bacteria are variable between hospitals and local areas. Further study, such as examination of the usage and MIC value of antimicrobial drugs, will enable us to gain more detailed information on the drug-resistant bacteria.

Strengthening National Disease Surveillance and Response-Haiti, 2010-2015.

PubMed

Juin, Stanley; Schaad, Nicolas; Lafontant, Donald; Joseph, Gerard A; Barzilay, Ezra; Boncy, Jacques; Barrais, Robert; Louis, Frantz Jean; Jean Charles, Nadia Lapierre; Corvil, Salomon; Barthelemy, Nickolsno; Dismer, Amber; Pierre, Jean Samuel; Archer, Roodly W; Antoine, Mayer; Marston, Barbara; Katz, Mark; Dely, Patrick; Adrien, Paul; Fitter, David L; Lowrance, David; Patel, Roopal

2017-10-01

Haiti's health system has faced many challenges over the years, with competing health priorities in the context of chronic financial and human resource limitations. As a result, the existing notifiable disease surveillance system was unable to provide the most basic epidemiologic data for public health decision-making and action. In the wake of the January 2010 earthquake, the Haitian Ministry of Public Health and Population collaborated with the U.S. Centers for Disease Control and Prevention, the Pan American Health Organization, and other local and international partners to implement a functional national surveillance system. More than 7 years later, it is important to take the opportunity to reflect on progress made on surveillance and response in Haiti, including disease detection, reporting, outbreak investigation, and response. The national epidemiologic surveillance network that started with 51 sites in 2010 has been expanded to 357 sites as of December 2015. Disease outbreaks identified via the surveillance system, or other surveillance approaches, are investigated by epidemiologists trained by the Ministry of Health's Field Epidemiology Training Program. Other related surveillance modules have been developed on the same model and electronic platform, allowing the country to document the impact of interventions, track progress, and monitor health problems. Sustainability remains the greatest challenge since most of the funding for surveillance come from external sources.

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.

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.

The use of in vitro technologies coupled with high resolution accurate mass LC-MS for studying drug metabolism in equine drug surveillance.

PubMed

Scarth, James P; Spencer, Holly A; Timbers, Sarah E; Hudson, Simon C; Hillyer, Lynn L

2010-01-01

The detection of drug abuse in horseracing often requires knowledge of drug metabolism, especially if urine is the matrix of choice. In this study, equine liver/lung microsomes/S9 tissue fractions were used to study the phase I metabolism of eight drugs of relevance to equine drug surveillance (acepromazine, azaperone, celecoxib, fentanyl, fluphenazine, mepivacaine, methylphenidate and tripelennamine). In vitro samples were analyzed qualitatively alongside samples originating from in vivo administrations using LC-MS on a high resolution accurate mass Thermo Orbitrap Discovery instrument and by LC-MS/MS on an Applied Biosystems Sciex 5500 Q Trap.Using high resolution accurate mass full-scan analysis on the Orbitrap, the in vitro systems were found to generate at least the two most abundant phase I metabolites observed in vitro for all eight drugs studied. In the majority of cases, in vitro experiments were also able to generate the minor in vivo metabolites and sometimes metabolites that were only observed in vitro. More detailed analyses of fentanyl incubates using LC-MS/MS showed that it was possible to generate good quality spectra from the metabolites generated in vitro. These data support the suggestion of using in vitro incubates as metabolite reference material in place of in vivo post-administration samples in accordance with new qualitative identification guidelines in the 2009 International Laboratory Accreditation Cooperation-G7 (ILAC-G7) document.In summary, the in vitro and in vivo phase I metabolism results reported herein compare well and demonstrate the potential of in vitro studies to compliment, refine and reduce the existing equine in vivo paradigm. © 2010 John Wiley & Sons, Ltd.

Review of syndromic surveillance: implications for waterborne disease detection

PubMed Central

Berger, Magdalena; Shiau, Rita; Weintraub, June M

2006-01-01

Syndromic surveillance is the gathering of data for public health purposes before laboratory or clinically confirmed information is available. Interest in syndromic surveillance has increased because of concerns about bioterrorism. In addition to bioterrorism detection, syndromic surveillance may be suited to detecting waterborne disease outbreaks. Theoretical benefits of syndromic surveillance include potential timeliness, increased response capacity, ability to establish baseline disease burdens, and ability to delineate the geographical reach of an outbreak. This review summarises the evidence gathered from retrospective, prospective, and simulation studies to assess the efficacy of syndromic surveillance for waterborne disease detection. There is little evidence that syndromic surveillance mitigates the effects of disease outbreaks through earlier detection and response. Syndromic surveillance should not be implemented at the expense of traditional disease surveillance, and should not be relied upon as a principal outbreak detection tool. The utility of syndromic surveillance is dependent on alarm thresholds that can be evaluated in practice. Syndromic data sources such as over the counter drug sales for detection of waterborne outbreaks should be further evaluated. PMID:16698988

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

Laboratory-based Salmonella surveillance in Fiji, 2004-2005.

PubMed

Dunn, John; Pryor, Jan; Saketa, Salanieta; Delai, Wasale; Buadromo, Eka; Kishore, Kamal; Naidu, Shakila; Greene, Sharon; Varma, Jay; Chiller, Tom

2005-09-01

Although foodborne diseases are an important public health problem worldwide, the burden of foodborne illness is not well described in most Pacific Island Countries and Territories. Laboratory-based surveillance programs can detect trends and outbreaks, estimate burden of illness, and allow subtyping of enteric pathogens (e.g. Salmonella serotyping), which is critical for linking illness to food vehicles and animal reservoirs. To enhance public health capacity in Fiji for foodborne disease surveillance, we developed the Salmonella Surveillance Project (SSP), a collaboration to pilot laboratory-based surveillance for Salmonella. A network of national and international partners was formed including epidemiologists, microbiologists, and environmental health personnel. Ministry of Health personnel were trained in foodborne disease surveillance and outbreak investigation. Three clinical microbiology laboratories from different parts of the country functioned as sentinel sites, reporting all laboratory-confirmed Salmonella infections using a standardized case report form. Non-Typhi Salmonella isolates were collected for serotyping. In 2004-2005, 86 non-Typhi Salmonella and 275 S. Typhi laboratory-confirmed infections were reported. Salmonella enterica serotype I 3,10: r:- and Salmonella enterica serotype Weltevreden were the most commonly isolated non-Typhi serotypes. In Fiji, the SSP utilized international partnerships to facilitate training, and to enhance laboratory capacity and surveillance for salmonellosis. Incorporating laboratory-based foodborne disease reporting into national disease surveillance will enable public health officials to describe the burden of foodborne illness, identify outbreaks, conduct analytic epidemiology studies, and improve food safety.

A simplified method of performance indicators development for epidemiological surveillance networks--application to the RESAPATH surveillance network.

PubMed

Sorbe, A; Chazel, M; Gay, E; Haenni, M; Madec, J-Y; Hendrikx, P

2011-06-01

Develop and calculate performance indicators allows to continuously follow the operation of an epidemiological surveillance network. This is an internal evaluation method, implemented by the coordinators in collaboration with all the actors of the network. Its purpose is to detect weak points in order to optimize management. A method for the development of performance indicators of epidemiological surveillance networks was developed in 2004 and was applied to several networks. Its implementation requires a thorough description of the network environment and all its activities to define priority indicators. Since this method is considered to be complex, our objective consisted in developing a simplified approach and applying it to an epidemiological surveillance network. We applied the initial method to a theoretical network model to obtain a list of generic indicators that can be adapted to any surveillance network. We obtained a list of 25 generic performance indicators, intended to be reformulated and described according to the specificities of each network. It was used to develop performance indicators for RESAPATH, an epidemiological surveillance network of antimicrobial resistance in pathogenic bacteria of animal origin in France. This application allowed us to validate the simplified method, its value in terms of practical implementation, and its level of user acceptance. Its ease of use and speed of application compared to the initial method argue in favor of its use on broader scale. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

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

PubMed

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

2017-12-01

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

LWT Based Sensor Node Signal Processing in Vehicle Surveillance Distributed Sensor Network

NASA Astrophysics Data System (ADS)

Cha, Daehyun; Hwang, Chansik

Previous vehicle surveillance researches on distributed sensor network focused on overcoming power limitation and communication bandwidth constraints in sensor node. In spite of this constraints, vehicle surveillance sensor node must have signal compression, feature extraction, target localization, noise cancellation and collaborative signal processing with low computation and communication energy dissipation. In this paper, we introduce an algorithm for light-weight wireless sensor node signal processing based on lifting scheme wavelet analysis feature extraction in distributed sensor network.

Strengthening National Disease Surveillance and Response—Haiti, 2010–2015

PubMed Central

Juin, Stanley; Schaad, Nicolas; Lafontant, Donald; Joseph, Gerard A.; Barzilay, Ezra; Boncy, Jacques; Barrais, Robert; Louis, Frantz Jean; Jean Charles, Nadia Lapierre; Corvil, Salomon; Barthelemy, Nickolsno; Dismer, Amber; Pierre, Jean Samuel; Archer, Roodly W.; Antoine, Mayer; Marston, Barbara; Katz, Mark; Dely, Patrick; Adrien, Paul; Fitter, David L.; Lowrance, David; Patel, Roopal

2017-01-01

Abstract. Haiti’s health system has faced many challenges over the years, with competing health priorities in the context of chronic financial and human resource limitations. As a result, the existing notifiable disease surveillance system was unable to provide the most basic epidemiologic data for public health decision-making and action. In the wake of the January 2010 earthquake, the Haitian Ministry of Public Health and Population collaborated with the U.S. Centers for Disease Control and Prevention, the Pan American Health Organization, and other local and international partners to implement a functional national surveillance system. More than 7 years later, it is important to take the opportunity to reflect on progress made on surveillance and response in Haiti, including disease detection, reporting, outbreak investigation, and response. The national epidemiologic surveillance network that started with 51 sites in 2010 has been expanded to 357 sites as of December 2015. Disease outbreaks identified via the surveillance system, or other surveillance approaches, are investigated by epidemiologists trained by the Ministry of Health’s Field Epidemiology Training Program. Other related surveillance modules have been developed on the same model and electronic platform, allowing the country to document the impact of interventions, track progress, and monitor health problems. Sustainability remains the greatest challenge since most of the funding for surveillance come from external sources. PMID:29064361

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

PubMed

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.

Antiretroviral drug susceptibility among drug-naive adults with recent HIV infection in Rakai, Uganda

PubMed Central

Eshleman, Susan H.; Laeyendecker, Oliver; Parkin, Neil; Huang, Wei; Chappey, Colombe; Paquet, Agnes C.; Serwadda, David; Reynolds, Steven J.; Kiwanuka, Noah; Quinn, Thomas C.; Gray, Ronald; Wawer, Maria

2009-01-01

Objective To analyze antiretroviral drug susceptibility in HIV from recently infected adults in Rakai, Uganda, prior to the availability of antiretroviral drug treatment. Methods Samples obtained at the time of HIV seroconversion (1998–2003) were analyzed using the GeneSeq HIV and PhenoSense HIV assays (Monogram Biosciences, Inc., South San Francisco, California, USA). Results Test results were obtained for 104 samples (subtypes: 26A, 1C, 66D, 9A/D, 1C/D, 1 intersubtype recombinant). Mutations used for genotypic surveillance of transmitted antiretroviral drug resistance were identified in six samples: three had nucleoside reverse transcriptase inhibitor (NRTI) surveillance mutations (two had M41L, one had K219R), and three had protease inhibitor surveillance mutations (I47V, F53L, N88D); none had nonnucleoside reverse transcriptase inhibitor (NNRTI) surveillance mutations. Other resistance-associated mutations were identified in some samples. However, none of the samples had a sufficient number of mutations to predict reduced antiretroviral drug susceptibility. Ten (9.6%) of the samples had reduced phenotypic susceptibility to at least one drug (one had partial susceptibility to didanosine, one had nevirapine resistance, and eight had resistance or partial susceptibility to at least one protease inhibitor). Fifty-three (51%) of the samples had hypersusceptibility to at least one drug (seven had zidovudine hypersusceptibility, 28 had NNRTI hypersusceptibility, 34 had protease inhibitor hypersusceptibility). Delavirdine hyper-susceptibility was more frequent in subtype A than D. In subtype D, efavirenz hypersusceptibility was associated with substitutions at codon 11 in HIV-reverse transcriptase. Conclusion Phenotyping detected reduced antiretroviral drug susceptibility and hypersusceptibility in HIV from some antiretroviral-naive Ugandan adults that was not predicted by genotyping. Phenotyping may complement genotyping for analysis of antiretroviral drug

Antiretroviral drug susceptibility among drug-naive adults with recent HIV infection in Rakai, Uganda.

PubMed

Eshleman, Susan H; Laeyendecker, Oliver; Parkin, Neil; Huang, Wei; Chappey, Colombe; Paquet, Agnes C; Serwadda, David; Reynolds, Steven J; Kiwanuka, Noah; Quinn, Thomas C; Gray, Ronald; Wawer, Maria

2009-04-27

To analyze antiretroviral drug susceptibility in HIV from recently infected adults in Rakai, Uganda, prior to the availability of antiretroviral drug treatment. Samples obtained at the time of HIV seroconversion (1998-2003) were analyzed using the GeneSeq HIV and PhenoSense HIV assays (Monogram Biosciences, Inc., South San Francisco, California, USA). Test results were obtained for 104 samples (subtypes: 26A, 1C, 66D, 9A/D, 1C/D, 1 intersubtype recombinant). Mutations used for genotypic surveillance of transmitted antiretroviral drug resistance were identified in six samples: three had nucleoside reverse transcriptase inhibitor (NRTI) surveillance mutations (two had M41L, one had K219R), and three had protease inhibitor surveillance mutations (I47V, F53L, N88D); none had nonnucleoside reverse transcriptase inhibitor (NNRTI) surveillance mutations. Other resistance-associated mutations were identified in some samples. However, none of the samples had a sufficient number of mutations to predict reduced antiretroviral drug susceptibility. Ten (9.6%) of the samples had reduced phenotypic susceptibility to at least one drug (one had partial susceptibility to didanosine, one had nevirapine resistance, and eight had resistance or partial susceptibility to at least one protease inhibitor). Fifty-three (51%) of the samples had hypersusceptibility to at least one drug (seven had zidovudine hypersusceptibility, 28 had NNRTI hypersusceptibility, 34 had protease inhibitor hypersusceptibility). Delavirdine hypersusceptibility was more frequent in subtype A than D. In subtype D, efavirenz hypersusceptibility was associated with substitutions at codon 11 in HIV-reverse transcriptase. Phenotyping detected reduced antiretroviral drug susceptibility and hypersusceptibility in HIV from some antiretroviral-naive Ugandan adults that was not predicted by genotyping. Phenotyping may complement genotyping for analysis of antiretroviral drug susceptibility in populations with nonsubtype B

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

Laboratory-supported influenza surveillance in Victorian sentinel general practices.

PubMed

Kelly, H; Murphy, A; Leong, W; Leydon, J; Tresise, P; Gerrard, M; Chibo, D; Birch, C; Andrews, R; Catton, M

2000-12-01

Laboratory-supported influenza surveillance is important as part of pandemic preparedness, for identifying and isolating candidate vaccine strains, for supporting trials of anti-influenza drugs and for refining the influenza surveillance case definition in practice. This study describes the implementation of laboratory-supported influenza surveillance in Victorian sentinel general practices and provides an estimate of the proportion of patients with an influenza-like illness proven to have influenza. During 1998 and 1999, 25 sentinel general practices contributed clinical surveillance data and 16 metropolitan practices participated in laboratory surveillance. Serological, virus-antigen detection, virus culture and multiplex polymerase chain reaction procedures were used to establish the diagnosis of influenza. Two laboratories at major teaching hospitals in Melbourne provided additional data on influenza virus identification. General practice sentinel surveillance and laboratory identification of influenza provided similar data on the pattern of influenza in the community between May and September. The clinical suspicion of influenza was confirmed in 49 to 54 per cent of cases seen in general practice.

Analytical surveillance of emerging drugs of abuse and drug formulations

PubMed Central

Thomas, Brian F.; Pollard, Gerald T.; Grabenauer, Megan

2012-01-01

Uncontrolled recreational drugs are proliferating in number and variety. Effects of long-term use are unknown, and regulation is problematic, as efforts to control one chemical often lead to several other structural analogs. Advanced analytical instrumentation and methods are continuing to be developed to identify drugs, chemical constituents of products, and drug substances and metabolites in biological fluids. Several mass spectrometry based approaches appear promising, particularly those that involve high resolution chromatographic and mass spectrometric methods that allow unbiased data acquisition and sophisticated data interrogation. Several of these techniques are shown to facilitate both targeted and broad spectrum analysis, which is often of particular benefit when dealing with misleadingly labeled products or assessing a biological matrix for illicit drugs and metabolites. The development and application of novel analytical approaches such as these will help to assess the nature and degree of exposure and risk and, where necessary, inform forensics and facilitate implementation of specific regulation and control measures. PMID:23154240

Postmarketing Surveillance for “Modified-Risk” Tobacco Products

PubMed Central

2012-01-01

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

Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

PubMed

Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

2013-08-01

Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

Australian Paediatric Surveillance Unit : progress report.

PubMed

Morris, A; Ridley, G F; Elliott, E J

2002-02-01

The Australian Paediatric Surveillance Unit (APSU), through active surveillance, collects information on the epidemiology of rare or uncommon childhood conditions. This research resource allows paediatricians to collaborate at State, national and international levels. The APSU sends a monthly report card to all (currently 971) paediatricians in Australia, who in turn indicate whether or not they have seen a patient in the last month with any of the conditions listed (98% response rate in 1999). Study investigators, notified by the APSU of positive case reports, obtain demographic and clinical data on the patient from the reporting doctor by postal questionnaire (90% response rate in 1999). Since 1993, the APSU has monitored 27 conditions, including conditions that are vaccine-preventable, otherwise infectious, genetic, congenital and non-communicable. Information collected is disseminated to paediatricians and other health professionals via an annual report, newsletters and publications and is made available to the International Network of Paediatric Surveillance Units. Information provided by the APSU has raised awareness among paediatricians of rare and uncommon childhood conditions, and has been used by health authorities for planning of prevention and intervention strategies and allocation of health resources.

What is a missing link among wireless persistent surveillance?

NASA Astrophysics Data System (ADS)

Hsu, Charles; Szu, Harold

2011-06-01

The next generation surveillance system will equip with versatile sensor devices and information focus capable of conducting regular and irregular surveillance and security environments worldwide. The community of the persistent surveillance must invest the limited energy and money effectively into researching enabling technologies such as nanotechnology, wireless networks, and micro-electromechanical systems (MEMS) to develop persistent surveillance applications for the future. Wireless sensor networks can be used by the military for a number of purposes such as monitoring militant activity in remote areas and force protection. Being equipped with appropriate sensors these networks can enable detection of enemy movement, identification of enemy force and analysis of their movement and progress. Among these sensor network technologies, covert communication is one of the challenging tasks in the persistent surveillance because it is highly demanded to provide secured sensor nodes and linkage for fear of deliberate sabotage. Due to the matured VLSI/DSP technologies, affordable COTS of UWB technology with noise-like direct sequence (DS) time-domain pulses is a potential solution to support low probability of intercept and low probability of detection (LPI/LPD) data communication and transmission. This paper will describe a number of technical challenges in wireless persistent surveillance development include covert communication, network control and routing, collaborating signal and information processing, and etc. The paper concludes by presenting Hermitian Wavelets to enhance SNR in support of secured communication.

Finding Common Ground: A Call for Collaboration. Promoting State Interagency Efforts To Reduce the Impact of Perinatal Alcohol and Other Drug Use on Families.

ERIC Educational Resources Information Center

Jones, Virginia H.; Hutchins, Ellen

This manual assists state agencies in developing public policy and programs to address prevention and treatment for the abuse of alcohol and other drugs by women during pregnancy. It stresses the importance of collaborative action among the many agencies involved. The first chapter is a specific call for collaboration, noting several federal…

Hepatitis A, B, and C in Canada. Results from the National Sentinel Health Unit Surveillance System, 1993-1995.

PubMed

elSaadany, Susie; Gully, Paul; Giulivi, Antonio

2002-01-01

To estimate the incidence of and to describe the risk factors that were associated with the acquisition of hepatitis A, B, and C in well-defined Canadian populations from the Sentinel Health Unit Surveillance System (SHUSS). We used the 1993 to 1995 data on hepatitis A, B, and C infection in Canada, collected by SHUSS, a national surveillance system established by the Laboratory Centre for Disease Control in Health Canada in 1993, through consultation and collaboration with provincial partners. We calculated the rates of, and described and discussed the risk factors that were associated with, hepatitis A, B, and C infection, based on the SHUSS surveillance data. From 1993 to 1995, SHUSS reported 92 cases of hepatitis A, 89 hepatitis B, and 720 hepatitis C, yielding a rate of 3.9, 3.8, and 30.3 per 100,000, respectively. The reported rates varied substantially among participating health units, ranging from 0.8 to 8.1 per 100,000 for hepatitis A, 0.0 to 9.0 for hepatitis B, and 5.4 to 73.3 for hepatitis C. The most frequently reported risk factor for hepatitis A was a history of street drug use, followed by recent international travel and household contact with a hepatitis A case, household crowding, and a history of raw or undercooked shellfish consumption. The most frequently reported risk factors for the acquisition of hepatitis B included history of street drug use and occupational exposure. The most frequently reported risk factor for the acquisition of hepatitis C was a history of street drug use, followed by health care exposure and occupational exposure. Only 5% of persons with hepatitis B infection had a history of hepatitis B immunization. Despite the limitations of possible bias due to selective participation of SHUSS and the lack of information on risk factors among controls, the high exposure to known risk factors and the low rate of vaccination among hepatitis patients can provide useful information for the development of public health policies to

Antimicrobial Drug Use and Resistance in Europe

PubMed Central

van de Sande-Bruinsma, Nienke; Verloo, Didier; Tiemersma, Edine; Monen, Jos; Goossens, Herman; Ferech, Matus

2008-01-01

Our study confronts the use of antimicrobial agents in ambulatory care with the resistance trends of 2 major pathogens, Streptococcus pneumoniae and Escherichia coli, in 21 European countries in 2000–2005 and explores whether the notion that antimicrobial drug use determines resistance can be supported by surveillance data at national aggregation levels. The data obtained from the European Surveillance of Antimicrobial Consumption and the European Antimicrobial Resistance Surveillance System suggest that variation of consumption coincides with the occurrence of resistance at the country level. Linear regression analysis showed that the association between antimicrobial drug use and resistance was specific and robust for 2 of 3 compound pathogen combinations, stable over time, but not sensitive enough to explain all of the observed variations. Ecologic studies based on routine surveillance data indicate a relation between use and resistance and support interventions designed to reduce antimicrobial drug consumption at a national level in Europe. PMID:18976555

How to: Surveillance of Clostridium difficile infections.

PubMed

Krutova, M; Kinross, P; Barbut, F; Hajdu, A; Wilcox, M H; Kuijper, E J

2018-05-01

The increasing incidence of Clostridium difficile infections (CDI) in healthcare settings in Europe since 2003 has affected both patients and healthcare systems. The implementation of effective CDI surveillance is key to enable monitoring of the occurrence and spread of C. difficile in healthcare and the timely detection of outbreaks. The aim of this review is to provide a summary of key components of effective CDI surveillance and to provide some practical recommendations. We also summarize the recent and current national CDI surveillance activities, to illustrate strengths and weaknesses of CDI surveillance in Europe. For the definition of key components of CDI surveillance, we consulted the current European Society of Clinical Microbiology and Infectious Diseases (ESCMID) CDI-related guidance documents and the European Centre for Disease Prevention and Control (ECDC) protocol for CDI surveillance in acute care hospitals. To summarize the recent and current national CDI surveillance activities, we discussed international multicentre CDI surveillance studies performed in 2005-13. In 2017, we also performed a new survey of existing CDI surveillance systems in 33 European countries. Key components for CDI surveillance are appropriate case definitions of CDI, standardized CDI diagnostics, agreement on CDI case origin definition, and the presentation of CDI rates with well-defined numerators and denominators. Incorporation of microbiological data is required to provide information on prevailing PCR ribotypes and antimicrobial susceptibility to first-line CDI treatment drugs. In 2017, 20 European countries had a national CDI surveillance system and 21 countries participated in ECDC-coordinated CDI surveillance. Since 2014, the number of centres with capacity for C. difficile typing has increased to 35 reference or central laboratories in 26 European countries. Incidence rates of CDI, obtained from a standardized CDI surveillance system, can be used as an important

Strengthening systems for communicable disease surveillance: creating a laboratory network in Rwanda

PubMed Central

2011-01-01

Background The recent emergence of a novel strain of influenza virus with pandemic potential underscores the need for quality surveillance and laboratory services to contribute to the timely detection and confirmation of public health threats. To provide a framework for strengthening disease surveillance and response capacities in African countries, the World Health Organization Regional Headquarters for Africa (AFRO) developed Integrated Disease Surveillance and Response (IDSR) aimed at improving national surveillance and laboratory systems. IDSR emphasizes the linkage of information provided by public health laboratories to the selection of relevant, appropriate and effective public health responses to disease outbreaks. Methods We reviewed the development of Rwanda's National Reference Laboratory (NRL) to understand essential structures involved in creating a national public health laboratory network. We reviewed documents describing the NRL's organization and record of test results, conducted site visits, and interviewed health staff in the Ministry of Health and in partner agencies. Findings were developed by organizing thematic categories and grouping examples within them. We purposefully sought to identify success factors as well as challenges inherent in developing a national public health laboratory system. Results Among the identified success factors were: a structured governing framework for public health surveillance; political commitment to promote leadership for stronger laboratory capacities in Rwanda; defined roles and responsibilities for each level; coordinated approaches between technical and funding partners; collaboration with external laboratories; and use of performance results in advocacy with national stakeholders. Major challenges involved general infrastructure, human resources, and budgetary constraints. Conclusions Rwanda's experience with collaborative partnerships contributed to creation of a functional public health laboratory

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...

Emerging Infectious Diseases in Free-Ranging Wildlife–Australian Zoo Based Wildlife Hospitals Contribute to National Surveillance

PubMed Central

Cox-Witton, Keren; Reiss, Andrea; Woods, Rupert; Grillo, Victoria; Baker, Rupert T.; Blyde, David J.; Boardman, Wayne; Cutter, Stephen; Lacasse, Claude; McCracken, Helen; Pyne, Michael; Smith, Ian; Vitali, Simone; Vogelnest, Larry; Wedd, Dion; Phillips, Martin; Bunn, Chris; Post, Lyndel

2014-01-01

Emerging infectious diseases are increasingly originating from wildlife. Many of these diseases have significant impacts on human health, domestic animal health, and biodiversity. Surveillance is the key to early detection of emerging diseases. A zoo based wildlife disease surveillance program developed in Australia incorporates disease information from free-ranging wildlife into the existing national wildlife health information system. This program uses a collaborative approach and provides a strong model for a disease surveillance program for free-ranging wildlife that enhances the national capacity for early detection of emerging diseases. PMID:24787430

A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras

PubMed Central

Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

2014-01-01

Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt “CVMNK” genotype in codons 72-76. PMID:25075788

A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras.

PubMed

Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

2014-07-01

Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt "CVMNK" genotype in codons 72-76.

Factors influencing men undertaking active surveillance for the management of low-risk prostate cancer.

PubMed

Davison, B Joyce; Oliffe, John L; Pickles, Tom; Mroz, Lawrence

2009-01-01

To identify and describe decision-making influences on men who decide to manage their low-risk prostate cancer with active surveillance. Qualitative, semistructured interview. The Prostate Centre at Vancouver General Hospital in Canada. 25 patients diagnosed with low-risk prostate cancer and on active surveillance. An interpretative, descriptive, qualitative design. Factors that influenced men's decisions to take up active surveillance. The specialists' description of the prostate cancer was the most influential factor on men choosing active surveillance. Patients did not consider their prostate cancer to be life threatening and, in general, were relieved that no treatment was required. Avoiding treatment-related suffering and physical dysfunction and side effects such as impotence and incontinence was cited as the major reason to delay treatment. Few men actively sought treatment or health-promotion information following their treatment decision. Female partners played a supportive role in the decision. The need for active treatment if the cancer progressed was acknowledged. Patients were hopeful that new treatments would be available when and if they needed them. Being older and having comorbidities did not preclude the desire for future active treatment. Patients carried on with their lives as usual and did not report having any major distress related to being on active surveillance. The study findings indicate that men are strongly influenced by the treating specialist in taking up active surveillance and planning future active treatments. As such, most men relied on their specialists' recommendation and did not perceive the need for any adjunct therapy or support until the cancer required active treatment. Oncology nurses should work collaborative-ly with specialists to ensure that men receive the information they need to make informed treatment decisions.

Lessons learned during active epidemiological surveillance of Ebola and Marburg viral hemorrhagic fever epidemics in Africa.

PubMed

Allaranga, Yokouide; Kone, Mamadou Lamine; Formenty, Pierre; Libama, Francois; Boumandouki, Paul; Woodfill, Celia J I; Sow, Idrissa; Duale, Sambe; Alemu, Wondimagegnehu; Yada, Adamou

2010-03-01

To review epidemiological surveillance approaches used during Ebola and Marburg hemorrhagic fever epidemics in Africa in the past fifteen years. Overall, 26 hemorrhagic epidemic outbreaks have been registered in 12 countries; 18 caused by the Ebola virus and eight by the Marburg virus. About 2551 cases have been reported, among which 268 were health workers (9,3%). Based on articles and epidemic management reports, this review analyses surveillance approaches, route of introduction of the virus into the population (urban and rural), the collaboration between the human health sector and the wildlife sector and factors that have affected epidemic management. Several factors affecting the epidemiological surveillance during Ebola and Marburg viruses hemorrhagic epidemics have been observed. During epidemics in rural settings, outbreak investigations have shown multiple introductions of the virus into the human population through wildlife. In contrast, during epidemics in urban settings a single introduction of the virus in the community was responsible for the epidemic. Active surveillance is key to containing outbreaks of Ebola and Marburg viruses Collaboration with those in charge of the conservation of wildlife is essential for the early detection of viral hemorrhagic fever epidemics. Hemorrhagic fever epidemics caused by Ebola and Marburg viruses are occurring more and more frequently in Sub-Saharan Africa and only an adapted epidemiological surveillance system will allow for early detection and effective response.

Proceedings of the Sixth Integrated Communications, Navigation and Surveillance (ICNS) Conference & Workshop 2006

NASA Technical Reports Server (NTRS)

Ponchak, Denise (Compiler)

2006-01-01

The Integrated Communications, Navigation and Surveillance (ICNS) Technologies Conference and Workshop provides a forum for government, industry, and academic communities performing research and technology development for advanced digital communications, navigation, and surveillance security systems and associated applications supporting the national and global air transportation systems. The event s goals are to understand current efforts and recent results in near- and far-term research and technology demonstration; identify integrated digital communications, navigation and surveillance research requirements necessary for a safe, high-capacity, advanced air transportation system; foster collaboration and coordination among all stakeholders; and discuss critical issues and develop recommendations to achieve the future integrated CNS vision for the national and global air transportation system.

Proceedings of the Fourth Integrated Communications, Navigation, and Surveillance (ICNS) Conference and Workshop

NASA Technical Reports Server (NTRS)

Fujikawa, Gene (Compiler)

2004-01-01

The Integrated Communications, Navigational and Surveillance (ICNS) Technologies Conference and Workshop provides a forum for Government, industry, and academic communities performing research and technology development for advanced digital communications, navigation, and surveillance security systems and associated applications supporting the national and global air transportation systems. The event's goals are to understand current efforts and recent results in near-and far-term research and technology demonstration; identify integrated digital communications, navigation and surveillance research requirements necessary for a safe, high-capacity, advanced air transportation system; foster collaboration and coordination among all stakeholders; and discuss critical issues and develop recommendations to achieve the future integrated CNS vision for the national and global air transportation system.

Animal NARMS Surveillance Data

USDA-ARS?s Scientific Manuscript database

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...

Tramadol post-marketing surveillance in health care professionals.

PubMed

Knisely, Janet S; Campbell, Eleanor D; Dawson, Kathryn S; Schnoll, Sidney H

2002-09-01

Tramadol has been marketed in the US since 1995. The US Food and Drug Administration agreed to release tramadol as a non-scheduled drug if proactive post-marketing surveillance studies would be conducted. This study was one of two phase IV protocols that were part of the overall surveillance program. It focused on impaired health professionals who are a high risk/high access population for drug abuse. All active participants in four state monitoring programs between November 1, 1995 and August 15, 1998 (n = 1,601) were recruited for the study. With the exceptions of implementing a standardized intake interview and urine testing for tramadol metabolites, all states operated their programs in the usual fashion. The programs were alerted to persistent non-prescribed tramadol use so that appropriate interventions could be employed. Despite availability of tramadol and the conditions that might lead to its abuse, the incidence rate for tramadol use in the study population was only 69 per thousand persons per year and the incidence rate for tramadol abuse or dependence was 6.9 per thousand persons per year.

Appropriating Video Surveillance for Art and Environmental Awareness: Experiences from ARTiVIS.

PubMed

Mendes, Mónica; Ângelo, Pedro; Correia, Nuno; Nisi, Valentina

2018-06-01

Arts, Real-Time Video and Interactivity for Sustainability (ARTiVIS) is an ongoing collaborative research project investigating how real-time video, DIY surveillance technologies and sensor data can be used as a tool for environmental awareness, activism and artistic explorations. The project consists of a series of digital contexts for aesthetic contemplation of nature and civic engagement, aiming to foster awareness and empowerment of local populations through DIY surveillance. At the core of the ARTIVIS efforts are a series of interactive installations (namely B-Wind!, Hug@tree and Play with Fire), that make use of surveillance technologies and real-time video as raw material to promote environmental awareness through the emotion generated by real-time connections with nature. Throughout the project development, the surveillance concept has been shifting from the use of surveillance technology in a centralized platform, to the idea of veillance with distributed peer-to-peer networks that can be used for science and environmental monitoring. In this paper we present the history of the ARTiVIS project, related and inspiring work, describe ongoing research work and explore the present and future challenges of appropriating surveillance technology for artistic, educational and civic engagement purposes.

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. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

28 CFR 550.43 - Drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug counseling. 550.43 Section 550.43 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.43 Drug...

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school

PubMed Central

Stanley, A G; Jackson, D; Barnett, D B

2005-01-01

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK. PMID:15801942

Characterization of Adolescent Prescription Drug Abuse and Misuse Using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS®) System

PubMed Central

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®) System. Method Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all intentional exposures from 2007 through 2009 were used to describe adolescent prescription opioid (oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, buprenorphine, and tramadol) and stimulant (methylphenidate and amphetamines) exposures. Results A total of 16,209 intentional adolescent exposures to prescription drugs were identified, 68% to opioids and 32% to stimulants. The mean age was 16.6 years (SD ± 1.7 years). Slightly more than half (52.4%) of drug mentions involved females. The five most frequently misused or abused drugs were hydrocodone (32%), amphetamines (18%), oxycodone (15%), methylphenidate (14%), and tramadol (11%). Of all exposures, 38%were classified as suspected suicidal. Of adolescents who intentionally exposed themselves to prescription drugs, 30% were treated in a health care facility, 2,792 of whom were admitted to the hospital, including 1,293 to the intensive care unit. A total of 17.2% of intentional exposures were associated with no effect, 38.9% minor effects, 23.3% moderate effects, 3.6% major effects, and 0.1% were associated with death. Oxycodone and methadone were associated with the most deaths. No deaths were associated with exposures to stimulants. Conclusions Prescription drug misuse and abuse poses an important health problem and results in thousands of hospitalizations of adolescents per year. Further work is needed to develop focused interventions and educational programs to prevent prescription drug abuse and misuse by adolescents. PMID:23357446

Sequence editing by Apolipoprotein B RNA-editing catalytic component-B and epidemiological surveillance of transmitted HIV-1 drug resistance

PubMed Central

Gifford, Robert J.; Rhee, Soo-Yon; Eriksson, Nicolas; Liu, Tommy F.; Kiuchi, Mark; Das, Amar K.; Shafer, Robert W.

2008-01-01

Design Promiscuous guanine (G) to adenine (A) substitutions catalysed by apolipoprotein B RNA-editing catalytic component (APOBEC) enzymes are observed in a proportion of HIV-1 sequences in vivo and can introduce artifacts into some genetic analyses. The potential impact of undetected lethal editing on genotypic estimation of transmitted drug resistance was assessed. Methods Classifiers of lethal, APOBEC-mediated editing were developed by analysis of lentiviral pol gene sequence variation and evaluated using control sets of HIV-1 sequences. The potential impact of sequence editing on genotypic estimation of drug resistance was assessed in sets of sequences obtained from 77 studies of 25 or more therapy-naive individuals, using mixture modelling approaches to determine the maximum likelihood classification of sequences as lethally edited as opposed to viable. Results Analysis of 6437 protease and reverse transcriptase sequences from therapy-naive individuals using a novel classifier of lethal, APOBEC3G-mediated sequence editing, the polypeptide-like 3G (APOBEC3G)-mediated defectives (A3GD) index’, detected lethal editing in association with spurious ‘transmitted drug resistance’ in nearly 3% of proviral sequences obtained from whole blood and 0.2% of samples obtained from plasma. Conclusion Screening for lethally edited sequences in datasets containing a proportion of proviral DNA, such as those likely to be obtained for epidemiological surveillance of transmitted drug resistance in the developing world, can eliminate rare but potentially significant errors in genotypic estimation of transmitted drug resistance. PMID:18356601

Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application.

PubMed

Jha, Ashish K; Laguette, Julia; Seger, Andrew; Bates, David W

2008-01-01

Computerized monitors can effectively detect and potentially prevent adverse drug events (ADEs). Most monitors have been developed in large academic hospitals and are not readily usable in other settings. We assessed the ability of a commercial program to identify and prevent ADEs in a community hospital. and Measurement We prospectively evaluated the commercial application in a community-based hospital. We examined the frequency and types of alerts produced, how often they were associated with ADEs and potential ADEs, and the potential financial impact of monitoring for ADEs. Among 2,407 patients screened, the application generated 516 high priority alerts. We were able to review 266 alerts at the time they were generated and among these, 30 (11.3%) were considered substantially important to warrant contacting the physician caring for the patient. These 30 alerts were associated with 4 ADEs and 11 potential ADEs. In all 15 cases, the responsible physician was unaware of the event, leading to a change in clinical care in 14 cases. Overall, 23% of high priority alerts were associated with an ADE (95% confidence interval [CI] 12% to 34%) and another 15% were associated with a potential ADE (95% CI 6% to 24%). Active surveillance used approximately 1.5 hours of pharmacist time daily. A commercially available, computer-based ADE detection tool was effective at identifying ADEs. When used as part of an active surveillance program, it can have an impact on preventing or ameliorating ADEs.

[A review on the advancement of internet-based public health surveillance program].

PubMed

Zhao, Y Q; Ma, W J

2017-02-10

Internet data is introduced into public health arena under the features of fast updating and tremendous volume. Mining and analyzing internet data, researchers can model the internet-based surveillance system to assess the distribution of health-related events. There are two main types of internet-based surveillance systems, i.e. active and passive, which are distinguished by the sources of information. Through passive surveillance system, information is collected from search engine and social media while the active system gathers information through provision of the volunteers. Except for serving as a real-time and convenient complementary approach to traditional disease, food safety and adverse drug reaction surveillance program, Internet-based surveillance system can also play a role in health-related behavior surveillance and policy evaluation. Although several techniques have been applied to filter information, the accuracy of internet-based surveillance system is still bothered by the false positive information. In this article, we have summarized the development and application of internet-based surveillance system in public health to provide reference for a better surveillance program in China.

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...

Heroin and fentanyl overdoses in Kentucky: Epidemiology and surveillance.

PubMed

Slavova, Svetla; Costich, Julia F; Bunn, Terry L; Luu, Huong; Singleton, Michael; Hargrove, Sarah L; Triplett, Jeremy S; Quesinberry, Dana; Ralston, William; Ingram, Van

2017-08-01

The study aims to describe recent changes in Kentucky's drug overdose trends related to increased heroin and fentanyl involvement, and to discuss future directions for improved drug overdose surveillance. The study used multiple data sources (death certificates, postmortem toxicology results, emergency department [ED] records, law enforcement drug submissions, and prescription drug monitoring records) to describe temporal, geographic, and demographic changes in drug overdoses in Kentucky. Fentanyl- and heroin-related overdose death rates increased across all age groups from years 2011 to 2015 with the highest rates consistently among 25-34-year-olds. The majority of the heroin and fentanyl overdose decedents had histories of substantial exposures to legally acquired prescription opioids. Law enforcement drug submission data were strongly correlated with drug overdose ED and mortality data. The 2016 crude rate of heroin-related overdose ED visits was 104/100,000, a 68% increase from 2015 (62/100,000). More fentanyl-related overdose deaths were reported between October, 2015, and September, 2016, than ED visits, in striking contrast with the observed ratio of >10 to 1 heroin-related overdose ED visits to deaths. Many fatal fentanyl overdoses were associated with heroin adulterated with fentanyl; <40% of the heroin overdose ED discharge records listed procedure codes for drug screening. The lack of routine ED drug testing likely resulted in underreporting of non-fatal overdoses involving fentanyl and other synthetic drugs. In order to inform coordinated public health and safety responses, drug overdose surveillance must move from a reactive to a proactive mode, utilizing the infrastructure for electronic health records. Copyright © 2017 Elsevier B.V. All rights reserved.

Youth Risk Behavior Surveillance--United States, 1995.

ERIC Educational Resources Information Center

Kann, Laura; And Others

1996-01-01

The Youth Risk Behavior Surveillance System (YRBSS) monitors six categories of health-risk behaviors: injury-inviting behaviors, tobacco use, alcohol and other drug use, sexual behaviors, unhealthy diet, and physical inactivity. This report summarizes results from the national survey, 35 state surveys, and 16 local surveys conducted among high…

The Canadian Pharmacogenomics Network for Drug Safety: a model for safety pharmacology.

PubMed

Ross, Colin J D; Visscher, Henk; Sistonen, Johanna; Brunham, Liam R; Pussegoda, Kusala; Loo, Tenneille T; Rieder, Michael J; Koren, Gideon; Carleton, Bruce C; Hayden, Michael R

2010-07-01

Adverse drug reactions (ADRs) rank as one of the top 10 leading causes of death in the developed world, and the direct medical costs of ADRs exceed $100 billion annually in the United States alone. Pharmacogenomics research seeks to identify genetic factors that are responsible for individual differences in drug efficacy and susceptibility to ADRs. This has led to several genetic tests that are currently being used to provide clinical recommendations. The Canadian Pharmacogenomics Network for Drug Safety is a nation-wide effort established in Canada to identify novel predictive genomic markers of severe ADRs in children and adults. A surveillance network has been established in 17 of Canada's major hospitals to identify patients experiencing specific ADRs and to collect biological samples and relevant clinical history for genetic association studies. To identify ADR-associated genetic markers that could be incorporated into predictive tests that will reduce the occurrence of serious ADRs, high-throughput genomic analyses are conducted with samples from patients that have suffered serious ADRs and matched control patients. ADRs represent a significant unmet medical problem with significant morbidity and mortality, and Canadian Pharmacogenomics Network for Drug Safety is a nation-wide network in Canada that seeks to identify genetic factors responsible for interindividual differences in susceptibility to serious ADRs. Active ADR surveillance is necessary to identify and recruit patients who suffer from serious ADRs. National and international collaborations are required to recruit sufficient patients for these studies. Several pharmacogenomics tests are currently in clinical use to provide dosing recommendations, and the number of pharmacogenomics tests is expected to significantly increase in the future.

21 CFR 26.18 - Regulatory collaboration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

Quality of care and economic considerations of active surveillance of men with prostate cancer

PubMed Central

2018-01-01

The current health care climate mandates the delivery of high-value care for patients considering active surveillance for newly-diagnosed prostate cancer. Value is defined by increasing benefits (e.g., quality) for acceptable costs. This review discusses quality of care considerations for men contemplating active surveillance, and highlights cost implications at the patient, health-system, and societal level related to pursuit of non-interventional management of men diagnosed with localized prostate cancer. In general, most quality measures are focused on prostate cancer care in general, rather that active surveillance patients specifically. However, most prostate cancer quality measures are pertinent to men seeking close observation of their prostate tumors with active surveillance. These include accurate documentation of clinical stage, informed discussion of all treatment options, and appropriate use of imaging for less-aggressive prostate cancer. Furthermore, interventions that may help improve the quality of care for active surveillance patients are reviewed (e.g., quality collaboratives, judicious antibiotic use, etc.). Finally, the potential economic impact and benefits of broad acceptance of active surveillance strategies are highlighted. PMID:29732278

Quality of care and economic considerations of active surveillance of men with prostate cancer.

PubMed

Filson, Christopher P

2018-04-01

The current health care climate mandates the delivery of high-value care for patients considering active surveillance for newly-diagnosed prostate cancer. Value is defined by increasing benefits (e.g., quality) for acceptable costs. This review discusses quality of care considerations for men contemplating active surveillance, and highlights cost implications at the patient, health-system, and societal level related to pursuit of non-interventional management of men diagnosed with localized prostate cancer. In general, most quality measures are focused on prostate cancer care in general, rather that active surveillance patients specifically. However, most prostate cancer quality measures are pertinent to men seeking close observation of their prostate tumors with active surveillance. These include accurate documentation of clinical stage, informed discussion of all treatment options, and appropriate use of imaging for less-aggressive prostate cancer. Furthermore, interventions that may help improve the quality of care for active surveillance patients are reviewed (e.g., quality collaboratives, judicious antibiotic use, etc.). Finally, the potential economic impact and benefits of broad acceptance of active surveillance strategies are highlighted.

[Current and future legislation of illegal drugs in Tokyo].

PubMed

Abe, Tetsuya

2013-01-01

Abuse of illegal drugs is widespread among young people, especially in the so-called "dance club scene" or "rave scene". Severe and even fatal poisonings have been attributed to the consumption of such drugs of abuse. The actions against these drugs by the Tokyo Metropolitan Government and subsequently by the Government of Japan have gone some way to reducing the potential harm caused by these substances. However, alternative products have been advertised on a number of websites. During our careful surveillance of illegal drugs in 2011, we found seven unregulated drugs advertised. This means that we have an obligation to continue strict surveillance of illegal drugs and to structure a system of temporary bans on illegal drugs.

Practical applications of injury surveillance: a brief 25-year history of the Connecticut Injury Prevention Center.

PubMed

Lapidus, Garry; Borrup, Kevin; DiVietro, Susan; Campbell, Brendan T; Beebe, Rebecca; Grasso, Damion; Rogers, Steven; Joseph, D'Andrea; Banco, Leonard

2016-04-01

The mission of the Connecticut Injury Prevention Center (CIPC), jointly housed in Connecticut Children's Medical Center and Hartford Hospital, is to reduce unintentional injury and violence among Connecticut residents, with a special focus on translating research into injury prevention programmes and policy. The CIPC engages in four core activities: research, education and training, community outreach programmes and public policy. As surveillance is an essential element of injury prevention, the CIPC has developed a robust statewide fatal and non-fatal injury surveillance system that has guided our prior work and continues to inform our current projects. The purpose of this article is to review the projects, programmes, and collaborative relationships that have made the CIPC successful in reducing unintentional injury and violence in Connecticut throughout the course of its 25 years history. Retrospective review of the application of injury surveillance. We believe that the application of our surveillance system can serve as a model for others who wish to engage in collaborative, community-based, data-driven injury prevention programmes in their own communities. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Impacts of national surveillance for uncommon conditions in childhood.

PubMed

Zurynski, Yvonne A; Peadon, Elizabeth; Bower, Carol; Elliott, Elizabeth J

2007-11-01

The Australian Paediatric Surveillance Unit (APSU) facilitates the conduct of national collaborative research that is consistent with national health priorities, has potential to impact on public health, and addresses gaps in knowledge. Since 1993 paediatricians and other child health specialists have contributed monthly data on rare childhood conditions to the APSU. Over 40 conditions, including infectious diseases, injuries, vaccine-preventable diseases and genetic disorders have been studied. Information on epidemiology, frequency, diagnosis, management and short-term outcomes of these conditions is collected and provides evidence to support changes to clinical practice, prevention policy and allocation of health resources. In this review we give examples of the value of information gathered through the APSU surveillance system in the last 14 years.

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What must I do if I want to make changes to my postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE FDA...

Rare disease surveillance: An international perspective

PubMed Central

Elliott, Elizabeth J; Nicoll, Angus; Lynn, Richard; Marchessault, Victor; Hirasing, Remy; Ridley, Greta

2001-01-01

BACKGROUND: The International Network of Paediatric Surveillance Units (INoPSU) was established in 1998 and met formally for the first time in Ottawa, Ontario in June 2000. OBJECTIVES: To document the methodology and activities of existing national paediatric surveillance units; the formation of INoPSU; the diseases studied by INoPSU members; and the impact of such studies on education, public health and paediatric practice. METHODS: Directors of paediatric surveillance units in Australia, Britain, Canada, Germany, the Netherlands, Latvia, Malaysia, Papua New Guinea, New Zealand and Switzerland were asked to provide information on each unit’s affiliations, funding and staffing; the method of case ascertainment, the mailing list and response rates; and diseases studied. Original articles that reported data derived from units were identified by a search of an electronic database (MEDLINE), and additional information was obtained from units’ annual reports. RESULTS: Worldwide, 10 units (established from 1986 to 1997), use active national surveillance of more than 8500 clinicians each month to identify cases of rare or uncommon diseases in a childhood population (younger than 15 years of age) of over 47 million (monthly response rate 73% to 98%). By January 1999, units had initiated 147 studies on 103 different conditions, and 63 studies were completed. CONCLUSION: INoPSU enhances collaboration among units from four continents, providing a unique opportunity for simultaneous cross-sectional studies of rare diseases in populations with diverse geographical and ethnic characteristics. It facilitates the sharing of ideas regarding current methodology, ethics, the most appropriate means of evaluating units and their potential application. PMID:20084246

HIV surveillance in MENA: recent developments and results.

PubMed

Bozicevic, Ivana; Riedner, Gabriele; Calleja, Jesus Maria Garcia

2013-11-01

To provide an overview of the current level of development and results from the national HIV surveillance systems of the 23 countries of the Middle East and North Africa (MENA), and to assess the quality of HIV surveillance systems in the period 2007-2011. A questionnaire was used to collect the information about the structure, activities and the results of HIV surveillance systems from the National AIDS Programmes. Assessment of the quality was based on four indicators: timeliness of data collection, appropriateness of populations under surveillance, consistency of the surveillance sites and groups measured over time, and coverage of the surveillance system. Only in four countries did surveillance systems enable assessment of epidemic trends in the same populations and locations over time, such as in pregnant women (Morocco, Iran), injecting drug users (Iran, Pakistan), female sex workers (Djibouti, Morocco) and male sex workers (Pakistan). There is increasing evidence of HIV infection being firmly established in at least one of the populations most at risk of HIV in nine MENA countries, while lower risk populations show elevated HIV prevalence in South Sudan, Djibouti and some parts of Somalia. The performance of HIV surveillance systems in several of the MENA countries has improved in recent years. The extent of HIV epidemics in the populations most at risk of HIV is still largely unknown in 10 countries. Multiple data sources that most of the countries still lack would enable indirectly estimation not only of the patterns of HIV epidemics but also the effectiveness of HIV responses.

HIV surveillance in MENA: recent developments and results

PubMed Central

Bozicevic, Ivana; Riedner, Gabriele; Calleja, Jesus Maria Garcia

2013-01-01

Objectives To provide an overview of the current level of development and results from the national HIV surveillance systems of the 23 countries of the Middle East and North Africa (MENA), and to assess the quality of HIV surveillance systems in the period 2007–2011. Methods A questionnaire was used to collect the information about the structure, activities and the results of HIV surveillance systems from the National AIDS Programmes. Assessment of the quality was based on four indicators: timeliness of data collection, appropriateness of populations under surveillance, consistency of the surveillance sites and groups measured over time, and coverage of the surveillance system. Results Only in four countries did surveillance systems enable assessment of epidemic trends in the same populations and locations over time, such as in pregnant women (Morocco, Iran), injecting drug users (Iran, Pakistan), female sex workers (Djibouti, Morocco) and male sex workers (Pakistan). There is increasing evidence of HIV infection being firmly established in at least one of the populations most at risk of HIV in nine MENA countries, while lower risk populations show elevated HIV prevalence in South Sudan, Djibouti and some parts of Somalia. Conclusions The performance of HIV surveillance systems in several of the MENA countries has improved in recent years. The extent of HIV epidemics in the populations most at risk of HIV is still largely unknown in 10 countries. Multiple data sources that most of the countries still lack would enable indirectly estimation not only of the patterns of HIV epidemics but also the effectiveness of HIV responses. PMID:23434789

Surveillance of infectious diseases in the Arctic.

PubMed

Bruce, M; Zulz, T; Koch, A

2016-08-01

This study reviews how social and environmental issues affect health in Arctic populations and describes infectious disease surveillance in Arctic Nations with a special focus on the activities of the International Circumpolar Surveillance (ICS) project. We reviewed the literature over the past 2 decades looking at Arctic living conditions and their effects on health and Arctic surveillance for infectious diseases. In regards to other regions worldwide, the Arctic climate and environment are extreme. Arctic and sub-Arctic populations live in markedly different social and physical environments compared to those of their more southern dwelling counterparts. A cold northern climate means people spending more time indoors, amplifying the effects of household crowding, smoking and inadequate ventilation on the person-to-person spread of infectious diseases. The spread of zoonotic infections north as the climate warms, emergence of antibiotic resistance among bacterial pathogens, the re-emergence of tuberculosis, the entrance of HIV into Arctic communities, the specter of pandemic influenza or the sudden emergence and introduction of new viral pathogens pose new challenges to residents, governments and public health authorities of all Arctic countries. ICS is a network of hospitals, public health agencies, and reference laboratories throughout the Arctic working together for the purposes of collecting, comparing and sharing of uniform laboratory and epidemiological data on infectious diseases of concern and assisting in the formulation of prevention and control strategies (Fig. 1). In addition, circumpolar infectious disease research workgroups and sentinel surveillance systems for bacterial and viral pathogens exist. The ICS system is a successful example of collaborative surveillance and research in an extreme environment. Published by Elsevier Ltd.

The Armed Forces Health Surveillance Center: enhancing the Military Health System's public health capabilities.

PubMed

DeFraites, Robert F

2011-03-04

Since its establishment in February 2008, the Armed Forces Health Surveillance Center (AFHSC) has embarked on a number of initiatives and projects in collaboration with a variety of agencies in the Department of Defense (DoD), other organizations within the federal government, and non-governmental partners. In 2009, the outbreak of pandemic H1N1 influenza attracted the major focus of the center, although notable advances were accomplished in other areas of interest, such as deployment health, mental health and traumatic brain injury surveillance.

Modelling the evolution of drug resistance in the presence of antiviral drugs

PubMed Central

Wu, Jianhong; Yan, Ping; Archibald, Chris

2007-01-01

Background The emergence of drug resistance in treated populations and the transmission of drug resistant strains to newly infected individuals are important public health concerns in the prevention and control of infectious diseases such as HIV and influenza. Mathematical modelling may help guide the design of treatment programs and also may help us better understand the potential benefits and limitations of prevention strategies. Methods To explore further the potential synergies between modelling of drug resistance in HIV and in pandemic influenza, the Public Health Agency of Canada and the Mathematics for Information Technology and Complex Systems brought together selected scientists and public health experts for a workshop in Ottawa in January 2007, to discuss the emergence and transmission of HIV antiviral drug resistance, to report on progress in the use of mathematical models to study the emergence and spread of drug resistant influenza viral strains, and to recommend future research priorities. Results General lectures and round-table discussions were organized around the issues on HIV drug resistance at the population level, HIV drug resistance in Western Canada, HIV drug resistance at the host level (with focus on optimal treatment strategies), and drug resistance for pandemic influenza planning. Conclusion Some of the issues related to drug resistance in HIV and pandemic influenza can possibly be addressed using existing mathematical models, with a special focus on linking the existing models to the data obtained through the Canadian HIV Strain and DR Surveillance Program. Preliminary statistical analysis of these data carried out at PHAC, together with the general model framework developed by Dr. Blower and her collaborators, should provide further insights into the mechanisms behind the observed trends and thus could help with the prediction and analysis of future trends in the aforementioned items. Remarkable similarity between dynamic, compartmental

Modelling the evolution of drug resistance in the presence of antiviral drugs.

PubMed

Wu, Jianhong; Yan, Ping; Archibald, Chris

2007-10-23

The emergence of drug resistance in treated populations and the transmission of drug resistant strains to newly infected individuals are important public health concerns in the prevention and control of infectious diseases such as HIV and influenza. Mathematical modelling may help guide the design of treatment programs and also may help us better understand the potential benefits and limitations of prevention strategies. To explore further the potential synergies between modelling of drug resistance in HIV and in pandemic influenza, the Public Health Agency of Canada and the Mathematics for Information Technology and Complex Systems brought together selected scientists and public health experts for a workshop in Ottawa in January 2007, to discuss the emergence and transmission of HIV antiviral drug resistance, to report on progress in the use of mathematical models to study the emergence and spread of drug resistant influenza viral strains, and to recommend future research priorities. General lectures and round-table discussions were organized around the issues on HIV drug resistance at the population level, HIV drug resistance in Western Canada, HIV drug resistance at the host level (with focus on optimal treatment strategies), and drug resistance for pandemic influenza planning. Some of the issues related to drug resistance in HIV and pandemic influenza can possibly be addressed using existing mathematical models, with a special focus on linking the existing models to the data obtained through the Canadian HIV Strain and DR Surveillance Program. Preliminary statistical analysis of these data carried out at PHAC, together with the general model framework developed by Dr. Blower and her collaborators, should provide further insights into the mechanisms behind the observed trends and thus could help with the prediction and analysis of future trends in the aforementioned items. Remarkable similarity between dynamic, compartmental models for the evolution of wild and

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Galdoz, Erwin G.; 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.more » 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

[Tuberculosis Laboratory Surveillance Network (TuLSA) study group. The first step for national tuberculosis laboratory surveillance: Ankara, 2011].

PubMed

Sezen, Figen; Albayrak, Nurhan; Özkara, Şeref; Karagöz, Alper; Alp, Alpaslan; Duyar Ağca, Filiz; İnan Süer, Asiye; Müderris, Tuba; Ceyhan, İsmail; Durmaz, Rıza; Ertek, Mustafa

2015-04-01

The most effective method for monitoring country-level drug resistance frequency and to implement the necessary control measures is the establishment of a laboratory-based surveillance system. The aim of this study was to summarize the follow up trend of the drug-resistant tuberculosis (TB) cases, determine the load of resistance and evaluate the capacities of laboratories depending on laboratory quality assurance system for the installation work of National Tuberculosis Laboratory Surveillance Network (TuLSA) which has started in Ankara in 2011. TuLSA studies was carried out under the coordination of National Tuberculosis Reference Laboratory (NRL) with the participation of TB laboratories and dispensaries. Specimens of TB patients, reported from health institutions, were followed in TB laboratories, and the epidemiological information was collected from the dispensaries. One isolate per patient with the drug susceptibility test (DST) results were sent to NRL from TB laboratories and in NRL the isolates were rechecked with the genotypical (MTBDRplus, Hain Lifescience, Germany) and phenotypical (MGIT 960, BD, USA) DST methods. Molecular epidemiological analysis were also performed by spoligotyping and MIRU/VNTR. Second-line DST was applied to the isolates resistant to rifampin. A total of 1276 patients were reported between January 1st to December 31th 2011, and 335 cases were defined as "pulmonary TB from Ankara province". The mean age of those patients was 43.4 ± 20 years, and 67.5% were male. Three hundred seventeen (94.6%) patients were identified as new cases. The average sample number obtained from pulmonary TB cases was 3.26 ± 2.88, and 229 (68.3%) of them was culture positive. DST was applied to all culture positive isolates; 90.4% (207/229) of cases were susceptible to the five drugs tested (ethambutol, isoniazid, pyrazinamide, rifampicin, streptomycin). Eight (3.5%) of the isolates were multidrug-resistant (MDR-TB), while no extensively drug

The global agenda on influenza surveillance and control.

PubMed

Stöhr, Klaus

2003-05-01

In collaboration with its many partners, WHO has developed a new Global Agenda on Influenza Surveillance and Control. The Global Agenda defines 17 priority activities that are critical to reducing the morbidity and mortality from annual influenza epidemics and preparing for the next pandemic. The Global Agenda will provide the foundation for global and national intervention plans, facilitate international coordination of prevention and control activities and contribute to renewed interest in epidemic influenza prevention and pandemic preparedness.

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.

Mapping of the US Domestic Influenza Virologic Surveillance Landscape.

PubMed

Jester, Barbara; Schwerzmann, Joy; Mustaquim, Desiree; Aden, Tricia; Brammer, Lynnette; Humes, Rosemary; Shult, Pete; Shahangian, Shahram; Gubareva, Larisa; Xu, Xiyan; Miller, Joseph; Jernigan, Daniel

2018-07-17

Influenza virologic surveillance is critical each season for tracking influenza circulation, following trends in antiviral drug resistance, detecting novel influenza infections in humans, and selecting viruses for use in annual seasonal vaccine production. We developed a framework and process map for characterizing the landscape of US influenza virologic surveillance into 5 tiers of influenza testing: outpatient settings (tier 1), inpatient settings and commercial laboratories (tier 2), state public health laboratories (tier 3), National Influenza Reference Center laboratories (tier 4), and Centers for Disease Control and Prevention laboratories (tier 5). During the 2015-16 season, the numbers of influenza tests directly contributing to virologic surveillance were 804,000 in tiers 1 and 2; 78,000 in tier 3; 2,800 in tier 4; and 3,400 in tier 5. With the release of the 2017 US Pandemic Influenza Plan, the proposed framework will support public health officials in modeling, surveillance, and pandemic planning and response.

The Adverse Drug Event Collaborative: a joint venture to measure medication-related patient harm.

PubMed

Seddon, Mary E; Jackson, Aaron; Cameron, Chris; Young, Mary L; Escott, Linda; Maharaj, Ashika; Miller, Nigel

2012-01-25

To measure the extent of patient harm caused by medications (rate of Adverse Drug Events) in three DHBs, using a standardised trigger tool method. Counties Manukau, Capital and Coast and Canterbury DHBs decided to work collaboratively to implement the ADE Trigger Tool (TT). Definitions of ADE were agreed on and triggers refined. A random sample of closed charts (from March 2010 to February 2011) was obtained excluding patients who were admitted for <48 hours, children under the age of 18 and psychiatric admissions. In each DHB trained reviewers scanned these in a structured way to identify any of the 19 triggers. If triggers were identified, a more detailed, though time-limited review of the chart was done to determine whether an ADE had occurred. The severity of patient harm was categorised using the National Coordinating Council for Medication Error Reporting and Prevention Index. No attempt was made to determine preventability of harm and ADEs from acts of omission were excluded. The ADE TT was applied to 1210 charts and 353 ADE were identified, with an average rate of 28.9/100 admissions and 38/1,000 bed days. 94.5% of the ADE identified were in the lower severity scales with temporary harm, however in 5 patients it was considered that the ADE contributed to their death, 9 required an intervention to sustain life and 4 suffered permanent harm. The most commonly implicated drugs were morphine and other opioids, anticoagulants, antibiotics, Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and diuretics. Patients who suffered an ADE were more likely to be female, older with more complex medical illnesses, and have a longer length of stay. The rate of medication-related harm identified by the ADE TT is considerably higher than that identified through traditional voluntary reporting mechanisms. The ADE TT provides a standardised measure of harm over time that can be used to determine trends and the effect of medication safety improvement programmes. This study not

Deciphering Suicide and Other Manners of Death Associated with Drug Intoxication: A Centers for Disease Control and Prevention Consultation Meeting Summary.

PubMed

Stone, Deborah M; Holland, Kristin M; Bartholow, Brad; E Logan, Joseph; LiKamWa McIntosh, Wendy; Trudeau, Aimee; Rockett, Ian R H

2017-08-01

Manner of death (MOD) classification (i.e., natural, accident, suicide, homicide, or undetermined cause) affects mortality surveillance and public health research, policy, and practice. Determination of MOD in deaths caused by drug intoxication is challenging, with marked variability across states. The Centers for Disease Control and Prevention hosted a multidisciplinary meeting to discuss drug intoxication deaths as they relate to suicide and other MOD. The meeting objectives were to identify individual-level, system-level, and place-based factors affecting MOD classification and identify potential solutions to classification barriers. Suggested strategies included improved standardization in death scene investigation, toxicology, and autopsy practice; greater accountability; and creation of job aids for investigators. Continued collaboration and coordination of activities are needed among stakeholders to affect prevention efforts.

Descriptive review of tuberculosis surveillance systems across the circumpolar regions.

PubMed

Bourgeois, Annie-Claude; Zulz, Tammy; Soborg, Bolette; Koch, Anders

2016-01-01

Tuberculosis is highly prevalent in many Arctic areas. Members of the International Circumpolar Surveillance Tuberculosis (ICS-TB) Working Group collaborate to increase knowledge about tuberculosis in Arctic regions. To establish baseline knowledge of tuberculosis surveillance systems used by ICS-TB member jurisdictions. Three questionnaires were developed to reflect the different surveillance levels (local, regional and national); all 3 were forwarded to the official representative of each of the 15 ICS-TB member jurisdictions in 2013. Respondents self-identified the level of surveillance conducted in their region and completed the applicable questionnaire. Information collected included surveillance system objectives, case definitions, data collection methodology, storage and dissemination. Thirteen ICS-TB jurisdictions [Canada (Labrador, Northwest Territories, Nunavik, Nunavut, Yukon), Finland, Greenland, Norway, Sweden, Russian Federation (Arkhangelsk, Khanty-Mansiysk Autonomous Okrug, Yakutia (Sakha Republic), United States (Alaska)] voluntarily completed the survey - representing 2 local, 7 regional and 4 national levels. Tuberculosis reporting is mandatory in all jurisdictions, and case definitions are comparable across regions. The common objectives across systems are to detect outbreaks, and inform the evaluation/planning of public health programmes and policies. All jurisdictions collect data on confirmed active tuberculosis cases and treatment outcomes; 11 collect contact tracing results. Faxing of standardized case reporting forms is the most common reporting method. Similar core data elements are collected; 8 regions report genotyping results. Data are stored using customized programmes (n=7) and commercial software (n=6). Nine jurisdictions provide monthly, bi-annual or annual reports to principally government and/or scientific/medical audiences. This review successfully establishes baseline knowledge on similarities and differences among circumpolar

Descriptive review of tuberculosis surveillance systems across the circumpolar regions

PubMed Central

Bourgeois, Annie-Claude; Zulz, Tammy; Soborg, Bolette; Koch, Anders

2016-01-01

Background Tuberculosis is highly prevalent in many Arctic areas. Members of the International Circumpolar Surveillance Tuberculosis (ICS-TB) Working Group collaborate to increase knowledge about tuberculosis in Arctic regions. Objective To establish baseline knowledge of tuberculosis surveillance systems used by ICS-TB member jurisdictions. Design Three questionnaires were developed to reflect the different surveillance levels (local, regional and national); all 3 were forwarded to the official representative of each of the 15 ICS-TB member jurisdictions in 2013. Respondents self-identified the level of surveillance conducted in their region and completed the applicable questionnaire. Information collected included surveillance system objectives, case definitions, data collection methodology, storage and dissemination. Results Thirteen ICS-TB jurisdictions [Canada (Labrador, Northwest Territories, Nunavik, Nunavut, Yukon), Finland, Greenland, Norway, Sweden, Russian Federation (Arkhangelsk, Khanty-Mansiysk Autonomous Okrug, Yakutia (Sakha Republic), United States (Alaska)] voluntarily completed the survey – representing 2 local, 7 regional and 4 national levels. Tuberculosis reporting is mandatory in all jurisdictions, and case definitions are comparable across regions. The common objectives across systems are to detect outbreaks, and inform the evaluation/planning of public health programmes and policies. All jurisdictions collect data on confirmed active tuberculosis cases and treatment outcomes; 11 collect contact tracing results. Faxing of standardized case reporting forms is the most common reporting method. Similar core data elements are collected; 8 regions report genotyping results. Data are stored using customized programmes (n=7) and commercial software (n=6). Nine jurisdictions provide monthly, bi-annual or annual reports to principally government and/or scientific/medical audiences. Conclusion This review successfully establishes baseline knowledge

Descriptive review of tuberculosis surveillance systems across the circumpolar regions.

PubMed

Bourgeois, Annie-Claude; Zulz, Tammy; Soborg, Bolette; Koch, Anders; On Behalf Of The International Circumpolar Surveillance-Tuberculosis Working Group

2016-01-01

Background Tuberculosis is highly prevalent in many Arctic areas. Members of the International Circumpolar Surveillance Tuberculosis (ICS-TB) Working Group collaborate to increase knowledge about tuberculosis in Arctic regions. Objective To establish baseline knowledge of tuberculosis surveillance systems used by ICS-TB member jurisdictions. Design Three questionnaires were developed to reflect the different surveillance levels (local, regional and national); all 3 were forwarded to the official representative of each of the 15 ICS-TB member jurisdictions in 2013. Respondents self-identified the level of surveillance conducted in their region and completed the applicable questionnaire. Information collected included surveillance system objectives, case definitions, data collection methodology, storage and dissemination. Results Thirteen ICS-TB jurisdictions [Canada (Labrador, Northwest Territories, Nunavik, Nunavut, Yukon), Finland, Greenland, Norway, Sweden, Russian Federation (Arkhangelsk, Khanty-Mansiysk Autonomous Okrug, Yakutia (Sakha Republic), United States (Alaska)] voluntarily completed the survey - representing 2 local, 7 regional and 4 national levels. Tuberculosis reporting is mandatory in all jurisdictions, and case definitions are comparable across regions. The common objectives across systems are to detect outbreaks, and inform the evaluation/planning of public health programmes and policies. All jurisdictions collect data on confirmed active tuberculosis cases and treatment outcomes; 11 collect contact tracing results. Faxing of standardized case reporting forms is the most common reporting method. Similar core data elements are collected; 8 regions report genotyping results. Data are stored using customized programmes (n=7) and commercial software (n=6). Nine jurisdictions provide monthly, bi-annual or annual reports to principally government and/or scientific/medical audiences. Conclusion This review successfully establishes baseline knowledge on

Detection of Rare Antimicrobial Resistance Profiles by Active and Passive Surveillance Approaches

PubMed Central

Mather, Alison E.; Reeve, Richard; Mellor, Dominic J.; Matthews, Louise; Reid-Smith, Richard J.; Haydon, Daniel T.; Reid, Stuart W. J.

2016-01-01

Antimicrobial resistance (AMR) surveillance systems are generally not specifically designed to detect emerging resistances and usually focus primarily on resistance to individual drugs. Evaluating the diversity of resistance, using ecological metrics, allows the assessment of sampling protocols with regard to the detection of rare phenotypes, comprising combinations of resistances. Surveillance data of phenotypic AMR of Canadian poultry Salmonella Heidelberg and swine Salmonella Typhimurium var. 5- were used to contrast active (representative isolates derived from healthy animals) and passive (diagnostic isolates) surveillance and assess their suitability for detecting emerging resistance patterns. Although in both datasets the prevalences of resistance to individual antimicrobials were not significantly different between the two surveillance systems, analysis of the diversity of entire resistance phenotypes demonstrated that passive surveillance of diagnostic isolates detected more unique phenotypes. Whilst the most appropriate surveillance method will depend on the relevant objectives, under the conditions of this study, passive surveillance of diagnostic isolates was more effective for the detection of rare and therefore potentially emerging resistance phenotypes. PMID:27391966

Applying a New Model for Sharing Population Health Data to National Syndromic Influenza Surveillance: DiSTRIBuTE Project Proof of Concept, 2006 to 2009.

PubMed

Olson, Donald R; Paladini, Marc; Lober, William B; Buckeridge, David L

2011-08-02

The Distributed Surveillance Taskforce for Real-time Influenza Burden Tracking and Evaluation (DiSTRIBuTE) project began as a pilot effort initiated by the International Society for Disease Surveillance (ISDS) in autumn 2006 to create a collaborative electronic emergency department (ED) syndromic influenza-like illness (ILI) surveillance network based on existing state and local systems and expertise. DiSTRIBuTE brought together health departments that were interested in: 1) sharing aggregate level data; 2) maintaining jurisdictional control; 3) minimizing barriers to participation; and 4) leveraging the flexibility of local systems to create a dynamic and collaborative surveillance network. This approach was in contrast to the prevailing paradigm for surveillance where record level information was collected, stored and analyzed centrally. The DiSTRIBuTE project was created with a distributed design, where individual level data remained local and only summarized, stratified counts were reported centrally, thus minimizing privacy risks. The project was responsive to federal mandates to improve integration of federal, state, and local biosurveillance capabilities. During the proof of concept phase, 2006 to 2009, ten jurisdictions from across North America sent ISDS on a daily to weekly basis year-round, aggregated data by day, stratified by local ILI syndrome, age-group and region. During this period, data from participating U.S. state or local health departments captured over 13% of all ED visits nationwide. The initiative focused on state and local health department trust, expertise, and control. Morbidity trends observed in DiSTRIBuTE were highly correlated with other influenza surveillance measures. With the emergence of novel A/H1N1 influenza in the spring of 2009, the project was used to support information sharing and ad hoc querying at the state and local level. In the fall of 2009, through a broadly collaborative effort, the project was expanded to enhance

The Armed Forces Health Surveillance Center: enhancing the Military Health System’s public health capabilities

PubMed Central

2011-01-01

Since its establishment in February 2008, the Armed Forces Health Surveillance Center (AFHSC) has embarked on a number of initiatives and projects in collaboration with a variety of agencies in the Department of Defense (DoD), other organizations within the federal government, and non-governmental partners. In 2009, the outbreak of pandemic H1N1 influenza attracted the major focus of the center, although notable advances were accomplished in other areas of interest, such as deployment health, mental health and traumatic brain injury surveillance. PMID:21388560

Drug resistant Mycobacterium tuberculosis in Mexico.

PubMed

Zazueta-Beltran, Jorge; León-Sicairos, Claudia; Canizalez-Roman, Adrián

2009-04-30

Tuberculosis (TB) remains a serious public health problem, worsened by an increased frequency of multidrug-resistant (MDR) Mycobacterium tuberculosis strains. The World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Disease (IUATLD) launched the Global Project on Anti-Tuberculosis Drug Resistance Surveillance to measure the prevalence of drug resistance. Data from the global reports on resistance to anti-tuberculosis (anti-TB) drugs have shown that drug resistance still presents worldwide and that MDR-TB is present in almost all the world. Though the Global Project (WHO) has been operating since 1994, very few countries and states have reported new information. Data from repeated surveys employing comparable methodologies over several years are essential to determine with any certainty in which direction the prevalence of drug resistance is moving. Drug-resistant tuberculosis and MDR-TB have been identified in Mexico, even with the existence of a National Tuberculosis Program based on Directly Observed Treatment, Short-course (DOTS). This review discusses available surveillance data on drug susceptibility data for TB in different states of Mexico.

Use of Bibliometric Analysis to Assess the Scientific Productivity and Impact of the Global Emerging Infections Surveillance and Response System Program, 2006-2012.

PubMed

Reaves, Erik J; Valle, Ruben; Chandrasekera, Ruvani M; Soto, Giselle; Burke, Ronald L; Cummings, James F; Bausch, Daniel G; Kasper, Matthew R

2017-05-01

Scientific publication in academic literature is a key venue in which the U.S. Department of Defense's Global Emerging Infections Surveillance and Response System (GEIS) program disseminates infectious disease surveillance data. Bibliometric analyses are tools to evaluate scientific productivity and impact of published research, yet are not routinely used for disease surveillance. Our objective was to incorporate bibliometric indicators to measure scientific productivity and impact of GEIS-funded infectious disease surveillance, and assess their utility in the management of the GEIS surveillance program. Metrics on GEIS program scientific publications, project funding, and countries of collaborating institutions from project years 2006 to 2012 were abstracted from annual reports and program databases and organized by the six surveillance priority focus areas: respiratory infections, gastrointestinal infections, febrile and vector-borne infections, antimicrobial resistance, sexually transmitted infections, and capacity building and outbreak response. Scientific productivity was defined as the number of scientific publications in peer-reviewed literature derived from GEIS-funded projects. Impact was defined as the number of citations of a GEIS-funded publication by other peer-reviewed publications, and the Thomson Reuters 2-year journal impact factor. Indicators were retrieved from the Web of Science and Journal Citation Report. To determine the global network of international collaborations between GEIS partners, countries were organized by the locations of collaborating institutions. Between 2006 and 2012, GEIS distributed approximately US $330 million to support 921 total projects. On average, GEIS funded 132 projects (range 96-160) with $47 million (range $43 million-$53 million), annually. The predominant surveillance focus areas were respiratory infections with 317 (34.4%) projects and $225 million, and febrile and vector-borne infections with 274 (29

The importance of waterborne disease outbreak surveillance in the United States.

PubMed

Craun, Gunther Franz

2012-01-01

Analyses of the causes of disease outbreaks associated with contaminated drinking water in the United States have helped inform prevention efforts at the national, state, and local levels. This article describes the changing nature of disease outbreaks in public water systems during 1971-2008 and discusses the importance of a collaborative waterborne outbreak surveillance system established in 1971. Increasing reports of outbreaks throughout the early 1980s emphasized that microbial contaminants remained a health-risk challenge for suppliers of drinking water. Outbreak investigations identified the responsible etiologic agents and deficiencies in the treatment and distribution of drinking water, especially the high risk associated with unfiltered surface water systems. Surveillance information was important in establishing an effective research program that guided government regulations and industry actions to improve drinking water quality. Recent surveillance statistics suggest that prevention efforts based on these research findings have been effective in reducing outbreak risks especially for surface water systems.

Characterization of adolescent prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-related Surveillance (RADARS(®)) System.

PubMed

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

2013-02-01

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(®)) System. Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all intentional exposures from 2007 through 2009 were used to describe adolescent prescription opioid (oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, buprenorphine, and tramadol) and stimulant (methylphenidate and amphetamines) exposures. A total of 16,209 intentional adolescent exposures to prescription drugs were identified, 68% to opioids and 32% to stimulants. The mean age was 16.6 years (SD ± 1.7 years). Slightly more than half (52.4%) of drug mentions involved females. The five most frequently misused or abused drugs were hydrocodone (32%), amphetamines (18%), oxycodone (15%), methylphenidate (14%), and tramadol (11%). Of all exposures, 38% were classified as suspected suicidal. Of adolescents who intentionally exposed themselves to prescription drugs, 30% were treated in a health care facility, 2,792 of whom were admitted to the hospital, including 1,293 to the intensive care unit. A total of 17.2% of intentional exposures were associated with no effect, 38.9% minor effects, 23.3% moderate effects, 3.6% major effects, and 0.1% were associated with death. Oxycodone and methadone were associated with the most deaths. No deaths were associated with exposures to stimulants. Prescription drug misuse and abuse poses an important health problem and results in thousands of hospitalizations of adolescents per year. Further work is needed to develop focused interventions and educational programs to prevent prescription drug abuse and misuse by adolescents. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Informatics for neglected diseases collaborations.

PubMed

Bost, Frederic; Jacobs, Robert T; Kowalczyk, Paul

2010-05-01

Many different public and private organizations from across the globe are collaborating on neglected diseases drug-discovery and development projects with the aim of identifying a cure for tropical infectious diseases. These neglected diseases collaborations require a global, secure, multi-organization data-management solution, combined with a platform that facilitates communication and supports collaborative work. This review discusses the solutions offered by 'Software as a Service' (SaaS) web-based platforms, despite notable challenges, and the evolution of these platforms required to foster efficient virtual research efforts by geographically dispersed scientists.

Developing the foundation for syndromic surveillance and health information exchange for yolo county, california.

PubMed

Chaudhary, Osama

2012-01-01

This report delineates Yolo County Health Department's process to ascertain its optimal methods of participation in syndromic surveillance and health information exchange. As a health department serving a county of just 200,000 residents, Yolo County Health Department needed to operate within strict financial constraints. Meaningful Use legislation enabled it to pursue both syndromic surveillance and health information exchange participation whilst complying with its budgetary restrictions. The Health Information Technology for Economic and Clinical Health (HITECH), a segment of the American Recovery and Reinvestment Act of 2009, has incentivized the 'Meaningful Use' of electronic health records (EHRs) by providing incentive reimbursements and non-compliance penalties. The Meaningful Use of EHRs is to take place over 3 Stages: Stage 1 has begun, Stage 2 is imminent, and Stage 3 is currently being discussed. Having been solicited by both health information exchange and syndromic surveillance options which were cost-prohibitive, Yolo County Health Department focused attention on BioSense 2.0, a Meaningul Use-ready and virtually free syndromic surveillance program developed by the Federal Centers for Disease Control and Prevention. In collaboration with Sacramento County Department of Health and Human Services, and with support from several other area counties, Yolo County Health Department submitted a Funding Opportunity application for BioSense 2.0 regional implementation. Through this collaboration, Yolo County Health Department has begun participating in the formative stages of the Sacramento Area Center for Advanced Biosurveillance (SAC-B). Via SAC-B, Yolo County Health Department will be able to participate in syndromic surveillance in the BioSense 2.0 program, and simultaneously expand its electronic health data sharing towards a more comprehensive health information exchange. LASTLY, OVER THE COURSE OF THESE PROJECTS, THREE OTHER METHODS OF PARTICIPATING IN

Towards an integrated approach in surveillance of vector-borne diseases in Europe

PubMed Central

2011-01-01

Vector borne disease (VBD) emergence is a complex and dynamic process. Interactions between multiple disciplines and responsible health and environmental authorities are often needed for an effective early warning, surveillance and control of vectors and the diseases they transmit. To fully appreciate this complexity, integrated knowledge about the human and the vector population is desirable. In the current paper, important parameters and terms of both public health and medical entomology are defined in order to establish a common language that facilitates collaboration between the two disciplines. Special focus is put on the different VBD contexts with respect to the current presence or absence of the disease, the pathogen and the vector in a given location. Depending on the context, whether a VBD is endemic or not, surveillance activities are required to assess disease burden or threat, respectively. Following a decision for action, surveillance activities continue to assess trends. PMID:21967706

77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``FDA... that address nearly all aspects of the FDA approval and surveillance processes, including application...

77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Oversight of... nearly all aspects of the FDA approval and surveillance processes, including application submission...

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

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

PubMed

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

2015-08-20

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. 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. 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. 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. Understanding the information-seeking behavior associated with online evidence sources can offer insight into the information

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

PubMed

Reist, M; Jemmi, T; Stärk, K D C

2012-07-01

Animal health and residue surveillance verifies the good health status of the animal population, thereby supporting international free trade of animals and animal products. However, active surveillance is costly and time-consuming. The development of cost-effective tools for animal health and food hazard surveillance is therefore a priority for decision-makers in the field of veterinary public health. The assumption of this paper is that outcome-based formulation of standards, legislation leaving room for risk-based approaches and close collaboration and a mutual understanding and exchange between scientists and policy makers are essential for cost-effective surveillance. We illustrate this using the following examples: (i) a risk-based sample size calculation for surveys to substantiate freedom from diseases/infection, (ii) a cost-effective national surveillance system for Bluetongue using scenario tree modelling and (iii) a framework for risk-based residue monitoring. Surveys to substantiate freedom from infectious bovine rhinotracheitis and enzootic bovine leucosis between 2002 and 2009 saved over 6 million € by applying a risk-based sample size calculation approach, and by taking into account prior information from repeated surveys. An open, progressive policy making process stimulates research and science to develop risk-based and cost-efficient survey methodologies. Early involvement of policy makers in scientific developments facilitates implementation of new findings and full exploitation of benefits for producers and consumers. Copyright © 2012 Elsevier B.V. All rights reserved.

Drug sales data analysis for outbreak detection of infectious diseases: a systematic literature review.

PubMed

Pivette, Mathilde; Mueller, Judith E; Crépey, Pascal; Bar-Hen, Avner

2014-11-18

This systematic literature review aimed to summarize evidence for the added value of drug sales data analysis for the surveillance of infectious diseases. A search for relevant publications was conducted in Pubmed, Embase, Scopus, Cochrane Library, African Index Medicus and Lilacs databases. Retrieved studies were evaluated in terms of objectives, diseases studied, data sources, methodologies and performance for real-time surveillance. Most studies compared drug sales data to reference surveillance data using correlation measurements or indicators of outbreak detection performance (sensitivity, specificity, timeliness of the detection). We screened 3266 articles and included 27 in the review. Most studies focused on acute respiratory and gastroenteritis infections. Nineteen studies retrospectively compared drug sales data to reference clinical data, and significant correlations were observed in 17 of them. Four studies found that over-the-counter drug sales preceded clinical data in terms of incidence increase. Five studies developed and evaluated statistical algorithms for selecting drug groups to monitor specific diseases. Another three studies developed models to predict incidence increase from drug sales. Drug sales data analyses appear to be a useful tool for surveillance of gastrointestinal and respiratory disease, and OTC drugs have the potential for early outbreak detection. Their utility remains to be investigated for other diseases, in particular those poorly surveyed.

Watching the Games: public health surveillance for the Sydney 2000 Olympic Games

PubMed Central

Jorm, L; Thackway, S; Churches, T; Hills, M

2003-01-01

Design: Planning for the system took almost three years. Its major components included increased surveillance of communicable diseases; presentations to sentinel emergency departments; medical encounters at Olympic venues; cruise ship surveillance; environmental and food safety inspections; surveillance for bioterrorism; and global epidemic intelligence. A daily report integrated data from all sources. Setting: Sydney, Australia. Surveillance spanned the period 28 August to 4 October 2000. Participants: Residents of Sydney, athletes and officials, Australian and international visitors. Main results: No outbreaks of communicable diseases were detected. There were around 5% more presentations to Sydney emergency departments than in comparable periods in other years. Several incidents detected through surveillance, including injuries caused by broken glass, and a cluster of presentations related to the use of the drug ecstasy, prompted further action. Conclusions: Key elements in the success of public health surveillance for the Games included its careful planning, its comprehensive coverage of public health issues, and its timely reporting and communication processes. Future systems need to be flexible enough to detect the unexpected. PMID:12540684

Health & Demographic Surveillance System Profile: The Nairobi Urban Health and Demographic Surveillance System (NUHDSS).

PubMed

Beguy, Donatien; Elung'ata, Patricia; Mberu, Blessing; Oduor, Clement; Wamukoya, Marylene; Nganyi, Bonface; Ezeh, Alex

2015-04-01

The Nairobi Urban Health and Demographic Surveillance System (NUHDSS) was the first urban-based longitudinal health and demographic surveillance platform in sub-Saharan Africa (SSA). The NUHDSS was established in 2002 to provide a platform to investigate the long-term social, economic and health consequences of urban residence, and to serve as a primary research tool for intervention and impact evaluation studies focusing on the needs of the urban poor in SSA. Since its inception, the NUHDSS has successfully followed every year a population of about 65,000 individuals in 24,000 households in two slum communities--Korogocho and Viwandani--in Nairobi, Kenya. Data collected include key demographic and health information (births, deaths including verbal autopsy, in- and out-migration, immunization) and other information that characterizes living conditions in the slums (livelihood opportunities, household amenities and possessions, type of housing etc.). In addition to the routine data, it has provided a robust platform for nesting several studies examining the challenges of rapid urbanization in SSA and associated health and poverty dynamics. NUHDSS data are shared through internal and external collaborations, in accordance with the Centre's guidelines for publications, data sharing. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Surveillance Recommendations in Reducing Risk of and Optimally Managing Breast Cancer-Related Lymphedema

PubMed Central

Ostby, Pamela L.; Armer, Jane M.; Dale, Paul S.; Van Loo, Margaret J.; Wilbanks, Cassie L.; Stewart, Bob R.

2014-01-01

Breast cancer survivors are at increased risk for the development of breast cancer-related lymphedema (BCRL), a chronic, debilitating, and disfiguring condition that is progressive and requires lifelong self-management of symptoms. It has been reported that over 40% of the 2.5 million breast cancer survivors in the United States may meet the criteria for BCRL during their lifetimes. Ongoing surveillance, beginning with pre-operative assessment, has been effective in identifying subclinical lymphedema (LE). A prospective model for surveillance is necessary in order to detect BCRL at an early stage when there is the best chance to reduce risk or slow progression. Physical methods for monitoring and assessment, such as circumferential arm measures, perometry, bioimpedance; exercise programs; prophylactic and early-intervention compression garments; and referral for complete decongestive therapy are all interventions to consider in the development of a BCRL surveillance program. In addition, supportive-educative programs and interactive engagement for symptom self-management should also be implemented. The importance of interdisciplinary collaboration is integral to the success of an effective personalized medicine program in breast cancer-related lymphedema surveillance. PMID:25563360

Surveillance of contrast-media-induced hypersensitivity reactions using signals from an electronic medical recording system.

PubMed

Kim, Min-Hye; Park, Chang-Han; Kim, Duk-In; Kim, Kyung-Mook; Kim, Hui-Kyu; Lim, Kyu-Hyoung; Song, Woo-Jung; Lee, Sang-Min; Kim, Sae-Hoon; Kwon, Hyouk-Soo; Park, Heung-Woo; Yoon, Chang-Jin; Cho, Sang-Heon; Min, Kyung-Up; Kim, You-Young; Chang, Yoon-Seok

2012-03-01

Contrast-media (CM) hypersensitivity is a well-known adverse drug reaction. Surveillance of adverse drug reactions usually depends on spontaneous reports. However, the rate of spontaneous reports is low. Recent progress in information technology enables the electronic search on signals of adverse drug reactions from electronic medical recording (EMR) systems. To analyze the incidence and clinical characteristics of CM hypersensitivity using an EMR-based surveillance system. The surveillance system used signals from standardized terms within the international classification of nursing practice terms that can indicate symptoms of CM hypersensitivity and from the order codes for procedures that used contrast media, antihistamine, and epinephrine. The search strategy was validated by allergists comparing the electronic search strategy versus manually reviewing medical charts over one month. The main study covered for one year period. Detection rate of the electronic search method was 0.9% (7/759), while that of the manual search method was 0.8% (6/759). EMR-based electronic search method was highly efficient: reduced the charts that needed to be reviewed by 96% (28/759). The sensitivity of electronic screening was 66.7%, specificity was 99.6%, and the negative predictive value was 99.7%. CM hypersensitivity reactions were noted in 266 among 12,483 cases (2.1%). Urticaria was the most frequent symptom (74.4%). CT was the most frequent procedure (3.6%) that induced CM hypersensitivity. A surveillance system using EMR may be a useful tool in the study of drug hypersensitivity epidemiology and may be used in an adverse drug reaction alarm system and as a clinical, decision making support system. Copyright © 2012 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Surveillance for Waterborne Disease Outbreaks and Other Health Events Associated with Recreational Water -United States, 2007-2008*

EPA Science Inventory

Problem/Condition: Since 1978, CDC, the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have collaborated on the Waterborne Disease and Outbreak Surveillance System (WBDOSS) for collecting and reporting data on occurrences and causes...

Surveillance for Waterborne Disease Outbreaks and Other Health Events Associated with Recreational Water -United States, 2007-2008

EPA Science Inventory

Background: Since 1978, CDC, EPA, and the Council of State and Territorial Epidemiologists have collaborated on the Waterborne Disease and Outbreak Surveillance System (WBDOSS) to capture data on waterborne disease outbreaks associated with recreational water. WBDOSS is the prima...

Comparing national infectious disease surveillance systems: China and the Netherlands.

PubMed

Vlieg, Willemijn L; Fanoy, Ewout B; van Asten, Liselotte; Liu, Xiaobo; Yang, Jun; Pilot, Eva; Bijkerk, Paul; van der Hoek, Wim; Krafft, Thomas; van der Sande, Marianne A; Liu, Qi-Yong

2017-05-08

Risk assessment and early warning (RAEW) are essential components of any infectious disease surveillance system. In light of the International Health Regulations (IHR)(2005), this study compares the organisation of RAEW in China and the Netherlands. The respective approaches towards surveillance of arboviral disease and unexplained pneumonia were analysed to gain a better understanding of the RAEW mode of operation. This study may be used to explore options for further strengthening of global collaboration and timely detection and surveillance of infectious disease outbreaks. A qualitative study design was used, combining data retrieved from the literature and from semi-structured interviews with Chinese (5 national-level and 6 provincial-level) and Dutch (5 national-level) experts. The results show that some differences exist such as in the use of automated electronic components of the early warning system in China ('CIDARS'), compared to a more limited automated component in the Netherlands ('barometer'). Moreover, RAEW units in the Netherlands focus exclusively on infectious diseases, while China has a broader 'all hazard' approach (including for example chemical incidents). In the Netherlands, veterinary specialists take part at the RAEW meetings, to enable a structured exchange/assessment of zoonotic signals. Despite these differences, the main conclusion is that for the two infections studied, the early warning system in China and the Netherlands are remarkably similar considering their large differences in infectious disease history, population size and geographical setting. Our main recommendations are continued emphasis on international corporation that requires insight into national infectious disease surveillance systems, the usage of a One Health approach in infectious disease surveillance, and further exploration/strengthening of a combined syndromic and laboratory surveillance system.

Cost analysis of an integrated vaccine-preventable disease surveillance system in Costa Rica✩

PubMed Central

Toscano, C.M.; Vijayaraghavan, M.; Salazar-Bolaños, H.M.; Bolaños-Acuña, H.M.; Ruiz-González, A.I.; Barrantes-Solis, T.; Fernández-Vargas, I.; Panero, M.S.; de Oliveira, L.H.; Hyde, T.B.

2015-01-01

Introduction Following World Health Organization recommendations set forth in the Global Framework for Immunization Monitoring and Surveillance, Costa Rica in 2009 became the first country to implement integrated vaccine-preventable disease (iVPD) surveillance, with support from the U.S. Centers for Disease Control and Prevention (CDC) and the Pan American Health Organization (PAHO). As surveillance for diseases prevented by new vaccines is integrated into existing surveillance systems, these systems could cost more than routine surveillance for VPDs targeted by the Expanded Program on Immunization. Objectives We estimate the costs associated with establishing and subsequently operating the iVPD surveillance system at a pilot site in Costa Rica. Methods We retrospectively collected data on costs incurred by the institutions supporting iVPD surveillance during the preparatory (January 2007 through August 2009) and implementation (September 2009 through August 2010) phases of the iVPD surveillance project in Costa Rica. These data were used to estimate costs for personnel, meetings, infrastructure, office equipment and supplies, transportation, and laboratory facilities. Costs incurred by each of the collaborating institutions were also estimated. Results During the preparatory phase, the estimated total cost was 128,000 U.S. dollars (US$), including 64% for personnel costs. The preparatory phase was supported by CDC and PAHO. The estimated cost for 1 year of implementation was US$ 420,000, including 58% for personnel costs, 28% for laboratory costs, and 14% for meeting, infrastructure, office, and transportation costs combined. The national reference laboratory and the PAHO Costa Rica office incurred 64% of total costs, and other local institutions supporting iVPD surveillance incurred the remaining 36%. Conclusions Countries planning to implement iVPD surveillance will require adequate investments in human resources, laboratories, data management, reporting, and

Cost analysis of an integrated vaccine-preventable disease surveillance system in Costa Rica.

PubMed

Toscano, C M; Vijayaraghavan, M; Salazar-Bolaños, H M; Bolaños-Acuña, H M; Ruiz-González, A I; Barrantes-Solis, T; Fernández-Vargas, I; Panero, M S; de Oliveira, L H; Hyde, T B

2013-07-02

Following World Health Organization recommendations set forth in the Global Framework for Immunization Monitoring and Surveillance, Costa Rica in 2009 became the first country to implement integrated vaccine-preventable disease (iVPD) surveillance, with support from the U.S. Centers for Disease Control and Prevention (CDC) and the Pan American Health Organization (PAHO). As surveillance for diseases prevented by new vaccines is integrated into existing surveillance systems, these systems could cost more than routine surveillance for VPDs targeted by the Expanded Program on Immunization. We estimate the costs associated with establishing and subsequently operating the iVPD surveillance system at a pilot site in Costa Rica. We retrospectively collected data on costs incurred by the institutions supporting iVPD surveillance during the preparatory (January 2007 through August 2009) and implementation (September 2009 through August 2010) phases of the iVPD surveillance project in Costa Rica. These data were used to estimate costs for personnel, meetings, infrastructure, office equipment and supplies, transportation, and laboratory facilities. Costs incurred by each of the collaborating institutions were also estimated. During the preparatory phase, the estimated total cost was 128,000 U.S. dollars (US$), including 64% for personnel costs. The preparatory phase was supported by CDC and PAHO. The estimated cost for 1 year of implementation was US$ 420,000, including 58% for personnel costs, 28% for laboratory costs, and 14% for meeting, infrastructure, office, and transportation costs combined. The national reference laboratory and the PAHO Costa Rica office incurred 64% of total costs, and other local institutions supporting iVPD surveillance incurred the remaining 36%. Countries planning to implement iVPD surveillance will require adequate investments in human resources, laboratories, data management, reporting, and investigation. Our findings will be valuable for

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

Surveillance versus clinical adjudication: differences persist with new ventilator-associated event definition.

PubMed

McMullen, Kathleen M; Boyer, Anthony F; Schoenberg, Noah; Babcock, Hilary M; Micek, Scott T; Kollef, Marin H

2015-06-01

The National Healthcare Safety Network (NHSN) has recently supported efforts to shift surveillance away from ventilator-associated pneumonia to ventilator-associated events (VAEs) to decrease subjectivity in surveillance and minimize concerns over clinical correlation. The goals of this study were to compare the results of an automated surveillance strategy using the new VAE definition with a prospectively performed clinical application of the definition. All patients ventilated for ≥2 days in a medical and surgical intensive care unit were evaluated by 2 methods: retrospective surveillance using an automated algorithm combined with manual chart review after the NHSN's VAE methodology and prospective surveillance by pulmonary physicians in collaboration with the clinical team administering care to the patient at the bedside. Overall, a similar number of events were called by each method (69 vs 67). Of the 1,209 patients, 56 were determined to have VAEs by both methods (κ = .81, P = .04). There were 24 patients considered to be a VAE by only 1 of the methods. Most discrepancies were the result of clinical disagreement with the NHSN's VAE methodology. There was good agreement between the study teams. Awareness of the limitations of the surveillance definition for VAE can help infection prevention personnel in discussions with critical care partners about optimal use of these data. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

HIV-1 drug-resistance surveillance among treatment-experienced and -naïve patients after the implementation of antiretroviral therapy in Ghana.

PubMed

Nii-Trebi, Nicholas I; Ibe, Shiro; Barnor, Jacob S; Ishikawa, Koichi; Brandful, James A M; Ofori, Sampson B; Yamaoka, Shoji; Ampofo, William K; Sugiura, Wataru

2013-01-01

Limited HIV-1 drug-resistance surveillance has been carried out in Ghana since the implementation of antiretroviral therapy (ART). This study sought to provide data on the profile of HIV-1 drug resistance in ART-experienced and newly diagnosed individuals in Ghana. Samples were collected from 101 HIV-1-infected patients (32 ART-experienced cases with virological failure and 69 newly diagnosed ART-naïve cases, including 11 children), in Koforidua, Eastern region of Ghana, from February 2009 to January 2010. The pol gene sequences were analyzed by in-house HIV-1 drug-resistance testing. The most prevalent HIV-1 subtype was CRF02_AG (66.3%, 67/101) followed by unique recombinant forms (25.7%, 26/101). Among 31 ART-experienced adults, 22 (71.0%) possessed at least one drug-resistance mutation, and 14 (45.2%) had two-class-resistance to nucleoside and non-nucleoside reverse-transcriptase inhibitors used in their first ART regimen. Importantly, the number of accumulated mutations clearly correlated with the duration of ART. The most prevalent mutation was lamivudine-resistance M184V (n = 12, 38.7%) followed by efavirenz/nevirapine-resistance K103N (n = 9, 29.0%), and zidovudine/stavudine-resistance T215Y/F (n = 6, 19.4%). Within the viral protease, the major nelfinavir-resistance mutation L90M was found in one case. No transmitted HIV-1 drug-resistance mutation was found in 59 ART-naïve adults, but K103N and G190S mutations were observed in one ART-naïve child. Despite expanding accessibility to ART in Eastern Ghana, the prevalence of transmitted HIV-1 drug resistance presently appears to be low. As ART provision with limited options is scaled up nationwide in Ghana, careful monitoring of transmitted HIV-1 drug resistance is necessary.

Frontiers of parasitology research in the People's Republic of China: infection, diagnosis, protection and surveillance

PubMed Central

2012-01-01

Control and eventual elimination of human parasitic diseases in the People's Republic of China (P.R. China) requires novel approaches, particularly in the areas of diagnostics, mathematical modelling, monitoring, evaluation, surveillance and public health response. A comprehensive effort, involving the collaboration of 188 scientists (>85% from P.R. China) from 48 different institutions and universities (80% from P.R. China), covers this collection of 29 articles published in Parasites & Vectors. The research mainly stems from a research project entitled “Surveillance and diagnostic tools for major parasitic diseases in P.R. China” (grant no. 2008ZX10004-011) and highlights the frontiers of research in parasitology. The majority of articles in this thematic series deals with the most important parasitic diseases in P.R. China, emphasizing Schistosoma japonicum, Plasmodium vivax and Clonorchis sinensis plus some parasites of emerging importance such as Angiostrongylus cantonensis. Significant achievements have been made through the collaborative research programme in the following three fields: (i) development of strategies for the national control programme; (ii) updating the surveillance data of parasitic infections both in human and animals; and (iii) improvement of existing, and development of novel, diagnostic tools to detect parasitic infections. The progress is considerable and warrants broad validation efforts. Combined with the development of improved tools for diagnosis and surveillance, integrated and multi-pronged control strategies should now pave the way for elimination of parasitic diseases in P.R. China. Experiences and lessons learned can stimulate control and elimination efforts of parasitic diseases in other parts of the world. PMID:23036110

Lyme Disease in West Virginia: An Assessment of Distribution and Clinicians' Knowledge of Disease and Surveillance.

PubMed

Singh, Sarah; Parker, David; Mark-Carew, Miguella; White, Robert; Fisher, Melanie

2016-01-01

Lyme disease case misclassification, a top public health concern, may be attributed to the current disconnect between clinical diagnosis and surveillance. This study examines Lyme disease distribution in West Virginia (WV) and determines clinicians' knowledge of both disease and surveillance. Lyme disease surveillance data for 2013 were obtained from the WV Bureau for Public Health. A validated survey, distributed to clinicians at an academic medical center, assessed clinicians' knowledge of disease diagnosis and surveillance. There were 297 adult Lyme disease cases of which 83 were confirmed. Clinician survey responses resulted in a correct response rate of 70% for Lyme disease knowledge questions. Fewer than half of all clinicians were aware of the surveillance criteria for confirming Lyme disease cases. Neither medical specialty nor previous treatment of patients with Lyme disease were significantly associated with clinicians' knowledge of the disease. Clinicians in WV are familiar with symptoms and clinical management of Lyme disease. However, they are less knowledgeable about diagnosis and public health surveillance comprising reporting and confirming cases of the disease. Clinicians and public health authorities should collaborate more closely to promote education and awareness as a key step to successfully reducing the burden of Lymne disease.

Health & Demographic Surveillance System Profile: The Muzaffarpur-TMRC Health and Demographic Surveillance System

PubMed Central

Malaviya, Paritosh; Picado, Albert; Hasker, Epco; Ostyn, Bart; Kansal, Sangeeta; Singh, Rudra Pratap; Shankar, Ravi; Boelaert, Marleen; Sundar, Shyam

2014-01-01

The Muzaffarpur-TMRC Health and Demographic Surveillance System (HDSS), established in 2007, was developed as an enlargement of the scope of a research collaboration on the project Visceral Leishmaniasis in Bihar, which had been ongoing since 2005. The HDSS is located in a visceral leishmaniasis (VL)-endemic area in the Muzaffarpur district of Bihar state in India. It is the only HDSS conducting research on VL, which is a vector-borne infectious disease transmitted by female phlebotomine sandflies and is fatal if left untreated. Currently the HDSS serves a population of over 105 000 in 66 villages. The HDSS collects data on vital events including pregnancies, births, deaths, migration and marriages, as well as other socio-economic indicators, at regular intervals. Incident VL cases are identified. The HDSS team is experienced in conducting both qualitative and quantitative studies, sample collection and rapid diagnostic tests in the field. In each village, volunteers connect the HDSS team with the community members. The Muzaffarpur-TMRC HDSS provides opportunities for studies on VL and other neglected tropical diseases (NTDs) and their interaction with demographic events such as migration. Queries related to research collaborations and data sharing can be sent to Dr Shyam Sundar at [drshyamsundar@hotmail.com]. PMID:25186307

Hajj: infectious disease surveillance and control.

PubMed

Memish, Ziad A; Zumla, Alimuddin; Alhakeem, Rafat F; Assiri, Abdullah; Turkestani, Abdulhafeez; Al Harby, Khalid D; Alyemni, Mohamed; Dhafar, Khalid; Gautret, Philippe; Barbeschi, Maurizio; McCloskey, Brian; Heymann, David; Al Rabeeah, Abdullah A; Al-Tawfiq, Jaffar A

2014-06-14

Religious festivals attract a large number of pilgrims from worldwide and are a potential risk for the transmission of infectious diseases between pilgrims, and to the indigenous population. The gathering of a large number of pilgrims could compromise the health system of the host country. The threat to global health security posed by infectious diseases with epidemic potential shows the importance of advanced planning of public health surveillance and response at these religious events. Saudi Arabia has extensive experience of providing health care at mass gatherings acquired through decades of managing millions of pilgrims at the Hajj. In this report, we describe the extensive public health planning, surveillance systems used to monitor public health risks, and health services provided and accessed during Hajj 2012 and Hajj 2013 that together attracted more than 5 million pilgrims from 184 countries. We also describe the recent establishment of the Global Center for Mass Gathering Medicine, a Saudi Government partnership with the WHO Collaborating Centre for Mass Gatherings Medicine, Gulf Co-operation Council states, UK universities, and public health institutions globally. Copyright © 2014 Elsevier Ltd. All rights reserved.

Twenty Years of Active Bacterial Core Surveillance

PubMed Central

Schaffner, William; Farley, Monica M.; Lynfield, Ruth; Bennett, Nancy M.; Reingold, Arthur; Thomas, Ann; Harrison, Lee H.; Nichols, Megin; Petit, Susan; Miller, Lisa; Moore, Matthew R.; Schrag, Stephanie J.; Lessa, Fernanda C.; Skoff, Tami H.; MacNeil, Jessica R.; Briere, Elizabeth C.; Weston, Emily J.; Van Beneden, Chris

2015-01-01

Active Bacterial Core surveillance (ABCs) was established in 1995 as part of the Centers for Disease Control and Prevention Emerging Infections Program (EIP) network to assess the extent of invasive bacterial infections of public health importance. ABCs is distinctive among surveillance systems because of its large, population-based, geographically diverse catchment area; active laboratory-based identification of cases to ensure complete case capture; detailed collection of epidemiologic information paired with laboratory isolates; infrastructure that allows for more in-depth investigations; and sustained commitment of public health, academic, and clinical partners to maintain the system. ABCs has directly affected public health policies and practices through the development and evaluation of vaccines and other prevention strategies, the monitoring of antimicrobial drug resistance, and the response to public health emergencies and other emerging infections. PMID:26292067

HIV-1 drug resistance surveillance in antiretroviral treatment-naive individuals from a reference hospital in Guatemala, 2010-2013.

PubMed

Avila-Ríos, Santiago; García-Morales, Claudia; Garrido-Rodríguez, Daniela; Tapia-Trejo, Daniela; Girón-Callejas, Amalia Carolina; Mendizábal-Burastero, Ricardo; Escobar-Urias, Ingrid Yessenia; García-González, Blanca Leticia; Navas-Castillo, Sabrina; Pinzón-Meza, Rodolfo; Mejía-Villatoro, Carlos Rodolfo; Reyes-Terán, Gustavo

2015-04-01

The recent expansion of antiretroviral treatment (ART) coverage in middle/low-income countries has been associated with increasing prevalence of HIV pre-ART drug resistance (PDR). We assessed PDR prevalence, patterns, and trends in Guatemala. Blood samples from 1,084 ART-naive individuals, enrolled from October 2010 to December 2013 at the Roosevelt Hospital in Guatemala City, were obtained. PDR was evaluated using the WHO mutation list for transmitted drug resistance (TDR) surveillance. An overall PDR prevalence of 7.3% (95% CI 5.8-9.0%) was observed for the whole study period. TDR to nonnucleoside reverse transcriptase inhibitors (NNRTI) was the highest (4.9%, p<0.001), followed by nucleoside RT inhibitors (1.8%) and protease inhibitors (1.0%). No significant trends in PDR prevalence were observed during the study period. However, higher NNRTI PDR levels were found in individuals with >500 and 350-500 CD4(+) T cells/μl (7.4% and 8.7%, respectively) compared to individuals with <350 CD4(+) T cells/μl (3.7%; p=0.039 and p=0.007, respectively), as well as a tendency of higher levels of NNRTI transmitted drug resistance (DR) in individuals with recent infection determined by HIV incidence tests (9.7%), suggesting increasing trends in time. Clusters of viruses with NNRTI PDR suggesting complex transmission networks were observed. No associations between PDR and demographic variables were found. PDR in Guatemala remains at an intermediate level. Nevertheless, we have shown evidence suggesting increasing trends in NNRTI PDR, which need to be taken into account in national HIV management policies.

The antimicrobial resistance containment and surveillance approach--a public health tool.

PubMed Central

Simonsen, Gunnar S.; Tapsall, John W.; Allegranzi, Benedetta; Talbot, Elizabeth A.; Lazzari, Stefano

2004-01-01

Antimicrobial drug resistance (AMR) is widely recognized as a global public health threat because it endangers the effectiveness of treatment of infectious diseases. In 2001 WHO issued the Global Strategy for Containment of Antimicrobial Resistance, but it has proved difficult to translate the recommendations of the Global Strategy into effective public health actions. The purpose of the Antimicrobial Resistance Containment and Surveillance (ARCS) approach is to facilitate the formulation of public health programmes and the mobilization of human and financial resources for the containment of AMR. The ARCS approach highlights the fundamental link between rational drug use and containment of AMR. Clinical management of human and animal infections should be improved through better disease control and prevention, high quality diagnostic testing, appropriate treatment regimens and consumer health education. At the same time, systems for supplying antimicrobial drugs should include appropriate regulations, lists of essential drugs, and functional mechanisms for the approval and delivery of drugs. Containment of AMR is defined in the ARCS approach as the continuous application of this package of core interventions. Surveillance of the extent and trends of antimicrobial resistance as well as the supply, selection and use of antimicrobial drugs should be established to monitor the process and outcome of containment of AMR. The ARCS approach is represented in the ARCS diagram (Fig. 2) which provides a simplified, but comprehensive illustration of the complex problem of containment and monitoring of AMR. PMID:15654407

Improving surveillance for injuries associated with potential motor vehicle safety defects

PubMed Central

Whitfield, R; Whitfield, A

2004-01-01

Objective: To improve surveillance for deaths and injuries associated with potential motor vehicle safety defects. Design: Vehicles in fatal crashes can be studied for indications of potential defects using an "early warning" surveillance statistic previously suggested for screening reports of adverse drug reactions. This statistic is illustrated with time series data for fatal, tire related and fire related crashes. Geographic analyses are used to augment the tire related statistics. Results: A statistical criterion based on the Poisson distribution that tests the likelihood of an expected number of events, given the number of events that actually occurred, is a promising method that can be readily adapted for use in injury surveillance. Conclusions: Use of the demonstrated techniques could have helped to avert a well known injury surveillance failure. This method is adaptable to aid in the direction of engineering and statistical reviews to prevent deaths and injuries associated with potential motor vehicle safety defects using available databases. PMID:15066972

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.

PubMed

Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

2014-05-01

To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010). Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Methodology and results of integrated WNV surveillance programmes in Serbia

PubMed Central

Šekler, Milanko; Petrić, Dušan; Lazić, Sava; Debeljak, Zoran; Vidanović, Dejan; Ignjatović Ćupina, Aleksandra; Lazić, Gospava; Lupulović, Diana; Kolarević, Mišo; Plavšić, Budimir

2018-01-01

Studies conducted during the past few years have confirmed active West Nile virus (WNV) circulation in Serbia. Based on these studies and the epidemiological situation, the Veterinary Directorate of the Ministry of Agriculture and Environmental Protection launched national WNV surveillance programmes in 2014 and 2015. The programmes encompassed the territory of Serbia and were conducted by the veterinary service in collaboration with entomologists and ornithologists. The objective of the programmes was early detection of WNV and timely reporting to the public health service and local authorities to increase both clinical and mosquito control preparedness. The WNV surveillance programmes were based on direct and indirect surveillance of the presence of WNV by the serological testing of initially seronegative sentinel horses and chickens as well as through viral detection in pooled mosquito and wild bird samples. The most intense WNV circulation was observed in all seven districts of Vojvodina Province (northern Serbia) and Belgrade City, where most of the positive samples were detected among sentinel animals, mosquitoes and wild birds. The West Nile virus surveillance programmes in 2014 and 2015 showed satisfactory results in their capacity to indicate the spatial distribution of the risk for humans and their sensitivity to early detect viral circulation at the enzootic level. Most of the human cases were preceded by the detection of WNV circulation as part of the surveillance programmes. According to the existing data, it can be reasonably assumed that WNV infection, now an endemic infection in Serbia, will continue to present a significant problem for the veterinary service and public health. PMID:29624622

Molecular identification of Aspergillus species collected for the Transplant-Associated Infection Surveillance Network.

PubMed

Balajee, S Arunmozhi; Kano, Rui; Baddley, John W; Moser, Stephen A; Marr, Kieren A; Alexander, Barbara D; Andes, David; Kontoyiannis, Dimitrios P; Perrone, Giancarlo; Peterson, Stephen; Brandt, Mary E; Pappas, Peter G; Chiller, Tom

2009-10-01

A large aggregate collection of clinical isolates of aspergilli (n = 218) from transplant patients with proven or probable invasive aspergillosis was available from the Transplant-Associated Infection Surveillance Network, a 6-year prospective surveillance study. To determine the Aspergillus species distribution in this collection, isolates were subjected to comparative sequence analyses by use of the internal transcribed spacer and beta-tubulin regions. Aspergillus fumigatus was the predominant species recovered, followed by A. flavus and A. niger. Several newly described species were identified, including A. lentulus and A. calidoustus; both species had high in vitro MICs to multiple antifungal drugs. Aspergillus tubingensis, a member of the A. niger species complex, is described from clinical specimens; all A. tubingensis isolates had low in vitro MICs to antifungal drugs.

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 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... documentation of the date and reason for any deviation from the plan. (c) All data collected and analyses...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What records are the investigators in my surveillance plan required to keep? 822.32 Section 822.32 Food and Drugs FOOD AND DRUG ADMINISTRATION... documentation of the date and reason for any deviation from the plan. (c) All data collected and analyses...

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... documentation of the date and reason for any deviation from the plan. (c) All data collected and analyses...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 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... documentation of the date and reason for any deviation from the plan. (c) All data collected and analyses...

Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

PubMed

Chrischilles, Elizabeth A; Gagne, Joshua J; Fireman, Bruce; Nelson, Jennifer; Toh, Sengwee; Shoaibi, Azadeh; Reichman, Marsha E; Wang, Shirley; Nguyen, Michael; Zhang, Rongmei; Izem, Rima; Goulding, Margie R; Southworth, Mary Ross; Graham, David J; Fuller, Candace; Katcoff, Hannah; Woodworth, Tiffany; Rogers, Catherine; Saliga, Ryan; Lin, Nancy D; McMahill-Walraven, Cheryl N; Nair, Vinit P; Haynes, Kevin; Carnahan, Ryan M

2018-03-01

The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71). This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety. Copyright © 2018 John Wiley & Sons, Ltd.

Epidemiology of symptomatic drug-induced long QT syndrome and Torsade de Pointes in Germany.

PubMed

Sarganas, Giselle; Garbe, Edeltraut; Klimpel, Andreas; Hering, Rolf C; Bronder, Elisabeth; Haverkamp, Wilhelm

2014-01-01

Drug-induced long QT syndrome (diLQTS) leading to Torsade de Pointes (TdP) is a potentially lethal condition, which has led to several post-marketing drug withdrawals in the past decade. The true incidence of diLQTS/TdP is largely unknown. One explanation is under-reporting of this potentially life-threatening adverse event by physicians and other medical staff to pharmacovigilance agencies. To gain more insight into the incidence of diLQTS and TdP, the Berlin Pharmacovigilance Center (PVZ-FAKOS) has actively and prospectively identified patients who developed this particular type of drug-induced adverse event. Here, the basic characteristics of the affected patients are summarized and suspected drugs are discussed. Furthermore, an extrapolation of the Berlin incidence rates to the German Standard Population is presented. Using a Berlin-wide network of 51 collaborating hospitals (>180 clinical departments), adult patients presenting with long QT syndrome (LQTS/TdP) between 2008 and 2011 were identified by active surveillance of these hospitals. Drug exposures as well as other possible risk factors were obtained from the patient's files and in a face-to-face interview with the patient. One-hundred and seventy patients of possible LQTS/TdP were reported to the Pharmacovigilance Center of whom 58 cases were confirmed in a thorough validation process. The majority (66%) of these cases were female and 60% had developed LQTS/TdP in the outpatient setting. Thirty-five (60%) of 58 confirmed cases were assessed as drug-related based on a standardized causality assessment applying the criteria of the World Health Organization. Drugs assessed as related in more than two cases were metoclopramide, amiodarone, melperone, citalopram, and levomethadone. The age-standardized incidence of diLQTS/TdP in Berlin was estimated to be 2.5 per million per year for males and 4.0 per million per year for females. While European annual reporting rates based on spontaneous reports suggest an

[Laboratory surveillance for invasive meningococcal disease in Chile, 2006-2012].

PubMed

Araya, Pamela; Díaz, Janepsy; Seoane, Mabel; Fernández, Jorge; Terrazas, Solana; Canals, Andrea; Vaquero, Alejandra; Barra, Gisselle; Hormazábal, Juan C; Pidal, Paola; Valenzuela, M Teresa

2014-08-01

Laboratory surveillance of Invasive Meningococcal Disease (IMD) is performed by the Institute of Public Health of Chile. It confirms identification, classifies in serogroups and analyzes the genetic profiles of Neisseria meningitidis isolates from laboratories throughout the country. To show the results of this surveillance from 2006 to 2012. A descriptive data analysis of the confirmed cases of IMD and serological characterization, susceptibility and genetic profiles of the isolates. The analysis was disaggregated by serogroup, age and region. From 2006 to 2012, 486 isolates of N. meningitidis were confirmed. In 2011 a rise in IMD rates was observed due to an increase in W serogroup cases, mainly affecting children aged 5 years or less. Serogroup W became the most prevalent during 2012 (58.3%), replacing the historically prevalent serogroup B. Predominating strains belonged to ST-32 complex/ET-5 complex (40, 4% of strains) and ST-41/44 complex/ Lineage 3 (45, 9% of strains). Laboratory surveillance has allowed the early detection of increasing IMD caused by serogroup W, which is emergent in Chile. This information has reinforced the daily monitoring of new cases, in collaboration with all the clinical laboratories of the country.

The Pioneering Role of the Vaccine Safety Datalink Project (VSD) to Advance Collaborative Research and Distributed Data Networks

PubMed Central

Fahey, Kevin R.

2015-01-01

Introduction: Large-scale distributed data networks consisting of diverse stakeholders including providers, patients, and payers are changing health research in terms of methods, speed and efficiency. The Vaccine Safety Datalink (VSD) set the stage for expanded involvement of health plans in collaborative research. Expanding Surveillance Capacity and Progress Toward a Learning Health System: From an initial collaboration of four integrated health systems with fewer than 10 million covered lives to 16 diverse health plans with nearly 100 million lives now in the FDA Sentinel, the expanded engagement of health plan researchers has been essential to increase the value and impact of these efforts. The collaborative structure of the VSD established a pathway toward research efforts that successfully engage all stakeholders in a cohesive rather than competitive manner. The scientific expertise and methodology developed through the VSD such as rapid cycle analysis (RCA) to conduct near real-time safety surveillance allowed for the development of the expanded surveillance systems that now exist. Building on Success and Lessons Learned: These networks have learned from and built on the knowledge base and infrastructure created by the VSD investigators. This shared technical knowledge and experience expedited the development of systems like the FDA’s Mini-Sentinel and the Patient Centered Outcomes Research Institute (PCORI)’s PCORnet Conclusion: This narrative reviews the evolution of the VSD, its contribution to other collaborative research networks, longer-term sustainability of this type of distributed research, and how knowledge gained from the earlier efforts can contribute to a continually learning health system. PMID:26793736

Computerized pharmacy surveillance and alert system for drug-related problems.

PubMed

Ferrández, O; Urbina, O; Grau, S; Mateu-de-Antonio, J; Marin-Casino, M; Portabella, J; Mojal, S; Riu, M; Salas, E

2017-04-01

Because of the impact of drug-related problems (DRPs) on morbidity and mortality, there is a need for computerized strategies to increase drug safety. The detection and identification of the causes of potential DRPs can be facilitated by the incorporation of a pharmacy warning system (PWS) in the computerized prescriber order entry (CPOE) and its application in the routine validation of inpatient drug therapy. A limited number of studies have evaluated a clinical decision support system to monitor drug treatment. Most of these applications have utilized a small range of drugs with alerts and/or types of alert. The objective of this study was to describe the implementation of a PWS integrated in the electronic medical record (EMR). The PWS was developed in 2003-2004. Pharmacological information to generate drug alerts was entered on demographic data, drug dosage, laboratory tests related to the prescribed drug and drug combinations (interactions, duplications and necessary combinations). The PWS was applied in the prescription reviews conducted in patients admitted to the hospital in 2012. Information on 83% of the drugs included in the pharmacopeia was introduced into the PWS, allowing detection of 2808 potential DRPs, representing 79·1% of all potential DRPs detected during the study period. Twenty per cent of PWS DRPs were clinically relevant, requiring pharmacist intervention. The PWS detected most potential DRPs, thus increasing inpatient safety. The detection ability of the PWS was higher than that reported for other tools described in the literature. © 2017 John Wiley & Sons Ltd.

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The pharmacist and adverse drug reaction reporting.

PubMed

Pearson, K

1982-08-01

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

WHO Collaborating Centre for Acquired Immunodeficiency Syndrome for the Eastern Mediterranean Regional Office, Faculty of Medicine, Kuwait University, Kuwait.

PubMed

Altawalah, Haya; Al-Nakib, Widad

2014-01-01

In the early 1980s, the World Health Organization (WHO) designated the Virology Unit of the Faculty of Medicine, Health Sciences Centre, Kuwait University, Kuwait, a collaborating centre for AIDS for the Eastern Mediterranean Regional Office (EMRO), recognizing it to be in compliance with WHO guidelines. In this centre, research integral to the efforts of WHO to combat AIDS is conducted. In addition to annual workshops and symposia, the centre is constantly updating and renewing its facilities and capabilities in keeping with current and latest advances in virology. As an example of the activities of the centre, the HIV-1 RNA viral load in plasma samples of HIV-1 patients is determined by real-time PCR using the AmpliPrep TaqMan HIV-1 test v2.0. HIV-1 drug resistance is determined by sequencing the reverse transcriptase and protease regions on the HIV-1 pol gene, using the TRUGENE HIV-1 Genotyping Assay on the OpenGene® DNA Sequencing System. HIV-1 subtypes are determined by sequencing the reverse transcriptase and protease regions on the HIV-1 pol gene using the genotyping assays described above. A fundamental program of Kuwait's WHO AIDS collaboration centre is the national project on the surveillance of drug resistance in human deficiency virus in Kuwait, which illustrates how the centre and its activities in Kuwait can serve the EMRO region of WHO. © 2014 S. Karger AG, Basel.

Screening and surveillance. OSHA's medical surveillance provisions.

PubMed

Papp, E M; Miller, A S

2000-02-01

The OSH Act requires OSHA to include provisions for medical examinations of employees in its standards. However, the specific test and examinations criteria are not outlined in the OSH Act. Instead, each standard has specific medical surveillance requirements. These are specific to the adverse health effects triggered by exposure to the hazardous substance. The OSHA uses the term medical surveillance to refer to its employee examination and testing provisions. Most occupational health professionals call this activity employee screening and reserve the term surveillance for aggregate analysis of population data. It is important to remember this distinction when referring to OSHA standards. Many standards are challenged in court resulting in changes to medical surveillance provisions of the standards. Some court decisions support OSHA's language. In either case, the court often sets precedents for future standards.

A Collaborative Web-Based Architecture For Sharing ToxCast Data

EPA Science Inventory

Collaborative Drug Discovery (CDD) has created a scalable platform that combines traditional drug discovery informatics with Web2.0 features. Traditional drug discovery capabilities include substructure, similarity searching and export to excel or sdf formats. Web2.0 features inc...

Research Priorities for FCTC Articles 20, 21, and 22: Surveillance/Evaluation and Information Exchange

PubMed Central

2013-01-01

Introduction: Framework Convention on Tobacco Control (FCTC) Articles 20, 21, and 22 call for strong monitoring and reporting of tobacco use and factors influencing use and disease (Articles 20 and 21) and for collaboration among the Parties and relevant organizations to share resources, knowledge, and expertise on all relevant tobacco control strategies (Article 22). Methods: This paper provides background information and discusses research strategies that would strengthen these efforts and better inform the Parties. By necessity, Articles 20 and 21 are discussed separately from Article 22, although 1 example that relates to both 20/21 and 22 is discussed at the end. Results: Twelve important research opportunities on surveillance and evaluation are recognized, along with 4 on collaboration. The authors believe that the 6 most important areas for research would study (a) possible underreporting of tobacco use among certain demographic groups in some countries, (b) measures of industry activities, (c) optimal sampling strategies, (d) sentinel surveillance, (e) networks of tobacco companies and their partners as they promote tobacco use and interfere with implementation of the FCTC, and (f) network/relationship factors that impact diffusion of knowledge and decision making on the implementation of the FCTC. In addition, we call for a review process of existing surveillance and evaluation strategies to coordinate activities to make optimal use of existing resources. This activity would involve networking as prescribed in Article 22. Conclusions: Studies and activities such as these would facilitate control of the tobacco epidemic. PMID:23335488

Research priorities for FCTC Articles 20, 21, and 22: surveillance/evaluation and information exchange.

PubMed

Giovino, Gary A; Kulak, Jessica A; Kalsbeek, William D; Leischow, Scott J

2013-04-01

Framework Convention on Tobacco Control (FCTC) Articles 20, 21, and 22 call for strong monitoring and reporting of tobacco use and factors influencing use and disease (Articles 20 and 21) and for collaboration among the Parties and relevant organizations to share resources, knowledge, and expertise on all relevant tobacco control strategies (Article 22). This paper provides background information and discusses research strategies that would strengthen these efforts and better inform the parties. By necessity, Articles 20 and 21 are discussed separately from Article 22, although 1 example that relates to both 20/21 and 22 is discussed at the end. Twelve important research opportunities on surveillance and evaluation are recognized, along with 4 on collaboration. The authors believe that the 6 most important areas for research would study (a) possible underreporting of tobacco use among certain demographic groups in some countries, (b) measures of industry activities, (c) optimal sampling strategies, (d) sentinel surveillance, (e) networks of tobacco companies and their partners as they promote tobacco use and interfere with implementation of the FCTC, and (f) network/relationship factors that impact diffusion of knowledge and decision making on the implementation of the FCTC. In addition, we call for a review process of existing surveillance and evaluation strategies to coordinate activities to make optimal use of existing resources. This activity would involve networking as prescribed in Article 22. Studies and activities such as these would facilitate control of the tobacco epidemic.

The role of diagnostic laboratories in support of animal disease surveillance systems.

PubMed

Zepeda, C

2007-01-01

Diagnostic laboratories are an essential component of animal disease surveillance systems. To understand the occurrence of disease in populations, surveillance systems rely on random or targeted surveys using three approaches: clinical, serological and virological surveillance. Clinical surveillance is the basis for early detection of disease and is usually centered on the detection of syndromes and clinical findings requiring confirmation by diagnostic laboratories. Although most of the tests applied usually perform to an acceptable standard, several have not been properly validated in terms of their diagnostic sensitivity and specificity. Sensitivity and specificity estimates can vary according to local conditions and, ideally, should be determined by national laboratories where the tests are to be applied. The importance of sensitivity and specificity estimates in the design and interpretation of statistically based surveys and risk analysis is fundamental to establish appropriate disease control and prevention strategies. The World Organisation for Animal Health's (OIE) network of reference laboratories acts as centers of expertise for the diagnosis of OIE listed diseases and have a role in promoting the validation of OIE prescribed tests for international trade. This paper discusses the importance of the epidemiological evaluation of diagnostic tests and the role of the OIE Reference Laboratories and Collaborating Centres in this process.

Describing perspectives of health care professionals on active surveillance for the management of prostate cancer.

PubMed

Pang, Kittie; Fitch, Margaret; Ouellet, Veronique; Chevalier, Simone; Drachenberg, Darrel E; Finelli, Antonio; Lattouf, Jean-Baptiste; So, Alan; Sutcliffe, Simon; Tanguay, Simon; Saad, Fred; Mes-Masson, Anne-Marie

2018-06-08

Over the last decade, active surveillance has proven to be a safe approach for patients with low-risk prostate cancer. Although active surveillance presents several advantages for both patients and the health care system, all eligible patients do not adopt this approach. Our goal was to evaluate the factors that influence physicians to recommend active surveillance and the barriers that impact adherence to this approach. Focus groups (n = 5) were held with physicians who provided care for men with low-risk prostate cancer and had engaged in conversations with men and their families about active surveillance. The experience of health care professionals (HCPs) was captured to understand their decisions in proposing active surveillance and to reveal the barriers and facilitators that affect the adherence to this approach. A content analysis was performed on the verbatim transcripts from the sessions. Although physicians agreed that active surveillance is a suitable approach for low-risk prostate cancer patients, they were concerned about the rapidly evolving and non-standardized guidelines for patient follow-up. They pointed out the need for additional tools to appropriately identify proper patients for whom active surveillance is the best option. Urologists and radiation-oncologists were keen to collaborate with each other, but the role of general practitioner remained controversial once patients were referred to a specialist. Integration of more reliable tools and/or markers in addition to more specific guidelines for patient follow-up would increase the confidence of both patients and physicians in the choice of active surveillance.

ACTIVE SURVEILLANCE FOR PAPILLARY THYROID MICROCARCINOMA: NEW CHALLENGES AND OPPORTUNITIES FOR THE HEALTH CARE SYSTEM

PubMed Central

Haser, Grace C.; Tuttle, R. Michael; Su, Henry K.; Alon, Eran E.; Bergman, Donald; Bernet, Victor; Brett, Elise; Cobin, Rhoda; Dewey, Eliza H.; Doherty, Gerard; Dos Reis, Laura L.; Harris, Jeffrey; Klopper, Joshua; Lee, Stephanie L.; Levine, Robert A.; Lepore, Stephen J.; Likhterov, Ilya; Lupo, Mark A.; Machac, Josef; Mechanick, Jeffrey I.; Mehra, Saral; Milas, Mira; Orloff, Lisa A.; Randolph, Gregory; Revenson, Tracey A.; Roberts, Katherine J.; Ross, Douglas S.; Rowe, Meghan E.; Smallridge, Robert C.; Terris, David; Tufano, Ralph P.; Urken, Mark L.

2017-01-01

Objective The dramatic increase in papillary thyroid carcinoma (PTC) is primarily a result of early diagnosis of small cancers. Active surveillance is a promising management strategy for papillary thyroid microcarcinomas (PTMCs). However, as this management strategy gains traction in the U.S., it is imperative that patients and clinicians be properly educated, patients be followed for life, and appropriate tools be identified to implement the strategy. Methods We review previous active surveillance studies and the parameters used to identify patients who are good candidates for active surveillance. We also review some of the challenges to implementing active surveillance protocols in the U.S. and discuss how these might be addressed. Results Trials of active surveillance support nonsurgical management as a viable and safe management strategy. However, numerous challenges exist, including the need for adherence to protocols, education of patients and physicians, and awareness of the impact of this strategy on patient psychology and quality of life. The Thyroid Cancer Care Collaborative (TCCC) is a portable record keeping system that can manage a mobile patient population undergoing active surveillance. Conclusion With proper patient selection, organization, and patient support, active surveillance has the potential to be a long-term management strategy for select patients with PTMC. In order to address the challenges and opportunities for this approach to be successfully implemented in the U.S., it will be necessary to consider psychological and quality of life, cultural differences, and the patient’s clinical status. PMID:26799628

Epidemiology, surveillance and control of Nipah virus infections in Malaysia.

PubMed

Chua, K B

2010-12-01

The outbreak of Nipah virus, affecting pigs and pig-farm workers, was first noted in September 1998 in the north-western part of peninsular Malaysia. By March 1999, the outbreak had spread to other pig-farming areas of the country, inclusive of the neighbouring country, Singapore. A total of 283 human cases of viral encephalitis with 109 deaths were recorded in Malaysia from 29 September 1998 to December 1999. During the outbreak period, a number of surveillances under three broad groups; Surveillance in Human Health Sector, Surveillance in Animal Health Sector, and Surveillance for the Reservoir Hosts, were carried out to determine the prevalence, risk of virus infections and transmission in human and swine populations as well as the source and reservoir hosts of Nipah virus. Surveillance data showed that the virus spread rapidly among pigs within infected farms and transmission was attributed to direct contact with infective excretions and secretions. The spread of the virus among pig farms within and between states of peninsular Malaysia was due to movement of pigs. The transmission of the virus to humans was through close contact with infected pigs. Human to human transmission was considered a rare event though the Nipah virus could be isolated from saliva, urine, nasal and pharyngeal secretions of patients. Field investigations identified fruitbats of the Pteropid species as the natural reservoir hosts of the viruses. The outbreak was effectively brought under control following the discovery of the virus and institution of correct control measures through a combined effort of multi-ministerial and multidisciplinary teams working in close co-operation and collaboration with other international agencies.

Multidrug-resistant and extensively drug-resistant tuberculosis: implications for the HIV epidemic and antiretroviral therapy rollout in South Africa.

PubMed

Andrews, Jason R; Shah, N Sarita; Gandhi, Neel; Moll, Tony; Friedland, Gerald

2007-12-01

Drug-resistant tuberculosis (TB) is emerging as a major clinical and public health challenge in areas of sub-Saharan Africa where there is a high prevalence of human immunodeficiency virus (HIV) infection. TB drug-resistance surveillance in this region has been limited by laboratory capacity and the public health infrastructure; however, with the maturation of the HIV epidemic, the burden of drug-resistant TB is increasing rapidly. The recent discovery of large numbers of cases of multidrug-resistant (MDR) TB and extensively drug-resistant (XDR) TB in South Africa likely represents an unrecognized and evolving epidemic rather than sporadic, localized outbreaks. The combination of a large population of HIV-infected susceptible hosts with poor TB treatment success rates, a lack of airborne infection control, limited drug-resistance testing, and an overburdened MDR-TB treatment program provides ideal conditions for an MDR-TB and XDR-TB epidemic of unparalleled magnitude. In the present article, we review the history of drug-resistant TB in South Africa, describe its interaction with the HIV epidemic and the resultant consequences, and suggest measures necessary for controlling MDR-TB and XDR-TB in this context. A successful response to the emergence of MDR-TB and XDR-TB will necessitate increased resources for and collaboration between TB and HIV programs.

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

PubMed

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

2017-07-01

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

2008: A Year of Transition. DoD Global Emerging Infections Surveillance and Response System

DTIC Science & Technology

2009-04-01

surveillance program to 72 countries, 20 Navy ships, 1 foreign ship, and 6 clinics along the Mexican border (four in California, two in Mexico ... Mexico Mongolia Morocco Mozambique Nepal Nicaragua Nigeria Northern Mariana Islands Oman Pakistan Palau Panama Paraguay Peru Philippines Poland Portugal...tested for Arenaviruses, Rift Valley fever virus, rickettsia, Barto- nella, pox viruses, and leishmaniasis in collaboration with the National Museums

Health & Demographic Surveillance System profile: the Muzaffarpur-TMRC Health and Demographic Surveillance System.

PubMed

Malaviya, Paritosh; Picado, Albert; Hasker, Epco; Ostyn, Bart; Kansal, Sangeeta; Singh, Rudra Pratap; Shankar, Ravi; Boelaert, Marleen; Sundar, Shyam

2014-10-01

The Muzaffarpur-TMRC Health and Demographic Surveillance System (HDSS), established in 2007, was developed as an enlargement of the scope of a research collaboration on the project Visceral Leishmaniasis in Bihar, which had been ongoing since 2005. The HDSS is located in a visceral leishmaniasis (VL)-endemic area in the Muzaffarpur district of Bihar state in India. It is the only HDSS conducting research on VL, which is a vector-borne infectious disease transmitted by female phlebotomine sandflies and is fatal if left untreated. Currently the HDSS serves a population of over 105,000 in 66 villages. The HDSS collects data on vital events including pregnancies, births, deaths, migration and marriages, as well as other socio-economic indicators, at regular intervals. Incident VL cases are identified. The HDSS team is experienced in conducting both qualitative and quantitative studies, sample collection and rapid diagnostic tests in the field. In each village, volunteers connect the HDSS team with the community members. The Muzaffarpur-TMRC HDSS provides opportunities for studies on VL and other neglected tropical diseases (NTDs) and their interaction with demographic events such as migration. Queries related to research collaborations and data sharing can be sent to Dr Shyam Sundar at [drshyamsundar@hotmail.com]. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

CCCT - Investigational Drug Steering Committee

Cancer.gov

The Investigational Drug Steering Committee (IDSC) collaborates with NCI in the design and prioritization of early phase drug development trials conducted by the Experimental Therapeutics Clinical Trials Network (ETCTN).

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

PubMed

Stang, Paul E; Ryan, Patrick B; Racoosin, Judith A; Overhage, J Marc; Hartzema, Abraham G; Reich, Christian; Welebob, Emily; Scarnecchia, Thomas; Woodcock, Janet

2010-11-02

The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.

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

PubMed

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

2013-09-01

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

Surveillance for waterborne disease and outbreaks associated with drinking water and water not intended for drinking-United States, 2005-2006

EPA Science Inventory

PROBLEM/CONDITION: Since 1971, 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 (WBDOSS) for collecting and reporting data related to o...

Advancements in web-database applications for rabies surveillance.

PubMed

Rees, Erin E; Gendron, Bruno; Lelièvre, Frédérick; Coté, Nathalie; Bélanger, Denise

2011-08-02

Protection of public health from rabies is informed by the analysis of surveillance data from human and animal populations. In Canada, public health, agricultural and wildlife agencies at the provincial and federal level are responsible for rabies disease control, and this has led to multiple agency-specific data repositories. Aggregation of agency-specific data into one database application would enable more comprehensive data analyses and effective communication among participating agencies. In Québec, RageDB was developed to house surveillance data for the raccoon rabies variant, representing the next generation in web-based database applications that provide a key resource for the protection of public health. RageDB incorporates data from, and grants access to, all agencies responsible for the surveillance of raccoon rabies in Québec. Technological advancements of RageDB to rabies surveillance databases include (1) automatic integration of multi-agency data and diagnostic results on a daily basis; (2) a web-based data editing interface that enables authorized users to add, edit and extract data; and (3) an interactive dashboard to help visualize data simply and efficiently, in table, chart, and cartographic formats. Furthermore, RageDB stores data from citizens who voluntarily report sightings of rabies suspect animals. We also discuss how sightings data can indicate public perception to the risk of racoon rabies and thus aid in directing the allocation of disease control resources for protecting public health. RageDB provides an example in the evolution of spatio-temporal database applications for the storage, analysis and communication of disease surveillance data. The database was fast and inexpensive to develop by using open-source technologies, simple and efficient design strategies, and shared web hosting. The database increases communication among agencies collaborating to protect human health from raccoon rabies. Furthermore, health agencies have real

Advancements in web-database applications for rabies surveillance

PubMed Central

2011-01-01

Background Protection of public health from rabies is informed by the analysis of surveillance data from human and animal populations. In Canada, public health, agricultural and wildlife agencies at the provincial and federal level are responsible for rabies disease control, and this has led to multiple agency-specific data repositories. Aggregation of agency-specific data into one database application would enable more comprehensive data analyses and effective communication among participating agencies. In Québec, RageDB was developed to house surveillance data for the raccoon rabies variant, representing the next generation in web-based database applications that provide a key resource for the protection of public health. Results RageDB incorporates data from, and grants access to, all agencies responsible for the surveillance of raccoon rabies in Québec. Technological advancements of RageDB to rabies surveillance databases include 1) automatic integration of multi-agency data and diagnostic results on a daily basis; 2) a web-based data editing interface that enables authorized users to add, edit and extract data; and 3) an interactive dashboard to help visualize data simply and efficiently, in table, chart, and cartographic formats. Furthermore, RageDB stores data from citizens who voluntarily report sightings of rabies suspect animals. We also discuss how sightings data can indicate public perception to the risk of racoon rabies and thus aid in directing the allocation of disease control resources for protecting public health. Conclusions RageDB provides an example in the evolution of spatio-temporal database applications for the storage, analysis and communication of disease surveillance data. The database was fast and inexpensive to develop by using open-source technologies, simple and efficient design strategies, and shared web hosting. The database increases communication among agencies collaborating to protect human health from raccoon rabies

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.

Dietary supplement adverse events: report of a one-year poison center surveillance project.

PubMed

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

[Drug surveillance and adverse reactions to drugs. The literature and importance of historical data].

PubMed

Mariani, L; Minora, T; Ventresca, G P

1996-12-01

The authors highlight the essential role of pharmacovigilance and the need for a simple, efficient and low-cost system of adverse reaction (AR) reporting which could cover the whole population and all marketed drugs, and suggest that the only one presently viable is based on spontaneous reporting. To support their proposal the authors provide a definition of AR and of the different monitoring system, and list as many drugs as possible to find in the literature that have been associated with a specific AR, together with the active molecule, the therapeutic indication, the features of the AR and the regulatory actions (withdrawal from the market, restriction of use). Moreover, by describing the "history" behind some of these drugs the authors highlight the contribution that pharmacovigilance and spontaneous reporting have had to the development of regulations for approval and marketing of new drugs. It is also highlighted how some of these unexpected events (thalidomide, DES) have had a significant and important contribution to pharmacological and toxicological knowledge.

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…

Drug policy: making effective drugs available without bankrupting the healthcare system.

PubMed

Laupacis, Andreas; Anderson, Geoffrey; O'Brien, Bernie

2002-01-01

To the extent possible, drug policy should be based upon good quality evidence. This must extend beyond the traditional focus on efficacy and safety in carefully selected patients, to evidence about real-world effectiveness, cost-effectiveness and safety of drugs. This paper will consider methods of improving the quality of the evidence currently available, and the implications of requiring that evidence. Historically, there has been a direct link between research evidence and policy at the level of licensing - drugs are only made available after they have been shown to be safe and efficacious in well-designed and independently assessed research studies. We propose that this reliance on evidence be logically extended to cover the formulary inclusion and post-marketing surveillance aspects of modern prescription drug policy. More specifically we propose that the decision to initially list a drug on a benefit formulary be based on evidence from relevant head-to-head comparisons and well-designed cost-effectiveness analyses. This evidence would be produced by industry in cooperation with independent peer-reviewed funding agencies. Drugs could only be added to a formulary if they met specific predetermined criteria, and drugs could be removed as superior alternatives became available. The provincial governments are monopsony buyers of medicines, and they wield the power to determine public payer "market access'for medicines. This power (within and across provinces) could be used more effectively to negotiate price in the context of reimbursement. The effect of different methods of influencing prescribing (e.g., 'limited access?) upon drug utilization and patient outcomes should be rigorously assessed, including the randomization of groups of patients or communities to different strategies. We also propose that all drugs on the formulary would be subject to a well-designed post-marketing surveillance program. This program would build on the existing passive reporting of

Drug safety data mining with a tree-based scan statistic.

PubMed

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Survey of Communicable Diseases Surveillance System in Hospitals of Iran: A Qualitative Approach

PubMed Central

Dehcheshmeh, Nayeb Fadaei; Arab, Mohammad; Foroushani, Abbas Rahimi; Farzianpour, Fereshteh

2016-01-01

Background: Communicable Disease Surveillance and reporting is one of the key elements to combat against diseases and their control. Fast and timely recognition of communicable diseases can be helpful in controlling of epidemics. One of the main sources of management of communicable diseases reporting is hospitals that collect communicable diseases’ reports and send them to health authorities. One of the focal problems and challenges in this regard is incomplete and imprecise reports from hospitals. In this study, while examining the implementation processes of the communicable diseases surveillance in hospitals, non-medical people who were related to the program have been studied by a qualitative approach. Methods: This study was conducted using qualitative content analysis method. Participants in the study included 36 informants, managers, experts associated with health and surveillance of communicable diseases that were selected using targeted sampling and with diverse backgrounds and work experience (different experiences in primary health surveillance and treatment, Ministry levels, university staff and operations (hospitals and health centers) and sampling was continued until arrive to data saturation. Results: Interviews were analyzed after the elimination of duplicate codes and integration of them. Finally, 73 codes were acquired and categorized in 6 major themes and 21 levels. The main themes included: policy making and planning, development of resources, organizing, collaboration and participation, surveillance process, and monitoring and evaluation of the surveillance system. In point of interviewees, attention to these themes is necessary to develop effective and efficient surveillance system for communicable diseases. Conclusion: Surveillance system in hospitals is important in developing proper macro - policies in health sector, adoption of health related decisions and preventive plans appropriate to the existing situation. Compilation, changing

Social Media Listening for Routine Post-Marketing Safety Surveillance.

PubMed

Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

2016-05-01

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

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

PubMed

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

2018-02-06

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

Illicit Drug Trafficking in West Africa -- Primary Surveillance Radar Introduction

DTIC Science & Technology

2012-03-22

States Party. All West African countries are Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic ...efforts against illicit drug trafficking and related crimes by Member States at the regional and national levels, especially within the framework of...Gambia, Guinea-Bissau, Guinea, Cape Verde, Mali, Mauritania and Senegal.29 14 Effective airspace management not only aids in countering illicit drug

Schweizer RU-38A Twin-Condor: covert surveillance aircraft

NASA Astrophysics Data System (ADS)

O'Toole, Michael J.; Schweizer, Paul H.

1997-11-01

The world order has changed and with it, governments are now faced with waging a new type of `ware.' Regional instability, drug trafficking, environmental issues, international terrorism, and illegal immigration are examples of escalating problems that cross international boundaries and threaten the security of nations. The first and most important element in coping with these illegal activities is the ability to detect and monitor events in a timely and secure fashion. Conventional means of gathering intelligence such as large airborne collection systems and satellites lack the flexibility, dwell times, and cost effectiveness to meet many of today's needs. There is a growing requirement for airborne platforms that can covertly perform surveillance missions during either day or night and in a cost effective manner. To meet this need, Schweizer Aircraft has recently developed the RU-38A twin-engine surveillance aircraft. This paper discusses the evolution and principle design concepts of this aircraft and how its unique performance enables the RU-38A to achieve new levels of surveillance capability.

Near real-time vaccine safety surveillance with partially accrued data.

PubMed

Greene, Sharon K; Kulldorff, Martin; Yin, Ruihua; Yih, W Katherine; Lieu, Tracy A; Weintraub, Eric S; Lee, Grace M

2011-06-01

The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010. Adjustments were made to two sequential analytic approaches. The Poisson-based approach compared the number of pre-defined adverse events observed following vaccination with the number expected using historical data. The expected number was adjusted for the proportion of the risk window elapsed and the proportion of inpatient data estimated to have accrued. The binomial-based approach used a self-controlled design, comparing the observed numbers of events in risk versus comparison windows. Events were included in analysis only if they occurred during a week that had already passed for both windows. Analyzing data before risk windows fully elapsed improved the timeliness of safety surveillance. Adjustments for data accrual lags were tailored to each data source and avoided biasing analyses away from detecting a potential safety problem, particularly early during surveillance. The timeliness of vaccine and drug safety surveillance can be improved by properly accounting for partially elapsed windows and data accrual delays. Copyright © 2011 John Wiley & Sons, Ltd.

Mother ship and physical agents collaboration

NASA Astrophysics Data System (ADS)

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

1999-07-01

This paper discusses ongoing research at the U.S. Army Research Laboratory that investigates the feasibility of developing a collaboration architecture between small physical agents and a mother ship. This incudes the distribution of planning, perception, mobility, processing and communications requirements between the mother ship and the agents. Small physical agents of the future will be virtually everywhere on the battlefield of the 21st century. A mother ship that is coupled to a team of small collaborating physical agents (conducting tasks such as Reconnaissance, Surveillance, and Target Acquisition (RSTA); logistics; sentry; and communications relay) will be used to build a completely effective and mission capable intelligent system. The mother ship must have long-range mobility to deploy the small, highly maneuverable agents that will operate in urban environments and more localized areas, and act as a logistics base for the smaller agents. The mother ship also establishes a robust communications network between the agents and is the primary information disseminating and receiving point to the external world. Because of its global knowledge and processing power, the mother ship does the high-level control and planning for the collaborative physical agents. This high level control and interaction between the mother ship and its agents (including inter agent collaboration) will be software agent architecture based. The mother ship incorporates multi-resolution battlefield visualization and analysis technology, which aids in mission planning and sensor fusion.

Comparative federal health care policy: evidence of collaborative federalism in Pakistan and Venezuela.

PubMed

Baracskay, Daniel

2013-01-01

Collaborative federalism has provided an effective analytical foundation for understanding how complex public policies are implemented in federal systems through intergovernmental and intersectoral alignments. This has particularly been the case in issue areas like public health policy where diseases are detected and treated at the local level. While past studies on collaborative federalism and health care policy have focused on federal systems that are largely democratic, little research has been conducted to examine the extent of collaboration in authoritarian structures. This article applies the collaborative federalism approach to the Islamic Republic of Pakistan and the Bolivarian Republic of Venezuela. Evidence suggests that while both nations have exhibited authoritarian governing structures, there have been discernible policy areas where collaborative federalism is embraced to facilitate the implementation process. Further, while not an innate aspect of their federal structures, Pakistan and Venezuela can potentially expand their use of the collaborative approach to successfully implement health care policy and the epidemiological surveillance and intervention functions. Yet, as argued, this would necessitate further development of their structures on a sustained basis to create an environment conducive for collaborative federalism to flourish, and possibly expand to other policy areas as well.

Use of Unstructured Event-Based Reports for Global Infectious Disease Surveillance

PubMed Central

Blench, Michael; Tolentino, Herman; Freifeld, Clark C.; Mandl, Kenneth D.; Mawudeku, Abla; Eysenbach, Gunther; Brownstein, John S.

2009-01-01

Free or low-cost sources of unstructured information, such as Internet news and online discussion sites, provide detailed local and near real-time data on disease outbreaks, even in countries that lack traditional public health surveillance. To improve public health surveillance and, ultimately, interventions, we examined 3 primary systems that process event-based outbreak information: Global Public Health Intelligence Network, HealthMap, and EpiSPIDER. Despite similarities among them, these systems are highly complementary because they monitor different data types, rely on varying levels of automation and human analysis, and distribute distinct information. Future development should focus on linking these systems more closely to public health practitioners in the field and establishing collaborative networks for alert verification and dissemination. Such development would further establish event-based monitoring as an invaluable public health resource that provides critical context and an alternative to traditional indicator-based outbreak reporting. PMID:19402953

Integrated Human Surveillance Systems of West Nile Virus Infections in Italy: The 2012 Experience

PubMed Central

Napoli, Christian; Bella, Antonino; Declich, Silvia; Grazzini, Giuliano; Lombardini, Letizia; Nanni Costa, Alessandro; Nicoletti, Loredana; Pompa, Maria Grazia; Pupella, Simonetta; Russo, Francesca; Rizzo, Caterina

2013-01-01

In Italy, a West Nile virus (WNV) surveillance plan was firstly implemented in 2008 and 2009 in two affected regions and, since 2010, according to a national plan, a WNV neuroinvasive disease (WNND) surveillance has to be carried out each year during the period 15 June–30 November, in those regions where WNV circulation has been demonstrated among humans, animals or vectors. Moreover, since WNV can be transmitted to humans even by blood transfusions and organ transplants obtained from infected donors, the national surveillance integrates the blood transfusions and organs transplant surveillances too. The paper describes the results of this integrated human surveillance in Italy in 2012. Overall, in 2012, 28 autochthonous confirmed cases of WNND were reported, 14 blood donations were found WNV positive by Nucleic Acid Amplification Test and no solid organ donors tested positive for WNV. Moreover, 17 cases of WNV fever were confirmed in Veneto region. When comparing the number of WNND cases reported to the surveillance system in previous 4 years (43 cases during the period 2008–2011), with those reported in 2012 an important increase was observed in 2012. The geographic distribution of human cases was consistent with the WNV circulation among animals and vectors. Moreover, the implementation of preventive measures for WNV transmission through blood components allowed the detection of blood donors positive for WNV, avoiding the further spread of the disease. Since surveillance strategies and preventive measures are based on the integration among human, animal and vector control activities, the Italian experience could be considered a good example of collaboration among different sectors of public health in a “one health” perspective. PMID:24351740

Optimal Deployment of Unmanned Aerial Vehicles for Border Surveillance

DTIC Science & Technology

2014-06-01

and intercept intruders that are trying to trespass a border. These intruders can include terrorists, drug traffickers, smugglers, illegal immigrants...routes, altitudes, and speeds in order to maximize the probability of detecting intruders trying to trespass a given border. These models will...Border surveillance is an important concern for most nations wanting to detect and intercept intruders that are trying to trespass a border. These

Markov Networks of Collateral Resistance: National Antimicrobial Resistance Monitoring System Surveillance Results from Escherichia coli Isolates, 2004-2012.

PubMed

Love, William J; Zawack, Kelson A; Booth, James G; Grӧhn, Yrjo T; Lanzas, Cristina

2016-11-01

Surveillance of antimicrobial resistance (AMR) is an important component of public health. Antimicrobial drug use generates selective pressure that may lead to resistance against to the administered drug, and may also select for collateral resistances to other drugs. Analysis of AMR surveillance data has focused on resistance to individual drugs but joint distributions of resistance in bacterial populations are infrequently analyzed and reported. New methods are needed to characterize and communicate joint resistance distributions. Markov networks are a class of graphical models that define connections, or edges, between pairs of variables with non-zero partial correlations and are used here to describe AMR resistance relationships. The graphical least absolute shrinkage and selection operator is used to estimate sparse Markov networks from AMR surveillance data. The method is demonstrated using a subset of Escherichia coli isolates collected by the National Antimicrobial Resistance Monitoring System between 2004 and 2012 which included AMR results for 16 drugs from 14418 isolates. Of the 119 possible unique edges, 33 unique edges were identified at least once during the study period and graphical density ranged from 16.2% to 24.8%. Two frequent dense subgraphs were noted, one containing the five β-lactam drugs and the other containing both sulfonamides, three aminoglycosides, and tetracycline. Density did not appear to change over time (p = 0.71). Unweighted modularity did not appear to change over time (p = 0.18), but a significant decreasing trend was noted in the modularity of the weighted networks (p < 0.005) indicating relationships between drugs of different classes tended to increase in strength and frequency over time compared to relationships between drugs of the same class. The current method provides a novel method to study the joint resistance distribution, but additional work is required to unite the underlying biological and genetic characteristics

Environment-Mediated Drug Resistance in Neuroblastoma

DTIC Science & Technology

2014-10-01

AD_________________ Award Number: W81XWH-12-1-0572 TITLE: Environment-Mediated Drug Resistance in Neuroblastoma PRINCIPAL INVESTIGATOR: Yu...Resistance in Neuroblastoma 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1-0572 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Yu, Hua E 5d. PROJECT...collaborative experiments have demonstrated that monocytes collaborate with MSC in inducing STAT3-dependent drug resistance in neuroblastoma (Task 1), that S1P

Multisensor data fusion for integrated maritime surveillance

NASA Astrophysics Data System (ADS)

Premji, A.; Ponsford, A. M.

1995-01-01

A prototype Integrated Coastal Surveillance system has been developed on Canada's East Coast to provide effective surveillance out to and beyond the 200 nautical mile Exclusive Economic Zone. The system has been designed to protect Canada's natural resources, and to monitor and control the coastline for smuggling, drug trafficking, and similar illegal activity. This paper describes the Multiple Sensor - Multiple Target data fusion system that has been developed. The fusion processor has been developed around the celebrated Multiple Hypothesis Tracking algorithm which accommodates multiple targets, new targets, false alarms, and missed detections. This processor performs four major functions: plot-to-track association to form individual radar tracks; fusion of radar tracks with secondary sensor reports; track identification and tagging using secondary reports; and track level fusion to form common tracks. Radar data from coherent and non-coherent radars has been used to evaluate the performance of the processor. This paper presents preliminary results.

[Stewardship of public health surveillance in the health system in Colombia: a case study].

PubMed

López, Yolanda Lucía; González, Claudia; Gallego, Berta Natalia; Moreno, Ana Lida

2009-12-01

With the reform of the Colombian health system in 1993, public health surveillance continued to be a governmental responsibility under the stewardship of the Ministry of Social Protection along with state and local health authorities. The effectiveness of the development and organization of state and municipality public health surveillance programs will be studied as they have evolved under the general social security system in Colombia. Qualitative study and case-study method are applied to several institutions as they function in 5 states and 11 counties, ten years after the health system reforms. Public health authorities have reduced resources for providing advice, technical assistance, supervision and control of the process of the public health surveillance. Weaknesses in administrative control are common. Quantity and quality of human resources, as well as, staffing and financial resources are inadequate to meet the responsibilities that have been assigned to each state and county. The public health surveillance has prioritized the notification and registration of cases, and the strength of development of particular areas occasionally has been subject to the particular interests of officials in charge, particularly in the public hospitals. Little commitment or interest is shown by mayors, insurance companies, and institutions providing health services that are supposed to be involved with monitoring. A lack of cross-institutional collaboration is apparent in the development of health services surveillance. The implementation of public health surveillance at state and local levels is weak due to problems with the governmental stewardship. These weaknesses are manifested in the lack of regulation, financing and control of the health system.

Surveillance for waterborne disease and outbreaks associated with recreational water use and other aquatic facility-associated health events-United States, 2005-2006

EPA Science Inventory

PROBLEM/CONDITION: Since 1971, CDC, the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have collaboratively maintained the Waterborne Disease and Outbreak Surveillance System for collecting and reporting data related to waterborne-d...

Evaluation of outbreak detection performance using multi-stream syndromic surveillance for influenza-like illness in rural Hubei Province, China: a temporal simulation model based on healthcare-seeking behaviors.

PubMed

Fan, Yunzhou; Wang, Ying; Jiang, Hongbo; Yang, Wenwen; Yu, Miao; Yan, Weirong; Diwan, Vinod K; Xu, Biao; Dong, Hengjin; Palm, Lars; Nie, Shaofa

2014-01-01

Syndromic surveillance promotes the early detection of diseases outbreaks. Although syndromic surveillance has increased in developing countries, performance on outbreak detection, particularly in cases of multi-stream surveillance, has scarcely been evaluated in rural areas. This study introduces a temporal simulation model based on healthcare-seeking behaviors to evaluate the performance of multi-stream syndromic surveillance for influenza-like illness. Data were obtained in six towns of rural Hubei Province, China, from April 2012 to June 2013. A Susceptible-Exposed-Infectious-Recovered model generated 27 scenarios of simulated influenza A (H1N1) outbreaks, which were converted into corresponding simulated syndromic datasets through the healthcare-behaviors model. We then superimposed converted syndromic datasets onto the baselines obtained to create the testing datasets. Outbreak performance of single-stream surveillance of clinic visit, frequency of over the counter drug purchases, school absenteeism, and multi-stream surveillance of their combinations were evaluated using receiver operating characteristic curves and activity monitoring operation curves. In the six towns examined, clinic visit surveillance and school absenteeism surveillance exhibited superior performances of outbreak detection than over the counter drug purchase frequency surveillance; the performance of multi-stream surveillance was preferable to signal-stream surveillance, particularly at low specificity (Sp <90%). The temporal simulation model based on healthcare-seeking behaviors offers an accessible method for evaluating the performance of multi-stream surveillance.

Tetanus Surveillance

MedlinePlus

... Links Tetanus Vaccination Maternal and Neonatal Tetanus Elimination Surveillance Recommend on Facebook Tweet Share Compartir Reported tetanus ... date on their 10-year booster shots. National surveillance for tetanus is monitored by the National Notifiable ...

Injury in China: a systematic review of injury surveillance studies conducted in Chinese hospital emergency departments

PubMed Central

2011-01-01

Background Injuries represent a significant and growing public health concern in China. This Review was conducted to document the characteristics of injured patients presenting to the emergency department of Chinese hospitals and to assess of the nature of information collected and reported in published surveillance studies. Methods A systematic search of MEDLINE and China Academic Journals supplemented with a hand search of journals was performed. Studies published in the period 1997 to 2007 were included and research published in Chinese was the focus. Search terms included emergency, injury, medical care. Results Of the 268 studies identified, 13 were injury surveillance studies set in the emergency department. Nine were collaborative studies of which eight were prospective studies. Of the five single centre studies only one was of a prospective design. Transport, falls and industrial injuries were common mechanisms of injury. Study strengths were large patient sample sizes and for the collaborative studies a large number of participating hospitals. There was however limited use of internationally recognised injury classification and severity coding indices. Conclusion Despite the limited number of studies identified, the scope of each highlights the willingness and the capacity to conduct surveillance studies in the emergency department. This Review highlights the need for the adoption of standardized injury coding indices in the collection and reporting of patient health data. While high level injury surveillance systems focus on population-based priority setting, this Review demonstrates the need to establish an internationally comparable trauma registry that would permit monitoring of the trauma system and would by extension facilitate the optimal care of the injured patient through the development of informed quality assurance programs and the implementation of evidence-based health policy. PMID:22029774

21 CFR 822.35 - Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan? 822.35 Section 822.35 Food and Drugs FOOD AND DRUG... Records and Reports § 822.35 Can you inspect my manufacturing site or other sites involved in my...

The African cholera surveillance network (Africhol) consortium meeting, 10-11 June 2015, Lomé, Togo.

PubMed

Munier, Aline; Njanpop-Lafourcade, Berthe-Marie; Sauvageot, Delphine; Mhlanga, Raymond B; Heyerdahl, Léonard; Nadri, Johara; Wood, Richard; Ouedraogo, Issaka; Blake, Alexandre; Akilimali Mukelenge, Laurent; Anné, Jean-Claude B; Banla Kere, Abiba; Dempouo, Lucienne; Keita, Sakoba; Langa, José P M; Makumbi, Issa; Mwakapeje, Elibariki R; Njeru, Ian J; Ojo, Olubunmi E; Phiri, Isaac; Pezzoli, Lorenzo; Gessner, Bradford D; Mengel, Martin

2017-01-01

The fifth annual meeting of the African cholera surveillance network (Africhol) took place on 10-11 June 2015 in Lomé, Togo. Together with international partners, representatives from the 11 member countries -Cameroon, Côte d'Ivoire, Democratic Republic of Congo, Guinea, Kenya, Mozambique, Nigeria, Tanzania, Togo, Uganda, Zimbabwe- and an invited country (Malawi) shared their experience. The meeting featured three sessions: i) cholera surveillance, prevention and control in participating countries, ii) cholera surveillance methodology, such as cholera mapping, cost-effectiveness studies and the issue of overlapping epidemics from different diseases, iii) cholera laboratory diagnostics tools and capacity building. The meeting has greatly benefitted from the input of technical expertise from participating institutions and the observations emerging from the meeting should enable national teams to make recommendations to their respective governments on the most appropriate and effective measures to be taken for the prevention and control of cholera. Recommendations for future activities included collecting precise burden estimates in surveillance sites; modeling cholera burden for Africa; setting up cross-border collaborations; strengthening laboratory capacity for the confirmation of suspected cholera cases and for vaccine impact assessment in settings where oral cholera vaccine would be used; adapting cholera surveillance to concurrent issues (e.g., Ebola); and developing national cholera control plans including rationale vaccination strategies together with other preventive and control measures such as improvements in water, sanitation and hygiene (WASH).

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

... (i) Intended to be implanted in the human body for more than 1 year or to be used to sustain or... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0123] Design and Methodology for Postmarket Surveillance Studies Under Section 522 of the Federal Food, Drug...

Surveillance of tuberculosis in Malawian prisons

PubMed Central

Banda, R. P.; Gausi, F.; Salaniponi, F. M.; Harries, A. D.; Mpunga, J.; Banda, H. M.; Munthali, C.; Ndindi, H.

2012-01-01

Setting: The Malawi National Tuberculosis Programme (NTP) has collaborated with the Prison Health Services (PHS) on tuberculosis (TB) control in prisons since 1996. Information on case finding and treatment outcomes is routinely collected, but there has not been any recent countrywide review of these prison data. Objectives: To determine 1) the number of prisoners registered for TB in 2007, 2) TB treatment outcomes in 2006 and 3) training of prison health care staff in all Malawian prisons. Design: Descriptive study involving a review of 2006 and 2007 data collected by the NTP during surveillance in 2008. Results: In 2007, 278 TB patients were registered in Malawian prisons, representing a TB case notification rate of 835 per 100 000 (higher than that in the general population, at 346/100 000). The treatment success rate for new smear-positive TB cases for 2006 was 73%, lower than the national average of 78%. In all, 52 prison health care staff had received 1 week of training in TB management, usually just after starting work in the prison. Conclusions: TB case notifications in Malawian prisons were higher than in the general population and treatment outcomes less favourable. The NTP and PHS need better collaboration to improve TB control in Malawian prisons. PMID:26392938

Advancing the Use of Emergency Department Syndromic Surveillance Data, New York City, 2012-2016.

PubMed

Lall, Ramona; Abdelnabi, Jasmine; Ngai, Stephanie; Parton, Hilary B; Saunders, Kelly; Sell, Jessica; Wahnich, Amanda; Weiss, Don; Mathes, Robert W

The use of syndromic surveillance has expanded from its initial purpose of bioterrorism detection. We present 6 use cases from New York City that demonstrate the value of syndromic surveillance for public health response and decision making across a broad range of health outcomes: synthetic cannabinoid drug use, heat-related illness, suspected meningococcal disease, medical needs after severe weather, asthma exacerbation after a building collapse, and Ebola-like illness in travelers returning from West Africa. The New York City syndromic surveillance system receives data on patient visits from all emergency departments (EDs) in the city. The data are used to assign syndrome categories based on the chief complaint and discharge diagnosis, and analytic methods are used to monitor geographic and temporal trends and detect clusters. For all 6 use cases, syndromic surveillance using ED data provided actionable information. Syndromic surveillance helped detect a rise in synthetic cannabinoid-related ED visits, prompting a public health investigation and action. Surveillance of heat-related illness indicated increasing health effects of severe weather and led to more urgent public health messaging. Surveillance of meningitis-related ED visits helped identify unreported cases of culture-negative meningococcal disease. Syndromic surveillance also proved useful for assessing a surge of methadone-related ED visits after Superstorm Sandy, provided reassurance of no localized increases in asthma after a building collapse, and augmented traditional disease reporting during the West African Ebola outbreak. Sharing syndromic surveillance use cases can foster new ideas and build capacity for public health preparedness and response.

Genomically Informed Surveillance for Carbapenem-Resistant Enterobacteriaceae in a Health Care System.

PubMed

Pecora, Nicole D; Li, Ning; Allard, Marc; Li, Cong; Albano, Esperanza; Delaney, Mary; Dubois, Andrea; Onderdonk, Andrew B; Bry, Lynn

2015-07-28

Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent public health concern. Rapid identification of the resistance genes, their mobilization capacity, and strains carrying them is essential to direct hospital resources to prevent spread and improve patient outcomes. Whole-genome sequencing allows refined tracking of both chromosomal traits and associated mobile genetic elements that harbor resistance genes. To enhance surveillance of CREs, clinical isolates with phenotypic resistance to carbapenem antibiotics underwent whole-genome sequencing. Analysis of 41 isolates of Klebsiella pneumoniae and Enterobacter cloacae, collected over a 3-year period, identified K. pneumoniae carbapenemase (KPC) genes encoding KPC-2, -3, and -4 and OXA-48 carbapenemases. All occurred within transposons, including multiple Tn4401 transposon isoforms, embedded within more than 10 distinct plasmids representing incompatibility (Inc) groups IncR, -N, -A/C, -H, and -X. Using short-read sequencing, draft maps were generated of new KPC-carrying vectors, several of which were derivatives of the IncN plasmid pBK31551. Two strains also had Tn4401 chromosomal insertions. Integrated analyses of plasmid profiles and chromosomal single-nucleotide polymorphism (SNP) profiles refined the strain patterns and provided a baseline hospital mobilome to facilitate analysis of new isolates. When incorporated with patient epidemiological data, the findings identified limited outbreaks against a broader 3-year period of sporadic external entry of many different strains and resistance vectors into the hospital. These findings highlight the utility of genomic analyses in internal and external surveillance efforts to stem the transmission of drug-resistant strains within and across health care institutions. We demonstrate how detection of resistance genes within mobile elements and resistance-carrying strains furthers active surveillance efforts for drug resistance. Whole-genome sequencing is increasingly

A collaborative approach to developing an electronic health record phenotyping algorithm for drug-induced liver injury

PubMed Central

Overby, Casey Lynnette; Pathak, Jyotishman; Gottesman, Omri; Haerian, Krystl; Perotte, Adler; Murphy, Sean; Bruce, Kevin; Johnson, Stephanie; Talwalkar, Jayant; Shen, Yufeng; Ellis, Steve; Kullo, Iftikhar; Chute, Christopher; Friedman, Carol; Bottinger, Erwin; Hripcsak, George; Weng, Chunhua

2013-01-01

Objective To describe a collaborative approach for developing an electronic health record (EHR) phenotyping algorithm for drug-induced liver injury (DILI). Methods We analyzed types and causes of differences in DILI case definitions provided by two institutions—Columbia University and Mayo Clinic; harmonized two EHR phenotyping algorithms; and assessed the performance, measured by sensitivity, specificity, positive predictive value, and negative predictive value, of the resulting algorithm at three institutions except that sensitivity was measured only at Columbia University. Results Although these sites had the same case definition, their phenotyping methods differed by selection of liver injury diagnoses, inclusion of drugs cited in DILI cases, laboratory tests assessed, laboratory thresholds for liver injury, exclusion criteria, and approaches to validating phenotypes. We reached consensus on a DILI phenotyping algorithm and implemented it at three institutions. The algorithm was adapted locally to account for differences in populations and data access. Implementations collectively yielded 117 algorithm-selected cases and 23 confirmed true positive cases. Discussion Phenotyping for rare conditions benefits significantly from pooling data across institutions. Despite the heterogeneity of EHRs and varied algorithm implementations, we demonstrated the portability of this algorithm across three institutions. The performance of this algorithm for identifying DILI was comparable with other computerized approaches to identify adverse drug events. Conclusions Phenotyping algorithms developed for rare and complex conditions are likely to require adaptive implementation at multiple institutions. Better approaches are also needed to share algorithms. Early agreement on goals, data sources, and validation methods may improve the portability of the algorithms. PMID:23837993

Window of Opportunity for New Disease Surveillance: Developing Keyword Lists for Monitoring Mental Health and Injury Through Syndromic Surveillance.

PubMed

Lauper, Ursula; Chen, Jian-Hua; Lin, Shao

2017-04-01

Studies have documented the impact that hurricanes have on mental health and injury rates before, during, and after the event. Since timely tracking of these disease patterns is crucial to disaster planning, response, and recovery, syndromic surveillance keyword filters were developed by the New York State Department of Health to study the short- and long-term impacts of Hurricane Sandy. Emergency department syndromic surveillance is recognized as a valuable tool for informing public health activities during and immediately following a disaster. Data typically consist of daily visit reports from hospital emergency departments (EDs) of basic patient data and free-text chief complaints. To develop keyword lists, comparisons were made with existing CDC categories and then integrated with lists from the New York City and New Jersey health departments in a collaborative effort. Two comprehensive lists were developed, each containing multiple subcategories and over 100 keywords for both mental health and injury. The data classifiers using these keywords were used to assess impacts of Sandy on mental health and injuries in New York State. The lists will be validated by comparing the ED chief complaint keyword with the final ICD diagnosis code. (Disaster Med Public Health Preparedness. 2017;11:173-178).

Cohort profile: the German ClinSurv HIV project--a multicentre open clinical cohort study supplementing national HIV surveillance.

PubMed

Bätzing-Feigenbaum, J; Kollan, C; Kühne, A; Matysiak-Klose, D; Gunsenheimer-Bartmeyer, B; Hamouda, O

2011-05-01

New forms of HIV/AIDS therapy require new surveillance instruments to meet shifting public health demands. The Clinical Surveillance of HIV Disease (ClinSurv HIV) project was established in 1999 as a collaboration between major HIV treatment centres in Germany and the Robert Koch Institute (RKI). The project contributes to national HIV surveillance and focuses on the changing epidemiology of HIV/AIDS after the introduction of new therapies in 1995. ClinSurv HIV is designed as an open multicentre observational cohort study of HIV-infected patients. Anonymized data on diagnoses, treatment and laboratory parameters are collected in a standardized format. Data are currently sampled biannually via 11 centres specializing in HIV diagnosis and care within the legal framework of the German Protection against Infection Act [Infektionsschutzgesetz (IfSG)]. A total of 14874 patients were enrolled in the study by 30 June 2009. Of these, 10221 patients (68.7%) were enrolled after 1 January 1999 and 6006 patients (40.4%) were known to have been diagnosed as positive for HIV before 1999. Evaluation indicators, such as the number of newly enrolled patients per half-year period, loss to follow-up, completeness of data per case, availability of data per possible clinical contact, and internal quality control parameters, show a very stable evolution in the cohort, which although open, can be observed. Comparison with the national HIV surveillance data suggests a high degree of representativeness according to major demographic variables. Bearing in mind the obvious strengths and weaknesses discussed, the German ClinSurv HIV cohort provides a broad range of research opportunities in the field of HIV/AIDS both within Germany and in international collaborative research.

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

The Potential Return on Public Investment in Detecting Adverse Drug Effects.

PubMed

Huybrechts, Krista F; Desai, Rishi J; Park, Moa; Gagne, Joshua J; Najafzadeh, Mehdi; Avorn, Jerry

2017-06-01

Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the health care system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs. We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773-$884 million for rofecoxib, $3-$10 million for cerivastatin, and $38-$63 million for troglitazone in the United States through the prevention of adverse events. By contrast, the yearly public investment in Food and Drug Administration initiated population-based pharmacovigilance activities in the United States is about $42.5 million at present. These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.

A Population Health Surveillance Theory

PubMed Central

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

2012-01-01

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

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.

A Focused Ethnographic Study of Alberta Cattle Veterinarians’ Decision Making about Diagnostic Laboratory Submissions and Perceptions of Surveillance Programs

PubMed Central

Sawford, Kate; Vollman, Ardene Robinson; Stephen, Craig

2013-01-01

The animal and public health communities need to address the challenge posed by zoonotic emerging infectious diseases. To minimize the impacts of future events, animal disease surveillance will need to enable prompt event detection and response. Diagnostic laboratory-based surveillance systems targeting domestic animals depend in large part on private veterinarians to submit samples from cases to a laboratory. In contexts where pre-diagnostic laboratory surveillance systems have been implemented, this group of veterinarians is often asked to input data. This scenario holds true in Alberta where private cattle veterinarians have been asked to participate in the Alberta Veterinary Surveillance Network-Veterinary Practice Surveillance, a platform to which pre-diagnostic disease and non-disease case data are submitted. Consequently, understanding the factors that influence these veterinarians to submit cases to a laboratory and the complex of factors that affect their participation in surveillance programs is foundational to interpreting disease patterns reported by laboratories and engaging veterinarians in surveillance. A focused ethnographic study was conducted with ten cattle veterinarians in Alberta. Individual in-depth interviews with participants were recorded and transcribed to enable thematic analysis. Laboratory submissions were biased toward outbreaks of unknown cause, cases with unusual mortality rates, and issues with potential herd-level implications. Decreasing cattle value and government support for laboratory testing have contributed to fewer submissions over time. Participants were willing participants in surveillance, though government support and collaboration were necessary. Changes in the beef industry and veterinary profession, as well as cattle producers themselves, present both challenges and opportunities in surveillance. PMID:23741397

[Drug delivery systems using nano-sized drug carriers].

PubMed

Nakayama, Masamichi; Okano, Teruo

2005-07-01

Nanotechnology has attracted great attention all over the world in recent several years and has led to the establishment of the novel technical field of "nanomedicine" through collaboration with advanced medical technology. Particularly, site-specific drug targeting using particle drug carrier systems has made substantial progress and been actively developed. This review explains the essential factors (size and chemical character) of drug carriers to allow long circulation in the bloodstream avoiding the reticuloendothelial system, and shows the present status and future perspective of several types of nano-carrier systems (water-soluble polymer, liposome and polymeric micelle). We also introduce the novel concept of multi-targeting system (combination of two or more targeting methodologies) for ideal drug therapies.

International Collaboration in Mental Health.

ERIC Educational Resources Information Center

Brown, Bertram S., Ed.; Torrey, E. Fuller, Ed.

Presented in five parts on research, services, training, drug abuse, and alcohol abuse are 31 reports of mental health studies and programs supported by the U.S. and other countries. Explained in the introduction are reasons the National Institute of Mental Health (NIMH) has supported international collaboration. The following are among subjects…

DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS). Global Influenza Surveillance Efforts

DTIC Science & Technology

2007-01-08

DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS) Global Influenza Surveillance Efforts 8 January 2007 COL (Ret.) Jose L...SUBTITLE DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS) Global Influenza Surveillance Efforts 5a. CONTRACT NUMBER 5b. GRANT...PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 Lab-Based Influenza Surveillance • Sentinel Surveillance • Air Force

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

VO 2 thin films synthesis for collaborators and various applications.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnson, Raegan Lynn; Clem, Paul G.

2016-11-01

Vanadium dioxide (VO 2) is an attractive material for a variety of applications due to its metal-to-insulator transition (MIT) observed at modest temperatures. This transition takes VO 2 from its low temperature insulating monoclinic phase to a high temperature (above 68°C) metallic rutile phase. This transition gives rise to a change in resistivity up to 5 orders of magnitude and a change in complex refractive index (especially at IR wavelengths), which is of interest for radar circuit protection and tunable control of infrared signature. Recently, collaborations have been initiated between CINT scientists and external university programs. The Enhanced Surveillance fundsmore » help fund this work which enabled synthesis of VO 2 films for several collaborations with internal and external researchers.« less

65 Years of influenza surveillance by a WHO-coordinated global network.

PubMed

Ziegler, Thedi; Mamahit, Awandha; Cox, Nancy J

2018-05-04

The 1918 devastating influenza pandemic left a lasting impact on influenza experts and the public, and the importance of global influenza surveillance was soon recognized. The WHO Global Influenza Surveillance Network (GISN) was founded in 1952 and renamed to Global Influenza Surveillance and Response System in 2011 upon the adoption by the World Health Assembly, of the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits ("PIP Framework"). The importance of influenza surveillance had been recognized and promoted by experts prior to the years leading up to the establishment of WHO. In the 65 years of its existence, the Network has grown to comprise 143 National Influenza Centers recognized by WHO, 6 WHO Collaborating Centers, 4 Essential Regulatory Laboratories, and 13 H5 Reference Laboratories. The Network has proven its excellence throughout these 65 years, providing detailed information on circulating seasonal influenza viruses, as well as immediate response to the influenza pandemics in 1957, 1968, and 2009, and to threats caused by animal influenza viruses and by zoonotic transmission of coronaviruses. For its central role in global public health, the Network has been highly recognized by its many partners and by international bodies. Several generations of world renown influenza scientists have brought the Network to where it is now and they will take it forward to the future, as influenza will remain a pre-eminent threat to humans and to animals. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Programmatic Impact of 5 Years of Mortality Surveillance of New York City Homeless Populations

PubMed Central

Marder, Dova; Begier, Elizabeth; Gutkovich, Alexander; Mos, Robert; Griffin, Angela; Zimmerman, Regina; Madsen, Ann

2013-01-01

A homeless mortality surveillance system identifies emerging trends in the health of the homeless population and provides this information to key stakeholders in a timely and ongoing manner to effect evidence-based, programmatic change. We describe the first 5 years of the New York City homeless mortality surveillance system and, for the first time in peer-reviewed literature, illustrate the impact of key elements of sustained surveillance (i.e., timely dissemination of aggregate mortality data and real-time sharing of information on individual homeless decedents) on the programs of New York City’s Department of Homeless Services. These key elements had a positive impact on the department’s programs that target sleep-related infant deaths and hypothermia, drug overdose, and alcohol-related deaths among homeless persons. PMID:24148068

Increases in self-reported fentanyl use among a population entering drug treatment: The need for systematic surveillance of illicitly manufactured opioids.

PubMed

Cicero, Theodore J; Ellis, Matthew S; Kasper, Zachary A

2017-08-01

Recent reports indicate a sharp increase in fentanyl-related overdose deaths across the United States, much of which is likely related to the introduction of cheap, illicitly manufactured fentanyl derivatives. In this study, we sought to estimate the magnitude of illicit fentanyl use from 2012 to 2016 using a national opioid abuse surveillance system. The study program surveyed 10,900 individuals entering substance abuse treatment for opioid use disorder, with participants asked to endorse past month 'use to get high' of fentanyl drugs, stratified by identifiable (i.e., branded) fentanyl formulations or a 'type unknown' drug alleged to contain fentanyl. Total past-month fentanyl-use rose modestly from 2012 to 2016. While use of known fentanyl products remained relatively stable (mean=10.9%; P=0.25), endorsements of 'unknown' fentanyl products nearly doubled from 9% in 2013 to 15.1% by 2016 (P<0.001). Data show no discernable indication that this increase is diminishing or stabilizing. This first attempt to assess the prevalence of illicit fentanyl use shows that recent increases in fentanyl use seem to be due almost entirely to 'unknown' fentanyl presumed to be illicitly manufactured. Given that it is difficult to assess the extent to which fentanyl may have been substituted for another drug (i.e., oxycodone, alprazolam, etc.) or was used as a heroin admixture, our data likely represent an underestimation of the full magnitude of illicit fentanyl abuse. As such, this growing public health problem requires immediate attention and more systematic efforts to identify and track its abuse. Copyright © 2017. Published by Elsevier B.V.

Description and implementation of a surveillance network for bluetongue in the Balkans and in adjoining areas of south-eastern Europe.

PubMed

Dall'Acqua, F; Paladini, C; Meiswinkel, R; Savini, L; Calistri, P

2006-01-01

During the recent severe outbreaks of bluetongue (BT) in the Mediterranean Basin, the BT virus (BTV) spread beyond its historical limits into the Balkan region. One of the primary impacts of BT is the cessation in livestock trade which can have severe economic and social consequences. The authors briefly describe the development of the collaborative East-BTnet programme which aims to assist all affected and at-risk Balkan states and adjoining countries in the management of BT, and in the development of individual national surveillance systems. The beneficiary countries involved, and led by the World organisation for animal health (Office International des Epizooties) Collaborating Centre for veterinary training, epidemiology, food safety and animal welfare of the Istituto Zooprofilattico dell'Abruzzo e del Molise 'G. Caporale' in collaboration with the Institute for the Protection and the Security of the Citizen, the European Commission Joint Research Centre (IPSC-JRC), were Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, the Former Yugoslavia Republic of Macedonia, Kosovo, Malta, Romania, Serbia and Montenegro, Slovenia and Turkey. A regional web-based surveillance network is a valuable tool for controlling and managing transboundary animal diseases such as BT. Its implementation in the Balkan region and in adjoining areas of south-eastern Europe is described and discussed.

Complementary surveillance strategies are needed to better characterise the epidemiology, care pathways and treatment outcomes of tuberculosis in children.

PubMed

du Preez, Karen; Schaaf, H Simon; Dunbar, Rory; Walters, Elisabetta; Swartz, Alvera; Solomons, Regan; Hesseling, Anneke C

2018-03-23

Tuberculosis (TB) in young and HIV-infected children is frequently diagnosed at hospital level. In settings where general hospitals do not function as TB reporting units, the burden and severity of childhood TB may not be accurately reflected in routine TB surveillance data. Given the paucibacillary nature of childhood TB, microbiological surveillance alone will miss the majority of hospital-managed children. The study objective was to combine complementary hospital-based surveillance strategies to accurately report the burden, spectrum and outcomes of childhood TB managed at referral hospital-level in a high TB burden setting. We conducted a prospective cohort study including all children (< 13 years) managed for TB at a large referral hospital in Cape Town, South Africa during 2012. Children were identified through newly implemented clinical surveillance in addition to existing laboratory surveillance. Data were collected from clinical patient records, the National Health Laboratory Service database, and provincial electronic TB registers. Descriptive statistics were used to report overall TB disease burden, spectrum, care pathways and treatment outcomes. Univariate analysis compared characteristics between children identified through the two hospital-based surveillance strategies to characterise the group of children missed by existing laboratory surveillance. During 2012, 395 children (180 [45.6%] < 2 years) were managed for TB. Clinical surveillance identified 237 (60%) children in addition to laboratory surveillance. Ninety (24.3%) children were HIV co-infected; 113 (29.5%) had weight-for-age z-scores <- 3. Extra-pulmonary TB (EPTB) was diagnosed in 188 (47.6%); 77 (19.5%) with disseminated TB. Favourable TB treatment outcomes were reported in 300/344 (87.2%) children with drug-susceptible and 50/51 (98.0%) children with drug-resistant TB. Older children (OR 1.7; 95% CI 1.0-2.8), children with EPTB (OR 2.3; 95% CI 1.5-3.6) and in-hospital deaths (OR 5

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct... Review and Action § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct... Review and Action § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct... Review and Action § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct... Review and Action § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct... Review and Action § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan...

Health & demographic surveillance system profile: the Nahuche Health and Demographic Surveillance System, Northern Nigeria (Nahuche HDSS).

PubMed

Alabi, Olatunji; Doctor, Henry V; Jumare, Abdulazeez; Sahabi, Nasiru; Abdulwahab, Ahmad; Findley, Sally E; Abubakar, Sani D

2014-12-01

The Nahuche Health and Demographic Surveillance System (HDSS) study site, established in 2009 with 137 823 individuals is located in Zamfara State, north western Nigeria. North-West Nigeria is a region with one of the worst maternal and child health indicators in Nigeria. For example, the 2013 Nigeria Demographic and Health Survey estimated an under-five mortality rate of 185 deaths per 1000 live births for the north-west geo-political zone compared with a national average of 128 deaths per 1000 live births. The site comprises over 100 villages under the leadership of six district heads. Virtually all the residents of the catchment population are Hausa by ethnicity. After a baseline census in 2010, regular update rounds of data collection are conducted every 6 months. Data collection on births, deaths, migration events, pregnancies, marriages and marriage termination events are routinely conducted. Verbal autopsy (VA) data are collected on all deaths reported during routine data collection. Annual update data on antenatal care and household characteristics are also collected. Opportunities for collaborations are available at Nahuche HDSS. The Director of Nahuche HDSS, M.O. Oche at [ochedr@hotmail.com] is the contact person for all forms of collaboration. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Cross-Disciplinary Consultancy to Bridge Public Health Technical Needs and Analytic Developers: Asyndromic Surveillance Use Case

PubMed Central

Faigen, Zachary; Deyneka, Lana; Ising, Amy; Neill, Daniel; Conway, Mike; Fairchild, Geoffrey; Gunn, Julia; Swenson, David; Painter, Ian; Johnson, Lauren; Kiley, Chris; Streichert, Laura

2015-01-01

Introduction: We document a funded effort to bridge the gap between constrained scientific challenges of public health surveillance and methodologies from academia and industry. Component tasks are the collection of epidemiologists’ use case problems, multidisciplinary consultancies to refine them, and dissemination of problem requirements and shareable datasets. We describe an initial use case and consultancy as a concrete example and challenge to developers. Materials and Methods: Supported by the Defense Threat Reduction Agency Biosurveillance Ecosystem project, the International Society for Disease Surveillance formed an advisory group to select tractable use case problems and convene inter-disciplinary consultancies to translate analytic needs into well-defined problems and to promote development of applicable solution methods. The initial consultancy’s focus was a problem originated by the North Carolina Department of Health and its NC DETECT surveillance system: Derive a method for detection of patient record clusters worthy of follow-up based on free-text chief complaints and without syndromic classification. Results: Direct communication between public health problem owners and analytic developers was informative to both groups and constructive for the solution development process. The consultancy achieved refinement of the asyndromic detection challenge and of solution requirements. Participants summarized and evaluated solution approaches and discussed dissemination and collaboration strategies. Practice Implications: A solution meeting the specification of the use case described above could improve human monitoring efficiency with expedited warning of events requiring follow-up, including otherwise overlooked events with no syndromic indicators. This approach can remove obstacles to collaboration with efficient, minimal data-sharing and without costly overhead. PMID:26834939

Cross-Disciplinary Consultancy to Bridge Public Health Technical Needs and Analytic Developers: Asyndromic Surveillance Use Case.

PubMed

Faigen, Zachary; Deyneka, Lana; Ising, Amy; Neill, Daniel; Conway, Mike; Fairchild, Geoffrey; Gunn, Julia; Swenson, David; Painter, Ian; Johnson, Lauren; Kiley, Chris; Streichert, Laura; Burkom, Howard

2015-01-01

We document a funded effort to bridge the gap between constrained scientific challenges of public health surveillance and methodologies from academia and industry. Component tasks are the collection of epidemiologists' use case problems, multidisciplinary consultancies to refine them, and dissemination of problem requirements and shareable datasets. We describe an initial use case and consultancy as a concrete example and challenge to developers. Supported by the Defense Threat Reduction Agency Biosurveillance Ecosystem project, the International Society for Disease Surveillance formed an advisory group to select tractable use case problems and convene inter-disciplinary consultancies to translate analytic needs into well-defined problems and to promote development of applicable solution methods. The initial consultancy's focus was a problem originated by the North Carolina Department of Health and its NC DETECT surveillance system: Derive a method for detection of patient record clusters worthy of follow-up based on free-text chief complaints and without syndromic classification. Direct communication between public health problem owners and analytic developers was informative to both groups and constructive for the solution development process. The consultancy achieved refinement of the asyndromic detection challenge and of solution requirements. Participants summarized and evaluated solution approaches and discussed dissemination and collaboration strategies. A solution meeting the specification of the use case described above could improve human monitoring efficiency with expedited warning of events requiring follow-up, including otherwise overlooked events with no syndromic indicators. This approach can remove obstacles to collaboration with efficient, minimal data-sharing and without costly overhead.

Markov Networks of Collateral Resistance: National Antimicrobial Resistance Monitoring System Surveillance Results from Escherichia coli Isolates, 2004-2012

PubMed Central

Love, William J.; Zawack, Kelson A.; Booth, James G.; Grӧhn, Yrjo T.

2016-01-01

Surveillance of antimicrobial resistance (AMR) is an important component of public health. Antimicrobial drug use generates selective pressure that may lead to resistance against to the administered drug, and may also select for collateral resistances to other drugs. Analysis of AMR surveillance data has focused on resistance to individual drugs but joint distributions of resistance in bacterial populations are infrequently analyzed and reported. New methods are needed to characterize and communicate joint resistance distributions. Markov networks are a class of graphical models that define connections, or edges, between pairs of variables with non-zero partial correlations and are used here to describe AMR resistance relationships. The graphical least absolute shrinkage and selection operator is used to estimate sparse Markov networks from AMR surveillance data. The method is demonstrated using a subset of Escherichia coli isolates collected by the National Antimicrobial Resistance Monitoring System between 2004 and 2012 which included AMR results for 16 drugs from 14418 isolates. Of the 119 possible unique edges, 33 unique edges were identified at least once during the study period and graphical density ranged from 16.2% to 24.8%. Two frequent dense subgraphs were noted, one containing the five β-lactam drugs and the other containing both sulfonamides, three aminoglycosides, and tetracycline. Density did not appear to change over time (p = 0.71). Unweighted modularity did not appear to change over time (p = 0.18), but a significant decreasing trend was noted in the modularity of the weighted networks (p < 0.005) indicating relationships between drugs of different classes tended to increase in strength and frequency over time compared to relationships between drugs of the same class. The current method provides a novel method to study the joint resistance distribution, but additional work is required to unite the underlying biological and genetic characteristics

Integrated surveillance and potential sources of Salmonella enteritidis in human cases in Canada from 2003 to 2009.

PubMed

Nesbitt, A; Ravel, A; Murray, R; McCormick, R; Savelli, C; Finley, R; Parmley, J; Agunos, A; Majowicz, S E; Gilmour, M

2012-10-01

Salmonella enteritidis has emerged as the most prevalent cause of human salmonellosis in Canada. Recent trends of S. enteritidis subtypes and their potential sources were described by integrating Salmonella data from several Canadian surveillance and monitoring programmes. A threefold increase in S. enteritidis cases from 2003 to 2009 was identified to be primarily associated with phage types 13, 8 and 13a. Other common phage types (4, 1, 6a) showed winter seasonality and were more likely to be associated with cases linked to international travel. Conversely, phage types 13, 8 and 13a had summer seasonal peaks and were associated with cases of domestically acquired infections. During agri-food surveillance, S. enteritidis was detected in various commodities, most frequently in chicken (with PT13, PT8 and PT13a predominating). Antimicrobial resistance was low in human and non-human isolates. Continued integrated surveillance and collaborative prevention and control efforts are required to mitigate future illness.

Integrated surveillance and potential sources of Salmonella Enteritidis in human cases in Canada from 2003 to 2009

PubMed Central

NESBITT, A.; RAVEL, A.; MURRAY, R.; McCORMICK, R.; SAVELLI, C.; FINLEY, R.; PARMLEY, J.; AGUNOS, A.; MAJOWICZ, S. E.; GILMOUR, M.

2012-01-01

SUMMARY Salmonella Enteritidis has emerged as the most prevalent cause of human salmonellosis in Canada. Recent trends of S. Enteritidis subtypes and their potential sources were described by integrating Salmonella data from several Canadian surveillance and monitoring programmes. A threefold increase in S. Enteritidis cases from 2003 to 2009 was identified to be primarily associated with phage types 13, 8 and 13a. Other common phage types (4, 1, 6a) showed winter seasonality and were more likely to be associated with cases linked to international travel. Conversely, phage types 13, 8 and 13a had summer seasonal peaks and were associated with cases of domestically acquired infections. During agri-food surveillance, S. Enteritidis was detected in various commodities, most frequently in chicken (with PT13, PT8 and PT13a predominating). Antimicrobial resistance was low in human and non-human isolates. Continued integrated surveillance and collaborative prevention and control efforts are required to mitigate future illness. PMID:22166269

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hills, Charles R

2011-01-25

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

Design of a framework for the deployment of collaborative independent rare disease-centric registries: Gaucher disease registry model.

PubMed

Bellgard, Matthew I; Napier, Kathryn R; Bittles, Alan H; Szer, Jeffrey; Fletcher, Sue; Zeps, Nikolajs; Hunter, Adam A; Goldblatt, Jack

2018-02-01

Orphan drug clinical trials often are adversely affected by a lack of high quality treatment efficacy data that can be reliably compared across large patient cohorts derived from multiple governmental and country jurisdictions. It is critical that these patient data be captured with limited corporate involvement. For some time, there have been calls to develop collaborative, non-proprietary, patient-centric registries for post-market surveillance of aspects related to orphan drug efficacy. There is an urgent need for the development and sustainable deployment of these 'independent' registries that can capture comprehensive clinical, genetic and therapeutic information on patients with rare diseases. We therefore extended an open-source registry platform, the Rare Disease Registry Framework (RDRF) to establish an Independent Rare Disease Registry (IRDR). We engaged with an established rare disease community for Gaucher disease to determine system requirements, methods of data capture, consent, and reporting. A non-proprietary IRDR model is presented that can serve as autonomous data repository, but more importantly ensures that the relevant data can be made available to appropriate stakeholders in a secure, timely and efficient manner to improve clinical decision-making and the lives of those with a rare disease. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

State Synergies and Disease Surveillance: Creating an Electronic Health Data Communication Model for Cancer Reporting and Comparative Effectiveness Research in Kentucky

PubMed Central

Reams, Christopher; Powell, Mallory; Edwards, Rob

2014-01-01

Purpose: This case study describes the collaboration between a state public health department, a major research university, and a health extension service funded as part of the Health Information Technology for Economic and Clinical Health (HITECH) Act to establish an interoperable health information system for disease surveillance through electronic reporting of systemic therapy data from numerous oncology practices in Kentucky. The experience of the Kentucky cancer surveillance system can help local and state entities achieve greater effectiveness in designing communication efforts to increase usage of electronic health records (EHRs) and health information exchanges (HIEs), help eligible clinicians meet these new standards in patient care, and conduct disease surveillance in a learning health system. Innovation: We document and assess the statewide efforts of early health information technology (HIT) adopters in Kentucky to facilitate the nation’s first electronic transmission of a clinical document architecture (CDA) from a physician office to a state cancer surveillance registry in November 2012. Successful transmission of the CDA not only represented a landmark for technology innovators, informaticists, and clinicians, but it also set in motion a new communication mechanism by which state and federal agencies can capture and trade vital cancer statistics in a way that is safe, secure, and timely. The corresponding impact this has on cancer surveillance and comparative effective research is immense. With guidance from the Centers for Disease Control and Prevention (CDC), the Kentucky Cancer Registry (KCR), the Kentucky Health Information Exchange (KHIE), and the Kentucky Regional Extension Center (KREC) have moved one step further in transforming the interoperable health environment for improved disease surveillance. Credibility: This case study describes the efforts of established and reputable agencies, including the KCR, the state department of health

Tetanus surveillance --- United States, 2001-2008.

PubMed

2011-04-01

Tetanus is a life-threatening but preventable disease caused by the toxin of Clostridium tetani, a ubiquitous, spore-forming, gram-positive bacillus found in high concentrations in soil and animal excrement. Reported tetanus cases have declined >95%, and deaths from tetanus have declined >99% in the United States since 1947, when the disease became reportable nationally. To update a previous report and to determine the populations at greatest risk for the disease, CDC analyzed cases reported to the National Notifiable Diseases Surveillance System (NNDSS) during 2001--2008. This report summarizes the results of that analysis, which found that 233 tetanus cases were reported during 2001--2008; among the 197 cases with known outcomes, the case-fatality rate was 13.2%. Average annual incidence during that period was 0.10 per 1 million population overall and 0.23 among persons aged ≥65 years. Incidence among Hispanics was nearly twice that among non-Hispanics, a difference accounted for by 16 cases among Hispanic injection drug users (IDUs). Among the 92 patients for whom tetanus toxoid-containing (TT) vaccination status was available, 37 (40.2%) had received no doses of TT vaccine. Thirty (15.4%) of 195 patients had diabetes, and 27 (15.3%) of 176 were IDUs. Of 51 patients with an acute wound and a surveillance report complete enough to evaluate tetanus prophylaxis, 49 (96.1%) had not received appropriate prophylaxis. Tetanus remains a rare but life-threatening disease in the United States. Health-care providers should ensure up-to-date TT vaccination of all their patients, especially persons aged ≥65 years, persons with diabetes, and injection drug users.

Integrating multiple programme and policy approaches to hepatitis C prevention and care for injection drug users: a comprehensive approach.

PubMed

Birkhead, Guthrie S; Klein, Susan J; Candelas, Alma R; O'Connell, Daniel A; Rothman, Jeffrey R; Feldman, Ira S; Tsui, Dennis S; Cotroneo, Richard A; Flanigan, Colleen A

2007-10-01

New York State is home to an estimated 230,000 individuals chronically infected with hepatitis C virus (HCV) and roughly 171,500 active injection drug users (IDUs). HCV/HIV co-infection is common and models of service delivery that effectively meet IDUs' needs are required. A HCV strategic plan has stressed integration. HCV prevention and care are integrated within health and human service settings, including HIV/AIDS organisations and drug treatment programmes. Other measures that support comprehensive HCV services for IDUs include reimbursement, clinical guidelines, training and HCV prevention education. Community and provider collaborations inform programme and policy development. IDUs access 5 million syringes annually through harm reduction/syringe exchange programmes (SEPs) and a statewide syringe access programme. Declines in HCV prevalence amongst IDUs in New York City coincided with improved syringe availability. New models of care successfully link IDUs at SEPs and in drug treatment to health care. Over 7000 Medicaid recipients with HCV/HIV co-infection had health care encounters related to their HCV in a 12-month period and 10,547 claims for HCV-related medications were paid. The success rate of transitional case management referrals to drug treatment is over 90%. Training and clinical guidelines promote provider knowledge about HCV and contribute to quality HCV care for IDUs. Chart reviews of 2570 patients with HIV in 2004 documented HCV status 97.4% of the time, overall, in various settings. New HCV surveillance systems are operational. Despite this progress, significant challenges remain. A comprehensive, public health approach, using multiple strategies across systems and mobilizing multiple sectors, can enhance IDUs access to HCV prevention and care. A holisitic approach with integrated services, including for HCV-HIV co-infected IDUs is needed. Leadership, collaboration and resources are essential.

Animal health surveillance: navigation amidst the flotsam of human frailty and fiscal inertia.

PubMed

Kellar, J A

2012-07-01

National veterinary services monitor endemic, emerging and exotic disease situations. They intervene when epidemic tendencies demand. They unravel complex disease situations. They do so as monopolies, in environments of political influence and budgetary restraint. When human, animal health and trade protection dictate, they design import or domestic disease control programs. As much as 80% of program expenditures are on surveillance. Their initiatives are scrutinized by treasuries from which they seek funding, industries from which they seek collaboration and trading partners from whom they seek recognition. In democracies, surveillance and control programs are often the products of a complicated consultative process. It involves individuals who have both a commitment to improving an existing animal health situation and access to the required resources. The generations that designed traditionally risk-averse national surveillance and control programs have given way to a new one which is more epidemiologically informed. Their successors design programs bearing epidemiologically based improvements. The transition, however, has not been overwhelmingly welcomed. Expenditures on surveillance are tolerated out of fear during outbreaks of foreign or re-emergence of indigenous disease. Between epidemics, they decline at the hands of producers' unwillingness and budgetary restraint. Human nature responds to the high cost of surveillance in forms ranging from naïveté through to conspiracy. While legislation cannot subdue such human frailty, several other opportunities exist. Education can remove the majority of problems caused by ignorance, leaving the minority that arise intentionally. Technology decreases the high cost of testing which tempts individuals to cut corners. International standards assist National Veterinary Services to overcome domestic resistance. Copyright © 2012 Elsevier B.V. All rights reserved.

Changes in drug use patterns reported on the web after the introduction of ADF OxyContin: findings from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Web Monitoring Program.

PubMed

Vosburg, Suzanne K; Haynes, Colleen; Besharat, Andrea; Green, Jody L

2017-09-01

This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use. Data were collected with the Researched Abuse, Diversion, and Addiction-Related Surveillance System Web Monitoring Program, an online surveillance system that collects and organizes posts about prescription drugs from social media websites, blogs, and forums from 3Q2009 to 4Q2014 using a commercially available web platform. Posts were categorized by whether they conveyed a switch to drugs other than reformulated OxyContin or a continuation of reformulated OxyContin abuse. "Switch posts" primarily discussed switching to immediate-release opioids. "Continue abusing" posts identified tampering strategies for alternate routes of administration, oral use, and continued use although post authors were generally unhappy with the experience. No reference to OxyContin cessation as a function of the introduction of the ADF was found; however, discontinued use was discussed. Web Monitoring data are useful for capturing cross sections of Internet conversation reflecting reactions to new drug formulations. These data support the notion that users will gravitate to non-ADFs generally, and to immediate-release non-ADF opioid formulations, specifically, as long as these options remain on the market. Copyright © 2017 John Wiley & Sons, Ltd.

Automated Health Surveillance

PubMed Central

Block, Bruce; Brennan, J.A.

1987-01-01

A successful health maintenance program requires physicians interested in and knowledgeable about the appropriate health surveillance actions to pursue. But even well-informed physicians need help transforming good intentions into effective health surveillance. An automated health surveillance system was designed and implemented to simplify documentation of health maintenance and remind physicians when actions were overdue. The system has increased insight into the complex process of health promotion and promises to be an important clinical, educational, and research tool.

The Frontlines of Medicine Project: a proposal for the standardized communication of emergency department data for public health uses including syndromic surveillance for biological and chemical terrorism.

PubMed

Barthell, Edward N; Cordell, William H; Moorhead, John C; Handler, Jonathan; Feied, Craig; Smith, Mark S; Cochrane, Dennis G; Felton, Christopher W; Collins, Michael A

2002-04-01

The Frontlines of Medicine Project is a collaborative effort of emergency medicine (including emergency medical services and clinical toxicology), public health, emergency government, law enforcement, and informatics. This collaboration proposes to develop a nonproprietary, "open systems" approach for reporting emergency department patient data. The common element is a standard approach to sending messages from individual EDs to regional oversight entities that could then analyze the data received. ED encounter data could be used for various public health initiatives, including syndromic surveillance for chemical and biological terrorism. The interlinking of these regional systems could also permit public health surveillance at a national level based on ED patient encounter data. Advancements in the Internet and Web-based technologies could allow the deployment of these standardized tools in a rapid time frame.

From surveillance to action: early gains from the National Violent Death Reporting System.

PubMed

Campbell, R; Weis, M A; Millet, L; Powell, V; Hull-Jilly, D; Hackman, H

2006-12-01

Drawing from the experiences of individual state programs that currently participate in the National Violent Death Reporting System (NVDRS), this article reviews some of the practical benefits that may accrue from the introduction of violent death surveillance systems. As a state-based surveillance system that uses multiple data sources and relies upon multiple stakeholders, the NVDRS program has fostered an array of initiatives within and among individual state programs. State-based initiatives highlighted in this article were selected on the basis of a purposive sampling strategy intended to illustrate key aspects of program development. The NVDRS state programs are in Alaska, California, Colorado, Georgia, Kentucky, Maryland, Massachusetts, New Jersey, New Mexico, North Carolina, Oklahoma, Oregon, Rhode Island, South Carolina, Utah, Virginia, and Wisconsin. The NVDRS has helped to build alliances and collaborative efforts between key stakeholders, facilitated the recognition of violent death as a public health problem through outreach and media attention, acted as a catalyst for new projects, enhanced surveillance of special populations and utility for evaluation, and identified key circumstances that will target interventions in state prevention planning. The NVDRS has implemented data collection efforts and is beginning to produce and analyze findings. In the process of implementing the data collection system and publicizing findings, state NVDRS programs are realizing other gains that strengthen their surveillance efforts. The use of data for prevention purposes will be the ultimate indicator of program success.

DXBC: a long distance wireless broadband communication system for coastal maritime surveillance applications

NASA Astrophysics Data System (ADS)

Vastianos, George E.; Argyreas, Nick D.; Xilouris, Chris K.; Thomopoulos, Stelios C. A.

2015-05-01

The field of Homeland Security focuses on the air, land, and sea borders surveillance in order to prevent illegal activities while facilitating lawful travel and trade. The achievement of this goal requires collaboration of complex decentralized systems and services, and transfer of huge amount of information between the remote surveillance areas and the command & control centers. It becomes obvious that the effectiveness of the provided security depends highly on the available communication capabilities between the interconnected areas. Although nowadays the broadband communication between remote places is presumed easy because of the extensive infrastructure inside residential areas, it becomes a real challenge when the required information should be acquired from locations where no infrastructure is available such as mountain or sea areas. The Integrated Systems Lab of NCSR Demokritos within the PERSEUS FP7- SEC-2011-261748 project has developed a wireless broadband telecommunication system that combines different communication channels from subGHz to microwave frequencies and provides secure IP connectivity between sea surveillance vessels and the Command and Control Centers (C3). The system was deployed in Fast Patrol Boats of the Hellenic Coast Guard that are used for maritime surveillance in sea boarders and tested successfully in two demonstration exercises for irregular migration and smuggling scenarios in the Aegean Archipelagos. This paper describes in detail the system architecture in terms of hardware and software and the evaluation measurements of the system communication capabilities.

High Levels of Transmitted HIV Drug Resistance in a Study in Papua New Guinea.

PubMed

Lavu, Evelyn; Kave, Ellan; Mosoro, Euodia; Markby, Jessica; Aleksic, Eman; Gare, Janet; Elsum, Imogen A; Nano, Gideon; Kaima, Petronia; Dala, Nick; Gurung, Anup; Bertagnolio, Silvia; Crowe, Suzanne M; Myatt, Mark; Hearps, Anna C; Jordan, Michael R

2017-01-01

Papua New Guinea is a Pacific Island nation of 7.3 million people with an estimated HIV prevalence of 0.8%. ART initiation and monitoring are guided by clinical staging and CD4 cell counts, when available. Little is known about levels of transmitted HIV drug resistance in recently infected individuals in Papua New Guinea. Surveillance of transmitted HIV drug resistance in a total of 123 individuals recently infected with HIV and aged less than 30 years was implemented in Port Moresby (n = 62) and Mount Hagen (n = 61) during the period May 2013-April 2014. HIV drug resistance testing was performed using dried blood spots. Transmitted HIV drug resistance was defined by the presence of one or more drug resistance mutations as defined by the World Health Organization surveillance drug resistance mutations list. The prevalence of non-nucleoside reverse transcriptase inhibitor transmitted HIV drug resistance was 16.1% (95% CI 8.8%-27.4%) and 8.2% (95% CI 3.2%-18.2%) in Port Moresby and Mount Hagen, respectively. The prevalence of nucleoside reverse transcriptase inhibitor transmitted HIV drug resistance was 3.2% (95% CI 0.2%-11.7%) and 3.3% (95% CI 0.2%-11.8%) in Port Moresby and Mount Hagen, respectively. No protease inhibitor transmitted HIV drug resistance was observed. The level of non-nucleoside reverse transcriptase inhibitor drug resistance in antiretroviral drug naïve individuals recently infected with HIV in Port Moresby is amongst the highest reported globally. This alarming level of transmitted HIV drug resistance in a young sexually active population threatens to limit the on-going effective use of NNRTIs as a component of first-line ART in Papua New Guinea. To support the choice of nationally recommended first-line antiretroviral therapy, representative surveillance of HIV drug resistance among antiretroviral therapy initiators in Papua New Guinea should be urgently implemented.

[Surveillance of work-related suicide in France: An exploratory study].

PubMed

Bossard, C; Santin, G; Lopez, V; Imbernon, E; Cohidon, C

2016-06-01

Despite a large media coverage of the phenomenon, the number of work-related suicides is currently unknown in France. There are nevertheless some data available to document this important issue. The aim of this study was to explore the feasibility of an epidemiological surveillance system for work-related suicides designed to quantify and describe work-related suicides mainly according to economic sectors and occupational categories. Existing data sources in France were identified and evaluated for their relevance and their potential use in a multi-sources surveillance system. A regional pilot study was performed using the main relevant sources identified to investigate different aspects of the system design. Four major data sources were identified to be used to describe work-related suicides: death certificates, social insurance funds, data collected by the officers of the labor inspectorate and data collected from autopsy reports in forensic departments. The regional pilot study gave an estimate of 28 cases of work-related suicide in two years. The findings point out the difficulties involved and the criteria for successful implement of such a system. The study provides some solutions for carrying out this system, the achievement of which will depend upon particular resources and partners' agreements. Recommendations for the next steps have been made based on this work, including possible collaboration with forensic departments, which collect essential data for surveillance. Copyright © 2016. Published by Elsevier Masson SAS.

Southern Hemisphere Influenza and Vaccine Effectiveness Research and Surveillance

PubMed Central

Huang, Qiu Sue; Turner, Nikki; Baker, Michael G; Williamson, Deborah A; Wong, Conroy; Webby, Richard; Widdowson, Marc-Alain

2015-01-01

The 2009 influenza A(H1N1)pdm09 pandemic highlighted the need for improved scientific knowledge to support better pandemic preparedness and seasonal influenza control. The Southern Hemisphere Influenza and Vaccine Effectiveness Research and Surveillance (SHIVERS) project, a 5-year (2012–2016) multiagency and multidisciplinary collaboration, aimed to measure disease burden, epidemiology, aetiology, risk factors, immunology, effectiveness of vaccination and other prevention strategies for influenza and other respiratory infectious diseases of public health importance. Two active, prospective, population-based surveillance systems were established for monitoring influenza and other respiratory pathogens among those hospitalized patients with acute respiratory illness and those enrolled patients seeking consultations at sentinel general practices. In 2015, a sero-epidemiological study will use a sample of patients from the same practices. These data will provide a full picture of the disease burden and risk factors from asymptomatic infections to severe hospitalized disease and deaths and related economic burden. The results during the first 2 years (2012–2013) provided scientific evidence to (a) support a change to NZ's vaccination policy for young children due to high influenza hospitalizations in these children; (b) contribute to the revision of the World Health Organization's case definition for severe acute respiratory illness for global influenza surveillance; and (c) contribute in part to vaccine strain selection using vaccine effectiveness assessment in the prevention of influenza-related consultations and hospitalizations. In summary, SHIVERS provides valuable international platforms for supporting seasonal influenza control and pandemic preparedness, and responding to other emerging/endemic respiratory-related infections. PMID:25912617

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

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.

Surveillance and monitoring of white-tailed deer for chronic wasting disease in the northeastern United States

USGS Publications Warehouse

Evans, Tyler S.; Schuler, Krysten L.; Walter, W. David

2014-01-01

Chronic wasting disease (CWD) is a prion disease that affects both wild and captive cervid populations. In the past 45 y, CWD has spread from northern Colorado to all bordering states, as well as the midwestern United States (Midwest) and northeastern United States (Northeast), Canada, and South Korea. Because CWD is a relatively new issue for wildlife management agencies in the Northeast, we surveyed a representative (e.g., cervid biologist, wildlife veterinarian) from 14 states to gain a better understanding of state-specific surveillance measures. Between 2002 and 2012, New York (37,093) and Pennsylvania (35,324) tested the greatest number of harvested white-tailed deer Odocoileus virginianus in the Northeast. Additionally, the 14 states surveyed have tested 121,730 harvested deer, or approximately 15,216/y, since CWD was first detected in 2005. The most common tissues used by agencies in the Northeast for testing were retropharyngeal lymph nodes, which have been determined to be the most reliable in detecting CWD in cervids. Understanding CWD surveillance efforts at a regional scale can help to provide guidance for the development of new surveillance plans or the improvement of existing ones. Furthermore, collaborations among state and regional agencies in the Northeast may attempt to identify deficiencies in surveillance by state or subregion.

Surveillance for falsified and substandard medicines in Africa and Asia by local organizations using the low-cost GPHF Minilab

PubMed Central

Petersen, Albert; Held, Nadja

2017-01-01

assess the sensitivity of the Minilab methodology in the detection of substandard medicines, and may underestimate the prevalence of poor-quality medicines. Conclusions Surveillance for poor-quality medicines can be carried out by local organizations in low- and middle-income countries using a simple, low-cost technology. Such surveillance can identify an important subgroup of the circulating substandard and falsified medical products and can help to prevent them from causing harm in patients. A collaboration of the national drug regulatory authorities with faith-based organizations and other NGOs may therefore represent a promising strategy towards the Sustainable Development Goal of “ensuring access to quality medicines”. PMID:28877208

Department of Defense influenza and other respiratory disease surveillance during the 2009 pandemic

PubMed Central

2011-01-01

The Armed Forces Health Surveillance Center’s Division of Global Emerging Infections Surveillance and Response System (AFHSC-GEIS) supports and oversees surveillance for emerging infectious diseases, including respiratory diseases, of importance to the U.S. Department of Defense (DoD). AFHSC-GEIS accomplishes this mission by providing funding and oversight to a global network of partners for respiratory disease surveillance. This report details the system’s surveillance activities during 2009, with a focus on efforts in responding to the novel H1N1 Influenza A (A/H1N1) pandemic and contributions to global public health. Active surveillance networks established by AFHSC-GEIS partners resulted in the initial detection of novel A/H1N1 influenza in the U.S. and several other countries, and viruses isolated from these activities were used as seed strains for the 2009 pandemic influenza vaccine. Partners also provided diagnostic laboratory training and capacity building to host nations to assist with the novel A/H1N1 pandemic global response, adapted a Food and Drug Administration-approved assay for use on a ruggedized polymerase chain reaction platform for diagnosing novel A/H1N1 in remote settings, and provided estimates of seasonal vaccine effectiveness against novel A/H1N1 illness. Regular reporting of the system’s worldwide surveillance findings to the global public health community enabled leaders to make informed decisions on disease mitigation measures and controls for the 2009 A/H1N1 influenza pandemic. AFHSC-GEIS’s support of a global network contributes to DoD’s force health protection, while supporting global public health. PMID:21388566

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

PubMed

Lassila, R; Rothschild, C; De Moerloose, P; Richards, M; Perez, R; Gajek, H

2005-07-01

Prospective surveillance studies to monitor drug safety in the postapproval period are rarely employed systematically, although they are of greatest value for caregivers, drug users and regulatory authorities. Safety issues have affected not only conventional pharmaceuticals, but also especially coagulation factors in haemophilia treatment. The reputation of postmarketing surveillance (PMS) studies has been questionable, mainly due to their misuse to solicit prescriptions. Other weaknesses include inappropriate design, lack of standardized observation, limited follow-up periods, absence of rigour in identifying potential adverse drug effects, and infrequent publication. Although well-designed clinical trials represent the gold standard for generating sound clinical evidence, a number of aspects would make PMS studies valuable, if properly conducted. One of their main advantages is broader inclusion, and absence of an 'experimental' design. Lack of proper guidelines, and standardization may constitute a reason for the generally low quality of PMS studies. This paper proposes guidelines for haemophilia-specific PMS studies, in order to improve the acceptance of a basically valuable tool. In the absence of consistent regulatory guidance it will be especially important that the design and supervision of PMS studies involves physicians from the beginning. This will not only make such studies more scientifically relevant, but also help to implement them into daily clinical practice. Specifically in haemophilia, PMS studies may provide valuable data on clinical outcomes, or Quality of Life, which is of great importance when considering adequate standards of care in haemophilia patients.

Mycobacterial interspersed repetitive unit typing and mutational profile for multidrug-resistant and extensively drug-resistant tuberculosis surveillance in Portugal: a 3-year period overview.

PubMed

Silva, Carla; Perdigão, João; Jordão, Luísa; Portugal, Isabel

2014-12-01

Multidrug tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) cases constitute a serious health problem in Portugal, of which the majority of isolates belong to the Lisboa family and the Q1 cluster, highly related to the Lisboa family. Here we sought to investigate the molecular basis of resistant TB as well as to determine the prevalence of specific drug resistance mutations and their association with MDR-TB and/or XDR-TB. In total, 74 Mycobacterium tuberculosis clinical isolates collected in Lisbon Health Region were genotyped by 24-loci mycobacterial interspersed repetitive units-variable number of tandem repeats (MIRU-VNTR), and the mutational profile associated with first- and second-line drug resistance was studied. Seven new mutations were found, whilst the remaining 28 mutations had been previously associated with drug resistance. None of the mutations was specifically associated with MDR-TB. The mutational patterns observed among isolates belonging to Lisboa3 and Q1 clusters were also observed in isolates with unique MIRU-VNTR patterns but closely related to these strains. Such data suggest that the genotyping technique employed discriminates isolates with the same mutational profile. To establish the most adequate genotyping technique, the discriminatory power of three different MIRU-VNTR sets was analysed. The 15-loci MIRU-VNTR set showed adequate discriminatory power, comparable with the 24-loci set, allowing clustering of 60% and 86% of the MDR-TB and XDR-TB isolates, respectively, the majority of which belonged to the Lisboa3 and Q1 clusters. From an epidemiological standpoint, this study suggests combined mutational and genotyping analysis as a valuable tool for drug resistance surveillance. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

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

PubMed

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

2016-01-01

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