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Sample records for cder pharmacovigilance review

  1. A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

    Science.gov (United States)

    Tanti, Amy; Micallef, Benjamin; Serracino-Inglott, Anthony; Borg, John-Joseph

    2017-01-01

    Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.

  2. Utilizing social media data for pharmacovigilance: A review.

    Science.gov (United States)

    Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O'Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

    2015-04-01

    Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. We identified studies describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to extract ADR information posted by users on any publicly available social media platform. We categorized the studies according to different characteristics such as primary ADR detection approach, size of corpus, data source(s), availability, and evaluation criteria. Twenty-two studies met our inclusion criteria, with fifteen (68%) published within the last two years. However, publicly available annotated data is still scarce, and we found only six studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular. Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing. In terms of sources, both health

  3. Utilizing Social Media Data for Pharmacovigilance: A Review

    Science.gov (United States)

    Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O’Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

    2015-01-01

    Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been

  4. The value of patient reporting to the pharmacovigilance system: a systematic review.

    Science.gov (United States)

    Inácio, Pedro; Cavaco, Afonso; Airaksinen, Marja

    2017-02-01

    Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting. © 2016 The British Pharmacological Society.

  5. Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions – a review of spontaneous reports

    Directory of Open Access Journals (Sweden)

    Brickel N

    2017-07-01

    Full Text Available Neil Brickel,1 Haris Shaikh,1 Andrew Kirkham,2 Greg Davies,1 Michelle Chalker,1 Pascal Yoshida3 1Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex, UK; 2Classic and Established Products, GlaxoSmithKline, Brentford, Middlesex, UK; 3Clinical Safety and Post-marketing Surveillance, GlaxoSmithKline KK, Tokyo, Japan Abstract: Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs. Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline’s routine pharmacovigilance includes regular reviews of global adverse event (AE reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs. After identification of increased rates of fatal SCAR cases with lamotrigine in Japan between September and December 2014, this analysis investigated the global incidence of fatal SCARs with lamotrigine and explored whether known risk factors may have contributed to these cases. Global fatal SCAR cases reported with lamotrigine administration from launch until January 2015 were reviewed for evidence of temporal association with dosing and the presence of risk factors, including comorbidities, concomitant medications, and noncompliance with the prescribing information (PI. Worldwide, the estimated cumulative exposure to lamotrigine was >8.4 million patient-years. Globally, there were 54,513 AE reports for lamotrigine, of which 3,454 (6.3% concerned SCARs. Of these, 122 (3.5% had a fatal outcome (attributable and nonattributable to lamotrigine, equating to 0.01 fatal SCARs per 1,000 patient-years. In Japan (estimated cumulative exposure 141,000 patient-years, 17 fatal SCARs were reported (attributable and nonattributable, equating to 0.12 per 1,000 patient

  6. Patient-centered pharmacovigilance: A review | Saleh | Tropical ...

    African Journals Online (AJOL)

    The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete “EBSCO”, Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library. Results: The review revealed that although the reports by patients were of good quality, the patients' ...

  7. Pharmacovigilance system in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Thamir M. Alshammari

    2017-03-01

    Full Text Available Pharmacovigilance plays an important role in ensuring that patients are receiving safe drugs. In Saudi Arabia, Saudi Food and Drug Authority, health institutions, marketing authorization holders and healthcare professional are involved in pharmacovigilance activities regardless of the level of the involvement. Although pharmacovigilance is well established in developed nations and it is considered a new concept in Saudi Arabia. It is a collective effort from various stakeholders to make pharmacovigilance successful toward promoting safe and effective use of medicines among the population. However, the practice of pharmacovigilance still needs more attention especially from marketing authorization holders and healthcare professionals. The aim of this review was to describe the current situation of pharmacovigilance in Saudi Arabia and the activities that have been conducted by the stakeholders.

  8. Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases.

    Science.gov (United States)

    Cliff-Eribo, Kennedy Obebi; Sammons, Helen; Choonara, Imti

    2016-10-01

    To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases. A systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities. 20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 - 37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America. Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America. There were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.

  9. Pharmacovigilance in Italy: An overview

    Science.gov (United States)

    Mazzitello, Carmela; Esposito, Stefania; De Francesco, Adele E.; Capuano, Annalisa; Russo, Emilio; De Sarro, Giovambattista

    2013-01-01

    Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy. Materials and Methods: The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Results: The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs. Conclusion: A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting. PMID:24347976

  10. The history of pharmacovigilance.

    Science.gov (United States)

    Caron, Jacques; Rochoy, Michaël; Gaboriau, Louise; Gautier, Sophie

    2016-04-01

    This article reviews the main historical events before the 21st century and explained their consequences in the current pharmacovigilance legislation. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  11. Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol.

    Science.gov (United States)

    Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Pham, Ba; Straus, Sharon E

    2017-01-19

    Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products. Our review conduct will follow the Joanna Briggs Institute scoping review methods manual. Literature searches were conducted in MEDLINE, EMBASE and the Cochrane Library from inception to 13 May 2016. Additional sources included searches of study registries, conference abstracts, dissertations, as well as websites of international regulatory authorities (eg, Food and Drug Administration (FDA), the WHO, European Medicines Agency). Search results will be supplemented by scanning the references of relevant reviews. We will include all publication types including published articles, editorials, websites and book sections that describe use of social media and crowd-sourced data for surveillance of adverse events associated with health products. Two reviewers will perform study selection and data abstraction independently, and discrepancies will be resolved through discussion. Data analysis will involve quantitative (eg, frequencies) and qualitative (eg, content analysis) methods. The summary of results will be sent to Health Canada, who commissioned the review, and other relevant policymakers involved with the Drug Safety and Effectiveness Network. We will compile and circulate a 1-page policy brief and host a 1-day stakeholder meeting to discuss the implications, key messages and finalise the knowledge translation strategy. Findings from this review will ultimately inform the design and development of a data analytics platform for social media and crowd

  12. Interstitial lung disease induced by fluoxetine: Systematic review of literature and analysis of Vigiaccess, Eudravigilance and a national pharmacovigilance database.

    Science.gov (United States)

    Deidda, Arianna; Pisanu, Claudia; Micheletto, Laura; Bocchetta, Alberto; Del Zompo, Maria; Stochino, Maria Erminia

    2017-06-01

    We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016). In the Italian Pharmacovigilance database (updated to August 2016), we found only one case of Interstitial Lung Disease, codified as "pulmonary disease". Our investigation shows that fluoxetine might be considered as a possible cause of Interstitial Lung Disease. In particular, although here we do not discuss the assessment of benefits and harms of fluoxetine, since this antidepressant is widely used, our review suggests that fluoxetine-induced Interstitial Lung Disease should be considered in patients with dyspnea, associated or not with dry cough, who are treated with this drug. An early withdrawn of fluoxetine could be useful to obtain a complete remission of this adverse drug reaction and special attention should be particularly devoted to long-term therapy, and to female and elderly patients. Although the spontaneous reporting system is affected by important limitations, drug post- marketing surveillance represents an important tool to evaluate the real world effectiveness and safety of drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Demyelinating disease in patients treated with TNF antagonists in rheumatology: data from BIOBADASER, a pharmacovigilance database, and a systematic review.

    Science.gov (United States)

    Cruz Fernández-Espartero, María; Pérez-Zafrilla, Beatriz; Naranjo, Antonio; Esteban, Carmen; Ortiz, Ana M; Gómez-Reino, Juan J; Carmona, Loreto

    2011-12-01

    To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95% CI). In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF-antagonists in BIOBADASER was 0.65 per 1000 patient-years (95% CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95% CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. Copyright © 2011. Published by Elsevier Inc.

  14. The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial.

    Science.gov (United States)

    Gamble, Carrol; Wolf, Andrew; Sinha, Ian; Spowart, Catherine; Williamson, Paula

    2013-01-01

    Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions. No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions.

  15. The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial.

    Directory of Open Access Journals (Sweden)

    Carrol Gamble

    Full Text Available Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU. The evidence-base of randomised controlled trials (RCTs in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug.The Summary of Product Characteristics (SmPC were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions.No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions.

  16. The reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.

    Science.gov (United States)

    2015-02-01

    Despite the fact that adverse effects are vastly under-reported, spontaneous reporting remains the foundation of pharmacovigilance. A small series of properly documented cases, when very specific, can suffice to constitute a signal. In France, reporting adverse effects to Regional Pharmacovigilance Centres (CRPVs) permits high-quality analysis of pharmacovigilance signals, so that they can be brought to the attention of the national agency responsible for making decisions about drugs, the French Health Products Agency (ANSM). The ANSM can use this information to protect patients by implementing the measures within its power or by initiating a European referral. When a decision taken at the national level concerns a drug marketed in several Member States of the European Union, a "harmonisation" procedure results in a decision taken at community level, applicable in all Member States. This means that a safety issue raised by a single Member State sometimes leads to a decision that protects the population of the entire European Union. But it also means that other European decisions can compel national agencies to allow back onto the market a drug that they sought to withdraw in order to protect their citizens. Negotiations with other Member States, the European Medicines Agency (EMA) and the European Commission must be supported by robust data: this is yet another reason for each country to have its own effective national pharmacovigilance database, the contents of which should be publicly accessible. This is unfortunately not yet the case in France in 2014. It also provides another good reason for healthcare professionals and patients to report adverse effects, so that the details can be recorded in national and European databases.

  17. Social media and pharmacovigilance: A review of the opportunities and challenges

    Science.gov (United States)

    Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

    2015-01-01

    Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. PMID:26147850

  18. Social media and pharmacovigilance: A review of the opportunities and challenges.

    Science.gov (United States)

    Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

    2015-10-01

    Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. © 2015 The British Pharmacological Society.

  19. Hiccups in Parkinson's disease: an analysis of cases reported in the European pharmacovigilance database and a review of the literature.

    Science.gov (United States)

    Lertxundi, U; Marquínez, A C; Domingo-Echaburu, S; Solinís, M Á; Calvo, B; Del Pozo-Rodríguez, A; García, M; Aguirre, C; Isla, A

    2017-09-01

    Some reports have suggested an association between dopamine agonists and hiccups, involuntary contractions that merit full clinical attention because they can be very debilitating. Many drugs frequently used to treat hiccups are formally contraindicated in Parkinson's disease due to their liability to worsen motor symptoms, making the treatment of hiccups problematic in this disease. The objective of the present study was to analyze all spontaneous reports of hiccups from the European Pharmacovigilance Database in patients with Parkinson's disease and/or on dopaminergic drugs. Finally, we sought to identify evidence-based recommendations on the management of hiccups in Parkinson's disease. We searched for all reports of hiccups in the European Pharmacovigilance Database (EudraVigilance) and calculated proportional reporting ratios for dopamine agonists and hiccups. We reviewed the literature on Parkinson's disease, dopamine agonists, and hiccups, searching for specific treatment recommendations for hiccups in this disease. Both rotigotine and pramipexole fulfilled the criteria to generate a safety signal. We found 32 and 13 cases of hiccups associated with dopamine agonists in EudraVigilance and the literature, respectively. There were no specific recommendations for the management of hiccups in Parkinson's disease in the clinical guidelines consulted. We have found evidence that rotigotine and pramipexole are associated with the appearance of hiccups and that this adverse reaction occurs predominantly in males. Given the scarce information available, specific recommendations are needed in clinical guidelines for the adequate management of hiccups in Parkinson's disease.

  20. Pharmacovigilance and biosimilars: considerations, needs and challenges.

    Science.gov (United States)

    Casadevall, Nicole; Edwards, I Ralph; Felix, Thomas; Graze, Peter R; Litten, Jason B; Strober, Bruce E; Warnock, David G

    2013-07-01

    Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) healthcare system prepares for biosimilar approvals. These lessons emphasize the need for adequate efficacy and safety studies, post-marketing surveys and a robust pharmacovigilance system that can accurately track and trace biologics, including biosimilars and their reference products, from the patient to the manufacturer. We review the EU experience with biosimilar pharmacovigilance and discuss the implications for biosimilar pharmacovigilance in the USA. Furthermore, we review several aspects of biosimilar pharmacovigilance, including cohort event monitoring, traceability, biosimilar interchangeability, pharmacovigilance system development, nomenclature and counterfeit tracking. The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability. Stringent pharmacovigilance procedures are required to detect potential differences in safety signals between biosimilars and their reference products. Pharmacovigilance of biologics should include processes that are easily used by prescribing practitioners to ensure that data are consistent and new safety signals are properly reported and assigned to the correct product.

  1. [Red yeast-rice-induced muscular injuries: Analysis of French pharmacovigilance database and literature review].

    Science.gov (United States)

    Philibert, Christelle; Bres, Virginie; Jean-Pastor, Marie-Josèphe; Guy, Claire; Lebrun-Vignes, Bénédicte; Robin, Perrine; Pinzani, Véronique; Hillaire-Buys, Dominique

    2016-10-27

    Red yeast rice (RYR) is a dietary supplement containing monacolins obtained by fermentation of Monascus purpureus strains. Because of its structural homology with lovastatin, monacolin K inhibits HMG-CoA reductase and shows hypocholesterolemic properties comparable to synthetic statins. We studied all cases of myopathy involving RYR reported in the French national pharmacovigilance database (6 cases) and in scientific literature (9 cases). Among these cases, 9 showed elevated creatine kinase, 3 rhabdomyolysis and 2 myalgia. Recent studies seem to show good efficacy of the RYR, however, our work reports the existence of related muscular disorders. In addition, dietary supplements currently available on the market may show considerable variability of formulation and/or the presence of contaminants. When clinicobiological disorders occur, physicians should consider the eventual use of an herbal treatment. Copyright © 2014 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  2. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients

    Directory of Open Access Journals (Sweden)

    Jacob D

    2013-04-01

    Full Text Available Dalia Jacob,1 Belén Marrón,2 Jay Ehrlich,1 Peter A Rutherford3 1Baxter Healthcare Corporation, Deerfield, IL, USA; 2Baxter Healthcare Corporation, Madrid, Spain; 3Baxter Healthcare SA, Zurich, Switzerland Abstract: Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions. Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of

  3. Tamoxifen Pharmacovigilance: Implications for Safe Use in the Future.

    Science.gov (United States)

    Antimisiaris, Demetra; Bae, Ki-Hwan Gabriel; Morton, Laura; Gully, Zahara

    2017-09-01

    To survey the status of current tamoxifen pharmacovigilance documentation reflecting tamoxifen use in an academic outpatient multispecialty practice in older adults. This data will help provide information to develop improved pharmacovigilance for a growing cohort of older adult users. The data will be utilized by an interdisciplinary team developing new methods of identifying factors for individualized pharmacovigilance in older adults. Retrospective chart review to gather descriptive and quantitative data on tamoxifen pharmacovigilance. Multi-specialty clinic. Ninety-three patients 60 years of age and older. Quantitative report of tamoxifen monitoring as well as descriptive analysis of individual cases. We found 19 cases of serious adverse events possibly related to tamoxifen (thrombi, uterine malignancies). There were 15 cases with no documentation of pharmacovigilance. All cases had incomplete pharmacovigilance documented. There were two cases of hypercalcemia. There was one case of tamoxifen discontinuation resulting from muscle pain and with chronic muscle pain complaints while receiving tamoxifen. We observed a correlation in older age or high comorbidity burden patients and adverse events patients. Some studies direct the important pharmacovigilance toward prevention of thrombi, uterine malignancies, and hypercalcemia; however, it is not easy to identify recommendations for frequency or focus of monitoring to prevent adverse events for individual older adults based on existing recommendations. The data collected and presented in this study serve to heighten awareness of tamoxifen pharmacovigilance and as a starting point for the application of machine learning techniques and modeling to identify high-risk patients and individualized pharmacovigilance recommendations.

  4. Contribution of Latin America to pharmacovigilance.

    Science.gov (United States)

    González, Juan Camilo; Arango, Victoria E; Einarson, Thomas R

    2006-01-01

    Pharmacovigilance activities have been ongoing for 4 decades. However, little is known (especially outside of the area) about the contribution of Latin America to this field. To review and quantify the published literature on pharmacovigilance in Latin American countries. We searched electronic databases including MEDLINE (1966-2004), EMBASE (1980-2004), International Pharmaceutical Abstracts (1970-2004), Toxline (1992-2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-2004), Sistema de Información Esencial en Terapéutica y Salud (1980-2004), and the Pan American Health Organization Web site (1970-2004) for articles on pharmacovigilance or adverse drug reactions in any of the 19 major Latin American countries. Papers were retrieved and categorized according to content and country of origin by 2 independent reviewers. There were 195 usable articles from 13 countries. Fifty-one of the papers retrieved dealt with pharmacovigilance centers (15 national centers, 10 hospitals, 26 other), 55 covered pharmacovigilance itself (21 theoretical papers, 9 with description of models, 25 educational papers), and 89 were pharmacoepidemiologic studies of adverse drug reactions (69 case reports, 13 observational cohorts, 2 cohort studies, 1 randomized clinical trial, 4 clinical papers on adverse reaction management). Studies have increased exponentially since 1980. Five countries (Argentina, Brazil, Chile, Costa Rica, Venezuela) published reports from national centers. No studies were found from 6 countries: Dominican Republic, El Salvador, Honduras, Nicaragua, Paraguay, or Uruguay. Most studied categories were antiinfectives and drugs affecting the central nervous system, cardiovascular system, and musculoskeletal system. Contributions of Latin American countries to the field of pharmacovigilence have been remarkable, considering the constraints on these countries. A need exists for an increased number of formal pharmacovigilance studies and research

  5. Forensic pharmacovigilance: Newer dimension of pharmacovigilance.

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    Sewal, Rakesh K; Saini, Vikas K; Medhi, Bikash

    2015-08-01

    Drug safety for the patients is of paramount importance for a medical professional. Pharmacovigilance attempts to ensure the safety of patients by keeping a close vigil on the pattern of adverse events secondary to drug use. Number of medicolegal cases is at rise since last few years. Forensic sciences and pharmacovigilance need to work hand in hand to unlock the mystery of many criminal and civil proceedings. Pharmacovigilance offers its wide scope in forensic sciences by putting forward its expertise on adverse profile of drugs which may be instrumental in solving the cases and bringing the justice forth. It may range from as simple affairs as defining the adverse drug reaction on one hand to putting expert advice in critical criminal cases on the other one. Pharmacovigilance experts have to abide by the ethics of the practice while executing their duties as expert else it may tarnish the justice and loosen its dependability. As a budding discipline of science, it is confronted with several hurdles and challenges which include reluctance of medical professionals for being involved in court proceedings, extrapolations of facts and data and variations in law across the globe etc. These challenges and hurdles call the medical fraternity come forward to work towards the momentous application of pharmacovigilance in the forensic sciences. Evidence based practice e.g. testing the biological samples for the presence of drugs may prove to be pivotal in the success of this collaboration of sciences. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  6. Pharmacovigilance and Biomedical Informatics: A Model for Future Development.

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    Beninger, Paul; Ibara, Michael A

    2016-12-01

    The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology. The purpose of this review is to bring a novel lens to pharmacovigilance, looking at the evolution and development of the field of pharmacovigilance from the perspective of biomedical informatics, with the explicit goal of providing a foundation for discussion of the future direction of pharmacovigilance as a discipline. For this review, we searched [publication trend for the log10 value of the numbers of publications identified in PubMed] using the key words [informatics (INF), pharmacovigilance (PV), phar-macovigilance þ informatics (PV þ INF)], for [study types] articles published between [1994-2015]. We manually searched the reference lists of identified articles for additional information. Biomedical informatics has made significant contributions to the infrastructural development of pharmacovigilance. However, there has not otherwise been a systematic assessment of the role of biomedical informatics in enhancing the field of pharmacovigilance, and there has been little cross-discipline scholarship. Rapidly developing innovations in biomedical informatics pose a challenge to pharmacovigilance in finding ways to include new sources of safety information, including social media, massively linked databases, and mobile and wearable wellness applications and sensors. With biomedical informatics as a lens, it is evident that certain aspects of pharmacovigilance are evolving more slowly. However, the high levels of mutual interest in

  7. Pharmacovigilance: Empowering healthcare professionals

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    Mugoša Snežana S.

    2015-01-01

    Full Text Available Introduction: Spontaneous reporting of adverse reactions is of greatest importance for obtaining information about adverse drug reactions (ADRs after granting the marketing authorization. The most important role and also the greatest responsibility belong to healthcare professionals. Their active participation is a prerequisite for the existence of an effective national drug safety monitoring. Methods: This paper examines the legislative framework concerning the pharmacovigilance system in Montenegro. The information was collected from scientific articles and the website of the Agency for Medicines and Medical Devices of Montenegro. Topic: Key segments of pharmacovigilance system are presented, with a special reference to the importance of spontaneous reporting of ADRs, results of spontaneous reporting of ADRs according to the latest Agency's Annual report on the results of spontaneous reporting of adverse reactions to medicines, possible reasons for underreporting ADRs, as well as the new EU regulation on pharmacovigilance. Conclusions: Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance systems. Hence, continuous education of healthcare professionals is needed, with the aim of improving their awareness of the importance of ADRs and risk factors that lead to them, in order to reduce the incidence of ADRs and to increase the number of reported suspected ADRs.

  8. Strengthening pharmacovigilance in South Africa.

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    Mehta, U; Dheda, M; Steel, G; Blockman, M; Ntilivamunda, A; Maartens, G; Pillay, Y; Cohen, K

    2014-02-01

    This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.

  9. Pharmacovigilance programme of India

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    Kalaiselvan Vivekanandan

    2012-01-01

    Full Text Available The monitoring and reporting of adverse drug reactions (ADRs through pharmacovigilance is vital to patient safety and rational prescribing. In India, Central Drugs Standard Control Organization (CDSCO initiated Pharmacovigilance Programme of India (PvPI to report ADRs through ADRs monitoring centres in India. Indian Pharmacopoeia Commission (IPC is functioning as National Coordination Centre (NCC for PvPI. The ADRs are reported to NCC through VigiFlow by various centres are evaluated and committed to Uppsala Monitoring Centre, Sweden. The potential benefit of the PvPI is aimed to reducing or eliminating a harm of medicine. Continuous efforts of the healthcare professionals and the patients are expected to make this as one of the most successful and effective programmes. The present article updates the status and future plan of PvPI.

  10. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

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    Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

    2010-01-01

    Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

  11. Pharmacovigilance is... Vigilance.

    Science.gov (United States)

    Edwards, I Ralph; Bencheikh, Rachida Soulayamani

    2016-04-01

    The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes.

  12. French pharmacovigilance: Missions, organization and perspectives.

    Science.gov (United States)

    Vial, Thierry

    2016-04-01

    Pharmacovigilance aims to identify unknown adverse drug reactions once clinical development is complete, in order to promote improved use of drugs, and thus a reduction in risk for every exposed patient. We describe in this article the missions of French pharmacovigilance system, including French drug agency, Regional Centers of Pharmacovigilance, health professionals, pharmaceutical companies, patients and their associations. We also develop the French pharmacovigilance organization, its perspectives and challenges, both in French and European levels. Copyright © 2016. Published by Elsevier Masson SAS.

  13. Heparin pharmacovigilance in Brazil.

    Science.gov (United States)

    Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

    2011-01-01

    To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

  14. Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso.

    Science.gov (United States)

    Kabore, Lassane; Millet, Pascal; Fofana, Souleymane; Berdai, Driss; Adam, Caroline; Haramburu, Françoise

    2013-05-01

    Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need. The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements. We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results. The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not

  15. Impact of training on Nigerian healthcare professionals' knowledge and practice of pharmacovigilance.

    Science.gov (United States)

    Osakwe, Adeline; Oreagba, Ibrahim; Adewunmi, Adebowale J; Adekoya, Abisola; Fajolu, Iretiola

    2013-01-01

    Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation of the healthcare practitioners. Poor knowledge and practice of pharmacovigilance has necessitated training of healthcare professionals in different parts of Nigeria. The objectives of this study are to determine the knowledge and practice of pharmacovigilance amongst health professionals in Nigeria and the impact of previous training in pharmacovigilance on their knowledge and practice. In this descriptive cross sectional study, purposive and systematic random sampling method was used in selecting health facilities and health care practitioners respectively. Data were collected using a three-part peer-reviewed structured questionnaire administered through electronic mail (25) and self administration by healthcare professionals (316). Respondents who had received training on pharmacovigilance had better knowledge of correct definition of pharmacovigilance (P = 0.001) and better theoretical knowledge and practice scores of pharmacovigilance (P = 0.001). Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of pharmacovigilance. Overall, knowledge and practice of pharmacovigilance in Nigeria was still below average. The main challenges faced in the reporting and detecting of ADR were lack of awareness, poor communication, lack of continuity in training and poor funding. Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthened awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program.

  16. Specific features of medicines safety and pharmacovigilance in Africa.

    Science.gov (United States)

    Isah, Ambrose O; Pal, Shanthi N; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

    2012-02-01

    The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric

  17. Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Hadi MA

    2017-03-01

    Full Text Available Muhammad Abdul Hadi,1 Chin Fen Neoh,2 Rosdi M Zin,3 Mahmoud E Elrggal,4 Ejaz Cheema4 1School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK; 2Collaborative Drug Discovery Research Group, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Salangor, 3Pharmacy Department, Malacca Hospital, Malacca, Malaysia; 4Faculty of Pharmacy, Umm-Al-Qura University, Makkah, Saudi Arabia Abstract: Globally, adverse drug reactions (ADRs, one of the leading causes of morbidity and mortality, will continue to pose a threat to public health as long as drugs are being used to treat various ailments. Prompt ADR reporting is crucial in ensuring drug safety. The aim of this narrative review was to highlight the role of pharmacists in pharmacovigilance and to identify barriers and facilitators toward ADR reporting documented in the literature. The perspective of pharmacy students on pharmacovigilance and ADR reporting has also been discussed with an aim to highlight the need to improve content related to ADR reporting and pharmacovigilance in undergraduate pharmacy curriculum. Globally, although the role of pharmacists within national pharmacovigilance systems varies, it is very well recognized. In general, pharmacists acknowledge that ADR reporting is part of their professional responsibility and have a positive attitude toward reporting ADRs. However, current research evidence suggests that there are still critical knowledge gaps with regard to ADR reporting among pharmacists, especially in countries where the role of pharmacists within the health care system is limited. These knowledge gaps can be fulfilled through continuous professional development programs and reinforcing theoretical and practical knowledge in undergraduate pharmacy curriculums. Without adequately identifying and fulfilling training needs of pharmacists and other health care professionals, the efficiency of national pharmacovigilance systems is unlikely to

  18. Ulceration of the oral mucosa following direct contact with ferrous sulfate in elderly patients: a case report and a review of the French National Pharmacovigilance Database

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    Liabeuf S

    2014-04-01

    Full Text Available Sophie Liabeuf,1–3 Valérie Gras,1 Julien Moragny,1 Marie-Laure Laroche,4 Michel Andrejak1,3On behalf of the French National Network of Pharmacovigilance Centers1Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France; 2Clinical Research Centre, Clinical Pharmacology Division, Amiens University Medical Center and the Jules Verne University of Picardy, Amiens, France; 3INSERM U1088, Amiens, France; 4Regional Pharmacovigilance Center, Department of Pharmacology, Toxicology and Pharmacovigilance, Limoges University Medical Center, Limoges, FranceObjective: To report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients.Case summary: The first case report concerns the occurrence of widespread oral ulceration in an 87-year-old woman with Alzheimer’s disease. The ulceration extended from the side of the tongue to the floor of the mouth. No clear explanation was found and various local treatments were ineffective. Once it was realized that the ferrous sulfate tablets (given as an iron supplement were crushed prior to administration (due to the patient’s deglutition disorder, withdrawal of this treatment led to rapid resolution of the ulceration. Nine other cases of oral ulcerations associated with ferrous sulfate were identified in the French National Pharmacovigilance Database. All but one of the patients were over 80 years of age and the youngest patient (a 54-year-old had dysphagia associated with facial paralysis.Discussion: Only two other reports of oral ulceration due to ferrous sulfate have been published to date. Mucosal toxicity of ferrous sulfate (which is probably related to oxidative stress has previously been reported for the hypopharynx, the esophageal lumen, and (after inhalation of a tablet the tracheobronchial tree.Conclusion: The mucosal toxicity of ferrous

  19. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs

    Science.gov (United States)

    Aagaard, Lise; Hansen, Ebba Holme

    2009-01-01

    Background Despite surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after marketing. The aim of this article is to analyse ADRs reported by available ADR signal detection approaches and to explore which information about new and unexpected ADRs these approaches have detected. Methods We selected three therapeutic cases for the review: antibiotics for systemic use, non-steroidal anti-inflammatory medicines (NSAID) and selective serotonin re-uptake inhibitors (SSRI). These groups are widely used and represent different therapeutic classes of medicines. The ADR studies were identified through literature search in Medline and Embase. The search was conducted in July 2007. For each therapeutic case, we analysed the time of publication, the strengths of the evidence of safety in the different approaches, reported ADRs and whether the studies have produced new information about ADRs compared to the information available at the time of marketing. Results 79 studies were eligible for inclusion in the analysis: 23 antibiotics studies, 35 NSAID studies, 20 SSRI studies. Studies were mainly published from the end of the 1990s and onwards. Although the drugs were launched in different decades, both analytical and observational approaches to ADR studies were similar for all three therapeutic cases: antibiotics, NSAIDs and SSRIs. The studies primarily dealt with analyses of ADRs of the type A and B and to a lesser extent C and D, cf. Rawlins' classification system. The therapeutic cases provided similar results with regard to detecting information about new ADRs despite different time periods and organs attacked. Approaches ranging higher in the evidence hierarchy provided information about risks of already known or expected ADRs, while information about new and previously unknown ADRs was only detected by case reports, the lowest ranking approach in the evidence hierarchy. Conclusion Although the medicines were launched in different

  20. 21st century pharmacovigilance: efforts, roles, and responsibilities.

    Science.gov (United States)

    Pitts, Peter J; Louet, Hervé Le; Moride, Yola; Conti, Rena M

    2016-11-01

    In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Informatics applied to pharmacovigilance: Future perspectives

    Science.gov (United States)

    Menniti, Michele; Menniti, Annamaria; Patanè, Marinella; Esposito, Stefania; Giofrè, Chiara; Aiello, Rossana; Russo, Emilio

    2013-01-01

    Spontaneous adverse drugs reaction (ADRs) reporting represents a precious resource for control and information about the drug's safety and pharmacovigilance. The current reporting system is mainly based on handwritten forms and later manually loaded into a national electronic database by few local pharmacovigilance centers. This reporting system is complicated for both reporters and pharmacovigilance centers which often avoid reporting ADRs for several reasons such as the lack of data on the report. The reporting system might be implemented by improving online platform for ADRs upload; this could allow inspecting all ADRs loaded. Currently, the database is only accessible by the Italian Medicine Agency (AIFA) and local pharmacovigilance centers; neither reporters nor other healthcare professionals can access the database. Finally, it would be right to implement pharmacovigilance centers with specific professional figures qualified in the pharmacovigilance to support both citizens and reporters on various aspects of ADRs reporting. PMID:24347981

  2. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

    Science.gov (United States)

    Tsintis, Panos; La Mache, Edith

    2004-01-01

    In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed

  3. [Pharmacovigilance of major parmaceutical innovation].

    Science.gov (United States)

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

  4. [The new pharmacovigilance legislation in practice].

    Science.gov (United States)

    Broekmans, André W; Mol, Peter G M

    2014-01-01

    Recent European legislation has provided new tools to enhance the overseeing of medicinal products in the postmarketing phase. Package leaflets of newly approved medicines contain a black inverted triangle as a signal for enhanced monitoring. The leaflets also have clear instructions on how to report possible adverse drug reactions. Databases of drug reactions are accessible by the public. The most important change is the establishment of the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA). This Committee will review safety signals of medicinal products arising in the member states of the European Union. The Committee could recommend adaptation of the package leaflet, or suspension or revocation of the marketing authorisation. The PRAC is also involved in the assessment of risk management plans for medicinal products and post-authorisation efficacy and safety studies.

  5. The role of data mining in pharmacovigilance

    NARCIS (Netherlands)

    Hauben, Manfred; Madigan, David; Gerrits, Charles M; Walsh, Louisa; Van Puijenbroek, Eugene P

    A principle concern of pharmacovigilance is the timely detection of adverse drug reactions that are novel by virtue of their clinical nature, severity and/or frequency. The cornerstone of this process is the scientific acumen of the pharmacovigilance domain expert. There is understandably an

  6. [Pharmacovigilance in Portugal: Activity of the Central Pharmacovigilance Unit].

    Science.gov (United States)

    Batel-Marques, Francisco; Mendes, Diogo; Alves, Carlos; Penedones, Ana; Dias, Patricia; Martins, Angelina; Santiago, Luiz Miguel; Fontes-Ribeiro, Carlos; Caramona, Margarida; Macedo, Tice

    2015-01-01

    The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit. Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported. The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were anti-infectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable. The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs. In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.

  7. [Pharmacovigilance of hepatitis B vaccines].

    Science.gov (United States)

    Imbs, Jean-Louis; Decker, Nicole; Welsch, Marie

    2003-01-01

    Since the hepatitis B vaccine are on the market in France, until the end of 2002, 1211 observations of demyelinating disease of the central nervous system (1109 cases of which 895 multiple sclerosis) or peripheral (102 cases of which 49 Guillain Barre Syndrome), have been reported to the french network of pharmacovigilance and to the AFSSAPS. It is not possible to singularize these observations, neither from a clinical nor an epidemiological point of view. No risk factor has been detected. Only the chronology could suggest a causal relationship, the vaccine preceding the pathology in all the cases notified.

  8. Pharmacovigilance in Clinical Trials: Current Practice and Challenges.

    Science.gov (United States)

    Cheaib, N

    2016-01-01

    In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.

  9. Indian College of Physicians (ICP) Position Statement on Pharmacovigilance.

    Science.gov (United States)

    Dhamija, Puneet; Kalra, Sanjay; Sharma, Pramod Kumar; Kalaiselvan, V; Muruganathan, A; Balhara, Yatan Pal Singh; Badani, Rajesh; Bantwal, Ganapathi; Das, A K; Dhorepatil, Bharati; Ghosh, Sujoy; Jeloka, Tarun; Khandelwal, Deepak; Nadkar, Milind Y; Patnaik, Kuppili Pooja; Saboo, Banshi; Sahay, Manisha; Sahay, Rakesh; Tiwaskar, Mangesh; Unnikrishnan, A G

    2017-03-01

    Pharmacovigilance is the art and science of detection, understanding and prevention of adverse drug reactions and not merely a critical analysis of prescriptions and errors. This field starts with reporting by clinicians of a suspected adverse drug reaction (ADR) to the pharmacologist followed by joint causality analysis and ends at the application of new information by a clinician for benefit of patients. There are a number of ways, which can be utilised for reporting adverse effects using pen and paper format to software applications for smart phones. Varied types of activities spreading from systematic reviews to the mechanistic evaluation of ADR can be performed under the umbrella of pharmacovigilance. It is of utmost importance for clinicians to understand how to identify, communicate and understand adverse effects of drugs with an aim to prevent harm to patients. © Journal of the Association of Physicians of India 2011.

  10. Biologics, Pharmacovigilance, and Patient Safety: It's All in the Name.

    Science.gov (United States)

    Stevenson, James G; Green, Larry

    2016-08-01

    The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product. This approach supports the FDA's mission of protecting patient safety and public health, while minimizing the possibility of inadvertent switching of products and facilitating effective pharmacovigilance. No funding supported the writing of this article. Stevenson reports consulting fees from Amgen, Inc., AbbVie, and Pfizer and is employed by Visante. Green is employed by and owns stock in Amgen, Inc. Article concept was contributed primarily by Stevenson, along with Green. The manuscript was written and revised primarily by Stevenson, along with Green. Both authors contributed equally to data interpretation.

  11. Pharmacovigilance in Space: Stability Payload Compliance Procedures

    Science.gov (United States)

    Daniels, Vernie R.; Putcha, Lakshmi

    2007-01-01

    Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

  12. Pharmacovigilance: the devastating consequences of not thinking ...

    African Journals Online (AJOL)

    Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions: The burden of adverse drug reactions (ADRs) on patient care has been found to be high globally and is particularly high in South Africa.

  13. Adverse drug reactions in Nigerian children: a retrospective review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012.

    Science.gov (United States)

    Obebi Cliff-Eribo, Kennedy; Sammons, Helen; Star, Kristina; Ralph Edwards, I; Osakwe, Adeline; Choonara, Imti

    2016-11-01

    Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase. To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012. The data were analysed for annual reports, age and sex of patients, type of reporters, suspected drugs and adverse reactions. The most commonly reported ADRs and suspected drugs were ranked, and drugs associated with the fatalities were evaluated. A total of 297 reports of 473 ADRs in 297 children were received from doctors, pharmacists, other health-care professionals and consumers during the period. ADRs were most frequently reported for anti-retrovirals (74, 24%), antibiotics (71, 23%) and anti-malarials (60, 20%). The most frequently reported ADRs were rash (15.2%), fever (10.3%) and pruritus (6.8%). Anti-infective agents were responsible for more than half of the reports. Twenty-one children (7%) died, eight from acute renal failure. Seven of the cases of acute renal failure were associated with contaminated paracetamol/diphenhydramine hydrochloride and herbal medicines used for teething problems. In the majority of cases, the products were contaminated with diethylene glycol. There were 14 cases of Stevens-Johnson syndrome, three of which were fatal. Anti-infective agents (antibiotics, anti-malarials and anti-retrovirals) were associated with a majority of the ADRs. Stevens-Johnson syndrome was the most frequent severe ADR. Some of the fatalities were associated with sub-standard and herbal medications.

  14. Pharmacovigilance teaching in UK undergraduate pharmacy programmes.

    Science.gov (United States)

    Smith, Melvyn P; Webley, Sherael D

    2013-03-01

    Pharmacists in the UK are able to report spontaneous adverse drug reactions (ADRs) to the Medicines and Healthcare Products Regulatory Authority. The level of reporting by UK pharmacists remains low. This could be explained by poor knowledge of ADR reporting. The primary objective of this study was to investigate the level of pharmacovigilance education provided to pharmacy students on undergraduate pharmacy programmes in the UK. A cross-sectional survey was used to obtain data relating to the teaching of pharmacovigilance within schools of pharmacy. The survey was designed to reveal whether core elements pertinent to pharmacovigilance and specifically to spontaneous reporting were taught and to what extent. All of the respondents taught pharmacovigilance within an assessed compulsory module. A small number (23%) did not include pharmacovigilance law within their syllabus. In 54%, the amount of time devoted to teaching pharmacy students about their role in pharmacovigilance was less than 4 h in the 4-year course; only one respondent spent approximately 20 h, the remaining respondents (38%) spent between 4 and 8 h. The amount of time dedicated to the teaching of pharmacovigilance on pharmacy undergraduate degree programmes is low. Considering the importance of spontaneous reporting in drug safety and the shift in the role of the pharmacists, more time may need to be devoted to pharmacovigilance on pharmacy undergraduate courses. By doing so, new pharmacists would be more informed of the important role they play in drug safety and thereby potentially help enhance the level of ADR reporting. Copyright © 2012 John Wiley & Sons, Ltd.

  15. [Hospital pharmacists' perception of pharmacovigilance in Quebec].

    Science.gov (United States)

    Cerruti, L; Lebel, D; Bussières, J-F

    2016-03-01

    To assess the pharmacovigilance perception of Quebec's hospital pharmacists. Cross-sectional study. A questionnaire with 16 questions was developed in order to assess respondents' perception of their ability to practice pharmacovigilance, factors that can influence adverse drug reactions reporting and measures to increase reporting rate. The online questionnaire was sent to hospital pharmacist from Quebec in April 2014. The results were presented in the form of descriptive data. A total of 179/252 (71%) hospital pharmacists responded. More than 90% of respondents considered that they were able to practice all activities related to pharmacovigilance. During one year of practice, 98% of respondents faced at least one serious or unexpected adverse drug reaction and 77% notified at least one adverse drug reaction to Health Canada. The factors encouraging more than 89% of respondents to notify were: the severity, the rapidity of onset, the visibility of the reaction, the fact that the adverse drug reaction was unexpected or due to a recent marketed drug. More than 69% of respondents considered the overwork as the principal obstacle to the notification. The majority of respondents supported the implementation of 13/14 measures in order to increase reporting rate. Hospital pharmacists from Quebec presented a favorable ability to practice pharmacovigilance. Analysis of their perception of pharmacovigilance helped to identify improvements, such as the implementation of a pharmacovigilance coordinator in the health center. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  16. Pharmacovigilance and the Italian Medicines Agency

    Science.gov (United States)

    Pimpinella, Giuseppe; Tartaglia, Loriana

    2013-01-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of research areas and for the approval of the projects submitted by the regions. In April 2012, the AIFA started a program of visits at the regional pharmacovigilance centers (RPCs), aimed at monitoring their performances, evaluating the quality of the activities in order to understand the main differences and discrepancies and with a view to start a program of harmonization of the procedures in place. The outcome of the visits program highlighted major differences among the quality management systems of the various centers; hence, AIFA has decided to launch an initiative to promote in the next months the harmonization of procedures. The synergy among AIFA, regional structures, RPCs, and local structure responsible for pharmacovigilance is needed in order to establish a robust pharmacovigilance system working in full compliance with the provisions of the new EU legislation. PMID:24347980

  17. Pharmacovigilance in Russia: current state of affairs, challenges, and prospects.

    Science.gov (United States)

    Gildeeva, Geliya; Belostotsky, Andrey

    2017-12-01

    This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.

  18. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER) supplement. Magnet system special investigations

    Science.gov (United States)

    1981-01-01

    The results of magnet system special investigations listed below are summarized: 4 Tesla Magnet Alternate Design Study; 6 Tesla Magnet Manufacturability Study. The conceptual design for a 4 Tesla superconducting magnet system for use with an alternate (supersonic) ETF power train is described, and estimated schedule and cost are identified. The magnet design is scaled from the ETF 6 T Tesla design. Results of a manufacturability study and a revised schedule and cost estimate for the ETF 6 T magnet are reported. Both investigations are extensions of the conceptual design of a 6 T magnet system performed earlier as a part of the overall MED-ETF conceptual design described in Conceptual Design Engineering Report (CDER) Vol. V, System Design Description (SDD) 503 dated September, 1981, DOE/NASA/0224-1; NASA CR-165/52.

  19. Learning by doing in the student-run pharmacovigilance program

    NARCIS (Netherlands)

    Schutte, T.; Tichelaar, J.; Reumerman, M.O.; Van Eekeren, R.; Rolfes, L.; Richir, M.C.; Van Puijenbroek, E.; Van Agtmael, M.A.

    2015-01-01

    Background: Medication safety is an important topic in healthcare nowadays. Pharmacovigilance, the monitoring of drug safety after approval for marketing, depends mainly on the quality and quantity of reported adverse drug reactions (ADR). To increase pharmacovigilance awareness among medical

  20. [Pharmacovigilance in Germany : It is about time].

    Science.gov (United States)

    Douros, A; Schaefer, C; Kreutz, R; Garbe, E

    2016-06-01

    Pharmacovigilance is defined as the activities relating to the detection, assessment, and prevention of adverse drug reactions (ADRs). Although its beginnings in Germany date back more than 50 years, a stagnation in this field has been observed lately. Different tools of pharmacovigilance will be illustrated and the reasons for its stagnation in Germany will be elucidated. Spontaneous reporting systems are an important tool in pharmacovigilance and are based on reports of ADRs from treating physicians, other healthcare professionals, or patients. Due to several weaknesses of spontaneous reporting systems such as underreporting, media bias, confounding by comorbidity or comedication, and due to the limited quality of the reports, the development of electronic healthcare databases was publicly funded in recent years so that they can be used for pharmacovigilance research. In the US different electronic healthcare databases were merged in a project sponsored by public means resulting in more than 193 million individuals. In Germany the establishment of large longitudinal databases was never conceived as a public duty and has not been implemented so far. Further attempts to use administrative healthcare data for pharmacovigilance purposes are severely restricted by the Code of Social Law (Section 75, Book 10). This situation has led to a stagnation in pharmacovigilance research in Germany. Without publicly funded large longitudinal healthcare databases and an amendment of Section 75, Book 10, of the Code of Social Law, the use of healthcare data in pharmacovigilance research in Germany will remain a rarity. This could have negative effects on the medical care of the general population.

  1. EU's new pharmacovigilance legislation: considerations for biosimilars.

    Science.gov (United States)

    Calvo, Begoña; Zuñiga, Leyre

    2014-01-01

    Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

  2. Gathering and exploring scientific knowledge in pharmacovigilance.

    Science.gov (United States)

    Lopes, Pedro; Nunes, Tiago; Campos, David; Furlong, Laura Ines; Bauer-Mehren, Anna; Sanz, Ferran; Carrascosa, Maria Carmen; Mestres, Jordi; Kors, Jan; Singh, Bharat; van Mulligen, Erik; Van der Lei, Johan; Diallo, Gayo; Avillach, Paul; Ahlberg, Ernst; Boyer, Scott; Diaz, Carlos; Oliveira, José Luís

    2013-01-01

    Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers' analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/.

  3. Gathering and exploring scientific knowledge in pharmacovigilance.

    Directory of Open Access Journals (Sweden)

    Pedro Lopes

    Full Text Available Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers' analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/.

  4. Training in Post-authorization Pharmacovigilance

    Science.gov (United States)

    Ahuja, Vivek; Sharma, Varun

    2010-01-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices. PMID:21829787

  5. Training in post-authorization pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Vivek Ahuja

    2010-01-01

    Full Text Available Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

  6. Pharmacovigilance activities in ASEAN countries.

    Science.gov (United States)

    Suwankesawong, Wimon; Dhippayom, Teerapon; Tan-Koi, Wei-Chuen; Kongkaew, Chuenjid

    2016-09-01

    This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries. This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database. Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015). Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd. Copyright

  7. Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.

    Science.gov (United States)

    Bairy, Laxminarayana Kurady; Nayak, Veena; A, Avinash; Kunder, Sushil Kiran

    2016-08-01

    In recent years the development of antimicrobial resistance has been accelerating, the discovery of new antimicrobial agents has slowed substantially in past decades. This review mainly focuses on the problem of antimicrobial resistance(AMR); the various contributor mechanisms, consequences and future of AMR. The review also highlights the irrational use of antimicrobials, improving their usage and problems associated with pharmacovigilance of antimicrobial resistance. Pharmacovigilance in the form of surveillance of antibiotic use is being done in 90% of the countries worldwide through the WHONET program developed by WHO. However, the data comes from a limited area of the globe. Data from every part of the world is required, so that there is geographical representation of every region. A major hurdle in quantifying the extent of antimicrobial resistance is the fact that there are several known microbes, that may turn out to be resistant to one or more of the several known antimicrobial agents. The global action plan initiated by WHO, if implemented successfully will definitely reduce AMR and will help in evaluating treatment interventions.

  8. Pharmacovigilance Perceptions and Practice of Health Care ...

    African Journals Online (AJOL)

    Developed and developing countries have established formal spontaneous reporting programmes to detect serious adverse drug reactions however levels of reporting are universally low and vary from place to place. This study aimed at documenting the perception and practice of pharmacovigilance amongst health ...

  9. Pharmacovigilance : methods, recent developments and future perspectives

    NARCIS (Netherlands)

    Harmark, L.; van Grootheest, A. C.

    Background Pharmacovigilance, defined by the World Health Organisation as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge

  10. Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood ...

    African Journals Online (AJOL)

    DOWNLOAD FULL TEXT Open Access DOWNLOAD FULL TEXT Subscription or Fee Access. Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood Pressure. SEO Oriaifo, AA Omokhafe, JO Ohaju-Obodo, RI Okoli. Abstract. Imported herbal products that did not go through the official channel of laboratory testing ...

  11. Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood ...

    African Journals Online (AJOL)

    ... possible link between the constituents of the slimming tea and increased blood pressure and also provide evidence of other possible harmful effects that may occur with the use of the slimming tea. Keywords: Pharmacovigilance, hypertension, slimming tea. West African Journal of Pharmacology and Drug Research Vol.

  12. Gathering and exploring scientific knowledge in pharmacovigilance

    NARCIS (Netherlands)

    P. Lopes (Pedro); T. Nunes (Tiago); D. Campos (David); L.I. Furlong (Laura); A. Bauer-Mehren (Anna); F. Sanz (Ferran); M.C. Carrascosa (Maria); J. Mestres (Jordi); J.A. Kors (Jan); B. Singh (Bharat); E.M. van Mulligen (Erik); J. van der Lei (Johan); G. Diallo (Gayo); P. Avillach (Paul); E. Ahlberg (Ernst); S. Boyer (Scott); C. Diaz (Carlos); J.L. Oliveira (José Luis)

    2013-01-01

    textabstractPharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to

  13. Vaccine Pharmacovigilance: Adverse Effects Reported and the ...

    African Journals Online (AJOL)

    Routine utilization of vaccines during immunization in children is a tool in the reduction of childhood morbidity and mortality of infectious disease globally. This requires pharmacovigilance to ensure safety among the category of patients. Due to the exposure of new born to vaccine at birth, it became necessary to assess the ...

  14. Past, present, and future of pharmacovigilance in Korea

    Science.gov (United States)

    Kang, Dong Yoon; Ahn, Kyung-Min; Kang, Hye-Ryun

    2017-01-01

    As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status. RPVCs have played pivotal roles in establishment of pharmacovigilance system in Korea by monitoring voluntary ADR reports. RPVCs started with 3 hospitals in 2006 and have now expanded to 27 hospitals nationwide. The Korea Institute of Drug Safety & Risk Management was established in 2012 and in charge of operating the decentralized national pharmacovigilance system. The voluntary report of ADR, which is the basis of current pharmacovigilance system, has various limitations and an active surveillance system can be the overarching alternative. This change in pharmacovigilance paradigm is a global trend and Korea has excellent infrastructure such as broad distribution of electronic medical recording systems and a nationwide single healthcare insurance. As a result, the pharmacovigilance in Korea is now expected to progress to a new active surveillance system from traditional spontaneous reporting system. PMID:28765823

  15. Pharmacovigilance in veterinary medicine in Chile: a pilot study.

    Science.gov (United States)

    Iragüen, D; Urcelay, S; San Martín, B

    2011-04-01

    Iragüen, D., Urcelay, S., San Martín, B. Pharmacovigilance in veterinary medicine in Chile: a pilot study. J. vet. Pharmacol. Therap.34, 108-115. In Chile, there is no present government policy to survey and analyse adverse drug reactions (ADRs) in the field of veterinary medicine. The intent of this study is to assess, for the first time, ADR frequency in treated animals. To this purpose, a 6-month period pilot study based on WHO recommendations was conducted to monitor ADRs in cats and dogs for frequently used drugs and common labelled signs. Of a total of 149 detected ADRs, 29 (6 in cats and 23 in dogs) were notified by means of ADR report forms, while the rest was identified after reviewing patient clinical records, thus evidencing strong under-reporting problems. More than 70% of ADRs were related to antimicrobials, vaccines and tranquilizers. In dogs, there was a significant effect on ADRs' presentation when acepromazine, amoxicillin, carprofen, ivermectin, sextuple vaccine (polyvalent vaccine that confers immunity against canine distemper virus, canine parvovirus, Leptospira canicola, L. icterohemmoragiae, canine adenovirus type 2 and canine parainfluenza virus) and phytomenadione (subcutaneous injection) were administered. In the case of cats, a significant influence on ADRs was detected when acepromazine, amoxicillin or vitamin K was administered. Present results suggest the need for a pharmacovigilance programme in veterinary medicine for timely ADR-presenting drug detection and drug safety improvement. © 2010 Blackwell Publishing Ltd.

  16. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ... Animal and Plant Health Inspection Service Draft Guidelines on Pharmacovigilance of Veterinary Medicinal... (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products... guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the...

  17. The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

    Directory of Open Access Journals (Sweden)

    Elham Azhdari

    2013-02-01

    Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

  18. European pharmacovigilance: increasingly outsourced to drug companies.

    Science.gov (United States)

    2014-12-01

    New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest

  19. Pharmacovigilance in Calabria (Italy): Local experiences resonate international relevance

    OpenAIRE

    Giuseppe Pimpinella; Loriana Tartaglia

    2013-01-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of r...

  20. Medication errors: pharmacovigilance centres in detection and prevention

    Science.gov (United States)

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-01-01

    Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. As part of this project, a questionnaire on detecting medication errors was circulated to pharmacovigilance centres and poison control centres around the world, in order to assess their ability to detect and analyse medication errors. The results showed that through their databases pharmacovigilance centres can detect, identify, analyse, and classify medication errors and carry out root cause analysis, which is an important tool in preventing medication errors. The duties of pharmacovigilance centres in preventing medication errors include informing health-care professionals about the importance of reporting such errors and creating a culture of patient safety. Pharmacovigilance centres aim to prevent medication errors in collaboration with poison control centres. Such collaboration allows improved detection and improved preventive strategies. In addition, collaboration with regulatory authorities is important in finalizing decisions. Collaboration between pharmacovigilance centres and poison control centres should be strengthened and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload. PMID:19594539

  1. Medication errors: pharmacovigilance centres in detection and prevention.

    Science.gov (United States)

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-06-01

    1. Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. As part of this project, a questionnaire on detecting medication errors was circulated to pharmacovigilance centres and poison control centres around the world, in order to assess their ability to detect and analyse medication errors. 2. The results showed that through their databases pharmacovigilance centres can detect, identify, analyse, and classify medication errors and carry out root cause analysis, which is an important tool in preventing medication errors. 3. The duties of pharmacovigilance centres in preventing medication errors include informing health-care professionals about the importance of reporting such errors and creating a culture of patient safety. Pharmacovigilance centres aim to prevent medication errors in collaboration with poison control centres. Such collaboration allows improved detection and improved preventive strategies. In addition, collaboration with regulatory authorities is important in finalizing decisions. 4. Collaboration between pharmacovigilance centres and poison control centres should be strengthened and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload.

  2. Are we pharmacovigilant enough in ophthalmic practice?

    Directory of Open Access Journals (Sweden)

    Ashok Dubey

    2013-01-01

    Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

  3. ADVERSE DRUG REACTION (ADR) MONITORING AND PHARMACOVIGILANCE

    OpenAIRE

    D. KAVITHA

    2013-01-01

    The need for systematic follow up of medicines for adverse drug reactions once they are introduced into general use has been widely recognised today. Even in developing countries like India, national pharmacovigilance programme has been started for monitoring adverse drug reactions. In its first year this program mainly aimed to foster the culture of ADR notification among health care professionals. As a part of health care team every pharmacist must have knowledge about adverse drug reaction...

  4. Pharmacoepidemiology and its input to pharmacovigilance.

    Science.gov (United States)

    Faillie, Jean-Luc; Montastruc, François; Montastruc, Jean-Louis; Pariente, Antoine

    2016-04-01

    The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution requires a comparison of the approaches and a presentation of their respective merits, we have tried to show that this comparison did not necessarily mean opposing these methods, which would not serve any useful purpose. We wanted to underline the fact that the notion of contribution of one to the other implied a complementarity that we propose to demonstrate. Pharmacovigilance is essentially based on the study of spontaneous reports and the clinical and pharmaceutical analysis of the implication of given drugs in adverse drug reactions. It yields performances that are unequalled to this day when safety warning signs relate to rare adverse events or to drugs that are rarely used, or when the drug-related event has specificities that are not found for other aetiologies. Pharmacoepidemiology for its part, through its population-related studies and the possible use of a comparison group, enables a quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect, and therefore difficult to identify from spontaneous reporting. All in all, this is the major contribution of pharmacoepidemiology to pharmacovigilance, where it can be said that it complements pharmacovigilance in drug safety monitoring but in no way could replace it. Copyright © 2016. Published by Elsevier Masson SAS.

  5. Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

    Science.gov (United States)

    Agoro, Oscar O; Kibira, Sarah W; Freeman, Jenny V; Fraser, Hamish S F

    2017-10-12

    Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

  6. Traceability of biologicals: present challenges in pharmacovigilance.

    Science.gov (United States)

    Vermeer, Niels S; Spierings, Irina; Mantel-Teeuwisse, Aukje K; Straus, Sabine M J M; Giezen, Thijs J; Leufkens, Hubert G M; Egberts, Toine C G; De Bruin, Marie L

    2015-01-01

    Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual products within pharmacovigilance databases. The authors discuss the present challenges in the traceability of biologicals in relation to pharmacovigilance, by exploring the processes involved in ensuring traceability. They explore both the existing systems that are in place for the recording of exposure information in clinical practice, as well as the critical steps involved in the transfer of exposure data to various pharmacovigilance databases. The existing systems ensure the traceability of biologicals down to the manufacturer within pharmacy records, but do not support the routine recording of batch information. Expected changes in supply chain standards provide opportunities to systematically record detailed exposure information. Spontaneous reporting systems are the most vulnerable link in ensuring traceability, due to the manual nature of data transfer. Efforts to improve the traceability should, in the short term, be focused toward encouraging health professionals and patients to systematically record and report detailed exposure information. Long-term solutions lie in expanding the accessibility to, and increasing the electronic exchange of exposure data.

  7. Pharmacovigilance of herbal products in India.

    Science.gov (United States)

    Wal, P; Wal, A; Gupta, S; Sharma, G; Rai, Ak

    2011-07-01

    Herbal formulations being widely accepted therapeutic agents as antidiabetics, antiarthritics, hepatoprotectives, cough remedies, memory enhancers, and adaptogens. The commonest myth regarding herbal medicines is that these medicines are completely safe, and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects, or unwanted after-effects. There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilized. This may be because of differences in the use of nonorthodox drugs (e.g., herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs. The purpose of pharmacovigilance is to detect, assess, and understand, and to prevent the adverse effects or any other possible drug-related problems, related to herbal, traditional, and complementary medicines.

  8. Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

    Science.gov (United States)

    Laroche, Marie-Laure; Batz, Arnaud; Géniaux, Hélène; Féchant, Corinne; Merle, Louis; Maison, Patrick

    2016-04-01

    The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  9. Role of Pharmacovigilance in India: An overview

    Science.gov (United States)

    Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

    2015-01-01

    Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

  10. Patient-Reported Safety Information : A Renaissance of Pharmacovigilance?

    NARCIS (Netherlands)

    Härmark, Linda; Raine, June; Leufkens, Bert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-01-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years

  11. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    Science.gov (United States)

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).

  12. A global view of undergraduate education in pharmacovigilance

    NARCIS (Netherlands)

    Hartman, Jenny; Härmark, Linda; van Puijenbroek, Eugène

    2017-01-01

    PURPOSE: The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. METHOD: A web-based questionnaire was carried out containing 45 questions

  13. Risk management plans as a tool for proactive pharmacovigilance

    DEFF Research Database (Denmark)

    Vermeer, N S; Duijnhoven, R G; Straus, S M J M

    2014-01-01

    Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which...

  14. Knowledge, Attitude and Practice Regarding Pharmacovigilance and Consumer Pharmacovigilance among Consumers at Lalitpur District, Nepal.

    Science.gov (United States)

    Jha, N; Rathore, D S; Shankar, P R; Bhandary, S; Alshakka, M; Gyawali, S

    2017-01-01

    Adverse drug reactions (ADRs) can be a big threat to the health of people in Nepal as a variety of medicines are consumed in the country. Involving consumers in pharmacovigilance can strengthen ADR reporting. The study aims to find out knowledge, attitude and practice regarding pharmacovigilance and consumer pharmacovigilance among consumers at Lalitpur district, Nepal Methods: It was carried out in outpatients visiting in KIST Medical College and Teaching Hospital, Lalitpur, Nepal. Participant's knowledge, attitude and practice were measured by noting their agreement with a set of 21 statements along with multiple choice and open ended questions. A total of 157 outpatients were surveyed. The knowledge scores for males (12) was better compared to the females (11), but the scores for attitude and practice were same for both groups. The maximum score for knowledge was 29, attitude was 6 and practice was 10. The overall KAP scores was 45. The total scores for knowledge, attitude and practice for males (24) were better compared to female (22) respondents. Seventy-one patients (68%) who participated in this study favoured establishing a consumer centre for obtaining information about ADRs. Knowledge scores among consumers regarding pharmacovigilance is low and require advocacy and improvement.

  15. Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

    Science.gov (United States)

    Kunac, Desireé L; Tatley, Michael V

    2011-01-01

    Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and

  16. Pharmacoenvironmentology – a component of pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Gupta Varun

    2007-07-01

    Full Text Available Abstract According to WHO, Pharmacovigilance activities are done to monitor detection, assessment, understanding and prevention of any obnoxious adverse reactions to drugs at therapeutic concentration on animal and human beings. However, there is also a growing focus among scientists and environmentalists about the impact of drugs on environment and surroundings. The existing term 'Ecopharmacology' is too broad and not even defined in a clear manner. The term 'Pharmacoenvironmentology' seeks to deal with the environmental impact of drugs given to humans and animals at therapeutic doses.

  17. Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data.

    Science.gov (United States)

    Solomon, C; Gröner, A; Ye, J; Pendrak, I

    2015-04-01

    Fibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, corresponding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.

  18. An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice.

    Science.gov (United States)

    Currow, David C; Rowett, Debra; Doogue, Matthew; To, Timothy H M; Abernethy, Amy P

    2012-03-01

    Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and longer term use. Historically, voluntary reporting systems for pharmacovigilance have had low reporting rates, relying on ad hoc reporting and retrospective chart reviews, or prospective registries have often been limited to specific drugs or clinical conditions. Furthermore, these data are often irrelevant in hospice and palliative care due to the timeliness of which such data become available and the unique characteristics of our population and prescribing: compounding comorbidities, progressive organ failure, accumulation of symptom-specific medications, tendency to attribute toxicity to disease progression, use of old, off-patent medications, and incorporation of evolving evidence. There is a need for prospective, systematic pharmacovigilance in hospice and palliative care. Here we describe an international, Web-based, 128-bit secure initiative to collect pharmacovigilance data documenting net clinical benefit and safety of common medications. The intention is for a diverse and large group of clinical units to record data prospectively on a small deidentified consecutive cohort of patients started on the medication of interest. A new medication would be studied every 3 months. Three key time points (different for each medication) will be assessed for each patient, collecting easily codefiable data at baseline, a point at which clinical benefit should be experienced, and a point at which short- to medium-term toxicities may occur. Toxicities can additionally be recorded at any time they occur. Data collection will take a maximum of 10 minutes per patient. The intention is to create an efficient, relevant system to improve hospice and palliative care with maximally generalizable results.

  19. Statistical methods for active pharmacovigilance, with applications to diabetes drugs.

    Science.gov (United States)

    Zhuo, Lan; Farrell, Patrick J; McNair, Doug; Krewski, Daniel

    2014-01-01

    Pharmacovigilance aims to identify adverse drug reactions using postmarket surveillance data under real-world conditions of use. Unlike passive pharmacovigilance, which is based on largely voluntary (and hence incomplete) spontaneous reports of adverse drug reactions with limited information on patient characteristics, active pharmacovigilance is based on electronic health records containing detailed information about patient populations, thereby allowing consideration of modifying factors such as polypharmacy and comorbidity, as well as sociodemographic characteristics. With the present shift toward active pharmacovigilance, statistical methods capable of addressing the complexities of such data are needed. We describe four such methods here, and demonstrate their application in the analysis of a large retrospective cohort of diabetics taking anti-hyperglycemic medications that may increase the risk of adverse cardiovascular events.

  20. State of knowledge of Cameroonian drug prescribers on pharmacovigilance.

    Science.gov (United States)

    Nde, Francis; Fah, Aimé Bernard Djitafo; Simo, Francis Ampère; Wouessidjewe, Denis

    2015-01-01

    The present study conducted in Cameroon from June 2013 to February 2014 aimed to estimating the level of pharmacovigilance knowledge and practice of health professionals in Cameroon. We conducted a descriptive cross-sectional survey on 149 health professionals in Cameroon from June to September 2013. Data were analyzed using software IBM SPSS 20.0. We calculated proportions and odd ratio, and confident interval of their values, keeping a threshold of p of 0.05 to determine the level of significance. Ninety percent (90%) of declaration of side effects were made to the medical representatives and 4% to the National Pharmacovigilance Centre. Fifty four percent (54%) of physicians were not aware of the existence of a National Pharmacovigilance system. Ten (10%) of prescribers had never heard of pharmacovigilance, however respondents answered unanimously that they need training on pharmacovigilance. A wrong definition was given by most of the nurses and dentists (61,1% and 58,3% respectively) as compared to physicians and pharmacists (respectively 15.2% and 26,5%). Given the results of this study, the establishment of a National Pharmacovigilance system based on a solid legal foundation is necessary in Cameroon. This implementation must go through the involvement of all stakeholders and their awareness raising on the importance of this activity and its positive impact on the health of populations. Pharmacovigilance is a public health problem in Cameroon, with due to lack of good knowledge and practice of prescribers, precisely physicians, pharmacists, nurses, and dentists who are not always aware of an existing pharmacovigilance system in Cameroon.

  1. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

    Science.gov (United States)

    Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-10-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

  2. [Pharmacovigilance among dentists: a survey of practitioners in Dakar, Senegal].

    Science.gov (United States)

    Diouf, Massamba; Bodian, Salimata; Lo, Cheikh Mouhamadou Mbacké; Cisse, Daouda; Faye, Daouda; Touré, Babacar; Fall, Mamadou

    2013-01-01

    Since 1968, the World Health Organization has used an international pharmacovigilance programme to monitor and examine the effects of drugs. The purpose of this study was to assess the knowledge and attitudes of dentists toward pharmacovigilance. The paper presents the results of a cross-sectional descriptive study of 103 dentists in Senegal, based on an exhaustive selection process. Data were collected on the dentists' sociodemographic characteristics and their knowledge and attitudes toward pharmacovigilance. Over 50% of the sample were general practitioners. The average number of years of professional experience was 9 years. Painkillers (41.9%) were the most widely prescribed drugs, followed by antibiotics, which were particularly involved in the onset of adverse effects (41.8%). Adverse effects were observed by just 3.8% of the sample. Almost 90% of the participants were not aware of the existing pharmacovigilance system. The results suggest that pharmacovigilance training and education sessions for dentists are needed to improve their knowledge of pharmacovigilance and to foster positive attitudes toward adverse effects.

  3. Pharmacovigilance in China: current situation, successes and challenges.

    Science.gov (United States)

    Zhang, Li; Wong, Lisa Y L; He, Ying; Wong, Ian C K

    2014-10-01

    With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.

  4. Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme : A Prospective Cohort Study

    NARCIS (Netherlands)

    Schutte, Tim; Tichelaar, Jelle; Reumerman, Michael O; van Eekeren, Rike; Rolfes, Leàn; van Puijenbroek, Eugène P; Richir, Milan C; van Agtmael, Michiel A

    2017-01-01

    INTRODUCTION: Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run

  5. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal

    Directory of Open Access Journals (Sweden)

    Palaian S

    2011-12-01

    Full Text Available Pharmacovigilance can be helpful in protecting consumers from harmful effects of medicines. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In Nepal, pharmacovigilance activities were initiated in 2004. Objectives: The present study evaluated the knowledge, attitude and practices (KAP of the healthcare professionals towards ADRs and pharmacovigilance in Manipal Teaching Hospital (MTH, a tertiary care teaching hospital attached to the regional pharmacovigilance center in western Nepal. Methods: A cross-sectional study was carried out in 2007 using a pretested (Cronbach alpha=0.72 questionnaire having 25 questions (15 questions on knowledge, 5 on attitude and 5 on practice. The correct/positive responses were given a score of ‘2’ and the wrong/negative responses ‘1’, maximum possible score of ‘50’. Results: A total of 131 responses were obtained among which 42 were incomplete and remaining 89 [females 49 (55.1%] were analyzed. Of the 89 professionals, 29 (32.6% were doctors, 46 (51.8 nurses and 14 (15.7% pharmacists. The mean age was 28.32 (SD=8.46 years and the median (interquartile range of duration of the service 14.5 (6-36 months. The total KAP scores was 40.06 (SD=3.51 for doctors, 38.92 (SD=4.83 for pharmacists, and 35.82 (SD=3.75 for nurses. Among the 89 professionals, 59 (62.3% had not reported even a single ADR to the pharmacovigilance center. Conclusion: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals.

  6. Pharmacovigilance, risks and adverse effects of self-medication.

    Science.gov (United States)

    Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle; Abadie, Delphine; Lacroix, Isabelle; Berreni, Aurélia; Pugnet, Grégory; Durrieu, Geneviève; Sailler, Laurent; Giroud, Jean-Paul; Damase-Michel, Christine; Montastruc, François

    2016-04-01

    Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  7. Short and long-term impact of pharmacovigilance training on the pharmacovigilance knowledge of medical students.

    Science.gov (United States)

    Arici, M Aylin; Gelal, Ayse; Demiral, Yucel; Tuncok, Yesim

    2015-01-01

    The aim of this study was to evaluate the short and long-term impact of pharmacovigilance (PV) training on the 5th year medical students' knowledge about definitions and on the awareness of the regulatory aspects in PV. In academic year 2010/11, the students completed structured, questionnaire before and just after training. They also completed the same questionnaire 1-year after the training. The students' knowledge about PV significantly increased after training in the short term (P training. PV training increased the students' knowledge significantly. However, in the long-term, the impact of the training is limited. Repeated training of PV should be planned.

  8. Obstacles to transparency over pharmacovigilance data within the EMA.

    Science.gov (United States)

    2015-11-01

    In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held by the European Pharmacovigilance Risk Assessment Committee (PRAC), in order to defend their drug. They also provide for the possibility of holding non-public hearings to discuss public data. There is a great risk that the drug industry might use these provisions to influence the debate. The strings attached to the access that the EMA proposes to grant researchers to data contained in the centralised European pharmacovigilance database would allow the EMA to censor the publication of their findings. The EMA seems to regard pharmacovigilance data as commercially confidential information. Responding to these consultations provided an opportunity to remind the EMA that data about adverse effects are a public good, in the common interest, and that it is unacceptable to keep this information confidential.

  9. What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?

    Science.gov (United States)

    Price, John

    2016-12-01

    The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients. Opportunities related to potential future big data sources are discussed. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  10. Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

    Science.gov (United States)

    Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

    2017-03-22

    We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

  11. Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale.

    Science.gov (United States)

    Rachlis, Beth; Karwa, Rakhi; Chema, Celia; Pastakia, Sonak; Olsson, Sten; Wools-Kaloustian, Kara; Jakait, Beatrice; Maina, Mercy; Yotebieng, Marcel; Kumarasamy, Nagalingeswaran; Freeman, Aimee; de Rekeneire, Nathalie; Duda, Stephany N; Davies, Mary-Ann; Braitstein, Paula

    2016-10-01

    Targeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy (ART). Minimal data exist on the needs or capacity of facilities to conduct TSR. Using data from the International epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium, the present study had two objectives: (1) to develop a list of facility characteristics that could constitute key assets in the conduct of TSR; (2) to use this list as a starting point to describe the existing capacity of IeDEA-participating facilities to conduct pharmacovigilance through TSR. We generated our facility characteristics list using an iterative approach, through a review of relevant World Health Organization (WHO) and Uppsala Monitoring Centre documents focused on pharmacovigilance activities related to HIV and ART and consultation with expert stakeholders. IeDEA facility data were drawn from a 2009/2010 IeDEA site assessment that included reported characteristics of adult and pediatric HIV care programs, including outreach, staffing, laboratory capacity, adverse event monitoring, and non-HIV care. A total of 137 facilities were included: East Africa (43); Asia-Pacific (28); West Africa (21); Southern Africa (19); Central Africa (12); Caribbean, Central, and South America (7); and North America (7). Key facility characteristics were grouped as follows: outcome ascertainment and follow-up; laboratory monitoring; documentation-sources and management of data; and human resources. Facility characteristics ranged by facility and region. The majority of facilities reported that patients were assigned a unique identification number (n = 114; 83.2 %) and most sites recorded adverse drug reactions (n = 101; 73.7 %), while 82 facilities (59.9 %) reported having an electronic database on site. We found minimal information is available about facility characteristics that may contribute to pharmacovigilance activities. Our findings

  12. Safety profile of etifoxine: A French pharmacovigilance survey.

    Science.gov (United States)

    Cottin, Judith; Gouraud, Aurore; Jean-Pastor, Marie-Josèphe; Dautriche, Anne Disson-; Boulay, Charlène; Geniaux, Hélène; Auffret, Marine; Bernard, Nathalie; Descotes, Jacques; Vial, Thierry

    2016-04-01

    Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine-related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine-related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens-Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness-like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy-proven microscopic colitis of which one recurred after etifoxine re-administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  13. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  14. [Pharmacovigilance center --internal medicine interactions: A useful diagnostic tool].

    Science.gov (United States)

    Rochoy, M; Gautier, S; Bordet, R; Caron, J; Launay, D; Hachulla, E; Hatron, P-Y; Lambert, M

    2015-08-01

    Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  15. Pharmacovigilance of herbal medicines in Africa: Questionnaire study.

    Science.gov (United States)

    Skalli, Souad; Bencheikh, Rachida Soulaymani

    2015-08-02

    In order to describe and evaluate Herbal Medicine (HM) pharmacovigilance in African countries who are members of the WHO International Programme for Drug Monitoring a survey questionnaire was sent to the national centres and national drug regulatory agencies of these countries. Data collection was carried out from October 1st to 31st December, 2014. Among the total of 39 African countries, 34 (87.2%) answered the questionnaire and 25 (64.1%) accepted to share their data in this publication. Spontaneous adverse reaction reporting for HM is voluntary in 7 (43.7%) countries. HM pharmacovigilance programmes covered suspected adverse HM reactions in 14 (87.5%) countries; HM information in 7 (43.7%) countries; HM dependence or abuse in 6 (37.5%) countries; medication errors in 5 (31.2%) countries; falsification and adulteration in 2 (each 12.5%) countries and HM-drug interactions in 1 (6.3%) country. Groups in countries encouraged to submit herbal reports were pharmacists and physicians (both n=15); nurses (n=13); herbal therapists (n=12); patients (n=11) and local manufacturers (n=8). The number of herbal reports received by most countries was very low or even insignificant. VigiFlow is used by 10 countries. Information from pharmacovigilance activities is disseminated using many means. Only five countries have regulatory status and quality control of their HM products. The participants identified a need for HM regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharmacovigilance of HM is required in Africa. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Opportunities for Collaboration at the Interface of Pharmacovigilance and Manufacturing.

    Science.gov (United States)

    Beninger, Paul

    2017-04-01

    A case can be made that much common ground exists between pharmacovigilance and pharmaceutical manufacturing. Of the 8 major US statutes that shaped the pharmaceutical industry since early in the 20th Century, 7 followed fatally catastrophic events related to the use of a manufactured product, and 1 followed the discovery of a counterfeit product. To facilitate an understanding of the interplay between pharmacovigilance and manufacturing, it is convenient to divide manufacturing into 3 categories: (1) upstream sourcing of materials: pharmacovigilance plays an important role when adverse event clusters are seen during routine vigilance detection processes and the suspicion turns to possibly contaminated source material, (2) the manufacturing process itself: pharmacovigilance may be called on to conduct a health hazard evaluation if a manufacturing deviation is detected after product release (the assessment can inform the depth of a recall), and (3) downstream distribution and product use: there is only light regulation of the interval between product distribution after manufacturing release and just before administration to patients, a time during which product may be subject to an out-of-specification determination for environmental controls or subject to malfeasant activities, such as counterfeit substitution or product diversion. Recently introduced statutory remedies, including the FDA Safety and Innovation Act and the Drug Supply Chain Security Act in the United States and the Falsified Medicines Directive (directive 2011/62/EC) in the European Union, can provide capabilities to support pharmacovigilance signal management activities that have the potential to reduce the risk to patients of experiencing adverse events caused by counterfeit, diverted, or tampered product. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

  17. Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

    Directory of Open Access Journals (Sweden)

    Marília Berlofa Visacri

    2014-04-01

    Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

  18. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 1: Executive summary

    Science.gov (United States)

    1981-01-01

    Main elements of the design are identified and explained, and the rationale behind them was reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates are presented, and the engineering issues that should be reexamined are identified. The latest (1980-1981) information from the MHD technology program is integrated with the elements of a conventional steam power electric generating plant.

  19. Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal.

    Science.gov (United States)

    Palaian, Subish; Ibrahim, Mohamed I M; Mishra, Pranaya

    2010-07-01

    Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries. To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals. During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases. A high percentage of

  20. Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

    Directory of Open Access Journals (Sweden)

    Palaian S

    2010-09-01

    Full Text Available Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries. Objectives: To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. Methodology: Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008 were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals. Results: During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34% were related to case reports and letters. The median (interquartile range age of the patients described in the case reports was 46.5 (21.7-51.2 years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2. Majority of the published case reports were related to skin (n=13; 72.2%. Antimicrobials were responsible for 27.8% (n=5 of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were

  1. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 4: Supplementary engineering data

    Science.gov (United States)

    1981-01-01

    The reference conceptual design of the Magnetohydrodynamic Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD is summarized. Main elements of the design are identified and explained, and the rationale behind them is reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates, and identification of engineering issues that should be reexamined are also given. The latest (1980-1981) information from the MHD technology program are integrated with the elements of a conventional steam power electric generating plant. Supplementary Engineering Data (Issues, Background, Performance Assurance Plan, Design Details, System Design Descriptions and Related Drawings) is presented.

  2. Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

    Directory of Open Access Journals (Sweden)

    Driss Soussi Tanani

    2014-01-01

    Full Text Available The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP. Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October 2012; period 2: October 2012–December 2013. The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P<10-3. The average age was 40.7±17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7% predominated during the first period, while skin reactions (24.1% were in the second period (P=10-4, and 40.9% of cases in the first period were serious against 15.8% in second period (P=0.003. Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting. Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

  3. Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery

    NARCIS (Netherlands)

    Bate, Andrew; Beckmann, Juergen; Dodoo, Alexander; Härmark, Linda; Hartigan-Go, Kenneth; Hegerius, Anna; Lindquist, Marie; van Puijenbroek, Eugene; Tuccori, Marco; Hagemann, Ulrich

    The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step

  4. Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

    Science.gov (United States)

    Bate, Andrew; Beckmann, Jürgen; Dodoo, Alexander; Härmark, Linda; Hartigan-Go, Kenneth; Hegerius, Anna; Lindquist, Marie; van Puijenbroek, Eugène; Tuccori, Marco; Hagemann, Ulrich

    2017-03-01

    The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

  5. Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study.

    Science.gov (United States)

    Schutte, Tim; Tichelaar, Jelle; Reumerman, Michael O; van Eekeren, Rike; Rolfes, Leàn; van Puijenbroek, Eugène P; Richir, Milan C; van Agtmael, Michiel A

    2017-05-01

    Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme. In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme. From May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding. The student-run pharmacovigilance programme is a win-win venture. It offers students a valuable 'pharmacovigilance experience', creates awareness in future doctors, and has the potential to increase pharmacovigilance skills and knowledge.

  6. The EU-ADR Web Platform: delivering advanced pharmacovigilance tools.

    Science.gov (United States)

    Oliveira, José Luis; Lopes, Pedro; Nunes, Tiago; Campos, David; Boyer, Scott; Ahlberg, Ernst; van Mulligen, Erik M; Kors, Jan A; Singh, Bharat; Furlong, Laura I; Sanz, Ferran; Bauer-Mehren, Anna; Carrascosa, Maria C; Mestres, Jordi; Avillach, Paul; Diallo, Gayo; Díaz Acedo, Carlos; van der Lei, Johan

    2013-05-01

    Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitoring and exploring these data, enabling an in-depth analysis of adverse drug reactions risks. The EU-ADR Web Platform exploits the wealth of data collected within a large-scale European initiative, the EU-ADR project. Millions of electronic health records, provided by national health agencies, are mined for specific drug events, which are correlated with literature, protein and pathway data, resulting in a rich drug-event dataset. Next, advanced distributed computing methods are tailored to coordinate the execution of data-mining and statistical analysis tasks. This permits obtaining a ranked drug-event list, removing spurious entries and highlighting relationships with high risk potential. The EU-ADR Web Platform is an open workspace for the integrated analysis of pharmacovigilance datasets. Using this software, researchers can access a variety of tools provided by distinct partners in a single centralized environment. Besides performing standalone drug-event assessments, they can also control the pipeline for an improved batch analysis of custom datasets. Drug-event pairs can be substantiated and statistically analysed within the platform's innovative working environment. A pioneering workspace that helps in explaining the biological path of adverse drug reactions was developed within the EU-ADR project consortium. This tool, targeted at the pharmacovigilance community, is available online at https://bioinformatics.ua.pt/euadr/. Copyright © 2012 John Wiley & Sons, Ltd.

  7. Veterinary pharmacovigilance in India: A need of hour.

    Science.gov (United States)

    Kumar, Rishi; Kalaiselvan, Vivekanandan; Verma, Ravendra; Kaur, Ismeet; Kumar, Pranay; Singh, G N

    2017-01-01

    Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

  8. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

    Science.gov (United States)

    Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

    2015-09-01

    To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

  9. Performance assessment of the Thai National Center for Pharmacovigilance.

    Science.gov (United States)

    Kaewpanukrungsi, Wanida; Anantachoti, Puree

    2015-01-01

    The Thai National Pharmacovigilance Center (NPVC) has operated since 1983, but its performance has never been formally assessed. The paper aimed to present the main findings of performance assessment of the Thai NPVC. A survey was conducted. Data from January 2011-December 2013 were collected. The performance was assessed through four indicator domains. The NPVC has a clear mission to guide its roles and responsibilities. The center has a well-established structure, adequate budget, qualified personnel, and good IT infrastructure, but it has no in-house IT personnel.Safety surveillance function was considered excellent. The Thai adverse drug reaction database accumulate a number of quality reports. Typically, new signals of traditional or herbal medicines could be generated from the database.The risk management process was well established and carried out. The National Drug Safety Advisory Sub-Committee was composed of qualified representatives from related disciplines. Not only do these committee members make safety decisions, but they also provide key safety messages and communicate these to their member audiences.The risk communication function was evaluated to be unsatisfactory. It was not effectively distributed to individual health care professionals. The overall performance of the Thai NPVC was considerably good. The findings suggested that risk communication should be improved. Moreover, organizational performance should be routinely evaluated. If possible, benchmarking with international pharmacovigilance centers should also be performed.

  10. Pharmacovigilance Mobile Tool Design in the Field of Arhroplasty.

    Science.gov (United States)

    Åserød, Hanne; Babic, Ankica

    2017-01-01

    Pharmacovigilance is an important part of the patient safety and it has a great appeal to physicians. It is concerned with the safety of medical devices and treatments in the light of understanding the risks and dangers based on the already reported safety issues. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The research looked at how Human Computer Interaction could improve user experience. We have designed data entry for safety reporting and pharmacovigilance based on the web-bases system called WebBISS (Web-based implant search system). The expectation is not only to improve usability, but also to stimulate physicians to enter their safety data and become also contributors, and not only users of information. The expert evaluation has been generally positive and encouraged stronger help and error reporting functions. The high fidelity design has given a good impression of the future mobile solution.

  11. Modern Approaches to Continuous Audit in the Pharmacovigilance System Vinnytsia region: the Results of 2016

    Directory of Open Access Journals (Sweden)

    Fedir Hladkykh

    2017-12-01

    Full Text Available The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 is proposed, taking into account the capacity of health facilities at the local level.

  12. Safety of a pasteurized plasma-derived Factor VIII and von Willebrand factor concentrate: analysis of 33 years of pharmacovigilance data.

    Science.gov (United States)

    Kouides, Peter; Wawra-Hehenberger, Kathrin; Sajan, Anna; Mead, Henry; Simon, Toby

    2017-10-01

    Haemate-P/Humate-P (Humate-P) is a pasteurized human plasma-derived concentrate containing both Factor VIII and von Willebrand factor for treatment of hemophilia A and von Willebrand disease (VWD). We analyzed the safety of Humate-P based on more than 33 years of postmarketing pharmacovigilance data, representing an estimated exposure of approximately 25,000 patient-years. The analysis comprises reports of potential adverse drug reactions (ADRs) from all sources, reported as part of routine pharmacovigilance at CSL Behring. ADRs considered clinically relevant or potential risks of Humate-P were identified based on defined and standardized Medical Dictionary for Regulatory Activities queries. Recognizing the limitations of spontaneous reporting, we also reviewed the literature, including clinical trials with mandatory reporting. From 1982 to 2015, a total of 670 postmarketing cases had been reported via pharmacovigilance, for an overall reporting rate of approximately one ADR per 3900 administered standard doses. Of these cases, 343 involved ADRs considered clinically relevant risks (33 thromboembolic complications, 97 inhibitor formation, 110 hypersensitivity or allergic reactions) or potential risks (103 suspected virus transmissions) for Humate-P. Most thromboembolic complications occurred in patients undergoing surgery or with other known risk factors. Inhibitor formation occurred mostly in patients with hemophilia A (24 cases were high titer). Most patients with hypersensitivity or allergic reactions had VWD. None of the reported suspected virus transmission cases were confirmed to be associated with Humate-P. Reported results of company-sponsored studies showed a low incidence of adverse events possibly or probably related to Humate-P. More than 33 years of pharmacovigilance data continue to support the safety of Humate-P. © 2017 The Authors. Transfusion published by Wiley Periodicals, Inc. on behalf of AABB.

  13. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance

    National Research Council Canada - National Science Library

    Permanand, Govin; Mossialos, Elias; McKee, Martin

    2006-01-01

    ...), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU.

  14. Pharmacovigilance Programme of India: Recent developments and future perspectives.

    Science.gov (United States)

    Kalaiselvan, Vivekanandan; Thota, Prasad; Singh, Gyanendra Nath

    2016-01-01

    Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.

  15. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors - A Nationwide Study in the Netherlands.

    Science.gov (United States)

    Schutte, Tim; Tichelaar, Jelle; Reumerman, Michael O; van Eekeren, Rike; Rissmann, Robert; Kramers, Cornelis; Richir, Milan C; van Puijenbroek, Eugène P; van Agtmael, Michiel A

    2017-05-01

    Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the under-reporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in pharmacovigilance, by assessing their pharmacovigilance awareness, skills and knowledge. The study was a nationwide e-survey among medical students (third to sixth year) of all eight medical schools in the Netherlands. The survey consisted of questions regarding pharmacovigilance awareness, skills and knowledge. Overall, 874 students provided informed consent and participated (response 12%). Almost all students (96%) intended to report serious ADRs in their future practice. Almost half (44%) of the students did not know where to report an ADR, and 78% did not know which items were necessary for a good-quality ADR report. While more than 78% of the students agreed that pharmacovigilance is an important topic in their medical education, only 26% found that their current curriculum covered pharmacovigilance adequately. Although ADR reporting is considered relevant and important among future doctors, many do not know where and what to report. This is highly undesirable and should have consequences for pharmacotherapy teaching. © 2016 The Authors. Basic & Clinical Pharmacology & Toxicology published by John Wiley & Sons Ltd on behalf of Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  16. Perception of pharmacovigilance among doctors in a tertiary care hospital: influence of an interventional lecture.

    Science.gov (United States)

    Sanghavi, Dhara R; Dhande, Priti P; Pandit, Vijaya A

    2013-01-01

    One of the important pillars of an efficient pharmacovigilance system is contribution by healthcare professionals in the form of spontaneous reporting. This study was aimed at investigating the knowledge, attitude and practice of spontaneous ADR reporting among doctors in a teaching hospital in Pune, and to analyze the effect of an informative lecture about Pharmacovigilance on the same. This was an interventional study conducted among 220 doctors at a tertiary care teaching hospital, Pune. Each participant was explained the purpose of study and asked to fill in a questionnaire about their knowledge, attitude and practice of pharmacovigilance. Only 80 of them attended the interventional lecture on Pharmacovigilance and again filled up the questionnaire after a period of one month from this intervention. Merely 7.5% of the participants knew ADR reporting system in India. Majority of the respondents (95%) knew that, as doctors, they could report ADRs but were unaware about the methodology to report (92.5%) which affected their practice of Pharmacovigilance. All (100%) the participants expressed that proper training should be provided to clinicians for ADR reporting & 81% felt ADR reporting should be made mandatory. Only 80 participants (36.4%) attended the interventional lecture which reflected a poor response. Intervention improved their (96%) knowledge about ADR reporting system and now majority of them (92%) agreed that all sort of ADRs should be reported (p pharmacovigilance.

  17. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

    Science.gov (United States)

    Santoro, Aniello; Genov, Georgy; Spooner, Almath; Raine, June; Arlett, Peter

    2017-10-01

    This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

  18. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process

    Science.gov (United States)

    Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

    2017-01-01

    Background Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. Objective This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. Methods In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Results Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules

  19. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process.

    Science.gov (United States)

    Bousquet, Cedric; Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

    2017-09-21

    Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules

  20. Non-medical prescribers and pharmacovigilance: participation, competence and future needs.

    Science.gov (United States)

    Stewart, Derek; MacLure, Katie; Paudyal, Vibhu; Hughes, Carmel; Courtenay, Molly; McLay, James

    2013-04-01

    To determine UK non-medical prescribers' (NMPs) (supplementary or independent) current participation and self-reported competence in pharmacovigilance, and their perceptions of training and future needs. Non-medical prescribers in health care in the United Kingdom. Awareness of and participation in the Yellow Card Scheme (YCS); attitudes towards ADR reporting; strategies to encourage reporting; pharmacovigilance training; and demographics. The sample comprised nurse (n = 912) and pharmacist (n = 2,439) NMPs in the UK. Self-reported competence in pharmacovigilance, knowledge of and participation in the YCS, attitudes towards ADR reporting; strategies to encourage ADR reporting; pharmacovigilance training during NMP training. Six hundred and thirteen responses were received giving an overall response rate of 20.4 %. Response rates for nurse and pharmacist prescribers were 32.2 % (n = 293) and 13.1 % (n = 320) respectively. Three hundred and fifty-nine respondents (58.6 %) had submitted a Yellow Card. Although the majority of respondents (70.4 %) felt competent in pharmacovigilance, a third (34.2 %) said they needed further training. Respondents reported a positive attitude towards ADR reporting, yet only a minority (22.9 %) correctly answered factual questions about the YCS. Approximately a third of respondents (35.6 %) "couldn't remember" if pharmacovigilance was covered in their prescribing training. Publicity and education were commonly suggested measures to enhance contribution to the YCS. While NMPs report participation and competence in ADR reporting, there are several key issues to consider including the need for further training and support to optimise their role in pharmacovigilance.

  1. Prospects of consumer-initiated adverse drug reaction reporting in cardiovascular pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Vinu Wilson

    2015-01-01

    Full Text Available Drugs used for the treatment of cardiovascular disorders are frequently reported to cause adverse drug reactions (ADRs, second only to antimicrobials. ADRs strain the patients′ health and finances further and could prove fatal too. Pharmacovigilance programs aim to detect, monitor and understand ADRs in order to prevent them. Pharmacovigilance provides vital input to drug regulatory agencies to monitor safety of new as well as old drugs. Spontaneous reporting of suspected ADRs by healthcare professionals forms the backbone of pharmacovigilance programs worldwide including the Pharmacovigilance Program of India (PvPI launched in 2010. The PvPI has significantly contributed to strengthening pharmacovigilance in India but suffers from under-reporting of ADRs like similar programs worldwide. Consumer-initiated reporting of ADRs incorporated in pharmacovigilance programs of several countries has been found to decrease under-reporting rates besides supplementing traditional pharmacovigilance information. The PvPI has recently introduced the facility for consumers to report ADRs by contacting a hotline (1800-180-3024, through e-mail (pvpi.compat@gmail.com or by filling specifically designed ADR reporting forms, either in English language or vernacular translations, and submitting them to the nearest ADR monitoring centre. This is a welcome step in empowering patients as consumers of drugs with the mechanism to monitor their safety. It could potentially fill the huge gap in spontaneous ADR reporting and supplement the indigenous drug safety database with patients′ perspectives regarding ADRs e.g. effect on their quality of life. Whether it encourages rational prescription practices by doctors or enhances transparency regarding safety of investigational drugs in clinical trials needs to be seen.

  2. Effect of an educational intervention on knowledge and attitude regarding pharmacovigilance and consumer pharmacovigilance among community pharmacists in Lalitpur district, Nepal.

    Science.gov (United States)

    Jha, Nisha; Rathore, Devendra Singh; Shankar, Pathiyil Ravi; Bhandary, Shital; Pandit, Rabi Bushan; Gyawali, Sudesh; Alshakka, Mohamed

    2017-01-03

    Pharmacovigilance activities are in a developing stage in Nepal. ADR reporting is mainly confined to healthcare professionals working in institutions recognized as regional pharmacovigilance centers. Community pharmacists could play an important role in pharmacovigilance. This study was conducted among community pharmacists in Lalitpur district to examine their knowledge and attitude about pharmacovigilance before and after an educational intervention. Knowledge and attitude was studied before, immediately after and 6 weeks following the intervention among 75 community pharmacists. Responses were analysed using descriptive and inferential statistics. A pretested questionnaire having twelve and nine statements for assessing knowledge and attitude were used. The overall scores were obtained by adding the 'knowledge' and 'attitude' scores and 'overall' scores were summarized using median and interquartile range. Wilcoxon signed-rank test for repeated samples was used to compare the differences between knowledge and attitude of the pharmacists before and after the educational program. Knowledge scores [median (interquartile range)] improved significantly between pre-test [39 (44-46)], post-test [44 (44-44)] and retention period of 6 weeks after the intervention [46 (43-46)]. Knowledge score improved immediately post-intervention among both males [44 (41-47)] and females [44 (43-45)] but the retention scores (after 6 weeks) were higher [46 (42-48)] among males. Attitude scores improved significantly among females [46 (44-48)]. The overall scores were higher among pharmacists from rural areas. Knowledge and attitude scores improved after the educational intervention. Further studies in other regions of the country are required. The national pharmacovigilance center should promote awareness about ADR reporting among community pharmacists.

  3. Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

    Science.gov (United States)

    2013-01-01

    The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting. In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use. We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way. PMID:23758677

  4. A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria.

    Science.gov (United States)

    Awodele, O; Daniel, A; Popoola, T D; Salami, E F

    2013-01-01

    There is an increasing use of herbal products and herbal medicines globally with the belief that herbal medicines are always 'safe' and carry no risk because they are from natural sources. However, there are concerns regarding medicinal plants and their ability to produce adverse effects. The growing herbal medicine usage has increased the need to monitor the safety of herbal medicines. Thus, the recommended approach by the World Health Organization (WHO) is to include herbal medicines in existing national pharmacovigilance systems. This study aimed to determine the knowledge of pharmacovigilance of herbal medicines amongst herbal medicine practitioners. The study was carried out in Lagos West Senatorial District of Lagos State, Nigeria. Three categories of practitioners (378 respondents) were engaged and they include Traditional Herbal Sellers, Natural Health Practitioners and Pharmacists. The results showed that herbal medicines are commonly recommended for malaria, typhoid, diabetes and fever. 281 (74.3%) of the respondents claimed that herbal medicines have no adverse effects and only 91 (24.1%) of the respondents said there were some adverse effects reported by the users. Adverse effects reported include nausea, diarrhoea and weight loss. Amongst those that received reports of adverse effects, only 19 (20.9%) documented these reported adverse effects; none of these documentations were forwarded to the regulatory bodies or national pharmacovigilance centre in Nigeria. These results showed inadequate adverse effects monitoring (Pharmacovigilance) amongst the practitioners and underscore the necessity to educate and enlighten herbal medicine practitioners on the need for pharmacovigilance activity of herbal products.

  5. Pharmacovigilance on Twitter? Mining Tweets for Adverse Drug Reactions

    Science.gov (United States)

    O’Connor, Karen; Pimpalkhute, Pranoti; Nikfarjam, Azadeh; Ginn, Rachel; Smith, Karen L; Gonzalez, Graciela

    2014-01-01

    Recent research has shown that Twitter data analytics can have broad implications on public health research. However, its value for pharmacovigilance has been scantly studied – with health related forums and community support groups preferred for the task. We present a systematic study of tweets collected for 74 drugs to assess their value as sources of potential signals for adverse drug reactions (ADRs). We created an annotated corpus of 10,822 tweets. Each tweet was annotated for the presence or absence of ADR mentions, with the span and Unified Medical Language System (UMLS) concept ID noted for each ADR present. Using Cohen’s kappa1, we calculated the inter-annotator agreement (IAA) for the binary annotations to be 0.69. To demonstrate the utility of the corpus, we attempted a lexicon-based approach for concept extraction, with promising success (54.1% precision, 62.1% recall, and 57.8% F-measure). A subset of the corpus is freely available at: http://diego.asu.edu/downloads. PMID:25954400

  6. A day in the life of a pharmacovigilance case processor

    Directory of Open Access Journals (Sweden)

    Ritesh Bhangale

    2017-01-01

    Full Text Available Pharmacovigilance (PV has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug and “Vigilare” (Latin for to keep watch. It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

  7. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders.

    Science.gov (United States)

    Wettach, Carmen; Thomann, Janine; Lambrigger-Steiner, Claudia; Buclin, Thierry; Desmeules, Jules; von Mandach, Ursula

    2013-05-01

    To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.

  8. A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals.

    Science.gov (United States)

    Stergachis, Andy; Bartlein, Rebecca J K; Dodoo, Alexander; Nwokike, Jude; Kachur, S Patrick

    2010-05-30

    Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. The Global Fund-Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund-Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active

  9. Healthcare professionals' awareness and knowledge of adverse drug reactions and pharmacovigilance.

    Science.gov (United States)

    Almandil, Noor B

    2016-12-01

    To document the knowledge of, attitudes toward, and practices of adverse drug reaction (ADR) reporting and pharmacovigilance systems among healthcare professionals. Methods: This descriptive cross-sectional study was conducted using a questionnaire. This study took place at King Fahd Hospital of the University (KFHU), Khobar, Kingdom of Saudi Arabia,  between  April 2015 and  April 2016. Healthcare professionals, including physicians, pharmacists, pharmacy technicians, and nurses, were considered eligible and invited to take part in the study. A link to the online questionnaire was sent to each participant via E-mail, and a hard copy was circulated at the hospital after the objectives of the study were explained. The questionnaire comprised items regarding knowledge/awareness of pharmacovigilance and ADRs, perception/attitude towards pharmacovigilance and ADR reporting, and practices of ADR reporting. Descriptive statistics were used to analyze the data. Results: A total of 400 questionnaires were distributed to the healthcare professionals and 331 participants responded, providing a response rate of 82.75%. The healthcare professionals comprised 161 physicians, 39 pharmacists, 21 pharmacist technicians, and 110 nurses. Most of the participants were female (n=198) and Saudi (61.9%). Most healthcare professionals (62.5%) were unaware of the term pharmacovigilance; the pharmacists and pharmacist technicians had the highest rate of pharmacovigilance awareness (60.5% of the pharmacists and 40% of pharmacist technicians). Conclusion: There is a lack of awareness and knowledge of pharmacovigilance and ADR reporting among healthcare professionals working at KFHU.

  10. Pharmacovigilance in the Middle East: a survey of 13 arabic-speaking countries.

    Science.gov (United States)

    Wilbur, Kerry

    2013-01-01

    The importance of countries to support their own national pharmacovigilance cannot be understated. While adverse drug reaction (ADR) data from other countries is helpful in making medication safety decisions, information may not be relevant or applicable to domestic populations. The aim of this study was to inventory national pharmacovigilance systems in place in the Middle East region. The Uppsala Monitoring Centre Assessment of Country Pharmacovigilance Situation questionnaire (February 2008) was adapted and translated into Arabic and administered to the head of the identified centres responsible for medication safety in 13 Arabic-speaking Middle Eastern countries. This survey contains domains pertaining to general programme information; overview of technology and personnel support; suspected ADR reporting and subsequent data use; and pharmacovigilance activity and advocacy. Data for 11 countries were obtained: representatives from two countries did not participate (Lebanon, Syria). Six described formal national pharmacovigilance programmes (Egypt, Iraq, Jordan, Oman, Kingdom of Saudi Arabia and the United Arab Emirates), while five (Bahrain, Kuwait, Palestine, Qatar and Yemen) reported no active programme or designated centre. The majority are government funded, but staff resources are constrained, ranging from two to ten people. Sixty-seven percent of programmes facilitated submission of spontaneous ADRs to the centre by email, but none directly through a web-based platform. All used the information for drug regulatory purposes and five reported dissemination of safety information to the public. This is the first survey to inventory the status of pharmacovigilance in the Middle East. While a number of countries participate in suspected ADR reporting activities, an estimated population of 30-50 million is without formal domestic programmes. Current emphasis of drug safety in the region is on detection and prevention of counterfeit products reaching the consumer

  11. The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

    Science.gov (United States)

    Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

    2016-01-01

    With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    Science.gov (United States)

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  13. Gentamicin nephrotoxicity: Animal experimental correlate with human pharmacovigilance outcome

    Directory of Open Access Journals (Sweden)

    Olufunsho Awodele

    2015-04-01

    Full Text Available Background: National Agency for Food and Drugs Administration and Control (NAFDAC, which is responsible for pharmacovigilance activity in Nigeria, recently withdrew injection gentamicin 280 mg, used in the management of life-threatening and multidrug-resistant infections from circulation, due to reported toxicity. Thus, this study aimed to investigate the toxicity profile of the commonly used strengths (80 mg and 280 mg of gentamicin on kidney using animal models. Methods: Animals were divided into five groups of 16 rats each. For rats of groups 1 and 2, gentamicin (1.14 mg/kg each group was administered intramuscularly twice daily for 7 and 14 days, respectively, after which eight of them were sacrificed by cervical dislocation. Blood was collected via cardiac puncture and the kidneys were carefully removed and weighed immediately. The remaining eight animals were kept for reversibility study for another 7 and 14 days, respectively. For groups 3 and 4, gentamicin (4 mg/kg each group was administered as a single daily dose for 7 and 14 days, respectively, and eight animals from the groups were subjected to reversibility study for 7 and 14 days, respectively. Group 5, the control group animals, were given 10 ml/kg distilled water for 14 days. Histopathology of the kidneys, serum creatinine levels, and antioxidant enzyme activities were investigated. Results: Significant increase (p ≤ 0.001 in the level of creatinine of rats administered 4.0 mg/kg for 14 days was observed compared with all other groups. Significant (p ≤ 0.001 elevations in the lipid peroxidation in all gentamicin-administered animals and acute tubular necrosis in most of the gentamicin-administered animals were observed. Conclusion: Toxicity profile of gentamicin on the kidneys is dependent on both dose and duration of administration. The findings justify the decision made by NAFDAC to ban the use of high-dose inj. gentamicin 280 mg in Nigeria.

  14. Pharmacovigilance Discussion Forum--The European Generic Medicines Association's 8th Annual Meeting (January 21, 2015--London, UK).

    Science.gov (United States)

    Lam, S

    2015-01-01

    The practice and science of pharmacovigilance first emerged following the disaster caused by thalidomide in 1961, which led to the initiation of systemic international efforts to address drug safety issues spearheaded by the WHO. Systems were developed in member states of the WHO to analyze cases of adverse drug reactions (ADRs) and collate these data into a central database to aid national drug regulatory authorities in improving safety profiles of medicines. Pharmacovigilance is a key public health function for monitoring all medicinal products to assess their quality, efficacy and safety before and following authorization. These medicines are continually assessed to detect any aspect that could compromise their safety, and ensure that the necessary measures are taken. In July 2012, new legislation for pharmacovigilance in the E.U. came into effect as a result of the changes set out in the Directive 2010/84/EU and the European Commission (EC) implementing Regulation (EU) No 520/2012 to reduce the increasing number of ADRs. The latest developments in pharmacovigilance in Europe, including news on E.U. pharmacovigilance legislation, were discussed at the 8th European Generic Medicines Association (EGA) Pharmacovigilance Discussion Forum. The meeting facilitated constructive dialogue between regulators and industry on a range of topics including how to simplify pharmacovigilance activities and improve the processes of risk management plans, periodic safety update reports, signal detection, joint studies and inspections. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  15. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital.

    Science.gov (United States)

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2014-01-01

    With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. The 74.1% of the nurses definition of "severe adverse effect" of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance.

  16. Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

    Science.gov (United States)

    Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

    2017-07-01

    Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets.

  17. The impact of exposure model misspecification on signal detection in prospective pharmacovigilance.

    Science.gov (United States)

    van Gaalen, Rolina D; Abrahamowicz, Michal; Buckeridge, David L

    2015-05-01

    Pharmacovigilance monitors the safety of drugs after their approval and marketing. Timely detection of adverse effects is important. The true relationship between time-varying drug use and the adverse event risk is typically unknown. Yet, most current pharmacovigilance studies rely on arbitrarily chosen exposure metrics such as current exposure or use in the past 3 months. The authors used simulations to assess the impact of a misspecified exposure model on the timeliness of adverse effect detection. Prospective pharmacovigilance studies were simulated assuming different true relationships between time-varying drug use and the adverse event hazard. Simulated data were analyzed by fitting conventional parametric and more complex spline-based estimation models at multiple, pre-specified testing times. The 'signal' was generated on the basis of the corrected model-specific p-value selected to ensure a 5% probability of incorrectly rejecting the null hypothesis of no association. Results indicated that use of an estimation model that diverged substantially from the true underlying association-reduced sensitivity and increased the time to detection of a clinically important association. Time to signal detection in pharmacovigilance may depend strongly on the method chosen to model the exposure. No single estimation model performed optimally across different simulated scenarios, suggesting the need for data-dependent criteria to select the model most appropriate for a given study. Copyright © 2014 John Wiley & Sons, Ltd.

  18. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors - A Nationwide Study in the Netherlands

    NARCIS (Netherlands)

    Schutte, Tim; Tichelaar, Jelle; Reumerman, Michael O; van Eekeren, Rike; Rissmann, Robert; Kramers, Cornelis; Richir, Milan C; van Puijenbroek, Eugène P; van Agtmael, Michiel A

    2016-01-01

    Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the underreporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in

  19. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors - A Nationwide Study in the Netherlands

    NARCIS (Netherlands)

    Schutte, T.; Tichelaar, J.; Reumerman, M.O.; Eekeren, R. van; Rissmann, R.; Kramers, C.; Richir, M.C.; Puijenbroek, E.P. van; Agtmael, M.A. van

    2017-01-01

    Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the under-reporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in

  20. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  1. Pharmacovigilance implemented by patients: A necessity in the 21st century.

    Science.gov (United States)

    Lafond, Jean

    2016-04-01

    Pharmacovigilance should become a well-thought-out reflex for each of us, for any drugs taken on prescription or by self-medication. The issue of pharmacovigilance should naturally take its place in the dialogue between patients and health professionals, through advice given before medication is taken. Patients need to be told the importance of notifying any adverse drug reactions (ADRs). Pharmacovigilance would then become a post-hoc way of protecting patients. The importance of using pharmacovigilance should be promoted by emphasizing the fact that the life of a drug really starts after its marketing. This state of mind could be reinforced by a wider advertising campaign on the possibility of notifying the relevant authorities of any ADRs. Patient associations should encourage and help their members to do this. Notifying any ADRs should become a concern for all medical and paramedical staff: those who prescribe drugs, those who dispense them (pharmacists or pharmacy assistants), those who administer them (nurses), but also the consumers (patients) whose place is becoming more and more prominent. Copyright © 2016. Published by Elsevier Masson SAS.

  2. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    Science.gov (United States)

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

  3. An evaluation of the knowledge and perceptions of pharmacy students on pharmacovigilance activities in Nigeria.

    Science.gov (United States)

    Osemene, Kanayo P; Afolabi, Margaret O

    2017-07-12

    The use of the modified-prescription event monitoring technique has facilitated the understanding and reporting of pharmacovigilance (PV). However, in Nigeria, PV activities are largely misunderstood. Furthermore, there is a dearth of information on the knowledge and perceptions of pharmacy students on PV activities in relation to demographics. This study investigated and assessed the knowledge and perceptions of pharmacy students about pharmacovigilance as well as the demographic factors that are related to pharmacovigilance activities. A cross-sectional survey was conducted among final year pharmacy students in three universities in months of January and February, 2016 with permission from the institutions and with written consents from 342 respondents. Pre-tested questionnaire was used to elicit information on the study objectives. Data were analysed using appropriate descriptive and inferential statistical techniques. The study revealed that the mean score on knowledge of pharmacy students on pharmacovigilance activities was 4.3 ± 0.18 which was significant according to gender (P activities which was significant at P activities. Therefore, pharmacy student educators should enhance students' knowledge about PV through training, during clerkship, and lay more emphasis on relevant PV courses in the Pharmacy Curriculum.

  4. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-01-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining. PMID:25744369

  5. Classification of Recombinant Biologics in the EU: Divergence between National Pharmacovigilance Centers

    NARCIS (Netherlands)

    Klein, Kevin; De Bruin, Marie L.; Broekmans, Andre W.; Stolk, Pieter

    2015-01-01

    Background and Objective: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level

  6. Pharmacovigilance training for specialist oncology nurses-a two way evaluation

    NARCIS (Netherlands)

    Schutte, T.; Van Eekeren, R.; Richir, M.; Van Staveren, J.; Van Puijenbroek, E.P.; Tichelaar, J.; Van Agtmael, M.A.

    2017-01-01

    Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses.

  7. Quality management system as a tool for improvement of the dutch pharmacovigilance system

    NARCIS (Netherlands)

    Zweers, P.G.M.A.; Van Puijenbroek, E.P.; Van Grootheest, A.C.

    2009-01-01

    Introduction: The Netherlands Pharmacovigilance centre Lareb started as a regional organization in 1985. In 1995 it was appointed by the Health Authorities as the national centre for collection and analysis for reports of adverse drug reactions. Since then, Lareb has become a solid, professional

  8. Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia.

    Science.gov (United States)

    Alshammari, Thamir M; Alamri, Khaled K; Ghawa, Yazeed A; Alohali, Noura F; Abualkol, Shaza A; Aljadhey, Hisham S

    2015-12-01

    Drug safety has major implications for patients' lives. However, this concept is still considered new to some healthcare professionals. This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.

  9. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Science.gov (United States)

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

  10. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Directory of Open Access Journals (Sweden)

    Ruwen Böhm

    Full Text Available Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS. OpenVigil FDA provides disproportionality analyses to (i identify the drug most likely evoking a new adverse event, (ii compare two drugs concerning their safety profile, (iii check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

  11. National strategy for the integration of pharmacovigilance in the Moroccan TB Control Program.

    Science.gov (United States)

    Tanani, Driss Soussi; Serragui, Samira; Hammi, Sanae; Moussa, Latifa Ait; Soulaymani, Abdelmajid; Soulaymani, Rachida; Cherrah, Yahia

    2017-01-01

    The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). The integration of pharmacovigilance in MTCP was conducted in October 2012with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010-October2012; period 2: October 2012-December 2013). The detection of signals was based on the Information Component available inVigiMine. We used the SPSS version 10.0 and Med Calc version 7.3 for data analysis. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (Ppharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

  12. Cyberpharmacovigilance: What is the usefulness of the social networks in pharmacovigilance?

    Science.gov (United States)

    Bagheri, Haleh; Lacroix, Isabelle; Guitton, Emmanuelle; Damase-Michel, Christine; Montastruc, Jean-Louis

    2016-04-01

    Internet is changing the way people learn about health and illness. Health websites are among the most popular resources on the web. The sharing of patient experiences on a website could be an interesting source of information about adverse drug reactions (ADRs) or could generate "signals". Three examples of the use of patient forums in pharmacovigilance are discussed: (1) analysis of perceptions of risk by patients before and after withdrawal of benfluorex, and then following media coverage; (2) comparison of oral antineoplasic-induced ADRs collected on patient websites with those registered in the French pharmacovigilance database; (3) analysis of data found in the social media about drugs and pregnancy. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  13. Heart rhythm risturbances associated with rupatadine: a case series from the Spanish and Portuguese Pharmacovigilance Systems

    OpenAIRE

    Carvajal García-Pando, Alfonso; Macías, D.; Salado, Inés; Sáinz, M.; Ortega, Sara; Campo, C.; García del Pozo, Javier; Martín Arias, Luis; Velasco Martín, Alfonso; R Gonçalves; Pombal, R.; Carmona, R

    2009-01-01

    Producción Científica We searched the Spanish and Portuguese pharmacovigilance databases for spontaneous case reports of heart rhythm disturbances associated with rupatadine and other new H1 antihistamines. Five cases were found involving patients treated with rupatadine (13.9% of all reports relating to this drug). In all five cases, the reaction started after exposure and resolved when the drug was discontinued. In two cases, rupatadine was the only medication being taken by the patient,...

  14. [Cyamemazine (Tercian®): Exploration of extrapyramidal syndrome cases contained in the French pharmacovigilance database].

    Science.gov (United States)

    Khouri, Charles; Lepelley, Marion; Villier, Céline; Bougerol, Thierry; Mallaret, Michel

    2017-06-01

    Cyamemazine (Tercian®) is currently the most widely prescribed neuroleptic in France. This widespread use is due to its anxiolytics properties and to a claimed good safety profile. Although, prescription of cyamemazine is not devoid of the risks associated with the use of neuroleptics: extrapyramidal syndromes. This study aims at describing extrapyramidal syndromes induced by cyamemazine registered in the French pharmacovigilance database. All spontaneous reports of extrapyramidal syndromes in the French pharmacovigilance database between 1st January 1985 and 31th December 2015 were described and analyzed. During this period 132 cases following cyamemazine intake were reported in the French pharmacovigilance database. The extrapyramidal syndromes were considered as "serious" in 77% of cases. More than 80% of the cases were described with a dosage of cyamemazine under 100mg/day and no correlation between drug dose and seriousness of the cases were found. Thirty-six cases were described with a monotherapy of cyamemazine. We should keep in mind that despite its widespread use in various indications (e.g. anxiolytic) cyamemazine remains a neuroleptic and could induce extrapyramidal syndromes even with low dosage. Careful monitoring should be performed when introducing and with long-term use of cyamemazine, mostly in elderly patients or patient already being treated with neuroleptics. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  15. [Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center].

    Science.gov (United States)

    Saint-Martin, Caroline; Kanagaratnam, Lukshe; de Boissieu, Paul; Azzouz, Brahim; Abou Taam, Malak; Trenque, Thierry

    2016-10-01

    To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. An observational study on all ADR notifications recorded in the French pharmacovigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics. During the study period, 632 notifications were collected. The most frequently reported ATC (anatomical, therapeutic and chemical) classes were vaccines (15.9%), antineoplastics (12%) and antibiotics (11.1%). Forty-six percent of the notifications were serious. For serious ADRs, the most involved drugs were paracetamol, asparaginase and ibuprofen. Skin reactions were the most often reported ADRs. The most common lowest level terms (LLT) were urticaria (4.9%), hypersensitivity (4.1%), fever (2.9%) and vomiting (2.8%). ADR reporting to the pharmacovigilance system, in particular pediatric ADRs, should be encouraged. Information on the use of medicinal products, especially on self-medication use, need to be improve. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  16. Safety monitoring of local anaesthetic drugs from the perspective of Pharmacovigilance Programme of India

    Directory of Open Access Journals (Sweden)

    Pramod Kumar

    2017-01-01

    Full Text Available Pharmacovigilance Programme of India (PvPI was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs to the database and can draw signals for regulatory decisions. To foster the culture of spontaneous reporting, India has launched paperless and simple modes of reporting ADRs such as Helpline and an Android application. This will help to create a national centre of excellence at par with global drug safety monitoring standards. With the increasing popularity of regional anaesthesia, adverse events may occur due to local anaesthetic drugs, techniques and adjuvants. Uncommon but clinically significant ADRs can be identified in a nationwide pharmacovigilance programme. Anaesthesiologists in India are encouraged to report local anaesthesia-related ADRs to the national pharmacovigilance database.

  17. Comparison of two drug safety signals in a pharmacovigilance data mining framework.

    Science.gov (United States)

    Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

    2016-04-01

    Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database. © The Author(s) 2012.

  18. Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

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    Francesca Scicchitano

    2012-01-01

    Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  19. Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

    Directory of Open Access Journals (Sweden)

    Karen Maigetter

    2015-05-01

    Full Text Available Background Pharmacovigilance (PV data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI interviews and compares them with the World Health Organization’s (WHO’s minimum PV requirements for a Functional National PV System. Methods A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs, members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory

  20. Two decades of pharmacovigilance and clinical experience with highly purified rabies immunoglobulin F(ab')2 fragments.

    Science.gov (United States)

    Reveneau, Elisa; Cottin, Pascale; Rasuli, Anvar

    2017-03-01

    Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab')2 fragments from equine rabies immunoglobulin (F(ab')2 pERIG; FavirabTM) in rabies PEP. Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab')2 pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014. The general safety profile of F(ab')2 pERIG is discussed, as are the occurrence of rare anaphylactic reactions, and suspected intervention failure. Expert commentary: Over 20 years of clinical development and post-licensure experience has established the safety and effectiveness of F(ab')2 pERIG (FavirabTM) in rabies PEP.

  1. Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs.

    Science.gov (United States)

    Lu, Zhengwu

    2010-01-01

    To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience - summarization of this information is presented. Further, we presented a list of concrete technical considerations in dealing with EDC technology/system limitations based on literature assessment and industry implementation experience. It is recognized that cross-functional teams be involved in eCRF design process and decision making. To summarize the keys in designing eCRFs to address post-market study safety and pharmacovigilance needs, the first is to identify required data elements from the study protocol supporting data analyses and reporting requirements. Secondly, accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard should be considered and applied. Coding (MedDRA & WHODD) mapping should be managed and implemented as well when possible. Finally, we need to be on top of the EDC technologies, challenge the technologies, drive EDC improvement via working with vendors, and utilize the technologies to drive clinical effectiveness. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  2. Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?

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    Pramod Kumar Sharma

    2016-01-01

    Full Text Available Background and Objectives: Reporting adverse drug reactions (ADRs associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. Materials and Methods: The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. Results: A total of 106 (faculty = 56; residents = 50 participated in survey. The most common cause cited for not reporting an ADR was “do not know how to report” by 64.15%. Majority of them (64% had no information about the Pharmacovigilance Programme of India (PvPI, and only few (8.5% had actually reported or published an ADR. Interpretation and Conclusions: ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.

  3. The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

    Science.gov (United States)

    Smith, Meredith Y; Benattia, Isma

    2016-09-01

    Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

  4. Serotonin Syndrome: Analysis of Cases Registered in the French Pharmacovigilance Database.

    Science.gov (United States)

    Abadie, Delphine; Rousseau, Vanessa; Logerot, Sophie; Cottin, Judith; Montastruc, Jean-Louis; Montastruc, François

    2015-08-01

    More information would be required for a better understanding of the actual circumstances of serotonin syndrome (SS) occurrence in routine clinical practice. The objective of the study was to analyze characteristics of SS French pharmacovigilance reports, especially involved drugs and nature of drug-drug interactions (DDIs). We performed a retrospective analysis of SS registered in the French pharmacovigilance database between January 1, 1985 and May 27, 2013. Only cases whose clinical symptoms fulfilled Sternbach, Radomski, or Hunter SS diagnostic criteria were retained for the analysis. Most of the 125 (84.0%) analyzed cases were associated with a recent change in a serotonergic drug (introduction, increasing the dose or overdose). Antidepressants were the most often involved serotonergic drugs, mostly serotonin reuptake inhibitors (SRIs, 42.1%) and to a lesser extent serotonin-noradrenalin reuptake inhibitors (9.1%, mainly venlafaxine), tricyclic antidepressants (8.6%, mainly clomipramine), and some monoamine oxidase inhibitors (6.2%, mainly moclobemide). Nonpsychotropic medications were also involved, generally opioids (14.8%, mainly tramadol). Most of the cases (59.2%) resulted from pharmacodynamic DDIs, most often involving SRIs + opioids (mostly paroxetine + tramadol). However, SS also occurred with a single serotonergic drug in a significant number of cases (40.8%), most often SRIs (mainly fluoxetine) or venlafaxine at usual doses. Lastly, a major pharmacokinetic DDI could have played a role in 1/5 (20.8%) of cases. This is the first study about SS based on a large pharmacovigilance database and published in English. Our results reveal not only the frequent involvement of antidepressants and tramadol, the importance of DDIs (both pharmacodynamic and pharmacokinetic), but also the significant risk of SS even with a single serotonergic drug used at normal dose.

  5. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

    Directory of Open Access Journals (Sweden)

    Zhengwu Lu

    2009-10-01

    Full Text Available Zhengwu LuClinical Research Department, Abbott Vascular, Santa Clara, CA, USAAbstract: Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.Keywords: information technology, pharmacovigilance, safety, standard, risk management, adverse event

  6. Extent of pharmacovigilance among resident doctors in Edo and Lagos states of Nigeria.

    Science.gov (United States)

    Ohaju-Obodo, J O; Iribhogbe, O I

    2010-02-01

    Systematic attention to adverse drug reactions (ADRs) started with the thalidomide disaster in the early 60s of the 20(th) century. In 1968 ten countries supported a spontaneous reporting system for ADR and collaborated with the WHO pilot research project for international drug monitoring. This survey was conducted to determine the level of awareness of resident doctors about ADRs reporting, the extent of their involvement in pharmacovigilance activities and to build a useful data base that will improve the quality of health care in Nigeria. This cross-sectional observational survey was conducted in University of Benin Teaching Hospital (UBTH) and Irrua Specialist Teaching Hospital (ISTH), Lagos University Teaching Hospital (LUTH) and Lagos State University Teaching Hospital (LASUTH) in Edo and Lagos states, Nigeria, respectively. STUDY DESIGN / METHODS: A cross-sectional observational survey was used in this study. Total population under survey being 971 residents with the sample size of 350 statistically determined. The survey conducted revealed that 78.1% (258) of the respondents had inadequate knowledge about pharmacovigilance with 71.2% (235) unaware of the yellow forms for ADR reporting distributed by the National Agency for Food and Drug Administration and Control (NAFDAC). The respondents (92.4%) have observed ADRs in the course of their training and practice, yet only 25.5% of cases were reported. The reported cases (7.3%) were to the National Agency for Food and Drug Administration and Control. The study showed a statistically significant difference between the institution of respondents, knowledge and experience about pharmacovigilance (p Edo and Lagos states. This may be what obtains in other states in Nigeria.

  7. Pharmacovigilance: What to do if you see an adverse reaction and the consequences

    Energy Technology Data Exchange (ETDEWEB)

    Stenver, Doris I. [Danish Medicines Agency, 1 Axel Heides Gade, DK-2300 Copenhagen S (Denmark)], E-mail: dis@dkma.dk

    2008-05-15

    With outset in a recently identified safety signal - the association between gadolinium and nephrogenic systemic fibrosis - the article highlights the aim of pharmacovigilance and provides an overview of the European regulatory drug safety network. The main objective of the article is to provide appropriate information concerning the regulatory environment to health care professionals working in a clinical setting. The important role played by health care professionals in drug safety surveillance, as well as examples of how the regulatory decision making is functioning in practice, are described and exemplified by means of the gadolinium case.

  8. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  9. Drugs and dilated cardiomyopathies: a case/noncase study in the French PharmacoVigilance Database

    Science.gov (United States)

    Montastruc, Guillaume; Favreliere, Sylvie; Sommet, Agnès; Pathak, Atul; Lapeyre-Mestre, Maryse; Perault-Pochat, Marie-Christine; Montastruc, Jean-Louis

    2010-01-01

    AIMS To evaluate putative associations between drugs and dilated cardiomyopathy. METHODS We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. RESULTS Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were ‘suspect’. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. CONCLUSIONS The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors …), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals. PMID:20233200

  10. Bisphosphonate-related osteonecrosis of the jaw: data from the French national pharmacovigilance database.

    Science.gov (United States)

    de Boissieu, Paul; Gaboriau, Louise; Morel, Aurore; Trenque, Thierry

    2016-10-01

    The aim of this study was to describe bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the French national pharmacovigilance database. BRONJ was identified with the standardized MedDRA query (SMQ) 'osteonecrosis' among all data from 1985 to 31 December 2014. Because this SMQ was not specific to the jaw localization, selection of cases based on anatomy was performed after data extraction. For each case, demographic and medical information was analysed, as well as data about notification (year of notification, year of occurrence, outcome, seriousness). Known associated factors for BRONJ were also documented: dentoalveolar surgery, glucocorticoids, chemotherapy, anti-angiogenics, denosumab. Among 1404 SMQ notifications, 663 were located in the jaws and 629 were associated with bisphosphonate use. BRONJ reported in the database mainly affected women (n = 443, 71%) with an oncological indication (n = 440, 70%). BRONJ was considered as serious in 91%. Outcome was unfavourable for 92% of cases. Associated factors were identified for 70% of the patients. A peak of notification was noted in 2014 (13% of all cases), but on analysis by year of occurrence instead of by year of notification, this peak disappeared. SMQ 'osteonecrosis' appears to be an adequate tool to analyse BRONJ in a pharmacovigilance database. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  11. Therapeutic drug monitoring as a measure of proactive pharmacovigilance in child and adolescent psychiatry.

    Science.gov (United States)

    Gerlach, Manfred; Egberts, Karin; Dang, Su-Yin; Plener, Paul; Taurines, Regina; Mehler-Wex, Claudia; Romanos, Marcel

    2016-11-01

    Off-label or unlicensed use of psychotropic drugs is common rather than the exception in child and adolescent psychiatry. This use exposes patients to an unknown additional risk of ineffective or even harmful treatment. In addition, treatment with psychotropic drugs during a period of life when the patient undergoes marked developmental hormonal and neurobiological changes often requires different dosing regimes in later life and may result in adverse drug reactions, which are either not seen in adults at all or not in the same frequency. Areas covered: Given these critical safety issues, efficient pharmacovigilance methods as part of routine practice are essential for the improvement of patient care. The purpose of this article is to introduce methods to increase the safety of psychotropic drug use in youngsters. In particular, therapeutic drug monitoring (TDM) as a routine measure of proactive pharmacovigilance is discussed. Expert opinion: Given the special features of psychopharmacological therapy in children and adolescents in day-to-day clinical practise, proactive surveillance by using a close standardized 'patient monitoring' and long-term follow-up with TDM is very important. This approach could minimize the risk of exposing paediatric patients to ineffective treatments of uncertain or unknown risks.

  12. Causality assessment in pharmacovigilance: The French method and its successive updates.

    Science.gov (United States)

    Miremont-Salamé, Ghada; Théophile, Hélène; Haramburu, Françoise; Bégaud, Bernard

    2016-04-01

    The methods for causality assessment of adverse drug reactions were developed in the 1970s and 1980s, alongside the development of pharmacovigilance. The French method is one of the earlier of these, following on from the pioneering works by Irey and Karch and Lasagna. Initially published in 1978, it was updated in 1985, and again in 2011. The main alterations to the original method are presented in tables annexed to this paper. The successive versions improved the presentation, provided more formalised definitions of the criteria for assessing causality, while at the same time ensuring the method remained easy to use. Causality assessment enables the causal link between a drug and the occurrence of an adverse reaction to be formalised and explained. It contributes to diagnosis, and to determining the action to be taken in case of an adverse drug reaction. It can contribute to the quality and the relevance of the data stored in pharmacovigilance databases. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  13. Kounis Syndrome: An analysis of spontaneous reports from international pharmacovigilance database.

    Science.gov (United States)

    Renda, Francesca; Landoni, Giovanni; Trotta, Francesco; Piras, Desiderio; Finco, Gabriele; Felicetti, Patrizia; Pimpinella, Giuseppe; Pani, Luca

    2016-01-15

    The coincidental occurrence of a cardiac symptomatology (e.g. an acute coronary syndrome or a myocardial infarction), during an anaphylactic or anaphylactoid episode is known as Kounis Syndrome. A variety of drugs, substances, food and environmental exposures are associated with this reaction. There is an exponential increase in the number of published scientific articles reports on this syndrome, but since it is rare, the largest case series published so far included only 10 and 6 patients. We searched the global World Health Organization database called VigiBase™ to detect all cases of Kounis Syndrome ever reported (last update December 31st 2014). We identified 51 cases of Kounis Syndrome reported to International Pharmacovigilance Agency (VigiBase™). All these cases were reported in the period 2010-2014 and almost half cases (22 reports) belonged to the year 2014. Most cases occurred in the USA and non-steroidal anti-inflammatory drugs were the most frequent trigger drugs. We collected pharmacovigilance international data representing the largest case series ever published on the recently identified Kounis Syndrome. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  14. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

    Science.gov (United States)

    Lu, Zhengwu

    2009-01-01

    Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

  15. New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS).

    Science.gov (United States)

    Shin, Ju-Young; Jung, Sun-Young; Ahn, So-Hyeon; Lee, Shin Haeng; Kim, Su-Jin; Seong, Jong-Mi; Chung, Soo-Youn; Park, Byung-Joo

    2014-11-01

    Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS. In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications. Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance. The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information. Copyright © 2014 John Wiley & Sons, Ltd.

  16. Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project

    NARCIS (Netherlands)

    Bousquet, P.-J.; Demoly, P.; Romano, A.; Aberer, W.; Bircher, A.; Blanca, M.; Brockow, K.; Pichler, W.; Torres, M. J.; Terreehorst, I.; Arnoux, B.; Atanaskovic-Markovic, M.; Barbaud, A.; Bijl, A.; Bonadonna, P.; Burney, P. G.; Caimmi, S.; Canonica, G. W.; Cernadas, J.; Dahlen, B.; Daures, J.-P.; Fernandez, J.; Gomes, E.; Gueant, J.-L.; Kowalski, M. L.; Kvedariene, V.; Mertes, P.-M.; Martins, P.; Nizankowska-Mogilnicka, E.; Papadopoulos, N.; Ponvert, C.; Pirmohamed, M.; Ring, J.; Salapatas, M.; Sanz, M. L.; Szczeklik, A.; van Ganse, E.; de Weck, A. L.; Zuberbier, T.; Merk, H. F.; Sachs, B.; Sidoroff, A.

    2009-01-01

    Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of

  17. Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project.

    Science.gov (United States)

    Bousquet, P-J; Demoly, P; Romano, A; Aberer, W; Bircher, A; Blanca, M; Brockow, K; Pichler, W; Torres, M J; Terreehorst, I; Arnoux, B; Atanaskovic-Markovic, M; Barbaud, A; Bijl, A; Bonadonna, P; Burney, P G; Caimmi, S; Canonica, G W; Cernadas, J; Dahlen, B; Daures, J-P; Fernandez, J; Gomes, E; Gueant, J-L; Kowalski, M L; Kvedariene, V; Mertes, P-M; Martins, P; Nizankowska-Mogilnicka, E; Papadopoulos, N; Ponvert, C; Pirmohamed, M; Ring, J; Salapatas, M; Sanz, M L; Szczeklik, A; Van Ganse, E; De Weck, A L; Zuberbier, T; Merk, H F; Sachs, B; Sidoroff, A

    2009-02-01

    Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.

  18. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat.

    Science.gov (United States)

    Upadhyaya, Het B; Vora, Mukeshkumar B; Nagar, Jatin G; Patel, Pruthvish B

    2015-01-01

    Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR). Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP) toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Gujarat (India). A total of 22 questionnaires about KAP toward ADRs and pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from our institute. We were contacted directly to postgraduate students of respective clinical department; questionnaires were distributed and taken back after 30 min. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft Excel spreadsheet. Postgraduate residents (n = 101) from different clinical departments were enrolled in the study. Average 34.83% correct and 64.08% incorrect knowledge about ADRs and pharmacovigilance and an average 90.76% students were agreed to reporting ADRs is necessary, mandatory and increased patient's safety. Only 7.92% of postgraduate doctors were reported ADR at institute or ADR reporting center. We concluded that postgraduate students have a better attitude toward reporting ADRs, but have lack of knowledge and poor practices of ADRs. The majority of postgraduate students were felt ADR reporting and monitoring is very important, but few had ever reported ADRs because of lack of sensitization and knowledge of pharmacovigilance and ADR.

  19. Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

    Science.gov (United States)

    Hopf, Y M; Francis, J; Helms, P J; Haughney, J; Bond, C

    2016-01-01

    Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs. The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland. A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation. 121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach. It would

  20. Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance database.

    Science.gov (United States)

    Laroche, Marie-Laure; Quelven, Isabelle; Mazère, Joachim; Merle, Louis

    2015-01-01

    Radiopharmaceuticals are regarded as safe by the nuclear medicine community, but up to now, no survey has been conducted with from the perspective of pharmacovigilance. To describe the adverse reactions to radiopharmaceuticals (ARRPs) reported to the French Pharmacovigilance Database (FPVD). We selected and described all reports encompassing at least one radiopharmaceutical in the FPVD. The annual incidence of reported ARRPs used in diagnosis was also estimated. From 1989 to 2013, 304 reports of ARRPs were identified (43.0% serious, 12 deaths) in 54.6% women and 45.4% men; the median age was 58 years. Five therapeutic radiopharmaceuticals ((131)I-sodium iodide, (131)I-lipiodol, (89)Sr-chloride, (153)Sm-lexidronam, and (90)Y-ibritumomab-tiuxetan) were involved in 48 reports (97 adverse reactions: 86.6% serious, 9 deaths). Pulmonary disorders represented 44.3% of ARRPs used for therapy, mainly related to (131)I-lipiodol. There were 34 diagnostic radiopharmaceuticals involved in 256 reports (451 adverse reactions: 38.1% serious, 3 deaths); 8 diagnostic products ((99m)Tc-oxidronate, (18)F-fluorodeoxyglucose, (99m)Tc-tin pyrophosphate, (99m)Tc-tetrofosmin, (99m)Tc-dimercaptosuccinic acid, (201)Tl-chloride, (99m)Tc-sestamibi, and (111)In-pentetate) accounted for two-thirds of ARRPs. The most frequent adverse reactions were skin (34.4%), general (18.2%), nervous (9.0%), and gastrointestinal disorders (7.0%). There were 25 cases of altered images and 10 medication errors. The annual incidence of reported adverse reactions ranged from 1.2 × 10(-5) to 3.4 × 10(-5) diagnostic administrations. Reported ARRPs occurred rarely and were more serious in the therapeutic than in the diagnostic field. The notification of ARRPs was able to provide new guidance for safe use, as was the case for (131)I-lipiodol. Therefore, it is important to report ARRPs to a pharmacovigilance system. © The Author(s) 2014.

  1. Knowledge, attitudes and practice of pharmacovigilance among health care professionals in Indonesia

    Directory of Open Access Journals (Sweden)

    Grace Wangge

    2016-07-01

    Abstract Background: World Health Organization (WHO defines pharmacovigilance (PV as a science and activities related to detection, assessment, understanding and prevention of adverse effect or any other drug related problem. It aims to enhance patient care and patient safety in drug use. Although Indonesia has joined WHO international drug safety monitoring program since 1970s, the implementation is not applied effectively especially in developing country and there are poor contribution of health care professionals (HCPs as an agent of the program. In this study, we assessed current knowledge, activities and practice of PV among HCPs in Indonesia. Methods: This is a preliminary survey using a questionnaire distributed among HCPs through health seminar and internet. The questionnaire consists of statement/question about knowledge(6, activities(6 and whether HCPs who encounter ADRs handle and report it correctly.  If the respondents gave 80 % suitable answers in the knowledge or attitude sections, they were categorized as having “good” knowledge or attitude. We analyzed whether knowledge, attitude and other characteristic had any influence on the respodents PV practice. Results: We included 109 questionnaires from 118 distributed questionnaires. Most of the respondents were females (90 respondents, 82.6%, medical doctors (100 respondents, 91.7%, and were working in primary health care level. Good knowledge was found in 28 (25.7 % of respondents, while good attitude towards PV were found in less than 20 % (18 of the respondents. Only 4 (3.7 % of total respondents did a good pharmacovigilance practice.  We found no significant association between level of knowledge, attitude and other factors to the poor pratice of PV. Conclusion: The knowledge, activities and practices of pharmacovigilance among HCPs in Indonesia were poor and requires a continuous socialization among HCPs in different level of care. Key Words: pharmacovigilance, health care professionals, patient

  2. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    Science.gov (United States)

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  3. Heart rhythm disturbances associated with rupatadine: a case series from the Spanish and Portuguese pharmacovigilance systems.

    Science.gov (United States)

    Carvajal, A; Macías, D; Salado, I; Sáinz, M; Ortega, S; Campo, C; García del Pozo, J; Martín Arias, L H; Velasco, A; Gonçalves, S; Pombal, R; Carmona, R

    2009-05-01

    We searched the Spanish and Portuguese pharmacovigilance databases for spontaneous case reports of heart rhythm disturbances associated with rupatadine and other new H1 antihistamines. Five cases were found involving patients treated with rupatadine (13.9% of all reports relating to this drug). In all five cases, the reaction started after exposure and resolved when the drug was discontinued. In two cases, rupatadine was the only medication being taken by the patient, and no other condition that could explain the heart rhythm disturbances was diagnosed. The reporting odds ratio was 3.2 (95% confidence interval, 1.0-10.5). The reporting rate was 2 cases per 100,000 patients treated per year (95% confidence interval, 0.4-6.0). These results suggest a causal relationship between rupatadine and heart rhythm disturbances.

  4. [Evaluation of the website of the Nord-Pas-de-Calais regional pharmacovigilance center].

    Science.gov (United States)

    Rochoy, Michaël; Béné, Johana; Messaadi, Nassir; Auffret, Marine; Gautier, Sophie

    2016-06-01

    We posted the Nord-Pas-de-Calais regional pharmacovigilance center website and distributed a survey to its potential users between August 2014 and October 2014 (135 general practitioners, 45 pharmacists, 14 patients). Satisfaction was 7.3±1.6 out of 10 points for the visual aspect, 7.8±1.5 out of 10 points for navigation and 7.6±1.4 out of 10 points for content. The website was declared useful by 98% respondents, particularly for the reporting of adverse drugs reactions (89%). Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  5. Should methods of correction for multiple comparisons be applied in pharmacovigilance?

    Directory of Open Access Journals (Sweden)

    Lorenza Scotti

    2015-12-01

    Full Text Available Purpose. In pharmacovigilance, spontaneous reporting databases are devoted to the early detection of adverse event ‘signals’ of marketed drugs. A common limitation of these systems is the wide number of concurrently investigated associations, implying a high probability of generating positive signals simply by chance. However it is not clear if the application of methods aimed to adjust for the multiple testing problems are needed when at least some of the drug-outcome relationship under study are known. To this aim we applied a robust estimation method for the FDR (rFDR particularly suitable in the pharmacovigilance context. Methods. We exploited the data available for the SAFEGUARD project to apply the rFDR estimation methods to detect potential false positive signals of adverse reactions attributable to the use of non-insulin blood glucose lowering drugs. Specifically, the number of signals generated from the conventional disproportionality measures and after the application of the rFDR adjustment method was compared. Results. Among the 311 evaluable pairs (i.e., drug-event pairs with at least one adverse event report, 106 (34% signals were considered as significant from the conventional analysis. Among them 1 resulted in false positive signals according to rFDR method. Conclusions. The results of this study seem to suggest that when a restricted number of drug-outcome pairs is considered and warnings about some of them are known, multiple comparisons methods for recognizing false positive signals are not so useful as suggested by theoretical considerations.

  6. The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.

    Science.gov (United States)

    Hauben, Manfred; Hung, Eric; Wood, Jennifer; Soitkar, Amit; Reshef, Daniel

    2017-05-01

    The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes. These medical concepts (MCs) were mapped to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) used in FAERS to code AEs. Negative controls (NC) were MCs with circumscribed PTs not included in the corresponding US package insert (USPI). We calculated shrinkage-adjusted observed-to-expected (O/E) reporting frequencies for the aforementioned drug-PT pairs. We also formulated an adjudication framework to calculate performance at the MC level. Performance metrics [sensitivity, specificity, positive and negative predictive value (PPV, NPV), signal/noise (S/N), F and Matthews correlation coefficient (MCC)] were calculated for each analysis and compared. The PC reference set consisted of 11 drugs, 487 PTs, 27 MCs, 37 drug-MC combinations and 638 drug-event combinations (DECs). The NC reference set consisted of 11 drugs, 9 PTs, 5 MCs, 40 drug-MC combinations and 67 DECs. Most drug-event pairs were not highlighted by either analysis. A small percentage of signals of disproportionate reporting were lost, more noise than signal, with no gains. Specificity and PPV improved whereas sensitivity, NPV, F and MCC decreased, but all changes were small relative to the decrease in sensitivity. The overall S/N improved. This oncology drug restricted analysis improved the S/N ratio, removing proportionately more noise than signal, but with significant credible signal loss. Without broader experience and a calculus of costs and utilities of correct versus incorrect classifications in

  7. Evaluation and pharmacovigilance of projects promoting cultivation and local use of Artemisia annua for malaria

    Directory of Open Access Journals (Sweden)

    Oyweka Rosalia

    2011-04-01

    Full Text Available Abstract Background Several non-governmental organisations (NGOs are promoting the use of Artemisia annua teas as a home-based treatment for malaria in situations where conventional treatments are not available. There has been controversy about the effectiveness and safety of this approach, but no pharmacovigilance studies or evaluations have been published to date. Method A questionnaire about the cultivation of A. annua, treatment of patients, and side-effects observed, was sent to partners of the NGO Anamed in Kenya and Uganda. Some of the respondents were then selected purposively for more in-depth semi-structured interviews. Results Eighteen partners in Kenya and 21 in Uganda responded. 49% reported difficulties in growing the plant, mainly due to drought. Overall about 3,000 cases of presumed malaria had been treated with A. annua teas in the previous year, of which about 250 were in children and 54 were in women in the first trimester of pregnancy. The commonest problem observed in children was poor compliance due to the bitter taste, which was improved by the addition of sugar or honey. Two miscarriages were reported in pregnant patients. Only four respondents reported side-effects in other patients, the commonest of which was vomiting. 51% of respondents had started using A. annua tea to treat illnesses other than malaria. Conclusions Local cultivation and preparation of A. annua are feasible where growing conditions are appropriate. Few adverse events were reported even in children and pregnant women. Where ACT is in short supply, it would make sense to save it for young children, while using A. annua infusions to treat older patients who are at lower risk. An ongoing pharmacovigilance system is needed to facilitate reporting of any adverse events.

  8. Evaluation and pharmacovigilance of projects promoting cultivation and local use of Artemisia annua for malaria.

    Science.gov (United States)

    Willcox, Merlin L; Burton, Shelly; Oyweka, Rosalia; Namyalo, Rehema; Challand, Simon; Lindsey, Keith

    2011-04-11

    Several non-governmental organisations (NGOs) are promoting the use of Artemisia annua teas as a home-based treatment for malaria in situations where conventional treatments are not available. There has been controversy about the effectiveness and safety of this approach, but no pharmacovigilance studies or evaluations have been published to date. A questionnaire about the cultivation of A. annua, treatment of patients, and side-effects observed, was sent to partners of the NGO Anamed in Kenya and Uganda. Some of the respondents were then selected purposively for more in-depth semi-structured interviews. Eighteen partners in Kenya and 21 in Uganda responded. 49% reported difficulties in growing the plant, mainly due to drought. Overall about 3,000 cases of presumed malaria had been treated with A. annua teas in the previous year, of which about 250 were in children and 54 were in women in the first trimester of pregnancy. The commonest problem observed in children was poor compliance due to the bitter taste, which was improved by the addition of sugar or honey. Two miscarriages were reported in pregnant patients. Only four respondents reported side-effects in other patients, the commonest of which was vomiting. 51% of respondents had started using A. annua tea to treat illnesses other than malaria. Local cultivation and preparation of A. annua are feasible where growing conditions are appropriate. Few adverse events were reported even in children and pregnant women. Where ACT is in short supply, it would make sense to save it for young children, while using A. annua infusions to treat older patients who are at lower risk. An ongoing pharmacovigilance system is needed to facilitate reporting of any adverse events.

  9. The importance of monitoring adverse drug reactions in elderly patients: the results of a long-term pharmacovigilance programme.

    Science.gov (United States)

    Carnovale, Carla; Gentili, Marta; Fortino, Ida; Merlino, Luca; Clementi, Emilio; Radice, Sonia; ViGer Group

    2016-01-01

    To recognise and prevent ADRs (including DDIs) in the elderly through a 4-year post-marketing active pharmacovigilance programme. The programme was designed to enhance high quality spontaneous reporting of ADRs in elderly patients by sampling the Italian population and was termed 'Pharmacovigilance in Geriatry (ViGer)'. ADRs were collected for adults aged over 65 years of age treated in nursing homes, continuing care retirement communities and territorial health services in Lombardy. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analysed with respect to time, sex, category of ADR, seriousness, suspected medicines, notoriety. We analysed all the potential DDIs. We detected 1073 cases reports corresponding to 2110 ADRs. Vaccines, antibacterials for systemic use and antineoplastic agents were the pharmacotherapeutic subgroups most frequently involved. 18% of ADRs reports were classified as serious. In 752 reports patients were described as in polytherapy; in 55 patients (7.3%) the reported ADR were probably preventable because of DDIs involvement. The ViGer project demonstrated that active pos-marketing pharmacovigilance programmes are a valid strategy to increase awareness on geriatrics pharmacology, reduce underreporting and provide important information on previous unknown ADRs and DDIs, resulting in a therapy optimisation in clinical practice in the geriatric setting.

  10. Analysis of Patient Narratives in Disease Blogs on the Internet: An Exploratory Study of Social Pharmacovigilance.

    Science.gov (United States)

    Matsuda, Shinichi; Aoki, Kotonari; Tomizawa, Shiho; Sone, Masayoshi; Tanaka, Riwa; Kuriki, Hiroshi; Takahashi, Yoichiro

    2017-02-24

    Although several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as "an account of a struggle with disease." The objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance. We analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks. As of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and abnormal laboratory test result) tended to be

  11. A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 – 2011

    Science.gov (United States)

    Dube, Nomathemba Michell; Summers, Robert; Tint, Khin-San; Mayayise, Guistee

    2012-01-01

    Background Of the 1.6 million South African people infected with human immunodeficiency virus (HIV), approximately 970,000 (55%) have been initiated on HAART. Despite these numbers, very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. Methods A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. Results After HAART initiation, with an average lapse of 17.8 months (range: 0 – 83.8 months), 2,815 patients were enrolled into the study. Results show that patients were observed for 1,606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6% (1,958/2,815) of the study population. Almost all patients initiated HAART on first-line regimens (2,801/2,815). Some patients (6.7%, 190/2,815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5% (22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1%, 678/891), mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0%, 163/678); lipodystrophy (23.9%, 162/678); neuropathy (10.6%, 72/678); and suspected lactic acidosis (3.8%, 26/678). Conclusion The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However, adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should

  12. Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries.

    Science.gov (United States)

    Kovacs, Stephanie D; Mills, Brianna M; Stergachis, Andy

    2017-07-11

    Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank's grants for malaria prevention and control. All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance-related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug

  13. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil

    Science.gov (United States)

    2013-01-01

    Background Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service. Methods A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed. Results The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had

  14. The involvement of Pharmacovigilance Centres in medication errors detection: a questionnaire-based analysis.

    Science.gov (United States)

    Benabdallah, Ghita; Benkirane, Raja; Khattabi, Asmae; Edwards, I Ralph; Bencheikh, Rachida Soulaymani

    2011-01-01

    This study assesses the ability of Pharmacovigilance Centres (PVCs) to detect medication errors (ME) and to proceed to building Patient Safety (PS) via their information networks and to underline the limits for this challenge. This was an exploratory study conducted in PVCs members of the World Health Organization International Drug Monitoring network. A questionnaire specifically designed for the needs of the study was sent to a network via a confidential email system. The questionnaire asked for information, progress and improvement made by PVCs in PS and ME. Among the 88 countries, 21 answered. Reporting of Adverse Drug Reactions (ADRs) by health care professionals (HCP) is mandatory for 42% of PVCs. 100% of countries receive reports from HCP, 66% from patients and 24% from PCCs. ADRs reports are received by all communications means. There is an heterogeneity between countries regarding PVCs and PS activities. Among them, 4 PVCs have the prime activity of PS organization. PVCs are able to detect and analyze ME. There is a need to coordinate efforts between countries to optimize ME detection, and its analysis. Bridges need to be built linking PVCs, PCCs and PS organizations in order to avoid duplication of workload.

  15. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

    Science.gov (United States)

    Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

    2015-01-01

    A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

  16. Impact of manufacturing improvements on clinical safety of albumin: Australian pharmacovigilance data for 1988-2005.

    Science.gov (United States)

    Che, Yan; Wilson, Fiona J; Bertolini, Joseph; Schiff, Peter; Maher, Darryl W

    2006-12-01

    To evaluate the impact of manufacturing improvements on the clinical safety of human albumin solutions in Australia. This retrospective study examined the incidence of spontaneously reported post-market adverse drug reactions (ADRs) in Australia associated with successive generations of albumin products manufactured by the Bioplasma Division of CSL Limited (CSL Bioplasma) over 18 years (1988-2005). Key characteristics of each product generation which could affect clinical safety, such as purity, aggregates and prekallikrein activator (PKA) levels, were also identified from CSL batch release records. A total of 3.7 million bottles of iso-oncotic and hyperoncotic albumin products were distributed in Australia over the period. Improvements to manufacturing processes resulted in products with increased albumin purity, lower levels of impurities such as aggregates and PKA, and reduced batch-to-batch variation. The total ADR incidence (number of ADRs per 100 000 bottles distributed) associated with the products currently supplied was 1.5 and 1.7 for Albumex 4 (2VI) and Albumex 20 (2VI), respectively. This was a significant reduction compared with the earlier generation products Stable Plasma Protein Solution (14.1) and 20% Normal Serum Albumin (11.5), respectively (P<0.0001). In particular, hypotensive reactions declined substantially. Post-market pharmacovigilance data collected for successive generations of human albumin products supplied in Australia over 18 years indicates that manufacturing improvements have significantly improved the clinical safety profile of this product.

  17. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    Science.gov (United States)

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  18. A comparative evaluation of different teaching aids among fourth term medical students to improve the knowledge, attitude and perceptions about pharmacovigilance: An experimental study

    Directory of Open Access Journals (Sweden)

    Harish G. Bagewadi

    2015-04-01

    Full Text Available Objectives: The Study was designed to assess the awareness of Pharmacovigilance and Adverse Drug Reactions (ADR’s and to evaluate the effectiveness of different teaching aids.Materials and Methods: This was a questionnaire-based pre- and post-test on (KAP Knowledge, Attitude, Perception about pharmacovigilance. Students were given handouts regarding pharmacovigilance and ADR reporting one week before the educational interventions. Fourth term medical students (n=72 participated in the study. They were randomly allocated into group A (n=24, group B (n=24 and group C (n=24. A pre-validated 20-point questionnaire on Pharmacovigilance and Adverse Drug Reactions (ADR’s reporting was distributed to each group of students before the educational intervention to know their awareness. The interactive educational interventions on Pharmacovigilance were given using Overhead projector (OHP and transparencies to group A students, Black board (BB method to group B students, Power point presentation (PPT method to group C students respectively. Theoretical content was the same in all the educational interventions. The chi-square test and one way ANOVA was used for statistical calculation.Results: The overall response rates were expressed as percentages, Mean±SD. The Mean Pre-KAP scores on knowledge was (7.7±0.48 but the total post- KAP scores after (OHP, (BB, and (PPT were (12.1±0.39, (17.4±0.3, (19.4±0.21 respectively. The correct response rates were found to be statistically significant (P<0.001.The feedback from the students was encouraging; handouts before the class were greatly welcomed.Conclusion: The study greatly imparted knowledge about pharmacovigilance and ADR’s reporting and students preferred power point presentations the most.

  19. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use.

    Science.gov (United States)

    Knopp, Michael V; Balzer, Thomas; Esser, Marc; Kashanian, Franciska K; Paul, Predip; Niendorf, Hans P

    2006-06-01

    Although contrast agents have become indispensable tools in magnetic resonance and their safe and effective use the foundation of many essential diagnostic procedures, only limited summary information on their utilization and pharmacovigilance is available to the community. After voluntary access to the manufacturer spontaneous adverse event database, we assessed the available data for gadopentetate dimeglumine. Gadopentetate dimeglumine (Gd-DTPA, Magnevist; Berlex/Schering AG, Berlin, Germany) became commercially available in 1988 and is currently marketed in 101 countries. Using the manufacturer's continuous and cumulative database on product distribution and spontaneous adverse event (AE) reporting, we categorized AEs and assessed their cumulative occurrence after 10, 20, and 45 million applications that occurred in 1993, 1997, and 2002, respectively. Furthermore, we reviewed publications in Medline to assess prevalence of the 4 most common MR contrast agents in the indexed literature. Gd-DTPA has been used in more than 45 million magnetic resonance imaging procedures since 1988 and is currently used globally in more than 5 million applications annually. The broadest category of spontaneously reported AEs, subjective symptoms, occurs in less than 0.01% of procedures. Within the total AEs reported, the distribution of serious and nonserious reports was 9.3% and 90.7%, respectively. The rates of AE reporting have changed over time, with increased rates in the second reporting period (1993 to 1997), followed by substantially lower rates in subsequent years. AE reporting rates are the most comprehensive data available; however, there will always be some underestimation of the true event rates. Although no substantial differences were noted among major age groups, substantial differences in reporting frequency were found among regions, with the United States reporting nearly twice as many AEs as Europe in the postmarketing phase. The postmarketing utilization and

  20. Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

    Science.gov (United States)

    Théophile, Hélène; Dutertre, Jean-Paul; Gérardin, Marie; Valnet-Rabier, Marie-Blanche; Bidault, Irène; Guy, Claire; Haramburu, Françoise; Hillaire-Buys, Dominique; Méglio, Carmine; Arimone, Yannick

    2015-01-01

    Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use. A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method. To test the inter- and intra-rater reproducibility, two seniors and two juniors from a PhVC and a pharmaceutical company assessed the pairs twice with the updated method. A weighted kappa coefficient was used to measure the agreement of the two causality assessment methods with the consensual expert judgement (validity) as well as the agreement of the updated causality assessment over time (intra-rater reproducibility) and between evaluators (inter-rater reproducibility). Agreement between the current method and consensual expert judgement was fair for the PhVC team (weighted kappa [Kw] 0.33) and moderate for the pharmaceutical company team (Kw 0.41). For the updated method, agreement was better for both the PhVC (Kw 0.58) and the pharmaceutical company (Kw 0.52) teams. The inter- and intra-rater reproducibility of the updated method based on the intrinsic imputability was satisfactory overall (Kw 0.30-0.91). Discrepancies between evaluations from PhVC and pharmaceutical companies were observed with the updated method. The updated method performed better than the current one for drug causality assessment, suggesting that it should be used in routine pharmacovigilance. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  1. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling.

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    Santiago Vilar

    Full Text Available Identification of Drug-Drug Interactions (DDIs is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs, decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure, adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR. Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate.

  2. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    Full Text Available OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1 an interactive lecture, 2 a practical class, 3 a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4 educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations and the relevance (seriousness and expectancy of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001 and their knowledge of pharmacovigilance (p<0.0001. The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in

  3. Eosinophilic drug reactions detected by a prospective pharmacovigilance programme in a tertiary hospital.

    Science.gov (United States)

    Ramírez, Elena; Medrano-Casique, Nicolás; Tong, Hoi Y; Bellón, Teresa; Cabañas, Rosario; Fiandor, Ana; González-Ramos, Jessica; Herranz, Pedro; Trigo, Elena; Muñoz, Mario; Borobia, Alberto M; Carcas, Antonio J; Frías, Jesús

    2017-02-01

    We conducted a prospective evaluation of all eosinophilic drug reactions (EDRs) through the Prospective Pharmacovigilance Program from Laboratory Signals at Hospital to find out the incidence and distribution of these entities in our hospital, their causative drugs, and predictors. All peripheral eosinophilia >700 × 106  cells l-1 detected at admission or during hospitalisation, were prospectively monitored over 42 months. The spectrum of the localised or systemic manifestation of EDR, the incidence, the distribution of causative drugs, and the predictors were analysed. The incidence of EDR was 16.67 (95% Poisson confidence interval [CI]: 9.90-25.98) per 10 000 admissions. Of 274 cases of EDR, 154 (56.2%) cases in 148 patients were asymptomatic hypereosinophilia. In the remaining 120 (43.8%) cases, there was other involvement. Skin and soft tissue reactions were detected in 36 (13.1%) cases; visceral EDRs in 19(7.0%) cases; and drug-induced eosinophilic cutaneous and visceral manifestations were detected in the remaining 65 (23.7%) cases, 64 of which were potential drug reaction with eosinophilia and systemic symptoms (DRESS). After adjusting for age, sex, and hospitalisation wards, predictors of symptomatic eosinophilia were earlier onset of eosinophilia (hazard ratio [HR], 10.49; 95%CI: 3.13-35.16) higher eosinophil count (HR, 8.51; 95%CI: 3.28-22.08), and a delayed onset of corticosteroids (HR, 1.34; 95%CI: 1.01-1.73). A higher eosinophil count in patients with DRESS was significantly associated with greater impairment of liver function, prolonged hospitalisation, higher cumulative doses of corticosteroids, and if hypogammaglobinaemia was detected, a reactivation of human-herpesvirus 6 was subsequently detected. Half (53.3%, 64/120 cases) of symptomatic EDRs were potential DRESS. The main predictor of severity of EDR was an early severe eosinophilia. © 2016 The British Pharmacological Society.

  4. Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database.

    Science.gov (United States)

    Colin, Olivier; Favrelière, Sylvie; Quillet, Alexandre; Neau, Jean-Philippe; Houeto, Jean-Luc; Lafay-Chebassier, Claire; Pérault-Pochat, Marie-Christine

    2017-04-01

    Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period. To assess the association between PML and drug intake, we calculated an adverse drug report odds ratio (ROR) with its 95% confidence interval. We have studied the delay of onset of PML for each drug concerned. Among the 101 cases of PML, 39 drugs were mentioned as suspect. The main therapeutic classes suspected with significant ROR were antineoplastic agents (n = 85), immunosuppressants (n = 67), and corticosteroids. A latent interval from the time of drug initiation to the development of PML is established: the median time to onset was 365 days (123-1095 days). The onset of PML is highly variable and differs among drug classes [from 1 to 96 months (IQR: 39.0-126)]. An association between PML and some immunosuppressant drugs was found as expected, but also with antineoplastic agents and glucocorticoids. An important delay of PML onset after stopping treatment is suspected and should alert prescribers. Prescribers but also patients should be informed about the potential associations with all these drugs. Monitoring could be necessary for many drugs to early detect PML. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  5. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.

    Science.gov (United States)

    Bahri, Priya

    2010-12-01

    As a contribution to the debate on how best to communicate information on the effective and safe use of medicines to patients, healthcare professionals and the general public, this article proposes to distinguish between communication and transparency purposes, and to test a strategic health communication approach. Any organization aiming to improve medicines use could adapt this approach to its remits and legal obligations. The approach includes agreeing measurable communication objectives through shared problem ownership of all concerned parties, evidence-based design and a cyclic process for planning, implementation and evaluation of communication as a public health intervention. The evidence base, which supplements risk assessment for product- and situation-specific communication on safety concerns, would be derived from research into drug utilization, medical decision making and risk perception, as well as from the participation of patients and healthcare professionals. It is crucial to address the practical questions and concerns of medicine users and to find out why unfavourable patterns of medicine use persist, in order to develop behaviour change models for overcoming these obstacles. For this purpose, appropriate models for facilitating the participation of medicine users in the risk management process will need to be explored. Such two-way communication would inform risk assessment as well as the analysis of risk minimization options, allow for agreement upon communication objectives and enable understandable, attractive communication materials to be designed. The communication programme should use mixed media and repetition of messages for long-term success. This would require cooperation within healthcare and medical information systems. An evaluation of the effectiveness of the communication should support the sustainability of the programme and provide lessons for the future. Given its mission, the pharmacovigilance community has the standing and

  6. Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.

    Science.gov (United States)

    Kaguelidou, Florentia; Beau-Salinas, Frédérique; Jonville-Bera, Annie Pierre; Jacqz-Aigrain, Evelyne

    2016-10-01

    Term and preterm neonates are at high risk for serious adverse drug reactions (ADRs). A descriptive study of reports registered in the French pharmacovigilance database from 1986 to 2012 were obtained. All reports concerning neonates (≤1 month of life) with direct drug exposure were retrieved. Characteristics of the reports, including reported ADR(s), drug(s) and the causality assessment using the French causality assessment method, were described. A total of 1688 reports were analyzed and more than half of them were classified as serious (n = 995). Median age at ADR occurrence was 9 days. Overall, 3127 ADRs were described in these reports in relation to 2238 suspect/interacting drugs. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%) and blood and lymphatic system disorders (12%). In the majority of ADRs reported (73%), infants fully recovered and less than 4% of neonates deceased as a consequence of the reported ADR. One out of five ADRs was associated with drug administration errors. Therapeutic classes commonly incriminated were anti-infectives, nervous system and alimentary tract drugs. Substances most frequently related to serious ADRs were zidovudine, ibuprofen and nevirapine. Among the 10 most frequently encountered drug-ADR pairs, two substances were mainly implicated, zidovudine in haematological adverse reactions and phytomenadione in maladministrations. Anti-infective drugs, mainly antiretroviral therapy, account for the majority of ADRs reported in neonates. The specific issue of drug maladministration and medication errors remains to be addressed in neonates. © 2016 The British Pharmacological Society.

  7. Drug-induced panic attacks: Analysis of cases registered in the French pharmacovigilance database.

    Science.gov (United States)

    Abadie, Delphine; Essilini, Anaïs; Fulda, Virginie; Gouraud, Aurore; Yéléhé-Okouma, Mélissa; Micallef, Joëlle; Montastruc, François; Montastruc, Jean Louis

    2017-07-01

    The potential role of drugs in the onset of panic attacks (PAs) is poorly understood. The objective of our study was to characterize drug-induced PAs. We performed an analysis of PAs registered in the French pharmacovigilance database between 01/01/1985 and 05/11/2014. Among the 163 recorded cases, 136 (83.4%) were directly related to drugs, mainly antidepressants (11.3%, mainly serotonin reuptake inhibitors), mefloquine (7.2%), isotretinoin (5.2%), rimonabant (3.6%) and corticosteroids (4.7%). PAs are labelled in the Summary of Product Characteristics (SmPC) for a minority (8.6%) of these drugs. In 31.4% of these cases, withdrawal of the suspected drug was performed more than a week after the onset of PAs. PAs could also be secondary to another adverse drug reaction (ADR; n = 14, 8.6%), mainly an allergy to antineoplastic or immunomodulating agents. In 13 cases (8.0%), PAs occurred during a drug-withdrawal syndrome, mainly after benzodiazepines or opioids. Most cases (73%) involved patients without any previous psychiatric disorder. This is the first pharmacoepidemiological study about iatrogenic PAs. Beside antidepressants, the most often encountered drugs are not indicated for psychiatric diseases. This study also reveals that iatrogenic PAs mostly occur in patients without any psychiatric medical history and that PAs can be triggered by another ADR. Lastly, the many cases with delayed management underline the need to raise awareness of this relatively unknown ADR among physicians, especially since PAs are generally not labelled in SmPCs of the suspected drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Current challenges of pharmacovigilance in bleeding disorders: converting the burden to benefit.

    Science.gov (United States)

    Lassila, R; Armstrong, E

    2010-03-01

    Safety surveillance studies have proven essential in research and development of new biological therapies for bleeding disorders as well as other diseases. Although product safety regarding HIV, hepatitis, and other blood-borne infections is currently excellent, potential new infectious agents require continued vigilant monitoring. Inhibitor development is the most common serious side effect of haemophilia replacement therapy. Several aetiological factors associated with inhibitors have been identified, but their true impact is still largely unknown. Moreover, whether plasma-derived and recombinant factor products differ in their immunogenic profiles is an unresolved issue. Coagulation factor products under development and those currently on the market require uniform, long-term surveillance. The European Haemophilia Safety Surveillance (EUHASS) project was recently established to meet these goals. The pharmaceutical industry and clinicians face common challenges complying with these requirements. In rare diseases like haemophilia, obtaining adequate patient numbers poses a challenge. Another challenge is a lack of methods for assessing disease severity, a surprising deficiency in the era of modern medical and laboratory technology. National and international registries can be used to gather required safety surveillance information. Simultaneously, clinicians benefit from well-organized registry data in their daily practice and harmonize the quality of comprehensive haemophilia care by homogeneous follow-up platforms. Experience with such registries comes, for example, from Europe (PEDNET), the USA (CDC/UDC), the UK (UKHCDO), and Sweden (Malmö). It is important to commit to future pharmacovigilance efforts, aiming at high-quality safety surveillance programmes at both the pharmaceutical research community and clinical levels.

  9. Pharmacovigilance and adverse drug reaction reporting: a perspective of community pharmacists and pharmacy technicians in Sana’a, Yemen

    Science.gov (United States)

    Al-Worafi, Yaser Mohammed; Kassab, Yaman Walid; Alseragi, Wafa Mohammed; Almutairi, Masaad Saeed; Ahmed, Ali; Ming, Long Chiau; Alkhoshaiban, Ali Saleh; Hadi, Muhammad Abdul

    2017-01-01

    Objective The aim of this study was to compare the knowledge, attitude and barriers of pharmacy technicians and pharmacists toward pharmacovigilance, adverse drug reactions (ADRs) and ADR reporting in community pharmacies in Yemen. Methods This cross-sectional survey was conducted among community pharmacists and pharmacy technicians in the capital of Yemen, Sana’a. A total of 289 community pharmacies were randomly selected. The validated and pilot-tested questionnaire consisted of six sections: demographic data, knowledge about pharmacovigilance, experience with ADR reporting, attitudes toward ADR reporting, and the facilitators to improve ADR reporting. Results A total of 428 pharmacy technicians and pharmacists were contacted and 179 went on to complete a questionnaire (response rate: 41.8%). Of the 179 respondents, 21 (11.7%) were pharmacists and 158 (88.3%) were pharmacy technicians, of which, 176 (98.3%) were male and 3 (1.7%) were female. The mean age of the respondents was 25.87±2.63 years. There was a significant difference between the pharmacists and pharmacy technicians in terms of knowledge scores (PYemen to increase their awareness and participation in ADR reporting. PMID:28924350

  10. From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.

    Science.gov (United States)

    Trifirò, Gianluca; Sultana, Janet; Bate, Andrew

    2018-02-01

    In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients' medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

  11. A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

    Science.gov (United States)

    Chan, Cheng Leng; Ang, Pei San; Li, Shu Chuen

    2017-06-01

    Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

  12. An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

    NARCIS (Netherlands)

    Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; Jong-van den Berg, de Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

    2016-01-01

    BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized

  13. Use of a text message-based pharmacovigilance tool in Cambodia: pilot study.

    Science.gov (United States)

    Baron, Sophie; Goutard, Flavie; Nguon, Kunthy; Tarantola, Arnaud

    2013-04-16

    There is no functional pharmacovigilance system in Cambodia to our knowledge. Mobile phone-based tools, such as short message service (SMS) text messages, are increasingly used for surveillance purposes. To pilot-test the FrontlineSMS mobile phone-based tool for notification of adverse events, using Cambodia's only International Vaccination Center at the Institut Pasteur du Cambodge as a field site. People receiving vaccinations, aged over 18 years, and who owned a cell phone were recruited in the study following informed consent. The names and mobile phone numbers of the participants interviewed were entered each day into the FrontlineSMS software. Two days after being vaccinated, participants received an automatically generated SMS text message asking whether any adverse events had occurred. Their SMS reply was number-coded and exported from the software daily to an Excel spreadsheet and examined before being saved. If the participant replied with a code for a severe adverse event (8 or 9), they were automatically advised to consult the nearest doctor. The active surveillance study was conducted over 72 days in the spring of 2012. Patients agreed to be asked by SMS text message whether unwanted events had occurred after vaccination. Of 1331 persons aged over 18 years referred to the vaccination unit, 184 (13.8%) were asked and agreed to participate. When texted for clinical status 48 hours after vaccination, 52 (28.3%) participants did not reply, 101 (54.9%) sent an immediate SMS reply, and 31 (16.8%) sent an SMS reply after additional prompting. Of the initial 184 participants, 132 (71.7%) replied. These 132 participants received 135 vaccine doses and 109 (82.6%) reported no adverse events, whereas 23 (17.4%) reported adverse events, all benign. Notification using an SMS-based text message system is already used in Cambodia for syndromic surveillance in health centers and reporting by health care workers. Our results show that such tools can also be useful for

  14. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

    Directory of Open Access Journals (Sweden)

    Schjøtt J

    2014-07-01

    Full Text Available Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest, Haukeland University Hospital, Bergen, Norway Background: RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR reports published in a question–answer pair (QAP database (the RELIS database and the Norwegian ADR database, respectively. Objective: To describe the potential of RELIS's dual service to improve detection and communication of drug-safety problems. Materials and methods: We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS's potential to detect new drug-safety information through a limited number of QAPs and ADR reports. Results: A total of 5,427 (26% of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4% of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7% of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin and different aspects of abuse. Conclusion: RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the

  15. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff.

    Science.gov (United States)

    Varallo, Fabiana Rossi; Planeta, Cleopatra S; Mastroianni, Patricia de Carvalho

    2017-01-01

    Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention's impact on the professionals' knowledge and skills was assessed using the World Health Organization's definitions. The intervention's effect on the professionals' attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events. One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals' form-completion skills (ppharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals.

  16. Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

    Science.gov (United States)

    Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

    2017-06-20

    Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2017. Published by Elsevier Inc.

  17. Farmacovigilância da heparina no Brasil Heparin pharmacovigilance in Brazil

    Directory of Open Access Journals (Sweden)

    Daniela Rezende Garcia Junqueira

    2011-06-01

    in Brazil was conducted. RESULTS: Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. CONCLUSIONS: Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

  18. [The congress of the French Society of Pharmacology and Therapeutics celebrate in Nancy, 20 April 2016, 40 years of French Regional Pharmacovigilance Centres!].

    Science.gov (United States)

    Jonville-Béra, Annie-Pierre; Mallaret, Michel; Sgro, Catherine

    2016-09-01

    In 1976, the Regional Pharmacovigilance Centres were created in France to collect and analyze adverse drug reactions. Even if they have, to date, managed and transmitted more than 583,000 adverse drug reactions to the French and international health authorities, the missions of these university hospital structures supervised by clinical pharmacologists are not limited to this activity. They also provide a consulting and diagnostic aid for drug diseases. Their other main mission is information about drugs and their proper use for health professionals and patients on any matter relating to medicines. These queries are used to adjust and focus the training of health professionals in prevention of drug risks and improvement of drug use. Beside signal detection and identification of alerts, the 31 Regional Pharmacovigilance Centres collaborate with the French Drug Agency (Agence nationale de sécurité du medicament et des produits de santé [ANSM]) by achieving expertise on drugs and participation in various working groups and committees. Finally, Regional Pharmacovigilance Centres participate in scientific advancement through research and publication activities. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  19. Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance.

    Science.gov (United States)

    Monaco, Luca; Melis, Mauro; Biagi, Chiara; Donati, Monia; Sapigni, Ester; Vaccheri, Alberto; Motola, Domenico

    2017-03-01

    In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe. We are appointed to supervise digoxin, nicardipine, delapril, manidipine and hydrochlorothiazide/ramipril. ADRs are coded through MedDRA Preferred Terms and collected in the electronic Reaction Monitoring Report (eRMR). Statistical analysis is based on the Proportional Reporting Ratio (PRR) as a measure of disproportionality. Up to April 2016 we have analyzed 45 eRMR for each drug. Two signals for nicardipine were submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency (EMA): acute pulmonary oedema (off-label use as tocolytic) and thrombocytopenia. Our experience shows the scientific and regulatory value of signal detection activity on EV data in order to continuously evaluate the benefit/risk profile of recent and older drugs.

  20. Investigating patient narratives posted on Internet and their informativeness level for pharmacovigilance purpose: The example of comments about statins.

    Science.gov (United States)

    Kheloufi, Farid; Default, Anne; Blin, Olivier; Micallef, Joelle

    2017-09-01

    Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated. Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives. Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for

  1. Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system.

    Science.gov (United States)

    Magro, Lara; Arzenton, Elena; Moretti, Ugo; Sottosanti, Laura; Potenza, Simona; Leone, Roberto

    2016-12-01

    Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying whether the registries could be useful tools for a safer use of innovative drugs. All ADR reports included in the Italian Pharmacovigilance Network database from January 1st 2013 to December 31st 2015 (vaccines and literature cases excluded) were analysed. We compared the ADR reports of MR and non-MR drugs with the same ATC class at III level. The percentage of ADR reports with a completed 'Section 7' was significantly lower for MR compared to non-MR drugs (2.0 versus 6.2, p < 0.001). The difference concerned in particular the ADR reports related to abuse/misuse, medication errors and overdose. These reports, more strictly related to inappropriate use, were less frequent for MR drugs in all the considered ATC classes. Our study suggests that monitoring registries could be a useful tool for the reduction of frequency of ADRs related to inappropriate use, besides the control of pharmaceutical budget.

  2. Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.

    Directory of Open Access Journals (Sweden)

    Thibault B Ali

    Full Text Available This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS and the Canada Vigilance Adverse Reaction Database (CVARD concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR. A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P<0.0001 and CVARD (ROR = 3.67; CI95% = 1.92-7.00; P = 0.001 databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer's disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.

  3. Safety signal detection: the relevance of literature review.

    Science.gov (United States)

    Pontes, Helena; Clément, Mallorie; Rollason, Victoria

    2014-07-01

    Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of 79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit-risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects.

  4. Sistema de Farmacovigilância do Ceará: um ano de experiência Ceará State Pharmacovigilance System: a year of experience

    Directory of Open Access Journals (Sweden)

    Helena Lutéscia Coêlho

    1999-09-01

    Full Text Available No presente trabalho, o relato do primeiro ano de atividade do Sistema de Farmacovigilância do Ceará (SIFACE é apresentado como estratégia para a discussão de questões práticas e metodológicas envolvendo as dificuldades na implantação de atividade dessa natureza no Brasil. O SIFACE está sendo estruturado pelo GPUIM (Grupo de Prevenção ao Uso Indevido de Medicamentos, tendo como ponto de apoio as unidades de farmácias hospitalares. Foram processadas 63 notificações (119 suspeitas de reação adversa, em sua maioria correspondentes a mulheres (55,7% e a pacientes de 0-14 anos (34,4%, sendo os antibióticos e as reações dermatológicas os medicamentos e os tipos de reações mais freqüentes, respectivamente. Em 20% dos casos houve reexposição dos pacientes a fármacos aos quais aqueles eram intolerantes, o que ressalta a importância preventiva da farmacovigilância.This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. SIFACE is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM, based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs were processed, the majority among women (55.7% and children (34.4%. Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

  5. Abuse liability of centrally acting non-opioid analgesics and muscle relaxants--a brief update based on a comparison of pharmacovigilance data and evidence from the literature.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Eller, Jonas; Schönfeldt-Lecuona, Carlos

    2014-06-01

    There is a lack of data regarding the abuse liability of centrally acting non-opioid analgesics (NOA) and muscle relaxants (MR). A comparison of data retrieved from a German pharmacovigilance database (BfArM; accessed May 2013) and data from the literature concerning the abuse liability of NOA and MR approved in Germany was performed. The BfArM-database demonstrated cases of abuse only for clonidine and paracetamol, whereas the literature suggests evidence for an abuse potential of baclofen, clonidine, ketamine, metamizole, methocarbamol, orphenadrine, paracetamol, propyphenazone, and tizanidine. The low number of detected cases in the BfArM-database could be a result of under-reporting.

  6. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw.

    Science.gov (United States)

    Edwards, Beatrice J; Gounder, Mrinal; McKoy, June M; Boyd, Ian; Farrugia, Mathew; Migliorati, Cesar; Marx, Robert; Ruggiero, Salvatore; Dimopoulos, Meletios; Raisch, Dennis W; Singhal, Seema; Carson, Ken; Obadina, Eniola; Trifilio, Steve; West, Dennis; Mehta, Jayesh; Bennett, Charles L

    2008-12-01

    -related pharmacovigilance initiatives is now needed.

  7. Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.

    Science.gov (United States)

    Nikfarjam, Azadeh; Sarker, Abeed; O'Connor, Karen; Ginn, Rachel; Gonzalez, Graciela

    2015-05-01

    Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words' semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  8. Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

    Science.gov (United States)

    Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

    2014-09-01

    Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

  9. Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports.

    Science.gov (United States)

    Blake, Kevin V; Saint-Raymond, Agnes; Zaccaria, Cosimo; Domergue, Francois; Pelle, Benjamin; Slattery, Jim

    2016-02-01

    Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data. The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'. The proportional reporting ratio (PRR) is a measure of disproportionality for which the underlying principle is that a drug-event pair of interest is reported more often than expected relative to an independence model. The EMA's paediatric query, based on PRRs, was applied to the data in EudraVigilance to investigate the extent to which the known association between enalapril and renal toxicity was reflected in reported ADRs comparing children with adults and with adjustment for the effect of multiplicity. The comparison of PRRs for children (14.91, 95% confidence interval [CI] 13.05-17.04) versus adults (2.66, 95% CI 2.52-2.82) confirmed a higher risk of renal ADRs with enalapril when used in children compared with all other medicines and compared with adults. The EMA's paediatric query can be used to highlight an imbalance for a drug-event pair among ADRs for a medicine when used in children and as compared with adults. Applying the query in practice can help the EMA to decide on whether stand-alone paediatric medicine development is warranted, and which, if any, further studies are necessary. Ongoing evaluation of the query is contributing to the development of new methods and guidance.

  10. Filling quality of the reports of adverse drug reactions received at the Pharmacovigilance Centre of São Paulo (Brazil): missing information hinders the analysis of suspected associations.

    Science.gov (United States)

    Ribeiro, Adalton; Lima, Silvana; Zampieri, Maria-Elisa; Peinado, Mirtes; Figueras, Albert

    2017-12-01

    The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm. There were 820 reports from manufacturers and 179 from health centres. Only 4.4% (44) were fully filled, thus allowing the adequate analysis of the causal relationship between the suspected medication and the adverse event. In 30% of the reports from manufacturers, the information about the critical variables was lacking or incomplete, preventing the adequate evaluation of the report. It was also noted that the reports' poor filling quality was not related with less severity or with old and well-known medicines. The poor quality of the information included in the reports received by this centre, especially those sent by pharmaceutical manufacturers, hampers the identification of potential safety signals. Measures to improve the quality of the reports must be urgently adopted.

  11. Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

    Science.gov (United States)

    Sheth, Neha

    2009-01-01

    Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.

  12. Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation.

    Science.gov (United States)

    Leporini, Christian; Marrazzo, Giuseppina; Mumoli, Laura; Esposito, Stefania; Gallelli, Luca; Mangano, Giovanna; Brancati, Giacomino; De Francesco, Emanuela Adele; Russo, Emilio; De Sarro, Giovambattista

    2017-05-01

    The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.

  13. Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

    DEFF Research Database (Denmark)

    Acquavella, John; Ehrenstein, Vera; Schiødt, Morten

    2016-01-01

    -authorization safety study of cancer patients treated with antiresorptive therapies. METHODS: As part of a comprehensive pharmacovigilance plan, developed with regulators' input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab...

  14. Implementing a pharmacovigilance program to evaluate cutaneous adverse drug reactions in an antiretroviral access program

    Science.gov (United States)

    Mudzviti, Tinashe; Sibanda, Marvelous; Gavi, Samuel; Maponga, Charles Chiedza; Morse, Gene D.

    2012-01-01

    Background Cutaneous adverse drug reactions (cADRs) can cause significant morbidity and distress in patients especially in the HIV infected population on antiretroviral therapy. Adverse Drug Reaction monitoring and ascertaining causality in resource limited settings still remains a challenge. This study was carried out to evaluate causality and measure incidence of cADRs in HIV infected patients on highly active antiretroviral therapy. The study was also designed to test a 3-step approach in the monitoring and evaluation of ADRs in resource limited settings. Methodology A retrospective patient medical records review was carried out at the Parirenyatwa Family Care Centre, (Harare, Zimbabwe). Cases of cADRs were reported to the Medicines Control Authority of Zimbabwe (Drug regulating body in Zimbabwe) for assessment and causality classification. Results Two hundred and twenty-one patient records were randomly selected and reviewed to determine if any diagnosis of cADRs was made by clinicians. Causality assessment revealed 13.1% of cADRs which were due to an offending agent in the antiretroviral therapy against an initial incidence of 17.6% which had been determined by the physicians. Conclusions cADRs had an incidence of 13.1% within the population under study due to non nucleoside reverse transcriptase inhibitors (NNRTIs). Most reactions were due to the NNRTIs which contributed 72.4 % of all cADRs. A panel of experts from the drug regulatory authority can be used as an implementation based mechanism in ascertaining causality objectively in settings where resources are constrained. PMID:23277506

  15. Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.

    Science.gov (United States)

    Ali, Ayad K; Heran, Balraj S; Etminan, Mahyar

    2015-07-01

    Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD

  16. Risk of gastrointestinal complications associated to NSAIDs, low-dose aspirin and their combinations: Results of a pharmacovigilance reporting system.

    Science.gov (United States)

    Rafaniello, Concetta; Ferrajolo, Carmen; Sullo, Maria Giuseppa; Sessa, Maurizio; Sportiello, Liberata; Balzano, Antonio; Manguso, Francesco; Aiezza, Maria Luisa; Rossi, Francesco; Scarpignato, Carmelo; Capuano, Annalisa

    2016-02-01

    Gastrointestinal (GI) complications are one of the most limiting cause of use of NSAIDs. Beyond others well defined factors, history of peptic ulcer, older age, Helicobacter pylori infection and use of gastrotoxic drugs may affect their GI safety profile. In particular, the risk of GI complications associated to the use of antiplatelet drugs, especially low-dose acetylsalicylic acid (LDA) should deserve much attention. However, only few studies have focused on the effect of combination LDA/NSAIDs on the GI tract compared with the monotherapy and much less studies assessed this effect with multiple NSAIDs use. We aimed to characterize the GI safety profile of NSAIDs and LDA as monotherapy or their combinations in real-life conditions by analysing spontaneous adverse drug reactions (ADRs) reporting system in a Southern Italy. We used the case/non-case method in the Italian Pharmacovigilance Network (RNF). Cases were reports of GI events in the RNF between January 2007 and December 2011. Non-cases were all other reports during the same period. The association between NSAID and suspected GI ADRs was calculated using the reporting odds ratio (ROR) with 95% confidence intervals as a measure of disproportionality while adjusting for age, and concomitant use of antineoplastic agents or drugs for cardiovascular diseases. Sub-analysis were performed within the NSAID class. Among the 2816 adverse drug reactions recorded, we identified 374 (13.3%) cases of GI complications. Upper GI complications were the most frequently reported type of events. The highest associations were found for the combined use of NSAIDs and/or LDA, whilst the lowest associations were for their respective monotherapy. Looking at individual NSAIDs the highest association with GI events was observed for ketorolac exposure followed by nimesulide, diclofenac, aspirin, ketoprofen, and ibuprofen. This study highlights the primary role of the national spontaneous reporting system to bring out potential signals

  17. Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

    Directory of Open Access Journals (Sweden)

    Acquavella J

    2016-07-01

    . Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Follow-up will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naïve patients, zoledronic acid-naïve patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA® clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies. Keywords: cohort study, osteonecrosis of the jaw, pharmacovigilance, postmarketing drug surveillance, denosumab, zoledronic acid

  18. Trends of reporting of ‘serious’vs. ‘non-serious’ adverse drug reactions over time: a study in the French PharmacoVigilance Database

    Science.gov (United States)

    Moulis, Guillaume; Sommet, Agnès; Durrieu, Geneviève; Bagheri, Haleh; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2012-01-01

    AIM To investigate trends in spontaneous reporting to the French Pharmacovigilance system of ‘serious’ (SADRs) and ‘non-serious’ (NSADRs) adverse drug reactions over time. METHODS Annual SADR : NSADR ratios were calculated for each drug and their evolution tested with linear trend tests. RESULTS Among the 39 new active substances commercialized in France in 2000, 16 had sufficient data to perform linear trend tests. An increasing linear relation was found for five widely prescribed drugs, a non-significant increasing trend for eight others, i.e. drugs mostly used in hospitals. CONCLUSION ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later. PMID:22257367

  19. Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database.

    Science.gov (United States)

    de Boissieu, Paul; Kanagaratnam, Lukshe; Abou Taam, Malak; Roux, Marie-Paule; Dramé, Moustapha; Trenque, Thierry

    2014-09-01

    The purpose of this study was to identify a notoriety bias in a database of spontaneous reports and its consequences on the calculation of the reporting odds ratio (ROR). We used the case/noncase methodology to calculate the ROR for bisphosphonates and osteonecrosis of the jaw (ONJ) in the French national pharmacovigilance database (from 1985 to 2013). To evaluate notoriety bias, drug-related risk factors for ONJ [as specified in the summary of product characteristics (SPC) of bisphosphonates] were systematically scanned for notifications of reports of ONJ occurring under bisphosphonate therapy. When a risk factor was present, the ONJ was considered as not due to bisphosphonates, and a second ROR was calculated under the hypothesis of maximum bias. In total, 148 cases of ONJ were reported (143 with bisphosphonates and five without). The raw ROR was 3448 (95% confidence interval 1413-8417). After analysis of the reports, only 86 had no mention of a risk factor for ONJ. The ROR under the maximum bias hypothesis was 87 (95% confidence interval 63-121). Among ONJ where chemotherapy was being administered simultaneously to bisphosphonates, 27 reports did not consider the chemotherapy to be implicated, despite seven of these occurring in cases where ONJ was mentioned in the summary of product characteristics. The existence of a notoriety bias has an impact on measures of disproportionality. The detection of pharmacovigilance signals might be delayed. It is advisable to list all drugs being taken when an adverse drug reaction occurs, and not only those known to be associated with the observed reaction. Copyright © 2014 John Wiley & Sons, Ltd.

  20. Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France.

    Science.gov (United States)

    Auffret, Marine; Labreuche, Julien; Duhamel, Alain; Deheul, Sylvie; Cottencin, Olivier; Bordet, Régis; Gautier, Sophie; Rolland, Benjamin

    2017-03-01

    Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting. The 2012-2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among 'serious' and 'non-serious' reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences. A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in 'serious' reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space-time disorientation (5.1%). A standardized difference of pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system.

  1. Drug interactions between antihypertensive drugs and non-steroidal anti-inflammatory agents: a descriptive study using the French Pharmacovigilance database.

    Science.gov (United States)

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-04-01

    Drug-drug interactions (DDIs) between antihypertensive drugs and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to adverse drug reactions (ADRs). Guidelines are available to help prescribers deal with these drug associations, but their implementation is not well evaluated. The aims of this study were to assess the prevalence of NSAIDs exposure in patients treated with antihypertensive drugs, using the French Pharmacovigilance database, and explore the ADRs related to DDIs between antihypertensive drugs and NSAIDs. Over the 11, 442 notifications of ADRs recorded in this database in patients treated with oral antihypertensive drugs between 2008 and 2010, 517 (4.5 and 95% CI: 4.1-4.9) also included exposure to NSAIDs. These subjects were more frequently women, took more drugs in general, and were younger and less frequently treated with antiplatelet drugs. In 24.2% of them (125 patients), a DDI between NSAIDs and antihypertensive drugs was potentially the cause of the reported ADR. Acute renal failure caused by DDIs between NSAIDs and angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or diuretics was the most frequently reported ADR (20.7%). Finally, in the French Pharmacovigilance database, around one-fourth of associations NSAIDs  +  antihypertensive drugs are associated with a 'serious' ADR (mainly acute renal failure), suggesting that this well-known DDI is not enough taken into account by prescribers. © 2012 The Authors Fundamental and Clinical Pharmacology © 2012 Société Française de Pharmacologie et de Thérapeutique.

  2. Preliminary Results of a Novel Algorithmic Method Aiming to Support Initial Causality Assessment of Routine Pharmacovigilance Case Reports for Medication-Induced Liver Injury: The PV-RUCAM.

    Science.gov (United States)

    Scalfaro, Erik; Streefkerk, Henk Johan; Merz, Michael; Meier, Christoph; Lewis, David

    2017-08-01

    Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI. Performance was compared in different settings with regard to applicability and differentiation capacity. A PV-RUCAM score was developed based on the seven sections contained in the original RUCAM. The score provides cut-off values for or against DILI causality, and was applied on two datasets of bona fide individual case safety reports (ICSRs) extracted randomly from clinical trial reports and a third dataset of electronic health records from a global PV database. The performance of PV-RUCAM adjudication was compared against two standards: a validated causality assessment method (original RUCAM) and global introspection. The findings showed moderate agreement against standards. The overall error margin of no false negatives was satisfactory, with 100% sensitivity, 91% specificity, a 25% positive predictive value and a 100% negative predictive value. The Spearman's rank correlation coefficient illustrated a statistically significant monotonic association between expert adjudication and PV-RUCAM outputs (R = 0.93). Finally, there was high inter-rater agreement (K w = 0.79) between two PV-RUCAM assessors. Within the PV setting of a pharmaceutical company, the PV-RUCAM has the potential to facilitate and improve the assessment done by non-expert PV professionals compared with other methods when incomplete reports must be evaluated for suspected DILI. Prospective validation of the algorithmic tool is necessary prior to implementation for routine use.

  3. Is acetaminophen associated with a risk of Stevens-Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database.

    Science.gov (United States)

    Lebrun-Vignes, Bénédicte; Guy, Claire; Jean-Pastor, Marie-Josèphe; Gras-Champel, Valérie; Zenut, Marie

    2018-02-01

    Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but severe mostly drug-induced cutaneous reactions. Acetaminophen is an over-the-counter drug used worldwide to treat pain and reduce fever. In 2013, the US Food and Drug Administration informed the public that acetaminophen was associated with a rare risk of SJS/TEN. The aim of the present retrospective study was to analyse reports of acetaminophen as a possible suspect in the development of SJS/TEN from the French Pharmacovigilance Database (FPDB). Cases of TEN/SJS with acetaminophen as a suspect drug registered in the FPDB, collected from January 2002 to December 2013, were analysed by an expert group. The algorithm of drug causality for epidermal necrolysis (ALDEN) was used as a reference tool for SJS/TEN to assess the causality of each suspect drug. After exclusion of 16 nonvalidated cases, 112 cases (47 TEN, 51 SJS, 14 SJS/TEN overlaps) involving 574 suspected drugs (5⋅1/case) were analysed. In 80 cases, the acetaminophen ALDEN score was inferior or equal to that of other drugs, associated with a higher suspicion for causality. In 32 cases, acetaminophen had the highest score but matched with a 'very unlikely' or 'unlikely' causality in 12 cases. For the 20 remaining cases with a 'possible' or ' probable' causality, a protopathic or a confounding bias was likely in 14 cases. After analysis of the French pharmacovigilance data using the ALDEN algorithm, we found no obvious SJS/TEN risk related to the use of acetaminophen in this large national series. © 2017 The British Pharmacological Society.

  4. Pacific Island Pharmacovigilance

    DEFF Research Database (Denmark)

    McEwen, John; Vestergaard, Lasse S.; Sanburg, Amanda L C

    2016-01-01

    Many Pacific Island countries (PICs) are recipients of funding support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). However, most of these countries cannot be expected to meet Global Fund and World Health Organization (WHO) minimum requirements for a functioning...

  5. Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

    Science.gov (United States)

    Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

    2017-04-01

    To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

  6. Reviews

    Science.gov (United States)

    2004-01-01

    BOOK REVIEWS (99) Complete A-Z Physics Handbook Science Magic in the Kitchen The Science of Cooking Science Experiments You Can Eat WEB WATCH (101) These journal themes are pasta joke Microwave oven Web links CD REVIEW (104) Electricity and Magnetism, KS3 Big Science Comics

  7. Reviews

    Science.gov (United States)

    2002-11-01

    CD-ROM REVIEW (551) Essential Physics BOOK REVIEWS (551) Collins Advanced Science: Physics, 2nd edition Quarks, Leptons and the Big Bang, 2nd edition Do Brilliantly: A2 Physics IGCSE Physics Geophysics in the UK Synoptic Skills in Advanced Physics Flash! The hunt for the biggest explosions in the universe Materials Maths for Advanced Physics

  8. Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database.

    Science.gov (United States)

    Faillie, Jean-Luc; Babai, Samy; Crépin, Sabrina; Bres, Virginie; Laroche, Marie-Laure; Le Louet, Hervé; Petit, Pierre; Montastruc, Jean-Louis; Hillaire-Buys, Dominique

    2014-01-01

    In the recent past, concerns have raised regarding the potential risk of acute pancreatitis among type 2 diabetic patients using incretin-based drugs such as glucagon-like peptide 1 (GLP-1) analogs and dipeptidyl peptidase 4 (DPP-4) inhibitors. The aim of this study is to investigate the association between exposure to incretin-based drugs and the occurrence of pancreatitis reported in the French Pharmacovigilance Database. The case/non-case method was performed from serious adverse drug reactions (ADRs) involving antihyperglycemic agents (except insulin alone) reported to the French pharmacovigilance system between March 2008 (first marketing of an incretin-based drug in France) and March 2013. Cases were defined as reports of pancreatitis, and all other serious ADRs were considered non-cases. Disproportionality was assessed by calculating reporting odds ratios (ROR) adjusted for age, gender, history of pancreatitis, other antihyperglycemic drugs and other drugs associated with a higher risk of pancreatitis. Among 3,109 serious ADRs, 147 (4.7 %) reports of pancreatitis were identified as cases and 2,962 reports (95.3 %) of other ADRs as non-cases. Among the cases, 122 (83.0 %) involved incretin-based drugs. Disproportionality was found for all incretin-based drugs (adjusted ROR: 15.7 [95 % CI 9.8-24.9]), all GLP-1 analogs (29.4 [16.0-53.8]), exenatide (28.3 [12.8-62.3]), liraglutide (30.4 [15.4-60.0]), all DPP-4 inhibitors (12.1 [7.3-20.0]), sitagliptin (12.4 [7.3-21.0]), saxagliptin (15.1 [4.3-52.7]), and vildagliptin (7.4 [3.1-17.6]). Temporal analysis found disproportionality for incretin-based drugs since their first year of marketing in France. Compared with other antihyperglycemic agents, use of incretin-based drugs is associated with an increased risk of reported pancreatitis in France.

  9. Review

    African Journals Online (AJOL)

    In this review, I shall attempt to convince readers that improving your knowledge of bird sounds ... images of mine within this book include the Hartlaub's Turaco Tauraco hartlaubi (p. ... head and slams her book down as the memory arrives.

  10. review

    African Journals Online (AJOL)

    Acute intestinal obstruction in Nnewi Nigeria: a five-year review ... postoperative complication was burst abdomen (4%) and mortality was (9.2%). ... resection and anastomosis due to gangrenous bowel. The commonest causes of acute.

  11. Reviews

    Directory of Open Access Journals (Sweden)

    1990-06-01

    Full Text Available Michael Issacharoff. Discourse as Performance . Stanford: Stanford University Press, 1989. vii + 161 pp. Reviewed by Gerald Prince, University of Pennsylvania Thomas M. Kavanagh, ed. The Limits of Theory . Stanford: Stanford University Press, 1989. 254 pp. Reviewed by André J.M. Prévos, Pennsylvania State University, Worthington Scranton Campus Wendy B. Faris. Labyrinths of Language: Symbolic Landscape and Narrative Design in Modern Fiction . Baltimore and London: The Johns Hopkins Press, 1988. 242 pp. Reviewed by Carol Rigolot, Princeton University Eve Tavor Bannet. Structuralism and the Logic of Dissent: Barthes, Derrida, Foucault, Lacan . Urbana and Chicago: University of Illinois Press, 1989. 299 pp. Reviewed by Andrew J. McKenna, Loyoyla University of Chicago Gary Saul Morson and Caryl Emerson, eds. Rethinking Bakhtin: Extensions and Challenges . Evanston: Northwestern University Press, 1989. Reviewed by Lewis Bagby, University of Wyoming Fernando Moreno. Carlos Fuentes. La mort d'Artemio Cruz: entre le mythe et l'histoire . Paris: Editions Caribeennes, 1989. Reviewed by Susan Levine, Lawrence, Kansas

  12. Ontology-based Vaccine and Drug Adverse Event Representation and Theory-guided Systematic Causal Network Analysis toward Integrative Pharmacovigilance Research.

    Science.gov (United States)

    He, Yongqun

    2016-06-01

    Compared with controlled terminologies (e.g., MedDRA, CTCAE, and WHO-ART), the community-based Ontology of AEs (OAE) has many advantages in adverse event (AE) classifications. The OAE-derived Ontology of Vaccine AEs (OVAE) and Ontology of Drug Neuropathy AEs (ODNAE) serve as AE knowledge bases and support data integration and analysis. The Immune Response Gene Network Theory explains molecular mechanisms of vaccine-related AEs. The OneNet Theory of Life treats the whole process of a life of an organism as a single complex and dynamic network (i.e., OneNet). A new "OneNet effectiveness" tenet is proposed here to expand the OneNet theory. Derived from the OneNet theory, the author hypothesizes that one human uses one single genotype-rooted mechanism to respond to different vaccinations and drug treatments, and experimentally identified mechanisms are manifestations of the OneNet blueprint mechanism under specific conditions. The theories and ontologies interact together as semantic frameworks to support integrative pharmacovigilance research.

  13. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  14. Reviews

    NARCIS (Netherlands)

    Adema, Frits

    1995-01-01

    This is the second volume of a revision of Tabernaemontana (Apocynaceae). The volume covers the New World species (44) and the genus Stemmadenia (10 species). This part of the revision of Tabernaemontana comes up to the high standards set in the first volume [see the review by Leenhouts, Blumea 38

  15. Review

    DEFF Research Database (Denmark)

    Van Den Hazel, H B; Kielland-Brandt, Morten; Winther, Jakob R.

    1996-01-01

    The yeast vacuole, which is equivalent to the lysosome of higher eukaryotes, is one of the best characterized degradative organelles. This review describes the biosynthesis and function of yeast vacuolar proteases. Most of these enzymes are delivered to the vacuole via the early compartments...

  16. Reviews.

    Science.gov (United States)

    Science Teacher, 1989

    1989-01-01

    Reviews a software planetarium package called "Sky Travel." Includes two audiovisuals: "Conquest of Space" and "Windows on Science: Earth Science"; and four books: "Small Energy Sources: Choices that Work,""Stonehenge Complete,""Uneasy Careers and Intimate Lives: Women in Science…

  17. Review

    NARCIS (Netherlands)

    Wilde, de W.J.J.O.

    1994-01-01

    This review marks the appearance of Volume II, after the publication of Volume I, Pteridophytes and Gymnosperms, in 1990; several more volumes are expected in the future before completion of the Vascular plants as a whole. The present volume contains 73 families out of some 250-500 families which

  18. Reviews

    Science.gov (United States)

    2002-07-01

    BOOK REVIEWS (353) Dr Dyer's Academy Further Advanced Physics Physics 11-14, with Biology 11-14 and Chemistry 11-14 Nelson Modular Science: Books 1 and 2 Key Science: Physics, 3rd Edition Nelson Science: Physics, 2nd Edition Physics for AQA: Separate Award, Coordinated Award Physical Processes: A Visual Approach WEB WATCH (359) Physics Favourites: John Miller's selection

  19. Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

    Science.gov (United States)

    Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

    2015-07-10

    The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

  20. Reviews

    Directory of Open Access Journals (Sweden)

    Wilma D'Ambrosio

    2013-12-01

    Full Text Available In the wake of the great interest raised by Maurizio Gabrieli’s review of the book Musical Networks. Parallel Distributed Perception and Performance (various authors; edited by Niall Griffith and Peter M. Todd, MA: MIT Press, Cambridge, 1999 which appeared in our last issue of Analitica, the present review section no longer follows the format used up to now but offers a survey of texts dedicated to the relationship between music analysis and technology. This decision was also made as a result of the request for more information on the subject by many of our readers. In coming issues we plan to extend this bibliography and comment on at least some of the most interesting texts published in recent years, among which we would immediately like to draw attention to the important work by Baroni, Dalmonte and Jacoboni published in 1999 (Le regole della musica. Indagine sui meccanismi della comunicazione, Torino, I Manuali EDT/SIdM, 1999.

  1. Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study.

    Science.gov (United States)

    Poirot, Eugenie; Soble, Adam; Ntshalintshali, Nyasatu; Mwandemele, Asen; Mkhonta, Nomcebo; Malambe, Calisile; Vilakati, Sibonakaliso; Pan, Sisi; Darteh, Sarah; Maphalala, Gugu; Brown, Joelle; Hwang, Jimee; Pace, Cheryl; Stergachis, Andy; Vittinghoff, Eric; Kunene, Simon; Gosling, Roland

    2016-07-22

    Countries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ. The Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT. PROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb ≥25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient's Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were

  2. Aplicación de la minería de datos al Sistema Cubano de Farmacovigilancia Application of data mining to the Cuban Pharmacovigilance System

    Directory of Open Access Journals (Sweden)

    Omar Calzadilla Fernández de Castro

    2007-12-01

    Full Text Available En el año 1999, se crea la Unidad Nacional Coordinadora de Farmacovigilancia, la cual funciona como el órgano técnico-científico que desarrolla la política de vigilancia de seguridad de medicamentos del Ministerio de Salud Pública e integra las actividades de los centros provinciales y de otros programas concertados de farmacovigilancia en un sistema único. Entre sus funciones más relevantes se encuentran la de definir, diseñar y desarrollar los sistemas de información; administrar la base de datos nacional; depurar y validar la información contenida en ella; y realizar y coordinar estudios científicos sobre la seguridad de los medicamentos; así como elaborar informes para las autoridades sanitarias y el Sistema Nacional de Salud. En este sistema existe la necesidad de utilizar herramientas de análisis, por lo que se trazó el objetivo de definir, diseñar y desarrollar los sistemas de tratamiento de la información y administrar la base de datos nacional "VigiBaseCuba". Aplicando una serie de transformaciones, validaciones y la adecuación de la metodología CRISP-DM para la elaboración de proyectos de minería de datos, se conformó la base de datos nacional, en un sistema de gestión de bases de datos relacional con los registros de las notificaciones de sospechas de reacciones adversas a los medicamentos y un proceso de descubrimiento de conocimiento que permite gestionar eficazmente la seguridad de los medicamentos, así como desarrollar aplicaciones para la visualización de las señales de reacciones adversas y su evoluciónIn 1999, The National Coordinating Unit of Pharmacovigilance was created. It works as a scientific and technical agency that develops the drug safety surveillance policy of the Ministry of Public Health, and integrates the activities of the provincial centres and other pharmacovigilance programs in a unique system. Some of its most important functions are to define, design and develop the information

  3. Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

    Science.gov (United States)

    Bahk, Chi Y; Goshgarian, Melanie; Donahue, Krystal; Freifeld, Clark C; Menone, Christopher M; Pierce, Carrie E; Rodriguez, Harold; Brownstein, John S; Furberg, Robert; Dasgupta, Nabarun

    salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido (n = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered "well documented" 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals. Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.

  4. Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database

    Science.gov (United States)

    Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

    2011-01-01

    AIMS To investigate putative associations of reports of memory disorders and suspected drugs. METHODS We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. RESULTS Among the 188 284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4–93). The maximal number of cases occurred between 40–49 and 50–59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. CONCLUSIONS Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. PMID:21557759

  5. Large-scale adverse effects related to treatment evidence standardization (LAERTES): an open scalable system for linking pharmacovigilance evidence sources with clinical data.

    Science.gov (United States)

    2017-03-07

    Integrating multiple sources of pharmacovigilance evidence has the potential to advance the science of safety signal detection and evaluation. In this regard, there is a need for more research on how to integrate multiple disparate evidence sources while making the evidence computable from a knowledge representation perspective (i.e., semantic enrichment). Existing frameworks suggest well-promising outcomes for such integration but employ a rather limited number of sources. In particular, none have been specifically designed to support both regulatory and clinical use cases, nor have any been designed to add new resources and use cases through an open architecture. This paper discusses the architecture and functionality of a system called Large-scale Adverse Effects Related to Treatment Evidence Standardization (LAERTES) that aims to address these shortcomings. LAERTES provides a standardized, open, and scalable architecture for linking evidence sources relevant to the association of drugs with health outcomes of interest (HOIs). Standard terminologies are used to represent different entities. For example, drugs and HOIs are represented in RxNorm and Systematized Nomenclature of Medicine -- Clinical Terms respectively. At the time of this writing, six evidence sources have been loaded into the LAERTES evidence base and are accessible through prototype evidence exploration user interface and a set of Web application programming interface services. This system operates within a larger software stack provided by the Observational Health Data Sciences and Informatics clinical research framework, including the relational Common Data Model for observational patient data created by the Observational Medical Outcomes Partnership. Elements of the Linked Data paradigm facilitate the systematic and scalable integration of relevant evidence sources. The prototype LAERTES system provides useful functionality while creating opportunities for further research. Future work will

  6. Seizures during antidepressant treatment in psychiatric inpatients--results from the transnational pharmacovigilance project "Arzneimittelsicherheit in der Psychiatrie" (AMSP) 1993-2008.

    Science.gov (United States)

    Köster, M; Grohmann, R; Engel, R R; Nitsche, M A; Rüther, E; Degner, D

    2013-11-01

    There is little clinical data available about seizure rates in psychiatric inpatients, and there are no studies with reference data to the frequencies of antidepressant (AD) use for this important clinical population. This study investigates seizure rates during AD treatment in psychiatric inpatient settings, drawn from the transnational pharmacovigilance programme Arzneimittelsicherheit in der Psychiatrie (AMSP) in relation to the known frequencies of ADs used in the participating clinics. Comparisons are made to former publications and their limitations. Seventy-seven cases were identified with grand mal seizures (GMS) during AD treatment between 1993 and 2008, with a total number of 142,090 inpatients under surveillance treated with ADs in the participating hospitals. The calculated overall rate of reported seizures of patients during AD treatment in this collective is 0.05 % for ADs imputed alone or in combination with other psychotropic drug groups and 0.02 % when only ADs were given and held responsible for GMS. The patients receiving tri- or tetracyclic ADs (TCAs) had a 2-fold risk to develop a seizure as compared to the overall average rate in this sample. In 11 cases, there was only one AD imputed--the majority of these cases (9/11) were TCA. Monotherapy with selective serotonin reuptake inhibitors (SSRI) or dual serotonin and noradrenaline reuptake inhibitors (SNRI) were never imputed alone in this sample. The results of the study favour the assumption that SSRIs, noradrenergic and specific serotonergic antidepressants (NaSSA) and dual SNRI might be more appropriate than TCAs for the treatment of psychiatric patients with an enhanced seizure risk.

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

    Science.gov (United States)

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

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

  8. Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: the Medunsa National Pharmacovigilance Centre, 2007 - 2012.

    Science.gov (United States)

    Dube, N; Adewusi, E; Summers, R

    2013-05-01

    Stevens-Johnson syndrome (SJS) is an acute life-threatening condition often elicited by drugs. The government's indecisiveness in deciding to stop the use of nevirapine (NVP) in HIV-infected pregnant women owing to the increase of SJS among this population group in South Africa prompted this investigation. To investigate if pregnancy is a risk factor for SJS among HIV-infected women taking NVP-containing regimens and registered within the Medunsa National Pharmacovigilance Centre database. A matched case-control study with 5:1 matching was conducted. Women with SJS (cases) taking NVP-containing regimens were matched with women without SJS (controls) taking NVP-containing regimens. Controls were randomly selected and matched to cases by hospital, age, treatment duration and CD4 count. Conditional logistic regression was used to determine if pregnancy was a risk factor for SJS. Six SJS cases were identified and 30 controls selected. The median age of both cases and controls was 29 years and the average CD4 counts were 237 and 234 cells/microl respectively. Subjects were on NVP treatment for 18 - 31 days before the onset of SJS. Controls did not develop SJS after treatment of between 1 and 365 days. Pregnancy increased the chances of developing SJS 14-fold (OR 14.28, p = 0.006, 95% CI 1.54 - 131.82). NVP-containing ARV regimens taken during pregnancy increase the risk of developing SJS. Healthcare workers are advised to offer informed consent to patients and recommend effective contraception methods if NVP treatment is considered. In the light of our findings, further studies of the association between NVP, pregnancy and SJS are necessary before general conclusions can be reached.

  9. Hepatotoxicity related to agomelatine and other new antidepressants: a case/noncase approach with information from the Portuguese, French, Spanish, and Italian pharmacovigilance systems.

    Science.gov (United States)

    Montastruc, François; Scotto, Stefania; Vaz, Ines Ribeiro; Guerra, Leonor Nogueira; Escudero, Antonio; Sáinz, María; Falomir, Teresa; Bagheri, Haleh; Herdeiro, Maria Teresa; Venegoni, Mauro; Montastruc, Jean Louis; Carvajal, Alfonso

    2014-06-01

    Antidepressants have been associated with a low incidence of idiosyncratic hepatic injury. Some of them, nefazodone or amineptine, were observed to induce severe hepatic injury and withdrawn from the market. Recently, some cases of this severe condition have been reported in association with agomelatine use. Therefore, the objective of this study is to learn the risk of hepatic damage with agomelatine as compared with other new antidepressants. We took data from the Spanish, French, Italian, and Portuguese pharmacovigilance system databases. A case/noncase approach to assess the strength of the association between whichever antidepressant and hepatotoxicity was performed; cases were defined as reports of hepatotoxicity; noncases were reports of all reactions other than hepatotoxicity. Exposure was the recording of a new antidepressant in a report, whether or not it was suspected of causing the reaction. During the period surveyed, 3300 cases of hepatotoxicity were collected for the antidepressants assessed. They represent 10.3% of all cases collected for these drugs; the corresponding figure for all drugs was 6.0%. Meanwhile, 63 cases of hepatotoxicity associated with agomelatine were collected since its introduction until the end of the period studied; they account for a percentage of 14.6. Agomelatine was statistically associated with hepatotoxicity in Spain [reporting odds ratio (ROR), 4.9 (95% confidence interval [CI], 2.4-9.7)], France (ROR, 2.4 [95% CI, 1.5-3.7]), and Italy (ROR, 5.1 [95% CI, 1.7-14.0]). Current results support the idea of agomelatine to be related to a higher hepatotoxicity risk. Physicians should consider early discontinuation if the condition is suspected; health authorities should promptly explore the best regulatory actions to be taken.

  10. Opioid pharmacovigilance: A clinical-social history of the changes in opioid prescribing for patients with co-occurring chronic non-cancer pain and substance use.

    Science.gov (United States)

    Knight, Kelly R; Kushel, Margot; Chang, Jamie S; Zamora, Kara; Ceasar, Rachel; Hurstak, Emily; Miaskowski, Christine

    2017-08-01

    There is growing concern among US-based clinicians, patients, policy makers, and in the media about the personal and community health risks associated with opioids. Perceptions about the efficacy and appropriateness of opioids for the management of chronic non-cancer pain (CNCP) have dramatically transformed in recent decades. Yet, there is very little social scientific research identifying the factors that have informed this transformation from the perspectives of prescribing clinicians. As part of an on-going ethnographic study of CNCP management among clinicians and their patients with co-occurring substance use, we interviewed 23 primary care clinicians who practice in safety-net clinical settings. In this paper, we describe the clinical and social influences informing three historic periods: (1) the escalation of opioid prescriptions for CNCP; (2) an interim period in which the efficacy of and risks associated with opioids were re-assessed; and (3) the current period of "opioid pharmacovigilance," characterized by the increased surveillance of opioid prescriptions. Clinicians reported that interpretations of the evidence-base in favor of and opposing opioid prescribing for CNCP evolved within a larger clinical-social context. Historically, pharmaceutical marketing efforts and clinicians' concerns about racialized healthcare disparities in pain treatment influenced opioid prescription decision-making. Clinicians emphasized how patients' medical complexity (e.g. multiple chronic health conditions) and structural vulnerability (e.g. poverty, community violence) impacted access to opioids within resource-limited healthcare settings. This clinical-social history of opioid prescribing practices helps to elucidate the ongoing challenges of CNCP treatment in the US healthcare safety net and lends needed specificity to the broader, nationwide conversation about opioids. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

    2011-12-01

    To investigate putative associations of reports of memory disorders and suspected drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. Among the 188,284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4-93). The maximal number of cases occurred between 40-49 and 50-59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011

  12. Adverse drug reactions associated with the use of NSAIDs: a case/noncase analysis of spontaneous reports from the French pharmacovigilance database 2002-2006.

    Science.gov (United States)

    Lapeyre-Mestre, Maryse; Grolleau, Sabrina; Montastruc, Jean-Louis

    2013-04-01

    To evaluate the safety profile of eight oral nonsteroidal anti-inflammatory drugs (NSAIDs) available in France, using data reported through the French pharmacovigilance system. Data (from 2002 to 2006) were analysed for aceclofenac, diclofenac, ketoprofen, meloxicam, naproxen, nimesulide, piroxicam and tenoxicam, focusing on the reported rates of serious adverse drug reactions (ADRs) in the following system organ classes: gastrointestinal, hepatic, cutaneous, renal and cardiovascular. A total of 42 389 serious ADR reports were identified, and 38 506 were included in a case/noncase analysis. Ketoprofen was associated with the highest cumulative reported rate of serious ADRs (0.78 cases per million defined daily doses), followed by diclofenac (0.58), nimesulide (0.52), naproxen (0.50), piroxicam (0.47), tenoxicam (0.42), meloxicam (0.41) and aceclofenac (0.30). The most frequently reported serious ADRs were cutaneous, followed by gastrointestinal, hepatic, renal and rarely, cardiovascular events. In the case/noncase analysis, ketoprofen, piroxicam and naproxen were associated with the highest risk of serious gastrointestinal ADRs (odds ratios [ORs] of 6.87, 6.54 and 5.07, respectively). Nimesulide and aceclofenac were associated with the highest risk of liver ADRs (adjusted ORs of 4.53 and 3.67, respectively), as was meloxicam for cutaneous ADRs (adjusted OR of 3.15) and tenoxicam for renal ADRs (adjusted OR of 3.17). The most frequent serious ADRs reported with the selected oral NSAIDs are cutaneous, followed by gastrointestinal, hepatic and renal events. The highest risks for serious gastrointestinal, hepatic, cutaneous and renal adverse events were linked, respectively, with ketoprofen, nimesulide, meloxicam and tenoxicam compared with the other NSAIDs. © 2011 The Authors Fundamental and Clinical Pharmacology © 2011 Société Française de Pharmacologie et de Thérapeutique.

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

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

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

  14. [Antiemetics and cardiac effects potentially linked to prolongation of the QT interval: Case/non-case analysis in the national pharmacovigilance database].

    Science.gov (United States)

    Rochoy, M; Auffret, M; Béné, J; Gautier, S

    2017-02-01

    Observational retrospective studies have linked domperidone and prolonged QT interval, ventricular arrhythmias and risk of sudden death. Since then, antiemetic prescription was applied to other molecules (including metopimazine). The aim of this study was to evaluate the profile of adverse cardiac effects associated with QT prolongation for each antiemetic available in France. We conducted disproportionality analyses (case/non-case method), based on the observations recorded consecutively in the French national pharmacovigilance database between 2004 and 2013. Cases were defined by following MedDRA terms: prolongation of the QT interval, syncope, sudden death, cardiac arrest, ventricular arrhythmias including torsades de pointes; non-cases were other adverse events reported during the same period. We analyzed the presence of each antiemetic among cases and non-cases and measured the disproportionality by reporting odds ratios (ROR). We validate the assay with a positive control (methadone) and a negative control (acetaminophen). We compared 2093 cases (94 with antiemetics) to 253,665 non-cases (7015 with antiemetics). Among antiemetics, adverse cardiac effects studied were more frequently found with notifications including domperidone (ROR=2.0, 95% CI=[1.3; 3.0]), ondansetron (ROR=1.8, 95% CI=[1.3; 2.6]) and granisetron (ROR=3.4, 95% CI=[1.5; 7.6]). Metopimazine was not statistically associated with that risk (ROR=2.0; 95% CI=[0.8; 4.8]). We confirmed a risk of cardiac adverse event related to prolongation of the QT interval with domperidone and setrons. These results suggest caution when prescribing antiemetics and encourage systematic reporting of adverse cardiac effects observed with these molecules. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  15. Reviews

    Directory of Open Access Journals (Sweden)

    Philip Barker

    2002-12-01

    Full Text Available Teaching and Learning Online is a collection of seventeen papers divided into six sections. The papers have their origins in an 'expert' seminar held at the International Centre for Learner Managed Learning at Middlesex University, London. The seminar brought together a group of practitioners (academic, training and media from around the world to consider progress to date and the future of learning and teaching online. For the purposes of the book 'online' is understood to include 'electronic means of distributing and engaging with learning' (ix and only includes broadcast media to the degree that they overlap with 'the overall internet scenario' (ix. According to the book details of the original seminar are available from http:llwww.iclml.mdx.acuk/TLonline. Readers are invited to contribute to online discussion. However, at the time this review was written the Website was unavailable.

  16. Reviews

    Science.gov (United States)

    2005-07-01

    WE RECOMMEND When Physics Became King This book delves into the history of science since the 18th century. The History of the Laser An interesting read that will teach you far more than its title suggests. History of Physics Selected Reprints A fascinating collection of physics papers spanning four decades. Datalogging set-ups Five great products from Leybold Didactic’s CASSY range. Videocom Measure motion and convert it to graphs with this great device. Basic Raybox This simple piece of equipment offers great performance. WORTH A LOOK Virtual Physics Lab John Nunn’s software demystifies science using clear illustrations. HANDLE WITH CARE Microchem Electricity Kit This box of equipment for introducing electricity lacks quality. Raymond the Raybox A disappointing raybox. The basic version reviewed on p389 is better. WEB WATCH A rough guide to e-learning.

  17. More on the "Triple Whammy": antihypertensive drugs, non-steroidal anti-inflammatory agents and acute kidney injury - a case/non-case study in the French pharmacovigilance database.

    Science.gov (United States)

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-08-01

    It has been suggested that the risk of acute kidney injury (AKI) increases with the number of drugs associated between non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin converting enzyme inhibitors (ACEis) [or angiotensin receptor blockers (ARBs)] and diuretics. We aimed to investigate whether the number of drugs associated between NSAIDs, ACEis, ARBs and diuretics was associated to disproportionate reporting of AKI in the French Pharmacovigilance Database. In reports of Adverse Drug Reactions (ADRs) recorded between 01 January 2008 and 31 December 2010, we selected patients whose medications included at least one oral antihypertensive drug. We used a case/non-case methodology. Cases were AKI and non-cases were all the remaining reports. Among the 11,442 ADR reports in patients under antihypertensive drug recorded in the French Pharmacovigilance Database, 837 ADRs were AKI (7.3%, 95% CI 6.8-7.8). AKI and the number of drugs associated were disproportionately reported (one drug alone: adjusted ROR 2.19, 95% CI: 1.65-2.89, two drugs: adjusted ROR 5.27, 95% CI: 4.00-6.94, three and more: adjusted ROR 16.46, 95% CI: 11.38-23.80). There was no significant association between NSAIDs' half-lives and reporting of AKI (adjusted ROR=0.54, 95% CI: 0.25-1.15). Given the widespread use of these hazardous drugs in general population, caution is needed when they are associated.

  18. Questions about complementary and alternative medicine to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive pilot study

    Science.gov (United States)

    2014-01-01

    Background Provision of clinically relevant information about complementary and alternative medicine (CAM) to health care professionals is not well described. The aim of the study was to assess questions about CAM to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). Methods All question-answers pairs (QAPs) in the RELIS database indexed with alternative medicine from 2005-2010 constituted the study material. A randomly selected sample of 100 QAPs was characterized with regard to type of question (category, patient-specific or general), occupation and workplace of enquirer, the type of information search performed (simple or advanced), and if the answers contained information to provide factual or consultative replies (facts about or advice on clinical use of CAM, respectively). Proportions were compared with Fisher’s exact test with significance at the 0.05 level. Results One thousand and thirty-eight (7.7%) out of 13 482 questions involved CAM. Eighty-two out of 100 questions concerned products containing one or more herbs, vitamins and minerals as well as other substances. Thirty-eight out of 100 questions concerned the category documentation (substance identification and/or literature reports about clinical effects), 36 interactions, 16 adverse effects, 9 pregnancy and lactation, and 1 question concerned contraindications. Sixty-three questions were patient-specific and 37 general. Fifty-four questions came from physicians, 33 from pharmacists and 13 from others (including nurses, midwives, students, CAM practitioners, and the public). Pharmacists asked more frequently about interactions while physicians asked more frequently about adverse effects (p < 0.05). Seventy-six of the questions came from outside hospital, mainly general practice and community pharmacies. Fifty-nine answers were based on a simple and 41 on an advanced information search. Thirty-three factual and 38 consultative answers were provided. In 29 answers

  19. Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol)

    Science.gov (United States)

    Tavassoli, Neda; Lapeyre-Mestre, Maryse; Sommet, Agnès; Montastruc, Jean-Louis

    2009-01-01

    AIMS Three ‘weak’ opioid analgesics in association with paracetamol are marketed in France as step 2 analgesics: dextropropoxyphene, tramadol and codeine. These combinations are involved in several adverse drug reactions (ADRs), but no data are available about their comparative reporting rate. The aim was to compare the reporting rate of ADRs between tramadol/paracetamol (TRM+P), codeine/paracetamol (COD+P) and dextropropoxyphene/paracetamol (DXP+P). METHODS All spontaneous reports submitted to the French Pharmacovigilance Database from 1 January 1987 to 31 December 2006 suspected to be induced by one of the three step 2 analgesic combinations (DXP+P, TRM+P, COD+P) were extracted. Their consumption for the same period was obtained from the French Drug Agency. The number of ADRs, serious ADRs and different organ classes of ADRs were compared according to their consumption. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each variable using DXP+P as reference. RESULTS The reporting rate of ADRs was calculated as 24.9/100 000 person-years for DXP+P, 44.5/100 000 person-years for TRM+P and 12.5/100 000 person-years for COD+P. The reporting rate (OR 0.56, 95% CI 0.50, 0.63) and ‘seriousness»’ (OR 0.65, 95% CI 0.53, 0.80) of ADRs were significantly higher with TRM+P than with DXP+P. However, hepatobiliary ADRs were significantly more frequent with the DXP+P combination (OR 2.62, 95% CI 1.59, 4.37). In contrast, the reporting rate (OR 1.99, 95% CI 1.82, 2.18) and ‘seriousness’ (OR 2.64, 95% CI 2.24, 3.11) of ADRs were significantly higher with DXP+P than with COD+P. CONCLUSIONS Among the three step 2 analgesic combinations, reporting rate and ‘seriousness’ of ADRs are the highest with TRM+P and the lowest with COD+P. Our study suggests that the safety profile of DXP+P is worst than that of COD+P. PMID:19740400

  20. An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

    Science.gov (United States)

    2016-01-01

    Background Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. Objective To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes. Methods The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. Results Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (Padvertisement methods used and in their ability to recruit participants in early pregnancy. Conclusions Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs

  1. Alopecia induced by tumour necrosis factor-alpha antagonists: description of 52 cases and disproportionality analysis in a nationwide pharmacovigilance database.

    Science.gov (United States)

    Béné, Johana; Moulis, Guillaume; Auffret, Marine; Lefevre, Guillaume; Coquerelle, Pascal; Coupe, Patrick; Péré, Patrice; Gautier, Sophie

    2014-08-01

    The aim of this research was to describe the cases of TNF-α antagonist-related alopecia reported in the French Pharmacovigilance Database (FPVD) and to investigate the association between exposure to TNF-α antagonists and occurrence of alopecia. All spontaneous reports of TNF-α antagonist-related alopecia recorded in the FPVD between January 2000 and April 2012 were colligated and described. We conducted disproportionality analyses (case/non-case method) to assess the link between the occurrence of alopecia and exposure to TNF-α antagonists. Cases were all reports of alopecia and non-cases were all other reports recorded during the study period. Exposure to TNF-α antagonists was sought in cases and in non-cases. Reporting odds ratios (RORs) were calculated to assess the association. Docetaxel was used as positive control and acetaminophen as negative control. We performed sensitivity analyses excluding cases of androgenic alopecia and those occurring in psoriatic patients. Among 282 590 spontaneous reports of adverse drug reactions (ADRs) collated in the FPVD, 1068 cases (alopecia reports) were identified. Of these cases, 52 (4.9%) occurred during exposure to TNF-α antagonists (18 involved infliximab, 17 adalimumab, 15 etanercept and 2 certolizumab). Exposure to TNF-α antagonists was more frequent among alopecia reports than among other ADR reports for all TNF-α antagonists pooled (ROR 3.0, 95% CI 2.3, 4.0) as well as for each antagonist separately, with similar values. Sensitivity analyses yielded similar results. The RORs were 29.9 (95% CI 25.3, 35.5) with docetaxel and 0.3 (95% CI 0.2, 0.4) with acetaminophen. The present study confirms a strong link between TNF-α antagonist exposure (class effect) and the occurrence of alopecia. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination.

    Science.gov (United States)

    Perez-Vilar, Silvia; Weibel, Daniel; Sturkenboom, Miriam; Black, Steven; Maure, Christine; Castro, Jose Luis; Bravo-Alcántara, Pamela; Dodd, Caitlin N; Romio, Silvana A; de Ridder, Maria; Nakato, Swabra; Molina-León, Helvert Felipe; Elango, Varalakshmi; Zuber, Patrick L F

    2018-01-08

    New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5-9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2-27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7-157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4-90.3), and Enders'Edmonston (IRR: 8.5; 95% CI: 1.9-38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3-87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the

  3. [Aplasia cutis congenita and antithyroid drugs during pregnancy: Case series and literature review].

    Science.gov (United States)

    Sachs, C; Tebacher-Alt, M; Mark, M; Cribier, B; Lipsker, D

    2016-01-01

    Aplasia cutis congenita (ACC) following in utero exposure to antithyroid drugs such as methimazole/carbimazole (MTZ/CMZ) has been reported since 1972. Though currently included in MTZ/CMZ embryopathy, it remains poorly characterized and is little discussed. Having seen two cases within a short period of time, we carried out a literature review and searched the French pharmacovigilance database for notification of cases. We performed a search of the literature in the Medline database using the following keywords: "aplasia cutis congenita", "birth skin defects", "pregnancy" and "drug". All articles reporting cases of ACC following in utero exposure to antithyroid drugs were included. All cases of ACC under antithyroid drugs reported to French pharmacovigilance centres were analysed. Three hundred and sixty-eight articles were retrieved and 31 were analysed, including a further 4, mentioned in selected articles, giving 59 cases of ACC under MTZ/CMZ reported in the literature and having an intrinsic accountability score of plausible or dubious. ACC was typically isolated, single, small in size, and localised on the median scalp area. Exposure occurred in the first weeks of gestation. There were 6 familial cases involving siblings. Ten ACC and MTZ/CMZ cases were reported to pharmacovigilance centres in France. Practitioners should be aware of ACC following MTZ/CMZ exposure in utero, whether it occurs in isolation or not. It is likely a teratogenic effect of MTZ/CMZ enhanced by a genetic predisposition. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  4. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant Conceptual Design Engineering Report (CDER)

    Science.gov (United States)

    1981-01-01

    The reference conceptual design of the magnetohydrodynamic (MHD) Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD, is summarized. Main elements of the design, systems, and plant facilities are illustrated. System design descriptions are included for closed cycle cooling water, industrial gas systems, fuel oil, boiler flue gas, coal management, seed management, slag management, plant industrial waste, fire service water, oxidant supply, MHD power ventilating

  5. Identification of cellular targets involved in cardiac failure caused by PKI in oncology: an approach combining pharmacovigilance and pharmacodynamics.

    Science.gov (United States)

    Patras de Campaigno, Emilie; Bondon-Guitton, Emmanuelle; Laurent, Guy; Montastruc, Francois; Montastruc, Jean-Louis; Lapeyre-Mestre, Maryse; Despas, Fabien

    2017-07-01

    The aims of the present study were to evaluate the risk of cardiac failure (CF) associated with 15 anticancer protein kinase inhibitors (PKIs) through a case/noncase analysis and to identify which PK(s) and pathways are involved in PKI-induced CF. In order to evaluate the risk of CF, adjusted reporting odds ratios (aRORs) were calculated for the 15 anticancer PKIs in the World Health Organization safety report database (VigiBase®). We realised a literature review to identify 21 protein kinases (PKs) that were possibly involved in CF caused by PKIs. Pearson correlation coefficients (r) between aRORs and affinity data of the 15 PKIs for the 21 PKs were calculated to identify the cellular target most likely to be involved in PKI-induced CF. A total of 141 601 individual case safety reports (ICSRs) were extracted from VigiBase® for the following PKIs: afatinib, axitinib, bosutinib, crizotinib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ruxolitinib, sorafenib, sunitinib and vandetanib. Among them, 2594 ICSRs concerned CF. The disproportionality analysis revealed that, for dasatinib, imatinib, bosutinib, sunitinib and nilotinib, disproportionality for CF was significantly higher than for other PKIs, with aRORs of 2.52 [95% CI 2.26, 2.82], 1.79 (95% CI 1.57, 2.03), 1.73 (95% CI 1.18, 2.54), 1.67 (95% CI 1.51, 1.84) and 1.38 (95% CI 1.18, 1.61), respectively. Significant values for correlation coefficients between the product of dissociation constant (pKd) and aROR were observed for two non-receptor protein kinases: ABL1 (non-phosphorylated and phosphorylated forms) and ABL2 protein kinases, with values of r = 0.83 (P = 0.0001), r = 0.75 (P = 0.0014) and r = 0.78 (P = 0.0006), respectively. We observed a higher disproportionality for CF with dasatinib, imatinib, bosutinib, sunitinib and nilotinib than with other PKIs. In addition, the study highlighted the role of ABL tyrosine kinases in CF caused by anticancer PKIs. © 2017 The British

  6. Advancing pharmacovigilance through academic–legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis—a research on adverse drug events and reports (RADAR) report

    Science.gov (United States)

    Edwards, B J; Laumann, A E; Nardone, B; Miller, F H; Restaino, J; Raisch, D W; McKoy, J M; Hammel, J A; Bhatt, K; Bauer, K; Samaras, A T; Fisher, M J; Bull, C; Saddleton, E; Belknap, S M; Thomsen, H S; Kanal, E; Cowper, S E; Abu Alfa, A K

    2014-01-01

    Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts. Methods: The Research on Adverse Drug events And Reports methodology was used for assessment—the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration. Results: The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA. Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA. Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research. PMID:25230161

  7. Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study.

    Science.gov (United States)

    Viola, E; Trifirò, G; Ingrasciotta, Y; Sottosanti, L; Tari, M; Giorgianni, F; Moretti, U; Leone, R

    2016-12-01

    This study aims to evaluate the frequency of off-label use of ketorolac in Italy and the related suspected adverse drug reactions (ADRs) reported. All the suspected cases associated with ketorolac recorded in the Italian Pharmacovigilance database were retrieved. Case evaluations were carried out in order to identify the off-label use of ketorolac. Moreover, an analysis of the inappropriate use of ketorolac was conducted using the 'Arianna' database of Caserta local health unit. Up to December 2014, 822 reports of suspected ADRs related to ketorolac were retrieved in the database. The use of ketorolac was classified as off-label for 553 reports and on-label for 269. Among the off-label cases, 58.6% were serious compared to 39.0% of on-label cases. Gastrointestinal events were more frequently reported with off-label use. The analysis of Arianna database showed that 37,729 out of 61,910 patients, were treated off-label. The off-label use of ketorolac is widespread in Italy. This use increases the risk of serious ADR, especially in in case of prolonged duration of treatment and in elderly patients. The Italian Medicine Agency has decided to accurately monitor the appropriate use of the drug in Italy and, if necessary, take measures in order to minimize the risks.

  8. A question-answer pair (QAP) database integrated with websites to answer complex questions submitted to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive study.

    Science.gov (United States)

    Schjøtt, Jan; Reppe, Linda A; Roland, Pål-Didrik H; Westergren, Tone

    2012-01-01

    To assess a question-answer pair (QAP) database integrated with websites developed for drug information centres to answer complex questions effectively. Descriptive study with comparison of two subsequent 6-year periods (1995-2000 and 2001-2006). The Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). A randomised sample of QAPs from the RELIS database. Answer time in days compared with Mann-Whitney U test. Number of drugs involved (one, two, three or more), complexity (judgemental and/or patient-related or not) and literature search (none, simple or advanced) compared with χ(2) tests. 842 QAPs (312 from 1995 to 2000 and 530 from 2001 to 2006) were compared. The fraction of judgemental and patient-related questions increased (66%-75% and 54%-72%, respectively, p50% advanced) was similar in the two periods, but the fraction of answers referring to the RELIS database increased (13%-31%, p<0.01). Median answer time was reduced from 2 days to 1 (p<0.01), although the fraction of complex questions increased from the first to the second period. Furthermore, the mean number of questions per employee per year increased from 66 to 89 from the first to the second period. The authors conclude that RELIS has a potential to efficiently answer complex questions. The model is of relevance for organisation of drug information centres.

  9. A question–answer pair (QAP) database integrated with websites to answer complex questions submitted to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive study

    Science.gov (United States)

    Reppe, Linda A; Roland, Pål-Didrik H; Westergren, Tone

    2012-01-01

    Objective To assess a question–answer pair (QAP) database integrated with websites developed for drug information centres to answer complex questions effectively. Design Descriptive study with comparison of two subsequent 6-year periods (1995–2000 and 2001–2006). Setting The Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). Participants A randomised sample of QAPs from the RELIS database. Primary outcome measure Answer time in days compared with Mann–Whitney U test. Secondary outcome measure Number of drugs involved (one, two, three or more), complexity (judgemental and/or patient-related or not) and literature search (none, simple or advanced) compared with χ2 tests. Results 842 QAPs (312 from 1995 to 2000 and 530 from 2001 to 2006) were compared. The fraction of judgemental and patient-related questions increased (66%–75% and 54%–72%, respectively, p50% advanced) was similar in the two periods, but the fraction of answers referring to the RELIS database increased (13%–31%, p<0.01). Median answer time was reduced from 2 days to 1 (p<0.01), although the fraction of complex questions increased from the first to the second period. Furthermore, the mean number of questions per employee per year increased from 66 to 89 from the first to the second period. Conclusions The authors conclude that RELIS has a potential to efficiently answer complex questions. The model is of relevance for organisation of drug information centres. PMID:22422916

  10. The Impact of the Educational Intervention on Knowledge, Attitude, and Practice of Pharmacovigilance toward Adverse Drug Reactions Reporting among Health-care Professionals in a Tertiary Care Hospital in South India

    Science.gov (United States)

    Ganesan, Subramaniyan; Sandhiya, Selvarajan; Reddy, Kishtapati Chenchu; Subrahmanyam, D. K.; Adithan, Chandrasekaran

    2017-01-01

    Background: Knowledge, attitude, practice (KAP)-based educational intervention is an important tool to reduce underreporting of adverse drug reactions (ADRs). Hence, this study aimed to assess the KAP of doctors and nurses working in medicine and allied departments of Jawaharlal Institute of Postgraduate Medical Education and Research on spontaneous reporting of ADRs, following an educational intervention. The study also compared the quantity of ADRs reported before and after 1 year of introducing the educational intervention. Methodology: The study was a cross-sectional questionnaire-based study involving doctors and nurses working in a tertiary care hospital in South India. A predesigned structured questionnaire was prepared to suit our ADR monitoring center, validated and then distributed to doctors and nurses working in medicine and allied departments of the institute. The study participants were asked to fill KAP pretest questionnaire followed by interactive educational intervention and post-test questionnaire related to KAP after 1 year. The impact of educational intervention among doctors and nurses was evaluated by their response to the post-test questionnaire and the number of ADR reported after intervention. The appropriate statistical analysis was used through Graph Pad InStat version 3.0. Results: A total of 235 health-care professionals were involved in the pre-KAP questionnaire, an educational intervention, and post-KAP questionnaire. Among them, doctors were 39%, and nurses were 61%. The overall response rate among doctors and nurses following educational intervention was statistically significant (P pharmacovigilance. Continued educational intervention may inculcate ADR reporting culture among health-care professionals. PMID:28781488

  11. The Impact of the Educational Intervention on Knowledge, Attitude, and Practice of Pharmacovigilance toward Adverse Drug Reactions Reporting among Health-care Professionals in a Tertiary Care Hospital in South India.

    Science.gov (United States)

    Ganesan, Subramaniyan; Sandhiya, Selvarajan; Reddy, Kishtapati Chenchu; Subrahmanyam, D K; Adithan, Chandrasekaran

    2017-01-01

    Knowledge, attitude, practice (KAP)-based educational intervention is an important tool to reduce underreporting of adverse drug reactions (ADRs). Hence, this study aimed to assess the KAP of doctors and nurses working in medicine and allied departments of Jawaharlal Institute of Postgraduate Medical Education and Research on spontaneous reporting of ADRs, following an educational intervention. The study also compared the quantity of ADRs reported before and after 1 year of introducing the educational intervention. The study was a cross-sectional questionnaire-based study involving doctors and nurses working in a tertiary care hospital in South India. A predesigned structured questionnaire was prepared to suit our ADR monitoring center, validated and then distributed to doctors and nurses working in medicine and allied departments of the institute. The study participants were asked to fill KAP pretest questionnaire followed by interactive educational intervention and post-test questionnaire related to KAP after 1 year. The impact of educational intervention among doctors and nurses was evaluated by their response to the post-test questionnaire and the number of ADR reported after intervention. The appropriate statistical analysis was used through Graph Pad InStat version 3.0. A total of 235 health-care professionals were involved in the pre-KAP questionnaire, an educational intervention, and post-KAP questionnaire. Among them, doctors were 39%, and nurses were 61%. The overall response rate among doctors and nurses following educational intervention was statistically significant (P educational intervention, the quantity of ADR reported became double compared to pre-intervention. The KAP of health-care professionals improved following educational interventional program on pharmacovigilance. Continued educational intervention may inculcate ADR reporting culture among health-care professionals.

  12. A evolução da farmacovigilância no Brasil - DOI: 10.4025/actascihealthsci.v27i2.1377 The evolution of the pharmacovigilance in Brazil - DOI: 10.4025/actascihealthsci.v27i2.1377

    Directory of Open Access Journals (Sweden)

    Paula Nishiyama

    2005-03-01

    Full Text Available Este trabalho faz um breve relato sobre os aspectos conceituais e os marcos históricos que envolvem a Farmacovigilância. São abordados os caminhos que levaram ao desenvolvimento da Farmacovigilância no mundo e no Brasil, finalizando com as perspectivas da formação de um serviço de qualidade que contribuirá para minimizar os potenciais danos dos medicamentos e assim servir à saúde pública e aumentar o senso de confiança dos pacientes nos medicamentosThis work makes a brief story on the conceptual aspects and the historical landmarks that involve the Pharmacovigilance. There are related the ways that had taken the development of the Pharmacovigilance in the world and Brazil, concluding with the perspectives of the development of a qualified service that will contribute to minimize the injury caused by drugs use and so serving to the public health and increasing the reliable sense of the patients in drugs use

  13. Central and Peripheral Nervous System Disorders Following Ivermectin Mass Administration: A Descriptive Study Based on the Democratic Republic of Congo Pharmacovigilance System.

    Science.gov (United States)

    Nzolo, Didier; Anto, Francis; Hailemariam, Sarah; Bakajika, Didier; Muteba, Daniel; Makenga, Jean-Claude; Mesia, Gautier; Nsibu, Celestin; Mampunza, Samuel; Tona, Gaston

    2017-06-09

    The mainstay of onchocerciasis control currently is mass administration of ivermectin; however, this may be associated with serious adverse events, including deaths, when administered in areas where onchocerciasis and loiasis are co-endemic. The objective of the current study was to describe the central and peripheral nervous system disorders that occurred after mass administration of ivermectin in Democratic Republic of Congo (DRC). This is a retrospective descriptive study involving a review of data on adverse events related to mass administration of ivermectin. Data on reported serious adverse events following mass administration of ivermectin in the DRC were extracted from the World Health Organization (WHO) Global individual case safety report (ICSR) database (VigiBase). The review covered the period 2009-2013 and focused on central and peripheral nervous system disorders. Relevant demographic, clinical, and parasitological data, including age, sex, area of residence, adverse events, and parasite density were extracted. Descriptive statistics were analyzed using Stata 12. A total of 52 ICSRs related to ivermectin intake were available in VigiBase, with 51 (98.1%) from the Province of Equateur. All patients had central and peripheral nervous system disorders; 25 (48.1%) had altered mental status. Of these, 23 (92.0%) satisfied the criteria for "probable/possible Loa loa encephalopathy temporally related to mectizan(®)" (PLERM). The most frequent nervous system disorders among patients with PLERM were coma (74%), stupor (30%), headache (22%), and abnormal gait (22%). There were, on average, 2149.1 microfilariae per ml (mf/ml) in peripheral blood [95% confidence interval (CI) 463.6-3834.6; n = 23]. Post-treatment, 61% of PLERM cases had <1000 L. loa mf/ml of blood. One patient had microfilariae in the cerebrospinal fluid rather than the peripheral blood. We found 21.4% co-infection with Plasmodium falciparum and 4% mortality. PLERM may occur at even low

  14. Magnetohydrodynamics MHD Engineering Test Facility ETF 200 MWe power plant. Conceptual Design Engineering Report CDER. Volume 3: Costs and schedules

    Science.gov (United States)

    1981-01-01

    The estimated plant capital cost for a coal fired 200 MWE electric generating plant with open cycle magnetohydrodynamics is divided into principal accounts based on Federal Energy Regulatory Commision account structure. Each principal account is defined and its estimated cost subdivided into identifiable and major equipment systems. The cost data sources for compiling the estimates, cost parameters, allotments, assumptions, and contingencies, are discussed. Uncertainties associated with developing the costs are quantified to show the confidence level acquired. Guidelines established in preparing the estimated costs are included. Based on an overall milestone schedule related to conventional power plant scheduling experience and starting procurement of MHD components during the preliminary design phase there is a 6 1/2-year construction period. The duration of the project from start to commercial operation is 79 months. The engineering phase of the project is 4 1/2 years; the construction duration following the start of the man power block is 37 months.

  15. Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting.

    Science.gov (United States)

    Mascolo, Annamaria; Scavone, Cristina; Sessa, Maurizio; di Mauro, Gabriella; Cimmaruta, Daniela; Orlando, Valentina; Rossi, Francesco; Sportiello, Liberata; Capuano, Annalisa

    2017-09-01

    Causality assessment is a fundamental biomedical technique for the signal detection performed by Pharmacovigilance centers in a Spontaneous reporting system. Moreover, it is a crucial and important practice for detecting preventable adverse drug reactions. Among different methods for causality assessment, algorithms (such as the Naranjo, or Begaud Methods) seem for their operational procedure and easier applicability one of the most commonly used methods. With the upcoming of the new European Pharmacovigilance legislation including in the definition of the adverse event also effects resulting from abuse, misuse and medication error, all well-known preventable causes of ADRs, there was an emerging need to evaluate whether algorithms could fulfill this new definition. In this review, twenty-two algorithmic methods were identified and none of them seemed to fulfill perfectly the new criteria of adverse event although some of them come close. In fact, several issues were arisen in applying causality assessment algorithms to these new definitions as for example the impossibility to answer the rechallenge question in case of medication error or AEFI (Adverse Event Following Immunization). Moreover, the exact conditions at which events occurred, as for example dosage or mode of administration should be considered to better assess causality in conditions of abuse/overdose, or misuse as well as in conditions of lack of expected efficacy reports for biotechnological drugs and adverse event occurring after mixing of vaccines. Therefore, this review highlights the need of updating algorithmic methods to allow a perfect applicability in all possible clinical scenarios accordingly or not with the terms of marketing authorization. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Ogunwande Isiaka A

    2011-08-01

    Full Text Available Abstract Background Adverse drug reactions (ADRs contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria. Methods Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP and four Patent and Proprietary Medicine Stores (PPMS in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period. Results and Discussion A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases; of this number, purchases of sulphadoxine-pyrimethamine (SP and chloroquine (CQ were highest (39.3 and 25.2% respectiuvely. Other anti-malarials purchased were artesunate monotherapy (AS - 16.1%, artemether-lumefantrine (AL 10.0%, amodiaquine (AQ - 6.6%, quinine (QNN - 1.9%, halofantrine (HF - 0.2% and proguanil (PR - 0.2%. CQ was the cheapest (USD 0.3 and halofantrine the most expensive (USD 7.7. AL was 15.6 times ($4.68 more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1 after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%. Conclusion The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource

  17. Prevalence of immune-related systemic adverse events in patients treated with anti-Programmed cell Death 1/anti-Programmed cell Death-Ligand 1 agents: A single-centre pharmacovigilance database analysis.

    Science.gov (United States)

    Le Burel, Sébastien; Champiat, Stéphane; Mateus, Christine; Marabelle, Aurélien; Michot, Jean-Marie; Robert, Caroline; Belkhir, Rakiba; Soria, Jean-Charles; Laghouati, Salim; Voisin, Anne-Laure; Fain, Olivier; Mékinian, Arsène; Coutte, Laetitia; Szwebel, Tali-Anne; Dunogeant, Laetitia; Lioger, Bertrand; Luxembourger, Cécile; Mariette, Xavier; Lambotte, Olivier

    2017-09-01

    The growing use of immune checkpoint inhibitors (ICIs) is associated with the occurrence of immune-related adverse events (irAEs). Few data are published on systemic, immunohaematological and rheumatic irAEs. In a pharmacovigilance database analysis, we screened for these irAEs and calculated their prevalence. Participants were recruited via Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie (REISAMIC)1 a French registry of grade ≥2 irAEs occurring in ICI-treated patients. The pathologies of interest were systemic autoimmune and inflammatory diseases, rheumatic diseases and immune cytopenia. Out of 908 patients treated with anti-Programmed cell Death 1 (PD1)/anti-Programmed cell Death-Ligand 1 (PD-L1) agents (together with an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) agent in 40 cases) between December 2012 and December 2016 at a single centre, 21 patients experienced systemic irAEs. The types and the prevalence of irAEs were as follows: immune thrombocytopenia (0.2%), Sjögren syndrome (0.3%), rheumatoid arthritis (0.2%), polymyalgia rheumatica (0.2%), psoriatic arthritis (0.2%), seronegative polyarthritis (0.7%) and sarcoidosis (0.2%). Patients with Sjögren syndrome or seronegative polyarthritis were more likely to have received combination therapy with ipilimumab (2.5% for both). We described these 21 cases, together with nine additional cases from five other centres. Most irAE were moderately severe (grade 2, 63%). The median time to onset was 57°days (interquartile range (IQR) 24-117). The ICI was withdrawn in 12 cases, 25 patients (83%) received corticosteroids, and five patients (17%) received immunosuppressant/immunomodulatory agents. The irAEs resolved fully or partially in 28 cases (93%). Although systemic, immunohaematological and rheumatic diseases are rarely associated with ICI use, the prevalence is higher when two ICIs are combined. Corticosteroids are often effective and may enable

  18. Implemented data mining and signal management systems on spontaneous reporting systems' databases and their availability to the scientific community - a systematic review.

    Science.gov (United States)

    de Almeida Vieira Lima, Luis Miguel; Nunes, Nuno Goncalo Sales Craveiro; da Silva Dias, Pedro Goncalo Pires; Marques, Francisco Jorge Batel

    2012-04-01

    Adverse drug reactions' spontaneous reporting systems are an important element in worldwide pharmacovigilance, gathering potentially useful information for post-marketing drug safety surveillance. Data mining and signal management systems, providing the capability of reading and interpreting these systems' raw data (data that has not been subjected to processing or any other manipulation), improve its analysis process. In order for this analysis to be possible, both data mining and signal management systems and raw data should be available to researchers and the scientific community. The purpose of this work was to provide an overview of the spontaneous reporting systems databases reported in literature as having implemented a data mining and signal management system and the implementation itself, evidencing their availability to researchers. A systematic review was carried out, concluding that they are freely provided to researchers within institutions responsible for maintaining the spontaneous reporting systems, but not to most researchers within the scientific community.

  19. Traceability of biologicals : present challenges in pharmacovigilance

    NARCIS (Netherlands)

    Vermeer, Niels S; Spierings, Irina; Mantel-Teeuwisse, Aukje K; Straus, Sabine Mjm; Giezen, Thijs J; Leufkens, Hubert Gm; Egberts, Toine Cg; De Bruin, Marie L

    INTRODUCTION: Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual

  20. Traceability of biologicals : Present challenges in pharmacovigilance

    NARCIS (Netherlands)

    Vermeer, Niels S.; Spierings, Irina; Mantel-Teeuwisse, Aukje K.; Straus, Sabine MJM; Giezen, Thijs J.; Leufkens, Hubert GM; Egberts, Toine CG; De Bruin, Marie L.

    2015-01-01

    Introduction: Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual

  1. Pharmacovigilance of Herbal Products in India

    OpenAIRE

    Van der Wal, P.; Wal, A; Gupta, S; Sharma, G; Rai, AK

    2011-01-01

    Herbal formulations being widely accepted therapeutic agents as antidiabetics, antiarthritics, hepatoprotectives, cough remedies, memory enhancers, and adaptogens. The commonest myth regarding herbal medicines is that these medicines are completely safe, and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects,...

  2. Knowledge, perceptions and practices of pharmacovigilance ...

    African Journals Online (AJOL)

    Conclusion: The majority of pharmacists are familiar with the concept of PV, but less than half reported any ADR. They are willing to participate in PV processes but are unsure what their exact role playing should be. More than half indicated that they would like to see improvements to the current PV system in South Africa.

  3. Knowledge, perceptions and practices of pharmacovigilance ...

    African Journals Online (AJOL)

    M.C. Joubert

    knowledge, perceptions and practices of both community and hospital pharmacists to- wards the practice of PV. Objectives: The ... science and activities relating to the detection, assessment, understanding and prevention of ..... It can be seen from this graph that 50% found reporting to be time consuming whilst over 38% ...

  4. Pharmacovigilance: the devastating consequences of not thinking ...

    African Journals Online (AJOL)

    safety profile of the complex drug regimens that patients with HIV/. AIDS are often receiving. Additionally, a report by the Institute of Medicine in the United States estimated that between 44 000 and 98 000 people in US hospitals die each year because of medical errors, with medication errors playing a significant role in ...

  5. Active and passive surveillance of yellow fever vaccine 17D or 17DD-associated serious adverse events: systematic review.

    Science.gov (United States)

    Thomas, Roger E; Lorenzetti, Diane L; Spragins, Wendy; Jackson, Dave; Williamson, Tyler

    2011-06-20

    To identify the rate of serious adverse events attributable to yellow fever vaccination with 17D and 17DD strains reported in active and passive surveillance data. We conducted a systematic review of published literature on adverse events associated with yellow fever. We searched 9 electronic databases for peer reviewed and grey literature in all languages. There were no restrictions on date of publication. Reference lists of key studies were also reviewed to identify additional studies. We identified 66 relevant studies: 24 used active, 17 a combination of passive and active (15 of which were pharmacovigilance databases), and 25 passive surveillance. ACTIVE SURVEILLANCE: A total of 2,660,929 patients in general populations were followed for adverse events after vaccination, heavily weighted (97.7%) by one large Brazilian study. There were no observed cases of viscerotropic or neurotropic disease, one of anaphylaxis and 26 cases of urticaria (hypersensitivity). We also identified four studies of infants and children (n=2199), four studies of women (n=1334), and one study of 174 HIV+, and no serious adverse events were observed. PHARMACOVIGILANCE DATABASES: 10 of the 15 databases contributed data to this review, with 107,621,154 patients, heavily weighted (94%) by the Brazilian database. The estimates for Australia were low at 0/210,656 for "severe neurological disease" and 1/210,656 for YEL-AVD, and also low for Brazil with 9 hypersensitivity events, 0.23 anaphylactic shock events, 0.84 neurologic syndrome events and 0.19 viscerotropic events cases/million doses. The five analyses of partly overlapping periods for the US VAERS database provided an estimate of 6.6 YEL-AVD and YEL-AND cases per million, and estimates between 11.1 and 15.6 of overall "serious adverse events" per million. The estimates for the UK were higher at 34 "serious adverse events" and also for Switzerland with 14.6 "neurologic events" and 40 "serious events not neurological"/million doses

  6. CPAP Tips

    Medline Plus

    Full Text Available ... are some tips from the U.S. Food and Drug Administration (FDA) on how to safely and effectively ... views 3:03 FDA CDER Regulatory Science: Improving Drug Review with Data Standards - Duration: 3:01. USFoodandDrugAdmin ...

  7. CPAP Tips

    Medline Plus

    Full Text Available ... are some tips from the U.S. Food and Drug Administration (FDA) on how to safely and effectively ... views 9:28 FDA CDER Regulatory Science: Improving Drug Review with Data Standards - Duration: 3:01. USFoodandDrugAdmin ...

  8. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

  9. Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

    Directory of Open Access Journals (Sweden)

    M. Varenna

    2013-10-01

    Full Text Available The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.

  10. Progressive multifocal leukoencephalopathy in patients treated with fumaric acid esters: a review of 19 cases.

    Science.gov (United States)

    Gieselbach, Robbert-Jan; Muller-Hansma, Annemarie H; Wijburg, Martijn T; de Bruin-Weller, Marjolein S; van Oosten, Bob W; Nieuwkamp, Dennis J; Coenjaerts, Frank E; Wattjes, Mike P; Murk, Jean-Luc

    2017-06-01

    Progressive multifocal leukoencephalopathy (PML) is a rare and potentially fatal condition caused by a brain infection with JC polyomavirus (JCV). PML develops almost exclusively in immunocompromised patients and has recently been associated with use of fumaric acid esters (FAEs), or fumarates. We reviewed the literature and the Dutch and European pharmacovigilance databases in order to identify all available FAE-associated PML cases and distinguish possible common features among these patients. A total of 19 PML cases associated with FAE use were identified. Five cases were associated with FAE use for multiple sclerosis and 14 for psoriasis. Ten patients were male and nine were female. The median age at PML diagnosis was 59 years. The median duration of FAE therapy to PML symptom onset or appearance of first PML lesion on brain imaging was 31 months (range 6-110). In all cases a certain degree of lymphocytopenia was reported. The median duration of lymphocytopenia to PML symptom onset was 23 months (range 6-72). The median lymphocyte count at PML diagnosis was 414 cells/µL. CD4 and CD8 counts were reported in ten cases, with median cell count of 137 and 39 cells/µL, respectively. Three patients died (16% mortality). The association between occurrence of PML in patients with low CD4 and CD8 counts is reminiscent of PML cases in the HIV population and suggests that loss of T cells is the most important risk factor.

  11. A systematic review of prescription pattern monitoring studies and their effectiveness in promoting rational use of medicines.

    Science.gov (United States)

    Jain, Shipra; Upadhyaya, Prerna; Goyal, Jaswant; Kumar, Abhijit; Jain, Pushpawati; Seth, Vikas; Moghe, Vijay V

    2015-01-01

    Prescription pattern monitoring studies (PPMS) are a tool for assessing the prescribing, dispensing and distribution of medicines. The main aim of PPMS is to facilitate rational use of medicines (RUM). There is paucity of published data analysing the effectiveness of PPMS. The present review has been done to assess the effectiveness of prescription pattern monitoring studies in promoting RUM. Data search was conducted on internet. A multitude of PPMS done on different classes of drugs were collected and analyzed. PPMS using WHO prescribing indicators were also included. The present article reviews various prescription pattern monitoring studies of drugs conducted all over country and abroad. It was observed in the majority of such studies that physicians do not adhere to the guidelines made by regulatory agencies leading to irrational use of medicines. This in turn leads to increased incidence of treatment failure, antimicrobial resistance and economic burden on the patient and the community as a whole. The treatment of diseases by the use of essential drugs, prescribed by their generic names, has been emphasized by the WHO and the National Health Policy of India. We conclude that the prescription monitoring studies provide a bridge between areas like rational use of drugs, pharmacovigilance, evidence based medicine, pharmacoeconomics, pharmacogenetics and ecopharmacovigilance. In India, this is the need of the hour to utilise the data generated by so many prescription pattern monitoring studies done in every state and on every drug, so that the main aim of promoting rational use of drugs is fulfilled.

  12. Aspiring to Unintended Consequences of Natural Language Processing: A Review of Recent Developments in Clinical and Consumer-Generated Text Processing.

    Science.gov (United States)

    Demner-Fushman, D; Elhadad, N

    2016-11-10

    This paper reviews work over the past two years in Natural Language Processing (NLP) applied to clinical and consumer-generated texts. We included any application or methodological publication that leverages text to facilitate healthcare and address the health-related needs of consumers and populations. Many important developments in clinical text processing, both foundational and task-oriented, were addressed in community- wide evaluations and discussed in corresponding special issues that are referenced in this review. These focused issues and in-depth reviews of several other active research areas, such as pharmacovigilance and summarization, allowed us to discuss in greater depth disease modeling and predictive analytics using clinical texts, and text analysis in social media for healthcare quality assessment, trends towards online interventions based on rapid analysis of health-related posts, and consumer health question answering, among other issues. Our analysis shows that although clinical NLP continues to advance towards practical applications and more NLP methods are used in large-scale live health information applications, more needs to be done to make NLP use in clinical applications a routine widespread reality. Progress in clinical NLP is mirrored by developments in social media text analysis: the research is moving from capturing trends to addressing individual health-related posts, thus showing potential to become a tool for precision medicine and a valuable addition to the standard healthcare quality evaluation tools.

  13. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 2: Engineering. Volume 3: Costs and schedules

    Science.gov (United States)

    1981-01-01

    Engineering design details for the principal systems, system operating modes, site facilities, and structures of an engineering test facility (ETF) of a 200 MWE power plant are presented. The ETF resembles a coal-fired steam power plant in many ways. It is analogous to a conventional plant which has had the coal combustor replaced with the MHD power train. Most of the ETF components are conventional. They can, however, be sized or configured differently or perform additional functions from those in a conventional coal power plant. The boiler not only generates steam, but also performs the functions of heating the MHD oxidant, recovering seed, and controlling emissions.

  14. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD medications in the pediatric population: a qualitative review of empirical studies

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2011-12-01

    Full Text Available Lise Aagaard1-3, Ebba Holme Hansen1-31Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark; 2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark; 3Danish Pharmacovigilance Research Project (DANPREP, Copenhagen, DenmarkBackground: To review empirical studies of adverse drug reactions (ADRs reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD symptoms in the pediatric population.Methods: PubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.Results: The review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA. The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.Conclusion: Reported ADRs from use of

  15. Re-Viewing Peer Review

    Science.gov (United States)

    Flynn, Elizabeth A.

    2011-01-01

    In this article, the author revisits her essay, "Students as Readers of Their Classmates' Writing," by providing a review of the literature on peer review over the past three decades and comments on patterns she sees in waves of peer review research and theorizing. She describes her subsequent experience with peer review in her own classes, and…

  16. REVIEW ARTICLE

    African Journals Online (AJOL)

    HlVandmayresnltineeonfiisiortWepresenthereareviewofliterauneonLGV. KEY EQEDS: L V Literature, Review ... We present here a review of literatm-e on. LGV. 'l'hecausativeagent. Chlamydiaeasagroupareobligate intracellular .... vaginal sponges "16 Wade nonoxynol9,whiehhasantichlamydiaaetivity,is also advocated (1).

  17. Book Reviews

    Science.gov (United States)

    2013-01-01

    Michelle M. Lusardi, Milagros Jorge, Caroline C. Nielsen, Orthotics and Prosthetics in Rehabilitation, reviewed by Dellene Sakaguchi John M. Saxton (editor), Exercise and Chronic Disease: An Evidence-Based Approach, reviewed by Lisa Wickerson

  18. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2011-12-01

    Full Text Available Create Dangerously: The Immigrant Artist at Work, by Edwidge Danticat (reviewed by Colin Dayan Gordon K. Lewis on Race, Class and Ideology in the Caribbean, edited by Anthony P. Maingot (reviewed by Bridget Brereton Freedom and Constraint in Caribbean Migration and Diaspora, edited by Elizabeth Thomas-Hope (reviewed by Mary Chamberlain Black Europe and the African Diaspora, edited by Darlene Clark Hine, Trica Danielle Keaton & Stephen Small (reviewed by Gert Oostindie Caribbean Middlebrow: Leisure Culture and the Middle Class, by Belinda E dmondson (reviewed by Karla Slocum Global Change and Caribbean Vulnerability: Environment, Economy and Society at Risk, edited by Duncan McGregor, David Dodman & David Barker (reviewed by Bonham C. Richardson Encountering Revolution: Haiti and the Making of the Early Republic, by Ashli White (reviewed by Matt Clavin Red and Black in Haiti: Radicalism, Conflict, and Political Change, 1934-1957, by Matthew J. Smith (reviewed by Robert Fatton Jr. Cuba in the American Imagination: Metaphor and the Imperial Ethos, by Louis A. Pérez Jr. (reviewed by Camillia Cowling Seeds of Insurrection: Domination and Resistance on Western Cuban Plantations, 1808-1848, by Manuel Barcia (reviewed by Matt D. Childs Epidemic Invasions: Yellow Fever and the Limits of Cuban Independence, 1878-1930, by Mariola Espinosa (reviewed by Cruz Maria Nazario The Cuban Connection: Drug Trafficking, Smuggling, and Gambling in Cuba from the 1920s to the Revolution, by Eduardo Sáenz Rovner (reviewed by Ivelaw Lloyd Griffith Before Fidel: The Cuba I Remember, by Francisco José Moreno, and The Boys from Dolores: Fidel Castro’s Schoolmates from Revolution to Exile, by Patrick Symmes (reviewed by Pedro Pérez Sarduy Lam, by Jacques Leenhardt & Jean-Louis Paudrat (reviewed by Sally Price Healing Dramas: Divination and Magic in Modern Puerto Rico, by Raquel Romberg (reviewed by Grant Jewell

  19. Book reviews

    Directory of Open Access Journals (Sweden)

    T. Abdel-Motey., C. Urfels., K. Rodriguez., J. Mardikian., J.A. Drobnicki., V. Diodato.

    2000-10-01

    Full Text Available Title:(1 The Library and Information Professional’s Guide to the Internet. (2 Reinvention of the Public Library for the 21st Century. (3 Public Library Collection Development in the Information Age. (4 Making Sense of Journals in the Life Science: From Specialty Origins to Contemporary Assortment. (5 The Holocaust: Memories, Research, Reference. (6 How to Index Your Local Newspaper Using WordPerfect or Microsoft Word for Windows. (7 Effective Utilization and Management of Emerging Information Technologies. (8 Information Technology and Organizations: Challenges of New Technologies. (9 Facilities Planning for School Media and Technology Centers. (10 Libraries Without Walls 2: The Delivery of Library Services to Distance Users. (11 New International Directions in HIV Prevention for Gay and Bisexual Men. (12 Soaring to Excellence Videos: Tools of Our Trade III: Books, the Internet, and Beyond.Author:(1Reviewed by Teresa Abdel-Motey. (2Review by Claire Urfels. (3Reviewed by Dr. Ketty Rodriguez. (4Reviewed by Jackie Mardikian. (5Reviewed by John A. Drobnicki.(6Reviewed by Dr. Virgil Diodato. (7Reviewed by Dr. Lisa M. Covi. (8Reviewed by Tom Zillner. (9Reviewed by Dr. W. Bernard Lukenbill. (10Reviewed by Dr. Elizabeth Buchanan. (11Reviewed by Aisha White. (12Reviewed by Phyllis Tragash

  20. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2011-06-01

    Full Text Available Globalization and the Po st-Creole Imagination: Notes on Fleeing the Plantation,by Michaeline A. Crichlow with Patricia Northover (reviewed by Raquel Romberg Afro-Caribbean Religions: An Introduction to their Historical, Cultural, and Sacred Traditions, by Nathaniel Samuel Murrell (reviewed by James Houk Africas of the Americas: Beyond the Search for Origins in the Study of Afro-Atlantic Religions, edited by Stephan Palmié (reviewed by Aisha Khan Òrì?à Devotion as World Religion: The Globalization of Yorùbá Religious Culture, edited by Jacob K. Olupona & Terry Rey (reviewed by Brian Brazeal Sacred Spaces and Religious Traditions in Oriente Cuba, by Jualynne E. Dodson (reviewed by Kristina Wirtz The Coolie Speaks: Chinese Indentured Laborers and African Slaves of Cuba, by Lisa Yun (reviewed by W. Look Lai Cuba and Western Intellectuals since 1959, by Kepa Artaraz (reviewed by Anthony P. Maingot Inside El Barrio: A Bottom-Up View of Neighborhood Life in Castro’s Cuba, by Henry Louis Taylor, Jr. (reviewed by Mona Rosendahl On Location in Cuba: Street Filmmaking During Times of Transition, by Ann Marie Stock (reviewed by Cristina Venegas Cuba in The Special Period: Culture and Ideology in the 1990s, edited by Ariana Hernandez-Reguant (reviewed by Myrna García-Calderón The Cubans of Union City: Immigrants and Exiles in a New Jersey Community. Yolanda Prieto (reviewed by Jorge Duany Target Culebra: How 743 Islanders Took On the Entire U.S. Navy and Won, by Richard D. Copaken (reviewed by Jorge Rodríguez Beruff The World of the Haitian Revolution, edited by David Patrick Geggus & Norman Fiering (reviewed by Yvonne Fabella Bon Papa: Haiti’s Golden Years, by Bernard Diederich (reviewed by Robert Fatton, Jr. 1959: The Year that Inflamed the Caribbean, by Bernard Diederich (reviewed by Landon Yarrington Dominican Cultures: The Making of a Caribbean Society, edited by Bernardo Vega

  1. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-12-01

    Full Text Available The Atlantic World, 1450-2000, edited by Toyin Falola & Kevin D. Roberts (reviewed by Aaron Spencer Fogleman The Slave Ship: A Human History, by Marcus Rediker (reviewed by Justin Roberts Extending the Frontiers: Essays on the New Transatlantic Slave Trade Database, edited by David Eltis & David Richardson (reviewed by Joseph C. Miller "New Negroes from Africa": Slave Trade Abolition and Free African Settlement in the Nineteenth-Century Caribbean, by Rosanne Marion Adderley (reviewed by Nicolette Bethel Atlantic Diasporas: Jews, Conversos, and Crypto-Jews in the Age of Mercantilism, 1500-1800, edited by Richard L. Kagan & Philip D. Morgan (reviewed by Jonathan Schorsch Brother’s Keeper: The United States, Race, and Empire in the British Caribbean, 1937-1962, by Jason C. Parker (reviewed by Charlie Whitham Labour and the Multiracial Project in the Caribbean: Its History and Promise, by Sara Abraham (reviewed by Douglas Midgett Envisioning Caribbean Futures: Jamaican Perspectives, by Brian Meeks (reviewed by Gina Athena Ulysse Archibald Monteath: Igbo, Jamaican, Moravian, by Maureen Warner-Lewis (reviewed by Jon Sensbach Left of Karl Marx: The Political Life of Black Communist Claudia Jones, by Carole Boyce Davies (reviewed by Linden Lewis Displacements and Transformations in Caribbean Cultures, edited by Lizabeth Paravisini-Gebert & Ivette Romero-Cesareo (reviewed by Bill Maurer Caribbean Migration to Western Europe and the United States: Essays on Incorporation, Identity, and Citizenship, edited by Margarita Cervantes-Rodríguez, Ramón Grosfoguel & Eric Mielants (reviewed by Gert Oostindie Home Cooking in the Global Village: Caribbean Food from Buccaneers to Ecotourists, by Richard Wilk (reviewed by William H. Fisher Dead Man in Paradise: Unraveling a Murder from a Time of Revolution, by J.B. MacKinnon (reviewed by Edward Paulino Tropical Zion: General Trujillo, FDR, and the Jews of Sos

  2. Book Review: Book review

    Science.gov (United States)

    Freire, Olival

    2014-05-01

    This book concerns the many lives of Hugh Everett's seminal work on the interpretation of quantum mechanics. As these many lives were spread over time, like layers, the reading of this book is like an archeological tour as well as an adventure in physics, its philosophy and history. In short, the story traces the lives of his work. The first life was around 1956-1957 when Everett, a doctoral student under John Archibald Wheeler, wrote his dissertation at Princeton University and published it in the journal Review of Modern Physics. He presented an interpretation which dispensed with the need to collapse quantum states during measurements, thus dissolving the quantum measurement problem, and consistently reproduced results from quantum mechanics using Schrödinger's equation alone. Despite the face value of such a proposal it drew little attention until the end of the 1960s. This was when the second life of Everett's work began. In 1967 Bryce DeWitt appealed to Everett's work while working on the quantization of general relativity creating what is now called the Wheeler-DeWitt equation. Furthermore, DeWitt wanted give to Everett's work a wider audience than experts in quantum gravity. Supported by the editors of Physics Today a paper by himself presenting this interpretation as one of the possible ones for quantum mechanics triggered a heated debate on the subject in the periodical. Together with this new life a layer beneath the original publication of the dissertation appeared. In contact with Everett, DeWitt discovered that the 1957 dissertation and paper had been an abridged version of a more consistently developed interpretation. The full version of the work was then published in 1973 with the enticing title, suggested by DeWitt, of "The Many-Worlds Interpretation of Quantum Mechanics." This second life was larger than the first one, indeed it is alive until today, sparking a huge amount of technical work by physicists and philosophers attempting to solve what

  3. Narrative reviews

    Directory of Open Access Journals (Sweden)

    Jong-Myon Bae

    2014-09-01

    Full Text Available Although qualitative researches (QR are invaluable in understanding complex healthcare situations, the quantitative systematic reviews could not treat them. To improve quality of healthcare services, results of QR should be considered in healthcare decision-making processes. Several methods and theories for synthesizing evidences of QR have been developed. In order to activate the narrative reviews and mixed methods reviews in Korean healthcare academies, I arranged the related nomenclatures and suggested some issues to conduct them.

  4. Book Reviews

    OpenAIRE

    Book Review Editor, Christien Klaufus

    2015-01-01

    Rebel Mexico: Student Unrest and Authoritarian Political Culture During the Long Sixties, by Jaime M. Pensado, 2013, and Specters of Revolution: Peasant Guerrillas in the Cold War Mexican Countryside, by Alexander Aviña, 2014; reviewed by Wil G. PanstersWe are the face of Oaxaca: Testimony and Social Movements, by Lynn Stephen, 2013; reviewed by Jaime HoogestegerMaya Exodus: Indigenous struggle for citizenship in Chiapas, by Heidi Moksnes, 2012; reviewed by Gemma van der HaarLand and Freedom:...

  5. Systematic review

    DEFF Research Database (Denmark)

    Enggaard, Helle

    2016-01-01

    I have taken a Comprehensive Systematic Review Training course provide by Center of Clinical Guidelines in Denmark and Jonna Briggs Institute (JBI) and practice in developing a systematic review on how patients with ischemic heart disease experiences peer support. This insight and experience...... with systematic review is used to develop didactic practice end evidence based teaching in different part of the education. Findings: The poster will present how teacher’s training and experiences with systematic review contribute to the nursing education in relation to didactic, research methodology and patient...

  6. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2012-06-01

    Full Text Available The African Diaspora: A History Through Culture, by Patrick Manning (reviewed by Joseph C. Miller Atlas of the Transatlantic Slave Trade, by David Eltis & David Richardson (reviewed by Ted Maris-Wolf Abolition: A History of Slavery and Antislavery, by Seymour Drescher (reviewed by Gregory E. O’Malley Paths to Freedom: Manumission in the Atlantic World, edited by Rosemary Brana-Shute & Randy J. Sparks (reviewed by Matthew Mason You Are All Free: The Haitian Revolution and the Abolition of Slavery, by Jeremy D. Popkin (reviewed by Philippe R. Girard Fighting for Honor: The History of African Martial Arts in the Atlantic World, by T .J. Desch Obi (reviewed by Flávio Gomes & Antonio Liberac Cardoso Simões Pires Working the Diaspora: The Impact of African Labor on the Anglo-American World, 1650-1850, by Frederick C. Knight (reviewed by Walter Hawthorne The Akan Diaspora in the Americas, by Kwasi Konadu (reviewed by Ray Kea Tradition and the Black Atlantic: Critical Theory in the African Diaspora, by Henry Louis Gates Jr. (reviewed by Deborah A. Thomas From Africa to Jamaica: The Making of an Atlantic Slave Society, 1775-1807, by Audra A. Diptee (reviewed by D.A. Dunkley Elections, Violence and the Democratic Process in Jamaica 1944-2007, by Amanda Sives (reviewed by Douglas Midgett Caciques and Cemi Idols: The Web Spun by Taino Rulers between Hispaniola and Puerto Rico, by José R. Oliver (reviewed by Brian D. Bates The Latin American Identity and the African Diaspora: Ethnogenesis in Context, by Antonio Olliz Boyd (reviewed by Dawn F. Stinchcomb Reconstructing Racial Identity and the African Past in the Dominican Republic, by Kimberly Eison Simmons (reviewed by Ginetta E.B. Candelario Haiti and the Haitian Diaspora in the Wider Caribbean, edited by Philippe Zacaïr (reviewed by Catherine Benoît Duvalier’s Ghosts: Race, Diaspora, and U.S. Imperialism in Haitian Literatures, by Jana

  7. Book Reviews

    Directory of Open Access Journals (Sweden)

    Christien Klaufus, Book Review Editor

    2016-10-01

    Full Text Available American Crossings: Border Politics in the Western Hemisphere, edited by Maiah Jaskoski, Arturo C. Sotomayor & Harold A. Trinkunas, 2015; reviewed by Olivier Thomas Kramsch The Remittance Landscape: Spaces of Migration in Rural Mexico and Urban USA, by Sarah Lynn Lopez, 2015; reviewed by Christien Klaufus Latin America’s Emerging Middle Classes; Economic Perspectives, editado por Jeff Dayton-Johnson, 2015; reseñado por Ludolfo Paramio Cities, Business and the Politics of Urban Violence in Latin America, by Eduardo Moncada,2016; reviewed by Gerard Martin Who Counts? The Mathematics of Death and Life after Genocide, by Diane Nelson, 2015; reviewed by Finn Stepputat Owners of the Sidewalk: Security and Survival in the Informal City, by Daniel Goldstein, 2015; reviewed by Griet Steel Beyond Tradition, Beyond Invention: Cosmic Technologies and Creativity in Contemporary Afro-Cuban Religions, edited by Diana Espírito Santo and Anastasios Panagiotopoulos, 2015; reviewed by Ken Chitwood Cuba and the U.S. Empire. A Chronological History, by Jane Franklin, 2016; reviewed by Edgar Göll Haydée Santamaría, Cuban Revolutionary: She Led by Transgression, by Margaret Randall, 2015; Vilma Espín Guillois: el fuego de la libertad, by Yolanda Ferrer Gómez and Carolina Aguilar Ayerra, 2015; reviewed by Dirk Kruijt Revolutionary Ideology and Political Destiny in Mexico, 1928-1934: Lázaro Cárdenas and Adalberto Tejeda, by Eitan Ginzberg, 2015; reviewed by Heather Fowler-Salamini Political Landscapes: Forest, Conservation and Community in Mexico, by Christopher R. Boyer, 2015; reviewed by Mariel Aguilar-Støen A Sentimental Education for the Working Man. The Mexico City Penny Press, 1900-1910, por Robert M. Buffington, 2015; reseñado por Lucas Poy Pesos and Politics: Business, Elites, Foreigners and Government in Mexico, 1854-1940, by Mark Wasserman, 2015; reviewed by Benedicte Bull State Theory and Andean Politics: New Approaches to the Study

  8. Book Reviews

    Directory of Open Access Journals (Sweden)

    Book Review Editor, Barbara Hogenboom

    2014-03-01

    Full Text Available Rethinking Latin America: Development, Hegemony, and Social Transformation, by Ronaldo Munck (2013; reviewed by Peadar Kirby The Long, Lingering Shadow. Slavery, Race and Law in the American Hemisphere, by Robert J. Cottrol (2013; reviewed by Guno Jones Centering Animals in Latin American History, edited by Martha Few and Zeb Tortorici (2013; reviewed by Leopoldo Cavaleri Gerhardinger and Dannieli Firme Herbst River of Hope. Forging Identity and Nation in the Rio Grande Borderlands, by Omar S. Valério-Jiménez (2013; reviewed by Raymond Buve Enabling Peace in Guatemala: The Story of MINUGUA, by William Stanley (2013; reviewed by Dirk Kruijt Governing Indigenous Territories: Enacting Sovereignty in the Ecuadorian Amazon, by Juliet Erazo (2013; reviewed by Veronica Davidov Transnational Activism and National Movements in Latin America: Bridging the Divide, edited by Eduardo Silva (2013; reviewed by Roberta Rice Haiti’s New Dictatorship: The Coup, the Earthquake and the UN Occupation, by Justin Podur (2012; reviewed by Talitha Stam Cuba under Raúl Castro: Assessing the Reforms, por Carmelo Mesa-Lago y Jorge Pérez-López (2013; Cuban Economists on the Cuban Economy, editado por Al Campbell (2013; reseñado por Pablo Ospina Peralta Trumpets in the Mountains: Theater and the Politics of National Culture in Cuba, by Laurie A. Frederik (2012; reviewed by Jacqueline Loss Devoted to Death: Santa Muerte, the Skeleton Saint, by R. Andrew Chesnut (2012; reviewed by José Carlos G. Aguiar Foodscapes, Foodfields and Identities in Yucatán, by Steffan Igor Ayora-Diaz (2012; reviewed by Ester Katz

  9. Incretin-based therapy and acute cholecystitis: a review of case reports and EudraVigilance spontaneous adverse drug reaction reporting database.

    Science.gov (United States)

    Pizzimenti, V; Giandalia, A; Cucinotta, D; Russo, G T; Smits, M; Cutroneo, P M; Trifirò, G

    2016-04-01

    Glucagon-like peptide-1 (GLP-1) receptor agonists delay gastric and bowel emptying. A similar inhibitory effect of GLP-1 on gallbladder motility has been suggested, possibly leading to an increased risk of cholecystitis related to incretin-based medications, which include GLP-1 antagonists. Our objective was to review evidence in EudraVigilance, the European spontaneous reporting database and the scientific literature on this issue. Increasing evidence suggests an association of incretins with gallbladder adverse events. Pharmacovigilance data from EudraVigilance includes 200 serious ADR reports concerning cholecystitis related to the use of incretin-based therapies. Several mechanisms may explain this increased risk of cholecystitis, including rapid weight loss, inhibition of gallbladder contraction and emptying, reduced bile acids production, modulation of inflammation. The available data suggest the possibility of gallbladder disease in diabetic subjects treated with incretins and highlight the importance of evaluating risk factors for cholelithiasis and gallbladder diseases in patients with diabetes before starting this therapy. © 2016 John Wiley & Sons Ltd.

  10. Book review

    African Journals Online (AJOL)

    Book review. Jack Mapanje, skipping without ropes. New-Castle upon. Tyne: Bloodaxe Books, 1998, 80pp. The work under review is Jack Mapanje's third volume of verse after Of Chameleons and Gods and The Chattering Wagtails of Mikuyu Prison. It falls into three sections, namely, "From Mikuyu Prison to Exile", ...

  11. Software Reviews.

    Science.gov (United States)

    Mathematics and Computer Education, 1987

    1987-01-01

    Presented are reviews of several microcomputer software programs. Included are reviews of: (1) Microstat (Zenith); (2) MathCAD (MathSoft); (3) Discrete Mathematics (True Basic); (4) CALCULUS (True Basic); (5) Linear-Kit (John Wiley); and (6) Geometry Sensei (Broderbund). (RH)

  12. Review Article

    African Journals Online (AJOL)

    Dr Ahmed

    ABSTRACT. Carbon Capture and Storage (CCS) is one of the techniques for greenhouse gas (GHG) emissions reduction. This article reviews the current status of CCS technology, highlights costs and discusses legal and regulatory issues of CCS. The main purpose of the article is to review CCS and CO2-EOR experience ...

  13. Critical Review

    DEFF Research Database (Denmark)

    Rosenbaum, Ralph K.; Olsen, Stig Irving

    2017-01-01

    Manipulation and mistakes in LCA studies are as old as the tool itself, and so is its critical review. Besides preventing misuse and unsupported claims, critical review may also help identifying mistakes and more justifiable assumptions as well as generally improve the quality of a study. It thus...

  14. Book review

    African Journals Online (AJOL)

    Book review. Revisting Ancestral Wisdom: A Review of J.C. Chakanza's Wis- dom of the People Blantyre : CLAIM, 2000. Paperback. 469 pp. ill K750. A few years ago I did .... There have been illustrations of Malawian proverbs in the past. ... Samson Kambalu's illustrations also range from the realistic (e.g. 522 " kudyerana.

  15. Book Review

    African Journals Online (AJOL)

    Nekky Umera

    Book Review. Studies in English Literatures (Vol. X1) (Pp. 437-453). Title: Dealing With Evils. Sub-title: Essays on Writing from Africa. By. Annie Gagiano. Reviewer: Julia Devardhi. Department of English, Faculty of Education, Haramaya University, Ethiopia devardhi.julia@gmail.com. Anne Gagiano's collection of essays on ...

  16. Book Reviews

    OpenAIRE

    Giewwe, Paul; Loseby, Margaret; Bosch, Darrell J.; Lilyan E. Fulginiti

    2002-01-01

    Books reviewed include: Review of World Development Report 2000/2001: "Attacking Poverty", World Bank; CAP Regimes and the European Countryside by F. Brouwer and P. Lowe; Organisation for Economic Co-operation and Development, Income Risk Management in Agriculture; Agriculture and Economic Growth: Theory and Measurement by Yair Mundlak

  17. Book Reviews.

    Science.gov (United States)

    Journal of Chemical Education, 1983

    1983-01-01

    Reviews two textbooks: "Principles of Biochemistry" by Albert L. Lehninger and "Inorganic Chemistry, A Modern Introduction" by Therald Moeller. Also reviews text, study guide, and laboratory manual for Morris Hein's "Foundations of College Chemistry, Fifth Edition" and text/study guide for David A. Ucko's "Basics for Chemistry." (JN)

  18. Book Reviews

    Directory of Open Access Journals (Sweden)

    Book Review Editor, Christien Klaufus

    2015-10-01

    Full Text Available Rebel Mexico: Student Unrest and Authoritarian Political Culture During the Long Sixties, by Jaime M. Pensado, 2013, and Specters of Revolution: Peasant Guerrillas in the Cold War Mexican Countryside, by Alexander Aviña, 2014; reviewed by Wil G. PanstersWe are the face of Oaxaca: Testimony and Social Movements, by Lynn Stephen, 2013; reviewed by Jaime HoogestegerMaya Exodus: Indigenous struggle for citizenship in Chiapas, by Heidi Moksnes, 2012; reviewed by Gemma van der HaarLand and Freedom: The MST, the Zapatistas and Peasant Alternatives to Neoliberalism, by Leandro Vergara-Camus, 2014; reviewed by Jonathan DeVoreIndigenous Movements and Building the Plurinational State in Bolivia: Organisation and Identity in the Trajectory of the CSUTCB and CONAMAQ, by Radosław Powęska, 2013; reviewed by Ton SalmanMovimientos estudiantiles en la historia de América Latina IV, coordinado por Renate Marsiske, 2015; reseñado por Andrés Donoso RomoEl corazón de los libros, Alzate y Bartolache: Lectores y escritores novohispanos (S. XVIII, by Mauricio Sánchez Menchero, 2012; reviewed by Helge WendtAurality: Listening and Knowledge in Nineteenth-Century Colombia, por Ana María Ochoa Gautier, 2014; reseñado por Mercedes López RodríguezThe Vanguard of the Atlantic World: Creating Modernity, Nation, and Democracy in Nineteenth-Century Latin America, by James E. Sanders, 2014; reviewed by Michiel BaudMexico’s Once and Future Revolution: Social Upheaval and the Challenge of Rule since the Late Nineteenth Century, by Gilbert M. Joseph and Jürgen Buchenau, 2013; reviewed by Dirk KruijtThe Great Depression in Latin America, coordinado por Paulo Drinot and Alan Knight, 2014; reseñado por Juan Carlos KorolEnhancing Democracy. Public Policies and Citizen Participation in Chile, by Gonzalo Delamaza, 2014; reviewed by Camila Jara IbarraCritical Interventions in Caribbean Politics and Theory, by Brian Meeks, 2014; reviewed by Hebe VerrestBlack Power in the

  19. Proactive Reviews

    DEFF Research Database (Denmark)

    Kolbæk, Ditte

    2014-01-01

    This study explores how a world leading IT-company developed and implemented an innovative and simple educational design for organizational learning called Proactive Review, which was inspired by the thoughts of Senge, Nonaka, & Takeuchi and Cole & Engeström and explored as Design Based Research....... Valid feedback from various stakeholders improved the original design of After Action Reviews into Proactive Reviews, which is helpful for local as well as global companies to learn from experience. The educational design started with personal experience that was shared with colleagues who cooperated...... with solving a task. They found improved ways of doing the job and identified management challenges. They shared their experience with colleagues who did not attend the Proactive Review and addressed the management challenges to the senior management. Proactive Reviews were reported 50-100 times a year...

  20. Book Reviews

    African Journals Online (AJOL)

    Nutrigenomics makes this volume, the third in the series on the subject (see volumes 63 and 80) in World Review of Nutrition and Dietetics, an invaluable resource for health professionals and students of nutrition alike. This volume contains both.

  1. Proactive Review

    DEFF Research Database (Denmark)

    Kolbæk, Ditte

    2015-01-01

    This chapter will explore how to learn from working experience through the use of an educational approach called Proactive Review. From 2005 to 2012, Proactive Review was developed and implemented in a world-class IT company based in more than 40 countries across Europe, the Middle East, and Africa....... This chapter will include some of the theoretical considerations as well as the final educational design for a Proactive Review, as exemplified in a case study from the IT company. The aim of this chapter is to provide a theoretically based and proven educational design for Lessons Learned, including...... recommendations for successful Proactive Reviews. The theory section will explore theories regarding the following two topics: first, how an organization may understand the term “learning”; and second, the starting point of learning and how an organization may maintain a learning environment. The research...

  2. Reviews: Books.

    Science.gov (United States)

    Weiss, Bretta; And Others

    1993-01-01

    Reviews three books: "The Schoolhome: Rethinking Schools for Changing Families," by Jane Martin; "Godly Play," by Jerome Berryman; and "Five Kingdoms: An Illustrated Guide to the Phyla of Life on Earth," by Margulis and Schwartz. (TJQ)

  3. Systematic review

    DEFF Research Database (Denmark)

    Enggaard, Helle

    Title: Systematic review a method to promote nursing students skills in Evidence Based Practice Background: Department of nursing educate students to practice Evidence Based Practice (EBP), where clinical decisions is based on the best available evidence, patient preference, clinical experience...... and resources available. In order to incorporate evidence in clinical decisions, nursing students need to learn how to transfer knowledge in order to utilize evidence in clinical decisions. The method of systematic review can be one approach to achieve this in nursing education. Method: As an associate lecturer...... I have taken a Comprehensive Systematic Review Training course provide by Center of Clinical Guidelines in Denmark and Jonna Briggs Institute (JBI) and practice in developing a systematic review on how patients with ischemic heart disease experiences peer support. This insight and experience...

  4. Book Reviews

    Directory of Open Access Journals (Sweden)

    Book Review Editor, Barbara Hogenboom

    2014-10-01

    Full Text Available The Economic History of the Caribbean since the Napoleonic Wars, by Victor Bulmer-Thomas (2012; reviewed by Gert OostindieSubjects or Citizens: British Caribbean Workers in Cuba, 1900-1960, by Robert Whitney and Graciela Chailloux Laffita (2013; reviewed by Rose Mary AllenDebating Civil-Military Relations in Latin America, editado por David Mares y Rafael Martínez (2014; reseñado por Raul Benitez-ManautComparative Public Policy in Latin America, editado por Jordi Díez y Susan Franceschet (2012; reseñado por Gonzalo DelamazaEntre el desarrollo y el buen vivir. Recursos naturales y conflictos en los territorios indígenas, editado por José Aylwin, Salvador Martí i Puig, Claire Wright y Nancy Yañez (2013; reviewed by Almut Schilling-VacaflorDignity for the Voiceless. Willem Assies’s Anthropological Work in Context, editado por Ton Salman, Salvador Martí i Puig, y Gemma van der Haar (2014; reseñado por Ricardo Calla OrtegaDemocracy in ‘Two Mexicos’; Political Institutions in Oaxaca and Nuevo León, by Guadelupe Correa-Cabrera (2013; reviewed by Jos BartmanWhere the River Ends, by Shaylih Muehlmann (2013; reviewed by Maria L. Cruz-TorresKnowing History in Mexico. An ethnography of Citizenship, by Trevor Stack (2012; reviewed by Raymond BuveFor God and Revolution. Priest, Peasant, and Agrarian Socialism in the Mexican Huasteca, por Mark Saad Saka( 2013; reseñado por Antonio Escobar OhmstedeWorking Women, Entrepreneurs, and the Mexican Revolution: the Coffee Culture of Córdoba, Veracruz, by Heather Fowler-Salamini (2013; reviewed by Robert F. AlegreWar by Other Means. Aftermath in Post-Genocide Guatemala, edited by Carlota McAlister and Diana Nelson (2013; reviewed by Dirk KruijtLucha revolucionaria. Perú, 1958-1967, por Jan Lust (2013; reseñado por Dirk KruijtWomen in War. The Micro-Processes of Mobilization in El Salvador, by Jocelyn Viterna (2013; reviewed by Ralph SprenkelsZero Hunger: Political Culture and Antipoverty Policy in

  5. Graphic Review

    DEFF Research Database (Denmark)

    Breiting, Søren

    2002-01-01

    Introduktion til 'graphic review' som en metode til at føre forståelse fra en undervisngsgang til den næste i læreruddannelse og grundskole.......Introduktion til 'graphic review' som en metode til at føre forståelse fra en undervisngsgang til den næste i læreruddannelse og grundskole....

  6. !Book review

    African Journals Online (AJOL)

    In view of the fact that Soko's book was published in 1994, this is a belated review. The reasons for this are first that French, the language in which it is written, is not com- monly spoken or read in Malawi and second, that owing to the inadequate publicity given by the author and the publisher, this writer did not get a review ...

  7. Book Reviews

    Directory of Open Access Journals (Sweden)

    Christien Klaufus, Book Review Editor

    2016-04-01

    Full Text Available The Improbable Conquest: Sixteenth Century Letters from the Rio de la Plata, por Pablo García Loaeza y Victoria L. Garrett, 2015; reseñado por Judith Farberman Urban Space as Heritage in Late Colonial Cuba: Classicism and Dissonance on the Plaza de Armas of Havana: 1754-1828, by Paul Niell, 2015; reviewed by Joseph L. Scarpaci El Jefe Político. Un dominio negociando en el mundo rural del Estado de México. 1856-1911, por Romana Falcón, 2015; reseñado por Raymond Buve Miedo negro, poder blanco en la Cuba colonial, por Jorge Camacho, 2015; reseñado por Oleski Miranda Navarro Revolutionary Parks: Conservation, Social Justice, and Mexico’s National Parks, 1910-1940, by Emily Wakild, 2011; reviewed by Grant Burrier Sandino’s Nation: Ernesto Cardenal and Sergio Ramírez Writing Nicaragua, 1940-2012, by Stephen Henighan, 2014; reviewed by Grace A. Gomashie La cancha peronista. Fútbol y política (1946-1955, edited by Raanan Rein, 2015; reviewed by Alexis Sossa Rojas Chile y la Guerra Fría global, edited by Tanya Harmer and Alfredo Riquelme Segovia, 2014; reviewed by Ángela Vergara Challenging Social Inequality: The Landless Rural Workers Movement and Agrarian Reform in Brazil, edited by M. Carter, 2015; reviewed by Rebecca Tarlau Brazil: Reversal of Fortune, by Alfred P. Montero, 2014; reviewed by Edgar J. Marcolin Latin American Documentary Filmmaking – Major works, by David William Foster, 2013; reviewed by Leontien Cremers Telling and Being told: Storytelling and Cultural Control in Contemporary Yucatec Maya Literatures, por Paul Worley, 2013; reseñado por Ana Ugarte Bachata and Dominican Identity/La bachata y la identidad dominicana, by Julie Sellers, 2014; reviewed by Grant D. Moss Entrepreneurial Selves: Neoliberal Respectability and the Making of a Caribbean Middle Class, by Carla Freeman, 2014; reviewed by Emiel Martens

  8. Using Semantic Web Technologies to Reproduce a Pharmacovigilance Case Study

    NARCIS (Netherlands)

    Hildebrand, M.; Hoekstra, R.; van Ossenbruggen, J.

    2014-01-01

    We provide a detailed report of a reproduction study of a paper published in the International Journal of Medical Sciences (IJMS). We first use the PROV-O ontology to model our reconstruction of the computational work ow of the original experiment and to systematically explicate all information that

  9. From antiretroviral originator to generic drugs: bioequivalence and pharmacovigilance.

    Science.gov (United States)

    Bagheri, H; Garraffo, R; Dellamonica, P

    2014-10-01

    Antiretroviral drugs have been available in generic form in developing countries, which has expanded access to treatment; they have also become available in developed countries more recently. The validation of generic drugs (GD) compared to originator drugs (OD) is mandatory to ensure that using generics will lead to a decreased cost of treatment. The results were obtained by analyzing published data as well as European Medicines Agency recommendations. The GD should have the same qualitative and quantitative active principle formula, the same pharmaceutical forms, and the same criteria in terms of quality, effectiveness, and safety. This equivalence is based on bioequivalence rules: comparison of the concentration/time curves (AUC); Cmax and Tmax (90%), for which the confidence intervals in the range of 80-125% should be included. Naturally, that does not mean that the concentrations can vary from 80 to 125%: this would indicate unacceptable deviations. Conforming to these criteria allows substituting an OD by a GD. Adverse effects should not be different from those observed for the OD. Adverse effects observed when the GD is used must be notified, as is the case for the OD. Accountability is established according to 4 essential pieces of information: a prescriber, a patient, a drug, and an adverse effect. It is sometimes difficult to identify the provider of the GD that has been delivered. The level of safety concerning effectiveness and tolerance required is identical for OD and GD, in Europe. Analyzing confirmed adverse effects and therapeutic failures is the only way to identify differences that could question a GD's effectiveness. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  10. Using Semantic Web Technologies to Reproduce a Pharmacovigilance Case Study

    NARCIS (Netherlands)

    M. Hildebrand (Michiel); R Hoekstra; J.R. van Ossenbruggen (Jacco)

    2013-01-01

    htmlabstractWe provide a detailed report of a reproduction study of a paper published in the International Journal of Medical Sciences (IJMS). We first use the PROV-O ontology to model our reconstruction of the computational workflow of the original experiment and to systematically explicate all

  11. Cheminformatics-aided pharmacovigilance: application to Stevens-Johnson Syndrome.

    Science.gov (United States)

    Low, Yen S; Caster, Ola; Bergvall, Tomas; Fourches, Denis; Zang, Xiaoling; Norén, G Niklas; Rusyn, Ivan; Edwards, Ralph; Tropsha, Alexander

    2016-09-01

    Quantitative Structure-Activity Relationship (QSAR) models can predict adverse drug reactions (ADRs), and thus provide early warnings of potential hazards. Timely identification of potential safety concerns could protect patients and aid early diagnosis of ADRs among the exposed. Our objective was to determine whether global spontaneous reporting patterns might allow chemical substructures associated with Stevens-Johnson Syndrome (SJS) to be identified and utilized for ADR prediction by QSAR models. Using a reference set of 364 drugs having positive or negative reporting correlations with SJS in the VigiBase global repository of individual case safety reports (Uppsala Monitoring Center, Uppsala, Sweden), chemical descriptors were computed from drug molecular structures. Random Forest and Support Vector Machines methods were used to develop QSAR models, which were validated by external 5-fold cross validation. Models were employed for virtual screening of DrugBank to predict SJS actives and inactives, which were corroborated using knowledge bases like VigiBase, ChemoText, and MicroMedex (Truven Health Analytics Inc, Ann Arbor, Michigan). We developed QSAR models that could accurately predict if drugs were associated with SJS (area under the curve of 75%-81%). Our 10 most active and inactive predictions were substantiated by SJS reports (or lack thereof) in the literature. Interpretation of QSAR models in terms of significant chemical descriptors suggested novel SJS structural alerts. We have demonstrated that QSAR models can accurately identify SJS active and inactive drugs. Requiring chemical structures only, QSAR models provide effective computational means to flag potentially harmful drugs for subsequent targeted surveillance and pharmacoepidemiologic investigations. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  12. A review of the safety of anticoagulants in older people using the medicines management pathway: weighing the benefits against the risks

    Science.gov (United States)

    2011-01-01

    Anticoagulant drugs maintain a high potential for adverse events due to their inherent risk of haemorrhage and/or complex pharmacology. In addition, compromising the safety of these agents is the context in which they are principally used; that is, in the long-term prevention of thromboembolic diseases in an older patient population. These challenges are especially pronounced in the prevention of stroke in older persons with atrial fibrillation (AF), where the need for thromboprophylaxis is paramount and in whom the arrhythmia is most prevalent, but where the target population is simultaneously at high risk of adverse drug events. Essentially, this translates to the use of high-risk therapies on an indefinite basis, in persons who have multiple comorbidities, use polypharmacy, and who may have age-related functional and cognitive decline, culminating in a higher potential for medication misadventure. For this reason, anticoagulants mandate extra pharmacovigilance, and therefore the aim of this review is to address some of the key safety considerations in the use of anticoagulant drugs (warfarin, dabigatran, rivaroxaban), spanning the initiation of therapy to its ongoing management. Using the Medication Management Pathway (MMP) as a framework, in this review we canvas and highlight specific developments in practical strategies to facilitate the safe use of anticoagulants (particularly warfarin) in ‘at-risk' elderly patients including: comprehensive risk/benefit assessment using novel risk stratification tools; focused medicines review services; therapeutic drug monitoring services delivered in the primary care setting; and practical education strategies and resources targeting the older patient population. Until newer alternative anticoagulants become viable options for widespread use, clinicians will necessarily need to rely on specific resources and interventions to facilitate the safe use of currently available anticoagulants (i.e. warfarin) in

  13. Review article

    DEFF Research Database (Denmark)

    Karsdal, M A; Krarup, H; Sand, J.M.B

    2014-01-01

    and to facilitate improved drug development. The aim of this article was to review the serological biomarkers that may assist in early diagnosis of patients, separate fast from slow- or nonprogressors, and possibly assist in drug development for fibroproliferative diseases, exemplified by liver fibrosis. The lack...... of success of biochemical markers and the possible reasons for this is discussed in the context of other fields with biomarker success. METHOD: This is a personal opinion review article. RESULTS: Biochemical markers, originating from the fibrotic structure, may have increased specificity and sensitivity...

  14. Software Reviews.

    Science.gov (United States)

    Science Software Quarterly, 1984

    1984-01-01

    Provides extensive reviews of computer software, examining documentation, ease of use, performance, error handling, special features, and system requirements. Includes statistics, problem-solving (TK Solver), label printing, database management, experimental psychology, Encyclopedia Britannica biology, and DNA-sequencing programs. A program for…

  15. Book Reviews

    Science.gov (United States)

    Holeinger, Philip R.; And Others

    1986-01-01

    Presents and review six books. Topics include earth science topics (Philip R. Holzinger, 1985), the wild horse controversy (Richard Symanski, 1985), historical Dutch geography (Audrey M. Lambert, 1985), urban geography (Susan L. Cutter, 1985), a geopolitical atlas (Gerard Chaliand and Jean-Pierre Rageau, 1985), and remote sensing (Robert K. Holz,…

  16. Book review

    African Journals Online (AJOL)

    Oakhill, USA: Trentham Books. Stellenbosch, South Africa: Sun Media. Joy Papier*. Book review. * Director, Institute for Post-School Studies, University of the Western Cape, South Africa. Email: jpapier@uwc.ac.za. This publication, edited by Brenda Leibowitz of Stellenbosch University's Centre for. Teaching and Learning ...

  17. Book Reviews.

    Science.gov (United States)

    Pencek, Bruce; And Others

    1986-01-01

    Reviews of five books are presented. Topics are public property and private power (Hartog, 1983), essays on Julius Caesar (Blits, 1982), changes in the American political system (Shafer, 1983), the spiritual crisis in western civilizations (Harrington, 1983), and justice, pluralism and equality (Walzer, 1983). (JDH)

  18. REVIEW ARTICLE

    African Journals Online (AJOL)

    REVIEW ARTICLE. A Mannell. Department of Surgery, University of the Witwatersrand, Johannesburg, South Africa. Corresponding author: Aylwyn Mannell (mannell@mweb.co.za). The proliferative marker, Ki-67, is a human nuclear antigen, and forms an integral part of cell division in both normal and malignant tissue.

  19. RESENSIES/ REVIEWS

    African Journals Online (AJOL)

    RESENSIES/ REVIEWS. ELPHICK, Richard. 2012. The Equality of Believers. Protestant. Missionaries and the Racial Politics of South Africa. Charlottesville: University of Virginia Press, 2012. 437pp. http://dx.doi.org/10.4314/actat.v33i2.16. This book is a major contribution to the political and religious history of. South Africa.

  20. Systematic review

    DEFF Research Database (Denmark)

    Lødrup, Anders Bergh; Reimer, Christina; Bytzer, Peter

    2013-01-01

    in getting off acid-suppressive medication and partly explain the increase in long-term use of PPI. A number of studies addressing this issue have been published recently. The authors aimed to systematically review the existing evidence of clinically relevant symptoms caused by acid rebound following PPI...

  1. Systematic review

    DEFF Research Database (Denmark)

    Helgstrand, John Thomas; Berg, Kasper Drimer; Lippert, Solvej

    2016-01-01

    trials have challenged this dogma. The aim of this study was to evaluate how endocrine therapy (ET) affects survival in different clinical settings of PCa. Materials and methods A review of published phase II, III and IV studies evaluating the effect of ET on survival was performed. Results In localized...

  2. Research Review

    Science.gov (United States)

    Serig, Dan, Ed.

    2010-01-01

    This research review is dedicated to the memory of William Safire (1929-2009). A visionary leader, Safire brought other visionaries, researchers, educators, artists, and policymakers together to explore the confluence of arts education and neuroscience. He fostered the new field of neuroeducation in his work as chair of The Dana Foundation in…

  3. Invited review

    NARCIS (Netherlands)

    Haas, de Y.; Pszczola, M.; Soyeurt, H.; Wall, E.; Lassen, J.

    2017-01-01

    Phenotypes have been reviewed to select for lower-emitting animals in order to decrease the environmental footprint of dairy cattle products. This includes direct selection for breath measurements, as well as indirect selection via indicator traits such as feed intake, milk spectral data, and rumen

  4. PEER REVIEWER

    OpenAIRE

    Nur, Amin

    2015-01-01

    - PEER REVIEWER Judul: Exploration of Arbuscular Mycorrhizal Fungi From Sugarcane Rhizozphare In South Sulawesi (Zahraeni Kumalawati, Yunus Musa, Nur Amin, Laode Asrul Ifayanti Ridwan). ISSN 2277-8616; International Journal of scientific & Technology Research, Vol. 3 issue 1, January 2014. Hal. 201-203. Penerbit: Journal of Scientific & Technology Research.

  5. Research Review

    OpenAIRE

    Anonymous,

    1981-01-01

    Research Reviewed: "Statistical Estimation of Firm-Level Demand Functions: A Case Study in an Oligopolistic Industry"; "Predicting Debt Reschedulings in Developing Countries"; "Special Lectures in Economics"; "Analysis of Economic Time Series: A Synthesis"; "The Planning of Investment Programs in the Fertilizer Industry"

  6. BOOK REVIEW

    African Journals Online (AJOL)

    331. May 2014, Vol. 104, No. 5. BOOK REVIEW. Breast Care: A Health. Professional's Guide to Diagnosis and. Management of Common. Breast Conditions. By Jenny Edge and Dave Woods. Cape Town: Getup Electric Book Works,. 2014. ... skills workshops are often illustrated with line drawings, list essential equipment ...

  7. Audiovisual Review

    Science.gov (United States)

    Physiology Teacher, 1976

    1976-01-01

    Lists and reviews recent audiovisual materials in areas of medical, dental, nursing and allied health, and veterinary medicine; undergraduate, and high school studies. Each is classified as to level, type of instruction, usefulness, and source of availability. Topics include respiration, renal physiology, muscle mechanics, anatomy, evolution,…

  8. Literature review

    DEFF Research Database (Denmark)

    Nissen, Nina Konstantin; Holm, Lotte

    2015-01-01

    Improved understanding of how normal weight and moderately overweight people manage their body weight and shape could be used to inform initiatives to prevent and treat obesity. This literature review offers a thorough appraisal of existing research into perceptions and management of own body size...

  9. Book reviews

    NARCIS (Netherlands)

    NN,

    2004-01-01

    This book is a concise and rewritten version of the author’s ‘Anatomie der Hymenomyceten’, published in 1997 by Koeltz Verlag (CH), which, unfortunately, never has been reviewed in this journal. In almost 500 pages the author leads us through the exciting world of the anatomy, cytology, and

  10. Book Reviews.

    Science.gov (United States)

    International Journal of Early Childhood, 1994

    1994-01-01

    Reviews "La Educacion Preescolar: Desafio y Aventura" (Lavanchy Bobsien); "Working towards Better Childcare" (Peeters and Vandenbroeck, editors); "Children's Savings: A Study in the Development of Economic Behavior" (Sonuga-Barke and Webley); "Curvas de Crecimiento Estaturo-ponderal en Escolares" (Saez Crespo and others); and "Helping Bereaved…

  11. BOOK REVIEW

    African Journals Online (AJOL)

    MJM Venter

    2018-01-16

    Jan 16, 2018 ... This contribution provides a review of the book edited by Donna. Hornby, Rosalie Kingwill, Lauren Royston and Ben Cousins,. Untitled: Securing Land Tenure in Urban and Rural. South Africa. It deals with the topic of land tenure in urban and rural South Africa and challenges the requirement of title deeds.

  12. Book review

    African Journals Online (AJOL)

    Book review. * Dr Birgit Schreiber is the Director of the Centre for Student Support Services at the University of the. Western Cape, Cape Town, South Africa. Email: bschreiber@uwc.ac.za. Manuel Castells (2001), who is regarded as one of the most influential social scientists commenting on the role of higher education in ...

  13. Book review

    African Journals Online (AJOL)

    Book review. Paul Kishindo. Francois Nsengiyumva, The Role of the Church in the Development of the. Third World: A Theological Reflection on Paul's Epistle to the Romans,. Chancellor College Publications, 2011, pp 351. ISBN: 978 – 99960 – 23 – 11 – 8. Francois Nsengiyumva is an ordained Anglican priest teaching ...

  14. Book reviews

    DEFF Research Database (Denmark)

    Jensen, Niels Rosendal

    2009-01-01

    The review consists of two sections: In the first, community education is understood as an invitation to develop transversal, transdisciplinary research on a European level and dealing with adult education in order to improve a social Europe. In the second, the European question is understood as ...

  15. Book review

    African Journals Online (AJOL)

    Book review. Blurred boundaries: Femi Abodunrin's It Would Take Time: Conversation with Living Ancestors. Ibadan: Kraft Books. Limited, 2002. Paperback. ~. Blurred Boundaries. This expression captures best the significance of Femi Abodun- rin's recent publication. The text indeed transgresses boundaries; and this at ...

  16. Book Reviews

    African Journals Online (AJOL)

    Abel Esterhuyse

    Book Reviews. Warfare and Tracking in Africa, 1952-1990. By Timothy J. Stapleton. London & New York: Routledge, 2015. ISBN: 978-1-84893-558-7. Hardback, 204 pages. Tracking is defined as “the ability to pursue and close with an animal or human subject by following signs … left behind in the environment” (page. 1).

  17. BOOK REVIEW:

    African Journals Online (AJOL)

    Arianne

    BOOK REVIEW: The Ethics of War: Classic and Contemporary Readings,. Gregory M. Reichberg, Hendrik Syse and Endre Begby. (eds.), Oxford et al: Blackwell Publishing, 2006, pp.1-693. ISBN Pb 1-4051-2378-8. In no uncertain way have the 9/11 attacks and the subsequent attacks in. Madrid and London, the War on ...

  18. Peer Review

    OpenAIRE

    Ratna Winata, Lucia

    2016-01-01

    - Peer Review Identification of Patogenic Bacteria Escherichia Coli O157:H7 Staphilococcus Aureus from pasteurised and Non Pasteurised bovine Milk, Proceeding International Seminar "The Role of Veterinary Science to Support Millenium Development goals and the 12th Asian association of Veterinary Schools Congress, ISBN: 978-602-70438-0-0, Faculty of Veterinary medicine universitas Airlangga

  19. Concise review

    DEFF Research Database (Denmark)

    Dawson, Jonathan I; Kanczler, Janos; Tare, Rahul

    2014-01-01

    of diseases associated with an increasingly aged population. This review describes the state of the field and current steps to translate and apply skeletal stem cell biology in the clinic and the problems therein. Challenges are described along with key strategies including the isolation and ex vivo expansion...

  20. Clinical review

    DEFF Research Database (Denmark)

    Hjortrup, Peter Buhl; Haase, Nicolai; Wetterslev, Mik

    2013-01-01

    Neutrophil gelatinase-associated lipocalin (NGAL) may be an early marker of acute kidney injury (AKI), but elevated NGAL occurs in a wide range of systemic diseases. Because intensive care patients have high levels of comorbidity, our objective was to conduct a systematic review of the literature...

  1. Book reviews

    OpenAIRE

    Downes, Paul

    2017-01-01

    Review made by Dr. Paul Downes from Dublin City University, Ireland of three books: Highly Using Poetry to Promote Talking and Healing by Pooky Knightsmith, School bullying: Teachers helping students cope by Phillip T. Slee and How to Prevent and Tackle Bullying and School Violence: Evidence and Practices for Strategies for Inclusive and Safe Schools, NESET II report by Paul Downes & Carmel Cefai.

  2. Review Article

    African Journals Online (AJOL)

    2012-09-15

    Sep 15, 2012 ... School of Foreign Language Studies, Main Campus, Post Box No: 53, Haramaya University, Ethiopia ... copying. But this would result in further frustrations denying concentration on the students' side. Some clever students lack focus. Review Article ... students' independent examination and maximum.

  3. REVIEW ARTICLE

    African Journals Online (AJOL)

    These morbid events as well as mortality can be greatly reduced by specialized medical care that focuses on prevention and active intervention. This article reviews the most recent and evidence-based guidelines for preventive care and medical management of SCD and its most commonly encountered complications.

  4. Review Article

    African Journals Online (AJOL)

    Introduction: The primary cause of morbidity and mortality in the renal patient is a cardiovascular event. Insulin resistance (IR) contributes to this event by increasing cardiovascular disease (CVD) and accelerating rates of decline in kidney function. Here we review the historical background of IR in patients with chronic.

  5. Literature Reviews

    Science.gov (United States)

    Rhoades, Ellen A.

    2011-01-01

    The primary purpose of a literature review is to assist readers in understanding the whole body of available research on a topic, informing readers on the strengths and weaknesses of studies within that body. It is defined by its guiding concept or topical focus: an account of what was previously published on a specific topic. This prevents…

  6. REVIEW ARTICLE

    African Journals Online (AJOL)

    As malaria continues to kill many people in our world and spreading into areas that were never known to have it before, it becomes necessary to make occasional reviews of what therapeutic measures are ..... This is derived from a Chinese herbal remedy and covers a group of products. The two most widely used are.

  7. Retrenchment Review.

    Science.gov (United States)

    Bieschke, Suzanne M.

    This review of retrenchment in higher education covers background information, basic concerns, suggestions for making cuts, and lessons learned from experience. Contents concern financial pressures, enrollments, faculty relations during retrenchment, services and programs during retrenchment, administration during retrenchment, and case histories…

  8. Book Review.

    Science.gov (United States)

    Pecora, Peter J.; Cline, Stephanie

    1994-01-01

    Reviews two books: (1) "Advancing Family Preservation Practice" (E. Susan Morton and R. Kevin Brigsby, editors) which summarizes Intensive Family Preservation Services in the United States over the past decade; and (2) "Marketing Strategies for Nonprofit Organizations" (Siri Espy) which discusses marketing and its application…

  9. Literature review :

    Energy Technology Data Exchange (ETDEWEB)

    Dwyer, Stephen F.

    2013-03-01

    Typical engineering methods utilized to calculate stresses on a roof structure involve simplifying assumptions that render a complex non-linear structure a simple and basic determinate beam. That is, instead of considering the composite action of the entire roof structure, the engineer evaluates only a single beam that is deemed conservatively to represent an affected rafter or top chord of a truss. This simplification based on assumptions of a complex problem is where significant conservatism can be introduced. Empirical data will be developed to evaluate this issue. Simple wood beams will be tested to failure. More complex and complete sections of roof structures that include composite action will also be tested to failure. The results can then be compared. An initial step in this process involves a literature review of any work that has been performed on roof structure composite action. The following section summarizes the literature review that was completed.

  10. Impetigo - review.

    Science.gov (United States)

    Pereira, Luciana Baptista

    2014-01-01

    Impetigo is a common cutaneous infection that is especially prevalent in children. Historically, impetigo is caused by either group A β-hemolytic streptococci or Staphylococcus aureus. Currently, the most frequently isolated pathogen is S. aureus. This article discusses the microbiologic and virulence factors of group A β-hemolytic streptococci and Staphylococcus aureus, clinical characteristics, complications, as well as the approach to diagnosis and management of impetigo. Topical agents for impetigo therapy are reviewed.

  11. Impetigo - review*

    Science.gov (United States)

    Pereira, Luciana Baptista

    2014-01-01

    Impetigo is a common cutaneous infection that is especially prevalent in children. Historically, impetigo is caused by either group A β-hemolytic streptococci or Staphylococcus aureus. Currently, the most frequently isolated pathogen is S. aureus. This article discusses the microbiologic and virulence factors of group A β-hemolytic streptococci and Staphylococcus aureus, clinical characteristics, complications, as well as the approach to diagnosis and management of impetigo. Topical agents for impetigo therapy are reviewed. PMID:24770507

  12. Algebra review

    CERN Document Server

    Denlinger, Charles

    1978-01-01

    Algebra Review serves as a background supplement to Howard Anton and Bernard Kolman's books on finite mathematics-Applied Finite Mathematics and Applied Finite Mathematics with Calculus. This book discusses the number systems of algebra, algebraic notation, exponents and radicals, and fractional exponents. The polynomials and factoring, binomial theorem, and rational expressions are also elaborated. This text covers equations such as linear equations, quadratic equations, and higher degree equations. The Cartesian coordinate system, graphing equations in two variables, and some special functio

  13. Concise Review

    DEFF Research Database (Denmark)

    Rumman, Mohammad; Dhawan, Jyotsna; Kassem, Moustapha

    2015-01-01

    Adult stem cells (ASCs) are tissue resident stem cells responsible for tissue homeostasis and regeneration following injury. In uninjured tissues, ASCs exist in a nonproliferating, reversibly cell cycle-arrested state known as quiescence or G0. A key function of the quiescent state is to preserve...... of this review is to provide an update regarding the biological mechanisms of ASC quiescence and their role in tissue regeneration....

  14. Book Review:

    Science.gov (United States)

    Stewart, J. M.

    2006-02-01

    In 1952, Mme Yvonne Choquet-Bruhat published a major paper, Théorème d'existence pour certains systèmes d'équations aux dérivées partielles non linéaires (Acta Math. 88 141-225), which laid the foundation for modern studies of the Cauchy problem in general relativity. The fiftieth anniversary of this event was celebrated with an eponymous Cargèse Summer School in 2002. The proceedings of that summer school are summarized electronically (as audio, video, transparencies and lecture notes, where available) on a DVD archive included with this volume, and are also available on the internet. However the organizers decided that a separate volume describing the 'state of the art in mathematical general relativity' would be useful, and this book is the result. It includes some material not covered in the school and excludes some school material which has been covered adequately elsewhere. Unfortunately, I was unable to find, electronically, a table of contents, which every prospective purchaser would wish to see, and so this review does in fact list all the articles, ordered, roughly, by length. About one fifth of the book is devoted to a survey of Smoothness at Null Infinity and the Structure of Initial Data by Helmut Friedrich. This is a modern study of gravitational radiation, and the analysis of Einstein's equations. It is extremely helpful to survey all of this material, including some of the latest developments, using a consistent notation. This article is strongly recommended to anyone hoping to gain a foothold in this area. Note also that 47 pages of transparencies have become 84 book pages. Lars Andersson has surveyed, in The Global Existence Problem in General Relativity, some results and conjectures about the global properties of 3+1-dimensional spacetimes with a compact Cauchy surface. Again it is very useful to have essentially all of the known results presented in a consistent notation. This material is not on the DVD. Yvonne Choquet-Bruhat has

  15. Concise Review

    DEFF Research Database (Denmark)

    Toyserkani, Navid Mohamadpour; Jørgensen, Mads Gustaf; Tabatabaeifar, Siavosh

    2017-01-01

    review all clinical studies using adipose-derived cell therapy to identify reported adverse events with a special focus on risk of thromboembolic, immunological and oncological safety concerns. Our systematic search resulted in 70 included studies involving more than 1,400 patients that were treated....... Adipose-derived cell therapy has so far shown a favourable safety profile, but safety assessment description has, in general, been of poor quality, and only adverse events that are looked for will be found. We encourage future studies to maintain a strong focus on the safety profile of cell therapy, so...

  16. Book review

    Science.gov (United States)

    Busch, Paul

    This book is a homage to Jeffrey Bub, with twelve contributions from colleagues and friends-philosophers, physicists and mathematicians-working in the foundations and philosophy of modern physics. The range of topics covered reflects the scope of Bub's broad interests and life work in this field, and each article is a tribute to his commitment to conceptual and mathematical rigor. Some of the contributions are more didactic in nature, giving an accessible introduction to or survey of their subject. Others are reviews of a larger research program or critical assessments of the status of a problem of current interest, while some authors chose to report their recent research results.

  17. Book Reviews

    OpenAIRE

    Christien Klaufus, Book Review Editor

    2016-01-01

    The Improbable Conquest: Sixteenth Century Letters from the Rio de la Plata, por Pablo García Loaeza y Victoria L. Garrett, 2015; reseñado por Judith Farberman Urban Space as Heritage in Late Colonial Cuba: Classicism and Dissonance on the Plaza de Armas of Havana: 1754-1828, by Paul Niell, 2015; reviewed by Joseph L. Scarpaci El Jefe Político. Un dominio negociando en el mundo rural del Estado de México. 1856-1911, por Romana Falcón, 2015; reseñado por Raymond Buve Miedo negro, poder blanco ...

  18. 2008 annual merit review

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2009-01-18

    The 2008 DOE Vehicle Technologies Program Annual Merit Review was held February 25-28, 2008 in Bethesda, Maryland. The review encompassed all of the work done by the Vehicle Technologies Program: a total of 280 individual activities were reviewed, by a total of just over 100 reviewers. A total of 1,908 individual review responses were received for the technical reviews, and an additional 29 individual review responses were received for the plenary session review.

  19. Reviewer Database

    OpenAIRE

    Chief Editor

    2016-01-01

    REVIEWER DATABASEA S PaddaAarati KrishnanAarti KapilAbdul JilaniAbhaya JoglekarAbhijit PakhareAbhisek MishraAbhishek ArunAbhishek GuptaAbhishek JadhavAbhishek SinghAditi SinghAdrija RoyAdwitiya MukhopadhyayAhmed MandilA SubramanianAjit SahaiAkanksha GautamAkela MohamedAkhila GopinathanAkshay KumarAlankrata JainAli AbediAlisha SyiemliehAmal BasuAmandeep KaurA ChauhanAmarnath GuptaAmar SinhaAmir M KhanAmit KaushikAmit PawaiyaAmit SinghAmrita KansalAmrita SougaijamA WadheraAnand DixtA Neelakanta...

  20. Exploration Review

    Science.gov (United States)

    Wilburn, D.R.; Stanley, K.A.

    2013-01-01

    This summary of international mineral exploration activities for 2012 draws upon information from industry sources, published literature and U.S. Geological Survey (USGS) specialists. The summary provides data on exploration budgets by region and mineral commodity, identifies significant mineral discoveries and areas of mineral exploration, discusses government programs affecting the mineral exploration industry and presents analyses of exploration activities performed by the mineral industry. Three sources of information are reported and analyzed in this annual review of international exploration for 2012: 1) budgetary statistics expressed in U.S. nominal dollars provided by SNL Metals Economics Group (MEG) of Halifax, Nova Scotia; 2) regional and site-specific exploration activities that took place in 2012 as compiled by the USGS and 3) regional events including economic, social and political conditions that affected exploration activities, which were derived from published sources and unpublished discussions with USGS and industry specialists.

  1. Book Reviews

    Directory of Open Access Journals (Sweden)

    Paul Bartolo

    2013-05-01

    Full Text Available All of the reviewed books in this edition are relevant to an international dialogue between educational and health domains. Together they address a cluster of related themes relevant to teachers and parents, as well as to many other professionals workingwith children and young people. These themes include Social, Emotional and Behavioural Disorders (SEBD, Attachment Patterns at preschool and primary level, Anger expression and management, as well as individual differences in sensory processing. Cooper and Jacobs’ book offers a panoramic view of evidence to inform which approaches to promoting the educational engagement of students with SEBD, are most promising, with distinctive arguments therein in relation to labelling and interprofessional collaboration. Golding and her colleagues offer accounts of observational tools as resources for preschool and primary teachers, respectively, to identify attachment difficulties in children. This raises a myriad of issues for exploration. Irving Henry and her colleagues offer a resource for teachers and parents on anger, mainly within a cognitive-behavioural frame of reference. O’Connor identifies a range of theoretically informed, practical strategies for improving children’s concentration and learning through sensory processing. A common theme across most of these books is the need to go beyond a ‘one size fits all’ approach to more differentiated, interdisciplinary strategies for meeting children’s complex array of needs.

  2. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    , and way of life (Nicholas Tapp K.S. Nathan, Mohammad Hashim Kamali (eds; Islam in Southeast Asia; Political, social and strategic challenges for the 21st century (Bryan S. Turner Andrew Pawley, Robert Attenborough, Jack Golson, Robin Hide (eds; Papuan pasts; Cultural, linguistic and biological histories of Papuan-speaking peoples (Lourens de Vries Leo Howe, The changing world of Bali; Religion, society and tourism (Carol Warren Sarah Weiss; Listening to an earlier Java; Aesthetics, gender, and the music of wayang in Central Java (Andrew N. Weintraub REVIEW ESSAY Terry Crowley: Four grammars of Malakula languages Crowley, Terry (ed. by John Lynch; The Avava language of Central Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Tape: a declining language of Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Naman: a vanishing language of Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Nese: a diminishing speech variety of Northwest Malakula (Vanuatu (Alexandre Francois REVIEW ESSAY -- ‘The folly our descendants are least likely to forgive us’: the end of nature in Southeast Asia? Michael R. Dove, Percy E. Sajise, Amity A. Doolittle (eds; Conserving nature in culture; Case studies from Southeast Asia Jeyamalar Kathirithamby-Wells; Nature and nation; Forests and development in peninsular Malaysia Celia Lowe; Wild profusion; Biodiversity conservation in an Indonesian archipelago John F. McCarthy; The fourth circle; A political ecology of Sumatra’s rainforest frontier Budy P. Resosudarmo (ed.; The politics and economics of Indonesia’s natural resources Jeffrey R. Vincent, Rozali Mohamed Ali; Managing natural wealth; Environment and development in Malaysia (David Henley In: Bijdragen tot de Taal-, Land- en Volkenkunde no. 163 (2007, no: 2/3, Leiden

  3. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    Jon Fraenkel; The manipulation of custom; From uprising to intervention in the Solomon Islands (Jaap Timmer Clive Moore; Happy isles in crisis; The historical causes for a failing state in Solomon Islands, 1998-2004 (Jaap Timmer Peter Burns; The Leiden legacy; Concepts of law in Indonesia (Bryan S. Turner Terry Crowley; Bislama reference grammar (Kees Versteegh REVIEW ESSAY Matthew Isaac Cohen; Transnational and postcolonial gamelan Lisa Gold; Music in Bali Margaret J. Kartomi; The Gamelan Digul and the prison camp musician who built it; An Australian link with the Indonesian revolution Marc Perlman; Unplayed melodies; Javanese gamelan and the genesis of music theory Ted Solís (ed.; Performing ethnomusicology; Teaching and representation in world music ensembles Henry Spiller; Gamelan; The traditional sounds of Indonesia Andrew N. Weintraub; Power plays; Wayang golek theater of West Java REVIEW ESSAY Victor T. King; People and nature in Borneo Tim Bending; Penan histories; Contentious narratives in upriver Sarawak Rajindra K. Puri; Deadly dances in the Bornean rainforest; Hunting knowledge of the Penan Benalui, 2005 Reed L. Wadley (ed.; Histories of the Borneo environment; Economic, political and social dimensions of change and continuity In: Bijdragen tot de Taal-, Land- en Volkenkunde no. 162 (2006, no: 4, Leiden

  4. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-09-01

    upland Southeast Asia. (Guido Sprenger Guido Sprenger, Die Männer, die den Geldbaum fällten; Konzepte von Austausch und Gesellschaft bei den Rmeet von Takheung, Laos. (Oliver Tappe Review Essay Two books on East Timor. Carolyn Hughes, Dependent communities; Aid and politics in Cambodia and East Timor. David Mearns (ed., Democratic governance in Timor-Leste; Reconciling the local and the national. (Helene van Klinken Review Essay Two books on Islamic terror Zachary Abuza, Political Islam and violence in Indonesia. Noorhaidi Hasan, Laskar jihad; Islam, militancy, and the quest for identity in post-New Order Indonesia. (Gerry van Klinken Korte Signaleringen Janneke van Dijk, Jaap de Jonge en Nico de Klerk, J.C. Lamster, een vroege filmer in Nederlands-Indië. Griselda Molemans en Armando Ello, Zwarte huid, oranje hart; Afrikaanse KNIL-nazaten in de diaspora. Reisgids Indonesië; Oorlogsplekken 1942-1949. Hilde Janssen, Schaamte en onschuld; Het verdrongen oorlogsverleden van troostmeisjes in Indonesië. Jan Banning, Comfort women/Troostmeisjes. (Harry Poeze

  5. Book Review

    Directory of Open Access Journals (Sweden)

    Adrian Brown

    2011-01-01

    Full Text Available Phillip M. Morse and Herman Feshbach, Professors of Physics at the MIT, published their biblical-sized textbook ‘Methods of Theoretical Physics’ with McGraw-Hill in May 1953. At 1978 pages and published in two books, it is an intimidating twin tome that should still be atop the reading lists or the bookshelves of every mathematical physicist. What material is covered in this book? In the most concise of terms, this book is devoted to the study of differential equations and associated boundary conditions that describe physical fields. The thirteen chapters address what circumstances warrant the use of which differential equations, and most often addresses the question of coordinate system transformations, for example, how do Green's functions for Laplace's Equation transform under different coordinate systems? Under what circumstances the solutions can be expected to be separable? Many examples are covered to illustrate these points. Why is this book relevant to Software Programmers? This book is part of the background that any scientific programmer is likely to need in dealing with physical fields. This book was written before personal computers became ubiquitous, however it is still an outstanding effort to tie the methods of solving differential equations governing fields together in one book. The book never received a second edition, however, it was reprinted to an outstanding standard by Feshbach Publishing since 2004, run by the children of Herman Feshbach. Their website is feshbachpublishing.com. The majority of this review is a mini-commentary of the book showing what is covered in a very terse fashion, which may be useful as a summary even for those who have already read the full text. I then give a brief analysis of the approach to mathematical physics taken by the book. Finally, I will discuss who will benefit from reading this magnificent treatise, nearly 60 years after it was first published.

  6. PETC Review

    Energy Technology Data Exchange (ETDEWEB)

    Santore, R.R.; Blaustein, B.D.; Friedman, S.; Reiss, J.; Brown, J.; Price, M.M. (eds.)

    1993-01-01

    This issue of the PETC Review is devoted to explaining how the private sector can do business with DOE-and with PETC in particular-and how DOE works with academia, industry, and state and local groups to accomplish objectives of mutual interest. Over the past several years, the notion of cost-sharing'' has been receiving increased attention. Indeed, cost-shared RD D is becoming the norm, not only within DOE but also among other government agencies, including the Department of Defense. It may surprise some of our readership to learn that RD D cost-sharing is not a new government policy. In fact, it has been part of the DOE Acquisition Regulations from their inception in 1977. In lay terms, cost participation, a general kind of cost-sharing, is required for RD D efforts in which the non-Federal participant's goal is commercialization or in situations for which it is reasonable to expect that economic benefits will accrue to the participant as a result of the work. The policy is quite flexible and states that the degree of non-DOEcost participation depends on a number of factors, including the nature of the work performed and the extent of the project risk. As competition for RD D funds increases, it is to be expected that cost-sharing requirements for development, and even for basic research, will increase. Nevertheless, we think that Federal support of RD D will continue to be necessary to maintain this country's leadership in science, technology, industry, and living standards.

  7. Book Reviews

    Directory of Open Access Journals (Sweden)

    V. M. Clara van Groenendael

    1986-10-01

    Full Text Available - Dennis Tedlock, Dennis Tedlock, The Spoken Word - Reaction to R. de Ridder’s review of The Spoken Word and Popul Vuh (BKI 142-I, 1986, pp. 179-182. - J.G. de Casparis, Kenneth R. Hall, Maritime trade and state development in early Southeast Asia, Honolulu: University of Hawaii Press, 1985, 368 pp. - M. Hekker, J.E. Ellemers, Indische Nederlanders en gerepatrieerden, Muiderberg: Coutinho, 1985. 159 pp., foto’s., R.E.F. Vaillant (eds. - Tineke Hellwig, Els Postel-Coster, Het omheinde kweekbed; Machtsverhoudingen in de Minangkabause familieroman, Delft: Eburon, 233 pp., 1985. - H.A.J. Klooster, Sartono Kartodirdjo, Modern Indonesia, tradition and transformation. A socio-historical perspective, Yogyakarta: Gadjah Mada University Press, 1984, xii + 299 pp. - Gert J. Oostindie, W.S.M. Hoogbergen, De Boni-oorlogen 1757-1860. Marronage en guerilla [sic] in Oost-Suriname. Utrecht: Rijksuniversiteit 1985. [Bronnen voor de studie van Afro-amerikaanse samenlevingen in de Guyana’s, 528 pp. - P. Pink, V. M. Clara van Groenendael, The Dalang behind the Wayang. The role of the Surakarta and the Yogyakarta dalang in Indonesian-Javanese society, Verhandelingen van het Koninklijk Instituut voor Taal-, Land- en Volkenkunde 114, Dordrecht-Holland/Cinnaminson-U.S.A.: Foris publications, 1985, VIII + 242 pp., 3 maps. - P. Pink, J. Kats, De Wajang Poerwa, een vorm van Javaans Toneel, ingeleid door J.J. Ras en H.A. Poeze, Koninklijk Instituut voor Taal-, Land- en Volkenkunde, Indonesische Herdrukken, Dordrecht-Holland/Cinnaminson-U.S.A.: Foris publications, 1984, XL VIII + VIII + 446 pp. - S. Pompe, Hisako Nakamura, Divorce in Java, Gadjah Mada University Press, Yogyakarta 1983, xxiii + 145 pp. - J.M.C. Pragt, Wim Bakker, Bali verbeeld, Volkenkundig Museum Nusantara, Delft, 1985, 96 p., 120 afb.

  8. Book Review:

    Science.gov (United States)

    Barbour, J. B.

    2007-02-01

    These colloquium proceedings will be valuable, the blurb says, for graduate students and researchers in cosmology and theoretical astrophysics. Specifically, the book 'looks at both the strengths and weaknesses of the current big bang model in explaining certain puzzling data' and gives a 'comprehensive coverage of the expanding field of cosmology'. The reality is rather different. Conference proceedings rarely compare in value with a solid monograph or good review articles, and Current Issues in Cosmology is no exception. The colloquium was convened by the two editors, who have both long harboured doubts about the big bang, and was held in Paris in June 2004. The proceedings contain 19 presented papers and relatively brief summary comments by four panel speakers. The questions and answers at the end of each talk and a general discussion at the end were recorded and transcribed but contain little of interest. The nature of the colloquium is indicated by panellist Francesco Bertola's comment: 'While in the 1950s it was possible to speak of rival theories in cosmology, now the big-bang picture has no strong rivals. This is confirmed by the fact that out of 1500 members of the IAU Division VIII (Galaxies and the Universe) only a dozen, although bright people, devote their time to the heterodox views.' This was largely a platform for them to give their views. At least half of the dozen, all the 'usual suspects', were present: Geoffery and Margaret Burbidge, Jayant Narlikar, Halton Arp, Chandra Wickramasinghe and, in spirit only but playing a role somewhat like the ghost of Hamlet's father, the late Fred Hoyle. Doubters presented 12 of the 19 papers. Orthodoxy should certainly be challenged and the sociology of science questioned, but I found two main problems with this book. The papers putting the orthodox view are too short, even perfunctory. The most that a serious graduate student would get out of them is a reference to a far better review article or book on modern

  9. Book Review:

    Science.gov (United States)

    Sanders, J. H.

    1984-01-01

    Series presents as an introductory article a characteristically clear résumé of the quantum mechanical background of spectroscopy which, although too condensed to compete with the textbooks, provides an admirable checklist of what one needs to know. Pierre Cerez does the same for the physics of masers and lasers, and follows this with an account of present-day time and frequency standards. The establishment and world-wide distribution of these standards, and the related subjects of length, wavelength and optical frequency standards are covered in detail, and more history is related in a review of past measurements of the speed of light. Now that the measurement of the speed of light has become an irrelevance as a result of its definition as an exact quantity, thus abolishing the need for a direct standard of length, the article by K M Baird is bound to rouse nostalgia. In this connection it is a delight to find reprinted at the end of the volume the text of the article, published in 1773, giving an account of Roemer's method (1676) for measuring the speed of light and the first indication that it is finite. The most significant impact on the measurement of the fundamental constants was made by the discovery of quantum effects and the development of the quantum theory. Planck's constant plays the key role here, and quantum metrology has merged the quantum and classical fields. Thus the volt can be referred to a frequency, through the Josephson effect, in a particularly (and unexpectedly) direct manner, and magnetic field strengths can be compared as a ratio of frequencies, and measured in terms of the gyromagnetic ratio of the proton. Techniques of this sort are reviewed by Brian Petley of the National Physical Laboratory, who also contributes valuable articles on the particular measurements which involve magnetic moments, and a general survey of the significance of the fundamental constants as a whole. Laser spectroscopy has in recent years played an important part in

  10. Book Review:

    Science.gov (United States)

    Webb, Steve

    2008-11-01

    life and is a condensed history of the development of nuclear physics, political changes and world affairs over the period. It is succinctly arranged and the reader is taken remarkably rapidly through the salient details of the above story in a most readable way. The author states that his intention for the book is to bring the story to a much wider audience than those who work in nuclear or medical physics. Indeed he hopes it will be read by those who might call themselves non-scientists and also young people who might be inspired to pursue a career in physics. Throughout the book salient physics is compartmentalised into bite-sized boxes and explained through analogy, simple diagrams and hardly an equation in sight. Thus one such box entitled 'How to make Nukes work!' should not alarm readers or anti-terror watchdogs. The barest of information is given at all stages; just enough to follow the Rotblat story. In essence the book will be of most use to those who have only the vaguest ideas of the above story. Readers expecting a definitive, well-referenced, chronological tome, backed by a substantial bibliography of primary peer-reviewed papers, will be disappointed. Kit Hill points though to such a definitive work published two years ago by the University of Liverpool. This reviewer felt that maybe the book is a little too thin and in places longed for rather more substance and detail. The author would surely, in his defence, say 'look elsewhere'. This said, it can easily be read cover to cover in one short evening sitting. In a world burgeoned with paperwork to read, that might be considered an advantage. A second disappointment is that there is virtually nothing on the productivity of Rotblat over 30 years as Professor of Medical Physics. This reviewer feels that is a lost opportunity. Kit Hill, personal friend of Jo Rotblat and co-worker with Pugwash, was himself in a similar role (though working mainly with non-ionizing ultrasound radiation) and could have made his

  11. A systematic review of observational studies evaluating costs of adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Batel Marques F

    2016-08-01

    Full Text Available Francisco Batel Marques,1,2 Ana Penedones,1,2 Diogo Mendes,1,2 Carlos Alves,1,2 1CHAD – Centre for Health Technology Assessment and Drug Research, AIBILI – Association for Innovation and Biomedical Research on Light and Image, 2School of Pharmacy, University of Coimbra, Coimbra, Portugal Introduction: The growing evidence of the increased frequency and severity of adverse drug events (ADEs, besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs.Objective: To identify and characterize the best available evidence on ADE-associated costs.Methods: MEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated.Results: Twenty-nine (94% longitudinal observational studies and two (7% cross-sectional studies were included. Twenty-three (74% studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%. Twenty (65% studies evaluated any therapeutic group. Twenty (65% studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7% also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7

  12. Book Review:

    Science.gov (United States)

    Poisson, E.

    2006-09-01

    The motion of a charged particle interacting with its own electromagnetic field is an area of research that has a long history; this problem has never ceased to fascinate its investigators. On the one hand the theory ought to be straightforward to formulate: one has Maxwell's equations that tell the field how to behave (given the motion of the particle), and one has the Lorentz-force law that tells the particle how to move (given the field). On the other hand the theory is fundamentally ambiguous because of the field singularities that necessarily come with a point particle. While each separate sub-problem can easily be solved, to couple the field to the particle in a self-consistent treatment turns out to be tricky. I believe it is this dilemma (the theory is straightforward but tricky) that has been the main source of the endless fascination. For readers of Classical and Quantum Gravity, the fascination does not end there. For them it is also rooted in the fact that the electromagnetic self-force problem is deeply analogous to the gravitational self-force problem, which is of direct relevance to future gravitational wave observations. The motion of point particles in curved spacetime has been the topic of a recent Topical Review [1], and it was the focus of a recent Special Issue [2]. It is surprising to me that radiation reaction is a subject that continues to be poorly covered in the standard textbooks, including Jackson's bible [3]. Exceptions are Rohrlich's excellent text [4], which makes a very useful introduction to radiation reaction, and the Landau and Lifshitz classic [5], which contains what is probably the most perfect summary of the foundational ideas (presented in characteristic terseness). It is therefore with some trepidation that I received Herbert Spohn's book, which covers both the classical and quantum theories of a charged particle coupled to its own field (the presentation is limited to flat spacetime). Is this the text that graduate students

  13. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    John Bowden, Nikolaus Himmelmann (eds; Papers in Austronesian subgrouping and dialectology (Hein Steinhauer Sebastiaan Pompe; The Indonesian Supreme Court; A study of institutional collapse (Bryan S. Turner Gerd R. Zimmermann; Indonesien; Eine geographische Landeskunde (Robert Wessing REVIEW ESSAY Dick van der Meij; Latest editions of Indonesian classical texts A. Teeuw, R. Dumas, Muhammad Haji Salleh, R. Tol, M.J. van Yperen (eds; A merry senhor in the Malay world; Four texts of the Syair Sinyor Kosta Julian Millie; Bidasari; Jewel of Malay Muslim culture. A. Teeuw, S.O. Robson (eds; Bhom?ntaka; The death of Bhoma J. Noorduyn, A. Teeuw; Three Old Sundanese poems In: Bijdragen tot de Taal-, Land- en Volkenkunde (BKI, no. 162 (2006, no: 2/3, Leiden

  14. Peer Review and Post-Tenure Review.

    Science.gov (United States)

    Mignon, Charles; Langsam, Deborah

    1999-01-01

    Considers four themes related to peer and post-tenure review of college faculty: (1) post-tenure review as a summative moment in a cycle of formative occasions; (2) the post-tenure period as characterized by flux and change; (3) the post-tenure period as one of crisis in intellectual growth; (4) peer collaboration and review of teaching as…

  15. Environmental Review Records

    Data.gov (United States)

    Department of Housing and Urban Development — HUD’s Environmental Review Records page houses environmental reviews made publicly available through the HUD Environmental Review Online System (HEROS). This...

  16. AQUATOX Peer Review Documents

    Science.gov (United States)

    AQUATOX Release 2 underwent an external peer review in early 2003, and Release 3 underwent an external peer review in late 2008. Reviewers stated model enhancements have made AQUATOX one of the most exciting tools in aquatic ecosystem management.

  17. Book Review:

    Science.gov (United States)

    Carlip, S.

    2006-10-01

    The early 1980s, when I first learned theory, were desperate times for graduate students. We searched frantically for coherent introductions, passing tattered copies of review articles around like samizdat, struggling over obscure references to ancient models of strong interactions, and flocking to lectures—not least those by Joe Polchinski—that promised to really explain what was going on. If only this book had been around, it would have saved much grief. Volume I, The Bosonic String, offers a clear and well organized introduction to bosonic string theory. Topics range from the 'classical' (spectra, vertex operators, consistency conditions, etc.) to the 'modern' (D-branes first appear in an exercise at the end of chapter 1, noncommutative geometry shows up in chapter 8). Polchinski does not hesitate to discuss sophisticated matters—path integral measures, BRST symmetries, etc.—but his approach is pedagogical, and his writing is lucid, if sometimes a bit terse. Chapters end with problems that are sometimes difficult but never impossible. A very useful annotated bibliography directs readers to resources for further study, and a nearly 30-page glossary provides short but clear definitions of key terms. There is much here that will appeal to relativists. Polchinski uses the covariant Polyakov path integral approach to quantization from early on; he clearly distinguishes Weyl invariance from conformal invariance; he is appropriately careful about using complex coordinates on topologically nontrivial manifolds; he keeps the string world sheet metric explicit at the start instead of immediately hiding it by a gauge choice. Volume II includes an elegant introduction to anticommuting coordinates and superconformal transformations. A few conventions may cause confusion—%, Polchinski's stress energy tensor, for instance, differs from the standard general relativistic definition by a factor of -2π, and while this is briefly mentioned in the text, it could easily be

  18. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-04-01

    Nio Liem, De rechtspositie der Chinezen in Nederlands-Indië 1848-1942; Wetgevingsbeleid tussen beginsel en belang. (Mary Somers Heidhues Zhou Daguan, A record of Cambodia: the land and its people. (Un Leang REVIEW ESSAY Longitudinal studies in Javanese performing arts Benjamin Brinner, Music in Central Java; Experiencing music, expressing culture. Barbara Hatley, Javanese performances on an Indonesian stage; Contesting culture, embracing change. Felicia Hughes-Freeland, Embodied communities; Dance traditions and change in Java. (Matthew Isaac Cohen REVIEW ESSAY Development and reform in Vietnam Stéphanie Balme and Mark Stephanie (eds, Vietnam’s new order; International perspectives on the state and reform in Vietnam. Sujian Guo, The political economy of Asian transition from communism. Ian Jeffries, Vietnam: a guide to economic and political developments. Pietro Masina, Vietnam’s development strategies. (Tran Quang Anh KORTE SIGNALERINGEN Ulbe Bosma, Indiëgangers; Verhalen van Nederlanders die naar Indië trokken. Clara Brinkgreve, Met Indië verbonden; Een verhaal van vier generaties 1849-1949. Jack Botermans en Heleen Tichler, Het vergeten Indië; Stille getuigen van het dagelijks leven in het Indië van toen. Robin te Slaa en Edwin Klijn, De NSB; Ontstaan en opkomst van de Nationaal-Socialistische Beweging, 1931-1935. Mark Loderichs, Margaret Leidelmeijer, Johan van Langen en Jan Kompagnie, Verhalen in Documenten; Over het afscheid van Indië, 1940-1950. Frederik Erens en Adrienne Zuiderweg, Linggadjati, brug naar de toekomst; Soetan Sjahrir als een van de grondleggers van het vrije Indonesië. Peter Schumacher, met medewerking van Gerard de Boer, De zaak Aernout; Hardnekkige mythes rond een Indische moord ontrafeld. Cas Oorthuys, Een staat in wording; Fotoreportage van Cas Oorthuys over het Indonesië van 1947. René Kok, Erik Somers en Louis Zweers, Koloniale oorlog 1945-1949; Van Indië tot Indonesië. H.F. Veenendaal

  19. Book Reviews Volume 2

    OpenAIRE

    2016-01-01

    Book review by Tony Fahy of Ian Ang: Desperately Seeking the Audience Book review by Greta Jones of Thomas Richards The commodity culture of Victorian England: advertising and spectacle, 1851-1914 Book review by Colum Kenny of Broadcast and electronic media in Western Europe Book review by Mary Maher of Ann Shearer Survivors and the media Book review by Mary Maher of Andrea Millwood Hargrave Taste and Decency in Broadcasting Book review by Henry McClave of Joan Mulholland The l...

  20. Engineering Review Information System

    Science.gov (United States)

    Grems, III, Edward G. (Inventor); Henze, James E. (Inventor); Bixby, Jonathan A. (Inventor); Roberts, Mark (Inventor); Mann, Thomas (Inventor)

    2015-01-01

    A disciplinal engineering review computer information system and method by defining a database of disciplinal engineering review process entities for an enterprise engineering program, opening a computer supported engineering item based upon the defined disciplinal engineering review process entities, managing a review of the opened engineering item according to the defined disciplinal engineering review process entities, and closing the opened engineering item according to the opened engineering item review.

  1. [Acute psychotic disorders related to bupropion: review of the literature].

    Science.gov (United States)

    Javelot, T; Javelot, H; Baratta, A; Weiner, L; Messaoudi, M; Lemoine, P

    2010-12-01

    Bupropion, or amfebutamone, is an atypical antidepressant also used during tobacco cessation. From a structural standpoint, it resembles amphetamine drugs with psychostimulant effects, and endogenous monoamines. From a pharmacological standpoint, bupropion, and two of its most important active metabolites, inhibit dopamine and norepinephrine reuptake. It has recently been discovered that bupropion may act as a non-competitive cholinergic nicotinic receptor antagonist, and that it may inhibit the activation of reward systems triggered by nicotine. Buproprion's efficacy as a smoking cessation aid has been demonstrated by numerous clinical trials that have compared its effects with those of placebo and other nicotinic substitutes. In 2001, buproprion SR received marketing authorization in France as a smoking cessation aid, under the name ZYBAN®. Tobacco addiction indeed remains a major public health issue. Among patients with psychiatric conditions, chronic tobacco consumption is frequent. The development of non-nicotinic drugs may therefore enhance therapeutic possibilities. However, the psychotropic effects of these molecules should be taken into account. We have recently reported the case of a patient with schizoaffective disorder, who presented two acute bupropion-induced psychotic episodes. We have also undertaken an exhaustive bibliographical research on this subject. The aim of the present study is to present the information available to us, in order to suggest aetiopathogenic hypotheses and therapeutic proposals. The following databases were consulted on a regular basis, with no date restriction: Medline, Cochrane and Elsevier. The present study identified 22 cases of psychotic conditions associated with buproprion, as well as randomized and pharmacovigilance studies published in English, from December 1985 to November 2008. Since 2002, there have been three published case-reports on patients who underwent a tobacco cessation program. Psychotic disorders

  2. Book Reviews

    Directory of Open Access Journals (Sweden)

    Ratna Saptari

    1994-07-01

    , Harold Brookfield, South-East Asia’s environmental future; The search for sustainability. Tokyo: United Nations University Press, Kuala Lumpur: Oxford University Press, 1993, xxxii + 422 pp., maps, tables, figures, index., Yvonne Byron (eds. - Antje van der Hoek, Keebet von Benda-Beckmann, De emancipatie van Molukse vrouwen in Nederland. Utrecht: Van Arkel,1992, Francy Leatemia-Toma-tala (eds. - Michael Hitchcock, Brita L. Miklouho-Maklai, Exposing Society’s Wounds; Some aspects of Indonesian Art since 1966. Adelaide: Flinders University Asian studies Monograph No.5, illustrations, 1991, iii + 125 pp - Nico Kaptein, Fred R. von der Mehden, Two Worlds of Islam; Interaction between Southeast Asia and the Middle East.Gainesville etc: University Press of Florida 1993, xiii + 128 pp - Nico Kaptein, Karel Steenbrink, Dutch Colonialism and Indonesian Islam; Contacts and Conflicts 1596-1950. Amsterdam-Atlanta, GA: Rodopi, 1993. - Harry A. Poeze, Rudolf Mrázek, Sjahrir; Politics and exile in Indonesia. Ithaca, N.Y.: Cornell University, Southeast Asia Program, 1994. - W.G.J. Remmelink, Takao Fusayama, A Japanese memoir of Sumatra 1945-1946; Love and hatred in the liberation war. Ithaca: Cornell University (Cornell Modern Indonesia Project Monograph series 71, 1993, 151 pp., maps, illustrations. - Ratna Saptari, Diana Wolf, Factory Daughters; Gender, Household Dynamics, and Rural Industrialization in Java. Berkeley: University of California Press, 1992. - Ignatius Supriyanto, Ward Keeler, Javanese Shadow Puppets. Singapore (etc.: Oxford University Press, 1992, vii + 72 pp.,bibl., ills. (Images of Asia. - Brian Z. Tamanaha,S.J.D., Juliana Flinn, Review of diplomas and thatch houses; Asserting tradition in a changing Micronesia. Ann Arbor: University of Michigan Press, 1992. - Gerard Termorshuizen, Dorothée Buur, Indische jeugdliteratuur; Geannoteerde bibliografie van jeugdboeken over Nederlands-Indië en Indonesië, 1825-1991. Leiden, KITLV Uitgeverij, 1992, 470 pp

  3. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2005-01-01

    öder-Butterfill Andrew MacIntyre, The power of institutions; Political architecture and governance (Henk Schulte Nordholt Carol Ireson-Doolittle and Geraldine Moreno-Black, The Lao; Gender, power, and livelihood (Guido Sprenger David L. Gosling (with a foreword by Ninian Smart, Religion and ecology in India and Southeast Asia (Bryan S. Turner William C. Clarke, Remembering Papua New Guinea; An eccentric ethnography (Donald Tuzin Review essay Gerben Nooteboom: Competition, collateral damage, or ‘just accidents’? Three explanations of ethnic violence in Indonesia: - Jacques Bertrand, Nationalism and ethnic conflict in Indonesia - Cristina Eghenter, Bernard Sellato, and G. Simon Devung (eds, Social science research and conservation management in the interior of Borneo; Unravelling past and present interactions of people and forests - Nancy Lee Peluso and Michael Watts (eds, Violent environments - Günther Schlee (ed., Imagined differences; Hatred and the construction of identity

  4. Book Review

    Science.gov (United States)

    1999-07-01

    The International Cryogenic Engineering Conferences (ICEC) are held biennially and are medium-scale events (a few hundred participants) involving a wide range of cryogenic specialists. The Proceedings of the 17th Conference reflects this range clearly, comprising four sections. The first, and shortest, presents the texts of (some of) the plenary invited papers and covers topics ranging from `The first collection of liquid hydrogen' to `The application of bulk high-temperature superconductors'. Then follow three sections of approximately equal length (250--300 pages each) covering, respectively, refrigeration, superconductivity and cryogenics. The rapid recent development of closed cycle refrigerators is reflected in the content of the first section and is a firm indicator that the topic of cryogenic engineering is spreading out from its current twin, but limited, areas of the research laboratory and the large-scale particle or energy research facility. Expansion into both industry, commerce and medicine is apparent, as is the provision of facilities for other technologies (for example, high-field magnets for NMR, extending to 1 GHz). Later in this volume some of these future applications are described. The Kleemenko cycle, as lucidly explained by Bill Little, consists of a development of the Joule--Thomson expansion technique for cooling in which the expansion and cooling of a single component gas is replaced by the expansion and cooling of a mixture of gas and liquid phase. Pulse tube coolers now come in a variety of forms and sizes, in single stage and double stage forms, providing a lowest temperature so far of around 2 K with 2 stages or 20 K with a single stage. The ability of this design is to reduce mechanical vibration levels well below those achievable with conventional Gifford--McMahon or Stirling cycle coolers and this volume includes a review of developments of these types, as well as a number of research papers setting out the leading edge of

  5. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    Melaka and Enyan anak Usen, Iban art; Sexual selection and severed heads: weaving, sculpture, tattooing and other arts of the Iban of Borneo (Viktor T. King John Roosa; Pretext for mass murder; The September 30th Movement and Suharto’s coup d’état in Indonesia (Gerry van Klinken Vladimir Braginsky; The heritage of traditional Malay literature; A historical survey of genres, writings and literary views (Dick van der Meij Joel Robbins, Holly Wardlow (eds; The making of global and local modernities in Melanesia; Humiliation, transformation and the nature of cultural change (Toon van Meijl Kwee Hui Kian; The political economy of Java’s northeast coast c. 1740-1800; Elite synergy (Luc Nagtegaal Charles A. Coppel (ed.; Violent conflicts in Indonesia; Analysis, representation, resolution (Gerben Nooteboom Tom Therik; Wehali: the female land; Traditions of a Timorese ritual centre (Dianne van Oosterhout Patricio N. Abinales, Donna J. Amoroso; State and society in the Philippines (Portia L. Reyes Han ten Brummelhuis; King of the waters; Homan van der Heide and the origin of modern irrigation in Siam (Jeroen Rikkerink Hotze Lont; Juggling money; Financial self-help organizations and social security in Yogyakarta (Dirk Steinwand Henk Maier; We are playing relatives; A survey of Malay writing (Maya Sutedja-Liem Hjorleifur Jonsson; Mien relations; Mountain people and state control in Thailand (Nicholas Tapp Lee Hock Guan (ed.; Civil society in Southeast Asia (Bryan S. Turner Jan Mrázek; Phenomenology of a puppet theatre; Contemplations on the art of Javanese wayang kulit (Sarah Weiss Janet Steele; Wars within; The story of Tempo, an independent magazine in Soeharto’s Indonesia (Robert Wessing REVIEW ESSAY Sean Turnell; Burma today Kyaw Yin Hlaing, Robert Taylor, Tin Maung Maung Than (eds; Myanmar; Beyond politics to societal imperatives Monique Skidmore (ed.; Burma at the turn of the 21st century Mya Than; Myanmar in ASEAN

  6. Book Reviews

    Directory of Open Access Journals (Sweden)

    J. van Baal

    1965-01-01

    Full Text Available - R.J. Mohr, Bernard J. Siegel, Biennial Review of Anthropology 1963. Stanford University Press. Stanford, California, 1963. 306 pp. - P.E. de Josselin de Jong, Jean Poirier, Guide d’enquête monographique appliquée aux sociétés malgaches. Faculté des lettres et sciences humaines de Madagascar, Tananarive 1962. - P.E. de Josselin de Jong, Jean Poirier, L’inventaire ethno-topographique. Departement des sciences humaines, Faculté des lettres et sciences humaines, Université de Madagascar, Tananarive 1963. - H.Th. Fischer, P. van Emst, Panorama der Volken, I (Volken van Amerika en Oceanië, onder redactie van P. van Emst. Romen en zonen, Roermond 1964. 515 blz., vele ills. - C. Nooteboom, W. Frölich, Völkerkundliche Forschungen, Martin Heydrich zum 70. Geburtstag überreicht von Freunden und Schülern, herausgegeben von W. Frölich (Ethnologica, Neue Folge, Band 2, Köln, 1960. 557 S., 46 Tafeln, 116 Abb. - J. van Baal, Claude Levi-Strauss, Totemism. Translated from the French by Rodney Needham. Beacon Press, Boston, 1963. 116 pp. - J.J. Fahrenfort, Luc de Heusch, Le Pouvoir et le Sacré. Annales de Centre d’ Etude des Religions I. Université de Bruxelles. Institut de Sociologie (Solvay 1962. 228 pp. - H.J.M. Claessen, Montserrat Palau Marti, Le Roi-Dieu au Bénin, Sud Togo, Dahomey, Nigeria Occidentale. Collection Mondes d’Outre-mer, Série: Nations. Berger Levrault, Paris 1964. - P.E. de Josselin de Jong, F. Sierksma, Profiel van een incarnatie. G.A. van Oorschot, Amsterdam 1964. 244 blz. - B.A.L. Cranstone, Carl A. Schmitz, Wantoat: Art and religion of the Northeast New Guinea Papuans. Translated from the German by Mrs. G.E. van Baaren-Pape. Mouton (the Hague, Paris, 1963. 159 pp. 47 plates. - A.A. Gerbrands, William Fagg, Nigerian images. Lund Humphries, London, 1963. 47 pages, 144 plates by Herbert List. - A.A. Gerbrands, Marcelle Urbain-Faublée, L’art malgache. Presses Universitaires de France, Paris, 1963. 141 pag. 100

  7. Book Review:

    Science.gov (United States)

    Fallone, B. G.

    2004-01-01

    This book represents the proceedings of the five day programme on IMRT techniques presented at the 2003 American Association of Physicists in Medicine (AAPM) Summer School held in Colorado Springs, Colorado. The book is essentially an overview of IMRT techniques, discussing the history, the mathematical processes involved in the planning stages, the biological indices for evaluations, the off-line and on-line medical imaging that is required, the various IMRT delivery techniques available, positioning and motion verification, shielding and QA issues, and some clinical applications. There is some additional discussion on modulated electron and proton therapy, views on the clinical and financial impact of IMRT, as well as some speculation on the future uses of IMRT. The fact that the book is an `overview' must be emphasized. Medical physicists who are well-read in IMRT, or have implemented IMRT, even partially, may be a little disappointed with the book. Although specific details were purposely omitted, the well-read physicist would have preferred to go right to the `heart of the matter', something this book fails to do. As is typical of many proceedings-type books, there is a certain level of inconsistency of writing styles, as well as some redundancy between the different chapters. It is unfortunate that such a large volume does not have an index to allow a reader to explore a particular subject pertaining to IMRT. The reader would have to guide himself/herself by the table of contents before each chapter which could be a problem if the reader requires some information quickly. It is interesting to note that the book lends itself to a variety of professionals interested in IMRT, including administrators. It may be a source of help for medical physicists who wish to discuss IMRT issues with higher level administration, for example. Some clinical applications are also reviewed. The lack of details concerning the advantages of IMRT with respect to clinical outcome is

  8. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2009-05-01

    and sails the boat downstream: Malay Sufi poems of the boat (Suryadi Gilles Gravelle; Meyah: An east Bird’s Head language of Papua, Indonesia (Ian Tupper Penny Edwards; Cambodge: The cultivation of a nation, 1860-1945 (Un Leang J. Stephen Lansing; Perfect order: Recognizing complexity in Bali (Carol Warren Roxana Waterson (ed.; Southeast Asian lives: Personal narratives and historical experience (C.W. Watson Jean DeBernardi; The way that lives in the heart: Chinese popular religion and spirit mediums in Penang, Malaysia (Robert Wessing REVIEW ESSAY Environmental and archaeological perspectives on Southeast Asia Peter Boomgaard; Southeast Asia: An environmental history Peter Boomgaard (ed.; A world of water: Rain, rivers and seas in Southeast Asian histories Ian Glover and Peter Bellwood (eds; Southeast Asia: From prehistory to history Avijit Gupta (ed.; The physical geography of Southeast Asia (Eric C. Thompson

  9. Book Review:

    Science.gov (United States)

    Fabris, Júlio C.

    2004-04-01

    very skilful way. We can say that he has found an efficient way to solve the usual dilemma in teaching this subject: physics first, mathematics later, but without sacrificing the full consistency of the theory. The book is divided into three parts. In the first, covering five chapters of the 24 in the whole book, Newtonian physics and special relativity are reviewed. This review is done in a manner that prepares the reader for the subsequent discussion of general relativity itself. The principle of relativity, the variational principle, the geometrical content of Newtonian theory and the main ideas behind special relativity are all presented. In general, this first part is quite standard, except for the emphasis on geometrical aspects, such as the employment of different coordinates in a physical problem, the consequences of specific geometries, such as that of a sphere, and the notion of a spacetime manifold. This allows the author to introduce the reader to the idea of non-Euclidean geometries and their intrinsic properties. The heart of the book is, in some sense, in the second part, containing 14 chapters and covering almost two thirds of the book. Here, the principle of equivalence is fully discussed as well as the idea that gravity can be represented by the geometry of spacetime. Gravity is no longer conceived as a force but instead as the curvature of spacetime. First, the author shows how Newtonian gravity can be obtained as the limit of a specific spacetime geometry, which is after all the weak field limit of a general pseudo-Riemannian spacetime. From this, he is able to introduce geometries that represent gravity outside this weak field limit. The general approach followed by the author could be summarized as follows. The equivalence principle is encoded in curved spacetime. When gravitation effects are weak and the velocity small compared with the velocity of light, we can recover Newtonian theory from this spacetime structure. Now, let us assume a specific

  10. Book Review:

    Science.gov (United States)

    Borcherds, P. H.

    2004-09-01

    There is a new tradition in England called Apple Day which is held on some day in October. The actual day varies from place to place. For instance, in 2003, 23 October was Apple Day at Woolsthorpe Manor, the house where Isaac Newton was born and where, during the Plague, he is said to have developed the theory of gravity. (For information on future Apple Days see, for example, http://www.nationaltrust.org.uk/main/thingstodo.) Last year in our garden we picked an apple which weighed one pound, thirteen and a half ounces (1 lb 13 1/2 oz or 29 1/2 oz). The following day we went to an Apple Day event where there were many exotic apples on display, varieties which are not sold in shops. One of the varieties there was called 'Twenty Ounce'. By now you may be wondering what all this has to do with the book being reviewed. We shall return to this later. This entertaining book is ostensibly about units, in particular about Imperial and metric units, but there are numerous informative digressions. The author reminds us that almost every country 'with the exception of the United States, North and South Yemen, Burma and Brunei' has gone metric. He points out that the United States (US) became officially metric in 1893. However, as early as 1866, the US legal definition of the metre was 39.370000 inches. He tells us that after World War II the (US) inch was rounded down (from 25.400051) to 25.4 mm. There is no mention that the Imperial (British) inch was simultaneously rounded up from 25.399956 mm to 25.4 mm. The author frequently digresses, covering such matters as the trisection of angles and Eratosthenes' graphic solution for duplicating the cube. There is an informative discussion on the length of the day: appropriately 25 December, which lasts for 24 h and 30 s, is the longest day. He shows how with cycles and epicycles one can construct an ellipse. Ptolemy did not realize the importance of the focus of the ellipse. The author discusses various topics in the development of

  11. A scoping review of rapid review methods.

    Science.gov (United States)

    Tricco, Andrea C; Antony, Jesmin; Zarin, Wasifa; Strifler, Lisa; Ghassemi, Marco; Ivory, John; Perrier, Laure; Hutton, Brian; Moher, David; Straus, Sharon E

    2015-09-16

    Rapid reviews are a form of knowledge synthesis in which components of the systematic review process are simplified or omitted to produce information in a timely manner. Although numerous centers are conducting rapid reviews internationally, few studies have examined the methodological characteristics of rapid reviews. We aimed to examine articles, books, and reports that evaluated, compared, used or described rapid reviews or methods through a scoping review. MEDLINE, EMBASE, the Cochrane Library, internet websites of rapid review producers, and reference lists were searched to identify articles for inclusion. Two reviewers independently screened literature search results and abstracted data from included studies. Descriptive analysis was conducted. We included 100 articles plus one companion report that were published between 1997 and 2013. The studies were categorized as 84 application papers, seven development papers, six impact papers, and four comparison papers (one was included in two categories). The rapid reviews were conducted between 1 and 12 months, predominantly in Europe (58 %) and North America (20 %). The included studies failed to report 6 % to 73 % of the specific systematic review steps examined. Fifty unique rapid review methods were identified; 16 methods occurred more than once. Streamlined methods that were used in the 82 rapid reviews included limiting the literature search to published literature (24 %) or one database (2 %), limiting inclusion criteria by date (68 %) or language (49 %), having one person screen and another verify or screen excluded studies (6 %), having one person abstract data and another verify (23 %), not conducting risk of bias/quality appraisal (7 %) or having only one reviewer conduct the quality appraisal (7 %), and presenting results as a narrative summary (78 %). Four case studies were identified that compared the results of rapid reviews to systematic reviews. Three studies found that the conclusions between

  12. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2004-10-01

    Full Text Available -Johann Angerler, Achim Sibeth, Vom Kultobjekt zur Massenware; Kulturhistorische und kunstethnologische Studie zur figürlichen Holzschnitzkunst der Batak in Nordsumatra/Indonesien. Herbolzheim: Centaurus, 2003, 416 pp. [Sozialökonomische Prozesse in Asien und Afrika 8.] -Greg Bankoff, Eva-Lotta E. Hedman ,Philippine politics and society in the twentieth century; Colonial legacies, post colonial trajectories. London: Routledge, 2000, xv + 206 pp. [Politics in Asia Series.], John T. Sidel (eds -Peter Boomgard, Andrew Dalby, Dangerous tastes; The story of spices. London: British Museum Press, 2002, 184 pp. -Max de Bruijn, G.J. Schutte, Het Indisch Sion; De Gereformeerde kerk onder de Verenigde Oost-Indische Compagnie. Hilversum: Verloren, 2002, 254 pp. [Serta Historica 7.] -Laura M. Calkins, Jacqueline Aquino Siapno, Gender, Islam, nationalism and the state in Aceh; The paradox of power, co-optation and resistance. London: RoutledgeCurzon, 2002, xxi + 240 pp. -H.J.M. Claessen, Deryck Scarr, A history of the Pacific islands; Passages through tropical time. Richmond: Curzon, 2001, xviii + 323 pp. -Matthew Isaac Cohen, Sean Williams, The sound of the ancestral ship; Highland music of West Java. Oxford: Oxford University Press, 2001, xii + 276 pp. -Freek Colombijn, Raymond K.H. Chan ,Development in Southeast Asia; Review and prospects. Aldershot: Ashgate, 2002, xx + 265 pp., Kwan Kwok Leung, Raymond M.H. Ngan (eds -Heidi Dahles, Shinji Yamashita, Bali and beyond; Explorations in the anthropology of tourism. Translated and with an introduction by J.S. Eades, New York: Berghahn, 2003, xix + 175 pp. [Asian Anthropologies.] -Frank Dhont, Hans Antlöv ,Elections in Indonesia; The New Order and beyond. With contributions by Hans Antlöv, Syamsuddin Haris, Endang Turmudi, Sven Cederroth, Kaarlo Voionmaa. London: RoutledgeCurzon, 2004, xii + 164 pp. [Nordic Institute of Asian Studies Monograph Series 88.], Sven Cederroth (eds -Frank Dhont, Aris Ananta

  13. Book Reviews

    Directory of Open Access Journals (Sweden)

    Judith Nagata

    1986-04-01

    Full Text Available - Matthias Stiefel, W.F. Wertheim, Matthias Stiefel, Rejoinder to Duller’s review in BKI 142-I, with comments by H.J. Duller., W.F. Wertheim (eds. - K.A. Adelaar, James T. Collins, The historical relationship of the languages of central Maluku, Indonesia, Pacific Linguistics Series D, No. 47, 1983. - J.G. de Casparis, Antoinette M. Barrett Jones, Early tenth-century Java from the inscriptions. A study of economic, social and administrative conditions in the first quarter of the century, Verhandelingen van het Koninklijk Instituut voor Taal-, Land- en Volkenkunde No. 107, Dordrecht/Cinnaminson 1984. XI + 204 pp. - P.J. Drooglever, L. de Jong, Het Koninkrijk der Nederlanden in de Tweede Wereldoorlog, deel 11a, Nederlands-Indië I, eerste en tweede helft, Martinus Nijhoff, Leiden 1984, 1199 pp., kaarten, foto’s. - David T. Hill, Julie Southwood, Indonesia: Law, propaganda and terror, with foreword by W.F. Wertheim, Zed press, 1983, 272 pp., Patrick Flanagan (eds. - V.J.H. Houben, C.Ch. van den Haspel, Overwicht in overleg. Hervormingen van justitie, grondgebruik en bestuur in de Vorstenlanden op Java 1880-1930, VKI 111, Dordrecht: Foris publications, 1985. - Maarten Kuitenbrouwer, J. van Goor, Imperialisme in de marge. De afronding van Nederlands-Indië, Utrecht 1985. - Harry A. Poeze, Hansje Galesloot, De Nederlandse vakbondsperiodieken van het IISG; Systematisch overzicht. Amsterdam: Stichting Internationaal Instituut voor Sociale Geschiedenis, 1985, xiv + 241 pp., Tom van der Meer (eds. - Harry A. Poeze, Frits G.P. Jacquet, Sources of the history of Asia and Oceania in the Netherlands. Part II: Sources 1796-1949. München etc.: Saur, 1983, 547 pp. - Harry A. Poeze, Mies Campfens, De Nederlandse archieven van het Internationaal Instituut voor sociale geschiedenis te Amsterdam. Amsterdam: Van Gennep, 1984, 294 pp. - Harry A. Poeze, Henk Hondius, Inventaris van het archief van de Sociaal-Democratische arbeiders partij (SDAP 1894-1946. Amsterdam

  14. Book Review:

    Science.gov (United States)

    Swenson, C. A.

    1984-01-01

    maintained a very active interest in the affairs of the CCT. The above outline of the author's background is given here to emphasize his qualifications for presuming to undertake the writing of such an extensive and comprehensive monograph, and for doing it so well, since no similar information is given in "Temperature" nor in any of the advertising. He successfully conveys the viewpoints of both the basic scientist, whose interests are in standards thermometry and forefront research, and the person whose goals are the selection and use of the most appropriate thermometer. After an historical introduction, each of the various chapters (Thermodynamic and practical temperature scales, The measurement of thermodynamic temperatures, Fixed points and comparison baths, Resistance thermometry, Thermocouples, Radiation thermometry, Mercury-in-glass thermometry) and subsections has a similar format. This includes a capsule theoretical introduction and analysis of the subject to orient the reader and to establish limitations and approximations, a description of the current state of the art, and, finally, a nuts-and-bolts presentation which, where appropriate, includes industrial applications. Numerous tables, both in the text and in the appendices, document these discussions, along with an extensive listing of citations (close to 500) to original papers, review articles and other monographs. The coverage of topics is thorough and well-balanced, and suffers only moderately (but not deleteriously) from the biases of the author. My interests in low temperature thermometry extend upwards to 0 °C, and the author's treatment of this area is comprehensive and is done with understanding. He appears to have done equally well done equally well in the sections on higher temperature and more applied thermometry. The theoretical discussions are to educate the reader about the basic physics and consequent limitations and problems in each area. This is a difficult task which is done well on the

  15. Three Book Reviews

    OpenAIRE

    Kent Parades Scribner; Susan Haag; Steven J. Fountaine

    1993-01-01

    This issue of the Archives contains reviews of three books: Robert Leestma and Herbert J. Walberg (Eds.), Japanese Educational Productivity, reviewed by Steven J. Fountaine, Thomas Sowell, Inside American Education: The Decline, the Deception, the Dogmas, reviewed by Susan Haag, Chester E. Finn Jr. and Theodor Rebarbar (Eds.), Education Reform in the '90s, reviewed by Kent Parades Scribner

  16. Three Book Reviews

    Directory of Open Access Journals (Sweden)

    Kent Parades Scribner

    1993-04-01

    Full Text Available This issue of the Archives contains reviews of three books: Robert Leestma and Herbert J. Walberg (Eds., Japanese Educational Productivity, reviewed by Steven J. Fountaine, Thomas Sowell, Inside American Education: The Decline, the Deception, the Dogmas, reviewed by Susan Haag, Chester E. Finn Jr. and Theodor Rebarbar (Eds., Education Reform in the '90s, reviewed by Kent Parades Scribner

  17. Reviewer Database

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2016-06-01

    Full Text Available REVIEWER DATABASEA S PaddaAarati KrishnanAarti KapilAbdul JilaniAbhaya JoglekarAbhijit PakhareAbhisek MishraAbhishek ArunAbhishek GuptaAbhishek JadhavAbhishek SinghAditi SinghAdrija RoyAdwitiya MukhopadhyayAhmed MandilA SubramanianAjit SahaiAkanksha GautamAkela MohamedAkhila GopinathanAkshay KumarAlankrata JainAli AbediAlisha SyiemliehAmal BasuAmandeep KaurA ChauhanAmarnath GuptaAmar SinhaAmir M KhanAmit KaushikAmit PawaiyaAmit SinghAmrita KansalAmrita SougaijamA WadheraAnand DixtA NeelakantanAnil PurtyAnimesh JainAnisha MohanAnjali AroraAnjan DattaAnju GahlotAnkita BajpaiAnku SaikiaAnmol GoyalAnu AgrawalAnu BhardwajAnuj JangraAnupama AryaA MohokarAnurag ChaudaryA SrivastavaAr BondArnab GhoshArpan YagnikArpit PrajapatiArshad AyubArti RauthanArun SainiArun SharmaArun ShiraliArun SugumaranArun VargheseArun WanjpeArvind NathArvind SinghAsha RAshish ChauhanAshish SinhaAshish SrivastavaAshish YadavAshok BhardwajAshok SrivastavaAshu GroverAshutosh SarwaAshwani SinhaAshwini KumarAthar AnsariAtul PuthiaAustin OkpanmaAvijit DasAvijit SinghaAvinash SunthliaB P MathurB VermaBabu DilipBadri MisraBaridalyne NongkynrihBhaswati SenguptaBhavana PandeyBhavana PantBhola NathBhupinder AnandBhupinder SinghBhuwan SharmaBiju SomanBimlesh KumarBinod KumarBinod PatroBishwas AcharyaBiswajit PaulB ChakravarthyB MannaC M S RawatC P MishraC M SinghChandra PrabhaChibi RushithaChitrangada MistryD SrivastavaDaksh SharmaDaneshwar SinghDanish ImtiazDebabrata RoyDeep ShikhaDeepa NairDeepak ChopraDeepak GuptaDeepak SharmaDeepika MittalNandanwarD SharmaDevi NairDharma BhattaD GahwaiDheeraj SharmaDhiraj SrivastavaDhrubajyotiDileepanDinesh BhatnagarDipanjan DeyDivya RajaseharanEkta GuptaEmanuel CummingsEnakshi GanguliFabrice JotterandFatma KarasuFomboh RichardGagan GargGajendra GuptaGarima MittalG BandyopadhyayGeetanjali KapoorGeetu SinghGhos AhmedGirish ChavanGirjesh YadavGita NegiGmsubba RaoGnanakshiGobezie TemesgenGokul ShindeGouri PadhyKassa GideboGunjan NathH ChopraHameeda Ali

  18. Calculus super review

    CERN Document Server

    2012-01-01

    Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Calculus I Super Review includes a review of functions, limits, basic derivatives, the definite integral, combinations, and permutations. Take the Super Review quizzes to see how much you've learned - and where you need more study. Makes an excellent study aid and textbook companion. Great for self-study!DETAILS- From cover to cover, each in-depth topic review is easy-to-follow and easy-to-grasp - Perfect when preparing for

  19. Book Review:

    Science.gov (United States)

    Fulling, S. A.

    2006-05-01

    classes of systems: quantum mechanics, linear (free) fields, and interacting fields. DeWitt's characteristic tools of effective actions, heat kernels, and ghost fields are developed. Chapters 26 and 31 outline new approaches developed in collaboration with DeWitt's recent students C Molina-Paris and C Y Wang, respectively. The first of these is a ghost-free formulation of gauge theory built on ideas of G A Vilkovisky. The second is a systematic attempt (following J Schwinger, L V Keldysh, and others) to replace the in-out matrix elements by expectation values in a single (initial) state. Most of parts VI and VII consist of special topics, such as anomalies, particle creation by external fields, Unruh acceleration temperature, black holes, and Euclideanization. Chapter 30, on black holes and Hawking radiation, will be very familiar to readers of DeWitt's influential review article [4]. Chapter 28, on anomalies, makes a careful distinction (missing from many treatments) between 'critical' anomalies, which render equations of motion inconsistent in the (would-be) quantum theory, and harmless anomalies that merely invalidate predictions that would classically follow from certain symmetries. The trace anomalies in the stress tensor of matter and the axial-current anomaly in quantum electrodynamics are harmless. Examples of critical anomalies are the chiral anomaly of a spinor field coupled to a non-Abelian gauge field and the anomaly in the conservation law of the stress tensor of certain pathological theories [5]. DeWitt's chapter calculates the trace and chiral anomalies in detail. The axial anomaly is mentioned only in a one-line summary (and not defined or indexed—generally speaking, I found the book's long index surprisingly unhelpful), and the Alvarez Witten anomaly is not mentioned at all. The last two chapters of part VII treat the most important particular quantum field theories. Chapter 34 develops many of the textbook predictions of quantum eletrodynamics from De

  20. Book Reviews: Volume 4

    OpenAIRE

    2016-01-01

    J. Fiske Power plays, power works, reviewed by David E. Butler M. Skovmand and K. Schroder {eds.) Media cultures: reappraising transnational media, reviewed by Richard Fitzsimons B. Gunter and T. Viney Seeing is believing: religion and television in the 1990's, reviewed by Tony Fleck A. Millwood Hargrave {ed.), Broadcasting Standards Council: Violence in factual television, reviewed by Muiris MacConghail J. A. Walker Arts TV - A history of arts television in Britain, reviewed by B...

  1. Cadaveric simulation: a review of reviews.

    Science.gov (United States)

    Yiasemidou, M; Gkaragkani, E; Glassman, D; Biyani, C S

    2017-11-14

    Traditional surgical training, largely based on the Halstedian model "see one, do one, teach one" is not as effective in the era of working time restrictions and elaborate shift-patterns. As a result, contemporary surgeons turned to educational methods outside the operating theatre such as simulation. Cadavers are high fidelity models but their use has ethical and cost implications and their availability may be limited. In this review, we explore the role of cadaveric simulation in modern surgical education. All the Evidence-Based Medicine databases were searched for relevant reviews. The resulting studies were assessed for inclusion to this review, according to pre-determined criteria. Data extraction was performed using a custom-made spreadsheet, and the quality of included reviews was assessed using a validated scoring system (AMSTAR). The literature review yielded 33 systematic reviews; five of which matched the inclusion criteria and were included in this review of reviews. Cadaveric simulation was found to have good face (subjective assessment of usefulness) and content validity (whether a specific element adds or retracts to the educational value) while trainees improved their surgical skills after practicing on cadavers. However, concerns have been raised about ethical issues, high cost and availability. Cadavers are an effective medium for surgical teaching, and it may be appropriate for them to be used whenever surrounding conditions such cost and availability allow. Further research is required to provide evidence on whether there is equivalence between cadavers and other educational media which may not bear the same shortcomings.

  2. Systematic reviews in context: highlighting systematic reviews ...

    African Journals Online (AJOL)

    For example, in the 18th century James Lind conducted a clinical trial followed by a systematic review of contemporary treatments for scurvy; which showed fruits to be an effective treatment for the disease. However, surveys of the peerreviewed literature continue to provide empirical evidence that systematic reviews are ...

  3. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report

    Directory of Open Access Journals (Sweden)

    Sarayu A Pai

    2016-01-01

    Interpretation & conclusions: In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  4. Reviews of recent publications

    Directory of Open Access Journals (Sweden)

    2007-06-01

    Full Text Available Benthien, Claudia and Inge Stephan, eds. Meisterwerke: Deutschsprachige Autorinnen im 20 Jahrhundert Reviewed by Barbara Kosta Finney, Gail, ed. Visual Culture in Twentieth-Century Germany: Text as Spectacle Reviewed by Hester Baer Gigliotti, Simone and Berel Lang, eds. The Holocaust: A Reader Reviewed by Erin McGlothlin Matejka, Ladislav and Krystyna Pomorska, eds. Readings in Russian Poetics: Formalist and Structuralist Views Reviewed by Peter Steiner Rigaud-Drayton, Margaret. Henri Michaux: Poetry, Painting, and the Universal Sign Reviewed by Claire Nodot-Kaufman Van Cauwelaert, Didier. One Way: A Novel Reviewed by Amy L. Hubbell

  5. BMRAT reviewer acknowledgement 2015

    OpenAIRE

    Lili Hami

    2016-01-01

    Contributing reviewers The editors of Biomedical Research and Therapy would like to thank all our reviewers who have contributed to the journal in Volume 2 (2015). [Biomed Res Ther 2016; 3(2.000): 528-532

  6. Monthly Weather Review

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Supplements to the Monthly Weather Review publication. The Weather Bureau published the Monthly weather review Supplement irregularly from 1914 to 1949. The...

  7. Rate Review Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — As of September 1, 2011, the Affordable Care Act and rate review regulation require review of rate increases of 10 percent or more. A non-grandfathered health plan...

  8. Registration Review Process

    Science.gov (United States)

    EPA will review each registered pesticide at least every 15 years to determine whether it continues to meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. There are currently 745 registration review cases.

  9. Registration Review Schedules

    Science.gov (United States)

    This schedule indicates plans for completion of risk assessments, proposed interim decisions and interim decisions for pesticides in the Registration Review program, EPA reviews all registered pesticides at least every 15 years as required by FIFRA.

  10. Marine prostanoids - a review

    Digital Repository Service at National Institute of Oceanography (India)

    Wahidullah, S.; DeSouza, L.

    The occurrence and structure of prostaglandins including clavulones, punaglandins and claviridenones in marine organisms is reviewEd. by comparison of the spectral data reported the identity of 20-acetoxy claviridenones b and c with 20 acetoxy...

  11. Reviews of recent publications

    Directory of Open Access Journals (Sweden)

    1999-06-01

    Full Text Available Lucile C. Charlebois. Understanding Camilo José Cela Reviewed by Jessica A. Folkart Rainer Nägele. Echoes of Translation: Reading Between Texts Reviewed by Carol Jacobs Siegfried Mews (ed.. A Bertolt Brecht Reference Companion Reviewed by Horst Lange Suzanne Nalbantian. Æsthetic Autobiography: From Life to Art in Marcel Proust, James Joyce, Virginia Woolf and Anaïs Nin Reviewed by Laurence M. Porter

  12. IRIS Toxicological Review of Acrylamide (External Review ...

    Science.gov (United States)

    EPA has conducted a peer review by EPA’s Science Advisory Board (SAB) of the scientific basis supporting the human health hazard and dose-response assessment of acrylamide that once finalized will appear on the Integrated Risk Information System (IRIS) database. Peer review is meant to ensure that the science is used credibly and appropriately in derivation of the dose-response assessments and toxicological characterization. The draft Toxicological Review of Acrylamide provides scientific support and rationale for the hazard identification and dose-response assessment pertaining to a chronic exposure to acrylamide.

  13. Diversifying customer review rankings.

    Science.gov (United States)

    Krestel, Ralf; Dokoohaki, Nima

    2015-06-01

    E-commerce Web sites owe much of their popularity to consumer reviews accompanying product descriptions. On-line customers spend hours and hours going through heaps of textual reviews to decide which products to buy. At the same time, each popular product has thousands of user-generated reviews, making it impossible for a buyer to read everything. Current approaches to display reviews to users or recommend an individual review for a product are based on the recency or helpfulness of each review. In this paper, we present a framework to rank product reviews by optimizing the coverage of the ranking with respect to sentiment or aspects, or by summarizing all reviews with the top-K reviews in the ranking. To accomplish this, we make use of the assigned star rating for a product as an indicator for a review's sentiment polarity and compare bag-of-words (language model) with topic models (latent Dirichlet allocation) as a mean to represent aspects. Our evaluation on manually annotated review data from a commercial review Web site demonstrates the effectiveness of our approach, outperforming plain recency ranking by 30% and obtaining best results by combining language and topic model representations. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Scientometrics of peer review.

    Science.gov (United States)

    Squazzoni, Flaminio; Brezis, Elise; Marušić, Ana

    2017-01-01

    This article aims to introduce a special issue on "Scientometrics of peer review", which collects papers originally presented at workshops and conferences organised by the COST ACTION TD1306 "New frontiers of peer review". Peer review is the cornerstone of science and is one of the underlying processes that bring about publication traces that are at the heart of bibliometric studies. Unfortunately, despite its importance, quantitative studies on peer review are still poorly developed, often due to lack of data. The issue aims to promote the establishment of peer review as an interdisciplinary field of research and stimulate further quantitative research.

  15. Algebra & trigonometry super review

    CERN Document Server

    2012-01-01

    Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Algebra and Trigonometry Super Review includes sets and set operations, number systems and fundamental algebraic laws and operations, exponents and radicals, polynomials and rational expressions, equations, linear equations and systems of linear equations, inequalities, relations and functions, quadratic equations, equations of higher order, ratios, proportions, and variations. Take the Super Review quizzes to see how much y

  16. Systematic review automation technologies

    Science.gov (United States)

    2014-01-01

    Systematic reviews, a cornerstone of evidence-based medicine, are not produced quickly enough to support clinical practice. The cost of production, availability of the requisite expertise and timeliness are often quoted as major contributors for the delay. This detailed survey of the state of the art of information systems designed to support or automate individual tasks in the systematic review, and in particular systematic reviews of randomized controlled clinical trials, reveals trends that see the convergence of several parallel research projects. We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review. Several projects focus on automating, simplifying and/or streamlining specific tasks of the systematic review. Some tasks are already fully automated while others are still largely manual. In this review, we describe each task and the effect that its automation would have on the entire systematic review process, summarize the existing information system support for each task, and highlight where further research is needed for realizing automation for the task. Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow. We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials, appraises them, extracts and synthesizes data, evaluates the risk of bias, performs meta-analysis calculations, and produces a report in real time. PMID:25005128

  17. Reviews of recent publications

    Directory of Open Access Journals (Sweden)

    2001-06-01

    Full Text Available Alonso, Carlos J. The Burden of Modernity: The Rhetoric of Cultural Discourse in Spanish America Reviewed by Melvin S. Arrington, Jr. Kolocotroni, Vassiliki, Jane Goldman, and Olga Taxidou, eds, Modernism: An Anthology of Sources and Documents Reviewed by Gerd Bayer Motte, Warren. Small Worlds: Minimalism in Contemporary French Literature Reviewed by William Cloonan Melton, Judith M. The Face of Exile: Autobiographical Journeys Reviewed by Claude P. Desmarais Redding, Arthur. Raids on Human Consciousness: Writing, Anarchism, and Violence Reviewed by Gail Finney Chambers, Ross. Facing It: AIDS Diaries and the Death of the Author Reviewed by Melissa A. Fitch Marx-Scouras, Danielle. The Cultural Politics of Tel Quel: Literature and the Left in the Wake of Engagement Reviewed by Diane Fourny Foster, David William. Buenos Aires: Perspectives on the City and Cultural Production Reviewed by Gustavo Geirola Nelson, Ardis L., ed. Guillermo Cabrera Infante: Assays, essays, and other arts Reviewed by José Luis Martinez-Dueñas Fox, Claire F. The Fence and the River: Culture and Politics at the U.S.-Mexico Border Reviewed by Robert Neustadt

  18. New drugs in the pipeline: A review

    Directory of Open Access Journals (Sweden)

    Dr Vivek Lal

    2013-04-01

    Full Text Available Pharmacology is a rapidly advancing science. The essence of rational pharmacotherapeutics is to maximize the efficacy of a pharmaceutical Interventional product for a specific indication, with a simultaneous minimization of its adverse effects. With this primary objective in mind, research and development activities of pharmaceutical companies and other healthcare research organizations focus on the development and screening of new chemical entities (NCE. Once a definite pharmacological action of the NCE has been discovered, which is expected to be of satisfactory therapeutic value, the molecule is taken for a thorough pre-clinical animal testing in order to determine its feasibility for human clinical trials. Positive outcomes of the animal studies facilitate the submission of an Investigational New Drug (IND application with the requisite drug regulatory authority of that particular country. The molecule then undergoes Phase I-III Clinical Trials before it can get a marketing approval. Alternatively, an existing molecule can be modified as per the structure activity relationships to enhance its efficacy or safety. There are numerous examples of structural modifications yielding much better pharmacokinetic and or pharmacodynamic profiles. Introduction of new and better drugs ensure a continuous improvement in the management of patients with all types of ailments. A post marketing surveillance facilitates evidence based medicine, so also in the detection, assessment and analysis of adverse events which constitutes the discipline of Pharmacovigilance.

  19. NASA Product Peer Review Process

    Science.gov (United States)

    Jenks, Ken

    2009-01-01

    This viewgraph presentation describes NASA's product peer review process. The contents include: 1) Inspection/Peer Review at NASA; 2) Reasons for product peer reviews; 3) Different types of peer reviews; and 4) NASA requirements for peer reviews. This presentation also includes a demonstration of an actual product peer review.

  20. Sscience & technology review; Science Technology Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    This review is published ten times a year to communicate, to a broad audience, Lawrence Livermore National Laboratory`s scientific and technological accomplishments, particularly in the Laboratory`s core mission areas - global security, energy and the environment, and bioscience and biotechnology. This review for the month of July 1996 discusses: Frontiers of research in advanced computations, The multibeam Fabry-Perot velocimeter: Efficient measurement of high velocities, High-tech tools for the American textile industry, and Rock mechanics: can the Tuff take the stress.

  1. Peer review statement

    Science.gov (United States)

    2017-10-01

    All papers published in this volume of IOP Conference Series: Materials Science and Engineering have been peer reviewed through processes administered by the proceedings Editors. Reviews were conducted by expert referees to the professional and scientific standards expected of a proceedings journal published by IOP Publishing.

  2. Archives: African Research Review

    African Journals Online (AJOL)

    Items 1 - 47 of 47 ... Archives: African Research Review. Journal Home > Archives: African Research Review. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. 1 - 47 of 47 Items. 2017 ...

  3. Humanities Review Journal

    African Journals Online (AJOL)

    Humanities Review Journal is published in June and December by Humanities Research Forum. The Journal publishes original, well-researched papers, review essays, interviews, resume, and commentaries, which offer new insights into the various disciplines in the Humanities. The focus is on issues about Africa.

  4. Peer review statement

    Science.gov (United States)

    2017-12-01

    All papers published in this volume of IOP Conference Series: Earth and Environmental Science have been peer reviewed through processes administered by the proceedings Editors. Reviews were conducted by expert referees to the professional and scientific standards expected of a proceedings journal published by IOP Publishing.

  5. Energy and technology review

    Energy Technology Data Exchange (ETDEWEB)

    1984-03-01

    The Lawrence Livermore National Laboratory publishes the Energy and Technology Review Monthly. This periodical reviews progress mode is selected programs at the laboratory. This issue includes articles on in-situ coal gasification, on chromosomal aberrations in human sperm, on high speed cell sorting and on supercomputers.

  6. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Regulatory Review Presidential Documents Other Presidential Documents Memorandum of January 30, 2009 Regulatory Review Memorandum for the Heads of Executive Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at...

  7. Peer review statement

    Science.gov (United States)

    2017-09-01

    All papers published in this volume of IOP Conference Series: Materials Science and Engineering have been peer reviewed through processes administered by the proceedings Editors. Reviews were conducted by expert referees to the professional and scientific standards expected of a proceedings journal published by IOP Publishing.

  8. LBS Management Review: Submissions

    African Journals Online (AJOL)

    Author Guidelines. The Lagos Business School Management Review is published by management professionals for practising managers, without sacrificing academic standards. The Review welcomes articles that enhance knowledge about the process of managing an organisation as well as reflect techniques, trends and ...

  9. Peer review statement

    Science.gov (United States)

    2017-11-01

    All papers published in this volume of IOP Conference Series: Materials Science and Engineering have been peer reviewed through processes administered by the proceedings Editors. Reviews were conducted by expert referees to the professional and scientific standards expected of a proceedings journal published by IOP Publishing.

  10. Why Write Book Reviews?

    Science.gov (United States)

    Obeng-Odoom, Franklin

    2014-01-01

    The pressure to publish or perish or, more recently, to be visible or vanish, marginalises a culture of critical reading and reflection that has historically been the province of book reviews. Today, book reviews are roundly rejected by academic bureaucrats as unimportant, easy to write and hence, easy to get published, mere summaries, uncritical…

  11. Mizan Law Review

    African Journals Online (AJOL)

    Mizan Law Review publishes peer reviewed scholarly articles that identify, examine, explore and analyze legal and related principles, stipulations and concepts based on research findings. Mizan's articles aim at interpretation, description, exploration and diagnosis towards the solution of problems (or legal issues) ...

  12. Archives: Mizan Law Review

    African Journals Online (AJOL)

    Items 1 - 20 of 20 ... Archives: Mizan Law Review. Journal Home > Archives: Mizan Law Review. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. 1 - 20 of 20 Items. 2017. Vol 11, No 1 ...

  13. Acknowledgment to Reviewers 2015

    Directory of Open Access Journals (Sweden)

    Dijana Vuletić

    2016-06-01

    Full Text Available The editors of South-east European forestry would like to express their sincere gratitude to the following reviewers for evaluating manuscripts in 2015. Their generous contributions of time and expertise are greatly appreciated. Reviewers who evaluated two or more manuscripts in 2015 are underlined.

  14. Nigerian Music Review

    African Journals Online (AJOL)

    Nigerian Music Review is aimed at the scholarly review of the developments in various musical practices in Nigeria. It considers well researched articles in any of the following areas: Musicology, Ethnomusicology, African Music, Music Education, Performance, Composition, Music Technology, Music & Related Disciplines, ...

  15. Reviews of recent publications

    Directory of Open Access Journals (Sweden)

    2004-06-01

    Full Text Available Bohn, Willard. The Rise of Surrealism: Cubism, Dada, and the Pursuit of the Marvelous Reviewed by Elena Cueto As Folkart, Jessica A. Angles on Otherness in Post-Franco Spain: The Fiction of Cristina Fernández Cubas Reviewed by Jorge Marí Marí, Jorge. Lecturas espectaculares: El cine en la novela española desde 1970 Reviewed by Salvador A. Oropesa Meredith, James H. Understanding the Literature of World War II: A Student Casebook to Issues, Sources, and Historical Documents Reviewed by Cornelius Partsch Moran, Michael G. and Michelle Ballif, eds. Twentieth-Century Rhetorics and Rhetoricians: Critical Studies and Sources Reviewed by David Malcolm

  16. MELCOR Peer Review

    Energy Technology Data Exchange (ETDEWEB)

    Boyack, B.E. [Los Alamos National Lab., NM (United States); Dhir, V.K. [Santa Monica, CA. (United States); Gieseke, J.A. [Battelle, Columbus, OH (United States); Haste, T.J. [AEA Technology, Winfrith (United Kingdom); Kenton, M.A. [Gabor, Kenton and Associates, Inc., Westmont, IL (United States); Khatib-Rahbar, M. [Energy Research, Inc., Rockville, MD (United States); Leonard, M.T. [Science Applications International Corp., Wolfheze (Netherlands); Viskanta, R. [Purdue Univ., Lafayette, IN (United States). Heat Transfer Lab.

    1992-03-01

    MELCOR is a fully integrated, engineering-level computer code that models the progression of severe accidents in light water reactor nuclear power plants. The newest version of MELCOR is Version 1.8.1, July 1991. MELCOR development has reached the point that the United States Nuclear Regulatory Commission sponsored a broad technical review by recognized experts to determine or confirm the technical adequacy of the code for the serious and complex analyses it is expected to perform. For this purpose, an eight-member MELCOR Peer Review Committee was organized. The Committee has completed its review of the MELCOR code: the review process and findings of the MELCOR Peer Review Committee are documented in this report. The Committee has determined that recommendations in five areas are appropriate: (1) MELCOR numerics, (2) models missing from MELCOR Version 1.8.1, (3) existing MELCOR models needing revision, (4) the need for expanded MELCOR assessment, and (5) documentation.

  17. ADE Guide for External Reviewers.

    Science.gov (United States)

    ADE Bulletin, 2002

    2002-01-01

    Helps external reviewers of academic departments draw on the experience of those who have learned by trial and error. Outlines the steps taken by an external reviewer. Considers the particular task for an external reviewer and presents some notes on self-preservation for the external reviewer. Discusses the external reviewer's responsibility of…

  18. Swedish encapsulation station review

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Sven Olof; Brunzell, P.; Heibel, R.; McCarthy, J.; Pennington, C.; Rusch, C.; Varley, G. [NAC International, Zuerich (Switzerland)

    1998-06-01

    In the Encapsulation Station (ES) Review performed by NAC International, a number of different areas have been studied. The main objectives with the review have been to: Perform an independent review of the cost estimates for the ES presented in SKB`s document `Plan 1996`. This has been made through comparisons between the ES and BNFL`s Waste Encapsulation Plant (WEP) at Sellafield as well as with the CLAB facility. Review the location of the ES (at the CLAB site or at the final repository) and its interaction with other parts of the Swedish system for spent fuel management. Review the logistics and plant capacity of the ES. Identify important safety aspects of the ES as a basis for future licensing activities. Based on NAC International`s experience of casks for transport and storage of spent fuel, review the basic design of the copper/steel canister and the transport cask. This review insides design, manufacturing, handling and licensing aspects. Perform an overall comparison between the ES project and the CLAB project with the objective to identify major project risks and discuss their mitigation 19 refs, 9 figs, 35 tabs

  19. Human Factors Review Plan

    Energy Technology Data Exchange (ETDEWEB)

    Paramore, B.; Peterson, L.R. (eds.)

    1985-12-01

    ''Human Factors'' is concerned with the incorporation of human user considerations into a system in order to maximize human reliability and reduce errors. This Review Plan is intended to assist in the assessment of human factors conditions in existing DOE facilities. In addition to specifying assessment methodologies, the plan describes techniques for improving conditions which are found to not adequately support reliable human performance. The following topics are addressed: (1) selection of areas for review describes techniques for needs assessment to assist in selecting and prioritizing areas for review; (2) human factors engineering review is concerned with optimizing the interfaces between people and equipment and people and their work environment; (3) procedures review evaluates completeness and accuracy of procedures, as well as their usability and management; (4) organizational interface review is concerned with communication and coordination between all levels of an organization; and (5) training review evaluates training program criteria such as those involving: trainee selection, qualification of training staff, content and conduct of training, requalification training, and program management.

  20. Tolerability and Safety Profile of Cariprazine in Treating Psychotic Disorders, Bipolar Disorder and Major Depressive Disorder: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Lao, Kim S J; He, Ying; Wong, Ian C K; Besag, Frank M C; Chan, Esther W

    2016-11-01

    Cariprazine is a novel antipsychotic agent recently approved for treating schizophrenia and bipolar mania in the USA. The sample sizes of published randomized controlled trials (RCTs) of the drug are small; previous meta-analyses included few RCTs and did not specifically investigate the tolerability/safety profile of cariprazine. Our objective was to conduct a meta-analysis of published RCTs to systematically review the tolerability and safety of cariprazine versus placebo. We searched the clinical trial registers (the metaRegister of controlled trials, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform) and electronic databases (PubMed, Embase, PsycINFO and Cochrane library) up to June 2016 to identify phase II/III RCTs of cariprazine in patients with schizophrenia, bipolar disorder or major depressive disorder. We conducted a meta-analysis to investigate outcomes, including risks of discontinuation due to adverse events (AEs), extrapyramidal side effects (EPS) or related events, metabolic syndrome and cardiovascular-related events. We included nine RCTs, with a total of 4324 subjects. The risk of discontinuation due to AEs for cariprazine was similar to that for placebo (risk ratio [RR] 1.13, 95 % confidence interval [CI] 0.77-1.66). Cariprazine was associated with higher risks of EPS-related events than was placebo, including risk of akathisia (RR 3.92, 95 % CI 2.83-5.43), tremor (RR 2.41, 95 % CI 1.53-3.79) and restlessness (RR 2.17, 95 % CI 1.38-3.40). The cariprazine treatment group was more likely to have clinically significant weight gain (RR 1.68, 95 % CI 1.12-2.52). No statistically significant differences in results were found in other metabolic parameters or cardiovascular-related events. There was a statistically significant higher risk of EPS-related AEs and a slight increase in mean body weight with cariprazine. There were no statistically significant effects on prolactin level or cardiovascular