Contribution of Latin America to pharmacovigilance.

PubMed

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

Pharmacovigilance and Biomedical Informatics: A Model for Future Development.

PubMed

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 log 10 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

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

PubMed

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.

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

PubMed

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.

[Pharmacovigilance of hepatitis B vaccines].

PubMed

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.

Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database.

PubMed

Petronijevic, Marija; Ilic, Katarina; Suzuki, Ayako

2011-04-01

The main aim of this study was to determine the most frequently reported drugs to the Serbian Pharmacovigilance Database (SPD) with suspected induced hepatotoxicity. Additionally, reasons for the low reporting rate of adverse drug reactions (ADRs) in Serbia were identified. Retrospective observational study of spontaneously reported ADRs recorded in the SPD from January 1995 to December 2008 was performed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hepatobiliary disorders (HD). Drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification. Medline and WHO-UMC databases were used to address specific queries suggested by our results. The questionnaire was used to investigate the health care professionals' knowledge and practice related to spontaneous reporting. Among the 1804 reports of ADRs recorded in the SPD between 1995 and 2008, 70 (3.9%) cases of HD were identified. Drugs most frequently associated with hepatotoxicity were anti-infectives for systemic use, drugs affecting the nervous system, herbal products, hypolipemics, and anticoagulant drugs (26.83, 24.39, 12.20, 9.76, and 8.54% cases, respectively). Four cases (5.71%) of liver injury resulted in death, which accounted for 10.26% of all ADR fatalities reported to the SPD. The main reasons for not reporting ADRs were lack of reporting knowledge (30.26%), well-known ADRs (29.89%), and insecurity about causality relationship (15.50%). Anti-infectives, nervous system drugs, and herbal products were the most common drug classes reported for hepatotoxicity in Serbia. There is a need for additional education about ADRs, and enhanced reporting by health care professionals. Copyright © 2011 John Wiley & Sons, Ltd.

Today's challenges in pharmacovigilance: what can we learn from epoetins?

PubMed

Ebbers, Hans C; Mantel-Teeuwisse, Aukje K; Moors, Ellen H M; Schellekens, Huub; Leufkens, Hubert G

2011-04-01

Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of both pharmaceutical companies and regulators to characterize and minimize known and potential safety concerns. Concurrently, comprehensive surveillance systems are implemented, intended to identify and confirm adverse drug reactions, including the creation of large pharmacovigilance databases and the cooperation with epidemiological centres. Although the ambitions are high, not much is known about how effective all these measures are, or will be. In this review we analyse how the pharmacovigilance community has acted upon two adverse events associated with the use of erythropoiesis-stimulating agents: the sudden increase in pure red cell aplasia and the possible risk of tumour progression associated with these products. These incidents provide important insight for improving pharmacovigilance, but also pose new challenges for regulatory decision making.

Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment.

PubMed

Moulis, Guillaume; Bagheri, Haleh; Sailler, Laurent; Jonville-Bera, Annie-Pierre; Weber, Emmanuelle; Guy, Claire; Petitpain, Nadine; Laroche, Marie-Laure; Favrelière, Sylvie; Béné, Johana; Baldin, Bernadette; Villeval-Federici, Laure; Tebacher-Alt, Martine; Bres, Virginie; Veyrac, Gwenaëlle; Grandvuillemin, Aurélie; Mauprivez, Cédric; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

2014-10-01

Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns. We selected in the French PharmacoVigilance Database all ADRs associated with TPO-RAs from TPO-RA marketing until the 31st of December 2013. Medical charts were reviewed. We conducted disproportionality analyses comparing romiplostim exposure in the reports of a given ADR pattern (thrombosis, neurological, cutaneous, gastrointestinal or hematological) to romiplostim exposure in all other TPO-RA-related ADR reports. Reporting Odds Ratios (RORs) were adjusted for age and gender. We also compared the number of reports of a given ADR pattern per million daily defined doses (DDDs) dispensed in France during the study period. We described 45 reports (53 ADRs) with romiplostim and 26 reports (37 ADRs) with eltrombopag. There were 19 venous thromboses. At least one other risk factor was present in 83.3% of the cases. Ten (55.6%) patients had been splenectomized previously. There were eight arterial thromboses. Another risk factor was noticed in all cases. There was no signal for an excess risk of thrombosis with romiplostim versus eltrombopag (ROR: 1.45, 95% CI [0.48-4.45]). There was a signal for a higher risk of gastrointestinal ADRs with eltrombopag (ROR: 30.28, 95% CI [3.23-383.86]) and of hematological ADRs with romiplostim (ROR: 14.36, 95% CI [1.73-119.08]). Dispensing data-adjusted comparisons led to similar results. This study suggests different ADR patterns between romiplostim and eltrombopag. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Pharmacovigilance in Asia

PubMed Central

Biswas, Pipasha

2013-01-01

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change. PMID:24347987

Atropinic burden of prescriptions forms in patients with Alzheimer disease: a cross-sectional study in a French PharmacoVigilance Database.

PubMed

Montastruc, François; Rouanet, Sarah; Gardette, Virginie; Rousseau, Vanessa; Bagheri, Haleh; Montastruc, Jean-Louis

2015-07-01

Atropinic drugs in patients with Alzheimer disease (AD) can decrease the effects of anticholinesterase drugs and/or induce adverse drug reactions (ADRs). Several atropinic risk scales defining an atropinic burden of drugs were proposed but were little used in AD patients. All ADRs' notifications of AD patients registered in the Midi-Pyrénées PharmacoVigilance Database between 1999 and 2013 were analyzed using Anticholinergic Drug Scale (ADS) and Anticholinergic Duran's list. The primary objective was to quantify atropinic burden in AD patients and the secondary one to investigate associated factors. Among the 475 notifications, at least one atropinic drug was found in 282 notifications (59.4%) according to ADS and 214 (45.1%) according to Duran. Mean number of atropinics per notifications was 0.9 ± 0.9 (ADS) and 0.7 ± 0.9 (Duran). Mean atropinic burden per notifications was 1.2 ± 1.5 (ADS) and 0.9 ± 1.3 (Duran). Atropinic burden ≥ 3 was found in 87 notifications (18.2%) according to ADS and 50 (10.5%) according to Duran. There was no association between atropinic burden and age of patients. The number of drugs is associated to a high atropinic burden. The present work found an association between an atropinic drug and an anticholinesterase agent in around 1 out of 2 AD patients and a clinically significant atropinic burden (≥ 3) in around 1 to 2 AD patients out of 10. The benefit harm balance of atropinic drugs must be discussed before each prescription in AD patients.

From Pharmacovigilance to Clinical Care Optimization.

PubMed

Celi, Leo Anthony; Moseley, Edward; Moses, Christopher; Ryan, Padhraig; Somai, Melek; Stone, David; Tang, Kai-Ou

2014-09-01

In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of individuals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general.

[Pharmacovigilance of major parmaceutical innovation].

PubMed

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.

Methylprednisolone liver toxicity: A new case and a French regional pharmacovigilance survey.

PubMed

Dumortier, Jérôme; Cottin, Judith; Lavie, Caroline; Guillaud, Olivier; Hervieu, Valérie; Chambon-Augoyard, Christine; Scoazec, Jean-Yves; Vukusic, Sandra; Vial, Thierry

2017-09-01

Reported hepatotoxicity induced by corticosteroids is very rare, and the diagnosis is highly challenging in the context of auto-immune disease. We report here a case of high-dose methylprednisolone (MP)-induced acute hepatitis confirmed by liver histology in a patient with multiple sclerosis (MS) and a case series (n=4) notified to the French Pharmacovigilance center of Lyon. In all 5 cases, other common causes of hepatitis were excluded. The causal relationship with MP pulse therapy was supported by the fact that MP was the only culprit drug. In addition, 3 of these 5 patients underwent unintended single or multiple positive MP rechallenge. Our 5 patients scored a RUCAM score from 6 (probable) to 10 (highly probable). MP-induced liver injury is probably very rare, since only less than 30 cases have been reported in the literature. Nevertheless, our cases strongly illustrates that many cases could have been unrecognized; final diagnosis in 3 of 5 of our patients was made after the second or third episode of acute hepatitis. In conclusion, these cases we report here strongly illustrates that high-dose MP-induced liver injury can occur in patients treated for MS or auto-immune disorder. Unintended re-challenge can confirm the diagnosis and can help to distinguish it from autoimmune hepatitis. Performing liver function tests routinely both before and after MP administration would be beneficial, as the timely recognition of this complication and early drug withdrawal may prevent progression of severe necrosis hepatic injury. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Online reporting of adverse drug reactions: a study from a French regional pharmacovigilance center.

PubMed

Abadie, Delphine; Chebane, Leyla; Bert, Max; Durrieu, Geneviève; Montastruc, Jean-Louis

2014-01-01

In France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrénées Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate. To assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports. In a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, "seriousness" and nature of ADRs) of online notifications reported to the RPVC between July 7(th), 2010 (first online notification) and December 31(th), 2011. We performed comparisons to a random sample of "conventional" notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period. The total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26 days) earlier than "conventional" ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19 days with the new tool). In comparison to "conventional" notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for "seriousness" of ADRs. It is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting

Specific features of medicines safety and pharmacovigilance in Africa

PubMed Central

Pal, Shanthi N.; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

2012-01-01

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

Are we pharmacovigilant enough in ophthalmic practice?

PubMed Central

Dubey, Ashok; Handu, Shailendra S

2013-01-01

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. PMID:23571233

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

PubMed

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.

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

PubMed

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

2011-02-01

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 Elsevier Inc. All rights reserved.

Pharmacovigilance in Israel - tools, processes, and actions.

PubMed

Schwartzberg, Eyal; Berkovitch, Matitiahu; Dil Nahlieli, Dorit; Nathan, Joseph; Gorelik, Einat

2017-08-01

Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs) during the medication's life cycle. This activity, known as pharmacovigilance (PV), is performed worldwide by the pharmaceutical industry as well as by regulatory agencies. In 2012, the Israeli Ministry of Health (MOH) established a Pharmacovigilance and Drug Information Department. The Department is tasked with identifying, monitoring, and initiating activities aimed at minimizing risks associated with medication utilization. To enable this, the MOH has devised procedures for PV and promoted extensive legislation in this area that require marketing authorization holders (MAHs) and medical institutions in Israel to report ADRs and new safety information to the MOH. A computerized database was created to support the reporting process. The objective of this article is to characterize the PV tools and activities implemented in Israel. Since September 2014, The Israeli Pharmacovigilance and Drug Information Department receives ICSRs at a central computerized database developed for this purpose. The data were analyzed by Department personnel and ICSRs were characterized according to their seriousness, source, categories of drugs involved, and the reporting format. Additionally, the Department reviewed signals detected from ADR reports and from other sources and assessed the resulting regulatory actions. An analysis of the Individual Case Safety Reports (ICSRs) submitted to the MOH's ADRs central database reveals that during the review period, a total of 16,409 ICSRs were received by the Department and 850 signals were identified, resulting in the following PV activities: inquiry and enhanced follow-up (430, 50.6%), prescriber's and patient's leaflets updates (204, 24%), recall of products/batches (6, 0.7%), alerts for health care professionals (63, 7.4%). Eighty five (10

Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database.

PubMed

Massoullié, Grégoire; Wintzer-Wehekind, Jérome; Chenaf, Chouki; Mulliez, Aurélien; Pereira, Bruno; Authier, Nicolas; Eschalier, Alain; Clerfond, Guillaume; Souteyrand, Géraud; Tabassome, Simon; Danchin, Nicolas; Citron, Bernard; Lusson, Jean-René; Puymirat, Étienne; Motreff, Pascal; Eschalier, Romain

2016-05-01

Multicentre registries of myocardial infarction management show a steady improvement in prognosis and greater access to myocardial revascularization in a more timely manner. While French registries are the standard references, the question arises: are data stemming solely from the activity of French cardiac intensive care units (ICUs) a true reflection of the entire French population with ST-segment elevation myocardial infarction (STEMI)? To compare data on patients hospitalized for STEMI from two French registries: the French registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) and the Échantillon généraliste des bénéficiaires (EGB) database. We compared patients treated for STEMI listed in the FAST-MI 2010 registry (n=1716) with those listed in the EGB database, which comprises a sample of 1/97th of the French population, also from 2010 (n=403). Compared with the FAST-MI 2010 registry, the EGB database population were older (67.2±15.3 vs 63.3±14.5 years; P<0.001), had a higher percentage of women (36.0% vs 24.7%; P<0.001), were less likely to undergo emergency coronary angiography (75.2% vs 96.3%; P<0.001) and were less often treated in university hospitals (27.1% vs 37.0%; P=0.001). There were no significant differences between the two registries in terms of cardiovascular risk factors, comorbidities and drug treatment at admission. Thirty-day mortality was higher in the EGB database (10.2% vs 4.4%; P<0.001). Registries such as FAST-MI are indispensable, not only for assessing epidemiological changes over time, but also for evaluating the prognostic effect of modern STEMI management. Meanwhile, exploitation of data from general databases, such as EGB, provides additional relevant information, as they include a broader population not routinely admitted to cardiac ICUs. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Active pharmacovigilance in China: recent development and future perspectives.

PubMed

Li, Xinling; Li, Haona; Deng, Jianxiong; Zhu, Feng; Liu, Ying; Chen, Wenge; Yue, Zhihua; Ren, Xuequn; Xia, Jielai

2018-04-10

The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has been paid to the importance of implementing such systems in China. However, less has been done to evaluate the state of implementation and future needs of such systems. This paper reviews China's recent approaches to active pharmacovigilance by examining: (1) information collected from scientific articles and the websites of the China Food and Drug Administration and the China National Center for Adverse Drug Reaction Monitoring, (2) information available on China's spontaneous reporting systems (SRS) and active pharmacovigilance system, and (3) annual reports and internal reports on this subject. Areas that improved most meaningfully for China's active pharmacovigilance in recent years appear to include: (1) quicker reporting and more intelligent scanning methods for adverse drug reactions (ADRs), (2) the use of pharmacovigilance approaches to mine electronic hospital records, and (3) the development of integrated systems including the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program. Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is

Training in Post-authorization Pharmacovigilance.

PubMed

Ahuja, Vivek; Sharma, Varun

2010-04-01

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.

Training in Post-authorization Pharmacovigilance

PubMed Central

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

EU's new pharmacovigilance legislation: considerations for biosimilars.

PubMed

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.

[Pharmacovigilance of vaccines].

PubMed

Autret-Leca, E; Bensouda-Grimaldi, L; Jonville-Béra, A P; Beau-Salinas, F

2006-02-01

Safety of vaccines must be excellent to make vaccine's strategy acceptable, since it usually has a deferred individual benefit but immediate adverse drug reactions (ADRs). Pharmacovigilance of vaccines after their marketing is crucial because, prior to its availability on the market, the size of clinical trials is insufficient to identify rare or deferred adverse effects. The Pharmacovigilance is based on "spontaneous reporting" of ADRs to the Pharmacovigilance Regional Centre (PVRC) which establishes a relationship between each drug taken by the patient and the ADRs occurrence (imputability). This method is crucial to generate alerts, but under-estimates the real frequency of ADRs (1 to 10% of severe ADRs are reported). Thus pharmacoepidemiology studies are necessary to confirm the alerts identified by spontaneous reporting. ADRs can be specific, related to the antigen of an attenuated alive virus vaccine (lymphocyte meningitis after anti-mumps vaccine) or non-specific, related to a component different from the antigen (aluminium hydroxide involved in the "macrophagic myofasciitis", allergic reactions to neomycin, latex, egg or gelatine). Importance of Pharmacovigilance of vaccines is illustrated. Data, especially case-control studies, about the relationship between multiple sclerosis and hepatitis B vaccine are summarised. Data about the relationship between Crohn's disease or autism and MMR vaccine are analysed. As vaccines are used in healthy people, their safety must be excellent to be accepted. To monitor them after their marketing is the unique way to detect rare ADRs. This surveillance is made through reporting of ADRs to the PVRC. However, an active and intensive surveillance of ADRs as the one set up from the marketing of Prevenar should be systematic.

Innovations for the future of pharmacovigilance.

PubMed

Almenoff, June S

2007-01-01

Post-marketing pharmacovigilance involves the review and management of safety information from many sources. Among these sources, spontaneous adverse event reporting systems are among the most challenging and resource-intensive to manage. Traditionally, efforts to monitor spontaneous adverse event reporting systems have focused on review of individual case reports. The science of pharmacovigilance could be enhanced with the availability of systems-based tools that facilitate analysis of aggregate data for purposes of signal detection, signal evaluation and knowledge management. GlaxoSmithKline (GSK) recently implemented Online Signal Management (OSM) as a data-driven framework for managing the pharmacovigilance of marketed products. This pioneering work builds upon the strong history GSK has of innovation in this area. OSM is a software application co-developed by GSK and Lincoln Technologies that integrates traditional pharmacovigilance methods with modern quantitative statistical methods and data visualisation tools. OSM enables the rapid identification of trends from the individual adverse event reports received by GSK. OSM also provides knowledge-management tools to ensure the successful tracking of emerging safety issues. GSK has developed standard procedures and 'best practices' around the use of OSM to ensure the systematic evaluation of complex safety datasets. In summary, the implementation of OSM provides new tools and efficient processes to advance the science of pharmacovigilance.

Pharmacovigilance in Space: Stability Payload Compliance Procedures

NASA Technical Reports Server (NTRS)

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.

Advancing Drug Safety Through Prospective Pharmacovigilance.

PubMed

Pitts, Peter J; Le Louet, Hervé

2018-01-01

Much has changed in a relatively short period of time. There is a raging debate over the level of evidence expected to first introduce a treatment to patients based on smaller, more adaptive data sets. Some argue for less data followed by postapproval follow-up, others for more adaptive clinical trial designs and end-point modification driven by patient-focused drug development and use of real-world evidence. The transition in both the review and postmarketing regulatory framework is happening in front of our eyes in real time. To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance must be a priority as the world's many regulatory systems build the capacity to harness electronic health information to improve health, care quality, and safety. Globally, the widely variable ability of nations to build reliable regulatory systems (from precise review to robust pharmacovigilance) is a dangerous source of health care inequality. Developing validated tools and techniques for "predictive pharmacovigilance" will assist all health systems in better understanding the risks and benefits of the medicines they regulate by understanding what should be happening once a new medicine moves from risk-benefit regulatory efficacy to real-world risk-effectiveness. This will be of particular utility for smaller regulatory agencies with fewer resources. By comparing preapproval predictive pharmacovigilance data, developing regulatory authorities will be able to better understand the potential gap between what was predicted and what was actually measured (via more traditional pharmacovigilance methodologies). Predictive pharmacovigilance recognizes the value of understanding the imperfect reporting of real-world clinical use and that the absence of reporting is, in itself, an important postmarketing signal.

Pharmacovigilance in pharmaceutical companies: An overview

PubMed Central

Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

2013-01-01

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs). PMID:24347978

Pharmacovigilance in pharmaceutical companies: An overview.

PubMed

Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

2013-12-01

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

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

PubMed

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.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

PubMed

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

Gathering and Exploring Scientific Knowledge in Pharmacovigilance

PubMed Central

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/. PMID:24349421

Updating the French archeomagnetic directional database for the past two millennia

NASA Astrophysics Data System (ADS)

Le Goff, M.; Warmé, N.; Gallet, Y.; Genevey, A.

2009-04-01

Research in archeomagnetism began in France during the 1930's with the pioneering work of Emile Thellier. Combining instrumental and methodological developments, together with the patient establishment of a collaboration with archeologists, Thellier's activity led to the construction of the first directional secular variation curve in France spanning the past two millennia. After Thellier's retirement, Ileana Bucur continued this work, enriching the French archeomagnetic database up to more than 200 directional data, among which 120 dated results were used to construct in 1994 a revised version of the French directional secular variation curve, which is still considered as a reference today. Since 1994, the acquisition of archeomagnetic directional data has been continuously pursued at IPGP and the present study aims to update the French archeomagnetic dataset for the past two millennia. We have sampled about 400 burned structures from more than sixty different archeological sites mostly located near Paris, in the Ile-de-France region. Domestic kilns here represent approximately 2/3 of those structures, which were found in ancient agricultural settlements generally dated to the High Middle Ages. More than one hundred structures were dated using archeological constraints, such as the typo-morphology of ceramics, coins or archives, with enough precision and accuracy to be considered for improving the French reference directional secular variation curve over the past two millennia. We will discuss the present status of the French archeomagnetic directional database, which thus contains more than 600 data, 90% of which are defined with an a95 of less than 2°. We will also illustrate its increasingly potential as a dating tool for archeological purposes.

Pharmacovigilance and post-black market surveillance.

PubMed

Langlitz, Nicolas

2009-06-01

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

Pharmacovigilance in China: current situation, successes and challenges.

PubMed

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.

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

PubMed

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.

The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.

PubMed

Moore, Nicholas

2013-05-01

Over the years since 1961 and the identification of thalidomide as the common link in thousands of birth defects, daily pharmacovigilance activities and signal generation have evolved from the analysis of individual case reports and imputology, to case series and underreporting, to spontaneous report databases and disproportionality analyses, to data mining in population databases. Regulatory requirements have also changed from purely passive monitoring and reacting to alerts to a proactive approach that includes risk management plans and risk minimization, and from reporting only by healthcare professionals to patient reporting and exploration of social media. The emphasis only on risk assessment is changing towards assessment of the risk/benefit ratio and the exploration of real-life efficacy studies to complement the measure of real-life risk. The interactions between industry and regulators have been amplified and strengthened. However, most adverse reactions, including severe ones, are related to well-known and often pharmacological effects of the older drugs, possibly with genetic predispositions. Prevention is the next frontier for pharmacovigilance, beyond simply generating alerts, and it involves not only the removal of drugs from the market, but also promotion of proper drug prescribing by better trained physicians and the proper use of drugs by better informed patients.

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

PubMed

Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2012-09-01

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. 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. 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). 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.

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

PubMed Central

Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2012-01-01

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. PMID:23826016

Nationwide incidence of motor neuron disease using the French health insurance information system database.

PubMed

Kab, Sofiane; Moisan, Frédéric; Preux, Pierre-Marie; Marin, Benoît; Elbaz, Alexis

2017-08-01

There are no estimates of the nationwide incidence of motor neuron disease (MND) in France. We used the French health insurance information system to identify incident MND cases (2012-2014), and compared incidence figures to those from three external sources. We identified incident MND cases (2012-2014) based on three data sources (riluzole claims, hospitalisation records, long-term chronic disease benefits), and computed MND incidence by age, gender, and geographic region. We used French mortality statistics, Limousin ALS registry data, and previous European studies based on administrative databases to perform external comparisons. We identified 6553 MND incident cases. After standardisation to the United States 2010 population, the age/gender-standardised incidence was 2.72/100,000 person-years (males, 3.37; females, 2.17; male:female ratio = 1.53, 95% CI1.46-1.61). There was no major spatial difference in MND distribution. Our data were in agreement with the French death database (standardised mortality ratio = 1.01, 95% CI = 0.96-1.06) and Limousin ALS registry (standardised incidence ratio = 0.92, 95% CI = 0.72-1.15). Incidence estimates were in the same range as those from previous studies. We report French nationwide incidence estimates of MND. Administrative databases including hospital discharge data and riluzole claims offer an interesting approach to identify large population-based samples of patients with MND for epidemiologic studies and surveillance.

First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals.

PubMed

Durrieu, Geneviève; Palmaro, Aurore; Pourcel, Laure; Caillet, Céline; Faucher, Angeline; Jacquet, Alexis; Ouaret, Shéhérazade; Perault-Pochat, Marie Christine; Kreft-Jais, Carmen; Castot, Anne; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

2012-10-01

Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients' reports with reports from healthcare professionals (HCPs). During the 2009-10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations. For the first time, patients were offered the opportunity to report suspected ADRs to pandemic vaccines directly to regional pharmacovigilance centres. The aim of the study was to compare the characteristics of patient and HCP ADR reports in order to assess the qualitative and quantitative contribution of patient reporting to the French Pharmacovigilance System. All spontaneous ADRs registered into the French Pharmacovigilance Database from 21 October 2009 to 15 June 2010, in which either one of the most frequently administered pandemic vaccines (i.e. Panenza® or Pandemrix®) was involved, were analysed. ADRs were classified as 'serious', 'medically serious' and 'non-serious'. This study focused on 'serious' and 'medically serious' ADRs. An ADR was ranked as 'medically serious' when it required medical intervention or hospitalization within less than 24 hours. In each level of seriousness, frequency of 'unlabelled' ADRs, ADRs of 'special interest', imputability scores and category of ADRs according to Medical Dictionary for Regulatory Activitives (MedDRA®) primary System Organ Class were compared between patient and professional reports. Among the 4746 reports received during the study period, 1006 (21.2%) originated from patients. HCPs reported significantly more 'medically serious' or 'serious' ADRs than patients (15.1% [565/3740] vs 8.4% [85/1006], respectively; p < 0.001). No difference was found in 'unlabelled, serious' ADRs between patients and HCPs (56.5% [n = 13] vs 56.7% [n = 136], respectively). In this first French experience

Adapting and applying common methods used in pharmacovigilance to the environment: A possible starting point for the implementation  of eco-pharmacovigilance.

PubMed

Wang, Jun; Zhang, Mengya; Li, Shulan; He, Bingshu

2018-07-01

Now, the occurrence of pharmaceuticals in natural environment has been frequently reported around the world. As a kind of biologically active compounds specially designed to be effective even at very low concentration levels, pharmaceuticals in the environment could have adverse impacts to the health of human beings or other non-targeted organisms due to long-term exposures. To minimize the pharmaceutical pollution from the perspective of drug administration, a new concept called as eco-pharmacovigilance (EPV) has been proposed as a kind of pharmacovigilance(PV) for the environment. However, as a new and comprehensive science, EPV has not sophisticated methods in practice and formalized implementation model up to now. Since EPV is a special kind of PV, it could be feasible to draw on the experience of PV as a possible and reasonable starting point for EPV. In this paper, we discussed the common methods and activities used in PV including spontaneous reporting, intensive monitoring, database studies, and their potential applicability to the environment. And we concluded that these common methods in PV could be adapted and applied to EPV. But there is still the need for organizational, technical and financial supports of the EPV system. Copyright © 2018 Elsevier B.V. All rights reserved.

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

PubMed

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

European Union pharmacovigilance capabilities: potential for the new legislation

PubMed Central

Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

2015-01-01

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. PMID:26301067

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

PubMed

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.

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

PubMed

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.

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

PubMed

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.

Multinomial modeling and an evaluation of common data-mining algorithms for identifying signals of disproportionate reporting in pharmacovigilance databases.

PubMed

Johnson, Kjell; Guo, Cen; Gosink, Mark; Wang, Vicky; Hauben, Manfred

2012-12-01

A principal objective of pharmacovigilance is to detect adverse drug reactions that are unknown or novel in terms of their clinical severity or frequency. One method is through inspection of spontaneous reporting system databases, which consist of millions of reports of patients experiencing adverse effects while taking one or more drugs. For such large databases, there is an increasing need for quantitative and automated screening tools to assist drug safety professionals in identifying drug-event combinations (DECs) worthy of further investigation. Existing algorithms can effectively identify problematic DECs when the frequencies are high. However these algorithms perform differently for low-frequency DECs. In this work, we provide a method based on the multinomial distribution that identifies signals of disproportionate reporting, especially for low-frequency combinations. In addition, we comprehensively compare the performance of commonly used algorithms with the new approach. Simulation results demonstrate the advantages of the proposed method, and analysis of the Adverse Event Reporting System data shows that the proposed method can help detect interesting signals. Furthermore, we suggest that these methods be used to identify DECs that occur significantly less frequently than expected, thus identifying potential alternative indications for these drugs. We provide an empirical example that demonstrates the importance of exploring underexpected DECs. Code to implement the proposed method is available in R on request from the corresponding authors. kjell@arboranalytics.com or Mark.M.Gosink@Pfizer.com Supplementary data are available at Bioinformatics online.

Evaluation of algorithms to identify incident cancer cases by using French health administrative databases.

PubMed

Ajrouche, Aya; Estellat, Candice; De Rycke, Yann; Tubach, Florence

2017-08-01

Administrative databases are increasingly being used in cancer observational studies. Identifying incident cancer in these databases is crucial. This study aimed to develop algorithms to estimate cancer incidence by using health administrative databases and to examine the accuracy of the algorithms in terms of national cancer incidence rates estimated from registries. We identified a cohort of 463 033 participants on 1 January 2012 in the Echantillon Généraliste des Bénéficiaires (EGB; a representative sample of the French healthcare insurance system). The EGB contains data on long-term chronic disease (LTD) status, reimbursed outpatient treatments and procedures, and hospitalizations (including discharge diagnoses, and costly medical procedures and drugs). After excluding cases of prevalent cancer, we applied 15 algorithms to estimate the cancer incidence rates separately for men and women in 2012 and compared them to the national cancer incidence rates estimated from French registries by indirect age and sex standardization. The most accurate algorithm for men combined information from LTD status, outpatient anticancer drugs, radiotherapy sessions and primary or related discharge diagnosis of cancer, although it underestimated the cancer incidence (standardized incidence ratio (SIR) 0.85 [0.80-0.90]). For women, the best algorithm used the same definition of the algorithm for men but restricted hospital discharge to only primary or related diagnosis with an additional inpatient procedure or drug reimbursement related to cancer and gave comparable estimates to those from registries (SIR 1.00 [0.94-1.06]). The algorithms proposed could be used for cancer incidence monitoring and for future etiological cancer studies involving French healthcare databases. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Off-Label Baclofen Prescribing Practices among French Alcohol Specialists: Results of a National Online Survey

PubMed Central

Rolland, Benjamin; Paille, François; Fleury, Benoit; Cottencin, Olivier; Benyamina, Amine; Aubin, Henri-Jean

2014-01-01

Objective To evaluate, among alcohol specialists belonging to the Société Française d’Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices. Methods On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician’s prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB’s efficacy and safety. Results In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5±43.6 mg/d; maximum dose 188±93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation. Conclusion A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices

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

PubMed

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.

Pharmacy students' knowledge and perceptions about pharmacovigilance in Malaysian public universities.

PubMed

Elkalmi, Ramadan Mohamed; Hassali, Mohamed Azmi; Ibrahim, Mohamed Izham M; Widodo, Riyanto T; Efan, Qais M A; Hadi, Muhammad Abdul

2011-06-10

To assess senior pharmacy students' knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia. A cross-sectional study was conducted between December 1, 2010, and January 31, 2010, using a validated self-administered questionnaire delivered to a sample of 510 final-year (fourth-year) pharmacy students at 5 Malaysian public universities. Four hundred twenty-one (84%) students responded to the survey. About 60% (n = 240) indicated that they had taken courses on the concept of pharmacovigilance during their current pharmacy curriculum. The mean score for knowledge about pharmacovigilance and ADR reporting was 6.9 ± 1.4. There was a significant difference in the mean scores for knowledge about pharmacovigilance across the 5 universities. The majority (82.3%) of respondents felt it was necessary to confirm the causal relationship between the drug and the ADR. About 57.8% (n = 241) of the respondents believed that pharmacy students are competent and capable of reporting ADRs during their clerkships. The majority (87.0%) of respondents perceived that pharmacy students should be taught how to report ADRs. The results of this study demonstrate that the majority of final-year pharmacy students in Malaysian public universities have insufficient knowledge about pharmacovigilance and ADR reporting.

Biosimilars: pharmacovigilance and risk management.

PubMed

Zuñiga, Leyre; Calvo, Begoña

2010-07-01

Biosimilars cannot be authorized based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorization clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk-benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit-risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialized with a brand name or the INN plus the manufacturer's name. (c) 2010 John Wiley & Sons, Ltd.

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.

PubMed

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.

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

PubMed

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.

Pharmacy Students’ Knowledge and Perceptions About Pharmacovigilance in Malaysian Public Universities

PubMed Central

Elkalmi, Ramadan Mohamed; Hassali, Mohamed Azmi; Ibrahim, Mohamed Izham M.; Widodo, Riyanto T.; Efan, Qais M. A.; Hadi, Muhammad Abdul

2011-01-01

Objective. To assess senior pharmacy students’ knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia Methods. A cross-sectional study was conducted between December 1, 2010, and January 31, 2010, using a validated self-administered questionnaire delivered to a sample of 510 final-year (fourth-year) pharmacy students at 5 Malaysian public universities. Results. Four hundred twenty-one (84%) students responded to the survey. About 60% (n = 240) indicated that they had taken courses on the concept of pharmacovigilance during their current pharmacy curriculum. The mean score for knowledge about pharmacovigilance and ADR reporting was 6.9 ± 1.4. There was a significant difference in the mean scores for knowledge about pharmacovigilance across the 5 universities. The majority (82.3%) of respondents felt it was necessary to confirm the causal relationship between the drug and the ADR. About 57.8% (n = 241) of the respondents believed that pharmacy students are competent and capable of reporting ADRs during their clerkships. The majority (87.0%) of respondents perceived that pharmacy students should be taught how to report ADRs. Conclusion. The results of this study demonstrate that the majority of final-year pharmacy students in Malaysian public universities have insufficient knowledge about pharmacovigilance and ADR reporting. PMID:21829270

A global view of undergraduate education in pharmacovigilance.

PubMed

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

2017-07-01

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. A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants. The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula. This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.

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

PubMed

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

Mechanism-based Pharmacovigilance over the Life Sciences Linked Open Data Cloud.

PubMed

Kamdar, Maulik R; Musen, Mark A

2017-01-01

Adverse drug reactions (ADR) result in significant morbidity and mortality in patients, and a substantial proportion of these ADRs are caused by drug-drug interactions (DDIs). Pharmacovigilance methods are used to detect unanticipated DDIs and ADRs by mining Spontaneous Reporting Systems, such as the US FDA Adverse Event Reporting System (FAERS). However, these methods do not provide mechanistic explanations for the discovered drug-ADR associations in a systematic manner. In this paper, we present a systems pharmacology-based approach to perform mechanism-based pharmacovigilance. We integrate data and knowledge from four different sources using Semantic Web Technologies and Linked Data principles to generate a systems network. We present a network-based Apriori algorithm for association mining in FAERS reports. We evaluate our method against existing pharmacovigilance methods for three different validation sets. Our method has AUROC statistics of 0.7-0.8, similar to current methods, and event-specific thresholds generate AUROC statistics greater than 0.75 for certain ADRs. Finally, we discuss the benefits of using Semantic Web technologies to attain the objectives for mechanism-based pharmacovigilance.

Opportunities for Collaboration at the Interface of Pharmacovigilance and Manufacturing.

PubMed

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.

What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?

PubMed

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.

Use of Epinephrine in Patients with Drug-Induced Anaphylaxis: An Analysis of the Beijing Pharmacovigilance Database

PubMed Central

Wang, Tiansheng; Ma, Xiang; Xing, Yan; Sun, Shusen; Zhang, Hua; Stürmer, Til; Wang, Bin; Li, Xiaotong; Tang, Huilin; Jiao, Ligong; Zhai, Suodi

2017-01-01

Background Few studies assessing the use of epinephrine in drug-induced anaphylaxis (DIA) in the hospital setting are available. We utilized the Beijing Pharmacovigilance Database (BPD) to evaluate the appropriateness of epinephrine for DIA management. Methods DIA cases collected in the BPD from January 2004 to December 2014 were adjudicated and analyzed for demographics, causative drugs, clinical signs, outcomes, initial treatment, route, dosing, and cardiovascular adverse events (CAE) of epinephrine. Results DIA was primarily caused by antibiotics (38.4%), radiocontrast agents (11.9%), traditional Chinese medicine injections (10.9%), and chemotherapeutic drugs (10.3%). Only 708 (59.5%) patients received epinephrine treatment. Patients who received epinephrine were more likely to experience wheezing (p < 0.001) and respiratory arrest (p < 0.001). Among 518 patients with a complete record of the epinephrine administration route, the percentage of patients receiving it by intramuscular (IM) injection, subcutaneous (SC) injection, intravenous (IV) bolus injection, or IV continuous infusion was 16.9, 31.5, 43.5, and 8.1%, respectively. Among the 427 patients with a record of both the administration route and the dosing, an overdose was more likely with IV bolus (94.1%) in contrast to IM injection (56.6%; p < 0.001) or SC injection (43.7%; p < 0.001). Among the patients analyzed for CAE (n = 349), 17 patients accounted for 19 CAE, and 13 (76.5%) of these patients were overdosed with epinephrine. Conclusion Underuse, inappropriate IV bolus use, and overdosing were the 3 major problems with epinephrine use in DIA in China. Educational training for health care professionals on the appropriate use of epinephrine in managing anaphylactic reactions is suggested. PMID:28505618

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

PubMed

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.

Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance

PubMed Central

Hauben, Manfred; Hung, Eric Y.

2016-01-01

Introduction: There is an interest in methodologies to expeditiously detect credible signals of drug-induced pancreatitis. An example is the reported signal of pancreatitis with rasburicase emerging from a study [the ‘index publication’ (IP)] combining quantitative signal detection findings from a spontaneous reporting system (SRS) and electronic health records (EHRs). The signal was reportedly supported by a clinical review with a case series manuscript in progress. The reported signal is noteworthy, being initially classified as a false-positive finding for the chosen reference standard, but reclassified as a ‘clinically supported’ signal. Objective: This paper has dual objectives: to revisit the signal of rasburicase and acute pancreatitis and extend the original analysis via reexamination of its findings, in light of more contemporary data; and to motivate discussions on key issues in signal detection and evaluation, including recent findings from a major international pharmacovigilance research initiative. Methodology: We used the same methodology as the IP, including the same disproportionality analysis software/dataset for calculating observed to expected reporting frequencies (O/Es), Medical Dictionary for Regulatory Activities Preferred Term, and O/E metric/threshold combination defining a signal of disproportionate reporting. Baseline analysis results prompted supplementary analyses using alternative analytical choices. We performed a comprehensive literature search to identify additional published case reports of rasburicase and pancreatitis. Results: We could not replicate positive findings (e.g. a signal or statistic of disproportionate reporting) from the SRS data using the same algorithm, software, dataset and vendor specified in the IP. The reporting association was statistically highlighted in default and supplemental analysis when more sensitive forms of disproportionality analysis were used. Two of three reports in the FAERS database were

French database of children and adolescents with Prader-Willi syndrome

PubMed Central

Molinas, Catherine; Cazals, Laurent; Diene, Gwenaelle; Glattard, Melanie; Arnaud, Catherine; Tauber, Maithe

2008-01-01

Background Prader-Willi syndrome (PWS) is a rare multisystem genetic disease leading to severe complications mainly related to obesity. We strongly lack information on the natural history of this complex disease and on what factors are involved in its evolution and its outcome. One of the objectives of the French reference centre for Prader-Willi syndrome set-up in 2004 was to set-up a database in order to make the inventory of Prader-Willi syndrome cases and initiate a national cohort study in the area covered by the centre. Description the database includes medical data of children and adolescents with Prader-Willi syndrome, details about their management, socio-demographic data on their families, psychological data and quality of life of the parents. The tools and organisation used to ensure data collection and data quality in respect of good clinical practice procedures are discussed, and main characteristics of our Prader-Willi population at inclusion are presented. Conclusion this database covering all the aspects of PWS clinical, psychological and social profiles, including familial psychological and quality of life will be a powerful tool for retrospective studies concerning this complex and multi factorial disease and could be a basis for the design of future prospective multicentric studies. The complete database and the Stata.do files are available to any researcher wishing to use them for non-commercial purposes and can be provided upon request to the corresponding author. PMID:18831731

Application of the British Food Standards Agency nutrient profiling system in a French food composition database.

PubMed

Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Méjean, Caroline; Fezeu, Léopold; Hercberg, Serge

2014-11-28

Nutrient profiling systems are powerful tools for public health initiatives, as they aim at categorising foods according to their nutritional quality. The British Food Standards Agency (FSA) nutrient profiling system (FSA score) has been validated in a British food database, but the application of the model in other contexts has not yet been evaluated. The objective of the present study was to assess the application of the British FSA score in a French food composition database. Foods from the French NutriNet-Santé study food composition table were categorised according to their FSA score using the Office of Communication (OfCom) cut-off value ('healthier' ≤ 4 for foods and ≤ 1 for beverages; 'less healthy' >4 for foods and >1 for beverages) and distribution cut-offs (quintiles for foods, quartiles for beverages). Foods were also categorised according to the food groups used for the French Programme National Nutrition Santé (PNNS) recommendations. Foods were weighted according to their relative consumption in a sample drawn from the NutriNet-Santé study (n 4225), representative of the French population. Classification of foods according to the OfCom cut-offs was consistent with food groups described in the PNNS: 97·8 % of fruit and vegetables, 90·4 % of cereals and potatoes and only 3·8 % of sugary snacks were considered as 'healthier'. Moreover, variability in the FSA score allowed for a discrimination between subcategories in the same food group, confirming the possibility of using the FSA score as a multiple category system, for example as a basis for front-of-pack nutrition labelling. Application of the FSA score in the French context would adequately complement current public health recommendations.

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.

PubMed

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 <0.2 was identified for six out of the ten most frequent 'serious' ADRs, and eight of the ten 'non-serious' ADRs. A proactive regional 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.

The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, south west Nigeria.

PubMed

Oreagba, I A; Ogunleye, O J; Olayemi, S O

2011-01-01

Community Pharmacists both have an important responsibility in monitoring the ongoing safety of medicines and are widely accessible to do it. This study aims to investigate the knowledge, perceptions and practice of Pharmacovigilance amongst community pharmacists in Lagos State, South West Nigeria A cross-sectional observational survey was used in this study. A multistage random sampling technique was employed in the selection of 420 community pharmacies in Lagos. About 55% of respondents have ever heard of the word 'Pharmacovigilance' out of which less than half (representing only 18% of all respondents) could define the term 'Pharmacovigilance'. Forty percent of the respondents stated that patients reported ADRs to them at least once a month, and 20% reported to the relevant authorities. However only 3% of respondents actually reported an ADR to the National Pharmacovigilance Centre. The most important reason for poor reporting was lack of knowledge about how to report ADRs (44.6%).Meanwhile, 90% of respondents believed that the role of the pharmacists in ADR reporting was important. Most community pharmacists were willing to practice pharmacovigilance if they were trained. Community pharmacists in Lagos had poor knowledge about pharmacovigilance. Reporting rate was also poor. There is an urgent need for educational programs to train pharmacists about pharmacovigilance and ADR reporting. Copyright © 2010 John Wiley & Sons, Ltd.

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

PubMed

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

Mining pharmacovigilance data using Bayesian logistic regression with James-Stein type shrinkage estimation.

PubMed

An, Lihua; Fung, Karen Y; Krewski, Daniel

2010-09-01

Spontaneous adverse event reporting systems are widely used to identify adverse reactions to drugs following their introduction into the marketplace. In this article, a James-Stein type shrinkage estimation strategy was developed in a Bayesian logistic regression model to analyze pharmacovigilance data. This method is effective in detecting signals as it combines information and borrows strength across medically related adverse events. Computer simulation demonstrated that the shrinkage estimator is uniformly better than the maximum likelihood estimator in terms of mean squared error. This method was used to investigate the possible association of a series of diabetic drugs and the risk of cardiovascular events using data from the Canada Vigilance Online Database.

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

PubMed

Dinnett, Eleanor M; Kean, Sharon; Tolmie, Elizabeth P; Ronald, Elizabeth S; Gaw, Allan

2013-06-12

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.

Renin angiotensin system blockers-associated angioedema in the Thai population: analysis from Thai National Pharmacovigilance Database.

PubMed

Win, Thet Su Zin; Chaiyakunapruk, Nathorn; Suwankesawong, Wimon; Dilokthornsakul, Piyameth; Nathisuwan, Surakit

2015-09-01

Renin-angiotensin-aldosterone system (RAS) blockers are commonly used for cardiovascular diseases. Currently, little information exists for the Asian population on angioedema, a rare yet serious adverse event. This study aimed to describe characteristics of RAS blockers-associated angioedema (RASBA) in Thai patients. A retrospective study using the national pharmacovigilance database of Thailand was undertaken. Cases indicating the presence of angioedema with RAS blockers uses from 1984-2011 were identified. Patient demographics, co-morbidities, concomitant drugs, information for the RAS blockers and angioedema were obtained as well as causality assessment and quality of reports. A total of 895 cases were identified. Mean age was 59.9+12.8 years and 66.5% being female. Most angioedema events (48.6%) occurred during the first week of treatment. Angiotensin converting enzyme inhibitors (87.7%) were the most commonly implicated agents followed by angiotensin receptor blockers (10.5%), aldosterone antagonist (2.1%) and direct renin inhibitor (0.2%). Out of the 895 cases incorporated in this study, 165 (18.4%) were classified as serious events and resulted in hospitalization. The overall case fatality rate was 0.4%. Respiratory disturbance occurred in 46 cases (5.1%). Patients with respiratory complications tended to be younger (53.4+13.9 vs 60.3+12.7 years old; p=0.002) and with higher frequency of allergy history (26.1% vs 14.7%; p=0.032) compared to those without respiratory complications. Based on multivariate logistic regression, the adjusted OR for history of allergy was 2.23 (95%CI: 1.04 - 4.78, p = 0.041). RASBA in Thai population occurred mostly in elderly female patients and often led to hospitalization. Since large number of patients is regularly exposed to RAS-blockers, a nationwide attempt to raise awareness of clinicians when prescribing RAS-blockers is prudent.

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

PubMed

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

The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul.

PubMed

Toklu, Hale Zerrin; Uysal, Meral Keyer

2008-10-01

We investigated the knowledge and attitudes of community pharmacists towards pharmacovigilance and adverse drug reactions (ADRs) in Kadiköy district of Istanbul (Turkey). The community pharmacies in Kadikoy. Kadikoy is one of the biggest districts of Istanbul and has the largest number of pharmacies. Kadikoy district was divided into two regions, the central and the peripheral. Between December 2005 and June 2006 we conducted a survey about the knowledge and attitude of community pharmacists (n = 219) using a face-to-face questionnaire. The questionnaire consisted of questions about the sociodemographic characteristics of the pharmacists, their knowledge of pharmacovigilance and their attitudes towards ADR reporting. The knowledge of pharmacovigilance practice, ADR reporting compliance rates, reasons for not reporting ADR and perceptions of the Turkish community pharmacists on pharmacovigilance practice were evaluated. Although all 411 pharmacies in the Kadikoy district were visited, only 53% of the community pharmacists (n = 219) consented to participate in the study. Of those that did respond, only 17.2% of the pharmacists had any knowledge about 'pharmacovigilance'. Sixty-five percent of the pharmacists stated that patients reported an ADR to them during the previous 12 months, and 21% of pharmacists reported to the concerned organizations. Our survey showed that only 7% actually reported an ADR to the national pharmacovigilance center. On the other hand, 89% of the pharmacists believed that the role of the pharmacist in ADR reporting was essential. The results show that Turkish community pharmacists have poor knowledge about pharmacovigilance. There is an urgent need for educational programs to train them about pharmacovigilance and ADR reporting.

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.

PubMed

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, p<0.01). Number of drugs and literature search (>50% 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.

Description and analysis of genetic variants in French hereditary breast and ovarian cancer families recorded in the UMD-BRCA1/BRCA2 databases.

PubMed

Caputo, Sandrine; Benboudjema, Louisa; Sinilnikova, Olga; Rouleau, Etienne; Béroud, Christophe; Lidereau, Rosette

2012-01-01

BRCA1 and BRCA2 are the two main genes responsible for predisposition to breast and ovarian cancers, as a result of protein-inactivating monoallelic mutations. It remains to be established whether many of the variants identified in these two genes, so-called unclassified/unknown variants (UVs), contribute to the disease phenotype or are simply neutral variants (or polymorphisms). Given the clinical importance of establishing their status, a nationwide effort to annotate these UVs was launched by laboratories belonging to the French GGC consortium (Groupe Génétique et Cancer), leading to the creation of the UMD-BRCA1/BRCA2 databases (http://www.umd.be/BRCA1/ and http://www.umd.be/BRCA2/). These databases have been endorsed by the French National Cancer Institute (INCa) and are designed to collect all variants detected in France, whether causal, neutral or UV. They differ from other BRCA databases in that they contain co-occurrence data for all variants. Using these data, the GGC French consortium has been able to classify certain UVs also contained in other databases. In this article, we report some novel UVs not contained in the BIC database and explore their impact in cancer predisposition based on a structural approach.

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

PubMed

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.

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

PubMed

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

Suspected adverse drug reaction reports with oral anticoagulants in Portugal: a pharmacovigilance study.

PubMed

Caldeira, Daniel; Rodrigues, Raquel; Abreu, Daisy; Anes, Ana Marta; Rosa, Mário M; Ferreira, Joaquim J

2018-04-01

In this pharmacovigilance study, we aimed to determine the incidence of spontaneously reported suspected adverse drug reactions (ADRs) related to oral anticoagulants: non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, rivaroxaban) and vitamin K antagonists (VKA) Research design and methods: In this retrospective observational study, we extracted all the individual case safety reports related to oral anticoagulants recorded in the Portuguese Pharmacovigilance Database (January 2010 to April 2015). The annual incidence of suspected ADRs was estimated using drug exposure data. Disproportionality of reporting ADR was addressed through reporting odds ratio (ROR) and 99% confidence intervals. We appraised 794 suspected ADR (78% related to NOACs). The annual number of ADRs increased overtime with 9 ADRs/million Defined Daily Dose (DDD) at the end of 2014. The incidence of NOACs ADRs decreased from 2012 onwards. VKA showed a disproportion in 'Investigation' (ROR 0.10, 99%CI 0.05-0.22) and 'Injury, poisoning and procedural complications' (ROR 0.36, 99%CI 0.19-0.69) ADRs compared with NOACs. NOACs had a higher significant disproportion of 'Nervous system disorders' related ADRs (ROR 3.98, 99%CI 1.50-10.53). Reporting of ADRs associated with oral anticoagulants (mainly NOACs), is increasing. Exploratory disproportion analyses showed an increase of reports of nervous system ADRs with NOACs, and INR-related ADRs with VKA.

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

PubMed

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.

Pharmacovigilance and principle of nonmaleficence in sex reassignment.

PubMed

Zamarytė, Kristina; Stakišaitis, Donatas; Širinskienė, Agnė; Narbekovas, Andrius; Juškevičius, Jonas

2012-01-01

Physicians are obliged to provide treatment that is consistent with their commitment to avoid or minimize harm (nonmaleficence) and their commitment to do good (beneficence). Therefore, if patient's desires were contradictory to the primary aim of medicine, the doctor's calling would require him/her to thoroughly analyze the cause of the disease and provide an adequate as well as ethical treatment rather than obediently follow patient's requests. Yet, chemical and surgical sex reassignment is one of the areas where some physicians surrender to the desire of their patients instead of finding out what their real condition is and trying to manage it in a way the essence of medicine would require. The objective of this article was to provide specific pharmacovigilance search details for the evaluation of the current situation and the scientific background of the treatment of gender dysphoria and to analyze its conformity with one of the two main ethical principles of medicine - nonmaleficence. Literature retrieval was accessed through Medline (1979-2011) using the terms "gender dysphoria," "replacement hormonal therapy," and "pharmacovigilance." The article concludes that hormonal and surgical interventions have not proven to be medically justified and could be harmful, not treating the cause, but resulting in irreversible disability. Thus, these interventions contradict the principle of nonmaleficence and goals of basic therapeutics and pharmacovigilance. They are not based on clinical trials and are lacking a thorough follow-up assessment.

A methodology to compile food metrics related to diet sustainability into a single food database: Application to the French case.

PubMed

Gazan, Rozenn; Barré, Tangui; Perignon, Marlène; Maillot, Matthieu; Darmon, Nicole; Vieux, Florent

2018-01-01

The holistic approach required to assess diet sustainability is hindered by lack of comprehensive databases compiling relevant food metrics. Those metrics are generally scattered in different data sources with various levels of aggregation hampering their matching. The objective was to develop a general methodology to compile food metrics describing diet sustainability dimensions into a single database and to apply it to the French context. Each step of the methodology is detailed: indicators and food metrics identification and selection, food list definition, food matching and values assignment. For the French case, nutrient and contaminant content, bioavailability factors, distribution of dietary intakes, portion sizes, food prices, greenhouse gas emission, acidification and marine eutrophication estimates were allocated to 212 commonly consumed generic foods. This generic database compiling 279 metrics will allow the simultaneous evaluation of the four dimensions of diet sustainability, namely health, economic, social and environmental, dimensions. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

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.

Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies.

PubMed

Rodrigues, Eliana; Barnes, Joanne

2013-01-01

Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance

Hearing impairment associated with oral terbinafine use: a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™.

PubMed

Scholl, Joep H G; van Puijenbroek, Eugene P

2012-08-01

The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR) reporting and from Vigibase™, the ADR database of the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre. The objective of the current study was to identify whether the observed association between oral terbinafine use and hearing impairment, based on cases received by Lareb, constitutes a safety signal. Cases of hearing impairment in oral terbinafine users are described. In a case/non-case analysis, the strength of the association in Vigibase™ and the Lareb database was determined (date of analysis August 2011) by calculating the reporting odds ratios (RORs), adjusted for possible confounding by age, sex and ototoxic concomitant medication. For the purpose of this study, RORs were calculated for deafness, hypoacusis and the combination of both, defined as hearing impairment. In the Lareb database, six reports concerning individuals aged 31-82 years, who developed hearing impairment after starting oral terbinafine, were present. The use of oral terbinafine was disproportionally associated with hypoacusis in both the Lareb database (adjusted ROR 3.9; 95% CI 1.7, 9.0) and in Vigibase™ (adjusted ROR 1.7; 95% CI 1.0, 2.8). Deafness was not disproportionally present in either of the databases. Based on the described cases and the statistical analyses from both databases, a causal relationship between the use of oral terbinafine and hearing impairment is possible. The mechanism by which terbinafine could cause hearing impairment has not been elucidated yet. The pharmacological action of terbinafine is based on the inhibition of squalene epoxidase, an enzyme present in both fungal and human cells. This inhibition might result in a decrease in

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

PubMed Central

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

The importance of intra-hospital pharmacovigilance in the detection of medication errors

PubMed

Villegas, Francisco; Figueroa-Montero, David; Barbero-Becerra, Varenka; Juárez-Hernández, Eva; Uribe, Misael; Chávez-Tapia, Norberto; González-Chon, Octavio

2018-01-01

Hospitalized patients are susceptible to medication errors, which represent between the fourth and the sixth cause of death. The department of intra-hospital pharmacovigilance intervenes in the entire process of medication with the purpose to prevent, repair and assess damages. To analyze medication errors reported by Mexican Fundación Clínica Médica Sur pharmacovigilance system and their impact on patients. Prospective study carried out from 2012 to 2015, where medication prescriptions given to patients were recorded. Owing to heterogeneity, data were described as absolute numbers in a logarithmic scale. 292 932 prescriptions of 56 368 patients were analyzed, and 8.9% of medication errors were identified. The treating physician was responsible of 83.32% of medication errors, residents of 6.71% and interns of 0.09%. No error caused permanent damage or death. This is the pharmacovigilance study with the largest sample size reported. Copyright: © 2018 SecretarÍa de Salud.

Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database.

PubMed

Sandberg-Wollheim, Magnhild; Neudorfer, Orit; Grinspan, Augusto; Weinstock-Guttman, Bianca; Haas, Judith; Izquierdo, Guillermo; Riley, Claire; Ross, Amy Perrin; Baruch, Peleg; Drillman, Talya; Coyle, Patricia K

2018-01-01

Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile. The Teva Pharmaceutical Industries Ltd global pharmacovigilance database comprises data from more than 7000 pregnancies, during which women with MS were exposed to treatment with branded GA. We analyzed data from Teva's global pharmacovigilance database. Pregnancy outcomes for patients treated with branded GA were compared with reference rates of abnormal pregnancy outcomes reported in two large registries representing the general population. Pregnancies exposed to branded GA were not at higher risk for congenital anomalies than what is expected in the general population. These data provide evidence that branded GA exposure during pregnancy seems safe, without teratogenic effect.

Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database

PubMed Central

Sandberg-Wollheim, Magnhild; Grinspan, Augusto; Weinstock-Guttman, Bianca; Haas, Judith; Izquierdo, Guillermo; Riley, Claire; Ross, Amy Perrin; Baruch, Peleg; Drillman, Talya; Coyle, Patricia K.

2018-01-01

Abstract Background: Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile. The Teva Pharmaceutical Industries Ltd global pharmacovigilance database comprises data from more than 7000 pregnancies, during which women with MS were exposed to treatment with branded GA. Methods: We analyzed data from Teva's global pharmacovigilance database. Pregnancy outcomes for patients treated with branded GA were compared with reference rates of abnormal pregnancy outcomes reported in two large registries representing the general population. Results: Pregnancies exposed to branded GA were not at higher risk for congenital anomalies than what is expected in the general population. Conclusions: These data provide evidence that branded GA exposure during pregnancy seems safe, without teratogenic effect. PMID:29507538

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

PubMed Central

Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

2016-01-01

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

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

PubMed Central

Vural, Fisun; Ciftci, Seval; Vural, Birol

2015-01-01

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. PMID:28058321

Data mining for signals in spontaneous reporting databases: proceed with caution.

PubMed

Stephenson, Wendy P; Hauben, Manfred

2007-04-01

To provide commentary and points of caution to consider before incorporating data mining as a routine component of any Pharmacovigilance program, and to stimulate further research aimed at better defining the predictive value of these new tools as well as their incremental value as an adjunct to traditional methods of post-marketing surveillance. Commentary includes review of current data mining methodologies employed and their limitations, caveats to consider in the use of spontaneous reporting databases and caution against over-confidence in the results of data mining. Future research should focus on more clearly delineating the limitations of the various quantitative approaches as well as the incremental value that they bring to traditional methods of pharmacovigilance.

Pharmacovigilance in Crisis: Drug Safety at a Crossroads.

PubMed

Price, John

2018-05-01

Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers. The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine-learning to automate pharmacovigilance operations. These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

Good pharmacovigilance practices: technology enabled.

PubMed

Nelson, Robert C; Palsulich, Bruce; Gogolak, Victor

2002-01-01

The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports. Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of-the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value. In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.

Treatment performances of French constructed wetlands: results from a database collected over the last 30 years.

PubMed

Morvannou, A; Forquet, N; Michel, S; Troesch, S; Molle, P

2015-01-01

Approximately 3,500 constructed wetlands (CWs) provide raw wastewater treatment in France for small communities (<5,000 people equivalent). Built during the past 30 years, most consist of two vertical flow constructed wetlands (VFCWs) in series (stages). Many configurations exist, with systems associated with horizontal flow filters or waste stabilization ponds, vertical flow with recirculation, partially saturated systems, etc. A database analyzed 10 years earlier on the classical French system summarized the global performances data. This paper provides a similar analysis of performance data from 415 full-scale two-stage VFCWs from an improved database expanded by monitoring data available from Irstea and the French technical department. Trends presented in the first study are confirmed, exhibiting high chemical oxygen demand (COD), total suspended solids (TSS) and total Kjeldahl nitrogen (TKN) removal rates (87%, 93% and 84%, respectively). Typical concentrations at the second-stage outlet are 74 mgCOD L(-1), 17 mgTSS L(-1) and 11 mgTKN L(-1). Pollutant removal performances are summarized in relation to the loads applied at the first treatment stage. While COD and TSS removal rates remain stable over the range of applied loads, the spreading of TKN removal rates increases as applied loads increase.

Psychiatric disorders, acne and systemic retinoids: comparison of risks.

PubMed

Le Moigne, M; Bulteau, S; Grall-Bronnec, Marie; Gerardin, M; Fournier, Jean-Pascal; Jonville-Bera, A P; Jolliet, Pascale; Dreno, Brigitte; Victorri-Vigneau, C

2017-09-01

The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids. Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators. Each report was subjected to double-blind analysis by two psychiatric experts. A disproportionality analysis was performed, calculating the number of psychiatric ADRs divided by the total number of notifications for each drug of interest. Concerning acne systemic treatments: all 71 reports of severe psychiatric disorders involved isotretinoin, the highest proportion of mild/moderate psychiatric adverse events was reported with isotretinoin (14.1%). Among systemic retinoids, the highest proportion of severe and mild/moderate psychiatric events occurred with isotretinoin and alitretinoin. Our study raises the hypothesis that psychiatric disorders associated with isotretinoin are related to a class effect of retinoids, as a signal emerges for alitretinoin. Complementary studies are necessary to estimate the risk and further determine at-risk populations.

Reporting rates of yellow fever vaccine 17D or 17DD-associated serious adverse events in pharmacovigilance data bases: systematic review.

PubMed

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

2011-07-01

To assess the reporting rates of serious adverse events attributable to yellow fever vaccination with 17D and 17DD strains as reported in pharmacovigilance databases, and assess reasons for differences in reporting rates. We searched 9 electronic databases for peer reviewed and grey literature (government reports, conferences), in all languages. Reference lists of key studies were also reviewed to identify additional studies. We identified 2,415 abstracts, of which 472 were selected for full text review. We identified 15 pharmacovigilance databases which reported adverse events attributed to yellow fever vaccination, of which 10 contributed data to this review with about 107,600,000 patients (allowing for overlapping time periods for the studies of the US VAERS database), and the data are very heavily weighted (94%) by the Brazilian database. The estimates of serious adverse events form three groups. 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 provide an estimate of 3.6/cases per million YEL-AND in one analysis and 7.8 in another, and 3.1 YEL-AVD in one analysis and 3.9 in another. The estimates for the UK used only the inclusive term of "serious adverse events" not further classified into YEL-And or YEL-AND and reported 34 "serious adverse events." The Swiss database used the term "serious adverse events" and reported 7 such events (including 4 "neurologic reactions") for a reporting rate of 25 "serious adverse events"/million doses. Reporting rates for serious adverse events following yellow fever vaccination are low. Differences in reporting rates may be due to differences in definitions, surveillance system organisation, methods of reporting cases

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

PubMed

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.

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

PubMed

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.

Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

PubMed

Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

2015-04-01

Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

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

PubMed

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.

[Summarizing of medicinal alerts in Ivory Coast from 2001 till 2010].

PubMed

N'Guessan-Irié, Amenan Geneviève; Yavo, Jean-Claude; Guillaume Amari, Antoine Serge; Yapi, Ange Désiré

2012-01-01

STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory. The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010. It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections. These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance. © 2012 Société Française de Pharmacologie et de Thérapeutique.

Knowledge and Perception about Pharmacovigilance among Pharmacy Students of Universities in Sana'a Yemen.

PubMed

Othman, Gamil Qasem; Ibrahim, Mohamed Izham Mohamed; Alshakka, Mohammed; Ansari, Mukhtar; Al-Qadasi, Farouk; Halboup, Abdulsalam M

2017-06-01

Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana'a Yemen. A cross-sectional study design was conducted among 385 final year pharmacy students. One public and four private universities were selected randomly using a validated self-administered questionnaire. The questionnaire contained data about student demographic data, knowledge and perception about the ADRs. The data was analysed by SPSS program and Chi-square tests were used to assess the significance of association. The male students were more knowledgeable than female (p=0.035), as well as private university students had better ideas on how to report ADRs than public university students (p=0.009). Private university students reported that pharmacovigilance topic is well covered in their curriculum compared to public university students (p≤0.001). A significant difference was seen amongst the students of public and private universities when asked about reporting ADRs in future, former found more confident (p≤0.001). Furthermore, the private university students also had more command on the concept of post-marketing surveillance than public university students (p≤0.001). The private university students in Yemen were more known to causality assessment of ADRs as compared to the students of public universities (p≤0.001). The results of perception revealed regarding perception toward ADRs and pharmacovigilance. Female students (p≤0.018) and private universities students (p≤0.001) had positive perception than male and public university students respectively. The findings showed poor knowledge among students in Sana'a Universities and positive perception towards pharmacovigilance and ADRs reporting. A poor knowledge

Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis

PubMed Central

Vilar, Santiago; Harpaz, Rave; Chase, Herbert S; Costanzi, Stefano; Rabadan, Raul

2011-01-01

Background Adverse drug events (ADE) cause considerable harm to patients, and consequently their detection is critical for patient safety. The US Food and Drug Administration maintains an adverse event reporting system (AERS) to facilitate the detection of ADE in drugs. Various data mining approaches have been developed that use AERS to detect signals identifying associations between drugs and ADE. The signals must then be monitored further by domain experts, which is a time-consuming task. Objective To develop a new methodology that combines existing data mining algorithms with chemical information by analysis of molecular fingerprints to enhance initial ADE signals generated from AERS, and to provide a decision support mechanism to facilitate the identification of novel adverse events. Results The method achieved a significant improvement in precision in identifying known ADE, and a more than twofold signal enhancement when applied to the ADE rhabdomyolysis. The simplicity of the method assists in highlighting the etiology of the ADE by identifying structurally similar drugs. A set of drugs with strong evidence from both AERS and molecular fingerprint-based modeling is constructed for further analysis. Conclusion The results demonstrate that the proposed methodology could be used as a pharmacovigilance decision support tool to facilitate ADE detection. PMID:21946238

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

PubMed

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.

Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.

PubMed

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.

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

PubMed

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

Harnessing Scientific Literature Reports for Pharmacovigilance

PubMed Central

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

2017-01-01

Summary Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:28326432

Knowledge and Perception about Pharmacovigilance among Pharmacy Students of Universities in Sana’a Yemen

PubMed Central

Othman, Gamil Qasem; Ibrahim, Mohamed Izham Mohamed; Alshakka, Mohammed; Ansari, Mukhtar; Al-Qadasi, Farouk

2017-01-01

Introduction Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. Aim To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana’a Yemen. Materials and Methods A cross-sectional study design was conducted among 385 final year pharmacy students. One public and four private universities were selected randomly using a validated self-administered questionnaire. The questionnaire contained data about student demographic data, knowledge and perception about the ADRs. The data was analysed by SPSS program and Chi-square tests were used to assess the significance of association. Results The male students were more knowledgeable than female (p=0.035), as well as private university students had better ideas on how to report ADRs than public university students (p=0.009). Private university students reported that pharmacovigilance topic is well covered in their curriculum compared to public university students (p≤0.001). A significant difference was seen amongst the students of public and private universities when asked about reporting ADRs in future, former found more confident (p≤0.001). Furthermore, the private university students also had more command on the concept of post-marketing surveillance than public university students (p≤0.001). The private university students in Yemen were more known to causality assessment of ADRs as compared to the students of public universities (p≤0.001). The results of perception revealed regarding perception toward ADRs and pharmacovigilance. Female students (p≤0.018) and private universities students (p≤0.001) had positive perception than male and public university students respectively. Conclusion The findings showed poor knowledge among students in Sana’a Universities and positive perception

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

PubMed

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

2018-06-01

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.

Costs of dengue in three French territories of the Americas: an analysis of the hospital medical information system (PMSI) database.

PubMed

Uhart, M; Blein, C; L'Azou, M; Thomas, L; Durand, L

2016-05-01

Dengue is a major emerging public health concern in tropical and subtropical countries. Severe dengue can lead to hospitalisation and death. This study was performed to assess the economic burden of hospitalisations for dengue from 2007 to 2011 in three French territories of the Americas where dengue is endemic (French Guiana, Martinique and Guadeloupe). Data on dengue-associated hospitalisations were extracted from the French national hospital administrative database, Programme de Médicalisation des Systèmes d'Information (PMSI). The numbers of stays and the corresponding number of hospitalised patients were determined using disease-specific ICD-10 codes. Associated hospital costs were estimated from the payer perspective, using French official tariffs. Overall, 4183 patients (mean age 32 years; 51 % male) were hospitalised for dengue, corresponding to 4574 hospital stays. In nearly all hospital stays (98 %; 4471), the illness was medically managed and the mean length of stay was 4.3 days. The mean cost per stay was €2522, corresponding to a total hospital cost of €11.5 million over the 5 years assessed. The majority of hospitalisations (80 % of patients) and associated costs (75 % of total hospital costs) were incurred during two epidemics. Severe dengue is associated with significant hospital costs that escalate during outbreaks.

Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods.

PubMed

Gerritsen, Roald; Faddegon, Hans; Dijkers, Fred; van Grootheest, Kees; van Puijenbroek, Eugène

2011-09-01

Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented in medical education over the last decade, with a shift in training methods from those aimed predominantly at the transfer of knowledge towards those that are more practice based and skill oriented. It is conceivable that these changes have an impact on pharmacovigilance training in vocational training programmes. Therefore, this study compares the effectiveness of a skill-oriented, practice-based pharmacovigilance training method, with a traditional, lecture-based pharmacovigilance training method in the vocational training of general practitioners (GPs). The traditional, lecture-based method is common practice in the Netherlands. The purpose of this study was to establish whether the use of a practice-based, skill-oriented method in pharmacovigilance training during GP traineeship leads to an increase of reported ADRs after completion of this traineeship, compared with a lecture-based method. We also investigated whether the applied training method has an impact on the documentation level of the reports and on the number of unlabelled events reported. A retrospective cohort study. The number of ADR reports submitted to the Netherlands Pharmacovigilance Centre Lareb (between January 2006 and October 2010) after completion of GP vocational training was compared between the two groups. Documentation level of the reports and the number of labelled/unlabelled events reported were also compared. The practice-based cohort reported 32 times after completion of training (124 subjects, 6.8 reports per 1000 months of follow-up; total follow-up of 4704 months). The lecture-based cohort reported 12 times after training (135 subjects, 2.1 reports per 1000 months of follow-up; total follow

Homeopathy in France in 2011-2012 according to reimbursements in the French national health insurance database (SNIIRAM).

PubMed

Piolot, Michel; Fagot, Jean-Paul; Rivière, Sébastien; Fagot-Campagna, Anne; Debeugny, Gonzague; Couzigou, Patrice; Alla, François

2015-08-01

The use of homeopathic medicine is poorly described and the frequency of combined allopathic and homeopathic prescriptions is unknown. To analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance. The French national health insurance databases (SNIIRAM) were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012. A total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period, i.e. 10.2% of the overall population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements. A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Allopathic medicines were coprescribed with 55% of homeopathic prescriptions. Many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Technical improvement of cohort constitution in administrative health databases: Providing a tool for integration and standardization of data applicable in the French National Health Insurance Database (SNIIRAM)].

PubMed

Ferdynus, C; Huiart, L

2016-09-01

Administrative health databases such as the French National Heath Insurance Database - SNIIRAM - are a major tool to answer numerous public health research questions. However the use of such data requires complex and time-consuming data management. Our objective was to develop and make available a tool to optimize cohort constitution within administrative health databases. We developed a process to extract, transform and load (ETL) data from various heterogeneous sources in a standardized data warehouse. This data warehouse is architected as a star schema corresponding to an i2b2 star schema model. We then evaluated the performance of this ETL using data from a pharmacoepidemiology research project conducted in the SNIIRAM database. The ETL we developed comprises a set of functionalities for creating SAS scripts. Data can be integrated into a standardized data warehouse. As part of the performance assessment of this ETL, we achieved integration of a dataset from the SNIIRAM comprising more than 900 million lines in less than three hours using a desktop computer. This enables patient selection from the standardized data warehouse within seconds of the request. The ETL described in this paper provides a tool which is effective and compatible with all administrative health databases, without requiring complex database servers. This tool should simplify cohort constitution in health databases; the standardization of warehouse data facilitates collaborative work between research teams. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Pharmacovigilance in resource-limited countries.

PubMed

Olsson, Sten; Pal, Shanthi N; Dodoo, Alex

2015-01-01

In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO's global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

Hospital medication errors in a pharmacovigilance system in Colombia.

PubMed

Machado Alba, Jorge Enrique; Moreno Gutiérrez, Paula Andrea; Moncada Escobar, Juan Carlos

2015-11-01

this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). The data analysis was performed using SPSS 22.0 for Windows, considering p-values < 0.05 significant. there were 9 062 medication errors in 45 hospital pharmacies. Real errors accounted for 51.9% (n = 4 707), of which 12.0% (n = 567) reached the patient (Categories C to I) and caused harm (Categories E to I) to 17 subjects (0.36%). The main process involved in errors that occurred (categories B to I) was prescription (n = 1 758, 37.3%), followed by dispensation (n = 1 737, 36.9%), transcription (n = 970, 20.6%) and administration (n = 242, 5.1%). The errors in the administration process were 45.2 times more likely to reach the patient (CI 95%: 20.2-100.9). medication error reporting systems and prevention strategies should be widespread in hospital settings, prioritizing efforts to address the administration process. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Affective norms for 720 French words rated by children and adolescents (FANchild).

PubMed

Monnier, Catherine; Syssau, Arielle

2017-10-01

FANchild (French Affective Norms for Children) provides norms of valence and arousal for a large corpus of French words (N = 720) rated by 908 French children and adolescents (ages 7, 9, 11, and 13). The ratings were made using the Self-Assessment Manikin (Lang, 1980). Because it combines evaluations of arousal and valence and includes ratings provided by 7-, 9-, 11-, and 13-year-olds, this database complements and extends existing French-language databases. Good response reliability was observed in each of the four age groups. Despite a significant level of consensus, we found age differences in both the valence and arousal ratings: Seven- and 9-year-old children gave higher mean valence and arousal ratings than did the other age groups. Moreover, the tendency to judge words positively (i.e., positive bias) decreased with age. This age- and sex-related database will enable French-speaking researchers to study how the emotional character of words influences their cognitive processing, and how this influence evolves with age. FANchild is available at https://www.researchgate.net/profile/Catherine_Monnier/contributions .

Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department.

PubMed

Almenoff, June S; LaCroix, Karol K; Yuen, Nancy A; Fram, David; DuMouchel, William

2006-01-01

There is increasing interest in using disproportionality-based signal detection methods to support postmarketing safety surveillance activities. Two commonly used methods, empirical Bayes multi-item gamma Poisson shrinker (MGPS) and proportional reporting ratio (PRR), perform differently with respect to the number and types of signals detected. The goal of this study was to compare and analyse the performance characteristics of these two methods, to understand why they differ and to consider the practical implications of these differences for a large, industry-based pharmacovigilance department. We compared the numbers and types of signals of disproportionate reporting (SDRs) obtained with MGPS and PRR using two postmarketing safety databases and a simulated database. We recorded signal counts and performed a qualitative comparison of the drug-event combinations signalled by the two methods as well as a sensitivity analysis to better understand how the thresholds commonly used for these methods impact their performance. PRR detected more SDRs than MGPS. We observed that MGPS is less subject to confounding by demographic factors because it employs stratification and is more stable than PRR when report counts are low. Simulation experiments performed using published empirical thresholds demonstrated that PRR detected false-positive signals at a rate of 1.1%, while MGPS did not detect any statistical false positives. In an attempt to separate the effect of choice of signal threshold from more fundamental methodological differences, we performed a series of experiments in which we modified the conventional threshold values for each method so that each method detected the same number of SDRs for the example drugs studied. This analysis, which provided quantitative examples of the relationship between the published thresholds for the two methods, demonstrates that the signalling criterion published for PRR has a higher signalling frequency than that published for MGPS

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

PubMed Central

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

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

PubMed

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

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.

PubMed

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

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

PubMed

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.

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

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.

Veterinary pharmacovigilance in India: A need of hour.

PubMed

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.

Medication exposure and spontaneous abortion: a case-control study using a French medical database.

PubMed

Abadie, D; Hurault-Delarue, C; Damase-Michel, C; Montastruc, J L; Lacroix, I

2015-01-01

Few studies have been conducted to investigate drug effects on spontaneous abortion risk. The objective of the present study was to evaluate the potential association between first trimester drug exposure and spontaneous abortion occurrence. The authors performed a nested case-control study using data from TERAPPEL, a French medical database. Cases were the women who had a spontaneous abortion (before the 22nd week of amenorrhea) and controls were women who gave birth to a child. Analyzed variables were: maternal age, obstetric history, tobacco, and alcohol and drug consumption during the first trimester of pregnancy. For comparison of drug exposures between cases and controls, the authors calculated odds ratios (ORs) by means of multivariate logistic regressions adjusted on age and on other drug exposures. The study included 838 cases and 4,508 controls that were identified in the database. In adjusted analyses, cases were more exposed than controls to "non-selective monoamine reuptake inhibitors" [OR=2.2 (CI 95% 1.5-3.3)], "antiprotozoals" [OR = 1.6 (CI 95% 1.1 - 2.5)] and "centrally acting antiobesity products" [OR = 3.4 (CI 95% 1.9 - 6.2)]. Conversely, controls were more exposed than cases to H1 antihistamines [OR = 0.6 (CI 95% 0.4 - 0.9)]. This exploratory study highlights some potential associations between first trimester drug exposure and risk of spontaneous abortion. Further studies have to be carried out to investigate these findings.

[French brain tumor database: general results on 40,000 cases, main current applications and future prospects].

PubMed

Zouaoui, S; Rigau, V; Mathieu-Daudé, H; Darlix, A; Bessaoud, F; Fabbro-Peray, P; Bauchet, F; Kerr, C; Fabbro, M; Figarella-Branger, D; Taillandier, L; Duffau, H; Trétarre, B; Bauchet, L

2012-02-01

This work aimed at prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis was available. The objectives were to (i) create a national database and network to perform epidemiological studies, (ii) implement clinical and basic research protocols, and (iii) harmonize the health care of patients affected by PCNST. The methodology is based on a multidisciplinary national network already established by the French Brain Tumor DataBase (FBTDB) (Recensement national histologique des tumeurs primitives du système nerveux central [RnhTPSNC]), and the active participation of the Scientific Societies involved in neuro-oncology in France. From 2004 to 2009, 43,929 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included gliomas (42,4%), all other neuroepithelial tumors (4,4%), tumors of the meninges (32,3%), nerve sheath tumors (9,2%), lymphomas (3,4%) and others (8,3%). Cryopreservation was reported for 9603 PCNST specimens. Tumor resections were performed in 78% cases, while biopsies accounted for 22%. Median age at diagnosis, sex, percentage of resections and number of cryopreserved tumors were detailed for each histology, according to the WHO classification. Many current applications and perspectives for the FBTDB are illustrated in the discussion. To our knowledge, this work is the first database in Europe, dedicated to PCNST, including clinical, surgical and histological data (with also cryopreservation of the specimens), and which may have major epidemiological, clinical and research implications. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Birth defects observed with maternal carbimazole treatment: Six cases reported to Nice's Pharmacovigilance Center.

PubMed

Koenig, D; Spreux, A; Hiéronimus, S; Chichmanian, R-M; Bastiani, F; Fénichel, Patrick; Brucker-Davis, F

2010-12-01

To report cases of embryopathy occurring following first trimester exposure to anti-thyroid drugs. Retrospective screening of the database of our Pharmacovigilance Center from 1987 to date. We report six cases of embryopathy, all following carbimazole exposure during the first trimester: two cases of abdominal wall defect, including one associated with facial dysmorphia; one case of digestive malformation (patent omphalomesenteric duct); two cases of aplasia cutis including one with facial dysmorphism; one case of bilateral choanal atresia with aorta coarctation associated with poorly controlled insulin dependent diabetes. Four out of five patients were euthyroid with treatment during the first trimester. We found a context suggesting genetic predisposition to congenital malformation in three cases: two cases of parental cleft lip/palate, one case of consanguinity. Outcome was favorable in all cases. We want to raise awareness about the potential teratogenicity of carbimazole, probably on a predisposed genetic background. We suggest better reporting of congenital anomalies in children of women with Graves'disease, with or without in utero exposure to anti-thyroid drugs. In light of current literature, propylthiouracil should be the first line treatment for hyperthyroid women wishing a pregnancy. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

PubMed

O'Callaghan, J; Griffin, B T; Morris, J M; Bermingham, Margaret

2018-06-01

In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

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

PubMed

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

Heparin pharmacovigilance in Brazil.

PubMed

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.

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

PubMed

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; Favirab TM ) 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 (Favirab TM ) in rabies PEP.

Evolution of the Antidepressant Prescribing in Alzheimer's Disease and Related Disorders Between 2010 and 2014: Results from the French National Database on Alzheimer's Disease (BNA).

PubMed

David, Renaud; Manera, Valeria; Fabre, Roxane; Pradier, Christian; Robert, Philippe; Tifratene, Karim

2016-07-02

Safety warnings from health authorities are currently intended to limit the use of psychotropic agents in dementia-related conditions. Evidence concerning the use of antidepressants in dementia is, however, scarce and contradictory. To evaluate antidepressant use among individuals with Alzheimer's disease (AD) and related disorders in the French population between 2010 and 2014. Antidepressant prescriptions in individuals with AD, mixed dementia (MD), and vascular dementia (VaD) in the French National Alzheimer Database between 2010 and 2014 were analyzed (N = 199,544). Multivariate analysis showed an annual significant increase (p < 0.001) in the prescription rate of antidepressants from 26% (2010) to 31% (2014), and identified female gender, younger age, higher education, living in long-term facilities, more severe cognitive decline, and presence of vascular signs (VaD and MD) as associated factors for antidepressant prescribing. The annual increase of antidepressant prescribing among individuals with AD, MD, and VaD in French specialized settings may be partially related to the lack of current valuable medications for dementia-related behavioral symptoms.

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.

PubMed

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; West, D P

2014-10-01

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. 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. 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. 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. This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

Cost-effectiveness of left ventricular assist devices for patients with end-stage heart failure: analysis of the French hospital discharge database.

PubMed

Tadmouri, Abir; Blomkvist, Josefin; Landais, Cécile; Seymour, Jerome; Azmoun, Alexandre

2018-02-01

Although left ventricular assist devices (LVADs) are currently approved for coverage and reimbursement in France, no French cost-effectiveness (CE) data are available to support this decision. This study aimed at estimating the CE of LVAD compared with medical management in the French health system. Individual patient data from the 'French hospital discharge database' (Medicalization of information systems program) were analysed using Kaplan-Meier method. Outcomes were time to death, time to heart transplantation (HTx), and time to death after HTx. A micro-costing method was used to calculate the monthly costs extracted from the Program for the Medicalization of Information Systems. A multistate Markov monthly cycle model was developed to assess CE. The analysis over a lifetime horizon was performed from the perspective of the French healthcare payer; discount rates were 4%. Probabilistic and deterministic sensitivity analyses were performed. Outcomes were quality-adjusted life years (QALYs) and incremental CE ratio (ICER). Mean QALY for an LVAD patient was 1.5 at a lifetime cost of €190 739, delivering a probabilistic ICER of €125 580/QALY [95% confidence interval: 105 587 to 150 314]. The sensitivity analysis showed that the ICER was mainly sensitive to two factors: (i) the high acquisition cost of the device and (ii) the device performance in terms of patient survival. Our economic evaluation showed that the use of LVAD in patients with end-stage heart failure yields greater benefit in terms of survival than medical management at an extra lifetime cost exceeding the €100 000/QALY. Technological advances and device costs reduction shall hence lead to an improvement in overall CE. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

[Prospective study of drug-induced interstitial nephritis in eleven French nephrology units].

PubMed

Leven, Cyril; Hudier, Laurent; Picard, Sylvie; Longuet, Hélène; Lorcy, Nolwenn; Cam, Gérard; Boukerroucha, Zakaria; Dolley-Hitze, Thibault; Le Cacheux, Philippe; Halimi, Jean-Michel; Cornec Le Gall, Emilie; Hanrotel-Saliou, Catherine; Arreule, Audrey; Massad, Michel; Duveau, Agnès; Couvrat-Desvergnes, Grégoire; Renaudineau, Eric

2014-11-01

Certain medications have been associated with drug-induced acute interstitial nephritis (AIN), but few prospective studies have been published. This prospective observational study aims to record and assess incidents of drug-induced AIN observed over a period of one year in nephrology units in France. The goal is to determine which medications are involved in AIN and to expound the clinical and biological presentation, management, and evolution of AIN. Between April 2012 and April 2013, drug-associated cases of AIN were prospectively recorded in 24 patients registered in 11 nephrology units that belong to the Société de Néphrologie de l'Ouest (SNO). Data sheets, including suspected and concomitant drug(s), kidney function assessment, biological disturbances, clinical signs, histological data, management, and evolution, were collected by the Rennes Regional Pharmacovigilance Center and recorded in the French pharmacovigilance database. In order, the most frequently involved medications in the AIN cases were: vitamin K antagonists (33.3% of the cases, almost exclusively fluindione), antibiotics (20.8% of cases) non-steroidal anti-inflammatory drugs (20.8% of cases), and proton pump inhibitors (16.7% of cases). The mean delay of onset to AIN was 8.3 weeks. At the time of diagnosis, mean serum creatinine was 366 μM, higher for vitamin K antagonists (VKAs), except in the case of warfarin. During the course of an AIN event, 70% of patients had complete blood count and/or urine analysis abnormalities, 55% had clinical signs of systemic hypersensitivity, and 13% of patients had hepatic disorders. Renal biopsies were performed in 54% of patients; however, only 37% of patients requiring therapeutic anticoagulation underwent a biopsy. Suspected drugs were discontinued in all patients and the majority was treated with oral corticosteroids. Renal function often continued to be impaired after an AIN event. At baseline, 25% of patients had chronic kidney disease (CKD); after

Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

PubMed

Baldo, Paolo; De Paoli, Paolo

2014-10-01

Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis

PubMed Central

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-01-01

Introduction: Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar®), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups “41-65” (39.07%) and “over 65” (27.9%) were the most affected. Conclusions: Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed. PMID:24347984

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

PubMed

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

Mining approximate temporal functional dependencies with pure temporal grouping in clinical databases.

PubMed

Combi, Carlo; Mantovani, Matteo; Sabaini, Alberto; Sala, Pietro; Amaddeo, Francesco; Moretti, Ugo; Pozzi, Giuseppe

2015-07-01

Functional dependencies (FDs) typically represent associations over facts stored by a database, such as "patients with the same symptom get the same therapy." In more recent years, some extensions have been introduced to represent both temporal constraints (temporal functional dependencies - TFDs), as "for any given month, patients with the same symptom must have the same therapy, but their therapy may change from one month to the next one," and approximate properties (approximate functional dependencies - AFDs), as "patients with the same symptomgenerallyhave the same therapy." An AFD holds most of the facts stored by the database, enabling some data to deviate from the defined property: the percentage of data which violate the given property is user-defined. According to this scenario, in this paper we introduce approximate temporal functional dependencies (ATFDs) and use them to mine clinical data. Specifically, we considered the need for deriving new knowledge from psychiatric and pharmacovigilance data. ATFDs may be defined and measured either on temporal granules (e.g.grouping data by day, week, month, year) or on sliding windows (e.g.a fixed-length time interval which moves over the time axis): in this regard, we propose and discuss some specific and efficient data mining techniques for ATFDs. We also developed two running prototypes and showed the feasibility of our proposal by mining two real-world clinical data sets. The clinical interest of the dependencies derived considering the psychiatry and pharmacovigilance domains confirms the soundness and the usefulness of the proposed techniques. Copyright © 2014 Elsevier Ltd. All rights reserved.

Evaluation of an ontological resource for pharmacovigilance.

PubMed

Jaulent, Marie-Christine; Alecu, Iulian

2009-01-01

In this work, we present a methodology for evaluating an ontology designed in a previous study to describe adverse drug reactions. We evaluate it in term of its fitness for grouping cases in pharmacovigilance. We define as gold standard the Standardized MedDRA Queries (SMQs) developed manually to group terms representing similar medical conditions. We perform an automatic search in the ontology in order to retrieve concepts related to the medical conditions. An optimal query is built for each medical condition. The evaluation relies on the comparison between the terms in the SMQ and the terms subsumed by the query. The result is quantified by sensitivity and specificity. We applied this methodology for 24 SMQs and we obtain a mean sensitivity of 0.82. This work allows validating the semantic resource and provides, in perspective, tools to maintain the ontology while the knowledge is evolving.

Does language matter? A case study of epidemiological and public health journals, databases and professional education in French, German and Italian

PubMed Central

Baussano, Iacopo; Brzoska, Patrick; Fedeli, Ugo; Larouche, Claudia; Razum, Oliver; Fung, Isaac C-H

2008-01-01

Epidemiology and public health are usually context-specific. Journals published in different languages and countries play a role both as sources of data and as channels through which evidence is incorporated into local public health practice. Databases in these languages facilitate access to relevant journals, and professional education in these languages facilitates the growth of native expertise in epidemiology and public health. However, as English has become the lingua franca of scientific communication in the era of globalisation, many journals published in non-English languages face the difficult dilemma of either switching to English and competing internationally, or sticking to the native tongue and having a restricted circulation among a local readership. This paper discusses the historical development of epidemiology and the current scene of epidemiological and public health journals, databases and professional education in three Western European languages: French, German and Italian, and examines the dynamics and struggles they have today. PMID:18826570

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

PubMed

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

[Clinical assessment of drug safety].

PubMed

Imbs, J-L; Welsch, M

2007-09-01

The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.

Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting.

PubMed

Lamarque, Véronique; Merle, Louis; Demarez, Jean Paul

2008-01-01

The use of generics results in savings for the budget of the health insurance, and no player of health could question seriously the principle. The generic drug of a reference medicinal product defines itself as a drug having the same qualitative and quantitative composition in active ingredients, the same dosage form and the bioequivalence with this reference medicinal product was demonstrated by appropriate studies of bioavailability. It is the right to switch granted to the pharmacists in 1999 that is at the origin of the real development of these specialties on the French pharmaceutical market. Nevertheless, about 10 years later, it seems that the system in place does not offer all the necessary securities with regard to pharmacovigilance, notably for the products with narrow therapeutic margin. By strengthening and/or by completing the role played by the health care professionals and the public institutions concerned, it is highly possible to improve the robustness of the system. Also, the recent arrival in Europe of the biosimilars, similar molecules but not bioequivalent to biological products, cause an even more tricky specific situation than that of the generics because of their nature, of the difficulty to manufacture them, and of the risk of immunogenicity. If the substitution is not permitted in several European countries including France, the other issues can appear especially in case of interchangeability requiring also, the reinforcement of certain measures.The various aspects are described in this article with concrete proposals on how the current system can be made safer, both for the generics and the biosimilars.

Diversity of Mycobacterium tuberculosis lineages in French Polynesia.

PubMed

Osman, Djaltou Aboubaker; Phelippeau, Michael; Drancourt, Michel; Musso, Didier

2017-04-01

French Polynesia is an overseas territory located in the South Pacific. The incidence of tuberculosis in French Polynesia has been stable since 2000 with an average of 20 cases/y/100,000 inhabitants. Molecular epidemiology of Mycobacterium tuberculosis in French Polynesia is unknown because M. tuberculosis isolates have not been routinely genotyped. From 2009 to 2012, 34 isolates collected from 32 French Polynesian patients were identified as M. tuberculosis by probe hybridization. These isolates were genotyped using spoligotyping and 24-loci mycobacterial interspersed repetitive units (MIRUs)-variable number of tandem repeat (VNTR). Spoligotype patterns obtained using commercial kits were compared with the online international database SITVIT. MIRU-VNTR genotyping was performed using an in-house protocol based on capillary electrophoresis sizing for 24-loci MIRU-VNTR genotyping. The results of the spoligotyping method revealed that 25 isolates grouped into six previously described spoligotypes [H1, H3, U likely (S), T1, Manu, and Beijing] and nine isolates grouped into six new spoligotypes. Comparison with the international database MIRU-VNTRplus distributed 30 isolates into five lineages (Haarlem, Latin American Mediterranean, S, X, and Beijing) and four as unassigned isolates. Genotyping identified four phylogenetic lineages belonging to the modern Euro-American subgroup, one Beijing genotype responsible for worldwide pandemics, including remote islands in the South Pacific, and one Manu genotype of the ancestral lineage of M. tuberculosis. Copyright © 2015. Published by Elsevier B.V.

Statistical Signal Process in R Language in the Pharmacovigilance Programme of India.

PubMed

Kumar, Aman; Ahuja, Jitin; Shrivastava, Tarani Prakash; Kumar, Vipin; Kalaiselvan, Vivekanandan

2018-05-01

The Ministry of Health & Family Welfare, Government of India, initiated the Pharmacovigilance Programme of India (PvPI) in July 2010. The purpose of the PvPI is to collect data on adverse reactions due to medications, analyze it, and use the reference to recommend informed regulatory intervention, besides communicating the risk to health care professionals and the public. The goal of the present study was to apply statistical tools to find the relationship between drugs and ADRs for signal detection by R programming. Four statistical parameters were proposed for quantitative signal detection. These 4 parameters are IC 025 , PRR and PRR lb , chi-square, and N 11 ; we calculated these 4 values using R programming. We analyzed 78,983 drug-ADR combinations, and the total count of drug-ADR combination was 4,20,060. During the calculation of the statistical parameter, we use 3 variables: (1) N 11 (number of counts), (2) N 1. (Drug margin), and (3) N .1 (ADR margin). The structure and calculation of these 4 statistical parameters in R language are easily understandable. On the basis of the IC value (IC value >0), out of the 78,983 drug-ADR combination (drug-ADR combination), we found the 8,667 combinations to be significantly associated. The calculation of statistical parameters in R language is time saving and allows to easily identify new signals in the Indian ICSR (Individual Case Safety Reports) database.

Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study.

PubMed

Gony, Mireille; Badie, Kattalin; Sommet, Agnès; Jacquot, Julien; Baudrin, Dominique; Gauthier, Pierre; Montastruc, Jean Louis; Bagheri, Haleh

2010-05-01

Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. The aim of this pilot study was to assess the effect of regular visits of a Clinical Research Assistant (CRA) on the improvement of ADR reporting in non-university hospitals. We set up an ADR report collecting system that involved regular visits by a CRA to non-university hospitals, which was similar to a system that already existed in university hospitals in Toulouse, France. Two areas in our region were chosen: Haute Garonne and Gers. We compared firstly the reporting rate (number of reports/number of beds) of total ADRs (i.e. spontaneously reported ADRs plus solicited ADRs collected by the CRA) and secondly, the percentage of serious ADRs reported by non-university hospitals in these two areas, in 2005 (the year prior to CRA visits) and after the start of CRA visits (2006 until the end of December 2008). We also compared the reporting rate of total ADRs in Haute Garonne and Gers non-university hospitals with those reported during the same period with a control group (the Ariège area, which has a similar number of beds to Gers and that was not visited by the CRA). The characteristics of ADRs collected by the CRA were also described. A total of 687 reports were collected by the CRA: 40% were classified as serious, including two deaths. The number of ADRs and the reporting rate increased significantly between 2005 and 2008 in non-university hospitals of Haute-Garonne and Gers, but not in Ariège. In Gers, the reporting rate was 3% in 2005 and 25% in 2008. In Haute-Garonne, the reporting rate was 11% in 2005 and 40% in 2008. The difference between the number of spontaneous and solicited reports also increased. This study shows that regular visits by a CRA increases the number of ADRs collected by a Regional

Informativeness of patient initial reports of adverse drug reactions. Can it be improved by a pharmacovigilance centre?

PubMed

Kheloufi, F; Default, A; Rouby, F; Laugier-Castellan, D; Boyer, M; Rodrigues, B; Ponte-Astoul, J; Jean-Pastor, M J; Blin, O; Micallef, J

2017-08-01

Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports. A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor. Overall, 240 reports concerning 522 ADR and involving 278 drugs were reported over this 4-year period. Mean number of available key elements of information in initial reports was increased from 11/16 to 15/16 after review of reports by the PVC. Time to onset and duration of the ADR were respectively available in only 51 and 58% of the reports before review compared to 83 and 90% after review. Medical history and concomitant medication were missing in 75% of the initial reports compared to less than 30% of the reports after review. Contacting the reporter enabled an increase of informativeness of most elements of information for more than 90% of the reports. Patient reports often need to be completed on key elements of information that are required to assess reports. Both upstream education of patients and downstream intervention of a pharmacovigilance assessor to complete missing information could help to enhance the informativeness of such reports.

Comparative study for surgical management of thymectomy for non-thymomatous myasthenia gravis from the French national database EPITHOR.

PubMed

Orsini, Bastien; Santelmo, Nicola; Pages, Pierre Benoit; Baste, Jean Marc; Dahan, Marcel; Bernard, Alain; Thomas, Pascal Alexandre

2016-09-01

Thymectomy may be part of the therapeutic strategy in patients with myasthenia gravis (MG) without thymoma. Median sternotomy is still considered as the gold standard, but during the last 15 years, several groups have demonstrated the non-inferiority of cervicotomy with upper sternotomy and minimally invasive techniques. To date, there is no consensus on surgical procedure choice. The aim of our study was to compare the morbidity and mortality of three techniques [cervicotomy with upper sternotomy versus sternotomy versus video-assisted thoracic surgery (VATS)/robotic-assisted thoracic surgery (RATS)] from the national database EPITHOR and to analyse French epidemiology. From the national thoracic surgery database EPITHOR, we have extracted all the details regarding thymectomies performed for non-thymomatous MG. We have divided thymectomy into three groups: A-sternotomy; B-cervicotomy with upper sternotomy; C-VATS/RATS. We investigated the postoperative morbidity and mortality without analysis of the long-term evolution of the disease not available on EPITHOR. From 2005 to 2013, 278 patients were included: 131 (47%) in Group A, 31 (11%) in Group B and 116 (42%) in Group C. The sex ratio F/M was 2.3. The mean age was, respectively, 42 ± 17, 42 ± 16, 35 ± 14 years old (P < 0.01). The number of patients without comorbidities was 63 (48%), 25 (81%) and 78 (65%), respectively (P < 0.01). The operative time was 94 ± 37, 79 ± 42 and 112 ± 59 min, respectively (P < 0.01). The number of patients who presented at least one postoperative complication was 12 (14%), 0 and 3 (9%) (P= 0.03), respectively. The postoperative lengths of stay were 7.7 ± 4.5, 5 ± 1.7 and 4.5 ± 2 days, respectively (P < 0.01). There was no death. In our study, we were unable to prove the superiority of minimally invasive techniques due to the important differences between the groups. However, this study shows us major changes in French surgical procedures during the last decade with an

[Health status of populations living in French overseas territories in 2012, compared with metropolitan France: An analysis of the national health insurance database].

PubMed

Filipovic-Pierucci, A; Rigault, A; Fagot-Campagna, A; Tuppin, P

2016-06-01

This study uses healthcare consumption to compare the health status of beneficiaries of the French national health insurance general scheme between individuals living in French overseas territories (FOT) and those living in metropolitan France. Data were extracted from the French national health insurance database (Sniiram) for 2012, using algorithms, 56 groups of diseases and 27 groups of hospital activity were isolated. Standardized morbidity ratio for age and sex (SMR) were used to compare FOT to mainland France. Compared with mainland France, people living in the four FOT had high SMR for diabetes care (Guadeloupe 1.9; Martinique 1.7; Guyane 1.9; La Réunion 2.3), dialysis (2.7; 2.4; 3.8; 4.4), stroke (1.2; 1.1; 2.0; 1.5), and hospitalization for infectious diseases (1.9; 2.5; 2.4; 1.4) and obstetrics (1.4; 1.2; 1.9; 1.2). Care for inflammatory bowel disease or cancer were less frequent except for prostate in Martinique and Guadeloupe (2.3). People living in Martinique, Guadeloupe and la Reunion had more frequently care for psychotic disorders (2.0; 1.7; 1.2), dementia (1.1; 1.3; 11), epileptic seizures (1.4; 1.4; 16) and hospitalizations for burns (2.6; 1.7; 2.9). In la Reunion, people had more frequently coronary syndrome (1.3), cardiac heart failure (1.6), chronic respiratory diseases except cystic fibrosis (1.5), drug addiction (1.4) and hospitalizations for cardiovascular catheterization (1.4) and toxicology, poisoning, alcohol (1.7). Other differences were observed by gender: HIV infection, peripheral arterial disease, some chronic inflammatory disease (lupus) were more frequent in women living in Martinique or Guadeloupe, compared to women from mainland France and psychotic disorders for men. From la Reunion, men had more frequently liver and pancreatic diseases and hospitalisation for toxicology, poisoning, alcohol than men from mainland France. This study highlights the utility of administrative database to compare and follow population health status

A Predictive Score for Bronchopleural Fistula Established Using the French Database Epithor.

PubMed

Pforr, Arnaud; Pagès, Pierre-Benoit; Baste, Jean-Marc; Thomas, Pascal; Falcoz, Pierre-Emmanuel; Lepimpec Barthes, Francoise; Dahan, Marcel; Bernard, Alain

2016-01-01

Bronchopleural fistula (BPF) remains a rare but fatal complication of thoracic surgery. The aim of this study was to develop and validate a predictive model of BPF after pulmonary resection and to identify patients at high risk for BPF. From January 2005 to December 2012, 34,000 patients underwent major pulmonary resection (lobectomy, bilobectomy, or pneumonectomy) and were entered into the French National database Epithor. The primary outcome was the occurrence of postoperative BPF at 30 days. The logistic regression model was built using a backward stepwise variable selection. Bronchopleural fistula occurred in 318 patients (0.94%); its prevalence was 0.5% for lobectomy (n = 139), 2.2% for bilobectomy (n = 39), and 3% for pneumonectomy (n = 140). The mortality rate was 25.9% for lobectomy (n = 36), 16.7% for bilobectomy (n = 6), and 20% for pneumonectomy (n = 28). In the final model, nine variables were selected: sex, body mass index, dyspnea score, number of comorbidities per patient, bilobectomy, pneumonectomy, emergency surgery, sleeve resection, and the side of the resection. In the development data set, the C-index was 0.8 (95% confidence interval: 0.78 to 0.82). This model was well calibrated because the Hosmer-Lemeshow test was not significant (χ(2) = 10.5, p = 0.23). We then calculated the logistic regression coefficient to build the predictive score for BPF. This strong model could be easily used by surgeons to identify patient at high risk for BPF. This score needs to be confirmed prospectively in an independent cohort. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Epidemiology of pancreatic cancer in France: descriptive study from the French national hospital database.

PubMed

Maire, Frédérique; Cibot, Jean-Olivier; Compagne, Catherine; Hentic, Olivia; Hammel, Pascal; Muller, Nelly; Ponsot, Philippe; Levy, Philippe; Ruszniewski, Philippe

2017-08-01

Although indirect evidence suggests that the incidence of pancreatic adenocarcinoma has increased in the last decade, few data are available in European countries. The aim of the present study was to update the epidemiology of pancreatic cancer in France in 2014 from the French national hospital database (Programme de Médicalisation des Systèmes d'Information). All patients hospitalized for pancreatic cancer in France in 2014 in public or private institutions were included. Patient and stays (length, type of support, institutions) characteristics were studied. The results were compared with those observed in 2010. A total of 13 346 (52% men, median age 71 years) new patients were treated for pancreatic cancer in 2014, accounting for a 12.5% increase compared with 2010. Overall, 22% of patients were operated on. Liver metastases were present in 60% of cases. The disease accounted for 146 680 hospital stays (+24.8% compared with 2010), 76% of which were related to chemotherapy (+32%). The average annual number and length of stay were 7 and 2.6 days, respectively. In 2014, 11 052 deaths were reported (+15.8%). Approximately 13 350 new cases of pancreatic cancer were observed in France in 2014. The increase in incidence was associated with a marked increase in hospital stays for chemotherapy.

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

PubMed

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

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. 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. 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 ( P <0.05). The mean knowledge scores for pharmacists was 3.33±2.852 compared to 0.15±0.666 for pharmacy technicians. With regard to attitudes toward ADR reporting, all pharmacists (100%) showed a positive attitude, while only 43% of pharmacy technicians showed a positive attitude. Pharmacists have a significantly better knowledge than pharmacy technicians with regard to pharmacovigilance. More than half of pharmacy technicians showed a negative attitude toward ADR reporting. Therefore, educational interventions and training is very important for community pharmacists and pharmacy technicians in Yemen to increase their awareness and participation in ADR reporting.

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

PubMed Central

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 (P<0.05). The mean knowledge scores for pharmacists was 3.33±2.852 compared to 0.15±0.666 for pharmacy technicians. With regard to attitudes toward ADR reporting, all pharmacists (100%) showed a positive attitude, while only 43% of pharmacy technicians showed a positive attitude. Conclusion Pharmacists have a significantly better knowledge than pharmacy technicians with regard to pharmacovigilance. More than half of pharmacy technicians showed a negative attitude toward ADR reporting. Therefore, educational interventions and training is very important for community pharmacists and pharmacy technicians in Yemen to increase their awareness and participation in ADR reporting. PMID:28924350

[Benefits of large healthcare databases for drug risk research].

PubMed

Garbe, Edeltraut; Pigeot, Iris

2015-08-01

Large electronic healthcare databases have become an important worldwide data resource for drug safety research after approval. Signal generation methods and drug safety studies based on these data facilitate the prospective monitoring of drug safety after approval, as has been recently required by EU law and the German Medicines Act. Despite its large size, a single healthcare database may include insufficient patients for the study of a very small number of drug-exposed patients or the investigation of very rare drug risks. For that reason, in the United States, efforts have been made to work on models that provide the linkage of data from different electronic healthcare databases for monitoring the safety of medicines after authorization in (i) the Sentinel Initiative and (ii) the Observational Medical Outcomes Partnership (OMOP). In July 2014, the pilot project Mini-Sentinel included a total of 178 million people from 18 different US databases. The merging of the data is based on a distributed data network with a common data model. In the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) there has been no comparable merging of data from different databases; however, first experiences have been gained in various EU drug safety projects. In Germany, the data of the statutory health insurance providers constitute the most important resource for establishing a large healthcare database. Their use for this purpose has so far been severely restricted by the Code of Social Law (Section 75, Book 10). Therefore, a reform of this section is absolutely necessary.

[Critical analysis of French DRG based information system (PMSI) databases for the epidemiology of cancer: a longitudinal approach becomes possible].

PubMed

Olive, F; Gomez, F; Schott, A-M; Remontet, L; Bossard, N; Mitton, N; Polazzi, S; Colonna, M; Trombert-Paviot, B

2011-02-01

Use of French Diagnosis Related Groups (DRGs) program databases, apart from financial purposes, has recently been improved since a unique anonymous patient identification number has been created for each inpatient in administrative case mix database. Based on the work of the group for cancer epidemiological observation in the Rhône-Alpes area, (ONC-EPI group), we review the remaining difficulties in the use of DRG data for epidemiological purposes and we consider a longitudinal approach based on analysis of database over several years. We also discuss limitations of this approach. The main problems are related to a lack of quality of administrative data, especially coding of diagnoses. These errors come from missing or inappropriate codes, or not being in accordance with prioritization rules (causing an over- or under-reporting or inconsistencies in coding over time). One difficulty, partly due to the hierarchy of coding and the type of cancer, is the choice of an extraction algorithm. In two studies designed to estimate the incidence of cancer cared in hospitals (breast, colon-rectum, kidney, ovaries), a first algorithm, including a code of cancer as principal diagnosis with a selection of surgical procedures less performed than the second one including a code of cancer as principal diagnosis only, for which the number of hospitalizations per patient ratio was stable across time and space. The chaining over several years allows, by tracing the trajectory of the patient, to detect and correct inaccuracies, errors and missing values, and for incidence studies, to correct incident cases by removing prevalent cases. However, linkage, complete only since 2007, does not correct data in all cases. Ways of future improvement certainly pass through improved algorithms for case identification and especially by linking DRG data with other databases. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance.

PubMed

Lupattelli, Angela; Spigset, Olav; Nordeng, Hedvig

2018-06-15

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.

PubMed

Dupuch, Marie; Grabar, Natalia

2015-04-01

Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs or biologics. The detection of adverse drug reactions is performed using statistical algorithms and groupings of ADR terms from the MedDRA (Medical Dictionary for Drug Regulatory Activities) terminology. Standardized MedDRA Queries (SMQs) are the groupings which become a standard for assisting the retrieval and evaluation of MedDRA-coded ADR reports worldwide. Currently 84 SMQs have been created, while several important safety topics are not yet covered. Creation of SMQs is a long and tedious process performed by the experts. It relies on manual analysis of MedDRA in order to find out all the relevant terms to be included in a SMQ. Our objective is to propose an automatic method for assisting the creation of SMQs using the clustering of terms which are semantically similar. The experimental method relies on a specific semantic resource, and also on the semantic distance algorithms and clustering approaches. We perform several experiments in order to define the optimal parameters. Our results show that the proposed method can assist the creation of SMQs and make this process faster and systematic. The average performance of the method is precision 59% and recall 26%. The correlation of the results obtained is 0.72 against the medical doctors judgments and 0.78 against the medical coders judgments. These results and additional evaluation indicate that the generated clusters can be efficiently used for the detection of pharmacovigilance signals, as they provide better signal detection than the existing SMQs. Copyright © 2014. Published by Elsevier Inc.

Pharmacovigilance data mining with methods based on false discovery rates: a comparative simulation study.

PubMed

Ahmed, I; Thiessard, F; Miremont-Salamé, G; Bégaud, B; Tubert-Bitter, P

2010-10-01

The early detection of adverse reactions caused by drugs that are already on the market is the prime concern of pharmacovigilance efforts; the methods in use for postmarketing surveillance are aimed at detecting signals pointing to potential safety concerns, on the basis of reports from health-care providers and from information available in various databases. Signal detection methods based on the estimation of false discovery rate (FDR) have recently been proposed. They address the limitation of arbitrary detection thresholds of the automatic methods in current use, including those last updated by the US Food and Drug Administration and the World Health Organization's Uppsala Monitoring Centre. We used two simulation procedures to compare the false-positive performances for three current methods: the reporting odds ratio (ROR), the information component (IC), the gamma Poisson shrinkage (GPS), and also for two FDR-based methods derived from the GPS model and Fisher's test. Large differences in FDR rates were associated with the signal-detection methods currently in use. These differences ranged from 0.01 to 12% in an analysis that was restricted to signals with at least three reports. The numbers of signals generated were also highly variable. Among fixed-size lists of signals, the FDR was lowered when the FDR-based approaches were used. Overall, the outcomes in both simulation studies suggest that improvement in effectiveness can be expected from use of the FDR-based GPS method.

A generic method for improving the spatial interoperability of medical and ecological databases.

PubMed

Ghenassia, A; Beuscart, J B; Ficheur, G; Occelli, F; Babykina, E; Chazard, E; Genin, M

2017-10-03

The availability of big data in healthcare and the intensive development of data reuse and georeferencing have opened up perspectives for health spatial analysis. However, fine-scale spatial studies of ecological and medical databases are limited by the change of support problem and thus a lack of spatial unit interoperability. The use of spatial disaggregation methods to solve this problem introduces errors into the spatial estimations. Here, we present a generic, two-step method for merging medical and ecological databases that avoids the use of spatial disaggregation methods, while maximizing the spatial resolution. Firstly, a mapping table is created after one or more transition matrices have been defined. The latter link the spatial units of the original databases to the spatial units of the final database. Secondly, the mapping table is validated by (1) comparing the covariates contained in the two original databases, and (2) checking the spatial validity with a spatial continuity criterion and a spatial resolution index. We used our novel method to merge a medical database (the French national diagnosis-related group database, containing 5644 spatial units) with an ecological database (produced by the French National Institute of Statistics and Economic Studies, and containing with 36,594 spatial units). The mapping table yielded 5632 final spatial units. The mapping table's validity was evaluated by comparing the number of births in the medical database and the ecological databases in each final spatial unit. The median [interquartile range] relative difference was 2.3% [0; 5.7]. The spatial continuity criterion was low (2.4%), and the spatial resolution index was greater than for most French administrative areas. Our innovative approach improves interoperability between medical and ecological databases and facilitates fine-scale spatial analyses. We have shown that disaggregation models and large aggregation techniques are not necessarily the best ways to

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

PubMed

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.

Evaluation of 'SAEFVIC', A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia.

PubMed

Clothier, Hazel J; Crawford, Nigel W; Russell, Melissa; Kelly, Heath; Buttery, Jim P

2017-06-01

Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community). The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia. We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination. AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population. SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly

[Relevance of the hemovigilance regional database for the shared medical file identity server].

PubMed

Doly, A; Fressy, P; Garraud, O

2008-11-01

The French Health Products Safety Agency coordinates the national initiative of computerization of blood products traceability within regional blood banks and public and private hospitals. The Auvergne-Loire Regional French Blood Service, based in Saint-Etienne, together with a number of public hospitals set up a transfusion data network named EDITAL. After four years of progressive implementation and experimentation, a software enabling standardized data exchange has built up a regional nominative database, endorsed by the Traceability Computerization National Committee in 2004. This database now provides secured web access to a regional transfusion history enabling biologists and all hospital and family practitioners to take in charge the patient follow-up. By running independently from the softwares of its partners, EDITAL database provides reference for the regional identity server.

Economic burden of osteoporosis in women: data from the 2008 French hospital database (PMSI).

PubMed

Maravic, Milka; Jouaneton, Baptiste; Vainchtock, Alexandre; Tochon, Valerie

2012-01-01

To estimate the number and costs of hospitalisations associated with osteoporosis in France. Data for women aged 50 years and over were extracted from the 2008 French Hospital National Database. Criteria for acute care were established according to ICD-10 codes related to osteoporosis. As coding rules are not systematically used, an additional extraction which included surgical stays for hip fractures was performed in order to be more exhaustive. The two datasets were merged and duplicate stays excluded. Among women hospitalised in acute care during 2008, we selected those progressing to rehabilitation care within the year. We assessed the numbers of hospitalisations and women, proportion of surgical management, length of stay in acute care and numbers of rehabilitation days and costs. Hospital costs were calculated according to the National Hospital Tariff and National Scale of Costs, respectively, for acute and rehabilitation care based on 2009 tariffs. There were 67.807 hospitalisations (64.793 patients) associated with osteoporosis; 83% of total hospitalisations were in patients aged ≥75 years. A total of 80% of hospitalisations were associated with surgical management of fractures and 31.458 patients (49%) progressed from hospitalisation to rehabilitation. The mean ±SD length of stay was 12±8 days for hospitalisation and 43±31 days for rehabilitation care. The overall cost of hospitalisations was €415.4 million, of which 4.2% was related to medical devices. The overall cost of rehabilitation was €331.8 million. In 2008, postmenopausal osteoporosis was associated with a substantial economic burden at hospital in France.

Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance.

PubMed

Fornasier, G; Taborelli, M; Francescon, S; Polesel, J; Aliberti, M; De Paoli, P; Baldo, P

2018-05-21

Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance. Setting CRO Aviano, Italian National Cancer Institute. Method From February 2013 to April 2015, we conducted an observational study enrolling 154 patients (≥ 18 years) undergoing treatment with at least one of ten targeted-therapies included in the study. Main outcome ADR reporting in the real-world setting. Patient satisfaction with clinical pharmacist support. Results Reported ADRs in the real setting do not always correspond with data described in the respective SPCs. Unknown ADRs were also identified such as hyperglycaemia with lenalidomide and sorafenib; and hypomagnesaemia with bevacizumab. We also observed a 124.3% increase in spontaneous reports. Conclusion This study shows the high value of active pharmacovigilance programs, and our results might be a starting point for developing a randomised trial which should aim to demonstrate the impact of the pharmacist on improving patient's adherence and in measuring the difference in ADRs reports in the different arms followed or not by the pharmacist.

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review.

PubMed

Black, Corri; Tagiyeva-Milne, Nara; Helms, Peter; Moir, Dorothy

2015-10-01

A systematic review of the literature published in English over 10 years was undertaken in order to describe the use of electronic healthcare data in the identification of potential adverse drug reactions (ADRs) in children. MEDLINE and EMBASE were searched using MESH headings and text words. Titles, keywords and abstracts were checked for age <18 years, potential ADRs and electronic healthcare data. Information extracted included age, data source, pharmacovigilance method, medicines and ADRs. Studies were quality assessed. From 14 804 titles, 314 had a full text review and 71 were included in the final review. Fifty were published in North America, 10 in Scandinavia. Study size ranged from less than 1000 children to more than 10 million. Sixty per cent of studies used data from one source. Comparative observational studies were most commonly reported (66.2%) with 15% using passive surveillance. Electronic healthcare data set linkage and the quality of the data source were poorly reported. ADRs were classified using the International Classification of Disease (ICD10). Multi-system reactions were most commonly studied, followed by central nervous system and mental and behavioural disorders. Vaccines were most frequently prescribed followed by corticosteroids, general anaesthetics and antidepressants. Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children. This growing and important health protection activity could be enhanced by consistent reporting of studies to improve the identification, interpretation and generalizability of the evidence base. © 2015 The British Pharmacological Society.

Utilizing social media data for pharmacovigilance: A review.

PubMed

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

Utilizing Social Media Data for Pharmacovigilance: A Review

PubMed Central

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

Secondary Prevention Three and Six Years after Stroke Using the French National Insurance Healthcare System Database.

PubMed

Mechtouff, Laura; Haesebaert, Julie; Viprey, Marie; Tainturier, Valérie; Termoz, Anne; Porthault-Chatard, Sylvie; David, Jean-Stéphane; Derex, Laurent; Nighoghossian, Norbert; Schott, Anne-Marie

2018-05-14

Secondary prevention is inadequate in the first 2 years after stroke but what happens after that is less documented. The aim of this study was to assess the use and the adherence to preventive drugs 3 and 6 years after experiencing a transient ischemic attack (TIA) or an ischemic stroke (IS). The population study was from the AVC69 cohort (IS or TIA admitted in an emergency or stroke unit in the Rhône area, France, for an IS or a TIA during a 7-month period). Medication use was defined as ≥1 purchase during the studied year and adherence as Continuous Measure of Medication Acquisition ≥0.8 using the French medical insurance health care funding database. The study population consisted of 210 patients at 3 years and 163 patients at 6 years. Medication use at 3 and 6 years was, respectively, 80.9 and 79.8% for antithrombotics, 69.1 and 66.3% for antihypertensives, 60.5 and 55.2% for statins and 48.6 and 46.6% for optimal treatment defined as the treatment achieved by the use of the 3 drugs. Adherence to each class was good at 3 years and tends to decrease at 6 years. More than one patient out of 2 do not use the optimal preventive treatment. © 2018 S. Karger AG, Basel.

Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.

PubMed

Choonara, Imti

2013-05-01

Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

Standardized classification unsuitable for spontaneous reporting: the example of osteonecrosis of the jaw.

PubMed

de Boissieu, Paul; Trenque, Thierry

2015-07-01

This study assessed the impact of using a standardized definition of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the analysis of a spontaneous reporting database. All notifications of osteonecrosis of the jaw (ONJ) in the French National Pharmacovigilance Database as of 31 December 2013 were analyzed. First, we considered all reports of ONJ with bisphosphonates as BRONJ. Second, we applied the 2014 definition of BRONJ from the American Association of Oral and Maxillofacial Surgeons (AAOMS), retaining only bisphosphonates as antiresorptive medication. In the absence of any one of these criteria, or missing data, cases were not considered as BRONJ. The first analysis found 158 cases of ONJ, among which 153 were associated with bisphosphonate use. The second analysis identified only 43 cases of BRONJ (28.1%). The definition of BRONJ as laid down by the AAOMS is not suitable for use in spontaneous reporting database. The use of the AAOMS definition alone should be avoided, as it leads to the exclusion of over 70% of cases. When cases of ONJ are identified, all results should be presented including confirmed and excluded cases.

Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.

PubMed

Mosha, Dominic; Mazuguni, Festo; Mrema, Sigilbert; Abdulla, Salim; Genton, Blaise

2014-09-15

There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy. Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome. 1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08-0.3). Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.

False-positive results in pharmacoepidemiology and pharmacovigilance.

PubMed

Bezin, Julien; Bosco-Levy, Pauline; Pariente, Antoine

2017-09-01

False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing. If envisioning this problematic in the context of pharmacoepidemiology and pharmacovigilance however, that both evaluate drugs in an observational settings, information brought by statistical testing and the significance of such should only be considered as additional to the estimates provided and their confidence interval, in a context where differences have to be a clinically meaningful upon everything, and the results appear robust to the biases likely to have affected the studies. In the following article, we consequently illustrate these biases and their consequences in generating false-positive results, through studies and associations between drug use and health outcomes that have been widely disputed. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India.

PubMed

Tandon, Vishal R; Mahajan, Vivek; Khajuria, Vijay; Gillani, Zahid

2015-01-01

The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students. UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.

Pharmacovigilance in practice: erythropoiesis-stimulating agents.

PubMed

Hedenus, Michael; Ludwig, Heinz; Henry, David H; Gasal, Eduard

2014-10-01

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other problems related to medical products after they have been licensed for marketing. The purpose of PV is to advance the safe use of marketed medical products. Regulatory agencies and license holders collaborate to collect data reported by health care providers, patients, and the public as well as data from systematic reviews, meta-analyses, and individual clinical and nonclinical studies. They validate and analyze the data to determine whether safety signals exist, and if warranted, develop an action plan to mitigate the identified risk. Erythropoiesis-stimulating agents (ESAs) provide an example of how PV is applied in reality. Among other approved indications, ESAs may be used to treat anemia in patients with chemotherapy-induced anemia. ESAs increase hemoglobin levels and reduce the need for transfusions; they are also associated with a known increased risk of thromboembolic events. Starting in 2003, emerging data suggested that ESAs might reduce survival. As a result of PV activities by regulatory agencies and license holders, labeling for ESAs addresses these risks. Meta-analyses and individual clinical studies have confirmed that ESAs increase the risk of thromboembolic events, but when used as indicated, ESAs have not been shown to have a significant effect on survival or disease progression. Ongoing safety studies will provide additional data in the coming years to further clarify the risks and benefits of ESAs. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

A unique database for gathering data from a mobile app and medical prescription software: a useful data source to collect and analyse patient-reported outcomes of depression and anxiety symptoms.

PubMed

Watanabe, Yoshinori; Hirano, Yoko; Asami, Yuko; Okada, Maki; Fujita, Kazuya

2017-11-01

A unique database named 'AN-SAPO' was developed by Iwato Corp. and Japan Brain Corp. in collaboration with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes patients' depression/anxiety score data from a mobile app named AN-SAPO and medical records from medical prescription software named 'ORCA'. On the mobile app, depression/anxiety severity can be evaluated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together with the patients' medical records on ORCA. Currently, this database is used at the Himorogi Group's psychiatric clinics and has over 2000 patients' records accumulated since November 2013. Since the database covers patients' demographic data, prescribed drugs, and the efficacy and safety information, it could be a useful supporting tool for decision-making in clinical practice. We expect it to be utilised in wider areas of medical fields and for future pharmacovigilance and pharmacoepidemiological studies.

Predicting growth in English and French vocabulary: The facilitating effects of morphological and cognate awareness.

PubMed

D'Angelo, Nadia; Hipfner-Boucher, Kathleen; Chen, Xi

2017-07-01

The present study investigated the contribution of morphological and cognate awareness to the development of English and French vocabulary knowledge among young minority and majority language children who were enrolled in a French immersion program. Participating children (n = 75) were assessed in English and French on measures of morphological awareness, cognate awareness, and vocabulary knowledge from Grades 1 to 3. Hierarchical linear modeling was used to investigate linear trends in English and French vocabulary growth for minority and majority language children and to identify metalinguistic contributions to Grade 1 and Grade 3 English and French vocabulary performance and rate of growth. Results demonstrated a similar pattern of prediction for both groups of children. English and French morphological awareness and French-English cognate awareness significantly predicted concurrent and longitudinal vocabulary development after controlling for nonverbal reasoning, phonological awareness, and word identification. The contributions of morphological awareness to English vocabulary and cognate awareness to French vocabulary strengthened between Grades 1 and 2. These findings highlight the emerging importance of morphological and cognate awareness in children's vocabulary development and suggest that these metalinguistic factors can serve to broaden the vocabulary repertoire of children who enter school with limited language proficiency. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Triptans use and overuse: A pharmacoepidemiology study from the French health insurance system database covering 4.1 million people.

PubMed

Braunstein, David; Donnet, Anne; Pradel, Vincent; Sciortino, Vincent; Allaria-Lapierre, Véronique; Lantéri-Minet, Michel; Micallef, Joëlle

2015-11-01

The objective of this study was to estimate and to characterize the actual patterns of triptan use and overuse in France using a drug reimbursement database. We included all people covered by the French General Health Insurance System (GHIS) from the Provence-Alpes-Côte-d'Azur (PACA) and Corsica administrative areas who had at least one dispensed dose of triptans between May 2010 and December 2011. All dispensed doses of triptans, migraine prophylactic treatment and psychotropic medications were extracted from the GHIS database. Triptan overuse was defined as triptan use >20 defined daily doses (DDD) per month on a regular basis for more than three consecutive months. Risk of overuse was assessed using logistic regression adjusted for gender and age. We included 99,540 patients who had at least one prescription of a triptan over the 20 months of the study. Among them, 2243 patients (2.3%) were identified as overusers and received 20.2% of the total DDD prescribed. Twelve percent of overusers and 6.9% of non-overusers were aged more than 65 years (OR: 1.81). Overusers did not have a greater number of prescribers and pharmacists than non-overusers. They were more frequently prescribed a prophylactic medication for migraine treatment (56.8% vs 35.9%, OR: 2.36), benzodiazepines (69.9% vs 54.7%, OR: 1.93) and antidepressants (49.4% vs 30.2%, OR: 2.33). This work suggests that triptan overuse may be due to insufficient prescriber awareness of appropriate prescribing. The off-label prescription of triptans among the elderly necessitates investigating their cardiovascular risk profile in this sub-group. © International Headache Society 2015.

French Teaching Aids.

ERIC Educational Resources Information Center

Miller, J. Dale

Supplementary teaching materials for French language programs are presented in this text. Primarily intended for secondary school students, the study contains seven units of material. They include: (1) French gestures, (2) teaching the interrogative pronouns, (3) French cuisine, (4) recreational learning games, (5) French-English cognates, (6)…

French for Marketing. Using French in Media and Communications.

ERIC Educational Resources Information Center

Batchelor, R. E.; Chebli-Saadi, M.

The textbook, entirely in French, is designed to help prepare anglophone students for French language usage in the media and telecommunications. It is organized according to two major themes. The first part addresses the French of advertising; chapter topics include the actors in advertising (agencies, announcers, supports), forms of advertising,…

Pharmacovigilance in Europe and North America: divergent approaches.

PubMed

Wiktorowicz, Mary; Lexchin, Joel; Moscou, Kathy

2012-07-01

Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United States annually and are among the top 10 leading causes of death. Regulators are developing active surveillance approaches to assess the risks of medicines in the post-market phase to enhance passive adverse drug reaction reporting systems that capture only one to ten percent of ADRs. The objective of this study is to compare international approaches to active surveillance and the manner in which regulatory agencies access and use post-market evidence in their decisions. A conceptual framework is used to guide the comparative analysis of pharmacovigilance governance and policy in the United Kingdom, France, the European Union, the United States and Canada using data gathered from key informant interviews and document review. While research networks are emerging internationally, we found a greater reliance on industry funding and oversight of post-market research in Europe compared to an emphasis on publicly funded programs in North America. Copyright © 2012 Elsevier Ltd. All rights reserved.

Cardiovascular risk profile of patients with peripheral arterial occlusive disease during nilotinib therapy.

PubMed

Bondon-Guitton, E; Combret, S; Pérault-Pochat, M C; Stève-Dumont, M; Bagheri, H; Huguet, F; Despas, F; Pathak, A; Montastruc, J L

2016-08-01

Over the past few years, data have suggested that severe peripheral arterial occlusive disease (PAOD) is associated with nilotinib exposure. However, the characteristics of this adverse drug reaction are poorly described since its frequency is low. As far as we know, no study using a spontaneous adverse drug reactions reporting system was performed to describe the characteristics of cases of PAOD related to nilotinib. We performed a study to describe the cardiovascular risk profile of cases of PAOD in patients treated with nilotinib spontaneously reported to the French Pharmacovigilance Database (FPVD). We selected all cases of "vascular disorders," as the System Organ Class in MedDRA®, in which nilotinib was "suspected" and recorded in the French Pharmacovigilance Database between 2007 and 21 October 2014. We then identified cases of PAOD with a Low Level Term and through a detailed summary of the clinical description. We identified 25 cases of POAD. Most of the patients were older than 60 years (84 %) or had another cardiovascular risk factor such as hypercholesterolemia, arterial hypertension, overweight/obesity, smoking, or diabetes mellitus (72 %). Females (13 cases) and males (12 cases) were equally represented, but the presence of cardiovascular risk factors was more frequent in females than in males. The mean time from initiation of nilotinib to PAOD onset was 24 months and was significantly longer in patients aged less than 60 years compared with those aged over 60 years (33.8 ± 24.6 months vs. 22.6 ± 17.5 months, p = 0.002). Pre-existing cardiovascular risk factors, especially diabetes mellitus, also seem to accelerate its occurrence. The FPVD is a useful tool in describing the cardiovascular risk profile of patients with PAOD during nilotinib exposure. Physicians have to be particularly vigilant in patients older than 60 years of age; in patients younger than 60 years of age, long-term surveillance has to be maintained.

The French Revolution and the French Language: A Paradox?

ERIC Educational Resources Information Center

Djite, Paulin

1992-01-01

Explores the relationship between revolutionary ideals and the subsequent expansion and promotion of the French language. It is shown, through a linguistic and sociopolitical history of the French Revolution and the French language, that there is no incompatibility between the two and that the movement of Francophonie is a continuation of France's…

Adherence to Hypothermia Guidelines: A French Multicenter Study of Fullterm Neonates

PubMed Central

Chevallier, Marie; Ego, Anne; Cans, Christine; Debillon, Thierry

2013-01-01

Aim The objective of this study was to describe the French practice of hypothermia treatment (HT) in full-term newborns with hypoxic-ischemic encephalopathy (HIE) and to analyze the deviations from the guidelines of the French Society of Neonatology. Materials and Methods From May 2010 to March 2012 we recorded all cases of HIE treated by HT in a French national database. The population was divided into three groups, "optimal HT" (OHT), “late HT” (LHT) and “non-indicated” HT (NIHT), according to the guidelines. Results Of the 311 newborns registered in the database and having HT, 65% were classified in the OHT group, 22% and 13% in the LHT and NIHT groups respectively. The severity of asphyxia and HIE were comparable between newborns with OHT and LHT, apart from EEG. HT was initiated at a mean time of 12 hours of life in the LHT group. An acute obstetrical event was more likely to be identified among newborns with LHT (46%), compared to OHT (34%) and NIHT (22%). There was a gradation in the rate of complications from the NIHT group (29%) to the LHT (38%) group and the OHT group (52%). Despite an insignificant difference in the rates of death or abnormal neurological examination at discharge, nearly 60% of newborns in the OHT group had an MRI showing abnormalities, compared to 44% and 49% in the LHT and NIHT groups respectively. Conclusion The conduct of the HT for HIE newborns is not consistent with French guidelines for 35% of newborns, 22% being explained by an excessive delay in the start of HT, 13% by the lack of adherence to the clinical indications. This first report illustrates the difficulties in implementing guidelines for HT and should argue for an optimization of perinatal care for HIE. PMID:24391817

French vertical-flow constructed wetland design: adaptations for tropical climates.

PubMed

Molle, P; Latune, R Lombard; Riegel, C; Lacombe, G; Esser, D; Mangeot, L

2015-01-01

The French Outermost Regions are under tropical climate yet still have to comply with both French and EU regulations. French vertical-flow constructed wetland systems appear well adapted to the technical specifics of these regions but their adaptation to tropical climate requires new design guidelines to be defined (area needed, number of filters, type of plants, material to be used, etc.). A study was started in 2008, with backing from the national water authorities, to implement full-scale experimental sites and assess the impacts of local context on design and performances. This paper reports the monitoring results on three vertical-flow constructed wetlands fed directly with raw wastewater (known as the 'French system') in Mayotte and French Guiana. The plants, now in operation for between 1 and 6 years, range from 160 to 480 population equivalent (p.e.). Monitoring consisted of 28 daily composite flow samples in different seasons (dry season, rainy season) at the inlet and outlet of each filter. Performances are benchmarked against French mainland area standards from Irstea's database. Results show that performances are improved by warmer temperature for chemical oxygen demand (COD), suspended solids (SS) and total Kjeldahl nitrogen (TKN) and satisfy national quality objectives with a single stage of filters. Treatment plant footprint can thus be reduced as only two parallel filters are needed. Indeed, warm temperatures allow faster mineralization of the sludge deposit, making it possible to operate at similar rest and feeding period durations. Systems operated using one twin-filter stage can achieve over 90% COD, SS and TKN removal for a total surface of 0.8 m²/p.e.

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India

PubMed Central

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. PMID:25523367

Eco-pharmacovigilance of non-steroidal anti-inflammatory drugs: Necessity and opportunities.

PubMed

He, Bing-Shu; Wang, Jun; Liu, Juan; Hu, Xia-Min

2017-08-01

Eco-pharmacovigilance (EPV) is a practical and powerful approach to minimize the potential risks posed by pharmaceutical residues in environment. However, it is impracticable to practise rigorous and unitary EPV process for all the existing and new pharmaceuticals. Here, we focused on non-steroidal anti-inflammatory drugs (NSAIDs), and discussed the necessity and potential opportunities of practising EPV of NSAIDs. We found that the consumption of NSAIDs is huge and ubiquitous across the globe. NSAIDs were worldwidely reported as one of the most dominant and frequently detected groups in environmental matrices including wastewater, surface water, suspended solids, sediments, groundwater, even drinking water. Besides, there is definitive evidence for the adverse impacts of NSAID residues on scavenging birds and aquatic species. These data suggested the necessity of implementing EPV of NSAIDs. From the perspective of drug administration, we identified some things that can be done as management practice options for EPV implementation on NSAIDs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Potentially inappropriate drug prescription in the elderly in France: a population-based study from the French National Insurance Healthcare system.

PubMed

Bongue, B; Laroche, M L; Gutton, S; Colvez, A; Guéguen, R; Moulin, J J; Merle, L

2011-12-01

Inappropriate prescribing is a known risk factor for adverse drug event occurrence in the elderly. In various countries, several studies have used insurance healthcare databases to estimate the national prevalence of potentially inappropriate medications (PIM) in the elderly, as defined by explicit PIM lists. Recently, a representative sample of the French National Insurance Healthcare database, known as the "Echantillon Généraliste des Bénéficiaires" (EGB), was created, making it possible to assess the quality of drug prescription in France. Our objective was to evaluate the prevalence and the regional distribution of PIM prescription in the elderly aged 75 years and over in France, using the French PIM list and the EGB database. The list of drugs reimbursed to patients aged 75 years and over from 1 March 2007 to 29 February 2008 was extracted from the EGB. Drugs were classified as inappropriate using the French PIM list. A PIM user was defined as a person receiving at least one PIM reimbursement during the study period. Interregion variability was estimated from logistic regression. In 53.6% (95% CI: 53.0-54.1) of the elderly aged 75 years and over, at least one PIM was given during the study period. The three main drug groups identified were cerebral vasodilators (19.4%), drugs with antimuscarinic properties (19.3%), and long half-life benzodiazepines (17.8%). There was an important disparity in PIM prescription among the French regions. In 14 out of 22 regions, the risk of PIM prescription was significantly elevated. This geographical variation differed for the different drug groups. PIM prescription in the elderly is a major and worrying problem in France. As in other countries, recent accessibility of the National Insurance Healthcare database makes it possible to create local indicators that the regional health agencies could use to manage public health policy in closer alignment to the needs of the patients within each French region.

Sugar composition of French royal jelly for comparison with commercial and artificial sugar samples.

PubMed

Daniele, Gaëlle; Casabianca, Hervé

2012-09-15

A gas chromatographic method was developed to quantify the major and minor sugars of 400 Royal Jellies (RJs). Their contents were compared in relation to the geographical origins and different production methods. A reliable database was established from the analysis of 290 RJs harvested in different French areas that took into account the diversity of geographical origin, harvesting season, forage sources available in the environment corresponding to natural food of the bees: pollen and nectar. Around 30 RJ samples produced by Italian beekeepers, about sixty-ones from French market, and around thirty-ones derived from feeding experiments were analysed and compared with our database. Fructose and glucose contents are in the range 2.3-7.8% and 3.4-7.7%, respectively, whatever the RJ's origin. On the contrary, differences in minor sugar composition are observed. Indeed sucrose and erlose contents in French RJs are lesser than 1.7% and 0.3%, respectively, whereas they reach 3.9% and 2.0% in some commercial samples and 5.1% and 1.7% in RJs produced from feeding experiments. This study could be used to discriminate different production methods and provide an additional tool for identifying unknown commercial RJs. Copyright © 2012 Elsevier Ltd. All rights reserved.

Unplanned medication discontinuation as a potential pharmacovigilance signal: a nested young person cohort study

PubMed Central

2014-01-01

Background Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people. Methods Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation. Results During the study period, 79 patients were prescribed orlistat (81% female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52% and 77% at 1 and 3-months. Almost 20% of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1–2 compared to SIMD 9–10 OR 0.09 (95% CI0.01 – 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (≥17 yr versus, OR 3.07 (95% CI1.03 – 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24% of patients. Urinary retention was reported for 7.6% of patients. Conclusions Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people. PMID:24594374

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

PubMed

Permanand, Govin; Mossialos, Elias; McKee, Martin

2006-01-01

Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), 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.

Comparing Written Competency in Core French and French Immersion Graduates

ERIC Educational Resources Information Center

Lappin-Fortin, Kerry

2014-01-01

Few studies have compared the written competency of French immersion students and their core French peers, and research on these learners at a postsecondary level is even scarcer. My corpus consists of writing samples from 255 students from both backgrounds beginning a university course in French language. The writing proficiency of core French…

Regional and latitudinal patterns of soft-bottom macrobenthic invertebrates along French coasts: Results from the RESOMAR database

NASA Astrophysics Data System (ADS)

Gallon, Régis K.; Lavesque, Nicolas; Grall, Jacques; Labrune, Céline; Gremare, Antoine; Bachelet, Guy; Blanchet, Hugues; Bonifácio, Paulo; Bouchet, Vincent M. P.; Dauvin, Jean-Claude; Desroy, Nicolas; Gentil, Franck; Guerin, Laurent; Houbin, Céline; Jourde, Jérôme; Laurand, Sandrine; Le Duff, Michel; Le Garrec, Vincent; de Montaudouin, Xavier; Olivier, Frédéric; Orvain, Francis; Sauriau, Pierre-Guy; Thiebaut, Éric; Gauthier, Olivier

2017-12-01

This study aims to describe the patterns of soft bottom macrozoobenthic richness along French coasts. It is based on a collaborative database developed by the "Réseau des Stations et Observatoires Marins" (RESOMAR). We investigated patterns of species richness in sublittoral soft bottom habitats (EUNIS level 3) at two different spatial scales: 1) seaboards: English Channel, Bay of Biscay and Mediterranean Sea and 2) 0.5° latitudinal and longitudinal grid. Total observed richness, rarefaction curves and three incidence-based richness estimators (Chao2, ICE and Jacknife1) were used to compare soft bottom habitats species richness in each seaboard. Overall, the Mediterranean Sea has the highest richness and despite higher sampling effort, the English Channel hosts the lowest number of species. The distribution of species occurrence within and between seaboards was assessed for each major phylum using constrained rarefaction curves. The Mediterranean Sea hosts the highest number of exclusive species. In pairwise comparisons, it also shares a lower proportion of taxa with the Bay of Biscay (34.1%) or the English Channel (27.6%) than that shared between these two seaboards (49.7%). Latitudinal species richness patterns along the Atlantic and English Channel coasts were investigated for each major phylum using partial LOESS regression controlling for sampling effort. This showed the existence of a bell-shaped latitudinal pattern, highlighting Brittany as a hotspot for macrobenthic richness at the confluence of two biogeographic provinces.

SPOT 5/HRS: A Key Source for Navigation Database

DTIC Science & Technology

2003-09-02

SUBTITLE SPOT 5 / HRS: A Key Source for Navigation Database 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT ......strategic objective. Nice data ….. What after ?? Filière SPOT Marc BERNARD Page 15 Producing from HRS u Partnership with IGN ( French

Two centuries of French patents as documentation of musical instrument construction

NASA Astrophysics Data System (ADS)

Jean, Haury

2005-09-01

The French Patent Office I.N.P.I. has preserved the originals of ca. 12000 French patents filed between 1791 and present days that are concerned with music-related inventions. As an I.N.P.I. pilot project, these were identified, collected, and classified by the present author, and the actual database named ``Musique & Brevets'' is going to be expanded with English, American, and German material, bringing currently a knowledge base up to 1900. It is expected to be made available on an I.N.P.I. website. This is an unequaled initiative that covers all branches of musical instrument manufacture, mechanical musical instruments, early recording and reproducing of music, but also educational material and methods for printing music. There already exists a number of websites presenting inventions on musical instruments, but these are restricted to one particular instrument and its related patents. ``Musique & Brevets'' intends to be exhaustive and make links between patents filed in different countries at the same time. The paper will present the content of the database, the access to texts and drawings of the patents via specific links, and their importance for the study of history and construction of musical instruments.

The mini mental state examination at the time of Alzheimer's disease and related disorders diagnosis, according to age, education, gender and place of residence: a cross-sectional study among the French National Alzheimer database.

PubMed

Pradier, Christian; Sakarovitch, Charlotte; Le Duff, Franck; Layese, Richard; Metelkina, Asya; Anthony, Sabine; Tifratene, Karim; Robert, Philippe

2014-01-01

was firstly to describe the MMSE (Mini-Mental State Examination) score upon initial diagnosis of Alzheimer's disease and related disorders among the French population, according to age. Secondly, education, gender and place of residence were studied as factors potentially associated with delayed Alzheimer's disease diagnosis. we conducted a cross sectional analysis of the French National Alzheimer database (BNA). Data from 2008 to 2012 were extracted. Patients were selected at the moment of their first diagnosis of AD (n = 39,451). The MMSE score at initial diagnosis dropped significantly with increasing age. The test score increased with the degree of educational background regardless of age. Gender and place of residence were significantly related to the MMSE score, women and persons living in medical institutions having lower MMSE scores under the age of 90 years and at all educational levels. Health care professionals should be aware of these risk factors in order to maximize chances of earliest possible diagnosis of Alzheimer's disease and related disorders.

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

PubMed

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

2012-01-01

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. A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. 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). 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 introduce less toxic first-line ARV regimens

Invitation Refusals in Cameroon French and Hexagonal French

ERIC Educational Resources Information Center

Farenkia, Bernard Mulo

2015-01-01

Descriptions of regional pragmatic variation in French are lacking to date the focus has been on a limited range of speech acts, including apologies, requests, compliments and responses to compliments. The present paper, a systematic analysis of invitation refusals across regional varieties of French, is designed to add to the research on…

The first successful use of a low stringency familial match in a French criminal investigation.

PubMed

Pham-Hoai, Emmanuel; Crispino, Frank; Hampikian, Greg

2014-05-01

We describe how a very simple application of familial searching resolved a decade-old, high-profile rape/murder in France. This was the first use of familial searching in a criminal case using the French STR DNA database, which contains approximately 1,800,000 profiles. When an unknown forensic profile (18 loci) was searched against the French arrestee/offender database using CODIS configured for a low stringency search, a single low stringency match was identified. This profile was attributed to the father of the man suspected to be the source of the semen recovered from the murder victim Elodie Kulik. The identification was confirmed using Y-chromosome DNA from the putative father, an STR profile from the mother, and finally a tissue sample from the exhumed body of the man who left the semen. Because of this identification, the investigators are now pursuing possible co-conspirators. © 2014 American Academy of Forensic Sciences.

A new data management system for the French National Registry of human alveolar echinococcosis cases.

PubMed

Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

2014-01-01

Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries. © A. Charbonnier et al., published by EDP Sciences, 2014.

A new data management system for the French National Registry of human alveolar echinococcosis cases

PubMed Central

Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

2014-01-01

Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries. PMID:25526544

Impact of Resident Rotations on Critically Ill Patient Outcomes: Results of a French Multicenter Observational Study.

PubMed

Chousterman, Benjamin G; Pirracchio, Romain; Guidet, Bertrand; Aegerter, Philippe; Mentec, Hervé

2016-01-01

The impact of resident rotation on patient outcomes in the intensive care unit (ICU) has been poorly studied. The aim of this study was to address this question using a large ICU database. We retrospectively analyzed the French CUB-REA database. French residents rotate every six months. Two periods were compared: the first (POST) and fifth (PRE) months of the rotation. The primary endpoint was ICU mortality. The secondary endpoints were the length of ICU stay (LOS), the number of organ supports, and the duration of mechanical ventilation (DMV). The impact of resident rotation was explored using multivariate regression, classification tree and random forest models. 262,772 patients were included between 1996 and 2010 in the database. The patient characteristics were similar between the PRE (n = 44,431) and POST (n = 49,979) periods. Multivariate analysis did not reveal any impact of resident rotation on ICU mortality (OR = 1.01, 95% CI = 0.94; 1.07, p = 0.91). Based on the classification trees, the SAPS II and the number of organ failures were the strongest predictors of ICU mortality. In the less severe patients (SAPS II<24), the POST period was associated with increased mortality (OR = 1.65, 95%CI = 1.17-2.33, p = 0.004). After adjustment, no significant association was observed between the rotation period and the LOS, the number of organ supports, or the DMV. Resident rotation exerts no impact on overall ICU mortality at French teaching hospitals but might affect the prognosis of less severe ICU patients. Surveillance should be reinforced when treating those patients.

Inhibitor development in patients receiving recombinant factor VIII (Recombinate rAHF/Bioclate): a prospective pharmacovigilance study.

PubMed

Ewenstein, B M; Gomperts, E D; Pearson, S; O'Banion, M E

2004-09-01

Clinical trials to date have not been adequately powered to assess comparatively infrequent events such as inhibitor development in previously treated patients (PTPs). Comprehensive large-scale pharmacovigilance studies can be useful for this purpose. We prospectively collected inhibitor development reports worldwide among recipients of Recombinate rAHF recombinant factor VIII (rFVIII), also formerly distributed under the product name Bioclate, for the entire postlicensure period from 1993 through 2002. To determine level of exposure to rFVIII we also compiled the Recombinate rAHF/Bioclate International Units (IU) distributed annually. To estimate inhibitor incidence separately for previously untreated or minimally treated patients (PUPs) with 1-50 exposure days and PTPs with >50 exposure days, we used haemophilia A incidence and prevalence data and pooled mean annual rFVIII consumption per PUP and PTP from international multicentre prospective clinical trials. Documented inhibitor cases totalled 89, and the total quantity of Recombinate rAHF/Bioclate rFVIII distributed was 6.48 x10(9) IU. No lot association or other clustering of inhibitor events was evident in PTPs. The incidence of all reported inhibitors, expressed as a percentage of patients treated, was 11.9% (CI: 5.05-28.0%) for PUPs when compared with 0.123% (CI: 0.030-0.512%) for PTPs. The rates for high-titre inhibitors (>5 BU) only were 5.96% (CI: 3.00-11.8%) for PUPs and 0.0554% (CI: 0.0113-0.271%) for PTPs. Thus, incidence rates for both all inhibitors and high-titre inhibitors in PTPs were 1% of the corresponding rates in PUPs. Data from prospective PUP clinical trials involving intensive active monitoring suggest that true inhibitor incidence may be approximately twice that estimated in this pharmacovigilance study. Nevertheless, inhibitor development in PTPs receiving Recombinate rAHF/Bioclate is infrequent.

Mining Adverse Drug Reactions in Social Media with Named Entity Recognition and Semantic Methods.

PubMed

Chen, Xiaoyi; Deldossi, Myrtille; Aboukhamis, Rim; Faviez, Carole; Dahamna, Badisse; Karapetiantz, Pierre; Guenegou-Arnoux, Armelle; Girardeau, Yannick; Guillemin-Lanne, Sylvie; Lillo-Le-Louët, Agnès; Texier, Nathalie; Burgun, Anita; Katsahian, Sandrine

2017-01-01

Suspected adverse drug reactions (ADR) reported by patients through social media can be a complementary source to current pharmacovigilance systems. However, the performance of text mining tools applied to social media text data to discover ADRs needs to be evaluated. In this paper, we introduce the approach developed to mine ADR from French social media. A protocol of evaluation is highlighted, which includes a detailed sample size determination and evaluation corpus constitution. Our text mining approach provided very encouraging preliminary results with F-measures of 0.94 and 0.81 for recognition of drugs and symptoms respectively, and with F-measure of 0.70 for ADR detection. Therefore, this approach is promising for downstream pharmacovigilance analysis.

French Nuclear Forces,

DTIC Science & Technology

1984-05-05

integrated military structure of NATO. This paper briefly reviews French declaratory strategy, ex- plores France’s current and projected force structure, 2...major tendgn- cies in French foreign policy--independent, European, and Atlanticist--without forcing a choice between them. It per- mits France to... French politics, while they admit France m enjoys widespread agreement on defense issues, question the 0 C depth of the consensus. For example, Pierre

The French Strategic Dilemma.

DTIC Science & Technology

1984-03-01

THE FRENCH STRATEGIC DILEMMA This paper identifies a basic strategic dilemma for France . On the one hand, French leaders identify the political purpose...are inducing a need for France to provide a more explicit definition of the role of French nuclear weapons in the West European security system. In...defense policy in France . This section concludes with an assessment of the alternative scenarios for the evolution of French defense policy in the 1980s

Learning to Read in English and French: Emergent Readers in French Immersion

ERIC Educational Resources Information Center

Chung, Sheila Cira; Koh, Poh Wee; Deacon, S. Hélène; Chen, Xi

2017-01-01

This longitudinal study investigated the predictors of word reading in English and French for 69 children in early total French immersion from first through third grade. The influence of phonological awareness, orthographic processing, and vocabulary in English and French on the achievement and growth of word reading in the 2 languages were…

The French Revolution on Film: American and French Perspectives

ERIC Educational Resources Information Center

Harison, Casey

2005-01-01

It is not hard to locate negative or condescending images of the French Revolution in aspects of popular American culture, including film. Despite a handful of instances where nuanced or ambiguous "messages" may be identified, the number of American film interpretations of the French Revolution that might be judged historically…

An experimental investigation of masking in the US FDA adverse event reporting system database.

PubMed

Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred

2010-12-01

A phenomenon of 'masking' or 'cloaking' in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database. To explore the nature, extent and possible consequences of masking in the US FDA Adverse Event Reporting System (AERS) database by applying various experimental unmasking protocols to a set of drugs and events representing realistic pharmacovigilance analysis conditions. This study employed AERS data from 2001 through 2005. For a set of 63 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs), disproportionality analysis was carried out with respect to all drugs included in the AERS database, using a previously described urn-model-based algorithm. We specifically sought masking in which drug removal induced an increase in the statistical representation of a drug-event combination (DEC) that resulted in the emergence of a new SDR. We performed a series of unmasking experiments selecting drugs for removal using rational statistical decision rules based on the requirement of a reporting ratio (RR) >1, top-ranked statistical unexpectedness (SU) and relatedness as reflected in the WHO Anatomical Therapeutic Chemical level 4 (ATC4) grouping. In order to assess the possible extent of residual masking we performed two supplemental purely empirical analyses on a limited subset of data. This entailed testing every drug and drug group to determine which was most influential in uncovering masked SDRs. We assessed the strength of external evidence for a causal association for a small number of masked SDRs involving a subset of 29 drugs for which level of evidence

A search engine to access PubMed monolingual subsets: proof of concept and evaluation in French.

PubMed

Griffon, Nicolas; Schuers, Matthieu; Soualmia, Lina Fatima; Grosjean, Julien; Kerdelhué, Gaétan; Kergourlay, Ivan; Dahamna, Badisse; Darmoni, Stéfan Jacques

2014-12-01

PubMed contains numerous articles in languages other than English. However, existing solutions to access these articles in the language in which they were written remain unconvincing. The aim of this study was to propose a practical search engine, called Multilingual PubMed, which will permit access to a PubMed subset in 1 language and to evaluate the precision and coverage for the French version (Multilingual PubMed-French). To create this tool, translations of MeSH were enriched (eg, adding synonyms and translations in French) and integrated into a terminology portal. PubMed subsets in several European languages were also added to our database using a dedicated parser. The response time for the generic semantic search engine was evaluated for simple queries. BabelMeSH, Multilingual PubMed-French, and 3 different PubMed strategies were compared by searching for literature in French. Precision and coverage were measured for 20 randomly selected queries. The results were evaluated as relevant to title and abstract, the evaluator being blind to search strategy. More than 650,000 PubMed citations in French were integrated into the Multilingual PubMed-French information system. The response times were all below the threshold defined for usability (2 seconds). Two search strategies (Multilingual PubMed-French and 1 PubMed strategy) showed high precision (0.93 and 0.97, respectively), but coverage was 4 times higher for Multilingual PubMed-French. It is now possible to freely access biomedical literature using a practical search tool in French. This tool will be of particular interest for health professionals and other end users who do not read or query sufficiently in English. The information system is theoretically well suited to expand the approach to other European languages, such as German, Spanish, Norwegian, and Portuguese.

A Search Engine to Access PubMed Monolingual Subsets: Proof of Concept and Evaluation in French

PubMed Central

Schuers, Matthieu; Soualmia, Lina Fatima; Grosjean, Julien; Kerdelhué, Gaétan; Kergourlay, Ivan; Dahamna, Badisse; Darmoni, Stéfan Jacques

2014-01-01

Background PubMed contains numerous articles in languages other than English. However, existing solutions to access these articles in the language in which they were written remain unconvincing. Objective The aim of this study was to propose a practical search engine, called Multilingual PubMed, which will permit access to a PubMed subset in 1 language and to evaluate the precision and coverage for the French version (Multilingual PubMed-French). Methods To create this tool, translations of MeSH were enriched (eg, adding synonyms and translations in French) and integrated into a terminology portal. PubMed subsets in several European languages were also added to our database using a dedicated parser. The response time for the generic semantic search engine was evaluated for simple queries. BabelMeSH, Multilingual PubMed-French, and 3 different PubMed strategies were compared by searching for literature in French. Precision and coverage were measured for 20 randomly selected queries. The results were evaluated as relevant to title and abstract, the evaluator being blind to search strategy. Results More than 650,000 PubMed citations in French were integrated into the Multilingual PubMed-French information system. The response times were all below the threshold defined for usability (2 seconds). Two search strategies (Multilingual PubMed-French and 1 PubMed strategy) showed high precision (0.93 and 0.97, respectively), but coverage was 4 times higher for Multilingual PubMed-French. Conclusions It is now possible to freely access biomedical literature using a practical search tool in French. This tool will be of particular interest for health professionals and other end users who do not read or query sufficiently in English. The information system is theoretically well suited to expand the approach to other European languages, such as German, Spanish, Norwegian, and Portuguese. PMID:25448528

Structural Validation of a French Food Frequency Questionnaire of 94 Items.

PubMed

Gazan, Rozenn; Vieux, Florent; Darmon, Nicole; Maillot, Matthieu

2017-01-01

Food frequency questionnaires (FFQs) are used to estimate the usual food and nutrient intakes over a period of time. Such estimates can suffer from measurement errors, either due to bias induced by respondent's answers or to errors induced by the structure of the questionnaire (e.g., using a limited number of food items and an aggregated food database with average portion sizes). The "structural validation" presented in this study aims to isolate and quantify the impact of the inherent structure of a FFQ on the estimation of food and nutrient intakes, independently of respondent's perception of the questionnaire. A semi-quantitative FFQ ( n  = 94 items, including 50 items with questions on portion sizes) and an associated aggregated food composition database (named the item-composition database) were developed, based on the self-reported weekly dietary records of 1918 adults (18-79 years-old) in the French Individual and National Dietary Survey 2 (INCA2), and the French CIQUAL 2013 food-composition database of all the foods ( n  = 1342 foods) declared as consumed in the population. Reference intakes of foods ("REF_FOOD") and nutrients ("REF_NUT") were calculated for each adult using the food-composition database and the amounts of foods self-reported in his/her dietary record. Then, answers to the FFQ were simulated for each adult based on his/her self-reported dietary record. "FFQ_FOOD" and "FFQ_NUT" intakes were estimated using the simulated answers and the item-composition database. Measurement errors (in %), spearman correlations and cross-classification were used to compare "REF_FOOD" with "FFQ_FOOD" and "REF_NUT" with "FFQ_NUT". Compared to "REF_NUT," "FFQ_NUT" total quantity and total energy intake were underestimated on average by 198 g/day and 666 kJ/day, respectively. "FFQ_FOOD" intakes were well estimated for starches, underestimated for most of the subgroups, and overestimated for some subgroups, in particular vegetables. Underestimation were

French Dictionaries. Series: Specialised Bibliographies.

ERIC Educational Resources Information Center

Klaar, R. M.

This is a list of French monolingual, French-English and English-French dictionaries available in December 1975. Dictionaries of etymology, phonetics, place names, proper names, and slang are included, as well as dictionaries for children and dictionaries of Belgian, Canadian, and Swiss French. Most other specialized dictionaries, encyclopedias,…

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

PubMed

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.

French MALE UAV Program

DTIC Science & Technology

2003-09-02

ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) MoD- France 8...1French Air Force MINISTÈRE DE LA DÉFENSE 1 SIDM CONOPS 2 FAF IMAGERY ARCHITECTURE 3 FUTURE FRENCH MALE UAV PROGRAM FRENCH MALE UAV PROGRAM Report...2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE French Male UAV Program 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM

Descriptive analysis and comparison of two French occupational exposure databases: COLCHIC and SCOLA.

PubMed

Mater, Gautier; Paris, Christophe; Lavoué, Jérôme

2016-05-01

Several countries have built databases of occupational hygiene measurements. In France, COLCHIC and SCOLA co-exist, started in 1987 and 2007, respectively. A descriptive comparison of the content of the two databases was carried out during the period 1987-2012, including variables, workplaces and agents, as well as exposure levels. COLCHIC and SCOLA contain, respectively, 841,682 (670 chemicals) and 152,486 records (70). They cover similar industries and occupations, and contain the same ancillary information. Across 17 common agents with >500 samples, the ratio of the median concentration in COLCHIC to the median concentration in SCOLA was 3.45 [1.03-14.3] during 2007-2012. This pattern remained when stratified by industry, task, and occupation, but was attenuated when restricted to similar sampling duration. COLCHIC and SCOLA represent a considerable source of information, but result from different purposes (prevention, regulatory). Potential differences due to strategies should evaluated when interpreting data from these databases. © 2016 Wiley Periodicals, Inc.

Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

PubMed

Haas, Jennifer S; Amato, Mary; Marinacci, Lucas; Orav, E John; Schiff, Gordon D; Bates, David W

2012-08-01

While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. Compared with the package insert, patients taking zolpidem were significantly (p < 0.001) more likely to report fatigue (9.0% vs 1.0%), itching (4.5% vs 1.0%) and muscle aches (5.6% vs 1.0%). Elicited rates of depression and hallucination were similar to those reported in the package insert. Patients taking varenicline were significantly more likely to report confusion (1.7% vs 0.1%), depression (3.4% vs 0.1%), fatigue (6.0% vs 1.0%), hallucinations (1.7% vs 0.1%), muscle aches (6.0% vs 1.0%) and sexual dysfunction (4.3% vs 0.1%). Automated phone pharmacovigilance can provide estimates of possible ADEs in clinical practice. In the case of varenicline, these data support some of the safety concerns that have come to light postmarketing, while others such as depression and hallucination related to zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs

Development of Gender Typicality and Felt Pressure in European French and North African French Adolescents.

PubMed

Hoffman, Adam J; Dumas, Florence; Loose, Florence; Smeding, Annique; Kurtz-Costes, Beth; Régner, Isabelle

2017-11-14

Trajectories of gender identity were examined from Grade 6 (M age  = 11.9 years) to Grade 9 in European French (n = 570) and North African French (n = 534) adolescents, and gender and ethnic group differences were assessed in these trajectories. In Grade 6, boys of both ethnic groups reported higher levels of gender typicality and felt pressure for gender conformity than girls. European French girls and boys and North African French girls reported decreasing gender typicality from Grade 6 to Grade 9, whereas North African French boys did not change. Felt pressure decreased among girls, did not change in European French boys, and increased in North African French boys. Ethnic and gender differences in gender identity development are discussed. © 2017 The Authors. Child Development © 2017 Society for Research in Child Development, Inc.

What can we learn from parents about enhancing participation in pharmacovigilance?

PubMed Central

Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L; Turner, Mark A; Young, Bridget

2013-01-01

Aims To investigate parents' views and experiences of direct reporting of a suspected ADR in their child. Methods We audio-recorded semi-structured qualitative interviews with parents of children with suspected ADRs. Our sample included parents with (n = 17) and without (n = 27) previous experience of submitting a Yellow Card. Results Parents in both groups described poor awareness of the Yellow Card Scheme. Parents who had participated in the Yellow Card Scheme were generally happy to report their child's ADR via the Scheme and valued the opportunity to report concerns independently of health practitioners. They expressed motivations for reporting that have not previously been described linked to the parental role, including how registering a concern about a medicine helped to resolve uncomfortable feelings about their child's ADR. Parents who had not previously submitted a Yellow Card expressed uncertainty about the legitimacy of their involvement in reporting and doubts about the value of the information that they could provide. Conclusion Promoting wider participation in pharmacovigilance schemes will depend on raising public awareness. Additionally, our findings point to the need to empower lay people to submitting reports and to reassure them about the value of their reports. PMID:22905902

Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

PubMed

van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C

2007-03-01

Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project

PubMed Central

Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M.; Corripio, Iluminada; Aguilar, Eduardo J.; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J.

2016-01-01

Background: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Methods: Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. Results: The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). Conclusions: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. PMID:26506856

Evaluation of the French Immersion Weekends, French Centre, University of Calgary, 1979-80.

ERIC Educational Resources Information Center

Klinck, Patricia

Four French immersion weekends for continuing education students at the University of Calgary were evaluated. Each weekend involved recreational activities for twenty students and four French-speaking monitors at one of two recreational retreats near Calgary. The purpose of the program was to promote fluency in French by encouraging its use in a…

SyllabO+: A new tool to study sublexical phenomena in spoken Quebec French.

PubMed

Bédard, Pascale; Audet, Anne-Marie; Drouin, Patrick; Roy, Johanna-Pascale; Rivard, Julie; Tremblay, Pascale

2017-10-01

Sublexical phonotactic regularities in language have a major impact on language development, as well as on speech processing and production throughout the entire lifespan. To understand the impact of phonotactic regularities on speech and language functions at the behavioral and neural levels, it is essential to have access to oral language corpora to study these complex phenomena in different languages. Yet, probably because of their complexity, oral language corpora remain less common than written language corpora. This article presents the first corpus and database of spoken Quebec French syllables and phones: SyllabO+. This corpus contains phonetic transcriptions of over 300,000 syllables (over 690,000 phones) extracted from recordings of 184 healthy adult native Quebec French speakers, ranging in age from 20 to 97 years. To ensure the representativeness of the corpus, these recordings were made in both formal and familiar communication contexts. Phonotactic distributional statistics (e.g., syllable and co-occurrence frequencies, percentages, percentile ranks, transition probabilities, and pointwise mutual information) were computed from the corpus. An open-access online application to search the database was developed, and is available at www.speechneurolab.ca/syllabo . In this article, we present a brief overview of the corpus, as well as the syllable and phone databases, and we discuss their practical applications in various fields of research, including cognitive neuroscience, psycholinguistics, neurolinguistics, experimental psychology, phonetics, and phonology. Nonacademic practical applications are also discussed, including uses in speech-language pathology.

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

PubMed

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

The Development of French Nuclear Forces

DTIC Science & Technology

1987-11-01

4.1 a rc I -MM RON -- .’-.U . . tn L) L- _*z T M - N EppCV :c 4:-ea THE DEVELOPMENT OF FRENCH NUCLEAR FORCES SMEEC TEV46 P 1 9 1988 Martin J. Wisda...TABLES 1. Transformation of the French Nuclear Force ..... . 100 2. Characteristics of French Nucleac Weapons . . .. 01 3. French Defense Expenditures...pap-er is to examine how and why the French undertook the development of their own nuclear force and through this examination, argue that the French

Drug–drug interactions with imatinib

PubMed Central

Récoché, Isabelle; Rousseau, Vanessa; Bourrel, Robert; Lapeyre-Mestre, Maryse; Chebane, Leila; Despas, Fabien; Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle

2016-01-01

Abstract Many patients treated with imatinib, used in cancer treatment, are using several other drugs that could interact with imatinib. Our aim was to study all the drug–drug interactions (DDIs) observed in patients treated with imatinib. We performed 2 observational studies, between the 1st January 2012 and the 31st August 2015 in the Midi-Pyrénées area (South Western France), using the French health insurance reimbursement database and then the French Pharmacovigilance Database (FPVD). A total of 544 patients received at least 1 reimbursement for imatinib. Among them, 486 (89.3%) had at least 1 drug that could potentially interact with imatinib. Paracetamol was the most frequent drug involved (77.4%). Proton pump inhibitors, dexamethasone and levothyroxine, were found in >10% of patients. In the FPVD, among a total of 25 reports of ADRs with imatinib recorded in the Midi-Pyrénées area, 10 (40%) had potential DDIs with imatinib. Imatinib was most frequently prescribed by hospital physicians and drugs interacting with imatinib, by general practitioners. Our study showed that at least 40% of the patients treated with imatinib were at risk of DDIs and that all prescribers must be cautious with DDIs in patients treated with imatinib. During imatinib treatment, we particularly recommend to limit the dose of paracetamol at 1300 mg per day, to avoid the use of dexamethasone, and to double the dose of levothyroxine. PMID:27749579

Immersion francaise precoce: Francais I (Early French Immersion: French I).

ERIC Educational Resources Information Center

Burt, Andy; And Others

This manual for first grade French instruction accompanies the early French immersion program. It is based on general and specific learning objectives for the four language skills the child needs to develop (listening, speaking, reading, and writing). The introduction to the manual provides an overview of the program for the primary grades and…

Mixed method versus full top-down microcosting for organ recovery cost assessment in a French hospital group.

PubMed

Hrifach, Abdelbaste; Brault, Coralie; Couray-Targe, Sandrine; Badet, Lionel; Guerre, Pascale; Ganne, Christell; Serrier, Hassan; Labeye, Vanessa; Farge, Pierre; Colin, Cyrille

2016-12-01

The costing method used can change the results of economic evaluations. Choosing the appropriate method to assess the cost of organ recovery is an issue of considerable interest to health economists, hospitals, financial managers and policy makers in most developed countries. The main objective of this study was to compare a mixed method, combining top-down microcosting and bottom-up microcosting versus full top-down microcosting to assess the cost of organ recovery in a French hospital group. The secondary objective was to describe the cost of kidney, liver and pancreas recovery from French databases using the mixed method. The resources consumed for each donor were identified and valued using the proposed mixed method and compared to the full top-down microcosting approach. Data on kidney, liver and pancreas recovery were collected from a medico-administrative French database for the years 2010 and 2011. Related cost data were recovered from the hospital cost accounting system database for 2010 and 2011. Statistical significance was evaluated at P < 0.05. All the median costs for organ recovery differ significantly between the two costing methods (non-parametric test method; P < 0.01). Using the mixed method, the median cost for recovering kidneys was found to be €5155, liver recovery was €2528 and pancreas recovery was €1911. Using the full top-down microcosting method, median costs were found to be 21-36% lower than with the mixed method. The mixed method proposed appears to be a trade-off between feasibility and accuracy for the identification and valuation of cost components when calculating the cost of organ recovery in comparison to the full top-down microcosting approach.

Management and cost analysis of cancer patients treated with G-CSF: a cohort study based on the French national healthcare insurance database.

PubMed

Tilleul, Patrick; Jacot, William; Emery, Corinne; Lafuma, Antoine; Gourmelen, Julie

2017-12-01

To describe the management and costs associated with G-CSF therapy in cancer patients in France. This study analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer. Then the costs and characteristics of patients associated with the use of different G-CSF products were analyzed in the sub-set of breast cancer patients. The most frequent malignancies in the database population were breast cancer (23.3%), hematological malignancies (22.2%), and lung cancer (12.4%). The reimbursed G-CSF was pegfilgrastim in 34.1% of cases, lenograstim in 26.7%, and filgrastim in 17.9%. More than one G-CSF product was reimbursed to 21.3% of patients. The total annual reimbursed health expenses per patient, according to the type of G-CSF, were €27,001, €24,511, and €20,802 for patients treated with filgrastim, lenograstim, and pegfilgrastim, respectively. Ambulatory care accounted for, respectively, 35%, 38%, and 41% of those costs. In patients with breast cancer, ambulatory care cost was €7,915 with filgrastim, €7,750 with lenograstim, and €6,989 with pegfilgrastim, and the respective cost of G-CSF was €1,733, €1,559, and €3,668. All available G-CSF products have been shown to be effective in cancer patients, and both daily G-CSFs and pegylated G-CSF are recommended in international guidelines. Nevertheless, this analysis of G-CSF reimbursement indicates that the choice of product can markedly affect the total cost of ambulatory care.

Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases.

PubMed

Berdaï, Driss; Thomas-Delecourt, Florence; Szwarcensztein, Karine; d'Andon, Anne; Collignon, Cécile; Comet, Denis; Déal, Cécile; Dervaux, Benoît; Gaudin, Anne-Françoise; Lamarque-Garnier, Véronique; Lechat, Philippe; Marque, Sébastien; Maugendre, Philippe; Méchin, Hubert; Moore, Nicholas; Nachbaur, Gaëlle; Robain, Mathieu; Roussel, Christophe; Tanti, André; Thiessard, Frantz

2018-02-01

Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database. These databases, although developed for other purposes, have already been used for many years with regard to post-registration studies (PRS). The use thereof will continue to increase with the recent creation of the French National Health Data System (SNDS [2016 health system reform law]). At the same time, other databases are available in France, offering an illustration of "product use under actual practice conditions" by patients and health professionals (cohorts, specific registries, data warehouses, etc.). Based on a preliminary analysis of requests for PRS, approximately two-thirds appeared to have found at least a partial response in existing databases. Using these databases has a number of disadvantages, but also numerous advantages, which are listed. In order to facilitate access and optimise their use, it seemed important to draw up recommendations aiming to facilitate these developments and guarantee the conditions for their technical validity. The recommendations drawn up notably include the need for measures aiming to promote the visibility of research conducted on databases in the field of PRS. Moreover, it seemed worthwhile to promote the interoperability of health data warehouses, to make it possible to match information originating from field studies with information originating from databases, and to develop and share algorithms aiming to identify criteria of interest (proxies). Methodological documents, such as the French National

French Antilles and Guiana.

PubMed

1983-11-01

This discussion of French Antilles and Guiana cover the following: the people, geography, history, government, political conditions, economy, and relations with the US. In 1983 the population totaled 303,000 with an annual growth rate of 0.09%. The infant mortality rate (1981) was 12.6/1000 and life expectancy 68 years. About 98% of the people of Martinique are of Afro European or Afro European Indian descent. The remainder are the old planter families and a sizable number of metropolitan French. Most of the work force are employed in agriculture or food processing and associated industries. Most permanent residents of Guadeloupe are of mixed Afro European descent. A few thousand Metropolitan French reside there. Most French Guianese live along the coast, about 1/2 of them in the capital. Martinique is the northernmost of the Windward Islands, which are part of the Lesser Antilles chain in the Caribbean Sea southeast of Puerto Rico. Guadeloupe comprises 2 of the Leeward Islands, which are also part of the Lesser Antilles chain. French Guiana is located on the northern coast of South America, a few degrees north of the Equator. Indians were the 1st known indigenous inhabitants of French Guiana and the French Antilles. Columbus sighted Guadeloupe in 1493, Martinique in 1493 or 1502, and the Guiana coast probably during his 3rd voyage in 1498. French Guiana, Guadeloupe, and Martinique, as overseas departments of France since 1946, are integral parts of the French Republic. Their relationship to Metropolitan France is somewhat similar to that of Alaska and Hawaii to the counterminous US. Each department has a general council composed of 1 representative elected by each canton. Guadeloupe and Martinique each elect 2 senators to the French Senate and 3 deputies to the National Assembly. French Guiana elects 1 senator and 1 deputy. In each of the 3 departments exist individuals and small political parties that advocate immediate independence, but their adherents form only

Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review.

PubMed

Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Jeblee, Serena; Warren, Rachel; Khan, Paul A; Robson, Reid; Pham, Ba'; Hirst, Graeme; Straus, Sharon E

2018-06-14

social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied. Open Science Framework ( https://osf.io/kv9hu/ ).

Productivity of lexical categories in French-speaking children with cochlear implants.

PubMed

Le Normand, M-T; Ouellet, C; Cohen, H

2003-11-01

The productivity of lexical categories was studied longitudinally in a sample of 17 young hearing-impaired French-speaking children with cochlear implants. Age of implantation ranged from 22 months to 76 months. Spontaneous speech samples were collected at six-month intervals over a period of 36 months, starting at the one-word stage. Four general measures of their linguistic production (number of utterances, verbal fluency, vocabulary, and grammatical production) as well as 36 specific lexical categories, according to the CHILDES codes, were computed in terms of tokens, i.e., total number of words. Cochlear-implanted children (CI) were compared to a French database of normally hearing children aged 2-4 compiled by the first author. Follow-up results indicate that, at the two-year post-implantation follow-up, noun, and verb morphology was significantly impaired. At the three-year follow-up, the cochlear-implanted group had recovered on adjectives, determiners and nouns, main verbs, and auxiliaries. The two groups differed significantly in processing locative adverbs, prepositions, pronouns, and verbs (infinitive verb, modal, and modal lexical), but individual variability within the cochlear-implanted group was substantial. Results are discussed in terms of recovery and developmental trends and variability in the acquisition of lexical categories by French children two years and three years post-implantation.

A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.

PubMed

Pacurariu, Alexandra C; Coloma, Preciosa M; van Haren, Anja; Genov, Georgy; Sturkenboom, Miriam C J M; Straus, Sabine M J M

2014-12-01

New pharmacovigilance legislation in the European Union has underlined the importance of signal management, giving the European Medicines Agency's newly established Pharmacovigilance Risk Assessment Committee (PRAC) the mandate to oversee all aspects of the use of medicinal products including detection, assessment, minimization, and communication relating to the risk of adverse reactions. In this study, we describe the signals as brought to the PRAC during the first 18 months of its operation and the ensuing regulatory actions. Data were collected from publicly available sources, for the period July 2012-December 2013, classified according to predefined rules, and described using the appropriate descriptive statistics. Suspected adverse drug reactions were categorized into the Medical Dictionary for Regulatory Affairs and drug names were mapped to the Anatomical Therapeutic Chemical codes. During the study period, 125 signals concerning 96 medicinal products were discussed by the PRAC. The majority of signals were triggered by spontaneous reports (62%) and the median drug age (since marketing authorization) for drugs that prompted a signal was 12 years, significantly less compared with drugs that had no signal within the same period (20 years). The mean time until a decision was reached by the PRAC was 75 days (median 30 days, range 0-273) with 43% of all decisions taken during the first meeting. The decisions to start a referral and to send a direct healthcare professional communication took the least amount of time [54 days (median 27 days, range 0-186) and 51 days (median 0 days, range 0-153)]. The importance of spontaneous reporting in signal detection and monitoring of safety issues throughout the entire life cycle of a medicinal product is confirmed in this study. The amount of time a drug has been on the market is correlated with the number of signals detected. The PRAC decision-making process seems efficient particularly with respect to serious concerns

Possible Pedagogical Applications of a Talking Computer Terminal for the French-Speaking Blind to Foreign Language Teaching.

ERIC Educational Resources Information Center

Trescases, Pierre

A computer system developed as a database access facilitator for the blind is found to have application to foreign language instruction, specifically in teaching French to speakers of English. The computer is programmed to translate symbols from the International Phonetic Alphabet (IPA) into appropriate phonemes for whatever language is being…

Etonogestrel implant migration to the vasculature, chest wall, and distant body sites: cases from a pharmacovigilance database.

PubMed

Kang, Sarah; Niak, Ali; Gada, Neha; Brinker, Allen; Jones, S Christopher

2017-12-01

To describe clinical outcomes of etonogestrel implant patients with migration to the vasculature, chest wall and other distant body sites spontaneously reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a standardized Medical Dictionary for Regulatory Activities (MedDRA) query in the FAERS database (through November 15, 2015), with reports coded with one or more MedDRA preferred terms that indicate complications with device placement or migration of the device from the original site of insertion to the vasculature, chest wall and other distant body sites. We excluded any cases previously described in the medical literature. We identified 38 cases of pronounced etonogestrel implant migration. Migration locations included the lung/pulmonary artery (n=9), chest wall (n=1), vasculature at locations other than the lung/pulmonary artery (n=14) and extravascular migrations (n=14) to other body sites (e.g., the axilla and clavicle/neck line/shoulder). The majority of cases were asymptomatic and detected when the patient desired implant removal; however, seven cases reported symptoms such as pain, discomfort and dyspnea in association with implant migration. Three cases also describe pulmonary fibrosis and skin reactions as a result of implant migration to the vasculature, chest wall and other distant body sites. Sixteen cases reported surgical removal in an operating room setting. Our FAERS case series demonstrates etonogestrel implant migration to the vasculature, chest wall and other body sites distant from the site of original insertion. As noted by the sponsor in current prescribing information, a key determinant in the risk for etonogestrel contraceptive implant migration appears to be improper insertion technique. Although migration of etonogestrel implants to the vasculature is rare, awareness of migration and education on proper insertion technique may reduce the risk. Published by Elsevier Inc.

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports.

PubMed

Hoffman, Keith B; Dimbil, Mo; Tatonetti, Nicholas P; Kyle, Robert F

2016-06-01

Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug-AE pairs to analyze, the issue of focus is daunting. Our objective was to develop a signaling platform that focuses on AEs with historically demonstrated regulatory interest and to analyze such AEs with a disproportional reporting method that offers broad signal detection and acceptable false-positive rates. We analyzed over 1500 US FDA regulatory actions (safety communications and drug label changes) from 2008 to 2015 to construct a list of eligible signal AEs. The FDA Adverse Event Reporting System (FAERS) was used to evaluate disproportional reporting rates, constrained by minimum case counts and confidence interval limits, of these selected AEs for 109 training drugs. This step led to 45 AEs that appeared to have a low likelihood of being added to a label by FDA, so they were removed from the signal eligible list. We measured disproportional reporting for the final group of eligible AEs on a test group of 29 drugs that were not used in either the eligible list construction or the training steps. In a group of 29 test drugs, our model reduced the number of potential drug-AE signals from 41,834 to 97 and predicted 73 % of individual drug label changes. The model also predicted at least one AE-drug pair label change in 66 % of all the label changes for the test drugs. By concentrating on AE types with already demonstrated interest to FDA, we constructed a signaling system that provided focus regarding drug-AE pairs and suitable accuracy with regard to the issuance of FDA labeling changes. We suggest that focus on historical regulatory actions may increase the utility of pharmacovigilance signaling systems.

Richard J. French, Ph.D. | NREL

Science.gov Websites

J. French, Ph.D. Photo of Richard J. French Rick French Researcher IV-Chemistry Richard.French Laboratory equipment design and construction Computer-aided design (CAD) Education Ph.D., Chemistry, Oregon State University B.S., Chemistry, Wheaton College Professional Experience Research Scientist, National

Linking a pharmaceutical claims database with a birth defects registry to investigate birth defect rates of suspected teratogens.

PubMed

Colvin, Lyn; Slack-Smith, Linda; Stanley, Fiona J; Bower, Carol

2010-11-01

Data linkage of population administrative data is being investigated as a tool for pharmacovigilance in pregnancy in Australia. Records of prescriptions of known or suspected teratogens dispensed to pregnant women have been linked to a birth defects registry to determine if defects associated with medicine exposure can be detected. The Pharmaceutical Benefits Scheme is a national claims database that has been linked with population-based data to extract linkages for women with a pregnancy event in Western Australia from 2002 to 2005 (n = 106 074). Records of births to the women who were dispensed medicines in categories D or X of the Australian ADEC pregnancy risk category were linked to the Birth Defects Registry of Western Australia. Population rates of registered birth defects per 1000 births were calculated for each medicine. There were 47 medicines dispensed at least once during pregnancy with 23 associated with a registered birth defect to a woman dispensed the medicine. When the birth defect rate for each medicine was compared with the rate for all other women not dispensed that medicine, most medicines showed an increased risk. Medicines with the higher risks were medroxyprogesterone acetate (OR: 1.8; 95%CI: 1.4-2.3), follitropin alfa (OR: 2.5; 95%CI: 1.2-5.0), carbamazepine (OR: 3.1; 95%CI: 1.7-5.6) and enalapril maleate (OR: 8.1; 95%CI: 1.6-41.7). Many known associations between medicines and birth defects were identified, suggesting that linked administrative data could be an important means of pharmacovigilance in pregnancy in Australia. Copyright © 2010 John Wiley & Sons, Ltd.

French perspectives on psychiatric classification.

PubMed

Crocq, Marc-Antoine

2015-03-01

This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11.

French perspectives on psychiatric classification

PubMed Central

Crocq, Marc-Antoine

2015-01-01

This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11. PMID:25987863

Nonverbal Aspects of Verbal Behavior in French Canadian French-English Bilinguals.

ERIC Educational Resources Information Center

Grujic, Zdenda; Libby, William L., Jr.

The present study was designed to investigate whether known intercultural differences in nonverbal behavior extend to specific nonverbal repertoires accompanying, and perhaps facilitating the act of speaking a verbal language. Conversations in the form of structured interviews between 48 French-Canadian, French-English bilinguals (24 males and 24…

Illustrated French Idioms.

ERIC Educational Resources Information Center

Ainsa, Serge M.

Designed to promote an awareness of the everyday French language, this supplementary textbook was developed to enable students of French to use idiomatic expressions from the early learning stages to the more advanced levels. The units are arranged as follows according to the verb component of the expression: "avoir,""etre,""faire," the three…

HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?

PubMed

Martelli, Nicolas; Devaux, Capucine; van den Brink, Hélène; Billaux, Mathilde; Pineau, Judith; Prognon, Patrice; Borget, Isabelle

2017-01-01

The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs. A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients. Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices. Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.

America's Tolerance for French Radicalism

ERIC Educational Resources Information Center

Wolin, Richard

2008-01-01

The publication of Francois Cusset's "French Theory" raises a series of fascinating questions concerning the trans-Atlantic transmission and circulation of ideas. Most important, it impels everyone to inquire why for a time French thought managed to flourish in American universities while French intellectuals rapidly abandoned the entire…

Third Semester College French, A Different Approach: Practical French for Careers.

ERIC Educational Resources Information Center

Rickert, Blandine

An alternative approach used in a third semester French course at the University of Colorado at Denver is described. The approach was adopted to improve student motivation. The course focuses on the learning of practical French for everyday situations, while traveling abroad for business or pleasure. Emphasis is on conversational, communicative…

21 CFR 169.115 - French dressing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false French dressing. 169.115 Section 169.115 Food and... § 169.115 French dressing. (a) Description. French dressing is the separable liquid food or the..., lecithin, or polyglycerol esters of fatty acids. (d) Nomenclature. The name of the food is “French dressing...

Optimum use of CDOT French and Hamburg data (French and Hamburg tests).

DOT National Transportation Integrated Search

2013-11-01

The Colorado Department of Transportation (CDOT) has been collecting data from the Hamburg Rutter and the : French Rutter for over 20 years. No specifications have been written in that time for either the Hamburg Rutter : or the French Rutter. This r...

Complementary exploratory and confirmatory factor analyses of the French WISC-V: Analyses based on the standardization sample.

PubMed

Lecerf, Thierry; Canivez, Gary L

2018-06-01

Interpretation of the French Wechsler Intelligence Scale for Children-Fifth Edition (French WISC-V; Wechsler, 2016a) is based on a 5-factor model including Verbal Comprehension (VC), Visual Spatial (VS), Fluid Reasoning (FR), Working Memory (WM), and Processing Speed (PS). Evidence for the French WISC-V factorial structure was established exclusively through confirmatory factor analyses (CFAs). However, as recommended by Carroll (1995); Reise (2012), and Brown (2015), factorial structure should derive from both exploratory factor analysis (EFA) and CFA. The first goal of this study was to examine the factorial structure of the French WISC-V using EFA. The 15 French WISC-V primary and secondary subtest scaled scores intercorrelation matrix was used and factor extraction criteria suggested from 1 to 4 factors. To disentangle the contribution of first- and second-order factors, the Schmid and Leiman (1957) orthogonalization transformation (SLT) was applied. Overall, no EFA evidence for 5 factors was found. Results indicated that the g factor accounted for about 67% of the common variance and that the contributions of the first-order factors were weak (3.6 to 11.9%). CFA was used to test numerous alternative models. Results indicated that bifactor models produced better fit to these data than higher-order models. Consistent with previous studies, findings suggested dominance of the general intelligence factor and that users should thus emphasize the Full Scale IQ (FSIQ) when interpreting the French WISC-V. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The new IAGOS Database Portal

NASA Astrophysics Data System (ADS)

Boulanger, Damien; Gautron, Benoit; Thouret, Valérie; Fontaine, Alain

2016-04-01

IAGOS (In-service Aircraft for a Global Observing System) is a European Research Infrastructure which aims at the provision of long-term, regular and spatially resolved in situ observations of the atmospheric composition. IAGOS observation systems are deployed on a fleet of commercial aircraft. The IAGOS database is an essential part of the global atmospheric monitoring network. It contains IAGOS-core data and IAGOS-CARIBIC (Civil Aircraft for the Regular Investigation of the Atmosphere Based on an Instrument Container) data. The IAGOS Database Portal (http://www.iagos.fr, damien.boulanger@obs-mip.fr) is part of the French atmospheric chemistry data center AERIS (http://www.aeris-data.fr). The new IAGOS Database Portal has been released in December 2015. The main improvement is the interoperability implementation with international portals or other databases in order to improve IAGOS data discovery. In the frame of the IGAS project (IAGOS for the Copernicus Atmospheric Service), a data network has been setup. It is composed of three data centers: the IAGOS database in Toulouse; the HALO research aircraft database at DLR (https://halo-db.pa.op.dlr.de); and the CAMS data center in Jülich (http://join.iek.fz-juelich.de). The CAMS (Copernicus Atmospheric Monitoring Service) project is a prominent user of the IGAS data network. The new portal provides improved and new services such as the download in NetCDF or NASA Ames formats, plotting tools (maps, time series, vertical profiles, etc.) and user management. Added value products are available on the portal: back trajectories, origin of air masses, co-location with satellite data, etc. The link with the CAMS data center, through JOIN (Jülich OWS Interface), allows to combine model outputs with IAGOS data for inter-comparison. Finally IAGOS metadata has been standardized (ISO 19115) and now provides complete information about data traceability and quality.

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.

PubMed

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.

European-French Cross-Cultural Adaptation of the Developmental Coordination Disorder Questionnaire and Pretest in French-Speaking Switzerland.

PubMed

Ray-Kaeser, Sylvie; Satink, Ton; Andresen, Mette; Martini, Rose; Thommen, Evelyne; Bertrand, Anne Martine

2015-05-01

The Developmental Coordination Disorder Questionnaire (DCDQ'07) is a Canadian-English instrument recommended for screening children aged 5 to 15 years who are at risk for developmental coordination disorder. While a Canadian-French version of the DCDQ'07 presently exists, a European-French version does not. To produce a cross-cultural adaptation of the DCDQ'07 for use in areas of Europe where French is spoken and to test its cultural relevance in French-speaking Switzerland. Cross-cultural adaptation was done using established guidelines. Cultural relevance was analyzed with cognitive interviews of thirteen parents of children aged 5.0 to 14.6 years (mean age: 8.5 years, SD = 3.4), using think-aloud and probing techniques. Cultural and linguistic differences were noted between the European-French, the Canadian-French, and the original versions of the DCDQ'07. Despite correct translation and expert committee review, cognitive interviews revealed that certain items of the European-French version were unclear or misinterpreted and further modifications were needed. After rewording items as a result of the outcomes of the cognitive interview, the European-French version of the DCDQ'07 is culturally appropriate for use in French-speaking Switzerland. Further studies are necessary to determine its psychometric properties.

Towards a French Revolution

ERIC Educational Resources Information Center

Breach, H. T.

1972-01-01

Contends that secondary school students lose their appeal for French as they advance in school. Suggests that French teachers endeavor to motivate students by focusing more attention on their students and less on their own credentials. (DS)

Insurance statements related to regional anaesthesia: A French database analysis.

PubMed

Boutonnet, Mathieu; Trouiller, Pierre; Lopard, Eric; Amalberti, René; Houselstein, Thierry; Pasquier, Pierre; Auroy, Yves; De Saint Maurice, Guillaume

2016-10-01

Adverse events in the perioperative period remain frequent, occurring in about 30% of the hospital admission and may be avoidable in nearly 50% of cases. Improving safety needs a continuous assessment of the risk level. Data from the MACSF-Sou medical insurance company, including all the statements declared by anaesthesiologists and intensivists, were analyzed retrospectively by three experts, senior anaesthesiologists, of the SFAR, the French society of anesthesia and intensive care (Société française d'anesthésie réanimation) to describe the risk associated with regional anaesthesia. One hundred and sixty-four events were analyzed, involving young patients (mean age of 48.3±15years; sex ratio: 0.57). The most involved surgical specialties were: orthopaedic surgery (61%) and obstetric surgery (13.4%). Reported events were predominantly peripheral nerve injury (64.6%). Mechanical complications of puncture (pneumothorax, haemothorax, complications of axial punctures) accounted for approximately 15% of events, infection for 11%. The revelation was predominant in the postoperative course (137 cases, 83.6%), particularly after the release of the operating room in over 47% of cases, including 39 cases (22%) after discharge from the hospital. Collaboration with insurance companies allows a relevant approach of the perioperative risk. In most cases, liability related to regional anaesthesia involved young patients in the perioperative course of scheduled surgery. One of the future challenges in managing, the anaesthetic and perioperative risks should be to invest more accurately the postoperative care both in the hospital or ambulatory settings. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

The French Revolution.

ERIC Educational Resources Information Center

Baltimore City Public Schools, MD.

This outline on the French Revolution is designed to illustrate how this period of French history influenced various aspects of contemporary culture. Four main sections are treated: (1) ideas that led to the Revolution, (2) the reigns of the Bourbon kings, (3) the Revolution, and (4) the rise of Napoleon as a reaction to chaos. A list of 16mm…

[Utilization of methylphenidate(Ritalin) in France].

PubMed

Frances, C; Hoizey, G; Millart, H; Trenque, T

2002-01-01

Methylphenidate (Ritalin) is the only psychostimulant approved in France and indicated in attention deficit hyperactivity disorder in children over 6 years. It is under restricted prescription and distribution conditions. As such, it requires a hospital initiated prescription from either a neurology, psychiatry or pediatric specialist and it is covered by the "narcotics" schedule. The French Pharmacovigilance database spontaneous adverse drug reactions reporting, since it was approved in 1995, were analyzed. 21 adverse drug reactions were reported. In 16 cases, methylphenidate was suspected. They were generally non-serious, mild side effects and in most cases promptly resolved. These results do not suggest methylphenidate misuse in France or an overuse in between 1300 and 4000 treated children, to date. Until more information is available concerning the long-term effects of methylphenidate, and in order to limit misuse, inappropriate or overuse, the current prescription and dispensing regulation should be maintained in France, and could well be developed in other countries.

Are consumers ready to take part in the Pharmacovigilance System?--a Portuguese preliminary study concerning ADR reporting.

PubMed

Matos, Cristiano; van Hunsel, Florence; Joaquim, João

2015-07-01

New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. Consumers are more likely to do

French roots of French neo-lamarckisms, 1879-1985.

PubMed

Loison, Laurent

2011-01-01

This essay attempts to describe the neo-Lamarckian atmosphere that was dominant in French biology for more than a century. Firstly, we demonstrate that there were not one but at least two French neo-Lamarckian traditions. This implies, therefore, that it is possible to propose a clear definition of a (neo)Lamarckian conception, and by using it, to distinguish these two traditions. We will see that these two conceptions were not dominant at the same time. The first French neo-Lamarckism (1879-1931) was structured by a very mechanic view of natural processes. The main representatives of this first period were scientists such as Alfred Giard (1846-1908), Gaston Bonnier (1853-1922) and Félix Le Dantec (1869-1917). The second Lamarckism - much more vitalist in its inspiration - started to develop under the supervision of people such as Albert Vandel (1894-1980) and Pierre-Paul Grassé (1895-1985). Secondly, this essay suggests that the philosophical inclinations of these neo-Lamarckisms reactivated a very ancient and strong dichotomy of French thought. One part of this dichotomy is a material, physicalist tradition, which started with René Descartes but developed extensively during the 18th and 19th centuries. The other is a spiritual and vitalist reaction to the first one, which also had a very long history, though it is most closely associated with the work of Henri Bergson. Through Claude Bernard, the first neo-Lamarckians tried to construct a mechanical and determinist form of evolutionary theory which was, in effect, a Cartesian theory. The second wave of neo-Lamarckians wanted to reconsider the autonomy and reactivity of life forms, in contrast to purely physical systems.

Inferring pregnancy episodes and outcomes within a network of observational databases

PubMed Central

Ryan, Patrick; Fife, Daniel; Gifkins, Dina; Knoll, Chris; Friedman, Andrew

2018-01-01

Administrative claims and electronic health records are valuable resources for evaluating pharmaceutical effects during pregnancy. However, direct measures of gestational age are generally not available. Establishing a reliable approach to infer the duration and outcome of a pregnancy could improve pharmacovigilance activities. We developed and applied an algorithm to define pregnancy episodes in four observational databases: three US-based claims databases: Truven MarketScan® Commercial Claims and Encounters (CCAE), Truven MarketScan® Multi-state Medicaid (MDCD), and the Optum ClinFormatics® (Optum) database and one non-US database, the United Kingdom (UK) based Clinical Practice Research Datalink (CPRD). Pregnancy outcomes were classified as live births, stillbirths, abortions and ectopic pregnancies. Start dates were estimated using a derived hierarchy of available pregnancy markers, including records such as last menstrual period and nuchal ultrasound dates. Validation included clinical adjudication of 700 electronic Optum and CPRD pregnancy episode profiles to assess the operating characteristics of the algorithm, and a comparison of the algorithm’s Optum pregnancy start estimates to starts based on dates of assisted conception procedures. Distributions of pregnancy outcome types were similar across all four data sources and pregnancy episode lengths found were as expected for all outcomes, excepting term lengths in episodes that used amenorrhea and urine pregnancy tests for start estimation. Validation survey results found highest agreement between reviewer chosen and algorithm operating characteristics for questions assessing pregnancy status and accuracy of outcome category with 99–100% agreement for Optum and CPRD. Outcome date agreement within seven days in either direction ranged from 95–100%, while start date agreement within seven days in either direction ranged from 90–97%. In Optum validation sensitivity analysis, a total of 73% of

Long-Term Population-Based Genotyping Study of Mycobacterium tuberculosis Complex Isolates in the French Departments of the Americas†

PubMed Central

Brudey, Karine; Filliol, Ingrid; Ferdinand, Séverine; Guernier, Vanina; Duval, Philippe; Maubert, Bertrand; Sola, Christophe; Rastogi, Nalin

2006-01-01

The three French overseas departments of the Americas are characterized both by insular (Guadeloupe and Martinique) and continental (French Guiana) settings with a tuberculosis case detection rate that varies from less than 10 per 100,000 per year in insular areas to an estimated incidence of more than 55 per 100,000 in French Guiana. Under a long-term genotyping program, more than three-fourths of all the Mycobacterium tuberculosis isolates (n = 744) received from the three settings were fingerprinted over a 10-year period (1994 to 2003) by spoligotyping and variable number of tandem DNA repeats (VNTRs) in order to understand the current trends in their detection rates, drug resistance, and groups and subpopulations at risk of contracting the disease and to pinpoint the circulating phylogeographical clades of the bacilli. The major difference in the study populations was the nationality of the patients, with a high percentage of immigrants from high-incidence neighboring countries in French Guiana and a low but increasing percentage in the French Caribbean. The rate of recent transmission was calculated to be 49.3% in French Guiana, compared to 27.2% and 16.9% in Guadeloupe and Martinique, respectively. At the phylogeographic level, 77.9% of the isolates studied belonged to four major clades (Haarlem, Latin-American and Mediterranean, T, and X) which are already reported from neighboring Caribbean islands in an international database and may underline potential interregional transmission events. PMID:16390968

The French Revolution: A Simulation Game

ERIC Educational Resources Information Center

Kiernan, James Patrick

1978-01-01

Describes a college-level simulation game about the French Revolution. Based on George Lefebvre's "The Coming of the French Revolution," the role-play focuses on social and economic causes of the revolution and allows students to understand citizens' grievances against the French government. (AV)

Teaching for Content: Greek Mythology in French.

ERIC Educational Resources Information Center

Giauque, Gerald S.

An intermediate-level university French course in Greek mythology was developed to (1) improve student skills in reading, writing, speaking, and comprehending French, (2) familiarize students with Greek mythology, and (3) prepare students to deal better with allusions to Greek mythology in French literature. The texts used are a French translation…

A prediction model-based algorithm for computer-assisted database screening of adverse drug reactions in the Netherlands.

PubMed

Scholl, Joep H G; van Hunsel, Florence P A M; Hak, Eelko; van Puijenbroek, Eugène P

2018-02-01

The statistical screening of pharmacovigilance databases containing spontaneously reported adverse drug reactions (ADRs) is mainly based on disproportionality analysis. The aim of this study was to improve the efficiency of full database screening using a prediction model-based approach. A logistic regression-based prediction model containing 5 candidate predictors was developed and internally validated using the Summary of Product Characteristics as the gold standard for the outcome. All drug-ADR associations, with the exception of those related to vaccines, with a minimum of 3 reports formed the training data for the model. Performance was based on the area under the receiver operating characteristic curve (AUC). Results were compared with the current method of database screening based on the number of previously analyzed associations. A total of 25 026 unique drug-ADR associations formed the training data for the model. The final model contained all 5 candidate predictors (number of reports, disproportionality, reports from healthcare professionals, reports from marketing authorization holders, Naranjo score). The AUC for the full model was 0.740 (95% CI; 0.734-0.747). The internal validity was good based on the calibration curve and bootstrapping analysis (AUC after bootstrapping = 0.739). Compared with the old method, the AUC increased from 0.649 to 0.740, and the proportion of potential signals increased by approximately 50% (from 12.3% to 19.4%). A prediction model-based approach can be a useful tool to create priority-based listings for signal detection in databases consisting of spontaneous ADRs. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

U.S.-French Commercial Ties

DTIC Science & Technology

2008-05-19

Z39-18 U.S.- French Commercial Ties Summary U.S. commercial ties with France are extensive, mutually profitable, and growing. With over $1.2 billion...relationship. The scale of sales of U.S.-owned companies operating in France and French -owned companies operating in the United States outweighs trade...with investments valued at $65.9 billion was the number one foreign investor in France . During that same year, French companies had direct

Cultural Understanding: French, Level One. Selected Cultural Concepts Which May Be Developed in French Level I.

ERIC Educational Resources Information Center

Walpole, Earl L.

This manual was prepared to instruct the language teacher on concepts of French culture to be taught in a beginning French class to students of any age. The cultural concepts are cross-referenced and intended to be used with five of the most widely used French texts. Certain deeper cultural concepts are meant to be used for longer unit…

France: Africans and the French Revolution.

ERIC Educational Resources Information Center

Fatunde, Tunde

1989-01-01

The French Revolution had profound and long-term effects for Africans, both in Africa and throughout the Western hemisphere. Revolutionary leaders not only opposed the emancipation of slaves in French territories but supported an intensified slave trade, sparking numerous rebellions. French exploitation of Africans extended well into the twentieth…

Cholesterol embolisms as possible adverse drug reaction of direct oral anticoagulants.

PubMed

Muller-Hansma, A H G; Daemen-Gubbels, C R G M; Schut, N H

2018-04-01

The Netherlands Pharmacovigilance Centre Lareb has received two reports of cholesterol crystal embolisms associated with the use of a direct oral anticoagulant (DOAC). The European pharmacovigilance database contains several other cases concerning this association, and one report was published in the scientific literature. Cholesterol crystal embolisms were described in association with the use of several other antithrombotic drugs, although the role as an independent risk factor is not conclusive. The case series described in this article, indicates the possibility of an adverse drug reaction when a patient develops cholesterol crystal embolisms while using a DOAC.

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK.

PubMed

Layton, D; Sinclair, H K; Bond, C M; Hannaford, P C; Shakir, S A W

2002-09-01

The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies. Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization. A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p = 0.0006 and 8.8 vs. 5.8%, p = 0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms. Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-up rates.

Trends in initiation of direct oral anticoagulant therapies for atrial fibrillation in a national population-based cross-sectional study in the French health insurance databases

PubMed Central

Huiart, Laetitia; Ferdynus, Cyril; Renoux, Christel; Beaugrand, Amélie; Lafarge, Sophie; Bruneau, Léa; Suissa, Samy; Maillard, Olivier; Ranouil, Xavier

2018-01-01

Objective Unlike several other national health agencies, French health authorities recommended that the newer direct oral anticoagulant (DOAC) agents only be prescribed as second choice for the treatment of newly diagnosed non-valvular atrial fibrillation (NVAF), with vitamin K antagonists (VKA) remaining the first choice. We investigated the patterns of use of DOACs versus VKA in the treatment of NVAF in France over the first 5 years of DOAC availability. We also identified the changes in patient characteristics of those who initiated DOAC treatment over this time period. Methods Based on the French National Health Administrative Database, we constituted a population-based cohort of all patients who were newly treated for NVAF between January 2011 and December 2015. Trends in drug use were described as the percentage of patients initiating each drug at the time of treatment initiation. A multivariate analysis using logistic regression model was performed to identify independent sociodemographic and clinical predictors of initial anticoagulant choice. Results The cohort comprised 814 446 patients who had received a new anticoagulant treatment for NVAF. The proportion of patients using DOACs as initial anticoagulant therapy reached 54% 3 months after the Health Ministry approved the reimbursement of dabigatran for NVAF, and 61% by the end of 2015, versus VKA use. In the multivariate analysis, we found that DOAC initiators were younger and healthier overall than VKA initiators, and this tendency was reinforced over the 2011–2014 period. DOACs were more frequently prescribed by cardiologists in 2012 and after (adjusted OR in 2012: 2.47; 95% CI 2.40 to 2.54). Conclusion Despite recommendations from health authorities, DOACs have been rapidly and massively adopted as initial therapy for NVAF in France. Observational studies should account for the fact that patients selected to initiate DOAC treatment are healthier overall, as failure to do so may bias the risk�

Evolution of multiple sclerosis in France since the beginning of hepatitis B vaccination.

PubMed

Le Houézec, Dominique

2014-12-01

Since the implementation of the mass vaccination campaign against hepatitis B in France, the appearance of multiple sclerosis, sometimes occurring in the aftermath of vaccinations, led to the publication of epidemiological international studies. This was also justified by the sharp increase in the annual incidence of multiple sclerosis reported to the French health insurance in the mid-1990s. Almost 20 years later, a retrospective reflection can be sketched from these official data and also from the national pharmacovigilance agency. Statistical data from these latter sources seem to show a significant correlation between the number of hepatitis B vaccinations performed and the declaration to the pharmacovigilance of multiple sclerosis occurring between 1 and 2 years later. The application of the Hill's criteria to these data indicates that the correlation between hepatitis B vaccine and multiple sclerosis may be causal.

Role of Pharmacovigilance in India: An overview.

PubMed

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

Role of Pharmacovigilance in India: An overview

PubMed Central

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

Evolution of the prevalence of intestinal parasitic infections among the French armed forces in French Guiana.

PubMed

Christen, Jacques-Robert; Mura, Marie; Roudaut, Gwenaëlle; Drogoul, Anne-Sophie; Demar, Magalie; Briolant, Sébastien; Garnotel, Eric; Simon, Fabrice; Pommier De Santi, Vincent

2016-07-01

Two cross-sectional studies were performed 2 years apart in French military personnel deployed from France to French Guiana. In 2011, military medical centres in French Guiana reported 40 cases of intestinal parasitism in service members returning from illegal gold mining sites in the rainforest. In 2013, 48 out of 132 service members returning from French Guiana after a 4-month mission had eosinophilia and seven were infected with hookworm. A presumptive first-line treatment with albendazole could be the most pragmatic strategy. © International Society of Travel Medicine, 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Association Between Psychotropic and Cardiovascular Iatrogenic Alerts and Risk of Hospitalizations in Elderly People Treated for Dementia: A Self-Controlled Case Series Study Based on the Matching of 2 French Health Insurance Databases.

PubMed

Zerah, Lorene; Boddaert, Jacques; Leperre-Desplanques, Armelle; Bonnet-Zamponi, Dominique; Verny, Marc; Deligne, Jean; Boelle, Pierre-Yves

2017-06-01

Elderly people are at risk of repeated hospitalizations, some of which may be drug related and preventable. In 2011, a group of French healthcare experts selected 5 iatrogenic alerts (IAs), based on criteria identified in a literature search and from their professional experience, to assess the appropriateness of medication in elderly patients. Our objective was to examine the association between hospitalizations and IAs in elderly patients treated for Alzheimer disease who are particularly sensitive to adverse drug events. A 2-year (January 1, 2011, to December 31, 2012) longitudinal national database study, with a study design similar to self-controlled case series, was performed to analyze data on drug prescriptions and hospitalization. IAs were defined as (1) long half-life benzodiazepine; (2) antipsychotic drugs in patients with Alzheimer disease; (3) co-prescription of 3 or more psychotropic drugs; (4) co-prescription of 2 or more diuretics; and (5) co-prescription of 4 or more antihypertensive drugs. Data were obtained by matching of 2 French National Health Insurance Databases. France. All affiliates, aged ≥75 years, receiving treatment for Alzheimer disease, alive on January 1, 2011 were included. We calculated the relative increase in the number of hospitalizations in patients with IAs. The analysis was performed over four 6-month periods. A total of 10,754 patients were included. During the periods with IAs, hospitalization rates increased by 0.36/year compared with 0.23/year in the periods without for the same patient, and the number of hospitalizations doubled [proportional fold change = 1.9, 95% confidence interval (1.8, 2.1)]. We estimated that 22% [95% confidence interval (20%, 23%)] of all hospitalizations were associated with IAs, 80% of which were due to psychotropic IAs. The IAs could be used as a simple and clinically relevant tool by prescribing physicians to assess the appropriateness of the prescription in elderly patients treated for

[Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

PubMed

Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

2018-01-01

The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

French-Canadians, Acadians and the French in New England. A Learning Activity Packet.

ERIC Educational Resources Information Center

Maine Univ., Orono. New England - Atlantic Provinces - Quebec Center.

The history of the French-Canadians from their beginnings to the present time is the topic of this Learning Activity Packet (LAP). Designed to acquaint students with the French, Canada's earliest permanent settlers following the Indians, the unit is divided into six objectives which include learning activities for each. Students are expected to…

Hierarchies of Authenticity in Study Abroad: French from Canada versus French from France?

ERIC Educational Resources Information Center

Wernicke, Meike

2016-01-01

For many decades, Francophone regions in Canada have provided language study exchanges for French as a second language (FSL) learners within their own country. At the same time, FSL students and teachers in Canada continue to orient to a native speaker standard associated with European French. This Eurocentric orientation manifested itself in a…

Driving in French for American Tourists.

ERIC Educational Resources Information Center

Grosse, Philip

This booklet is intended to assist the English-speaking tourist driving in a French-speaking country to communicate with service station attendants and to read road signs. The booklet is divided into three sections: (1) an English-French listing of parts of the car and useful expressions; (2) common European road signs; and (3) a French-English…

Natural course and prognosis of anaplastic gangliogliomas: a multicenter retrospective study of 43 cases from the French Brain Tumor Database

PubMed Central

Terrier, Louis-Marie; Bauchet, Luc; Rigau, Valérie; Amelot, Aymeric; Zouaoui, Sonia; Filipiak, Isabelle; Caille, Agnès; Almairac, Fabien; Aubriot-Lorton, Marie-Hélène; Bergemer-Fouquet, Anne-Marie; Bord, Eric; Cornu, Philippe; Czorny, Alain; Dam Hieu, Phong; Debono, Bertrand; Delisle, Marie-Bernadette; Emery, Evelyne; Farah, Walid; Gauchotte, Guillaume; Godfraind, Catherine; Guyotat, Jacques; Irthum, Bernard; Janot, Kevin; Le Reste, Pierre-Jean; Liguoro, Dominique; Loiseau, Hugues; Lot, Guillaume; Lubrano, Vincent; Mandonnet, Emmanuel; Menei, Philippe; Metellus, Philippe; Milin, Serge; Muckenstrum, Bertrand; Roche, Pierre-Hugues; Rousseau, Audrey; Uro-Coste, Emmanuelle; Vital, Anne; Voirin, Jimmy; Wager, Michel; Zanello, Marc; François, Patrick; Velut, Stéphane; Varlet, Pascale; Figarella-Branger, Dominique; Pallud, Johan

2017-01-01

Abstract Background. Anaplastic gangliogliomas (GGGs) are rare tumors whose natural history is poorly documented. We aimed to define their clinical and imaging features and to identify prognostic factors. Methods. Consecutive cases of anaplastic GGGs in adults prospectively entered into the French Brain Tumor Database between March 2004 and April 2014 were screened. After diagnosis was confirmed by pathological review, clinical, imaging, therapeutic, and outcome data were collected retrospectively. Results. Forty-three patients with anaplastic GGG (median age, 49.4 y) from 18 centers were included. Presenting symptoms were neurological deficit (37.2%), epileptic seizure (37.2%), or increased intracranial pressure (25.6%). Typical imaging findings were unifocal location (94.7%), contrast enhancement (88.1%), central necrosis (43.2%), and mass effect (47.6%). Therapeutic strategy included surgical resection (95.3%), adjuvant radiochemotherapy (48.8%), or radiotherapy alone (27.9%). Median progression-free survival (PFS) and overall survival (OS) were 8.0 and 24.7 months, respectively. Three- and 5-year tumor recurrence rates were 69% and 100%, respectively. The 5-year survival rate was 24.9%. Considering unadjusted significant prognostic factors, tumor midline crossing and frontal location were associated with shorter OS. Temporal and parietal locations were associated with longer and shorter PFS, respectively. None of these factors remained statistically significant in multivariate analysis. Conclusions. We report a large series providing clinical, imaging, therapeutic, and prognostic features of adult patients treated for an intracerebral anaplastic GGG. Our results show that pathological diagnosis is difficult, that survivals are only slightly better than for glioblastomas, and that complete surgical resection followed with adjuvant chemoradiotherapy offers longer survival. PMID:28453747

The French connection: some contributions of French-language research in the post-Piagetian era.

PubMed

Larivée, S; Normandeau, S; Parent, S

2000-01-01

This article presents French-speaking researchers' contribution to the field of differential developmental psychology. Following a brief review of key Piagetian ideas pertaining to his conceptualization of individual differences, the core of the article traces methodological and theoretical transformations that were necessary for understanding individual differences within a general theory of cognitive development. On a methodological level, French-speaking researchers went from standardizing Piaget's clinical method to constructing developmental scales and operational tests. On a theoretical level, Reuchlin's writings guided Longeot, and several other French (Lautrey and Bideaud) and Genevan (de Ribaupierre and Rieben) researchers into a scientific quest for a genuine integration of differential and developmental psychology. We present an overview of the pluralistic and multidimensional model of cognitive functioning and development that emerged from the work of the French-Swiss team of researchers. Concluding remarks focus on the actual research agendas of researchers interested in resolving the challenging issue of understanding relationships between inter- and intraindividual differences and general tendencies in cognitive development.

A georeferenced Landsat digital database for forest insect-damage assessment

NASA Technical Reports Server (NTRS)

Williams, D. L.; Nelson, R. F.; Dottavio, C. L.

1985-01-01

In 1869, the gypsy moth caterpillar was introduced in the U.S. in connection with the experiments of a French scientist. Throughout the insect's period of establishment, gypsy moth populations have periodically increased to epidemic proportions. For programs concerned with preventing the insect's spread, it would be highly desirable to be able to employ a survey technique which could provide timely, accurate, and standardized assessments at a reasonable cost. A project was, therefore, initiated with the aim to demonstrate the usefulness of satellite remotely sensed data for monitoring the insect defoliation of hardwood forests in Pennsylvania. A major effort within this project involved the development of a map-registered Landsat digital database. A complete description of the database developed is provided along with information regarding the employed data management system.

The French Revolution and "Revisionism."

ERIC Educational Resources Information Center

Langlois, Claude

1990-01-01

Outlines revisionist interpretations of the French Revolution that challenged the dominant historiographical tradition during the 1950s and 1960s. Distinguishes four central characteristics of revisionist works. Identifies a key split in current French Revolution historiography between reflection on nineteenth-century…

Switches to English during French Service Encounters: Relationships with L2 French Speakers' Willingness to Communicate and Motivation

ERIC Educational Resources Information Center

McNaughton, Stephanie; McDonough, Kim

2015-01-01

This exploratory study investigated second language (L2) French speakers' service encounters in the multilingual setting of Montreal, specifically whether switches to English during French service encounters were related to L2 speakers' willingness to communicate or motivation. Over a two-week period, 17 French L2 speakers in Montreal submitted…

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

PubMed

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

Research Perspectives on Core French: A Literature Review

ERIC Educational Resources Information Center

Lapkin, Sharon; Mady, Callie; Arnott, Stephanie

2009-01-01

This article reviews the research literature on core French in three main areas: student diversity, delivery models for the core French program, and instructional approaches. These topics are put into context through a discussion of studies on community attitudes to French as a second language (FSL), dissatisfaction with core French outcomes and…

French Flight Test Program LEA Status

DTIC Science & Technology

2010-09-01

RTO-EN-AVT-185 17 - 1 French Flight Test Program LEA Status Francois FALEMPIN MBDA France 1 avenue Reaumur Le Plessis Robinson FRANCE ...TITLE AND SUBTITLE French Flight Test Program LEA Status 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT ...Bouchez, Nicolas Gascoin, Measurement for fuel reforming for scramjet thermal management: status of COMPARER project - AIAA-2009-7373. French

Diagnostic performance of brain MRI in pharmacovigilance of natalizumab-treated MS patients.

PubMed

Wattjes, Mike P; Wijburg, Martijn T; Vennegoor, Anke; Witte, Birgit I; Roosendaal, Stefan D; Sanchez, Esther; Liu, Yaou; Martins Jarnalo, Carine O; Richert, Nancy D; Uitdehaag, Bernard Mj; Barkhof, Frederik; Killestein, Joep

2016-08-01

In natalizumab-treated multiple sclerosis (MS) patients, magnetic resonance imaging (MRI) is considered as a sensitive tool in detecting both MS disease activity and progressive multifocal leukoencephalopathy (PML). To investigate the performance of neuroradiologists using brain MRI in detecting new MS lesions and asymptomatic PML lesions and in differentiating between MS and PML lesions in natalizumab-treated MS patients. The secondary aim was to investigate interrater variability. In this retrospective diagnostic study, four blinded neuroradiologists assessed reference and follow-up brain MRI scans of 48 natalizumab-treated MS patients with new asymptomatic PML lesions (n = 21) or new MS lesions (n = 20) or no new lesions (n = 7). Sensitivity and specificity for detection of new lesions in general (MS and PML lesions), MS and PML lesion differentiation, and PML detection were determined. Interrater agreement was calculated. Overall sensitivity and specificity for the detection of new lesions, regardless of the nature of the lesions, were 77.4% and 89.3%, respectively; for PML-MS lesion differentiation, 74.2% and 84.7%, respectively; and for asymptomatic PML lesion detection, 59.5% and 91.7%, respectively. Interrater agreement for the tested categories was fair to moderate. The diagnostic performance of trained neuroradiologists using brain MRI in pharmacovigilance of natalizumab-treated MS patients is moderately good. Interrater agreement among trained readers is fair to moderate. © The Author(s), 2015.

Is There a Cardiotoxicity Associated With Metallic Head Hip Prostheses? A Cohort Study in the French National Health Insurance Databases.

PubMed

Lassalle, Marion; Colas, Sandrine; Rudnichi, Annie; Zureik, Mahmoud; Dray-Spira, Rosemary

2018-07-01

There are four distinguishable types of THA devices in wide use, as defined by the femoral and acetabular bearing surfaces: metal-on-polyethylene (MoP), ceramic-on-polyethylene (CoP), metal-on-metal (MoM), and ceramic-on-ceramic (CoC). Metallic head THAs (MoP and MoM) can potentially induce cardiac toxicity because cobalt species, generated at the head-neck trunnion, and in the case of MoM devices, at the articular surface as well, can be absorbed systemically. However, studies have provided inconsistent results. The purpose of this study was to assess the risk of dilated cardiomyopathy (DCM) or heart failure (HF) associated with metallic head THAs using data from the French national health insurance databases. Between 2008 and 2011 in France, 399,968 patients ≥ 55 years had a first THA. A total of 127,481 were excluded after we applied the exclusion criteria regarding arthroplasty and 17,137 as a result of a history of DCM/HF, recorded in the French national health insurance reimbursement databases, between January 1, 2006, and the date of inclusion. The final cohort included 255,350 individuals (43% men; mean age 72 ± 9 years). Of them, 93,581 (37%) had been implanted with MoP, 58,095 (23%) with CoP, 11,298 (4%) with MoM, and 92,376 (36%) with CoC THAs. Patients were followed until December 2015. Patients with incident DCM/HF were identified by a new entitlement to the long-term disease scheme or a first hospitalization with a diagnosis of DCM or HF. MoP and CoP THAs are generally implanted in old patients, whereas MoM and CoC are mostly indicated in young, active male patients. Thus, to consider the specific indications of the bearing couples, analyses were separately performed in two distinct subcohorts, one comprising patients with MoP or CoP and one comprising patients with MoM or CoC THA. In each subcohort, the DCM/HF risk was compared between patients with metallic head versus nonmetallic head THAs (MoP versus CoP, MoM versus CoC). Hazard ratios

French Army - Family Psychological and Social Support

DTIC Science & Technology

2006-04-01

Major de l’armée de Terre, Bureau condition du personnel 14 rue Saint-Dominique 00453 Armées FRANCE The French Army is permanently engaged on...ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) French Army...RTO-MP-HFM-134 21E - 1 French Army – Family Psychological and Social Support LCL G. BOUILLAUD French Army Staff, Quality Of Life Etat

[International bibliographic databases--Current Contents on disk and in FTP format (Internet): presentation and guide].

PubMed

Bloch-Mouillet, E

1999-01-01

This paper aims to provide technical and practical advice about finding references using Current Contents on disk (Macintosh or PC) or via the Internet (FTP). Seven editions are published each week. They are all organized in the same way and have the same search engine. The Life Sciences edition, extensively used in medical research, is presented here in detail, as an example. This methodological note explains, in French, how to use this reference database. It is designed to be a practical guide for browsing and searching the database, and particularly for creating search profiles adapted to the needs of researchers.

7 CFR 993.6 - Non-French prunes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Non-French prunes. 993.6 Section 993.6 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Order Regulating Handling Definitions § 993.6 Non-French prunes. Non-French prunes means prunes commonly...

7 CFR 993.6 - Non-French prunes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Non-French prunes. 993.6 Section 993.6 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Order Regulating Handling Definitions § 993.6 Non-French prunes. Non-French prunes means prunes commonly...

Prescription medicines and the risk of road traffic crashes: a French registry-based study.

PubMed

Orriols, Ludivine; Delorme, Bernard; Gadegbeku, Blandine; Tricotel, Aurore; Contrand, Benjamin; Laumon, Bernard; Salmi, Louis-Rachid; Lagarde, Emmanuel

2010-11-16

In recent decades, increased attention has been focused on the impact of disabilities and medicinal drug use on road safety. The aim of our study was to investigate the association between prescription medicines and the risk of road traffic crashes, and estimate the attributable fraction. We extracted and matched data from three French nationwide databases: the national health care insurance database, police reports, and the national police database of injurious crashes. Drivers identified by their national health care number involved in an injurious crash in France, between July 2005 and May 2008, were included in the study. Medicines were grouped according to the four risk levels of the French classification system (from 0 [no risk] to 3 [high risk]). We included 72,685 drivers involved in injurious crashes. Users of level 2 (odds ratio [OR]  = 1.31 [1.24-1.40]) and level 3 (OR  = 1.25 [1.12-1.40]) prescription medicines were at higher risk of being responsible for a crash. The association remained after adjustment for the presence of a long-term chronic disease. The fraction of road traffic crashes attributable to levels 2 and 3 medications was 3.3% [2.7%-3.9%]. A within-person case-crossover analysis showed that drivers were more likely to be exposed to level 3 medications on the crash day than on a control day, 30 days earlier (OR  = 1.15 [1.05-1.27]). The use of prescription medicines is associated with a substantial number of road traffic crashes in France. In light of the results, warning messages appear to be relevant for level 2 and 3 medications and questionable for level 1 medications. A follow-up study is needed to evaluate the impact of the warning labeling system on road traffic crash prevention.

English versus French: Language Rivalry in Tunisia.

ERIC Educational Resources Information Center

Battenburg, John

1997-01-01

Examines the competition between English and French in Tunisian educational institutions and programs. Scrutinizes two periods in postprotectorate Tunisia: the introduction of English and the spread of English. Findings indicate that the decline in French linguistic influence may be accompanied by a future decrease in French political and economic…

Commercial French in a Liberal Arts Setting.

ERIC Educational Resources Information Center

Abrate, Jayne

Drury College (Missouri) has developed a commercial French course that is practical, situation-oriented, and provides instruction in correspondence and translation. The course is considered part of the cultural segment of the French program. It enrolls majors in business, French, and a variety of other disciplines, and emphasizes contextual…

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants.

PubMed

Wong, Carmen K; Ho, Samuel S; Saini, Bandana; Hibbs, David E; Fois, Romano A

2015-07-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), one of the world's largest spontaneous reporting systems, is difficult to use because of report duplication and a lack of standardisation in the recording of drug names. Unresolved data quality issues may distort statistical analyses, rendering the results difficult to interpret when detecting and monitoring adverse effects of pharmaceutical products. The aim of this study was to develop and implement a data cleaning protocol to identify and resolve drug nomenclature issues. The key 'data treatment' plan involved standardising drug names held in the FAERS database. Four million five hundred and six thousand five hundred and seventy-seven. Individual Safety Reports submitted to the FAERS between 1 January 2003 and 31 August 2012 were included for this study. OpenRefine was used to standardise drug name variants in the database such that they were consistent with international non-proprietary nomenclature defined by the World Health Organisation Anatomical Therapeutic Chemical classification. Drug variants where generic constituents could not be confidently determined, undecipherable drug names and non-medicinal products were retained verbatim. After the standardisation process, more than 16 611 916 drug entries were cleaned to their relevant international non-proprietary name. The cleaned drug table comprised 71 858 drug name variants and includes both standardised and original terms. Ninety-nine per cent of drug names was standardised using this method. The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world. Copyright © 2015 John Wiley & Sons, Ltd.

French space program: report to Cospar

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

Not Available

1975-01-01

Programs and results obtained are reviewed for all French laboratories working in areas of research related to space. Main topics include lunar specimen studies; spectroscopic planetology; space radiation; ionospheric and magnetospherics; aeronomy; meteorology, comprising the Meteosat program and the Eole experiment and earth resources investigations; geodesy; and geodynamics-research covering space biology and exobiology is also discussed. French satellites and sounding rockets are listed, as well as French experiments onboard foreign spacecraft. (GRA)

Q Fever in French Guiana

PubMed Central

Eldin, Carole; Mahamat, Aba; Demar, Magalie; Abboud, Philippe; Djossou, Félix; Raoult, Didier

2014-01-01

Coxiella burnetii, the causative agent of Q fever, is present worldwide. Recent studies have shown that this bacterium is an emerging pathogen in French Guiana and has a high prevalence (24% of community-acquired pneumonia). In this review, we focus on the peculiar epidemiology of Q fever in French Guiana. We place it in the context of the epidemiology of the disease in the surrounding countries of South America. We also review the clinical features of Q fever in this region, which has severe initial presentation but low mortality rates. These characteristics seem to be linked to a unique genotype (genotype 17). Finally, we discuss the issue of the animal reservoir of C. burnetii in French Guiana, which is still unknown. Further studies are necessary to identify this reservoir. Identification of this reservoir will improve the understanding of the Q fever epidemic in French Guiana and will provide new tools to control this public health problem. PMID:25092817

French from Four to Seven. A Handbook for Teaching French to the Very Young.

ERIC Educational Resources Information Center

Kodjak, Barbara Hippel

The handbook is a compilation of ideas, strategies, resources, and suggestions for teaching French to children aged 4-7. It presupposes a school program in which French is taught as a foreign language for a brief period each day, although the ideas are adaptable to immersion instruction. Introductory sections describe the book's format and…

Information behaviour of French-speaking speech-language therapists in Belgium: results of a questionnaire survey.

PubMed

Durieux, Nancy; Pasleau, Françoise; Piazza, Aurelie; Donneau, Anne-Françoise; Vandenput, Sandrina; Maillart, Christelle

2016-03-01

Speech-language therapists (SLTs) are encouraged to implement evidence-based practice (EBP). Nevertheless, EBP use by practitioners can be questioned. The objective of this study was to explore Belgian French-speaking SLTs' information behaviour and their awareness of EBP. The collected data allow one to determine how far they have embraced this approach. The two Belgian French-speaking SLT professional associations promoted an online questionnaire survey by email. Additionally, clinical supervisors of students were asked to participate. In March 2012, 2068 emails were sent. The participation rate was at least 20% (n = 415). The reported information needs mainly concerned treatment or diagnosis. Most of the time, to attempt to fulfil their information needs, SLTs relied on their own resources (personal experience and libraries) and on colleagues in the workplace. When they searched on the Internet, they preferred to use a general search engine rather than a specialised bibliographic database. Barriers to obtaining scientific information are highlighted. Only 12% of the respondents had already heard about EBP. This study provides the first overview of the information behaviour of SLTs working in the French community of Belgium. Several recommendations are suggested for SLTs and librarians. © 2015 Health Libraries Group.

The Future of Intensive French in Canada

ERIC Educational Resources Information Center

Netten, Joan; Germain, Claude

2009-01-01

This article examines the oral proficiency in French of students in core French, intensive French (IF), and post-IF to determine the effectiveness of these programs. Between 2003 and 2009, students in nine jurisdictions were assessed using the New Brunswick Middle School Scale (MSS). Students were tested prior to beginning IF (multiple grade…

Tuning History: The French Experience

ERIC Educational Resources Information Center

Lamboley, Jean-Luc

2017-01-01

The paper shows that Tuning Project has generated indifference more than resistance within the French academic community. It proposes an analysis of the reasons of this situation: difficulties arising from Tuning itself, the resistance of the French academic tradition, the institutional inhibitors and facilitators. The impact of Tuning on French…

Culture Curriculum: French, Level II.

ERIC Educational Resources Information Center

Hall, Ruth Wellman

This teacher's guide to cultural instruction at level 2 integrates materials derived from several sources. The guide is based on: (1) suggestions from "French for Secondary Schools," New York State Education Department; (2) general information concerning the geography, products, industries, regions, cities of France, the French Union, and the city…

Tactical UAV’s in the French Army

DTIC Science & Technology

2003-09-02

French Army Technical Service, France 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR... FRENCH ARMY PROJECTION PLATOON Platoon Maintenance Facilities (1st & 2nd echelons) Platoon HQ Launching System Ground Control Station / Remote Data...Tactical UAV’s in the French Army LtCol Pierre-Yves HENRY, Technical Service of the French Army, Program Officer for Battlefield Surveillance Report

Report: Immersion French at Meriden Junior School

ERIC Educational Resources Information Center

Esposito, Marie-Josee

2006-01-01

In this article, the author describes the French immersion program at Meriden Junior School, an Anglican school for girls from pre-Kindergarten to Year 12 in Sydney. Four teachers (one of whom is the coordinator) and three assistants are involved in the program. They include six French native speakers and one non-French-born teacher who speaks…

French Naval Policy Outside of Europe.

DTIC Science & Technology

1980-09-01

strategy" and "indi- rect strategy.ŝ In today’s world, direct strategy used against France would consist of overt armed aggression against French ter...8217 away at French interests one by one when he is afraid or unable to attack France directly. He would alternate local thrusts with calls for nego...of little importance to France were it not for the fact that it can endanger vital French inter- 4 ests without triggering France’s strategic

Effectiveness of a Heritage Educational Program for the Acquisition of Oral and Written French and Tahitian in French Polynesia

ERIC Educational Resources Information Center

Nocus, Isabelle; Guimard, Philippe; Vernaudon, Jacques; Paia, Mirose; Cosnefroy, Olivier; Florin, Agnes

2012-01-01

The research examines the effects of a bilingual pedagogical program (French/Tahitian) on the acquisition of oral and written French as well as the Tahitian language itself in primary schools in French Polynesia. 125 children divided into an experimental group (partially schooled in Tahitian for 300 min per week) and a control group (schooled in…

Act Up-Paris: French Lessons

ERIC Educational Resources Information Center

Nakayama, Thomas K.

2012-01-01

The francophone world has always been at the center of the HIV/AIDS epidemic. From the mythical (French Canadian) "patient zero," Gaetan Dugas, to Rock Hudson's flight to Paris for medical treatment and the blaming of Haiti for AIDS, as well as the close relationships between Belgian and French and their former African colonies,…

A Successful French Weekend Camp.

ERIC Educational Resources Information Center

Baughin, Judith A.

A weekend immersion French language camp was organized by Raymond Walters College of the University of Cincinnati with the cooperation of a group of interested high school French teachers. The extensive planning and the activities of the weekend are described in detail. The most important aspects of the planning process are noted. These were (1)…

Does adoption of electronic health records improve organizational performances of hospital surgical units? Results from the French e-SI (PREPS-SIPS) study.

PubMed

Plantier, Morgane; Havet, Nathalie; Durand, Thierry; Caquot, Nicolas; Amaz, Camille; Philip, Irène; Biron, Pierre; Perrier, Lionel

2017-02-01

Electronic health records (EHR) are increasingly being adopted by healthcare systems worldwide. In France, the "Hôpital numérique 2012-2017" program was implemented as part of a strategic plan to modernize health information technology (HIT), including promotion of widespread EHR use. With significant upfront investment costs as well as ongoing operational expenses, it is important to assess this system in terms of its ability to result in improvements in hospital performances. The aim of this study was to evaluate the impact of EHR use on the organizational performances of acute care hospital surgical units throughout France. This retrospective study was based on data derived from three national databases for year the 2012: IPAQSS (Indicators of improvement in the quality and the management of healthcare, "IPAQSS"), Hospi-Diag (French hospital performance indicators), and the national accreditation database. National data and methodological support were provided by the French Ministry of Health (DGOS) and the French National Authority for Health (HAS). Multivariate linear models were used to assess four organizational performance indicators: the occupancy rate of surgical inpatient beds, operating room utilization, the activity per surgeon, and the activity per both nurse anesthetist and anesthesiologist which were dependent variables. Several independent variables were taken into account, including the degree of EHR use. The models revealed a significant positive impact of EHR use on operating room utilization and bed occupancy rates for surgical inpatient units. No significant association was found between the activity per surgeon or the activity per nurse anesthetist and anesthesiologist with EHR use. All four organizational performance indicators were impacted by the type of hospital, the geographical region, and the severity of the pathologies. We were able to verify the purported potential benefits of EHR use on the organizational performances of surgical

The Renewal of the French Amphibious Doctrine

DTIC Science & Technology

2003-01-01

The forces ashore must be sustained and supported by fires. These requirements may seem obvious, but in the case of the French armed forces, the new...0 The Renewal of the French Amphibious Doctrine EWS 2003 Subject Area Topical Issues THE RENEWAL OF THE FRENCH AMPHIBIOUS DOCTRINE CG#2...FACAD: Major Ralston Submitted by Capt L.Danigo, Troupes de Marine. France Report Documentation Page Form

French Plans for Fifth Generation Computer Systems.

DTIC Science & Technology

1984-12-07

centrally man- French industry In electronics, compu- aged project in France that covers all ters, software, and services and to make the facets of the...Centre National of Japan’s Fifth Generation Project , the de Recherche Scientifique (CNRS) Cooper- French scientific and industrial com- ative Research...systems, man-computer The National Projects interaction, novel computer structures, The French Ministry of Research and knowledge-based computer systems

Appropriating Written French: Literacy Practices in a Parisian Elementary Classroom

ERIC Educational Resources Information Center

Rockwell, Elsie

2012-01-01

In this article, I examine French language instruction in an elementary classroom serving primarily children of Afro-French immigrants in Paris. I show that a prevalent French language ideology privileges written over oral expression and associates full mastery of written French with rational thought and full inclusion in the French polity. This…

[From the French Society of Plastic and Reconstructive Surgery to the French Society of Plastic Reconstructive and Aesthetic Surgery].

PubMed

Glicenstein, J

2004-04-01

(The) 3rd December 1952, 11 surgeons and other specialists found the French Society of Plastic and Reconstructive Surgery (SFCPR) which was officially published on (the) 28 September 1953. The first congress was during October 1953 and the first president as Maurice Aubry. The first secretary was Daniel Morel Fatio. The symposiums were after about three of four times each year and the thematic subjects were initially according the reconstructive surgery. The review "Annales de chirurgie plastique" was free in 1956. The members of the Society were about 30 initially, but their plastic surgery in the big hospitals at Paris and other big towns in France. The "specialty" of plastic surgery was created in 1971. On "syndicate", one French board of plastic reconstructive and aesthetic surgery, the increasing of departments of plastic surgery were the front of increasing of the plastic surgery in French and of the number of the French Society of Plastic Reconstructive surgery (580 in 2003). The French Society organized the International Congress of Plastic Surgery in 1975. The society SFCPR became the French Society of plastic reconstruction and Aesthetic Surgery (SFCPRE) in 1983 and the "logo" (front view) was in the 1994 SOF.CPRE.

Evaluation of reporting quality for observational studies using routinely collected health data in pharmacovigilance.

PubMed

Nie, Xiaolu; Zhang, Ying; Wu, Zehao; Jia, Lulu; Wang, Xiaoling; Langan, Sinéad M; Benchimol, Eric I; Peng, Xiaoxia

2018-06-01

To appraise the reporting quality of studies which concerned linezolid related thrombocytopenia referring to REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. Medline, Embase, Cochrane library and clinicaltrial.gov were searched for observational studies concerning linezolid related thrombocytopenia using routinely collected health data from 2000 to 2017. Two reviewers screened potential eligible articles and extracted data independently. Finally, reporting quality assessment was performed by two senior researchers using RECORD statement. Of 25 included studies, 11 (44.0%) mentioned the type of data in the title and/or abstract. In 38 items derived from RECORD statement, the median number of items reported in the included studies was 22 (interquartile range (IQR) 18 to 27). Inadequate reporting issues were discovered in the following aspects: validation studies of the codes or algorithms, study size estimation, quantitative variables, subgroup statistical methods, missing data, follow-up/matching or sampling strategy, sensitivity analysis and cleaning methods, funding and role of funders and accessibility of protocol, raw data. This study provides the evidence that the reporting quality of post-marketing safety evaluation studies conducted using routinely collected health data was often insufficient. Future stakeholders are encouraged to endorse the RECORD guidelines in pharmacovigilance.

On Translating French Occurring in English into Spanish.

ERIC Educational Resources Information Center

Sebastian, Robert N.

1989-01-01

Explores problems encountered during attempts to translate French expressions occurring in English (such as concierge) into Spanish, particularly when the English interpretation of the expression is different from the standard French usage. Spanish translations are provided for about 200 French terms and expressions commonly used in English. (61…

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting.

PubMed

Kabanywanyi, Abdunoor M; Mulure, Nathan; Migoha, Christopher; Malila, Aggrey; Lengeler, Christian; Schlienger, Raymond; Genton, Blaise

2010-07-14

To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania. Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008). Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing

Risk stratification of thyroid nodules on ultrasonography with the French TI-RADS: description and reflections

PubMed Central

2016-01-01

The widespread use of ultrasonography places it in a key position for use in the risk stratification of thyroid nodules. The French proposal is a five-tier system, our version of a thyroid imaging reporting and database system (TI-RADS), which includes a standardized vocabulary and report and a quantified risk assessment. It allows the selection of the nodules that should be referred for fine-needle aspiration biopsies. Effort should be directed towards merging the different risk stratification systems utilized around the world and testing this unified system with multi-center studies. PMID:26324117

Snakebites in French Guiana: Conclusions of an international symposium.

PubMed

Kallel, Hatem; Hommel, Didier; Mehdaoui, Hossein; Megarbane, Bruno; Resiere, Dabor

2018-05-01

A workshop on epidemiology and management of snakebites in French Guiana was performed at Cayenne, French Guiana from September 15 to September 16, 2017, under the auspices of the French Regional Health Agency (ARS) and the Pan American Health Organization (PAHO). The activity was attended by experts from France (Angers, Martinique, French Guiana, Guadeloupe, and Paris), Costa Rica, Brazil, Saint Lucia, and Surinam. The epidemiology, clinical manifestations, clinical grading and the management of snakebite in French Guiana were discussed. The conclusions of this symposium illustrated the urgent need to ensure accessibility of effective and safe polyvalent viperid antivenom in French Guiana. Finally, the results of this symposium have forged ties based on mutual goals and objectives. Copyright © 2018 Elsevier Ltd. All rights reserved.

French NATO Policy: The Next Five Years

DTIC Science & Technology

1990-06-01

tradeoffs on the ambitious French modernization programs. Most dramatic have been the projected strategic consequences of perestroika: France , like... project power into areas of French influence in the Third World. In the mid-I 980s, France was spending roughly 3.9 percent of gross domestic product on...policy environment and its effects on the basic assumptions underpinning French policy. He concludes that in the future, France will be easier to work

In-Hospital Economic Burden of Metastatic Renal Cell Carcinoma in France in the Era of Targeted Therapies: Analysis of the French National Hospital Database from 2008 to 2013.

PubMed

Maroun, Rana; Maunoury, Franck; Benjamin, Laure; Nachbaur, Gaëlle; Durand-Zaleski, Isabelle

2016-01-01

The aim of this study was to assess the economic burden of hospitalisations for metastatic renal cell carcinoma (mRCC), to describe the patterns of prescribing expensive drugs and to explore the impact of geographic and socio-demographic factors on the use of these drugs. We performed a retrospective analysis from the French national hospitals database. Hospital stays for mRCC between 2008 and 2013 were identified by combining the 10th revision of the International Classification of Diseases (ICD-10) codes for renal cell carcinoma (C64) and codes for metastases (C77 to C79). Incident cases were identified out of all hospital stays and followed till December 2013. Descriptive analyses were performed with a focus on hospital stays and patient characteristics. Costs were assessed from the perspective of the French National Health Insurance and were obtained from official diagnosis-related group tariffs for public and private hospitals. A total of 15,752 adult patients were hospitalised for mRCC, corresponding to 102,613 hospital stays. Of those patients, 68% were men and the median age at first hospitalisation was 69 years [Min-Max: 18-102]. Over the study period, the hospital mortality rate reached 37%. The annual cost of managing mRCC at hospital varied between 28M€ in 2008 and 42M€ in 2012 and was mainly driven by inpatient costs. The mean annual per capita cost of hospital management of mRCC varied across the study period from 8,993€ (SD: €8,906) in 2008 to 10,216€ (SD: €10,527) in 2012. Analysis of the determinants of prescribing expensive drugs at hospital did not show social or territorial differences in the use of these drugs. This study is the first to investigate the in-hospital economic burden of mRCC in France. Results showed that in-hospital costs of managing mRCC are mainly driven by expensive drugs and inpatient costs.

French Modular Impoundment: Final Cost and Performance Evaluation

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

Drown, Peter; French, Bill

This report comprises the Final Cost and Performance Report for the Department of Energy Award # EE0007244, the French Modular Impoundment (aka the “French Dam”.) The French Dam is a system of applying precast modular construction to water control structures. The “French Dam” is a term used to cover the construction means/methods used to construct or rehabilitate dams, diversion structures, powerhouses, and other hydraulic structures which impound water and are covered under FDE’s existing IP (Patents # US8414223B2; US9103084B2.)

Philosophical foundations of French and U.S. nosology.

PubMed

Kroll, J

1979-09-01

The author examines the philosophical foundations of French and American nosology with a view toward understanding the relatively minor influence of French psychiatry in America. Despite the excellence of its descriptive psychiatry, much of French nosological writing is based on philosophical viewpoints that are antithetical to the empirical and pragmatic traditions of American psychiatry. French nosology, which is closely involved with the metaphysical issues of existentialism, phenomenalism, and structuralism, reveals these interests in language and concepts that do not easily permit its hypotheses to be scientifically tested, a prerequisite for any American classification.

French Romanticism and Napoleon's "Geometric Men."

ERIC Educational Resources Information Center

Cole, Robert A.

1982-01-01

French intellectual thought changed during the Napoleonic Era. The effects of the Enlightenment philosophers, the French Revolution, the Industrial Revolution, and Romanticism on the development of Napoleon's philosophical outlook are used to illustrate the changes occurring in France as a whole in the early nineteenth century. (AM)

More French, s'il vous plait!

ERIC Educational Resources Information Center

McGillivray, W. Russ, Ed.

The collection of essays on French second language instruction in Canada, directed to parents, includes: "Our Brave New World" (Andrew Kniewasser); "French in Your School: Identifying and Achieving the Right Program" (Carolyn Hodych, Jos Scott); "So, You're Worried About Becoming an Immersion Parent" (Judy Gibson);…

Accident study of torrential protective structures based on the French RTM database

NASA Astrophysics Data System (ADS)

Boncompain, Ingrid; Quefféléan, Yann; Carladous, Simon

2017-04-01

Torrential protective structures such as dikes, sediment traps, and check dams aim to reduce damage on elements at risk. They are built given a reference scenario. Nevertheless, this scenario can be exceeded or structures can fail because of their design or their ageing. We later talk about "accidents". The 1996 Aras disaster near Biescas (Spain) showed that consequences can be significant: 35 of 40 check dams were destroyed which involved 87 fatalities in a campsite. The accident probability and its consequences must be taken into account to analyze risk. Databases are useful tools to extract needed information. In France, the Restoration of Mountainous Areas department (RTM) has been public funded to develop a database, specific to mountainous areas (the Alps and the Pyrenees). Almost 12 500 check dams, 80 sediment traps and 600 dikes were registered in public forests in 2011. These samples were assumed significant for check dams and sediment traps but not for dikes because the most part was missing. In parallel, more than 31 000 torrential events were registered. Given these elements, an accident study was developed. We first extracted 1 925 events with accidents on protective structures: 39 % occurred during the 19th century and 53 % have occurred since 1900. Sediment traps were involved in 37 events, check dams in 336, and dikes in 1488. Then, a detailed analysis was specifically carried out for check dams. Event phenomena were extracted: torrential flood, liquid flood, snow avalanche, rock fall, and landslide. Accident typology was also specified: scouring, breaking of several check dams, total or partial destruction of one structure, overflowing. Causes of accidents on check dams were first analyzed. Torrential floods were responsible of 85 % of events (284 of 336) even if other phenomena must be also taken into account. Almost 45 % of events (152 of 336) involved total destruction of one or several check dams. Taking into account events for the last 150

Metropolitan French: Familiarization & Short-Term Training.

ERIC Educational Resources Information Center

Iszkowski, Marie-Charlotte

The U.S. Department of State's Foreign Service Institute French Familiarization and Short-Term (FAST) course for personnel working and living in France consists of 10 weeks of French language instruction combined with practical and cultural information. An introductory section outlines FAST course objectives and sample teaching techniques in…

"So She Has Been Educated by a Vulgar, Silly, Conceited French Governess!" Social Anxieties, Satirical Portraits, and the Eighteenth-Century French Instructor

ERIC Educational Resources Information Center

Hegele, Arden

2011-01-01

Maria Edgeworth's pedagogical short stories "Mademoiselle Panache" (1800, 1801) and "The Good French Governess" (1801) portray contrasting French instructors, and illustrate a transformation in English girls' education in French at the end of the eighteenth century. While "Mademoiselle Panache" looks back to the…

Using the French Tutor Multimedia Package or a Textbook to Teach Two French Past Tense Verbs: Which Approach Is More Effective?

ERIC Educational Resources Information Center

Corbeil, Giselle

2007-01-01

This paper examines the difference in learning outcomes between two groups of students, one of which used the "French Tutor," a multimedia package, and the other a textbook to learn the formation and use of two French past tense verbs: the perfect and the imperfect. Unlike the textbook, the "French Tutor" included visual…

Gastrointestinal illnesses among French forces deployed to Djibouti: French military health surveillance, 2005-2009.

PubMed

Ollivier, Lénaïck; Decam, Christophe; Pommier de Santi, Vincent; Darar, Houssein Y; Dia, Aïssata; Nevin, Remington L; Romand, Olivier; Bougère, Jacques; Deparis, Xavier; Boutin, Jean-Paul

2010-10-01

Despite an increase in foreign tourism and in the numbers of foreign military personnel deployed to Djibouti, little is known about the risk of gastrointestinal illness in this country in eastern Africa. To assess risk and to describe common features of gastrointestinal illnesses, reports of illness derived from military health surveillance data collected during 2005-2009 among French service members deployed to Djibouti were reviewed. Diarrhea was the most common problem; it had an annual incidence ranging from 260 to 349 cases per 1,000 person-years. The risk was higher among soldiers deployed short-term (four months) than among soldiers deployed long-term (two years). This five-year review of French health surveillance data documents a significant burden of diarrhea among French soldiers in Djibouti. The identification of factors associated with risk may permit efficient targeting of interventions to reduce morbidity from gastrointestinal illness.

Trends in food and nutritional intakes of French adults from 1999 to 2007: results from the INCA surveys.

PubMed

Dubuisson, Carine; Lioret, Sandrine; Touvier, Mathilde; Dufour, Ariane; Calamassi-Tran, Gloria; Volatier, Jean-Luc; Lafay, Lionel

2010-04-01

Two independent cross-sectional dietary surveys (the Individual and National Food Consumption Surveys, INCA), performed in 1998-99 (INCA1) and in 2006-07 (INCA2) on nationally representative samples of French people, were used to analyse trends in the dietary habits and nutritional intake of French adults. Food consumption was recorded through 7-d dietary records, and nutritional intakes were assessed using the French food composition database. After exclusion of under-reporters, analyses were performed on 3267 adults, aged 18-79 years: 1345 from INCA1 and 1922 from INCA2. The trends highlighted over the 8-year period showed a decrease in consumption of dairy products, meat, bread, potatoes, pastries/croissant-like pastries/cakes/biscuits and sugar/confectionery. In contrast, the consumption of fruits and vegetables, rice, ice cream and chocolate increased. Other food groups, like fish and snacking foods, remained stable. Food choices were mostly age specific. These age differences remained consistent over the years and underlined two opposite dietary trends: a 'traditional' one mainly followed by the elderly, and a 'snacking and convenience' one mainly adopted by young adults. The overall trends in food consumption did not influence the mean energy intake, but did slightly modify the contribution of each macronutrient to energy intake. These repeated surveys highlighted the fact that trends in French food habits have moved towards an average European diet at the crossroads between Mediterranean and Northern diets, and that food consumption changes impacted, to a lesser extent, nutritional intake.

End stage renal disease in French Guiana (data from R.E.I.N registry): South American or French?

PubMed

Rochemont, Dévi Rita; Meddeb, Mohamed; Roura, Raoul; Couchoud, Cécile; Nacher, Mathieu; Basurko, Célia

2017-06-30

End-Stage renal disease (ESRD) causes considerable morbidity and mortality, and significantly alters patients' quality of life. There are very few published data on this problem in the French Overseas territories. The development of a registry on end stage renal disease in French Guiana in 2011 allowed to describe the magnitude of this problem in the region for the first time. Using data from the French Renal Epidemiology and Information Network registry (R.E.I.N). Descriptive statistics on quantitative and qualitative variables in the registry were performed on prevalent cases and incident cases in 2011, 2012 and 2013. French Guiana has one of the highest ESRD prevalence and incidence in France. The two main causes of ESRD were hypertensive and diabetic nephropathies. The French Guianese population had a different demographic profile (younger, more women, more migrants) than in mainland France. Most patients had at least one comorbidity, predominantly (95.3%) hypertension. In French Guiana dialysis was initiated in emergency for 71.3% of patients versus 33% in France (p < 0.001). These first results give important public health information: i) End stage renal disease has a very high prevalence relative to mainland France ii) Patients have a different demographic profile and enter care late in the course of their renal disease. These data are closer to what is observed in the Caribbean or in Latin America than in Mainland France.

Strategies for improved French-language health services

PubMed Central

Gauthier, Alain P.; Timony, Patrick E.; Serresse, Suzanne; Goodale, Natalie; Prpic, Jason

2015-01-01

Abstract Objective To identify strategies to improve the quality of health services for Francophone patients. Design A series of semistructured key informant interviews. Setting Northeastern Ontario. Participants A total of 18 physicians were interviewed. Ten physicians were interviewed in French, 7 physicians were women, and 10 physicians were located in urban communities. Methods Purposive and snowball sampling strategies were used to conduct a series of semistructured key informant interviews with family physicians practising in communities with a large Francophone population. Principles of grounded theory were applied, guided by a framework for patient-professional communication. Results were inductively derived following an iterative data collection–data analysis process and were analyzed using a detailed thematic approach. Main findings Respondents identified several strategies for providing high-quality French-language health services. Some were unique to non–French-speaking physicians (eg, using appropriate interpreter services), some were unique to French-speaking physicians (eg, using a flexible dialect), and some strategies were common to all physicians serving French populations (eg, hiring bilingual staff or having pamphlets and posters in both French and English). Conclusion Physicians interviewed for this study provided high-quality health care by attributing substantial importance to effective communication. While linguistic patient-to-physician concordance is ideal, it might not always be possible. Thus, conscious efforts to attenuate communication barriers are necessary, and several effective strategies exist. PMID:26505060

French Security Policy in Transition: Dynamics of Continuity and Change

DTIC Science & Technology

1995-03-01

significant social division requires a strong state. As a commentator on the French assessment in Entreprise France noted, the French analysts in this project ...O N M E N T . . . 9 Chal lenges to the French Framework . . . . . . 9 The Place of France . . . . . . . . . . . . . . . . . . 11 4. THE C H A...of French diplomatic maneuvers or actions. French d6tente policy toward the Soviet Union permitted France to define an "independent" course within

French for Business: A Case Study.

ERIC Educational Resources Information Center

McCullough, Brenda

The paper discusses the development and evolution of the French for Business undergraduate language course at Oregon State University, focusing on: (1) instructor preparation; (2) course structure; (3) course content; (4) the business student as teacher and mentor; (5) cultural exchanges with French-speaking business students; (6) oral and written…

French-African Cultures: A Resource Unit.

ERIC Educational Resources Information Center

Forbes, Barbara

This resource unit concerns French-African cultures and their influence on other cultures. The materials may be incorporated into Levels 3, 4, and 5 French classes. Topics in the outline include environmental aspects; historical background; and cultural differences expressed in Senegal, Guinee, Mali, Cote d'Ivoire, Haute Volta, Togo, Dahomey,…

Management of neutropenic patients in the intensive care unit (NEWBORNS EXCLUDED) recommendations from an expert panel from the French Intensive Care Society (SRLF) with the French Group for Pediatric Intensive Care Emergencies (GFRUP), the French Society of Anesthesia and Intensive Care (SFAR), the French Society of Hematology (SFH), the French Society for Hospital Hygiene (SF2H), and the French Infectious Diseases Society (SPILF).

PubMed

Schnell, David; Azoulay, Elie; Benoit, Dominique; Clouzeau, Benjamin; Demaret, Pierre; Ducassou, Stéphane; Frange, Pierre; Lafaurie, Matthieu; Legrand, Matthieu; Meert, Anne-Pascale; Mokart, Djamel; Naudin, Jérôme; Pene, Frédéric; Rabbat, Antoine; Raffoux, Emmanuel; Ribaud, Patricia; Richard, Jean-Christophe; Vincent, François; Zahar, Jean-Ralph; Darmon, Michael

2016-12-01

Neutropenia is defined by either an absolute or functional defect (acute myeloid leukemia or myelodysplastic syndrome) of polymorphonuclear neutrophils and is associated with high risk of specific complications that may require intensive care unit (ICU) admission. Specificities in the management of critically ill neutropenic patients prompted the establishment of guidelines dedicated to intensivists. These recommendations were drawn up by a panel of experts brought together by the French Intensive Care Society in collaboration with the French Group for Pediatric Intensive Care Emergencies, the French Society of Anesthesia and Intensive Care, the French Society of Hematology, the French Society for Hospital Hygiene, and the French Infectious Diseases Society. Literature review and formulation of recommendations were performed using the Grading of Recommendations Assessment, Development and Evaluation system. Each recommendation was then evaluated and rated by each expert using a methodology derived from the RAND/UCLA Appropriateness Method. Six fields are covered by the provided recommendations: (1) ICU admission and prognosis, (2) protective isolation and prophylaxis, (3) management of acute respiratory failure, (4) organ failure and organ support, (5) antibiotic management and source control, and (6) hematological management. Most of the provided recommendations are obtained from low levels of evidence, however, suggesting a need for additional studies. Seven recommendations were, however, associated with high level of evidences and are related to protective isolation, diagnostic workup of acute respiratory failure, medical management, and timing surgery in patients with typhlitis.

The many encounters of Thomas Kuhn and French epistemology.

PubMed

Simons, Massimiliano

2017-02-01

The work of Thomas Kuhn has been very influential in Anglo-American philosophy of science and it is claimed that it has initiated the historical turn. Although this might be the case for English speaking countries, in France an historical approach has always been the rule. This article aims to investigate the similarities and differences between Kuhn and French philosophy of science or 'French epistemology'. The first part will argue that he is influenced by French epistemologists, but by lesser known authors than often thought. The second part focuses on the reactions of French epistemologists on Kuhn's work, which were often very critical. It is argued that behind some superficial similarities there are deep disagreements between Kuhn and French epistemology. This is finally shown by a brief comparison with the reaction of more recent French philosophers of science, who distance themselves from French epistemology and are more positive about Kuhn. Based on these diverse appreciations of Kuhn, a typology of the different positions within the philosophy of science is suggested. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prescription Medicines and the Risk of Road Traffic Crashes: A French Registry-Based Study

PubMed Central

Orriols, Ludivine; Delorme, Bernard; Gadegbeku, Blandine; Tricotel, Aurore; Contrand, Benjamin; Laumon, Bernard; Salmi, Louis-Rachid; Lagarde, Emmanuel

2010-01-01

Background In recent decades, increased attention has been focused on the impact of disabilities and medicinal drug use on road safety. The aim of our study was to investigate the association between prescription medicines and the risk of road traffic crashes, and estimate the attributable fraction. Methods and Findings We extracted and matched data from three French nationwide databases: the national health care insurance database, police reports, and the national police database of injurious crashes. Drivers identified by their national health care number involved in an injurious crash in France, between July 2005 and May 2008, were included in the study. Medicines were grouped according to the four risk levels of the French classification system (from 0 [no risk] to 3 [high risk]). We included 72,685 drivers involved in injurious crashes. Users of level 2 (odds ratio [OR]  = 1.31 [1.24–1.40]) and level 3 (OR  = 1.25 [1.12–1.40]) prescription medicines were at higher risk of being responsible for a crash. The association remained after adjustment for the presence of a long-term chronic disease. The fraction of road traffic crashes attributable to levels 2 and 3 medications was 3.3% [2.7%–3.9%]. A within-person case-crossover analysis showed that drivers were more likely to be exposed to level 3 medications on the crash day than on a control day, 30 days earlier (OR  = 1.15 [1.05–1.27]). Conclusion The use of prescription medicines is associated with a substantial number of road traffic crashes in France. In light of the results, warning messages appear to be relevant for level 2 and 3 medications and questionable for level 1 medications. A follow-up study is needed to evaluate the impact of the warning labeling system on road traffic crash prevention. Please see later in the article for the Editors' Summary PMID:21125020

Left Dislocation in Near-Native French

ERIC Educational Resources Information Center

Donaldson, Bryan

2011-01-01

The present study is concerned with the upper limits of SLA--specifically, mastery of the syntax-discourse interface in successful endstate learners of second-language (L2) French (near-native speakers). Left dislocation (LD) is a syntactic means of structuring spoken French discourse by marking topic. Its use requires speakers to coordinate…

Targeted eco-pharmacovigilance for ketoprofen in the environment: Need, strategy and challenge.

PubMed

Wang, Jun; Zhao, Shu-Qi; Zhang, Meng-Ya; He, Bing-Shu

2018-03-01

Implementing "targeted" eco-pharmacovigilance(EPV) which focuses on individual or specific pharmaceuticals on a prioritised basis is a feasible, economical and customized approach to reduce the environmental concentrations and risks of pharmaceuticals. Non-steroidal anti-inflammatory drugs(NSAIDs) remaining in environment are a kind of priority hazard substances, due to a notable case that diclofenac residues caused the loss of more than 99% of vultures across the Indian sub-continent. Ketoprofen, as another widely used NSAID with comparable or even higher global consumption than diclofenac, in the environment has been shown to present a potential risk to non-target terrestrial and aquatic species. Based on the review of 85 articles reporting the analyses of ketoprofen residues in environment since 2010, we found that this NSAID frequently present in various environmental compartments around the world. Therefore, it is urgent to implement EPV targeting ketoprofen pollution. Here, we provide some recommendations for implementing the targeted EPV for ketoprofen, including: Closely monitoring ketoprofen in the natural environment; Reducing the residues of ketoprofen through source control; Encouraging urine source separation and treatment; Limiting the application of veterinary ketoprofen; Designing and constituting a framework system of targeted EPV. But some challenges, such as ambiguity in the accountability of the main bodies responsible for continued monitoring of ketoprofen residues, the lack of optimized urine source separation scenarios and procedure, the need for detailed design and application schemes of the framework system of targeted EPV, etc. should be addressed. Copyright © 2017 Elsevier Ltd. All rights reserved.

French Nuclear Strategy in an Age of Terrorism

DTIC Science & Technology

2006-12-01

PAGES 115 14. SUBJECT TERMS French Nuclear Strategy, Deterrence, Nuclear Doctrine, France , European Nuclear Deterrence, Franco-American Relations...Certain Idea of France (Princeton, NJ: Princeton University Press, 1993); Wilfrid L Kohl, French Nuclear Diplomacy (Princeton, NJ: Princeton University...nuclear program. 1. A Nuclear France : Inception of the force de frappe The French nuclear program started during the Fourth Republic, immediately

The French-Canadian data set of Demirjian for dental age estimation: a systematic review and meta-analysis.

PubMed

Jayaraman, Jayakumar; Wong, Hai Ming; King, Nigel M; Roberts, Graham J

2013-07-01

Estimation of age of an individual can be performed by evaluating the pattern of dental development. A dataset for age estimation based on the dental maturity of a French-Canadian population was published over 35 years ago and has become the most widely accepted dataset. The applicability of this dataset has been tested on different population groups. To estimate the observed differences between Chronological age (CA) and Dental age (DA) when the French Canadian dataset was used to estimate the age of different population groups. A systematic search of literature for papers utilizing the French Canadian dataset for age estimation was performed. All language articles from PubMed, Embase and Cochrane databases were electronically searched for terms 'Demirjian' and 'Dental age' published between January 1973 and December 2011. A hand search of articles was also conducted. A total of 274 studies were identified from which 34 studies were included for qualitative analysis and 12 studies were included for quantitative assessment and meta-analysis. When synthesizing the estimation results from different population groups, on average, the Demirjian dataset overestimated the age of females by 0.65 years (-0.10 years to +2.82 years) and males by 0.60 years (-0.23 years to +3.04 years). The French Canadian dataset overestimates the age of the subjects by more than six months and hence this dataset should be used only with considerable caution when estimating age of group of subjects of any global population. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Creation of the First French Database in Primary Care Using the ICPC2: Feasibility Study.

PubMed

Lacroix-Hugues, V; Darmon, D; Pradier, C; Staccini, P

2017-01-01

The objective of our study was to assess the feasibility of gathering data stored in primary care Electronic Health records (EHRs) in order to create a research database (PRIMEGE PACA project). The software for EHR models of two office and patient data management systems were analyzed; anonymized data was extracted and imported into a MySQL database. An ETL procedure to code text in ICPC2 codes was implemented. Eleven general practitioners (GPs) were enrolled as "data producers" and data were extracted from 2012 to 2015. In this paper, we explain the ways to make this process feasible as well as illustrate its utility for estimating epidemiological indicators and professional practice assessments. Other software is currently being analyzed for integration and expansion of this panel of GPs. This experimentation is recognized as a robust framework and is considered to be the technical foundation of the first regional observatory of primary care data.

Lafayette School District: French Immersion Program

ERIC Educational Resources Information Center

Boudreaux, Nicole

2007-01-01

From 1969 to the late 1980's, most French programs in schools were based on a traditional foreign language instructional model, usually offering 30 minutes a day of French language instruction in elementary grades, increasing to 50 minutes a day in middle school. Contingent on funding and political swings over time, programs expanded from…

Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis.

PubMed

Kieseier, Bernd C; Benamor, Myriam

2014-12-01

Teriflunomide, indicated for the treatment of relapsing-remitting multiple sclerosis, is contraindicated in pregnancy based on signs of developmental toxicity in the offspring of rats and rabbits; developmental toxicity has also been observed in preclinical studies of other disease-modifying therapies. Despite the requirement to use reliable contraception in clinical trials evaluating the safety and efficacy of teriflunomide, a number of pregnancies have been reported. This work reports pregnancy outcomes in teriflunomide clinical trials. Pregnancy outcomes were evaluated in a retrospective analysis of the global pharmacovigilance database. The following information was collected from the pharmacovigilance database or individual patient files: treatment allocation, pregnancy outcome, teriflunomide exposure, and use of the accelerated elimination procedure. At data cut-off, 83 pregnancies were reported in female patients and 22 pregnancies were documented in partners of male patients. All newborns were healthy and did not have any structural or functional abnormalities at birth. Available data do not indicate any teratogenic signals in patients treated with teriflunomide.

7 CFR 993.109 - Modified definition of non-French prunes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false Modified definition of non-French prunes. 993.109... definition of non-French prunes. The definition of non-French prunes set forth in § 993.6 is modified to read as follows: Non-French Prunes means prunes commonly known as Imperial, Sugar, Robe de Sargent, Burton...

The French Sleep Disturbance Scale for Children.

PubMed

Putois, Benjamin; Leslie, Wendy; Gustin, Marie Paule; Challamel, Marie-Josèphe; Raoux, Aude; Guignard-Perret, Anne; Weick, Diane; Sauzeau, Jean-Baptiste; Herbillon, Vania; Zourou, Filio; Spruyt, Karen; Franco, Patricia

2017-04-01

The psychometric properties of the Sleep Disturbance Scale for Children (SDSC) have been shown to be accurate, even when translated into several languages. The aim of the present study was to translate, adapt, and validate the SDSC for a French-speaking population. After forward- and back-translation, the tool was further translated and adapted into the French language. It was then pretested in terms of clarity on 33 French-speaking parents. Pretesting demonstrated that the questionnaire was well understood, indicating good clarity. During the validation phase, a total of 447 French-speaking parents of children aged between 4 and 16  years completed the SDSC. Among these, 66 children were diagnosed with sleep disorders by a pediatric specialist after a sleep consultation and polysomnographic recordings. The factor analysis revealed five factors: difficulty in initiating and maintaining sleep (DIMS), sleep breathing disorders (SBD), disorders of excessive somnolence (DOES), parasomnias (PARA) and non-restorative sleep (NRS). This psychometric structure is reliable and logical in comparison with the experts' diagnoses. Convergent validity, divergent and internal reliability are very good. Inter-parental concordance in scoring the child's sleep problem does show differences in the ways in which parents report their children's sleep patterns. Cut-off was calculated for the total score (45). This study validated a 25-item French version of the questionnaire. The French SDSC could therefore be used to aid screening of sleep disorders in the general population. Copyright © 2016 Elsevier B.V. All rights reserved.

French Higher Education: A Cartoon Essay

ERIC Educational Resources Information Center

Hall, Matthew Henry

2012-01-01

In this cartoon essay, the author shares his experience from a travel to Paris to see the French higher education system. From his travel, he learned that in France, "degree" inflation may be an issue, but not grade inflation. On the flight home, the author reflects how French and American academics answer one question about the state of…

TEST OF FRENCH UNDERGROUND PERSONNEL SHELTERS

DTIC Science & Technology

The objective of this project was to investigate the predicted behavior of French underground personnel shelters, equipment, and instrumentation...structures designed by French engineers were tested: one cast-in- place rectangular structure, one precase circular shelter, two entranceways at...precast rings for the circular structure, and instrumentation were shipped from France and incorporated in the shelters. Preshot and postshot

Reading Speed of Contracted French Braille

ERIC Educational Resources Information Center

Laroche, Louise; Boule, Jacinthe; Wittich, Walter

2012-01-01

This study was designed to address three hypotheses: (1) The reading speed of both readers of French braille and readers of French print will be faster in the silent condition; however, this gain in speed will be larger for print readers; (2) Individuals who acquired braille before age 10 will display faster reading speeds at lower error rates…

But Do They Speak French? A Comparison of French Immersion Programs in Immersion Only and English/Immersion Settings. Research Report 79-01.

ERIC Educational Resources Information Center

Parkin, Michael

Students' use of French in unsupervised classroom situations and outside the classroom was investigated in immersion center schools (all students are involved in French immersion programs) and dual track schools (French immersion programs co-exist with regular English language programs). A total of 414 students in grades 3 and 4 were observed…

[Comparing results of methicillin-resistant Staphylococcus aureus (MRSA) surveillance using the French DRG-based information system (PMSI)].

PubMed

Nuemi, G; Astruc, K; Aho, S; Quantin, C

2013-10-01

The surveillance of methicillin-resistant Staphylococcus aureus (MRSA) is a national priority. The rate of MRSA infections is one of six indicators tracked by the Department of Health. Since 2002, the French institute for public health surveillance (InVS) has monitored MRSA infections to estimate incidence density. Today, the use of the French administrative database (PMSI) could facilitate this surveillance. The aim of this study was to compare MRSA incidence density computed at a national level using PMSI databases with the results from the InVS taken as the reference. PMSI databases for the years 2006 to 2009 were used. The reference results were those published by the InVS from 2006 to 2009. MRSA density defined as the number of MRSA infections recorded per year over 1000 hospital stays was computed. It was then compared with the MRSA incidence density measured by InVS. The time course of MRSA incidence in the PMSI records was modeled using a Poisson regression. The incidence density measured by the InVS was higher than the MRSA density computed using the PMSI, but this difference appeared to decrease over time. The PMSI density/InVS MRSA incidence density ratio was 0.8% in 2006 and about 9.2% in 2009. We observed inverted trends with a growing trend in MRSA density identified by the PMSI. Furthermore, the year of study was significantly associated with incidence density (P=0.01). Using PMSI data as an additional source of information in the hospital MRSA surveillance process makes it possible to detect and analyze patient repeats at the regional and national levels with linkage facilities. Estimation of incidence density for hospitals not participating to this surveillance system will be the next step. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Perspective view of span over French Creek and east abutment, ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

Perspective view of span over French Creek and east abutment, looking NW. - Pennsylvania Railroad, French Creek Trestle, Spanning French Creek, north of Paradise Street, Phoenixville, Chester County, PA

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

PubMed Central

He, Yongqun

2016-01-01

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. PMID:27458549

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

PubMed

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.

People’s War: The French in Indochina

DTIC Science & Technology

1990-04-02

AUTHOR: Thomas L. Phelps, Lt Col, USAF TITLE: People’s War: The French in Indochina FORMAT: Individual Study Project DATE: 2 April 1990 PAGES: 47...though opposed to French control, often had close economic and social ties to France . Vietnamese leaders influenced by socialist or communist ideas wanted...benefits of Indochina and left the political administration of the region to France . However, French difficulties increased because the Japanese

Gastrointestinal Illnesses among French Forces Deployed to Djibouti: French Military Health Surveillance, 2005–2009

PubMed Central

Ollivier, Lénaïck; Decam, Christophe; de Santi, Vincent Pommier; Darar, Houssein Y.; Dia, Aïssata; Nevin, Remington L.; Romand, Olivier; Bougère, Jacques; Deparis, Xavier; Boutin, Jean-Paul

2010-01-01

Despite an increase in foreign tourism and in the numbers of foreign military personnel deployed to Djibouti, little is known about the risk of gastrointestinal illness in this country in eastern Africa. To assess risk and to describe common features of gastrointestinal illnesses, reports of illness derived from military health surveillance data collected during 2005–2009 among French service members deployed to Djibouti were reviewed. Diarrhea was the most common problem; it had an annual incidence ranging from 260 to 349 cases per 1,000 person-years. The risk was higher among soldiers deployed short-term (four months) than among soldiers deployed long-term (two years). This five-year review of French health surveillance data documents a significant burden of diarrhea among French soldiers in Djibouti. The identification of factors associated with risk may permit efficient targeting of interventions to reduce morbidity from gastrointestinal illness. PMID:20889897

Negation in Near-Native French: Variation and Sociolinguistic Competence

ERIC Educational Resources Information Center

Donaldson, Bryan

2017-01-01

This study investigated how adult second language (L2) speakers of French with near-native proficiency realize verbal negation, a well-known sociolinguistic variable in contemporary spoken French. Data included 10 spontaneous informal conversations between near-native speakers of French and native speakers (NSs) closely acquainted with them.…

Ten Projects to Involve Your Students Directly in French.

ERIC Educational Resources Information Center

van Lent, Peter C.

1981-01-01

Proposes 10 activities to provide French classes of all levels with a broad spectrum of language projects involving direct and active use of French including students polling each other, skits based on television commercials, geographical "show and tell," cooking French dishes, writing a monthly newspaper, and field trips. (BK)

[The Confusion Assessment Method: Transcultural adaptation of a French version].

PubMed

Antoine, V; Belmin, J; Blain, H; Bonin-Guillaume, S; Goldsmith, L; Guerin, O; Kergoat, M-J; Landais, P; Mahmoudi, R; Morais, J A; Rataboul, P; Saber, A; Sirvain, S; Wolfklein, G; de Wazieres, B

2018-05-01

The Confusion Assessment Method (CAM) is a validated key tool in clinical practice and research programs to diagnose delirium and assess its severity. There is no validated French version of the CAM training manual and coding guide (Inouye SK). The aim of this study was to establish a consensual French version of the CAM and its manual. Cross-cultural adaptation to achieve equivalence between the original version and a French adapted version of the CAM manual. A rigorous process was conducted including control of cultural adequacy of the tool's components, double forward and back translations, reconciliation, expert committee review (including bilingual translators with different nationalities, a linguist, highly qualified clinicians, methodologists) and pretesting. A consensual French version of the CAM was achieved. Implementation of the CAM French version in daily clinical practice will enable optimal diagnosis of delirium diagnosis and enhance communication between health professionals in French speaking countries. Validity and psychometric properties are being tested in a French multicenter cohort, opening up new perspectives for improved quality of care and research programs in French speaking countries. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Discrimination of English and French orthographic patterns by biliterate children.

PubMed

Jared, Debra; Cormier, Pierre; Levy, Betty Ann; Wade-Woolley, Lesly

2013-04-01

We investigated whether young English-French biliterate children can distinguish between English and French orthographic patterns. Children in French immersion programs were asked to play a dictionary game when they were in Grade 2 and again when they were in Grade 3. They were shown pseudowords that contained either an English spelling pattern or a French spelling pattern, and they were asked to decide whether each pseudoword should go in an English dictionary or a French dictionary if it became a real word. Comparison groups of monolingual English children, monolingual French children, and English-French bilingual university students were also tested on the task. French immersion students in both grades were above chance in discriminating between the two types of pseudowords but were well below adult performance on the task. Measures obtained in kindergarten showed that early print knowledge had some ability to predict later ability to discriminate between the orthographic patterns of the two languages. Further analyses indicated that exposure to print in each language in Grades 1 to 3 was strongly related to discrimination performance. The findings are interpreted as being consistent with the statistical learning hypothesis. Copyright © 2012 Elsevier Inc. All rights reserved.

Risk of Progressive Multifocal Leukoencephalopathy in the Combination Antiretroviral Therapy Era in the French Hospital Database on Human Immunodeficiency Virus (ANRS-C4).

PubMed

Melliez, Hugues; Mary-Krause, Murielle; Bocket, Laurence; Guiguet, Marguerite; Abgrall, Sophie; De Truchis, Pierre; Katlama, Christine; Martin-Blondel, Guillaume; Henn, Aurelia; Revest, Matthieu; Robineau, Olivier; Khuong-Josses, Marie-Aude; Canestri, Anna; De Castro, Nathalie; Joly, Véronique; Mokhtari, Saadia; Risso, Karine; Gasnault, Jacques; Costagliola, Dominique

2018-04-04

Risk factors for progressive multifocal leukoencephalopathy (PML) in individuals with human immunodeficiency virus (HIV) infection are poorly documented in the era of combination antiretroviral therapy (cART). We studied HIV-1-infected individuals aged ≥15 years who had no history of PML and were prospectively followed up between 1997 and 2011 in the French Hospital Database on HIV (FHDH-ANRS CO4) cohort. Cox models were used to calculate adjusted hazard ratios (HRs), focusing on sub-Saharan origin, suggested to be protective, and recent cART initiation, potentially associated with an increased risk of PML. PML developed in 555 individuals, in 57 during the first 6 months of cART. From 1997-2000 to 2009-2011, the incidence fell from 1.15 (95% confidence interval [CI], .98-1.31) to 0.49 (.37-.61) per 1000 person-years. Sub-Saharan African origin had no clear influence (HR, 0.80; 95% CI, .58-1.11). Compared with men who have sex with men, injection drug users (IDUs) were at higher risk (HR, 1.80 [95% CI, 1.32-2.45] for male and 1.68 [1.13-2.48] for female IDUs). When IDUs were excluded, hepatitis C virus seropositivity was associated with an increased risk (HR, 1.40; 95% CI, 1.02-1.93). Compared with no cART initiation, initiation <6 months previously was associated with PML onset (HR, 4.91; 95% CI, 2.42-9.95). Recent cART initiation is associated with an increased risk of PML, as are injection drug use and hepatitis C virus seropositivity. Sub-Saharan African origin had no protective effect.

Validation of the French version of the BACS (the brief assessment of cognition in schizophrenia) among 50 French schizophrenic patients.

PubMed

Bralet, Marie-Cécile; Falissard, Bruno; Neveu, Xavier; Lucas-Ross, Margaret; Eskenazi, Anne-Marie; Keefe, Richard S E

2007-09-01

Schizophrenic patients demonstrate impairments in several key dimensions of cognition. These impairments are correlated with important aspects of functional outcome. While assessment of these cognition disorders is increasingly becoming a part of clinical and research practice in schizophrenia, there is no standard and easily administered test battery. The BACS (Brief Assessment of Cognition in Schizophrenia) has been validated in English language [Keefe RSE, Golberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensibility, and comparison with a standard neurocognitive battery. Schizophr. Res 2004;68:283-97], and was found to be as sensitive to cognitive dysfunction as a standard battery of tests, with the advantage of requiring less than 35 min to complete. We developed a French adaptation of the BACS and this study tested its ease of administration and concurrent validity. Correlation analyses between the BACS (version A) and a standard battery were performed. A sample of 50 stable schizophrenic patients received the French Version A of the BACS in a first session, and in a second session a standard battery. All the patients completed each of the subtests of the French BACS . The mean duration of completion for the BACS French version was 36 min (S.D.=5.56). A correlation analysis between the BACS (version A) global score and the standard battery global score showed a significant result (r=0.81, p<0.0001). The correlation analysis between the BACS (version A) sub-scores and the standard battery sub-scores showed significant results for verbal memory, working memory, verbal fluency, attention and speed of information processing and executive functions (p<0.001) and for motor speed (p<0.05). The French Version of the BACS is easier to use in French schizophrenic patients compared to a standard battery (administration shorter and completion rate better) and its good psychometric properties suggest

The French Muséum national d'histoire naturelle vascular plant herbarium collection dataset

NASA Astrophysics Data System (ADS)

Le Bras, Gwenaël; Pignal, Marc; Jeanson, Marc L.; Muller, Serge; Aupic, Cécile; Carré, Benoît; Flament, Grégoire; Gaudeul, Myriam; Gonçalves, Claudia; Invernón, Vanessa R.; Jabbour, Florian; Lerat, Elodie; Lowry, Porter P.; Offroy, Bérangère; Pimparé, Eva Pérez; Poncy, Odile; Rouhan, Germinal; Haevermans, Thomas

2017-02-01

We provide a quantitative description of the French national herbarium vascular plants collection dataset. Held at the Muséum national d'histoire naturelle, Paris, it currently comprises records for 5,400,000 specimens, representing 90% of the estimated total of specimens. Ninety nine percent of the specimen entries are linked to one or more images and 16% have field-collecting information available. This major botanical collection represents the results of over three centuries of exploration and study. The sources of the collection are global, with a strong representation for France, including overseas territories, and former French colonies. The compilation of this dataset was made possible through numerous national and international projects, the most important of which was linked to the renovation of the herbarium building. The vascular plant collection is actively expanding today, hence the continuous growth exhibited by the dataset, which can be fully accessed through the GBIF portal or the MNHN database portal (available at: https://science.mnhn.fr/institution/mnhn/collection/p/item/search/form). This dataset is a major source of data for systematics, global plants macroecological studies or conservation assessments.

The French Muséum national d'histoire naturelle vascular plant herbarium collection dataset.

PubMed

Le Bras, Gwenaël; Pignal, Marc; Jeanson, Marc L; Muller, Serge; Aupic, Cécile; Carré, Benoît; Flament, Grégoire; Gaudeul, Myriam; Gonçalves, Claudia; Invernón, Vanessa R; Jabbour, Florian; Lerat, Elodie; Lowry, Porter P; Offroy, Bérangère; Pimparé, Eva Pérez; Poncy, Odile; Rouhan, Germinal; Haevermans, Thomas

2017-02-14

We provide a quantitative description of the French national herbarium vascular plants collection dataset. Held at the Muséum national d'histoire naturelle, Paris, it currently comprises records for 5,400,000 specimens, representing 90% of the estimated total of specimens. Ninety nine percent of the specimen entries are linked to one or more images and 16% have field-collecting information available. This major botanical collection represents the results of over three centuries of exploration and study. The sources of the collection are global, with a strong representation for France, including overseas territories, and former French colonies. The compilation of this dataset was made possible through numerous national and international projects, the most important of which was linked to the renovation of the herbarium building. The vascular plant collection is actively expanding today, hence the continuous growth exhibited by the dataset, which can be fully accessed through the GBIF portal or the MNHN database portal (available at: https://science.mnhn.fr/institution/mnhn/collection/p/item/search/form). This dataset is a major source of data for systematics, global plants macroecological studies or conservation assessments.

The French Muséum national d’histoire naturelle vascular plant herbarium collection dataset

PubMed Central

Le Bras, Gwenaël; Pignal, Marc; Jeanson, Marc L.; Muller, Serge; Aupic, Cécile; Carré, Benoît; Flament, Grégoire; Gaudeul, Myriam; Gonçalves, Claudia; Invernón, Vanessa R.; Jabbour, Florian; Lerat, Elodie; Lowry, Porter P.; Offroy, Bérangère; Pimparé, Eva Pérez; Poncy, Odile; Rouhan, Germinal; Haevermans, Thomas

2017-01-01

We provide a quantitative description of the French national herbarium vascular plants collection dataset. Held at the Muséum national d’histoire naturelle, Paris, it currently comprises records for 5,400,000 specimens, representing 90% of the estimated total of specimens. Ninety nine percent of the specimen entries are linked to one or more images and 16% have field-collecting information available. This major botanical collection represents the results of over three centuries of exploration and study. The sources of the collection are global, with a strong representation for France, including overseas territories, and former French colonies. The compilation of this dataset was made possible through numerous national and international projects, the most important of which was linked to the renovation of the herbarium building. The vascular plant collection is actively expanding today, hence the continuous growth exhibited by the dataset, which can be fully accessed through the GBIF portal or the MNHN database portal (available at: https://science.mnhn.fr/institution/mnhn/collection/p/item/search/form). This dataset is a major source of data for systematics, global plants macroecological studies or conservation assessments. PMID:28195585

French-Algonquian Interaction in Canada: A Michif Case Study

ERIC Educational Resources Information Center

Rosen, Nicole

2008-01-01

This paper discusses the language contact situation between Algonquian languages and French in Canada. Michif, a French-Plains Cree mixed language, is used as a case study for linguistic results of language contact. The paper describes the phonological, morphological, and syntactic conflict sites between the grammars of Plains Cree and French, as…

[High blood pressure and obesity: disparities among four French overseas territories].

PubMed

Atallah, A; Atallah, V; Daigre, J-L; Boissin, J-L; Kangambega, P; Larifla, L; Inamo, J

2014-06-01

The epidemiological characteristics of hypertension and obesity in French overseas territories (FOTs) have never been compared. This cross-sectional survey included representative population-based samples of 602, 601, 620 and 605 men and women aged more than 15 years, respectively, from four FOTs of Guadeloupe, Martinique, French Guiana, and French Polynesia. Hypertension was defined as blood pressure (BP) at least 140/90mmHg or the current use of antihypertensive treatment. The prevalence of hypertension was 29.2% in Guadeloupe, 17.9% in French Guiana, 27.6% in Martinique and 24.5% in French Polynesia. Considering the Guadeloupe population as the reference group, prevalence of hypertension was significantly lower in French Guiana (P<0.001), even after controlling for age and sex (PU0.006). Awareness and treatment of hypertension were similar in French Guiana, Martinique and Guadeloupe (68.8-75.1% and 69.0-73.4%, respectively). Awareness was lower in French Polynesia (50.0%, adjusted P value U0.04), as was treatment of hypertension (32.4%, adjusted P value U0.001). Control of hypertension was also lower in French Polynesia (8.8%, adjusted P value U0.001) compared with the other territories (29.7-31.8%). French Polynesia had the highest prevalence of obesity (33.1%, adjusted P value<0.001) as compared with the other territories (17.9-22.8%). It had also the largest population attributable fraction of hypertension due to obesity (35.5%) compared with Guadeloupe (13.3%), Martinique (12.3%) and French Guiana (23.6%). Wide variations were observed in the prevalence and the management of hypertension between these FOTs, and an especially challenging low control of hypertension was found in French Polynesia. Obesity appears a key target to prevent hypertension, particularly in French Polynesia. Copyright © 2014. Published by Elsevier SAS.

French Interim MALE UAV Program

DTIC Science & Technology

2003-09-02

MINISTÈRE DE LA DÉFENSE June, 13th 2002 Lcl Monsterleet FAF Staff J. Caron EADS S&DE-ISR FRENCH INTERIM MALE UAV PROGRAM 4 INDUSTRIAL STATUS Report...2003 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE French Interim Male UAV Program 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c...PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) EADS

Project TANDEM (Tsunamis in the Atlantic and the English ChaNnel: Definition of the Effects through numerical Modeling) (2014-2018): a French initiative to draw lessons from the Tohoku-oki tsunami on French coastal nuclear facilities

NASA Astrophysics Data System (ADS)

Hébert, Hélène; Abadie, Stéphane; Benoit, Michel; Créach, Ronan; Frère, Antoine; Gailler, Audrey; Garzaglia, Sébastien; Hayashi, Yutaka; Loevenbruck, Anne; Macary, Olivier; Marcer, Richard; Morichon, Denis; Pedreros, Rodrigo; Rebour, Vincent; Ricchiuto, Mario; Silva Jacinto, Ricardo; Terrier, Monique; Toucanne, Samuel; Traversa, Paola; Violeau, Damien

2014-05-01

TANDEM (Tsunamis in the Atlantic and the English ChaNnel: Definition of the Effects through numerical Modeling) is a French research project dedicated to the appraisal of coastal effects due to tsunami waves on the French coastlines, with a special focus on the Atlantic and Channel coastlines, where French civil nuclear facilities have been operating since about 30 years. This project aims at drawing conclusions from the 2011 catastrophic tsunami, and will allow, together with a Japanese research partner, to design, adapt and validate numerical methods of tsunami hazard assessment, using the outstanding database of the 2011 tsunami. Then the validated methods will be applied to estimate, as accurately as possible, the tsunami hazard for the French Atlantic and Channel coastlines, in order to provide guidance for risk assessment on the nuclear facilities. The project TANDEM follows the recommendations of International Atomic Energy Agency (IAEA) to analyse the tsunami exposure of the nuclear facilities, as well as the recommendations of the French Nuclear Safety Authority (Autorité de Sûreté Nucléaire, ASN) in the aftermath of the 2011 catastrophe, which required the licensee of nuclear facilities to conduct complementary safety assessments (CSA), also including "the robustness beyond their design basis". The tsunami hazard deserves an appraisal in the light of the 2011 catastrophe, to check whether any unforeseen tsunami impact can be expected for these facilities. TANDEM aims at defining the tsunami effects expected for the French Atlantic and Channel coastlines, basically from numerical modeling methods, through adaptation and improvement of numerical methods, in order to study tsunami impacts down to the interaction with coastal structures (thus sometimes using 3D approaches) (WP1). Then the methods will be tested to better characterize and quantify the associated uncertainties (in the source, the propagation, and the coastal impact) (WP2). The project will

Multilingual Immigrants' French and English Acquisition in Grade 6 French Immersion: Evidence as Means to Improve Access

ERIC Educational Resources Information Center

Mady, Callie

2018-01-01

This study seeks to examine the success of voluntary immigrants in Grade 6 French immersion with a double comparison to Canadian-born (a) Anglophones and (b) multilingual students (children of voluntary immigrants). The findings, that show the immigrant students to outperform the other two groups in French and English, are explored through a…

Les affaires "en francais" (Business "In French").

ERIC Educational Resources Information Center

Sanko, Helene N.

1993-01-01

A French brochure entitled "700 Current Words for Business" was developed to familiarize the business community with modern French business vocabulary and avoid intrusion of terminology from other languages. Some terms are neologisms. Translations from Latin, Japanese, and English illustrate the etymology and morphological patterns of…

French Military Applications of Virtual Reality

DTIC Science & Technology

2000-11-01

UNCLASSIFIED Defense Technical Information Center Compilation Part Notice ADPO10631 TITLE: French Military Applications of Virtual Reality...numbers comprise the compilation report: ADPO10609 thru ADP010633 UNCLASSIFIED 23-1 FRENCH MILITARY APPLICATIONS OF VIRTUAL REALITY Jean Paul Papin* and...Pascal Hue DGA/DCE/ETC4/ETAS Etablissement Technique d’ Angers BP 36 49460 MONTREUIL JUIGNE, France INTRODUCTION France is now applying virtual

Photocopy of photograph (from Mrs. Martin, grandniece of John French, ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

Photocopy of photograph (from Mrs. Martin, grandniece of John French, Clinton, Missouri) Circa 1900, photographer unknown JOHN AND ALMIRA FRENCH IN FRONT OF WEST AND SOUTH FACADES - John French Farm, South Grand River, Deepwater, Henry County, MO

A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

PubMed

Liu, Xiao; Chen, Hsinchun

2015-12-01

Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

Japon: Le francais en sursis? (Japan: French in Stay of Execution?)

ERIC Educational Resources Information Center

Pecheur, Jacques

1991-01-01

In Japan, second-language instruction and specifically French instruction are at a crossroads. Despite appearances of normalcy, survival of university-level French instruction is threatened by greater current interest in Asian languages. In response, the French Embassy and Japanese Association of French Professors have established a policy to…

Reevaluating the French Revolution.

ERIC Educational Resources Information Center

Stromberg, Roland N.

1986-01-01

Analyzes previous interpretations concerning the French Revolution. Discusses several weaknesses of the Marxist views in light of recent philosophical and sociological thinking about social change. (RKM)

[Using cancer case identification algorithms in medico-administrative databases: Literature review and first results from the REDSIAM Tumors group based on breast, colon, and lung cancer].

PubMed

Bousquet, P-J; Caillet, P; Coeuret-Pellicer, M; Goulard, H; Kudjawu, Y C; Le Bihan, C; Lecuyer, A I; Séguret, F

2017-10-01

The development and use of healthcare databases accentuates the need for dedicated tools, including validated selection algorithms of cancer diseased patients. As part of the development of the French National Health Insurance System data network REDSIAM, the tumor taskforce established an inventory of national and internal published algorithms in the field of cancer. This work aims to facilitate the choice of a best-suited algorithm. A non-systematic literature search was conducted for various cancers. Results are presented for lung, breast, colon, and rectum. Medline, Scopus, the French Database in Public Health, Google Scholar, and the summaries of the main French journals in oncology and public health were searched for publications until August 2016. An extraction grid adapted to oncology was constructed and used for the extraction process. A total of 18 publications were selected for lung cancer, 18 for breast cancer, and 12 for colorectal cancer. Validation studies of algorithms are scarce. When information is available, the performance and choice of an algorithm are dependent on the context, purpose, and location of the planned study. Accounting for cancer disease specificity, the proposed extraction chart is more detailed than the generic chart developed for other REDSIAM taskforces, but remains easily usable in practice. This study illustrates the complexity of cancer detection through sole reliance on healthcare databases and the lack of validated algorithms specifically designed for this purpose. Studies that standardize and facilitate validation of these algorithms should be developed and promoted. Copyright © 2017. Published by Elsevier Masson SAS.

[Use of social media by French urologists: Results from a study of the National French Urological Association].

PubMed

Misrai, V; Castagnola, C; Descotes, J-L; Rouprêt, M

2015-06-01

Social Media (SoMe) have changed the face of modern medicine. Our purpose was to make an inventory on the use of SoMe within urologists members of the French Urological Association (AFU). A 15 questions-survey was sent by email 2 months to urologists AFU members before the 108th French Congress of Urology (#CFU2014). At the same time, the activity of urologists using Twitter was analyzed over the period of the national conference with the symplur software (www.symplur.com). Overall, 270 (17.3%) surveys were completed. Only 50% of responders had an online SoMe account. The most commonly used social media platforms were: Facebook (36.1%) followed by LinkedIn (28.2%), Google+ (19.6%), YouTube (18.7%) and Twitter (17.4%). The use of SoMe was higher in the age groups 30-40 and 40-50 years than in older age groups (83% versus 36%). Only 38.7% of respondents reported using SoMe in a professional field. At the congress #CFU2014, there were over 1000 tweets generated by 173 different contributors. Only a minority of French urologists have reported to be connected to SoMe and a predominantly personal use. The emergence of Twitter in French urological conferences is very new but seems promising. Further studies are needed, especially within the members of the residents French urological association to better characterize the true impact of SoMe in urology. 4. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Did the new French pay-for-performance system modify benzodiazepine prescribing practices?

PubMed

Rat, Cédric; Penhouet, Gaëlle; Gaultier, Aurélie; Chaslerie, Anicet; Pivette, Jacques; Nguyen, Jean Michel; Victorri-Vigneau, Caroline

2014-07-11

French general practitioners (GPs) were enrolled in a new payment system in January 2012. As part of a national agreement with the French National Ministry of Health, GPs were asked to decrease the proportion of patients who continued their benzodiazepine treatment 12 weeks after its initiation and to decrease the proportion of patients older than 65 who were prescribed long half-life benzodiazepines. In return, GPs could expect an extra payment of up to 490 euros per year. This study reports the evolution of the corresponding prescribing practices of French GPs during that period regarding patients who were prescribed a benzodiazepine for the first time. The national healthcare system's administrative database was used to report the longitudinal follow-up of two historical cohorts of French patients from the Pays de la Loire area. The "2011" and "2012" cohorts included all patients who initiated benzodiazepine regimens from April 1 to June 30 in 2011 and 2012, respectively.The primary outcomes were the proportion of those study patients who continued benzodiazepine treatment after 12 weeks and the proportion of study patients >65 years who were prescribed long half-life benzodiazepines.Analyses were performed using a multi-level regression. In total, 41,436 and 42,042 patients initiated benzodiazepine treatment in 2011 and 2012, respectively. A total of 18.97% of patients continued treatment for more than 12 weeks in 2012, compared with 18.18% in 2011. In all, 27.43% and 28.06% of patients >65 years continued treatment beyond 12 weeks in 2011 and 2012, respectively. The proportion of patients >65 years who were prescribed long half-life benzodiazepines decreased from 53.5% to 48.8% (p < 0.005) due to an increase in short half-life benzodiazepine prescriptions. Patients >65 years who were prescribed short half-life benzodiazepines were more likely to continue treatment after 12 weeks (p < 0.005). Despite the pay-for-performance strategy, the number of short half

Insurance statements from French anaesthesiologists and intensivists: A database analysis.

PubMed

Boutonnet, Mathieu; Trouiller, Pierre; Lopard, Eric; Amalberti, René; Houselstein, Thierry; Pasquier, Pierre; Auroy, Yves; De Saint-Maurice, Guillaume

2016-10-01

From its origins, anaesthesia is a leading medical specialty for improving patient safety. However, perioperative adverse events remain frequent and may be preventable in 50% of cases. We conducted a collaborative retrospective study analysis of the insurance-database of the MACSF-Sou Medical insurance company to assess the perioperative risk. Retrospective study, including all the statements declared by anaesthesiologists to the MACSF-Sou Medical insurance company. A description of risk in perioperative medicine was performed by the assessment of these statements by three experts member of the SFAR. All the statements concerning regional anaesthesia and dental injuries were excluded. Eight hundred and seventy statements were analyzed. The patients involved were predominantly women (sex-ratio: 0.86), with a mean age of 56 years (±18). Three hundred and fifteen cardiac arrests, 157 severe systemic complications, 340 moderate complications and 106 conflicts were analyzed. Most of the events were revealed postoperatively (79.3%) and almost half of them after the discharge of the postanesthetic care unit. The medical consequences were considered as serious. Death followed 35.9% of the events declared. Relative or true hypovolaemia and stroke were responsible for a large part of postoperative mortality and morbidity. Collaborating with insurance companies allows a relevant approach of the perioperative risk. The study highlighted the importance of the delayed complications and is a plea for a more intense implication of anaesthesia in the postoperative care with the aim of improving patient safety. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

[The opening of the French national health database: Opportunities and difficulties. The experience of the Gazel and Constances cohorts].

PubMed

Goldberg, M; Carton, M; Gourmelen, J; Genreau, M; Montourcy, M; Le Got, S; Zins, M

2016-09-01

In France, the national health database (SNIIRAM) is an administrative health database that collects data on hospitalizations and healthcare consumption for more than 60 million people. Although it does not record behavioral and environmental data, these data have a major interest for epidemiology, surveillance and public health. One of the most interesting uses of SNIIRAM is its linkage with surveys collecting data directly from persons. Access to the SNIIRAM data is currently relatively limited, but in the near future changes in regulations will largely facilitate open access. However, it is a huge and complex database and there are some important methodological and technical difficulties for using it due to its volume and architecture. We are developing tools for facilitating the linkage of the Gazel and Constances cohorts to the SNIIRAM: interactive documentation on the SNIIRAM database, software for the verification of the completeness and validity of the data received from the SNIIRAM, methods for constructing indicators from the raw data in order to flag the presence of certain events (specific diagnosis, procedure, drug…), standard queries for producing a set of variables on a specific area (drugs, diagnoses during a hospital stay…). Moreover, the REDSIAM network recently set up aims to develop, evaluate and make available algorithms to identify pathologies in SNIIRAM. In order to fully benefit from the exceptional potential of the SNIIRAM database, it is essential to develop tools to facilitate its use. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

View looking Eastnortheast at French Creek trestle, which appears at ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

View looking Eastnortheast at French Creek trestle, which appears at left center of frame. Bridge in foreground is west entrance to abandoned Phoenix iron works. - Pennsylvania Railroad, French Creek Trestle, Spanning French Creek, north of Paradise Street, Phoenixville, Chester County, PA

French Alps, Mont Blanc, French/Italian Border

NASA Image and Video Library

1992-04-02

In this southeast looking view, Mont Blanc, on the French/Italian border, (48.0N, 4.5E) the highest mountain peak in all of Europe, is just below and right of center (below the end of the prominent valley of the Aosta River, in the center of the photo. The rivers flow out of the Alps into Italy toward Turin. Chamonix, the famous resort town and center of Alpine mountain climbing, lies in the valley just below Mont Blanc.

The Amma-Sat Database

NASA Astrophysics Data System (ADS)

Ramage, K.; Desbois, M.; Eymard, L.

2004-12-01

The African Monsoon Multidisciplinary Analysis project is a French initiative, which aims at identifying and analysing in details the multidisciplinary and multi-scales processes that lead to a better understanding of the physical mechanisms linked to the African Monsoon. The main components of the African Monsoon are: Atmospheric Dynamics, the Continental Water Cycle, Atmospheric Chemistry, Oceanic and Continental Surface Conditions. Satellites contribute to various objectives of the project both for process analysis and for large scale-long term studies: some series of satellites (METEOSAT, NOAA,.) have been flown for more than 20 years, ensuring a good quality monitoring of some of the West African atmosphere and surface characteristics. Moreover, several recent missions, and several projects will strongly improve and complement this survey. The AMMA project offers an opportunity to develop the exploitation of satellite data and to make collaboration between specialist and non-specialist users. In this purpose databases are being developed to collect all past and future satellite data related to the African Monsoon. It will then be possible to compare different types of data from different resolution, to validate satellite data with in situ measurements or numerical simulations. AMMA-SAT database main goal is to offer an easy access to satellite data to the AMMA scientific community. The database contains geophysical products estimated from operational or research algorithms and covering the different components of the AMMA project. Nevertheless, the choice has been made to group data within pertinent scales rather than within their thematic. In this purpose, five regions of interest where defined to extract the data: An area covering Tropical Atlantic and Africa for large scale studies, an area covering West Africa for mesoscale studies and three local areas surrounding sites of in situ observations. Within each of these regions satellite data are projected on

Techniques of Teaching Business Correspondence in French.

ERIC Educational Resources Information Center

Abrate, Jayne

A framework for using the material contained in French high school business correspondence manuals to teach business correspondence in French as a second language is presented. The intent is to introduce the function of various letter formats and to facilitate deciphering the content of the letters. Exercises promote situational analysis of…

Call Me "Madame": Re-Presenting Culture in the French Language Classroom

ERIC Educational Resources Information Center

Siskin, H. Jay

2007-01-01

This study examines autobiographies of American teachers of French in order to make explicit their beliefs regarding French language and culture. The themes of class and power are prominent in these teachers' belief systems, as is the desire for self-transformation through mastery of French and miming a subset of French behaviors. These notions…

[Emergency eye care in French university hospitals].

PubMed

Bourges, J-L

2018-03-01

The patient's request for urgent care in ophthalmology (PRUCO) at health care centers is constantly growing. In France, university hospitals are managing 75% of these cases. We sought to quantify PRUCO referred to French university hospital emergency units as well as to approach the structure and the territorial distribution of emergency eye care provided by French university hospitals. We conducted a quick cross-sectional survey sent to the 32 metropolitan and overseas French university hospitals. It inquired for each hospital whether emergency eye care units were available, whether ophthalmologists were on duty or on call overnight and how many PRUCO were managed in 2016. The 32 university hospitals completed the survey. A total of 398650 PRUCO were managed in French university hospitals in 2016. The emergency unit was exclusively dedicated to eye care for 70% of the hospitals, with 47% (15/32) of them employing an ophthalmologist on duty overnight. Every hospital but one had at least one ophthalmologist on call. The city of Paris set aside, university hospitals took care of an annual mean of 9000 PRUCO (min=500; max=32,250). The 32 French university hospitals are actively responding to patient's requests for urgent care in ophthalmology with very heterogeneous patient volumes and organizational systems. Half of them employ ophthalmologists on duty. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

PubMed Central

Nomura, Kaori; Takahashi, Kunihiko; Hinomura, Yasushi; Kawaguchi, Genta; Matsushita, Yasuyuki; Marui, Hiroko; Anzai, Tatsuhiko; Hashiguchi, Masayuki; Mochizuki, Mayumi

2015-01-01

Background The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection. Methods Two AE data sources from 2010 were examined, ie, JADER cases (JP) and Japanese cases extracted from the FAERS (FAERS-JP). Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS), were used on drug-event combinations for three substances frequently recorded in both systems. Results The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37) in the JP and 3.3±3.5 (maximum 62) in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and paroxetine. Signals identified by GPS for the JP and FAERS-JP, as referenced by Japanese labeling, showed higher positive sensitivity than was expected. Conclusion The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data. PMID:26109846

Validation of the French version of the Child Post-Traumatic Stress Reaction Index: psychometric properties in French speaking school-aged children.

PubMed

Olliac, Bertrand; Birmes, Philippe; Bui, Eric; Allenou, Charlotte; Brunet, Alain; Claudet, Isabelle; Sales de Gauzy, Jérôme; Grandjean, Hélène; Raynaud, Jean-Philippe

2014-01-01

Although the reliable and valid Child Post-Traumatic Stress Reaction Index (CPTS-RI) is a widely used measure of posttraumatic stress disorder (PTSD) symptoms in children, it has not been validated in French-speaking populations. The present study aims to assess the psychometric properties of the CPTS-RI in three samples of French-speaking school-children. Data was obtained from three samples. Sample 1 was composed of 106 children (mean (SD) age = 11.7(0.7), 50% females) victims of an industrial disaster. Sample 2 was composed of 50 children (mean (SD) age = 10.8(2.6), 44% females) who had received an orthopaedic surgical procedure after an accident. Sample 3 was composed of 106 children (mean (SD) age = 11.7(2.2), 44% females) admitted to an emergency department after a road traffic accident. We tested internal consistency using Cronbach's alpha. We examined test-retest reliability using intraclass correlation coefficient. In order to assess the convergent validity of the French version of the CPTS-RI and the Clinician Administered PTS Scale-Child and Adolescent (CAPS-CA), spearman-correlation coefficient was computed. To verify the validity of the cut-off scores, a ROC curve was constructed which evaluated the sensitivity and specificity of each score compared to the diagnosis with the CAPS-CA. We also used principal components analysis with varimax rotation to study the structure of the French version of the CPTS-RI. Cronbach's alpha coefficient was 0.87 for the French version of the CPTS-RI. Two-week test-retest intraclass correlation coefficient (n = 30) was 0.67. The French version of the CPTS-RI was well correlated with the CAPS-CA (r = 0.76, p < 0.001). Taking the CAPS-CA as the diagnostic reference, with a diagnostic cut-off of >24 for the CPTS-RI, the sensitivity and specificities were 100% and 62.6%, respectively. The French version of the CPTS-RI demonstrated a three-factor structure. The CPTS-RI is reliable and valid in French-speaking children.

French Phonology for Teachers: A Programmed Introduction.

ERIC Educational Resources Information Center

Green, Jerald R.; Poulin, Norman A.

This programed, self-instructional course has the following terminal objectives: (1) to present some notions of the science of linguistics and the major branches of linguistics, (2) to teach the segmental and suprasegmental phonemes of French, (3) to identify the major articulatory problems of French for the native speaker of English, (4) to…

Le Francais Courant (Contemporary French), Part II.

ERIC Educational Resources Information Center

Dade County Public Schools, Miami, FL.

This course has been developed basically within the limits of Units 4-6 of "A-LM French: Level 1", second edition. The primary objectives are to develop French vocabulary relative to the family, home, transportation, and foods by continuing to work with short dialogues based on everyday, teenage experiences. While reviewing previously studied…

Perception of resyllabification in French.

PubMed

Gaskell, M Gareth; Spinelli, Elsa; Meunier, Fanny

2002-07-01

In three experiments, we examined the effects of phonological resyllabification processes on the perception of French speech. Enchainment involves the resyllabification of a word-final consonant across a syllable boundary (e.g., in chaque avion, the /k/ crosses the syllable boundary to become syllable initial). Liaison involves a further process of realization of a latent consonant, alongside resyllabification (e.g., the /t/ in petit avion). If the syllable is a dominant unit of perception in French (Mehler, Dommergues, Frauenfelder, & Segui, 1981), these processes should cause problems for recognition of the following word. A cross-modal priming experiment showed no cost attached to either type of resyllabification in terms of reduced activation of the following word. Furthermore, word- and sequence-monitoring experiments again showed no cost and suggested that the recognition of vowel-initial words may be facilitated when they are preceded by a word that had undergone resyllabification through enchainment or liaison. We examine the sources of information that could underpin facilitation and propose a refinement of the syllable's role in the perception of French speech.

Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore.

PubMed

Hauben, Manfred; Aronson, Jeffrey K

2007-01-01

Anecdotal reports of adverse drug reactions are generally regarded as being of poor evidential quality. This is especially relevant for postmarketing drug safety surveillance, which relies heavily on spontaneous anecdotal reports. The numerous limitations of spontaneous reports cannot be overemphasised, but there is another side to the story: these datasets also contain anecdotal reports that can be considered to describe definitive adverse reactions, without the need for further formal verification. We have previously defined four categories of such adverse reactions: (i) extracellular or intracellular tissue deposition of the drug or a metabolite; (ii) a specific anatomical location or pattern of injury; (iii) physiological dysfunction or direct tissue damage demonstrable by physicochemical testing; and (iv) infection, as a result of the administration of an infective agent as the therapeutic substance or because of demonstrable contamination. In this article, we discuss the implications of these definitive ('between-the-eyes') adverse effects for pharmacovigilance.

Radical Reform of the French University System

ERIC Educational Resources Information Center

Bereziat, Gilbert

2008-01-01

The French university system is in crisis. After its dismantlement during the French revolution, its rebirth was progressive under the third republic (1871-1945). But it was only after 1968 that the current universities developed, with an autonomy that is strictly supervised by the state. Since 1986 all experiments at modernizing the management of…

Perception of Canadian-French Word-Final Vowels in Lexical and Morphosyntactic Minimal Pairs by Canadian English Learners of French

ERIC Educational Resources Information Center

Law, Franzo II

2011-01-01

This study investigated the perception of Canadian French word-final vowels by English-dominant and French-dominant bilinguals living in Montreal. In a modified identification task, listeners selected the response that rhymed with the target word, embedded in a carrier sentence. Minimal sets of real and nonsense target words were used, contrasting…

The A2iA French handwriting recognition system at the Rimes-ICDAR2011 competition

NASA Astrophysics Data System (ADS)

Menasri, Farès; Louradour, Jérôme; Bianne-Bernard, Anne-Laure; Kermorvant, Christopher

2012-01-01

This paper describes the system for the recognition of French handwriting submitted by A2iA to the competition organized at ICDAR2011 using the Rimes database. This system is composed of several recognizers based on three different recognition technologies, combined using a novel combination method. A framework multi-word recognition based on weighted finite state transducers is presented, using an explicit word segmentation, a combination of isolated word recognizers and a language model. The system was tested both for isolated word recognition and for multi-word line recognition and submitted to the RIMES-ICDAR2011 competition. This system outperformed all previously proposed systems on these tasks.

Contemporary Counterinsurgency (COIN) Insights from the French-Algerian War (1954-1962)

DTIC Science & Technology

2008-02-03

Council for Higher Education Accreditation. USAWC STRATEGY RESEARCH PROJECT CONTEMPORARY COUNTERINSURGENCY (COIN) INSIGHTS FROM THE FRENCH -ALGERIAN WAR...Colonel Kenneth M. DeTreux TITLE: Contemporary Counterinsurgency (COIN) Insights from the French - Algerian War (1954-1962) FORMAT: Strategy Research Project ...illustrative case study. This project researches and examines three main elements from the French Algerian experience: the Algerian insurgency, the French

Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System.

PubMed

Nogueira Guerra, Leonor; Herdeiro, Maria Teresa; Ribeiro-Vaz, Inês; Clérigo, Maria Inês Pinto; Rocha, Cristina; Araújo, Ana; Pêgo, Alexandra; Rebelo Gomes, Eva

2015-01-01

Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years. Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients' demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups. We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%). Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.

French immersion in Canada: Theory and practice

NASA Astrophysics Data System (ADS)

Safty, Adel

1991-12-01

French immersion programs are rapidly becoming an integral part of the Canadian education system. Its educational and linguistic achievements have been the subject of an abundant literature that continues to grow. The popularity of the program has helped it expand at a phenomenal rate. From one school and a handful of students in the experimental classes 25 years ago, there are now more than 17,000 schools offering French immersion instruction to close to 250,000 students in all major Canadian cities. The major theoretical foundations on which French immersion was explicitly and sometimes implicitly based may be summarized as follows: Early exposure to a second language is better than late exposure.

Amplitude, frequency, and timbre with the French horn

NASA Astrophysics Data System (ADS)

Konz, Nicholas; Ruiz, Michael J.

2018-07-01

The French horn is used to introduce the three basic properties of periodic waves: amplitude, frequency, and waveform. These features relate to the perceptual characteristics of loudness, pitch, and timbre encountered in everyday language. Visualizations are provided in the form of oscilloscope screenshots, spectrograms, and Fourier spectra to illustrate the physics. Introductory students will find the musical relevance interesting as they experience a real-world application of physics. Demonstrations playing the French horn are provided in an accompanying video (Ruiz 2018 Video: Amplitude, frequency, and timbre with the French horn http://mjtruiz.com/ped/horn/).

Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.

PubMed

Awodele, Olufunsho; Ibrahim, Ali; Orhii, Paul

2016-03-16

Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals. A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17. Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia. More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.

GénoPlante-Info (GPI): a collection of databases and bioinformatics resources for plant genomics

PubMed Central

Samson, Delphine; Legeai, Fabrice; Karsenty, Emmanuelle; Reboux, Sébastien; Veyrieras, Jean-Baptiste; Just, Jeremy; Barillot, Emmanuel

2003-01-01

Génoplante is a partnership program between public French institutes (INRA, CIRAD, IRD and CNRS) and private companies (Biogemma, Bayer CropScience and Bioplante) that aims at developing genome analysis programs for crop species (corn, wheat, rapeseed, sunflower and pea) and model plants (Arabidopsis and rice). The outputs of these programs form a wealth of information (genomic sequence, transcriptome, proteome, allelic variability, mapping and synteny, and mutation data) and tools (databases, interfaces, analysis software), that are being integrated and made public at the public bioinformatics resource centre of Génoplante: GénoPlante-Info (GPI). This continuous flood of data and tools is regularly updated and will grow continuously during the coming two years. Access to the GPI databases and tools is available at http://genoplante-info.infobiogen.fr/. PMID:12519976

The French Regions and Their Social Health

ERIC Educational Resources Information Center

Jany-Catrice, Florence

2009-01-01

In this article, a new indicator designed to capture the multidimensionality of the social health of the French regions is put to the test. Drawing on regional data for 2004, this indicator of social health (ISH) sheds new light on the social performance of the French regions. The worst performers are the highly urbanised regions, whereas others,…

Gender Differences in Motivation to Learn French

ERIC Educational Resources Information Center

Kissau, Scott

2006-01-01

There is concern among second language educators in Canada that male students are losing interest in studying French as a second language (FSL). In response, in the fall of 2003, a study was conducted to investigate gender differences in second language (L2) motivation among Grade 9 core French students. Building upon the traditional model of L2…

The use of a medico economic database as a part of French apheresis registry.

PubMed

Kanouni, T; Aubas, P; Heshmati, F

2017-02-01

An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP. Copyright © 2016 Elsevier Ltd. All rights reserved.

Old French for Undergraduates at the University of Minnesota, Morris.

ERIC Educational Resources Information Center

Campbell, David E.

Old French for undergraduates, as it is offered to students at the University of Minnesota, Morris, represents a break with tradition. A rationale for the program and course descriptions accentuate benefits accrued from undergraduate medieval studies. Syllabuses for French 80, The History of the Language; French 90, Directed Medieval Studies; and…

Nephrotic syndrome under treatment with dasatinib: be aware of a possible adverse drug reaction.

PubMed

Muller-Hansma, A H G; van der Lugt, J; Zwaan, C M

2017-12-01

The protein kinase inhibitor dasatinib, targeting BCR-ABL and Src family kinases, is used in chronic myeloid leukaemia and Philadelphia-chromosome positive acute lymphoblastic leukaemia. The Netherlands Pharmacovigilance Centre Lareb has received one report of nephrotic syndrome associated with the use of dasatinib. With some other protein kinase inhibitors, targeting vascular endothelial growth factor, nephrotic syndrome is a well-known adverse drug reaction. The Dutch and European pharmacovigilance databases and scientific literature contain several cases indicating a causal relationship between dasatinib and nephrotic syndrome. Nephrotic syndrome was recently added to the list of adverse drug reactions in the Dutch summary of product characteristics for dasatinib. It is important to recognise the possibility of this adverse drug reaction when a patient develops nephrotic syndrome under treatment with dasatinib.

Measuring Morale within the French Army

DTIC Science & Technology

2006-04-01

Measuring Morale within the French Army 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK...RTO-MP-HFM-134 29 - 1 Measuring Morale within the French Army Commandant Jean Michel FORET EMAT/Centre de Relations Humaines 14 rue Saint...Dominique 00453 Armées FRANCE crh.emat@emat.terre.defense.gouv.fr ABSTRACT The evaluation of the operational capabilitity of the Army passes by

Listeners feel the beat: entrainment to English and French speech rhythms.

PubMed

Lidji, Pascale; Palmer, Caroline; Peretz, Isabelle; Morningstar, Michele

2011-12-01

Can listeners entrain to speech rhythms? Monolingual speakers of English and French and balanced English-French bilinguals tapped along with the beat they perceived in sentences spoken in a stress-timed language, English, and a syllable-timed language, French. All groups of participants tapped more regularly to English than to French utterances. Tapping performance was also influenced by the participants' native language: English-speaking participants and bilinguals tapped more regularly and at higher metrical levels than did French-speaking participants, suggesting that long-term linguistic experience with a stress-timed language can differentiate speakers' entrainment to speech rhythm.

Transformation in the French Air Force in an Era of Change

DTIC Science & Technology

2008-01-01

Abria.indd 6 10/30/08 1:15:37 PM Transformation in the French Air Force in an Era of Change Général d’armée aérienne Stéphane Abrial, chef...l’armée l’air,” sponsored by the Centre d’études stratégiques aérospatiales, 3 June 2008. The French Air Force, like all defense organizations...related to our equipment, because the French aircraft Gen Stéphane Abrial is the chief of staff of the French Air Force. He completed the French Air

[Physician Emile Littré, French translator and publisher of Hippocrates].

PubMed

Frøland, Anders

2006-01-01

To-day, the French author and scholar Emile Littré (1801-1881) is best known as the founder of a widely used dictionary of the French language. He was one of the most diligent French authors in the nineteenth century and had a huge knowledge of modern and ancient languages, medicine, science, history, and philosophy. Apart from the dictionary, his most impressive work was the edition and translation of the complete collection of the Hippocratic writings (1839-61). The translation was meant to serve as a textbook for French doctors, but the rapid development in medicine made it obsolete in that respect before it was completed. Instead it is now a philological and historical monument. Littré also published a large number of books and articles on positivism, history, politics, philology, and medicine. He was politically active as supporter of the French republic during the periods of monarchy and was elected lifelong senator of the French National Assembly after the 1870-71 war. He was elected member of the French Academy in spite of intense opposition from the Roman Catholic Church. He was an atheist, but was baptised on his deathbed by his wife. His edition of the Hippocratic writings still remains the only complete collection in Greek and a modern language.

Assessment of iron deficiency and anemia in pregnant women: an observational French study.

PubMed

Harvey, Thierry; Zkik, Asmaa; Auges, Marie; Clavel, Thierry

2016-01-01

We explored the prevalence and management of iron deficiency and anemia among pregnant women in France. In this prospective, observational, multicenter registry study, randomly selected investigators (gynecologists/obstetricians/midwives registered in the CEGEDIM(®) database) assessed pregnant women presenting for a consultation. Participants completed a questionnaire at study inclusion. A total of 1506 patients were enrolled by 95 investigators. Overall, investigators estimated a moderate or significant risk of iron deficiency in almost 60% of women. The overall prevalence of anemia (15.8%) increased with longer pregnancy duration. Medication (mainly iron-based) was prescribed to 57.3% of patients. In French clinical practice, the estimated risk of iron deficiency and prevalence of anemia during pregnancy align with expectations and are managed according to national/international recommendations.

MRI criteria differentiating asymptomatic PML from new MS lesions during natalizumab pharmacovigilance.

PubMed

Wijburg, Martijn T; Witte, Birgit I; Vennegoor, Anke; Roosendaal, Stefan D; Sanchez, Esther; Liu, Yaou; Martins Jarnalo, Carine O; Uitdehaag, Bernard Mj; Barkhof, Frederik; Killestein, Joep; Wattjes, Mike P

2016-10-01

Differentiation between progressive multifocal leukoencephalopathy (PML) and new multiple sclerosis (MS) lesions on brain MRI during natalizumab pharmacovigilance in the absence of clinical signs and symptoms is challenging but is of substantial clinical relevance. We aim to define MRI characteristics that can aid in this differentiation. Reference and follow-up brain MRIs of natalizumab-treated patients with MS with asymptomatic PML (n=21), or asymptomatic new MS lesions (n=20) were evaluated with respect to characteristics of newly detected lesions by four blinded raters. We tested the association with PML for each characteristic and constructed a multivariable prediction model which we analysed using a receiver operating characteristic (ROC) curve. Presence of punctate T2 lesions, cortical grey matter involvement, juxtacortical white matter involvement, ill-defined and mixed lesion borders towards both grey and white matter, lesion size of >3 cm, and contrast enhancement were all associated with PML. Focal lesion appearance and periventricular localisation were associated with new MS lesions. In the multivariable model, punctate T2 lesions and cortical grey matter involvement predict for PML, while focal lesion appearance and periventricular localisation predict for new MS lesions (area under the curve: 0.988, 95% CI 0.977 to 1.0, sensitivity: 100%, specificity: 80.6%). The MRI characteristics of asymptomatic natalizumab-associated PML lesions proved to differ from new MS lesions. This led to a prediction model with a high discriminating power. Careful assessment of the presence of punctate T2 lesions, cortical grey matter involvement, focal lesion appearance and periventricular localisation allows for an early diagnosis of PML. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

French Forces for the 21st Century

DTIC Science & Technology

2000-01-01

With their role in dis- suasion, prevention, projection , and protection, the French armed forces are global, nuclear, conventional, and un... projection and support ■ rebuilding additional forces should a major threat reappear. Army France is currently downsizing, restructuring, and...darmerie and the French counterparts to the Defense Intelligence Agency and Central Intelligence Agency. France and America are bound by common

Discrimination of English and French Orthographic Patterns by Biliterate Children

ERIC Educational Resources Information Center

Jared, Debra; Cormier, Pierre; Levy, Betty Ann; Wade-Woolley, Lesly

2013-01-01

We investigated whether young English-French biliterate children can distinguish between English and French orthographic patterns. Children in French immersion programs were asked to play a dictionary game when they were in Grade 2 and again when they were in Grade 3. They were shown pseudowords that contained either an English spelling pattern or…

Student Engagement in an Ottawa French Immersion High School Program

ERIC Educational Resources Information Center

Makropoulos, Josee

2010-01-01

This article makes a contribution to the field of French immersion studies by examining the engagement realities of two groups of students in an Ottawa French immersion high school program: those with and without a parent who makes them eligible for minority French language instruction as outlined by Section 23 of the "Canadian Charter of…

[A study on English loan words in French plastic surgery].

PubMed

Hansson, E; Tegelberg, E

2014-10-01

The French language is less and less used as an international scientific language and many French researchers publish their work in English. Nowadays, Annales de Chirurgie Plastique Esthétique is the only international plastic surgical journal published completely in French. The use of English loan words in French plastic surgery has never been studied. The aim of this study was to describe the frequency and types of English loan words in French plastic surgery. A corpus consisting of all the articles in a number of Annales de Chirurgie Plastique Esthethique, chosen by default, was created. The frequency of English loan words was calculated and the types of words were analysed. The corpus contains 367 (0.8%) English loan words. Most of them are non-integrated loan words and calques. The majority of the plastic surgical loan words describe surgical techniques. The French plastic surgical language seems to be influenced by English. The usage of loan words does not always follow the recommendations and the usage is sometimes ambiguous. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Do 11-Month-Old French Infants Process Articles?

ERIC Educational Resources Information Center

Halle, Pierre A.; Durand, Catherine; de Boysson-Bardies, Benedicte

2008-01-01

The first part of this study examined (Parisian) French-learning 11-month-old infants' recognition of the six definite and indefinite French articles: "le", "la", "les", "un", "une", and "des". The six articles were compared with pseudoarticles in the context of disyllabic or monosyllabic…

Teaching French as a Multicultural Language: The French-Speaking World Outside of Europe. Language in Education: Theory and Practice, 39.

ERIC Educational Resources Information Center

Ogden, John D.

This booklet proposes to approach the teaching of French from a multicultural perspective. The introductory section presents the reasons for recommending this orientation and the pedagogical advantages to be derived from it, emphasizing the fact that French serves as a link between several Francophone nations and their widely different cultures.…

Building Global Partnerships: 112 Gripes about the French Revisited

DTIC Science & Technology

2012-04-01

concerned about the French, Krauthammer declared, but then seemed to reconsider —well, we’re not so sure about the French. Alas, thence it came, out of...French language? A: Gratitude.”6 To this day, when many Americans think of France, they recall the valiant acts of courage displayed by American...after having thrown a last look toward the land of liberty where she sought salvation.”18 Certainly such an emotional plea, coupled with American

The French Revolution.

ERIC Educational Resources Information Center

Scrofani, E. Robert; Johnston, Anne

This 10-day unit on the French Revolution is designed to help high school students understand the interplay of economic, social, and political forces in the process of revolutionary change, and the development of modern democratic forms of government. Critical thinking and geographic skill activities are employed throughout the unit and include…

Coronary Artery Disease in French Canadians-Investigation of a Suggested Vulnerable Population.

PubMed

Ayoub, Chadi; Bernick, Jordan; Arasaratnam, Punitha; Chow, Jonathan D H; Hossain, Alomgir; Ruddy, Terrence; Hillis, Graham S; Kritharides, Leonard; Chow, Benjamin J W

2016-10-01

There is a perception among Canadian physicians that coronary artery disease (CAD) and adverse cardiac events are more common in those of French Canadian heritage. We sought to compare the prevalence of CAD using coronary computed tomographic angiography (CCTA) in French Canadians and non-French white Canadians. Consecutive patients were prospectively enrolled in our institutional CCTA registry. Of 10,868 CCTA examinations, we analyzed white patients who identified themselves as French Canadian or non-French Canadian. These 2 groups were compared for baseline characteristics, cardiovascular risk factors, and routine markers for CAD on CTCA. Propensity score adjustments were also made to account for differences in demographics. We identified 1683 French Canadians (mean age, 58.5 ± 10.7 years; 54.2% men) and 5077 non-French white Canadians (mean age, 59.4 ± 11.4 years; 57.3% men). French Canadians were more likely to have a smoking history (64.1% vs 56.1%), diabetes (15.6% vs 13.6%), and a family history of premature CAD (53.3% vs 44.6%) (P < 0.05 for all). There was no significant difference in measures of CAD between French Canadians and non-French white Canadians in obstructive CAD (32.5% vs 32.2%; P = 0.997), total plaque score (4.6 ± 4.3 vs 4.5 ± 4.4; P = 0.616) and Agatston score (168.1 ± 319.8 vs 183.6 ± 433.7; P = 0.371). After propensity score adjustment, there was still no significant difference between the groups. Our study suggests that French Canadians in the Champlain region have a greater prevalence of cardiovascular risk factors compared with non-French Canadians; however, they do not appear to have a greater prevalence or severity of coronary atherosclerosis as assessed by CCTA. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Multilingualism and Web Advertising: Addressing French-Speaking Consumers

ERIC Educational Resources Information Center

Martin, Elizabeth

2011-01-01

Drawing inferences from both quantitative and qualitative data, this study examines the extent to which American companies tailor their Web advertising for global audiences with a particular focus on French-speaking consumers in North America, Europe, Africa, the Caribbean and French Polynesia. Explored from a sociolinguistic and social semiotic…

Acoustical Measurements of Selected Intonation Contours of French.

ERIC Educational Resources Information Center

Howie, John M.

Recent studies of rising intonation contours in French, in particular the acoustical differences that serve to distinguish Yes/No questions from other rising intonations are reviewed. The preliminary results of a pilot study of rising intonations in French, in which average curves were obtained from spectrographic measurements of fundamental…

The Spelling Skills of French-Speaking Dyslexic Children

ERIC Educational Resources Information Center

Plisson, Anne; Daigle, Daniel; Montesinos-Gelet, Isabelle

2013-01-01

Learning to spell is very difficult for dyslexic children, a phenomenon explained by a deficit in processing phonological information. However, to spell correctly in an alphabetic language such as French, phonological knowledge is not enough. Indeed, the French written system requires the speller to acquire visuo-orthographical and morphological…

The World of Business and Commerce as Seen by French Literary Authors.

ERIC Educational Resources Information Center

Elton, Maurice G. A.

It is argued that while it is important to make the French second language curriculum relevant to today's world, it is also important not to neglect the cultural and literary components of the traditional French major, including those learning French for business. In light of this, several French novels, plays, and stories in which business is a…

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.

PubMed

Lu, Ellen; Wang, Bing Wei; Guimond, Colleen; Synnes, Anne; Sadovnick, A Dessa; Dahlgren, Leanne; Traboulsee, Anthony; Tremlett, Helen

2013-03-01

When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.

Four cases of acute chagasic myocarditis in French Guiana.

PubMed

Carme, B; Aune, I; Nguyen, G; Aznar, C; Beaudet, B

2001-01-01

The authors report four cases of acute chagasic myocarditis which had been diagnosed and treated in Cayenne, French Guiana, in the past 6 years. This French territory, which has the highest standard of living in South America, should be considered an area of risk for sporadic Chagas disease with epidemiologic features similar to those of the disease found in dense Amazon forest areas. Appropriate measures must be taken to screen and promptly manage Chagas disease in the French Guiana population.

Intensity Accents in French 2 Year Olds' Speech.

ERIC Educational Resources Information Center

Allen, George D.

The acoustic features and functions of accentuation in French are discussed, and features of accentuation in the speech of French 2-year-olds are explored. The four major acoustic features used to signal accentual distinctions are fundamental frequency of voicing, duration of segments and syllables, intensity of segments and syllables, and…

Building a Writing Community through Learning of French

ERIC Educational Resources Information Center

Bissoonauth-Bedford, Anu.; Stace, Ray

2015-01-01

This paper reports on a pilot study designed to develop writing proficiency in French via collaborative writing activities at intermediate level at the University of Wollongong in Australia. Twenty four students in the final year of French studies program took part in this innovative approach which integrates multimodal functionality of the…

French immersion experience and reading skill development in at-risk readers.

PubMed

Kruk, Richard S; Reynolds, Kristin A A

2012-06-01

We tracked the developmental influences of exposure to French on developing English phonological awareness, decoding and reading comprehension of English-speaking at-risk readers from Grade 1 to Grade 3. Teacher-nominated at-risk readers were matched with not-at-risk readers in French immersion and English language programs. Exposure to spoken French phonetic and syllabic forms and to written French orthographic and morphological forms by children attending French immersion programs was expected to promote phonological, decoding and reading comprehension achievement. Growth in all outcomes was found, with children in immersion experiencing higher final status in phonological awareness and more rapid growth and higher final status in decoding, using multilevel modeling. At-risk readers in French immersion experienced faster growth and higher final status in reading comprehension. Benefits to reading of exposure to an additional language are discussed in relation to cross-language transfer, phonological grain size and enhanced executive control processes.

MRI in France: the French paradox.

PubMed

Lavayssière, R; Cabée, A E

2001-04-01

Although France is a modern, developed country, which spends nearly 10% of the gross national product on healthcare and has a highly praised level of medicine, the number of modern imaging scanners, such as CT (595), MRI (182), and PET (5), is quite low when compared to other European countries. Politics and a long-standing tradition of centralization are prominent among reasons for such an underdevelopment. This situation has resulted in another French paradox not linked to wine consumption. The French life expectancy is very high, but the number of imaging equipment is very low.

Structural Influences on Initial Accent Placement in French

ERIC Educational Resources Information Center

Astesano, Corine; Bard, Ellen Gurman; Turk, Alice

2007-01-01

In addition to the phrase-final accent (FA), the French phonological system includes a phonetically distinct Initial Accent (IA). The present study tested two proposals: that IA marks the onset of phonological phrases, and that it has an independent rhythmic function. Eight adult native speakers of French were instructed to read syntactically…

A New Receptive Vocabulary Size Test for French

ERIC Educational Resources Information Center

Batista, Roselene; Horst, Marlise

2016-01-01

Researchers have developed several tests of receptive vocabulary knowledge suitable for use with learners of English, but options are few for learners of French. This situation motivated the authors to create a new vocabulary size measure for French, the "Test de la taille du vocabulaire" (TTV). The measure is closely modelled on…

French and European American Child-Mother Play: Culture and Gender Considerations

ERIC Educational Resources Information Center

Suizzo, Marie-Anne; Bornstein, Marc H.

2006-01-01

Research on French and European American mothers' childrearing practices, and potential effects of these differences on children's behavioral development, is scarce. This study compared 33 French and 39 European American 20-month-old children and their mothers on exploratory, symbolic, and social play and interaction. French children engaged in…

Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD).

PubMed

Vinsonneau, Christophe; Allain-Launay, Emma; Blayau, Clarisse; Darmon, Michael; Ducheyron, Damien; Gaillot, Theophile; Honore, Patrick M; Javouhey, Etienne; Krummel, Thierry; Lahoche, Annie; Letacon, Serge; Legrand, Matthieu; Monchi, Mehran; Ridel, Christophe; Robert, René; Schortgen, Frederique; Souweine, Bertrand; Vaillant, Patrick; Velly, Lionel; Osman, David; Van Vong, Ly

2015-12-01

Acute renal failure (ARF) in critically ill patients is currently very frequent and requires renal replacement therapy (RRT) in many patients. During the last 15 years, several studies have considered important issues regarding the use of RRT in ARF, like the time to initiate the therapy, the dialysis dose, the types of catheter, the choice of technique, and anticoagulation. However, despite an abundant literature, conflicting results do not provide evidence on RRT implementation. We present herein recommendations for the use of RRT in adult and pediatric intensive care developed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system by an expert group of French Intensive Care Society (SRLF), with the participation of the French Society of Anesthesia and Intensive Care (SFAR), the French Group for Pediatric Intensive Care and Emergencies (GFRUP), and the French Dialysis Society (SFD). The recommendations cover 4 fields: criteria for RRT initiation, technical aspects (access routes, membranes, anticoagulation, reverse osmosis water), practical aspects (choice of the method, peritoneal dialysis, dialysis dose, adjustments), and safety (procedures and training, dialysis catheter management, extracorporeal circuit set-up). These recommendations have been designed on a practical point of view to provide guidance for intensivists in their daily practice.

The French are different. French and American medicine in the context of AIDS.

PubMed Central

Feldman, J

1992-01-01

Medicine has often been approached as a thing apart from culture, as a uniform Western science. Within the past 10 years, we have begun to recognize that medicine is a system of beliefs and practices intrinsically linked to its larger sociocultural context. Still, it is generally perceived as uniform across North America and Western Europe. My recent research on French and American medical perspectives on the acquired immunodeficiency syndrome (AIDS) challenges this view by exploring differences in the structure of health care, the physician-patient relationship, and the conceptualizations of disease, particularly AIDS. These differences are not specific to AIDS, but the disease serves to exemplify them and to act as a medium for expressing what makes French and American medicine distinct. Global epidemics such as AIDS require both international response and cross-cultural understanding. PMID:1413782

Idiopathic intracranial hypertension: a comparison between French and North-American white patients.

PubMed

Mrejen, S; Vignal, C; Bruce, B B; Gineys, R; Audren, F; Preechawat, P; Gaudric, A; Gout, O; Newman, N J; Vighetto, A; Bousser, M-G; Biousse, V

2009-01-01

To compare French and American white patients with idiopathic intracranial hypertension (IIH), and to determine prognostic factors associated with visual loss. Medical records of all consecutive white patients with definite IIH seen between 2001 and 2006 in three French tertiary care medical centers and one American tertiary medical center were reviewed. Demographics, associated clinical features, and visual function at presentation and follow-up were collected. French white patients were compared to American white patients. One hundred and thirty-four patients (66 French, 68 American) were included. American patients were 8.7 times more likely than French patients to have visual acuity 20/60 or worse or visual field constriction (95% CI: 2.1-36.1, p=0.0001). American patients were treated more aggressively than French patients. French patients were older (31 vs. 28 years, p=0.02) and more likely to have anemia (20 vs. 2%, p<0.001). American patients had a longer duration of symptoms prior to diagnosis (12 vs. 4 weeks, p=0.01) and longer follow-up than French patients (26 vs. 11 months, p=0.001). Multivariable analysis found that nationality was an independent risk factor for visual loss. French and American patients did not differ regarding gender proportion, frequency of obesity, sleep apnea, endocrine diseases, or systemic hypertension. Cerebrospinal fluid (CSF) opening pressures were similar in both groups. American patients with IIH had worse visual outcomes than French patients despite more aggressive treatment. These differences are not explained by differences in previously known risk factors.

The Italian Pharmacovigilance Program: An Observational Study of Adverse Effects of Natalizumab in Multiple Sclerosis Therapy.

PubMed

Giacoppo, Sabrina; Ruscica, Maria; Grimaldi, Luigi Maria; Bramanti, Placido; Mazzon, Emanuela

2017-09-02

BACKGROUND This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. MATERIAL AND METHODS The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy. Secondary objectives of this study were to evaluate the effectiveness of Natalizumab therapy for a careful examination of the risk/benefit ratio and to assess the actions undertaken in case of adverse reactions. RESULTS Among 88 RR-MS patients, 55.68% did not report any type of adverse reaction, 35.22% showed expected adverse reactions (58.70% slight, 22.58% moderate, and 19.35% severe), and 9.10% showed unexpected adverse effects (62.50% slight, 25.00% moderate, and 12.50% severe). Approximately 4.54% of the patients treated with Natalizumab interrupted the therapy. Overall, among all patients, 56.62% showed ameliorated condition, 32.53% had stable disease condition, and 10.85% worsened. CONCLUSIONS We provide a short overview of evidence, which may be useful to better characterize the efficacy and potential adverse effects correlated to Natalizumab therapy.

The Italian Pharmacovigilance Program: An Observational Study of Adverse Effects of Natalizumab in Multiple Sclerosis Therapy

PubMed Central

Giacoppo, Sabrina; Ruscica, Maria; Grimaldi, Luigi Maria; Bramanti, Placido; Mazzon, Emanuela

2017-01-01

Background This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. Material/Methods The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy. Secondary objectives of this study were to evaluate the effectiveness of Natalizumab therapy for a careful examination of the risk/benefit ratio and to assess the actions undertaken in case of adverse reactions. Results Among 88 RR-MS patients, 55.68% did not report any type of adverse reaction, 35.22% showed expected adverse reactions (58.70% slight, 22.58% moderate, and 19.35% severe), and 9.10% showed unexpected adverse effects (62.50% slight, 25.00% moderate, and 12.50% severe). Approximately 4.54% of the patients treated with Natalizumab interrupted the therapy. Overall, among all patients, 56.62% showed ameliorated condition, 32.53% had stable disease condition, and 10.85% worsened. Conclusions We provide a short overview of evidence, which may be useful to better characterize the efficacy and potential adverse effects correlated to Natalizumab therapy. PMID:28864818

Overuse of preoperative laboratory coagulation testing and ABO blood typing: a French national study.

PubMed

Beloeil, H; Ruchard, D; Drewniak, N; Molliex, S

2017-12-01

Following publication of guidelines on routine preoperative tests, the French Society of Anaesthesiology and Intensive Care (SFAR), in association with French national public health insurance, conducted a survey to evaluate adherence to guidelines and the economic consequences. Using the French Hospital Discharge Database and National Health Insurance Information system, tests performed during the 30 days before surgery were analysed for two situations: (1) standard laboratory coagulation tests and ABO blood typing in children able to walk and scheduled for tonsillectomy/adenoidectomy; and (2) ABO blood typing in adults before laparoscopic cholecystectomy, thyroidectomy, lumbar discectomy or breast surgery. Guidelines do not recommend any preoperative tests in these settings. Between 2013 and 2015, a coagulation test was performed in 49% of the 241 017 children who underwent tonsillectomy and 39% of the 133 790 children who underwent adenoidectomy. A similar pattern was observed for ABO blood typing although re-operation rates for bleeding on the first postoperative day were very low (0.12-0.31% for tonsillectomy and 0.01-0.02% for adenoidectomy). Between 2012 and 2015, ABO blood typing was performed in 32-45% of the 1 114 082 patients who underwent one of the four selected procedures. The transfusion rate was very low (0.02-0.31%). The mean cost for the four procedures over the 4 yr period was €5 310 000 (sd €325 000). Standard laboratory coagulation tests and ABO blood typing are still routinely prescribed before surgery and anaesthesia despite current guidelines. This over-prescription represents a high and unnecessary cost, and should therefore be addressed. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

PubMed

Sessa, Maurizio; Rossi, Claudia; Rafaniello, Concetta; Mascolo, Annamaria; Cimmaruta, Daniela; Scavone, Cristina; Fiorentino, Sonia; Grassi, Enrico; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

2016-12-01

The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

[Drugs in pregnancy: study in the EFEMERIS database (2004 to 2008)].

PubMed

Hurault-Delarue, C; Lacroix, I; Vidal, S; Montastruc, J-L; Damase-Michel, C

2011-10-01

To analyze the evolution of drug prescriptions during pregnancy from 2004 to 2008 in Haute-Garonne (France) and the impact of recommendations concerning drugs in pregnancy sent by French health authorities (AFSSAPS) and French college of gynaecologists and obstetricians to health professionals during the period. This descriptive study of reimbursed drug prescriptions during pregnancy concerns women included in the EFEMERIS database who have given birth from July 1st, 2004 to June 30th, 2008. The health insurance service records of Haute-Garonne were used. Taking into account 2 subsequent delistings of drugs for reimbursement during the period, we observed a significant increase of reimbursed drug prescriptions dispensed to pregnant women (8.7 different substances for women who have given birth in 2004 and 9.4 in 2008). Vitamins, immunserums, immunoglobulins and homeopathy prescriptions have especially increased. Paracetamol, iron, folic acid and phloroglucinol were the most prescribed drugs during all the periods. Since 2004, EFEMERIS represents a monitoring centre for the prescription of reimbursed drugs to pregnant women. This analysis allowed to exhibit trends in prescription patterns. Most of the alerts or recommendations had a positive but limited impact. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

The French Huguenots of Colonial South Carolina: Assimilation or Acculturation

DTIC Science & Technology

1990-01-01

pressure. 4 After the Revocation. many French Protestants left France in large 2 numbers. They fled to Switzerland. Germany. Holland. the British Isles...diversity of Huguenot occupations in the colony, it is probable that not all French Protestants who left France originally came from the wine-growing...or silk-producing districts of France . Therefore. the association of the French ethnic identity with these two products borders on modern-day 25

Assimilation and Affirmative Action in French Education Systems

ERIC Educational Resources Information Center

Langan, Elise S.

2008-01-01

The French education system was created as a means to uphold the republican principles emanating from the Revolution. The first Article of the 1958 French Constitution says the Republic assures equality before the law of all citizens without distinction of origin or race. Theoretically at least, it is not only forbidden to discriminate, but to…

Portfolio langagier en francais (Language Portfolios in French).

ERIC Educational Resources Information Center

Laplante, Bernard; Christiansen, Helen

2001-01-01

Suggests that first-year college students learning French should create a language portfolio that contains documents that illustrate what they have learned in French, along with a brief statement of what linguistic skill the document demonstrates. The goal of the portfolio is to make students more aware of their own learning, their strengths, and…

Latest developments for the IAGOS database: Interoperability and metadata

NASA Astrophysics Data System (ADS)

Boulanger, Damien; Gautron, Benoit; Thouret, Valérie; Schultz, Martin; van Velthoven, Peter; Broetz, Bjoern; Rauthe-Schöch, Armin; Brissebrat, Guillaume

2014-05-01

In-service Aircraft for a Global Observing System (IAGOS, http://www.iagos.org) aims at the provision of long-term, frequent, regular, accurate, and spatially resolved in situ observations of the atmospheric composition. IAGOS observation systems are deployed on a fleet of commercial aircraft. The IAGOS database is an essential part of the global atmospheric monitoring network. Data access is handled by open access policy based on the submission of research requests which are reviewed by the PIs. Users can access the data through the following web sites: http://www.iagos.fr or http://www.pole-ether.fr as the IAGOS database is part of the French atmospheric chemistry data centre ETHER (CNES and CNRS). The database is in continuous development and improvement. In the framework of the IGAS project (IAGOS for GMES/COPERNICUS Atmospheric Service), major achievements will be reached, such as metadata and format standardisation in order to interoperate with international portals and other databases, QA/QC procedures and traceability, CARIBIC (Civil Aircraft for the Regular Investigation of the Atmosphere Based on an Instrument Container) data integration within the central database, and the real-time data transmission. IGAS work package 2 aims at providing the IAGOS data to users in a standardized format including the necessary metadata and information on data processing, data quality and uncertainties. We are currently redefining and standardizing the IAGOS metadata for interoperable use within GMES/Copernicus. The metadata are compliant with the ISO 19115, INSPIRE and NetCDF-CF conventions. IAGOS data will be provided to users in NetCDF or NASA Ames format. We also are implementing interoperability between all the involved IAGOS data services, including the central IAGOS database, the former MOZAIC and CARIBIC databases, Aircraft Research DLR database and the Jülich WCS web application JOIN (Jülich OWS Interface) which combines model outputs with in situ data for

Analysis of subsequent publication of scientific orally presented abstracts of the French National Congress of Radiology. Part II: Focus on the French abstracts.

PubMed

Dangouloff-Ros, V; Ronot, M; Lagadec, M; Vilgrain, V

2015-05-01

To evaluate the publication rate of scientific abstracts that were presented orally at the 2008, 2009, and 2010 annual meetings of the French Society of Radiology by French radiologists, and to perform a French regional analysis. Orally presented abstracts were identified by examining online abstract books of the 2008, 2009, and 2010 annual meetings of the French Society of Radiology, and cross-checked by reviewing the paper version of abstracts for the same period. Only abstracts from French teams were selected. The administrative region of submission was noted for each abstract and for each region the total population, the number of active radiologists, the number of active members of the French Society of Radiology and the number of academic radiologists were noted. Imaging subspecialties were also noted. 625 abstracts were identified resulting in 268 publications (publication rate: 43%). The median number of presentations and publications per region was 18 (range: 1-255) and 7 (range: 0-101), respectively. The ratio per million inhabitants was 7.5 and 3 respectively. The median number of presentations and publications per 100 active radiologists (respectively members of the FSR) was 7 and 3 (respectively 10 and 4). The median number of presentations and publications per academic radiologist were 2.6, and 1.2, respectively. The regional variations for each indicator were high (40-180%). Three subspecialties had a publication rate of more than 50%: thoracic imaging (58%), abdominal imaging (52%), and genitourinary imaging (51%). The publication rate of orally presented French scientific abstracts was high, with important variations according to the regions of origin and imaging subspecialties. Copyright © 2015 Éditions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

Prehospital Emergencies in Illegal Gold Mining Sites in French Guiana.

PubMed

Egmann, Gérald; Tattevin, Pierre; Palancade, Renaud; Nacher, Matthieu

2018-03-01

Illegal gold mining is flourishing in French Guiana, existing outside the law due to both the high cost of gold mining permits and the challenges of law enforcement within the Amazon forest. We report the characteristics of, and the medical responses to, medical emergencies in illegal gold mining sites. We performed a retrospective study of all medical emergencies reported from illegal gold mining sites to the centralized call office of SAMU 973 from 1998 through 2000 and from 2008 through 2010. According to the national health care system, any medical emergency within the territory is handled by the prehospital emergency medical service (SAMU 973), irrespective of the patients' legal status. Data were extracted from the SAMU 973 notebook registry (1998-2000) or the SAMU 973 computerized database (2008-2010) and werre collected using a standardized questionnaire. Of 71,932 calls for medical emergencies in French Guiana during the study periods, 340 (0.5%) originated from illegal gold mining sites. Of these, 196 (58%) led to medical evacuation by helicopter, whereas the overall rate of evacuation by helicopter after placing a call to SAMU 973 was only 4% (3020/71,932; P<0.0001 for comparison with illegal gold mining sites). Medical emergencies were classified as illness (48%, mostly infectious), trauma (44%, mostly weapon wounds), and miscellaneous (8%). Medical emergencies at illegal gold mining sites in the Amazon forest mostly include infectious diseases, followed by trauma, and often require medical evacuation by helicopter. Our study suggests that implementation of preventive medicine within gold mining sites, irrespective of their legal status, could be cost-effective and reduce morbidity. Copyright © 2017 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

When citizens and scientists work together : a french collaborative science network on earthworms communities distribution

NASA Astrophysics Data System (ADS)

Guernion, Muriel; Hoeffner, Kevin; Guillocheau, Sarah; Hotte, Hoël; Cylly, Daniel; Piron, Denis; Cluzeau, Daniel; Hervé, Morgane; Nicolai, Annegret; Pérès, Guénola

2017-04-01

Scientists have become more and more interested in earthworms because of their impact on soil functioning and their importance in provision of many ecosystem services. To improve the knowledge on soil biodiversity and integrate earthworms in soil quality diagnostics, it appeared necessary to gain a large amount of data on their distribution. The University of Rennes 1 developed since 2011 a collaborative science project called Observatoire Participatif des Vers de Terre (OPVT, participative earthworm observatory). It has several purposes : i) to offer a simple tool for soil biodiversity evaluation in natural and anthropic soils through earthworm assessment, ii) to offer trainings to farmers, territory managers, gardeners, pupils on soil ecology, iii) to build a database of reference values on earthworms in different habitats, iv) to propose a website (https://ecobiosoil.univ-rennes1.fr/OPVT_accueil.php) providing for example general scientific background (earthworm ecology and impacts of soil management), sampling protocols and online visualization of results (data processing and earthworms mapping). Up to now, more than 5000 plots have been prospected since the opening of the project in 2011., Initially available to anyone on a voluntary basis, this project is also used by the French Ministry of Agriculture to carry out a scientific survey throughout the French territory.

Resveratrol: French Paradox Revisited

PubMed Central

Catalgol, Betul; Batirel, Saime; Taga, Yavuz; Ozer, Nesrin Kartal

2012-01-01

Resveratrol is a polyphenol that plays a potentially important role in many disorders and has been studied in different diseases. The research on this chemical started through the “French paradox,” which describes improved cardiovascular outcomes despite a high-fat diet in French people. Since then, resveratrol has been broadly studied and shown to have antioxidant, anti-inflammatory, anti-proliferative, and anti-angiogenic effects, with those on oxidative stress possibly being most important and underlying some of the others, but many signaling pathways are among the molecular targets of resveratrol. In concert they may be beneficial in many disorders, particularly in diseases where oxidative stress plays an important role. The main focus of this review will be the pathways affected by resveratrol. Based on these mechanistic considerations, the involvement of resveratrol especially in cardiovascular diseases, cancer, neurodegenerative diseases, and possibly in longevity will be is addressed. PMID:22822401

The Great Drama: Germany and the French Revolution.

ERIC Educational Resources Information Center

Kurz, Gerhard

Revolution did not spread to Germany from France at the end of the 18th century, yet the German and other European states were forced to come to terms with the principles of the French Revolution such as political and legal freedoms and national unity. Germany was affected by the French Revolution particularly by the reactions of German…

French Basic Course. Volume 8, Lessons 76-85.

ERIC Educational Resources Information Center

Defense Language Inst., Monterey, CA.

Volume 8 of the Basic Course in French contains 10 lessons, one for each day of the sixteenth and seventeenth weeks of the intermediate phase. Every fifth lesson is a review. The objective of the intermediate phase is to enable the student to distinguish and use the most essential structures of French. The approach is audio-lingual and…

What is French for déjà vu? Descriptions of déjà vu in native French and English speakers.

PubMed

Fortier, Jonathan; Moulin, Chris J A

2015-11-01

Little is known about how people characterise and classify the experience of déjà vu. The term déjà vu might capture a range of different phenomena and people may use it differently. We examined the description of déjà vu in two languages: French and English, hypothesising that the use of déjà vu would vary between the two languages. In French, the phrase déjà vu can be used to indicate a veridical experience of recognition - as in "I have already seen this face before". However, the same is not true in English. In an online questionnaire, we found equal rates of déjà vu amongst French and English speakers, and key differences in how the experience was described. As expected, the French group described the experience as being more frequent, but there was the unexpected finding that they found it to be more troubling. Copyright © 2015 Elsevier Inc. All rights reserved.

The Effects of Collaborative Models in Second Life on French Learning

ERIC Educational Resources Information Center

Hsiao, Indy Y. T.; Yang, Stephen J. H.; Chia-Jui, Chu

2015-01-01

French is the ninth most widely used language globally, but French-learning environments in Taiwan have been insufficient. Language acquisition is easier in a natural setting, and so such a setting should be available to language learners wherever possible. This study aimed to (1) create an authentic environment for learning French in Second Life…

Cross-Cultural Adaptation of the CHAMPS Questionnaire in French Canadians with COPD

PubMed Central

Mak, Susanne; Soicher, Judith E.; Mayo, Nancy E.; Wood-Dauphinee, Sharon; Bourbeau, Jean

2016-01-01

Physical activity is difficult to measure in individuals with COPD. The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire demonstrated strong clinometric properties when used with the elderly and with those affected by chronic disease. Study objectives were to translate, culturally adapt the CHAMPS into French, and reexamine its test-retest reliability and construct validity in French and English Canadians with COPD. This paper presents the cross-cultural adaptation of the CHAMPS; results of its clinometric testing will be described in another article. The CHAMPS examines the degree of physical activity performed in a typical week through two summary scales, caloric expenditure and activity frequency. The CHAMPS was only in English; thus, a cross-cultural adaptation was needed to translate the CHAMPS into French for use in French Canadians with COPD. Cross-cultural adaptation consisted of forward and back translation, with expert review at each stage of translation: minor inconsistencies were uncovered and rectified. Five French participants with COPD completed the finalized Canadian French CHAMPS and participated in cognitive debriefing; no problematic items were identified. A structured and stepwise, cross-cultural adaptation process produced the Canadian French CHAMPS, with items of equivalent meaning to the English version, for use in French Canadians with COPD. PMID:27445570

Cross-Cultural Adaptation of the CHAMPS Questionnaire in French Canadians with COPD.

PubMed

Mak, Susanne; Soicher, Judith E; Mayo, Nancy E; Wood-Dauphinee, Sharon; Bourbeau, Jean

2016-01-01

Physical activity is difficult to measure in individuals with COPD. The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire demonstrated strong clinometric properties when used with the elderly and with those affected by chronic disease. Study objectives were to translate, culturally adapt the CHAMPS into French, and reexamine its test-retest reliability and construct validity in French and English Canadians with COPD. This paper presents the cross-cultural adaptation of the CHAMPS; results of its clinometric testing will be described in another article. The CHAMPS examines the degree of physical activity performed in a typical week through two summary scales, caloric expenditure and activity frequency. The CHAMPS was only in English; thus, a cross-cultural adaptation was needed to translate the CHAMPS into French for use in French Canadians with COPD. Cross-cultural adaptation consisted of forward and back translation, with expert review at each stage of translation: minor inconsistencies were uncovered and rectified. Five French participants with COPD completed the finalized Canadian French CHAMPS and participated in cognitive debriefing; no problematic items were identified. A structured and stepwise, cross-cultural adaptation process produced the Canadian French CHAMPS, with items of equivalent meaning to the English version, for use in French Canadians with COPD.

McMaster Optimal Aging Portal: an evidence-based database for geriatrics-focused health professionals.

PubMed

Barbara, Angela M; Dobbins, Maureen; Brian Haynes, R; Iorio, Alfonso; Lavis, John N; Raina, Parminder; Levinson, Anthony J

2017-07-11

The objective of this work was to provide easy access to reliable health information based on good quality research that will help health care professionals to learn what works best for seniors to stay as healthy as possible, manage health conditions and build supportive health systems. This will help meet the demands of our aging population that clinicians provide high quality care for older adults, that public health professionals deliver disease prevention and health promotion strategies across the life span, and that policymakers address the economic and social need to create a robust health system and a healthy society for all ages. The McMaster Optimal Aging Portal's (Portal) professional bibliographic database contains high quality scientific evidence about optimal aging specifically targeted to clinicians, public health professionals and policymakers. The database content comes from three information services: McMaster Premium LiteratUre Service (MacPLUS™), Health Evidence™ and Health Systems Evidence. The Portal is continually updated, freely accessible online, easily searchable, and provides email-based alerts when new records are added. The database is being continually assessed for value, usability and use. A number of improvements are planned, including French language translation of content, increased linkages between related records within the Portal database, and inclusion of additional types of content. While this article focuses on the professional database, the Portal also houses resources for patients, caregivers and the general public, which may also be of interest to geriatric practitioners and researchers.

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

PubMed

Schjøtt, Jan; Erdal, Hilde

2014-02-14

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). 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. 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, search provided no

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

PubMed Central

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

Chine: Les Chances du Francais (The Fortunes of the French Language in China).

ERIC Educational Resources Information Center

Shuning, Zhang

1996-01-01

Examines the current situation in China surrounding the teaching of French as a Foreign Language. After the decline of French teaching subsequent to the Cultural Revolution, the language returned to favor around 1970. Chinese students are infatuated with French; many study it as a first or second foreign language. Additionally, French literature…

Resource Management Strategy in the French Navy

DTIC Science & Technology

1991-06-01

central question is whether the French Navy will be able to both upgrade an ageing fleet, and man that projected new fleet with qualified personnel...figures are given in French francs and the dollar equivalent, using an exchange rate of 5.5 francs per dollar. In the most general terms, this thesis...hours worked. The other 240 million francs ($43.6 million) includes projected DCN work hours and the cost of outfitting the ship (i.e. radars, guns

Raising FLAGS: Renewing Core French at the Pre-Service Teacher Level

ERIC Educational Resources Information Center

Carr, Wendy

2010-01-01

A new program for core French teacher candidates called FLAGS (French Language and Global Studies) was established at the University of British Columbia (UBC) in 2007. The program is intended for those who are keen to teach core French and possess rudimentary proficiency in the language but may not necessarily have the same proficiency or prior…

[Is there a correlation between the SIGAPS score and publishing articles in French?].

PubMed

Griffon, Nicolas; Devos, Patrick; Gehanno, Jean-François; Darmoni, Stefan J

2012-09-01

SIGAPS score determines to a great extent each university hospital's funding for research. This score is considered to reflect the scientific production. Due to its financial impact, he may modify authors' attitudes leading them to publish their articles in French. Our objective was to evaluate the association between the SIGAPS score and publications in French. Based on Rouen University Hospital's (RUH) SIGAPS data from 2007 to 2010, we used Spearman's correlation to establish an association between SIGAPS score of each author and the fact that they published in French. A positive correlation was found between SIGAPS score and author's number of publications in French (r(s)=0.51; IC(95%)=[0.44; 0.58]). The relationship between the SIGAPS score and the author's publication rate in French was negative but higher (r(s)=-0.87; IC(95%)=[-1.0; -0.68]; author's deciles). The relationship between the SIGAPS score and the number of publications in French is not surprising as the SIGAPS score is based on the number of publications. As regards to the publication rate in French, this was even more interesting as our results showed that the more productive an author was, the less they published their results in French. Publications in French did not appear to be the best way to improve individual SIGAPS score. There is high heterogeneity between authors who are very prolific, with one third having a publication rate in French high above the average and one third who had a publication rate in French well below the average. There was a high negative correlation between SIGAPS score and the publication rate in French for RUH's researchers (author's deciles). Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Are the French neurology residents satisfied with their training?

PubMed

Codron, P; Roux, T; Le Guennec, L; Zuber, M

2015-11-01

There have been dramatic changes in neurology over the past decade; these advances require a constant adaptation of residents' theoretical and practical training. The French Association of Neurology Residents and the College of Neurology Teachers conducted a national survey to assess the French neurology residents' satisfaction about their training. A 16-item questionnaire was sent via e-mail to French neurology residents completing training in 2014. Data were collected and processed anonymously. Of eligible respondents, 126 returned the survey, representing approximately 40% of all the French neurology residents. Most residents (78%) rated their clinical training favorably. Seventy-two percent reported good to excellent quality teaching of neurology courses from their faculty. However, many residents (40%) felt insufficient their doctoral thesis supervision. All residents intended to enter fellowship training after their residency, and most of them (68%) planned to practice in a medical center. French neurology residents seemed satisfied with the structure and quality of their training program. However, efforts are required to improve management of the doctoral thesis and make private practice more attractive and accessible during the residency. In the future, similar surveys should be scheduled to regularly assess neurology residents' satisfaction and the impact of the forthcoming national and European reforms. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

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

PubMed Central

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.

2016-01-01

Aim 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. Methods 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. Results 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. Conclusions Half (53.3%, 64/120 cases) of symptomatic EDRs were potential DRESS. The main predictor of severity of EDR was an early severe eosinophilia. PMID:27543764

The French health care system: liberal universalism.

PubMed

Steffen, Monika

2010-06-01

This article analyzes the reforms introduced over the last quarter century into the French health care system. A particular public-private combination, rooted in French history and institutionalized through a specific division of the policy field between private doctors and public hospitals, explains the system's core characteristics: universal access, free choice, high quality, and a weak capacity for regulation. The dual architecture of this unique system leads to different reform strategies and outcomes in its two main parts. While the state has leverage in the hospital sector, it has failed repeatedly in attempts to regulate the ambulatory care sector. The first section of this article sets out the main characteristics and historical landmarks that continue to affect policy framing and implementation. Section 2 focuses on the evolution in financing and access, section 3 on management and governance in the (private) ambulatory care sector, and section 4 on the (mainly public) hospital sector. The conclusion compares the French model with those developed in the comparative literature and sets out the terms of the dilemma: a state-run social health insurance that lacks both the legitimacy of Bismarckian systems and the leverages of state-run systems. The French system therefore pursues contradictory policy goals, simultaneously developing universalism and liberalism, which explains both the direct state intervention and its limits.

ARIANE: integration of information databases within a hospital intranet.

PubMed

Joubert, M; Aymard, S; Fieschi, D; Volot, F; Staccini, P; Robert, J J; Fieschi, M

1998-05-01

Large information systems handle massive volume of data stored in heterogeneous sources. Each server has its own model of representation of concepts with regard to its aims. One of the main problems end-users encounter when accessing different servers is to match their own viewpoint on biomedical concepts with the various representations that are made in the databases servers. The aim of the project ARIANE is to provide end-users with easy-to-use and natural means to access and query heterogeneous information databases. The objectives of this research work consist in building a conceptual interface by means of the Internet technology inside an enterprise Intranet and to propose a method to realize it. This method is based on the knowledge sources provided by the Unified Medical Language System (UMLS) project of the US National Library of Medicine. Experiments concern queries to three different information servers: PubMed, a Medline server of the NLM; Thériaque, a French database on drugs implemented in the Hospital Intranet; and a Web site dedicated to Internet resources in gastroenterology and nutrition, located at the Faculty of Medicine of Nice (France). Accessing to each of these servers is different according to the kind of information delivered and according to the technology used to query it. Dealing with health care professional workstation, the authors introduced in the ARIANE project quality criteria in order to attempt a homogeneous and efficient way to build a query system able to be integrated in existing information systems and to integrate existing and new information sources.

[French immigration policy].

PubMed

Weil, P

1994-01-01

From the late nineteenth century through 1974, France permitted immigration to furnish workers and to compensate for the low level of fertility. Intense immigration from North Africa, the economic crisis of the 1970s, and other factors led to policy changes in 1974. French immigration policy since 1974 has fluctuated between guaranteeing foreigners equal rights regardless of their religion, race, culture, or national origin, and attempting to differentiate among immigrants depending on their degree of assimilability to French culture. From 1974 to 1988, France had five different policies regarding whether to permit new immigration and what to do about illegal immigrants. In July 1984, the four major political parties unanimously supported a measure in Parliament that definitively guaranteed the stay in France of legal immigrants, whose assimilation thus assumed priority. Aid for return to the homeland was no longer to be widely offered, and immigration of unskilled workers was to be terminated except for those originating in European Community countries. Major changes of government in 1988 and 1993 affected only the modalities of applying these principles. The number of immigrants has fluctuated since 1974. Unskilled workers, the only category whose entrance was specifically controlled by the 1984 measures, have declined from 174,000 in 1970 to 25,000 in the early 1990s. The number of requests for political asylum declined from 60,000 in 1989 to 27,000 in 1993, and in 1991, 15,467 persons were granted refugee status. The number of immigrants of all types permitted to remain in France declined from 250,000 or 3000 per year in the early 1970s to around 110,000 at present. Although the decline is significant, it appears insufficient to the government in power since 1993. Although migratory flows are often explained as the product of imbalance in the labor market or in demographic growth, the French experience suggests that government policies, both in the sending and

Using Early Silent Film to Teach French: The Language of "Cinema Muet."

ERIC Educational Resources Information Center

Bloom, Michelle E.

1995-01-01

Discusses the use of early silent films in second-language classrooms, focusing on the experiences of one instructor in using early French silents in elementary and intermediate French courses. Sample lesson plans and information on the availability of French silents are also provided. (Contains 17 references.) (MDM)

Francophonie: The French Journal of the Association for Language Learning, 1994-1997.

ERIC Educational Resources Information Center

Smalley, Alan, Ed.

1997-01-01

This journal focuses on the teaching and learning of French. Selected titles in this volume include the following: "Practical Ideas for Teaching Reluctant Learners in Key Stage 4"; "Learning to Count in French"; "Oh No! The Target Language . . . !""French and the English 'Invasion'"; "The Sounds of…

Debate-Creating vs. Accounting References in French Medical Journals.

ERIC Educational Resources Information Center

Salager-Meyer, Francoise

2000-01-01

Investigates the quantitative and qualitative evolution of debate-creating vs. accounting references in 90 French medical articles published between 1810 and 1995. Suggests that nineteenth-century French academic writing tends to be more polemical or oppositional than cooperative by contrast to its twentieth-century counterpart. Suggests that the…

Pediatric bacterial meningitis in French Guiana.

PubMed

Elenga, N; Sicard, S; Cuadro-Alvarez, E; Long, L; Njuieyon, F; Martin, E; Kom-Tchameni, R; Balcaen, J; Moreau, B; Boukhari, R

2015-01-01

Controlling vaccine-preventable infectious diseases is a public health priority in French Guiana but there is currently no epidemiological data on pediatric bacterial meningitis in this overseas department. Our aim was to describe data related to pediatric bacterial meningitis in French Guiana and compare it with that of metropolitan France. We conducted a multicenter retrospective study from 2000 to 2010 to describe the clinical picture, biological data, epidemiology, and outcome of pediatric bacterial meningitis case patients in French Guiana. The median age of bacterial meningitis patients was 6months [0-15] and the sex ratio 1.06. We observed a total of 60 bacterial meningitis case patients. Most presented with pneumococcal meningitis (24 patients; 40%); 11 with Haemophilus influenzae type b meningitis (23%), five with group B streptococcal meningitis (8.5%), and five others (8.5%) with staphylococcal meningitis (three patients presented with coagulase-negative staphylococci and two with Staphylococcus aureus). Only one patient presented with group B meningococcal meningitis, an 18-month-old infant. We recorded 14 deaths (overall case fatality: 23%); eight were due to Streptococcus pneumoniae (case fatality: 33%). The overall sequelae rate was 28%. It was 32% for patients presenting with pneumococcal meningitis. We observed that 38% of children who had never been vaccinated were infected by a vaccine-preventable bacterium. We observed many differences in the distribution of the bacteria and in the patients' prognosis when comparing the French Guiana data with that of metropolitan France. Improving vaccination coverage would decrease the incidence of H. influenzae meningitis. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Immigrants Outperform Canadian-Born Groups in French Immersion: Examining Factors That Influence Their Achievement

ERIC Educational Resources Information Center

Mady, Callie

2015-01-01

This paper examines the French achievement results of three groups of students: Canadian-born English/French bilingual, Canadian-born multilingual and immigrant multilingual Grade 6 French immersion students, by investigating how the variables of integrative and instrumental motivations, attitudes to the learning situation, French language…

French Immersion Programs Across Canada: The Influence of Cumulative Amounts of Time, Starting Age and Yearly Time Allotment on the Learning of French. A Review of Evaluations of French Immersion Programs. Research Report 81-12.

ERIC Educational Resources Information Center

MacNab, G. L.