1. The French Pharmacovigilance Surveys: A French Distinctiveness, a Real Input
- Author
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Baptiste Jacquot, Aurélie Grandvuillemin, Claire Ferard, Malak Abou Taam, Réseau français des centres régionaux de pharmacovigilance, Marie-Christine Perault-Pochat, Céline Mounier, Anne-Charlotte Thery, Annie-Pierre Jonville-Béra, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
- Subjects
Descriptive statistics ,Drug-Related Side Effects and Adverse Reactions ,business.industry ,[SDV]Life Sciences [q-bio] ,Surveys ,medicine.disease ,030226 pharmacology & pharmacy ,3. Good health ,Europe ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Anatomical therapeutic chemical ,Regulation in pharmacovigilance ,Agency (sociology) ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Optimal distinctiveness theory ,Medical emergency ,Drug reaction ,Duration (project management) ,business - Abstract
International audience; INTRODUCTION: According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the French national agency for medicines and health products safety (ANSM). The objective is to validate a signal, to characterize it, or to provide strengthened monitoring of a drug. MATERIAL AND METHODS: All the available data were retrieved by ANSM/Regional Pharmacovigilance Centers (RPC) and assessed by a nominate RPC which provides a report for discussion during the monthly Committee between ANSM and the Regional Pharmacovigilance Network (RPN). A descriptive analysis of the minutes available on the ANSM website between 2016 and 2018 has been done: objective, data sources, duration of the survey, number of suspected adverse drug reactions, nature of the drugs and of the signals and recommendations for actions. RESULTS: Between 2016 and 2018, a total of 115 surveys were discussed concerning 135 drugs, mainly from the nervous system according to the anatomic therapeutic chemical classification (n=31, 27%). They involved a whole pharmacological class for 18 ones. The main objective of the 115 surveys was to provide a strenghtened monitoring for some drugs (72%) or to validate one or more than one signal (28%). Result from surveys allowed to detect one or several new potential safety signals in 63 ones (55%), an off-label-use in 12 (10%) or to characterize some others signals in all the studies. The Committee recommended one or several actions by survey: 67 prolongations (58%) of the survey and regulatory or investigatory actions which included 43 European actions (37%), 37 label changes (32%), 30 national communications (26%) and 29 additional monitoring (25%). DISCUSSION/CONCLUSION: The current process allows a collegiate, clinical and pharmacological discussion with integration of the regulatory framework. A significant number of new signals are detected and/or validated. This efficient tool which is unique in Europe and is allowed by the decentralized pharmacovigilance which leads to a great reactivity of decision-making. It has to be reassessed and to be adapted continuously to the new challenges of the growing multiplication of signals.
- Published
- 2020