The French pharmacovigilance surveys: A French distinctiveness, a real input.

Autor:	Abou Taam M; Direction de la surveillance, ANSM, 93100 Saint-Denis, France. Electronic address: malak.abou-taam@ansm.sante.fr., Jacquot B; Direction de la surveillance, ANSM, 93100 Saint-Denis, France., Ferard C; Direction de la surveillance, ANSM, 93100 Saint-Denis, France., Thery AC; Direction de la surveillance, ANSM, 93100 Saint-Denis, France., Mounier C; Direction de la surveillance, ANSM, 93100 Saint-Denis, France., Grandvuillemin A; Centre régional de pharmacovigilance de Bourgogne, CHU de Dijon, 21079 Dijon, France., Jonville-Béra AP; Service de pharmacosurveillance, centre régional de pharmacovigilance, Centre-Val-de-Loire, CHRU de Tours, 37044 Tours, France., Perault-Pochat MC; Centre régional de pharmacovigilance du Poitou Charente, CHU de Poitiers, 86021 Poitiers, France.
Jazyk:	angličtina
Zdroj:	Therapie [Therapie] 2021 Sep-Oct; Vol. 76 (5), pp. 441-447. Date of Electronic Publication: 2020 May 24.
DOI:	10.1016/j.therap.2020.05.011
Abstrakt:	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. (Copyright © 2020 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)
Databáze:	MEDLINE
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