On French Pharmacovigilance System
10.3820/jjpe1996.2.103
- VernacularTitle:フランスの医薬品監視システムについて
- Author:
Yutaka NOJIMA
;
Takeshi MAYAMA
;
Hiroshi FUKUSHIMA
;
Tadashi KUSUNOKI
- Publication Type:Journal Article
- Keywords:
pharmacovigilance;
post-marketing surveillance;
spontaneous reporting;
adverse reaction
- From:Japanese Journal of Pharmacoepidemiology
1997;2(2):103-110
- CountryJapan
- Language:Japanese
-
Abstract:
Spontaneous reporting system of adverse reactions (ADRs) is indispensable to secure drug safety. Although good systems of western countries are well-known in Japan, it seems that the French pharmacovigilance system is not familiar, as compared with the yellow-card system in the UK and the MEDWatch program in the US.
This report outlines various features of the French system according to our information collected by a visit to the French medicines agency and one of the regional centers. The “good pharmacovigilance practices, ” enforced by the agency in 1995, is used as a reference.
Notable features are summarized as follows : (1) decentralized activities by the 31 regional centers collecting spontaneous ADR reports from healthcare professionals, (2) centralized EDP-system retaining ADR data, (3) official decision-making process called “inquiry”, which opens when a signal of safety issues comes up, and synthesizes a consensus and proposal on necessary measures, (4) bidirectional communication between the regional centers and prescribers, reporting ADRs and providing safety information by Q & A, (5) collaboration of specialist committees and pharmaceutical companies with the above elements, and so forth.
The system is characterized by these elements constructing collectively an effctive system to prevent ADRs and reduce the seriousness. These findings will be helpful, even in Japan, when subjects for improvement of a reporting system are discussed.
