ORGANIZATION AND RESULTS OF PHARMACOVIGIL ANCE IN FRANCE

Pharmacovigilance represents all methods of detection, assessment, inf ormation and prevention of adverse drug reactions (ADRs). It mainly in volves the post-marketing phase because of the low probability of dete cting all possible adverse effects of a drug during pre-marketing deve lopment. The most widely used method for pharmacovigilance is spontane ous reporting which is an excellent signal generator but precludes sat isfactory calculation of incidence rates. The French Pharmacovigilance System has been set up in 1973; reporting of ADRs has been made manda tory in 1984 for prescribers. This system consists in a network of 30 regional centres under supervision of a coordinating committee at the French Drug Agency. The number of ADR cases received, assessed and rec orded by the regional centres is around 10,000 per year; a similar num ber of cases are reported to the Drug Agency by the pharmaceutical ind ustry. Moreover, Regional Centres work as Drug Information Centres ans wering more than 23,000 inquiries per year.