Regional Centers of Pharmacovigilance: a complementary source of efficiency

Spontaneous reporting remains so far the most used and cost-effective method for detecting new adverse reactions associated with marketed drugs. In France, this routine surveillance involves a network of 31 regional centres. In this study, the numbers of reported cases were compared between centres...

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Bibliographic Details
Published inTherapie Vol. 53; no. 4; p. 397
Main Authors Mazé, F, Bégaud, B
Format Journal Article
LanguageFrench
Published France 01.07.1998
Subjects
Adverse Drug Reaction Reporting Systems - organization & administration
Adverse Drug Reaction Reporting Systems - standards
Drug Therapy - standards
Drug-Related Side Effects and Adverse Reactions
France
Humans
France
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Summary:Spontaneous reporting remains so far the most used and cost-effective method for detecting new adverse reactions associated with marketed drugs. In France, this routine surveillance involves a network of 31 regional centres. In this study, the numbers of reported cases were compared between centres for three different drug-event associations having justified regulatory decisions. The number of reports differed greatly, both between centres and for the relative numbers of reports of each type in each centre. This study showed that the observed differences between centres probably resulted in a complementary and efficient surveillance of the whole French territory.
ISSN:0040-5957