Standardized assessment of adverse drug reactions: the method used in France. Special workshop--clinical.

Abstract

The method used in France since 1977 for assessing adverse drug reaction (ADRs) is based on a three-stage process: assessment of three chronological criteria (challenge, dechallenge, and rechallenge); assessment of clinical and biological findings; and a combination of chronological and symptomatological assessments to obtain a 3-degree global score (1: doubtful, 2: possible, 3: probable). Bibliographical data (previously reported or unreported ADR) are assessed quite separately; thus, the method has a good sensitivity for detecting new ADRs.