title: [Update of the French drug reaction assessment method].
abstract: A tripartite group, entitled « CRI » (for Cercle de réflexion sur             l'imputabilité), involving French pharmacovigilance staff from the French           network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and           from French Health Authorities (Agence française de sécurité sanitaire des produits de           santé) has worked to update the French drug reaction assessment method. Following           assessment of strengths and weaknesses of the previous method, several points for           improvement are proposed: a more precise wording and a more discriminating scale for some           of the chronological and semiological criteria, a wider distribution of the intrinsic           score from 5 to 7 levels, a new bibliographic scale for differentiating expected and           unexpected adverse drug reactions, and a new informativness scale. This updated method           would lead to a more relevant assessment of relationship between a drug and the occurrence           of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of           relationship between a drug and the occurrence of an adverse reaction.
authors.affiliation: Cellule Plan de Gestion de Risque, Afssaps, Saint-Denis, France.
authors.forename: Yannick
authors.initials: Y
authors.lastname: Arimone
authors.forename: Irène
authors.initials: I
authors.lastname: Bidault
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Dutertre
authors.forename: Marie
authors.initials: M
authors.lastname: Gérardin
authors.forename: Claire
authors.initials: C
authors.lastname: Guy
authors.forename: Françoise
authors.initials: F
authors.lastname: Haramburu
authors.forename: Dominique
authors.initials: D
authors.lastname: Hillaire-Buys
authors.forename: Carmine
authors.initials: C
authors.lastname: Meglio
authors.forename: Catherine
authors.initials: C
authors.lastname: Penfornis
authors.forename: Hélène
authors.initials: H
authors.lastname: Théophile
authors.forename: Marie-Blanche
authors.initials: MB
authors.lastname: Valnet-Rabier
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000639:trends*; D004345:Drug Industry; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005602:France / Q000453:epidemiology; D006077:Government Agencies; D006801:Humans; D060735:Pharmacovigilance