title: [Not Available].
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.affiliation: Département de Pharmacovigilance, Afssaps, Saint-Denis, France.
authors.forename: Irène
authors.initials: I
authors.lastname: Bidault
authors.affiliation: Pharmacovigilance, Laboratoire Orphan Europe, Puteaux, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Dutertre
authors.affiliation: Service de Pharmacologie Clinique, CHU Nantes, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Gérardin
authors.affiliation: Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Saint-Étienne, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Guy
authors.affiliation: Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Bordeaux, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Haramburu
authors.affiliation: Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Montpellier, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Hillaire-Buys
authors.affiliation: Pharmacovigilance, Laboratoire Lilly, Suresnes, France.
authors.forename: Carmine
authors.initials: C
authors.lastname: Meglio
authors.affiliation: Global Pharmacovigilance & Epidemiology, Sanofi-Aventis Research & Development, Chilly-Mazarin, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Penfornis
authors.affiliation: Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Bordeaux, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Théophile
authors.affiliation: Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Besançon, France. Electronic address: methodecri@googlegroups.com.
authors.forename: Marie-Blanche
authors.initials: MB
authors.lastname: Valnet-Rabier
keywords: adverse drug reaction; algorithm; algorithme; causality assessment; drug safety; effet indésirable; imputabilité; pharmacovigilance