title: Updating the French method for the causality assessment of adverse drug reactions.
abstract: The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.
authors.affiliation: Cellule Plan de Gestion de risque, ANSM, 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 / Q000639:trends*; D015984:Causality; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D015203:Reproducibility of Results