Updating the French method for the causality assessment of adverse drug reactions

Therapie. 2013 Mar-Apr;68(2):69-76. doi: 10.2515/therapie/2013016. Epub 2013 Jun 18.

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.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / trends*
  • Causality
  • Drug Interactions
  • Drug-Related Side Effects and Adverse Reactions
  • France
  • Humans
  • Pharmacovigilance*
  • Product Surveillance, Postmarketing
  • Reproducibility of Results