Experts' Opinion in Causality Assessment: Results of Consensus Meetings

Abstract

The weaknesses and the nonreproducibility of most causality assessment methods could be explained, at least in part, by the following reasons: (a) they pretend to be applied to all adverse drug events, and (b) they propose levels for the various criteria but do not clearly define their limits. In order to try and resolve these issues, Roussel Uclaf has organized French consensus meetings with university experts and specialists in industrial or official pharmacovigilance. A consensus has been reached on the definition of adverse reactions, on the limits of the various chronologic criteria and on the evaluation of the clinical context. Most situations have been considered, reducing the individual interpretation and ensuring an excellent reproducibility. On the basis of these results, and using the same method for organizing the meeting, a first international consensus on drug-induced liver disorders has been recently obtained in Paris.