ADVERSE DRUG-REACTIONS - PHYSICIANS OPINIONS VERSUS A CAUSALITY ASSESSMENT METHOD

Since spontaneous reporting of adverse drug reactions depends on the p hysician's opinion of the relationship between the drug and the advers e event, we compared physicians' opinions with the scores obtained by the causality assessment method used in France. During a 2 month perio d, all physicians who reported adverse drug reactions (ADRs) to our ph armacovigilance centre expressed their opinions on the causal link by means of visual analogue scales. ADR reports were then assessed with t he French causality assessment method by a clinical pharmacologist who was blind to physicians' opinions. The assessment by both physicians and the standardized method was performed for 75 ADR cases involving 1 20 drugs. Physicians used a wide range of assessments, with a preponde rance of extreme scores, resulting in a U-shaped distribution, while t he standardized method gave generally low scores. Scores given by phys icians were very high (causality considered very likely or likely) in 60 % of cases and very low (causality considered unlikely or dubious/p ossible) in 32 % of cases. Scores obtained using the causality assessm ent method were low (causality dubious/possible) in 89 % of cases and causality considered likely in only 11 cases, essentially in cases wit h positive rechallenge. Complete agreement occurred in only 6 % of cas es. Adding complete agreement and minor discrepancies raised the perce ntage to 49 %.