Standardized assessment of drug-adverse reaction associations--rationale and experience.

The assessment of the causal relationship between the suspected drug and the adverse event represents one of the most important goals in the evaluation of individual case reports. Because of the variability of clinical judgement, there is a growing interest in systems of assessment based on clearly defined, operational criteria. In this paper we describe our approach toward this goal, the results achieved and the practical experience gained in the evaluation of over 600 case reports processed by the drug monitoring unit of our company.