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Objectives:  To evaluate agreement between causality assessments of reported adverse drug reactions (ADRs) obtained from decisional algorithms, with those obtained from an expert panel using the WHO global introspection method (GI), according to different levels of imputability and to evaluate the influence of confounding variables.

Method:  Two hundred reports were included in this study. An independent researcher used decisional algorithms, while an expert panel assessed the same ADR reports using the GI, both aimed at evaluating causality. Reports were divided according to the presence, absence or lack of information on confounding variables.

Results:  The rates of concordance between assessments made using the algorithms and GI according to levels of imputability were: 45% for ‘certain’, 61% for ‘probable’, 46% for ‘possible’ and 17% for drug unrelated terms. When confounding variables …