Abstract

Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs. Beside other methods, statistical methods are used to detect new ADRs in the framework of signal detection. Groupings of terms containing similar ADRs allow to increase the signal intensity and to improve the detection of new ADRs. SMQs have become reference groupings in the field of pharmacovigilance. They are built on the MedDRA terminology and thanks to the study of scientific literature. Even if SMQs are built manually by experts, they still show some shortcomings: they tend to be over-inclusive and thus become too sensitive, although they can also miss several relevant terms. Moreover, the spectrum of available SMQs is limited. The objective of this work is to propose an automated method for a flexible creation of groupings of terms. This method is based on exploitation of the semantic distance between MedDRA terms. In a first experience, we used ARD terms alone and obtained results with a high precision (mean 74% within the interval [49; 91]). In a second experience, we used ADR terms and their formal definitions and this worsened the results because the semantic information within definitions may be missing. We assume that more exhaustive definitions will have a positive effect on results.KeywordsPharmacovigilanceSignal detectionGrouping of termsSMQsSemantic distanceFormal definitions

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