A Knowledge Management Platform for Documentation of Case Reports in Pharmacovigilance

Most countries have developed information systems to report drug adverse effects. However, as in other domains where systematic reviews are needed, there is little guidance on how systematic documentation of drug adverse effects should be performed. The objective of the VigiTermes project is to develop a platform to improve documentation of pharmacovigilance case reports for the pharmaceutical industry and regulatory authorities. In order to improve systematic reviews of adverse drug reactions, we developed a prototype that first reproduces and standardizes search strategies, then extracts information from the Medline abstracts which were retrieved and annotates them. The platform aims at providing transparent access and analysis tools to pharmacovigilance experts investigating relevance of safety signals related to drugs. The platform's architecture consists in the integration of two vendor tools ITM (R) and Luxid (R) and one academic web service for knowledge extraction from medical literature. Whereas a manual search performed by a pharmacovigilance expert retrieved 578 publications, the system proposed a list of 229 publications thus decreasing time required for review by 60%. Recall was 70% and additional developments are required in order to improve exhaustivity.