Adverse drug reactions in Europe

The European Medicines Agency has recently implemented some major changes in the regulatory framework for medicines. These changes are thought to result in a decrease in adverse drug reactions, thereby lowering medication related morbidity, mortality, and (monetary) societal costs. However, at least for Europe, no accurate and reliable information exists on the current burden of disease and societal costs of adverse drug reactions. This project develops and tests a conceptual framework for measuring (a) the burden of disease and (b) societal costs of adverse drug reactions. The project thereby helps determine whether the aims and resources of the new regulatory framework for medicines are proportionate to the burden of disease and costs caused by adverse drug reactions.

By making the evaluation of the risks of medicines sounder, this conceptual framework can help evaluate and improve the new regulatory system for medicines.