Huge efforts and resources have been allocated to Pharmacovigilance around the world, with enormous progress in the last two decades. Signal Detection, Risk Management and Risk Minimisation are only a few examples of fairly recent developments. The effects of these and other developments in Pharmacovigilance are real and there are metrics that measure these processes. However the actual impact of Pharmacovigilance on reducing serious morbidity and mortality has not been measured.
PRAC, EMA and ENCePP are interested in measuring the impact of pharmacovigilance process. An ENCePP Special Interest Group on Impact has been formed, of which the DSRU is an active member. We have now moved the project further and appointed Samantha Lane as a Research Fellow to work on the project. Her work will initially identify product withdrawals in the EU and examine the quantitative basis for the studies that supported the withdrawal decision (relative and absolute risks) then relate these to usage data obtained from other sources. The objective is to measure quantitatively the beneficial effect on public health burden (serious morbidity and mortality) of the Regulatory decision.