PRAC adopts Pharmacovigilance Impact Strategy

Tony Anderson

By 2016-05-23

PRAC adopts pharmacovigilance impact strategy at its January 2016 meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) adopted the ‘Strategy on Measuring the Impact of Pharmacovigilance Activities’.

PRAC adopts pharmacovigilance impact strategy at its January 2016 meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) adopted the ‘Strategy on Measuring the Impact of Pharmacovigilance Activities’. The new Strategy details how to gather data and knowledge on the concrete effect of measures and processes meant to ensure the safe use of medicines in the EU. Various activities are carried out in Europe to ensure that medicines are used as safely as possible. These include the proactive planning of risk minimization measures before a medicine is authorized; the collection and management of suspected adverse reaction reports; the detection and management of potential new safety signals for medicines; and the planning of post-authorization studies to generate data on the use of medicines in the real world. As new information emerges from these activities, regulators may take further actions to minimize risks, e.g. updating patients and doctors on the best use of a medicine or restricting a medicine’s use if its benefits no longer outweigh its risks in a certain population.

 It is anticipated that the following activities will be undertaken:

Collecting and collating the available data relating to measuring the impact of pharmacovigilance activities Systematically compiling the effectiveness results of risk minimization studies performed by companies Identifying routinely collected data on pharmacovigilance activities Conducting collaborative targeted studies of key pharmacovigilance processes Identifying methods to perform impact studies, including studies on health outcomes.