Pharmacolovigilance

Role of the Post-Marketing Authorisation Studies in Drug Risk Surveillance: Specifications and Methodologies

¹ AP-HP, Centre de Pharmaco-épidémiologie, Paris, France
² AP-HP, Hôpital Bichat, Département d’Épidémiologie Biostatistique et Recherche Clinique, Paris, France
³ Université Paris Diderot, Sorbonne Paris Cité, France
⁴ INSERM, CIE 801, Paris, France
⁵ Direction Evaluation de Santé, Sécurité et Gestion du Risque, Pfizer, Paris, France
⁶ Département de la Surveillance du Risque, du Bon Usage et de l’Information sur les Médicaments, Afssaps, Saint Denis, France

Correspondence and offprints: Véronique Lamarque-Garnier, Direction Evaluation de Santé, Sécurité et Gestion du Risque, Laboratoire Pfizer, 23-25 avenue du Docteur Lannelongue, 75768 Paris cedex 14, France. E-mail: veronique.lamarque@pfizer.com

Received: 8 April 2011
Accepted: 30 May 2011

Abstract

Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS “Post-Authorisation Safety Studies”), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part of the community revision.

These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact ... can complete available safety data.The Giens Round Table examined PASS from the risk management plans of a sample of marketing authorisation holders (participants to the Round Table) and identified the main characteristics of proposed actions. Concerning the specifications and the choice of methodology, only a general outline has been sketched in view of the complexity and diversity of drug risks situations.