Measuring Effectiveness of Risk Minimisation Measures

Abstract

Knowledge about the benefit-risk profile of a drug is limited at the time of drug approval and grows over time when the drug is increasingly used in routine daily practice. After drug approval the drug is used within a broader and more heterogeneous population with more comorbidities, for a longer period of time and under less controlled circumstances compared with the use during premarketing clinical trials. The dynamics of the benefits and the risks of a drug require a life cycle approach in which the benefit-risk balance is continuously evaluated. Proactive pharmacovigilance is part of the life cycle approach and is aimed at early detection and minimisation of risks. The World Health Organisation (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.The responsible regulatory authorities at European and Dutch level are the European Medicines Agency (EMA) and the Dutch Medicines Evaluation Board (CBG-MEB), the Netherlands Pharmacovigilance Centre (LAREB) and the Dutch Health Care Inspectorate (IGZ). Risk minimisation measures (RMMs) are interventions that aim to optimise the benefit-risk balance of a drug by minimising its risks during drug use in clinical practice. These measures intend to prevent or reduce the occurrence or the severity of adverse drug reactions (ADRs).