Risk management and drug utilization research

Proactive pharmacovigilance is part of the lifecycle approach aimed at early detection and minimization of risks, as stated in the strategic plans of the European Medicines Agency and the US Food and Drug Administration. An Risk Management Plan consists of a set of activities and interventions that are designed to identify, characterize, prevent, or minimize risks during the life cycle of a drug. The process of drug approval in Europe involves the assessment of the need for additional activities to ensure that the benefit-risk balance remains optimal when the drug is used in clinical practice. The impact of risk minimization measures in healthcare systems requires assessment to ensure that their objectives are fulfilled and that the measures in place are proportionate, considering the benefit-risk-profile of the product and the efforts required by healthcare professionals and patients to implement these measures.