Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems.

PURPOSE: To describe the impetus for and evolution, components, and potential impact on patients, health care providers, and health systems of risk evaluation and mitigation strategies (REMS) required by the Food and Drug Administration (FDA) for managing known or potential serious drug risks.

SUMMARY: A 2006 report from the Institute of Medicine criticizing FDA for drug withdrawals due to safety problems provided the impetus for FDA to enhance postmarketing surveillance and to require REMS for medications with actual or potential safety concerns. Components of REMS may include medication guides, patient package inserts, communication plans for health care providers, and elements to ensure safe use (e.g., special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, use of patient registries). Recent increases in the number of drugs with REMS requirements, MedWatch alerts, and the development of the new Sentinel Initiative reflect FDA's commitment to drug safety. Patients may be overwhelmed by information about drugs with REMS requirements, which could deter the use of potentially beneficial therapies. Pharmacists can help patients weigh the risks and benefits of drug therapy. Pharmacists, other health care providers, and health systems may find REMS requirements challenging, but FDA is cognizant of the need to balance the goals of ensuring drug safety and providing patient access to drugs without placing an undue burden on the health system.

CONCLUSION: The goal of improving drug safety is sought by the FDA, patients, health care providers, and health systems alike. Collaboration among health care providers may provide efficiencies in meeting FDA REMS requirements.