Understanding the Food and Drug Administration Risk Evaluation and Mitigation Strategies (REMS)

Abstract

The Director's Forum series is written and edited by Robert Weber and Scott Mark and is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. As the Food and Drug Administration (FDA) approval process becomes more stringent with regard to postmarketing surveillance for medications, directors of pharmacy will need to understand expectations of inpatient pharmacy services to ensure patient safety and meet requirements. This article provides background information regarding the FDA Risk Evaluation and Mitigation Strategies (REMS) programs and potential implications for hospital pharmacy.