The number and complexity of risk evaluation and mitigation strategies (REMS) have grown significantly, presenting health care providers with additional challenges in an already stressful environment. Lack of standardization among REMS programs makes it difficult for health care providers to navigate the various systems. As the number of FDA-mandated REMS programs has increased, so too have the challenges faced by the health care professionals who prescribe or handle medications covered by these programs. It is critical that concerns among pharmacists, nurses, physicians, patients, and others regarding REMS requirements be addressed and put forth to FDA and manufacturers to avoid unintended consequences that compromise patient access or care.

Pharmacists should play an integral role in implementing and assessing REMS programs within hospitals. This educational activity will provide an update on current REMS provisions required by the FDA, including recent draft guidance and potential changes FDA may implement as a result of feedback from stakeholders in the health arena. Practical approaches that pharmacists can take in proactively assessing and managing the growing number and scope of REMS will also be described. Recommendations on how REMS can be integrated into the existing infrastructure of the hospital, including the P&T committee will be provided. Case studies will be presented, demonstrating approaches to training pharmacists in assessing REMS and elements to assure safe use.