The authority of FDA with respect to drug safety was strengthened in 2007 by the Food and Drug Administration Amendments Act (FDAAA), especially as it relates to requirements for postmarketing studies and risk evaluation and mitigation strategies (REMS). While risk minimization plans were required for certain medications prior to the enactment of FDAAA, the requirements outlined in FDAAA represent an evolution in FDA requirements to manage known or potential serious drug risks. FDAAA not only authorizes the FDA to require manufacturers to submit proposed REMS prior to approval of a drug if such is warranted, but it also authorizes the agency to require post-approval REMS for products that initially did not require such, but subsequent safety data suggest REMS are necessary to ensure that the benefits of the drug outweigh potential risks. Examples of strategies for managing risks associated with potentially harmful drugs may include medication guides, patient package inserts, communication plans for health care professionals, patients, and caregivers, and/or restricted drug distribution systems.
These new policies present unique challenges for health care providers, including those practicing in hospitals and health systems. 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 increases, so will the challenges faced by 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.
Health-system pharmacists should play an integral role in implementing and assessing REMS programs within hospitals and components of integrated health systems to both improve medication safety and ensure access to therapeutic options for the patients they serve. This educational activity will include a primer on FDAAA and its implications for health-system pharmacists and pharmacies with emphasis on the essential components of risk evaluation and mitigation strategies (REMS). This knowledge-based educational activity will also include a discussion about the challenges and opportunities associated with restricted drug distribution systems (RDDS).