173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)

In this episode, we will discuss the definition of REMS (Risk Evaluation and Mitigation Strategies), why they exist, the role of FDA in administering REMS, types and examples of REMS, and how they impact pharmacy practice.

Key Concepts

1. The REMS (Risk Evaluation and Mitigation Strategies) program was developed in 2007 as part of the FDA’s drug risk management strategies designed to balance risk and benefits of certain drugs.
2. Elements of REMS vary depending on the drug, but commonly include medication guides, communication plans, and other elements to assure safe use.
3. REMS can require patients, providers, and pharmacies to take certain actions including training, registration, enrollment, safety monitoring, documentation of safety concerns, and follow prescribing and dispensing regulations. 
4. The FDA captures and assesses data on a regular basis to make changes in the REMS program. It also has authority to enforce compliance and take punitive actions against non-compliant parties.

References

• Risk Evaluation and Mitigation Strategies. Food and Drug Administration. May 16, 2023. Accessed October 17, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems