The US Food and Drug Administration (FDA) implemented Risk Evaluation and Mitigation Strategy (REMS) programs to ensure benefits outweigh the safety risks of particular medications. With over 60 medications with REMS programs and varying requirements for each, operationalizing to comply with requirements can be challenging. In this podcast, we talk about some of those challenges and how to operationalize recommendations for those who routinely see these medications in practice, as well as for those who come across them sporadically.
REFERENCES/RESOURCES
- Institute for Safe Medication Practices (ISMP). Proper deployment of REMS to reduce potential drug-related harm and medication errors – Part I. ISMP Medication Safety Alert! Acute Care. 2023;28(14):1-3.
- Institute for Safe Medication Practices (ISMP). Incorporating REMS program requirements into systems and processes – Part II. ISMP Medication Safety Alert! Acute Care. 2023;28(15):1-5.
- Approved Risk Evaluation and Mitigation Strategies (REMS)