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)






Imran Qureshi, PharmD, BCPP (he/him/his) is a board certified psychiatric pharmacist at The Johns Hopkins Hospital. He works in both the inpatient and outpatient settings and with child/adolescent and adult patient populations. His interests in psychiatry include schizophrenia and treatment resistant depression. Imran is a native of Baltimore and is a fan of the Ravens and Orioles.
Lindsey Cooper, PharmD, BCCCP (she/her) is a critical care clinical specialist at Prisma Health Richland in Columbia, South Carolina. She completed her pharmacy education at Wilkes University in Wilkes Barre, Pennsylvania. She completed her PGY1 pharmacy practice residency and PGY2 critical care residency at Prisma Health Richland. Dr. Cooper primarily covers the Surgical / Trauma ICU and serves as the residency coordinator for the PGY1 acute care pharmacy residency program.