Clinical Conversations: SICP: Impact and Challenges of Risk Evaluation and Mitigation Strategy (REMS) Programs in Practice

ASHPOfficial

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.

The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.