REMS for Psychiatric Medications: The Good, the Bad, and the Ugly

What do you need to know about REMS and how do they impact clinical care?

The drug safety program REMS (Risk Evaluation and Mitigation Strategy) was established by the US Food and Drug Administration to prevent and monitor specific adverse events associated with a specific medication or a class of medications to ensure the benefits outweigh the risks associated with the medication(s). As a result, REMS requires additional measures and steps, which may impact access, safety, and clinician workload.

Catherine E. Cooke, PharmD, MS, and Megan Ehret, PharmD, MS, were part of an evaluation program to better understand the good, the bad, and the ugly in REMS for 3 psychiatric medications: esketamine, olanzapine pamoate, and clozapine. The results and clinical pearls from their focus groups of multidisciplinary health care providers and advocacy groups will be discussed in their upcoming session on World Schizophrenia Day at the 2023 American Psychiatric Association Annual Meeting in San Francisco.¹

Dr Cooke is a research associate professor in the Practice, Sciences, and Health Outcomes Research Department at the School of Pharmacy, University of Maryland. Dr Ehret is a professor in the Practice, Sciences, and Health Outcomes Research Department at the School of Pharmacy, University of Maryland. Their session will be held 8:00am to 9:30am PDT on March 24, 2023, at the 2023 American Psychiatric Association Annual Meeting.

Are you attending the 2023 APA Annual Meeting? Share your favorite clinical pearls with us via PTEditor@mmhgroup.com.

Reference

1. Cooke CE, Ehret M, Love R. Evaluation of the REMs programs for psychiatric medications. 2023 American Psychiatric Association Annual Meeting. San Francisco. May 24, 2023.