A Conversation About the Clozapine REMS

Michael Asbach, DMSc, PA-C, Psych-CAQ, and Autumn Roque, DNP, APRN, PMHNP-BC, sat down to discuss the latest news on the clozapine Risk Evaluation and Mitigation Strategy (REMS).

In a joint meeting of the US Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee, members decided the clozapine REMS protocol was no longer necessary. Even further, it may be a barrier to access.

"I'm excited to see an opportunity to maybe roll back a regulation that is going too far and is actually leading to an outcome other than what we desire. The desire here is to make patients safe, not necessarily withhold care that may be lifesaving," said Asbach.

Asbach and Roque are the authors of the column "Clinician's Corner" for Psychiatric Times. You can read the latest installment, "To Be or Not to Be? Understanding False Positives in Bipolar Diagnosis."

Mr Asbach is a psychiatric physician associate and serves as associate director of interventional psychiatry at DENT Neurologic Institute in New York. Ms Roque is a clinical associate professor in the Hahn School of Nursing and Health Science at the University of San Diego.