Answering 3 Clinical Questions in the Wake of the Removal of the Clozapine REMS Requirement

In February 2025, the US Food and Drug Administration announced the clozapine REMS (Risk Evaluation and Mitigation Strategy) protocol was no longer necessary and may even be a barrier to access.¹ Michael Asbach, DMSc, PA-C, Psych-CAQ, answers 3 clinical questions in the wake of this REMS removal.

1. Is it necessary to still monitor bloodwork? The short answer is yes. While the REMS program is no longer a legal requirement, blood work still needs to be monitored weekly.
2. What should we do with long-term patients on clozapine in terms of monitoring? Blood work monitoring should be continued even for patients stable on clozapine long-term, but should be done within the context of the individual patient's full clinical picture. Shared-decision making is key here. Involving the patient in a conversation about the risks and benefits of adjusting their monitoring schedule helps promote autonomy and build trust.
3. Should the removal of the REMS change which patients are considered for clozapine treatment? The removal of the REMS lowers the administrative burden of prescribing clozapine. This increases access to clozapine, which can now be provided to a different variety of patients.

"It is more important than ever that we as providers are taking the lead," said Asbach.

Mr Asbach is a psychiatric physician associate and serves as associate director of interventional psychiatry at DENT Neurologic Institute in New York.

Reference

1. Duerr HA. FDA officially removes REMS requirement for clozapine. Psychiatric Times. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine