In February 2025, the US Meals and Drug Administration introduced the clozapine REMS (Danger Analysis and Mitigation Technique) protocol was now not obligatory and should even be a barrier to entry.1 Michael Asbach, DMSc, PA-C, Psych-CAQ, solutions 3 medical questions within the wake of this REMS elimination.
- Is it essential to nonetheless monitor bloodwork? The quick reply is sure. Whereas the REMS program is now not a authorized requirement, blood work nonetheless must be monitored weekly.
- What ought to we do with long-term sufferers on clozapine by way of monitoring? Blood work monitoring ought to be continued even for sufferers steady on clozapine long-term, however ought to be completed inside the context of the person affected person’s full medical image. Shared-decision making is vital right here. Involving the affected person in a dialog in regards to the dangers and advantages of adjusting their monitoring schedule helps promote autonomy and construct belief.
- Ought to the elimination of the REMS change which sufferers are thought of for clozapine therapy? The elimination of the REMS lowers the executive burden of prescribing clozapine. This will increase entry to clozapine, which may now be supplied to a unique number of sufferers.
“It’s extra essential than ever that we as suppliers are taking the lead,” mentioned Asbach.
Mr Asbach is a psychiatric doctor affiliate and serves as affiliate director of interventional psychiatry at DENT Neurologic Institute in New York.
Reference
1. Duerr HA. FDA formally removes REMS requirement for clozapine. Psychiatric Instances. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine
