Michael Asbach, DMSc, PA-C, Psych-CAQ, and Autumn Roque, DNP, APRN, PMHNP-BC, sat down to debate the most recent information on the clozapine Threat Analysis and Mitigation Technique (REMS).
In a joint assembly of the US Meals and Drug Administration’s Drug Security and Threat Administration Advisory Committee and Psychopharmacologic Medication Advisory Committee, members determined the clozapine REMS protocol was now not mandatory. Even additional, it could be a barrier to entry.
“I am excited to see a possibility to possibly roll again a regulation that’s going too far and is definitely resulting in an consequence aside from what we need. The need right here is to make sufferers secure, not essentially withhold care which may be lifesaving,” stated Asbach.
Asbach and Roque are the authors of the column “Clinician’s Nook” for Psychiatric Occasions. You possibly can learn the most recent installment, “To Be or To not Be? Understanding False Positives in Bipolar Analysis.”
Mr Asbach is a psychiatric doctor affiliate and serves as affiliate director of interventional psychiatry at DENT Neurologic Institute in New York. Ms Roque is a medical affiliate professor within the Hahn College of Nursing and Well being Science on the College of San Diego.
