APA Takes Action on Problems with Clozapine REMS

Last month, the FDA announced that beginning on October 12, all prescribers of clozapine—a medication used for the treatment of schizophrenia—are required to be certified in a Clozapine REMS (Risk Evaluation and Mitigation Strategy) Program. This change was part of an effort to improve the monitoring and management of patients taking the medication. Since the program’s launch, however, APA members have reported numerous technical, personnel, and process problems that they say could affect the appropriate prescribing and dispensing of clozapine.

Several challenges with the FDA’s Clozapine REMS rollout have been reported, including the following:

* Technical issues related to website operation and certification.
* Intermittent or nonexistent access to customer service representatives.
* Issues related to a certified prescriber’s ability to cover for or designate others to prescribe clozapine such as psychiatric residents.
* Unnecessary registration burdens that could create potentially harmful delays in the initiation or discontinuation of clozapine treatment.

In response, the FDA recently released an alert stating that prescribers and pharmacists should continue clozapine prescribing and dispensing, using their clinical judgment to consider the best interests of the patient even if they encounter problems with the Clozapine REMS certification program.

APA has been in contact with the FDA to share its clinical concerns and has agreed to collaborate to effect an appropriate implementation of the clozapine REMS. APA will also continue to gather information from its district branch and state association executives as well as the APA councils on Research and Quality Care.

To read more about the issues around clozapine, see the Psychiatric News article “Why Won't Clinicians Use Clozapine Despite Proven Superiority?”