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Update: FDA and Clozapine Risk Evaluation Mitigation & Evaluation Strategy Program

In late July, the FDA approved modifications to the Clozapine REMS program with a final implementation date of November 15. Several of these modifications, such as patient re-enrollment, prescriber re-certification, and a new patient monitoring form, impact PMH-RNs, PMH-APRNs, and those you serve.

During the past several months, APNA, represented by Donna Rolin, PhD, APRN, PMHCNS-BC, PMHNP-BC, and fellow professional association stakeholders have been in dialogue with the FDA regarding these changes. Communications include this September 15 letter, this November 18 letter, and meetings with the FDA on October 21 and November 19.

In response to this dialogue, the FDA issued a November 19 announcement of temporary suspension of many of these new modifications. In addition to removing certain requirements for pharmacists and clozapine wholesalers, the announcements included the following guidance for health care professionals:

“Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range.

We encourage pharmacists and prescribers to continue working with the Clozapine REMS to complete certification and patient enrollment.”

For those who prescribe clozapine, you may find this December 1 virtual forum, hosted by SMI Adviser, helpful: Initial Impressions of Clozapine REMS: Troubleshooting and Brainstorming New Workflows.