FDA Issues New Requirements for Prescribing and Dispensing Clozapine

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The Risk Evaluation and Mitigation Strategy (REMS) Program for clozapine is being modified to take additional steps to help patients manage the potential risks of the antipsychotic, including severe neutropenia. The update affects both clinicians and pharmacies.

The new requirements, which take effect February 28, include the following:

• Clinicians who prescribe clozapine must be certified in the REMS Program. (This is not necessary for inpatient providers whose patients are already enrolled.)

• Pharmacies that dispense the drug must also be certified in the Clozapine REMS Program. Additionally, pharmacies are no longer allowed to handle patient enrollments.

• Patients must be enrolled in the program prior to obtaining a prescription (outpatient) or being given their first dose of clozapine (inpatient).

See the linked Center for Drug Evaluation Statement for all the modifications.