July 29, 2021

The U.S. FDA has approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program for clozapine, a drug used to treat schizophrenia. The changes will go into effect on November 15, 2021, and require the following actions from prescribers and pharmacies:

 

  • Prescribers and pharmacies must be recertified in the Clozapine REMS program by November 15, 2021, and prescribers must re-enroll their patients in the REMS by then as well. Both prescribers and pharmacies can begin recertification and re-enrollment as soon as August 16, 2021. Without recertification, prescribers will not be able to prescribe clozapine and pharmacies will not be able to dispense it as of November 15. Patients not re-enrolled in the REMS program will not be able to receive clozapine after changes to the program go into

 

  • Pharmacies must obtain authorization to dispense the drug through the REMS Contact Center or online via the REMS website. They may no longer use telecommunication verification to verify safe use

 

  • A new Patient Status Form will be required for all outpatients receiving clozapine. This form documents absolute neutrophil count (ANC) monitoring, which is required as the drug can cause severe neutropenia – a condition in which the body has too few white blood cells and becomes vulnerable to serious, potentially fatal The form must be submitted on a monthly basis.

Clozapine first received FDA approval in 1989. It is available as a brand name medication and as a generic, and is only intended to treat schizophrenia after other therapies have failed.

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