FDA Announces Changes to Clozapine REMS Program

On January 16, the Food and Drug Administration (FDA) announced modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program that go into effect on February 28. Key changes that will affect prescribers, pharmacies, and patients include the following:

• Prescribers and pharmacies must be certified in the Clozapine REMS Program by February 28 or they will no longer be able to prescribe or dispense clozapine.

• After February 28, pharmacies will no longer be allowed to enroll patients in the Clozapine REMS Program. Instead, patient enrollment must be completed by the prescriber or the prescriber designee.

• Inpatient prescribers are not required to be certified if they are prescribing to patients already enrolled in the program.

• If a patient’s absolute neutrophil count is not current, this will not prevent clozapine from being dispensed. ■