To ensure that patients have continued access to clozapine, the Food and Drug Administration (FDA) has temporarily exercised additional enforcement discretion with regard to certain Clozapine REMS program requirements.

Clozapine is an atypical antipsychotic indicated for treatment-resistant schizophrenia and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. The treatment is only available through the restricted Clozapine REMS program due to the risk of severe neutropenia. Patients who receive clozapine must be enrolled in the program and comply with the absolute neutrophil count (ANC) testing and monitoring requirements.

According to a recent FDA communication, health care professionals and patients have been experiencing difficulties with the Clozapine REMS program, including issues related to clozapine access following discharge from an inpatient setting.

Under the Clozapine REMS, inpatient pharmacies are only allowed to dispense a 7-day supply of clozapine to a discharged patient. To address concerns with patient access and ensure continuity of care, the FDA does not intend to object if:

  • Inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency upon discharge from the facility (eg, weekly monitoring = 7 days’ supply; twice monthly monitoring = 14 days’ supply; monthly monitoring = 30 days’ supply)

Additionally, the FDA does not intend to object if: pharmacists dispense clozapine without a REMS dispense authorization (RDA); and wholesalers ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.

Additional information is available on the Clozapine REMS website.

Reference

FDA is temporarily exercising enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. News release. US Food and Drug Administration. Accessed November 2, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program?