The Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program

Get Prepared for Upcoming Changes to the Program

Effective February 28, 2019:

Prescribers will need to be certified by the Clozapine REMS Program to dispense clozapine. The FDA's Center for Drug Evaluation Research's announced that the requirements are intended to ensure safe and continued access to the medication.

Prescribers and pharmacies must be certified by February 28 or they will no longer be able to prescribe/dispense clozapine. Enrollment of patients in the Clozapine REMS program will now be the responsibility of the prescribers, as pharmacies will no longer be allowed to manage patient enrollment.

Learn about the key new prescriber requirements and the differences between outpatient and inpatient prescribing requirements below:

Prescribers in OUTPATIENT settings must:

  • Certify in the Clozapine REMS Program
    • If you need to prescribe clozapine but are not yet certified in the Clozapine REMS Program, go immediately to clozapinerems.com. Once a prescriber is certified, his/her prescriber designees must also enroll online.
    • The certification requires the completion of an enrollment form, a review of educational resources, and an assessment on prescriber knowledge.
  • Enroll patients in the Clozapine REMS Program
    • Patient enrollment in the Clozapine REMS Program is confirmed prior to dispensing. Patients not previously enrolled can only be registered by a provider after the deadline.
    • If the patient is not enrolled in the Clozapine REMS Program, a dispense will not be authorized.
  • Obtain an absolute neutrophil count (ANC) for patients in accordance with the clozapine Prescribing Information and aligned with the patient's monitoring frequency.
    • Submit the ANC directly to the Clozapine REMS Program according to the patient's monitoring frequency (i.e. within 7, 15, or 31 days), so the current ANC is in the Program database prior to the dispense.
    • If the last ANC on file for a patient indicates moderate or severe neutropenia, a dispense will not be authorized unless the prescriber documents that the benefits of clozapine outweigh the risks associated with neutropenia (i.e. a Treatment Rationale is on file). A Treatment Rationale can be submitted by logging into your account at clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678.
    • If a patient does not have an ANC on file with the REMS, a dispense will not be authorized.

Prescribers in INPATIENT settings must:

  • Are not required to be certified if they are prescribing for patients already enrolled in the program.
  • Must enroll the patient in the Clozapine REMS Program prior to receiving their first dose if the patient is initiated on clozapine while in an inpatient setting.
  • Should use clinical judgement to determine whether the benefits of receiving clozapine outweigh the risks if a patient has an ANC indicating moderate or severe neutropenia in the inpatient setting.