Prescriber
All prescribers of clozapine products must certify in the Clozapine REMS Program. Certification requires prescribers to:
  • Enroll: Complete the Enrollment form (name, address, NPI, DEA)
  • Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Assess: Successfully complete the Knowledge Assessment


The initial PDA launch is scheduled to go live on Friday 5/20. Prescribers are encouraged to certify in the Clozapine REMS Program as soon as possible - but the initial PDA launch will not prevent a dispense from being authorized if a prescriber is not certified. Click on the Important Program Update button for more information.

Pharmacy
All pharmacies dispensing clozapine products must certify in the Clozapine REMS Program. Certification requires pharmacies to:
  • Enroll: Complete the Enrollment form (name, address, NPI, DEA)
  • Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Assess: Successfully complete the Knowledge Assessment
  • Implement: Implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements

The initial PDA launch is scheduled to go live on Friday 5/20. Pharmacies should click on the Important Program Update button for more information on how it affects them.



What is the Clozapine REMS Program?

Clozapine is associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/μL). The requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs, and is required by the FDA for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS Program replaces the individual clozapine patient registries and the National Non-Rechallenge Master File (NNRMF).

***Important Program Update (as of 12/16/2016)*** X
The full launch for the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program will not be implemented in 2016.
While it was announced in May 2016 that the full REMS program launch would occur in December 2016, recent technical and logistical challenges necessitate that the date of this launch be postponed. The Clozapine Product Manufacturer's Group and the U.S. Food and Drug Administration are continuing to work to ensure that patients relying on clozapine are able to maintain access to this medication, while also ensuring that the risks associated with it are appropriately managed. A phased approach to implementing the Clozapine REMS Program is needed in order to carefully balance patient access and ensuring the safe use of clozapine during the transition to a fully implemented Clozapine REMS Program.
Prescribers and pharmacies that have not certified in the Clozapine REMS Program are encouraged to use this additional time to certify in the program before the full launch, which includes a fully implemented predispense authorization (PDA) for pharmacies. In addition, prescribers should submit absolute neutrophil count (ANC) results to the Clozapine REMS Program according to the patients monitoring frequency (i.e. within 7, 15, or 31 days) to ensure the ANC is current. If prescribers and/or pharmacies are not certified in the Clozapine REMS Program and the ANC in the Clozapine REMS Program is not current after the full launch, this will impact the pharmacy's ability to dispense clozapine, negatively affecting patient care.
Updated information will be sent to prescribers and pharmacies once an implementation date has been confirmed.
During this extension, prescribers and pharmacies should continue to adhere to the Clozapine REMS Program requirements. The following are the current requirements of the Clozapine REMS Program.
  1. Prescribers are required to:
    • Enroll patients in the Clozapine REMS Program
      • Patient enrollment in the Clozapine REMS Program is confirmed prior to dispensing clozapine
      • Patients may be enrolled by logging into your account on www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
      • 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 patients monitoring frequency
    • Submit the ANC directly to the Clozapine REMS Program according to the patients monitoring frequency (i.e. within 7, 15, or 31 days) so the current ANC is in the REMS Program database prior to the dispense
      • ANCs should be submitted directly to the REMS Program and not to the pharmacy to ensure timely data entry into the system
        • ANCs may be submitted to the program by logging into your account on www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
        • ANCs may also be submitted using the ANC reporting form (available under the Resources tab on www.clozapinerems.com). However it will take up to 48 hours to process this form
      • If a patient does not have an ANC on file with the REMS, a dispense will not be authorized
      • If the last ANC on file for a patient indicates moderate or severe neutropenia, a dispense will not be authorized
      • A patient with an ANC that indicates moderate or severe neutropenia must have a Treatment Rationale on file before the dispense can be authorized
        • A Treatment Rationale can be submitted by logging into your account at www.clozapinerems.com or by calling the Clozapine REMS Program Contact Center at 844-267-8678
        • The ANC reporting form can also be used to submit a Treatment Rationale. However, it will take up to 48 hours to process this form
  2. Pharmacies are required to:
    • Outpatient pharmacies are required to obtain a PDA prior to dispensing clozapine and inpatient pharmacies are required to complete an eligibility check prior to dispensing clozapine
      • A PDA will not be issued or the eligibility check will not be successful if the patient is not enrolled in the Clozapine REMS Program
      • Pharmacies may still enroll patients in the Clozapine REMS Program by calling the Clozapine REMS Program Contact Center at 844-267-8678
  3. Currently, the following will not prevent a patient from receiving clozapine from the pharmacy:
    • Pharmacy not certified
    • Prescriber not certified
    • ANC not current (i.e. within 7, 15, or 31 days of the dispense date) based on the patient's monitoring frequency (MF)
      • Although not required, pharmacies are encouraged to contact the prescriber to acquire the most recent patient ANC information for patient safety purposes. In the future, patients that do not have a current ANC on file may not be allowed to receive clozapine.
For additional information about the Clozapine REMS Program, please call at the Clozapine REMS Program Contact Center at 844-267-8678.
For additional information about the Clozapine REMS Program, please call 844-267-8678.