Administrative Letter 22-04
October 18, 2021
Administrative Letter 22-04
Re: Updated Clozapine REMS Program
In an effort to keep you and your staff informed regarding updates in the clozapine REMS program, Developmental Disabilties Services is offering the following guidance.
The Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program the FDA requires for certain medications. Medications required to participate in a REMS program are agents that can be associated with potentially serious health concerns or adverse effects. The REMS program supports safe use of medication by helping to ensure the benefit provided with use outweighs potential risks.
Because clozapine can be associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/µL) which can lead to serious and/or fatal infections, use of this medication requires monitoring of ANC (a type of WBC) to ensure individuals receiving this medication are safe.
Currently, prescribers order blood sample monitoring according to a schedule determined by duration of therapy and previous ANC values for anyone receiving clozapine. These values are submitted to a centralized database.
REMS Program Changes:
The clozapine REMS program will switch to a new database with revised submission guidelines. Healthcare providers will continue to monitor ANC blood values according to the recommended schedule; however, results will only be submitted on a monthly basis.
REGISTRATION FOR THE NEW PROGRAM BEGAN: AUGUST 16, 2021
DEADLINE: NOVEMBER 15, 2021
HEALTHCARE PRESCRIBERS and PHARMACIES MUST:
Certify in the new REMS program by completing the following tasks:
- Complete Enrollment Form at www.clozapineREMS.com
- Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
- Successfully complete the Clozapine REMS Knowledge Assessment for Healthcare Providers
*Healthcare Providers must enroll each patient that will continue to receive clozapine in the new REMS Program.
**Pharmacies must also implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements.
Why Were Changes Made?
- To prevent unintended interruptions in treatment
- To ensure compliance of ANC monitoring
- To ensure documentation is complete with risk versus benefit assessments
- To ensure patients are educated regarding severe neutropenia
- To ensure safety monitoring occurs continuously throughout therapy
- To decrease healthcare provider burden (monthly versus more frequent submission of Patient Status Forms)
Preparedness for Providers:
Consider verifying with healthcare prescribers that re-enrollment has occurred for any service recipient receiving clozapine. The healthcare prescriber prescribing clozapine and the pharmacy dispensing clozapine must also re-enroll in the new REMS program in order to continue prescribing and filling prescriptions for clozapine. Individuals will be unable to fill prescriptions for clozapine after November 15, 2021 if re-enrollement has not been completed for the patient, prescriber, and pharmacy.
Developmental Disabilities Director