Modifications to the Clozapine Risk Evaluation and Mitigation Strategy go into effect November 15, 2021. Are you up to date?
Beginning November 15, 2021, new US Food and Drug Administration (FDA)-approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) will go into effect. These changes hope to ensure that the benefits of clozapine outweigh the risk of severe neutropenia.
The Clozapine REMS focuses on appropriate management and monitoring of clozapine-induced severe neutropenia. Additionally, it provides a centralized system for prescribers and pharmacists in managing patient risk, no matter which clozapine product is being used.
"The purpose of this new Clozapine REMS Program is to ensure that the benefits of a patient taking clozapine are greater than the potential life threatening risk of severe neutropenia, a well established rare adverse event," said John J. Miller, MD, Editor in Chief of Psychiatric TimesTM.
Of the modifications, there are 2 key changes of which to be aware:
1) Pharmacies will no longer be able to use telecommunication verification, also known as the switch system, to verify safe use conditions for clozapine. Pharmacists will need to go to www.clozapinerems.com or call the Clozapine Contact Center directly to verify information and obtain a REMS dispense authorization.
2) There is a new patient status form to document monitoring for all outpatients, which must be submitted monthly.
To participate in the new Clozapine REMS, health care professionals who prescribe clozapine therapy will need to recertify and re-enroll all patients continuing on clozapine treatment in the Clozapine REMS program by November 15, 2021.
Recertification of prescribers and reenrollment of patients must be done with the revised Clozapine REMS materials, found on the site, www.clozapinerems.com. Prescribers must create new login credentials, review the Prescriber Training, complete and submit the Knowledge Assessment and Prescriber Enrollment Form to become recertified. Patients can then be reenrolled using the appropriate Patient Enrollment Form.
A Transition Contact Center is available at 888-586-0758 to answer questions about recertification and reenrollment.
1. US Food and Drug Administration. Frequently asked questions | Clozapine REMS modification. Updated July 29, 2021. Accessed September 16, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/frequently-asked-questions-clozapine-rems-modification?utm_medium=email&utm_source=govdelivery