Today—Monday, November 15—is the last day for physicians and pharmacies to recertify in the updated Clozapine Risk Evaluation and Mitigation Strategy (REMS), a safety program required by the Food and Drug Administration (FDA) to manage patients’ risk of neutropenia associated with clozapine treatment. Physicians must also re-enroll all their clozapine patients in the REMS program by today’s deadline. After today, noncertified prescribers and pharmacies will no longer be able to receive or dispense clozapine.
Clozapine is an effective medication for treating patients with refractory schizophrenia, but in rare instances the medication can lead to a rapid and severe loss of neutrophils (a type of white blood cell). This loss of neutrophils can potentially lead to fatal infections; thus, patients taking clozapine must undergo regular blood testing. The FDA’s REMS program ensures that physicians/pharmacies that dispense clozapine understand and can manage these risks.
In July the FDA approved modifications to the Clozapine REMS, which necessitated the recertification and reenrollment process. Among the important changes:
- Physicians must use a new patient status form to document neutrophil monitoring for all patients prescribed clozapine and submit the form to REMS monthly. The new form also requires physicians to submit neutrophil results for patients who have recently discontinued clozapine.
- Pharmacies will no longer be permitted to use telecommunication to verify a patient can use clozapine safely. Instead, they must obtain authorization to dispense either through the Clozapine Call Center (888-586-0758) or online at www.clozapineREMS.com.
To recertify and re-enroll patients in the Clozapine REMS, visit https://www.newclozapinerems.com. More information on the changes for prescribers is posted at cpmg-prchanged-whats changed prescriber v00_04 clean.pdf.
Help Push the 988 Crisis Hotline Over the Finish Line
A dedicated phone number for individuals in crisis or experiencing suicidal thoughts—988—goes into effect July 16, 2022, but many states are not prepared for its implementation, putting people’s lives at stake. Join APA and other coalition organizations for “REIMAGINE: A Week of Action to Reimagine Our National Response to People in Crisis” this week to learn about what needs to be done to ensure that the 988 crisis hotline is implemented across the nation. Free, virtual events are being held throughout the week; they will highlight personal stories and how to coordinate federal and state advocacy efforts to establish and fully fund a more effective crisis response. Register today and join in the effort to build a better, more equitable crisis system for all people in this country.