Clozapine REMS To Transition November 15 - Drug Information Update

Recertification and re-enrollment required to prevent interruption in treatment

If your email program has trouble displaying this email, view it as a web page. Clozapine REMS Requirements Changing November 15, 2021 The U.S. Food and Drug Administration is reminding all stakeholders of the upcoming transition for the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. Beginning November 15, 2021, significant requirements for health care professionals will go into effect. All patients, prescribers, pharmacies, and authorized representatives of pharmacies are required to recertify and re-enroll in the new system to prevent interruptions in treatment due to clerical delays.   FDA approved modifications to the Clozapine REMS on July 29, 2021. Health care professionals who have already recertified and re-enrolled in the new system after August 16, 2021, do not need to take further action. Prescribers, pharmacies, and authorized representatives of pharmacies that have not enrolled by November 15 will not be able to prescribe, dispense, or distribute clozapine.  The modification included other important changes that will take effect on November 15.  Important changes for health care providers:  Patients must be re-enrolled by their prescriber. Patients should contact their prescriber if they have any questions.  A new Patient Status Form is used to document the absolute neutrophil count (ANC) results, monitoring frequency, and appropriateness to continue treatment. To decrease burden on the prescribers and prevent unintended interruptions in treatment for patients due to clerical delays, the requirement to document ANCs will now be submitted monthly via the Patient Status Form. Patient monitoring must still continue per the Prescribing Information.   Important changes for pharmacies:  The REMS administrator has changed, and the current "switch" pharmacy management system is being removed as a method to verify clozapine dispensing. With the changes to the pharmacy management system, pharmacists will no longer use the switch system to obtain a pre-dispense authorization, now called a REMS dispense authorization (RDA). Pharmacists need to obtain an RDA by accessing the Clozapine REMS website or the Clozapine REMS Contact Center.   For complete information on the new Clozapine REMS requirements and to learn more about how to re-certify and re-enroll, please visit the Clozapine REMS website or contact the Clozapine REMS Transition Contact Center at 1-888-586-0758. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA