| If your email program has trouble displaying this email, view it as a web page. |  | Clozapine REMS Requirements Will Change November 15, 2021 oday, the U.S. Food and Drug Administration approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. Beginning November 15, 2021, significant requirements for health care professionalswill go into effect. Re-certification and Re-enrollment required for all stakeholders - Health care professionals prescribing clozapine will be required to re-enroll all patients that are currently prescribed clozapine and continuing treatment into the new Clozapine REMS.
- Health care professionals prescribing clozapine, pharmacists and authorized representatives of pharmacies dispensing clozapine, and wholesalers/distributors distributing clozapine must re-certify or re-enroll in the Clozapine REMS by November 15, 2021, to continue prescribing, dispensing, or distributing the drug.
- Patients will be re-enrolled by their prescriber. Patients should contact their prescriber if they have any questions.
All stakeholders may start to recertify and re-enroll beginning August 16, 2021. Go to the Clozapine REMS website for more information. Important changes for Health care Providers: - 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 a 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. | | | | 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. | | | | |
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