Keeping Up with Clozapine REMS: A Guide to Navigating the November 15 Changes-Presentation and Q&A

Video Transcription

Video Summary

The video is a webinar discussing the changes to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) that will occur on November 15th. The webinar is led by Dr. Rob Cotez, Dr. Jonathan Meyer, Dr. Donna Rowland, and Dr. Ray Love. The speakers explain that prescribers, patients, and pharmacies will need to go through a re-enrollment process in the new REMS system. They discuss the steps and requirements for prescriber recertification, patient enrollment, and the use of the new monthly patient status form. They also explain the process for obtaining REMS dispense authorizations and the limitations on overrides for pharmacists. The speakers acknowledge some challenges and concerns with the new system, including the need for more clarity on certain aspects and the potential impact on patient access to medication. They mention that various organizations have provided feedback to the FDA and the Clozapine Product Manufacturers Group requesting changes to the REMS system, including the possibility of delaying the implementation date. The webinar provides information and guidance to clinicians on what they need to do to navigate the upcoming changes to the Clozapine REMS.

Keywords

webinar

Clozapine REMS

changes

re-enrollment process

prescriber recertification

patient enrollment

monthly patient status form

REMS dispense authorizations

limitations on overrides

challenges