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

Presentation Slides

Pdf Summary

The document discusses the changes in the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program and provides guidance for prescribers and pharmacists on navigating these changes. The Clinical Support System for Serious Mental Illness (CSS-SMI), funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) and implemented by the American Psychiatric Association (APA), is responsible for the initiative. The document includes information on faculty members involved in the initiative, their disclosures, and learning objectives for participants.<br /><br />The content covers various aspects of the Clozapine REMS changes. It begins with a discussion on severe neutropenia due to clozapine, including hypothesized mechanisms, risk factors, and team-based management strategies for managing neutropenia in patients. It highlights the concept of Benign Ethnic Neutropenia (BEN) and its association with lower ANC values in certain ethnic groups.<br /><br />The document also provides details on ANC monitoring recommendations for patients with BEN, including specific ANC ranges and treatment recommendations for BEN patients. It discusses the history and genetics of BEN, as well as its association with African heritage and the DARC genetics.<br /><br />The guide further delves into the new requirements for prescribers and pharmacists participating in the Clozapine REMS. It emphasizes the need for prescribers to re-certify, add designees, and re-enroll patients. It introduces the Monthly Patient Status Form, which is now required for each patient and summarizes the changes and actions required for prescribers.<br /><br />For pharmacists, the document discusses the need for re-certification, obtaining a REMS Dispense Authorization (RDA) prior to dispensing clozapine, and the changes in the Dispense Rationale requirements. It also mentions the improved search feature to find participating pharmacies.<br /><br />Overall, the document aims to provide guidance and clarification on the changes in the Clozapine REMS program and offers a comprehensive overview of the requirements and actions needed by prescribers and pharmacists.

Keywords

Clozapine Risk Evaluation and Mitigation Strategy

REMS program changes

prescriber guidance

pharmacist guidance

Clinical Support System for Serious Mental Illness

severe neutropenia management

Benign Ethnic Neutropenia

ANC monitoring recommendations

prescriber re-certification

REMS Dispense Authorization