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New Clozapine REMS: Staying Informed for the Novem ...
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The document summarizes the changes regarding the Clozapine REMS (Risk Evaluation and Mitigation Strategy) program, which is designed to ensure the safe use of clozapine, a medication used to treat serious mental illnesses. The program is a collaboration between the American Psychiatric Association (APA) and the Substance Abuse and Mental Health Services Administration (SAMHSA).<br /><br />The document provides information from three presenters: Dr. Robert O. Cotes, an SMI (Serious Mental Illness) physician expert, Donna Rolin, an SMI nurse expert, and Megan Ehret, a pharmacist expert. Dr. Cotes discusses clozapine-induced neutropenia, a potential side effect of clozapine that can cause a decrease in white blood cell count. He explains the mechanisms, incidence rates, and peak occurrence of neutropenia, as well as the condition known as Benign Ethnic Neutropenia (BEN), which is more common in certain ethnic groups.<br /><br />Donna Rolin focuses on the changes in the Clozapine REMS program for prescribers. She explains that prescribers must re-certify with the new program and provides instructions on how to do so. She also discusses the introduction of a new monthly Patient Status Form (PSF) that prescribers must complete for each patient in order to continue their treatment.<br /><br />Megan Ehret discusses the changes in the REMS program for pharmacists. She explains that pharmacies must re-certify by a certain date and obtain a REMS Dispense Authorization (RDA) before dispensing clozapine. She also discusses changes in dispense rationales and certification requirements for pharmacies.<br /><br />Throughout the document, there are references to additional resources and websites for further information on the Clozapine REMS program. The document also includes a question and answer section for presenters to address any inquiries.<br /><br />Overall, the document provides a comprehensive overview of the changes to the Clozapine REMS program and aims to keep prescribers and pharmacists informed about the new requirements and procedures.
Keywords
Clozapine REMS program
Risk Evaluation and Mitigation Strategy
safe use of clozapine
serious mental illnesses
American Psychiatric Association
Substance Abuse and Mental Health Services Administration
clozapine-induced neutropenia
Benign Ethnic Neutropenia
prescribers
pharmacists
Funding for SMI Adviser was made possible by Grant No. SM080818 from SAMHSA of the U.S. Department of Health and Human Services (HHS). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, SAMHSA/HHS or the U.S. Government.
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