Description 

The FDA recently eliminated the Clozapine Risk Evaluation and Mitigation Strategies (REMS), removing the expectation from prescribers to report results of Absolute Neutrophil Count (ANC) blood tests before pharmacies dispense clozapine. Eliminating the REMS has left many clozapine stakeholders with questions about what this means for their practice, for pharmacies, for insurance companies, and for their patients and families. Join us as we bring together a panel of experts, including leading psychiatrists and pharmacy leaders, to discuss how we continue to make clozapine accessible and what are best practices for monitoring. There will be time for questions.

Format 

Recorded webinar

Learning Objectives 

• Gain clarity on the FDA’s decision to eliminate the Clozapine Risk Evaluation and Mitigation Strategies (REMS).
• Discuss how the removal of REMS affects prescribing practices for psychiatrists and other healthcare professionals.
• Explore the potential challenges and benefits of this change for patient monitoring and treatment plans.

Target Audience 

Medical Students, Residents/Fellows, Psychiatrists, and other mental health professionals

Estimate Time to Complete 

Estimated Duration: 1.0 hour
Program Start Date: March 13, 2025
Program End Date: March 13, 2028

How to Earn Credit

Participants who wish to earn a certificate of participation may do so by completing all sections of the course including the evaluation. After evaluating the program, course participants will be provided with an opportunity to print a certificate of participation showing the event date and hours earned.

Faculty and Planner Disclosures 

The American Psychiatric Association adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME activity — including faculty, planners, reviewers or others — are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. 

Instructors 

• Robert O. Cotes, M.D., is a Professor in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine. He is founder and Co-Director of the Clinical & Research Program for Psychosis at Grady Health System. He was Co-Director of the SMI Adviser Clozapine Center of Excellence from 2020-2024 and serves as Editor-In-Chief of Community Mental Health Journal. His research focuses on clozapine, cardiometabolic side effects of antipsychotic medication, other pharmacologic and psychosocial interventions for people with schizophrenia, and understanding the potential for digital biomarkers in mental health.
• Megan J. Ehret, PharmD, M.S., BCPP, FAAPP is Professor, Vice-Chair of Academic Affairs, and Co-Director of the Mental Health Program at the University Of Maryland School Of Pharmacy with a practice site at The University of Maryland Mid Town Campus. Additionally, she also has the privilege of working with the State of Maryland Medicaid Program in evaluating antipsychotic use in the state, including development of clinical criteria for antipsychotics and authorizing and reviewing psychotropic use in the pediatric population. She is a Past-President of AAPP and is the current BCPP Recertification Director. Dr. Ehret has worked with the State of Maryland to establish regulations permitting community pharmacists the authority to administer maintenance injections. She has developed an interactive training program for students in administering long-acting injectable medications.
• Raymond C. Love, PharmD, BCPP, FASHP, FAAPP is Professor Emeritus at the University of Maryland School of Pharmacy and a consultant to the National Association of State Mental Health Program Directors. Dr. Love has been working with clozapine since before its FDA approval in the United States and published numerous articles on its use. Most recently, Dr. Love has played an integral role in organizing stakeholder groups who sought changes to or elimination of the Clozapine REMS.
• Stephen R. Marder, M.D., is a Professor of Psychiatry, and the Director of the Section on Psychosis at the UCLA Semel Institute for Neuroscience and Human Behavior. He is also the Director of the VISN 22 Mental Illness Research, Education Clinical Center (MIRECC) for the Department of Veterans Affairs. Dr. Marder’s research has focused on improving the lives of individuals with psychotic disorders, particularly schizophrenia. His research -- supported by the VA, the Brain and Behavior Research Foundation, and the National Institute of Mental Health -- has focused on the development of pharmacological, psychosocial, and rehabilitation approaches for improving functioning and quality of life.

Planners  

• Vishal Madaan, MD.
• Amy Cohen, PhD.

Accessibility for Participants with Disabilities 

The American Psychiatric Association is committed to ensuring accessibility of its website to people with disabilities. Please contact the American Psychiatric Association at 202-559-3900, if you require assistance seven (7) business days prior to the start of a live webinar. 

Technical Requirements 

This internet-based CME activity is best experienced using any of the following: 

• The latest and 2nd latest public versions of Google Chrome, Mozilla Firefox, or Safari 
• Internet Explorer 11+ 

This Web site requires that JavaScript and session cookies be enabled. Certain activities may require additional software to view multimedia, presentation, or printable versions of the content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Acrobat Reader, Microsoft PowerPoint, and Windows Media Player. 

Optimal System Configuration: 

• Browser: Google Chrome (latest and 2nd latest version), Safari (latest and 2nd latest version), Internet Explorer 11.0+, Firefox (latest and 2nd latest version), or Microsoft Edge (latest and 2nd latest version) 
• Operating System: Windows versions 8.1+, Mac OS X 10.5 (Leopard) +, Android (latest and 2nd latest version), or iOS/iPad OS (latest and 2nd latest version) 
• Internet Connection: 1 Mbps or higher 

Minimum Requirements: 

• Windows PC: Windows 8.1 or higher; 1 GB (for 32-bit)/2 GB (for 64-bit) or higher RAM; Microsoft DirectX 9 graphics device with WDDM driver; audio playback with speakers for programs with video content 
• Macintosh: Mac OS X 10.5 or higher with latest updates installed; Intel, PowerPC G5, or PowerPC G4 (867MHz or faster) processor; 512 MB or higher RAM; audio playback with speakers for programs with video content 

For assistance: Contact educme@psych.org for questions about this activity | Contact learningcenter@psych.org for technical assistance