Course Description
Despite its proven efficacy, clozapine remains dramatically underutilized. This session examines why through historical context, landmark trials, and systemic barriers like the former REMS program. Learners will explore how clozapine management has evolved and what it will take to change current practice patterns. Leave with a renewed perspective on clozapine’s critical role in treating serious mental illness.
***There is NO continuing education credit associated with this activity.***
This is one of seven modules in the A New Era in Clozapine Management educational series. Complete your complimentary registration now to access this module. The other 6 modules are ACPE, AMA, ANCC, and AAPA accredited.
Learning Objectives
- Identify historical and systemic factors that contributed to the underutilization of clozapine in the U.S.
- Discuss the impact of landmark trials on shaping clozapine’s clinical role, focusing on outcomes and safety monitoring.
- Explain the history and regulatory impact of the clozapine REMS program, including the policy implications of its removal.
Target Audience
We invite you to participate in this online course if you are a pharmacist, physician, nurse practitioner, physician assistant, nurse, or other health care professional involved in the care of individuals with serious mental illness.
Faculty
View biographical information
John M. Kane, MD | Co-Director, Institute of Behavioral Science, Feinstein Institutes for Medical Research Professor, Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
John M. Kane, MD served as chair of psychiatry for 34 years at the Zucker Hillside Hospital and is currently the Co-Director of the Institute of Behavioral Research at the Feinstein Institutes for Medical Research. He also served as the inaugural chair of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell for 12 years. He is the recipient of many awards, including the Lieber Prize, the APA’s Kempf Award and Foundations Prize, the New York State Office of Mental Health Lifetime Achievement Award, The Dean Award from the American College of Psychiatrists. He has served as President of the American Society of Clinical Psychopharmacology, the Psychiatry Research Society and the Schizophrenia International Research Society. Dr. Kane has been the principal investigator on 24 U.S. National Institutes of Health grants focusing on schizophrenia, psychobiology and treatment, recovery, and improving the quality and cost of care. He is the author of over 930 peer-reviewed papers and serves on the editorial boards of numerous journals.
Continuing Education Credit and Disclosures
***There is NO continuing education credit associated with this activity.***
Activity Dates: 11/3/2025-11/3/2027
View CME Outfitters disclosure declaration
Disclosure Declaration: It is the policy of CME Outfitters, LLC to ensure independence, balance, objectivity, and scientific rigor, and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.
View faculty, program planning committee, and reviewers disclosures of interest
Faculty for This Clozapine Module:
- John M. Kane, MD discloses: Grant support – Lundbeck, Janssen, Otsuka, Sunovion; Consultant – AbbVie, Alkermes, Allergan, Boehringer-Ingelheim, Bristol Meyer-Squibb, Cerevel, Click Therapeutics, Dainippon Sumitomo, H. Lundbeck, HealthRhythms, HLS Therapeutics, Indivior, Intracellular Therapies, Janssen Pharmaceutical, Johnson & Johnson, LB Pharmaceuticals, Mapi, Maplight, Merck, Minerva, Neurocrine, Newron, Novartis, NW PharmaTech, Otsuka, Roche, Saladax, Sunovion, Teva, Terran; Shareholder (directly purchased) - LB Pharmaceuticals, Inc., North Shore Therapeutics (private/stock); Vanguard Research Group (private); NW Pharmatech, Saladax, Reviva, Terran, MedicCell
Planning Committee:
- Andria F. Church, PharmD, BCPP (AAPP) has nothing to disclose
- Candice Gillett, MPH (CMEO) has nothing to disclose
Peer Reviewers and Content Reviewers:
- Content Reviewer (AAPP) - Beth DeJongh, PharmD, FAAPP, BCPP, BCPS has nothing to disclose
- Content Reviewer (CMEO) - Scott J. Hershman, MD, FACEHP, CHCP has nothing to disclose
- Peer Reviewer - Kristen Choi, PhD, PMHNP-BC, FAAN has nothing to disclose
- Peer Reviewer - Chad Koyanagi, MD has nothing to disclose
- Peer Reviewer - Michael Shuman, PharmD, BCPP has nothing to disclose
Disclosures were obtained from the CME Outfitters, LLC staff: Nothing to disclose.
*All identified conflicts of interest have been mitigated.
AAPP owns the copyright, is licensed or has received permissions for use of, or is otherwise permitted to use copyrighted materials within any CPE activity. Authors and speakers are required to obtain necessary copyright permissions for content in CPE activities. AAPP complies with copyright laws and regulations.
View disclaimer and disclosure of off-label use
Unlabeled Use Disclosure: Faculty of this CME/CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. CME Outfitters, LLC, the faculty, planners, and American Association of Psychiatric Pharmacists do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.
Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
View fair balance and integrity statement
It is the policy of AAPP to ensure independence, balance, objectivity, scientific rigor, and integrity in continuing education activities. Those involved in the development of this continuing education activity have made all reasonable efforts to ensure that information contained herein is accurate in accordance with the latest available scientific knowledge at the time of accreditation of this continuing education activity. Information regarding drugs (e.g., their administration, dosages, contraindications, adverse reactions, interactions, special warnings, and precautions) and drug delivery systems is subject to change, however, and the reader is advised to check the manufacturer’s package insert for information concerning recommended dosage and potential problems or cautions prior to dispensing or administering the drug or using the drug delivery systems.
Fair balance is achieved through ongoing and thorough review of all materials produced by faculty, and all educational and advertising materials produced by supporting organizations, prior to educational offerings. Approval of credit for this continuing education activity does not imply endorsement by AAPP for any product or manufacturer identified.