Course Description
With the FDA’s REMS program removed, the responsibility for clozapine monitoring now lies fully with clinicians. This session covers the rationale for ANC monitoring, practical strategies for managing neutropenia, and how to adjust to post-REMS requirements. Learn how to maintain patient safety while minimizing unnecessary barriers and stay ahead of regulatory changes with up-to-date, practical guidance.
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 and 6 other ACPE, AMA, ANCC, and AAPA accredited modules.
Learning Objectives
- Explain the rationale for ANC monitoring and its role in clozapine safety.
- Identify strategies for managing neutropenia in clozapine-treated patients.
- Discuss changes in clinical practice following the removal of the REMS program.
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
Deanna L. Kelly, PharmD, BCPP | Dr. William and Carol Carpenter Professor of Psychiatry for Mental Illness Research Director, Maryland Psychiatric Research Center (MPRC) University of Maryland School of Medicine
Dr. Deanna L. Kelly is an internationally recognized expert, researcher and clinician specializing in new treatments for people with severe mental health conditions. With 28 years of experience in clinical trials, particularly in people with psychotic disorders and schizophrenia, Dr. Kelly has led the field of psychiatry with studying more holistic science-based approaches with dietary interventions and supplemental treatments.
She is one of the leading experts in understanding the role of gluten and mental health, studies the gut microbiome in connection to brain function and behavior, has tested anti-inflammatory dietary interventions for improving psychiatric symptoms such as luteolin, prebiotics, ashwagandha, and gluten free diets and is helping to advance the field of metabolic psychiatry with advocating and studying ketogenic diets for mental health conditions. She strongly believes that diet has the potential to help improve mental health conditions and has NIH funded science demonstrating her results. She is also an expert in the use of an underused medication clozapine with over 50 publications, national advocacy and has briefed both Congress and the Food and Drug Administration on this topic. Dr. Kelly is the Dr. William and Carol Carpenter Professor of Psychiatry for Mental Illness Research at University of Maryland Baltimore School of Medicine. She is also the Director of the prestigious Maryland Psychiatric Research Center located in Baltimore, Maryland. She is a graduate of Duquesne University School of Pharmacy where she earned both her Bachelor’s degree and doctorate. She is currently board certified in psychiatric pharmacy practice. With over 250 published peer reviewed scientific papers, 20 books and chapters and over 200 invited lectures under her belt, she has helped to shape treatment guidelines and evidence-based care in schizophrenia. She has been awarded the Maltz Prize for Innovative and Promising Schizophrenia Research by the Brain and Behavior Research Foundation, the Judith J. Saklad Memorial Award by the American Association of Psychiatric Pharmacists (AAPP) and named one of Maryland’s Top 100 Women. Additionally, she has been given several other honors such as the G. Van Greene Distinguished Lecturer at Mercer University, fellow of the American College of Neuropsychopharmacology (ACNP) and designated a prominent MPower Professor in Maryland. Additionally, her work and scientific expertise has been featured in the New York Times, National Geographic, National Public Radio (NPR) online, Women’s Day Magazine, Gluten-Free Living, MedPage Today, the Daily News, Vice Media, Clinical Psychiatry News, Psychiatric News, Metabolic Mind, and Medscape Medical News. She is an author on the soon to be released book on gluten and mental health, Get Your Brain off Grain.
Course Requirements
To receive ACPE credit for this session, you must:
- Register for this course.
- Complete the pre-test (if applicable) before starting the activity.
- Review the full content of the activity and reflect upon its teachings.
- Complete the post-test at the end of the activity no later than the closing activity date.
- Complete the evaluation at the end of the activity.
- If necessary, complete the post-test retest no later than the closing activity date.
- Receive a passing grade (70%).
- Provide the necessary details in your profile to ensure correct reporting by AAPP to CPE Monitor.
Continuing Education Credit and Disclosures
Activity Dates: 11/3/2025-11/3/2027
 | Pharmacist ACPE Contact Hours: 0.5 ACPE Number: 0284-9999-25-043-H01-P (Knowledge) |
| The American Association of Psychiatric Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. |
| Jointly Accredited Provider | ||
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| In support of improving patient care, this activity has been planned and implemented by CME Outfitters, LLC, and American Association of Psychiatric Pharmacists. CME Outfitters is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. | ||
- This activity was planned by and for the healthcare team, and learners will receive 1.0 Interprofessional Continuing Education Credit for learning and change.
- Physicians (ACCME): CME Outfitters, LLC, designates this internet point-of-care activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
- Nurses (ANCC): This activity is designated for 1.0 contact hours.
- All other healthcare professionals may receive a Certificate of Participation stating this activity was certified for AMA PRA Category 1 Credit™.
View CMEO Credit Claiming Process
At the end of the course, you will be provided with the activity’s evaluation link and print your certificate or statement of credit. Credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately. This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit https://www.cmeoutfitters.com/privacy-and-confidentiality-policy
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:
- Deanna L. Kelly, PharmD, BCPP discloses: Speakers Bureau - AbbVie, Alkermes, Axsome, BMS, ITCI, Luye, Neurocrine, Teva; Consultant - AbbVie, Alkermes, Axsome, BMS, ITCI, Luye, Neurocrine, Teva
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.