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Clozapine Monitoring: Form Follows Function
Abigail L Donovan1,2, Cheryl Y S Foo1,2, Carol Lim1,2
1Psychosis Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston.
Psychiatric Services (Washington, D.C.)
|March 17, 2026
Summary
The clozapine REMS program is gone, allowing for a new monitoring system. This system uses a three-phase framework with shared decision-making for clozapine treatment.
Area of Science:
- Psychiatry and Pharmacology
- Treatment Monitoring Systems
Background:
- The clozapine Risk Evaluation and Mitigation Strategies (REMS) program has been eliminated.
- This elimination creates a need for a revised clozapine monitoring approach.
Purpose of the Study:
- To propose a new conceptual framework for clozapine monitoring.
- To integrate medical and psychiatric care through a phased treatment model.
Main Methods:
- The proposed system is structured into three distinct phases: clozapine trial, treatment optimization, and treatment consolidation.
- Each phase features specific treatment goals and monitoring schedules.
- Shared decision-making involving prescribers, patients, and families/guardians is central to each phase's initiation.
Main Results:
- The new framework facilitates a structured approach to clozapine management.
- Reverse medical-psychiatric integration is incorporated throughout the treatment phases.
- Therapeutic decision points are established for evaluating treatment options.
Conclusions:
- The proposed three-phase monitoring system offers a structured alternative to the previous clozapine REMS program.
- This model emphasizes integrated care and patient-centered decision-making for clozapine therapy.
- The framework supports optimized and consolidated clozapine treatment.
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