Avery Risinger, PharmD; Nicole Gramlich, PharmD, BCPP; Courtney Iuppa, PharmD, BCPP; Carrie Kriz, MS; Ellie S. R. Elliott, PharmD, BCPP, FAAPP; Dayton L. Antley, PharmD, BCPS, BCPP
Since FDA (Food and Drug Administration) approval in 1990, clozapine has become the first line agent for treatment resistance schizophrenia (TRS).1,2
While it offers superior efficacy compared to other antipsychotics, clozapine carries risk of adverse reactions such as agranulocytosis, myocraditis, seizures, and severe constipation.3,4
Manufacturer-led systems were utilized to monitor for agranulocytosis until 2015 when the centralized risk evaluation and mitigation strategy (REMS) programs was approved. Though implemented with safety in mind, REMS prevented many patients and prescribers from considering clozapine as an option for TRS.4
Enrollment requirements, laboratory delays, monitoring frequency, and transportation hindered access to treatment, leading some to conclude that the adminsitrative burdens related to clozapine outweigh its potential benefits.5
Various studies reinforced that risk of agranulocytosis sharply declines after a few months of treatment.5-9 Another study suggested that adherence to monitoring improves with reduction in frequency.10
Consideration of these and other results led to further discussion of REMS requirements. An FDA panel convened in November of 2024 and ultimately voted to abolish the program effective February of 2025.11
While the package insert has not changed and risks remain, the hope is that removing some of the administrative burden associated with REMS will improve patient access to clozapine.
We do not yet have quantifiable data to determine whether prescribing rates have changed following REMS removal. Therefore, this study sought to survey clinical pharmacists for an early assessment of process improvement and recommendations for clozapine management in the post-REMS era.
Perceived changes in clozapine treatment process for patients and treatment team following REMS removal.
Assess clinical pharmacists' perspective on changes in clozapine access.
Assess clinical pharmacists' perception of patient safety changes since REMS removal.
Assess the perceived impact of clozapine REMS removal on workflow.
Assess institutional changes resulting from REMS program removal.
Assess any areas of concern regarding program removal.
Assess the reported confidence level of the clinical pharmacist and care team in managing clozapine.