Prevalence and frequency of haematological testing in patients initiating clozapine in the USA

Katsiaryna Bykov1, Mufaddal Mahesri2, Krista F Huybrechts2

  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA kbykov@bwh.harvard.edu.

BMJ Mental Health
|July 10, 2026
PubMed

Insights

Hematological testing for clozapine initiation was underutilized before treatment and in the first six months. Testing rates improved after six months, aligning with recommendations.

Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacy
  • Health Services Research

Background:

  • Clozapine initiation in the USA previously mandated the Clozapine Risk Evaluation and Mitigation Strategy (REMS) for haematological testing.
  • Despite REMS elimination in June 2025, clinical guidelines for clozapine testing persist.
  • Adherence to clozapine testing protocols in real-world practice remains under-examined.

Purpose of the Study:

  • To determine the prevalence and frequency of haematological testing in patients prescribed clozapine.
  • To evaluate testing rates before clozapine initiation and during the initial 24 months of therapy.

Main Methods:

  • A retrospective cohort study analyzed data from three US health insurance claims databases (2000-2022).
  • Assessed the proportion of patients with pre-initiation testing (within 60 days) and testing frequency (tests per 30 days) during the first 24 months of clozapine treatment.
  • Identified tests using billing codes; assumed hospitalized patients received testing.

Main Results:

  • Out of 62,003 clozapine initiations, 71% had pre-initiation testing.
  • Mean testing rates were 2.2 tests/30 days (months 0-6), 2.0 tests/30 days (months 7-12), and 1.5 tests/30 days (months 13-24).
  • Testing rates were lower than expected before initiation and during the first six months of therapy.

Conclusions:

  • Haematological testing adherence before clozapine initiation and in early treatment phases was suboptimal.
  • Testing frequency met recommendations in later treatment stages (after 6 months).
  • Further investigation is needed to understand the reasons for underutilization of recommended clozapine testing, particularly in the initial treatment period.
Abstract

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