There is life after the UK Clozapine Central Non-Rechallenge Database

Journal article

Ebenezer Oloyede, Cecilia Casetta, Olubanke Dzahini, Aviv Segev, Fiona Gaughran, Sukhi Shergill, Alek Mijovic, Marinka Helthuis, Eromona Whiskey, James Hunter MacCabe and David Taylor 2021. There is life after the UK Clozapine Central Non-Rechallenge Database . Schizophrenia Bulletin. 47 (4), pp. 1088-1098. https://doi.org/10.1093/schbul/sbab006
AuthorsEbenezer Oloyede, Cecilia Casetta, Olubanke Dzahini, Aviv Segev, Fiona Gaughran, Sukhi Shergill, Alek Mijovic, Marinka Helthuis, Eromona Whiskey, James Hunter MacCabe and David Taylor
Abstract

Background and Aims
In the United Kingdom, patients on clozapine whose hematological parameters fall below certain thresholds are placed on the Central Non-Rechallenge Database (CNRD), meaning that they cannot be prescribed clozapine again except under exceptional circumstances. This practice was discontinued in the United States in 2015 by expanding the hematological monitoring guidelines, allowing more patients to receive clozapine. Our objective was to investigate the implications this policy change would have on clozapine utilization in the United Kingdom.

Methods
This was an observational, retrospective analysis of patients registered on the CNRD in a large mental health trust. The first objective was to compare the number of patients placed on the CNRD under the United Kingdom and the US Food and Drug Administration (FDA) criteria. The second objective was to explore the hematological and clinical outcomes of CNRD patients. The third objective was to investigate the hematological outcomes of patients rechallenged on clozapine after nonrechallengeable status.

Results
One hundred and fifteen patients were placed on CNRD from 2002 to 2019, of whom 7 (6%) met the equivalent criteria for clozapine discontinuation under the FDA guidelines. Clinical outcomes, as measured by the Clinical Global Impression-Severity scale, were worse 3 months after clozapine cessation than on clozapine (t = −7.4862; P < .001). Sixty-two (54%) patients placed on CNRD were rechallenged. Fifty-nine of those (95%) were successfully rechallenged; 3 patients were placed back on CNRD, only one of which would have had to stop clozapine again under FDA criteria.

Conclusion
Implementation of the updated FDA’s monitoring criteria in the United Kingdom would significantly reduce clozapine discontinuation due to hematological reasons. The evidence suggests an urgent need for revising the UK clozapine monitoring guidelines to improve outcomes in treatment-resistant schizophrenia.

KeywordsClozapine; Clozapine central non-rechallenge database; Neutropenia; Clozapine rechallenge
Year2021
JournalSchizophrenia Bulletin
Journal citation47 (4), pp. 1088-1098
PublisherOxford Academic
ISSN0586-7614
1745-1701
Digital Object Identifier (DOI)https://doi.org/10.1093/schbul/sbab006
Official URLhttps://academic.oup.com/schizophreniabulletin/article/47/4/1088/6129024
Publication dates
Online05 Feb 2021
PrintJul 2021
Publication process dates
Deposited06 Jun 2023
Output statusPublished
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https://repository.canterbury.ac.uk/item/94w45/there-is-life-after-the-uk-clozapine-central-non-rechallenge-database

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