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There Is Life After the UK Clozapine Central Non-Rechallenge Database

Oloyede, Ebenezer, Casetta, Cecilia, Dzahini, Olubanke, Segev, Aviv, Gaughran, Fiona, Shergill, Sukhi S., Mijovic, Alek, Helthuis, Marinka, Whiskey, Eromona, MacCabe, James Hunter, and others. (2021) There Is Life After the UK Clozapine Central Non-Rechallenge Database. Schizophrenia Bulletin, 47 (4). pp. 1088-1098. ISSN 0586-7614. (doi:10.1093/schbul/sbab006) (Access to this publication is currently restricted. You may be able to access a copy if URLs are provided) (KAR id:96368)

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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.

Item Type: Article
DOI/Identification number: 10.1093/schbul/sbab006
Uncontrolled keywords: clozapine, clozapine central non-rechallenge database, neutropenia, clozapine rechallenge
Subjects: R Medicine
Divisions: Divisions > Division of Natural Sciences > Kent and Medway Medical School
Depositing User: Rachael Heller
Date Deposited: 28 Sep 2022 08:40 UTC
Last Modified: 29 Sep 2022 09:45 UTC
Resource URI: (The current URI for this page, for reference purposes)

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