Safer use of clozapine

Taylor, David

doi:10.1111/acps.13427

Cited by 1 publication

(1 citation statement)

References 18 publications

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“…A recent meta-analysis reported the cumulative incidence of neutropenia as 0.3 to 0.4 cases per 100 person-years of exposure, and other studies have reported similar findings, questioning the current standard of hematologic regulation 35,39 . In addition, mild to moderate neutropenia does not predict the progression to life-threatening neutropenia and life-threatening neutropenia may be overestimated 40,41 . Ongoing hematologic monitoring beyond 6 months may not be an evidence-based practice and the Netherlands Clozapine Collaboration Group has suggested that stopping hematologic monitoring after the first 6 months of clozapine treatment could be considered when a “mentally competent and adequately informed patient explicitly wants to stop having routine blood tests.” The group still recommends low-frequency (eg, quarterly) hematologic monitoring with resumption of monitoring if neutropenia is suspected 42 .…”

Section: Clozapine and Remsmentioning

confidence: 99%

The Modernization of Clozapine

Leung

León²,

Frye

et al. 2022

J Clin Psychopharmacol

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Purpose: Although clozapine was Food and Drug Administration (FDA) approved more than 3 decades ago, major barriers and gaps in knowledge continue to prevent its effective and safe use. We review modern-day problems encountered with clozapine in the United States (US).Methods: Information surrounding current administrative, clinical, research, and technological gaps or barriers related to clozapine use in the US was reviewed. Findings:The history of how clozapine became FDA approved likely contributes to gaps in knowledge. The frequency of safety warnings added to the FDA prescribing information may add to fears about clozapine, as evidence by numerous published survey studies. The clozapine Risk Evaluation and Mitigation Strategy (REMS) program has been modified several times in the last decade, causing access and safety issues for patients, which are discussed. Evidence may suggest that the FDA REMS requirements for hematologic monitoring are too cumbersome, and there may be ability to safely loosen requirements. The COVID-19 pandemic brought forth the ability for extended interval monitoring but also greater awareness of the clozapine-inflammation interaction. Newer guidelines published describe considerations in personalizing clozapine titration based on principles of ethnopsychopharmacology. Emerging technologies to support the use of clozapine are not widely available.Implications: Clozapine is a unique life-saving drug but it is underused in the US, despite its established efficacy. The 2021 REMS changes led to significant difficulties for providers and patients. We highlight the importance of the clozapine-inflammation interaction, therapeutic drug monitoring, and the ability for individual care based on patient-specific factors. There is an urgent need for advancing technology used for clozapine monitoring, evaluating barriers created by REMS, and establishing consistent practices throughout the US.

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Section: Clozapine and Remsmentioning

confidence: 99%