Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes

Shamir N Kalaria,1 Deanna L Kelly21Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, USA; 2Department of Psychiatry, School of Medicine, Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USACorrespondence: Deann...

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Autores principales:	Kalaria SN, Kelly DL
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	clozapine schizophrenia patient outcomes point-of-care testing devices regulatory therapeutic drug monitoring Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/2e45f311c95b432ea81d205bc7dba4ec
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spelling	oai:doaj.org-article:2e45f311c95b432ea81d205bc7dba4ec2021-12-02T05:41:53ZDevelopment of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes1178-2021https://doaj.org/article/2e45f311c95b432ea81d205bc7dba4ec2019-08-01T00:00:00Zhttps://www.dovepress.com/development-of-point-of-care-testing-devices-to-improve-clozapine-pres-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Shamir N Kalaria,1 Deanna L Kelly21Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, USA; 2Department of Psychiatry, School of Medicine, Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USACorrespondence: Deanna L KellyMaryland Psychiatric Research Center (MPRC), 55 Wade Avenue, Catonsville 21228, MD, USATel +1 410 402 6861Email dlkelly@som.umaryland.eduAbstract: Although clozapine has demonstrated superior efficacy in patients with schizophrenia and other serious mental health illness, drug utilization rates are significantly low due to safety concerns and administration challenges. Previous research indicates that current barriers to clozapine use include lack of confidence and knowledge by prescriber, therapeutic monitoring requirements, lack of support and infrastructure to for adequate monitoring and patient adherence, and inadequate understanding of clozapine’s benefit-risk profile by policy makers and payers. One potential solution to optimizing clozapine therapy and improving clinical outcomes is the use of point-of-care testing (POCT) devices. Although the drug development process for currently used therapeutics is widely acknowledged, little is known regarding the development of POCT devices by the clinical community. The aim of this review is to provide a summary of the regulatory approval process and current availability of POCT devices for monitoring clozapine therapeutics. The potential role of POCT devices in clinical trials to inform personalized dosing strategies and improve patient outcomes will also be discussed.Keywords: clozapine, schizophrenia, patient outcomes, point-of-care testing devices, regulatory, therapeutic drug monitoringKalaria SNKelly DLDove Medical Pressarticleclozapineschizophreniapatient outcomespoint-of-care testing devicesregulatorytherapeutic drug monitoringNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 2365-2370 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	clozapine schizophrenia patient outcomes point-of-care testing devices regulatory therapeutic drug monitoring Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	clozapine schizophrenia patient outcomes point-of-care testing devices regulatory therapeutic drug monitoring Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Kalaria SN Kelly DL Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
description	Shamir N Kalaria,1 Deanna L Kelly21Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, USA; 2Department of Psychiatry, School of Medicine, Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USACorrespondence: Deanna L KellyMaryland Psychiatric Research Center (MPRC), 55 Wade Avenue, Catonsville 21228, MD, USATel +1 410 402 6861Email dlkelly@som.umaryland.eduAbstract: Although clozapine has demonstrated superior efficacy in patients with schizophrenia and other serious mental health illness, drug utilization rates are significantly low due to safety concerns and administration challenges. Previous research indicates that current barriers to clozapine use include lack of confidence and knowledge by prescriber, therapeutic monitoring requirements, lack of support and infrastructure to for adequate monitoring and patient adherence, and inadequate understanding of clozapine’s benefit-risk profile by policy makers and payers. One potential solution to optimizing clozapine therapy and improving clinical outcomes is the use of point-of-care testing (POCT) devices. Although the drug development process for currently used therapeutics is widely acknowledged, little is known regarding the development of POCT devices by the clinical community. The aim of this review is to provide a summary of the regulatory approval process and current availability of POCT devices for monitoring clozapine therapeutics. The potential role of POCT devices in clinical trials to inform personalized dosing strategies and improve patient outcomes will also be discussed.Keywords: clozapine, schizophrenia, patient outcomes, point-of-care testing devices, regulatory, therapeutic drug monitoring
format	article
author	Kalaria SN Kelly DL
author_facet	Kalaria SN Kelly DL
author_sort	Kalaria SN
title	Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
title_short	Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
title_full	Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
title_fullStr	Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
title_full_unstemmed	Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
title_sort	development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/2e45f311c95b432ea81d205bc7dba4ec
work_keys_str_mv	AT kalariasn developmentofpointofcaretestingdevicestoimproveclozapineprescribinghabitsandpatientoutcomes AT kellydl developmentofpointofcaretestingdevicestoimproveclozapineprescribinghabitsandpatientoutcomes
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Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes

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