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Perspectives

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

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Pages 2365-2370 | Published online: 20 Aug 2019

References

  • McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemol Rev. 2008;30:67–76. doi:10.1093/epirev/mxn001
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatment s meta-analysis. Lancet. 2013;382:951–962. doi:10.1016/S0140-6736(13)60733-323810019
  • Crilly J. The history of clozapine and its emergence in the US market: a review and analysis. Hist Psychiatry. 2007;18:39–60. doi:10.1177/0957154X0707033517580753
  • Nucifora FC, Mihaljevic M, Lee BJ, Sawa A. Clozapine as a model for antipsychotic development. Neurotherapeutics. 2017;14:750–761. doi:10.1007/s13311-017-0552-928653280
  • Kane J, Honigfeld G, Singer J, et al. Cloazpaine for the treatment-resistant schizophrenic: a double blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988;45:789–796. doi:10.1001/archpsyc.1988.018003300130013046553
  • Curry B, Palmer E, Mounce C, et al. Assessing prescribing practices of clozapine before and after the implementation of an updated risk evaluation and mitigation strategy. Ment Health Clin. 2018;8:63–67. doi:10.9740/mhc.2018.03.06329955547
  • Sayer M, Love R, Freudenreich O, et al. M115: Improving clozapine use in the united states: a survey of barriers and solutions informing a workgroup to devise a national strategy. Schizophr Bull. 2017;43:S252. doi:10.1093/schbul/sbx022.110
  • Kelly DL, Ben-Yoav H, Payne GF, et al. Blood draw barriers for treatment with clozapine and development of a point-of-care monitoring device. Clin Schizophr Relat Psychoses. 2018;12:23–30. doi:10.3371/CSRP.KEBE.07041526218235
  • Himeke C, Bauman P, Bergemann N, et al. AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: update 2011. Pharmacopsychiatry. 2011;44:195–235. doi:10.1055/s-0031-1286287
  • Remington G, Agid O, Foussais G, et al. Clozapine and therapeutic drug monitoring: is there sufficient evidence for an upper threshold? Psychopharmacology. 2013;225:505–518. doi:10.1007/s00213-012-2922-723179967
  • St John A. The evidence to support point of care testing. Clin Biochem Rev. 2010;31:111–119.24150515
  • Price CP, Kricka LJ, Kricka LJ. Improving healthcare accessibility through point-of-care technologies. Clin Chem. 2007;53:1665–1675. doi:10.1373/clinchem.2006.08470717660275
  • US Department of Health and Human Services. Protection of human subjects. 21 CFR 809.3; Revised 4 1, 2018 Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=809.3 Accessed 126, 2018.
  • Van Norma GA. Drugs, devices, and the FDA: part 2: an overview of approval processes: FDA approval of medical devices. JACC Basic Transl Sci. 2016;1:277–287. doi:10.1016/j.jacbts.2016.03.00930167516
  • Center for Medicare and Medicaid Services (CMS). Department of Health and Human Services: Clinical Laboratory Improvement Amendments of 1988 (CLIA):1998.
  • US Food and Drug Administration (FDA) Guidance for industry and FDA staff. Administrative procedures for CLIA categorization. 2017.
  • US Food and Drug Administration (FDA) Guidance for industry and FDA staff. Select updates for recommendations for clinical laboratory improvement amendments of 1988 (CLIA) Waiver Applications for manufacturers of in-vitro diagnostic devices. 2018.
  • US Food and Drug Administration (FDA) Guidance for industry and FDA staff. Recommendations for dual 510(k) and CLIA waiver by application studies. 2018.
  • Goossen RB, Freeman DJ, Satchell AM, Urquhart BL. Monitoring clozapine: are fingerprick blood and plasma clozapine levels equivalent to arm venipuncture blood and plasma levels? Ther Drug Monit. 2003;25:469–472.12883231
  • Ellison JC, Dufresne RL. A review of the clinical utility of serum clozapine and norclozapine levels. Ment Health Clin. 2015;5:68–73. doi:10.9740/mhc.2015.03.068
  • Ben-Yoav H, Chocron SE, Winkler TE, et al. An electrochemical micro-system for clozapine antipsychotic treatment monitoring. Electrochim Acta. 2015;163:260–270. doi:10.1016/j.electacta.2015.02.112
  • Salamone S, Courtney JB, Sard H; Inventors. Saladax Biomedical Inc. Clozapine immunoassay. US patent 8,771,972 B2. 2011 7 8.
  • Siskand D, McCartney L, Goldschlager R, et al. Clozapine vs. first- and second generation antipsychotics in treatment refractory schizophrenia: a systematic review and meta-analysis. Br J Psychiatry. 2016;209:385–392. doi:10.1192/bjp.bp.115.17726127388573
  • U.S. Food and Drug and Administration. FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines. 2015.
  • Bui HN, Bogers JP, Cohen D, Njo T, Herruer MH. Evaluation of the performance of a point-of-care method for total and differential white blood cell count in clozapine users. Int J Lab Hem. 2016;38:703–709. doi:10.1111/ijlh.2016.38.issue-6
  • Bogers JP, Bui H, Herruer M, Cohen D. Capillary compared to venous blood sampling in clozapine treatment: patients’ and healthcare practitioners’ experiences with a point-of-care device. Eur Neuropsychopharmacol. 2015;25:319–324. doi:10.1016/j.euroneuro.2014.11.02225548103
  • Rao LV, Ekberg BA, Connor D, et al. Evaluation of a new point of care automated complete blood count (CBC) analyzer in various clinical settings. Clin Chim Acta. 2008;389:120–125. doi:10.1016/j.cca.2007.12.00618187044
  • Nielsen J, Thode D, Stenager E, et al. Hematological clozapine monitoring with a point-of-care device: a randomized cross-over trial. Eur Neuropsychopharmacol. 2012;22:401–405. doi:10.1016/j.euroneuro.2011.10.00122137859
  • Athelas. Clinical third party accuracy validation of the Athleas device: CBC device compared with venous Sysmex 5000 in POC clinic. Published 81, 2017 Available from: https://athelas.com/a4ab6c781c91ee7290ced2991f4036e9.pdf. Accessed 121, 2018.
  • US Food and Drug Administration (FDA). Guidance for industry and FDA staff. Class II special controls guidance document: premarket notifications for automated differential cell counter for immature or abnormal blood cells. 2001.
  • Rooney KD, Schilling UM. Point of care testing in the overcrowded emergency department-can it make a difference? Crit Care. 2014;18:692–699. doi:10.1186/s13054-014-0692-925672600
  • St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev. 2013;34:61–74.24151342
  • Wang P, Kricka LJ. Current and emerging trends in point-of-care technology and strategies for clinical validation and implementation. Clin Chem. 2018;64:10–14. doi:10.1373/clinchem.2017.28297029158253
  • Guest PC, Martins-de-Souza D. Enabling point-of-care testing and personalized medicine for schizophrenia. NPJ Schizophr. 2017;3:1. doi:10.1038/s41537-016-0005-128560247