{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T18:22:47Z","timestamp":1770488567781,"version":"3.49.0"},"reference-count":6,"publisher":"American Association of Psychiatric Pharmacists (AAPP)","issue":"2","license":[{"start":{"date-parts":[[2019,9,24]],"date-time":"2019-09-24T00:00:00Z","timestamp":1569283200000},"content-version":"vor","delay-in-days":572,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction:<\/jats:title>\n                  <jats:p>Clozapine is an atypical antipsychotic medication approved for treatment-resistant schizophrenia and suicidal behavior in schizophrenia or schizoaffective disorders. Despite its therapeutic efficacy, clozapine is associated with several adverse effects, including agranulocytosis. In late 2015, the Food and Drug Administration updated the risk evaluation and mitigation strategy (REMS) for clozapine with new requirements for monitoring, prescribing, and dispensing. The purpose of this study was to evaluate clozapine prescribing practices at a Kentucky state psychiatric hospital before and after the implementation of the updated REMS program.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods:<\/jats:title>\n                  <jats:p>The primary outcome of this study was to evaluate clozapine prescribing practices by identifying the number of patients on clozapine therapy in the 6 months pre and post updated REMS implementation. Included in the study were patients at a Kentucky state psychiatric hospital on clozapine therapy for the 24 months before the updated REMS implementation and in the 6-month study period after the implementation. The secondary objective of this study examined psychiatrist comfort level of prescribing clozapine.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results:<\/jats:title>\n                  <jats:p>Since the implementation of the updated REMS program, there has been an increased percentage of patients that were prescribed clozapine at a Kentucky state psychiatric hospital. This increase was not statistically significant (P\u2009=\u2009.2610).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion:<\/jats:title>\n                  <jats:p>The prescribing practices of clozapine within this facility did not differ significantly comparing pre- and post-REMS change in terms of number of patients prescribed clozapine, patient's dose, and therapy duration. Data from this study contributes to the body of knowledge evaluating this new standard of practice under the updated REMS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.9740\/mhc.2018.03.063","type":"journal-article","created":{"date-parts":[[2018,2,26]],"date-time":"2018-02-26T19:12:20Z","timestamp":1519672340000},"page":"63-67","source":"Crossref","is-referenced-by-count":12,"title":["Assessing prescribing practices of clozapine before and after the implementation of an updated risk evaluation and mitigation strategy"],"prefix":"10.9740","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9923-1882","authenticated-orcid":false,"given":"Brent","family":"Curry","sequence":"first","affiliation":[{"name":"(Corresponding author) Clinical Pharmacist, Central State Hospital, Louisville, Kentucky, brent.curry@ky.gov"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7340-2452","authenticated-orcid":false,"given":"Emma","family":"Palmer","sequence":"first","affiliation":[{"name":"Assistant Professor, Sullivan University College of Pharmacy, Louisville, Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5428-3902","authenticated-orcid":false,"given":"Crystal","family":"Mounce","sequence":"first","affiliation":[{"name":"Clinical Pharmacist, KentuckyOne Health \u2013 Jewish Hospital, Louisville, Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5680-0272","authenticated-orcid":false,"given":"Gilbert","family":"Smith","sequence":"first","affiliation":[{"name":"Director of Pharmacy, Central State Hospital, Louisville, Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-9251","authenticated-orcid":false,"given":"Vital","family":"Shah","sequence":"first","affiliation":[{"name":"Associate Hospital Director\/Medical Director, Central State Hospital, Louisville, Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"4719","reference":[{"key":"2020060307264741400_i2168-9709-8-2-63-b01","doi-asserted-by":"publisher","first-page":"102","DOI":"10.1186\/1471-244X-14-102","article-title":"Clozapine: a review of clinical practice guidelines and prescribing trends","volume":"14","author":"Warnez","year":"2014","journal-title":"BMC Psychiatry"},{"issue":"1","key":"2020060307264741400_i2168-9709-8-2-63-b02","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1001\/archpsyc.60.1.82","article-title":"Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial (InterSePT)","volume":"60","author":"Meltzer","year":"2003","journal-title":"Arch Gen Psychiatry"},{"key":"2020060307264741400_i2168-9709-8-2-63-b03","unstructured":"Clozaril (clozapine) tablets, 25 mg [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corp.; 2015Sep. Distributed by Novartis Pharmaceuticals Corp."},{"key":"2020060307264741400_i2168-9709-8-2-63-b04","unstructured":"Medication Guides: Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) [Internet]. Silver Spring (MD): Food and Drug Administration [updated2011Nov]. Available from: https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM244570.pdf"},{"key":"2020060307264741400_i2168-9709-8-2-63-b05","unstructured":"FDA Drug Safety Communication: FDA Modifies Monitoring for Neutropenia Associated with Schizophrenia Medicine Clozapine; Approves New Shared REMS Program for All Clozapine Medicines [Internet]. Silver Spring (MD): Food and Drug Administration; [updated2015Sept 9]. Available from: http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm461853.htm"},{"key":"2020060307264741400_i2168-9709-8-2-63-b06","article-title":"Clozapine REMS still plagued by problems","author":"Smith","year":"2016","journal-title":"Clinical Psychiatry News. [Internet]"}],"container-title":["Mental Health Clinician"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/meridian.allenpress.com\/mhc\/article-pdf\/8\/2\/63\/2184015\/mhc_2018_03_063.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/meridian.allenpress.com\/mhc\/article-pdf\/8\/2\/63\/2184015\/mhc_2018_03_063.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,15]],"date-time":"2024-11-15T16:23:22Z","timestamp":1731687802000},"score":1,"resource":{"primary":{"URL":"https:\/\/mhc.kglmeridian.com\/view\/journals\/mhcl\/8\/2\/article-p63.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,1]]},"references-count":6,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2018,3,1]]}},"URL":"https:\/\/doi.org\/10.9740\/mhc.2018.03.063","relation":{},"ISSN":["2168-9709"],"issn-type":[{"value":"2168-9709","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,1]]}}}