{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T09:59:43Z","timestamp":1792144783215,"version":"4.4.0"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Clozapine is an effective medication for treatment-resistant schizophrenia but can cause agranulocytosis. Since its approval, patients taking clozapine have been required to undergo regular blood testing to screen for neutropenia. In 2015, the risk management programs were merged into a single risk evaluation and mitigation strategy (REMS), which mandates that prescribers undergo a certification process in which they attest to understanding the risk of agranulocytosis and commit to performing required blood testing. It is unknown how the clozapine REMS program has affected clinical practice.<\/jats:p><\/jats:sec>Objective<\/jats:title>To understand physicians\u2019 perceptions of and experiences with the clozapine REMS program.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This survey study included US physicians who prescribed clozapine in 2021 or 2022. A 57-question, closed-field questionnaire was administered via paper or online. The first survey wave took place from May to October 2022 and the second from October 2022 to January 2023.<\/jats:p><\/jats:sec>Exposures<\/jats:title>Gender, race and ethnicity, practice specialty, practice setting, practice region, professional time in clinical practice, years since graduation from medical school, and number of patients prescribed clozapine in the past 3 years.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Experiences with and perceptions of the REMS certification process, patient initiation, and the REMS safe use requirements were measured using Likert scales. Descriptive statistics and multivariable modeling were used to analyze the study results.<\/jats:p><\/jats:sec>Results<\/jats:title>Of 750 physicians contacted, 196 responded (30% response rate). Most respondents were male (129 [67%]), most identified as Asian (48 [25%]) or White (124 [63%]), and most were psychiatrists (165 [86%]); almost half (88 [45%]) practiced in an outpatient group setting. Most respondents reported that the information provided during certification was clear (179 [92%]) and contained useful drug information (145 [75%]) and that the paperwork associated with required blood testing facilitated physician-patient conversation (102 [53%]). Most respondents wanted certification materials to include all clinically important risks (172 [89%]) and benefits (139 [72%]) and reported frequent delays in medication access owing to required blood testing (115 [60%]). Two-thirds of respondents agreed that the positives of the certification process (123 [64%]) and blood testing requirements (129 [68%]) outweighed the negatives. In multivariable analysis, negative REMS perceptions were less common among physicians in practice longer (\u226535 vs &amp;lt;15 years since medical school: odds ratio [OR], 0.28; 95% CI, 0.10-0.80) and among American Indian or Alaska Native, Black, and Native Hawaiian or Other Pacific Islander physicians compared with White physicians (OR, 0.08; 95% CI, 0.01-0.73).<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this survey study of physician prescribers of clozapine, a majority were satisfied with the clozapine REMS program but highlighted the need for enhanced educational materials and administrative efficiency.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.59311","type":"journal-article","created":{"date-parts":[[2025,2,13]],"date-time":"2025-02-13T16:11:23Z","timestamp":1739463083000},"page":"e2459311","source":"Crossref","is-referenced-by-count":6,"title":["Physician Experiences With and Perspectives on Clozapine Prescribing"],"prefix":"10.1001","volume":"8","author":[{"given":"Ameet","family":"Sarpatwari","sequence":"first","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"},{"name":"Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhigang","family":"Lu","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimiliano","family":"Russo","sequence":"additional","affiliation":[{"name":"Department of Statistics, The Ohio State University, Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heidi","family":"Zakoul","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su Been","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita A.","family":"Toyserkani","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther H.","family":"Zhou","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"LaCivita","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Hyatt Hawkins Shaw","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald J.","family":"Dal Pan","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"},{"name":"Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2025,2,13]]},"reference":[{"issue":"9","key":"zoi241652r2","doi-asserted-by":"publisher","first-page":"789","DOI":"10.1001\/archpsyc.1988.01800330013001","article-title":"Clozapine for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine.","volume":"45","author":"Kane","year":"1988","journal-title":"Arch Gen Psychiatry"},{"issue":"1","key":"zoi241652r3","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1016\/j.coph.2003.09.010","article-title":"What\u2019s 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