{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T05:12:54Z","timestamp":1788412374915,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,2,20]],"date-time":"2024-02-20T00:00:00Z","timestamp":1708387200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:p>The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS\u2010covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5\u20137) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226\u2009for MM drugs). Although 765 (68%) respondents thought the certification process provided useful drug information, 757 (67%) wanted materials to include benefit data and 944 (84%) non\u2010REMS\u2010related risk data. A majority (704, 63%) thought the safe use requirements facilitated discussion with patients, but a similar number (637, 57%) attributed delayed medication access to these requirements. In multivariable modeling, MM drug and isotretinoin\u00a0respondents were less likely than sodium oxybate respondents to agree that the certification process provided useful drug information (MM drug: odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.25\u20130.55; isotretinoin: OR\u2009=\u20090.39, 95% CI\u2009=\u20090.25\u20130.61), and isotretinoin, clozapine, and bosetan respondents were more likely than sodium oxybate respondents to agree that the safe use requirements often delayed medication access (isotretinoin: OR\u2009=\u20095.83, 95% CI\u2009=\u20093.70\u20139.19; clozapine: OR = 1.65, 95% CI = 1.08\u20132.54; bosentan: OR = 1.78, 95% CI = 1.12\u20132.85). Most physicians believe REMS programs convey useful drug safety information and facilitate discussion with patients but also seek information on benefits and non\u2010REMS\u2010related risks and better integration of REMS processes into clinical workflows.<\/jats:p>","DOI":"10.1002\/cpt.3189","type":"journal-article","created":{"date-parts":[[2024,2,20]],"date-time":"2024-02-20T09:00:55Z","timestamp":1708419655000},"page":"1293-1303","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians"],"prefix":"10.1002","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5043-6206","authenticated-orcid":false,"given":"Ameet","family":"Sarpatwari","sequence":"first","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhigang","family":"Lu","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4953-9341","authenticated-orcid":false,"given":"Massimiliano","family":"Russo","sequence":"additional","affiliation":[{"name":"Harvard Medical School  Boston Massachusetts USA"},{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heidi","family":"Zakoul","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"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's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6946-6138","authenticated-orcid":false,"given":"Gita A.","family":"Toyserkani","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"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, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"LaCivita","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine Hyatt Hawkins","family":"Shaw","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Zendel","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4874-5864","authenticated-orcid":false,"given":"Gerald J.","family":"Dal Pan","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8867-2666","authenticated-orcid":false,"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,20]]},"reference":[{"key":"e_1_2_11_1_1","unstructured":"Pub L No 110\u201385 121 Stat 823 (September 27 2007)."},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1803910"},{"key":"e_1_2_11_3_1","unstructured":"US Food and Drug Administration.Approved Risk Evaluation and Mitigation Strategies<https:\/\/www.accessdata.fda.gov\/scripts\/cder\/rems\/index.cfm>. Accessed December 19 2023."},{"key":"e_1_2_11_4_1","unstructured":"US Department of Health and Human Services Office of Inspector General.FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety<https:\/\/oig.hhs.gov\/oei\/reports\/OEI\u201004\u201011\u201000510.asp> (2023). Accessed December 19 2023."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.17"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2019.1340"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/M22-1743"},{"key":"e_1_2_11_8_1","first-page":"4","article-title":"Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function","volume":"4","author":"Blanchette C.M.","year":"2015","journal-title":"Drugs"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-01017-z"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0288008"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2021.04.009"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2021.04.025"},{"key":"e_1_2_11_13_1","unstructured":"Frysh P.Schizophrenia: is the FDA hindering the most effective med? WebMD<https:\/\/www.webmd.com\/schizophrenia\/features\/schizophrenia\u2010fda\u2010hindering\u2010clozapine> (2021). Accessed December 19 2023."},{"key":"e_1_2_11_14_1","unstructured":"American Association for Public Opinion Research. Standard definitions<https:\/\/aapor.org\/standards\u2010and\u2010ethics\/standard\u2010definitions\/>. Accessed December 19 2023."},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-021-01070-2"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03261984"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004190"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijd.13950"},{"key":"e_1_2_11_19_1","unstructured":"FDA briefing document: risk evaluation and mitigation strategy (REMS) for isotretinoin products \u201ciPLEDGE REMS\u201d. Combined Meeting of the Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee<https:\/\/www.fda.gov\/media\/166485\/download>. Accessed December 19 2023."},{"key":"e_1_2_11_20_1","unstructured":"Stocum L.Nearly two\u2010thirds still locked out of iPLEDGE. Dermatology Times<https:\/\/www.dermatologytimes.com\/view\/nearly\u2010two\u2010thirds\u2010still\u2010locked\u2010out\u2010of\u2010ipledge> (2022). Accessed December 19 2023."},{"key":"e_1_2_11_21_1","unstructured":"American Academy of Dermatology Association.AADA Keeps pressure on IPMG to fix ipledge REMS program<https:\/\/www.aad.org\/member\/publications\/impact\/2022\u2010issue\u20103\/academy\u2010pressures\u2010ipmg\u2010to\u2010fix\u2010ipledge>. Accessed December 19 2023."},{"key":"e_1_2_11_22_1","unstructured":"March 28\u201329. Joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting announcement<https:\/\/www.fda.gov\/advisory\u2010committees\/advisory\u2010committee\u2010calendar\/march\u201028\u201029\u20102023\u2010joint\u2010meeting\u2010drug\u2010safety\u2010and\u2010risk\u2010management\u2010advisory\u2010committee\u2010and\u2010dermatologic>. Accessed December 19 2023."},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.44386"},{"key":"e_1_2_11_24_1","unstructured":"US Food and Drug Administration.Challenges and opportunities for REMS integration innovation and modernization<https:\/\/www.fda.gov\/drugs\/news\u2010events\u2010human\u2010drugs\/challenges\u2010and\u2010opportunities\u2010rems\u2010integration\u2010innovation\u2010and\u2010modernization\u201010112022> (2022). Accessed December 19 2023."},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp0907708"},{"key":"e_1_2_11_26_1","unstructured":"US Food and Drug Administration.Policy for certain REMS requirements during the COVID\u201019 public health emergency guidance for industry and health care professionals<https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/policy\u2010certain\u2010rems\u2010requirements\u2010during\u2010covid\u201019\u2010public\u2010health\u2010emergency\u2010guidance\u2010industry\u2010and> (2023). Accessed December 19 2023."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.3189","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T05:25:25Z","timestamp":1715577925000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.3189"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,20]]},"references-count":26,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1002\/cpt.3189"],"URL":"https:\/\/doi.org\/10.1002\/cpt.3189","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,20]]},"assertion":[{"value":"2023-11-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}