{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T02:44:55Z","timestamp":1791945895162,"version":"4.3.4"},"reference-count":17,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T00:00:00Z","timestamp":1789862400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T00:00:00Z","timestamp":1789862400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To help ensure that a drug's benefits outweigh its risks, the US Food and Drug Administration may require a Risk Evaluation and Mitigation Strategy (REMS) program with requirements such as laboratory tests or special education. Since physicians are often responsible for REMS testing or education, it is critical to understand how they view the implementation of REMS programs. This study aimed to assess physicians' understanding of REMS programs, perception of the programs' value, and preferences for risk communication.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Between April 2022 and June 2023, we conducted approximately 1 h semi\u2010structured interviews with 50 physicians\u20146 to 9 per drug\u2014experienced with REMS programs covering the following drugs: alemtuzumab, ambrisentan, clozapine, isotretinoin, lenalidomide\/pomalidomide\/thalidomide, pegvaliase, and sodium oxybate. We used qualitative content analysis to code the transcript interviews.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Most physicians were knowledgeable about REMS\u2010related risks but expressed concern about side effects of the drugs not covered by the REMS programs. In the REMS certification process, physicians valued learning information about the clinical use of the drugs and monitoring algorithms intended to keep patients safe. Some physicians reported informational gaps in REMS enrollment forms, and several desired integration of REMS programs with electronic medical records (EMRs). Physicians preferred to learn about REMS programs via electronic communications that include a summary of the drug's benefit\u2013risk profile and REMS obligations, as well as accessible links to clinical trial results and scientific articles. Physicians also recommended that REMS\u00a0materials be updated in a timely fashion as new safety data emerge.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>While physicians largely expressed awareness of REMS testing requirements and found REMS programs to be valuable sources of risk communication, they would like more information on managing side effects, more accessible information on REMS requirements, integration of REMS programs with EMRs, and timely updates to REMS materials as new safety information emerges.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70476","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:28Z","timestamp":1789948828000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-3022-9013","authenticated-orcid":false,"given":"Heidi","family":"Zakoul","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2948-024X","authenticated-orcid":false,"given":"Carol","family":"Cosenza","sequence":"additional","affiliation":[{"name":"Center for Survey Research University of Massachusetts Boston  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 and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0469-2655","authenticated-orcid":false,"given":"Winta","family":"Tekle","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariel","family":"Freedman","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti","family":"Belitkar","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita A.","family":"Toyserkani","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate Heinrich","family":"Oswell","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"LaCivita","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States 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":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameet","family":"Sarpatwari","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1803910"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010021\u201001070\u20102"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmp1400488"},{"key":"e_1_2_9_5_1","unstructured":"U.S. Food & Drug Administration \u201cActive REMS \u201daccessed August 3 2026 https:\/\/fis.fda.gov\/sense\/app\/ca606d81\u20103f9b\u20104480\u20109e47\u20108a8649da6470\/sheet\/6840df68\u2010c772\u201045f1\u2010bc4f\u201039d8b04cbfc1\/state\/analysis."},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010016\u20100501\u20102"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801\u2010015\u20100042\u20105"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.5055\/jom.2011.0053"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.742775"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/intqhc\/mzm042"},{"key":"e_1_2_9_11_1","unstructured":"U.S. Food & Drug Administration \u201cEndothelin Receptor Antagonist REMS Information \u201daccessed August 3 2026 https:\/\/www.fda.gov\/drugs\/risk\u2010evaluation\u2010and\u2010mitigation\u2010strategies\u2010rems\/endothelin\u2010receptor\u2010antagonist\u2010rems\u2010information."},{"key":"e_1_2_9_12_1","unstructured":"U.S. Food & Drug Administration \u201cFDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine \u201daccessed August 3 2026 https:\/\/www.fda.gov\/drugs\/drug\u2010safety\u2010communications\/fda\u2010removes\u2010risk\u2010evaluation\u2010and\u2010mitigation\u2010strategy\u2010rems\u2010program\u2010antipsychotic\u2010drug\u2010clozapine."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.161.5.706"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/ACM.0000000000005174"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/ACM.0000000000003758"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010019\u201000060\u2010y"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100043\u20101767683"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.36518\/2689\u20100216.1558"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70476","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.70476","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70476","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:58:53Z","timestamp":1791943133000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70476"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,20]]},"references-count":17,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/pds.70476"],"URL":"https:\/\/doi.org\/10.1002\/pds.70476","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,20]]},"assertion":[{"value":"2026-01-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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