{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:30:40Z","timestamp":1786591840057,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"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":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse\u2010deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by \u201cindication\u201d are important considerations in ADF post\u2010marketing studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In a retrospective cohort study using claims data (2006\u20132018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18\u201364\u2009years old) initiating ADF or non\u2010ADF extended\u2010release\/long\u2010acting (ER\/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six\u2010month washout period) or prevalent new users.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 8415 (NC claims) and 147\u2009978 (MarketScan) ADF, and 10\u2009114 (NC claims) and 232\u2009028 (MarketScan) non\u2010ADF ER\/LA opioid initiators. Most had prior opioid exposure (ranging 64%\u201374%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non\u2010ADF ER\/LA initiators. Concurrent immediate\u2010release opioid prescriptions at initiation were more common in prevalent new users than traditional new users.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Careful consideration of the study design, comparator choice, and confounding by \u201cindication\u201d is crucial when examining ADF opioid use\u2010related outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5805","type":"journal-article","created":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T00:29:11Z","timestamp":1715214551000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Matching study design to prescribing intention: The prevalent\n                    <scp>new\u2010user<\/scp>\n                    design for studying\n                    <scp>abuse\u2010deterrent<\/scp>\n                    formulations of opioids"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1298-4433","authenticated-orcid":false,"given":"Bethany L.","family":"DiPrete","sequence":"first","affiliation":[{"name":"Department of Epidemiology, Gillings School of Global Public Health University of North Carolina  Chapel Hill North Carolina USA"},{"name":"Injury Prevention Research Center University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7203-8460","authenticated-orcid":false,"given":"GYeon","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice and Science, College of Pharmacy University of Kentucky  Lexington Kentucky USA"},{"name":"Institute for Pharmaceutical Outcomes &amp; Policy, College of Pharmacy University of Kentucky  Lexington Kentucky USA"},{"name":"Sanders\u2010Brown Center on Aging University of Kentucky  Lexington Kentucky USA"},{"name":"Department of Epidemiology and Environmental Health University of Kentucky  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3648-8197","authenticated-orcid":false,"given":"Daniela C.","family":"Moga","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice and Science, College of Pharmacy University of Kentucky  Lexington Kentucky USA"},{"name":"Institute for Pharmaceutical Outcomes &amp; Policy, College of Pharmacy University of Kentucky  Lexington Kentucky USA"},{"name":"Sanders\u2010Brown Center on Aging University of Kentucky  Lexington Kentucky USA"},{"name":"Department of Epidemiology and Environmental Health University of Kentucky  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4098-605X","authenticated-orcid":false,"given":"Nabarun","family":"Dasgupta","sequence":"additional","affiliation":[{"name":"Injury Prevention Research Center University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4541-6574","authenticated-orcid":false,"given":"Svetla","family":"Slavova","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Kentucky College of Public Health  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Slade","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Kentucky College of Public Health  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7214-0326","authenticated-orcid":false,"given":"Chris","family":"Delcher","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice and Science, College of Pharmacy University of Kentucky  Lexington Kentucky USA"},{"name":"Institute for Pharmaceutical Outcomes &amp; Policy, College of Pharmacy University of Kentucky  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian W.","family":"Pence","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Gillings School of Global Public Health University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3944-3912","authenticated-orcid":false,"given":"Shabbar I.","family":"Ranapurwala","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Gillings School of Global Public Health University of North Carolina  Chapel Hill North Carolina USA"},{"name":"Injury Prevention Research Center University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,8]]},"reference":[{"issue":"43","key":"e_1_2_11_2_1","first-page":"1487","article-title":"Vital signs: overdoses of prescription opioid pain relievers\u2014United States, 1999\u20132008","volume":"60","author":"Centers for Disease Control","year":"2011","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/1178632918819440"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2014.8071"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0000000000002031"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jrh.12496"},{"key":"e_1_2_11_7_1","unstructured":"U.S. Food and Drug Administration.Abuse\u2010deterrent opioids\u2014evaluation and labeling. Guidance for Industry.2015https:\/\/www.fda.gov\/media\/84819\/download"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/add.14380"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2012.05.029"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwg231"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40471\u2010015\u20100053\u20105"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40122\u2010021\u201000343\u2010z"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/add.15392"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4107"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwaa283"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5656"},{"issue":"4","key":"e_1_2_11_17_1","first-page":"335","article-title":"Confounding by indication","volume":"7","author":"Walker AM","year":"1996","journal-title":"Epidemiology"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4287"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.9191"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/pm\/pnab181"},{"key":"e_1_2_11_21_1","unstructured":"Agency for Healthcare Research and Quality.Healthcare cost and utilization project (HCUP). HCUP Tools and Software.www.hcup-us.ahrq.gov\/tools_software.jsp"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650\u2010199801000\u201000004"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3697"},{"key":"e_1_2_11_24_1","unstructured":"R: A Language and Environment for Statistical Computing. R Foundation for Statistical Comput Secur.2019https:\/\/www.R-project.org\/"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.1464"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr7103a1"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1080\/00325481.2019.1585688"},{"key":"e_1_2_11_28_1","article-title":"Abuse\u2010deterrent formulations and opioid\u2010related harms in North Carolina, 2010\u20102018","author":"DiPrete BL","journal-title":"Am J Epidemiol"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4564"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5805","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5805","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5805","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:13:08Z","timestamp":1786590788000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5805"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1002\/pds.5805"],"URL":"https:\/\/doi.org\/10.1002\/pds.5805","archive":["Portico"],"relation":{"has-preprint":[{"id-type":"doi","id":"10.22541\/au.168963248.87978327\/v1","asserted-by":"object"}]},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"2023-07-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5805"}}