{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T10:11:02Z","timestamp":1791886262745,"version":"4.3.4"},"reference-count":45,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2019,7,22]],"date-time":"2019-07-22T00:00:00Z","timestamp":1563753600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["Foreign Study Award"],"award-info":[{"award-number":["Foreign Study Award"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","award":["R21HD092879"],"award-info":[{"award-number":["R21HD092879"]}],"id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The purpose of the study is to develop an algorithm to identify pregnancies in administrative databases and apply it to assess pregnancy rates and outcomes in women prescribed isotretinoin or tretinoin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using the 2011 to 2015 Truven Health MarketScan Database, we identified pregnancies, including losses and terminations. In a cohort design, nonpregnant women filling a prescription for isotretinoin or tretinoin were matched to five women without either prescription. Women were followed for 365 days or until conception, medication discontinuation, or enrollment discontinuation (\u201cprescription episode\u201d). Rates of pregnancy, risks of pregnancy losses, and prevalence of infant malformations at birth were assessed by exposure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 2 179 192 livebirths, 8434 stillbirths, 2521 mixed births, 415 110 spontaneous abortions, 124 556 elective terminations, and 8974 unspecified abortions. There were 86 834 isotretinoin and 973 587 tretinoin episodes, matched to 5 302 105 unexposed women. Pregnancy rates were 3 (isotretinoin), 19 (tretinoin), and 34 (unexposed) per 1000 person\u2010years. Risk of spontaneous pregnancy losses were similar; however, terminations were more common in the isotretinoin\u2010exposed (28% [95% CI: 21%\u201036%]) than the tretinoin\u2010exposed (10% [95% CI: 9%\u201011%]) or unexposed pregnancies (6%). Malformations occurred in 4.5% (95% CI: 3.5%\u20105.6%) of the tretinoin\u2010exposed pregnancies and 4.2% of the unexposed pregnancies (adjusted odds ratio: 1.16 [95% CI: 0.85\u20101.58]); isotretinoin\u2010exposed births were too few to assess malformations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Administrative databases can complement risk evaluation and mitigation strategies (REMS) for known teratogens and contribute to safety surveillance for other medications. Here, isotretinoin\u2010exposed pregnancy rates were low, but existent, and many pregnancies were terminated. Tretinoin exposure was not associated with a meaningfully elevated risk of losses or malformations as compared with unexposed pregnancies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.4794","type":"journal-article","created":{"date-parts":[[2019,7,22]],"date-time":"2019-07-22T04:54:19Z","timestamp":1563771259000},"page":"1211-1221","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":113,"title":["Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6533-152X","authenticated-orcid":false,"given":"Sarah C.","family":"MacDonald","sequence":"first","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7300-0488","authenticated-orcid":false,"given":"Jacqueline M.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Panchaud","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. Chan School of Public Health  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas F.","family":"McElrath","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5805-8430","authenticated-orcid":false,"given":"Krista F.","family":"Huybrechts","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Hern\u00e1ndez\u2010D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. 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