{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T18:19:49Z","timestamp":1757701189824},"reference-count":12,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2013,8,3]],"date-time":"2013-08-03T00:00:00Z","timestamp":1375488000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2013,12]]},"abstract":"ABSTRACT<\/jats:title>Purpose<\/jats:title>The major concern associated with isotretinoin treatment is its high teratogenic potential. Therefore, ensuring use of contraception while on therapy is an important strategy for at\u2010risk patients and has been emphasized in all risk management programs. iPledge, the latest and most rigorous isotretinoin program, requires, among other stipulations, monthly assessments of contraceptive use for patients undergoing isotretinoin treatment. The purpose of this study is to evaluate isotretinoin usage patterns and assess concomitant use of isotretinoin and contraceptives before and after iPledge.<\/jats:p><\/jats:sec>Methods<\/jats:title>Female patients aged 13\u201345 years with a new prescription for isotretinoin products during 2004\u20132008 were identified in the IMS Health longitudinal prescription claims database. Monthly concomitant use of isotretinoin and contraceptives was estimated. Segmented regression analysis of interrupted time series data was used to assess changes in monthly proportion of concomitant use in the 24 months preceding versus following iPledge implementation.<\/jats:p><\/jats:sec>Results<\/jats:title>The number of isotretinoin prescriptions decreased after iPledge implementation. A small but significant increase in monthly proportion of patients concomitantly using isotretinoin and contraceptive therapies was observed immediately after iPledge implementation (1.3%, p<\/jats:italic>\u2010value\u2009=\u20090.02), particularly among younger patients (2.5%, p<\/jats:italic>\u2010value\u2009<\u20090.01). No changes in the proportion of concomitancy over time (i.e. slope) between the periods before and after iPledge implementation were observed.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>The findings of this pharmacy prescription claims\u2010based study suggest a small increase in concomitant use of isotretinoin and contraceptives coincident with the time of implementation of iPledge, particularly among younger women. Published 2013. This article is a U. S. Government work and is in the public domain in the USA.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3481","type":"journal-article","created":{"date-parts":[[2013,8,3]],"date-time":"2013-08-03T06:38:40Z","timestamp":1375511920000},"page":"1251-1257","source":"Crossref","is-referenced-by-count":34,"title":["Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States"],"prefix":"10.1002","volume":"22","author":[{"given":"Simone P.","family":"Pinheiro","sequence":"first","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology Office of Surveillance and Epidemiology USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth M.","family":"Kang","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology Office of Surveillance and Epidemiology USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clara Y.","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Biometrics VII, Office of Biostatistics, Office of Translational Sciences at the Center for Drug Evaluation and Research U.S. Food and Drug Administration USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura A.","family":"Governale","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology Office of Surveillance and Epidemiology USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther H.","family":"Zhou","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology Office of Surveillance and Epidemiology USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tarek A.","family":"Hammad","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Office of Pharmacovigilance and Epidemiology Office of Surveillance and Epidemiology USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,8,3]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/archderm.143.9.1187"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200730010-00002"},{"key":"e_1_2_7_4_1","unstructured":"Proceedings of the FDA joint Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committee Meeting February 2004. Lindstrom J. Isotretinoin \u2013 background and regulatory history.http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/04\/slides\/4017s1.htm. [14 July 2011]."},{"key":"e_1_2_7_5_1","unstructured":"Proceedings of the FDA joint Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committee Meeting February 2004. Pitts MR. Isotretinoin pregnancy exposures: Spontaneous reports 1\u2010year prior to & 1\u2010year after implementation of the current RMP.www.fda.gov\/ohrms\/dockets\/ac\/04\/slides\/4017S1_06_Pitts.ppt. [14 July 2011]."},{"key":"e_1_2_7_6_1","unstructured":"The iPledge program: The guide to best practices for the iPledge program.http:\/\/https:\/\/www.ipledgeprogram.com\/Documents\/Guide%20to%20Best%20Practices%20-%20iPLEDGE%20Program.pdf[14 July 2011]."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2710.2002.00430.x"},{"key":"e_1_2_7_8_1","unstructured":"MosherWD JonesJ.Use of contraception in the United States: 1982\u20132008. National Center for Health Statistics Division of Vital Statistics. Series 23; Number 29."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2010.09.017"},{"key":"e_1_2_7_10_1","unstructured":"Proceedings of the FDA joint Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committee Meeting December 2011. Wosinska M. iPledge: Effects on burden and access.http:\/\/www.fda.gov\/AdvisoryCommittees\/Calendar\/ucm275806.htm. [1 September 2012]."},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199507133330206"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.2165\/11319190-000000000-00000"},{"key":"e_1_2_7_13_1","unstructured":"FDA Communication.http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm094305.htm. [14 September 2012]."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.3481","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.3481","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.3481","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T21:26:48Z","timestamp":1698701208000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.3481"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,8,3]]},"references-count":12,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2013,12]]}},"alternative-id":["10.1002\/pds.3481"],"URL":"https:\/\/doi.org\/10.1002\/pds.3481","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,8,3]]}}}