{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T17:48:37Z","timestamp":1759772917608,"version":"3.37.3"},"reference-count":18,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,9,26]],"date-time":"2017-09-26T00:00:00Z","timestamp":1506384000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This study aimed to evaluate the effect of risk minimization measures on cyproterone acetate\/ethinylestradiol (CPA\/EE) use in the Netherlands. Potential indications of use and concomitant pharmacy dispensing of other hormonal contraceptives (HC) were assessed among new users in 2011, 2012, and 2014.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this retrospective drug utilization study, new CPA\/EE users were identified by pharmacy dispensings in the PHARMO Database Network in 2011, 2012, and 2014. Recent dispensing of drugs to treat acne and concomitant dispensing of other HC were also assessed. General practitioner records were linked to identify diagnoses of acne, other hyperandrogenic conditions, menstrual problems, or consultations for contraceptive management in the preceding year.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The number of new CPA\/EE users identified per year was 7876 in 2011 and 7562 in 2012 (3.7 new users per 1000 women in both years) and 1401 in 2014 (0.7 per 1000 women). The proportions of users with acne diagnosis or treatment were 55% in 2011, 52% in 2012, and 47% in 2014. Concomitant use of other HC was observed for 3% of new CPA\/EE users in 2011, and 2% in 2012 and 2014 (median duration 78\u00a0days). Another 25% were potential concomitant users (median duration 60\u00a0days).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This descriptive analysis showed similar proportions of CPA\/EE users examined with acne or other hyperandrogenic conditions, or with recent acne treatment, or concomitant dispensing of other HC in the Netherlands before and after the referral procedure. The key observation was a strong overall reduction of CPA\/EE use in the Netherlands.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4319","type":"journal-article","created":{"date-parts":[[2017,9,27]],"date-time":"2017-09-27T00:32:52Z","timestamp":1506472372000},"page":"1411-1417","source":"Crossref","is-referenced-by-count":5,"title":["Thrombotic risk minimization for <scp>D<\/scp>iane\u201035 and generics"],"prefix":"10.1002","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4719-1142","authenticated-orcid":false,"given":"Irene D.","family":"Bezemer","sequence":"first","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabeth","family":"Smits","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernie J.A.","family":"Penning\u2010van Beest","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alex","family":"Asiimwe","sequence":"additional","affiliation":[{"name":"Bayer Pharma AG, Pharmaceuticals Division Global Epidemiology  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ron M.C.","family":"Herings","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht The Netherlands"},{"name":"Department of Epidemiology &amp; Biostatistics VU Medical Center  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,9,26]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Diane\u201035 SmPC (Dutch): College ter Beoordeling van Geneesmiddelen;2015[cited 2016 30\u201005\u20102016]. Available from:http:\/\/db.cbg\u2010meb.nl\/IB\u2010teksten\/h11903.pdf."},{"key":"e_1_2_8_3_1","unstructured":"Cyproterone\/ethinylestradiol\u2010containing medicines: article\u2010107i procedure\u2013\u2013notification: European medicines agency;2013[cited 2016 30\u201005\u20102016]. Available from:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/cyproterone_ethinylestradiol_107i\/Procedure_started\/WC500138613.pdf."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b2890"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d6423"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06522-9"},{"key":"e_1_2_8_7_1","unstructured":"Lareb.Analysis of reports of thromboembolic adverse drug reactions associated with cyproterone\/ethinylestradiol. Netherlands Pharmacovigilance Center Lareb:2013."},{"key":"e_1_2_8_8_1","article-title":"Thrombosis and embolism during Diane\u201035 use: analysis of reports made to the Netherlands Pharmacovigilance Centre Lareb","volume":"158","author":"Hunsel FP","year":"2014","journal-title":"Ned Tijdschr Geneeskd"},{"key":"e_1_2_8_9_1","unstructured":"Benefits of Diane 35 and its generics outweigh risks in certain patient groups\u2013\u2013PRAC recommendation endorsed by CMDh [press release]. European Medicines Agency2013."},{"key":"e_1_2_8_10_1","unstructured":"Assessment report cyproterone acetate\/ethinylestradiol (2\u00a0mg\/0.035 mg) containing medicinal products: European medicines agency;2013[cited 2016 30\u201005\u20102016]. Available from:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Referrals_document\/cyproterone_ethinylestradiol_107i\/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee\/WC500144130.pdf."},{"key":"e_1_2_8_11_1","unstructured":"EU PAS register number EUPAS 8412\u2013\u2013drug utilization study on Diane\u00ae\u201035 (and generics) in European healthcare databases: European network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP); [updated 01\u201012\u20102016]. Available from:http:\/\/www.encepp.eu\/encepp\/viewResource.htm?id=16504."},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781119959946.ch18"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2009.09.010"},{"key":"e_1_2_8_14_1","unstructured":"ISPE.Guidelines for good pharmacoepidemiology practices (GPP)2015. 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