{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:26:14Z","timestamp":1760131574577},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2003,6,24]],"date-time":"2003-06-24T00:00:00Z","timestamp":1056412800000},"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":[[2003,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To demonstrate how the Intensive Medicines Monitoring Programme (IMMP) can be used to monitor adverse events associated with an intrauterine device, using the levonorgestrel\u2010releasing intrauterine device (Mirena) as an example.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A long\u2010term prospective observational cohort study using Prescription Event Monitoring (PEM) is currently being undertaken in women using Mirena in New Zealand. This report describes the method used and reports the early results for those women who used the device between March 1998 and March 2001. Adverse events were recorded by inserting doctors and general practitioners on registration forms and systematic follow\u2010up questionnaires.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between March 1998 and March 2001, the IMMP received 3519 registration forms for insertions in 3452 women. \u2018Difficult insertion\u2019 was the most frequently reported event (3.6% of all insertions). Approximately, 2% of the Mirena insertions were carried out under GA and there were three uterine perforations (0.9 per 1000 insertions) in the total cohort. To date, follow\u2010up questionnaires have been processed for 495 patients. The response rate for these was 83%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>As adapted in the IMMP, PEM is an effective tool for the early post\u2010marketing surveillance of an intrauterine device in real life clinical practice. Copyright \u00a9 2003 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.875","type":"journal-article","created":{"date-parts":[[2003,7,16]],"date-time":"2003-07-16T10:08:52Z","timestamp":1058350132000},"page":"371-377","source":"Crossref","is-referenced-by-count":38,"title":["Use of the New Zealand Intensive Medicines Monitoring Programme to study the levonorgestrel\u2010releasing intrauterine device (Mirena)"],"prefix":"10.1002","volume":"12","author":[{"given":"Lifeng","family":"Zhou","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mira","family":"Harrison\u2010Woolrych","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David M.","family":"Coulter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2003,6,24]]},"reference":[{"key":"e_1_2_1_2_2","first-page":"296","article-title":"Intensified adverse drug reaction reporting scheme","volume":"85","author":"McQueen EG","year":"1977","journal-title":"NZ Med J"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1099-1557(199803\/04)7:2<79::AID-PDS330>3.0.CO;2-1"},{"issue":"2","key":"e_1_2_1_4_2","first-page":"14","article-title":"Interim results of Multiload Cu375 monitoring reassuring","volume":"24","author":"Coulter DM","year":"1997","journal-title":"NZ Fam Phys"},{"key":"e_1_2_1_5_2","unstructured":"Schering NZ Ltd.Mirena intrauterine system data sheet.2001URL:http:\/\/www.medsafe.govt.nz\/Profs\/Datasheet\/m\/Mirenaius.htm[19 June 2003]."},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.2001.00020.x"},{"issue":"2","key":"e_1_2_1_7_2","first-page":"193","article-title":"Clinical experience with a levonorgestrel\u2010releasing intrauterine contraceptive device (LNG\u2010IUD) as a contraceptive and in the treatment of menorrhagia","volume":"19","author":"Bounds W","year":"1993","journal-title":"Br J Fam Plann"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/0010-7824(90)90046-X"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.2000.tb13228.x"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/1099-1557(200007\/08)9:4<273::AID-PDS512>3.0.CO;2-T"},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.643"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/0010-7824(86)90080-6"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(16)56455-3"},{"key":"e_1_2_1_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/0010-7824(94)90109-0"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/0010-7824(89)90014-0"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF01849748"},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-7824(02)00413-4"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.875","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.875","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T22:49:48Z","timestamp":1700174988000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.875"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,6,24]]},"references-count":16,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2003,7]]}},"alternative-id":["10.1002\/pds.875"],"URL":"https:\/\/doi.org\/10.1002\/pds.875","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,6,24]]}}}