Use of the New Zealand Intensive Medicines Monitoring Programme to study the XXXX -releasing intrauterine device (Mirena).

@entity1 @entity2692 @entity27475
PURPOSE: To demonstrate how the Intensive Medicines Monitoring Programme (IMMP) can be used to monitor adverse events associated with an intrauterine device, using the @entity2692 -releasing intrauterine device (Mirena) as an example. METHODS: A long-term prospective observational cohort study using Prescription Event Monitoring (PEM) is currently being undertaken in @entity1 using Mirena in New Zealand. This report describes the method used and reports the early results for those @entity1 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-up questionnaires. RESULTS: Between March 1998 and March 2001, the IMMP received 3519 registration forms for insertions in 3452 @entity1 . 'Difficult insertion' 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-up questionnaires have been processed for 495 @entity1 . The response rate for these was 83%. CONCLUSION: As adapted in the IMMP, @entity27475 is an effective tool for the early post-marketing surveillance of an intrauterine device in real life clinical practice.
