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J Lysholm - One of the best experts on this subject based on the ideXlab platform.

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David M. Coulter - One of the best experts on this subject based on the ideXlab platform.

  • use of the new zealand intensive medicines Monitoring Programme to study the levonorgestrel releasing intrauterine device mirena
    Pharmacoepidemiology and Drug Safety, 2003
    Co-Authors: Lifeng Zhou, Mira Harrisonwoolrych, David M. Coulter
    Abstract:

    Purpose To demonstrate how the Intensive Medicines Monitoring Programme (IMMP) can be used to monitor adverse events associated with an intrauterine device, using the levonorgestrel-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 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-up questionnaires. Results Between March 1998 and March 2001, the IMMP received 3519 registration forms for insertions in 3452 women. ‘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 patients. The response rate for these was 83%. Conclusion As adapted in the IMMP, PEM is an effective tool for the early post-marketing surveillance of an intrauterine device in real life clinical practice. Copyright © 2003 John Wiley & Sons, Ltd.

  • the new zealand intensive medicines Monitoring Programme in pro active safety surveillance
    Pharmacoepidemiology and Drug Safety, 2000
    Co-Authors: David M. Coulter
    Abstract:

    Purpose–The purpose of this paper is to demonstrate the pro-active nature of the New Zealand Intensive Medicines Monitoring Programme (IMMP) and make an assessment of its effectiveness in postmarketing drug safety evaluation. Methods–The IMMP undertakes prospective observational cohort studies of selected new drugs. Patient cohorts are established from prescription data received from dispensing pharmacists nationwide. Adverse events are reported by doctors on prescription follow-up questionnaires or as spontaneous reports. The method of signal generation is reviewed with particular emphasis on the review of individual event reports and their relationship to the medicine. Signals reported over the last 10 years are assessed for timeliness in advising the regulatory authority. Results–Mean cohort size is 10,964 patients and the mean study period for each drug was 58 months. A total of 153 signals were recorded from 11 drugs with 132 (86%) being notified to the regulatory authority prior to any publication in the literature. The use of ‘incidents’ in controlling for reporting bias is illustrated and examples are given of data on safety in pregnancy and lactation, the assessment of deaths, reassurance with drug scares, risk comparison and signal validation studies. Conclusion–PEM type methodology is effective and cost-efficient in pro-active safety surveillance even with limited resources. Copyright © 2000 John Wiley & Sons, Ltd.

  • The New Zealand Intensive Medicines Monitoring Programme.
    Pharmacoepidemiology and drug safety, 1998
    Co-Authors: David M. Coulter
    Abstract:

    The New Zealand Intensive Medicines Monitoring Programme which has been in operation for 20 years is described. The methodology is reviewed in detail and illustrated in the results. Some of the principles of early postmarketing surveillance and advantages and problems associated with the IMMP are discussed. The methodology is based on establishing cohorts of patients and the aggregation of adverse events from a combination of prescription follow-up (PFU) and intensified spontaneous reporting. In signal detection particular emphasis is placed on provisional ‘causality’ assessment and a study of the events thought not to be reactions (incidents) and in addition, their use in controlling for reporting bias particularly in respect of reaction rates and the identification of risk factors. With the small population base, cohorts are built up more slowly, but the longer duration of observation has advantages. Monitoring has been completed for 20 drugs with an average cohort size of 10,511 patients and a mean Monitoring period of 55 months. The use of duplicate prescriptions with PFU achieved much higher reporting rates than IMMP spontaneous reporting. Information on deaths was best obtained from questionnaires on reasons for cessation of therapy which also provided data on efficacy. © 1998 John Wiley & Sons, Ltd.

P Geborek - One of the best experts on this subject based on the ideXlab platform.

C M Fored - One of the best experts on this subject based on the ideXlab platform.