Coulter D M
Centre for Adverse Reactions Monitoring, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Pharmacoepidemiol Drug Saf. 2000 Jul;9(4):273-80. doi: 10.1002/1099-1557(200007/08)9:4<273::AID-PDS512>3.0.CO;2-T.
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 (c) 2000 John Wiley & Sons, Ltd.
目的——本文旨在展示新西兰强化药物监测计划（IMMP）的前瞻性，并评估其在上市后药物安全性评估中的有效性。方法——IMMP对选定的新药进行前瞻性观察队列研究。患者队列根据从全国配药药剂师处收到的处方数据建立。不良事件由医生通过处方随访问卷报告或作为自发报告上报。重点审查信号生成方法，特别是对单个事件报告及其与药物关系的审查。对过去10年报告的信号在向监管机构提供建议方面的及时性进行评估。结果——队列平均规模为10964名患者，每种药物的平均研究期为58个月。从11种药物中记录了总共153个信号，其中132个（86%）在文献发表之前就已通知监管机构。阐述了使用“事件”控制报告偏倚的情况，并给出了妊娠和哺乳期安全性数据、死亡评估、药物恐慌安抚、风险比较和信号验证研究的示例。结论——即使资源有限，PEM类型的方法在主动安全性监测中也是有效且具有成本效益的。版权所有（c）2000约翰·威利父子有限公司。
