Clark David W J, Harrison-Woolrych Mira
Department of Pharmacology and Toxicology, School of Medical Sciences, Intensive Medicines Monitoring Programme, University of Otago, Dunedin, New Zealand.
Curr Drug Saf. 2006 May;1(2):169-78. doi: 10.2174/157488606776930544.
The New Zealand Intensive Medicines Monitoring Programme (IMMP) was established in 1977 to enhance monitoring for previously unrecognised adverse drug reactions associated with selected new medicines. This involved establishing cohorts from prescription data and collection of event information: thus New Zealand was a pioneer in the development of the methodology now known as Prescription Event Monitoring (PEM). In the IMMP, PEM cohorts are established using information, supplied by pharmacies, from prescriptions for medicines that have been selected for monitoring. Events are identified subsequently from follow-up questionnaires to prescribing physicians and from other sources, including spontaneous reporting of events. The objective of this review is to illustrate how the IMMP methodology enables identification of signals of previously unrecognised adverse reactions. This is enhanced by high response rates from pharmacists and prescribers in providing prescription and event data respectively. In addition, high quality event reports are obtained from multiple sources including follow-up event returns from prescribers, reports received through the national spontaneous reporting programme, prescription returns and from record linkage to other databases. Collaboration with other national centres and with the WHO Collaborating centre for international drug monitoring in Uppsala, Sweden (WHO-UMC) enables information on cases from their databases to be used in validation of IMMP signals. The NZ IMMP methodology and signals of previously unrecognised adverse drug reactions arising from the IMMP databases are reviewed. Recent signals include amnesia and QTc prolongation with sibutramine; pain activation with sumatriptan; epistaxis with risperidone; psychiatric and visual disturbances with the COX-2 inhibitors celecoxib and rofecoxib and psoriasis with rofecoxib. In addition, other types of investigation are discussed along with the importance of rapid communication to prescribers of new information concerning the risks of medications. The IMMP has features that differ from those of other centres that incorporate PEM methodology. New Zealand is a small country (approximately 4 million) and thus communication is relatively easy. This facilitates good rapport with prescribing doctors. However, mainly because of the small population, several years may be required to achieve a large cohort. Although this has drawbacks in terms of rapid results, it enables a longitudinal approach to prescription data analysis, including aspects of prescribing such as reasons for cessation of therapy and changes in prescribing practise. Although not specifically reviewed in this article, the programme has also made significant contributions in determining the incidence of certain adverse drug reactions and in carrying out in-depth epidemiological investigations relating to the safe use of medicines. Through these activities, the New Zealand IMMP provides an ongoing contribution to safety in the use of medicines.
新西兰强化药物监测计划（IMMP）于1977年设立，旨在加强对与特定新药相关的此前未被识别的药物不良反应的监测。这包括从处方数据中建立队列以及收集事件信息：因此，新西兰是现在被称为处方事件监测（PEM）方法发展的先驱。在IMMP中，PEM队列是利用药房提供的有关已选定进行监测药物的处方信息建立的。随后通过向开处方医生发放随访问卷以及从包括事件自发报告在内的其他来源识别事件。本综述的目的是说明IMMP方法如何能够识别此前未被识别的不良反应信号。药剂师和开处方医生分别提供处方和事件数据时的高回复率增强了这一点。此外，还从多个来源获得了高质量的事件报告，包括开处方医生的随访事件反馈、通过国家自发报告计划收到的报告、处方反馈以及与其他数据库的记录链接。与其他国家中心以及瑞典乌普萨拉的世界卫生组织国际药物监测合作中心（WHO-UMC）的合作，使得能够将来自其数据库的病例信息用于验证IMMP信号。对新西兰IMMP方法以及从IMMP数据库中出现的此前未被识别的药物不良反应信号进行了综述。近期的信号包括西布曲明导致的失忆和QTc延长；舒马曲坦导致的疼痛激发；利培酮导致的鼻出血；COX-2抑制剂塞来昔布和罗非昔布导致的精神和视觉障碍以及罗非昔布导致的银屑病。此外，还讨论了其他类型的调查以及迅速向开处方医生传达有关药物风险的新信息的重要性。IMMP具有一些与采用PEM方法的其他中心不同的特点。新西兰是一个小国（约400万人口），因此沟通相对容易。这有助于与开处方医生建立良好的关系。然而，主要由于人口较少，可能需要数年时间才能形成一个大的队列。尽管这在快速得出结果方面有缺点，但它使得能够采用纵向方法进行处方数据分析，包括诸如治疗停止原因和处方实践变化等处方方面。尽管本文未专门对此进行综述，但该计划在确定某些药物不良反应的发生率以及开展与药物安全使用相关的深入流行病学调查方面也做出了重大贡献。通过这些活动，新西兰IMMP为药物使用安全做出了持续贡献。
