Mackay F J
Drug Safety Research Unit, Southampton, England.
Drug Saf. 1998 Nov;19(5):343-53. doi: 10.2165/00002018-199819050-00002.
The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.
药物安全研究单位（DSRU）是英国处方事件监测（PEM）的中心。PEM研究是非干预性观察队列研究，用于监测新上市药物的安全性。在英国，上市后监测的必要性已得到充分认可，而全科医疗是理想的数据来源。PEM研究以全科医生（社区）为基础，暴露情况基于英格兰的配药处方数据。迄今为止，已完成65项PEM研究，平均队列规模为10979名患者，DSRU数据库拥有超过700000名开具新药处方患者的临床信息。与自发报告计划不同，PEM可得出治疗期间报告事件的发生率。可对同类药物进行对比研究。DSRU汇总了暴露于新药的妊娠结局数据。也可专门检查儿童和老年人的数据。与英国计算机化全科医疗数据库的数据相比，PEM数据具有诸多优势。PEM是英国唯一能够以如此全面和系统的方式监测新上市药物的技术。
