Crombie I K, Brown S V, Hamley J G
J Epidemiol Community Health. 1984 Sep;38(3):226-31. doi: 10.1136/jech.38.3.226.
The feasibility of conducting postmarketing drug surveillance by record linkage in Tayside was assessed. The key feature of the method is that all hospital discharge data are already computerised by the area health board and may be accessed through the unique community health number (CHNo) which has been allocated to all Tayside residents. The 12 861 prescriptions for cimetidine dispensed in Tayside over a nine month period were collected and the CHNo identified for 76%. These corresponded to 3802 individuals and their discharge data, together with those for an equal number of controls matched by age, sex, and general practitioner were retrieved from the computer. The expected excess of those diseases for which cimetidine is prescribed (peptic ulcer and oesophagitis) was observed. Other drug-disease associations were observed but may have been due to confounding and emphasise the inadequacy of community based controls. The major advantages of record linkage are, firstly, the low cost of the method, the present study costing just over pounds 12 000, and, secondly, the duration of patient follow up which may may be extended for as many years as required simply by rerunning the computer programs. To assemble large patient cohorts the study would have to be extended to other area health boards that are currently developing similar computer systems. Record linkage may provide a cost effective method for the follow up of patients to identify serious adverse drug reactions, particularly those that take several years to develop.
评估了在泰赛德地区通过记录链接进行上市后药物监测的可行性。该方法的关键特征是,所有医院出院数据已由地区卫生委员会计算机化,并且可以通过分配给所有泰赛德居民的唯一社区健康编号(CHNo)进行访问。收集了泰赛德地区在九个月内发放的12861张西咪替丁处方,并确定了76%的CHNo。这些对应于3802个人及其出院数据,以及从计算机中检索出的同等数量的按年龄、性别和全科医生匹配的对照的出院数据。观察到了西咪替丁所治疗疾病(消化性溃疡和食管炎)预期的超额病例。还观察到了其他药物-疾病关联,但可能是由于混杂因素所致,这也凸显了基于社区对照的不足之处。记录链接的主要优点,首先是该方法成本低,本研究成本仅略高于12000英镑,其次是患者随访时间可以根据需要通过重新运行计算机程序延长数年。为了组建大型患者队列,该研究将不得不扩展到其他正在开发类似计算机系统的地区卫生委员会。记录链接可能为随访患者以识别严重药物不良反应,特别是那些需要数年时间才会出现的不良反应,提供一种具有成本效益的方法。