Waller Patrick, Shaw Mary, Ho Davidson, Shakir Saad, Ebrahim Shah
Drug Safety Research Unit, Southampton, UK.
Br J Clin Pharmacol. 2005 Feb;59(2):213-9. doi: 10.1111/j.1365-2125.2004.02236.x.
To review Hospital Episode Statistics (HES) data for England coded as being 'drug induced' during 1996-2000 and to consider their potential utility for assessing the public health burden of adverse drug reactions (ADRs) and studying drug safety.
ICD-10 codes including the words 'drug-induced' or 'due to' a medicine or which are recognized to be invariably caused by a drug were extracted along with external cause codes indicating that a drug was implicated (i.e. Y40-59 in ICD-10). We also calculated the proportions of patients with each 'drug-induced' code for whom an external cause code had been applied.
During the 5-year study period there were almost 53.8 million hospital admissions in England, of which 44 411 (0.083%) were coded as 'drug-induced' and 168 958 (0.314%) were associated with a relevant external cause code. The numbers of patients with 'drug-induced' codes used were generally stable during the study period (range 7454-8860 per year) but the application of external cause codes increased in each year and by 40% overall (from 24 786 in 1996 to 34 843 in 2000). The overall proportion of 'drug-induced' codes associated with a relevant external cause code was quite low (12-15%) but there was considerable variation between codes.
Comparisons with published studies indicate that HES data grossly underestimate the burden of drug-induced disorders as a cause of hospital admission. There are likely to be multiple underlying reasons including under-recognition, under-recording and limitations of the coding system. The potential of these data for identifying previously unrecognized serious ADRs is limited by constraints on the availability of detailed data regarding individual cases.
回顾1996 - 2000年期间英格兰医院事件统计(HES)数据中编码为“药物所致”的数据,并探讨其在评估药物不良反应(ADR)的公共卫生负担及研究药物安全性方面的潜在效用。
提取国际疾病分类第十版(ICD - 10)中包含“药物所致”或“由于”某种药物字样的编码,以及表明药物有牵连的外部原因编码(即ICD - 10中的Y40 - 59)。我们还计算了每个应用了外部原因编码的“药物所致”编码患者的比例。
在为期5年的研究期间,英格兰有近5380万例住院病例,其中44411例(0.083%)被编码为“药物所致”,168958例(0.314%)与相关外部原因编码相关。在研究期间,使用“药物所致”编码的患者数量总体稳定(每年7454 - 8860例),但外部原因编码的应用逐年增加,总体增加了40%(从1996年的24786例增至2000年的34843例)。与相关外部原因编码相关的“药物所致”编码的总体比例相当低(12 - 15%),但不同编码之间存在很大差异。
与已发表研究的比较表明,HES数据严重低估了药物所致疾病作为住院原因的负担。可能存在多种潜在原因,包括认识不足、记录不全以及编码系统的局限性。这些数据在识别先前未被认识到的严重ADR方面的潜力受到单个病例详细数据可用性限制的制约。