Schneeweiss S, Göttler M, Hasford J, Swoboda W, Hippius M, Hoffmann A K, Riethling A K, Krappweis J
Department of Medical Informatics, Biometry and Epidemiology, Pharmacoepidemiology Research Group, Ludwig-Maximilians-University, Munich, Germany.
Br J Clin Pharmacol. 2001 Aug;52(2):196-200. doi: 10.1046/j.0306-5251.2001.01425.x.
An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications.
Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment. Service areas of each acute care hospital were defined by 5 digit postal codes that covered 60% of all admissions. Drug dispensing information was available through claims processed by regional pharmacy computing centres. Quarterly incidences were estimated by dividing the number of events by the number of treated patients.
435 DRHs were reported during five quarters. The incidence of ADRs leading to admissions varied for specific drug groups from 1.5/10 000 treated patients to 24/10 000. Quarterly variation of incidences was moderate except for insulin and calcium antagonists. 95% confidence intervals overlap for all quarters within each group. Incidences are sensitive to changes in the definition of the source population.
Our pharmacovigilance monitoring system allows comparisons of population-based incidences of drug-related hospitalizations among drugs and over time. It provides important information for risk management and monitoring outcomes of pharmaceutical quality management programmes.
建立强化监测系统,以识别与药物相关的住院病例,并估算常用处方药基于人群的发病率。
药物警戒中心系统筛查急诊室或内科病房的非选择性入院病例,以确定与药物相关的住院治疗(DRH)。临床药理学家采用标准化因果关系评估。每家急症医院的服务区域由5位邮政编码定义,涵盖所有入院病例的60%。药物配药信息可通过区域药房计算中心处理的报销申请获得。通过将事件数量除以接受治疗的患者数量来估算季度发病率。
在五个季度内共报告了435例DRH。导致入院的药物不良反应(ADR)发病率因特定药物组而异,从每10000例接受治疗的患者中1.5例到24例不等。除胰岛素和钙拮抗剂外,发病率的季度变化较为温和。每组内所有季度的95%置信区间重叠。发病率对源人群定义的变化敏感。
我们的药物警戒监测系统允许比较不同药物之间以及不同时间基于人群的与药物相关住院治疗的发病率。它为风险管理和监测药品质量管理计划的结果提供重要信息。