Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine

Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine
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DOI:
10.1046/j.1365-2125.2000.00132.x
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发表时间:
2000-02-01
影响因子:
3.4
通讯作者:
Meier, PJ
Meier, PJ
中科院分区:
医学3区
文献类型:
--
作者:
Fattinger, K;Roos, M;Meier, PJ

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目的探讨药物暴露,药物不良反应(ADRs)的频率,类型的ADRs,易感的危险因素和ADR相关的过度住院时间在内科inpatients.Methods结构化的数据,患者的特征,“事件”(症状,实验室检查结果),诊断(ICD 10)和药物治疗收集使用计算机支持的数据输入系统和接口的数据检索从电子病历。通过“事件监测”收集ADR数据,以尽量减少药物监测员可能的偏倚。每个事件的因果关系进行了评估,与疾病(S)和药物therapy.Results的分析包括4331(100%)住院。中位观察期为8天。每例患者每天给予的不同药物的中位数为6种,在所有住院日的50%中在4种(Q(1))和9种(Q(3))不同药物之间变化。在41%的所有住院治疗中,至少1起与疾病无关的事件可能归因于药物治疗。临床相关ADR发生率为11%。在所有住院治疗中,3.3%的ADR是住院的原因。可能与ADR相关的死亡发生率为千分之1.4。临床相关ADR的易感因素为女性和多种药物。ADR相关的额外住院天数占住院days.Conclusions的8.6%,这些数据证明了开发的“事件监测”系统的可行性,在内科住院患者的ADR的定量分析。随着记录患者数量的增加,药物流行病学数据库提供了一个有价值的工具来研究住院患者中有关药物疗效和安全性的具体问题。
Aims To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients.Methods Structured data regarding patient characteristics, 'events' (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by 'event monitoring' to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy.Results The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q(1)) and 9 (Q(3)) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4 parts per thousand. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8.6% of hospital days.Conclusions These data demonstrate the feasibility of the developed 'event monitoring' system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drugs efficacy and safety in hospitalized patients.