Muehlberger N, Schneeweiss S, Hasford J
Department of Medical Informatics, Biometry and Epidemiology (IBE), Pharmacoepidemiology Research Group, University of Munich, Germany.
Pharmacoepidemiol Drug Saf. 1997 Oct;6 Suppl 3:S71-7. doi: 10.1002/(sici)1099-1557(199710)6:3+<s71::aid-pds282>3.3.co;2-9.
In an era of health care cost containment it is of particular interest to identify measures that reduce costs and at the same time improve health care quality. One of these cost cutting measures might be the reduction of the frequency of Adverse Drug Reactions (ADR). The objective of this paper is to summarize all original work on ADR frequencies at hospital admission and to come up with a valid estimate for the actual frequency of ADR-related hospital admissions. Additionally, we compared established concepts of ADR monitoring with respect to their utility for drug safety monitoring and pharmacoepidemiologic research. We reviewed 25 studies from the past 25 years. Analysing the effect of methodological characteristics showed that variation of reported ADR frequency mainly depends on differing study bases and the concepts of ADR monitoring. Investigations that thoroughly screened all members of the study population for the presence of adverse drug reactions (comprehensive ADR monitoring) generally yielded highest ADR proportions. Studies that concentrated screening on selected high-risk patients (preselective ADR monitoring) and those applying spontaneous or intensified spontaneous reporting detected lower ADR proportions (2.9% and 2.5%). The ADR proportion among admissions to departments of internal medicine was higher than among mixed hospital populations including surgical patients. In conclusion 4.2-6.0% (lower and upper quartile) and in median 5.8% of all admissions to medical departments are caused by adverse drug reactions. A two-step preselective ADR monitoring appears to be appropriate and efficient for both signal generation and signal validation as compared to spontaneous reporting and comprehensive monitoring. In conclusion, adverse drug reactions are a common cause of hospital admissions. As hospital care is expensive, attempts to prevent ADR and thus hospital admission need active encouragement.
在医疗成本控制的时代，确定既能降低成本又能提高医疗质量的措施格外重要。其中一项削减成本的措施可能是减少药物不良反应（ADR）的发生频率。本文的目的是总结所有关于入院时ADR发生率的原创研究，并对与ADR相关的入院实际发生率做出有效估计。此外，我们比较了已确立的ADR监测概念在药物安全监测和药物流行病学研究方面的效用。我们回顾了过去25年的25项研究。分析方法学特征的影响表明，报告的ADR频率差异主要取决于不同的研究基础和ADR监测概念。对研究人群所有成员进行全面筛查以确定是否存在药物不良反应的调查（全面ADR监测）通常得出最高的ADR比例。集中对选定的高危患者进行筛查的研究（预选ADR监测）以及采用自发或强化自发报告的研究检测到的ADR比例较低（分别为2.9%和2.5%）。内科住院患者中的ADR比例高于包括外科患者在内的混合医院人群。总之，内科住院患者中4.2 - 6.0%（下四分位数和上四分位数）以及中位数为5.8%的入院是由药物不良反应引起的。与自发报告和全面监测相比，两步预选ADR监测对于信号生成和信号验证似乎既合适又有效。总之，药物不良反应是住院的常见原因。由于住院治疗费用高昂，预防ADR从而避免住院的努力需要积极鼓励。
