Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, Switzerland.
Eur J Clin Pharmacol. 2011 Sep;67(9):909-18. doi: 10.1007/s00228-011-1020-9. Epub 2011 Mar 11.
The incidence of adverse drug events (ADE) is an important parameter in determining the quality of medical care. We identified the probability that a specific data source would identify ADEs in patients on the oncology ward, that could be assigned to one substance.
We captured all medical adverse events (AE) from five different data sources. Each AE was determined to be drug-related according to the WHO criteria and classified according to the severity, category, and causality of the ADE.
The study recorded 129 patients with 252 hospitalizations over a 5-month period. A total of 3,341 medical events were captured and resulted in 1,121 ADEs. In 122 patients, at least one ADE (95%) was observed. Only 39 hospitalizations were believed not to have an ADE (15%). No ADE was captured by all data sources. The patient record captured 550, the nursing record 569, the laboratory tests 387, the questionnaire 63, and the event monitoring during grand rounds 141 ADEs. Only the nursing record and the laboratory tests had a significantly different probability of observing indicative ADEs.
For all AEs reported in the data sources, physicians and nurses were the best source for ADEs. Data sources differed in identifying indicative ADEs and were influenced by specific patient parameters.
药物不良事件(ADE)的发生率是衡量医疗质量的一个重要参数。我们确定了特定数据源在肿瘤病房患者中识别可能归因于一种物质的 ADE 的概率。
我们从五个不同的数据源中捕获了所有的医疗不良事件(AE)。每个 AE 根据世界卫生组织(WHO)标准被确定为与药物相关,并根据 ADE 的严重程度、类别和因果关系进行分类。
该研究记录了 129 名患者在 5 个月期间的 252 次住院。共捕获了 3341 例医疗事件,导致 1121 例 ADE。在 122 名患者中,至少观察到一种 ADE(95%)。只有 39 次住院被认为没有 ADE(15%)。没有任何 ADE 被所有数据源捕获。患者记录捕获了 550 例,护理记录 569 例,实验室检查 387 例,问卷 63 例,大查房期间的事件监测 141 例 ADE。只有护理记录和实验室检查在观察指示性 ADE 方面有显著不同的概率。
对于报告的所有数据来源中的 AE,医生和护士是 ADE 的最佳来源。识别指示性 ADE 的数据源不同,并且受到特定患者参数的影响。