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药物不良事件的流行病学、比较检测方法及可预防性

Epidemiology, comparative methods of detection, and preventability of adverse drug events.

作者信息

Al-Tajir Ghada K, Kelly William N

机构信息

Drug Information Department, Al Qassimi Hospital, Sharjah, United Arab Emirates.

出版信息

Ann Pharmacother. 2005 Jul-Aug;39(7-8):1169-74. doi: 10.1345/aph.1E559. Epub 2005 May 31.

DOI:10.1345/aph.1E559
PMID:15928265
Abstract

BACKGROUND

Adverse drug events (ADEs) continue to be of concern to all health professionals. Even serious ADEs are underreported in all patient-care environments.

OBJECTIVE

To discover the incidence and the best detection methods and preventability for ADEs at Al Qassimi Hospital, a 360-bed facility in the United Arab Emirates.

METHODS

During the first and fourth quarters of 2003, data collection for ADEs was limited to spontaneous reporting. During the second and third quarters, active monitoring for ADEs took place in the adult, pediatric medical, and intensive care wards. ADEs were assessed for causality using the Naranjo algorithm and for severity and preventability. The incidence of ADEs was calculated and the detection methods were compared.

RESULTS

The incidence of ADEs detected through surveillance was significantly higher (p < 0.001) than for ADEs reported spontaneously for both inpatients (3.592 vs 0.068/100 patient days) and outpatients (0.299 vs 0.022/100 patient visits). Most ADEs were judged to be of mild to moderate severity. About 56% of ADEs were judged definite or probable and, of these, 13.8% were consistently judged preventable. The most prevalent drugs implicated were central nervous system (23.6%), antiinfective (17.1%), and cardiovascular (16.5%) agents. The best ADE detection method was using physicians' notes.

CONCLUSIONS

Active surveillance for ADEs, with the aid of ADE trigger alerts, yields a significantly higher number of reports than spontaneous reporting. Such surveillance is useful in identifying areas where improvements in the safe use of drugs can be made.

摘要

背景

药物不良事件(ADEs)一直是所有医疗专业人员关注的问题。即使是严重的药物不良事件,在所有患者护理环境中也存在报告不足的情况。

目的

在阿联酋一家拥有360张床位的卡西米医院,发现药物不良事件的发生率、最佳检测方法及可预防性。

方法

2003年第一和第四季度,药物不良事件的数据收集仅限于自发报告。在第二和第三季度,对成人、儿科医疗和重症监护病房进行了药物不良事件的主动监测。使用纳朗霍算法评估药物不良事件的因果关系,并评估其严重程度和可预防性。计算药物不良事件的发生率并比较检测方法。

结果

通过监测发现的住院患者(3.592对0.068/100患者日)和门诊患者(0.299对0.022/100患者就诊)药物不良事件的发生率显著高于自发报告的发生率。大多数药物不良事件被判定为轻度至中度严重程度。约56%的药物不良事件被判定为肯定或可能,其中13.8%被一致判定为可预防。涉及的最常见药物是中枢神经系统药物(23.6%)、抗感染药物(17.1%)和心血管药物(16.5%)。最佳的药物不良事件检测方法是使用医生记录。

结论

借助药物不良事件触发警报对药物不良事件进行主动监测,报告数量比自发报告显著更高。这种监测有助于识别可改进药物安全使用的领域。

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