Clarifying adverse drug events: A clinician's guide to terminology, documentation, and reporting

Clarifying adverse drug events: A clinician's guide to terminology, documentation, and reporting
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DOI:
10.7326/0003-4819-140-10-200405180-00009
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发表时间:
2004-05-18
影响因子:
39.2
通讯作者:
Samore, MH
Samore, MH
中科院分区:
医学1区
文献类型:
--
作者:
Nebeker, JR;Barach, P;Samore, MH

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药物不良事件导致大量的发病率和死亡率,但他们仍然被低估和误解。描述与药物相关的错误和患者伤害的术语引起了许多混乱。本文通过对一名患者发生多起药物不良事件的案例研究,阐明了不良事件、药物不良反应、药物不良事件、用药错误和副作用等关键术语。病例讨论说明了分析可疑药物和不良事件之间因果关系的临床方法。提供了有意义的药物不良事件记录的示例和依据,沿着了应报告给监管机构的事件类型概述。
Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.