Falconer Nazanin, Barras Michael, Martin Jennifer, Cottrell Neil
School of Pharmacy, Pharmacy Australia Centre of Excellence, The University of Queensland, 20 Cornwall Street, Woolloongabba, Brisbane, QLD, 4102, Australia.
Princess Alexandra Hospital, Metro South Health, Brisbane, QLD, 4102, Australia.
Eur J Clin Pharmacol. 2019 Feb;75(2):137-145. doi: 10.1007/s00228-018-2567-5. Epub 2018 Oct 11.
The multiplicity in terms and definitions of medication-related harm has been a long-standing challenge for health researchers, clinicians, and regulatory bodies. The purpose of this narrative review was to report the diversity of terms; compare definitions, classifications, and models describing medication harm; and suggest which may be useful in both clinical practice and the research setting.
A narrative review of key studies defining and/or classifying medication harm terminology was undertaken.
This review found that numerous terms are used to describe medication harm, and that there is a lack of consistency in current definitions, classifications, and applications. This lack of consistency applied across clinical jurisdictions and regulatory terminologies. A number of limitations in current definitions and classifications were identified. These included the exclusion of key types of medication harm events, ambiguous wording, and a lack of clarity and consensus on subclassifications. In general, there was some overlap in key models from the literature and these were presented to describe similarities and differences.
Without uniformity quantifying, comparing, combining, or extrapolating medication harm data, such as a rate of harm in a specific population, is a challenge for those involved in medication safety and pharmacovigilance. There is a pressing need for further discussion and international consensus on this topic. Adoption of standard descriptors by practitioner groups, regulatory and policy organisations would foster quality improvement and patient safety.
药物相关伤害的术语和定义繁多，长期以来一直是健康研究人员、临床医生和监管机构面临的挑战。本叙述性综述的目的是报告术语的多样性；比较描述药物伤害的定义、分类和模型；并指出哪些在临床实践和研究环境中可能有用。
对定义和/或分类药物伤害术语的关键研究进行叙述性综述。
本综述发现，有许多术语用于描述药物伤害，并且当前的定义、分类和应用缺乏一致性。这种缺乏一致性的情况在临床领域和监管术语中都存在。确定了当前定义和分类中的一些局限性。这些包括排除关键类型的药物伤害事件、措辞含糊以及对亚分类缺乏清晰度和共识。总体而言，文献中的关键模型存在一些重叠，现将其呈现以描述异同。
对于参与药物安全和药物警戒的人员来说，在没有统一标准的情况下量化、比较、合并或推断药物伤害数据，如特定人群中的伤害率，是一项挑战。迫切需要就这一主题进行进一步讨论并达成国际共识。从业者团体、监管和政策组织采用标准描述符将促进质量改进和患者安全。
