Clarification of terminology in drug safety
Clarification of terminology in drug safety
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DOI：
10.2165/00002018-200528100-00003
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发表时间：
2005-01-01
期刊：
影响因子：
4.2
通讯作者：
Ferner, RE
中科院分区：
文献类型：
--
作者：
Aronson, JK;Ferner, RE
围绕药物安全的名词必须清晰明确，以便患者、处方者、制造商和监管机构都能相互理解。特别是，需要明确不良事件和药物治疗之间的关系，如何对它们进行最佳分类，以及它们的频率、强度和严重性。因此，在本文中，我们讨论并定义了药物安全性领域中使用的术语，特别是有时被误解或误用的术语，包括药品、药物制剂、赋形剂、不良事件（或经历）和药物不良反应（或效应）。我们还讨论了用于定义不良反应的严重性、强度和风险的术语及其分类，而不是像通常那样从头开始定义，我们采取了一种新颖的方法，批判性地审查已提出或广泛使用的定义，并根据其优缺点的逻辑评估制定新的或修改的定义。我们希望，这些定义将导致讨论，从而能够广泛商定一套令人满意的定义。
Nomenclature surrounding drug safety needs to be clear and unambiguous, so that patients, prescribers, manufacturers, and regulators can all understand each other. In particular, it needs to make it clear how adverse events and drug therapy are related to one another, how they are best classified, and their frequency, intensity and seriousness.In this article, we therefore discuss and define terms used in the field of drug safety, particularly terms that are sometimes misunderstood or misused, including medicinal product, pharmaceutical formulation, excipient, adverse event (or experience) and adverse drug reaction (or effect). We also discuss terms used to define the seriousness, intensity, and risk of adverse reactions, and their classification.Instead of creating definitions from scratch, as is commonly done, we have taken the novel approach of critically examining definitions that have been proposed or widely used and have formulated new or modified definitions based on a logical appraisal of their merits and demerits. We hope that these definitions will lead to discussion that will allow a corpus of satisfactory definitions to be widely agreed.