Aronson Jeffrey K, Ferner Robin E
Department of Clinical Pharmacology, Radcliffe Infirmary, Oxford, UK.
Drug Saf. 2005;28(10):851-70. doi: 10.2165/00002018-200528100-00003.
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.
围绕药物安全性的术语必须清晰明确，以便患者、开处方者、制造商和监管机构都能相互理解。特别是，需要明确不良事件与药物治疗之间的关系、它们的最佳分类方式以及发生频率、强度和严重程度。因此，在本文中，我们将讨论并定义药物安全领域中使用的术语，尤其是那些有时被误解或误用的术语，包括药品、药物制剂、辅料、不良事件（或经历）和药物不良反应（或效应）。我们还将讨论用于定义不良反应的严重程度、强度和风险及其分类的术语。我们没有像通常那样从头开始创建定义，而是采用了一种新颖的方法，即批判性地审视已提出或广泛使用的定义，并根据对其优缺点的逻辑评估制定新的或经过修改的定义。我们希望这些定义能引发讨论，从而使一套令人满意的定义得到广泛认可。
