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药剂师及制药行业的职责。

The duty of the pharmacist and the pharmaceutical industry.

作者信息

Dwyer Peter

机构信息

Faculty of Medicine, School of Physiology & Pharmacology, Drug Development Program, University of New South Wales, Australia.

出版信息

Med Law. 2003;22(3):495-516.

Abstract

The common law duty of care, an essential element of the tort of negligence, focuses on conduct. Accordingly, any discussion of the existence, nature and content of the duty of care of a pharmaceutical manufacturer and of a pharmacist, requires analysis of their respective functions. Also relevant are the special nature and effects of drug products and their approval for and acceptance in, human therapy based upon a balancing of risks and benefits. Critical to a manufacturer's potential tortuous liability is the so-called 'learned intermediary, role of pharmacists, prescribers and other health professionals and whether they have current and accurate drug product information. Manufacturers are not necessarily the only source of drug information available to health professionals. These responsibilities serve patients who also need to be adequately informed so as to achieve optimal safety and efficacy when using prescribed medications.

摘要

普通法上的注意义务是过失侵权行为的一个基本要素,它关注的是行为。因此,任何关于药品制造商和药剂师注意义务的存在、性质和内容的讨论,都需要分析他们各自的职能。药品的特殊性质和效果,以及基于风险与收益平衡对其在人体治疗中的批准和接受情况,也具有相关性。对制造商潜在侵权责任至关重要的是药剂师、开处方者及其他健康专业人员所谓的“有见识的中间人”角色,以及他们是否拥有最新和准确的药品信息。制造商不一定是健康专业人员可获取的药品信息的唯一来源。这些职责服务于患者,患者也需要得到充分告知,以便在使用处方药时实现最佳的安全性和有效性。

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