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处方药的药品说明书:患者需要哪些最少信息?

Package inserts for prescribed medicines: what minimum information do patients need?

作者信息

Hermann F, Herxheimer A, Lionel N D

出版信息

Br Med J. 1978 Oct 21;2(6145):1132-5. doi: 10.1136/bmj.2.6145.1132.

Abstract

The information a patient needs about a prescribed medicine can be determined by considering what responsibilities he can assume in relation to taking medicine. When the medicine has been dispensed the patient needs to know how to take the drug; how to store the drug; how it is expected to help; and how to recognise problems and what to do about them. A guide was designed to specify what information is required to meet these needs. Using this guide, a set of minimum information on tetracycline was prepared that aimed at being brief, specific, and readable. The best format for the information remains to be determined. Since leaflets produced by professional organisations are generally unsuitable for these purposes, information sets should be put together by small independent groups consisting of clinical pharmacologists, clinicians, pharmacists, and consumers. Each country should produce its own sets, adapting model sets to the circumstances of local practice.

摘要

患者所需的关于处方药的信息可通过考虑其在服药方面能够承担何种责任来确定。当药物配好后,患者需要知道如何服药;如何储存药物;药物预期如何发挥作用;以及如何识别问题并应对这些问题。设计了一份指南来明确满足这些需求所需的信息。利用这份指南,编写了一套关于四环素的最低限度信息,力求简洁、具体且通俗易懂。信息的最佳呈现形式仍有待确定。由于专业组织制作的宣传册通常不适合这些用途,信息集应由临床药理学家、临床医生、药剂师和消费者组成的小型独立团体来整理。每个国家都应根据当地实际情况,参照示范信息集编写自己的信息集。

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