药品说明书的歧义现象及解决对策

发布时间：2018-04-12 06:57

本文选题：药品说明书 + 歧义　；参考：《中国药房》2015年22期

【摘要】：目的:为临床使用和修订药品说明书提供参考。方法:针对在阅读药品说明书过程中发现的歧义现象进行归纳与总结,并结合临床实际情况提出解决对策。结果与结论:药品说明书主要存在关键内容相互矛盾、语言表述不清、内容庞杂无重点或关键点不突出、同一说明书对应多种规格的药品、翻译痕迹明显或所翻译的意思表达不准确、用词未兼顾通俗性和规范性、断句错误或排版不规范等问题,容易造成患者和医务人员理解上的偏差。建议药品生产企业应高度重视药品说明书的制订;其制订者应正确理解药品说明书的意义,并充分了解阅读对象;药品上市前药品说明书应经过必要的人群测试和调研;提高药品说明书制订者的专业及文化素质;加强药品说明书的审批监管;建立药品说明书问题的反馈机制等。通过以上措施进一步完善说明书,使医药人员和患者均能在说明书的指导下准确无误地使用药品,确保用药安全。
[Abstract]:Objective: to provide reference for clinical use and revision of drug instructions.Methods: the ambiguity phenomena found in the course of reading drug instructions were summarized and the countermeasures were put forward.Results & conclusion: the key contents of the drug instruction are contradictory, the language is not clear, the content is complex, the key points are not prominent, and the same specification corresponds to many kinds of drugs of different specifications.It is easy for patients and medical staff to misunderstand such problems as obvious traces of translation or inaccurate expression of the translated meaning, lack of attention to both commonality and normality in the use of words, errors in sentence breakage or non-standard typesetting and so on.It is suggested that pharmaceutical manufacturers should attach great importance to the formulation of drug instructions, that the manufacturers should correctly understand the significance of the drug instructions and fully understand the reading objects, that the drug instructions should be tested and investigated by the necessary crowd before they go on the market.To improve the professional and cultural quality of drug instruction makers; to strengthen the supervision and approval of drug instructions; to establish a feedback mechanism for drug instructions.Through the above measures to further improve the instructions, so that medical personnel and patients under the guidance of the instructions to use drugs accurately, to ensure drug safety.
【作者单位】：西安交通大学医学院第一附属医院;
【分类号】：R952

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