药品说明书的歧义现象及解决对策

Ambiguity and Countermeasures in the Drug Instruction Manual

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。

OBJECTIVE：To provide reference for clinical use and revision of drug instruction manual.METHODS：The ambiguity in drug instructions manual was summarized and countermeasures of revision were presented based on the practical clinical conditions.RESULTS CONCLUSIONS：The problems of drug instruction manual that may mislead the patients and medical personnel were as follows as controversial main contents,unclear descriptions of instruction,unfocused contents or without key points,one instruction for multiple drugs,obvious or inaccurate translations,words without popularity and standardization and wrong sentence division or non-standard typesetting.It is suggested that the manufacturers should attach highly importance to the revision of drug instruction manual;the revisers should understand the meaning of drugs instruction manual and know the subjects;the premarketing instructions should be tested and investigated by necessary persons;the major and cultural quality of revisers should be improved;the approval monitoring should be strengthened and the feedback mechanism should be established to further improve the instructions,guide the medical staff and patients with accurate use of drugs and ensure the safe drug use of patients.