简析当前中成药说明书存在的问题

Analyze the Problems Existing in the Instruction Manual of Chinese Patent Medicine

目的探讨当前口服中成药说明书存在的相关问题,并总结其与之对应的防范措施。方法通过查阅近年中成药说明书相关文献以及结合药师的工作经验,对中成药品说明书的相关问题进行归纳、整理、讨论,对当前中成药说明书的规范程度和完整性进行探讨,并提出针对性的解决措施和建议。结果经分析可知,多数的中成药说明书存在功能主治方面表述不规范、禁忌标准较混乱、用法及用量换算公式较复杂、不良反应描述较含糊、贮藏项和有效期项标示过于简单、药理和毒理缺项严重等列问题,整体表现出不严谨、不全面,表明中成药说明书存在一些规范性问题,影响医师、药师和患者的合理安全用药。结论药品说明书需要药品生产企业、药品监管部门、药品使用单位共同努力和关注,并通过“真正”规范中成药说明书内容、通过促进药品生产企业重视药品说明书规范性的重要和必要、相关监管部门进一步加大监管力度等措施,以期最大程度规范当前中成药说明书存在的具体问题。

Objective To explore the related problems existing in the instructions of oral Chinese patent medicine,and summarize the corresponding preventive measures.Methods By consulting the literature related to the instructions of Chinese patent medicine in recent years and combining with the work experience of pharmacists,the problems related to the instructions of Chinese patent medicine were summarized,sorted out and discussed,the standardization and integrity of the instructions of Chinese patent medicine were discussed,and the corresponding solutions and suggestions were put forward.Results According to the analysis,there were a series of problems in most Chinese patent medicine instructions,such as nonstandard description of functions and indications,incomplete or nonstandard labeling of ingredients,simple and vague or not detailed usage and dosage,non objective or too simple description of adverse reactions,too simple labeling of storage items and expiration date items,and serious lack of items of pharmacology and toxicology.It shows that there are some normative problems in the instructions of Chinese patent medicine,which affect the rational and safe use of drugs by doctors,pharmacists and patients.Conclusion Drug instructions need the joint efforts and attention of drug manufacturers,drug regulatory departments and drug users,and through"truly"standardizing the contents of Chinese patent drug instructions,promoting the importance and necessity of drug manufacturers to attach importance to the standardization of drug instructions,and further strengthening the supervision of relevant regulatory departments.In order to standardize the specific problems existing in the current Chinese patent medicine instructions to the greatest extent.