2010年3月至2019年9月我国中成药药品说明书修订通告发布情况及现状分析

Analysis of Announcement and Current Status of Revision of Drug Instructions of Chinese Traditional Patent Medicine in China from Mar.2010 to Sept.2019

目的:探讨我国中成药药品说明书修订现状,促使中成药药品说明书规范化、合理化。方法:回顾我国药品说明书相关法律法规,查询2010年3月至2019年9月国家药品监督管理部门网站发布的有关中成药药品说明书的公告通知,分析涉及的中成药品种、修订项目等资料,总结中成药药品说明书修订中存在的问题。结果:近10年来国家药品监督管理部门共发布了83个中成药药品说明书修订公告及通知,涉及167个中成药品种,其中处方药66种、非处方药101种;修订项目以禁忌、注意事项、不良反应和增加"警示语"为主。但通过平时工作发现,中成药的药品说明书仍存在着书写不规范、落实情况差、监管力度不够和相关法律法规的约束力不强等情况,对患者的用药安全产生了严重影响。结论:我国中成药药品说明书修订还存在内容缺失等问题,有待进一步完善。

OBJECTIVE:To probe into the current status of revision of drug instructions of Chinese traditional patent medicine in China,so as to promote the standardization and rationalization of Chinese traditional patent medicine.METHODS:Relevant laws and regulations of drug instructions in China were reviewed.The announcement on drug instructions of Chinese traditional patent medicine in China published on the website of the State Drug Administration from Mar.2010 to Sept.2019 were collected.Related data of varieties and revision items of Chinese traditional patent medicine were analyzed,and the existing problems in revision of drug instructions of Chinese traditional patent medicine were summarized.RESULTS:In the past 10 years,the State Drug Administration had issued a total of 83 announcements and notices for the revision of drug instructions of Chinese traditional patent medicine,there were 167 varieties of Chinese traditional patent medicine,including 66 kinds of prescription drugs and 101 kinds of over-the-counter drugs.The revision items were mainly taboos,cautions,adverse drug reactions and warning words.However,through daily practice,it was found that there were still some problems in drug instructions of Chinese traditional patent medicine,such as non-standard writing,poor implementation,insufficient supervision and weak binding force of relevant laws and regulations,which had severe impacts on the safety of medication for patients.CONCLUSIONS:The revision of drug instructions of Chinese traditional patent medicine in China still has problems such as missing contents,which need to be further improved.