摘要
目的:为我国大陆地区完善非处方药管理体系提供参考。方法:通过分析我国台湾地区非处方药分类、注册管理、药品转类程序与配套措施、药品说明书和包装管理等措施,结合目前我国大陆地区非处方药管理的现状及问题,提出完善我国大陆地区非处方药管理体系的建议。结果与结论:台湾地区非处方药分为医师药师药剂生指示药(以下简称"指示药")和成药,指示药须经由医师、药师或药剂生等医药专业人员指导使用。指示药的注册管理按照《指示药审查基准》实施,该基准不仅对指示药的有效成分、剂型、适应证、用法用量、副作用、注意事项以及警示语等内容进行了规范,还规定了指示药的标签、药品说明书以及包装外盒的刊印要求。台湾地区还建立了药品转类评估机制,以扩大处方药转为非处方药的品种范围,并配备了一系列配套措施以降低药品转类之后产生的安全风险。此外,台湾地区还于2016年制定了《西药非处方药仿单外盒格式及相关规范》,对药品说明书和外盒进行了改版,不仅使其格式更为规范,用语也更通俗易懂,使民众更容易阅读。建议我国大陆地区可借鉴台湾地区的经验,为非处方药设置专门的注册渠道并简化审评审批要求,重视并完善处方药与非处方药转换的配套措施,鼓励药品生产企业在品牌建设的同时提高非处方药药品说明书标签的易懂性,从而构建一个有效引导的非处方药管理体系。
OBJECTIVE:To provide reference for the improvement of OTC drug management system in China's Mainland.METHODS: By analyzing the classification, registration management, conversion procedures and supporting measures,instructions and packaging management of OTC drugs in Taiwan Region of China,and considering the current situation and problems of OTC drug management in China's Mainland,suggestions for improving OTC drug management system in China's Mainland were put forward. RESULTS & CONCLUSIONS:OTC drugs of Taiwan Region could be divided into drugs instructed by physicians and pharmacists(hereinafter referred to as "instructed drugs")as well as patent drugs. The registration management of instructed drugs was implemented in accordance with the Criteria for the Review of Instructed Drugs. The criteria not only regulated the active ingredients,dosage forms,indications,usage and dosage,side effects,matters needing attention and warnings of instructed drugs,but also stipulated the requirements for labeling,instructions and outer-of-the-box printing of instructed drugs. Taiwan Region had also established a mechanism for evaluating drug conversion to expand the variety range of prescription drugs converted to OTC drugs,and had equipped a series of supporting measures to reduce the safety risks arising from drug conversion. In 2016,Taiwan Region also formulated the Format and Relevant Standards for Outer-of-the-Box of Generic Western OCT Drug,and revised the drug instructions and the outer-of-the-box. The format was more standardized and the terminology was easier to understand,which made it easier for the public to read. It is suggested that China's Mainland should refer to the experience of Taiwan Region,set up special registration channels for OTC drugs and simplify the requirements for examination and approval,pay attention to and improve the matching measures for the conversion of prescription drugs to OTC drugs,encourage brand building and improve intelligibility of OTC drug instructions,so as to build an effective
作者
颜建周
葛其南
朱梓荣
邵蓉
YAN Jianzhou;GE Qinan;ZHU Zirong;SHAO Rong(Research Center of National Drug Policy & Pharmaceutical Industry Economics,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药房》
CAS
北大核心
2019年第16期2161-2165,共5页
China Pharmacy
基金
国家社会科学基金重大项目(No.15ZDB167)
