从药品质量公告数据的分析看如何监管药品质量风险

发布时间：2018-01-13 18:00

本文关键词：从药品质量公告数据的分析看如何监管药品质量风险　出处：《中国药房》2016年04期 　论文类型：期刊论文

【摘要】：目的:探索以药品质量公告数据分析为基础的药品质量风险动态评估机制。方法:在对国家食品药品监督管理总局和各省药品监督管理部门发布的2013年药品质量公告数据整理的基础上,分析其中涉及的药品品类、品种、产地、生产企业数量和上榜频次分布情况。结果与结论:中药上榜的比例(0.75%)高于化学药(0.30%)。上榜频次在10次及以上的药品中,化学药以注射液居多(70%),中药以片剂居多(66.7%);且所有品种中,生产企业数量在100家以上的药品品种占到62.5%,生产企业数量在50家以上的药品品种占93.75%,可见生产企业数量较多的品种出问题的频次较高。药品质量公告数量排在前10位的省份表现出不同的问题品类分布特点,其中吉林、广西、内蒙古、四川的中药质量问题较为突出,涉及到的中药药品文号数量占比分别为85%、80%、97%和69%;而河南、山西、江苏、广东、安徽、山东的化药质量问题也值得关注,涉及到的化药药品文号数量占比分别为62%、61%、95%、57%、86%和65%。建议有关部门以药品质量公告数据为基础实施动态的风险评估机制,并加强对于地方药品质量公告数据采集的规范化管理。
[Abstract]:Objective: to explore the dynamic evaluation mechanism of drug quality risk based on the data analysis of drug quality bulletin. On the basis of the data of 2013 drug quality announcement issued by the State Administration of Food and Drug Administration and the drug supervision and administration departments of various provinces. Analysis of the drugs involved in the category, variety, origin. Results and conclusion: the proportion of traditional Chinese medicine on the list was 0.75) higher than that of chemical medicine 0.30%. Most of the chemical drugs were injection, and the traditional Chinese medicine was more than 66.7% in tablets. And of all the varieties, the number of production enterprises in more than 100 drug varieties accounted for 62.5%, the number of production enterprises in more than 50 drug varieties accounted for 93.75%. It can be seen that the number of production enterprises have more varieties with higher frequency of problems. The number of drug quality announcements in the top 10 provinces show different distribution characteristics of problem categories, including Jilin, Guangxi, Inner Mongolia. The quality of traditional Chinese medicine in Sichuan is more prominent, involving the number of traditional Chinese medicine drug number accounted for 85%, 80% and 69%; However, the quality of chemical drugs in Henan, Shanxi, Jiangsu, Guangdong, Anhui and Shandong are also worthy of attention. It is suggested that the relevant departments should implement a dynamic risk assessment mechanism based on the drug quality announcement data and strengthen the standardized management of local drug quality announcement data collection.
【作者单位】：北京中医药大学管理学院;
【基金】：北京中医药大学自主选题项目(No.2014-JYB22-JS-006)
【分类号】：R95
【正文快照】： “毒胶囊”事件把我国药品质量安全监管问题推到了风口浪尖上,面对众多的药品和药品生产企业,监管工作的确有相当大的难度。而随着大数据时代的到来,如何通过平时工作的累积和数据分析对具有高风险的企业和高风险的药品品种加以有效甄别,这个问题值得更多的研究者进行探讨,

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