从药品质量公告数据的分析看如何监管药品质量风险
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篇名: 从药品质量公告数据的分析看如何监管药品质量风险
TITLE:
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 drug quality dynamic evaluation mechanism based on analysis of drug quality announcement

data. METHODS:The sorts and types of drugs,places of origin,quantity of production enterprises and frequency distribution

of being mentioned were analyzed on the basis of drug quality announcement issued by CFDA and provincial administration in

2013. RESULTS & CONCLUSIONS:Frequency of TCM being mentioned (0.75%) was higher than that of chemical drug

(0.30%). Among drugs mentioned more than 10 times,the most chemical drugs were injection(70%)and the most TCM were

tablet(66.7%). Among all types,drug types produced by more than 100 enterprises accounted for 62.5%,and those produced by

more than 50 enterprises accounted for 93.75%,which indicated the frequency of problems was in relatively direct proportion to

the quantity of drug manufacturing enterprises. Top 10 provinces in the list of the number of drug quality announcements showed

different characteristics of problem type distribution. In compassion,the quality problems of TCM in Jilin,Guangxi,Mongolia,Sichuan

were prominent,and reference number proportion of involved TCM were 85%,80%,97% and 69%,respectively;the

quality problems of chemical drugs in Henan,Shanxi,Jiangsu,Guangdong,Anhui,Shandong should be paid attention,and reference

number proportion of involved chemical drugs were 62%,61%,95%,57%,86% and 65%,respectively. It is suggested

that the government should carry out the dynamic risk assessment system based on data of drug quality announcement,and strengthen

standard management of data collection of local drug quality announcement.

期刊: 2016年第27卷第4期
作者: 王玉伟,杨莉,吉垠霖,陈玄音,都恩环,耿冬梅
AUTHORS: WANG Yuwei,YANG Li,JI Yinlin,CHEN Xuanyin,DU Enhuan,GENG Dongmei
关键字: 药品;质量公告;监管;风险
KEYWORDS: Drug;Quality Announcement;Regulation;Risk
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