How to Administrate the Risk of Drug Quality Based on Drug Quality Announcement
10.6039/j.issn.1001-0408.2016.04.08
- VernacularTitle:从药品质量公告数据的分析看如何监管药品质量风险
- Author:
Yuwei WANG
;
Li YANG
;
Yinlin JI
;
Xuanyin CHEN
;
Enhuan DU
;
Dongmei GENG
- Publication Type:Journal Article
- Keywords:
Drug;
Quality Announcement;
Regulation;
Risk
- From:
China Pharmacy
2016;(4):458-460
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To explore drug quality dynamic evaluation mechanism based on analysis of drug quality announce-ment data. METHODS:The sorts and types of drugs,places of origin,quantity of production enterprises and frequency distribu-tion 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,Si-chuan 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 refer-ence 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 strength-en standard management of data collection of local drug quality announcement.
