零售药店质量负责人变更情况分析及监管对策  

Analysis of the Change of Quality Managers in Retail Drugstores and the Supervision Countermeasures

作　　者：张守钗 张丽 余佳 何林飞 ZHANG Shouchai;ZHANG Li;YU Jia;HE Linfei(Hangzhou Jianggan Food and Drug Inspection Team,Hangzhou,Zhejiang,China 310016;Hangzhou Service Center for Food and Drug Inspection,Hangzhou,Zhejiang,China 310000)

机构地区：[1]浙江省杭州市江干区食品药品稽查大队,浙江杭州310016 [2]浙江省杭州市食品药品查验服务中心,浙江杭州310000

出　　处：《中国药业》2019年第4期82-85,共4页China Pharmaceuticals

摘　　要：目的加强对零售药店质量负责人的监管,促进药品流通安全。方法对杭州市江干区2014年至2017年历年企业质量负责人变更数据进行统计与分析。结果质量负责人变更率由2014年的48.53%降至2017年的32.54%; 2014年及2015年变更率均显著高于2016年和2017年(P <0.01),但2014年与2015年,以及2016年与2017年变更率均相当(P> 0.05)。结论应从企业自身、监管部门、社会角度出发,提出相应对策,确保质量负责人的稳定性,发挥其应有作用,维护药品经营质量安全。Objective To strengthen the supervision of quality managers in the retail drugstores and promote the safety of drug circulation.Methods The change data of quality managers in the enterprises in Jianggan district of Hangzhou City from 2014 to 2017 were statistically analyzed.Results The change rate of quality managers decreased from 48.53%in 2014 to 32.54%in 2017,the change rates in 2014 and 2015 were significantly higher than those in 2016 and 2017(P<0.01),but the change rate between 2014 and 2015 was similar to that between 2016 and 2017(P >0.05).Conclusion From the point of view of enterprises,supervision departments and society,the corresponding countermeasures should be put forward to ensure the stability of quality managers,play their due roles and maintain the quality and safety of drug management.

关 键 词：质量负责人 零售药店 药品经营质量管理规范 药品流通监管 药品监管 

分 类 号：R95[医药卫生—药学]