药品网络抽检存在的问题及对策分析  

Problems and Solutions of Online Sampling and Testing of Pharmaceuticals

作　　者：李玥琦 周悦鹏 刘华明 沈俊杰 郗昊 王翀[2] 胡增峣 金瓯 Li Yueqi;Zhou Yuepeng;Liu Huaming;Shen Junjie;Xi Hao;Wang Chong;Hu Zengyao;Jin Ou(Suzhou Institute for Drug Control,Suzhou 215104,China;National Institutes for Food and Drug Control,Beijing 100050,China;National Medical Products Administration,Beijing 100037,China;Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104 [2]中国食品药品检定研究院,北京100050 [3]国家药品监督管理局,北京100037 [4]浙江省食品药品检验研究院,杭州310052

出　　处：《中国药事》2024年第4期377-380,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:在网络销售渠道开展药品抽检工作存在挑战,需改进抽检工作的实际操作和完善理论研究,以适应药品监管的新形势。方法:在药品网络抽检试点工作中,依据网售药品的特点,制定抽检方案并执行。分析抽查检验程序、处方开具及审核、药品储运等方面的困难及风险点,并提出对策和建议。结果与结论:建议修订和完善相关法律规章中关于网络抽检的内容,对抽样凭证和处方获取等作统一要求;核实样品真实性,优化混批样品的处置流程,设立动态检验机制。Objective:Supervision of pharmaceuticals through sampling and testing is challenging when it comes to online marketing.Practical operations of sampling and testing need to be adapted and theory study needs to be improved for the new situation of drug regulation.Methods:In this pilot project of online sampling and testing of pharmaceuticals,we created and executed the scheme based on the features of internet pharmaceuticals shopping.Existing problems and risks were analyzed involving procedure,prescription and logistics,and practical solutions were offered.Results and Conclusion:Related legislation needs to be revised to adapt online sampling and testing,credentials of sampling and acquisition of prescription need to be standardized.We propose to check the authenticity,optimize procedure of mixed batches,and setup a dynamic inspection mechanism.

关 键 词：药品抽检 网络抽样 抽检程序 处方药 混批 

分 类 号：R95[医药卫生—药学]