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
李玥琦 1周悦鹏 1刘华明 1沈俊杰 1郗昊 2王翀 2胡增峣 3金瓯4
作者信息
- 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
- 折叠
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.
Abstract
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Key words
pharmaceuticals sampling and testing/online sampling/sampling and testing procedures/prescription drug/mixed batches引用本文复制引用
出版年
2024
NETL
NSTL
万方数据