文章摘要
药品网络抽检存在的问题及对策分析
Problems and Sloutions of Online Sampling and Testing of Pharmaceuticals
投稿时间:2023-11-04  修订日期:2024-03-22
DOI:
中文关键词: 药品抽检  网络抽样  抽检程序  处方药  混批
英文关键词: drug sampling and testing  online sampling  sampling and testing workflow  prescription drug  blended batches
基金项目:
作者单位邮编
李玥琦 苏州市药品检验检测研究中心 215104
周悦鹏 苏州市药品检验检测研究中心 
刘华明 苏州市药品检验检测研究中心 
沈俊杰 苏州市药品检验检测研究中心 
郗昊 中国食品药品检定研究院 
王翀* 中国食品药品检定研究院 100050
胡增峣 国家药品监督管理局 
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中文摘要:
      目的:药品抽检工作在网络销售渠道开展存在挑战,需改进和完善抽检工作的实际操作和理论研究,以适应药品监管的新形势。方法: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,并提出可行对策和建议。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。
英文摘要:
      Objective: Supervision of pharmaceuticals through sampling and testing is challenging when it comes to network marketing. Practical operations and theory study of sampling and testing needs to be improved and adapted. Methods: In this pilot project of online sampling and testing of pharmaceuticals, we created and executed the scheme based on the features of internet drug shopping. Existing problems and risks are analyzed involving procedure, prescription and logistics, and practical solutions are offered. Results and conclusions: Related legislation needs to be revised to adapt online sampling, credentials of sampling and acquisition of prescription need to be standardized. We propose to check the authenticity, optimize procedure of blended batches, and setup a system to carry out tests dynamically.
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