基于NVIVO 12.0及政策文本的国家药品抽检发展历程分析  

Development Process of Drug Sampling and Testing Inspection in China:An Analysis Based on NVIVO 12.0 Software and Policy Text

作　　者：王瑞丽 朱嘉亮[2] 黄志禄 WANG Ruili;ZHU Jialiang;HUANG Zhilu(College of Business Administration,Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110016;National Institutes for Food and Drug Control,Beijing,China 102629)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]中国食品药品检定研究院,北京102629

出　　处：《中国药业》2021年第3期6-10,共5页China Pharmaceuticals

摘　　要：目的梳理药品抽检政策的发展历程,提出改进现行抽检模式的思路和方法。方法以我国政府1984年至2019年公开发布的32份药品抽检政策文本为研究对象,采用NVIVO 12.0软件对政策文本进行裂解编码,形成以"政策发文单位""政策目标""抽检工作重点"为一级节点的三级分析框架,将子节点与"发文时间"进行矩阵分析,梳理出我国不同阶段药品抽检工作的模式。结果我国药品抽检发展历程可分为探索阶段(1984年至2000年)、发展阶段(2001年至2007年)、创新阶段(2008年至2018年)、抽检新纪元阶段(2019年及以后),且各阶段政策发文单位、政策目标、抽检工作重点均呈现不同特点。结论我国应进一步加强药品检查、检验、查处的联动机制,完善药品质量公告制度,有效执行药品购样政策,合理规划抽检覆盖面,提升药品监管的科学性和有效性。Objective To sort out the development progress of drug sampling and testing in China,and to propose ideas and methods for improvement of the current drug sampling and testing mode.Methods Totally 32 drug sampling and testing policy texts publicly released by the Chinese government from 1984 to 2019 were taken as the research object,and NVIVO 12.0 software was used to encode the policy texts separately to form a three-level analysis framework with″the main body of policy release″″policy objectives″and″key points of sampling inspection and test work″as the first-level nodes,the mode of drug sampling and testing at different stages in China was sorted out after matrix coding of each child node and″policy release time″.Results The development progress of drug sampling and testing in China could be divided into the exploration stage(1984-2000),development stage(2001-2007),innovation stage(2008-2018),new era stage(2019 and beyond).The main body of policy release,policy objectives and key points of sampling and testing work in each stage had different characteristics.Conclusion It is suggested that China should further strengthen the linkage mechanism of drug inspection,sampling and testing,investigation at this stage,improve the drug quality announcement system,effectively implement the drug purchase policy,reasonably plan the coverage of sampling and testing,and improve the scientificity and effectiveness of drug supervision.

关 键 词：药品抽检 政策 发展历程 NVIVO软件 文本分析 

分 类 号：R951[医药卫生—药学]