摘要
目的 为药品追溯体系政策的制订提供理论依据.方法 采用计算机检索北大法宝政策数据库和国家药品监督管理局等部门的官方网站中有关我国中央政府层面发布的药品追溯体系政策文本,检索时限为 2016 年 1 月至 2022 年 10 月.采用Nvivo 12 Plus质性分析软件从政策工具及利益相关者 2 个维度进行政策文本分析.结果 共纳入 22 项政策文本.政策工具维度中,命令与规制型、激励型、能力建设型、系统变革型、信息与劝诫型工具分别占 61.72%,5.47%,22.66%,1.56%,8.59%;利益相关者维度中,政府相关部门、药品生产企业、药品经营企业、药品使用单位、消费者分别占 38.25%,20.74%,22.12%,13.36%,5.53%.结论 政策工具使用频率存在一定差异,政策工具与利益相关者耦合性欠佳.建议有效利用政策工具,完善相关法律法规,加强药品追溯体系能力建设,重视药品追溯体系信息宣传作用,提供激励引导型政策.
Abstract
Objective To provide a theoretical basis for the formulation of drug traceability system policy.Methods The relevant policy texts of drug traceability system were searched from the Peking University Treasure Policy Database,official websites of departments such as the National Medical Products Administration,and other policies issued by the central government of China from January 2016 to October 2022.Nvivo 12 Plus qualitative analysis software was adopted to analyze the policy texts from two dimensions of policy tools and stakeholders.Results Twenty-two policy texts were included.In the dimension of policy tools,command and regulation,incentive,capacity building,system transformation,and information and persuasion tools accounted for 61.72%,5.47%,22.66%,1.56%,and 8.59%,respectively.In the dimension of stakeholders,relevant government departments,drug manufacturers,drug distributors,drug users,and consumers accounted for 38.25%,20.74%,22.12%,13.36%,and 5.53%,respectively.Conclusion There are some differences in the frequency of using policy tools,and the coupling between policy tools and stakeholders is poor.It is recommended to effectively utilize policy tools,improve relevant laws and regulations,strengthen the construction of drug traceability system,pay attention to policies advocacy of drug traceability system,and provide incentive and guided policies.
基金项目
2021年卫生健康工作建议提案分析研究项目(BUCM-2021-KJ-GL0031)
维普
万方数据