【作者】 陈蕾；

【导师】 汤少梁；

【作者基本信息】 南京中医药大学 ， 公共管理， 2024， 硕士

【摘要】 目的:目前我国已经进入到药品集中带量采购常态化发展的新阶段,在药价得到显著降低的同时,药品断供等问题也为政策的持续发展提出了新的考验。本文是对2000年以来我国药品集中采购政策进行的文本分析,包括了对政策主题的归纳概括和趋势分析,以及对样本政策的量化评价,旨在总结政策存在的优势与不足,为后续政策的制定提供参考。方法:本文的数据来源为北大法宝法律数据库,筛选2000-2023年间发布的305项国家和省级层面药品集中采购政策文本作为研究对象。首先,从发文量、效力位阶和发文地区对政策进行综合性评估。其次,对文本进行预处理,并绘制词云图,通过LDA(Latent Dirichlet Allocation)主题模型挖掘政策的潜在主题,利用困惑度指标确定最优主题数,通过主题-词项的分布进行主题的识别,通过文档-主题分布计算不同时期主题强度的变化。最后,使用PMC指数(Policy Modeling Consistency Index)模型,对分层抽样的12份政策进行对比分析和曲面图绘制。结果:研究表明,我国的药品集中采购制度在发文量上的年度差异较大,以2009、2015、2019为节点可进行发展阶段的划分;在效力位阶上以地方规范性文件为主;在发文地区上呈现出一定的邻近效应。由词云图可知,政策的重点之一在于利益主体的行为规范。对LDA模型聚类的结果进行总结,可归纳政策主题为:“支付方式”、“采购范围”、“药品价格”、“部门合作”和“质量评价”。其中,“部门合作”为增长型主题,“支付方式”和“采购范围”为衰退型主题,“药品价格”和“质量评价”为平稳型主题。在对12份样本进行的PMC指标测算中,政策平均得分为6.47,为良好水平。国家层面的政策得分高于省级层面。政策评级集中在良好和及格,但在预测性、监督机制和主体合作上还存在不足,在政策主题和措施手段上得分相对较低。结论:我国的药品集中采购政策呈现出阶段性发展的特征,各阶段的主题热点和而不同。从政策文本出发,需要进一步丰富政策发展的内涵。在评价机制上,应当始终坚持质量与价格并重;在采购范围上,要动态调整参选调整药品目录和企业;在政策主体上,应注重与医保和医疗的协同。同时,在政策制定时,应关注预测性和灵活性,加强对政策宣传、药品配送等环节的关注,形成药品集中采购全链条的规范与监督。更多还原

【Abstract】 Objective:At present,China has entered a new stage of normalized development of centralised purchasing of drugs,while drug prices have been significantly reduced,problems such as drug supply cuts have also posed a new test for the continued development of the policy.This research is a textual analysis of China’s centralised drugs procurement policy since 2000,including a summary of policy themes and trend analysis,as well as a quantitative evaluation of the sample policy,aiming to summarize the strengths and weaknesses of the policy and to provide a reference for the development of subsequent policies.Method:The source of data is the Peking University Law Database,which screens 305 national and provincial-level centralised drug procurement policy texts issued between 2000 and 2023.Firstly,the overall policies are comprehensively assessed in terms of the number of texts issued,the level of effectiveness and the region in which they were issued.Secondly,the policy documents are preprocessed and word cloud maps are drawn,the potential themes of the policies are mined through the LDA(Latent Dirichlet Allocation)theme model,the optimal number of themes is determined by using the perplexity index,the themes are identified through the distribution of theme-phrase items,and the changes of theme intensity in different periods are calculated through the distribution of documents-themes,and the policy’s development trend is interpreted.Finally,12 policies were analyzed by Policy Modeling Consistency Index using stratified sampling method.Results:The study shows that China’s centralised drug procurement system has a large annual difference in the number of documents issued,which can be divided into stages of development with the nodes of 2009,2015,and 2019;shows a certain neighborhood effect in the region of issuance;and is dominated by local normative documents in terms of the order of effectiveness.From the word cloud diagram,it can be seen that one of the focuses of the policy lies in the regulation of the behavior between the subjects of interest.Summarizing the themes obtained from the clustering of the LDA model,the policy themes can be summarized as follows:"Payment method","Procurement scope","Drug price","sectoral cooperation",and"quality evaluation".Among them,"sectoral cooperation" is a growth theme,"payment methods" and"Procurement scope" are recession themes,"drug prices" and "quality assessment" are smooth themes.In the PMC indicator measure for the 12 samples,the average policy score was 6.47,a good level.Policies scored higher at the national level than at the provincial level.Policy ratings are concentrated in good and passing,but there are deficiencies in predictability,monitoring mechanisms and subjective cooperation,and lower scores on policy themes and means of measures.Conclusion:China’s centralised drug procurement policy has been characterised by a phased development,with different themes in each phase.Starting from the policy text,there is a need to further enrich the connotation of policy development.In the evaluation mechanism,quality and price should always be given equal importance;in the scope of procurement,dynamic participation should be made to adjust the drug catalogue and enterprises;in the supporting measures,incentives should be strengthened.At the same time,in policy development,attention should be paid to predictability and flexibility,sectoral cooperation should be strengthened,policy themes should be enriched,and the whole chain of drug procurement should be regulated and supervised.更多还原