Impact of the zero-markup drug policy on volume of medical service:based on 57 county hospitals of China

In the present study,we aimed to assess the long-term impact of zero-markup drug policy on volume of medical service in county hospitals of China.This study used 57 county hospitals’records of medical service from 2011 to 2015,and a fixed effect model was applied to examine the impact of the zero-markup drug policy on volume of medical service.The outcome indicators included the number of patient visits,the number of prescriptions,the number of discharged patients,the length of stay,the number of patients who had surgeries and the number of patients who had CT or MRI,monthly.The number of hospitals which implemented the zero-markup drug policy was increased continuously.By the end of 2015,41 hospitals(71.9%)implemented this policy.The panel regression showed that most indicators were insignificantly decreased,including the number of patient visits(P<0.01),the length of stay(P<0.05),the number of patients who had surgeries(P<0.01)and the number of patients who had CT or MRI(P<0.01).However,the number of prescriptions and the number of discharged patients were not significantly changed.The implementation of the zero-markup drug policy might affect the reduction of the volume of medical service in county-level hospitals and the reason needs to be clarified in future studies.

Research on Incentive Policies for Chinese Innovative Drug R&D - Taking Innovative Anti-tumor Drugs as an Example

Objective To provide reference for improving Chinese innovative drug research and development incentive policies.Methods Based on investigating the incentive policies for innovative drug research and development in clinical research,evaluation and approval in China,anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis.Results and Conclusion Driven by a series of incentive policies for innovative drug R&D,great achievements have been made on anti-tumor drugs.However,there are problems such as concentration of drug targets,homogenization of clinical trials,and gaps in some drugs with large clinical needs.To improve incentive policies for innovative drug R&D,China should adhere to the orientation of clinical value,focusing on basic research and translational research,improving evaluation and approval capabilities,and establishing a sound ecosystem for innovative drugs.

Effect of the Policies to Prevent Drug Shortage and Stabilize Drug Prices in Medical Institutions

Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling and quota sampling,532 medical institutions in 20 provinces were selected to carry out questionnaire surveys.Then,a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices.Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions,but it did not curb the growth of drugs on non-shortage list.Besides,the drugs on non-shortage list showed an overall fluctuation and upward trend.Meanwhile,from the perspective of drug prices,the price stability problem of drugs on the shortage list and on the non-shortage list became more serious,and the average price increase was 256% and 239%,respectively.The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions,which has been recognized by most medical institutions.However,there is an increasing trend in the number of drugs on non-shortage list.In addition,the price increase of drugs on both the shortage list and non-shortage list is severe.Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification,grading and the alternative use of drug shortages.It is recommended to strengthen the management of price stabilization of drugs on the shortage list.Further attention should be paid to the supply and price stabilization of drugs on non-shortage list.At the same time,trainings in the classification and substitution of drug shortage and information reporting system should be actively organized,thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.

Current situation and policy suggestion of adjuvant drugs management

通过调查我国11个省（区）、市的辅助用药政策与管理现状,分析发现我国辅助用药仍存在概念不明晰、评估不合理等主要问题,提出了统一辅助用药的概念界定、有效发挥临床药师的作用和发挥信息化建设的 管理支撑作用等具体政策建议.

An Evaluation Synthesis of US AIDS Drug Assistance Program Policy

US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.

An Analyze of Anti-Drug Policy and Its Effects of Enrique Pe?a Nieto’s Government in Mexico

The drug problem has gradually penetrated into Mexican politics,economy,culture,and other fields since the 20th century,and has become an important factor affecting Mexico’s development.Enrique Pe?a Nieto took office in 2012,and implemented a new anti-drug policy.His government has made reducing violence a major goal of the anti-drug operation,using the national gendarmerie to counter the drug violence,and reforming the judiciary to prevention crime.Enrique Pe?a Nieto’s anti-drug policy has achieved certain results at the beginning of his term.However,the weakness of the national gendarmerie,corruption,and the sluggish economic development have affected the anti-drug policy,and caused it to fail.The drug problem in Mexico is affected by multiple factors,and its solution is a long one.

The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises

Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.

中外创新药物医保支付的比较研究

按疾病诊断相关分组(DRG)付费是当前我国医保支付改革的重要研究方向,但在一定程度上限制了创新药物的临床推广使用。许多国家已对创新药物的额外支付进行了深入研究。该文以美国、法国、德国为例,分析总结DRG付费体系下创新药物额外支付的国际经验,并结合我国创新药物医保支付现状及DRG付费对创新药物发展的影响,提出了明确的纳入标准、选择合适支付模式、建立动态调整机制、完善支付方式等政策建议,以期在全面推进DRG付费改革中,为进一步建立和完善我国创新药物医保支付机制提供参考。

广西医疗机构落实国家药品集中带量采购政策的效果分析

目的探讨国家药品集中带量采购政策(后文简称“国家集采政策”)在广西壮族自治区的实施效果,为医疗机构后续开展集采药品相关工作提供参考。方法选取广西壮族自治区医疗机构国家集采政策实施前后的药品采购数据,以政策目标、利益相关方关注的问题等为导向,引入并研究6个二级指标(如可获得性、可负担性、药品安全性等)、18个三级指标(如约定采购量完成率、负担水平、药占比等)。采用描述性统计方法对国家集采政策实施前后(2019年和2020年)的数据进行差异性、变化趋势等分析。结果在可获得性方面:广西壮族自治区医疗机构参与度为92.55%,疾病覆盖率为40.16%,整体约定采购量完成率中值为287.82%,总体配送率为97.20%。在可负担性方面:2019-2022年药品价格总体的降幅为74.80%,人均住院药品费用、门诊药占比、住院药占比降幅依次为17.61%、10.22%、20.10%,除慢性病、抗肿瘤用药外,药品可负担水平均低于1。对医药的影响:2022年药品不良反应事件占比为66.00%,相比执行国家集采政策前增幅为1.29%,广西壮族自治区通过一致性评价的药品共12个品规,前8名的制药企业的市场集中度小于20.00%。对医疗医保的影响:直至2022年基本实现仿制药替代原研药,同类非中选药品使用比约为9.12%,未提出二次换药的人数占63.39%;药品费用支出减少共24.59亿元。结论国家集采政策在广西壮族自治区取得了显著的效果,但同时还需重点关注扩大专科病种用药覆盖面、中选药品的临床综合评价、优化待分配量选择方案等问题。

DIP支付方式下医保供给侧政策协同对费用控制的影响研究

目的:本研究旨在探索DIP支付方式与其他医保供给侧政策间的协同效果。方法:以全国DIP改革试点城市A市为处理组,未改革城市B市为对照组进行比较研究。收集2019—2022年共1120个公立医疗机构样本,采用双重差分法对住院医疗总费用及部分费用结构进行分析。结果:A市DIP改革对医疗机构住院医疗总费用、住院检查化验总费用产生显著的抑制效应,对住院药品总费用和住院材料总费用未产生影响。结论:DIP支付方式发挥显著控费效果,住院医疗总费用得到有效控制;单纯采取调价政策与集采政策的控费效果尚有不足;DIP与其他供给侧政策协同,促进医疗费用结构更加合理。建议医保部门注重发挥供给侧政策协同作用,共同推动医保基金使用效率提升。

我国药品集中带量采购制度理论与实践浅析

我国药品集中带量采购(以下简称集采)是发挥医保战略性购买功能、重构医药价格形成机制、规范药品流通秩序、降低患者药费负担、促进合理安全用药的制度创举。本文从制度创建的视角,系统性回顾了我国开展药品集采工作五年以来的制度内涵、运行效果和多方影响。制度运行的核心机制包括政府组织、联盟采购、平台操作的工作机制,质量优先、保障供应、为用而采的规则机制,以及集采与使用的运行维护机制;药品价格形成的核心机制包括量价挂钩的市场交换机制和“四个确保”的市场契约机制;制度实施涉及招标采购、供应配送、配备使用、接续工作4个关键环节和18个核心要素。集采政策实施后,临床用药替代效应明显、药品可及性提高、药品费用显著下降且主要惠及患者、药品市场集中度提高和产业格局逐步重塑。

危机变局中全球青少年毒品预防教育治理格局与实践路径

在全球毒品危机对青少年影响日益严峻的形势下,以联合国毒品和犯罪问题办公室为首的国际组织以可持续发展为目标、政策为支点、教育为关键的治理手段建立新发展范式,撬动全球教育变革。文章以多源流理论为分析框架,解析国际组织以理念和政策为内生动力,以“预防为主、科学干预、教育为首、可持续发展”为原则建立的青少年毒品危机治理新格局,全景式展现国际组织构建毒品预防框架与实践路径。基于国际比较视角,建设具有中国特色、与联合国接轨的高质量毒品预防教育体系。

我国医疗保险国谈药品单独支付政策省际比较研究

目的:对国家医疗保险谈判药品单独支付省级政策文本进行分析,总结关键措施及特点,为各省制定和优化单独支付政策提供借鉴。方法:检索各省、自治区、直辖市医疗保障局网站,收集有关单独支付的政策文件,对检索到的政策文本进行总结与分析。结果:各省份单独支付政策在目录发布、目录遴选方式、药品管理方式、政策待遇水平和政策衔接等方面存在差异。结论:单独支付政策是“三医”协同发展的重要推手。各省要平衡好单独支付目录各种政策要素,处理好医保基金控制和患者获得感以及理清单独支付政策与支持创新药发展的关系,减少“三医”协同障碍。

基于PMC指数模型的我国药品集中带量采购政策量化分析

目的:对我国药品集中带量采购政策进行量化评估,探究政策的现有问题和优化路径,为后续政策制定与完善提供参考借鉴。方法:采用ROSTCM软件对16项政策进行文本挖掘,构建PMC指数模型定量分析我国药品集中带量采购政策。结果:16项政策中,6项政策评级为优秀,10项政策评级为良好,政策总体的PMC指数得分均值为6.84。16项政策在一级变量X9政策评价(0.94)、X10政策公开(1.00)上得分较高,在X2政策时效(0.25)、X3发布机构(0.42)上得分较低。结论:研究发现,我国药品集中带量采购政策存在政策目标制定不够合理、政策内容分布不够协调、政策工具结构有待优化、激励约束方式有待丰富问题,因此建议加强顶层设计,合理制定政策长期、中期和短期目标;完善政策内容,推进药品集中带量采购政策体系建设;优化政策工具结构,发挥多种政策工具综合使用效能;丰富激励约束方式,提高医务人员积极性。

我国医保谈判药品“双通道”管理政策执行困境及推进策略

目的为我国医保谈判药品“双通道”管理政策的顺利实施落地提供参考。方法基于史密斯政策执行过程模型,从实施细则与监管体系、药品遴选、药品配备和质量控制、医保基金运行状况和信息化能力4个方面对医保谈判药品“双通道”政策的执行困境进行分析,并提出相应推进策略。结果与结论我国医保谈判药品“双通道”政策可能存在政策实施细则和全流程监管体系不够明确,部分医保谈判药品纳入“双通道”管理的适宜性和可操作性有待斟酌,药品配备和质量控制方面存在难点,各地医保基金管理和运行状况存在差异以及信息化能力不足等执行困境。对此,本研究认为可通过完善“双通道”政策实施细则、提高“双通道”药品目录合理性、建立“双通道”药店动态退出机制、推行专业化配送服务、完善电子处方流转平台等措施来推动“双通道”政策的实施落地。

国家医保谈判药品“双通道”管理实施现状与政策分析

目的:对最新版国家医保谈判药品“双通道”管理省级政策进行文本梳理和分析,对比各省份政策差异与创新举措,为完善“双通道”管理模式提供参考性建议。方法:检索2021年5月10日—2024年4月10日各省医疗保障局和卫生健康委等官方网站“双通道”管理相关政策文件,采用内容分析法对文本资料进行提取和统计分析。结果:各省“双通道”管理政策在药品准入、医药机构遴选、待遇保障、用药管理和限制性政策调整等方面共性与差异性共存。结论:“双通道”政策设计应因地制宜,建议细化药品目录准入标准,规范设置医药机构准入门槛,科学确定医保待遇水平,制定差异化的用药认定管理方式,进一步削弱政策限制性因素。

我国药品第三方物流仓储和运输监管政策对比

目的:比较各省份在药品第三方物流仓储和运输方面的监管政策,为加强药品第三方物流监管提出可行性建议。方法:通过检索国家药品监督管理局以及各省级药品监督管理局网站,获取有关药品第三方物流仓储和运输方面的监管政策,对比分析各省份政策和《药品经营质量管理规范》相关规定,并提出建议。结果:通过对比发现,各省份在仓储和运输方面的政策主要集中在仓储面积、仓储设施设备、冷库数量及容积要求、冷库供电保障、温湿度监测系统、仓储管理系统、车辆数量及车载设备、运输车辆管理、特殊药品运输、运输管理系统等方面,但各省份的具体规定又存在一定的差异。而且大多省份的政策文件还存在仓储管理政策不统一、仓储区域划分不明确、仓储设施设备规定不具体、运输相关政策不全面、未对运输常温药品过程中保证常温环境做出规定等问题。结论:药品监管部门应加强对药品第三方物流的科学监管,建立统一的第三方物流管理制度。药品第三方物流企业应当加强基础设施设备建设,努力提高自身仓储运输水平。各相关方共同努力,促进药品第三方物流行业健康有序发展。

我国儿童药研制的制约因素分析及政策建议——基于医药企业的视角

目的:为完善我国儿童药供应保障政策提供依据。方法:基于医药企业视角通过文献综述、问卷调研梳理药品全生命周期中儿童药研制的制约因素,分析其集中和迫切程度。结果:儿童药的主要制约因素包括:儿童临床试验开展难度大;注册审批规则中缺乏对儿童药特殊性的考虑和专门的材料要求;生产激励政策落地缺乏实施细则和措施;市场利益机制尚不完善等。其中,研发和使用支付是问题相对集中的环节。讨论及建议:建议我国开拓并合理使用儿童临床试验资源,多举措增加儿童药研发投入;制定儿童药申报的专项指南,鼓励成人药品注册时提交儿童研究计划;基于典型案例探索儿童药生产供应优化路径;在药品使用与支付规则中给予儿童药更多空间。

公共卫生视角下葡萄牙与挪威管控药物政策的演变及启示

在全球化背景下,公共卫生视角为管控药物政策提供了新的理解和处理方式。分析了葡萄牙与挪威在管控药物政策方面从刑事化向去刑事化和去病态化的转型过程及其对中国的启示。葡萄牙和挪威的经验表明了去刑事化和去病态化策略能够有效减少药物滥用及其相关的公共卫生和社会问题,同时促进管控药物使用者的社会融入与康复。针对中国当前在严格执法与满足公共卫生需求之间寻找平衡的努力,建议重新界定管控药物的法律地位,增强资源配置,加强跨部门合作,提高公众教育及社会意识,以期构建一个更加有效且人本关怀的药物政策框架。

基于政策文本分析我国药品追溯体系的建设及优化路径

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。