基本药物制度对慢性病用药可及性和卫生服务利用的影响及促进策略研究

The high cost of treating chronic diseases and lack of access to low-cost essential medicines continue to be major obstacles to chronic disease prevention and control in China. In our previous study, we measured the accessibility of essential medicines in Shaanxi Province, western China, the results revealed that medicine price reduced, while the health burden of chronic disease remains high. As such, we aim to measure the long-term impacts of the National Essential Medicine Policy on access to essential medicines for chronic diseases, and to describe chronic disease-related healthcare cost and utilization patterns over time. It' of great significance to do so. An in-depth evaluation study will be carried out. Firstly, using the open data kit approach, a validated monitoring platform will be established to measure drug prices and availability of selected essential medicines. Secondly, using claims data provided by local health insurance departments, we will use an interrupted time-series design to evaluate the changes in choice of pharmaceutical treatments and healthcare utilization patterns. Furthermore, we will explore the changes in drug and medical test revenues in secondary and tertiary hospitals in eastern, middle and western China. Thirdly, a fishbone diagram analysis and a key informant interview will be conducted to explore cheap chronic drug shortages mechanism, and to reach consensus around which measures to take to enhance chronic patients' access to essential medicines. Fourthly, a quality consistency and safety evaluation tool will be developed for originator brands and their generic equivalents. Finally, based on the above tools and results, a systematic database will be set up to support the policy making process with evidence based research. This study will explore strategies to promote access to high quality, low-cost essential medicines to treat chronic diseases. We envision that the results, by generating scientific evidences, will help promote equitable access to essential medicines and health care for chronic diseases, and finally help meet the Millennium Development Goals.

医药费用攀升、廉价药品短缺严重制约着我国慢性病防控。前期对陕西省基本药物可及性进行的评估研究中，我们发现：虽然药品价格降低，但慢性病患者药品可获得性和医疗负担并未实质性改善。因此，以慢性病用药和卫生服务利用为切入点，从微观视角对基本药物制度的远期效应进行跟踪评估意义凸显。 本课题拟首先引入开放数据技术开展药品价格和可获得性的常态化监测；接着基于城乡医保数据，利用分段时间序列模型评估慢性病基本用药和卫生服务利用变化趋势，对东中西部二级以上医疗机构药品与检查收入变动规律进行探析；然后采用鱼骨图模型和知情人访谈阐明廉价慢性病用药短缺机制，构建短缺药品长效供应保障策略；进一步探索原研药和仿制药质量一致性与安全评测工具；最终集成以上研究结果，建立基本药物制度决策数据库。本研究探寻基本药物制度核心目标促进策略，旨在为提高城乡慢性病患者对基本药物和卫生服务的公平可及、实现千年发展目标提供循证支持。

背景：.提高慢性病用药可及性和卫生服务利用水平是重大卫生决策问题。.内容：.（1）利用世卫组织和健康国际行动组织标准化法，调查陕西省降糖药与降压药可及性，以及胰岛素可及性。.（2）采用断点时间序列分析法对陕西两个县农村地区医疗服务利用情况进行分析。对陕西省10个城市基层医疗机构的慢性病用药金额和品种进行分析。.（3）对陕西省基层医疗机构的全科医生进行关于药品短缺情况的调查。基于平台分析2016至2017年期间短缺药品信息，探索药品短缺特征与成因。.（4）对仿制药政策环境进行系统综述；对全国部分三级医院内分泌科医生进行仿制药使用的知信行调查。.结果：.（1）陕西省样本公立医院和零售药店中常用高血压与糖尿病药品的可获得性一般，原研药可获得性高于仿制药；零售药店仿制和原研慢性病用药的可获得性均高于公立医院，仿制药可获得性高于原研药；原研药的价格明显高于仿制药。.胰岛素在三级医院的可获得性较好，样本机构进口胰岛素的可获得性均高于国产胰岛素，而进口胰岛素价格高于国产胰岛素。.（2）基本药物制度实施后，新农合患者到基层医疗机构门诊就诊率未发生明显变化，基层医疗机构住院服务受到的影响更为显著；基本药物制度实施前，基层医疗机构住院率呈现下降趋势；该制度实施后，基层医疗机构住院率长期表现为上升趋势。.（3）不同医疗机构和不同经济发展水平地区药品短缺情况存在差异；短缺药品一般为低价药和基本药物，其中呼吸系统、心血管系统用药短缺较为严重；药品短缺给医生工作带来不便，影响医患关系，增加了患者经济负担。.（4）目前我国总体的药品政策环境有利于慢性病仿制药可及性和质量的提高，但同时也存在着一些阻碍因素。大多数受访医生认为原研药比仿制药的质量好，超过一半的受访医生在开具处方时，经常或一直开具原研药。.意义：. 聚焦药品供给与短缺、药品可获得性与价格，以及仿制药的使用等关键科学问题，对慢性病用药可及性进行全面分析和探索，提供实证数据和政策建议，为提高慢性病患者用药可及性提供了强有力的证据支持。