【作者】 李萍；

【导师】 张新平；

【作者基本信息】 华中科技大学 ， 社会医学与卫生事业管理， 2009， 博士

【摘要】 研究目的提高农村地区基本药物可获得性具有重要的政治意义和理论价值。本课题以新型农村合作医疗制度为依托，紧紧围绕基本药物目录的制定和落实探讨相关策略，借鉴国际基本药物可获得性调查方法，以湖北省为例对我国农村地区基本约物可获得性的现状和存在的关键问题进行分析，提出适合我国国情的农村地区基本药物可获得性促进策略，为促进我国基本药物制度的建立和完善提供理论、政策和实证依据。研究方法采用文献研究与实证研究相结合的研究方法，综合运用文献法、现场调查、知情人访谈等多种方法收集资料。资料来源包括：(1)国内外基本药物可扶得性研究文献资料：(2)湖北省县乡两级医疗机构和零售药店基本药物价格调查，包括：湖北省县乡两级医疗机构药品采购价格和零售价格数据、临近零售药店药品零售价格数据和2008年3月份门诊处方资料。实际调查武汉、孝感和恩施3个市的农村医疗机构18家，其中县医院6家，乡镇卫生院12家。同期调查临近的零售药店18家。资料定量分析采用描述性统计、卡方检验等，定性分析采用利益集团分析、系统分析、归纳综合等。研究结果1、农村基本药物可获得性现状(1)地理可及性我国基本药物地理可及性差异较大，西部地区更易因地理性因素和机构分布性因素引发基本药物供应不足的情况。2006年全国农村地区设置村卫生室的比例达到了88．1％，尤其是西部地区最高，达到了94．0％。基本药物的地理可及性有了较大的改善。(2)可获得性湖北省农村地区基本药物可获得性偏低，基本药物供应以仿制药品为主。在调查的39种药品中，原研药品在医疗机构中供应的品种数为9个，零售药店中有6个。仿制药品中可获得性低的品种占调查药品总数的43．6％，可获得性高的品种有5个，占12．8％。仿制药品在医疗机构及其临近药店分布具有一致性。对核心目录品种，零售药店基本药物可获得性高于国内同类研究水平，公立医疗机构可获得性低于国内同类研究水平。(3)价格水平湖北省农村地区县乡两级医疗机构仿制药采购价格具有明显优势，仅为国际参考价格的60％，仿制药的零售价格为国际参考价格的0．9倍。医疗机构对调查的原研药和仿制药的顺价加成比例中位数分别为20．5％和32．5％，最高达150％。由于未严格执行顺价加成政策，仿制药品采购价格的实惠最终没有转移到患者身上。零售药店仿制药品零售价格MPR值的中位数为0．5，除甲硝唑外，其他药品在医疗机构的零售价格均高于零售药店价格，二者的零售价格比最大高达4．66倍。医疗机构基本药物零售价格平均为零售药店零售价格的1．57倍。(4)可负担性计算了7种疾病的16个基本药物治疗的可负担性。对于农村地区平均收入水平的人群来说，12种仿制药品可负担性较好，固定疗程时间内仿制药品总费用远低于湖北农民人均纯收入(日标准)。对于农村地区低收入人群来说，无论是在医疗机构和零售药店，基本药物可负担性均差。一旦患病，仍然存在因病致贫、因病返贫的可能性，而基本药物可获得性较低更增加了这种可能性。(5)使用合理性湖北农村地区基本药物使用率不高，《WHO示范目录(2007年版)》、《国家基本药物目录(2004年版)》及《湖北省新型农村合作医疗药品目录(第二版)》基本药物使用率分别为44．3％、77．5％、71．8％。处方分析指标中处方平均用药数为2．5种，高于理想值2。处方费用中位数为32元，远高于全国11．46元的平均水平。注射处方比例达50％。基本药物可获得性不高，存在不合理使用的情况。2、农村基本药物可获得性低的根本原因(1)基本药物工作国家层面缺乏统筹(2)政府责任退位、缺位(3)农村经济文化发展水平低下结论1、我国农村基本药物地理可及性有了较大改善，但可获得性不高。2、我国多数仿制药品采购价格低于国际参考价，但顺价加成率过高，医疗机构中基本药物的销售环节患者未得到实惠。3、医疗机构的零售价格高于零售药店价格，部分品种差价悬殊。4、多数基本药物可负担性较好，低收入人群可负担性较差。5、基本药物门诊使用率不高，存在不合理用药现象。6、农村基本药物可获得性涉及环节多，影响可获得性的因素复杂，需要采取综合促进措施。建议建立国家基本药物制度，加强基本药物立法，建立跨地区多部门协作机制：严格科学实施基本药物的遴选；保障持续的财政支持；构建可靠的农村基本药物供心体系：建立基本药物供应使用的监督评价体系：加强宣传教育。本研究创新与不足在研究的内容上，首次对我国农村地区基本药物的可获得性现状进行系统研究，结合文献研究和知情人访谈，分析农村基本药物可获得性方面存在的关键问题及其成因，为完善并落实国家基本药物制度，改善农村地区基本药物可获得性，提出针对性的政策建议，具有较强的政策参考价值。在方法学上的应用上，借鉴WHO／HAI关于药品可获得性和价格调查方法，结合我国农村基本药物应用的特点，进行适当调整，使得调查结果更能反映我国农村地区基本药物使用的真实情况。具有一定的方法创新性。不足之处在于实证研究以湖北为例，只能代表我国中部地区的一般情况，尚不足以说明全国农村基本药物可获得性的整体水平。应用快速评价方法实施的横断面调查，不能动态反映基本药物可获得性的变化情况。更多还原

【Abstract】 ObjectIt has policy importance and theory value to improve access to essential medicines inrural of China. In order to evaluate the status of access to essential medicines, analyze thekey problems, and provide reference for policy adjustment based on NCMS, a survey basedon the method recommend by World Health Organization and Health Action InternationalEurope was conducted in rural areas of Hubei province. After summarizing relative theoriesand influencing factors of access to essential medicines, strategies on promoting access toessential medicines were proposed, which are meaningful to the setting of nationalessential medicines policy.Data and MethodsBoth quantitative and qualitative methods were used. Literature review, fieldinvestigation and statistical methods were used in this study. The data included: literaturedata on access to essential medicines; data on availability and price in hospitals and retailpharmacies of counties and towns surveyed, including procurement price and retail price ofessential medicines and prescriptions in hospitals, while retail price in retail pharmacies. 18hospitals and 18 retail pharmacies belonging to Wuhan, Xiaogan and Enshi were surveyed. Results1、The status of access to essential medicines in Hubei province(1)The difference of geographical accessibility in rural of China was large. West ofChina was easy to lack of essential medicines caused by geographical factors. But it wasimproved by increasing the proportion of village health facilities.(2)Low availability of essential medicines, ever innovator brand or generics surveyed,was found in both sectors, and more in the hospitals. The most of essential medicines foundwas generics.9 innovator brand were found in the hospitals and 6 in retail pharmacies.Generics of low availability was 43.6%, while generics of high availability was 12.8%.(3) The median MPRs of procurement prices for LPGs (60% of the MSH referenceprice) had indicated efficient procurement. For retail prices in hospitals, the median MPRsof generics was 0.9 times the international reference prices. Even though the hospitalsreceived a good procurement prices, the markups between procurement and retail priceswere high (median markups rate of innovator brands and generics: 20.5% and 32.5%,respectively). Therefore, the hospitals still attained a lot of profits from selling medicinesand the benefits of low procurement prices were not transferred to the patients.The median MPRs of generics of retail prices in retail pharmacies was 0.5 times theinternational reference prices. Retail prices in hospitals were higher than in retailpharmacies except Metronidazole. The largest retail prices ratio between the two sectorswas 4.66. The retail price in hospitals was1.57 times of that in retail pharmacies.(4) The affordability was chiefly determined by the availability and price. Theaffordability of 16 medicines to 7 diseases was calculated. For the social average incomepopulation, the affordability of 12 medicines was much optimistic. But for the low-incomepopulation, even the expenditure of essential medicines for treatments was unaffordable,namely the common diseases would cause poverty.(5) The percentage usage of essential medicines was not high, and irrational use ofmedicines was existed. The percentage usage of essential medicines belonged to WHOEssential Medicine List (2007), National Essential Medicine List (2004, China) and NewRural Cooperative Medical System Essential Medicine List (Second Edition) were 44.3%、77.5%and 71.8%. The average number of drugs per prescription was 2.5, higher than 2. 2、The roots causing low access to essential medicines in rural were(1)lack of systemic planning in entirety at country level;(2)missing or retreat of government function;(3)low economic and culture development in rural.Conclusions1、Though geographical accessibility in rural was improved, availability of essentialmedicines was low.2、The procurement prices in hospitals was far away lower than the international referenceprices. Since the markups between procurement and retail prices were high the benefits oflow procurement prices were not transferred to the patients.3、Retail prices in hospitals were higher than in retail pharmacies, and the difference ofsome medicines between the two sectors was large.4、The affordability was much optimistic for the social average income population ,whileunaffordable for the low-income population.5、The percentage usage of essential medicines was not high, and irrational use ofmedicines was existed.6、It needs to take synthetical measures to improve access to essential medicines.SuggestionsWe suggested that essential medicines policy should be estabilished, essential medicines listshould be selected strictly, running mechanism of stable financial policy should be set up,supervision and evaluating system should be strengthened, and improving advertising andeducation on essential medicines.更多还原