【作者】 吴公平；

【导师】 孙振球；

【作者基本信息】 中南大学 ， 社会医学与卫生事业管理， 2011， 博士

【摘要】 研究背景民生问题是我国政府在全面建设小康社会进程中最为关注的问题之一。药品安全问题是与民生密切相关的重要的一环。全面开展药品监督网络建设和药品供应网络建设(以下简称“两网”建设)是按照国务院提出的“标本兼治,着力治本”的工作方针而开展的一项民心工程、德政工程；是从根本上保证广大群众用药安全有效的重要举措,对于维护群众的身体健康和用药的合法权益,促进全面建设小康社会具有十分重要的意义。“两网”建设”是解决“买药贵,买药难”问题的一项重要举措,是推进新型合作医疗顺利进行的重要基础。药品监督网络建设主要是建设县(区)、乡(镇)、村三级监管网络,在县(区)成立药品安全领导小组,在乡(镇)成立药品监管工作站,在行政村设立药品信息员。药品供应网是指在政府引导下构建的,以市场在药品资源配置起基础性作用所形成的全省药品供应体系。大力推进药品监管网络和供应网络建设,是实施国务院提出的“药品放心工程”的重要组成部分是规范药品市场秩序、确保广大人民群众用药安全的有效措施。在“两网”建设背景下,结合我省实际对药品监督和供应情况进行调查研究,并在此基础上探讨和论证农村药品监督管理和药品供应模式显得尤为重要。从我省目前现实情况来看,城市和农村在药品供应上依然存在巨大的“城乡差别”,对于城市来说,主要面临的是“药价虚高’问题。而和城市相比,我省农村大部分地区在药品供应上面临的问题更多,不仅“买药贵”,而且“买药难”,其主要表现在：农村药店数量少且布局不合理,农村居民在日常生活中很难方便快捷地买到所需的药品。“买药难”和“买药贵”使得假冒伪劣药品在农村有了适合的滋生土壤,游医药贩有一定的生存空间,从而给农民群众的生命健康安全带来了极大隐患。加之农民自身的健康用药知识比较欠缺,使得农民用药问题更加突出。所以药品“两网”建设的重点在农村,兼顾城市。农村药品供应网络和监管机制历来是我国药监工作中最薄弱的环节。保证农村药品供应网络的健全和用药质量,不仅直接关系到广大农民群众的身体健康和生命安全,而且关系到党和政府与农民群众的血肉联系,体现党和政府对农村、农民的关注与关怀。加强农村药品供应网络建设,完善监管机制,既是药监工作的重点,也是一项系统工程,更是基层药监工作的重中之重。我省药监系统对完善农村药品供应网络,强化农村用药监管,进行了有益的实践与探索。我省药品监督和供应网络建设已取得一定的成效,农村药物的合格率逐年增高,大部分地区达到95%,农村药品零售价建网后比建网前下降了18.89%。二、研究目的(1)了解湖南省药品监督网和供应网建设现状,发现其存在的问题,提出合理的建议和措施；(2)了解湖南省药品质量情况和药品价格变化情况；(3)制定适合于湖南省药品“两网”建设的综合评价指标体系,同时对指标进行量化和赋值；(4)用综合评分法构建湖南省药品“两网”建设现状综合评价模型,并对其进行实证研究。三、研究方法1.现状分析本研究现状分析主要以药品监督网络覆盖情况、药品监督协管员和信息员情况、监督工作开展情况、药品供应网络覆盖情况、药品配送人员情况、配送机构建设情况、药品不良反应、医疗器械不良反应、药物滥用、药品稽查打假情况作为反映湖南省药品“两网”建设现状的指标,对比湖南省14个市州(分别为长沙、永州、岳阳、湘潭、常德、衡阳、郴州、益阳、怀化、株洲、娄底、邵阳、张家界、湘西)的现状,并以2008年到2010年的统计数据分析其动态趋势。2.德尔菲法本次研究按照德尔菲法设计专家咨询问卷,对从事药品监督管理、药品企业管理或医学教学及相关专业工作的20名专家进行了咨询,专家对各指标的重要性进行打分。在完成各项指标评价后,专家采用自我评价方法,填写一份判断依据和熟悉程度的权威调查表,以确定专家意见的权威程度。3.建立综合评价模型本研究采用综合评分法建立综合评价模型。综合评分法是建立在专家评价法基础上的一种重要的综合评价方法。首先,根据评价目的及评价对象的特征选定必要的评价指标,逐个指标定出评价等级,每个等级的标准用分值表示；然后,以恰当的方式确定各指标的权重,并选定累积总分的方案以及综合评价等级总分值范围,最后总得分s=(?),以此为准则,对评价对象进行分析和评价,以确定优劣等级。四、研究结果(1)目前,药品“两网”建设己进入深化阶段,监督网络和供应网络乡镇覆盖率均达到100%,监督网络和供应网络行政村未覆盖数逐年减少,“两员”队伍逐渐发展壮大,药品配送机构和配送人员数量不断增加,药品质量控制水平得到逐步提升。有效缓解了群众买药难、看病贵、用药不安全的问题,使民心工程、政绩工程建设绩效凸现明显。(2)药品价格有所下降,趋向合理：2008年零售价格与国家限价均值为16.37%,2009年17.31%,2010年19.27%,逐年上升；2008年药物零售价格加成率为15.11%,2009年14.60%,2010年12.27%,逐年下降；2008年药物使用价格加成率为40.87%,2009年26.19%,2010年22.47%,逐年下降。(3)本研究采用专家咨询法,建立药品监督—药品供应—建网绩效为结构的一级评价指标,确定8个二级指标、56个三级指标的评价指标体系；并在此基础上建立了以综合评分法以基础的综合评价模型；专家咨询中,一级指标的专家判断系数、熟悉程度系数和权威程度系数均在0.7以上,一、二、三级指标的专家协调系数分别为0.8023、0.7552和06741,三个一级指标的权重分别为34.058%、34.420%和31.522%。(4)采用本研究构建的综合评价模型对湖南省14个市州进行实证研究,建网现状从好到坏的顺序是：衡阳、张家界、永州、株洲、长沙、湘西、郴州、岳阳、怀化、湘潭、邵阳、益阳、娄底、常德,加权RSR法横向评价的顺序为：衡阳、永州、张家界、长沙、株洲、郴州、邵阳、常德、湘西、怀化、娄底、岳阳、湘潭、益阳；综合评分法和加权秩和比法的结果呈正相关,其相关系数为0.780,p值小于0.01；加权RSR法分档排序的结果为：上档(衡阳、永州、张家界、长沙)、中档(株洲、郴州、邵阳、常德、湘西自治州、怀化、娄底、岳阳)、下档(湘潭、益阳)；综合评分法和加权RSR法纵向评价结果一致,从好到差依次为：2010年、2009年、2008年。五、本研究的创新点(1)系统全面的分析了湖南省药品监督和供应网络建设现状,并对湖南省各地市的药品质量情况和价格情况进行了比较。(2)率先构建了药品“两网”建设的综合评价模型。本研究采用综合评分法建立了综合评价模型,确定了各级指标的权重分配和具体的赋分量表。(3)率先开展了药品“两网”建设现状的实证研究。对湖南省14个地市的“两网”建设现状进行了横向比较,对湖南省2008年、2009年和2010年三年度进行了纵向比较,得出各市州“两网”工作开展的现状和发展情况,验证了本研究所构建的综合评价模型操作性强,具有推广应用价值。六、结论(1)目前,药品“两网”建设已进入深化阶段,监督网络和供应网络乡镇覆盖率均达到100%,监督网络和供应网络行政村未覆盖数逐年减少；“两员”队伍逐渐发展壮大,药品配送机构数量和配送人员数量不断增加；药品质量提高,药品价格下降。(2)本研究采用专家咨询法,建立药品监督—药品供应—建网绩效为结构的评价指标体系,指标体系符合湖南省药品“两网”建设的实际情况,具有较强的科学性和可行性。(3)采用科学的方法和评价确定了各级指标的权重；提出了各评价对象的综合得分计算公式为：s=(?)；构建了基于综合评分法的综合评价模型,具有较强的操作性。更多还原

【Abstract】 Background:People’s livelihood is one of the most concerned issues of the Chinese government in the process of building a well-off society. As everybody knowns, drug safety problem is closely related to people’s livelihood.Effective supervision of drugs has a great bearing on ensuring the safe use of pharmaceuticals by consumers and on safeguarding the right to life and health of the general public. The Chinese government has always attached great importance to supervision over drug safety, and has always been committed to the goal of strengthening such supervision and guaranteeing public drug safety. For this purpose, it has gradually established the drug supervision network and continuously improved the drug supply network.Drug supervision network construction is construction of the county (area), countryside (town) and the village of three regulatory networks. The county-level supervision mainly include establishment of drug safety leading group. Drug supervision stations were established in the countryside and drugs information officer was set up in village. In addition, it has established a network for drug supply, fully satisfying the public’s needs for drugs. In Hunan Province, the supply of drug is still great difference between urban and rural area. In cities, it is a problem that it is too expensive to see a doctor. However, in rural, it is the main problem that it is not only too expensive to see a doctor but also too difficulty to buy medicine. The result is that there are a lot of fake medicine in rural area. Therefore, the key of construction of drug supervision network and drug supply network is mainly in rural. In the vast rural areas, it is important to steadily enhance the guarantee level for the quality of drugs and the supply for drugs, due to the constant improvement in people’ s livelihood that comes along with China’ s accelerating economic development. We had researched the two networks construction of rural drug and gained a widespread popularity among local government, proprietors and farmers in Hunan Province. Construction of rural two networks of drug makes farmers buy drug at ease and ensure the safety of drug use and is deeply welcome by local government and farmers.Objectives:(1). To study the status of drug supervision network and supply network in Hunan Province, analyze existing problems and provide reasonable advices for their progress.(2). To understand the quality of medicine and the changes in drug price in Hunan Province.(3). To formulate the suitable evaluation index system for drug supervision network and supply network in Hunan Province, and quantify the index.(4). To construct an evaluation model for drug supervision network and supply network in Hunan Province with comprehensive evaluation method.Methods:1. Current situation analysisAn on-the-spot investigation and evaluation w as conducted on two nets construction of14cities in Hunan province from2008to2010. We analyzed on the current situation of main drug supervision network coverage, coordinators and information of14cities in Hunan province. We also investigated the supervision work of drug supply, drug distribution network coverage, personnel, distribution mechanism, construction situation of adverse drug reaction, medical device adverse reactions, drug abuse, drug inspection crackdown as a reflection of the drug in Hunan province " two netwoks" construction status indicators.2. Delphi MethodThe Delphi questionnaire design expert consultation was used in our research. Totally20experts who engaged in drug supervision and management of enterprise management, drug or medical teaching scored the importance of each index.20experts also complete a judgment and the degree of familiarity of the authoritative expert opinion questionnaire by self evaluation method.3. The establishment of the comprehensive evaluation modelThe comprehensive evaluation method was used to construct an evaluation model. The comprehensive evaluation method is based on expert evaluation method. Firstly, the necessary evaluation indexes were selected according to the evaluation purpose and the characteristics of the objects. Each index set assessment grades and each grade standard scores indicated. Secondly, the weight of each index, accumulative scores and the scheme of comprehensive evaluation grade of total value range were selected. Finally, the total scores were got by S=(?)WiSi. The analysis and evaluation were conducted to determine the degrees through the total scores.Results:(1). The coverage of drug supervision network and supply network had reached100%in Hunan Province. The number of drug distribution mechanism and person is increasing constantly. The levels of quality control of drugs had gradually improved.(2). The drug prices had declined year after year. The wholesale prices of drug were16.37%in average in2008. It is gradually rising which was17.31%in2009,19.27%in2010respectively. The plus rate of wholesale prices of drug was dropped which was15.11%in2008,14.60%in2009and12.27%in2010respectively. The plus rate of use price of drug was also dropped gradually which was40.87%in2008,26.19%in2009and22.47%in2010respectively.(3). We had built an expert evaluation method as the structure of drug supervision-drug supply-network performance. It included8level two indexes,56level three indexes in the evaluation index system; A comprehensive evaluation model is established on the basis of comprehensive scores received from the Index System; In expert consultation,each level indicators’expert judgment coefficient,familiarity coefficient and authority degree coefficient are above0.7,expert coordination coefficients in level one,level two,level three indicators were respectively0.8023、0.7552and0.6741,3level one indicators weights were34.058%、34.420%and31.522%.(4). The comprehensive evaluation model designed by this research is implemented to conduct an empirical study in14cities of in Hunan province.The rank from good to bad is Hengyang, Zhangjiajie, Yongzhou, Zhuzhou, Changsha, Xiangxi, Chenzhou, Yueyang, Huaihua, Xiangtan, Shaoyang, Yiyang, Loudi, Changde. The rank of weighted RSR method was Hengyang, Yongzhou, Zhangjiajie, Changsha, Zhuzhou, Chenzhou, Shaoyang, Changde, Xiangxi, Huaihua, Loudi, Yueyang, Xiangtan, Yiyang. It was a positive correlation between the results of the comprehensive evaluation model and that of weighted RSR method. The correlation coefficient was0.780(p<0.01). The rank of weighted RSR method is weighted RSR file sort results for:the file (Hengyang, Yongzhou, Zhangjiajie, Changsha), intermediate (Zhuzhou, Chenzhou, Shaoyang, Changde, Xiangxi, Huaihua, Loudi, Yueyang), the next file (Xiangtan, Yiyang). The result of the comprehensive evaluation model was in accordance with that of weighted RSR method. The rank from good to bad was2010,2009and2008.Innovation:(1). We analysed the status of drug supervision network and supply network in Hunan Province and compared the quality of medicine and the changes in drug price in Hunan Province.(2). We had firstly formulate the suitable evaluation index system for drug supervision network and supply network in Hunan Province and determined the levels of index weight distribution and specific tax scale.(3). We firstly construct an evaluation model for drug supervision network and supply network in Hunan Province. We also compared the status of drug supervision network and supply network in14cities in Hunan Province. We also compared those of Hunan Province among2008,2009and2010. We concluded that the research model of comprehensive evaluation was feasibility and maneuverability.Conclusions:(1) At present, the construction of drug supervision and supply networks has come into an advanced stage and the coverage-rate of drug "2S" networks has reached100%, with a decreasing number of villages which are not accessible to the networks. The number of people who work for the networks and agencies that provide drugs has been increasing constantly. The quality of drugs has improved and the prices of which have decreased.(2) Expert-consultation method was used in this study to establish primary evaluative indexes for the assessment of the construction of the networks, The method was proved to be scientific and practical.(3) Scientific method and assessment were introduced to determine the weight of each evaluative index, with scoring regulations and evaluative factors in detail. Formula for synthetical evaluation was put forward: S=(?)WiSi. A model for synthetical evaluation was established based on the comprehensive scoring method, which is considered to be very practical.更多还原