山东省农村基本药物制度的政策效应研究
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摘要
研究背景和政策现状
在我国30多年市场经济体制改革的进程中,社会经济迅速发展,人民群众的物质文化生活水平不断提高。如此同时,在医疗卫生服务领域却出现了越发难以控制的“看病难,看病贵”现象,在农村地区显得尤为突出。2009年3月国务院常务会议通过《关于深化医药卫生体制改革的意见》,该政策颁布标志着新一轮医改正式启动,“新医改”方案表明我国政府将从完善制度的角度化解社会矛盾。“新医改”方案提出完善国家基本医疗卫生制度,而实现国家基本医疗卫生制度的措施之一就是要建立以国家基本药物制度为基础的药品供应保障体系,所以,推行基本药物制度成为当前卫生政策的热点。
为配合国家基本药物制度的实施,国家各部委连续出台系列配套政策和法规,截止到2010年底已颁布涉及基本药物目录遴选、价格限定、质量监督、招标采购规范等文件,山东省自2010年3月15日起在各试点区县基层卫生机构开始实施基本药物制度。
此次制定的基本药物目录是结合居民用药特点和参照国际经验,国家共确定目录品种307种,山东省增补216种药物。山东省27个县区的农村试点基层卫生机构实施基本药物制度,主要措施包括卫生机构仅销售和使用目录内药品,取消药品加成,通过新农合提高基本药物的报销比例,试点实施基本药物制度依然维持已形成的供货渠道不变。
研究意义与目的
山东省基本药物制度是在卫生服务体系相对薄弱的农村基层卫生机构试点实施,该制度实施的情况及效果如何,能否从一定程度上缓解“看病难、看病贵”现象,能否有效平衡卫生服务体系中各利益相关者的关系,能否从整体上达到基本药物制度对卫生服务系统影响的政策目的,这需要对基本药物制度试点结果进行系统评价。本研究根据山东省基本药物制度试点的实施情况,探讨基本药物制度实施的效果与政策影响,明确基本药物制度实施过程中存在的突出问题,对我国基本药物制度建设的整体推进和可持续发展具有十分重要的意义。
本研究的主要目的一是要从理论上界定基本药物制度政策效应的范畴,明确基本药物制度实施评价的方法学；其二是通过对山东省试点区县基本药物制度实施的实证研究,明确基本药物制度实施的政策效应,分析基本药物制度实施的状况及问题；其三是为改进和完善基本药物制度的实施推广提供政策建议。
文献综述与政策效应的界定
文献综述围绕基本药物分别就世界卫生组织建议、国际、国内已发表的研究共分为三部分。世界卫生组织对于国家基本药物制度的建议,主要包括基本药物的遴选、可负担性、基本药物筹资、供应体系、药品管制、合理使用、药品研究、人力资源开发、监测与评估,文章对其每部分政策要点做简单概括；国际范围内研究主要分析卫生行动国际和合理用药国际网络组织开发的测量方法；国内围绕新医改政策内容中基本药物制度的研究并不多,期刊文章多是论述性、系统综述和少量分析性文章,没有检索到与本内容相关度高的系统研究。
卫生政策属于国家公共政策范畴,文章介绍公共政策的内容和步骤,霍弗博特的政策评价模型和常用的定性定量方法学,卫生政策评价的研究进展显示当前在卫生领域进行政策评价的要点和趋势,山东省农村基本药物政策的现状决定本研究采用定性访谈和定量前后对比分析法较为适宜。
界定政策效应范畴要遵循国际研究惯例,首先确定政策效应层面,具体包括结构、过程、结果三个政策层面,再通过咨询专家意见确定政策效应领域,在每个领域选择针对性指标和内容,最后界定适合山东省农村基本药物制度的实施情况和影响程度的政策效应范畴。
实证研究方案的设计
本研究采用定性访谈和前后对比定量分析法,依据形成的政策效应范畴,研究方案主要包括调查表格设计、样本选取、现场实施和质量控制等。依据调查对象的不同,分别针对卫生院和新农合机构设计定量问卷四份,同时分别准备定性访谈提纲；利用典型抽样方法选取崂山区和莒县为实证研究样本区域,每个样本区域随机抽取三所乡镇卫生院,每个卫生院选取一所村卫生室,每个卫生院实施前后各抽取处方100张,访谈各级卫生人员31人；对于数据处理,除利用EXCEL分析以外,处方数据使用SPSS软件进行分析,其中采用严格的质量控制,现场调查在2010年8月和9月实施。
研究结果
研究结果是依据政策效应体系分别对崂山区和莒县实施基本药物制度前后对比情况的分析,主要的研究结果有如下七个方面。
(1)基本药物配备。莒县和崂山区卫生机构配备比例相当,分别为62%和64.6%,西药配备比例均高于中成药,国家目录品种比省级增补目录配备程度高；基本药物未配备的主要原因是“无对应医疗项目”和“医生无使用习惯”；基层临床急需儿科用药、某些专科用药、止血药品等。
(2)基本药物合理使用。根据每张处方中药品的种类数量均数、使用抗生素处方的比例和使用注射剂处方比例这三个指标,其中莒县此三个指标依次是降低、不变、不变,而崂山区依次是升高、升高、不变。
(3)基本药物的价格。依据部分核心基本药物的情况,基本药物制度实施前后比较,药品加成比例都下降为零；崂山区个别产品价格高于国家限价,莒县则全部低于限价,基本药物品规差异较大。
(4)基本药物供应体系。此部分结果来自于知情人访谈,主要有当前供货企业是区域性商业公司,采购频率不定,回款时间不定等。
(5)对卫生院的影响。在实施基本药物制度后,莒县卫生院医疗收入变化平稳,崂山区则呈激增态势；药品收入莒县下降明显,而崂山区增长明显；财政补偿是维持卫生机构正常运转的必要条件。
(6)对患者的影响。莒县卫生院门诊人次和出院人次变化不明显,次均药费下降明显；崂山区门诊和出院则迅速增加,卫生院门诊次均药费略有增加。
(7)对新农合机构影响。实施基本药物制度后门诊补偿人次莒县变化不大,崂山区则增加；门诊次均自付金额莒县降低,崂山区维持不变；基本药物制度对基金运行影响有限,基金运行相对平稳。
结果部分最后总结样本区域政策结构层面内容。
研究结论与政策建议
基于实证研究的结果,讨论政策结构、过程和结果层面的突出性问题,分别选择基本药物遴选、机构补偿和药品费用,其中重点讨论药品费用,总结形成崂山区和莒县实施基本药物制度的政策效应结论。
(1)崂山区实施基本药物制度的政策效应
政策结构层面,现行目录药品存在不合理性。崂山区没有实施乡村卫生一体化管理,本次实施基本药物制度仅在乡镇卫生院实施,农村居民在村卫生室就医得不到新农合补偿,该区居民医疗需求在实施制度之前受限制,当地又有以慢性病为主的疾病谱。
政策过程层面,崂山区自2010年3月15日起作为使用目录内产品,取消原有15%左右的药品价格加成,提高新农合对基本药物的补偿比例,当地政府对卫生机构的财政支持是基层卫生机构推行基本药物制度的关键性保障作用。
政策结果层面,在实施基本药物制度之后,卫生院医疗收入和药品收入均有所增长。居民医疗需求出现释放迹象,同时,本研究认为处方中药品种类数量增多也是居民医疗需求释放的一种表现形式,于此同时,居民的次均门诊药费小幅增加。新农合补偿人次增多,基本药物制度对新农合影响基金运行程度有限。另外,乡村两级卫生机构的关系因政策实施竞争性凸显。
(2)莒县实施基本药物制度的政策效应
政策结构层面,同样目录药品存在不合理性。莒县推行乡村卫生一体化管理,本次乡村两级机构均实施基本药物制度,居民在卫生室就诊可以得到新农合补偿。数据表明莒县的医疗需求已经释放。
政策过程层面,该县自2010年5月1日起,在乡村两级卫生机构使用国家和省增补目录内产品,维持原先供货渠道,取消价格加成,调整新农合机构补偿比例。省市县三级政府对莒县卫生系统的财政支持是基层卫生机构推行基本药物制度的关键。
政策结果层面,该县实施基本药物制度之后,乡镇卫生院医疗收入保持平稳变化,药品收入出现明显下降趋势。居民门诊人次保持平稳变化,由于现行目录狭窄迫使住院患者上行,处方药品种类数量趋于减少是药品合理使用的表现,居民的次均药费降低,次均自付药费金额明显降低。新农合补偿人次变化不大,基本药物制度对新农合基金运行影响有限。基本药物制度实施强化了乡村卫生一体化网络。
本研究从政策完善和可持续性实施的角度提出建议,一是应依据居民医疗需求和基层医疗服务机构现状,建立起科学规范的基本药物遴选程序和遴选办法,在合适时机调整和增减基本药物的目录品种；其次是进一步规范和完善医疗卫生机构的补偿机制；三是要结合医疗费用支付方式等制度改革,从控制用药数量和用药结构等要素来达到预期目标；另外研究认为,加强乡村卫生一体化等体系建设是有效落实基本药物制度的重要条件。
研究的创新点、不足及展望
本文在国内首次从理论和实证角度研究了基本药物制度政策效应的评价范畴；提出处方中药品种类数量增加也是医疗需求释放的一种表现形式的思维模式；也为系统评价基本药物制度的实施效果和政策影响奠定研究框架。研究存在的不足一是基本药物制度实施时间较短,政策效果和影响尚未完全释放,某些研究结论尚待进一步验证；二是现有方法学尚不能够完全剔除相关混杂因素的影响。为此,研究尚需在结合相关制度建设和基本药物制度的配套政策建设基础上继续推进。
Background and Current Situation
Going through 30 years of marketization reform process in China, the economic has been developed rapidly, however, a phenomenon is widespread in the medical field, that "medical treatment is difficult and expensive", and that prominent particularly in rural areas, the existence of this phenomenon has affected the economic and social reform to advancement continually. March in 2009, the State Council executive meeting adopted the To Deepen Medical and Health System, which marks the official launch of a new round of medical reform, the program put forward a sound national basic health system, and to establish a national essential medicines system around the national basic medical care health system, the implementation of essential medicines system has become a hot health policy currently.
To line with the implementation of national essential medicines system, series of the supporting policies and regulations were introduced consecutively from national ministries. By the end of 2010, that have been issued involved the selection of essential medicines list, price limits, quality control, and bidding documents, from March 15,2010, the pilot districts and counties began to implement essential medicines system at primary health facilities in Shandong Province.
The development of the essential medicine list is a combination of population characteristics and the light of international experience in medicine, the state identified a total of 307 species list, Shandong Province added 216 drugs. There were 27 pilot districts and counties to implement essential medicines system at primary health facilities in rural areas around Shandong Province. The main measures included the sale and use of directory medicines only, the abolition of drug price addition, improved reimbursement through the new rural cooperative scheme, supply channels unchanged.
Research Significance and Objectives
Essential medicine system in Shandong Province have been implemented in the pilot primary health service system, and how well the implementation of the system, can alleviate to some extent from the "medical treatment is difficult and expensive" phenomenon, can balance the relationship between various stakeholders effectively, can meet whole objectives of policy, which requires evaluation of essential medicines system. To explore the effect of essential medicines system implementation in pilot areas, a comprehensive research of essential medicines system implementation is necessary, which is very important in the process of construction of essential medicines system and the overall promotion of sustainable development.
There were three main purposes of this study, the first one was to define the policy effects scope of the essential medicines system in theory, and select evaluation methodology of the policy; The other purpose is that through empirical research in the pilot district and county of Shandong Province, in which implementation of essential medicines system, to make the policy effect clearly, and to analyze the status and problems of the essential medicines system; The third is to improve and perfect the essential medicines system, then to promote policy recommendations.
Literature Review and Define Policy Effects Scope
Surrounding essential medicines, literature review was composed of three parts, recommendations by WHO, international and domestic research. World Health Organization for the recommendations to the national drugs policy, including the selection of essential medicines, affordability, financing, supply system, drugs control, rational use, drug research, human resources development, monitoring and evaluation, summary of policy was made in the article on brief; international research related to measurement methods of Health Action International (HAI) and International Network for Rational Use Drugs (INRUD); There was seldom systematic study around the new essential medicines system in China, and most of the journal articles were discussion.
Health policy belongs to state public policy; the article describes the content of public policy and procedures, Hofferbert's policy evaluation model and the commonly qualitative and quantitative methodologies. Progress of health policy evaluation shows main points to current policy evaluation, considering the trends of essential medicines in rural Shandong Province, the status of the policy determined that qualitative interviews and quantitative analysis of before and after contrast are more appropriate.
Following the international research system, the level of policy effects should be determined firstly, they are structure, process and outcome, and then to determine the effect areas by consulting experts' opinion, select the specific indicators in each area and content, at last then to define the policy effects scope, through which the policy implementation and the policy impact of essential medicines system in rural of Shandong Province were shown.
Empirical Study Design
The study used qualitative interviews and quantitative analysis of before and after contrast. The research programs include survey forms design, samples selection, sites implementation and quality control. Based on the different subjects for health facilities and the New Rural Cooperative Medical Scheme, four quantitative questionnaires and one qualitative interviews outline were designed respectively. The typical sampling method was used, Ju County and Laoshan District were selected as the sample areas, and then three township health centers were randomly selected from each sample area, each village clinic was selected respectively, in the health centers each of 100 prescriptions were collected before and after policy, interviews 31 health workers at all levels. For data processing, EXCEL and SPSS software were applied, which all employs quality control strictly. Site survey was implemented during August and September in 2010.
Results
Based on policy effect system, the results are shown according to Laoshan District and Ju County respectively, the seven aspects research result are following below.
(1) Equipment of essential medicines. Proportion of equipped essential medicines in health facilities were 64.6% and 62% around Laoshan District and Ju County respectively, proportion of equipped western medicine in list is higher than traditional Chinese medicine, proportion of equipped in the national list is higher than the provincial supplementary list, the main reason of absent essential medicines are that primary health facilities with no corresponding medical items and doctors without habits, some clinical medicines such as pediatric drugs, specialty drugs, homeostatic drugs are needed urgently.
(2) Rational use of essential medicines. There are three indicators in article, average number of drugs per encounter, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed, which in turn Ju County the three indicators are reduced, unchanged, unchanged, and Laoshan District followed by increased, increased, unchanged.
(3) Price of essential medicines. According to the situation after and before the implementation of the essential medicines system, part of the core essentials medicines price has fallen to zero proportion addition. Individual product prices in Laoshan District are higher than the national limit, all Ju County is lower than the limit, and specifications are different vastly in both areas.
(4) Essential medicines supply system. The results come from interviews, which all current supplier firms are regional commercial companies, purchasing frequency variable, uncertain time of payment, and so on.
(5) The impact on Health Center. After the implementation of essential medicine system, Ju County Health Center medical income change smoothly, Laoshan District the trend showed a sharp increase; Ju County drug income declined significantly, while the Laoshan District growth significantly; financial compensation is to maintain the normal operation of health facilities necessary conditions.
(6) The impact on patients. The number of outpatient and inpatient in Ju County health centers did not change significantly, that average drugs cost of outpatient and inpatient per time decreased significantly; Laoshan District, the number of outpatient and inpatient increase rapidly, average drugs cost of outpatient per time increased slightly.
(7) Impact of the New Rural Cooperative Medical Scheme. After the implementation of essential medicine system, the number of out-patient compensated in Ju County change little, while increased in Laoshan District; OOP of patient are reduced in Ju County, Laoshan District remain unchanged; that essential medicine system impact on the Fund is limited, the Fund is running relatively smoothly.
At the end of results, policy structure issues of samples were shown.
Conclusions and Policy Recommendations
Based on results in empirical research, this part is to discuss policy structure; process and outcome level respectively, corresponding to the selection of essential medicines, compensation to health facilities and drug costs, which focused on drug costs.
(1) Policy effects of essential medicines system in Laoshan District
At policy structure level, the current medicines list is unreasonable. Laoshan District did not implement the integrated management of rural health, so essential medicines system is only implemented in township Health Centers, medical care in village health clinics without compensation. Before the implementation of the system, medical needs are restricted, chronic disease spectrum is dominated in the areas.
At policy process level, Health Centers use list products since March 15,2010, canceled about 15% of addition drug prices and improve the new rural cooperative scheme compensation. The local governments financial for implementation of essential medicines are a key role.
At policy outcome level, medical income and drug revenue of the heath centers grow after implement of essential medicines system. There are signs of medical needs release at the same time, this study suggests that increasing the number of prescription drugs is also a type of medical needs release form. At the same time, outpatient drug cost per times increase slightly. Increased compensation for passengers NCMS, essential medicine system is a limited extent for new rural cooperative funds to run. In addition, the relationship between village clinics and health centers become more competitive after policy implementation.
(2) Policy effects of essential medicines system in Ju County
At policy structure level, the selection of irrational drugs led to low proportion of primary organizations. Ju County implements integrated management of rural health, rural two primary agencies implement essential medicines system, and residents could be compensated in both agencies. Data show that the medical needs of areas have been released.
At policy process level, since May 1,2010, the two health facilities in the country use the national and provincial products and maintain the original supply channels, removal price addition, and to adjust the compensation proportion of new rural cooperative scheme. Province, city and county levels of government financial support to primary health system is the key to essential medicines.
At policy outcome level, township health centers medical income remained steady change and significant downward trend in drug income after the policy. Outpatient population change stable, due to the current list narrow hospitalized patients are force d upward; prescription drugs tends to reduce, the number of species is the performance of the rational use of drugs. Both drug costs and OOP reduced significantly. NCMS change little in compensation for passengers. The essential medicines system has a limited impact on running of new rural cooperative fund. The policy strengthen integrated rural health network.
On the perspective to improve and implement the policy continuously, the recommendations of the research as follow, the first one should be based on the medical needs of residents and the status of primary health care services, then to establish scientific and standardized selection procedures and selection essential medicines approach, at the right time to adjust and change the List; Second is to further improve health sector compensation mechanism; Third, to achieve the desired goals of control medicines cost, payment methods and medical system reform, the number of drugs and control structure elements are necessary; Last suggestion is to enhance integration of rural health system, which is a an important condition for implementation of essential medicines system effectively.
Research Innovation, Defect and Prospect
From a theoretical and empirical perspective in this paper, it is the first time in domestic to define the policy effects of essential medicines system; and proposed that prescription drugs increased is a form of the medical needs release; and notes a research framework of essential medicines system evaluation. One of the shortcomings is that implementation time of the essential medicines system was shorter, policy effectiveness and impact have not been fully released, some of the research findings need further verification; second, the existing methodology is not able to completely remove the relevant confounding factors. To this end, researchers still need to promote in the light of essential medicine system based on the construction of supporting policies and related systems.
在我国30多年市场经济体制改革的进程中,社会经济迅速发展,人民群众的物质文化生活水平不断提高。如此同时,在医疗卫生服务领域却出现了越发难以控制的“看病难,看病贵”现象,在农村地区显得尤为突出。2009年3月国务院常务会议通过《关于深化医药卫生体制改革的意见》,该政策颁布标志着新一轮医改正式启动,“新医改”方案表明我国政府将从完善制度的角度化解社会矛盾。“新医改”方案提出完善国家基本医疗卫生制度,而实现国家基本医疗卫生制度的措施之一就是要建立以国家基本药物制度为基础的药品供应保障体系,所以,推行基本药物制度成为当前卫生政策的热点。
为配合国家基本药物制度的实施,国家各部委连续出台系列配套政策和法规,截止到2010年底已颁布涉及基本药物目录遴选、价格限定、质量监督、招标采购规范等文件,山东省自2010年3月15日起在各试点区县基层卫生机构开始实施基本药物制度。
此次制定的基本药物目录是结合居民用药特点和参照国际经验,国家共确定目录品种307种,山东省增补216种药物。山东省27个县区的农村试点基层卫生机构实施基本药物制度,主要措施包括卫生机构仅销售和使用目录内药品,取消药品加成,通过新农合提高基本药物的报销比例,试点实施基本药物制度依然维持已形成的供货渠道不变。
研究意义与目的
山东省基本药物制度是在卫生服务体系相对薄弱的农村基层卫生机构试点实施,该制度实施的情况及效果如何,能否从一定程度上缓解“看病难、看病贵”现象,能否有效平衡卫生服务体系中各利益相关者的关系,能否从整体上达到基本药物制度对卫生服务系统影响的政策目的,这需要对基本药物制度试点结果进行系统评价。本研究根据山东省基本药物制度试点的实施情况,探讨基本药物制度实施的效果与政策影响,明确基本药物制度实施过程中存在的突出问题,对我国基本药物制度建设的整体推进和可持续发展具有十分重要的意义。
本研究的主要目的一是要从理论上界定基本药物制度政策效应的范畴,明确基本药物制度实施评价的方法学；其二是通过对山东省试点区县基本药物制度实施的实证研究,明确基本药物制度实施的政策效应,分析基本药物制度实施的状况及问题；其三是为改进和完善基本药物制度的实施推广提供政策建议。
文献综述与政策效应的界定
文献综述围绕基本药物分别就世界卫生组织建议、国际、国内已发表的研究共分为三部分。世界卫生组织对于国家基本药物制度的建议,主要包括基本药物的遴选、可负担性、基本药物筹资、供应体系、药品管制、合理使用、药品研究、人力资源开发、监测与评估,文章对其每部分政策要点做简单概括；国际范围内研究主要分析卫生行动国际和合理用药国际网络组织开发的测量方法；国内围绕新医改政策内容中基本药物制度的研究并不多,期刊文章多是论述性、系统综述和少量分析性文章,没有检索到与本内容相关度高的系统研究。
卫生政策属于国家公共政策范畴,文章介绍公共政策的内容和步骤,霍弗博特的政策评价模型和常用的定性定量方法学,卫生政策评价的研究进展显示当前在卫生领域进行政策评价的要点和趋势,山东省农村基本药物政策的现状决定本研究采用定性访谈和定量前后对比分析法较为适宜。
界定政策效应范畴要遵循国际研究惯例,首先确定政策效应层面,具体包括结构、过程、结果三个政策层面,再通过咨询专家意见确定政策效应领域,在每个领域选择针对性指标和内容,最后界定适合山东省农村基本药物制度的实施情况和影响程度的政策效应范畴。
实证研究方案的设计
本研究采用定性访谈和前后对比定量分析法,依据形成的政策效应范畴,研究方案主要包括调查表格设计、样本选取、现场实施和质量控制等。依据调查对象的不同,分别针对卫生院和新农合机构设计定量问卷四份,同时分别准备定性访谈提纲；利用典型抽样方法选取崂山区和莒县为实证研究样本区域,每个样本区域随机抽取三所乡镇卫生院,每个卫生院选取一所村卫生室,每个卫生院实施前后各抽取处方100张,访谈各级卫生人员31人；对于数据处理,除利用EXCEL分析以外,处方数据使用SPSS软件进行分析,其中采用严格的质量控制,现场调查在2010年8月和9月实施。
研究结果
研究结果是依据政策效应体系分别对崂山区和莒县实施基本药物制度前后对比情况的分析,主要的研究结果有如下七个方面。
(1)基本药物配备。莒县和崂山区卫生机构配备比例相当,分别为62%和64.6%,西药配备比例均高于中成药,国家目录品种比省级增补目录配备程度高；基本药物未配备的主要原因是“无对应医疗项目”和“医生无使用习惯”；基层临床急需儿科用药、某些专科用药、止血药品等。
(2)基本药物合理使用。根据每张处方中药品的种类数量均数、使用抗生素处方的比例和使用注射剂处方比例这三个指标,其中莒县此三个指标依次是降低、不变、不变,而崂山区依次是升高、升高、不变。
(3)基本药物的价格。依据部分核心基本药物的情况,基本药物制度实施前后比较,药品加成比例都下降为零；崂山区个别产品价格高于国家限价,莒县则全部低于限价,基本药物品规差异较大。
(4)基本药物供应体系。此部分结果来自于知情人访谈,主要有当前供货企业是区域性商业公司,采购频率不定,回款时间不定等。
(5)对卫生院的影响。在实施基本药物制度后,莒县卫生院医疗收入变化平稳,崂山区则呈激增态势；药品收入莒县下降明显,而崂山区增长明显；财政补偿是维持卫生机构正常运转的必要条件。
(6)对患者的影响。莒县卫生院门诊人次和出院人次变化不明显,次均药费下降明显；崂山区门诊和出院则迅速增加,卫生院门诊次均药费略有增加。
(7)对新农合机构影响。实施基本药物制度后门诊补偿人次莒县变化不大,崂山区则增加；门诊次均自付金额莒县降低,崂山区维持不变；基本药物制度对基金运行影响有限,基金运行相对平稳。
结果部分最后总结样本区域政策结构层面内容。
研究结论与政策建议
基于实证研究的结果,讨论政策结构、过程和结果层面的突出性问题,分别选择基本药物遴选、机构补偿和药品费用,其中重点讨论药品费用,总结形成崂山区和莒县实施基本药物制度的政策效应结论。
(1)崂山区实施基本药物制度的政策效应
政策结构层面,现行目录药品存在不合理性。崂山区没有实施乡村卫生一体化管理,本次实施基本药物制度仅在乡镇卫生院实施,农村居民在村卫生室就医得不到新农合补偿,该区居民医疗需求在实施制度之前受限制,当地又有以慢性病为主的疾病谱。
政策过程层面,崂山区自2010年3月15日起作为使用目录内产品,取消原有15%左右的药品价格加成,提高新农合对基本药物的补偿比例,当地政府对卫生机构的财政支持是基层卫生机构推行基本药物制度的关键性保障作用。
政策结果层面,在实施基本药物制度之后,卫生院医疗收入和药品收入均有所增长。居民医疗需求出现释放迹象,同时,本研究认为处方中药品种类数量增多也是居民医疗需求释放的一种表现形式,于此同时,居民的次均门诊药费小幅增加。新农合补偿人次增多,基本药物制度对新农合影响基金运行程度有限。另外,乡村两级卫生机构的关系因政策实施竞争性凸显。
(2)莒县实施基本药物制度的政策效应
政策结构层面,同样目录药品存在不合理性。莒县推行乡村卫生一体化管理,本次乡村两级机构均实施基本药物制度,居民在卫生室就诊可以得到新农合补偿。数据表明莒县的医疗需求已经释放。
政策过程层面,该县自2010年5月1日起,在乡村两级卫生机构使用国家和省增补目录内产品,维持原先供货渠道,取消价格加成,调整新农合机构补偿比例。省市县三级政府对莒县卫生系统的财政支持是基层卫生机构推行基本药物制度的关键。
政策结果层面,该县实施基本药物制度之后,乡镇卫生院医疗收入保持平稳变化,药品收入出现明显下降趋势。居民门诊人次保持平稳变化,由于现行目录狭窄迫使住院患者上行,处方药品种类数量趋于减少是药品合理使用的表现,居民的次均药费降低,次均自付药费金额明显降低。新农合补偿人次变化不大,基本药物制度对新农合基金运行影响有限。基本药物制度实施强化了乡村卫生一体化网络。
本研究从政策完善和可持续性实施的角度提出建议,一是应依据居民医疗需求和基层医疗服务机构现状,建立起科学规范的基本药物遴选程序和遴选办法,在合适时机调整和增减基本药物的目录品种；其次是进一步规范和完善医疗卫生机构的补偿机制；三是要结合医疗费用支付方式等制度改革,从控制用药数量和用药结构等要素来达到预期目标；另外研究认为,加强乡村卫生一体化等体系建设是有效落实基本药物制度的重要条件。
研究的创新点、不足及展望
本文在国内首次从理论和实证角度研究了基本药物制度政策效应的评价范畴；提出处方中药品种类数量增加也是医疗需求释放的一种表现形式的思维模式；也为系统评价基本药物制度的实施效果和政策影响奠定研究框架。研究存在的不足一是基本药物制度实施时间较短,政策效果和影响尚未完全释放,某些研究结论尚待进一步验证；二是现有方法学尚不能够完全剔除相关混杂因素的影响。为此,研究尚需在结合相关制度建设和基本药物制度的配套政策建设基础上继续推进。
Background and Current Situation
Going through 30 years of marketization reform process in China, the economic has been developed rapidly, however, a phenomenon is widespread in the medical field, that "medical treatment is difficult and expensive", and that prominent particularly in rural areas, the existence of this phenomenon has affected the economic and social reform to advancement continually. March in 2009, the State Council executive meeting adopted the To Deepen Medical and Health System, which marks the official launch of a new round of medical reform, the program put forward a sound national basic health system, and to establish a national essential medicines system around the national basic medical care health system, the implementation of essential medicines system has become a hot health policy currently.
To line with the implementation of national essential medicines system, series of the supporting policies and regulations were introduced consecutively from national ministries. By the end of 2010, that have been issued involved the selection of essential medicines list, price limits, quality control, and bidding documents, from March 15,2010, the pilot districts and counties began to implement essential medicines system at primary health facilities in Shandong Province.
The development of the essential medicine list is a combination of population characteristics and the light of international experience in medicine, the state identified a total of 307 species list, Shandong Province added 216 drugs. There were 27 pilot districts and counties to implement essential medicines system at primary health facilities in rural areas around Shandong Province. The main measures included the sale and use of directory medicines only, the abolition of drug price addition, improved reimbursement through the new rural cooperative scheme, supply channels unchanged.
Research Significance and Objectives
Essential medicine system in Shandong Province have been implemented in the pilot primary health service system, and how well the implementation of the system, can alleviate to some extent from the "medical treatment is difficult and expensive" phenomenon, can balance the relationship between various stakeholders effectively, can meet whole objectives of policy, which requires evaluation of essential medicines system. To explore the effect of essential medicines system implementation in pilot areas, a comprehensive research of essential medicines system implementation is necessary, which is very important in the process of construction of essential medicines system and the overall promotion of sustainable development.
There were three main purposes of this study, the first one was to define the policy effects scope of the essential medicines system in theory, and select evaluation methodology of the policy; The other purpose is that through empirical research in the pilot district and county of Shandong Province, in which implementation of essential medicines system, to make the policy effect clearly, and to analyze the status and problems of the essential medicines system; The third is to improve and perfect the essential medicines system, then to promote policy recommendations.
Literature Review and Define Policy Effects Scope
Surrounding essential medicines, literature review was composed of three parts, recommendations by WHO, international and domestic research. World Health Organization for the recommendations to the national drugs policy, including the selection of essential medicines, affordability, financing, supply system, drugs control, rational use, drug research, human resources development, monitoring and evaluation, summary of policy was made in the article on brief; international research related to measurement methods of Health Action International (HAI) and International Network for Rational Use Drugs (INRUD); There was seldom systematic study around the new essential medicines system in China, and most of the journal articles were discussion.
Health policy belongs to state public policy; the article describes the content of public policy and procedures, Hofferbert's policy evaluation model and the commonly qualitative and quantitative methodologies. Progress of health policy evaluation shows main points to current policy evaluation, considering the trends of essential medicines in rural Shandong Province, the status of the policy determined that qualitative interviews and quantitative analysis of before and after contrast are more appropriate.
Following the international research system, the level of policy effects should be determined firstly, they are structure, process and outcome, and then to determine the effect areas by consulting experts' opinion, select the specific indicators in each area and content, at last then to define the policy effects scope, through which the policy implementation and the policy impact of essential medicines system in rural of Shandong Province were shown.
Empirical Study Design
The study used qualitative interviews and quantitative analysis of before and after contrast. The research programs include survey forms design, samples selection, sites implementation and quality control. Based on the different subjects for health facilities and the New Rural Cooperative Medical Scheme, four quantitative questionnaires and one qualitative interviews outline were designed respectively. The typical sampling method was used, Ju County and Laoshan District were selected as the sample areas, and then three township health centers were randomly selected from each sample area, each village clinic was selected respectively, in the health centers each of 100 prescriptions were collected before and after policy, interviews 31 health workers at all levels. For data processing, EXCEL and SPSS software were applied, which all employs quality control strictly. Site survey was implemented during August and September in 2010.
Results
Based on policy effect system, the results are shown according to Laoshan District and Ju County respectively, the seven aspects research result are following below.
(1) Equipment of essential medicines. Proportion of equipped essential medicines in health facilities were 64.6% and 62% around Laoshan District and Ju County respectively, proportion of equipped western medicine in list is higher than traditional Chinese medicine, proportion of equipped in the national list is higher than the provincial supplementary list, the main reason of absent essential medicines are that primary health facilities with no corresponding medical items and doctors without habits, some clinical medicines such as pediatric drugs, specialty drugs, homeostatic drugs are needed urgently.
(2) Rational use of essential medicines. There are three indicators in article, average number of drugs per encounter, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed, which in turn Ju County the three indicators are reduced, unchanged, unchanged, and Laoshan District followed by increased, increased, unchanged.
(3) Price of essential medicines. According to the situation after and before the implementation of the essential medicines system, part of the core essentials medicines price has fallen to zero proportion addition. Individual product prices in Laoshan District are higher than the national limit, all Ju County is lower than the limit, and specifications are different vastly in both areas.
(4) Essential medicines supply system. The results come from interviews, which all current supplier firms are regional commercial companies, purchasing frequency variable, uncertain time of payment, and so on.
(5) The impact on Health Center. After the implementation of essential medicine system, Ju County Health Center medical income change smoothly, Laoshan District the trend showed a sharp increase; Ju County drug income declined significantly, while the Laoshan District growth significantly; financial compensation is to maintain the normal operation of health facilities necessary conditions.
(6) The impact on patients. The number of outpatient and inpatient in Ju County health centers did not change significantly, that average drugs cost of outpatient and inpatient per time decreased significantly; Laoshan District, the number of outpatient and inpatient increase rapidly, average drugs cost of outpatient per time increased slightly.
(7) Impact of the New Rural Cooperative Medical Scheme. After the implementation of essential medicine system, the number of out-patient compensated in Ju County change little, while increased in Laoshan District; OOP of patient are reduced in Ju County, Laoshan District remain unchanged; that essential medicine system impact on the Fund is limited, the Fund is running relatively smoothly.
At the end of results, policy structure issues of samples were shown.
Conclusions and Policy Recommendations
Based on results in empirical research, this part is to discuss policy structure; process and outcome level respectively, corresponding to the selection of essential medicines, compensation to health facilities and drug costs, which focused on drug costs.
(1) Policy effects of essential medicines system in Laoshan District
At policy structure level, the current medicines list is unreasonable. Laoshan District did not implement the integrated management of rural health, so essential medicines system is only implemented in township Health Centers, medical care in village health clinics without compensation. Before the implementation of the system, medical needs are restricted, chronic disease spectrum is dominated in the areas.
At policy process level, Health Centers use list products since March 15,2010, canceled about 15% of addition drug prices and improve the new rural cooperative scheme compensation. The local governments financial for implementation of essential medicines are a key role.
At policy outcome level, medical income and drug revenue of the heath centers grow after implement of essential medicines system. There are signs of medical needs release at the same time, this study suggests that increasing the number of prescription drugs is also a type of medical needs release form. At the same time, outpatient drug cost per times increase slightly. Increased compensation for passengers NCMS, essential medicine system is a limited extent for new rural cooperative funds to run. In addition, the relationship between village clinics and health centers become more competitive after policy implementation.
(2) Policy effects of essential medicines system in Ju County
At policy structure level, the selection of irrational drugs led to low proportion of primary organizations. Ju County implements integrated management of rural health, rural two primary agencies implement essential medicines system, and residents could be compensated in both agencies. Data show that the medical needs of areas have been released.
At policy process level, since May 1,2010, the two health facilities in the country use the national and provincial products and maintain the original supply channels, removal price addition, and to adjust the compensation proportion of new rural cooperative scheme. Province, city and county levels of government financial support to primary health system is the key to essential medicines.
At policy outcome level, township health centers medical income remained steady change and significant downward trend in drug income after the policy. Outpatient population change stable, due to the current list narrow hospitalized patients are force d upward; prescription drugs tends to reduce, the number of species is the performance of the rational use of drugs. Both drug costs and OOP reduced significantly. NCMS change little in compensation for passengers. The essential medicines system has a limited impact on running of new rural cooperative fund. The policy strengthen integrated rural health network.
On the perspective to improve and implement the policy continuously, the recommendations of the research as follow, the first one should be based on the medical needs of residents and the status of primary health care services, then to establish scientific and standardized selection procedures and selection essential medicines approach, at the right time to adjust and change the List; Second is to further improve health sector compensation mechanism; Third, to achieve the desired goals of control medicines cost, payment methods and medical system reform, the number of drugs and control structure elements are necessary; Last suggestion is to enhance integration of rural health system, which is a an important condition for implementation of essential medicines system effectively.
Research Innovation, Defect and Prospect
From a theoretical and empirical perspective in this paper, it is the first time in domestic to define the policy effects of essential medicines system; and proposed that prescription drugs increased is a form of the medical needs release; and notes a research framework of essential medicines system evaluation. One of the shortcomings is that implementation time of the essential medicines system was shorter, policy effectiveness and impact have not been fully released, some of the research findings need further verification; second, the existing methodology is not able to completely remove the relevant confounding factors. To this end, researchers still need to promote in the light of essential medicine system based on the construction of supporting policies and related systems.
引文
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