【作者】 王迪飞；

【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， 2012， 博士

【摘要】 研究目的：研究目的是系统的描述基本药物制度实施中的社会医疗保险问题、评价在社会保险干预不足下基本药物制度政策效果、分析基本药物制度中有关医保政策制定和执行的难点并在此基础上提出相应干预策略。研究方法：研究方法包括文献法、利益集团访谈、处方调查分析等。通过文献论证现有基本药物制度中社会医疗保险干预的问题。通过类实验设计和时间序列分析法,回顾性调查2009年1月至2011年7月社会医疗保险干预不足的情况下,基本药物制度对基层医疗机构药品使用的影响。通过间断时间序列,分析政策干预前后的药品使用指标水平的变化和趋势的变化,估算政策干预对于合理用药指标的干预效果。通过利益集团访谈的方法,确定各利益集团在基本药物实施政策制定和执行中的立场、态度、权利、作用等。结果和结论：在社会医疗保险干预不足下,基本药物制度推行过程中出现了许多问题。比较突出的问题集中在基本药物费用支付方式、基本药物报销、定价、招标采购等方面。首先,由于社会医疗保险在许多地区仍然没有实现门诊统筹,影响门诊基本药物可负担性。其次,社会医疗保险没有完全执行对于基本药物“优先报销、报销比例明显高于非基本药物”的政策要求。基本药物和社会医疗保险甲类药品报销比例和优先性没有本质区别。第三,社会医疗保险作为支付方,在基本药物遴选、定价、招标、配备等流程中的管理不足,其功能被限于被动支付基本药物费用。第四,社会医疗保险按项目支付的支付模式不能促进基本药物的合理使用。在社会医疗保险干预不足的情况下,湖北省基本药物制度政策效果不一致。本研究通过类实验设计和时间序列分析法,回顾性调查2009年1月至2011年7月,在社会医疗保险干预不足的情况下,基本药物制度对基层医疗机构药品使用的影响。正面的影响包括基本药物使用率提高,单张处方药品价格下降。干预后,实验组中医疗机构基本药物使用率达92.109%。与假设没有干预的情况相比,基本药物使用率提高了36.753%。干预后,平均处方费用为31.095元,与假设没有干预的情况相比,平均处方费用降低了13.448元。但对于其他合理用药指标,基本药物制度干预效果不大。基本药物制度实施前后,单张处方药品个数、抗菌药物使用率、注射剂使用率这三项指标的水平变化和趋势变化不明显。其他可能的负面影响包括：诱导患者向使用更多上级医院的门诊和服务、基层医疗机构功能萎缩、基层医生服务积极性下降、患者药品费用和就医成本不降反升等。通过利益相关者的研究,我们发现在基本药物制度与社会医疗保险有关的政策制定中,有11个具有较大影响力的利益集团参与。虽然非政府团体和国际组织在基本药物制度社会医疗保险有关政策的制定中发挥了一定的作用,但卫生部、财政部、人保部、发改委等中央部委在政策制定中起到了决定性的作用。由于管理不同领域的公共事务的各政府部门具有相应权利,社会医疗保险部门制定政策干预由卫生行政部门管理的公立医疗机构存在极大障碍。政府部门在社会医疗保险干预基本药物制度中政策中不同的利益也对政策制定和执行产生了阻碍。例如,社会医疗保险部门最为关注的利益为保障社会医疗保险资金的平稳运行,而卫生部门最关注的是保障公立医疗机构的利益。卫生行政部门和社会医疗保险部门都在寻求制定和执行最有利于扩大自身权利和利益的政策。由于社会医疗保险部门和卫生行政部门缺乏促进基本药物制度实施的共识,通过社会医疗保险干预基本药物制度政策制定和执行的交易成本高、难度大。建议：首先,社会医疗保险干预基本药物制度政策的制定和实施首先必须是政治上可行的。针对医保部门的政治策略包括：(1)加强与发改委、财政部之间的联系,为社会医保获得更多的医保资金以强化医保作为支付方的实力；(2)争取获得国内药品生产、流通企业的支持；(3)争取主要媒体的支持,宣传医保干预的优势和降低患者支付水平的好处；(4)强化与研究机构的联系,共同开展课题,完善医保干预基本药物制度的方法,评价干预效果；(5)争取地方政府的支持,扩大医保干预的范围和效果；(6)支持“管办分开”等削弱卫生行政机构和医疗机构联系的政策,孤立医保干预的反对者；(7)利用社会医保已有的影响力,抵制卫生行政部门单方面提出的,以最大化自身利益为主的政策提案。第二,社会医疗保险部门和卫生行政部门应建立起在推行基本药物制度的共识。对于中央政府的可行的策略是,政府通过采取问责制的方法,使卫生行政部门和社会医疗保险部门均对基本药物制度的政策产出负责。评价标准应交由专业研究研所和专业国际机构独立研制。评价应以指标评价为主,包括政策背景、过程、产出、影响等部分。对于基本药物制度的评价工作的开展,应由独立第三方(例如发改委)组建的政策效果评价组负责。第三,应建立激励机制、改革支付方式、控制管理患者就医为主的策略干预基本药物制度实施。作为基本药物费用的支付方,社会医疗保险应直接参与到基本药物目录和处方集的遴选中,如有必要可以考虑管理药品招标、采购。社会医疗保险干预政策的制定应以促进基层医疗机构适当竞争,管理病人卫生服务利用行为,量化政策投入产出,提高基本药物生产流通使用整体效率为主要策略。建议通过社会医疗保险参保者信息和医保基金承受能力,确定基本药物覆盖的疾病和种类,在此基础上,确定基本药物目录和处方集；在给予病人一定选择权的情况下,管理病人就医行为,规定仅有在规定的医疗机构使用基本药物才能获得医保的报销；在基本药物需求大致可估算的条件下,实现按量采购基本药物,基本药物价格与采购量挂钩；医保按医疗机构服务质量、卫生产出等标准给与补偿,使药品成为成本而不是索要补偿的手段。创新与不足：本研究的创新点主要有两处。第一,在国内药物政策研究中首次使用间断时间序列和分层回归的分析方法研究基本药物制度政策效果。在卫生政策很难开展随即对照试验的情况下,这种准试验方法是最严格的试验设计。用时间序列分析和分层回归法分析在社会医疗保险干预不足下基本药物制度政策效果的优势是能够很好的控制对于模型内部效度的威胁因素(例如历史趋势等)。通过评价一个序列的产出变量,间断回归结论的可靠性明显高于横截面分析政策干预前后两个数据点的结论。其次,这个方法还能够评价政策效果产生的方式,而横断面干预前后两点式分析无法做到的。第二,将政策过程理论和利益集团分析结合并,并首次运用于分析国内药物干预政策分析中。政策问题分析不局限与对于具体的、政策执行中出现各种现象的解释和理解,而是被视为与政策制定者和制定方式相互联系一种结果。这样的分析视角更有利于找到政策问题的根源。本研究的不足主要有两点。受各种条件限制,本研究仅分析62000处方中的5个最重要的合理用药的指标。对于另一些指标,例如,病人信息、基本信息、治疗情况、药品报销情况等其他有用的处方信息没有分析。因此本研究仅仅能够从宏观上判断基本药物制度在基层医疗机构的政策效果,而不能准确评价基本药物制度对于疾病用药和患者就医行为的具体影响。第二,利益集团的结果容易受调查者主观判断的影响。因此,利益集团分析可能含有一定的主观成分。更多还原

【Abstract】 Objective:The purpose of this study is to systematically evaluate social insurance related problems in implementing essential medicines policy in China and to study intervention strategy from the perspective of social health insurance. Empirical study which retrospective evaluate the policy effect was carried out in order to measure how essential medicines impact medicine use in primary health centers without adequate intervention from social health insurance. Stakeholder analysis was carried out to study the problems in policy formulation and implementation. On the basis of quantitative and qualitative analysis we propose intervention strategies.Method:Literature review, stakeholder interview, and prescription analysis were used in this study. Literature review was used to identify the existing problems of social health insurance in implementing essential medicines policy. Quasi-experimental design was used to retrospectively evaluate policy impact of essential medicines system without effective social health insurance’s intervention. We use this strong design and segmented regression to estimate the change inlevel and trend of medicines use indicators. We use stakeholder interview to describe the position, attitude, power and impact of stakeholders in health-insurance related policy intervention and to study how stakeholders influence policy formulation and implementation.Result and ConclusionMany problems occurred in the essential medicine policy’s implementation. The mains issues are the unchanged fee-for-service payment schemes, the unsatisfactory reimbursement rate for essential medicines,unreasonable pricing, and inefficient tendering and procurement. In most areas, social health insurance system does not effectively cover outpatients’cost. Hence, essential medicines’expenditure was not covered by social health insurance schemes. Secondly, social health insurance schemes had not give priority to the reimbursement of essential medicines. Essential medicines are reimbursed at similar rate compared to other medicines. Thirdly, as a payer for medicines cost, social health insurance system had not managing key policy components including medicines selection, pricing, tendering and procurement. At last, social health insurance system as a payer wasunable to control rational medicine use of essential medicines.Without adequate intervention from social health insurance system, the essential medicines policy in Hubei yield mixed policy effect. We use interrupted time series design and segmented regression analysis to study and estimate the policy effect. We retrospectively study the prescription from January 2009 to July 2011. It is estimated that the policy intervention increase the use rate of essential medicines to 92.109%, raised by a policy effect of 36.753%. After the intervention, the average cost per prescription was 31.095 yuan, down by 13.448 yuan had the policy not implemented.However, the positive policy effect had not extended to all indicators. The policy had less effect on the use rate of injection, the use rate of antibiotics, and the average number of medicines per prescription. The change of level and trend of these three indicators were less considerable or statistically insignificant. Other negative policy effect may exist including the increase of outpatient and inpatient service utilization of hospitals, the decreasing role of primary health care facilities in curing disease, and the increasing cost in health care seeking among patients.We found by stakeholder study that 11 stakeholders had not involved in policy formulation process. While non-government sector and international organization had play significant role in policy formulation, major government department including ministry of health, ministry of finance, committee of development and reform, and ministry of human resource and social security had dominant role in policy formulation. The decision making was on joint consensus model which means a policy had to be endorsed by all major government departmentsbefore publication. As different government department had various powers in managing public issues, there are significant obstacles to formulate and implement intervention from social health insurance system. In addition, the vested interest of different government department induces self-seeking behavior among government department. While the social insurance system cares most of sustaining the funds of social health insurance schemes, the ministry of health advocate for maximizing the interest of public health provision system. A share interest among government department was lacking in implementing essential medicines policy.Policy recommendationFirstly, the intervention from health insurance system must be political feasible. Politics strategies for social health insurance authority include (1) strengthen the link to powerful but neutral government department; (2) gain support from national pharmaceutical companies; (3) gain support from mass media; (4) strengthen corporation with research institute on study policy effect; (5) persuade provincial government to increase pilot program; (6) support the existing pilot policy that deemphasize the link between health facilities and health bureaucratic system such as the separation of medicine and health care service and the separation of powers in hospital management; (7) impede policy proposal that only maximize the power and resource of health bureaucratic system. Secondly, a shared value should be established among government department. For the central government, accountability should be introduced in order to push government department in achieving health related goals rather than their own interest. Careful policy evaluation system should be designed by independent professional institute in order to obtain unbiased evidence.Policy evaluation should be carried out by a third party organization.Thirdly, we recommend the health insurance authority establish a new incentive model which reward physicians to protect the health of patients rather than made them rely on government’s subsidy. Secondly, we recommend health insuranceusing a new payment schemes for essential medicines to replace the fee-for-service scheme. Our third recommendation would be on patients’health resource utilization control. Patients’ medicines reimbursement should be subject to which provider he chooses. Our last recommendation would be on control medicines price and procurement. Social health insurance may intervene in the essential medicines pricing and procurement in order to yield better policy outcome. Innovation and drawbacksThere are two major innovations in the study. The study is the first policy intervention study of China’s pharmaceutical policy using interrupted time series design and segmented regression. The study design is a strong alternative to randomized control trial which is rarely possible in health policy research. The use of this method successful addresses most validity threads such as historical influence and materiality. By evaluating a sequence of the outcome variables, the conclusion is reliable.Secondly, the study is the first of its kind which extensively study policy formulation and stakeholder’s influence. Using theories of policy processes and stakeholder analysis, we extend the policy analysis from problems in implementation to policy formulation.The limitation of the study is of two folds. Because of certain limitations, this study only analyzed part of the information on the 62000 prescriptions. Other useful information, such as the patient information, diagnosis, treatment, and drug reimbursement had not been analyzed. Therefore, the result of the study is constraint and is unable todescribe detailed policy impact on patients’health outcome. Secondly, the result of the interest groups and their influence on policy formulation and implementation maybe suffer from subjective judgment.更多还原