【作者】 王珩；

【导师】 冯占春；

【作者基本信息】 华中科技大学 ， 社会医学与卫生事业管理， 2013， 博士

【副题名】以安徽省为例

【摘要】 研究目的本研究在总结国外先进经验和进行深入政策梳理的基础上，设计调查工具并进行现场调查，了解目前基本药物制度在县级医院的实施现状，掌握实施与未实施―零差率‖销售的医院之间的效果差异，分析影响实施效果的机构、医生、患者以及外部配套政策等各方面因素，通过理论分析和实践调研两方面给予基本药物制度在县级医院取得有效的可持续的效果提供政策建议。材料与方法(1)文献分析以卫生政策可持续性理论为贯穿整个研究的主线，从基本药物制度实施效果及其影响因素两方面，对比国外的先进经验，总结国内目前制度实施中存在的问题。(2)现场调查资料分析确定县医院最常见8个病种的36种基本药物作为调查药品目录。选择安徽省内合肥市、芜湖市和马鞍山市的10家县级医院作为调查现场。调查结果指标包括机构药品可获得性、可负担性和合理用药。使用SPSS16.0对机构、医生、患者的基本情况以及处方/病历质量指标进行描述性分析；计数资料使用率或构成比表示，采用卡方检验或Fisher确切概率法进行比较，检验水准ɑ=0.05；医生合理用药处方质量指标以及患者基本药物相关知识知晓水平及态度影响因素采用多重线性回归分析。研究结果(1)总体情况共调查10家县医院，其中5家实行了基本药物―零差率‖销售。调取并统计4个门诊病种处方5044份、4个住院病种2640份病历，医生行为处方5460份。共计有578名具有处方权的医生和1064名患者完成调查问卷。(2)基本药物可获得性实施―零差率‖销售的医院基本药物存储率为85.87%，未实施―零差率‖销售的医院为89.22%，两者之间的差异有统计学意义（P=0.038）。(3)基本药物的可负担性实施基本药物―零差率‖销售的县医院平均有30%的药品不可负担；未实施的县医院平均37.22%的药品为不可负担。(4)机构合理用药实施基本药物―零差率‖销售的医院与未实施―零差率‖销售的医院相比，患者所取到的药品标示清楚比例较高（分别为46.6%和37.3%）、患者知道服药剂量的比例较低（分别为75.0%和78.8%）、患者的平均接诊时间和配药时间较长，处方药品数量和实际配药数量均较高。(5)医生合理用药实施基本药物―零差率‖销售的医院与未实施―零差率‖销售的医院相比，门诊病种处方中的平均药品数量较多（分别为2.34和2.3），通用名比例较低（分别为96.8%和99.1%）、抗生素比例较高（分别为21.2%和18.26%）、基本药物比例较高（分别为38.8%和34.03%）；住院病种的抗生素比例较高（分别为21.37%和20.0%），注射剂比例较高（分别为87.58%和85.73%），基本药物比例较高（分别为65.5%和57.7%）。(6)患者基本药物知晓程度和态度1064名患者中，听说过―基本药物‖概念的仅有159人（14.9%），其知识来源主要是：医务人员（45.3%），电视（39.6%）和网络（27%）；19.2%的患者表示不愿意使用基本药物，原因主要为不信赖其疗效（87.7%），认为质量难以保证（26.5%）。患者的年龄、职业、文化程度、医保类型等与其基本药物知识了解程度以及使用意愿不相关。(7)医生合理用药影响因素影响医生处方药品数量的因素有学历和专业；影响处方通用名使用比例的因素有学历、专业、教育培训经历及对国家基本药物制度的态度；影响处方抗生素使用比例的因素有年龄、学历、专业；影响处方注射剂使用比例的因素有学历和专业；影响处方基本药物使用比例的因素有学历、专业和药品专业知识。研究结论(1)县级医院基本药物的可获得性总体上较高，但实施基本药物―零差率‖销售的县医院的可获得性反而低于未实施的县医院。(2)实施基本药物―零差率‖销售的县医院药品可负担性要明显优于未实施基本药物―零差率‖销售的县医院。(3)实施基本药物―零差率‖销售的县医院与未实施的县医院处方/病历相比，处方药品数量偏高，通用名使用比例偏低，抗生素和注射剂使用比例偏高，基本药物使用比例较高。(4)医生的年龄、学历、专业、接受的教育培训经历、对药品的专业知识了解程度等因素均会对其处方的合理性产生影响。(5)基本药物制度对于广大人民群众的宣传教育力度不够，方式单一。(6)政府缺乏有效的监管，补偿不到位；机构内部未形成竞争性的人事制度，无法产生激励作用。政策建议(1)建立科学适用的县级医院基本药物目录统一遴选标准，以―适用、经济、有效‖为原则；遴选参与主体构成公开透明，综合考虑；地方增补目录考虑地区经济社会发展水平及健康问题的差异性。(2)合理定价，规范配送，确保基本药物的可及性建立平衡定价机制，在确保低价的同时要保证生产企业的积极性；集中招标采购过程中做到价格和质量的平衡；尝试中标企业直接负责药品配送，减少中间环节。(3)转变医院管理理念，优先配备并使用基本药物改变―以药养医‖观念，加强医院精细化管理，提高医院运行效率，制定促进基本药物优先合理使用具体实施办法及措施、明确本单位基本药物配备使用比例、培训考核方案等；加大对医务人员处方行为的监督。(4)加强培训，规范医生处方行为加强对医学生和医务人员的教育培训考核；建立健全激励约束机制，成立处方管理部门，对医生处方行为进行分类和限制；加大医生处方抽查、点评力度，明确奖惩措施并真正落实。建立起体现医务人员劳务价值的薪酬制度、竞争性的人事制度和激励性的分配制度，提高合理用药。(5)落实政府办医责任，构建多渠道的补偿机制建立新型财政补偿制度，落实政府办医主要责任的同时，形成医疗保险基金购买服务补偿、医院服务价格补偿等多元化的渠道。(6)优化基本药物报销政策，发挥医疗保险的杠杆作用社会医保部门参与基本药物制度各环节制定；基本药物取消起付线，有条件的地区实行门诊基本药物100%报销；住院病种实行总额预付和按病种付费方式。创新与不足(1)创新在国内卫生政策研究领域首次将卫生项目的可持续性理论引入基本药物制度在县级医院的实施效果之中；在分析合理用药指标与医生方面影响因素过程中，能够做到将医生的处方与其问卷一一对应，弥补了现有的相关研究中两者分开的缺陷；从理论和实证两个角度为基本药物制度在县级医院实施效果的分析提供依据，将实施的机构和未实施的机构进行对比，不仅增强了结果的可信性，更能从比较分析中得出实施效果的核心影响因素。(2)不足实证调查只选取安徽省内的三个地市作为现场，结果在一定程度上无法反映全国的现状，在接下来的研究中，可以考虑做多个省份之间的对比；由于本研究从制度本身、实施制度的主体、外部配套政策三个方面，较为全面地囊括了制度各方面可能的影响因素，针对基本药物制度核心的医疗保险和政府补偿两方面内容未进行深入透彻的分析，今后的研究需要在此基础上，对每一点进行深挖掘。更多还原

【Abstract】 [Aim] Study tools were designed based on summarizing foreign advanced experiences andreviewing domestic and foreign drug policies. Field investigation were carried out in Anhuiprovince so as to understand current implementation situation of essential medicine systemin county hospitals and observe the differences of policy effect between those hospitals thatexecute―zero markup‖policy and those not. Influence factors of essential medicine policyimplementation effect were analyzed from hospital management, doctors, patients andexternal supporting policies aspects. Based on the results of theoretical analysis and fieldsurvey, policy suggestions were present in order to help essential medicine policy toachieve sustainable effect in Chinese county level hospitals.[Materials and Methods](1) Literature ReviewingSustainability of health policy theory was the mainline that run through the wholeresearch. Implementation effect of essential medicine policy and its influencing factorswere compared to the advanced experience of foreign countries. We summed up thedomestic problems in the implementation of the policy.(2) Field survey data analysis36drugs that treat8common disease entities in county hospitals were selected asSurvey Drug Catalogue. Ten county hospitals in Hefei, Wuhu and Ma Anshan cities ofAnhui province were selected as research sites. Outcome indicators include availability,affordability and rational drug use. SPSS16.0was used to complete data statistic analysis.Descriptive analysis was used to describe fundamental status of hospitals, doctors andpatients. Proportion or constituent ratio was used to express enumeration data, chi-squaretest or Fisher exact probability was used to make a comparison, and α=0.05was set as thesignificant level. Influence factor of rational drug use of doctors was analyzed by multiplelinear regressions. [Results](1) General situationTen county hospitals were investigated, and5of them have implemented the―zero markup policy‖of essential medicines.5044disease entities prescriptions wereselected and counted (including hypertension, diabetes, pelvic inflammatory disease andchildren diarrhea), as well as2640medical records (including cerebral infarction,pneumonia in children, gallstone, cesarean section), and5640doctors‘prescriptions werealso included. A total of578prescribers and1064patients completed the questionnaire.(2) Availability of essential medicinesThe average storage proportion in county hospitals which implemented the―zero markup policy‖was85.87%, and the proportion in those not was89.22%. And thedifference between the two had statistical significance (P=0.038).(3) Affordability of essential medicinesThe county hospitals which implemented the―zero markup policy‖of essentialmedicines had a proportion of30%medicines unaffordable, and those not had a proportionof37.22%medicines unaffordable.(4) Institutions‘rational use of medicinesThe proportion of the medicines with clearly marked patients got from the hospitalpharmacies in the hospitals which implemented the―zero markup policy‖was higher thanthose not (46.6%and37.3%respectively). The proportion of patients who were familiarwith the medication doze in the hospitals which implemented the―zero markup policy‖waslower than those not (75.0%and78.8%respectively). Compared with the hospitals whichhaven‘t implemented the―zero markup policy‖, the average treatment time and dispensingtime of the patients in hospitals which implemented the policy was longer, the numbers ofprescription drugs and the actual numbers of dispensing were also higher.(5)Doctors‘rational use of medicinesCompared the hospitals which implemented the―zero markup policy‖with those not,the average drug numbers was higher (2.34and2.3respectively), the proportion of generalname used was lower (96.8%and99.1%respectively), the average antibiotics proportionwas higher (21.2%and18.26%respectively), and the proportion of essential medicines washigher (38.8%and34.03%respectively) for those four outpatient disease entities. Compared with hospitals which haven‘t implemented the―zero markup policy‖, theantibiotics proportion in hospitals which implemented the policy was higher (21.37%and20.00%respectively), the proportion of injections was higher (87.58%and85.73%respectively), and the proportion of essential medicines was higher (65.5%and57.7%respectively) for those four inpatient disease entities.(6) Patients‘awareness and attitudes towards essential medicinesOf all the1064patients, only159(14.9%) have heard of―essential medicines‖, and thetop three sources of knowledge was medical staff (45.3%), television (39.6%) and thenetwork (27.0%) respectively.19.2%of the patients showed that they were unwilling to usethe essential medicines if doctors recommended, and the reason was mainly not trust thetherapeutic effectiveness of essential medicines(87.7%), or the quality of essentialmedicines was difficult to guarantee(26.5%). There was no relationship between thepatients‘demographic characteristics such as age, job, education degree, health insurancetypes and their awareness of essential medicines and willingness to use essential medicines.(7) Influencing factors of rational drug use among doctorsThe drug number of doctor‘s prescriptions would influenced by their degree andprofession; the proportion of general name used in doctor‘s prescriptions would influencedby their degree, profession, educational and training experiences and their attitudes towardsessential medicine policy. Doctors‘age, degree and profession were the influencing factorsof the antibiotics proportion. The proportion of injections used in the prescriptions wasaffected by doctors‘degree and profession. Furthermore, doctors‘degree, profession andpharmaceutical expertise would influence the proportion of essential medicines in theprescriptions.[Conclusions](1) Generally the availability of essential medicine was high in county hospitals. In countyhospitals that implemented―zero markup policy‖, the availability of essential medicine waslower than those not implement the policy.(2) Affordability in hospitals that implement―zero markup policy‖was obviously betterthose not implement the policy.(3) Compared to the hospitals that not implement the―zero markup policy‖, in hospitalswhich implement the policy, the drug number was higher, the percentages of drugs prescribed by generic name was lower, the antibiotic, injection and essential drugproportion were higher.(4) Doctor’s age, degree, profession, educational and training experience, professional drugknowledge could affect the rationality of their prescription.(5) The publicity degree of essential medicine policy was inadequate for patients.(6)The government did not carried out stringent regulatory on hospitals and thecompensation to hospitals was far enough. County hospitals haven‘t established acompetitive employment mechanism so there was no incentive for doctors to use essentialmedicines.[Suggestions](1) Establish a scientific and practicable essential medicine list for county hospitals.Unify the drug selection standards and adhere to the principle of―suitable, economicaland effective‖; ensure the openness and comprehensiveness of the selection body; take areadifferences into consideration.(2) Ensure the timely distribution of essential medicine for county hospitals.Set up a balanced pricing mechanism and ensure the enthusiasm of medicinemanufactures; realize the balance between low price and high quality in the process ofcentralized bid procurement; manufactures who win the bidding can take the responsibilityof distribution so as to cut down intermediate links.(3) County level hospitals change concept and use essential medicine as first choice.County level hospitals should change the idea of "drug-maintaining-medicine‖;reinforce delicacy management and enhance operating efficiency; draw up measures topromote the preferential use of essential medicine; define the essential medicine allocateratio and assessment programs for doctors; strengthen the prescription check andsupervision among doctors.(4) Enforce training and standardize prescription pattern among doctors.Reinforce education and examination of relevant knowledge on essential medicineamong doctors， perfect motivation and restriction mechanism; establish prescriptionmanagement department and impose restrictions on their prescription pattern; intensifyprescription selective inspection and comment; set up a remuneration system that canreflect the labor value of doctors; build a competitive personnel system and an inspirational allocation system.(5) Government commit to their responsibility in the policy.A new type of financial compensation mechanism should be built. Diversifiedcompensation channel should be formed such as health insurance fund and hospital riskfund compensation, and establish.(6) Optimize the reimbursement policy and bring the role of health insurance departmentsinto play.Pay line for essential drugs could be cancelled and in areas where conditions permitthe100%reimbursement for hospital medication drugs can be implemented. In countyhospital, the DRGs prepaid system for inpatient can be carried out.[Innovation and deficiency](1) InnovationIt‘s the first time to introduce health program sustainability theory into the study ofessential medicine policy implementation effect in county hospitals both home and aboard.There was no study concerning the corresponding relationship between a doctor‘s conditionand his or her prescription by now. We integrated surveys on doctors with their prescriptionrecords for the first time. The basis for the analysis of essential medicine policyimplementation effect from both theoretical and empirical aspects, thus enhanced thecredibility of research results, also get core influence factors by comparative analysis.(2) DeficiencyOnly three cities in Anhui province were selected as field test sites, so the results maybe not able to reflect the whole status quo in the whole country. So comparisons betweendifferent provinces should be made in the following studies. Our study included all thepossible influence factors comprehensively from three aspects (policy itself, main policybodies and external supporting policies). However, thorough analysis on medical insuranceand government compensation, two core elements of essential medicine policy, haven‘tbeen done, and this deficiency should be remedied in the future studies.更多还原