【作者】 杨小兵；

【导师】 卢祖洵； 李汉帆；

【作者基本信息】 华中科技大学 ， 社会医学与卫生事业管理， 2006， 博士

【摘要】 一、研究目的卫生部—联合国儿章基金会(UNICEF)合作开展的农村初级卫生保健项目(2001～2005年周期)在我国西部正式启动以来，已是三年有余。作为初级卫生保健项目的重要内容之一，农村合理用药各项工作和适宜干预措施的实施，使贫困的西部地区药品流通秩序混乱的状况得到极大改善，乡村两级卫生人员的医疗行为得到了规范，更为重要的是，乡村医生推荐处方的使用和村级基本用药目录的推广，乡村医生乱用抗生素和激素的现象得到遏制。但是，作为农村初级卫生保健重要机构的乡镇卫生院，对其不合理用药尚缺乏深入细致的调查研究；而作为农村初级卫生保健主要技术支持机构的县级医院，对其用药情况更是缺乏必要的定量信息和评价。此外，县、乡、村三级医疗机构在药品的采购、支出、用药的规范管理、以及在项目执行过程中的技术督导、问题反馈、运行机制等方面的情况还缺乏实际的了解。与此同时，项目相关工作的进展状况如何、近年来项目实施的整体效果如何、存在有哪些瓶颈问题，等等，这不仅关系到包括合理用药子项目在内的初保项目最终目标的实现，而且对我国农村卫生改革和农村卫生政策的制订具有重要的参考价值。通过本课题研究，旨在进一步回顾和评价初保项目促进合理用药各项措施的实施效果，发现存在的问题；深入分析县、乡、村三级医疗机构不合理用药的严重程度，探索全面、系统以及富有建设性的干预策略和措施；通过对县、乡、村三级医疗机构不合理用药现状的纵向综合比较，紧密结合当前农村的卫生实际，对农村基本药物政策的推行提出切实可行的建议，丰富合理用药的内涵，赋予合理用药政策的可行性；同时，深入了解农村药品集中招标采购、乡村卫生组织一体化管理在促进合理用药过程中的重要作用，总结乡村医生推荐处方和村级基本药物目录的使用情况，并对处方的修订、完善提供思路；探讨农村三级医疗卫生服务网络中基本药物及合理用药政策与农村新型合作医疗制度的结合点并提出新的政策建议。二、研究内容与方法本研究分为四个部分：第一部分：西部农村县、乡、村三级医疗机构合理用药处方分析以西部三省的5个项目县为研究现场，抽取5个县级医疗机构、5个乡级医疗机构、10个村级医疗机构的门诊处方，全面、系统分析三级医疗机构不合理用药的程度以及合理用药干预措施的实施效果。第二部分：新型农村合作医疗试点运行与合理用药分析抽取宁夏隆德县医院门诊合作医疗处方，分析药物的使用情况，探讨新型农村合作医疗试点运行在促进合理用药过程中地位和作用。第三部分：西部农村县、乡、村三级医疗机构药品购销体制与合理用药干预措施分析深入分析县级医疗机构药品集中招标采购、乡村两级医疗机构药品统一管理体制对药品合理使用的重要意义；作为促进合理用药的重要工具，乡村医生推荐处方及村级基本药物目录在西部农村推行的现实情况及存在的问题。第四部分：研究总结系统提出本研究的结论，分析农村各级医疗机构促进合理用药亟待解决的问题并提出可行性建议；最后，总结本研究的创新之处以及继续开展相关研究的构想。纵观本课题的研究内容，贯穿其间的研究方法主要有：1、快速评价方法：确定合理用药快速评价指标，综合运用定量、定性和参与性研究对农村各级医疗机构药物的使用情况进行分析；2、描述性分析：通过计算平均数、率等指标反映农村各级医疗机构药品使用的客观情况；3、对比分析：采用x~2检验等方法比较指标之间的差异；4、多因素分析：采用多元逐步回归分析方法筛选影响处方费用的主要因素。三、研究结果1、县级医疗机构不合理用药的情况普遍而严重，应引起足够的重视处方分析结果表明，在县级医疗机构的3873张处方中，平均处方用药数为3.21种，多种药物联合使用常见，含9种以上药物的处方占3.85％；平均处方费用32.60元，单张处方最高费用达978元，超过100元的大处方占5.99％；抗生素的不合理使用较为突出，主要表现在超剂量用药、给药方式不合理、重复用药、作用机制相同的抗生素联用等方面，在前60种常用药物中，抗生素的使用占54％，此外，含一种或一种以上的抗生素处方占抽样处方的45.34％，联用两种抗生素的处方占16.21％；激素的使用也存在诸多不合理现象，在每100张抽样处方中，有10张处方使用了激素，并且，抗生素与激素的联合使用率达4.98％；注射的使用比例较高，每100张处方中含注射处方26张，其中，使用了静脉注射的高达58.40％。与WHO合理用药指标相比较，上述处方分析结果明显偏高，其不合理用药的情况普遍而严重。2、乡级医疗机构不合理用药的状况改善极为有限，合理用药干预措施尚缺乏足够的约束力处方分析结果表明，在乡级医疗机构的3733张处方中，平均处方用药数2.33种，平均处方费用15.62元，单张处方最高费用615元。尽管20元以内的处方占抽样处方的78.04％，但不合理的大处方并不少见，费用超过50元的处方占4.74％，而超过100元的大处方占0.88％。在常用药物的使用中，抗生素的使用比例高达46.99％，激素的使用率为8.52％，联用两种以上抗生素的处方占抽样处方的13.10％，并且，无论是从总的抽样处方来分析，还是从各项目县乡级医疗机构的前后比较分析，在统计学检验上均提示上述药物使用指标在2003年和2004年之间无显著性差异。注射的使用比例尽管在部分乡级医疗机构明显降低，但从总体上看其使用比例仍高达34.53％，且近两年也无明显变化。与WHO合理用药指标相比较，尽管平均处方用药数略低，但抗生素、注射的使用情况不容乐观，激素的使用也存在诸多的不合理问题，特别是近两年来的处方比较分析，提示农村初级卫生保健项目针对乡级医疗机构而采取的合理用药干预措施执行效果尚不明显。3、村级医疗机构不合理用药情况的改善取得明显成效，合理用药意识得到加强处方分析结果表明，在村级医疗机构的3206张抽样处方中，平均处方用药数2.20种，平均处方费用3.16元，单张处方费用最高42.60元，最低费用0.1元，费用在10元以内的处方占总抽样处方的97.41％，不合理的大处方鲜有所见。尽管抗生素的使用率达44.79％，且各地存在较大的差异，但在给药方式上更趋于合理，用药范围也以村级基本药物目录为基准；在激素类药品的使用上，每100张处方中，仅发现含激素处方1.53张，且随时间推移各项目县村级医疗机构使用激素的情况明显减少，甚至部分项目县未发现有激素使用，提示激素的滥用得到了有效遏制；抗生素的联合使用情况也不多见，在总抽样处方中，联用2利，或2种以上抗生素的处方仅占8.00％，且各村级医疗机构抗生素联用率呈逐年下降趋势；不安全注射和滥用注射的情况得到有效控制，在410张含有注射的处方中，通过静脉给药方式的处方仅有32张，即92.20％的注射服务是通过相对安全的肌肉注射或皮下注射的方式进行的。由此可见，除抗生素的使用比率较高外，其余指标均在WHO合理用药标准之内，这也充分说明，针对村级医疗机构的各项合理用药干预措施取得了显著成效。4、新型农村合作医疗试点运行对规范用药行为、降低处方费用有着极大的促进作用处方分析结果表明，新型农村合作医疗平均处方用药数2.91种，平均处方费用13.05元，单张处方最高费用65.60元，最低费用0.44元。在药物的使用上，严格遵照合作医疗基本用药目录所规定的范围，抗生素的使用率为46.67％，而联用2种或2种以上抗生素的处方仅占抽样处方的9.20％；激素类药物的使用率为5.06％，含注射处方占抽样处方的比例为6.67％。与该试点县普通门诊处方相比较，上述各项指标均较低；而与西部5县门诊处方的总体水平相比，除合作医疗处方中抗生素的使用率略高外，其余各项指标均有明显下降，提示新型农村合作医疗的试点运行对规范处方用药行为、降低处方费用、减少不合理的注射服务起者较好的约束作用。5、影响处方费用的多因素分析为促进合理用药的费用监控提供了参照影响处方费用的多元回归分析表明，单张处方用药种数对处方费用的贡献最大，是否使用抗生素、是否使用注射等也与处方费用呈正相关，呼吸系统疾病等常见病对处方费用也有一定的影响，这些结果提示，要降低不合理的处方费用，必须从处方行为入手，严格单张处方的药物数量限制，针对疾病所使用的抗生素、静脉注射也需要进行严格的合理性审核。6、农村药品供销体制的改善彰显合理用药的经济性和安全性无论是县级医疗机构的药品集中招标采购，还是乡、村两级医疗机构的药品统一管理、代购分发体制，都从源头上保证了药品的质量，降低了药品的价格，体现了合理用药的安全性和经济性。尽管目前农村药品供销体制在实际的执行过程中还存在诸多的困难和问题，但体制的运行对规范农村地区药品市场的作用值得肯定，特别是对基层医疗机构而言，药品质量的保障作用尤为显著，其在促进药物的合理使用上所体现出来的积极作用已初步凸现。7、乡村医生推荐处方及基本药物目录是促进合理用药的核心措施农村基层医疗机构是实行基本药物政策最直接、最重要的前言阵地，也是最具有决定性的一个环节。而作为“治疗处方集”的一种形式，乡村医生推荐处方为基本药物的选用提供了空间。推荐处方与基本药物目录密切相关，相互促进，在解决农村药品供应、保障农村群众的用药权益、有效控制处方费用、保证有限的药品被安全、有效、合理地使用等方面发挥着重要作用。四、研究创新1、全面、系统地对农村县、乡、村三级医疗机构药物使用情况及其影响因素进行了分析，肯定了农村初级卫生保健项目在促进合理用药过程中富有成效的一面，也对各级医疗机构不合理用药的程度进行了深入地阐述；2、深入探讨了促进合理用药与新型农村合作医疗试点运行之间的密切关系，总结出农村基本药物政策不仅是合理用药完整内涵的重要组成部分，也是新型农村合作医疗进一步拓展的核心；3、系统地分析了农村药品集中招标采购、乡村卫生组织一体化管理、乡村医生推荐处方及基本药物目录在促进合理用药过程中的重要作用，并对其存在的问题提出了适宜的干预策略和措施。更多还原

【Abstract】 1.ObjectivesIt has been more than three years since the "Ministry of Health-UNICEF Project of Primary Health Care (PHC)" (2001-2005) was initiated in Western China. As an important part of the project, the endeavors on rational use of drugs in rural areas has greatly improved the drug circulation system and regulated the iatric conducts of both town and village health workers. What is more, the abuse of antibiotics and hormone has reduced sharply with the application of the standard prescription for village doctors and the generalization of the essential drugs directory for village level. However, there is no subtle research on the irrational drug use in the town hospital, which is the main part of the rural PHC system at present. Furthermore, there is lack of necessary quantitative data and relevant evaluation about the drug use in county hospitals which play a very important role because of the technological support it provided. Moreover, there is no practical understanding about the things such as the drug stock and expenditure, the normalized management of drugs use, and the tech-supervision, feedback and operational mechanism of the project in the 3-level medical organizations. Meanwhile, there are many concerns about how the project gets along, what about the general effect, what’s the bottleneck, and so on. These issues not only relate to whether the ultimate goal can be achieved, but also can provide valuable reference for the reform of China rural health and policy making.The objectives of this research included: to review and estimate the effect of the rational drug use promoting project and find out the problems in the execution of the project; to analyze thoroughly the severity of irrational drug use, explore comprehensive and constructive intervention strategies and measures; to" make practical recommendations on the essential drug policy performing, enrich the implication of rational drug use, and enhance feasibility of the policy by longitudinal comparison of irrational drug use in 3-level medical organizations. Meanwhile, this study intended to explore further the role of the mass advertised bidding and the integrated management of village and town medical organizations in rational drug use. On the other hand, by summarizing the information about the use of standard prescription and essential drug, this research would provide idea in revising and improving prescription. In addition, the study was designed to find out the joint of China New Cooperative Medical System and rational drug use policy and to bring forward some politics advices.2. MethodsThe research contains four parts:Part 1: Analysis of rational drug use of prescription in 3-level medical organizationsIn the selected five project counties in western regions, outpatient prescriptions from 10 village health posts, 5 town medical centers and 5 county hospitals were randomly sampled. The severity of their irrational drug use was analyzed thoroughly and the effect of the intervention measures was evaluated.Part 2: China New Cooperative Medical Service and Rational Drug Use Descriptions were sampled from Longde County Hospital, Ningxia Province. The situation of drug use was analyzed. And the position and functions of CMS in the promotion of rational drug use were explored.Part 3: Analysis of drug purchase-sale system in 3-level medical organizations andrational-drug-use intervention measures.This section analyzed thoroughly the significant meaning of mass advertised biddingin county level and the integrated management of village medical organizations onrational drug use. It also summarized the actual situation of the application of standardprescription and essential drug in western rural areas and tried to find out the existingproblems.Part 4: SummaryThe conclusion would be drawn out systematically. Feasible advice would be put forward after analyzing urgent problems about rational drug use in village medical organizations. Finally, the innovation of the research will be concluded and advice for the further study would be given.In brief, the main methods used in this study are as the following:Rapid Evaluation Method: firstly ascertain indicators of rational drug use, thenanalyze the situation by quantitative, qualitative and participative investigationmethod;Descriptive analysis: calculating the indicators such as means, rates to show theobjective situation of rural medical organizations;Comparing analysis: using chi-square test to compare the difference of variousindicators;Multivariate analysis: using multiple stepwise regression to select the maininfluencing factors of description fee.3. Results3.1 Irrational drug use in county hospital is serious and common, and should receive sufficient attention.In 3873 prescriptions from county hospitals, the average number of drug was 3.21 per prescription; and 3.85% of all the prescriptions contained 9 or more kinds of drugs. It shows that the combined use of drugs is usual. The average prescription fee was 32.60 yuan in spot-checked prescriptions, in which the highest was 978 yuan, and 5.99% of which were over 100 yuan. The abuse of antibiotics was prominent, which mainly included over dosage, unreasonable administration mode, repeated use of drugs, combining use of drugs of the similar function, and so on. In 60 kinds of drugs that were mostly often used, antibiotics accounted for 54%. Of all prescriptions sampled, 45.34% contained 1 or more kinds of antibiotics, and 16.21% contained 2 kinds of antibiotics. The use of hormone also had some unreasonable factors. Ten in every 100 prescriptions used hormone. Antibiotics and hormone combined use could be seen in 4.98% of the sampled prescriptions. The injection rate is high, and there are 26 using injections in every 100 prescriptions. Of all the injection prescriptions, the intravenous mode accounted for 58.40%. Compared with the criteria of WHO, the values of all the above indicators were obviously higher, which shows that the irrational drug use is serious and general.3.2 The situation of irrational drug use in town hospital was improved within a limited degree and the execution power of intervention measures was weak.In 3733 prescriptions from town hospitals, the average number of drugs was 2.33 per prescription; the average fee was 32.60 yuan. Among all the selected prescriptions, the highest fee was 615 yuan. Although the prescriptions of less than 20 yuan accounted for as high as 78.04%, the unreasonable exorbitant prescriptions are not rare. Of all the prescriptions, the fee over 50 yuan accounts for 4.74%, while those with over 100 yuan accounted for 0.88%. Of the most often used drugs, antibiotics contributed 46.99%; and the hormone accounted for 8.52%. Of all the prescriptions, 13.10% contained 2 or more kinds of antibiotics. There is no statistical significance between the 2003 and 2004 with regard to the above indicators. The total injection rate is still as high as 34.53% in recent years though it is obviously lower than before in some town hospitals. Compared with the criterion of WHO rational drug use indicators, although the average number of drugs in single prescription is a bit smaller, the situation of antibiotics and injection use, as well as hormone, is not so optimistic. The comparison analysis of prescription of recent two years shows intervention measures in the rural primary health care project did not have significant effect.3.3 The status of irrational drug use in village health posts has been improved significantly; the awareness of rational drug use has been strengthened.In 3206 prescriptions from village health posts, the average number of drugs was 2.20 per prescription; the average fee was 3.16 yuan. Among all the prescriptions, the highest was 42.60 yuan and the lowest is 0.1 yuan. The prescriptions with the fee less than 10 yuan accounted for 97.41%, and the unreasonable exorbitant prescriptions were very rare. Although the rate of using antibiotics is as high as 44.79%, there were big difference among different areas. The administration mode tended to be more reasonable, and the prescription drugs were mainly based on the village-level essential drug directory. As for the use of hormone, there are only 1.53 in 100 prescriptions containing hormone, and the use of hormone reduced obviously along with time passing. In some project counties, the use of hormone was even not found. All of these shows that the abuse of hormone has been successfully controlled. The combining use of antibiotics was not common, for example, the proportion of 2 or more antibiotics combining use was only 8.00%, which shows a declined trend year by year. Unsafe injection and injection abuse has been successfully controlled. There were only 32 prescriptions which contained intravenous mode in the total 410 injection prescriptions, i.e. 92.20% of injection were carried out in intramuscular or subcutaneous mode, which is safer than intravenous mode. We can see from the above results that all the values of indicators except for the proportion of antibiotics use satisfied the WHO criterion. This also demonstrates sufficiently the significant effect of the intervention measures.3.4 CMS has a great promotion impact on Rational Drug UseWith regard to CMS prescriptions, the average number of drug was 2.19 per prescrioption; the average fee was 13.05 yuan. Among all the selected prescriptions, the highest fee was 65.60 yuan and the lowest was 0.44 yuan. The use of drugs were strictly based on the CMS essential drug directory. The proportion of antibiotics use was 46.67%; and the proportion of combining use of 2 or more antibiotics was only 9.20%. The proportion of hormone was 5.06% and injection was 6.67%. Compared with the prescription in ordinary outpatient departments in this project county, all of the indicator values are lower; Comparing with the total level of the 5 western counties, the value of every indicator was obviously lower except that the proportion of antibiotics was slightly higher. These results imply that CMS has a good passive effect on regulating drug use and decreasing both the description fee and irrational injection.3.5 The multivariate analysis of description fee provides reference for rational drug useThe results of multiple regression shows the number of drugs in spot-checked prescriptions contributed the most to the prescription fee; use of antibiotics or injection increased the fee; and some common diseases such as the respiratory system diseases had some influences on the fee. The results indicate that in order to cut down the description fee, it is essential to start with the regulation of description behaviors, which include strict controlling of the number of drugs in single prescription and the rationality censoring of antibiotics and intravenous injection.3.6 The improvement of the supply and marketing system of drugs in rural areas show the security and economy of rational drug useBoth the mass advertised bidding in county level and the integrated management of village medical organizations assured originally the quality of drugs and lowered the price of drugs, which shows the security and economy of rational drug use. Although there are many problems and difficulties in the executive process, the effect of the system on regulation of the drugs markets in rural areas should be affirmed. Especially for the basic level medical institutions, the effect of drug quality ensuring is significant; and the effect of promoting drug rational use begins to appear.3.7 The standard prescription and essential drug directory are the core intervention to promote rational drug useThe rural basic medical institutions play the most direct and important role in the practice of rational drug use, and is also the most determinant segment. With their close relationship and mutual promotion, the standard prescription and basic drug directory play a key role in supplying medical drug, protecting the right of drug using for rural population, as well as controlling prescription fee, safety, efficiency and rationalization of drug use.4. Innovations4.1 By analyzing thoroughly and systematically the situation of drug use in 3-level medical organizations in rural areas and evaluating the influencing factors, the significant effect of the rural primary health care project on promotion of rational drug use has been affirmed, and the degree of irrational drug use in every level medical organizations has been analyzed deeply.4.2 This study explored deeply the close relationship between CMS and Rational Drug Use, and draw out conclusion that the basic drug policy is not only the important part of rational drug use, but also is the hinge to further improve the CMS.4.3 The research analyzed thoroughly the effect of mass advertised bidding in county level, the integrated management of village medical organizations and the standard prescription on rational drug use, and found out the existing problems and brought forward intervention measures.更多还原