基层医疗卫生机构用药监管的透明策略研究
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摘要
【目的】鉴于当前国家基本药物制度推进过程中，基本药物的合理使用情况不理想，而提高透明度是药品领域公认的必要措施。但国内外学者对基本药物使用环节的透明研究不够深入，药品信息透明度测量的定量研究更少，在国内外尚未见报道。本研究目的是对基层医疗卫生机构用药监管的透明现状进行测量，对推进监管透明面临的形势进行研判，提出以促进基层医疗卫生机构基本药物合理使用为目标的透明策略，为推动基层医疗卫生机构基本药物使用监管和提升监管力度提供理论和技术支撑。
【方法】本研究运用文献研究、政策文件研究对基层医疗卫生机构用药监管的透明相关规定、所处条件、面临的形势进行收集、整理和分析。运用文献研究、专家研讨等方法确定透明度测量方案和遴选测量指标。运用现场观察、知情人访谈等方法进行现场调查，并采取多人评分计算平均分法对现场拍照的资料进行评分，9名经过培训的调查员独立评分，计算每个指标90人次的平均分。采用单因素方差分析、多重比较统计学检验等统计学方法对现场调查测量结果进行分析。
【结果】
（一）推进药物使用监管透明工作具备了一定的内外部条件。药物使用的基本关系为药物需求-提供-利用。在医疗机构内部，药物使用的关键人物包括医生、护士、药师、管理者。另一重要关键人物是患者。对医疗机构药品提供过程和药品使用进行监管产生的信息会影响患者需求，并反过来影响药品提供行为。针对药物使用的相关主体，我国法律法规、部门规章等已经明确提出了一些政策要求。这些政策为推进药品使用信息透明工作提供了政策依据。地方在推进院务公开或信息公开方面将药物信息纳入公开范围，在公开内容、公开形式方面积累了一定的实践基础，并发现了通过公开基本药物信息促进基本药物使用的典型案例。国际环境比较关注药品领域的透明度，澳大利亚等国家为医疗卫生机构公示药品使用等信息做出了较好的榜样，为推进我国药物使用监管透明提供了可以借鉴的经验。
（二）推进药物使用监管透明工作面临不利因素。一方面，政策执行的监督力度不够。虽然政策有相关规定，但是我国卫生监督队伍只能开展用药宏观的监测和评价，无法监管到每个医疗机构和医务人员。而他们的用药行为直接影响到药物使用的质量和效果。因此对医疗机构内部药物使用的监管不能依靠现有的卫生监督队伍和主管卫生行政部门。另一方面，用药的关键人物在意识和技能方面存在较大问题。医务人员缺乏透明行医的意识，缺乏与患者用药的解释、用药指导等沟通交流。患者也缺乏获取用药信息的主动性，仅限于被动接受或者主观判断。医务人员在用药禁忌、用药配伍等临床技能方面的不足和用药积极性不高等因素严重影响基本药物的合理使用。
（三）基于理论、政策、国内外实践等文献研究和专家研讨，经过三轮遴选，本研究确定了八个类别33个信息公开指标。对山东省随机调查的10个乡镇卫生院进行调查，对公示内容进行拍照。调查员从完整性、清晰性、可获得性、易理解性、及时性五个维度对公开信息的透明度进行测量。结果显示，33个指标中有12个指标的透明度相对较好，另有21个指标的总透明度和各维度评分都是零。完整性最好的是指标21“药品报销费用”，得分为7.67分；清晰性最高的是指标6“公开基本药物临床应用管理办法”，得分为8.28分；可获得性最高的是指标16“公开基本药物价格等基本信息”，得分为9.44分；易理解性最高的是指标4“公开新农合医保报销补偿流程”，得分为6.87分；及时性最好的是指标21“药品报销费用”，得分为8.78分。经TOPSIS分析，透明程度排在前三位的指标分别是指标21“药品报销费用”、指标4“公开新农合医保报销补偿流程”和指标2“公开取药、换药的地点和流程”。八个类别中，类别一“服务流程”在完整性、清晰性、可获得性、易理解性四个维度透明度均排第一，分别得分为153.39、204、234、174分。经TOPSIS分析，透明程度排在前三位的类别分别是类别一“服务流程”、类别六“药品费用”和类别二“药事管理组织与制度”。透明度未得分的指标和类别大部分是体现药物使用质量和效果方面的结果性指标和类别。以上分析可见，我国基层医疗卫生机构基本药物使用监管信息的透明度处于初级阶段。主要表现为公开内容较少，尤其是质量和效果的结果性信息公开程度非常差。已有的公开内容存在不全面、信息不完整、内容不易理解、公开不及时等问题。公开现状与政策层面的要求差距较大。
（四）基于知情权理论、沟通行为理论和自我管理理念的理论基础，基于我国基层医疗卫生机构基本药物用药监管的透明度处于初级阶段的现状，本研究提出四项促进用药监管信息透明策略:一是将药品监管信息透明化作为药品监管的重要内容，作为提升监管力度的重要手段，为衡量一个地区监管水平的重要内容。通过提升药品使用环节的用药信息透明程度，使基层医疗卫生机构和医务人员的用药行为和用药结果接受患者、社会、政府以及供方自身的多方监督，从而提高监管力度。可以依托正在开展的院务公开工作推进药物信息透明。二是将影响药品使用关键人物作为监管重点。首先应通过完善法律，制度，教育、激励约束机制等措施，提高监管主体和监管对象的透明意识。其次，要明确信息透明的内容，透明内容应随着公众透明意识的提高而逐步扩展透明范围。监管的医疗行为应包括医生开处方；药师依据处方配发药品；护士依据处方使用药品，患者的遵医嘱情况和管理者制定的政策和执行等情况。三是建立信息透明的激励约束机制。在医疗机构内部建立考核激励机制是提高透明的根本措施。应建立以提倡合理用药、提高基本药物使用率作为药物使用的考核目标。考核方式可分为日常检查和定期抽查。通过调整考核内容逐步实现透明目标。四是提供药品信息透明的条件保障，包括建设信息系统支持性平台，明确关键人物用药职责并加强教育，提高透明行医意识。信息系统不但要对用药信息进行监测、统计和发布，还要针对关键人物预设提醒告知等辅助服务，对患者提供用药信息查询、用药常识等宣传教育服务，并保证相关人物较为容易的获得相关信息。在医疗机构内部的医师、护士、药师之间有药物使用的相互监督职责，这一点在政策中已有明确规定。应发挥关键人物的作用。尤其是药师的作用。在对医务人员进行透明教育的同时，要对患者进行群体式和个体式教育，倡导患者自我管理，提高患者使用基本药物、合理用药的自觉性和主动性。
【结论】研究表明，基层医疗卫生机构基本药物使用监管透明状况较差；应将监管信息透明化作为提升监管水平的重要内容，逐步实现监管信息发布、反馈、完善改进等多方联动，最终达到促进基本药物合理使用的目的。
【创新点】本研究率先从完整性、可获得性、易理解性、清晰性、及时性五个维度对用药信息监管的透明度进行测量；系统的提出了促进基层医疗卫生机构基本药物使用监管信息透明的策略。这些内容在国内研究中尚属首次，填补了从透明和监管两个角度对促进基本药物在基层医疗卫生机构使用的理论基础和策略研究的空白，研究结果对国际药品监管透明度测量方法方面也是有益的补充和完善。
【Purpose】Currently, the rational use of essential drugs hasn’t achieved expectedresults during implementation and promotion of the national essential drug system inChina. Improving transparency of the pharmaceutical industry has been widelyaccepted as a necessary measure. However, global scholars haven’t conductedin-depth researches on information transparency of essential drug use. So far, noquantitative research on measurement of information transparency has been related inthe world. The paper aims to evaluate the status quo of information transparency ofessential drug use in primary healthcare institutions, analysis difficulties andchallenges to be tackled, and put forward informationtransparency strategies with theobjective of promoting rational use of essential drugs in primary healthcareinstitutions, thus providing theoretical and technical support for primary healthcareinstitutions to implement and enhance regulatory measures on essential drug use.
【Methods】The paper collected and analyzed information regarding the currentstatus of transparent regulations on essential drug use in primary healthcareinstitutions based on literature review and policy study. Literature review and expertconsultation were applied to identify transparency measurement scheme and selectmeasurement indicators. Data collected from field observation and key informantinterview were measured by the average score on each indicator from90person-timemeasurements by9investigators. Univariate analysis and multiple comparison testand other statistical methods were applied to analyze the measurement results basedonfield research.
【Results】
(1)Favorable internal and external environments were available to promotetransparent regulation on drug use. Drug demand, supply and utilization wereinvolved in the drug use chain. Doctors, nurses, pharmacists and regulators were keyparticipants in drug use within in healthcare institutions. Patient was another keyparticipant. Regulation on drug supply and utilization in healthcare institutions had certain impact on patient demand which in turn would affect drug supply. As animportant stakeholder during drug use, policymakers developed specific laws,regulations and rules, which provided policy basis to promote informationtransparency for drug use. After disclosing drug information to the public, localgovernments accumulated practical experience regarding the contents and methods ofinformation disclosure and identified typical cases that promoted essential drug usebased on disclosed information of essential drugs.Pharmaceutical transparency was afocus of the international community. Australia and other countries had demonstratedgood examples of disclosing drug use information in healthcare institutions, providingvaluable experience for China to promote transparent regulation on drug use.
(2) China was also faced with unfavorable environment when promotingtransparent regulation. On one hand, China lacked adequate supervision onimplementation of related policies. Although China had specific policies andregulations, the health inspection team could only monitor and evaluate drug use fromthe macro perspective because it was impossible to supervise each healthcareinstitution and each medical staff whose prescribing behavior had direct impact ondrug use quality and effectiveness. Therefore, the current health inspection teams andhealth administration departments could not implement effective supervision on druguse within healthcare institutions. On the other hand, key participants lacked theawareness and skills for rational drug use. Medical staff lacked the awareness ofpracticing medicine with transparency and the skills of explaining rational drug use tothe patients. Patients also lacked the initiative to obtain drug use information andpreferred to use drugs according to receivedinformation or subjective judgment. Therational use of essential drugs was affected by many factors, such as inadequateclinical knowledge and skills of drug contraindications and compatibility amongmedical staffs.
(3) Based on review of literatures with regard to theories, policies andinternational practices of information disclosure, the study identified33informationdisclosure indicators of8fields after three rounds of consultation and selection.10township hospitals in Shandong Province were randomly selected for investigation.Information transparency was measured from5dimensions: integrity, clarity, accessibility, comprehensibility and timeliness. The results indicated that12out of the33indicators had excellent transparency while the other21indicators scored0in eachdimension and total transparency. Indicator21“drug reimbursement” had the greatestintegrity, scoring7.67; indicator6“administrative measures on disclosing clinicalapplication of essential drugs” had the greatest clarity, scoring8.28; indicator16“disclosing essential drug price and other information” had the greatest accessibility,scoring9.44; indicator4“disclosing NCMS reimbursement process” had the greatestcomprehensibility, scoring6.87; indicator “drug reimbursement” had the greatesttimeliness, scoring8.87.TOPSIS analysis revealed that the top three indicators withthe greatest transparency included indicator21“drug reimbursement”, indicator4“disclosing NCMS reimbursement process” and indicator2“disclosing the sites andprocess for dispensary service and dressing change”. Among the8indicator fields,field1“service process” ranked first with regard to integrity, clarity, accessibility andcomprehensibility, scoring153.39,204,234and174respectively. TOPSIS analysisrevealedthatthe top three fields with the greatest transparency included field1“service process”, field6“drug expense” and field2“pharmacy administrationmechanism”. Most indicators and fields receiving low scores on transparency wereindicators and fields reflecting drug use quality and effectiveness. The resultsindicated that China was still at the preliminary stage of transparent regulation onessential drug use in primary healthcare institutions, manifested as very little publicinformation, especially drug use quality and effectiveness. The information disclosedto the public also lacked integrity, comprehensibility and timeliness. There was a hugegap between policy requirements and the current status of information disclosure.
(4) Based on theories regarding the right to know, communication behaviorand self-management, with reference to the fact that China was still at the preliminarystage of transparent regulation on essential drug use in primary healthcare institutions,the study put forward4strategies to promote transparent regulation on drug use: I. Tointegrate regulatory information transparency as an important measure to enhancedrug regulation and an important indicator to measure drug regulation in a certainarea.Enhanced information transparency within drug use process could encouragepatients, suppliers, government and society to supervise drug use behavior of medical staffs in primary healthcare institutions and subsequent results to enhance drugregulation. Drug information transparency could be enhanced based on the on-goingcampaign for disclosure of hospital affairs. II. To focus on supervision of keystakeholders in drug use process. Firstly, we should improve the awareness ofinformation transparency among regulators and regulatory targets by enhancing laws,regulations, education and incentive and restraint mechanisms. Secondly, we shouldclarify the scope of information transparency which should be extended in line withthe improved public awareness of information transparency. Following medicalbehaviors should be supervised, including prescription by doctors, drug delivery bypharmacists, drug administration by nurses, patient compliance with doctors’ advice,and implementation of policies developed by the management team. Thirdly, weshould establish incentive and restraint mechanisms for information transparency.Establishment of assessment and incentive mechanisms within healthcare institutionswas the radical measure to improve information transparency. We should alsointegrate rational drug use and improved utilization of essential drugs as assessmentindicators. Assessment might include routine inspection and regular spot check.Information transparency could be achieved by gradually adjusting assessmentcontents. Fourthly, China should provide necessary conditions to ensure transparencyof drug information, such as establishing supportive platforms for informationsystems, clarifying drug use responsibilities for key participants and enhancingeducation to improve their awareness of practicing medicine with transparency.Information systems did not only monitor, collect and public drug use information,but also provide notice and warnings for key participants, respond to enquiries ondrug use information submitted by patients and publicizing related knowledge andeducation to patients, and ensure stakeholders had easy access to related information.It was clearly stated in policy requirements that doctors, nurses and pharmacists wererequired to supervise each other on drug use behaviors. The role of key participants,especially pharmacists, should be given full play to. While training medical staffs toimprove transparency, we should also provide patients with group and personalizededucation to advocate self-management and enhance awareness and initiative ofrational use of essential drugs.
【Conclusions】The study reveals poor regulatory transparency of essential drug usein primary healthcare institutions, and proposes to integrate regulatory transparency asan important measure to improveregulation on drug use so as to gradually improveand coordinate disclosure and feedback of regulatory information and eventuallyrealize rational use of essential drugs.
【Innovations】It is the first the study to measure regulatory transparency of essentialdrug use from the perspective of integrity, accessibility, comprehensibility, clarity andtimeliness and proposes strategies to improve regulatory transparency of essentialdrug use in primary healthcare institutions. This is the first study of its kind in China.The study fills the gap of theoretical basis and policy research to improve essentialdrug use in primary healthcare institutions from the perspective of informationtransparency and drug regulation, thus complementing and improving measurement ofinformation transparency in drug regulation and administrationacross the world.
【方法】本研究运用文献研究、政策文件研究对基层医疗卫生机构用药监管的透明相关规定、所处条件、面临的形势进行收集、整理和分析。运用文献研究、专家研讨等方法确定透明度测量方案和遴选测量指标。运用现场观察、知情人访谈等方法进行现场调查，并采取多人评分计算平均分法对现场拍照的资料进行评分，9名经过培训的调查员独立评分，计算每个指标90人次的平均分。采用单因素方差分析、多重比较统计学检验等统计学方法对现场调查测量结果进行分析。
【结果】
（一）推进药物使用监管透明工作具备了一定的内外部条件。药物使用的基本关系为药物需求-提供-利用。在医疗机构内部，药物使用的关键人物包括医生、护士、药师、管理者。另一重要关键人物是患者。对医疗机构药品提供过程和药品使用进行监管产生的信息会影响患者需求，并反过来影响药品提供行为。针对药物使用的相关主体，我国法律法规、部门规章等已经明确提出了一些政策要求。这些政策为推进药品使用信息透明工作提供了政策依据。地方在推进院务公开或信息公开方面将药物信息纳入公开范围，在公开内容、公开形式方面积累了一定的实践基础，并发现了通过公开基本药物信息促进基本药物使用的典型案例。国际环境比较关注药品领域的透明度，澳大利亚等国家为医疗卫生机构公示药品使用等信息做出了较好的榜样，为推进我国药物使用监管透明提供了可以借鉴的经验。
（二）推进药物使用监管透明工作面临不利因素。一方面，政策执行的监督力度不够。虽然政策有相关规定，但是我国卫生监督队伍只能开展用药宏观的监测和评价，无法监管到每个医疗机构和医务人员。而他们的用药行为直接影响到药物使用的质量和效果。因此对医疗机构内部药物使用的监管不能依靠现有的卫生监督队伍和主管卫生行政部门。另一方面，用药的关键人物在意识和技能方面存在较大问题。医务人员缺乏透明行医的意识，缺乏与患者用药的解释、用药指导等沟通交流。患者也缺乏获取用药信息的主动性，仅限于被动接受或者主观判断。医务人员在用药禁忌、用药配伍等临床技能方面的不足和用药积极性不高等因素严重影响基本药物的合理使用。
（三）基于理论、政策、国内外实践等文献研究和专家研讨，经过三轮遴选，本研究确定了八个类别33个信息公开指标。对山东省随机调查的10个乡镇卫生院进行调查，对公示内容进行拍照。调查员从完整性、清晰性、可获得性、易理解性、及时性五个维度对公开信息的透明度进行测量。结果显示，33个指标中有12个指标的透明度相对较好，另有21个指标的总透明度和各维度评分都是零。完整性最好的是指标21“药品报销费用”，得分为7.67分；清晰性最高的是指标6“公开基本药物临床应用管理办法”，得分为8.28分；可获得性最高的是指标16“公开基本药物价格等基本信息”，得分为9.44分；易理解性最高的是指标4“公开新农合医保报销补偿流程”，得分为6.87分；及时性最好的是指标21“药品报销费用”，得分为8.78分。经TOPSIS分析，透明程度排在前三位的指标分别是指标21“药品报销费用”、指标4“公开新农合医保报销补偿流程”和指标2“公开取药、换药的地点和流程”。八个类别中，类别一“服务流程”在完整性、清晰性、可获得性、易理解性四个维度透明度均排第一，分别得分为153.39、204、234、174分。经TOPSIS分析，透明程度排在前三位的类别分别是类别一“服务流程”、类别六“药品费用”和类别二“药事管理组织与制度”。透明度未得分的指标和类别大部分是体现药物使用质量和效果方面的结果性指标和类别。以上分析可见，我国基层医疗卫生机构基本药物使用监管信息的透明度处于初级阶段。主要表现为公开内容较少，尤其是质量和效果的结果性信息公开程度非常差。已有的公开内容存在不全面、信息不完整、内容不易理解、公开不及时等问题。公开现状与政策层面的要求差距较大。
（四）基于知情权理论、沟通行为理论和自我管理理念的理论基础，基于我国基层医疗卫生机构基本药物用药监管的透明度处于初级阶段的现状，本研究提出四项促进用药监管信息透明策略:一是将药品监管信息透明化作为药品监管的重要内容，作为提升监管力度的重要手段，为衡量一个地区监管水平的重要内容。通过提升药品使用环节的用药信息透明程度，使基层医疗卫生机构和医务人员的用药行为和用药结果接受患者、社会、政府以及供方自身的多方监督，从而提高监管力度。可以依托正在开展的院务公开工作推进药物信息透明。二是将影响药品使用关键人物作为监管重点。首先应通过完善法律，制度，教育、激励约束机制等措施，提高监管主体和监管对象的透明意识。其次，要明确信息透明的内容，透明内容应随着公众透明意识的提高而逐步扩展透明范围。监管的医疗行为应包括医生开处方；药师依据处方配发药品；护士依据处方使用药品，患者的遵医嘱情况和管理者制定的政策和执行等情况。三是建立信息透明的激励约束机制。在医疗机构内部建立考核激励机制是提高透明的根本措施。应建立以提倡合理用药、提高基本药物使用率作为药物使用的考核目标。考核方式可分为日常检查和定期抽查。通过调整考核内容逐步实现透明目标。四是提供药品信息透明的条件保障，包括建设信息系统支持性平台，明确关键人物用药职责并加强教育，提高透明行医意识。信息系统不但要对用药信息进行监测、统计和发布，还要针对关键人物预设提醒告知等辅助服务，对患者提供用药信息查询、用药常识等宣传教育服务，并保证相关人物较为容易的获得相关信息。在医疗机构内部的医师、护士、药师之间有药物使用的相互监督职责，这一点在政策中已有明确规定。应发挥关键人物的作用。尤其是药师的作用。在对医务人员进行透明教育的同时，要对患者进行群体式和个体式教育，倡导患者自我管理，提高患者使用基本药物、合理用药的自觉性和主动性。
【结论】研究表明，基层医疗卫生机构基本药物使用监管透明状况较差；应将监管信息透明化作为提升监管水平的重要内容，逐步实现监管信息发布、反馈、完善改进等多方联动，最终达到促进基本药物合理使用的目的。
【创新点】本研究率先从完整性、可获得性、易理解性、清晰性、及时性五个维度对用药信息监管的透明度进行测量；系统的提出了促进基层医疗卫生机构基本药物使用监管信息透明的策略。这些内容在国内研究中尚属首次，填补了从透明和监管两个角度对促进基本药物在基层医疗卫生机构使用的理论基础和策略研究的空白，研究结果对国际药品监管透明度测量方法方面也是有益的补充和完善。
【Purpose】Currently, the rational use of essential drugs hasn’t achieved expectedresults during implementation and promotion of the national essential drug system inChina. Improving transparency of the pharmaceutical industry has been widelyaccepted as a necessary measure. However, global scholars haven’t conductedin-depth researches on information transparency of essential drug use. So far, noquantitative research on measurement of information transparency has been related inthe world. The paper aims to evaluate the status quo of information transparency ofessential drug use in primary healthcare institutions, analysis difficulties andchallenges to be tackled, and put forward informationtransparency strategies with theobjective of promoting rational use of essential drugs in primary healthcareinstitutions, thus providing theoretical and technical support for primary healthcareinstitutions to implement and enhance regulatory measures on essential drug use.
【Methods】The paper collected and analyzed information regarding the currentstatus of transparent regulations on essential drug use in primary healthcareinstitutions based on literature review and policy study. Literature review and expertconsultation were applied to identify transparency measurement scheme and selectmeasurement indicators. Data collected from field observation and key informantinterview were measured by the average score on each indicator from90person-timemeasurements by9investigators. Univariate analysis and multiple comparison testand other statistical methods were applied to analyze the measurement results basedonfield research.
【Results】
(1)Favorable internal and external environments were available to promotetransparent regulation on drug use. Drug demand, supply and utilization wereinvolved in the drug use chain. Doctors, nurses, pharmacists and regulators were keyparticipants in drug use within in healthcare institutions. Patient was another keyparticipant. Regulation on drug supply and utilization in healthcare institutions had certain impact on patient demand which in turn would affect drug supply. As animportant stakeholder during drug use, policymakers developed specific laws,regulations and rules, which provided policy basis to promote informationtransparency for drug use. After disclosing drug information to the public, localgovernments accumulated practical experience regarding the contents and methods ofinformation disclosure and identified typical cases that promoted essential drug usebased on disclosed information of essential drugs.Pharmaceutical transparency was afocus of the international community. Australia and other countries had demonstratedgood examples of disclosing drug use information in healthcare institutions, providingvaluable experience for China to promote transparent regulation on drug use.
(2) China was also faced with unfavorable environment when promotingtransparent regulation. On one hand, China lacked adequate supervision onimplementation of related policies. Although China had specific policies andregulations, the health inspection team could only monitor and evaluate drug use fromthe macro perspective because it was impossible to supervise each healthcareinstitution and each medical staff whose prescribing behavior had direct impact ondrug use quality and effectiveness. Therefore, the current health inspection teams andhealth administration departments could not implement effective supervision on druguse within healthcare institutions. On the other hand, key participants lacked theawareness and skills for rational drug use. Medical staff lacked the awareness ofpracticing medicine with transparency and the skills of explaining rational drug use tothe patients. Patients also lacked the initiative to obtain drug use information andpreferred to use drugs according to receivedinformation or subjective judgment. Therational use of essential drugs was affected by many factors, such as inadequateclinical knowledge and skills of drug contraindications and compatibility amongmedical staffs.
(3) Based on review of literatures with regard to theories, policies andinternational practices of information disclosure, the study identified33informationdisclosure indicators of8fields after three rounds of consultation and selection.10township hospitals in Shandong Province were randomly selected for investigation.Information transparency was measured from5dimensions: integrity, clarity, accessibility, comprehensibility and timeliness. The results indicated that12out of the33indicators had excellent transparency while the other21indicators scored0in eachdimension and total transparency. Indicator21“drug reimbursement” had the greatestintegrity, scoring7.67; indicator6“administrative measures on disclosing clinicalapplication of essential drugs” had the greatest clarity, scoring8.28; indicator16“disclosing essential drug price and other information” had the greatest accessibility,scoring9.44; indicator4“disclosing NCMS reimbursement process” had the greatestcomprehensibility, scoring6.87; indicator “drug reimbursement” had the greatesttimeliness, scoring8.87.TOPSIS analysis revealed that the top three indicators withthe greatest transparency included indicator21“drug reimbursement”, indicator4“disclosing NCMS reimbursement process” and indicator2“disclosing the sites andprocess for dispensary service and dressing change”. Among the8indicator fields,field1“service process” ranked first with regard to integrity, clarity, accessibility andcomprehensibility, scoring153.39,204,234and174respectively. TOPSIS analysisrevealedthatthe top three fields with the greatest transparency included field1“service process”, field6“drug expense” and field2“pharmacy administrationmechanism”. Most indicators and fields receiving low scores on transparency wereindicators and fields reflecting drug use quality and effectiveness. The resultsindicated that China was still at the preliminary stage of transparent regulation onessential drug use in primary healthcare institutions, manifested as very little publicinformation, especially drug use quality and effectiveness. The information disclosedto the public also lacked integrity, comprehensibility and timeliness. There was a hugegap between policy requirements and the current status of information disclosure.
(4) Based on theories regarding the right to know, communication behaviorand self-management, with reference to the fact that China was still at the preliminarystage of transparent regulation on essential drug use in primary healthcare institutions,the study put forward4strategies to promote transparent regulation on drug use: I. Tointegrate regulatory information transparency as an important measure to enhancedrug regulation and an important indicator to measure drug regulation in a certainarea.Enhanced information transparency within drug use process could encouragepatients, suppliers, government and society to supervise drug use behavior of medical staffs in primary healthcare institutions and subsequent results to enhance drugregulation. Drug information transparency could be enhanced based on the on-goingcampaign for disclosure of hospital affairs. II. To focus on supervision of keystakeholders in drug use process. Firstly, we should improve the awareness ofinformation transparency among regulators and regulatory targets by enhancing laws,regulations, education and incentive and restraint mechanisms. Secondly, we shouldclarify the scope of information transparency which should be extended in line withthe improved public awareness of information transparency. Following medicalbehaviors should be supervised, including prescription by doctors, drug delivery bypharmacists, drug administration by nurses, patient compliance with doctors’ advice,and implementation of policies developed by the management team. Thirdly, weshould establish incentive and restraint mechanisms for information transparency.Establishment of assessment and incentive mechanisms within healthcare institutionswas the radical measure to improve information transparency. We should alsointegrate rational drug use and improved utilization of essential drugs as assessmentindicators. Assessment might include routine inspection and regular spot check.Information transparency could be achieved by gradually adjusting assessmentcontents. Fourthly, China should provide necessary conditions to ensure transparencyof drug information, such as establishing supportive platforms for informationsystems, clarifying drug use responsibilities for key participants and enhancingeducation to improve their awareness of practicing medicine with transparency.Information systems did not only monitor, collect and public drug use information,but also provide notice and warnings for key participants, respond to enquiries ondrug use information submitted by patients and publicizing related knowledge andeducation to patients, and ensure stakeholders had easy access to related information.It was clearly stated in policy requirements that doctors, nurses and pharmacists wererequired to supervise each other on drug use behaviors. The role of key participants,especially pharmacists, should be given full play to. While training medical staffs toimprove transparency, we should also provide patients with group and personalizededucation to advocate self-management and enhance awareness and initiative ofrational use of essential drugs.
【Conclusions】The study reveals poor regulatory transparency of essential drug usein primary healthcare institutions, and proposes to integrate regulatory transparency asan important measure to improveregulation on drug use so as to gradually improveand coordinate disclosure and feedback of regulatory information and eventuallyrealize rational use of essential drugs.
【Innovations】It is the first the study to measure regulatory transparency of essentialdrug use from the perspective of integrity, accessibility, comprehensibility, clarity andtimeliness and proposes strategies to improve regulatory transparency of essentialdrug use in primary healthcare institutions. This is the first study of its kind in China.The study fills the gap of theoretical basis and policy research to improve essentialdrug use in primary healthcare institutions from the perspective of informationtransparency and drug regulation, thus complementing and improving measurement ofinformation transparency in drug regulation and administrationacross the world.
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