Transparent Strategy Research On Regulatory Of Essential Drug Use In Primary Healthcare Institutions

【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.