| BackgroundSince the1940s when anti-malarials began experience mass production, the irrational drug use has gradually grown. Over a long period of time, domestic and foreign healthcare facilities have been multiply using polypharmacy and seriously abusing antibiotics and injections, especially in the developing world. In China, excessive prescription, drug abuse, no indications of medication and the consequences resulting from the grass-roots medical institutions’irrational drug use equally deserve much attention. A number of studies have shown that recovery issues, disability, adverse drug reaction and drug resistance caused by irrational drug use and their corresponding disease s and economic burden are serious. Therefore, it becomes necessary to study the intervention and practice of irrational drug use of health care providersTraditional and general promoted measures for intervention of irrational drug use are established based on education and on-the-job training WHO advocates for medical-major students’and doctors’rational drug use, medicine use in communities, formulated essential drug list and essential drugs system, unbinding knowledge promotion, and administrative means. However, the study on factors influencing irrational drug use shows that, the doctor’motivation of irrational drug use is correlated with social economic development, health care system, compensation mechanism and other endogenous factors, as well as endogenous factors such as doctors’inducing the needs of patients. General education of medical intervention and basic measures for drug system promotion cannot eliminate or change the economic incentives for doctors’excessive medication.Studies on physician-induced demand show that realization of doctors’ motivation relies on the serious information asymmetry between patients and health care providers and the attorney-client relationship between doctors and patients. The doctors as patients’agent, advantageous in information, are responsible for making treatment plan and administration decision for patients and directly benefit from the decisions. Therefore, the rational doctors can carry our self-interest irrational drug use relying on the information asymmetry without being found; in addition, revenue and expenditure management mode in medical institutions, doctor income distribution system and design of drug price policy may lead to more serious irrational drug use. Therefore, traditional training&education of rational drug use and administrative intervention measures will have difficulty to change the doctors’tendency to seeking interest through drug use.At present, our governments have realized that the "rational drug use regulation" is difficult to address the root causes of drug benefit stimulation to doctor income. Therefore, in the new-round reform of the medical and health system, basic drug system is carried out in primary healthcare facilities to standardize drug use; what’s more, Zero-markup Policy, reform of medical compensation mechanism, performance appraisal system, payment system adjustment and other comprehensive reforms are also implemented in these institutions, so as to adjust the providers’economic incentive system then eliminate correlation between medicine and doctors’income and rationalize doctors’drug use.However, advanced theories and complicated mechanisms are required to adjust economic incentive mechanism then rationalize doctors’drug use in primary healthcare facilities. Since in the current comprehensive reform of primary healthcare facilities, a number of economic compensation policies and conduct regulations for the health care providers have been released and issued, it will be theoretically and empirically significant to realize organic integration of incentive and restraint mechanism in policy design, play the linkage effect of incentive and regulation in implementation of matching policies, and promote providers to consciously achieve rational drug use, through incentive compatibility constraint.ObjectivesBased on information economics and principal-agent model, this study finds out the root causes of irrational drug use in primary healthcare facilities, theoretically studies the inherent relationship between government regulation, compensation mechanism of medical institution and health insurance payment, worked out the three factors’ incentive and constraint mechanism on providers, and accordingly designs incentive regulation contract to promote rational drug use and empirically studies the effect on medical institutions’expenditure structure, doctors’drug use and patients medication; what’s more, optimization model of rational drug use in primary healthcare facilities is put forward according to analysis of current Zero-markup Policy, compensation mechanism and payment reform results.Specific objectives as follows:1. To find out the root causes of primary healthcare facilitiesirrational drug use in primary healthcare facilities and standardize incentive regulation mechanism for providers’rational drug use;2. To study the provider’s behaviors of information rent-seeking in pharmaceutical bidding, pricing, prescribing, compensating, and payment. To study on the mechanism and effect of screening, price and prescription regulation on the information rent-seeking in theory and case.3. To analyze incentive mechanism of different compensation systems, and measure the incentive effect of specific and comprehensive compensation, respectively.4. To analyze effect of regulation, incentive, and financial risk of different payment method, and design the strategy of mixed payment method.5. To design optimal physician-patient contract, using incentive compatibility, with more rational drug use based on practical effect of incentive regulation, compensation mechanism of health institutions and mixed payment mode on standardization of providers’ medication;Methods(Ⅰ) Data sources and study design of study1. Survey on grassroots health institutions and clinics design and difference-in-difference (D-in-D) analysisFrom2008fourth survey on national health services and2011special survey on monitoring of medical reform, this study selects94samples of survey on primary health care institutions and prescription, collect data about2007-2010operation, data of income and expenditure, outpatient service, drug use, use of basic medicine and insurance drugs, the amount of prescriptions, etc. of basic health care providers; then, in order to ensure the comparability and accuracy of data, the names of primary healthcare facilities and organization code are matched and accordingly those institutions and clinics which participate in the two surveys are selected as the research objects. Then, a total of83primary healthcare facilities (community health service centers or township health centers) in83sample areas are eligible to be data sources for this study. After the selection of survey object, the basic health institutions are classified according to the fact whether the corresponding area started the implementation of Zero-markup Policy in2009, and those implement the policy are all classified as intervention group (including data in2007and2010) while those fail to implement the policy (including data in2007and2010) are taken as control groups, followed by horizontal and longitudinal comparisons; then D-in-D Estimation is carried out to analyze net effect of intervention effect.2. Special survey and quasi-experimental designNingxia Hui Autonomous Region is determined as the study field on payment way reform, to find out the effect of mixed payment reform started from2010. Those administrative villages implementing the payment reform as intervention group, while those not implementing the reform are regarded as control group. The13towns in intervention group contain57administrative villages, while the12towns in control group include54administrative villages. Respectively in2010and2011, special surveys were carried out in village clinics and doctors in pilot area, and then the data about their health services, use of drug and antibiotic, income and expenditure indexes before and after intervention of payment in intervention area and control area were collected and contrasted. Questionnaire survey were done to collect village clinics’ yearly budget, personnel, medical service development, dug procurement, consumption amount of drugs and antibiotics, basic information of village doctors and their income sources. Through interviewing village doctors, the information about their interests, behavior changes as well as opinions, feelings and evaluation about payment reform before and after medical payment reform were summarized. In order to scientifically evaluate the causal relationship between payment reform and health related results in Ningxia, quasi-experimental design was adopted in this study; before the intervention, the administrative villages in pilot counties experienced random assignment, to ensure the balance and comparability between the intervention group and the control group.(Ⅱ) Literature and policy data collectionThe research data and literature at home and abroad are looked up, historical and current policy files defined by China’s Governments related with medical service and drug price regulation, compensation of grassroots health institutions and medical insurance management are reviewed; a series of reform guidance and specific measures for implementation, drug bidding procurement methods used in basic health institutions, Zero-markup Policy, compensation policy, data of all payment reform progress, prescription management method and policies of rational drug use issued by central and local governments are accessed. The statistics from World Health Organization (WHO), National Bureau of Statistics, Ministry of Health and the main government departments of sample areas are referred to, and the main results from fourth survey on national health services and2011medical and health system reform are turned to.(Ⅲ) Analytical methods1. Literature review and summarizingThe collected literature, policy documents and other secondary data are summarized, and accordingly the regulation and measures for drug bidding, reimbursement, compensation, payment, supervision and prescription issue in basic health institutions are analyzed.2. Evaluation methods of prescription indexes in grassroots health institutionsThe grassroots health institutions’prescription indexes, including average number of prescription drugs, antimicrobial prescription proportion, injection rate, percentage of essential drugs and the average cost of prescription are summarized followed by horizontal and longitudinal comparative analysis.3. Difference-in-difference Estimation (D-in-D)D-in-D estimation model is adopted to eliminate confounding factors, variables are controlled to remain the equilibrium between intervention group and control group, and the actual effect of outpatient prescription in intervention group, income and expenditure of grassroots health institutions are evaluated.4. Qualitative analysisAccording to grounded theory and thematic framework analysis, the large amount of information from interviews and discuss with insiders are induced and qualitatively analyzed, followed by description with the help of flow chart. 5. Statistical analysis toolsThe data from survey on clinics’prescription and grassroots health institutions are entered with Epidata3.1, and SPSS19is adopted for statistical analysis.Results(Ⅰ) Exogenous economic mechanism and endogenous Supplier-induced demand (SID) and the interaction between the two cause motivations for health providers’ irrational drug use.Exogenous economic mechanism, drug price policy, compensation mechanism for health institutions and other economic incentives, endogenous Supplier-induced demand (SID) and the interaction between the two cause motivations for health providers’irrational drug use. The asymmetric information and the principal-agent relationship between doctors and patients encourage irrational drug use. Different from general rent-seeking, different-intensity regulation for information rent-seeking will weaken health providers’ initiative or slack the efforts for drug cost savings, thus incentive regulations must be started according to health providers’level of rational drug use and efforts for drug cost savings, so as to make different compensation rules.(Ⅱ) In the process of grassroots health institutions’drug bidding, the number of drugs brand are strictly limited, to reduce drug bid price, but the regulations for drug quality reach poor effect.The investigation of actual health institutions’ drug bidding reform shows that the role of information screening receives much attention in the bidding process, and competition mechanism is introduced in the bidding process. However, current policies focus on drug price, so the regulations for bidding price achieve good effect, but requirements for the quality of bidding drugs are ignored and providers reflect the efficacy of drugs in primary healthcare facilities has declined.(Ⅲ) In primary health institutions, the proportion of Chinese medicine improves, while that of Western medicine declines, antibiotics have little decrease, which is correlated with doctors’prescribing habits and drug consumption cost.Zero-markup Policy and regulatory measures for prescribing help to eliminate economic incentive of doctor-induced demand in primary healthcare facilities, then the amount of outpatient prescription decreases, western medicine and Chinese traditional medicine respectively declines and rises, basic medical insurance and system of basic drugs promote rational drug use; use of antibiotic drugs shows that transfusion ratio decreases while hormone and injections decrease little; use of antibiotic drugs keeps rising even if the intervention policy is implemented, which is related with the suppliers’ medication habit over the years, patients’ long-term drug resistance and drug selection effect; according to disease classification, antibiotic drugs for non-communicable disease (NCD) are reduced gradually, while hormone, infusion and injection for communicable diseases have declined. Manpower cost and fixed cost caused by drug consumption can be economic incentives for drug use in health institutions health institutions.(Ⅳ) The primary healthcare facilities turn to comprehensive compensation mode and performance evaluation methods to change grassroots doctors’ distorted economic incentives and standardize their prescribing behavior.The implementation of Zero-markup Policy helps the basic health institutions’ economic compensation and the parallel General Health Reform&performance evaluation, including performance in health providing such as rational drug use, and corresponding comprehensive compensation, thus the incentive mechanism to gain economic compensation relying on drug sale through markup income in basic health institutions is changed and grassroots doctors’ prescribing is standardized.(Ⅴ) Poor effect of regulation of medicine overuse wit comprehensive compensation mode of primary healthcare facilities has been realized, which is related with unreasonable design of performance evaluation system.Currently, comprehensive compensation mode fails to effectively promote primary healthcare facilities’ standard medication. In addition to the lag effect of policy implementation, the design of performance evaluation mechanism in the comprehensive compensation mode matters a lot, including the lower compensation level than required due to low-level basic health institutions whose approved budget shows more income than expenditure, influencing health institutions’ subsidy level. In addition, the performance appraisal system embraces multi-dimensional comprehensive examination mechanism rather than special assessment for standards of rational drug use, which weakens the incentive of compensation level on standardizing medication. (Ⅵ) Unreasonable performance salary fails to form effective wage gap thus cannot produce effective incentive to doctors’rational drug use.Grass-roots medical personnel’s unreasonable performance salary is followed by effective economic incentive mechanism and possible irrational drug use. On the one hand, the performance standards in some areas pay more attention to quantity than to quality, failing to reflect the quality differences of doctors. The service quality receives little concern, and the salary system embraces no objective standards to judge quality of services and medication, which is also one of the reasons for poor implementation of drug specification under the zero-markup policy. On the other hand, the low proportion of performance salary fails to form effective wage gap coupled with dropped overall income levels, thus doctors’ enthusiasm and rational drug use in work receive no effective motivation.(Ⅶ) Prescription fee and salary system are introduced into mixed payment way, thus the income risk is regulated and providers’rational use of drugs is ensured.The mixed payment-"Capitation+performance appraisal"-implemented in Ningxia rural area shows that, in the reform of mixed payment characterized in in-advance payment, to introduce fee-for-service with a particular form such as prescription fee and to reduce providers’income risk through the salary system can help the mixed payment way to reach a balance between regulation (such as medication shortage) and incentive for suppliers (such as excessive medication), namely incentive and constraint are formed for providers, so as to promote rational use of drugs.(Ⅷ) Optimal physician-patient contract, for the purpose of rational medicine use, has been designed, based on the principle of incentive compatibility.After theoretical study on the mechanism of incentive and regulation of policies issued in comprehensive reform in primary healthcare facilities, and case study on the effect of the above, normative study were used to design optimal doctor-patient contract for the purpose of rational medicine use, based on the results of theoretical and case study.Suggestions(I) Policies issued in comprehensive reform should be coordinate to improve the rational use of medicine. The health care providers are advantageous in information access, so that general government regulation means are low-efficient and ineffectiveness in regulating primary health institutions’drug use. In the incentive regulation embracing incentive compatibility constraint mechanism, some or all the drug costs are transferred to the providers, so that the interests of both sides agree, followed by cost sharing and benefit sharing mechanism payment between payer and providers; in addition, specific compensation mechanism and mode of payment can be designed to increase suppliers’potential risk and expected income, thus the primary healthcare facilities’ doctors can consciously aware the better expected return from standard drug use than the results from induced over medication, so as to achieve the rational drug use.(Ⅱ) Full competition mechanism can be introduced in primary healthcare facilities’drug bidding, and the drug selection process should focus on quality evaluation.Medical service market is difficult to witness full competition, since providers can, relying on information advantages, induce patients to take expensive medicines or overuse drugs for more profit. In order to ensure full competition in drug price, the market competition can be transferred to tendering; franchise bidding method can be referred to to plan drug bidding process; based on the separation of decision-making rights for drugs purchasing in health institutions, the objective selection of drugs (especially based on for drug quality index) and strict limit of the bidding drug brands quantity can regulate the price and quality of bidding drugs; in addition, the winner of bidding firms can be promised to obtain a regional exclusive production and management right, so as to encourage the bidding firms to obtain real information of cost and quality of drugs in the process "to reduce price for winning market"(Ⅲ) The economic incentive factors in drug pricing mechanism can be separated so as to regulate the basic health institutions’medication level with the help of incentive supporting measures.As long as drug pricing mechanism involves addition rate, namely in the regulation of conditional revenue ratio, the providers all tend to induce the patients for more drug demand due to economic incentive, resulting in the drugs with cost effect are high in price but low in market position, thus "bad money drives out good". Therefore, in the drug pricing mechanism, negative effect of economic incentives shall be eliminated; addition ratio of drugs shall be completely canceled, a zero markup pricing method shall be adopted to change the doctors’profit-driven prescribing mode and distorted economic incentive in the drug pricing mechanism. The retail price of drugs can be reduced to gain more market share and medical service quality shall be increased, and accordingly, cross subsidies, as incentive supporting measures of Zero-markup Policy, can be made for economic losses from drug zero addition; what’s more, government intervention is required to offer financial subsidies or health insurance compensation for reasonable losses.(Ⅳ) Economic incentives and non-economic incentive measures can be combined to promote rational drug use in primary healthcare facilities.The primary healthcare facilities should witness comprehensive reform involving basic system for drugs, Zero-markup Policy, physician prescribing behavior specification and the like to regulate the providers’information rent-seeking. The measures for elimination of doctors’negative economic incentive have achieved the expected effect to a certain extent; however, this does not mean suitable incentive mechanism has been established and rational drug use has been formed. For example, the use of antibacterial drug in the classification according to disease type situation is still not optimistic. Unexpected results indicate that condition and motivation for inhibition of service suppliers’induced-demand have no complete correlation with the results of their rational use of drugs. Therefore, economic incentive mechanism in line with rational drug use value shall be established by turning to the compensation mechanism and medical insurance payment of health institutions, and non-economic incentive mechanism promoting standard medication in communities shall be also adopted to jointly promote rational drug use in primary healthcare facilities.(Ⅴ) The key for the comprehensive compensation mode in primary healthcare facilities is to create a suitable supplier incentive mechanism.Suitable incentive mechanism shall be created according to comprehensive compensation based on performance appraisal. Comprehensive compensation system aims to form more scientific and reasonable compensation mechanism for health institutions and medical personnel income distribution mechanism with the help of performance appraisal system. Evaluation mechanism of suppliers’reasonable drug use shall be designed, proportion of performance salary shall be improved, and wage gap shall be reasonably formed to establish suitable economic incentive mechanism to promote the rational use of drugs.(Ⅵ) Prescription-fee system shall be introduced into compensation mechanism in primary healthcare facilities, so as to strengthen grass-roots doctors’enthusiasm for standardized medication.Primary healthcare facilities will implement Zero-markup Policy in Drug Sale, cancel the economic incentive for grassroots doctors’prescribing, reduces the doctors’ enthusiasm in daily work, while the current reform of payment way may also exacerbate this phenomenon. Based on reform practice and results of mixed payment in Ningxia rural areas, the prescription fees system and incentive factors are introduced into basic health institutions and the negative incentive from drug addiction income shall be transferred into positive incentive from appropriate medical service.(Ⅵ) Global budget should be implemented to the primary healthcare facilities where the situation of irrational use of medicine was not optimistic after the implementation of Zero-markup policy and comprehensive reform.The reason of irrational use of medicines after the implementation of Zero-markup policy and comprehensive reform is lack of financial risk for the health care providers. Consequently, the payment with high risk could be taken to reduce the level of the rational use of medicines. Because the Per-diem and DRGs are too difficult to implement in grassroots health institutions, and capitation is focused on public health, global became the choice of the payment to provide enough risk to reduce the irrational medicine use, with the help of performance appraisal and performance salary.(Ⅷ) A variety of fiscal input shall change the Compensation System for Medial Cost Through Drug-selling and compensation incentive shall promote the rational use of drugs.At present, the income loss due to Zero-markup Policy in primary healthcare facilities shall deserve economic compensation in a variety of ways, and the routine&special allowances (including funds for public health service), general fee income and medical insurance payment should be the main income source of basic health institutions, those institutions who sufficient conditions shall gradually reversed the "Compensation System for the Medial Cost Through Drug-selling", In addition, different ways of investment should match corresponding incentive mechanism. Fiscal subsidies shall be determined according to the results of performance evaluation to comprehensively reflect overall operation efficiency of health institutions, quality and quantity of service, residents’ satisfaction, etc. The enthusiasm of the medical staff shall be aroused. General fee based on the reasonable pricing help to promote the level of medical personnel’s rational drug use and improve the quality of medical services. The medical insurance fund will play a guiding role for health institutions and medical personnel in the financing and payment process. Influenced by many investment ways, the investors’ shall widely recognize the drug cost effectiveness and long-term benefits to promote rational drug use with consensus. The investments can, under the influence of corresponding compensation incentive mechanism, effectively control the medical staffs’ use of drugs and utilize a variety of economic means to promote the rational drug use. |
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