q The Author 2005. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. doi:10.1093/heapol/czi018 The impact of China’s retail drug price control policy on hospital expenditures: a case study in two Shandong hospitals QINGYUE MENG,1,2 GANG CHENG,1 LYNN SILVER,2,3 XIAOJIE SUN,1 CLAS REHNBERG4 AND GÖRAN TOMSON2,4 1 Center for Health Management and Policy, Shandong University, Jinan, China, 2Division of International Health, Karolinska Institute, Stockholm, Sweden, 3Pharmaceutical Sciences, School of Health Sciences, University of Brası́lia, Brazil and 4Medical Management Center, Karolinska Institute, Stockholm, Sweden In China, 44.4% of total health expenditures in 2001 were for pharmaceuticals. Containment of pharmaceutical expenditures is a top priority for policy intervention. Control of drug retail prices was adopted by the Chinese government for this purpose. This study aims to examine the impact of this policy on the containment of hospital drug expenditures, and to analyze contributing factors. This is a retrospective pre/post-reform case study in two public hospitals. Financial records were reviewed to analyze changes in drug expenditures for all patients. A tracer condition, cerebral infarction, was selected for in-depth examination of changes in prices, utilization, expenditures and rationality of drugs. In the two hospitals, a total of 104 and 109 cerebral infarction cases, hospitalized respectively before and after the reform, were selected. Prescribed daily dose (PDD) was used for measuring drug utilization, and the contribution of price and utilization to changes in drug expenditures were decomposed. Rationality of drug use post-reform was reviewed based on published literature. Drug expenditures for all patients still increased rapidly in the two hospitals after implementation of the pricing policy. In the provincial hospital, drug expenditures per patient for cerebral infarction cases declined, but not significantly. This was mainly attributable to reduced utilization. In the municipal hospital, drug expenditure per patient increased by 50.1% after the reform, mainly due to greater drug utilization. Three to five fold higher drug expenditure per inpatient day in the provincial hospital was due to use of more expensive drugs. Of the top 15 drugs for treating cerebral infarction cases after the reform, 19.5% and 46.5% of the expenditures, in the provincial and municipal hospitals, respectively, were spent on drugs with prices set by the government. A large proportion of expenditures for the top 15 drugs, at least 65% and 41% in the provincial and municipal hospitals, respectively, was spent on allopathic drugs without an adequate evidence base of safety and efficacy supporting use for cerebral infarction. Control of retail prices, implemented in isolation, was not effective in containing hospital drug expenditures in these two Chinese hospitals. Utilization, more than price, determined drug expenditures. Improvement of rational use of drugs and correcting the present incentive structure for hospitals and drug prescribers may be important additional strategies for achieving containment of drug expenditures. Key words: China, drug price, policy, hospital, expenditure Introduction The rapid rise of medical and pharmaceutical expenditures has become a critical barrier to health care for the poor and its control is a key objective for health policy makers (Bloor and Freemantle 1996; Centre for Health Statistics and Information 1998; Wu and Yang 1999; Maynard and Bloor 2003). China is no exception. Pharmaceutical expenditures have grown at a rate well above overall economic growth for the past two decades (Wei 1999). Drug expenditure per capita in real terms increased from 36.6 yuan in 1990 to 184.3 yuan in 2001 (US$1 ¼ 8.2 Chinese yuan), an annual rate of increase of 15.7% (Zhao et al. 2003). Internationally, a number of approaches have been used for containing drug expenditures. These approaches can be divided between those which affect the supply of drugs on the market and those addressing the demand generated by health professionals and consumers for pharmaceuticals (Figure 1) (Gross et al. 1996; Ess et al. 2003). Conflicts of interest in the operation of health systems, such as the case of physicians who both prescribe and dispense, have been associated with higher drug utilization and expenditures, and the separation of the two activities has been a longstanding feature of codes of ethics of the medical profession in many countries. It is, however, still the norm in other countries, 186 Qingyue Meng et al. the average of the industrial sector (MoH 2000). The number of pharmaceutical manufacturers rose from 3097 in 1990 to 5396 in 1997 (China State Economic and Trade Commission 1999). By the end of the 1980s, the shortage of pharmaceuticals that had existed during the planned economy era had been fully resolved (Dong et al. 1999). Figure 1. Internationally used approaches to controlling drug expenditures and may be increasing (Ess et al. 2003). Less research is available on other institutional arrangements where hospital or prescriber income is highly dependent on drug sales. Development of straight salary compensation for pharmacists and public interest drug distribution and retailing systems in some countries, such as Sweden, have also helped to eliminate conflicts of interests in the pharmacy setting. In China, a number of measures have been taken by policy makers to slow the growth rate of drug expenditure. These have included the use of a drug list and consumer cost-sharing in social health insurance schemes, capping the annual growth rate of incomes of hospitals, controlling prices of pharmaceuticals, and regulating mark-ups. Drug lists and modified payment systems have been recommended and implemented since the mid-1990s, and have been confirmed as effective in controlling rapid increases in drug expenditures for health insurance schemes (Hu et al. 2001; Yip and Eggleston 2001). However, the slower growth rates of drug expenditures in health insurance schemes is of limited significance in the total societal expenditures for drugs, due to the low coverage of health insurance in China (Wu 1999). Most recently, direct control of retail prices of pharmaceuticals has become the key government strategy for constraining drug expenditures (MoH 2000). This exploratory study aims to examine whether the retail price policy was actually implemented in the institutions studied, whether it was effective in containing hospital drug expenditures, and the role of rationality of drug use in influencing the expenditure patterns identified for a tracer condition. Overview of the Chinese pharmaceutical sector and the context of the drug retail price control policy Extensive market-oriented economic reforms initiated in the late 1970s in China substantially influenced both the production and social sectors. In line with rapid economic growth, the health care and pharmaceutical sectors expanded rapidly. Between 1978 and 1997, the real gross pharmaceutical product increased by 17.6% annually, 4.4% higher than Private finance has become the main source for health expenditure over the past two decades. In 2001, 515 billion Chinese yuan was spent on health in China, accounting for 5.4% of gross domestic product (Zhao et al. 2003). Of total health expenditure, 15.5% came from the government health budget, 24.0% from employers and 60.5% from private individuals (Zhao et al. 2003). Health insurance schemes cover only about 14% of the total population, and the uninsured pay for medical services out-of-pocket (China Health Economics Institute 1999). Pharmaceutical expenditures were 230.3 billion yuan in 2001, accounting for 44.4% of total health expenditures (Zhao et al. 2003), which was much higher than that in either developed countries (OECD countries, 10.3– 18.5% in 1997) or middle-income countries (for example, Argentina 20.7% and Chile 15.7% in 1997) (Zerda et al. 2002; Maynard and Bloor 2003). Of total drug expenditures in China, 54.1% were incurred in hospital outpatient departments and clinics, 30.8% in inpatient care and 15.1% in pharmacy stores (Zhao et al. 2003). Hence, the hospital sector is the main retail supplier of drugs. Drugs have become a major source for financing public hospitals and have been the most profitable fee item in hospitals since the early 1980s. The net income for public hospitals from selling drugs was 36.7 billion yuan in 1997 (China State Economic and Trade Commission 1999). Given the widespread use of revenue-based bonus systems for both clinical departments and doctors in public hospitals, the latter have strong financial incentives to prescribe greater quantities or more expensive drugs. Under the planned economy system, drugs were directly distributed from state-owned drug wholesalers. From the early 1980s on, pharmaceutical manufacturers became free to develop a large sales force linking them to hospitals, pharmacies, prescribers and consumers. The number of pharmaceutical wholesalers and facilities increased from 4554 in 1993 to 16 519 in 1997 (Chinese Pharmacy Yearbook Editing Commission 1998). Currently, hospitals and pharmacy stores can purchase drugs either from wholesalers or directly from manufacturers. Between 1980 and 2000, the government controlled the entire cascade of drug prices, from manufacturers’ exit prices, to wholesale and retail prices. Manufacturers’ exit prices were based on production cost plus a 5% mark-up, to which a 15% mark-up was added for the wholesale price, and addition of a further 15% mark-up constituted the retail price (China State Commission of Planning and Development 1998). However, faced with the rapid expansion of the pharmaceutical sector and asymmetry of access to cost information between price regulators and manufacturers, the government was unable to generate the necessary cost estimates for setting appropriate exit prices. Furthermore, since mark-ups for both wholesalers and retailers, including hospitals, were a fixed percentage, China’s drug price controls and hospital drug expenditures expensive drugs were preferred by both. In order to attract wholesalers and hospitals to their products, manufacturers requested higher prices. Under this system, drug prices were thought to be unreasonably high (Hu and Li 2001; Du 2002; Wang and Wei 2003). 187 containing expenditures might be blocked by competing priorities, and that hospitals might naturally seek to maintain or increase revenues. Methods In late 2000, seeking to contain the rapid increase in pharmaceutical expenditures and to improve the rational use of drugs, the Chinese government changed its drug pricing policy from controlling the entire cascade of prices for all pharmaceuticals to controlling retail prices for selected products only. There were three key rationales for the new drug pricing policy (China State Commission of Planning and Development 2000). First, retail price is the final price charged to health care users. If retail prices could be effectively controlled, consumer access would improve. If retail prices were capped, manufacturers, wholesalers and retailers, including hospitals, would negotiate among themselves the distribution of profits. Secondly, it was more feasible for the government to set reasonable prices for the smaller number of drugs selected, a sub-set of frequently used and relatively costeffective drugs. This strategy would also considerably reduce the regulatory burden for the government. Policy-makers believed that if the prices of the selected drugs, which account for a large proportion of utilization, were controlled, users would stand to benefit. Thirdly, it was believed that price competition would be created with the new policy. Since overall drug prices were thought too high, and the prices of drugs set by the government would be decreased, it was believed that the prices of drugs set by the market might also decrease in order to compete. Given a constant drug utilization pattern, decreases of overall drug prices would reduce expenditures to users. The State Commission of Development and Planning decided to set retail prices for drugs listed under the Urban Health Insurance Scheme, because these were believed essential and frequently used. There are two parts to this list, A and B. Prices of Part A drugs are set by the central government and are definitive ceilings for retailers. The central government also sets guiding prices for Part B drugs, which are used by the provincial governments. Provinces can set price ceilings 5% higher or lower than the central guiding prices for Part B drugs. All retail prices charged to the users must be lower than these ceilings. The government declared that retail prices should be reduced by an average of 15% before the end of 2001 (China State Drug Administration 2003). The drug pricing policy is monitored through periodic checks in facilities and regulated by Departments of Price Administration at county, provincial and central government levels, in collaboration with Departments of Health and of Drug Administration. Drug retailers were asked to strictly follow and to publicly post the new drug prices. Patients have the right to question the prices of drugs prescribed and can report abuses to the Department of Price Administration or to the local Consumers’ Protection Association. The survival of Chinese public hospitals relies on market revenues and they have autonomy in allocating surpluses. It was therefore of concern that the policy’s objective of Selection of hospitals This is a retrospective pre/post-reform case study. The study was conducted in two public hospitals located in the capital city of Shandong Province, a provincial hospital (one of the largest in the province, with over 1 million outpatient visits annually), and a municipal hospital. In China, public hospitals dominate the provision of medical services and generate a large proportion of drug expenditures. The hospitals were purposively selected to represent different hospital types. The provincial hospital is directly managed by the provincial Department of Health and is one of 10 model hospitals in China. Model hospitals are selected by the Ministry of Health as examples for administration and service quality. The municipal health authority directly manages the municipal hospital. Selection of a medical condition and patients’ records Criteria for choosing a tracer diagnosis were that the condition should, in the Chinese context, be relatively intensive in consumption of drugs, with a wide range of types and substitutes; have inpatient care with a relatively long hospital stay; and have a stable composition of the case mix in a short time period. A panel of medical experts was organized to select the diagnosis. Cerebral infarction (ICD-10 code I63) was selected as an appropriate tracer condition for drug expenditure. In both hospitals, the majority, but not all, cases were confirmed by computerized tomographic examinations. Because the numbers of patients with the sole diagnosis of cerebral infarction were limited, cases with the secondary diagnoses of hypertension (essential hypertension) (ICD-10 code I10) or atherosclerotic heart disease (coronary) (ICD-10 code I25.1) were also selected. Cases with additional complications were excluded, to reduce variation in disease severity between the two time periods. The drug retail price control policy was implemented in late 2000. Because drug expenditure might not yet have been affected in 2001, the cases were selected from the beginning of 2002 for the post-reform period and from the end of 2000 backwards for pre-reform cases. All cases meeting the diagnostic criteria after 1 January 2002 were selected. In the provincial hospital, records of 49 cerebral infarction cases were selected, and in the municipal hospital, 55 cases were selected. In the provincial hospital, 49 cases from prior to the implementation of the policy were selected, and in the municipal hospital, 60 such cases. A total of 213 medical records of cerebral infarction patients were reviewed. The study periods covered January to August 2002 (post-reform), and May to December 2000 (pre-reform). 188 Qingyue Meng et al. Data collection Hospital medical records selected were copied by the investigators from Shandong University and relevant data were recorded. Indicators extracted included patients’ age, gender, occupation, insurance status and source, condition when admitted, diagnoses, expenditures by types of drugs (Western and Chinese drugs), and the names and quantities of all drugs prescribed. In addition, hospital financial records were reviewed to extract the number of outpatient visits and inpatient days, hospital income and expenditures by items, and numbers of hospital staff and beds. Local authorities from the government agencies involved were also interviewed to obtain information on the implementation of the new policy. Data analysis For examining the comparability of cases before and after the policy implementation, severity of selected cases was compared using four indirect indicators: age, health condition when admitted, and the secondary diagnoses of hypertension and of coronary artery disease. Prescribed daily dose (PDD) was employed to measure utilization of drugs instead of defined daily dose (DDD). DDD is the unit recommended by WHO for measuring drug utilization. However, in this study, many Chinese medicines were prescribed which had no ATC classification or DDD. PDD is the actual number of daily doses prescribed per capita or patient (Capella 1993). The PDD of each drug was calculated using formula (1), where PDDi represents the PDD of drug i, Qi represents the amount of drug i used per day in prescription i which involves drug i, and Fi represents period (days) of prescription i. P QF ð1Þ PDDi ¼ P i i Fi For examining the effects of changes in price and utilization on changes in drug expenditures, the price and utilization effects were decomposed. Compared with drug expenditures in period 1 (prior to reform), the percentage change of drug expenditures in period 2 was calculated using formula (2): X% ¼ ½ðDE2 2 DE1 Þ=DE1 p 100% ð2Þ where X% is the percentage change of drug expenditures, DE1 represents the drug expenditures in period 1 and DE2 is the drug expenditures in period 2. Drug expenditure is the product of drug price and utilization. The percentage change in drug expenditure between the two periods would be determined by changes in utilization, price, or both, and the introduction of new drugs. The effects of the above can be decomposed with formulae (3) – (5), based on formulae from William Cleverley (Cleverley 1992): PI% ¼ ½ðSP2i p Q1i =SP1i p Q1i Þ 2 1 p 100% ð3Þ UI% ¼ ½ðSP1i p Q2i =SP1i p Q1i Þ 2 1 p 100% ð4Þ JI% ¼ X% 2 ðPI% þ UI%Þ ð5Þ where PI% measures the percentage change in drug expenditures due to change in drug prices; UI% measures the percentage change in drug expenditures due to change in drug utilization; JI% measures the residual of percentage change in drug expenditures that are not explained by percentage changes of price and utilization, including joint effect of both price and utilization and introduction of new drugs; P1i and P2i stand for prices of drug i in period 1 and 2; Q1i and Q2i stand for utilization (PDDs) of drug i in period 1 and 2. During the study period, hospitals stopped using some drugs in period 2. Using formulae (3) and (4), if a drug was used only in period 1, the effect on percentage change was determined by its levels of price or utilization compared with the average. Since the computerized price systems were updated regularly, prices of some drugs were no longer available at the time of data collection. In the provincial hospital, it was possible to verify prices for about 35% of drugs prior to the reform and about 45% after the reform; and for about 25% in the municipal hospital prior to the reform and 40% after the reform. Drugs with prices were, however, the most frequently used ones and accounted for the majority of the total drug expenditures. In the provincial hospital, PDDs of drugs with prices accounted for 89.5 and 89.1% of total PDDs, and expenditures for the drugs with prices accounted for 86.5 and 87.8% of the total drug expenditures before and after the reform, respectively. In the municipal hospital, PDDs of drugs with prices accounted for 89.6 and 89.4% of total PDDs, and expenditures of the drugs with prices accounted for 78.8 and 79.6% of total drug expenditures before and after the reform, respectively. Calculations are based only on those drugs for which data were available. Since the drug price index was minus 4% between 2000 and 2002 (China State Commission of Planning and Development 2002), the monetary values of drug expenditures were not adjusted for inflation. The rational use of drugs To identify contributing factors to drug expenditures related to rational use, the top 15 drugs prescribed after the new price controls, by expenditure, were analyzed. They were annotated as prescribed, by brand or generic name. Traditional Chinese drugs were not analyzed regarding the rationality of their use. The evidence base on safety and efficacy of the ‘Western’ drugs (including some products developed in China but based on Western pathophysiological concepts) was analyzed and classified as follows: (1) (2) drugs and electrolyte solutions which are generally recognized as safe and effective for cerebral infarction and/or for common secondary diagnoses, such as infection, in hospitalized patients were denominated ‘good’, and included glucose saline, ceftriaxone (as Rocephin), azithromycin, clindamycin, isotonic sodium chloride, cefotaxime and pantoprazole; drugs which are useful in limited indications for cerebral infarction but which may be overused, such as mannitol, recommended only in cases of cerebral edema, were still denominated ‘good’; China’s drug price controls and hospital drug expenditures (3) (4) drugs which have some evidence of effectiveness but which are not currently considered consensual evidencebased treatment, such as Nicholin (citicholine) (Adibhatla and Hatcher 2002) and defibrase (Bell 1997), were denominated ‘some’; and drugs which are not recognized as safe and effective for cerebral infarction, or for other common accompanying diagnosis in hospitalized patients, were denominated ‘weak’ (Annex 1). Drugs were considered as not recognized as safe and efficacious if they were not part of consensus guidelines for cerebral infarction (Coull et al. 2002; Adams et al. 2003; European Stroke Initiative 2003), and if a review of publications indexed in Medline, from 1966 on, did not reveal a favourable balance of well-designed clinical trials supporting their use for this indication. The drugs cerebroprotein hydrolysate, kakonein and defibrase, absent from Medline, but primarily developed in China, were also reviewed on the Chinese Qinghua University database, CNKI (see Annex 1). Defibrase, a snake venom, had no articles on Medline; however, 111 on its use in cerebral infarction were found on CNKI, with some modestly sized, favourable RCTs. Ancrod, a related but apparently not identical venom from snakes of the same genus of Agkistrodon but a different species (A. rhodostoma rather than A. acutus), has significant trials cited in Medline with positive results. Defibrase was therefore classified as having ‘some’ evidence. For combination drugs, evidence on the combination was sought. Results Characteristics of expenditures for all patients and implementation of the drug control policy are first described, presenting changes in drug expenditure growth rates for all patients before and after implementation of the price control policy. With the tracer condition, drug expenditures, effects of price and utilization on drug expenditures, and rationality of use for patients are then presented. 189 Expenditure trends for all patients and implementation of the retail price control policy From 1998 to 2000, prior to the pricing reform, total revenues increased by 39.7% in the provincial and 42.0% in the municipal hospital (Table 1). From 2000 to 2002, total revenues increased by 46.6% in the provincial and by 69.1% in the municipal hospital. From 1998 to 2000, drug revenues for the provincial hospital increased by 32.5% and for the municipal hospital by 37.9%. From 2000 to 2002, drug revenues for the provincial hospital increased by 42.9% and for the municipal hospital by 49.5%. While part of these greater revenues was due to a higher patient load, the corrected values still rose, most markedly in the outpatient sector. From 1998 to 2000, drug revenues per outpatient visit and per inpatient day increased by 57.9 and 3.2% in the provincial hospital and by 30.6 and 21.4% in the municipal hospital, respectively. From 2000 to 2002, drug revenues per outpatient visit and per inpatient day increased by 37.9 and 22.2% in the provincial hospital and by 30.7 and 32.3% in the municipal hospital, respectively. Major differences in drug expenditures between hospitals were evident. These were 5.2-fold higher in the provincial hospital at baseline, and even when correcting for length of stay, were 4.3-fold higher. Drug prices in the two hospitals were monitored by the same level of the Departments of Price Administration as well as of Health and Drug Administration, generally every 2 months. When interviewing staff in Provincial and Municipal Departments of Price Administration, investigators were told that the hospitals studied had properly adjusted the drug prices according to the changes made by the government. The drug price recording systems in the two hospitals were checked with the updated price list of the government; this confirmed that the prices of drugs regulated by the government had been updated. It was found that the changes in prices of drugs for treating cerebral infarction cases were consistent with implementation of the drug pricing policy. In the provincial hospital, on average, prices of drugs set by the central government (Part A) decreased by 6.9% and prices of drugs set Table 1. Characteristics of hospitals studied for all patients Indicator No. of hospital beds No. of outpatients (1000 s) No. of inpatients Average length of stay (days) Total revenue (million yuan) Share of total drug revenues (%) Share of outpatient drug revenue (%) Share of inpatient drug revenue (%) Drug revenue per outpatient (yuan) Drug revenue per inpatient (yuan) Drug revenue per inpatient day (yuan) Provincial hospital Municipal hospital 1998 2000 2002 1998 2000 2002 1 275 985.4 23 419 16 240.9 59 20 39 49 4 026 271 1 380 974.3 24 579 17.5 336.5 56 22 34 76 4 632 280 1 392 1 005.1 29 699 16 493.4 54 21 33 104 5 490 342 110 86.3 5 989 12 18.34 42 17 25 36 775 63 112 104.2 6 362 12 26.0 41 19 22 47 909 76 112 126.6 6 658 12 44.0 36 18 19 61 1 230 100 190 Qingyue Meng et al. by both central and provincial governments (Part B) decreased by 17.6%. In the municipal hospital, prices of Part A and Part B drugs decreased by 17.4 and 11.3% on average, respectively. These changes in prices were close to the declaration made by the government that an average of 15% reduction would be expected after the control of retail prices. In the provincial hospital, a computerized price checking system was available at the hospital main entrance, with which users could check prices for drugs and professional services. In the municipal hospital, prices of common drugs were posted on the wall near the cashier’s window. In addition to external price monitoring, internal control systems had been created at both hospitals. Two staff members in the provincial and one in the municipal hospital were responsible for verifying prices charged to patients and assuring implementation of official fee schedules. From early 2002, the provincial hospital started to use a ‘daily accounting system’, which meant inpatients would be informed of their expenditures on drugs and other services every day of their stay and could question expenditures. The municipal hospital still used the traditional method, presenting bills at discharge. Drug prices and expenditure per patient for cerebral infarction Before comparing the drug expenditures on cerebral infarction cases, indicators of potential severity of cases in the two time periods were evaluated (Table 2). Except for age in the provincial hospital, no significant differences in severity related indicators were found between the two time periods. Drug expenditures between age groups in the provincial hospital were compared using the Spearman Test method, which showed no significant relationship between age and drug expenditures (R ¼ 20.0574, p ¼ 0.405). While there was a marked difference in length of stay between hospitals, it is not clear if this was due to variation in hospital practice or to patient severity. To examine the impact of implementation on hospital drug expenditures, expenditures per patient for cerebral infarction patients before and after implementation of the new policy were examined (Table 3). There were no statistically significant changes in drug expenditures per inpatient in the provincial hospital between the two periods. In the municipal Table 2. Comparison of cerebral infarction cases in the two time periods, 2000 and 2002 Indicators Age (mean) Condition when admitted (%) (1) Emergency (2) General With hypertension (%) Yes With coronary (%) Yes Provincial Municipal 2000 2002 p value 2000 2002 p value 59 64 0.045 63 65 0.418 53 47 49 51 0.838 50 50 36 64 0.169 61 65 0.675 60 55 0.577 12 19 0.408 17 9 0.276 Table 3. Drug expenditures (yuan) and length of stay per patient with cerebral infarction Indicators Provincial hospital Length of stay (days) Total expenditure per patient Drug expenditures per patient Western Chinese Municipal hospital Length of stay (days) Total expenditure per patient Drug expenditures per patient Western Chinese 2000 2002 20 10 327 7 931 6 215 1 716 8 6 5 1 10 2 193 1 392 879 483 Difference p value 19 873 673 312 361 21 21 454 21 258 2903 2355 0.589 0.358 0.287 0.387 0.205 11 2 878 2 090 1 756 334 1 685 698 877 2149 0.355 0.014* 0.002** 0.001** 0.066 *Significance at 0.05 level; **significance at 0.01 level. hospital, total expenditure per inpatient rose by 50.1%, driven by skyrocketing expenditures for Western drugs, up 97.9% between the two periods. Expenditures for Chinese medicines decreased, but not significantly. As in the overall data for all patients, the provincial hospital’s care for cerebral infarction patients was associated with far higher drug expenditures than at the municipal hospital, 5.7fold higher per patient before the reform, with the difference falling to 3.2-fold higher per patient after the reform. In the provincial hospital, length of stay, total expenditures and drug expenditures for cerebral infarction cases declined, a pattern distinct from the hospital’s overall trends, but these changes were not statistically significant. In the municipal hospital, the trends for total expenditures and drug expenditures for cerebral infarction cases were consistent with the trends for the general inpatient population. Relation of expenditures to insurance status of cerebral infarction patients Before and after the reform, the proportion of cerebral infarction patients covered by health insurance was 77.5 and 72.3% in the provincial hospital and 10.0 and 12.7% in the municipal hospital, respectively. There were no significant shifts in health insurance coverage within each hospital between the periods, though far more provincial hospital patients were insured. In the provincial hospital, drug expenditures per insured and uninsured inpatient were 7325.2 and 8199.0 yuan (t ¼ 20.501 and p ¼ 0.6379), respectively, in 2000. Conversely, in 2002, the drug expenditure per insured patient (5163.8 yuan) was lower than that of the uninsured (7313.3 yuan) (t ¼ 21.141 and p ¼ 0.001). There were no significant differences in drug expenditures between insured and uninsured patients in the municipal hospital in either time period. To explore explanations for the significant difference in drug expenditure per inpatient between the insured and uninsured in the provincial hospital in 2002, prices and utilization of drugs and hospital length of stay were compared. The average prices of drugs were 31.1 yuan per PDD for the insured and 31.3 China’s drug price controls and hospital drug expenditures 191 Table 4. Utilization of drugs per patient and per inpatient day and price per prescribed daily dose (PDD), cerebral infarction cases Indicator Total PDDs (all drugs) % of total PDDs represented by top 15 drugs PDDs per patient PDDs per inpatient day Number of types of drugs used Average price per PDD (yuan) Provincial hospital Municipal hospital 2000 2002 Change (%) 2000 2002 Change (%) 12 066 10 217 215 7 328 8 081 10 52 246 12 200 32 59 209 11 207 31 6 215 211 4 22 67 122 12 155 11 60 147 13 181 14 28 20 9 17 25 yuan per PDD for the uninsured, not a significant difference (t ¼ 20.136 and p ¼ 0.893). There was also no significant difference in hospital length of stay between the insured (18 days) and uninsured (19 days) (t ¼ 20.592 and p ¼ 0.557). However, drug utilization, at 166 PDDs per inpatient for the insured and 234 PDDs for the uninsured, showed a significant difference (t ¼ 21.141 and p ¼ 0.001). The difference in drug expenditure between the insured and uninsured mainly resulted from a difference in the quantity of drug utilization. Changes in drug utilization and price for cerebral infarction patients In the provincial hospital, both total utilization (PDD) and utilization per patient and per inpatient day for cerebral infarction fell in the second period (Table 4). PDDs used per inpatient day and per patient decreased by 10– 15% in the two periods. Price per PDD decreased slightly. In contrast, utilization of drugs increased by 10% in the second period in the municipal hospital. Utilization of drugs per patient and per inpatient day increased by 9 –20% between the two time periods. Price per PDD increased by nearly 25%. The utilization levels in PDD per day were relatively similar between the two hospitals, but the average price per PDD was very different, a result which may explain the higher overall expenditures per inpatient day in the provincial hospital. The provincial hospital charged 2.8 times more than the municipal hospital per PDD at baseline, falling to 2.2 in the second period. In the provincial hospital, price per PDD decreased by 1.2 yuan; in the municipal hospital, it increased by 2.8 yuan. In short, after implementation of the policy, unit price had decreased slightly in the provincial hospital and increased in the municipal hospital for cerebral infarction cases. factors (Table 5). It is clear that for both hospitals and for changes in either direction, the expenditure level was more sensitive to changes in utilization than to price changes. Drug utilization patterns and the evidence base for drugs used in the two hospitals The preceding section suggests that utilization rather than price was more influential in determining drug expenditures for the tracer condition. The utilization patterns of drugs were further analyzed to examine what types of drugs were used for treating cerebral infarction patients and differences between the two hospitals. Table 6 shows the top 15 drugs in terms of expenditures, by hospital, for the post-reform period, with their prices per PDD. Expenditures on these drugs accounted for 78.4% of total drug expenditures for the provincial hospital and 62.4% for the municipal hospital. Of the top 15 drugs used in the provincial hospital, one drug’s price was set by the central government and the prices of four drugs were set by both central and provincial governments. Prices of the rest (10 drugs) were set by the market. Expenditures on drugs with prices set by the government accounted for 19.5% of expenditure on the top 15 drugs in the provincial hospital. In the municipal hospital, five of the top 15 drugs’ prices were set by the central government, three by both central and provincial governments, and the remaining seven by the market. The drug prices set by the market increased by 0.96% in the provincial hospital and by 35.8% in the municipal hospital, in contrast to the decreases in prices set by both central and provincial governments. In the municipal hospital, expenditures on drugs with prices set by the government accounted for 46.5% of the top 15 drugs’ expenditures. Table 5. Price and utilization effects on drug expenditures per inpatient day, cerebral infarction cases Price and utilization effects on drug expenditures Of the total 12.3% decrease in drug expenditures for cerebral infarction cases per inpatient day in the provincial hospital, 7.45% was due to a decrease in drug utilization, price changes accounted for 5.26%, and other factors, including introduction of new drugs, were responsible for 0.39%. In the municipal hospital, of the total 36% increase in drug expenditures per inpatient day, 25.04% was attributable to the increase in drug utilization, 8.8% was due to price increases, and 2.2% to other Total change of drug expenditures Change due to utilization Change due to price Change due to both price and utilization Provincial hospital Municipal hospital 212.3% 36.0% 27.45% 25.26% 0.39% 25.04% 8.80% 2.20% 192 Table 6. Top 15 drugs by expenditure in two Shandong hospitals: price setting method, price per PDD and strength of evidence base, after the pricing policy reform Provincial hospital Drug name Price per PDD Expenditure (yuan) Evidence base 246.5 149.3 193.7 70.7 55.5 12.1 160.2 400.9 75 195 21 505 20 655 20 334 14 258 13 207 13 170 12 135 Weak Weak Weak NE Some Good Weak Good 98.1 198.8 60.4 256.0 88.6 74.9 117.2 11 021 9 143 8 727 8 449 7 944 6 525 6 446 248 714 Weak Weak NE NE Weak NE Good 65% Drug name Cerebroprotein hydrolysate injection (M) Panax notoginseng (CP) Xiangdan injection (C) Safflower injection (M) Aceglutamide (M) Cefotaxime sodium (C) Pantoprazole sodium injection (M) Mannitol (C) Isotonic sodium chloride (C) Glucose saline (C) Troxerutin (M) Clindamycin phosphate (M) Xueshuantong (CP) Defibrase for injection (M) Kakonein injection (CP) Expenditures for top 15 drugs % for Western drugs with weak evidence base (M): Prices set by the market; (C): prices set by the central government; (CP): prices set by both central and provincial governments. NE: Chinese medicine, not evaluated. Price per PDD Expenditure (yuan) Evidence base 61.4 60.3 27.2 62.0 67.4 33.6 93.1 6.9 14 979 8 094 6 220 5 146 4 922 4 016 3 630 3 595 Weak NE NE NE Weak Good Good Good 5.9 7.2 33.8 49.2 52.3 65.1 52.5 3 167 3 125 2 903 1 870 1 760 1 732 544 65 703 Good Good Weak Good NE Some Weak 41% Qingyue Meng et al. Deproteinized calf blood extractives injection (M) Buflomedilhydrochloride injection (M) Cerebroprotein hydrolysate injection (M) Kudiezi injection (M) Nicholin (citicholine) (M) Glucose saline (C) Fraxiparine (nadroparine calcium) (M) Rocephin (CP) Ginkgo leaf extract and dipyridamole injection (M) Cytidine 50 -triphosphate Na2 (M) Panax notoginseng [Bnrk] F.H.Chen (CP) Shexiang injection (M) Piracetam (CP) Breviscapine (M) Azithromycin (CP) Expenditures for top 15 drugs % for Western drugs with weak evidence base Municipal hospital China’s drug price controls and hospital drug expenditures In the post-reform period, the municipal hospital incorporated within the top 15 drugs six drugs not previously used for cerebral infarction patients; expenditure for these drugs accounted for 31.6% of the top 15 drugs’ expenditures. These drugs had a mean price per PDD of 24.1 yuan, compared with the overall mean price per PDD of 9.8 yuan. The provincial hospital incorporated five drugs not previously used within its top 15 drugs, with a mean price per PDD of 93.4 yuan compared with the overall mean of 31.6 yuan. The expenditure on these newly-used drugs accounted for 45.6% of total expenditures for the top 15 drugs. These findings suggest a shift to newly incorporated (although not necessarily new) drugs with higher prices. Of these drugs, only one in the provincial and three in municipal hospitals were subject to price regulation. This shows the difficulties of regulating prices when new products are launched. Regarding rationality of use post-reform, a high proportion of expenditure went on Western drugs with a weak evidence base in the published literature. Of the top 15 drugs in use in the provincial hospital, the majority of expenditure—158 633 yuan or 65%—was for poorly evidence-based Western drugs. Only 13% (31 788 yuan) of expenditures for the top 15 drugs was for Western drugs considered to be safe and effective, and this was primarily for antibiotics to treat co-existing infections and intravenous fluids. Drugs considered to be highly effective, such as acetylsalicylic acid, were not prominent in either PDD or expenditures. In the municipal hospital, not only were expenditures markedly lower, but a smaller proportion of the Western drugs employed had a weak evidence base (41%). However, these still accounted for more than one-third of expenditures. An average of 147 yuan per PDD of the top 15 drugs was prescribed in the provincial hospital compared with only 48 yuan in the municipal hospital. The prices of the top 15 drugs used in the provincial hospital were a mean of three times higher than prices of the top 15 drugs used in the municipal hospital. The markedly higher drug expenditures in the provincial hospital, even when corrected for length of stay, mainly resulted from use of more expensive drugs for cerebral infarction cases. Discussion The study found evidence of de-facto implementation of the retail price control policy in the two study hospitals. The findings show that formal actions were taken by different regulatory agencies and that the regulatees were aware of the new system. In contrast, the desired effect of reduction or stabilization of hospital drug expenditures was not identified in either hospital in the analysis of data for all patients. Increasing expenditures were due to a combination of factors. These included: increased production of services, increased utilization of drugs, and increased prices for some drugs. For the tracer condition of cerebral infarction, there may have been some stabilization of expenditures in the provincial hospital, but expenditures increased markedly in the municipal hospital. Utilization was a more potent determinant of expenditures than price. 193 Because the overall growth of drug expenditures was as rapid as before in the provincial hospital, we cannot conclude a positive impact of the new drug pricing policy on drug expenditure containment, even though drug expenditure per inpatient seemed to decline (no statistical significance) for cerebral infarction. The different trends in drug expenditures for all patients and those of the tracer condition may result from several factors, including the small size of tracer cases lacking representation of overall drug expenditures and the tracer condition being a unique case with a real decline in drug expenditures. Further study through expanding the sample size or the scope of tracers is needed in order to provide definitive explanations. A number of factors appear to have contributed to increasing hospital drug expenditures. These include: incorporation of drugs not previously employed, with higher average prices; irrational use of drugs; inter-hospital differences such as use of more expensive drugs, and possibly the social or insurance characteristics of a hospital’s patient population. A very high proportion of expenditures on cerebral infarction cases were for Western drugs without an adequate evidence base of safety and efficacy. While there is evidence that Chinese public hospitals have similar expenditure, income and incentive structures throughout the country (Meng et al. 1998), caution should be used in generalizing the findings from this small sample of two Shandong hospitals to China’s 15 700 other public hospitals at and above county level. The different regulatory, economic and administrative contexts may influence the implementation and results of the drug pricing policy. In addition, the modest number of cerebral infarction cases due to the short time period studied may constrain the validity of the analysis. We did not adjust drug inflation when comparing the drug expenditure changes between 2000 and 2002, given that the drug price index was claimed to be negative by the official statistics. However, the price index may not truly reflect the changes in drug prices if only drugs managed by the government were used for calculation. Drugs with prices that were set by the market and which increased during the study period may not be adequately included in calculations for the drug price index. Differences in severity of patients between the two hospitals are unlikely to explain the major inter-institutional differences in drug utilization and expenditures. Xu et al. (2001) found similarly for acute appendicitis; expenditure per case was 1163 yuan for provincial hospitals and 690 yuan for municipal hospitals in 1999, mainly resulting from differences in drug expenditures. It is well recognized in China that expenditures in tertiary hospitals are much higher than those in community hospitals for the same health conditions (Liu and Cheng 2002). Explanations put forward have included costlier inputs and higher quality provided in tertiary hospitals as well as the relatively higher ability to pay of users of tertiary hospitals (Centre for Health Statistics and Information 1998; Xu et al. 2001). For the case of cerebral infarction in this study, it appears that the provincial hospital used more expensive drugs, more of which lacked evidence of safety and efficacy, than the municipal hospital. Besides the abovementioned 194 Qingyue Meng et al. explanations from other studies, the drug prescribers in the provincial hospital may have higher expectations of income or other advantages from selling the drugs than prescribers in the municipal hospital, even though drug prescribers in both hospitals faced the same financial incentives. The study evaluated the impact of the policy only as regards hospital expenditures and did not evaluate whether the policy had an effect on improving access to essential drugs. The number of PDDs per outpatient visit was not studied. Lower prices due to the policy could, for example, have improved access to medicines, without having the desired effect on hospital drug expenditures. The rationality analysis, in spite of its striking findings, is likely to present a very conservative underestimate of the impact of irrational use on expenditures. This is because rationality of use was examined looking only at the drugs selected, and not the indications for individual patients. Had this latter approach been used, it is likely that an even greater proportion of expenditures would be considered unjustified, such as those due to overuse of antibiotics, although other, effective drugs, might also have been identified as underused. Furthermore, drugs with some, but not yet solid, evidence were not counted as irrational, and Chinese drugs were not evaluated. Additionally, the analysis was only performed for the post-reform period, and while it clearly demonstrates the important contribution of irrational use to drug expenditures, this situation may have preceded the policy. Why then, was the rapid increase in drug expenditures not constrained, given implementation of the policy? This may be explained from four dimensions. First, hospitals could shift to more expensive drugs not covered in the price control list. The data provide some preliminary support for this possibility. It has been reported that in some hospitals, drugs for which prices had been reduced were no longer available; instead, more expensive drugs were prescribed (Lu 2002). Secondly, public hospitals would attempt to maintain drug income levels in order to maintain their overall revenue level. While the government reduced prices of listed drugs, alternative sources of financing for hospitals were not created. To keep drug revenues stable, hospitals could increase drug utilization or irrational drug use. They may believe this to be necessary, given the widely held view that official prices of professional services set by the government are not high enough to cover costs of hospital services (Meng et al. 2002). Thirdly, corruption in drug purchasing and prescribing within hospitals could contribute to the rapid rise in drug expenditures. Many pharmaceutical companies send medical representatives to lobby doctors and drug purchasing managers to use their drugs, offering financial incentives. The returns to the drug prescribers and managers are usually based on the quantities of the drug sold. This would stimulate hospital staff to use unnecessary and expensive drugs without strict regulations on drug prescriptions. Finally, there is a lack of coordination of action by different government agencies on controlling drug expenditures—three different government departments are responsible for work related to drug expenditure containment. This situation can be exemplified by the lack of standard treatment protocols for common diseases such as stroke, or by the lack of costeffectiveness evaluation when approving new drugs for marketing. While regulators formally implemented the price regulation, important complementary actions were missing, such as setting criteria for drugs to be included on the price list, evaluation and price-setting of new drugs, their indications for use, and so forth. Effective price competition between regulated and unregulated drugs, a desired output of the policy, was not identified. This may be due to the higher returns from use of more expensive drugs in a setting of fixed markups, driving pharmaceutical manufacturers and wholesalers to increase prices that are not regulated by the government. The assumption of the drug pricing policy design is that drug consumers would prefer low-price drugs. However, this does not take into account that drug prescriptions are written by doctors, not by the patients who will pay. Price competition would be favoured if drug consumers or third party payers had access to comprehensive information about the quality, cost and efficacy of the drugs, as discussed below, and even then it may be difficult. Furthermore, the study illustrates a problem with price regulation found in other studies. Expenditure is a function of price and volume, but the regulator has control of only one component, the price. Control of utilization implies control of prescribing behaviour of doctors, restriction of consumers’ demand and other factors. Hence, the classical way of circumventing price regulation is to increase the volume component. In addition, the pharmaceutical market is characterized by introduction of new products with an initial high price. Overall, this study confirms the difficulties of using price regulation as an isolated strategy to curb pharmaceutical expenditures. Given a price-elasticity on the demand side, the use of price controls is unlikely to lower demand. People who pay out-of pocket are currently the dominant financiers of the Chinese health system and they are not well organized enough to exert sufficient pressure to contain the gaming responses to price controls, such as shifts to more expensive medicines. Recent studies have shown that unification of individual health insurance schemes in a city can help to control hospital charging behaviour and constrain hospital costs (Zhang et al. 2000; Meng et al. 2004). In the city studied, the insurance operators still work in isolation from each other, resulting in the absence of a strong, single third party payer. Irrational use of pharmaceuticals has been an increasing concern in China. Yang and colleagues reported that more than 98% of outpatients with common colds were given antibiotics by physicians (Yang et al. 1993). Zhan et al. (1998) also reported on the unnecessary prescribing of drugs in rural health facilities, resulting in safety problems and rising drug costs. Chen et al. (2003) analyzed rationality of use of the top 10 antibiotics for 571 inpatients using a drug utilization index, and found that four of the top 10 drugs were used irrationally. The underlying motivation behind the extensive irrational use of drugs may be financial incentives that stimulate hospitals to purchase, and physicians to prescribe, unnecessary and more China’s drug price controls and hospital drug expenditures expensive drugs. An aggravating factor may be the lack of widely accepted and used standard treatment protocols for the main pathologies, associated with a weakly evidence-based culture of medicine in China. This is reflected in the Chinese scientific literature, where it has been said that many articles on drug safety and efficacy were not rigorously designed and that more than 50% of Chinese medicines used lack an evidence base (Guo 2001). The findings of this study provide further evidence of the problem, and importantly, they link irrational use to its enormous opportunity costs in taking scarce health resources away from more useful applications. Summarizing, the price controls, while effective in lowering prices for regulated drugs, were implemented without fundamental changes in the incentive structures. In such a setting, the tendency may be to move away from, rather than towards, evidence-based medicine and cost-containment goals. This study provides an analysis of the impact of the policy in two specific contexts in Shandong province. Further research with larger and more representative samples would be useful. Conclusion The introduction of the new retail price control policy, while implemented, was not found to have a positive impact on containment of hospital drug expenditures in the two Chinese hospitals studied. The effects of the policy on access and on patient outcomes were not analyzed. 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Acknowledgements The research team is grateful to the Alliance for Health Policy and Systems Research for the financial support. They thank the staff of the two hospitals studied for their contribution in data collection. The Swedish Institute is acknowledged for supporting the first author to prepare the manuscript at Karolinska Institute and the Swedish Foundation for Cooperation in Research and Higher Education for supporting the third author’s work. Thanks to Associate Professor Dr Nils Wahlgren of the Department of Neurology of the Karolinska Institute, and secretary of the European Stroke Council, for reviewing the classification on rationality. Biographies Qingyue Meng is Professor of Health Economics and directs the Center for Health Management and Policy of Shandong University. He is a member of the Advisory Committee of Management and Policy to China’s Ministry of Health. Gang Cheng is a lecturer in the Center for Health Management and Policy of Shandong University, China. Lynn Silver is Professor of Pharmaceutical Sciences, School of Health Sciences, University of Brası́lia, Brazil. Xiaojie Sun is currently a master’s student in the Center for Health Management and Policy of Shandong University, China. Clas Rehnberg is Associate Professor of Health Economics, Medical Management Center, Karolinska Institute, Sweden. Goran Tomson is Professor of International Health, Division of International Health and Medical Management Center, Karolinska Institute, Sweden. Correspondence: Professor Qingyue Meng, Center for Health Management and Policy, Shandong University, Wenhua Xi Rd 44, Jinan, Shandong 250012, China. Email: [email protected]. Annex 1. Drugs with a weak evidence base The drugs considered as having a weak evidence base for use in acute cerebral infarction were cerebroprotein hydrolysate (0 articles in Medline, 2 small randomized controlled trials (RCTs) identified in CNKI); deproteinized calf blood extract—also searched as Actovegin and Solcoseryl (1 article in Russian with no abstract on the mechanism of Actovegin after ‘cerebral ischaemia’, 1 study in rats); buflomedilhydrochloride injection—also searched as Loftyl (1 clinical trial for acute cerebral ‘ischaemia’ with no placebo group, against nicergolin, and 2 studies of cerebral blood flow in a small number of patients after cerebral infarction) (Karoutas et al. 1987); Kobayashi et al. 1988; Bossi and Bossi 1989; gingkodypiridamole combination (0 articles); cytidine 50 triphosphate (although this is a precursor of citicholine, no specific literature was located for this substance); piracetam—this drug has a number of published trials, however metanalysis by the Cochrane collaboration considered the evidence of effectiveness insufficient and raised concern of possible increases in mortality, a second review considered that there was weak evidence for effectiveness for aphasia post-cerebral infarction (Greener et al. 2001; Ricci et al. 2002); aceglutamide (0 articles); troxerutin (0 articles); kakonein (0 articles on medline, and 3 small studies on CNKI); and Fraxiparine (this is nadroparine, a low molecular weight heparin (LMWH))—use of LMWH in acute cerebral infarction has been studied and while some trials were favourable, metanalysis of the literature by the Cochrane collaboration concluded that use of low molecular weight heparins increases the risk of death and haemorrhage in relation to aspirin, without concomitant benefits (Berge and Sandercock 2002).
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