Unveiling, Analyzing the Mechanisms of, and Proposing Solutions for Bribery in Japan's Medical Device Sector.

Both public and academic scrutiny of the financial relationships between the medical device industry and the healthcare society occur less frequently than those involving the pharmaceutical industry, and Japan is no exception to these shortcomings. This paper examines the ethical and legal challenges inherent in Japan's medical device industry through the lens of bribery scandals, placing these issues within the broader context of global healthcare corruption. It aims to derive lessons and suggest universal strategies for ethical and legal enhancements. The discussion includes two notable cases: one involving inappropriate transactions between a cancer center and a biliary stent manufacturer, and another concerning a corrupt donation scheme between a medical device company and a university's anesthesiology department, which was found guilty. In our analysis, we also acknowledge the industry's efforts toward compliance and reform to maintain a balanced perspective. The analysis not only highlights the unique culture and structure of the Japanese medical device industry, such as the exploitation of flexible pricing and opaque financial practices but also contrasts these issues with the tightly regulated pharmaceutical industry. This approach reveals both sector-specific challenges and common corruption drivers, enhancing our understanding of why such scandals occur and persist. We propose ethical and compliance-focused business measures such as centralizing donation decisions, limiting the financial independence of marketing divisions, and increasing transparency, alongside adopting mandatory disclosure practices based on successful models from the United States and Europe. By emphasizing integrity and presenting diverse perspectives, this study aims to elevate ethical and legal standards in the medical device industry and improve patient health outcomes worldwide.

Return on investment in science: twenty years of European Commission funded research in Alzheimer's dementia, breast cancer and prostate cancer.

Alzheimer's disease (AD), breast cancer (BC) and prostate cancer (PC) continue to be high in the research and innovation agenda of the European Commission (EC). This is due to their exceptionally large burden to the national health systems, the profound economic effects of opportunity costs attributable to decreased working ability, premature mortality and the ever-increasing demand for both hospital and home-based medical care. Over the last two decades, the EC has been steadily increasing both the number of proposals being funded and the amounts of financial resources being allocated to these fields of research. This trend has continued throughout four consecutive science funding cycles, namely framework programme (FP)5, FP6, FP7 and Horizon 2020 (H2020). We performed a retrospective assessment of the outputs and outcomes of EC funding in AD, BC and PC research over the 1999-2019 period by means of selected indicators. These indicators were assessed for their ability to screen the past, present and future for an array of causal relationships and long-term trends in clinical, epidemiological and public health sphere, while considering also the broader socioeconomic impact of funded research on the society at large. This analysis shows that public-private partnerships with large industry and university-based consortia have led to some of the most impactful proposals being funded over the analysed time period. New pharmaceuticals, small molecules and monoclonal antibodies alike, along with screening and prevention, have been the most prominent sources of innovation in BC and PC, extending patients' survival and enhancing their quality of life. Unlike oncology, dementia drug development has been way less successful, with only minor improvements related to the quality of supportive medical care for symptoms and more sensitive diagnostics, without any ground-breaking disease-modifying treatment(s). Significant progresses in imaging diagnostics and nanotechnology have been largely driven by the participation of medical device industry multinational companies. Clinical trials funded by the EC were conducted, leading to the development of brand-new drug molecules featuring novel mechanisms of action. Some prominent cases of breakthrough discoveries serve as evidence for the European capability to generate cutting-edge technological innovation in biomedicine. Less productive areas of research may be reconsidered as priorities when shaping the new agenda for forthcoming science funding programmes.

List prices and clinical value of anticancer drugs in China, Japan, and South Korea: a retrospective comparative study.

Background: High prices of anticancer drugs have raised concerns due to their financial impact on patients and healthcare systems. This study aimed to assess the initial and latest list prices and clinical value of reimbursed anticancer drugs in China, Japan, and South Korea. Methods: We identified anticancer drugs newly approved by the National Medical Products Administration of China from January 2012 to June 2022, and by the Pharmaceuticals and Medical Devices Agency of Japan and the Ministry of Food and Drug Safety of South Korea up until June 2022. We compared initial and latest treatment prices between countries and assessed clinical value using patients' survival, quality of life (QoL), and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). We calculated Spearman rank correlation coefficients of treatment prices with clinical value for individual countries and employed regression analyses to investigate whether the relationship between prices and clinical value was modified by the country setting. Findings: Our cohort included 91 anticancer drug indications, with 60 listed for reimbursement in China, 91 in Japan, and 87 in South Korea. Median treatment prices were highest in Japan, followed by South Korea, and lowest in China, both for initial prices (US$64082 vs. US$45529 vs. US$19144, p < 0.0001) and latest prices (US$50859 vs. US$31611 vs. US$18666, p < 0.0001). Over time, China (ß = -0.047, p < 0.0001) and South Korea (ß = -0.049, p < 0.0001) witnessed more significant price reductions compared to Japan (ß = -0.013, p = 0.011). The correlations between both initial and latest treatment prices and clinical value (QoL and ESMO-MCBS) were more significant and stronger in China and South Korea than in Japan, although Japan exhibited slightly stronger correlations in terms of survival compared to China and South Korea. The relationship between clinical value and treatment prices may not be modified by the country setting. Interpretation: In comparison, South Korea's list prices and their correlations with clinical value appear reasonable. Policymakers in Japan could enhance efficiency by controlling prices and aligning them with clinical value, while China would need to take substantial steps to expand anticancer drug coverage. Funding: National Natural Science Foundation of China (72374149 and 72074163), and China Center for South Asian Studies, Sichuan University.

Successes and challenges of China's health care reform: a four-decade perspective spanning 1985-2023.

Chinese health system remains the crucial one for understanding the wider healthcare landscape across the Global South and in particular the leading Emerging Markets. Purpose of our observation was to understand the inner dynamics of mainland Chinese health reforms adopting a lengthy time horizon. We have analysed the public reports and seminal evidence on Chinese of multiple waves of national health reforms taking place since 1980s in terms of medical care and pharmaceuticals provision and financing. Chinese international trade with ASEAN nations and wider South-East Asia is accelerating its growth after the recovery of trade routes. In terms of health sector this means that global demand and supply of medical goods, services and pharmaceuticals remains largely driven by Chinese domestic developments. Furthermore, Chinese domestic manufacturing and sales of decent quality medical devices and services have grown exponentially. Some temporary pitfalls and increasing in rural-urban inequalities in equity of access and affordability of medical care and pharmaceuticals did take place. Despite these difficulties to generate a balanced development strategy for the largest global market, this is a clear path upwards. Further upcoming improvements expanding health insurance coverage are in strong demand for certain layers of the society. Domestic bottleneck weaknesses yet remain manufacturing, import and market penetration of cutting-edge pharmaceuticals such as monoclonal antibodies and targeted oncology agents. Yet some of these obstacles are likely to be overcome in foreseeable future with the adoption of responsible strategies by governmental agencies in health care arena.

Could high continuity of care (COC) have a negative impact on subjective health of hypertensive patients? A Japanese perspective.

BACKGROUND: Cardiovascular diseases, such as stroke and ischemic heart disease attributable to hypertension, are major causes of premature death in Japan and worldwide. Nevertheless, a low rate of blood pressure control among hypertensive patients has been observed in most countries. No previous studies have explored the effectiveness of physician visits among hypertensive patients in Japan. METHODS: To quantify the effects of persistence in physician visits among hypertensive patients, we evaluated the causal effect of physician visits on the health of hypertensive patients. We used 16 waves of nationally representative longitudinal data drawn from the Longitudinal Survey of Middle-aged and Elderly Persons in Japan (2005-2020). To examine the causal effect of physician visits on patients' health outcomes, we used inverse probability treatment weights and doubly robust estimation and obtained the estimates of the average treatment effects on the treated (ATETs). RESULTS: Covariates were well balanced among patients who had physician visits during the past two consecutive years (N = 67,210; 64.9% among hypertensive patients). The estimated ATETs suggest that three consecutive years of physician visits had a negative impact on poor subjective health. Furthermore, patients without habitual exercise tended to not continue physician visits and perceived poor subjective health. CONCLUSIONS: Although the impact of frequent physician visits on blood pressure stability remains uncertain, regular appointments every 30 days can be effective for individuals with hypertension, particularly if they receive continuous instruction from their family physician. Because it is important for physicians to strengthen hypertensive patients' blood pressure control, promoting consecutive physician visits to hypertensive patients with diabetes, lower educational attainment, or smoking habits is needed.

Methods for Improving the Variance Estimator of the Kaplan-Meier Survival Function, When There Is No, Moderate and Heavy Censoring-Applied in Oncological Datasets.

In case of heavy and even moderate censoring, a common problem with the Greenwood and Peto variance estimators of the Kaplan-Meier survival function is that they can underestimate the true variance in the left and right tails of the survival distribution. Here, we introduce a variance estimator for the Kaplan-Meier survival function by assigning weight greater than zero to the censored observation. On the basis of this weight, a modification of the Kaplan-Meier survival function and its variance is proposed. An advantage of this approach is that it gives non-parametric estimates at each point whether the event occurred or not. The performance of the variance of this new method is compared with the Greenwood, Peto, regular, and adjusted hybrid variance estimators. Several combinations of these methods with the new method are examined and compared on three datasets, such as leukemia clinical trial data, thalassaemia data as well as cancer data. Thalassaemia is an inherited blood disease, very common in Pakistan, where our data are derived from.

The Global South political economy of health financing and spending landscape - history and presence.

The Global South nations and their statehoods have presented a driving force of economic and social development through most of the written history of humankind. China and India have been traditionally accounted as the economic powerhouses of the past. In recent decades, we have witnessed reestablishment of the traditional world economic structure as per Agnus Maddison Project data. These profound changes have led to accelerated real GDP growth across many LMICs and emerging countries of the Global South. This evolution had a profound impact on an evolving health financing landscape. This review revealed hidden patterns and explained the driving forces behind the political economy of health spending in these vast world regions. The medical device and pharmaceutical industry play a crucial role in addressing the unmet medical needs of rising middle class citizens across Asia, Latin America, and Africa. Domestic manufacturing has only been partially meeting this ever rising demand for medical services and medicines. The rest was complemented by the participation of multinational pharmaceutical industry, whose focus on investment into East Asia and ASEAN nations remains part of long-term market access strategies. Understanding of the past remains essential for the development of successful health strategies for the present. Political economy has been driving the evolution of health financing landscape since the establishment of early modern health systems in these countries. Fiscal gaps these governments face in diverse ways might be partially overcome with the spreading of cost-effectiveness based decision-making and health technology assessment capacities. The considerable remaining challenges ranging from insufficient reimbursement rates, large out-of-pocket spending, and lengthy lag in the introduction of cutting-edge technologies such as monoclonal antibodies, biosimilars, or targeted oncology agents, might be partially resolved only in the long run.

A Correlation Study of the Colorectal Cancer Statistics and Economic Indicators in Selected Balkan Countries.

Colorectal cancer (CRC) is one of the most commonly diagnosed malignant neoplasms. The aim of the study was to evaluate and correlate most important epidemiological and economic indicators of CRC in 11 selected Balkan countries. The number of new CRC cases was 56,960, and the highest 5-year CRC prevalence was in Slovenia, Croatia, and Greece. Age-standardized CRC incidence rates were highest in Slovenia, Serbia, and Croatia, and age-standardized mortality rates were highest in Croatia, Serbia, and Bulgaria. Current Health Expenditure as % of Gross Domestic Product was the highest in Bosnia and Herzegovina and Serbia. The GDP per capita levels have shown positive correlation with the CRC incidence rate and prevalence. Absolute numbers of new and death-related CRC cases and 5-year prevalence in absolute numbers have shown strong positive correlation with GDP in million current US$. It has been shown that various economic indicators can be linked to the rate of incidence and prevalence of the CRC patients in the selected Balkan countries. Therefore, economic factors can influence the epidemiology of CRC, and heavy CRC burden in the Balkan region may be one of the indexes of the economic development.

Situation, Impacts, and Future Challenges of Tobacco Control Policies for Youth: An Explorative Systematic Policy Review.

Background: Tobacco use in youths is a major public health challenge globally, and approaches to the challenge have not been sufficiently addressed. The existing policies for tobacco control are not well specified by age. Objective: Our study aims to systematically investigate existing tobacco control policies, potential impacts, and national and international challenges to control tobacco use targeting the youth. Data sources: We used the statistics of the Global Youth Tobacco Survey (GYTS), studies, and approaches of tobacco control policies targeting youth. Considering country, continent, age, and significance, PubMed, Health Inter-Network Access to Research Initiative (HINARI), Scopus, the Cochrane Library, Google, and Google Scholar were searched. The related keywords were tobacco control, youth, smoking, smoking reduction policies, prevalence of tobacco use in youth, classification of tobacco control policies, incentives to prevent young people from using tobacco, WHO Framework Convention on Tobacco Control (FTCT), etc. The search strategy was by timeline, specific and popular policies, reliability, significance, and applicability. Results: We found 122 studies related to this topic. There were 25 studies focusing on situation, significance, and theoretical aspects of tobacco control policies associated with youth; 41 studies on national population polices and challenges; and 7 studies for global challenges to overcome the youth tobacco epidemic. All national policies have been guided by WHO-MPOWER strategies. Increases in tobacco tax, warning signs on packaging, restriction of tobacco product advertisements, national law to discourage young people, and peer-based approaches to quit tobacco are popular policies. Smuggling of tobacco products by youth and ignorance of smokeless tobacco control approach are major challenges. Limitation: Our study was flexible for the standard age of youth and we were not able to include all countries in the world and most of the studies focused on smoking control rather than all smokeless tobaccos. Conclusion: The policies of tobacco control adopted by many countries are based on the WHO Framework Convention on Tobacco Control but not necessarily focused on youth. Due to the physical and economic burden of tobacco consumption by youth, this is a high priority that needs to be addressed. Youth-focused creative policies are necessary, and more priority must be given to tobacco prevention in youth. Tobacco control should be a social, public health, and quality-of-life concern rather than a business and trade issue. Implication of key findings: There is limited research on how and in what ways tobacco control policies reach young people and their engagement with these policies from physical, physiological, and psychological aspects. Analysis of these aspects, popular polices practiced in different countries, and creative strategies support the need to review current practices and future ways to discourage youth from tobacco use.

Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016.

Introduction: Multiple myeloma (MM) is a plasma cell neoplasm with substantial morbidity and mortality. A comprehensive description of the global burden of MM is needed to help direct health policy, resource allocation, research, and patient care. Objective: To describe the burden of MM and the availability of effective therapies for 21 world regions and 195 countries and territories from 1990 to 2016. Design and Setting: We report incidence, mortality, and disability-adjusted life-year (DALY) estimates from the Global Burden of Disease 2016 study. Data sources include vital registration system, cancer registry, drug availability, and survey data for stem cell transplant rates. We analyzed the contribution of aging, population growth, and changes in incidence rates to the overall change in incident cases from 1990 to 2016 globally, by sociodemographic index (SDI) and by region. We collected data on approval of lenalidomide and bortezomib worldwide. Main Outcomes and Measures: Multiple myeloma mortality; incidence; years lived with disabilities; years of life lost; and DALYs by age, sex, country, and year. Results: Worldwide in 2016 there were 138 509 (95% uncertainty interval [UI], 121 000-155 480) incident cases of MM with an age-standardized incidence rate (ASIR) of 2.1 per 100 000 persons (95% UI, 1.8-2.3). Incident cases from 1990 to 2016 increased by 126% globally and by 106% to 192% for all SDI quintiles. The 3 world regions with the highest ASIR of MM were Australasia, North America, and Western Europe. Multiple myeloma caused 2.1 million (95% UI, 1.9-2.3 million) DALYs globally in 2016. Stem cell transplantation is routinely available in higher-income countries but is lacking in sub-Saharan Africa and parts of the Middle East. In 2016, lenalidomide and bortezomib had been approved in 73 and 103 countries, respectively. Conclusions and Relevance: Incidence of MM is highly variable among countries but has increased uniformly since 1990, with the largest increase in middle and low-middle SDI countries. Access to effective care is very limited in many countries of low socioeconomic development, particularly in sub-Saharan Africa. Global health policy priorities for MM are to improve diagnostic and treatment capacity in low and middle income countries and to ensure affordability of effective medications for every patient. Research priorities are to elucidate underlying etiological factors explaining the heterogeneity in myeloma incidence.

Budgetary Impact of Medicinal Therapies for Rare Diseases in Bulgaria.

BACKGROUND: Rare diseases have been continually outlined as one of the causes for the National Health Insurance Fund's (NHIF) deficit spending in Bulgaria. AIM: To estimate the budgetary impact of rare disease medicinal therapies from NHIF perspective for 2014 and 2016. MATERIALS AND METHODS: Budgetary impact of rare diseases is calculated as a percentage of NHIF total pharmaceutical spending. Total expenditure per ICD-10 code, mean annual number of patients reimbursed and mean annual cost per patient are analysed. RESULTS: Budgetary impact of rare diseases reached a plateau of about 9% of NHIF total pharmaceutical spending for 2014-2016. Mean number of patients reimbursed and mean annual cost per patient increased by median rates of 4.27% and 2.54%, respectively. Glycogen storage disease, neuropathic heredofamilial amyloidosis and C1 esterase inhibitor deficiency stood out, as they had the second, fourth and fifth most expensive medicinal treatment cost. While accounting for only 92 patients in 2016, these three conditions contributed for 22.89% of NHIF total expenditure on rare disease medicinal therapies. For comparison, coagulation defects, with the biggest total cost per indication, had a similar budgetary impact - 24.88%, but for 277 patients reimbursed. CONCLUSIONS: Our study does not support the concerns about uncontrolled growth of expenditures for rare disease medicinal therapies. Nevertheless, there is a need for enhanced post-marketing surveillance and performance-based payment of these treatments. Development, collection and analysis of local real-world data have been increasingly applied as a tool to advance these health policy goals.

Disability, Work Absenteeism, Sickness Benefits, and Cancer in Selected European OECD Countries-Forecasts to 2020.

BACKGROUND: Disability either due to illness, aging, or both causes remains an essential contributor shaping European labor markets. Ability of modern day welfare states to compensate an impaired work ability and absenteeism arising from incapacity is very diverse. The aims of this study were to establish and explain intercountry differences among selected European OECD countries and to provide forecasts of future work absenteeism and expenditures on wage replacement benefits. METHODS: Two major public registries, European health for all database and Organization for Economic Co-operation and Development database (OECD Health Data), were coupled to form a joint database on 12 core indicators. These were related to disability, work absenteeism, and sickness benefits in European OECD countries. Time horizon 1989-2013 was observed. Forecasting analysis was done on mean values of all data for each single variable for all observed countries in a single year. Trends were predicted on a selected time horizon based on the mean value, in our case, 7 years up to 2020. For this purpose, ARIMA prediction model was applied, and its significance was assessed using Ljung-Box Q test. RESULTS: Our forecasts based on ARIMA modeling of available data indicate that up to 2020, most European countries will experience downfall of absenteeism from work due to illness. The number of citizens receiving social/disability benefits and the number being compensated due to health-related absence from work will decline. As opposed to these trends, cancer morbidity may become the top ranked disability driver as hospital discharge diagnoses. Concerning development is the anticipated bold growth of hospital discharge frequencies due to cancer across the region. This effectively means that part of these savings on social support expenditure shall effectively be spent to combat strong cancer morbidity as the major driver of disability. CONCLUSION: We have clearly growing work load for the national health systems attributable to the clinical oncology acting as the major disability contributor. This effectively means that large share of these savings on public expenditure shall effectively be spent to combat strong cancer morbidity. On another side, we have all signs of falling societal responsibility toward the citizens suffering from diverse kinds of incapacity or impaired working ability and independence. Citizens suffering from any of these causes are likely to experience progressively less social support and publicly funded care and work support compared to the golden welfare era of previous decades.

Caffeine consumption patterns and determinants among adolescents in Serbia.

BACKGROUND: The number of adolescents who use caffeine is constantly increasing. As juvenile age is vulnerable, it is reasonable to expect that they will differently perceive reason and react to caffeine use than adults, and be more prone to unwanted physiological and psychological consequences of its consumption. AIM: Analysis of the scope and pattern of caffeine consumption among adolescents in Serbia. STUDY DESIGN: The cross-sectional survey was implemented in the study population of 191 Serbian adolescents during 2010. RESULTS: The median daily intake of caffeine was 95.6 mg. The major source of caffeine was brewed coffee, and the most common reasons for caffeine intake were leisure, peer influence, or habit. Only 57.6% of the subjects were aware that caffeine is present in consumed beverages. Sex affected the pattern, but not the overall level, of caffeine consumption. No association between caffeine consumption and smoking status, frequency of caffeine use in the family, or negative personal experience with caffeine effects was observed. CONCLUSION: Our investigation provides first and rather detailed insight into caffeine-containing beverage consumption scope and pattern among Serbian adolescents. For accurate estimation and analysis of caffeine intake in this population, randomized studies with prospective longitudinal design, caffeine content measurement, and more subjects involved are warranted.

Review of Diagnosis-Related Group-Based Financing of Hospital Care.

Since the 1990s, diagnosis-related group (DRG)-based payment systems were gradually introduced in many countries. The main design characteristics of a DRG-based payment system are an exhaustive patient case classification system (ie, the system of diagnosis-related groupings) and the payment formula, which is based on the base rate multiplied by a relative cost weight specific for each DRG. Cases within the same DRG code group are expected to undergo similar clinical evolution. Consecutively, they should incur the costs of diagnostics and treatment within a predefined scale. Such predictability was proven in a number of cost-of-illness studies conducted on major prosperity diseases alongside clinical trials on efficiency. This was the case with risky pregnancies, chronic obstructive pulmonary disease, diabetes, depression, alcohol addiction, hepatitis, and cancer. This article presents experience of introduced DRG-based payments in countries of western and eastern Europe, Scandinavia, United States, Canada, and Australia. This article presents the results of few selected reviews and systematic reviews of the following evidence: published reports on health system reforms by World Health Organization, World Bank, Organization for Economic Co-operation and Development, Canadian Institute for Health Information, Canadian Health Services Research Foundation, and Centre for Health Economics University of York. Diverse payment systems have different strengths and weaknesses in relation to the various objectives. The advantages of the DRG payment system are reflected in the increased efficiency and transparency and reduced average length of stay. The disadvantage of DRG is creating financial incentives toward earlier hospital discharges. Occasionally, such polices are not in full accordance with the clinical benefit priorities.

Five-year survival and costs of care in metastatic colorectal cancer: conventional versus monoclonal antibody-based treatment protocols.

AIM: To evaluate the costs and survival estimates of metastatic colorectal carcinoma patients treated with conventional cytostatic protocols and adjuvant monoclonal antibodies (mAbs). METHODS: Retrospective randomized case series and cost-of-illness analysis was used. Metastatic colorectal carcinoma cases (62) were randomly selected from the archive of the largest university military hospital in Southeastern Europe. RESULTS: A 6-month longer survival was attributed to mAbs (p = 0.581). Conventional protocols incurred € 5137 (95% CI: € 3758-€ 6517) versus € 22,113 (95% CI: € 16,201-€ 28,025) total direct medical costs in mAb-based group. ICER of € 32,108 per life year gained attributable to mAbs three-fold exceeded informal willingness to pay threshold of Serbia. CONCLUSION: mAbs adjuvant protocols had modest positive impact on 5-year survival rates. Costs were driven by targeted biologicals, but significantly higher costs of care were recorded in mAb-treated group in other domains, as well. More selective prescription and reimbursement criteria should be applied to increase cost-effectiveness of targeted oncology agents.

End-of-life costs of medical care for advanced stage cancer patients.

BACKGROUND/AIM: Cancer, one of the leading causes of mortality in the world, imposes a substantial economic burden on each society, including Serbia. The aim of this study was to evaluate the major cancer cost drivers in Serbia. METHODS: A retrospective, in-depth, bottom-up analysis of two combined databases was performed in order to quantify relevant costs. End-of-life data were obtained from patients with cancer, who deceased within the first year of the established diagnose, including basic demographics, diagnosis, tumour histology, medical resource use and related costs, time and cause of death. All costs were allocated to one of the three categories of cancer health care services: primary care (included home care), hospital outpatient and hospital inpatient care. RESULTS: Exactly 114 patients were analyzed, out of whom a high percent (48.25%) had distant metastases at the moment of establishing the diagnosis. Malignant neoplasms of respiratory and intrathoracic organs were leading causes of morbidity. The average costs per patient were significantly different according to the diagnosis, with the highest (13,114.10 EUR) and the lowest (4.00 EUR) ones observed in the breast cancer and melanoma, respectively. The greatest impact on total costs was observed concerning pharmaceuticals, with 42% of share (monoclonal antibodies amounted to 34% of all medicines and 14% of total costs), followed by oncology medical care (21%), radiation therapy and interventional radiology (11%), surgery (90%), imaging diagnostics (9%) and laboratory costs (8%). CONCLUSION. Cancer treatment incurs high costs, especially for end-of-life pharmaceutical expenses, ensued from medical personnel tendency to improve such patients' quality of life in spite of nearing the end of life. Reimbursement policy on monoclonal antibodies, in particular at end-stage disease, should rely on cost-effectiveness evidence as well as documented clinical efficiency.

Can didactic continuing education improve clinical decision making and reduce cost of quality? Evidence from a case study.

INTRODUCTION: Administration of human serum albumin (HSA) solutions for the resuscitation of critically ill patients remains controversial. The objective of this study was to assess the effect of continuing medical education (CME) on health care professionals' clinical decision making with regard to HSA administration and the costs of quality (COQ). A quasi-experimental study of time series association of CME intervention with COQ and use of HSA solution was conducted at the Surgery Department of the Hospital Valjevo, Serbia. The CME contained evidence-based criteria for HSA solution administration in surgical patients. The preintervention period was defined as January 2009 to May 2011. CME was provided in June 2011, with the postintervention period June 2011 to May 2012. METHODS: Total mortality rate, the rate of nonsurgical mortality, the rate of surgical mortality, the rate of sepsis patient mortality, index of irrational use of HSA solutions, and number of hospital days per hospitalized patient were collected for each month as quality indicators. Statistical analysis was performed by multivariate autoregressive integrated moving average (MARIMA) modeling. The specification of the COQ was performed according to a traditional COQ model. RESULTS: The CME intervention resulted in an average monthly reduction of the hospital days per hospitalized patient, the rate of sepsis patient mortality, index of irrational use of HSA solutions, and COQ for $593,890.77 per year. DISCUSSION: Didactic CME presenting evidence-based criteria for HSA administration was associated with improvements in clinical decisions and COQ. In addition, this study demonstrates that models combining MARIMA and traditional COQ models can be useful in the evaluation of CME interventions aimed at reducing COQ.