• The Journal of Korean Medicine
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• v.31 no.3
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• pp.1-7
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• 2010

Objectives: To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations. Methods: We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM. Results: Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study. Conclusion: Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.

• Health Policy and Management
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• v.30 no.3
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• pp.311-325
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• 2020

Background: Health statistics of pharmaceutical use and expenditure are essential to make and implement evidence-based pharmaceutical policy. This study aims to demonstrate the methods and results of pharmaceutical consumption and sales in 2018 according to the sources and methods given by the Organization for Economic Cooperation and Development (OECD). Methods: The medication list contains 39,346 medicines both reimbursed and non-reimbursed by the National Health Insurance in 2018. We used the therapeutic categories based on Anatomic Therapeutic Chemical Classification of World Health Organization. This study analyzed National Health Insurance claims data and supply data generated from wholesalers to health care facilities. The indicators are defined daily dose (DDD), per 1,000 inhabitants per day and US$ per capita. Results: In South Korea, the number of medications to which DDD were assigned was 18,055 and it was 45.9% of the total number of medications on the list. The consumption in anti-infective for systemic use (J) and musculo-skeletal system (M) was higher than the mean consumption among the OECD countries. The pharmaceutical sales per person in Korea was also higher than the mean sales per person across the OECD countries. Conclusion: We sought to explain the methods to produce pharmaceutical consumption and sales statistics which we had submitted annually to OECD. Considering the characteristics of pharmaceutical statistics, a direct comparison should be approached with caution. Since the growth in pharmaceutical spending has greatly increased over the past decade, we need to monitor pharmaceutical consumption and expenditure consistently.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.39 no.2
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• pp.64-71
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• 2016

Recently, nanotechnology has grown as one of the leading science technology along with other converging technologies such as biology, information, medicine etc., bringing the continuous investment of the government in nano-related field. However, it is difficult to measure and evaluate the performance of the national research and development programs because of the multidimensional character of the expected outcomes. This study aims to measuring efficiency of the national nanotechnology research and development programs using DEA model. The decision making units are nine nano-related ministries including the Ministry of Science, ICT and Future Planning. The input variables are total expenditure, number of the programs and average expenditure per program. The output variables are science, technology and economic indicator, and the combination of these outputs are respectively measured as seven different DEA cases. The Ministry of Science, ICT and Future was the first efficient ministry in total technical efficiency. Ministry of Agriculture, Food and Rural Affairs and the Ministry of Food and Drug Safety were efficient in pure technical efficiency, when the Ministry of Commerce Industry and Energy took the first in the scale efficiency. The program efficiency was affected by organizational characteristics such as the institution's scale, the concentration of the research paper or the patent, technology transfer or the commercialization. The result of this study could be utilized in development of the policy in the nanotechnology and the related field. Furthermore, it could be applied for the modification of expenditure management or the adjustment of the research and development programs' input and output scale for each ministry.

• Korean Journal of Clinical Pharmacy
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• v.30 no.2
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• pp.73-80
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• 2020

Objective: The Australian Pharmaceutical Benefits Scheme (PBS) is a national drug subsidy program. Given the similarity and comprehensiveness of the Australian PBS and the Korean National Health Insurance (NHI) data, these data are increasingly used for pharmacoepidemiological investigations, as well as international comparative studies. This study aims to introduce the various sources of publicly available PBS data and provide a practical guide to researchers conducting drug utilization studies. Methods: We searched literature and websites to detail and compare the collection, structure, components, and characteristics of each PBS data format. We identified different characteristics of the PBS data from the Korean NHI claims data which are mainly owing to their unique co-payment policies and data collection processes. In addition, the utilization and expenditure of atorvastatin, a widely used treatment for hyperlipidemia, were analyzed using two different sources of PBS data and the different results were interpreted. Results: There exist differences in when data were collected or non-subsidized uses of medicine were included among sources of PBS data. Additionally, two countries have different cost sharing methods inmedicine subsidy scheme; co-payment in Australia and co-insurance in Korea. Therefore, it should be noted that prescriptions under co-payment are not included in some data sources in Australia. Conclusion: Despite several analytical challenges, open access and easy data management are the strengths of the PBS data sources. A detailed knowledge of the PBS data can ensure robust methodology and interpretation of pharmacoepidemiological investigations or international comparative studies.

• Journal of Yeungnam Medical Science
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• v.10 no.1
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• pp.91-102
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• 1993

This study was carried out to assess medical care expenditure of residents in urban poor area. The study population included 377 family members of 85 households in the poor area of Daemyung 8-Dong, Nam-Gu, Taegu and 442 family members of 96 households in a control area. The data was collected through self-administered questionnaires completed by housewives. The survey was conducted from March 1 to May 31, 1992. The mean age was 31.1 years in the poor area and 37.1 years in the control area. The average number of households per house was 4.5 in the poor area and 4.5 in the control area. The frequency of medical care utilization per household in a one month period was 4.6 in the poor area and 4.3 in the control area. The average number of days of utilization was 12.9 in the poor area and 12.5 in the control area. The average monthly income of a househlod in the poor area was 848,600 Won compared to the control area's 1,752,300 Won. The average monthly consumption expenditure of a household in the poor area was 568,800 Won and that in the control area 1,238,400 Won. The average medical care monthly expenditure per household was 34,500 Won in the poor area and 58,400 Won in the control area. The proportion of the medical care expenditure to monthly income and to monthly consumption expenditure was 4.1% and 6.1% respectively in the poor area, and 3.3% and 4.7%, respectively in the control area. The premium of medical insurance was 1.5% in both areas. The proportion of cost for drug was 57.4%, for medical appliance was 1.2%, and for medical treatment was 41.1% in the poor area and in the control area 52.4%, 1.9%, 45.7%, respectively. The highest proportion of medical care expenditures in the poor area was herb clinic utilization (36.9%), while hospital and clinic(37.8%) was the highest proportion in the control area. Mean medical care expenditure per visit was 7,400 Won in the poor area and 12,600 Won in the control area. Mean medical care expinditure per day was 2.800 Won in the poor area and 6,300 Won in the control area.

• Journal of Home Health Care Nursing
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• v.6
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• pp.5-18
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• 1999

This study was attempt to encourage for developing on rehabilitation delivery system and programs as a substitute service instead of hospitalization for accident patients at work, such as hospital based home health care nursing service. It needs vary substitutes service of hospitalization to curtail the length of stay for inpatients who were hospitalized with workers compensation insurance. It focused on developing an estimation of early discharge day of accident inpatients based on a detail statement of treatment for 115 inpatients who were hospitalized at General Hospital in 1997. This study has four specific purpose as follows. First, to find out the status of health service utilization. Second, to estimate the early discharge days and income increasing effect based on the early discharge for those patients. Third, to identify the factors to affect total medical expenditure and the length of stay for those inpatients. Forth, to figure out the need of utilizing home health care nursing service for accident patients. In order to analyze of the length of stay and medical expenditure for inpatients who were hospitalized due to the accident, the authors conducted with micro-analysis and macroanalysis from medical records and medical expenditure records. Micro-analysis was done by nominal group discussion of 4 expertise with the critical criteria. such as a decrease in the amount of treatment after surgery, treatments, tests, drugs and changes in the tests consistency, drug methods, vital signs, start of ROM exercise, doctor's order, patient's outside visiting ability, stable conditions. In addition to identify affected variables for medical expenditure. the length of stay and income effect due to early discharge day, the data was analyzed with multiple regression analysis and linear regression analysis model by SPSS-PC for windows and Excell program. Results of this study as follows. First, the mean length of stay was 37.1 days, whereas the mean length of stay due to early discharge was 28.2 days at the hospital. The estimation of early discharge days were shown that depends on the length of stay. The longer length of stay, the longer length of early discharge days, such as under 7 days length of stay patients was to estimated the mean length of stay was 4.9 days and early discharge days was 4.6. whereas the mean length of stay was 122.6 days and early discharge days was 92.0 respectively. The mean medical expenditure per day were found to be 133.409 Won. whereas the mean medical expenditure per day was shown negative linear trends according to the length of stay at the hospital. The estimation results of the income effect due to 11 early discharge days per bed was around 2,150,000 won. However, it means not the real benefits from early discharge, but the income increasing amount without considering medical prime cost in general hospital. Therefore, it needs further analysis on the cost containments and benefits under the considering as well turn over rates per bed as the medical prime costs. The length of stay was most significant and the sign was positive to the total medical expenditure, as expected. Surgery and patient's residential area also an important variable in explaining medical expenditure. The level of complications was most significant variable in explaining the length of stay. The level of the needs on horne health care nursing service which can be used for early discharge accident patients were shown very high. The needs distribution varied from 65.5% of patients and 88.9% of caregivers, to 96.4% of doctors, and 99.1% of nurses. In addition horne health nurse responded that they can be managed the accident inpatients from early discharge. From these research findings. the following suggestions has been drawn it needs to develop strategies on rehabilitation delivery system in order to focused on consumer's side which is planned for 21 century health policy in Korea. Vary intermediate facilities and horne health care would have been developed in the community based for comprehensive rehabilitation services as a substitutes of hospitalization for shortening the length of stay of hospitalizations. In hospital based horne health care nursing service, it's available immediately to utilize for the patients who wanted rehabilitation services as a substitutes of hospitalization under the cooperations with workers compensation insurance company.

• Journal of Home Health Care Nursing
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• v.7 no.1
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• pp.58-72
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• 2000

This study was an attempt to encourage the development of a rehabilitation delivery system and programs as a substitute service for hospitalization on the case of car accident patients, such as hospital based home health care nursing services. Various substitute services for hospitalization are required to curtail the length of stay for inpatients who were hospitalized with car accident compensation insurance. It focused on developing an estimation an early discharge day for car accident inpatients based on detailed statements of treatment for 111 inpatients who were hospitalized at the General Hospital in 1997. This study had four specific purposes as follows. First. to find out the utilization of medical services. Second, to estimate the time of early discharge and income increasing effect based on early discharge for those patients. Third, to identify the factors affecting total medical expenditure and the length of stay for those inpatients. Forth, to figure out the need of utilizing home health care nursing service for accident patients. In order to analyze the length of stay and medical expenditure for inpatients who were hospitalized due to car accidents, the authors conducted micro- and macro-analysis of medical and medical expenditure records. Micro-analysis was done by nominal group discussion of 4 expertise with the critical criteria, such as a decrease in the amount of treatment after surgery, treatments, tests, drugs and changes in the test consistency, drug methods, vital signs, start of ROM exercise, doctor's order, patient's outside visiting ability, and stable conditions. In addition to identifying variables affecting medical expenditure, and the length of stay and income effect due to early discharge day, the data was analyzed with a multiple regression analysis and linear regression analysis model by SPSS-PC for windows and Excell program. Results of this study were as follows. First. the mean length of stay was 50.3 days. whereas the mean length of stay due to early discharge was 34.3 days at the hospital. The estimation of time of early discharge depended on the length of stay. The longer the length of stay, the longer the length of time of early discharge : for instance a length of stay under 10 days was estimated as correlating to a mean length of stay of 6.6 days and early discharge of 6.5. The mean length of stay was 217.4 days and the time of early discharge was 110.1 respectively. The mean medical expenditure per day was found to be 169.085 Won and the mean medical expenditure per day showed negative linear trends according to the length of stay at the hospital. The estimation results of the income effect due to being discharged 16 days early was around 2,244,000 won per bed. However. this sum does not represent the real benefits resulting from early discharge, but rather the income increasing amount without considering medical prime cost in the general hospital. Therefore, further analysis is required on the cost containments and benefits as turn over rate per bed as the medical prime costs. The length of stay was most significant and was positive to the total medical expenditure, as expected. Surgery and patient's residential area was also an important variable in explaining medical expenditure. The level of complications was the most significant variable in explaining the length of stay. There was a high level for need a home health care nursing service which further supports early discharge for accident patients. In addition, when the patient was discharged. they needed follow up care for complications suffered during the car accident. $86.8\%$ of discharged patients responded that they needed home health services after early discharge. From these research findings, the following suggestions have been drawn. Strategies on a health care delivery system must be developed in order to focus on the consumer's needs and being planned for 21 century health policy in Korea. Community based intermediate facilities or home health care should be developed for rehabilitation services as a substitute for hospitalization in order to shorten the length of stay would be. A hospital based home health care nursing service. it would be available immediately to utilize by patients who want rehabilitation services as a substitute for hospitalization with the cooperation of car insurance companies.

• Health Policy and Management
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• v.23 no.3
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• pp.210-223
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• 2013

Backgrounds: Escalating pharmaceutical expenditure has threatened the sustainability of National Health Insurance system in Korea. Generic medicines allow patients to access safe, effective, high-quality medicines at low cost, thus insurers could achieve significant financial savings by promotion of generics, if they are priced much lower than the originator. The purpose of this study was to review generic pricing as well as promotion policies in other countries and assess the implication of those policies. Methods: We reviewed the main measures adopted by the developed countries such as Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Sweden, United Kingdom, especially in countries where governments are the largest third-party payers or insurance finance resource is the national health insurance. Results: The foreign countries's experience with generic medicine policy shows that demand-side policies such as physician budgets, international nonproprietary name prescribing, generics substitution, patients co-payment as well as supply-side policies relating to pricing and reimbursement seems to play a critical role in developing the generic medicines market. Conclusion: Various strategy should be implemented to promote generic drug use.

• Journal of Korean Medicine for Obesity Research
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• v.16 no.2
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• pp.109-115
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• 2016

Objectives: The all anti-obesity drugs currently approved by the US Food and Drug Administration work by reducing energy intake. In fact, no approved drug targets energy expenditure. In Korean medicine, it is known to Qi or Yang invigorating therapy could increase energy metabolism. Aconitum carmichaeli Debx (ACD) is a Yang invigorating herb, often used for treat obesity in Korean medicine. In the present study, the authors investigated the regulatory effects of ACD in energy metabolism and mitochondrial biogenesis in C2C12 skeletal muscle cells. Methods: The water extract of ACD (0.2, 0.5 and 1.0 mg/ml) were treated in differentiated C2C12 cells. The protein or mRNA levels of target genes were analyzed and mitochondrial mass were investigated. Results: ACD activated the expressions of peroxisome proliferator-activated receptor gamma coactivator 1-alpha ($PGC-1{\alpha}$), nuclear respiratory factor 1 and TFAM and increased mitochondrial mass. ACD also increased adenosin monophosphate-activated protein kinase (AMPK), and acetyl-CoA carboxylase. Conclusions: This study suggests that ACD has the potential to increase energy metabolism and mitochondrial biogenesis by activating AMPK and $PGC1{\alpha}$.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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• pp.263-272
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• 2018

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.