• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.239-250
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• 2012

In recent years, national health insurance(NHI) coverage had been expanded gradually for cancer as a severe disease requiring high level of medical expenditure, to reduce patient's financial burden. But, subjective burdens level for out-of-pocket(OOP) money expense are still considerable owing to high medical cost and decent numbers of services not covered by benefit plan. This study aimed to investigate OOP medical expenditures and identify factors influencing subjective financial burden in cancer patients. A 28-items questionnaire for self-reporting by responders was designed to satisfy study goal and finalized following by one pilot study and experts' verification process. Subjects were enrolled during July to October 2010 through regular meetings organized by five patient or patient-advocacy groups had acknowledged the study purpose. Subjects who aged 20 or more, have histories of cancer diagnosis and anticancer drug use, and voluntarily agreed to participate in this study were recruited. Total 107 subjects included in the analysis have cancer lesions in breast, colon, kidney, liver or stomach at the stages from I to IV. Approximately 73% of them has passed less than 5 years since cancer diagnosis. For the OOP medical expenditure regarding cancer, less 6 million won was in 31%, 6-15 million won in 35% and more than 15 million won in 28% of responders, and more than half responders(58%) felt financial burden subjectively. 63% of responders had subscribed commercial insurances, resulting in money receipts of more than 10 million won since cancer diagnoses in 76% of responders. Logistic regression results showed significant differences in subjective OOP financial burden level depending on gender, household income level, benefit type, commercial insurance money receipt degree, year cancer diagnosed, cancer lesion, therapy type, duration of anticancer drug use, drug listing in national formulary, total OOP medical expenditure and total OOP anticancer drug expense. They had mixed feelings both wishes to expand NHI coverage to reduce financial burden(70%) and no willingness to increase premium(59%). This result suggested that NHI might direct future strategies to reduce absolute total OOP medical cost and expand benefit plan coverage in higher burden groups in particular.

• Korean Journal of Clinical Pharmacy
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• v.29 no.1
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• pp.9-17
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• 2019

Objective: The objective of the present study was to evaluate the effects of implementing a systematic Drug Utilization Review (DUR) system on contraindicated drug use and pharmaceutical expenditures in Korea. Methods: A literature search was conducted using search engines such as PubMed, EMBASE, NDSL, and RISS for relevant systematic studies. The database search was performed and updated in April 2018. Two independent reviewers evaluated the abstracts to find potentially eligible articles. Results: In total, 1433 potentially eligible studies were selected, and 11 articles were eventually shortlisted for inclusion in the present review system. The outcome showed that contraindicated drug use decreased after implementation of the DUR system in Korea. The analysis also showed that the DUR system contributed to a reduction in pharmaceutical expenditures. Conclusions: Our study showed that implementing the DUR system reduced both contraindicated drug use and pharmaceutical expenditures in Korea.

• Health Policy and Management
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• v.26 no.4
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• pp.333-342
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• 2016

Background: The use of therapeutic materials based on new health technology has increased in recent years in the field of medicine, raising concerns for medical practitioners regarding increased spending on the new therapeutic materials amid the rapid population ageing and increase of chronic diseases in Korea. While therapeutic materials have significant importance in the health care system, they have not been given appropriate attention in the academic world of Korea. The purpose of this study is to identify factors that affect the growth of expenditure on therapeutic materials and to derive implications for an effective management considering the diversity of therapeutic materials. Methods: Using the claims data of the National Health Insurance Services, specific utilization patterns of groups of therapeutic materials in the middle classification level of Health Insurance Review and Assessment Service from 2007 to 2014 were analyzed. Four categories (J5083: drug eluting coronary stent, D0302: nonmetallic anchor, K6014: gauze, K6023: gauze) that exhibit unique patterns with respect to price and volume were selected. Then, decomposition analysis was performed to identify the largest contributor to the spending growth by dividing the products into existing, new, and abandoned products for the period between 2010 and 2013. Results: The effect of new products had larger impact on spending growth than the effect of core items in drug eluting coronary stent (J5083) and nonmetallic anchor (D0302). In addition, existing products in general included items priced relatively lower when compared with another item manufactured by the same company. In the gauze category, however, existing products had the largest impact on expenditure and the effect of volume was greater than that in other categories. Conclusion: This study provides evidence that appropriate management measures classified by the characteristics of therapeutic materials are required for therapeutic materials pricing and reassessment in Korea.

• YAKHAK HOEJI
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• v.49 no.4
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• pp.255-259
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• 2005

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

• Journal of Digestive Cancer Research
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• v.11 no.2
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• pp.104-107
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• 2023

The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

• Health Policy and Management
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• v.21 no.2
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• pp.249-262
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• 2011

Since May 1st in 2008, the products of ginkgo biloba extract have had to be used with the patient's out-of-pocket payment due to reimbursement restriction guidelines. This study aims to analyze the policy effects of reimbursement restriction on pharmaceutical expenditures using interrupted time series(ITS) analysis. We retrieved monthly NHI claims data for the period between May, 2005 and December 2009. The ingredients identified as a substitute for ginkgo biloba have similar indications based on the similar pharmacological activities. The effects of changes in reimbursement scope were evaluated both for all relevant pharmaceuticals within the same therapeutic class and for 2 separate groups : ginkgo biloba's and its substitutes. According to the study results, restrictions on reimbursement scope resulted in savings of the drug expenditures in the targeted therapeutic class. Direct restriction on ginkgo biloba was associated with a decrease in expenditure level by 60.1% and changes in trend from an average increase rate of 1.4% to an average decrease rate of 1.5% for the therapeutic class, with a dramatic decrease in expenditure level(-191.5%) for ginkgo biloba itself, but with an increased expenditure level(+50.1%) and changes in trend from an average increase rate of 2.0% to an average decrease rate of 1.0% for the substitute group. Further policy to restrict nicergoline was associated with additional decrease in expenditure level for the therapeutic class. Additionally, we could identify the balloon effect - a new policy squeezing one part results in bulging out elsewhere. After the restriction of ginkgo biloba, the utilization of and expenditures on its substitutes increased significantly. In conclusion, we demonstrated that consecutively introduced policies effectively reduced overall expenditures on the therapeutic class of interest. Some ingredients played as a substitute while others did not. Further studies need to be conducted to identify which factors determine a substitute.

• Korean Journal of Clinical Pharmacy
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• v.29 no.2
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• pp.79-88
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• 2019

Backgrounds: Inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn's disease (CD) increased prevalence and economic burden. Objectives: This study aimed to investigate drug use pattern in IBD patients in a real world. Methods: National Health Insurance claim data from 2010 to 2014 were used in this population-based study. All IBD patients diagnosed during study period were enrolled. IBD medications included 5-aminosalicylic acid (ASA), glucocorticoid, immunomodulator and anti-tumor necrosis factor-${\alpha}$ agent(anti TNF-${\alpha}$). Growth rate of IBD prevalence, prescribed drug classes, duration of drug therapy and medication cost were analyzed. Number and percentage of patients for categorical variables, and mean and median for continuous variables were presented. Results: Total numbers of patients were 131,158 and 57,286 during 5 years, and their annual growth rate were 3.2 and 5.7% for UC and CD. UC and CD were prevalent in the 40-50 (41.2%) and 20-30 age groups (36.0%). About 60% of IBD patients was prescribed any of medications. 5-ASA was the most frequently prescribed, followed by corticosteroid and immunomodulator. Anti TNF-${\alpha}$ use was the lowest, but 5 times higher than UC in CD. Combination therapies with different class of drugs were in 29% for UC and 62% for CD. Mean prescription days per patient per year were 306 and 378, and the median medication cost per patient per year was KRW 420,000 (USD 383) and KRW 830,000 (USD755), for UC and CD, respectively. Conclusions: Increasing prevalence of IBD requires further studies to contribute to achieve better clinical outcomes of drug therapy.

• Korean Journal of Clinical Pharmacy
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• v.23 no.2
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• pp.89-96
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• 2013

This article aimed to introduce 'risk sharing' schemes for pharmaceuticals between drug manufacturers and healthcare payer. Published literature review was undertaken to summarize risk sharing concepts and collect information on existing scheme examples in other countries focusing on new anticancer drugs. Risk sharing schemes could be categorized into health outcomes-based and non-outcomes (financial) based ones. Outcome-based schemes could be broken down into performance-linked reimbursement and conditional coverage. Performance-linked reimbursement can be further broken into outcomes guarantee and pattern or process of care and conditional coverage included coverage with evidence development and conditional treatment continuation schemes. Non-outcome based schemes included market share and price volume at population level, and utilization caps and manufacturer funded treatment initiation at patient level. We reviewed the fifteen examples for anticancer drugs that risk sharing agreements in response to the inherent uncertainties and increased costs of eleven anticancer drugs. Of them, eight cases were coverage with evidence development schemes. The anticancer drugs except bevacizumab and cetuximab were all listed on the national health insurance formulary in Korea, with reimbursement criteria defined on the basis of approved indications and administrations. Risk sharing approach may be a useful tool to ensure values for drug expenditure, but there are a number of concerns such as high administration costs, lack of transparency and conflicts of interest, especially for performance-based health outcomes reimbursement schemes.

• The Korean Society of Law and Medicine
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• v.13 no.2
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• YAKHAK HOEJI
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• v.60 no.3
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• pp.146-153
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• 2016

Over-the-counter (OTC) drugs refer to medicines that are generally safe when used according to the product label. We aimed to assess and reflect upon changes in perception of health and health-related demands by decades in Korea according to the consumption and sales trends of OTC drugs. This study was conducted by literature search on the production and sale rankings of OTC drug market in Korea. Changes in the OTC drug market were analyzed and organized by decades to evaluate changes in drug demands and the influence of national and societal factors. There was a specific trend in the most popular drugs by decades. In the 1950s, drugs of top necessity were antibiotics and helminthics. In the 1960s, the pharmaceutical industry quickly grew and invigorators, such as Bacchus$^{(R)}$, Alps$^{(R)}$, Aronamin$^{(R)}$, were top manufactured drugs. Popularity of these invigorating drinks and vitamin products continued until the 1990s. In 1990s, sales of topical nonsteroidal anti-inflammatory drugs (Ketotop Plaster$^{(R)}$, Trast Patch$^{(R)}$), and in 2000s, gum disease medicine (Insadol$^{(R)}$) and liver and intestine supplement (Ursa$^{(R)}$) were prominent. However, after the separation of prescribing and dispensing in 2000, the sales of OTC drugs decreased dramatically from 58.7% of the total market share in 1990s to 39.6% in 2000 and this trend has continued. In 2012, thirteen OTC drugs were allowed to be sold in convenience stores, and as the sales of health functional foods have been expanding beyond pharmacies, sales of invigorators and nutritional supplements in pharmacies have continued to decrease. As government's drug expenditure will continue to grow, reclassification of OTC drugs based on established safety information and deliberate team efforts on continued development of OTC drugs to meet the health demands of Koreans are required by the healthcare professionals, pharmaceutical industries, and the government.