• YAKHAK HOEJI
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• v.51 no.6
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• pp.424-429
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• 2007

The demand for pharmaco-economic data has increased since the introduction of positive list system for drug insurance. A survey was conducted for pharmaceutical companies, universities and hospitals to find the current states and barriers for pharmaco-economic studies in Korea. The results showed that even those who are in charge of pharmaco-economic studies at companies/universities had a limited technical expertise. Government should pay more attention to the education of the relevant manpower, and the production of national statistics needed for economic evaluation.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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• pp.256-267
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• 2018

The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

• Journal of the Korea Safety Management & Science
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• v.23 no.1
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• pp.1-8
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• 2021

The purpose of this study is to investigated occupational accidents of child care worker. We surveyed 392 childcare worker to investigate their experience of occupational accidents. Fifteen percent of the respondents from occupational accdients survey for child care workers reported that they had experienced more than one occupational accident, but mostly did not claim Occupational Safety and Health Insurance. We suggested policy tasks to improve system for protecting child care workers.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Journal of Korea Technology Innovation Society
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• v.17 no.2
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• pp.421-447
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• 2014

Traditional medicine has been integrated into the national health system in many countries such as Korea, China, Taiwan, etc. Korea and China are most representative among them. The purpose of this study is to compare the policies on traditional medicine in Korea and China focusing on where it came from and where it is headed. In this regard, the study suggested the first analysis tool in the world for analyzing the policy of traditional medicine. The results of the study are as follows: First of all, the development process of Korean Medicine (KM) and Traditional Chinese Medicine (TCM) shows the same pattern, that is, both are influenced by its own national policies. Secondly, the difference between the two countries is due to the gap in the development status or the different aspects in national heath system. TCM is more vitalized in health system and has larger category, and stays ahead in globalization compared to KM. TCM covers Chinese medicine, integrative medicine and ethno-medicine. Korea emphasizes the role of KM in the declining birthrate and aging society, and promotes the overseas patient invitation strategy. China, on the other hand, establishes the medical system for emergency medical treatment and preventive treatment of major diseases and promotes overseas expansion of TCM service. In addition, Korea stressed the safety and distribution of herbal medicine, and China emphasizes production technologies. Korea has a strong medical device industry along with the government's fostering policy; however, in China, medical devices are in the R&D stage yet. Even though both countries promotes the drug development from natural products, Korea focuses on developing herbal cosmetics in application industry, but China shows weakness in policies on application industry. China shores up the foundation for culture and theory of traditional medicine, while Korea doesn't have related policy. Korea places emphasis on promoting collaboration with international organizations and medical volunteer programs, whereas China is more interested in mutual cooperation and real trade with other countries.

• Parasites, Hosts and Diseases
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• v.59 no.5
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• pp.507-512
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• 2021

Since 1993, vivax malaria has been recognized as a public health burden in Korea. Despite of pan-governmental malaria-control efforts and the dramatic reduction in the burden of this disease over the last 10 years, vivax malaria has not been well controlled and has remained continuously endemic. We focused interviewed and examined the charts of 28 confirmed vivax malaria patients given malarial therapy for whom daily records were kept from Gimpo-si, Gyeonggi-do of Korea. Various epidemiological characteristics of vivax malaria, including the incubation period, medication used, and recurrence, and an evaluation of the parasitic characteristics from the focused interviews of patients from this region are described here. Most of the participants indicated the 3 most common symptoms of malaria (headache, chills and fever). Of the 28 cases, 2 experienced a second attack and there were 17 and 11 cases with short- and long-term incubation periods, respectively, yielding a short-term to long-term ratio of 1.5. Based on the parasitemia stages, most of the participants were tested at 5 to 7 days (11 cases) and 7 to 15 days (11 cases) after initial wave of asexual parasites. In conclusion, public health authorities should consider developing management measures to decrease the time lag for diagnosis and drafting unified and robust guidelines for drug use for malaria and drawing up unified and robust guidelines on the use of medication for malaria. It also suggests that routine monitoring, surveillance, and precise medical surveys in high-risk vivax malaria endemic areas are pivotal to controlling this persistent public disease and finally eliminating it from Korea.

• Food Science of Animal Resources
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• v.38 no.1
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• pp.43-51
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• 2018

This study was conducted to analyze the microbiological contamination status of raw beef distributed in Korea, and evaluate the suitability of current aerobic plate count (APC) guidelines. We analyzed five years (2010-2014) of microbiological monitoring data obtained from the Ministry of Food and Drug Safety and investigated the microbiological status of raw beef collected from meat packing centers and meat shops in the Seoul/Gyeonggi, Gangwon, and Chungcheong regions in August 2015. From 2010-2014, most raw beef (>94%) displayed APC levels of < $1.0{\times}10^6CFU/g$. However, raw beef samples collected from all three regions in August 2015 had comparatively higher APC levels than those reported in previous years. To evaluate the relationship between the APC level and quality, changes in beef loin were evaluated during cold storage for 15 days at $4^{\circ}C$. On day 11, the mean APC level ($4.7{\times}10^6CFU/g$) conformed to current guidelines in Korea ($1.0{\times}10^7CFU/g$) and the pH value was 5.82. However, the sensory evaluation score for color and overall acceptability was under 3.0, meaning that the beef loin was not acceptable for eating. These results suggest that current APC guideline for raw beef should be lowered to $1.0{\times}10^6CFU/g$ to improve both the microbiological safety and palatability of raw beef.

• Korean Journal of Clinical Pharmacy
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• v.25 no.4
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• pp.280-285
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• 2015

Objectives: To suggest direction for improving policies by understanding current management of narcotics or psychotropic drugs and analyzing their distributions and usage. Method: We conducted a comparison analysis between health insurance claims and the amount supplied to health care institutions for narcotics or psychotropic drugs through health insurance claims data and drug distribution supply data from 2010 to 2012 collected from Korea Pharmaceutical Information Service Center (KPIS). Furthermore, we carried out literature investigation and online search to comprehend the current management of narcotics drugs in Korea. Results: The amount supplied to medical institutions for all drugs in 2012 was 19.4 trillion won, which increased from 19.5 trillion in 2011 by 0.54%. For narcotic drugs, the amount supplied was 318.4 billion won in 2011 and increased to 335.1 billion won by 5.3% in 2012, which exceeded the rate of increase for the amount supplied for all drugs. The proportion of amount claimed in the total amount supplied to medical institutions for all drugs was 60.5% in 2012, whereas the proportion of amount claimed for narcotic drugs was 55.6%, which showed that narcotic drugs were used relatively less within health insurance. Furthermore, management of the current domestic distribution supply data focuses on manufacturing and medical institution supply stages. Conclusion: Hereafter, the management of narcotics or psychotropic drugs needs to be improved by reinforcing active monitoring in optimal prescription and usage in patients by collecting and analyzing information on drug usage of patients.

• Journal of Korean Neurosurgical Society
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• v.58 no.1
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• pp.1-8
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• 2015

Treatment of Leptomeningeal carcinomatosis (LMC) from solid cancers has not advanced noticeably since the introduction of intra-cerebrospinal fluid (CSF) chemotherapy in the 1970's. The marginal survival benefit and difficulty of intrathecal chemotherapy injection has hindered its wide spread use. Even after the introduction of intraventricular chemotherapy with Ommaya reservoir, frequent development of CSF flow disturbance, manifested as increased intracranial pressure (ICP), made injected drug to be distributed unevenly and thus, the therapy became ineffective. Systemic chemotherapy for LMC has been limited as effective CSF concentration can hardly be achieved except high dose methotrexate (MTX) intravenous administration. However, the introduction of small molecular weight target inhibitors for primary cancer treatment has changed the old concept of 'blood-brain barrier' as the ultimate barrier to systemically administered drugs. Conventional oral administration achieves an effective concentration at the nanomolar level. Furthermore, many studies report that a combined treatment of target inhibitor and intra-CSF chemotherapy significantly prolongs patient survival. Ventriculolumbar perfusion (VLP) chemotherapy has sought to increase drug delivery to the subarachnoid CSF space even in patients with disturbed CSF flow. Recently authors performed phase 1 and 2 clinical trial of VLP chemotherapy with MTX, and 3/4th of patients with increased ICP got controlled ICP and the survival was prolonged. Further trials are required with newly available drugs for CSF chemotherapy. Additionally, new LMC biologic/pharmacodynamic markers for early diagnosis and monitoring of the treatment response are to be identified with the help of advanced molecular biology techniques.

• Toxicological Research
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• v.31 no.3
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• pp.289-297
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• 2015

Ethyl carbamate (EC) classified as a probable human carcinogen (Group 2A) is naturally formed in alcoholic beverages and fermented foods during fermentation process and/or during storage. The objective of this study was to analyze EC in 34 food items including 14 alcoholic beverages and 20 fermented foods sold in Korea. Each food was collected from 18 supermarkets in 9 metropolitan cities in Korea, and then made into composite. According to food composition and alcohol content, samples were divided into four matrices such as apple juice, milk, Soju (liquor containing about 20% alcohol), and rice porridge. The maximum EC value of $151.06{\mu}g/kg$ was found in Maesilju (liquor made from Maesil and Soju). Whisky and Bokbunjaju (Korean black raspberry wine) contained $9.90{\mu}g/kg$ and $6.30{\mu}g/kg$, respectively. EC was not detected in other alcoholic beverages. Of 20 fermented foods, Japanese-style soy sauce had highest level of $15.59{\mu}g/kg$ and traditional one contained $4.18{\mu}g/kg$. Soybean paste had $1.18{\mu}g/kg$, however, EC was not found in other fermented foods.