• The Journal of Internal Korean Medicine
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• v.30 no.1
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• pp.181-190
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• 2009

It is important to establish the safety of herbal medicine because of its frequent and widespread use in Korea. Several studies on the safety of herbal medicine have been performed and there have been rare serious adverse drug reactions from those reports in Korea. However, the results are not strongly supported because of not adopting appropriate enough research methodology as to make the safety issue clear. For improving the quality of the safety research on herbal medicine. including investigations of drug induced liver injury (DILl). the aim of this study was to suggest herbal medicine-induced liver injury investigation forms for performing reasonable safety research. After a systematic review of the preceding studies regarding herbal safety in Korea was performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as a following step. one a basic investigation form for herbal safety research and the other an advanced investigation form for suspected DILl cases, Those forms include the essential informations and data needed to make an appropriate assessment of whether DILl occurred during or after the use of herbal medicine. Guidelines for using those forms and other recommendations were also suggested. More rigorous studies are required for answering the safety issue of herbal medicine as well as the efficacy issue. We hope for wide use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.239-247
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• 2013

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

• 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.

• Journal of Food Hygiene and Safety
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• v.36 no.3
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• pp.213-219
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• 2021

Hazardous substances are formed during food manufacturing, processing, or cooking, and may pose a threat to food safety. Here, we present a dietary exposure assessment of Korean consumer's intake of hazardous materials through a Total Diet Study (TDS) which was conducted by the Ministry of Food and Drug Safety (MFDS). The levels of exposure to materials such as acrylamide, furan, biogenic amines, etc., were estimated and risk assessments were then performed. Acrylamide and furan were selected as hazards with high priority of reduction control due to their having a margin of exposure (MOE) lower than 10,000. Risk assessment of exposure to ethyl carbamate, benzene and 3-MCPD showed MOEs higher than 100,000, indicating "safe". Dietary exposure to polycyclic aromatic hydrocarbons and benzopyrene was also found to be safe MOE levels >10,000. In addition, the results indicated safe MOEs (>1,000,000) for heterocyclic amines, nitrosamines, and biogenic amines. Most of the potential food contaminants were being kept at safe levels, however, it is necessary to continue to monitor and control exposure levels in accordance with the 'as low as reasonably achievable' (ALARA) principle.

• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2001.10a
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• pp.54-60
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• 2001

• Korean Journal of Adult Nursing
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• v.24 no.6
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• pp.569-579
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• 2012

Purpose: The purpose of this study was to investigate the relationship between drug dosage calculation error prevention competence and medication safety organizational climate. Methods: We surveyed 207 nurses from 15 hospitals. An assessment survey was designed to assess the medication safety organizational climate which consisted of four subcategories including medication safety cultures, medication safety initiatives, medication error communication, and medication error management competence. The drug dosage calculation error prevention competence contains two subcategories; Dosage calculation habits and ability. The data were collected from July to August 2011. Descriptive statistics, t-test, ANOVA, partial Pearson correlation coefficient, canonical correlation were used. Results: Organizational climate was related to dosage calculation error prevention competence with two significant canonical variables. The first canonical correlation coefficient was .53 (Wilks' ${\lambda}$=0.71, df=8, p<.001) and that of the second was .21 (Wilks' ${\lambda}$=0.96, df=3, p=.027). The first variate indicated higher perception of medication safety cultures, safety initiatives, error communication and error management competence were related to better dosage calculation habits. The second variate showed higher perception of medication safety cultures and lower medication error management competence were related to higher calculation ability. Conclusion: Continuous supporting strategies for medication safety organizational climate should be implemented to improve drug dosage calculation habits.

• Proceedings of the Korea Environmental Mutagen Society Conference
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• 2004.11a
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• pp.108-109
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• 2004

• Korean Journal of Food Science and Technology
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• v.42 no.5
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• pp.541-548
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• 2010

In this study, contamination levels of 7 N-nitrosamine were investigated in processed meat products (n=51), processed fish products (n=62), salted fish pickles (n=20), and beer and malt beverages (n=21) using a GC/PCI-MS/MS method. The limits of detection (LOD) of the N-nitrosamines ranged from 0.2 to 0.5 ${\mu}g$/kg. In addition, methods were used to estimate the recovery of 7 N-nitrosamines, which ranged from 84 to 112%. N-nitrosamines were detected in 89 (58%) out of 154 samples. The exposure of an entire population group to N-nitrosamines through food intake was estimated using the average body weight of the total population and average daily food consumption, to perform risk assessment based on reports of a national health and nutrition survey. The results indicated that the daily intake of N-nitrosamines over a life time was $4.92{\times}10^{-7}$ mg/kg b.w./day. The margin of exposure (MOE) for the general population, estimated using the benchmark dose lower confidence limit 10 ($BMDL_{10}$) of N-nitrosodimethylamine, was 208,939, which was found to be safe.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.28 no.1
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• pp.15-21
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• 2022

The purpose of our study was to investigate the migration level of lead (Pb), cadmium (Cd), and barium (Ba) from glassware into a food simulant and to evaluate the exposure of each element. The test articles were glassware, including tableware, pots, and other containers. Pb, Cd, and Ba were analysed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). The analytical performance of the method was validated in terms of its linearity, limit of detection (LOD), limit of quantification (LOQ), recovery, precision, and uncertainty. The monitoring was performed for 110 samples such as glass cups, containers, pots, and bottles. a food simulant. Migration test was conducted at 25? for 24 hours in a dark place using 4% acetic acid as a food simulant. Based on the data; exposure assessment was carried out to compare the estimated daily intake (EDI) to the human safety criteria. The risk levels of Pb and Ba determined in this study were approximately 1.9% and 0.3% of the provisional tolerable weekly intake (PTWI) and tolerable daily intake (TDI) value, respectively, thereby indicating a low exposure to the population.

• Toxicological Research
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• v.17
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• pp.185-188
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• 2001

Genetically modified foods and food additives are derived from organisms that have been inserted foreign genetic materials by recombinant DNA techniques to improve the quality or any other pur-poses. The problems such as toxicity, allergenicity and antibiotics resistance in the safety of genetically modified foods are usually concerned. In Korea, the safety of foods is ensured by the Food Sanitation Act. Although there is no specific provision regarding the genetically modified foods in it, any foods that might cause negative effect(s) on public health or human life are prohibited to sell in the market. In order to systematically evaluate safety of genetically modified foods, the Korea Food and Drug Administration (KFDA) promulgated "Guidelines regarding review of safety assessment data for genetically modified foods and food additives (KFDA Notification 1999-46)". The objectives of these guidelines are to ensure safety of genetically modified foods and food additives. In order to evaluate the safety of genetically modified foods. KFDA operates a special expert committee composed by experts from government, universities, research institutes. and consumer's unions. Recently. manufacturers and consumers are interested in the issues on safety and labeling of genetically modified foods, because of increment of imported genetically modified crops and processed foods. Since government and consumers unions have different viewpoints, their positions regarding the issue are different each other. Therefore, the regulation of labeling on genetically modified foods is prepared and should be enforced at July 2000 in Korea. in Korea.