• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.3-36
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• 2022

In order to solve the pharmaceutical kickback problem, it is needed to establish legal system that allow ways to enable pharmaceutical promotion of medicines without kickbacks as well as provide sanction those who commit illegal act. Before the National Assembly and the government focused on strengthening sanctions. As a result, in 2014, a system of suspending medical care benefits was introduced, which could inflict heavy losses on pharmaceutical companies by withdrawing target medicines from the market. However, three years after the introduction, the system was abolished in 2018, recognizing the problem that the disposition could infringe on the patients' right to access to and choice of medicines. In 2021, the National Assembly made it possible for dispositions suspending medical care benefits regarding the third violation, which remained symbolic until then, replaced with administrative fines. Although the legislator's reflective stance on the system is more than clear, the Ministry of Health and Welfare still interprets that the old law should be applied to kickbacks for the period of the law. Moreover, regarding the substitution of fines at the discretion of the Minister of Health and Welfare under the old law, the narrow standards taken under the old law seems to be maintained. In this paper, firstly pharmaceutical kickback issue, the main reason for the introduction of the system, will be explained, after that the history of introduction and abolition of the system examined and last but not least the unconstitutionality of the system and the illegality of the disposition are to be examined.

• 동물약계
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• no.104
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• pp.3-6
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• 2006

동물약사감시 행정처분 결과 홍보/환경개선제 등 동물의약품 구매 협조 요청/제주 돼지콜레라 관련 제도개선 협의회 참석/소부루세라병 간이지니단킷트 도입 협의회 참석/구제역 특별방역대책 추진/동물용의약품등 자율점검제 실시 결과/방역용 소독약품 다수공급자물품계약 요청/통관단일창구 사용자 설명회 개최/제1차 이사회 개최/제14차 정기총회 개최/농협중앙회 소독약품 구매 관련 회의 참석/동물의약품등 제조업체 현황/동물용의약품등 수입자 현황/국내생산 동물용의약품 연도별 판매 현황/국내생산 동물용의약품 연도별 수출 현황/수입완제 동물용의약품 연도별 판매 현황/동물용의약품 연도별 내수 시장 규모/동물용의약품 약효별 허가(신고) 현황/내수 유통경로별 판매 현황(원료제외)/축종별 판매현황(원료제외)/원료 동물약품 원산지별 수입 현황/완제 동물약품 원산지별 수입 현황

• Proceedings of the Korea Information Processing Society Conference
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• 2024.05a
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• pp.436-438
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• 2024

의료 당국은 가능한 최상의 서비스를 보장하기 위해 코로나19와 같은 전염병 기간뿐만 아니라 일상적인 운영에서도 의료 공급망 프로세스를 효과적으로 관리해야 한다. 제품 리콜, 제품 공급 부족 모니터링, 만료 및 위조는 방지되어야 하는 중요한 의료 공급망 운영 중 일부이다. 본 논문에서는 블록체인과 분산형 스토리지 시스템을 사용한 위조 의약품 유통 방지 시스템을 제안한다. 제안하는 솔루션은 투명성을 높이고, 이해 관계자간의 커뮤니케이션을 개선하며, 제품 조달 일정을 단축하는 동시에 중요한 격차와 결함을 제거한다.

• Analytical Science and Technology
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• v.36 no.6
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• pp.300-314
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• 2023

The quality of the products was investigated by analyzing fluorine content, pH, preservatives and tar colors in 31 dentifrice products (6 items for children) and 15 mouthwash products (2 items for children) marketed. It was intended to provide correct information to consumers by checking whether the standards and product indications match. As a result of measuring the fluoride concentration, 26 dentifrice and 15 mouthwash products contained from 48 to 1,472 ppm and from 85 to 225 ppm, respectively. Fluorine detection rates of dentifrice and mouthwash products were 83.9 and 83.3 %, respectively showing similar levels. Of the 41 fluoride-detected dentifrice and mouthwash products, 40 were 90.7~109.8 % of the displayed amount and suitable for the fluorine content standard of 90.0 to 110.0 %, but one dentifrice was found to be inappropriate at 36.3 % of the content indicated on the product. The pH of the dentifrice was 5.1~9.4, and the mouthwash was 4.2~6.2, which met all standards. As a result of simultaneous analysis of the concentration of six preservatives, benzoic acid was detected the most in 15 cases with a 30.6 % detection rate, sorbic acid was detected in 9 cases (detection rate of 18.4 %), and all four types of methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate were not detected. As a result of analyzing the concentration of 10 types of tar colors, six types including red40, yellow4, yellow5, yellow203, green3, and blue1 were detected in a total of 9 cases (2 dentifrices and 7 mouthwashes) with blue1 being the most frequently detected. Detected fluorine concentration, added preservatives and tar colors were consistent with the product markings and it was well written on product packaging. The detected preservatives and tar colors were at a safe level due to low risk compared to Acceptable Daily Intake.

• Life and Agrochemicals
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• s.254
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• pp.38-40
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• 2010

식품의약품안전청은 '07-08년까지 전국 시장 등에서 유통되는 과일류 4,776건의 농약잔류량을 분석한 결과 9.81%인 4,767건에서 농약이 검출되지 않았거나 세척하지 않고 섭취해도 될 만큼 극미량만이 검출되었다고 밝혀 큰 반향을 일으켰다.

• Journal of Food Hygiene and Safety
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• v.34 no.3
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• pp.235-241
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• 2019

An analytical method was developed for the determination of an antibiotic fungicide, kasugamycin, in agricultural products (hulled rice, potato, soybean, mandarin and green pepper) using liquid chromatographytandem mass spectrometry (LC-MS/MS). Samples were extracted with methanol adjusted to pH 13 using 1 N sodium hydroxide, and purified with a HLB (hydrophilic lipophilic balance) cartridge. Linearity of a matrix-matched calibration curve using seven concentration levels, from 0.001 to 0.1 mg/kg, was excellent with a correlation coefficient ($R^2$) of more than 0.9998. The limits of detection (LOD) and quantification (LOQ) of instrument were 0.0005 and $0.001{\mu}g/mL$, respectively, and the LOQ of analytical method calculated as 0.01 mg/kg. The average recoveries at three spiking levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n=5) were in the range of 71.2~95.4% with relative standard deviation of less than 12.1%. The developed method was simple and all optimized results was satisfied with the criteria ranges requested in the Codex guidelines and Food Safety Evaluation Department guidelines. The present study could be served as a reference for the establishment of maximum residue limits (MRL) of kasugamycin and be used as basic data for safety management relative to kasugamycin residues in imported and domestic agricultural products.

• Journal of Food Hygiene and Safety
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• v.34 no.3
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• pp.242-250
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• 2019

An analytical method was developed for the determination of fenquinotrione, a triketone herbicide, in agricultural products. Fenquinotrione was metabolized to KIH-3653-M-2 in plants. Analyte extraction was conducted using 2% formic acid in acetonitrile and cleaned up using a hydrophillic-lipophillic balance (HLB) cartridge. The limits of detection (LOD) and quantification (LOQ) were 0.004 and 0.01 mg/kg, respectively. Matrix-matched calibration curves were linear over the calibration ranges ($0.001{\sim}0.1{\mu}g/mL$) into a blank extract with $r^2>0.99$. The recovery results for fenquinotrione and KIH-3653-M-2 ranged between 81.1 to 116.2% and 78.0 to 110.0% at different concentration levels (LOQ, $10{\times}LOQ$, $50{\times}LOQ$) with relative standard deviation (RSD) less than 4.6%. All values were corresponded with the criteria ranges requested in both the Codex (CAC/GL 40-1993, 2003) and MFDS guidelines (2016). Therefore, the proposed method can be used as an official analytical method for determination of fenquinotrione in the Republic of Korea.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.140-147
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• 2019

An analytical method was developed for the determination of quinoxyfen in agricultural products using the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The samples were extracted with 1% acetic acid in acetonitrile and water was removed by liquid-liquid partitioning with $MgSO_4$ (anhydrous magnesium sulfate) and sodium acetate. Dispersive solid-phase extraction (d-SPE) cleanup was carried out using $MgSO_4$, PSA (primary secondary amine), $C_{18}$ (octadecyl) and GCB (graphitized carbon black). The analytes were quantified and confirmed by using LC-MS/MS in positive mode with MRM (multiple reaction monitoring). The matrix-matched calibration curves were constructed using six levels ($0.001-0.25{\mu}g/mL$) and the coefficient of determination ($R^2$) was above 0.99. Recovery results at three concentrations (LOQ, 10 LOQ, and 50 LOQ, n=5) were in the range of 73.5-86.7% with RSDs (relative standard deviations) of less than 8.9%. For inter-laboratory validation, the average recovery was 77.2-95.4% and the CV (coefficient of variation) was below 14.5%. All results were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and Food Safety Evaluation Department guidelines (2016). The proposed analytical method was accurate, effective and sensitive for quinoxyfen determination in agricultural commodities. This study could be useful for the safe management of quinoxyfen residues in agricultural products.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.115-123
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• 2019

An analytical method was developed for the determination of fenpropimorph, a morpholine fungicide, in hulled rice, potato, soybean, mandarin and green pepper using QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) sample preparation and LC-MS/MS (liquid chromatography-tandem mass spectrometry). The QuEChERS extraction was performed with acetonitrile followed by addition of anhydrous magnesium sulfate and sodium chloride. After centrifugation, d-SPE (dispersive solid phase extraction) cleanup was conducted using anhydrous magnesium sulfate, primary secondary amine sorbents and graphitized carbon black. The matrix-matched calibration curves were constructed using seven concentration levels, from 0.0025 to 0.25 mg/kg, and their correlation coefficient ($R^2$) of five agricultural products were higher than 0.9899. The limits of detection (LOD) and quantification (LOQ) were 0.001 and 0.0025 mg/kg, respectively, and the limits of quantification for the analytical method were 0.01 mg/kg. Average recoveries spiked at three levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n=5) and were in the range of 90.9~110.5% with associated relative standard deviation values less than 5.7%. As a result of the inter-laboratory validation, the average recoveries between the two laboratories were 88.6~101.4% and the coefficient of variation was also below 15%. All optimized results were satisfied the criteria ranges requested in the Codex guidelines and Food Safety Evaluation Department guidelines. This study could serve as a reference for safety management relative to fenpropimorph residues in imported and domestic agricultural products.

• Journal of Food Hygiene and Safety
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• v.39 no.2
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• pp.61-71
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• 2024

In this study, we analyzed chlorogenic acid indicator components in preparation for the additional listing of green coffee bean extract in the Health Functional Food Code and optimized caffeine for simultaneous analysis. We extracted chlorogenic acid and caffeine using 30% methanol, phosphoric acid solution, and acetonitrile-containing phosphoric acid and analyzed them at 330 and 280 nm, respectively, using liquid chromatography. Our analysis validation results yielded a correlation coefficient (R²) revealing a significance level of at least 0.999 within the linear quantitative range. The chlorogenic acid and caffeine detection and quantification limits were 0.5 and 0.2 ㎍/mL and 1.4, and 0.4 ㎍/mL, respectively. We confirmed that the precision and accuracy results were suitable using the AOAC validation guidelines. Finally, we developed a simultaneous chlorogenic acid and caffeine analysis approach. In addition, we confirmed that our analysis approach could simultaneously quantify chlorogenic acid and caffeine by examining the applicability of each formulation through prototypes and distribution products. In conclusion, the results of this study demonstrated that the standardized analysis would expectably increase chlorogenic acidcontaining health functional food quality control reliability.