• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1998년도 제50차 추계 학술대회 연제집
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• pp.82-83
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• 1998

• 식품과학과 산업
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• 제41권2호
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• pp.5-15
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• 2008

• 한국임상약학회지
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• 제16권2호
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• 보건행정학회지
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• 제21권1호
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• pp.132-157
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• 2011

The purpose of this article is to examine the cause of policy non-compliance in the case of pharmaceutical rebates from the perspective of rational choice institutionalism. In Korea, there have been rebates practices between pharmaceutical companies and hospitals since the introduction of the Actual Remuneration System for insured medicine in 1999. The government has chosen the policy means of punishment to eliminate pharmaceutical rebates but the illegal practices are still widespread. Institution in rational choice institutionalism usually reflects the incentives and preferences of actors, and the Actual Remuneration System has resulted in a the lack of procedures to ensure savings on drug expenditures. Pharmaceutical rebates are the product of the institutions which reflect their incentives: the Actual Remuneration System, the current pricing policy for generic drugs, the drug distribution system, and so on. In the end, the problem of the rebates is the consequence of policy non-compliance as actors' rational choice because their incentives lead to opportunistic behaviors. We should therefore understand the incentive structure of policy stakeholders, which is derived from the view of new institutionalism; also, the newly designed Korean drug pricing policy reform must be compatible with the incentive structure.

• 대한치주과학회:학술대회논문집
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• 대한치주과학회 2005년도 제45회 종합학술대회 연제초록
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• pp.9-9
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• 2005

• 식품산업과 영양
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• 제10권1호
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• pp.1-5
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• 2005

• 분석과학
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• 제36권6호
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• pp.281-290
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• 2023

Zidovudine is an antiretroviral agent prescribed for the prevention and treatment of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). It is typically recommended to be used in combination with other antiretroviral drugs. Zidovudine has the potential to generate N-nitrosodimethylamine (NDMA) in the presence of dimethylamine and nitrite salt under acidic reaction conditions during the drug manufacturing process. NDMA is a potent human carcinogen that may be detected in drug substances or drug products. An analytical method was developed to determine NDMA in pharmaceuticals including zidovudine using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The analysis involved reversed-phase chromatography on a Kinetex F5 column with a mobile phase comprising water-acetonitrile mixtures. The detection of positively charged ions was conducted using atmospheric pressure chemical ionization (APCI). The calibration curve demonstrated excellent linearity (r = 0.9997) across the range of 1-50 ng/mL with a highly sensitive limit of detection (LOD) at 0.3 ng/mL. The developed method underwent thorough validation for specificity, linearity, accuracy, precision, robustness, and system suitability. This sensitive and specific analytical method was applied for detecting NDMA in zidovudine drug substance and its formulation currently available in the market, indicating its suitability for drug quality management purposes.

• 한국컴퓨터정보학회:학술대회논문집
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• 한국컴퓨터정보학회 2014년도 제49차 동계학술대회논문집 22권1호
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• pp.185-188
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• 2014

본 연구는 자재업체부터 마약류 생산 제약사 도매업체(물류) 대형병원까지의 전체 프로세스에 RFID 시스템을 구축하여 마약류의 도난 및 오남용을 방지하여 국민의 보건안전 및 의약품 관리강화를 도모하는 것으로 현재까지 기 구축된 제약사들의 RFID 시스템에서 기술적으로 고도화시킬 수 있는 방안을 도출하여 최적화된 현장적응형 RFID 서비스를 제공하고자 하는데 그 목적이 있다. 본 연구를 통하여 제약산업 내 제약사 도매업체 대형종합병원 의원에 대한 RFID 도입표준모델을 제시하고 Supply Chain의 유통 투명화를 위한 정보시스템 도입의 기반을 마련함으로써 제약산업 내 참여주체들간의 정보 신뢰성 제고는 물론 철저한 의약품 유통관리로 인한 건전한 의약품 소비문화를 정착시킬 수 있다.

• 한국임상약학회지
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• 제31권2호
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• pp.104-114
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• 2021

Objective: To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. Methods: We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. Results: Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. Conclusion: We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.

• Safe Food
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• 제3권4호
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• pp.18-25
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• 2008