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식품의약품안전청의 의약품안전사용정보방 웹사이트 구축을 위한 컨텐츠 개발
지은희(Eunhee Ji),박효영(Hyo Yung Park),노혜진(Hyejin Noh),이동은(Dong Eun Lee),한나영(Nayoung Han),정소현(Sohyun Jeong),김인화(In-Wha Kim),신완균(Wan Gyoon Shin),오정미(Jung Mi Oh) 대한약학회 2012 약학회지 Vol.56 No.3
The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman’s terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA’s ongoing initiative to address and promote the safe use of medications for the public.
강민구,강민정,지은희,유봉규,Kang, Min Gu,Kang, Min Jung,Ji, Eunhee,Yoo, Bong Kyu Korean College Of Clinical Pharmacy 2017 한국임상약학회지 Vol.27 No.3
Background: Recently, a fixed combination of grazoprevir and elbasvir (GE) has been introduced to the arsenal of chemotherapeutics to fight against this virus. The study aimed to provide information on the efficacy and safety of GE for the treatment of HCV infection by performing a meta-analysis of literature data. Methods: PubMed and EMBASE database searches were conducted. Among the literature retrieved, pivotal Phase III clinical studies were analyzed. Statistical analysis of the data was performed by RevMan. Results: Four pivotal Phase III clinical studies compared the efficacy and safety of GE. When HCV patients were treated with GE for 12 weeks, the sustained virologic response, defined as the viral RNA level below the lower limit of quantification at 12 weeks after the cessation of therapy (SVR12), was 94.7%. The clinical advantage of GE involves its use by patients with cirrhosis and/or renal failure without dose adjustment. If the genotype (GT) of the causative virus was GT1a with NS5A polymorphism or GT4 with resistance to peginterferon/ribavirin, treatment with GE plus ribavirin for 16 weeks resulted in a better outcome compared to treatment with GE alone for 12 weeks. Adverse events reported during the four clinical studies were 71.09% in the GE arms and it was 76.61% in the non-GE arms, with the most frequent events being mild central nervous system symptoms. Conclusion: GE was generally safe and effective for the treatment of HCV infection. However, since HCV mutates very rapidly and becomes resistant to antiviral agents, long-term monitoring should be mandatory.
다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석
송윤경,손민지,전아영,김재현,지은희,오정미,김인화,Song, Yun-Kyoung,Sohn, Minji,Jeon, Ah Young,Kim, Jae Hyun,Ji, Eunhee,Oh, Jung Mi,Kim, In-Wha 한국임상약학회 2018 한국임상약학회지 Vol.28 No.2
Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.
Levosulpiride 복용 이후 발생한 고프로락틴혈증 및 그 인과성 분석: 지역약국에서 보고된 부작용 증례
이희영,조유진,윤중식,지은희,Lee, Heeyoung,Jo, Yu Jin,Yoon, Joong Sik,Ji, Eunhee 한국임상약학회 2018 한국임상약학회지 Vol.28 No.2
Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as "possible" by the WHO-UMC and Naranjo scales, but as "probable" by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.