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약료서비스 R&D 고도화를 위한 우선순위 기반 전략과제 설정

한나영, 정채린, 송윤경, 윤정현, 장선미, 이의경, 신현택, 이영숙, 손현순, 지은희, 서동철, 김대경, 오정미

한국임상약학회 한국임상약학회지 제29권 제1호 2019.03 pp.45-55

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Background: Although the importance of pharmaceutical care service has been growing to meet the needs of customers with the improvement of clinical and humanistic outcomes, there was not a systematic strategy to promote research in Korea. The aim of this study was to suggest the core agendas for pharmaceutical care services research and development (R&D) considering priorities. Methods: Based on desk researches, we developed R&D agendas for the needs of improving pharmaceutical care services in the area of institution, community, and public health. To determine the priority of agendas in developing pharmaceutical care service, analytic hierarchy process (AHP) analysis was performed by the 14 experts. Criteria and subcriteria were assessed for significance by pairwise comparisons. Then, agendas were evaluated for importance according to each subcriteria, and rank ordered considering the weight calculated by multiplying the importance scores of the criteria and the subcriteria. Results: We derived 25 agendas including 13 for institutional pharmaceutical care service, 8 for community pharmaceutical care service, and 4 for publichealth related pharmaceutical care service. AHP model was constructed based on 4 criteria and 8 subcriteria by a hierarchical structure. From the AHP survey, the ‘Development of pharmaceutical care service for metabolic and chronic disease’ agenda accounted for the highest priority. Conclusion: We have developed the R&D agendas of the pharmaceutical care service which should be promoted. The results should be utilized by the government to nationally support the development of the standards and relevant regulations related to pharmaceutical care services in Korea.



신장이식 면역억제요법 가이드라인 개발을 위한 권고안 적용 범위 및 핵심질문 선정

허승연, 한나영, 손민지, 류정화, 양재석, 오정미

한국임상약학회 한국임상약학회지 제29권 제1호 2019.03 pp.18-24

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Background: Although a growing number of guidelines and clinical researches are available for immunosuppressive treatment of post-transplantation, there is no clinical practice guideline for the care of kidney transplant recipients in Korea. Selection of a researchable question is the most important step in conducting qualified guideline development. Thus, we aimed to formulate key questions for Korean guideline to aid clinical decision-making for immunosuppressive treatment. Methods: Based on previous published guidelines review, a first survey was constructed with 29 questions in the range of immunosuppressive treatments. The experts were asked to rate the clinical importance of the question using a 5-point Likert scale. The questions reached 60% or more from the first survey and additional new questions were included in the second survey. In analyzing the responses to items rated on the 9-point scale, consensus agreement on each question was defined as 75% or more of experts rating 7 to 9. Results: In the first survey, 50 experts were included. Among the 29 questions, 27 were derived to get 60% or more importance and 3 new questions were additionally identified. Through the second survey, 9 questions were selected that experts reached consensus on 75% and over of the options. Finally, we developed key questions using PICO (patient, intervention, comparison, and outcome) methodology. Conclusion: The experts reached a high level of consensus on many of key questions in the survey. Final key questions provide direction for developing clinical practice guideline in the immunosuppressive treatment of transplantation.



Tumor Necrosis Factor-alpha 저해제가 결핵 발생에 미치는 영향

박현진, 최보윤, 손민지, 한나영, 김인화, 오정미

한국임상약학회 한국임상약학회지 제28권 제4호 2018.12 pp.333-341

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Objective: Tumor necrosis factor-alpha (TNF-alpha) inhibitors are used as a treatment in various immune-mediated inflammatory diseases (IMIDs). Tuberculosis (TB) risk is reported in several meta-analyses in patients treated with TNF-alpha inhibitors. The purpose of this study is to collect, review, and evaluate the TB risk in TNF-alpha inhibitors according to IMIDs indications and between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors. Methods: A systematic literature search on systematic reviews and meta-analyses was performed in PubMed, MEDLINE, Cochrane library, and EMBASE. We identified meta-analyses that evaluated TB infection risk of TNF-alpha inhibitors in IMIDs patients. Results: Thirteen meta-analyses including 41 study results were included in this umbrella review. IMIDs patients treated with TNF-alpha inhibitors had an increased risk of TB than control group (placebo with or without standard therapy patients) (relative risk ratio (RR) 2.057, 95% confidence interval (CI) 1.697 to 2.495). Among them, RA patients with TNF-alpha inhibitors had a higher risk of TB than control group (RR 1.847, 95% CI 1.385 to 2.464), and non-RA patients with TNF-alpha inhibitors had an increased risk of TB (RR 2.236, 95% CI 1.284 to 3.894). In subgroup analysis on TB risk between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors in RA patients, the analysis indicated that monoclonal-antibody TNF-alpha inhibitors had higher risk of TB than solublereceptor TNF-alpha inhibitor (RR 2.880, 95% CI 1.730 to 4.792). Conclusion: This umbrella review confirms that the risk of TB is significantly increased in TNF-alpha inhibitor treated patients compared to control group.



다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석

송윤경, 손민지, 전아영, 김재현, 지은희, 오정미, 김인화

한국임상약학회 한국임상약학회지 제28권 제2호 2018.06 pp.146-153

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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.



설화의 문화교육 ‘효과’에 관한 연구 - 유학생을 대상으로 -


한국언어문화교육학회 언어와 문화 제14권 1호 2018.02 pp.157-173

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This study suggested specific and definite results regarding the effects of cultural education as unfolded through folk tales. To date, there have been many discussions regarding the goals and plans of folk tale-based cultural education. Compared to studies on cultural education with accumulated folk tales, however, it is difficult to find a study on its specific educational effects. In other words, there hasn’t been any qualitative study on the effects of cultural education. To test educational effects, this study attempted to derive specific and actual results as much as possible, using the outcome called ‘learners writing’. First, cultural keywords were presented to international students for the 1st writing. Then, cultural education was given through folk tales, and 2nd writing (i.e., cultural writing) was conducted. After that, the effects of cultural education through folk tales were confirmed by comparing the 1st writing to cultural writing. According to cultural writing on ‘family culture’ through the folk tale ‘the Heavenly Fairy and the Woodcutter’, three cultural education effects were confirmed as follows: First, a broad understanding of modernity and traditional culture was found. The folk tale was helpful for international students, who are more familiar with modern culture only, to have a better understanding of traditional culture, especially value oriented culture. Second, an understanding of Korean culture from a multicultural education standpoint was confirmed. In fact, this cultural education process allowed students to have an open view of diverse cultures, not just providing simple information. Lastly, narration-based cultural education was found. A cultural education that criticizes one-way communication was provided. According to the analysis of the effects of cultural education provided through folk tales, the potential and value of cultural education that folk tales can provide were confirmed.



국내 청각장애인의 의약품 안전사용 실태에 대한 심층면접조사

김혜로, 구희조, 오정미, 한은아

한국임상약학회 한국임상약학회지 제27권 제3호 2017.09 pp.178-185

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Objective: Because of communication difficulties, the hearing-impaired face many disadvantages throughout their lives. One of those is limited access to health care services, particularly medication service. Though they suffer from problems related to taking medication properly, there have been few studies on their actual condition of medication use in Korea. This study is to investigate any obstacles to properly taking medications and, therefore, to suggest preliminary evidence for policy measures to improve safe medication use among the hearing-impaired. Methods: Study participants consisted of hearing-impaired individuals living in Seoul. We also interviewed two sign language interpreters in order to illuminate health care state of the hearing- impaired. In-depth interview for each study participant was recorded and was translated into a written script for analysis. Results: Study participants were comprised of four women (66.6%) and two men (33.3%). There were one participants in 20's, two participants in 30's, one 40's, and two 50's. Sign language interpreters were all women. One was in her 30's and the other was in her 40's. Communication difficulties have been found to be key barrier to use medication safely. A negative image of pharmacists also hinders safe medication usage, lowering access to local pharmacy and leading discretional self-medication. This article provides pharmacists with solutions to promote adherence in this population. Conclusion: The hearing-impaired had limited access to medication-related information as well as using services in a hospital and local pharmacy due to their disability. Institutional improvement for safe medication usage among the hearing-impaired is necessary.



약사국가고시 실기시험 영역 선별을 위한 전문가 조사

한나영, 이주연, 곽혜선, 이병구, 이영숙, 이숙향, 용철순, 김주희, 오정미

한국임상약학회 한국임상약학회지 제27권 제3호 2017.09 pp.119-126

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Background: As the demands of pharmacist's role and quality performance have increased, the verification of pharmacist's abilityhas been required. In this study, we aimed to select appropriate items for assessment of pharmacist’s knowledge, attitude andperformance. Methods: Based on the pharmacist job analysis, we selected duties and tasks in consideration of applying pharmacypractical examination through brainstorming of internal researchers and group discussion with experts. Survey was conducted toevaluate the tasks according to the criteria detailed below: Realistic, Understandable, Measurable, Behavioral and Achievable(RUMBA). The subjects included professors at colleges of pharmacy and instructors of institutional or community pharmacy settings. Results: Nine duties including 41 tasks were drawn for the survey through primary internal researchers. Of the 90 respondents,95.6% were professors or preceptors who was engaged in practical training, and 62.2% had more than five years of practicalexperience. As a result of survey and discussion with expert panel, selected seven duties were selected as followings: ‘Patient(customer) reception’, ‘Drug preparation and distribution’, ‘Patient care’, ‘Administration’, ‘Patient counseling’, ‘Non-prescriptionmedication counseling’, and ‘Provision of drug information’. The final 20 tasks from seven duties were chosen to assess skills thata pharmacist should be able to perform. Conclusion: This is the first study to select the items that can be included in pharmacistpractical examination in the future, based on the RUMBA criteria. As a next step, it is necessary to study how to implememt these items.



중동호흡기증후군(MERS) 발생관련 전국 약학대학의 실무실습교육 대응현황

최경희, 최경숙, 이영숙, 김재연, 정경혜, 오정미, 최경업, 나현오, 김은경

한국임상약학회 한국임상약학회지 제27권 제1호 2016.12 pp.9-14

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Background: Pharmacy curriculum change was made from a 4-year program to a 2+4 year program in year 2009 in Korea. The change has resulted in more educational exposures on patient-centered practice environments for about 1,400 hours in the last year of the professional pharmacy program. When the Middle East Respiratory Syndrome (MERS) outbreak hit Seoul and suburban areas and propagated to other provinces in Korea, emergency response to avoid student infection in the pharmacy practice sites became an urgent issue. While other health professional programs such as medicine and nursing had activated emergency preparedness manuals, timely and clear guidelines were not disseminated to all pharmacy programs and protective measures largely relied on individual pharmacy program. Methods: A survey was developed by the Committee on Pharmacy Practice Experience Programs in the Korean College of Clinical Pharmacy to document the status of pharmacy programs during the Korea MERS outbreak in 2015. The 10-question survey was distributed to the pharmacy practice experience coordinators to 34 out of 35 pharmacy schools in Korea by emails. Results: Our findings showed that 82.4% of the program coordinators (28/34) responded to the survey, 96.4% of the programs did not have emergency preparedness manuals, administrative meetings were held in 89.3% of the pharmacy programs, the rotation schedules were modified or withheld in 53.6% of schools, and the changes were mostly observed from the programs classified as MERS outbreak regions. Conclusion: Further needs in establishing the emergency preparedness manual should be explored for pharmacy education stakeholders.



미네랄 골질환 합병증을 가진 투석환자에서 다학제 팀 서비스의 임상적 성과

한나영, 이상민, 홍진이, 노혜진, 지은희, 송윤경, 송지윤, 김인화, 김연수, 오정미

한국임상약학회 한국임상약학회지 제26권 제4호 2016.12 pp.318-323

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Background: Multidisciplinary team care (MTC) is a collaborative approach to treatment plan and ongoing care. We aimed to evaluate the clinical effect of MTC on the regulation of chronic kidney disease-mineral and bone disorder (CKD-MBD) complications in dialysis patients. Methods: This retrospective observational study was approved by the institutional review board. Among patients who have undergone dialysis at admission, the patients admitted to the nephrology ward were allocated to MTC group, and the others to usual care (UC) group. The MTC group had collaborative care by nephrologists, nurses, pharmacists, and nutritionists. The endpoints were the regulation of corrected calcium (cCa) and phosphate (P), the percent of patients in target level of cCa-P product (cCa×P), and the prescription rate of non-calcium based P-binders. Results: A total of 163 patients were included from January to December 2009. A significant difference was shown in the percentage of patients in target cCa×P level at admission (MTC vs. UC, 81.40% vs. 91.67%; P = 0.038), but there was no significant difference at discharge. During admission, the cCa and P levels of patients in only UC group were significantly changed. In addition, compared with UC group, patients in MTC group were more likely prescribed appropriate P-binders, when they had higher cCa×P levels than 55 mg2/dL2 (P <0.001). Conclusion: It was found that MTC had beneficial effect on improving the regulation of CKD-MBD and the appropriate phosphate binder uses. Therefore, application of the MTC is anticipated to enhance quality of clinical care in chronic diseases.



MICE 개최지 방문위험지각 세분화에 따른 방문전환행동, 만족도 및 충성도 차이연구

김은진, 유현경, 윤유식, 오정미

관광경영학회 관광경영연구 제20권 제6호 통권 73호 2016.11 pp.89-107

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This study aims to segment perceived risks of MICE destination and to analyze if there are differences among segmented groups in terms of MICE destination switching behavior, visiting satisfaction and loyalty. MICE industry has been grown and expected to expand more in the future. In order to effectively attract and manage MICE industry, it is important to understand what risks affect MICE destination choices and decision. From the literature review, the measurement of perceived risks of MICE destination have been developed and measured from on-site survey. Factor and cluster analysis with perceived risks were conducted and showed five underlying dimensions of perceived risks(function, time consumption, physical and environmental, social and psychological, economical risk) and three different segmented groups(highly, moderate, low perceived risk group). MANOVA analysis showed that there were differences among segmented groups in terms of visiting satisfaction and loyalty.



국내 시각장애인의 의약품 안전사용 실태에 대한 심층면접조사

구희조, 장선미, 오정미, 한나영, 한은아

한국임상약학회 한국임상약학회지 제26권 제1호 2016.03 pp.24-32

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Objective: The visually impaired have limited access to health care services and related information, and thus, they can have serious hurdles against properly taking medications. Despite that it is important to improve self-care ability of the visually impaired for correct medication use, there have been few studies investigating their needs for health care services in Korea, particularly focusing on proper medication usage. This study is to explore safety-related issues regarding mediation usage among the visually impaired based on in-depth interview. We particularly focus on any obstacles for safe use of medicines including experience on medication-related adverse effects in order to provide preliminary evidence for policy measures to improve proper medication use among the visually impaired. Methods: Study sample was visually impaired individuals who resided in Seoul area and were registered in the National Association of Visually Impaired. The association helped the process of recruiting the study participants. In-depth interview for each study participants was conducted. Each interview was recorded and later converted into a written script to extract core contents for the analysis. Results: The study participants comprised of three women (42.9%) and four men (57.1%). One was in his 20's, and there were four participants in 30's and two in 40's. Fully impaired participants were majority (5 out of 7). Limitation to physical access to health care providers and health information were the key factors to hamper safe medication utilization among the study participants. Difficulty reading medication information and may take the wrong medication or incorrect doses of medication, resulting in serious consequences, including overdose or inadequate treatment of health problems. Visually impaired patients report increased anxiety related to medication management and must rely on others to obtain necessary drug information. Pharmacists have a unique opportunity to pursue accurate medication adherence in this special population. This article reviews literature illustrating how severe medication mismanagement can occur in the visually impaired elderly and presents resources and solutions for pharmacists to take a larger role in adherence management in this population. Conclusion: The visually impaired had difficulties reading medication information and identifying medicines, and took incorrect doses of medications. Public support for safe medication use and medication management among the visually impaired is necessary.



문헌자료 고찰을 통한 우리나라 약국서비스 시행 현황

손현순, 김효정, 박혜경, 한나영, 오정미, 지은희

한국임상약학회 한국임상약학회지 제25권 제1호 2015.03 pp.18-26

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Background: The recent change in pharmaceutical education system following the paradigm shift to patient-oriented pharmacy service requires an in-depth discussion to reorganize a future direction and establish a basis for maximizing social values of community pharmacy service. Objective: This study was conducted to review the current status of community pharmacy service provision in Korea based on published literatures. Methods: The electronic databases of National Digital Science Library and Electronic National Assembly Library were used to search the journal articles and dissertation papers. A search term "community pharmacy" was used and the published period was limited to papers published after year 2001, when the legal separation of prescribing and dispensing was implemented. Relevant study reports were also searched manually. Information about pharmacy service provision and study outcomes were retrieved from the selected papers, and classified by predefined individual service scope. Results: A total 33 papers reporting services provided by community pharmacies were selected (journal article 11, dissertation paper 17, and study report 5). Pharmacy services identified in these papers could be classified into prescription dispensing service, pharmaceutical care service, self medication service, other products service, and health promotion service. Twenty papers reported prescription dispensing services, three papers reported pharmaceutical care service, and only two papers reported health promotion service. Current community pharmacy services are highly dependent on prescription drugs while expanded services such as pharmaceutical care and health promotion are peripheral. Most prevalent research topic was medication counseling service (18 papers), reflecting that community pharmacists generally consider it to be the most important and fundamental service. Overall, current pharmacy services are very limited and focus on prescription dispensing service. Conclusion: At this point of time requiring expansion and quality improvement of community pharmacy services, we suggest further lively discussion to strengthen pharmacist's functional identity and set conditions for providing socially expected services.



고중성지방혈증에서 fenofibrate에 대한 acipimox의 효과 비교

김승미, 지은희, 김현아, 한나영, 심미경, 신완균, 오정미

한국임상약학회 한국임상약학회지 제22권 제3호 2012.09 pp.195-201

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목적: 이상지방혈증 환자의 치료는 우선적으로 저밀도지단백을 감소시키고, 저밀도지단백이 목표수치에 도달한 이후 에 도 혈중 중성지방이 높을 경우 nicotinic acid 또는 fibrate를 사용하도록 권장되고 있다. 본 연구는 이상지방혈증이 있는 환자에서 acipimox의 효과를 fenofibrate와 비교하여 분석하고자 시행되었다. 방법: 본 연구는 서울에 있는 한 3차 대학병원의 환자를 대상으로 후향적으로 의무기록을 분석하여 시행되었다. 혈 중 중성지방 농도가 200 mg/dL 이상으로써 acipimox 또는 fenofibrate를 신규처방 받은 환자를 대상으로 각각의 약 물이 지단백에 미치는 영향을 36주간 추적하여 비교분석 하였다. 결과: Acipimox를 투여 받은 환자 41명, fenofibrate를 투여 받은 환자 62명이 모집되었으며, 각각의 약물을 복용한 환자군의 기본적인 인구학적인 특성은 유의하게 상이하지 않았다. 3개월 간의 약물투여 후 두 약물군 환자 모두에서 총콜레스테롤(p < 0.05) 및 저밀도지단백(p < 0.001)이 약물투여 전과 비교하였을 때 유의하게 감소하였고, 고밀도지 단 백은 모든 환자에서 유의하게 증가하였다(p < 0.05). 한편 중성지방 감소율은 acipimox군이 fenofibrate군에서보다 더 크게 나타났다(p < 0.05). 약물유해반응의 빈도는 두 약물군 간에 유의한 차이가 없었다. 결론: 총콜레스테롤, 저밀도지단백 콜레스테롤 등을 감소시키거나 고밀도지단백 콜레스테롤을 증가시키는 효과는 acipimox와 fenofibrate가 유의하게 다르지 않았으며, 중성지방을 감소시키는 효과는 acipimox가 fenofibrate보다 우 월 하였다.



결혼이주여성을 위한 문화교육과 문화적응 - 설화 <시부모 길들인 며느리>를 중심으로


국제한국언어문화학회 한국언어문화학 제9권 제1호 2012.06 pp.153-172

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이 논문에서는 현재의 문화교육이 동화와 통합유형의 방향으로 제한되어 있다는 점에 주목하여, 제 3의 문화교육의 방향으로 ‘변혁유형’의 문화교육을 제시하였다. 변혁유형의 문화교육은 기존의 정주자 중심의 문화교육과 달리 이주자 중심의 문화교육으로 이주자가 정주문화를 새롭게 변화 및 발전시키는 방향이다. 그래서 이주자는 동화와 통합보다도 더욱 강한 주체성과 정주자와의 성공적인 소통을 해야 하는데, 그만큼 변혁유형의 문화적응은 현실 속에서 실현되기 쉽지 않다. 그러나 변혁유형의 문화적응이 실현되기 어렵다고 해서 문화교육적 가치가 없는 것은 아니다. 오히려 문화교육적인 측면에서 변혁유형은 21세기 다문화사회에 반드시 제시되어야 할 방향으로, 이주자와 정주자 모두에게 유의미한 문화교육적 의미를 가지게 된다. 설화 <시부모 길들인 며느리>에서 이주자인 며느리는 지혜와 폭력이라는 주체성과 소통의 상징적인 행동들을 통해 시부모를 변화시키며 함께 잘 살아갔다. 실제로 오래 전부터 전승되어 온 설화 속에서 변혁유형의 문화적응을 하는 이주자를 만날 수 있었고, 변혁유형의 문화적응이 허상이 아님을 알 수 있었다. 즉 설화 속 며느리는 우리가 기대하는 순응과 합의 형태의 시집에서의 적응이 아닌 변혁이란 새로운 형태의 문화적응을 보여주고 있었다. 지금까지 제시된 문화교육과 달리 변혁유형의 문화교육은 이주자에 대한 새로운 시각과 공존을 제시해 줄 것이다. 변혁유형의 문화교육을 통해 더욱 건강한 다문화사회를 기대해 본다.
Culture education should be intended to reject conformity and pursue diversity depending on the learners’ patterns of behavior and attitude in multicultural society. Conventionally the assimilation and the integration model have been discussed for culture education but it’s not enough to cover diversity for the learners. This study has value in suggesting new approach to culture education with the revolution model which can be defined as a type of acculturation more oriented to immigrant culture because in the revolution model, immigrants have successfully changed and affected resident culture with their strong identity and communication. Hence the revolution model in culture education has meanings as follows ; firstly, the conventional model has limitation of one way education, in contrast the revolution model is mutual education between teachers and learners. Secondly, object for culture education was changed from only the immigrants to the residents and the immigrants together. To support revolution model, folktale <a daughter-in-law who tames a mother-in-law> was selected. To talk about multicultural society, culture diversity should be discussed and established. To do that, new model such as revolution was induced from folktales that have well reflected our traditional life style and this study will give guide line how to approach to culture education in multicultural society.



소비자의 의약품안전성 인식정도 및 관련정보 획득경로

지은희, 김수경, 오정미, 이숙향

한국임상약학회 한국임상약학회지 제21권 제4호 2011.12 pp.311-318

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Misinformation and inappropriate use of medication has become one of the most pressing concerns in drug safety. The purpose of this study was to survey public perception on drug safety as well as the channels most relied upon providing such information. The survey was performed for patients or their families visiting pharmacies in a local city in Korea. Analysis was performed from 367 respondents to the survey. The contents of this survey revealed that consumers were aware of the fact that medications should not be taken at any higher dosage or more often than directed by their prescriptions. The survey revealed a general awareness that symptoms might not be relieved immediately by their medications. However, the perception that there could be adverse drug reaction (ADR) at therapeutic dose was low except among the young or highly educated members. Respondents recognized that skin rashes were the most whereas drowsiness was the least common ADR symptom. There was a high awareness of drug-food or drug-drug interactions except in the case of certain nutraceuticals. Doctors and pharmacists were ranked as the most reliable resources to the consumer for providing drug related information. However, public relations or education programs were in need since there were still not negligible numbers of consumers depending on personal experience rather than health professionals.



효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안

이상민, 최보윤, 윤휘열, 전다혜, 김명규, 하지혜, 김영훈, 지은희, 강원구, 한나영, 신완균, 오정미

한국임상약학회 한국임상약학회지 제21권 제4호 2011.12 pp.339-346

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Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.



의약분업 이후 의원 및 약국에서의 항생제 사용 실태

송윤경, 이현경, 지은희, 오정미

한국임상약학회 한국임상약학회지 제21권 제4호 2011.12 pp.332-338

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This study aimed to investigate the prescription of antibiotics in clinics, and evaluate their usage appropriateness after the 2000 Korean separation of dispensary from medical practice. A retrospective study was performed on the antibiotic use for 4 years from August 2000 to July 2004 in three clinics (general, internal medicine and ear-nose-and-throat (ENT) clinics). Moreover, prescription of antibiotics for acute upper respiratory infection (AURI), concomitant drugs, duplicate antibiotics and patient adherence were assessed for 260 patients experienced AURI in a pharmacy. The prescription rates of antibiotics amongst the whole prescription decreased annually during the study period, but those in ENT clinic still constituted more than 90%. The usage of penicillins declined, but that of broad spectrum antibiotics such as amoxicillin/clavulanic acid and 1st/2nd generation cephalosporins increased. Moreover, the categories of antibiotics for the same indication were different among the clinics. For patients with AURI, the more antibiotics were prescribed as its missing days and days under its therapeutic dose increased. The drug interactions with concomitant drugs decreased annually, but the use of duplicate antibiotics was similar across the period. Potential inappropriate antibiotic use was common after the Korean policy, so the observation of pharmacists needs in addition to the patients and practitioners’ attention.



한국인 성인 환자를 대상으로 한 1일 1회 요법 아미카신의 약물동태학

김혜경, 안보숙, 지은희, 오정미

한국임상약학회 한국임상약학회지 제21권 제3호 2011.09 pp.208-214

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목적:이 연구의 목적은 한국인 성인 환자를 대상으로 아미카신 1일 1회 요법을 시행하였을 때의 약동학적 파라미터를 평가하고, 신기능에 따른 아미카신의 약동학적 파라미터를 비교함으로써 최적의 개인화 약물요법을 설계할 수 있도록 하는 것이다. 방법:그람 음성균 감염에 대해 1일 1회 요법으로 아미카신을 투여 받았던 353명의 한국 성인 환자를 대상으로 항정상태에서 아미카신의 농도를 2회(약물 투여 전 1시간 이내, 약물투여 종료 후 0.5~1시간 이내) 측정하였다. 각 환자의 약동학적 파라미터(분포용적, 청소율, 반감기) 및 혈중 최고 농도, 최저 농도는 환자의 나이, 체중, 신장, 성별, 혈중 크레아티닌 농도, 투여된 약물용량, 측정된 약물의 혈중농도, 감염의 종류 등을 감안하여 산출하였다. 크레아티닌 청소율에 따라 환자를 4군으로 분류하여 아미카신의 약동학적 파라미터를 비교분석하였다. 결과:본 연구에서 아미카신 혈중 최저, 최고 농도의 평균 ± 표준편차는 각각 1.14±1.95 mg/L, 26.35±9.28 mg/L이며, 청소율, 분포용적, 및 반감기의 평균 ± 표준편차는 각각 55.40±23.72 mL/hr/kg, 0.35±0.12 L/kg, 그리고 5.22 ±3.34 hrs로 산출되었다. 크레아티닌 청소율에 따른 아미카신의 청소율, 분포용적 및 반감기의 유의한 차이가 관찰되었다. 종합적으로 아미카신의 혈중 최저 농도는 크레아티닌 청소율이 40 mL/min 미만인 경우 40 mL/min 이상인 경우에 비해 유의하게 증가하였다. 결론: 아미카신의 약동학적 파라미터들은 신기능에 따라 유의한 차이가 있으므로 최적의 치료효과를 위해서는 환자의 크레아티닌 청소율에 따른 개인화 약물요법이 필요하다.


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