• Title/Summary/Keyword: Drug policy

검색결과 364건 처리시간 0.022초

생물학적동등성 인정 제네릭의약품에 대한 인식도 분석 (Analysis of Perception on the Bioequivalence-assured Generic Drugs)

  • 이의경;김동숙
    • 한국임상약학회지
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    • 제16권2호
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    • pp.139-146
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    • 2006
  • Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

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Influence of R&D intensity on Innovation Performance in the Korean Pharmaceutical Industry: Focusing on the Moderating Effects of R&D Collaboration

  • 김대중;엄기용
    • 지식경영연구
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    • 제19권3호
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    • pp.189-223
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    • 2018
  • This paper examined the effect of innovation networks comprising research and development (R&D) collaboration on innovation performance of Korean pharmaceutical firms. As co-assigned patents and co-affiliated publications are common technical outcomes of successful R&D collaboration in the pharmaceutical industry, social network analysis technique was applied for analyzing innovation networks through patent and publication data. Results of Social network analysis indicated that a small set of highly innovative firms in the Korean pharmaceutical industry were actively involved in patenting and publishing. And the analysis of structural equation model found the followings: (1) R&D intensity significantly affected patenting, publication and new drug development, (2) the activity of patenting and publishing was positively related with the innovation performance measured by new drug development, and (3) R&D collaboration in terms of degree centrality of co-patent network played significant moderating roles on the relationships among R&D intensity, patenting, and new drug development. These findings are expected to be helpful to researchers as well as policy-makers to devise innovation-promoting policies in the Korean pharmaceutical industry. Discussions and limitations of the study are provided in the last part.

폐렴원인균으로서 약제내성 폐렴사슬알균 ($Drug-resistant$ $Streptococcus$ $pneumoniae$)의 현황과 임상적 의미 (Clinical Implications of Drug-Resistant $Streptococcus$ $pneumoniae$ as a Cause of Community Acquired Pneumonia)

  • 신경철
    • Journal of Yeungnam Medical Science
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    • 제28권1호
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    • pp.13-19
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    • 2011
  • The emergence of antibiotic-resistant pathogens is a Serious clinical problem in the treatment of infectious diseases that increase mortality, morbidity, hospitalization length, and the cost of healthcare. In particular, $Streptococcus$ $pneumoniae$ is a major etiologic pathogen of pneumonia, sinusitis, otitis media, and meningitis. As the definition of penicillin resistance to $S.$ $pneumoniae$ was recently changed, macrolide-resistant $S.$ $pneumoniae$ is a major resistant pathogen in the community. Infections caused by antibiotic-resistant strains are associated with incorrect use of antibiotics and critical clinical outcomes. For the appropriate use of antibiotics to treat infections, physicians always should have up-to-date information on the current epidemiologic status of antibiotic resistance for common pathogens and their susceptibility to antimicrobials. Appropriate selection of antimicrobials, strict control of infection, vaccination, and development of a feasible national policy of infection control are important strategies for the control of antimicrobial resistance. This review article focuses on the current status of antibiotic-resistant $S.$ $pneumoniae$ in community-acquired pneumonia in Korea.

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환자의 신약 접근성 강화 정책 제안 (Policy Suggestions to Improve Patient Access to New Drugs in Korea)

  • 최유나;이형기
    • 한국임상약학회지
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    • 제31권1호
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    • pp.1-11
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    • 2021
  • Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

LC-MS/MS를 이용한 한국에서 유통되는 농산물의 잔류 농약 평가 (Evaluation of Residual Pesticides in Commercial Agricultural Products Using LC-MS/MS in Korea)

  • 이화미;허수정;이현숙;박승영;김남선;신용우;최근화;김성일;남슬이;조대현
    • 한국식품과학회지
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    • 제45권4호
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    • pp.391-402
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    • 2013
  • 본 연구에서 한국 유통 농산물 17품목(쌀, 사과, 배, 오렌지, 복숭아, 딸기, 바나나, 파인애플, 포도, 키위, 수박, 토마토, 오이, 호박, 참외, 깻잎, 상추 등)을 대상으로 다성분 분석농약 60종을 분석하기 위하여 대상농산물의 대분류별로 곡류에서는 현미, 두류는 메주콩, 과실류에서는 감귤, 채소류는 고추, 서류에서는 감자, 버섯류에서는 느타리버섯을 선정하여 회수율 실험을 수행하였다. 60% 이상의 낮은 회수율을 나타내는 성분 중 fluquinconazole, methomyl은 4가지 이상의 농산물에서 공통적으로 낮은 회수율을 나타내었다. fluquinconazole은 식품에 적용하는 식품공전 4.1.3.22의 개별 시험법을 이용한 전처리 과정을 통해 과일류, 과채류, 콩류에서 개선된 회수율 결과를 얻을 수 있을 것으로 예상되며 methomyl 은 고추, 대두, 버섯 등 식품에 적용하는 식품공전 4.1.3.15의 개별 시험법을 통해 개선된 회수율 결과를 얻을 수 있을 것으로 예상된다. 버섯, 고추에서 공통적으로 60% 미만의 낮은 회수율을 나타내었던 butocarboxim은 현재 식품공전상 개별 시험법이 존재하지 않는 항목이므로 이에 대한 개별시험법을 개발하여 다종농약다성분 시험법을 보완할 필요가 있다고 사료된다. 한국 유통 농산물 17품목(쌀, 사과, 배, 오렌지, 복숭아, 딸기, 바나나, 파인애플, 포도, 키위, 수박, 토마토, 오이, 호박, 깻잎, 상추)을 대상으로 다성분 분석농약 60종을 분석하여 농약 잔류실태를 조사하였다. 조사대상 농산물 358건 중 대부분의 농산물인 291건(81.3%)의 농산물은 농약이 검출되지 않았으며, 67건(18.7%)의 농산물에서 농약이 검출되었으나, 잔류허용기준 미만으로 검출되었다. 쌀 등 17품목에의 다소비 농산물의 농약 잔류실태를 조사한 결과 농약의 잔류량은 잔류허용기준 미만으로 ADI 대비 EDI는 0.000009%에서 0.0861%로 위해도가 아주 낮은 것으로 조사되었으며 비교적 안전한 수준으로 농산물에 대한 농약관리가 이루어지는 것으로 판단되었다.

연구개발제품(硏究開發製品)의 경제성분석(經濟性分析) 연구(硏究) - 히루딘을 중심으로 - (A Study on Economic Analysis of R&D Output -With Respect to Hirudin-)

  • 현병환;임재환
    • 농업과학연구
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    • 제24권1호
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    • pp.55-62
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    • 1997
  • Hirudin is a potent thrombin inhibitor originally derived from the medicinal leech. Leeches were commonly used at the turn of the century for bloodletting and are still used today in some countries. So, hirudin is being developed as a alternative to heparin which has several shortcomings. This study is intended to analyze R&D trends, potential market for hirudin and existing anticoagulant drug market. Anticoagulant drug market in Korea is estimated by over 1,200 billion won in 2010 and revenues in the world market are forecasted to reach 1.62 billion dollar in 1999.

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소아청소년의 결핵 감염과 질병에 대한 최신 지견 (Update on Tuberculosis in Children and Adolescents)

  • 김종현
    • Pediatric Infection and Vaccine
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    • 제16권2호
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    • pp.107-114
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    • 2009
  • Tuberculosis is a disease with high morbidity and mortality in children worldwide. Despite significant improvements in diagnostic methods, scientific researches and clinical trials for new regimens of treatment or prevention in adult tuberculosis, childhood tuberculosis has been relatively neglected. Children are at high risk of severe disease, and reactivation of latent infection in adulthood perpetuates the epidemic. Therefore, a policy of tuberculosis control in childhood should be emphasized to improve control in the total population. To understand the new view of childhood tuberculosis, this article describes changes in the disease's national epidemiology, new diagnostic tools and treatment strategies, and multi-drug resistance.

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한의학과 중의학 담당행정조직의 기능과 역할 비교 연구 (A Comparative Study on Traditional Medicine in Korea and China;Administrative Structure, Role and Function)

  • 오재근;윤태형;김윤신;박해모
    • 대한한의학회지
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    • 제29권4호
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    • pp.13-29
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    • 2008
  • Because of the changes of a variety of aspects of disease theory alternative to standard medicine, demand for traditional medicine has increased. This study was undertaken to grasp and compare traditional-medicine administrative structure, functions and role between Korea and China. According to our research, both nations promote policy related to traditional-medicine, yet there are various differences because of each nation's scale, political structure, medical system, etc. Especially, compare to the Korean government, the Chinese government not only has paid more attention to traditional medicine but also established and promoted a synthesis development strategy for a long time. Additionally, there is weakness in Korea's traditional medicine policy compared to the Chinese's Synthetic development-strategy, which is the Oriental-policy Department and Korea Food&Drug administration. Therefore, to make up for the weakness, they will have to organize their role better and make a long-term development-strategy plan for traditional medicine.

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12개 미래 예측 한의약 정책 과제의 실현 평가 연구 (Assessment of the Forecasting Studies on 12 Traditional Korean Medicine Policy Realization)

  • 박주영;신현규
    • 대한예방한의학회지
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    • 제17권1호
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    • pp.65-76
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    • 2013
  • Objectives : Aim of this study is to contribute to establishment of the Traditional Korean Medicine (TKM) policies in the future. Final assessment for 12 of the forecasting projects was carried out on the TKM policies that deduced by professionals in 1996 whether or not to realize in 2013. Methods : We investigated governmental and private research projects, reports and papers, and laws and systems on the forecasting projects. We reviewed them through the Traditional Korean Medicine Information Portal OASIS (http://oasis.kiom.re.kr), Korean studies Information Service System (KISS) (http://kiss.kstudy.com/) and DBpia (http://www.dbpia.co.kr/), Akomnews(http://www.akomnews.com/), THE MINJOK MEDICINE NEWS(http://www.mjmedi.com/), Ministry of Government Legislation(http://www.law.go.kr/). Results : Of the 12 forecasting projects, five were judged as 'realization', four were as 'partial realization' and three were as 'un-realization', The realization rate was 75.0%. Three un-realized projects included the TKM insurance coverage for various herbal medicines, leadership secure on medical technicians and commercialization of the TKM managing system on senior medicare policy. Realization of the future forecasting TKM policy projects was decided depending on conditions such as the importance, domestic capability levels, principal agents, methods and restrains. Conclusions : Continuous studies and new developed forecasting projects for the TKM policies will be required to realize the projects in the future.

의약품 보험급여 결정을 위한 경제성평가 연구의 평가 (Review of Economic Evaluation Studies for Drug Reimbursement Decision)

  • 최상은
    • 보건행정학회지
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    • 제15권4호
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    • pp.1-25
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    • 2005
  • Legislation on pharmaceutical reimbursement decision using economic evaluation results was made in Korea in fm, but has yet to be fully implemented. We evaluated the quality of Korean economic evaluation studies of pharmaceuticals to understand gaps between legislation and implementation. From this evaluation, we propose policy options that might strengthen the research Infrastructure In order to support such studies. We reviewed 23 published studies for drugs conducted between 1996 and 2004. Evaluation criteria included methodological characteristics, healthcare system characteristics, population characteristics, and applicability of results. Large variation in study quality was observed, particularly with study design, outcome data, treatment patterns and interpretation. Korean clinical data used was mostly from observational studies of 1-2 hospitals. Foreign data was extracted from clinical trials that did not Include Asian population and their selection criterion was not clarified. With respect to treatment patterns, medical records and hospital bills were used without adjustment regarding area, hospital type, and others. And next frequent situation relied on expert opinion from academic physicians in specialty practice. preference measures, when used, were not elicited from the Korean population. $78.3\%$ of studies did not clarify the funding source. If the Korean economic evaluation policy is to provide meaningful data for decision makers, the quality of cost-effectiveness studies will need to improve dramatically. This may involve access to or creation of better data, more diverse funding, unproved training of researchers and evaluators, and partnerships with technology manufacturers.