• 제목/요약/키워드: drug classification system

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의료질평가지원금 제도의 의약품안전사용서비스 평가지표 도입에 따른 의료기관의 행태 변화 (Changes in the Behavior of Healthcare Organizations Following the Introduction of Drug Utilization Review Evaluation Indicators in the Healthcare Quality Evaluation Grant Initiative)

  • 김현정;유기봉;원영주;장한솔;이광수
    • 보건행정학회지
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    • 제34권2호
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    • pp.178-184
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    • 2024
  • 연구배경: 본 연구는 의료질평가지원금 drug utilization review (DUR) 평가지표 도입 전·후의 DUR 점검률 및 의약품 중복처방 예방률 변화 차이를 비교하여 DUR 평가지표의 도입과 안전한 의약품 사용 간의 효과성을 파악하고자 한다. 방법: 본 연구는 2018년 건강보험심사평가원(Health Insurance Review and Assessment Service) DUR 자료(DUR 평가지표 도입 전)와 2023년 의료질평가지원금 평가 결과 산출 자료(DUR 평가지표 도입 후)를 활용하였다. 종속변수는 DUR 평가지표로, DUR 점검률과 의약품 중복처방 예방률 지표를 활용하였다. 독립변수는 DUR 평가지표 도입 여부이며, 통제변수는 의료기관 단위변수로, 종별 구분, 설립 구분, 소재지, DUR 청구 software 업체, 병상 수를 선정하였다. 결과: DUR 평가지표 도입 전·후의 의약품 중복처방 예방률 변화 차이를 분석한 결과, DUR 평가지표 도입 전·후의 의약품 중복처방 예방률은 통계적으로 유의미한 차이가 있었으며, DUR 평가지표 도입 후 의약품 중복처방 예방률이 유의미하게 증가하였다. 결론: 본 연구의 정책적 시사점은 다음과 같다. 첫째, DUR 시스템의 지속적인 평가 진행이 필요하다. 본 연구를 통해 DUR 평가지표 도입 후 의약품 중복처방 예방률이 유의하게 증가한 것을 확인하였다. 따라서 DUR 시스템의 효과를 계속해서 검토하고 의약품 사용의 안전성을 확대하기 위해 DUR 시스템의 지속적인 평가 진행이 필요할 것으로 판단된다. 둘째, DUR 시스템 정보를 활용하는 의료기관과 이를 관리하는 기관과의 협력 파트너십 구축이 필요하다. 의료기관의 적극적인 DUR 점검 참여와 관리기관의 다각적인 지원을 바탕으로 공동의 노력과 협력이 이루어진다면, DUR 시스템의 활성화를 통해 안전한 의약품 사용을 보장하고 국민건강을 보호하며, 의료의 질적 수준 향상을 불러올 것으로 판단된다.

주요 치료재료 품목군의 건강보험청구액 결정요인분석 (Analysis on the Determinants of Therapeutic Materials Expenditure in National Health Insurance)

  • 변진옥;이주향;김유리;이혜재
    • 보건행정학회지
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    • 제26권4호
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    • pp.333-342
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    • 2016
  • Background: The use of therapeutic materials based on new health technology has increased in recent years in the field of medicine, raising concerns for medical practitioners regarding increased spending on the new therapeutic materials amid the rapid population ageing and increase of chronic diseases in Korea. While therapeutic materials have significant importance in the health care system, they have not been given appropriate attention in the academic world of Korea. The purpose of this study is to identify factors that affect the growth of expenditure on therapeutic materials and to derive implications for an effective management considering the diversity of therapeutic materials. Methods: Using the claims data of the National Health Insurance Services, specific utilization patterns of groups of therapeutic materials in the middle classification level of Health Insurance Review and Assessment Service from 2007 to 2014 were analyzed. Four categories (J5083: drug eluting coronary stent, D0302: nonmetallic anchor, K6014: gauze, K6023: gauze) that exhibit unique patterns with respect to price and volume were selected. Then, decomposition analysis was performed to identify the largest contributor to the spending growth by dividing the products into existing, new, and abandoned products for the period between 2010 and 2013. Results: The effect of new products had larger impact on spending growth than the effect of core items in drug eluting coronary stent (J5083) and nonmetallic anchor (D0302). In addition, existing products in general included items priced relatively lower when compared with another item manufactured by the same company. In the gauze category, however, existing products had the largest impact on expenditure and the effect of volume was greater than that in other categories. Conclusion: This study provides evidence that appropriate management measures classified by the characteristics of therapeutic materials are required for therapeutic materials pricing and reassessment in Korea.

임신부에서 약물의 안전사용을 위한 연구의 필요성 (Necessity of Research for Safe Drug use in Pregnant Women)

  • 한정열;조금준;오정미
    • 한국모자보건학회지
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    • 제21권3호
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    • pp.159-165
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    • 2017
  • The thalidomide tragedy in the 1960s has resulted in a perpetuation of a certain perception amongst physicians and pregnant women that the use of medication during pregnancy is a potential teratogen. Consequently, physicians hesitate in prescribing medication to pregnant women. In addition, pregnant women often refuse medication despite therapeutic necessity because of this existing perception. Recently there have been frequent adverse pregnancy outcomes related to the recurrence of chronic diseases, such as hypertension and diabetes, following pregnancy in older women. And there are lots of unnecessary termination of pregnancy due to the of information of medication exposed to medication following over 50% of unintended pregnancy. In light of this, better dissemination of information regarding the safe usage of medication for pregnant women is required. This would not only be cost-effective in terms of medical expenditure, but also prove beneficial for the treatment of diseases. In addition, Korea needs to adapt to the increasing changes of the international information system regarding supporting the safe usage of medication during pregnancy. An example of this is shown by the recent changes to the labeling of medication by the United States Food and Drug Administration. The new labeling includes information on the risk of usage, rather than just an arbitrary alphabetic classification of B, C, D, or X. Furthermore, this information is limited in Korea because of the lack of research, which in turn is due to several limitations on ethics and methodology, as well as present regulations on the research of pregnant women. From this, we can learn that government support is critical for the establishment of research so that we can alter the perception that all medication is harmful to pregnant women.

Crystal Form of Celecoxib: Preparation, Characterization and Dissolution

  • Jin, Mi-Ryung;Sohn, Young-Taek
    • 대한화학회지
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    • 제62권5호
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    • pp.352-357
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    • 2018
  • Celecoxib (4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide) is a cyclooxygenase-2 inhibitor used in the treatment of arthritis, acute pain, and dysmenorrhoea. Celecoxib is a Biopharmaceutics Classification System (BCS) class II compound whose oral bioavailability is highly limited owing to its poor aqueous solubility. Several polymorphs of celecoxib have been identified as Form I, Form II, and Form III with melting points of about $162.8^{\circ}C$, $161.5^{\circ}C$, and $160.8^{\circ}C$, respectively. Form IV was generated from the precipitated suspension in the presence of HPMC (Hydroxypropyl methylcellulose) and Polysorbate 80. A rapid rate of dissolution is useful because the rate of dissolution of a drug typically increases its bioavailability. The aim of this study was to investigate the possibility of production of new crystal form of celecoxib that has higher solubility than Form III. New crystal form of celecoxib (Form A) has been isolated by recrystallization and characterized by differential scanning calorimetry (DSC), thermogravimetric (TG) analysis and powder X-ray diffractometry (PXRD). Form A was dissolved faster than Form III. At 30 minutes, the dissolution of Form A was 97.3%, whereas the dissolution of Form III was 82.2% (p < 0.1). After storage of three months at $20^{\circ}C$, in 24% RH (Relative Humidity), the crystal form was not transformed.

A Vascular Characteristic Index of Blood Pressure Variation using the Pulse Wave Signal

  • Kim, Gi-Ryon;Jung, Dong-Keun;Ye, Soo-Young;Jeon, Gye-Rok
    • Transactions on Electrical and Electronic Materials
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    • 제9권5호
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    • pp.213-219
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    • 2008
  • Pulse waves continuously change with respect to the characteristics and status of the cardiovascular system and in relation to the blood pressure (BP) and the pulse wave velocity (PWV). Monitoring the vascular condition by analyzing the variations in pulse waveforms has been used to diagnose vascular disorders and in drug treatment of arteriosclerosis and peripheral circulatory obstruction. In this paper, we investigated the vascular characteristic index with regard to the BP and classified by pulse wave signals. The pressure pulse wave and photoplethysmography (PPG) were measured simultaneously while subjects exercised, producing changes in the BP, to analyze the variation in the vascular characteristic index. We investigated the correlation between the BP and vascular characteristic index with regard to the classification methods of the pulse wave. The reflection index (RI) and vascular stiffness index were correlated with the diastolic BP, but no correlation was found between these parameters and the systolic BP. These results suggest the possibility of estimating BP through simple measurements of pulse waves.

Epilepsy Surgery in 2019 : A Time to Change

  • Phi, Ji Hoon;Cho, Byung-Kyu
    • Journal of Korean Neurosurgical Society
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    • 제62권3호
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    • pp.361-365
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    • 2019
  • Epilepsy has been known to humankind since antiquity. The surgical treatment of epilepsy began in the early days of neurosurgery and has developed greatly. Many surgical procedures have stood the test of time. However, clinicians treating epilepsy patients are now witnessing a huge tide of change. In 2017, the classification system for seizure and epilepsy types was revised nearly 36 years after the previous scheme was released. The actual difference between these systems may not be large, but there have been many conceptual changes, and clinicians must bid farewell to old terminology. Paradigms in drug discovery are changing, and novel anti-seizure drugs have been introduced for clinical use. In particular, drugs that target genetic changes harbor greater therapeutic potential than previous screening-based compounds. The concept of focal epilepsy has been challenged, and now epilepsy is regarded as a network disorder. With this novel concept, stereotactic electroencephalography (SEEG) is becoming increasingly popular for the evaluation of dysfunctioning neuronal networks. Minimally invasive ablative therapies using SEEG electrodes and neuromodulatory therapies such as deep brain stimulation and vagus nerve stimulation are widely applied to remedy dysfunctional epilepsy networks. The use of responsive neurostimulation is currently off-label in children with intractable epilepsy.

두족류의 진위 판별을 위한 Real-time Quantitative PCR 검사법 개발 및 검증 (Development and Validation of Quick and Accurate Cephalopods Grouping System in Fishery Products by Real-time Quantitative PCR Based on Mitochondrial DNA)

  • 정인영;서용배;양지영;권기성;김군도
    • 한국식품위생안전성학회지
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    • 제33권4호
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    • pp.280-288
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    • 2018
  • 본 연구는 국내에서 생산되거나 해외에서 수입되어 국내에서 유통되는 수산물 중에서 두족류를 문어류, 낙지류, 오징어류, 주꾸미류, 꼴뚜기류의 5개 그룹으로 구분하여 분석하였다. 두족류 5개 그룹을 판별을 하기 위해 미토콘드리아에 존재하는 유전자를 분석하였고, 그 중에서 COI (mitochondrial cytochrome C oxidase subunit I), 16s rRNA (16s ribosomal RNA), 12s rRNA (12s ribosomal RNA) 내에서 상당히 유사한 DNA 서열 부분과 일부 서열 변화 부분이 확인되었다. 명확하게 두족류 5개 그룹 판별을 하기 위해 COI, 16s rRNA, 12s rRNA 유전자의 일부 서열 변화 부분에서 그룹 특이적 프라이머 세트를 디자인하였다. 국내 외에서 확보한 두족류 시료(참문어, 낙지, 살오징어, 아메리카 대왕오징어, 갑오징어, 주꾸미, 모래주꾸미, 하이야주꾸미, 참꼴뚜기, 창꼴뚜기, 한치꼴뚜기)의 genomic DNA을 추출하여 각 그룹의 특이적 프라이머를 이용하여 SYBR 기반의 real-time PCR 시스템에 의해 분석되었고, threshold cycle (Ct) value와 같은 real-time PCR 결과 분석에 의해 두족류 내 그룹 판별이 가능하였다(Table 3).

임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구 (Survey of Institutional Review Board Risk Level Classification of Clinical Trials Among Korean University Hospitals)

  • 이선주;강수진;맹치훈;신유진;유소영
    • 대한기관윤리심의기구협의회지
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    • 제4권2호
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    • pp.36-41
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    • 2022
  • Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

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Differential Gene Expression Common to Acquired and Intrinsic Resistance to BRAF Inhibitor Revealed by RNA-Seq Analysis

  • Ahn, Jun-Ho;Hwang, Sung-Hee;Cho, Hyun-Soo;Lee, Michael
    • Biomolecules & Therapeutics
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    • 제27권3호
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    • pp.302-310
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    • 2019
  • Melanoma cells have been shown to respond to BRAF inhibitors; however, intrinsic and acquired resistance limits their clinical application. In this study, we performed RNA-Seq analysis with BRAF inhibitor-sensitive (A375P) and -resistant (A375P/Mdr with acquired resistance and SK-MEL-2 with intrinsic resistance) melanoma cell lines, to reveal the genes and pathways potentially involved in intrinsic and acquired resistance to BRAF inhibitors. A total of 546 differentially expressed genes (DEGs), including 239 up-regulated and 307 down-regulated genes, were identified in both intrinsic and acquired resistant cells. Gene ontology (GO) analysis revealed that the top 10 biological processes associated with these genes included angiogenesis, immune response, cell adhesion, antigen processing and presentation, extracellular matrix organization, osteoblast differentiation, collagen catabolic process, viral entry into host cell, cell migration, and positive regulation of protein kinase B signaling. In addition, using the PAN-THER GO classification system, we showed that the highest enriched GOs targeted by the 546 DEGs were responses to cellular processes (ontology: biological process), binding (ontology: molecular function), and cell subcellular localization (ontology: cellular component). Ingenuity pathway analysis (IPA) network analysis showed a network that was common to two BRAF inhibitorresistant cells. Taken together, the present study may provide a useful platform to further reveal biological processes associated with BRAF inhibitor resistance, and present areas for therapeutic tool development to overcome BRAF inhibitor resistance.

Nanotechnology in early diagnosis of gastro intestinal cancer surgery through CNN and ANN-extreme gradient boosting

  • Y. Wenjing;T. Yuhan;Y. Zhiang;T. Shanhui;L. Shijun;M. Sharaf
    • Advances in nano research
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    • 제15권5호
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    • pp.451-466
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    • 2023
  • Gastrointestinal cancer (GC) is a prevalent malignant tumor of the digestive system that poses a severe health risk to humans. Due to the specific organ structure of the gastrointestinal system, both endoscopic and MRI diagnoses of GIC have limited sensitivity. The primary factors influencing curative efficacy in GIC patients are drug inefficacy and high recurrence rates in surgical and pharmacological therapy. Due to its unique optical features, good biocompatibility, surface effects, and small size effects, nanotechnology is a developing and advanced area of study for the detection and treatment of cancer. Because of its deep location and complex surgery, diagnosing and treating gastrointestinal cancer is very difficult. The early diagnosis and urgent treatment of gastrointestinal illness are enabled by nanotechnology. As diagnostic and therapeutic tools, nanoparticles directly target tumor cells, allowing their detection and removal. XGBoost was used as a classification method known for achieving numerous winning solutions in data analysis competitions, to capture nonlinear relations among many input variables and outcomes using the boosting approach to machine learning. The research sample included 300 GC patients, comprising 190 males (72.2% of the sample) and 110 women (27.8%). Using convolutional neural networks (CNN) and artificial neural networks (ANN)-EXtreme Gradient Boosting (XGBoost), the patients mean± SD age was 50.42 ± 13.06. High-risk behaviors (P = 0.070), age at diagnosis (P = 0.037), distant metastasis (P = 0.004), and tumor stage (P = 0.015) were shown to have a statistically significant link with GC patient survival. AUC was 0.92, sensitivity was 81.5%, specificity was 90.5%, and accuracy was 84.7 when analyzing stomach picture.