• 제목/요약/키워드: Drug Utilization Review

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효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안 (Strategic Plans for the Implementation of Pharmacometric Methodology in Drug Regulatory Review Decisions)

  • 이상민;최보윤;윤휘열;전다혜;김명규;하지혜;김영훈;지은희;강원구;한나영;신완균;오정미
    • 한국임상약학회지
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    • 제21권4호
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    • pp.339-346
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    • 2011
  • 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.

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.

한국과 미국의 약사 연수 교육 분석을 통한 자기 주도적 약사 연수 교육 도입 방안 (A Study on the Introduction of Self-directed Pharmaceutical Training Education through the Analysis of Pharmaceutical Education in Korea and the U.S.)

  • 정수철
    • 한국콘텐츠학회논문지
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    • 제19권1호
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    • pp.598-607
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    • 2019
  • 현재 한국의 약사 연수 교육은 연간 8시간으로 대한약사회와 그 산하 지부 및 분회에서 주로 실시하고 있다. 정해진 시간에 다수의 약사들을 대상으로 진행되는 교육은 학습효과가 제한적이며 적극적인 학습 참여를 유도하기 어렵다. 본 연구에서는 약사 제도의 역사가 긴 미국의 약사 연수 교육을 문헌 연구 하여 한국의 약사 연수 교육의 발전 방안을 찾아보았다. 연구의 대상은 한국과 미국의 약사 연수 교육 운용 방식, 평가제도, 교과목 등이었다. 연구 결과 미국의 약사연수 교육은 다양한 방식이었으며 이수 시간이 길며 약사 면허 갱신 제도와 연계되어 있었다. 한국의 약사 연수 교육이 교육 시간의 연장, 교육 내용의 다양화, 자기 주도적 학습 및 현장 실습 교육을 도입 한다면 현재보다 더 발전할 것이다.

부산지역 의원급 외래 노인 골관절염환자의 비스테로이드소염제 사용양상평가 (Nonsteroidal Anti-inflammatory Drugs Utilization Patterns among the Elderly with Osteoarthritis at Primary Ambulatory Care Units in Busan Metropolitan City, Korea)

  • 최남경;김윤이;이승미;박병주
    • Journal of Preventive Medicine and Public Health
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    • 제37권2호
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    • pp.150-156
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    • 2004
  • Objectives : To investigate the utilization patterns of non-steroidal anti-inflammatory drugs (NSAIDs) among the elderly with osteoarthritis (OA) undergoing primary ambulatory care in Busan metropolitan city, Korea. Methods : OA patients, aged 65 years and over, were identified from the Korean National Health Insurance Review Agency drug prescription database. The subjects had at least one episode of claim for OA (ICD-10-CM: M15-M19) between August 1, 2000 and February 28, 2002. Trends in the determinations of NSAIDs utilization were identified using chi-squared tests for trend. Results : There were 47,711 osteoarthritic patients. The total number of visits by these patients was 177,443, with a total frequency for NSAID prescriptions of 214,952. Seventy-nine percent of the OA patients were female. NSAIDs were prescribed on 133,284 visits (75.1%) and the proportion of prescriptions was significantly increased with age. Only the proportion of visit when NSAIDs were prescribed decreased, from 65.1 to 43.5%, during the study period (p<0.001). However, the proportion of combined treatments with anti-ulcer drugs was increased. The use of NSAIDs injections was decreased. Of the individual NSAIDs, diclofenac (28.7% of total frequency of NSAID prescriptions), piroxicam (15.0%) and talniflumate (8.7%), were the most frequently prescribed. Among the NSAIDs prescribed OA visits, 45.7% used two or more NSAIDs. Conclusion : The total proportion of NSAIDs prescribed to the osteoarthritic patients was higher than in other studies. The decline in the use of NSAIDs during the study period, and the frequent selection of safer medications, such as combination therapy with anti-ulcer drug, may reflect the risk awareness of the use of NSAIDs.

약물군-약물군 조합으로 도출한 약력학적 기전의 추가 병용금기성분 (Pharmacodynamic Drug-Drug Interactions Considered to be Added in the List of Contraindications with Pharmacological Classification in Korea)

  • 제남경;김동숙;김주연;이숙향
    • 한국임상약학회지
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    • 제25권2호
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    • pp.120-129
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    • 2015
  • Objectives: Drug utilization review program in Korea has provided 'drug combinations to avoid (DCA)' alerts to physicians and pharmacists to prevent potential adverse drug events or inappropriate drug use. Seven hundred and six DCA pairs have been announced officially by the Ministry of Food and Drug Safety (MFDS) by March, 2015. Some DCA pairs could be grouped based on the drug interaction mechanism and its consequences. This study aimed to investigate the drug-drug interaction (DDI) pairs, which may be potential DCAs, generated by the drug class-drug class interaction method. Methods: Eleven additive/synergistic and one antagonistic drug class-drug class interaction groups were identified. By combining drugs of two interacting drug class groups, numerous DDI pairs were made. The status and severity of DDI pairs were examined using Lexicomp and Micromedex. Also, the DCA listing rate was calculated. Results: Among 258 DDI pairs generated by the drug class-drug class interaction method, only 142 pairs were identified as official DCA pairs by the MFDS. One hundred and four pairs were identified as potential DCA pairs to be listed. QT prolonging agents-QT prolonging agents, triptans-ergot alkaloids, tricyclic antidepressants-monoamine oxidase inhibitors, and dopamine agonists-dopamine antagonists were identified as drug class-drug class interaction groups which have less than 50 % DCA listing rate. Conclusion: To improve the clinicians' adaptability to DCA alerts, the list of DCA pairs needs to be continuously updated.

보훈의료지원 대상자의 외래 처방의약품 사용경향과 적정성 평가 (Trends and Appropriateness of Outpatient Prescription Drug Use in Veterans)

  • 이인향;심다영
    • 한국임상약학회지
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    • 제28권2호
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    • pp.107-116
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    • 2018
  • Objective: This study analyzed the national claims data of veterans to generate scientific evidence of the trends and appropriateness of their drug utilization in an outpatient setting. Methods: The claims data were provided by the Health Insurance Review & Assessment (HIRA). Through sampling and matching data, we selected two comparable groups; Veterans vs. National Health Insurance (NHI) patients and Veterans vs. Medical Aid (MAID) patients. Drug use and costs were compared between groups by using multivariate gamma regression models to account for the skewed distribution, and therapeutic duplication was analyzed by using multivariate logistic regression models. Results: In equivalent conditions, veteran patients made fewer visits to medical institutions (0.88 vs. 1), had 1.86 times more drug use, and paid 1.4 times more drug costs than NHI patients (p<0.05); similarly, veteran patients made fewer visits to medical institutions (0.96 vs. 1), had 1.11 times more drug use, and paid 0.95 times less drug costs than MAID patients (p<0.05). The risk of therapeutic duplication was 1.7 times higher (OR=1.657) in veteran patients than in NHI patients and 1.3 times higher (OR=1.311) than in MAID patients (p<0.0001). Conclusion: Similar patterns of drug use were found in veteran patients and MAID patients. There were greater concerns about the drug use behavior in veteran patients, with longer prescribing days and a higher rate of therapeutic duplication, than in MAID patients. Efforts should be made to measure if any inefficiency exists in veterans' drug use behavior.

국내 만성 B형 간염 환자의 경구용 항바이러스제 사용 현황 분석 (Analysis of Drug Utilization in Patients with Chronic Hepatitis B)

  • 이유정;배성진;제남경
    • 한국임상약학회지
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    • 제26권3호
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    • pp.220-229
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    • 2016
  • Background: The treatment goal for patients with chronic hepatitis B infection is to prevent progression of the disease to cirrhosis and hepatocellular carcinoma. Current therapies include standard and pegylated interferon-alfa and nucleoside/nucleotide analogues: lamivudine, adefovir, entecavir, telbivudine, clevudine, and tenofovir. This study aims to analyze changes in the prescribing patterns of chronic hepatitis B (CHB) medications in South Korea between 2013 and 2014. Methods: A cross-sectional study was conducted using National Patients Sample data compiled by the Health Insurance Review and Assessment Service from 2013 and 2014. Patients with CHB were identified with Korean Standard Classification of Diseases code-6 (B18.0 and B18.1) and those who were maintaining active prescriptions with CHB medications covering the index date (December $1^{st}$, each year) were included. The utilization of antiviral therapy was investigated during 2013 and 2014. Results: A total of 4,204 and 4,552 patients in 2013 and 2014 respectively, were included in the analysis. The proportion of male patients was two of third and the patients 41-60 years old accounted for 60% of all analyzed patients. The most utilized drug was entecavir (55.1% in 2013 and 44.8% in 2014) and the second most utilized drug was tenofovir in both years (18.8% in 2013 and 29.0% in 2014). The percentage of combination therapy was 13.6% and 13.1% in 2013 and 2014, respectively. The proportion of tenofovir prescriptions was increased in 2014 compared with 2013. Conclusion: With the development of new drugs and the changes in clinical practice guidelines, the prescription pattern of the antiviral agents for patients with CHB has changed. The rate of utilization of tenofovir has increased.

국내 가와사키병 환아의 약물사용 (Drug Utilization in Korean Children with Kawasaki Disease)

  • 차승희;제남경
    • 한국임상약학회지
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    • 제27권3호
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    • pp.127-135
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    • 2017
  • Background: Kawasaki disease (KD) is an acute febrile, systemic vasculitis as a leading cause of acquired heart disease in children. Intravenous immunoglobulin G (IVIG) and aspirin are the standard initial therapy in the treatment of acute KD. The purpose of this study was to investigate drug utilization in children with KD, and to compare "IVIG + high-dose aspirin" and "IVIG + moderate-dose aspirin" in preventing cardiac complications. Methods: We analyzed pediatric patient sample data compiled by the Health Insurance Review & Assessment Service from 2010 to 2015. We identified patients with KD using the KCD-6 code of M30.3. We excluded patients in chronic phase or ${\geq}1$0 years. We also excluded patients who were diagnosed KD in November or December. Drug utilization pattern were assessed in acute KD patients and 30-day and 60-day cardiac complications were investigated between "IVIG + high-dose aspirin" group and "IVIG + moderate-dose aspirin" group. Results: In acute phase, IVIG was administered to 95.8% patients, and 57.1% patients were prescribed moderate-dose aspirin and 25% patients were with high-dose aspirin. Steroid use was rapidly increased from 4.0% in 2010 to 11.3% in 2015. Both 30-day and 60-day cardiac complications occurred less in "IVIG + high-dose aspirin" group compared to "IVIG + moderate-dose aspirin" group, but not statistically significant (0.9% vs 1.8%, p=0.252 for 30-day complication rate; 1.5% vs 2.7%. p=0.073 for 60-day complication rate). Conclusion: We were not able to demonstrate which aspirin therapy is superior for preventing cardiac complications in acute KD patients and further research is warranted.

Biotransformation, a Promising Technology for Anti-cancer Drug Development

  • Gao, Fei;Zhang, Jin-Ming;Wang, Zhan-Guo;Peng, Wei;Hu, Hui-Ling;Fu, Chao-Mei
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권10호
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    • pp.5599-5608
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    • 2013
  • With the high morbidity and mortality caused by cancer, finding new and more effective anti-cancer drugs is very urgent. In current research, biotransformation plays a vital role in the research and development of cancer drugs and has obtained some achievements. In this review, we have summarized four applications as follows: to exploit novel anti-cancer drugs, to improve existing anti-cancer drugs, to broaden limited anti-cancer drug resources and to investigate correlative mechanisms. Three different groups of important anti-cancer compounds were assessed to clarify the current practical applications of biotransformation in the development of anti-cancer drugs.

인플루엔자 등 급성 호흡기계 질환과 의약품 사용의 계절적 상관성 분석 (Assessing Seasonality of Acute Febrile Respiratory Tract Infections and Medication Use)

  • 박주희;최원석;이혜영;김경훈;김동숙
    • 보건행정학회지
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    • 제28권4호
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    • pp.402-410
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    • 2018
  • Background: Monitoring appropriate medication categories can provide early warning of certain disease outbreaks. This study aimed to present a methodology for selecting and monitoring medications relevant to the surveillance of acute respiratory tract infections, such as influenza. Methods: To estimate correlations between acute febrile respiratory tract infection and some medication categories, the cross-correlation coefficient (CCC) was used and established. Two databases were used: real-time prescription trend of antivirals, anti-inflammatory drugs, antibiotics using Drug Utilization Review Program between 2012 and 2015 and physicians' number of encounters with acute febrile respiratory tract infections such as influenza outbreaks using the national level health insurance claims data. The seasonality was also evaluated using the CCC. Results: After selecting six candidate diseases that require extensive monitoring, influenza with highly specific medical treatment according to the health insurance claims data and its medications were chosen as final candidates based on a data-driven approach. Antiviral medications and influenza were significantly correlated. Conclusion: An annual correlation was observed between influenza and antiviral medications, anti-inflammatory drugs. Suitable models should be established for syndromic surveillance of influenza.