• 제목/요약/키워드: drug use evaluation

검색결과 256건 처리시간 0.027초

이비인후과 영역에서 일반의와 전문의에 의한 외래처방전의 비교 평가 (Comparative Evaluation of Drug Use for Outpatients Prescribed by General Practitioner and Specialized Practitioner in ENT Area)

  • 민현성;송태범;이명구;장제관;이종길;임성실
    • 약학회지
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    • 제54권4호
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    • pp.258-269
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    • 2010
  • As people are easy to access the National Health Insurance, medical health service has been increased. It contributed to extend human's average life expectancy and to get better health care. But also increased unnecessary health service or inappropriate drug use. Therefore, DUR (Drug Use Review) is needed to induce appropriate drug use. The purpose of this study is to evaluate outpatient prescriptions by General Practitioner (GP) and Specialized Practitioner, especially indication for ENT referral including common cold which is the frequent indications that have patient see doctor. This study was reviewed retrospectively prescriptions for ENT referral collected at the A pharmacy for ENT Clinic in Cheong-Ju, B pharmacy for GP Clinic in BoEun from Feb 2nd, 2009 to Feb 28th, 2009. Each pharmacy located closed to the each enrolled clinic. The numbers of collected prescriptions were each A pharmacy (n=2501), B pharmacy (n=1343). This study was classified Drug Related Problems (DRPs) those prescriptions had as total 6 groups according to following 6 categories; 1) Unnecessary Drug, 2) Wrong Drug, 3) Low Dose, 4) Overdose, 5) Wrong Instruction, 6) Wrong Combination. In results, Specialized Practitioner's prescriptions had more DRPs than General Practitioner's prescriptions (ENT 155.34% vs GP 130.01%). In detail, Specialized Practitioner's prescriptions had more DRPs in Low Dose (ENT 16.95% vs GP 4.77%), Overdose (ENT 6.72% vs G.P 5.51%), Wrong Instruction (ENT 7.91% vs GP 5.81%), Wrong Combination (ENT 29.31% vs GP 25.09%). These DRPs would be caused from lack of consideration for dosage and drug interaction. General Practitioner's prescriptions had more DRPs in Unnecessary Drug (ENT 70.37% vs GP 78.85%), Wrong drug (ENT 4.12% vs GP 9.98%). These DRPs would be associated with drug selection. This study was assumed that Specialized Practitioner is better prescriber than General Practitioner because Specialized Practitioner complete additional intern and residency training. But, Specialized Practitioner is not always better prescriber than General Practitioner. Furthermore, prescriptions of both Specialized Practitioner and General Practitioner had many problems. In conclusion, It could be cut down the excessive medical expense and expected more efficient medical care by reducing DRPs, thus contributing to the improvement of national health. In order to pharmacist must have good professional ability of pharmacotherapy to help the physician for the drug selection.

A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats

  • Han, Hyoung-Yun;Yang, Young-Su;Kim, Soo Nam;Han, Su-Cheol;Han, Kang-Hyun;Lee, Jong-Hwa;Jeong, Ja Young;Roh, Hang-Sik;Seok, Ji Hyeon;Kim, Jeong-Ah;Min, Byung-Sun
    • Natural Product Sciences
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    • 제21권1호
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    • pp.34-41
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    • 2015
  • The objective of this study is to characterize a toxicity of Epimedii Herba (EH) in F344 rats and to find a dose levels for the 13 weeks toxicity study. EH is well known as medicinal herb in many Asian countries for traditional medicines of antibacterial and antiviral effects, estrogenic and antiestrogenic effects, and for treatment of osteoporosis, hypotensives, fatigue, kidney disorders, and related complications. However, the indispensable and basic information of toxicological evaluation of EH extract is insufficient to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and MFDS guideline in this study. The extract of EH was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed of 5 male and female rats. In this study, there were no treatment of EH-related adverse changes in clinical observations, mortality, body weights, food consumption, urinalysis, gross finding at necropsy, and organ weight examination. Total red blood cell count, hematocrit, mean corpuscular hemoglobin concentration, total cholesterol, and phospholipid were decreased in males and females at 5000 mg/kg/day compared to the control animals. Mean corpuscular volume and reticulocyte counts were increased in males and females at 5000 mg/kg/day compared to control animals. Therefore, we recommend that dose level of 5000 mg/kg/day is a highest treatment group in 13-week EH extract exposure study for further toxicity assessment.

Molecular Mechanism of Tetrabromobisphenol A (TBBPA)-induced Target Organ Toxicity in Sprague-Dawley Male Rats

  • Choi, Jae-Seok;Lee, Young-Jun;Kim, Tae-Hyung;Lim, Hyun-Jung;Ahn, Mee-Young;Kwack, Seung-Jun;Kang, Tae-Seok;Park, Kui-Lea;Lee, Jae-Won;Kim, Nam-Deuk;Jeong, Tae-Cheon;Kim, Sang-Geum;Jeong, Hye-Gwang;Lee, Byung-Mu;Kim, Hyung-Sik
    • Toxicological Research
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    • 제27권2호
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    • pp.61-70
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    • 2011
  • Brominated flame retardants (BFRs) are present in many consumer products ranging from fabrics to plastics and electronics. Wide use of flame retardants can pose an environmental hazard, which makes it important to determine the mechanism of their toxicity. In the present study, dose-dependent toxicity of tetrabromobisphenol A (TBBPA), a flame retardant, was examined in male prepubertal rats (postnatal day 18) treated orally with TBBPA at 0, 125, 250 or 500 mg/kg for 30 days. There were no differences in body weight gain between the control and TBBPA-treated groups. However, absolute and relative liver weights were significantly increased in high dose of TBBPA-treated groups. TBBPA treatment led to significant induction of CYP2B1 and constitutive androstane receptor (CAR) expression in the liver. In addition, serum thyroxin (T4) concentration was significantly reduced in the TBBPA treated group. These results indicate that repeated exposure to TBBPA induces drug-metabolising enzymes in rats through the CAR signaling pathway. In particular, TBBPA efficiently produced reactive oxygen species (ROS) through CYP2B1 induction in rats. We measured 8-hydroxy-2'-deoxyguanosine (8-OHdG), a biomarker of DNA oxidative damage, in the kidney, liver and testes of rats following TBBPA treatment. As expected, TBBPA strongly induced the production of 8-OHdG in the testis and kidney. These observations suggest that TBBPA-induced target organ toxicity may be due to ROS produced by metabolism of TBBPA in Sprague-Dawley rats.

당뇨병환자에게 부적절하게 사용된 Metformin의 처방빈도 분석 (Frequency of Inappropriate Metformin Use in Patients with Diabetes Mellitus)

  • 신혜연;정기화
    • 약학회지
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    • 제54권6호
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    • pp.455-460
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    • 2010
  • We evaluated the inappropriateness of metformin use in patients with type 2 diabetes and chronic medical conditions to identify the frequency of the prescription metformin in violation of the food and drug administration (FDA) black box warning. We reviewed medical records of 307 outpatients who received metformin at endocrinology department in a hospital setting between January 1, 2005 and August 30, 2009. Of the 307 outpatients, 25 discontinued treatment of metformin due to elevated serum creatinine level (Scr${\geq}$1.5 mg/dl in male, Scr${\geq}$1.4 mg/dl in female), cancers, and/or liver disease. 5 were lost to follow-up. 89 (29.0%) of the patients had cardiovascular disease, 54.1% for hypertension, 9.8% for liver disease, and 60 (20.8%) for chronic kidney disease. 12 patients (3.9%) with chronic kidney disease and/or elevated serum creatinine level, and 1 patient (0.3%) with lactic acidosis were contraindicated to metformin use. Metformin should be avoided in 7 outpatients (2.3%) with active hepatitis and 1 patient (2.6%) with liver cirrhosis. Of the 307 outpatients, 13 (4.2%) patients who received metformin at the first visit and 16 (8.7%) patients who received metformin at the last visit violated to black box warning. 8 (2.6%) of the patients were in precautionary conditions to metformin use. Adjusted mean difference of serum creatinine was -0.16 mg/dl [95% CI: -0.22 to -0.11 (p<0.05)] and adjusted mean difference of alanine aminotransferase was 4.46 IU/l [95% CI: 2.47 to 6.44 (p<0.05)] between the first visit and the last visit. Critical number of elderly patients who are at the high risks of drug-disease and drug-laboratory interaction is exposed to the inappropriate metformin use in violation of black box warning. The periodic evaluation of metformin use and monitoring prescription through drug utility review (DUR) system is needed to improve patients' safety and to reduce adverse drug events.

의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구 (Development of Standards of Tattoo Machine for Safety and Performance Evaluation)

  • 김영균;조승관;이태우;여창민;정병조;권영미;차지훈;허찬희;박기정;김동섭;김한성
    • 대한의용생체공학회:의공학회지
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    • 제32권2호
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    • pp.151-157
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    • 2011
  • Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

Benzodiazepine계 약물과 그 문제점

  • 오강섭
    • 대한불안의학회:학술대회논문집
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    • 대한불안의학회 2005년도 춘계학술대회
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    • pp.88-103
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    • 2005
  • o Rational Use of BZ - relative safe, widely useful o Hidden side effects/disastrous effects in vulnerable patients o Review tolerance, dependency, withdrawal symptoms o Consider Drug interaction o Periodic Evaluation of Risk/Benefit of BZ o Advice to patients planning a pregnancy

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의약품 안전성 관리를 위한 연구 - 의약품 안전관리 제도개선 방안을 중심으로 - (A Study on Improving Korea's Regulatory System for Pharmaceutical Safety Management)

  • 채규한;조기원;나가타류지;박지선;홍정희;강종성
    • 약학회지
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    • 제57권3호
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    • pp.173-186
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    • 2013
  • To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

Neuroimaging in Randomized, Multi-Center Clinical Trials of Endovascular Treatment for Acute Ischemic Stroke: A Systematic Review

  • Chong Hyun Suh;Seung Chai Jung;Byungjun Kim;Se Jin Cho;Dong-Cheol Woo;Woo Yong Oh;Jong Gu Lee;Kyung Won Kim
    • Korean Journal of Radiology
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    • 제21권1호
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    • pp.42-57
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    • 2020
  • Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

유한요소해석을 이용한 마이크로 분사 노즐 특성 평가 (Evaluation of micro jet nozzle using finite elements method)

  • 임동욱;최두선;김태민;박정래;박규백;함휘찬;김지훈
    • Design & Manufacturing
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    • 제14권3호
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    • pp.57-62
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    • 2020
  • In the drug delivery system industry, the technology with even split injection becomes important for maximizing efficiency and minimizing the side effects. In conventional drug delivery system, infection can occur due to pain and splashing. Also, various applications are impossible due to disposable use, and it is the reason to avoid to use this system because of the complexity of the driving method. Therefore, in this study, a painless drug delivery device is developed for non-pain with electrical insulation breakdown method. Finite elements analysis was used to evaluate the ejection characteristics of drugs according to the shape of the micro ejection nozzle. The effect of the number of holes in the micro nozzle, the length of the nozzle and the inner shape of the nozzle on the drug discharge characteristics were analyzed.