• 한국임상약학회지
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• 제21권2호
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• pp.138-144
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• 2011

In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

• Journal of Interdisciplinary Genomics
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• 제3권1호
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• pp.7-12
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• 2021

Adverse drug reactions (ADRs) is a hypersensitivity reactions to specific medications, and remain a common and major problem in healthcare. ADRs suchc as drug-induced liver injury and life-threatening severe cutaneous adverse drug reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms can be occurred by uncontrolled expansion of oligoclonal T cells according to genetically predisposing HLA. In this review, I summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

• 한국콘텐츠학회논문지
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• 제19권1호
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• pp.234-241
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• 2019

의약품을 사용할 때 나타나는 부작용은 국민의 건강을 크게 위협할 수 있다. 현재 의약품 부작용에 대한 보고가 매우 미흡한 것이 현실이다. 이에 현재 약국에서 사용하고 있는 의약품 사용평가(DUR:Drug Utilization Review)에 의약품 부작용 보고를 연계하게 된다면 활성화될 수 있다. 의약품 사용평가가 활성화되어 있는 미국 의약품 관리 체계 연구를 통해 의약품 부작용 보고 활성화 방안을 찾을 수 있다. 약국에서 의약품 관리 프로그램으로 사용되는 'Pharm IT 3000'에서 의약품 부작용 보고의 활성화 방안을 연구해 보았다. 문헌연구와 실제 프로그램 운영 방식 연구를 통해 Pharm IT 3000 처방 조제 현황 항목에 의약품 사용평가를 연동시켜 부작용 보고가 편리하게 되는 방안을 찾게 되었다.

• 한국임상약학회지
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• 제18권1호
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• pp.18-27
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• 2008

This study investigated social relief schemes for serious adverse drug reactions in foreign countries and deduced lessons and implications for Korea to implement the scheme. A social relief scheme for serious adverse drug reactions provides reliefs for diseases and such health effects as disabilities or deaths that were caused by adverse reactions to pharmaceuticals prescribed at hospitals and clinics as well as those purchased at pharmacies notwithstanding their proper use. The US and the UK do not have specific relief schemes for adverse drug reactions but apply rules of strict liability or negligence. New Zealand and Nordic countries provide no-fault compensation schemes for health effects or injuries caused by medical treatments or medicinal products. Japan and Taiwan have operated the schemes since 1980 and 2000, respectively. In designing the scheme in Korea, we suggested that cases eligible for relief be confined to serious adverse reactions such as death or disability and then extended to diseases. It is desirable to encourage the reporting system of adverse drug reactions and quality use of medicines for the relief scheme to work efficiently.

• 한국임상약학회지
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• 제28권2호
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• 한국임상약학회지
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• 제20권2호
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• pp.151-158
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• 2010

Therapeutic drug monitoring of Mycophenolate mofetil(MMF) has been suggested in some clinical trials, but has not been widely adopted in Korea. The purpose of this study was to analyze the withdrawal rates of MMF and determine the characteristics of the patients who experienced adverse reactions with MMF therapy and to suggest the criteria for selecting patients who need monitoring of MMF levels. We retrospectively collected data of patients who started MMF between July 2007 and June 2008. A total of 154 adult patients were included in our study. Among them, ninety seven patients discontinued MMF with 59 cases being due to adverse drug reactions. Thirty one patients required dosage reduction of MMF with twenty three cases being due to adverse reactions. Twenty six patients continued the MMF without or with mild adverse reactions. Of the 82 adverse reaction cases, hematologic adverse reactions accounted for 38 cases (46%) and gastrointestinal (GI) adverse reactions accounted for 28 cases (34%). Older age and lower serum albumin levels were significantly different characteristics between the patients who withdraw MMF due to hematological adverse reactions and those who were able to continue therapy. The group who experienced GI adverse reactions had higher MMF dosages based on body weight and lower serum albumin levels. In conclusion, the factors affecting the adverse reactions of MMF were age, serum albumin level and higher dosage, therefore therapeutic drug monitoring of MMF should be considered in these patients.

• 정보처리학회논문지:소프트웨어 및 데이터공학
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• 제10권11호
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• pp.465-472
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• 2021

본 논문에서는 약물의 시판 후 이상 반응을 모니터링하기 위해 약물 리뷰 데이터로부터 약물 이상 반응을 탐지할 수 있는 방법을 제시하였다. 부정적인 약물 리뷰는 주로 약물 이상 반응을 언급하고 있다는 점을 고려하여 약물 리뷰들을 감성 분석하여 부정 리뷰를 추출하고, 부정 리뷰에 사전 기반 추출과 개체명 인식 기법을 적용하여 약물 이상 반응을 탐지하였다. 제안하는 BERT+ 알고리즘으로 부정 리뷰를 판별한 다음, MedDRA 표준 의학 용어 사전을 활용해 이상 반응 단어를 찾고, 개체명 인식 기법을 사용하여 구로 표현된 이상 반응 표현을 탐지하였다. 실험을 위해 비스테로이드성 소염진통제 세 종류의 약물 리뷰를 약물 리뷰 사이트로부터 수집하여 테스트하였으며, 실험 결과는 약물 리뷰를 통한 약물 이상 반응 탐지가 현재의 약물 감시 체계의 한계점을 보완할 수 있음을 보여준다.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 2002년도 제11차 추계학술대회
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• pp.11-11
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• 2002

• 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.

• 한국임상약학회지
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• 제16권2호
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• pp.155-164
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• 2006

Great inter-variability in drug response and adverse drug reactions is related to inter-variability of drug bioavailability, drug interaction and patient's disease and physyological state that cause change in absorption, distribution, metabolism and excretion of drugs. However, these alone do not sufficiently predict and explain inter-variability in drug response. In recent studies, it is reported that inter-variability in drug response and adverse drug reactions may largely resulted from genetically determined differences in drug absoption, distribution, metabolism and drug target proteins. Especially, the major human drug-metabolizing enzymes such as CYP450, N-acetyl tranferase, thiopurine S-methyl transferase, glutathione S-transferase are identified as the major gene variants that cause inter-individual variability in drug's response and adverse drug reactions. These variations may have most significant implications for those drugs that have narrow therapeutic index and serious adverse drug reactions. Therefore, the genetic variation such as polymorphisms in drug metabolizing enzymes can affect the response of individuals to drugs that are used in the treatment of depression, psychosis, cancer, cardiovascular disorders, ulcer and gastrointestinal disorders, pain and epilepsy, among others. This review describes the pharmacogenomics of the drug metabolizing enzymes associated with the drug response and its clinical applications.