• 한국컴퓨터정보학회논문지
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• 제14권3호
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• pp.183-192
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• 2009

약물부작용감시시스템 (Adverse drug event surveillance system)은 약물부작용신호를 이용하여 약물의 부작용 여부를 식별하는 시스템이다. 기존의 자발적 보고나 차트리뷰 보다 효율성이 뛰어난 시스템으로 분류할 수 있다. 본 논문에서는 약물부작용감시시스템을 구현하기 위하여 임상데이터마트(GDM)를 구축하였다. 특히, 데이터 품질관리 기법을 적용하여 구축된 CDM에 지식 탐사 기법 중 비교사학습 기법으로 적용하여 모델의 재현성을 평가하여 최적의 약물부작용 군집화 개수(n=4)를 도출하였다. 군집화 개수(n=4)를 이용하여 약물부작용 판별을 위한 K-means, Kohonen, two-step clustering model 알고리즘에 적용하여 분석함으로써 K-means 알고리즘이 가장 우수한 군집 효과를 나타냄을 확인하였다.

• 약학회지
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• 제50권3호
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• 한국콘텐츠학회논문지
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• 제9권2호
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• pp.106-114
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• 2009

본 연구에서는 국내 약물부작용감시시스템 연구의 활성화 및 상용화를 목표로 약물부작용 시스템 사례를 분석하고 비즈니스인텔리전스(BI) 기술을 적용하여 약물부작용감시시스템의 기술구조를 제시한다. 최근에는 전자적과정(electronic review)과 수동적 리뷰과정(manual review process)을 병행하는 방법으로 약물부작용을 탐지하는 추세이며, 본 연구에서는 BI 기술중 ETL(Extract, Transform, Loading)을 적용하여 CDW(Clinical DataWarehouse)구축하였다. 부작용 판별 결과 처방의사 701명, 대상 환자는 남자 1,528명, 여자 1,531명으로 기간 내 환자는 총 3059명 이었으며 이중에서 약물부작용으로 의심되는 사례는 전체 318,222건 중에서 약 0.6%에 해당하는 2,085건으로 확인되었다. 이를 신호별로 분류하면 단순유형의 T.Bilirubin> 3mg/dL(부작용 유형-LabR0005)가 전체 2085건에서 548건으로 가장 높았다.

• 한국임상약학회지
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• 제14권1호
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• pp.36-45
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• 2004

• 한국임상약학회지
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• 제21권4호
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• pp.383-389
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• 2011

약물요법에 있어 약물이상반응은 환자의 사망률과 이환율에 영향을 미치는 중요한 요인이다. 약물이상반응 발생시 이를 신속히 보고하는 것과 함께 약물치료과정에서 일어날 수 있는 약물 관련부작용을 조기에 인지하고 능동적으로 조치함으로써 환자에게 가해지는 위해를 최소화하는 것 또한 실제 환자치료의 질적인 관리에서 중요한 부분이다. 본 연구에서는 의료기록의 전산화에 따른 전산데이터들을 활용한 약물이상반응감시방법 중 하나로 평가 받고 있는 Computerized surveillance system (CSS)에 대한 사례 연구들의 방법들을 비교해 보고, 제시된 관련 시그널들 중 약물이상반응을 능동적인 방법 즉 실시간 혹은 예방적으로 적용 가능한 시그널들을 찾아 정리해 보고자 하였다. 이를 위해 가장 대표적인 연구가 진행되었던 연구사례들을 분석하였고 약 20여 개의 시그널들을 선정하여 분야별로 제시하였다.

• 대한한의학회지
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• 제36권1호
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.