임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

약물이상반응의 인과성 평가를 위한 한국형 알고리즘의 개발

Development of a Korean Algorithm for Causality Assessment of Adverse Drug Reactions

  • 홍경섭 (서울대학교병원 임상약리실,서울대학교병원 임상시험센터,서울대학교 의과대학 예방의학교실) ;
  • 신상구 (서울대학교병원 임상약리실,서울대학교병원 임상시험센터) ;
  • 양재석 (식품의약품안전청) ;
  • 이승미 (서울대학교 의과대학 예방의학교실) ;
  • 김윤이 (서울대학교 의과대학 예방의학교실) ;
  • 서화정 (서울대학교 의과대학 예방의학교실) ;
  • 김주한 (서울대학교 의과대학 예방의학교실) ;
  • 박병주 (서울대학교병원 임상시험센터,서울대학교 의과대학 예방의학교실)
  • Hong, Kyoung-Sup (Clinical Pharmacology Unit, Seoul National University Hospital,Clinical Trial Center, Seoul National University Hospital,Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Shin, Sang-Goo (Clinical Pharmacology Unit, Seoul National University Hospital,Clinical Trial Center, Seoul National University Hospital) ;
  • Yang, Jae-Seok (Korea Food and Drug Administration) ;
  • Lee, Seung-Mi (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Kim, Yoon-I (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Seo, Hwa-Jeong (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Kim, Ju-Han (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Park, Byung-Joo (Clinical Trial Center, Seoul National University Hospital,Department of Preventive Medicine, Seoul National University College of Medicine)
  • 발행 : 2002.12.30

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초록

Background : According to the study conducted on hospitalized patients in the United States, there were more than 2,000,000 serious ADRs in hospitalized patients, causing over 100,000 deaths annually. If true, then ADR is the $4^{th}$ leading cause of death in the United States. In Korea, ADR monitoring system has not been activated. ADR monitoring system in the Seoul National University Hospital and Korean Medical Association, representing the nationwide clinicians, was initiated on May 2001 and on May 2002, respectively. Until Oct $1^{st}$ 2002, only 30 cases, 16 cases from the Seoul National University Hospital and 14 cases from the Korean Medical Association were reported. At present, rapid and valid review, resulting in helpful feedback to the reporters is essential for the activation of ADRs monitoring system in Korea. In the same context, the algorithm, easy-to-use and in Korean, for the initial causality assessment became necessary. Methods : In this study, a draft algorithm was constructed after reviewing the three current algorithms: Naranjo, French, and RUCAM. Then a study was conducted to evaluate the validity and reliability of the algorithm. The test was done with three target users, a physician majoring in internal medicine, a general physician and pharmacist majoring in Pharmacoepidemiology, assessed the causality of the reported 26 ADR cases with the algorithm as test reviewers. Finally, the results were compared with the gold standard, the decision of the Committee for Drug Safety within the Korean Medical Association. Results : The average sensitivity and specificity was 96%, 38% respectively. According to the result of the test-retest reliability with Pearson correlation coefficient, two of 3 test reviewers showed significant correlations. Conclusion : The Korean Algorithm seemed to be valid and reliable. But it is important to make an additional effort to modify and update the Korean Algorithm. The development of the Korean Algorithm must be the first step to establish the Adverse Drug Monitoring System in Korean.

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