의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석

Comparison of WHO-ART Versus MedDRA, Internationally Standardized Terminology of Adverse Drug Reaction Classification

  • 임경화 (숙명여자대학교 약학대학) ;
  • 신현택 (숙명여자대학교 약학대학) ;
  • 손현순 (숙명여자대학교 약학대학) ;
  • 전효정 (숙명여자대학교 약학대학) ;
  • 이주현 (숙명여자대학교 약학대학) ;
  • 이유정 (숙명여자대학교 의약정보연구소) ;
  • 이영숙 (숙명여자대학교 의약정보연구소) ;
  • 송인숙 (숙명여자대학교 의약정보연구소)
  • Lim, Kyung-Hwa (College of Pharmacy, Sookmyung Women's University) ;
  • Shin, Hyun-Taek (College of Pharmacy, Sookmyung Women's University) ;
  • Sohn, Hyun-Soon (College of Pharmacy, Sookmyung Women's University) ;
  • Jun, Hyo-Jung (College of Pharmacy, Sookmyung Women's University) ;
  • Lee, Joo-Hyun (College of Pharmacy, Sookmyung Women's University) ;
  • Lee, Yoo-Jung (Drug Information Research Institute, Sookmyung Women's University) ;
  • Lee, Young-Sook (Drug Information Research Institute, Sookmyung Women's University) ;
  • Song, In-Sook (Drug Information Research Institute, Sookmyung Women's University)
  • 발행 : 2007.06.30

초록

This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate internationally standardized classifications (WHO-ART or MedDRA). We collected the relevant information on ADR terminology systems including WHO-ART and MedDRA by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For MedDRA, project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization). Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and MedDRA) were compared in the views of acceptability, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART was selected.

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