의약품 부작용의 심각도 조사 비교분석

Measuring the Seriousness of Adverse Drug Reactions : Comparisons between Korean Experts and WHO Working Group Members

  • 이진이 (숙명여자대학교 임상약학대학원) ;
  • 박세영 (숙명여자대학교 임상약학대학원) ;
  • 허지행 (숙명여자대학교 임상약학대학원) ;
  • 박미혜 (숙명여자대학교 임상약학대학원) ;
  • 하지혜 (식품의약품안전평가원, 임상연구과) ;
  • 이의경 (숙명여자대학교 임상약학대학원)
  • Rhee, Jin-Nie (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Park, Se-Young (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Heo, Ji-Haeng (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Park, Mi-Hae (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Ha, Ji-Hye (Clinical Research Division, National Institute of Food & Drug Safety Evaluation (NIFDS)) ;
  • Lee, Eui-Kyung (Graduate School of Clinical Pharmacy, Sookmyung Women's University)
  • 투고 : 2011.05.16
  • 심사 : 2011.07.05
  • 발행 : 2011.09.30

초록

This study measures seriousness of adverse drug reactions (ADRs) among Korean physicians and pharmacists using two times surveys based on Delphi technique. Each participant scored 20 ADR terms on a scale of one to ten (10 being the most serious). We repeated the exercise for the 49 first survey respondents and 32 re-evaluated score. We compared the results of our survey with those of WHO CIOMS (Council for International Organization of Medical Sciences) working groups members conducted in 1995. The overall mean ADR seriousness score was 6.49 for Koreans and 5.12 for WHO CIOMS members, presenting Korean experts perceived more seriously for each ADR. Mean score changes for the same respondents showed similar trends regardless of access to the first survey results. There were no statistically significant score differences between the physicians and the pharmacists. The high consensus of seriousness for each ADR between the Korean experts and the WHO CIOMS members implies that the similar results are reproducible, suggesting the possibility of developing standardized tools for measuring the seriousness of individual ADRs in the future.

키워드

참고문헌

  1. World Health Organization (WHO), Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals, In: Report of CIOMS Working Group IV; Geneva: 1998.
  2. 이의경 외, 의약품의 시판 후 안전관리를 위한 Risk- Benefit 분석 기반 연구, 식품의약품안전평가원, 2009.
  3. 최윤희, 손의동. 3차 병원에서 보고된 의약품 부작용 현황 조사와 약물 부작용 관리를 위한 약사의 인식도 조사. 한국임상약학회지 2003; 13(2): 72-81.
  4. 이의경 외, 의약품 안전관리 선진화 및 제약산업 경쟁력 강화를 위한 중장기 전략개발 연구, 식품의약품안전평가원, 2010.
  5. King P, Dolan P, Martinex C, Adjusting outcomes for quality: scaling the severity of adverse drug reactions. In: Proceedings of the Annual Meeting of the International Society of Technology Assessment in Health Care Meeting, Barcelona, Spain, May 1997.
  6. 임경화, 신현택, 손현순, et al., 의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석. 한국임상약학회지 2007; 17(1): 46-52.