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

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

의약품 자발적 부작용 보고자료의 통계처리 시스템

Statistical Analysis System of Spontaneous Adverse Drug Reaction Reports

  • 김시라 (가톨릭대학교 의료경영대학원 의료정보학과) ;
  • 왕보람 (가톨릭대학교 의료경영대학원 의료정보학과) ;
  • 이정선 (서울성모병원 약제부) ;
  • 김보리 (서울성모병원 약제부) ;
  • 나현오 (가톨릭 의과대학 약리학교실) ;
  • 박영민 (서울성모병원 피부과) ;
  • 최인영 (가톨릭대학교 의료경영대학원 의료정보학과)
  • Kim, Sira (Graduate School of Healthcare Management and Policy) ;
  • Wang, Boram (Graduate School of Healthcare Management and Policy) ;
  • Lee, Jungsun (Seoul St' Mary Hospital) ;
  • Kim, Bori (Seoul St' Mary Hospital) ;
  • La, Hyeno (Dept. of Pharmacology, The Catholic of the University, Catholic Medical Center) ;
  • Park, Young Min (Dept. of Dermatology, The Catholic of the University, Catholic Medical Center) ;
  • Choi, Inyoung (Graduate School of Healthcare Management and Policy)
  • 투고 : 2012.10.19
  • 심사 : 2012.11.20
  • 발행 : 2012.12.31
⟨ 이전 논문 다음 논문 ⟩

초록

Background: Spontaneous adverse drug reaction (ADR) reporting data has been used for safety of post-market drug surveillance. A system has been required that is able to detect signals associated with drugs by analyzing the collected ADR data. Methods: We developed the web-based automated analysis system (ADR-detector). We used the data which reported ADR spontaneously between March 2009 and December 2010 to Korean Food and Drug Administration. We used 3 statistical indicators for evaluating ADR signals: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The ADR reports which were detected as significant signals based on the indicators have been reviewed. Results: Among 153,774 reports, 9,955 cases were related to 4 analgesics which were most frequently reported analgesic drugs during the study period. The numbers of ADR reports associated with each drug are as follow: 5,623 reports in tramadol (56.5 %), 1,720 reports in fentanyl (17.3 %), 1,463 reports in tramadol-combination (14.7 %), and 1,149 reports in ketorolac (11.5 %). Top 5 ADR were nausea (3,351 reports - 33.7 %), vomiting (1,755 reports - 17.6 %), dizziness (1,130 - 11.4 %), rash (412 reports - 4.1 %), and pruritus (354 reports - 3.6 %). 6,674 ADR reports were significant based on PRR and ROR, and 336 reports were significant based on IC. Conclusion: By using the automated analysis system, not only statisticians but also general researchers are able to analyze ADR signals in real-time. Also ADR-detector would provide rapid review and cross-check of ADR.

키워드

과제정보

연구 과제 주관 기관 : 식품의약품안전청

참고문헌

  1. 박병주. 의약품 이상반응 자료의 분석방법 연구. 식품의약품안전청 용역연구사업 연구결과보고서, 2007;7-14.
  2. Park S, Chae SM. Social Relief Scheme for Serious Adverse Drug Reactions-Lessons from other countries for Korea. Kor J Clin Pharmacol Ther, 2008;18(1):18-27. (Korean)
  3. Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med, 1991;84(6):341-344.
  4. 2007년도 식품의약품통계연보. 제9호, 식품의약품 안전청, 2007;205-207.
  5. 김영식. 의약품 유해반응 모니터링 활성화 방안 연구 사업. 제12권, 식품의약품안전청 연구보고서, 2008;611-612.
  6. Seong JM, Choi NK, Jung SY, Kim YJ, Lee JY, Park BJ. Signal Detection of Sildenafil in Korean Spontaneous Adverse Event Reports. Kor Soc Pharmacoepidemiol Risk Manag, 2009;2(1):38-44. (Korean)
  7. Van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidem Dr S, 2002;11(1):3-10. https://doi.org/10.1002/pds.668
  8. Song YJ, Ha CW. The Use of COX-2 Selective Nonsteroidal Anti-inflammatory Drugs for the Treatment of Osteoarthritis. J Korean Knee Soc, 2009;21(2):84-92. (Korean)
  9. Ha JH. Risk signal detection of marketed NSNNAs (non-steroidal and non-narcotic analgesics). Doctoral Dissertation Sungkyun Kwan University, 2011. (Korean)
  10. Kim MG, Kang HR, Kim JH, Ju YS, Park SH, Hwang YI, Jang SH, Kim DG, Jung KS. Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital. Korean J Med, 2009:77(5):601-609. (Korean)
  11. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidem Dr S, 2001; 10(6):483-486. https://doi.org/10.1002/pds.677
  12. Egberts AC, Meyboom RH, van Puijenbroek EP. Use of meaures of disproportionality in pharmacovigilance: three Dutch examples.Pharmacoepidem Dr S, 2002; 25(6):453-458.
  13. Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RH. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Pharmacoepidem Dr S, 2000;23(6): 533-542.
  14. Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ, 1998;316:1295-1298. https://doi.org/10.1136/bmj.316.7140.1295
  15. Einarson TR. Drug-related hospital admissions. Ann Pharmacother, 1993;27(7):832-840. https://doi.org/10.1177/106002809302700702
  16. Morimoto T, Gandhi TK, Segar AC, Hsieh TC, Bates DW. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care, 2004;13:306-314. https://doi.org/10.1136/qshc.2004.010611
  17. Eva Kopecna, Veronika Descikova, Jiri Vlcek, Jana Mlada. Adverse drug reaction reporting in the Czech Republic 2005-2009. Int J Clin Pharm, 2011;33(4):683-689. https://doi.org/10.1007/s11096-011-9527-9