Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Study for Association between Adverse Drug Reactions and Causative Drugs in the Elderly Using Data-mining Analysis

데이터마이닝 분석을 이용한 노인약물유해반응과 원인약물의 연관성연구

  • Lee, Mee Woo (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital) ;
  • Lee, Jeong Seon (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital) ;
  • Han, Ok Yeon (Department of Pharmacy, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Choi, In Young (Department of Medical Informatics) ;
  • Jeong, Seung Hee (Clinical Research Coordinating Center of Catholic Medical Center) ;
  • Yim, Hyeon Woo (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital) ;
  • Lee, Dong Gun (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital) ;
  • La, Hyen O (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital) ;
  • Park, Young Min (Regional Pharmacovigilance Center of Seoul St. Mary's Hospital)
  • 이미우 (가톨릭대학교 서울성모병원 지역의약품안전센터) ;
  • 이정선 (가톨릭대학교 서울성모병원 지역의약품안전센터) ;
  • 한옥연 (가톨릭대학교 서울성모병원 약제부) ;
  • 최인영 (가톨릭대학교 의료정보학 교실) ;
  • 정승희 (가톨릭중앙의료원 임상연구지원센터) ;
  • 임현우 (가톨릭대학교 서울성모병원 지역의약품안전센터) ;
  • 이동건 (가톨릭대학교 서울성모병원 지역의약품안전센터) ;
  • 나현오 (가톨릭대학교 서울성모병원 지역의약품안전센터) ;
  • 박영민 (가톨릭대학교 서울성모병원 지역의약품안전센터)
  • Received : 2014.01.17
  • Accepted : 2014.03.13
  • Published : 2014.03.31
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older, using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequently implicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate of ADRs due to medications designated as "high-risk" in elderly by 2012 healthcare effectiveness data and information set (HEDIS) or "potentially inappropriate" by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriate medications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and IC showed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causative drug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases were graded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that management of the other medications including contrast media agents as well as close monitoring of PIMs are necessary for reducing ADRs in the elderly.

Keywords

References

  1. Hutchinson TA, Flegel KM, Kramer MS, et al, Frequency, severity and risk factors for adverse drug reactions in adult outpatients: a prospective study. J Chronic Dis 1986; 39:533-42. https://doi.org/10.1016/0021-9681(86)90198-0
  2. Beijer HJ, de Blaey CJ. Hospitalizations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46-54. https://doi.org/10.1023/A:1015570104121
  3. Pirmohamed M, James S, Meakin S, et al, Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. Br Med J 2004; 329: 15-9. https://doi.org/10.1136/bmj.329.7456.15
  4. El Desoky ES. Pharmacokinetic-pharmacodynamic crisis in the elderly. Am J Ther 2007; 14: 488-98. https://doi.org/10.1097/01.mjt.0000183719.84390.4d
  5. McLean AJ, Le Couteur DG. Aging biology and geriatric clinical pharmacology. Pharmacol Rev 2004; 56: 163-84. https://doi.org/10.1124/pr.56.2.4
  6. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for Potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012; 60: 616-31. https://doi.org/10.1111/j.1532-5415.2012.03923.x
  7. National Committee on Quality Assurance. $ HEDIS^{(R)}$ 2012 Final NDC lists: use of high-risk medications in the elderly (DAE). Washington, DC: 2012. Available from: http://www. NCQA.org/HEDISQualityMeasurement/HEDISMeasures/ HEDIS2012/HEDIS2012FinalNDC Lists.aspx. [accessed 2012 November 2].
  8. Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol Drug Saf 1996; 5: 363-75. https://doi.org/10.1002/(SICI)1099-1557(199611)5:6<363::AID-PDS249>3.0.CO;2-7
  9. KFDA. The 13th KFDA statistics annual report, 2011. Available from: http://www.kfda.go.kr/index.kfda?searchkey =title:contents&mid=97&searchword=annualreport&cd=&p ageNo=1&seq=12217&cmd=v. [accessed 2012 November 17]
  10. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10: 483-6. https://doi.org/10.1002/pds.677
  11. Egberts AC, Meyboom RH, van Puijenbroek EP. Use of measures of disproportionality in pharmacovigilance: three Dutch examples. Drug Saf 2002; 25: 453-8. https://doi.org/10.2165/00002018-200225060-00010
  12. Lindquist M, Ståhl M, Bate A, et al, A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf 2000; 23: 533-42. https://doi.org/10.2165/00002018-200023060-00004
  13. Korean society for pharmacoepidemiology and risk management. Pharmacoepidemiology, 1st ed. Seoul: Seoul national university press, 2011: 65-8, 323.
  14. Shalviri G, Mohammad K, Majdzadeh R, et al, Applying quantitiative methods for detecting new drug safety signals in pharmacovigilance national database. Pharmacoepidemiol Drug Saf 2007; 16: 1136-40. https://doi.org/10.1002/pds.1459
  15. Van Puijenbroek EP, Bate A, Leufkens HG, et al, A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 3-10. https://doi.org/10.1002/pds.668
  16. KFDA. Drug use pattern and evaluation for appropriateness in Geriatric patients. 2004. Available from: http://dl.nanet. go.kr/OpenFlashViewer.do [accessed 2012 November 20].
  17. Christiansen C. X-ray contrast media: an overview. Toxicology. 2005; 209: 185-7. https://doi.org/10.1016/j.tox.2004.12.020
  18. Shin MJ, Cho YJ. Management of adverse reaction to iodinated radio contrast media. J Korean Med Assoc 2012; 55: 779-90. https://doi.org/10.5124/jkma.2012.55.8.779
  19. Budnitz DS, Lovegrove MC, Shehab N, et al, Emergency Hospitalizations for adverse drug Events in older Americans. N Engl J Med 2011; 65: 2002-12.