한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제22권1호
  • /
  • Pages.41-46
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  • 2012
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  • 1226-6051(pISSN)
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  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
권호 표지

식품의약품안전청에 보고된 심혈관계 약물유해반응의 특성 분석

Characteristics of Cardiovascular Adverse Drug Reactions Reported to KFDA

  • 투고 : 2011.12.23
  • 심사 : 2012.03.02
  • 발행 : 2012.03.31
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초록

Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

키워드

참고문헌

  1. Bates DW, Cullen DJ, Laird N, et al., Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention. JAMA, 1994; 274(1): 29-34.
  2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279(15): 1200-1205. https://doi.org/10.1001/jama.279.15.1200
  3. Hallas J, Harvald B, Gram LF, et al., Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med. 1990; 228(2): 83-90. https://doi.org/10.1111/j.1365-2796.1990.tb00199.x
  4. http://www.pharmacovigilance.or.kr (Accessed on July 13th, 2011).
  5. http://ezdrug.kfda.go.kr ((Accessed on July 13th, 2011)
  6. Lundkvist J, Jonsson B. Pharmacoeconomics of adverse drug reactions. Fundam Clin Pharmacol. 2004; 18(3): 275- 280 https://doi.org/10.1111/j.1472-8206.2004.00239.x
  7. Pirmohamed M, Park BK. Cytochrome P450 enzyme polymorphisms and adverse drug reactions. Toxicology. 2003; 192(1): 23-32. https://doi.org/10.1016/S0300-483X(03)00247-6
  8. Bates DW, Spell N, Cullen DJ, et al., The cost of adverse drug event in hospitalized patients. Adverse drug events prevention study group. JAMA. 1997; 277(4): 307-311. https://doi.org/10.1001/jama.1997.03540280045032
  9. 손명균, 이용원, 정한영 외. 약물유해반응의 인과관계 판정을 위한 Naranjo와 WHO-UMC 지표의 비교. 대한내과학회지. 2008; 74(2): 181-187.
  10. 김민강, 강혜련, 김주희 외. 단일기관에서 전산을 통해 수집된 자발적 약물유해반응 보고사례들의 분석. 대한내과학회지. 2009; 77(5): 601-609.
  11. 이진이, 박세영, 허지행 외. 의약품 부작용의 심각도 조사 비교 분석. 한국임상약학회지. 2011; 21(3): 237-242.
  12. Fitzgerald GA, Coxibs and cardiovascular disease. N Engl J Med. 2004; 351(17): 1709-1711. https://doi.org/10.1056/NEJMp048288
  13. Schmidt H, Woodcock BG, Geisslinger G. Benefit-risk assessment of rofecoxib in the treatment of osteoarthritis. Drug Saf. 2004; 27(3): 185-196. https://doi.org/10.2165/00002018-200427030-00003
  14. Kaul S, Diamond GA, Diabetes: Breaking news! Rosiglitazone and cardiovascular risk. Nat Rev Cardiol. 2010; 7(12): 670-2. https://doi.org/10.1038/nrcardio.2010.160
  15. Yee MS, Pavitt DV, Dhanjil S, et al., The effects of rosiglitazone on atherosclerotic progression in patients with Type 2 diabetes at high cardiovascular risk. Diabet Med. 2010; 27(12): 1392-1400 https://doi.org/10.1111/j.1464-5491.2010.03089.x
  16. Scheen AJ. Cardiovascular risk-benefit profile of sibutramine. Am J Cardiovasc Drugs. 2010; 10(5): 321-324. https://doi.org/10.2165/11584800-000000000-00000
  17. Broeyer FJ, Osanto S, Ritsema E, et al., Evaluation of biomarkers for cardiotoxicity of anthracyclin-based chemotherapy. J Cancer Res Clin Oncol. 2008; 134(9): 961-968. https://doi.org/10.1007/s00432-008-0372-8
  18. Smith LA, Cornelius VR, Plummer CJ, et al., Cardiotoxicity of anthracycline agents for the treatment of cancer: systematic review and meta-analysis of randomised controlled trials. BMC Cancer. 2010; 10: 337-350. https://doi.org/10.1186/1471-2407-10-337
  19. 임경화, 신현택, 손현순 외. 의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석. 한국임상약학회지. 2007; 17(1): 46-52.
  20. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992; 49(9): 2229-2232.
  21. Tharpe N. Adverse drug reactions in women's health care. J Midwifery Womens Health. 2011; 56(3): 205-213. https://doi.org/10.1111/j.1542-2011.2010.00050.x
  22. Hofer-Dueckelmann C, Prinz E, Beindl W, et al., Adverse drug reactions (ADRs) associated with hospital admissions - elderly female patients are at highest risk. Int J Clin Pharmacol Ther. 2011; 49(10): 577-86. https://doi.org/10.5414/CP201514
  23. 김현아. 약물유해반응 보고에 대한 개국약국 약사들의 태도 및 지식에 관한 연구. 한국임상약학회지. 2009; 19(2): 159-166.
  24. Francisca G, Amaia CL, Beatriz PP, et al., Underreporting of recognized adverse drug reactions by primary care physicians: an exploratory study. Pharmacoepidemiol Drug Saf. 2011; 20(12): 1287-1294. https://doi.org/10.1002/pds.2172
  25. 김정은, 견진옥, 진선민 외. 노인 입원환자에서 발생한 약물유해반응의 특성. 천식 및 알레르기. 2010; 30(3): 216-221.
  26. 최남경, 권혁부, 박병주 외. 자발적 부작용신고제도 인식도 및 약물 유해사례 경험에 대한 설문조사: 고양시 의사 및 약사를 대상으로. 약물역학위해관리학회지. 2008; 1(1): 44-52.
  27. 송홍지, 최남경, 박병주. 약물 부작용 감시와 가정의의 역할. 가정의학회지. 2007; 28(1): 815-823.