한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제31권1호
  • /
  • Pages.21-26
  • /
  • 2021
  • /
  • 1226-6051(pISSN)
  • /
  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
권호 표지
DOI QR코드

DOI QR Code

국내 허가사항에 반영된 약물 유전정보 분석

Analysis of Pharmacogenetic Information in Korea Drug Labels

  • 이미진 (순천대학교 약학대학) ;
  • 김수경 (이화여자대학교 임상바이오헬스대학원) ;
  • 이정 (이화여자대학교 약학대학) ;
  • 곽혜선 (이화여자대학교 임상바이오헬스대학원) ;
  • 최경희 (순천대학교 약학대학)
  • Lee, Mijin (College of Pharmacy, Sunchon National University) ;
  • Kim, Sukyung (Graduate School of Clinical Biohealth, Ewha Womans University) ;
  • Yee, Jeong (College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University) ;
  • Gwak, Hye Sun (Graduate School of Clinical Biohealth, Ewha Womans University) ;
  • Choi, Kyung Hee (College of Pharmacy, Sunchon National University)
  • 투고 : 2020.09.23
  • 심사 : 2020.12.27
  • 발행 : 2021.03.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background: Pharmacogenomics is the study of how genetic mutations in patients affect their response to drugs. Pharmacogenomic studies aim to maximize drug effects and minimize adverse drug events. The Food and Drug Administration and the European Medicine Agency published guidelines for pharmacogenetics in 2005 and 2006, respectively; the Korean Ministry of Food and Drug Safety followed suit in 2015. Methods: This study analyzed pharmacogenomic information in the Korean Ministry of Food and Drug Safety's integrated drug information system to evaluate whether domestic pharmaceutical products reflect the current research on pharmacogenomic differences. Results: In June 2020, the Korean pharmacogenomic database contained genomic data on 90 compounds. Of these, 45 compounds were classified as "Antineoplastic and immunomodulating agents." The other 45 non-antineoplastic agents were in the following categories: Anti-infectives, Mental & behavior disorder, Hormone & metabolism related diseases, Cardiovascular system, Skin & subcutaneous tissue disease, Genito-urinary system and sex hormones, Blood and blood forming organs, Nervous system, Alimentary tract and metabolism, Musculo-skeletal system, and Other conditions including the respiratory system. In addition, 30 additives unrelated to the main ingredient were associated with genetic precautions. Conclusion: This study showed that antineoplastic and immunomodulating agents accounted for half the drugs associated with pharmacogenetic information. For antitumor and immunomodulatory drugs, genomic tests were recommended depending on the indication; this was in contrast to genomic testing recommendations for non-antineoplastic medications. Genomic tests were rarely requested or recommended for non-antineoplastic medications because the relationships between genotype and efficacy among those drugs were relatively weak.

키워드

참고문헌

  1. Ginsburg GS, Phillips KA. Precision medicine: From science to value. Health Aff (Millwood) 2018;37(5):694-701. https://doi.org/10.1377/hlthaff.2017.1624
  2. Jameson JL, Longo DL. Precision medicine-personalized, problematic, and promising. N Engl J Med 2015;372(23):2229-34. https://doi.org/10.1056/NEJMsb1503104
  3. Sadee W. Pharmacogenomics: Harbinger for the era of personalized medicine? Mol interv 2005;5(3):140-3. https://doi.org/10.1124/mi.5.3.1
  4. Hess GP, Fonseca E, Scott R, Fagerness J. Pharmacogenomic and pharmacogenetic-guided therapy as a tool in precision medicine: current state and factors impacting acceptance by stakeholders. Genet Res (Camb) 2015;97:e13. https://doi.org/10.1017/S0016672315000099
  5. Whirl-Carrillo M, McDonagh EM, Hebert J, et al. Pharmacogenomics knowledge for personalized medicine. Clin Pharmacol Ther 2012;92(4):414-7. https://doi.org/10.1038/clpt.2012.96
  6. Wake DT, Ilbawi N, Dunnenberger HM, Hulick PJ. Pharmacogenomics: prescribing precisely. Med Clin North Am 2019;103(6):977-90. https://doi.org/10.1016/j.mcna.2019.07.002
  7. Silber BM. Pharmacogenomics, biomarkers, and the promise of personalized medicine, In: Kalow W, Meyer UA, Tyndale RF, eds. Pharmacogenomics. New York: Marcel Dekker Inc, 2001:11-32.
  8. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5. https://doi.org/10.1001/jama.279.15.1200
  9. Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 2001;286(18):2270-9. https://doi.org/10.1001/jama.286.18.2270
  10. Alvarado I, Wong M, Licinio J. Advances in the pharmacogenomics of adverse drug reactions. Pharmacogenomics J 2002;2(5):273. https://doi.org/10.1038/sj.tpj.6500142
  11. Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet 2000;356(9242):1667-71. https://doi.org/10.1016/S0140-6736(00)03167-6
  12. Choi JR, Kim J-O, Kang DR, et al. Proposal of pharmacogenetics-based warfarin dosing algorithm in Korean patients. J Hum Genet 2011;56(4):290-5. https://doi.org/10.1038/jhg.2011.4
  13. Johnson JA, Caudle KE, Gong L, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for pharmacogenetics-guided warfarin dosing: 2017 Update. Clin Pharmacol Ther 2017;102(3):397-404. https://doi.org/10.1002/cpt.668
  14. Shendre A, Dillon C, Limdi NA. Pharmacogenetics of warfarin dosing in patients of African and European ancestry. Pharmacogenomics 2018;19(17):1357-71. https://doi.org/10.2217/pgs-2018-0146
  15. Kaye JB, Schultz LE, Steiner HE, Kittles RA, Cavallari LH, Karnes JH. Warfarin pharmacogenomics in diverse populations. Pharmacotherapy 2017;37(9):1150-63. https://doi.org/10.1002/phar.1982
  16. Beutler E, Duparc S ; G6PD Deficiency Working Group. Glucose-6-phosphate dehydrogenase deficiency and antimalarial drug development. Am J Trop Med Hyg 2007;77(4):779-89. https://doi.org/10.4269/ajtmh.2007.77.779
  17. Shin J, Johnson JA. Pharmacogenetics of β-Blockers. Pharmacotherapy 2007;27(6):874-87. https://doi.org/10.1592/phco.27.6.874
  18. Parry HM, Doney AS, Palmer CN, Lang CC. State of play of pharmacogenetics and personalized medicine in heart failure. Cardiovasc Ther 2013;31(6):315-22. https://doi.org/10.1111/1755-5922.12030
  19. Arranz MJ, Gonzalez-Rodriguez A, Perez-Blanco J, et al. A pharmacogenetic intervention for the improvement of the safety profile of antipsychotic treatments. Transl Psychiatry 2019;9(1):177. https://doi.org/10.1038/s41398-019-0511-9
  20. Voskuil MD, Bangma A, Weersma RK, Festen EAM. Predicting (side) effects for patients with inflammatory bowel disease: The promise of pharmacogenetics. World J Gastroenterol 2019;25(21):2539-48. https://doi.org/10.3748/wjg.v25.i21.2539
  21. Paez D, Tobena M, Fernandez-Plana J, et al. Pharmacogenetic clinical randomised phase II trial to evaluate the efficacy and safety of FOLFIRI with high-dose irinotecan (HD-FOLFIRI) in metastatic colorectal cancer patients according to their UGT1A 1 genotype. Br J Cancer 2019;120(2):190-5. https://doi.org/10.1038/s41416-018-0348-7
  22. Hiratsuka M, Sasaki T, Mizugaki M. Genetic testing for pharmacogenetics and its clinical application in drug therapy. Clin Chim Acta 2006;363(1-2):177-86. https://doi.org/10.1016/j.cccn.2005.05.047
  23. US Food and Drug Administration. Table of Pharmacogenomic Biomarkers in Drug Labeling. Available from https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomicbiomarkers-drug-labeling. Accessed May 18, 2020.
  24. Ministry of Food and Drug Safety. Pharmacogenomic information of Korean. Available from https://nedrug.mfds.go.kr/pbp/CCBBK03. Accessed June 23, 2020.
  25. Lee JH, Je MK, Cho MJ, Son HS. Trends in the use of big data in the health care field. The Journal of Korean Institute of Communications and Information Sciences 2014;32(1):63-75.
  26. Kim Y-J, Jung S, Choi N, et al. Benzodiazepine prescription patterns for the elderly patients at ambulatory care in Korea. Korean Society for Pharmacoepidemiology and Risk Management 2008;1(1):60-7.
  27. Ozawa S. Drug-drug interactions with consideration of pharmacogenetics. Yakugaku Zasshi 2018;138(3):365-71. https://doi.org/10.1248/yakushi.17-00191-5
  28. Evans WE, Relling MV. Pharmacogenomics: translating functional genomics into rational therapeutics. Science 1999;286(5439):487-91. https://doi.org/10.1126/science.286.5439.487
  29. Gnanasakthy A, Barrett A, Evans E, D'Alessio D, Romano CD. A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012-2016). Value Health 2019;22(2):203-9. https://doi.org/10.1016/j.jval.2018.09.2842
  30. Jung NH. A study on the improvement of pharmacogenomics guidance in Korea. M.S. Thesis for Pharmacy. Seoul National University. 2019.
  31. National Institute of Food and Drug Safety Evaluation. Pharmacogenomic biomarker qualification guidelines. Available from http://www.nifds.go.kr/brd/m_15/view.do?seq=9116&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=28. Accessed August 12, 2020.
  32. Kalia M. Biomarkers for personalized oncology: recent advances and future challenges. Metabolism 2015;64(3 Suppl 1):S16-21. https://doi.org/10.1016/j.metabol.2014.10.027
  33. Schuck RN, Grillo JA. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling. AAPS J 2016;18(3):573-7. https://doi.org/10.1208/s12248-016-9891-4
  34. Vivot A, Boutron I, Ravaud P, Porcher R. Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs. Genet Med 2015;17(9):733-8. https://doi.org/10.1038/gim.2014.181