Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea

의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식

  • Lee, Iyn-Hyang (College of Pharmacy, Yeungnam University) ;
  • Kye, Seunghee (Department of Preventive Medicine & Public Health, School of Medicine, Ajou University) ;
  • Je, Nam Kyung (College of Pharmacy, Pusan National University) ;
  • Lee, Sukhyang (College of Pharmacy, Ajou University)
  • 이인향 (영남대학교 약학대학) ;
  • 계승희 (아주대학교 의과대학 예방의학교실) ;
  • 제남경 (부산대학교 약학대학) ;
  • 이숙향 (아주대학교 약학대학)
  • Received : 2014.07.23
  • Accepted : 2014.10.17
  • Published : 2014.12.31
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Abstract

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public's perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

Keywords

References

  1. Brosgart CL, Mitchell T, Charlebois E, et al. Off-label drug use in human immunodeficiency virus disease. J Acquir Immune Defic Syndr Hum Retrovirol 1996;12(1):56-62. https://doi.org/10.1097/00042560-199605010-00008
  2. Haw C, Stubbs J. A survey of the off-label use of mood stabilizers in a large psychiatric hospital. J Psychopharmacol 2005;19(4):402-7. https://doi.org/10.1177/0269881105053307
  3. Leslie DL, Rosenheck R. Off-label use of antipsychotic medications in medicaid. Am J Manag Care 2012;18(3): e109-17.
  4. Lindell-Osuagwu L, Korhonen MJ, Saano S, et al. Offlabel and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther 2009;34(3):277-87. https://doi.org/10.1111/j.1365-2710.2008.01005.x
  5. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166(9): 1021-26. https://doi.org/10.1001/archinte.166.9.1021
  6. Stafford RS. Regulating Off-Label Drug Use--Rethinking the Role of the FDA. New Engl J Med 2008;358(14):1427-29. https://doi.org/10.1056/NEJMp0802107
  7. Turner S. Unregistered and off-label drug use in paediatric inpatients Aust J Hosp Pharm 1999;29(5):265-68. https://doi.org/10.1002/jppr1999295265
  8. Goldberg AB, Greenberg MB, Darney PD. Misoprostol and pregnancy. New Engl J Med 2001;344(1):38-47. https://doi.org/10.1056/NEJM200101043440107
  9. Liang BA, Mackey T. Health care policy. Reforming offlabel promotion to enhance orphan disease treatment. Science 2010;327(5963):273-4. https://doi.org/10.1126/science.1181567
  10. Stone KJ, Viera AJ, Parman CL. Off-label applications for SSRIs. Am Fam Physician 2003;68(3):498-504.
  11. Weeks AD, Fiala C, Safar P. Misoprostol and the debate over off-label drug use. Int J Obstet Gynaecol 2005;112(3): 269-72. https://doi.org/10.1111/j.1471-0528.2004.00490.x
  12. Shin JY, Jung SY, Park BJ. Off-label drug use and its implications for evidence-based decising making. J Pharmacoepidem Risk Manage 2010;3:1-6.
  13. Novak E, Allen PJ. Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics. Pediatr Nurs 2007;33(1):64-70.
  14. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf 2006;5(5):703-18. https://doi.org/10.1517/14740338.5.5.703
  15. Maglione M, Maher AR, Hu J, et al. Off-Label Use of Atypical Antipsychotics: An Update. Rockville (MD): Agency for Healthcare Research and Quality (US), 2011.
  16. Mason J, Pirmohamed M, Nunn T. Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature. Eur J Clin Pharmacol 2012;68(1):21-8. https://doi.org/10.1007/s00228-011-1097-1
  17. Ufer M, Kimland E, Bergman U. Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf 2004;13(3):147-52. https://doi.org/10.1002/pds.858
  18. Steinman MA, Bero LA, Chren MM, et al. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med 2006;145(4):284-93. https://doi.org/10.7326/0003-4819-145-4-200608150-00008
  19. Ventola CL. Off-label drug information: regulation, distribution, evaluation, and related controversies. P T 2009; 34(8):428-40.
  20. Wilkes M, Johns M. Informed consent and shared decision-making: A requirement to disclose to patients offlabel prescriptions. PLoS Medicine 2008;5(11):1553-56.
  21. Lee IH, Seo M, Lee YS, et al. Development of regulation system for off-label drug use. Yakhak Hoeji 2014;58(2):112-24.
  22. Dresser R, Frader J. Off-label prescribing: A call for heightened professional and government oversight. J Law Med Ethics 2009;37(3):476-96. https://doi.org/10.1111/j.1748-720X.2009.00408.x
  23. EURORDIS. EURORDIS response to the European Commission Public Consultation "Legal proposal on information to patients". 2008.
  24. Mithani Z. Informed consent for off-label use of presciption medications. Am Med Assoc J Ethics 2012;14(7):576-81.
  25. Meadows WA, Hollowell BD. 'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use. Int J Impot Res 2008;20(2):135-44. https://doi.org/10.1038/sj.ijir.3901619
  26. Mukattash TL, Millership JS, Collier PS, et al. Public awareness and views on unlicensed use of medicines in children. Br J Clin Pharmacol 2008;66(6):838-45. https://doi.org/10.1111/j.1365-2125.2008.03290.x
  27. Bang V, Mallad A, Kannan S, et al. Awareness about and views of parents on the off-label drug use in children. Int J Risk Saf Med 2014;26(2):61-70.
  28. Lenk C, Koch P, Zappel H, et al. Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics. Eur J Pediatr 2009;168(12):1473-8. https://doi.org/10.1007/s00431-009-0956-6