Skip to main content
Have a personal or library account? Click to login
Generic Drugs – Decreasing Costs and Room for Increased Number of Kidney Transplantations Cover

Generic Drugs – Decreasing Costs and Room for Increased Number of Kidney Transplantations

By: Goce Spasovski  
Open Access
|Dec 2015

References

  1. 1. Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999; 341(23): 1725-1730.10.1056/NEJM199912023412303
  2. 2. Barnieh L, Yilmaz S, McLaughlin K, et al. The cost of kidney transplant over time. Prog Transplant. 2014; 24(3): 257-62.10.7182/pit2014710
  3. 3. James A, Mannon RB. The Cost of Transplant Immunosuppressant Therapy: Is This Sustainable? Curr Transplant Rep. 2015; 2(2): 113-121.10.1007/s40472-015-0052-y
  4. 4. Allard J, Fortin MC. Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients? Can J Kidney Health Dis. 2014; 1: 23.
  5. 5. Generic Drugs. Center for Drug evaluation and Research, U.S. Food and Drug Administration. [Cited 2015 July 13rd] Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm127615.pdf.
  6. 6. Generic Drugs. World Health Organisation. [Cited 2015 July 13rd] Available from: http://www.who.int/trade/glossary/story034/en/.
  7. 7. Generic Drugs. The Free Dictionary. [Cited 2015 July 13rd] Available from: http://medicaldictionary.thefreedictionary.com/Drugs%2c+generic.
  8. 8. EFPIA. The Pharmaceutical Industry in Figures, key data 2014. [Cited 2015 July 13rd] Available from: http://www.efpia.eu/uploads/Figures_2014_Final.pdf.
  9. 9. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther. 2003; (11): 2875-90.10.1016/S0149-2918(03)80340-5
  10. 10. Gondos A, Döhler B, Brenner H, Opelz G. Kidney graft survival in Europe and the United States: strikingly different long-term outcomes. Transplantation. 2013; 95(2): 267-74.10.1097/TP.0b013e3182708ea823060279
  11. 11. Roodnat JI, Hilbrands LB, Hené RJ, et al. 15-year follow-up of a multicenter, randomized, calcineurin inhibitor withdrawal study in kidney transplantation. Transplantation. 2014; 98(1): 47-53.10.1097/01.TP.0000442774.46133.7124521775
  12. 12. Gaynor JJ, Ciancio G, Guerra G, et al. Graft failure due to noncompliance among 628 kidney transplant recipients with long-term follow-up: a single-center observational study. Transplantation. 2014; 97(9): 925-33.10.1097/01.TP.0000438199.76531.4a24445926
  13. 13. Couzi L, Moulin B, Morin MP, et al. Factors predictive of medication nonadherence after renal transplantation: a French observational study. Transplantation. 2013; 95(2): 326-32.10.1097/TP.0b013e318271d7c123149477
  14. 14. Tamargo J, Le Heuzey JY, Mabo P. Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide. Eur J Clin Pharmacol. 2015; 71(5): 549-567.10.1007/s00228-015-1832-0441268825870032
  15. 15. Verbeeck RK, Musuamba FT. The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action. J Pharm Pharm Sci. 2012; 15(3): 376-88.10.18433/J3VC8J
  16. 16. Lionberger R, Jiang W, Huang SM, Geba G: Confidence in generic drug substitution. Clin Pharmacol Ther. 2013; 94: 438-440.10.1038/clpt.2013.10424048239
  17. 17. van Gelder T, Gabardi S. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs. Transpl Int. 2013; 26: 771-7.10.1111/tri.1207423441971
  18. 18. Waiser J, Slowinski T, Brinker-Paschke A, et al. Impact of the variability of cyclosporin A trough levels on long-term renal allograft function. Nephrol Dial Transplant. 2002; 17(7): 1310-7.10.1093/ndt/17.7.131012105257
  19. 19. Spasovski G, Masin-Spasovska J, Ivanovski N. Do we have the same clinical results with Neoral and Equoral treatment in kidney transplant recipients? A pilot study. Transpl Int. 2008; 21(4): 392-4.10.1111/j.1432-2277.2007.00612.x18069921
  20. 20. Borra LC, Roodnat JI, Kal JA, et al. High withinpatient variability in the clearance of tacrolimus is a risk factor for poor long-term outcome after kidney transplantation. Nephrol Dial Transplant. 2010; 25(8): 2757-63.10.1093/ndt/gfq09620190242
  21. 21. Sellarés J, de Freitas DG, Mengel M, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012; 12(2): 388-99.10.1111/j.1600-6143.2011.03840.x22081892
  22. 22. Vítko S, Ferkl M. Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial. Kidney Int Suppl. 2010; (115): S12-6.10.1038/ki.2009.50620150905
  23. 23. Alloway RR, Sadaka B, Trofe-Clark J, et al. A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients. Am J Transplant. 2012; 12(10): 2825-2831.10.1111/j.1600-6143.2012.04174.x347202022759200
  24. 24. Melilli E, Crespo E, Sandoval D, et al. De novo use of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring. Transpl Int. 2015; 28(11): 1283-90.10.1111/tri.1262626088437
  25. 25. Molnar AO, Fergusson D, Tsampalieros AK, et al. Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis. BMJ. 2015; 350: h3163.10.1136/bmj.h3163447631726101226
  26. 26. Johnston A. Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation. Eur J Hosp Pharm Sci Pract. 2013; 20(5): 302-307.10.1136/ejhpharm-2012-000258378663024089632
  27. 27. Harrison JJ, Schiff JR, Coursol CJ, et al. Generic immunosuppression in solid organ transplantation: a Canadian perspective. Transplantation. 2012; 93: 657-665.10.1097/TP.0b013e3182445e9d22267158
  28. 28. Alloway RR, Isaacs R, Lake K, et al. Report of the American Society of Transplantation conference on immunosuppressive drugs and the Use of generic immunosuppressants. Am J Transplant. 2003; 3: 1211-1215.10.1046/j.1600-6143.2003.00212.x14510694
  29. 29. Gordon EJ, Prohaska TR, Sehgal AR. The financial impact of immunosuppressant expenses on new kidney transplant recipients. Clin Transplant. 2008; 22: 738-748.10.1111/j.1399-0012.2008.00869.x259249418673373
  30. 30. van Gelder T. European Society for Organ Transplantation Advisory Committee recommendations on generic substitution of immunosuppressive drugs. Transpl Int. 2011; 24: 1135-1141.10.1111/j.1432-2277.2011.01378.x22032583
  31. 31. Minogue B. The two fundamental duties of the physician. Acad Med. 2000; 75: 431-442.10.1097/00001888-200005000-0000910824765
  32. 32. Maynard A. Health care rationing: doing it better in public and private health care systems. J Health Polit Policy Law. 2013; 38: 1103-1127.10.1215/03616878-237315723974472
  33. 33. Devaney A, Lee M. The use of generic immunosuppression for transplant patients: a UK perspective. Eur J Hosp Pharm. 2013; 20: 272-274. 10.1136/ejhpharm-2013-000336
DOI: https://doi.org/10.1515/prilozi-2015-0061 | Journal eISSN: 1857-8985 | Journal ISSN: 1857-9345
Language: English
Page range: 133 - 138
Published on: Dec 30, 2015
In partnership with: Paradigm Publishing Services
Publication frequency: 3 issues per year

© 2015 Goce Spasovski, published by Macedonian Academy of Sciences and Arts
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.