• 1
    Drug Shortages: FDA's ability to respond should be strengthened,” testimony, November 21, 2011, before the U.S. Senate, Committee on Health, Education, Labor, and Pensions (United States Government Accountability Office). Text from: Testimony. Available at: Accessed May 23, 2012.
  • 2
    Current Drug Shortages. [Web site]: FDA.; [updated 4/16/12.Available at: Accessed April 16, 2012.
  • 3
    Thomas JM. GAO Report Finds That FDA Needs Increased Authority to Address Shortages. In: Hyman P, and McNamara, eds. FDA Law Blog. 2011..
  • 4
    Aitken M. Prescription Drug Shortages: Examining a Public Heath Concern and Potential Solutions. Parsippany, NJ: IMS Institute for Healthcare Informatics, 2011 December 15, 2011.
  • 5
    Genzyme-Sanofi. US Campath Distribution Program [press release]. 2012.
  • 6
    ISMP. Drug shortages: National Survey reveals high level of frustration, low level of safety. Institue of Safe Medication Practices Medication Safety Alert Acute Care 2010; 15(19).
  • 7
    Kaakeh R, Sweet B, Reilly C et al. Impact of drug shortages on U.S. Health Systems. Am J Health-Syst Pharm 2011; 68: 18111819.
  • 8
    Office of the PressSecretary. Executive Order 13588—Reducing Prescription Drug Shortages. 2011. Available at: Accessed May 18, 2012.
  • 9
    Minimize the Impact of Drug Shortages on Patient Care. 2011. Available at: Accessed May 18, 2012
  • 10
    Hanaway MJ, Woodle ES, Mulgaonkar S et al. Alemtuzumab induction in renal transplantation. N Engl J Med 2011; 364: 19091919.
  • 11
    Soave R. Prophylaxis strategies for solid organ transplantation. Clin Infect Dis 2001; 33(Suppl 1): S26S31.
  • 12
    Martin SI, Fishamn JA, and AST Infectious Disease Community of Practice. Pneumocystis pneumonia in solid organ transplant recipients. Am J Transplant 2009; 9(Suppl 4): S227S233.
  • 13
    Patel R, Paya CV. Infections in solid organ transplant recipients. Clin Microbiol Rev 1997; 10: 86124.
  • 14
    Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med 2004; 351: 27152729.
  • 15
    Micromedex® Healthcare Series [Internet database] [database on the Internet]. Thomson Reuters (Healthcare) Inc.
  • 16
    Al Wakeel JS, Shaheen FA, Mathew MC et al. Six-month clinical outcome of cyclosporine microemulsion formulation (Sigmasporin Microral) in stable renal transplant patients previously maintained on sandimmun neoral. Transplant Proc 2008; 40: 22452251.
  • 17
    Curtis JJ, Lynn M, Jones PA. Neoral conversion from Sandimmune in maintenance renal transplant patients: An individualized approach. J Am Soc Nephrol 1998; 9: 12931200.
  • 18
    Taber DJ, Bailie G, Ashcraft EE et al. Does bioequivalence between modified cyclosporine formulations translate into equal outcomes? Transplantation 2005; 80: 16331635.
  • 19
    Taylor AL, Watson CJE, Bradley A. Immunosuppressive agents in solid organ transplantation: Mechanisms of action and therapeutic efficacy. Crit Rev Oncol/Hematol 2005; 56: 2346.
  • 20
    McGillicsuddy JW, Weimert N, Taber DJ et al. Can preemptive monitoring be as effective as universal prophylaxis when implemented as the standard of care in patients at moderate risk? Transplantation 2010; 89: 12181223.
  • 21
    Luan FL, Kommareddi M, Ojo AO. Universal prophylaxis is cost effective in cytomegalovirus serology-positive kidney transplant patients. Transplantation 2011; 91: 23744.
  • 22
    Chavin KC, Uber L, Baliga P, Rajagopalan P, Coder JB. The effects of prostaglandin E1 on hepatic allograft vascular inflow: A prospective randomized double-blind study. Am Surg 1996; 62: 184187.
  • 23
    Pereira SP, Rowbotham D, Fitt S, Shearer MJ, Wendon J, Williams R. Pharmacokinetics and efficacy of oral versus intravenous mixed-micellar phylloquinone (vitamin K1) in severe acute liver disease. J Hepatol 2005; 42: 365370.
  • 24
    Lubetsky A, Yonath H, Olchovsky D, Loebstein R, Halkin H, Ezra D. Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: A prospective randomized controlled study. Arch Inter Med 2003; 163: 24692473.
  • 25
    Organ Procurment and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2010 Annual Data Report. 2011.
  • 26
    Xia VW, Steadman RH. Antifibrinolytics in orthotopic liver transplantation: current status and controversies. Liver Transplantation 2005; 11: 1018.
  • 27
    Trasylol®. Available at: Accessed April 16, 2012.
  • 28
    Jordan SC, Toyoda M, Kahwaji J, Vo AA. Clinical aspects of intravenous immunoglobulin use in solid organ transplant recipients. Am J Transplant 2011; 11: 196202.
  • 29
    Boulis A. Responding to the immunoglobulin shortage: A case study. J Health Politics, Policy Law 2002; 27: 977999.
  • 30
    Hooks MA, Wades CS, Millikan WJ. Muromonab CD-3: A review of its pharmacology, pharmacokinetics, and clinical use in transplantation. Pharmacotherapy 1991; 11: 2637.
  • 31
    Baldi A, Malaise J, Mourad M, Squifflet JP. A prospective randomized study comparing poly-ATG to mono-OKT3 clonal antibodies for the first rejection therapy after kidney transplantation: long-term results. Transplant Proc 2000; 32: 429431.
  • 32
    Webster AC, Pankhurst T, Rinaldi F, Chapman JR, Craig JC. Polyclonal and monoclonal antibodies for treating acute rejection episodes in kidney transplant recipients. Cochr Database Syst Rev 2006; (2): CD004756.
  • 33
    Janssen-Cilag. Orthoclone®OKT3—Worldwide discontinuation [press release]. 4 January 2010.
  • 34
    Gaber AO, First MR, Tesi RJ et al. Results of the double-blind, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes after renal transplantation. Transplantation 1998; 66: 2937.
  • 35
    Hardinger KL, Schnitzler M, Miller B et al. Five-year follow-up of Thymoglobulin versus Atgam induction in renal transplantation. Transplantation 2004; 78: 136141.
  • 36
    Genzyme Corporation. Genzyme Receives Approval for Additional Manufacturing at Ireland Plant. United Business Media; 2012 Available at: http://http// Accessed May 23, 2012.
  • 37
    Approved Drug Products with Therapeutic Equivalence Evaluations. 32nd ed. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2012.
  • 38
    Fox ER, Birt A, James KB et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm 2009; 66: 13991406.