Causes and Consequences of the Worldwide Belatacept Shortage

Transplantation

Volumn 101, Issue 7, 2017, Pages 1520-1521

  Gabardi, Steven ^a,b   Van Gelder, Teun ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ALEMTUZUMAB; AZATHIOPRINE; BELATACEPT; COTRIMOXAZOLE; CYCLOSPORIN; GANCICLOVIR; IMMUNOGLOBULIN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID; TACROLIMUS; ABATACEPT; CALCINEURIN INHIBITOR; IMMUNOSUPPRESSIVE AGENT;

BLOOD PRESSURE; DOCTOR PATIENT RELATION; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; GRAFT SURVIVAL; HEALTH CARE FACILITY; HEALTH INSURANCE; HEALTH PROGRAM; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; PATIENT CARE; PRIORITY JOURNAL; REVIEW; UNITED STATES;

ABATACEPT; CALCINEURIN INHIBITORS; IMMUNOSUPPRESSIVE AGENTS;

EID: 85017150495     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0000000000001763     Document Type: Review

References (9)

1. Hart A, Smith JM, Skeans MA, et al. OPTN/SRTR 2015 annual data report: kidney. Am J Transplant. 2017;17:21-116[published online January 3 2017].
2. Food and Drug Administration. Guidance for industry changes to an approved NDA or ANDA. Available at: https://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf. Updated September 2009. Accessed March 9, 2017.
3. Vincenti F, Rostaing L, Grinyo J, et al. Belatacept and long-term outcomes in kidney transplantation. N Engl JMed. 2016;374:333-343.
4. Rostaing L, Massari P, Garcia VD, et al. Switching from calcineurin inhibitorbased regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011;6: 430-439.
5. Gupta DK, Huang SM. Drug shortages in the United States: a critical evaluation of root causes and the need for action. Clin Pharmacol Ther. 2013; 93:133-135.
6. Pauwels K, Simoens S, Casteels M, et al. Insights into European drug shortages: a survey of hospital pharmacists. PLoS One. 2015;10: e0119322.
7. Krisl JC, Fortier CR, Taber DJ. Disruptions in the supply of medications used in transplantation: implications and management strategies for the transplant clinician. Am J Transplant. 2013;13:20-30.
8. American Society of Health-System Pharmacists. Current Drug Shortages. Available at: https://www.ashp.org/drug-shortages/current-shortages. Updated March 2017. Accessed March 9, 2017.
9. International Pharmaceutical Federation. Report of the International Summit on Medicines Shortage. Available at: https://www.fip.org/files/fip/ publications/FIP-Summit-on-Medicines-Shortage.pdf. Updated September 2013. Accessed March 9, 2017.