Chemotherapy drug shortages in pediatric oncology: A consensus statement

Pediatrics

Volumn 133, Issue 3, 2014, Pages

  DeCamp, Matthew ^a,b   Joffe, Steven ^c   Fernandez, Conrad V ^d   Faden, Ruth R ^a   Unguru, Yoram ^a,e  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d DALHOUSIE UNIVERSITY   (Canada)

^e The Herman & Walter Samuelson Children's Hospital at Sinai   (United States)

Author keywords

Antineoplastic agents supply and distribution; Bioethics; Coordination; Ethics; Health care rationing; Medical; Pediatric oncology; Resource allocation

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CANCER CHEMOTHERAPY; CHILDHOOD CANCER; CONSENSUS; DRUG COST; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SHORTAGE; DRUG USE; DRUG UTILIZATION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HUMAN; MEDICAL ETHICS; OUTCOME ASSESSMENT; PRIORITY JOURNAL;

ANTINEOPLASTIC AGENTS/SUPPLY AND DISTRIBUTION; BIOETHICS; COORDINATION; ETHICS, MEDICAL; HEALTH CARE RATIONING; PEDIATRIC ONCOLOGY; RESOURCE ALLOCATION;

ADVISORY COMMITTEES; ANTINEOPLASTIC AGENTS; HEALTH CARE RATIONING; HUMANS; NEOPLASMS; PEDIATRICS;

EID: 84895177432     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2013-2946     Document Type: Article

References (37)

1. Dill S, Ahn M. Overview of U.S. drug shortages. November 6, 2012. Available at: www. fda.gov/downloads/Drugs/UCM327108.pdf. Accessed June 25, 2013
2. Link MP, Hagerty K, Kantarjian HM. Chemotherapy drug shortages in the United States: genesis and potential solutions. J Clin Oncol. 2012;30(7):692-694
3. Hoffman S. The drugs stop here: a public health framework to address the drug shortage crisis. Food Drug Law J. 2012;67(1):1-22
4. Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. Pharmacy and Therapeutics. 2011;36:740-757
5. Ralls MW, Blackwood RA, Arnold MA, Partipilo ML, Dimond J, Teitelbaum DH. Drug shortage-associated increase in catheter-related blood stream infection in children. Pediatrics. 2012;130(5). Available at: www.pediatrics.org/cgi/ content/full/130/5/e1369
6. Metzger ML, Billett A, Link MP. The impact of drug shortages on children with cancer-the example of mechlorethamine. N Engl J Med. 2012;367(26):2461-2463
7. Gardner RA, Thomson B, Hawkins DS. Substitution with doxorubicin for daunorubicin during induction for high risk pediatric acute lymphoblastic leukemia results in increased toxicity. Pediatr Blood Cancer. 2013;60(2):338-339
8. Goozner M. Drug shortages delay cancer clinical trials. J Natl Cancer Inst . 2012;104(12):891-892
9. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(19):1811-1819
10. McBride A, Holle LM, Westendorf C, et al. National survey on the effect of oncology drug shortages on cancer care. Am J Health Syst Pharm. 2013;70(7):609-617
11. Cherici C, McGinnis P, Russell W. Buyer beware: drug shortages and the gray market. Available at: https://www.premierinc.com/about/news/11-aug/Gray- Market/Gray-Mar-ket-Analysis-08152011.pdf. Accessed June 25, 2013
12. Chabner BA. Drug shortages -a critical challenge for the generic-drug market. N Engl J Med. 2011;365(23):2147-2149
13. Gatesman ML, Smith TJ. The shortage of essential chemotherapy drugs in the United States. N Engl J Med. 2011;365(18):1653-1655
14. Hoffman JH. CDER Drug Shortage Workshop: perspectives from the point of care-specialty settings (St. Jude Children's Research Hospital). Available at: www.fda.gov/downloads/Drugs/NewsEvents/UCM274581.pdf. Accessed June 25, 2013
15. Hunger SP, Loh ML, Whitlock JA, et al COG Acute Lymphoblastic Leukemia Committee. Children's Oncology Group's 2013 blueprint for research: acute lymphoblastic leukemia. Pediatr Blood Cancer. 2013;60(6):957-963
16. Bleyer WA. The U.S. pediatric cancer clinical trials programmes: international implications and the way forward. Eur J Cancer. 1997;33(9):1439-1447 (Pubitemid 27404903)
17. Valgus J, Singer EA, Berry SR, Rathmell WK. Ethical challenges: managing oncology drug shortages. J Oncol Pract. 2013;9(2):e21-e23
18. Rosoff PM, Patel KR, Scates A, Rhea G, Bush PW, Govert JA. Coping with critical drug shortages: an ethical approach for allocating scarce resources in hospitals. Arch Intern Med. 2012;172(19):1494-1499
19. Rosoff PM. Unpredictable drug shortages: an ethical framework for short-term rationing in hospitals. Am J Bioeth. 2012;12(1):1-9
20. Gibson JL, Bean S, Chidwick P, Godkin D, Sibbald RW, Wagner F. Ethical framework for resource allocation during a drug supply shortage. Healthc Q. 2012;15(3):26-35
21. Persad G, Wertheimer A, Emanuel EJ. Principles for allocation of scarce medical interventions. Lancet. 2009;373(9661):423-431
22. Obama B. Executive order 13688-reducing prescription drug shortages. Office of the Press Secretary (The White House). Available at: www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing- prescription-drug-shortages. Accessed June 25, 2013
23. Food and Drug Administration. Strategic plan for preventing and mitigating drug shortages. October 2013. Available at: www.fda.gov/downloads/ Drugs/DrugSafety/DrugShortages/UCM372566.pdf. Accessed November 9, 2013
24. Carney J. Drug Shortage Prevention Act of 2012. H.R. 3839 (112th Congress). Available at: www.govtrack.us/congress/bills/112/hr3839. Accessed June 25, 2013
25. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013;93(2):170-176
26. Phillips C. Workshop examines causes, potential remedies for drug shortages. NCI Cancer Bulletin. October 4, 2011. Available at: www.cancer.gov/ncicancerbulletin/100411/page6. Accessed June 25, 2013
27. Cosgrove DM, Fisher M, Gabow P, et al. Ten strategies to lower costs, improve quality, and engage patients: the view from leading health system CEOs. Health Aff (Millwood). 2013;32(2):321-327
28. Boulis A, Goold S, Ubel PA. Responding to the immunoglobulin shortage: a case study. J Health Polit Policy Law. 2002;27(6):977-999 (Pubitemid 36135089)
29. Centers for Disease Control and Prevention. Single dose/single-use vial position and messages. May 2, 2012. Available at: www.cdc.gov/injectionsafety/ PDF/CDC-SDV-Position05022012. pdf. Accessed June 25, 2013
30. Committee on Oversight and Government Reform. Shining light on the "gray market." An Examination why Hospitals are Forced to Pay Exorbitant Prices for Prescription Drugs Facing Critical Shortages. July 25, 2012. Available at: http://democrats.oversight.house.gov/uploads/7.25. 12%20Staff%20Report%20Shining%20Light%20on%20the%20Gray%20Market.pdf. Accessed June 25, 2013
31. Woodward C. Prices gone wild: grey market 'scalpers' scoring windfall in American drug market. CMAJ. 2012;184(2):E119 -E120
32. Cummings E. Gray Market Drug Reform and Transparency Act of 2013 (H.R. 1958, 113th Congress). Available at: www.govtrack.us/congress/bills/113/hr1958. Accessed June 25, 2013
33. American Society of Health-System Pharmacists. Drug shortages. Available at: www. ashp.org/shortages. Accessed June 25, 2013
34. US Food and Drug Administration. Drug shortages. Available at: www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. Accessed June 25, 2013
35. Department of Health and Human Services. Draft guidance for industry on notification to food and drug administration of issues that may result in a prescription drug shortage. Federal Register Volume 77, Number 38 (Monday, February 27, 2012)] [Notices] [Pages 11550-11553] Available at: www.gpo.gov/fdsys/pkg/FR-2012-02-27/html/2012-4439.htm. Accessed December 13, 2013
36. Barlas S. Track-and-trace drug verification: FDA plans new national standards, pharmacies tread with trepidation. Pharmacy and Therapeutics. 2011 April; 36(4):203-204,208,231
37. DeBruin D, Liaschenko J, Marshall MF. Social justice in pandemic preparedness. Am J Public Health. 2012;102(4):586-591