Shortages of essential drugs, including critical chemotherapy drugs, have become commonplace. Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges. Pediatric oncology is particularly susceptible to drug shortages, presenting an opportunity to examine these ethical issues and provide recommendations for preventing and alleviating shortages. We convened the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology (WG) and developed consensus on the core ethical values and practical actions necessary for a coordinated response to the problem of shortages by institutions, agencies, and other stakeholders. The interdisciplinary and multiinstitutional WG included practicing pediatric hematologist-oncologists, nurses, hospital pharmacists, bioethicists, experts in emergency management and public policy, legal scholars, patient/family advocates, and leaders of relevant professional societies and organizations. The WG endorsed 2 core ethical values: maximizing the potential benefits of effective drugs and ensuring equitable access. From these, we developed 6 recommendations: (1) supporting national polices to prevent shortages, (2) optimizing use of drug supplies, (3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, (4) developing an improved clearinghouse for sharing drug shortage information, (5) exploring the sharing of drug supplies among institutions, and (6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages. Each recommendation includes an ethical rationale, action items, and barriers that must be overcome. Implemented together, they provide a blueprint for effective and ethical management of drug shortages in pediatric oncology and beyond.
Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement
FINANCIAL DISCLOSURE: Dr Joffe was a paid member of a data monitoring committee for Genzyme/Sanofi until November 2012; the other authors have indicated they have no financial relationships relevant to this article to disclose.
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Matthew DeCamp, Steven Joffe, Conrad V. Fernandez, Ruth R. Faden, Yoram Unguru; on behalf of the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology, Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement. Pediatrics March 2014; 133 (3): e716–e724. 10.1542/peds.2013-2946
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