title: An Ethical Framework for Allocating Scarce Life-Saving Chemotherapy and Supportive Care Drugs for Childhood Cancer.
abstract: Shortages of life-saving chemotherapy and supportive care agents for children with cancer are frequent. These shortages directly affect patients' lives, compromise both standard of care therapies and clinical research, and create substantial ethical challenges. Efforts to prevent drug shortages have yet to gain traction, and existing prioritization frameworks lack concrete guidance clinicians need when faced with difficult prioritization decisions among equally deserving children with cancer. The ethical framework proposed in this Commentary is based upon multidisciplinary expert opinion, further strengthened by an independent panel of peer consultants. The two-step allocation process includes strategies to mitigate existing shortages by minimizing waste and addresses actual prioritization across and within diseases according to a modified utilitarian model that maximizes total benefit while respecting limited constraints on differential treatment of individuals. The framework provides reasoning for explicit decision-making in the face of an actual drug shortage. Moreover, it minimizes bias that might occur when individual clinicians or institutions are forced to make bedside rationing and prioritization decisions and addresses the challenge that individual clinicians face when confronted with bedside decisions regarding allocation. Whenever possible, allocation decisions should be supported by evidence-based recommendations. "Curability," prognosis, and the incremental importance of a particular drug to a given patient's outcome are the critical factors to consider when deciding how to allocate scarce life-saving cancer drugs.
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ). yunguru@lifebridgehealth.org.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Unguru
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Conrad V
authors.initials: CV
authors.lastname: Fernandez
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Brooke
authors.initials: B
authors.lastname: Bernhardt
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Stacey
authors.initials: S
authors.lastname: Berg
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Kim
authors.initials: K
authors.lastname: Pyke-Grimm
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Catherine
authors.initials: C
authors.lastname: Woodman
authors.affiliation: Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children's Hospital at Sinai, Baltimore, MD (YU); Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD (YU); IWK Health Centre, Departments of Pediatrics and Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada (CVF); Texas Children's Hospital, Houston, TX (BB); Texas Children's Cancer Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX (SB); Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Lucile Packard Children's Hospital, Stanford Palo Alto, CA (KPG); University of Iowa, Iowa City, IA (CW); Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
mesh_terms: D000970:Antineoplastic Agents / Q000600:supply & distribution* / Q000627:therapeutic use*; D002648:Child; D000066491:Clinical Decision-Making / Q000941:ethics*; D018954:Drugs, Essential / Q000600:supply & distribution* / Q000627:therapeutic use*; D005190:Family; D015276:Health Care Rationing / Q000941:ethics*; D006801:Humans; D033183:Interdisciplinary Communication; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents; D018954:Drugs, Essential