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).
J Natl Cancer Inst. 2016 Jan 29;108(6):djv392. doi: 10.1093/jnci/djv392. Print 2016 Jun.
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.
儿童癌症救命化疗药物和支持性护理药物经常短缺。这些短缺直接影响患者的生命，危及标准治疗方法和临床研究，并造成重大的伦理挑战。尽管人们一直在努力预防药物短缺，但现有的优先排序框架缺乏临床医生在面对同样值得救治的癌症儿童进行艰难的优先排序决策时所需的具体指导。本评论中提出的伦理框架基于多学科专家意见，并通过独立的同行顾问小组进一步加强。两步分配流程包括通过最大限度地减少浪费来缓解现有短缺的策略，并根据经过修改的功利主义模型在疾病之间和内部进行实际的优先级排序，该模型在尊重个体差异化治疗的有限限制的同时最大化总收益。该框架为在实际药物短缺时进行明确决策提供了依据。此外，它最大限度地减少了当个别临床医生或机构被迫进行床边配给和优先级排序决策时可能出现的偏见，并解决了个别临床医生在面对床边分配决策时所面临的挑战。只要有可能，分配决策都应得到基于证据的建议的支持。在决定如何分配稀缺的救命癌症药物时，应考虑“可治愈性”、预后以及特定药物对特定患者结果的增量重要性等关键因素。
