Leaving No Ethical Value Behind: Triage Protocol Design for Pandemic Rationing

Rationing of medical resources is a critical issue in the COVID-19 pandemic. Most existing triage protocols are based on a priority point system, in which a formula specifies the order in which the supply of a resource, such as a ventilator, is to be rationed for patients. A priority point system generates an identical priority ranking specifying claims on all units. Triage protocols in some states (e.g. Michigan) prioritize frontline health workers giving heavier weight to the ethical principle of instrumental value. Others (e.g. New York) do not, reasoning that if frontline workers obtain high enough priority, there is a risk that they obtain all units and none remain for the general community. This debate is pressing given substantial COVID-19 health risks for frontline workers. In this paper, we analyze the consequences of rationing medical resources through a reserve system. In a reserve system, resources are placed into multiple categories. Priorities guiding allocation of units can reflect different ethical values between these categories. A reserve system provides additional flexibility over a priority point system because it does not dictate a single priority order for the allocation of all units. It offers a middle-ground approach that balances competing objectives, such as in the medical worker debate. This flexibility requires attention to implementation, especially the processing order of reserve categories. We describe our model of a reserve system, characterize its potential outcomes, and examine distributional implications of particular reserve systems. We also discuss several practical considerations with triage protocol design.

A Novel Approach to Equitable Distribution of Scarce Therapeutics: Institutional Experience Implementing a Reserve System for Allocation of COVID-19 Monoclonal Antibodies.

BACKGROUND: In fall 2020, the Food and Drug Administration issued emergency use authorization for monoclonal antibody (mAb) therapies for outpatients with COVID-19. The Commonwealth of Massachusetts issued guidance outlining the use of a reserve system with a lottery for allocation of mAbs in the event of scarcity that would prioritize socially vulnerable patients for 20% of the infusion slots. The Mass General Brigham health system subsequently implemented such a reserve system. RESEARCH QUESTION: Can a reserve system be deployed successfully in a large health system in a way that promotes equitable access to mAb therapy among socially vulnerable patients with COVID-19? STUDY DESIGN AND METHODS: We conducted a retrospective review of the operation of the reserve system for allocation of mAb therapies to identify how referrals moved through the allocation process and what proportion of patients who were offered and received mAb therapies were socially vulnerable. RESULTS: Notwithstanding multiple operational challenges, the reserve system for allocation of mAb therapy worked as intended to enhance the number of socially vulnerable patients who were offered and received mAb therapy. A significantly higher proportion of patients offered mAb therapy were socially vulnerable (27.0%) than would have been the case if the infusion appointments had been allocated using a pure lottery system without a vulnerable reserve (19.8%), and a significantly higher proportion of patient who received infusions were socially vulnerable (25.3%) than would have been the case if the infusion appointments had been allocated using a pure lottery system (17.6%) INTERPRETATION: Our health system experience demonstrates that a reserve system with a lottery for tiebreaking is a viable way to distribute scarce therapeutics when enhancing access for certain groups is desirable.