Establishing an oncology stewardship committee during the era of drug shortages.

Abstract

212 Background: Chemotherapy shortages are common, causing rationing when demand exceeds supply. Hospital systems and pharmacies are responsible for chemotherapy ordering - there is no national distribution system. There is risk for inequitable and/or unethical allocation of scarce resources. Prescribing providers are at risk when making individual allocation decisions and leave themselves exposed to medicolegal risk. Given the frequency of supply shortages of antineoplastic, biologic or cellular therapies, we identified a need to create a framework for management of limited supplies and prioritization of allocation decisions. Methods: To ensure a consistent and transparent approach, the Oncology Stewardship Committee (OSC) was established, compromised of multidisciplinary representatives (adult/pediatric physicians, pharmacists, social workers, nurses, and ethicists). The committee based its work on a framework of ethical values and guiding principles, including maximizing benefits (urgency of need, likelihood of benefit, availability of alternatives) and fairness (not upon patient demographics, ability to pay, or financial impact to the health system). A tiered plan for each therapy in shortage was created (table), starting with monitoring and escalating to mitigation through conservation, allocation through a vetted pathway with an appeal process, and up to randomization if all other options were exhausted. Results: The OSC was assembled, agreed upon principles and processes, and launched in 2022. An example for which management escalated to “Tier 3” was fludarabine. During active management of fludarabine, 238 eligible patients were considered, 158 met restriction criteria and 80 were assigned an alternative therapy. Conclusions: The formation of an institutional OSC allowed for improved transparency and equitable allocation of scarce resources. In future, this framework will be used for ongoing drug shortages in addition to management of non-formulary requests.[Table: see text]