Understanding the Impact of Drug Shortages on Oncology Care Delivery

Summary

Objectives

PRIMARY OBJECTIVE:
I. To prospectively estimate the proportion of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs.

SECONDARY OBJECTIVES:
I. To prospectively estimate the rate of cancer care delivery problems attributable to a drug shortage of infusional therapeutic oncology drugs for patient populations treated with: a) all cancer drugs, b) all cancer drugs in shortage, and c) each individual cancer drug in shortage.
II. To assess strategies practices used during drug shortages (e.g., manage costs, stockpile, hire staff).

TERTIARY OBJECTIVES:
I. To assess practice factors (e.g., case mix, size, practice type) associated with the likelihood that a practice reports cancer care delivery problems.
II. To describe how practice-level strategies in response to drug shortages vary by practice characteristics.
III. To describe the possible effects on clinical trials (e.g., unable to enroll a patient or changing to an alternative treatment).
IV. To characterize cancer care delivery problems attributable to a shortage of supportive care agents.
V. To characterize cancer care delivery problems attributable to a shortage of oral anti-cancer agents.
VI. To characterize cancer care delivery problems attributable to a drug shortage over time within the same practices.

OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Pharmacy Baseline Survey, and the Baseline Number Treated Report in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey and Quarterly Number Treated Reports every 3 months for one year (4 total).