Off-Label Medication Use in the Inpatient Palliative Care Unit

Abstract

Context: Although off-label medications are frequently prescribed in palliative care, there are no published studies examining their use in the U.S.

Objectives: We examined the frequency of off-label medication use in cancer patients admitted to an acute palliative care unit (APCU).

Methods: This prospective observational study enrolled consecutive patients with advanced cancer admitted to the APCU of a tertiary care cancer center. We collected data on all prescription events, including indications for use, from admission to discharge. Off-label use was checked against the U.S. Food and Drug Administration-approved indications.

Results: Among the 201 patients, median survival was 10 days (95% CI 7-13), and 85 (42%) patients died in the APCU. We documented 6276 prescription events, and 2199 (35%) were off-label. Among off-label prescriptions, central nervous system agents (n = 1606, 73%), hormones and synthetic substitutes (n = 302, 14%), and autonomic drugs (n = 183, 8%) were most commonly prescribed. Haloperidol (n = 720, 33%), chlorpromazine (n = 292, 13%), dexamethasone (n = 280, 13%), glycopyrrolate (n = 175, 8%), hydromorphone (n = 161, 7%), and morphine (n = 156, 7%) were most frequently prescribed off-label. The most common indications for off-label prescribing were delirium (n = 783, 36%) and dyspnea (n = 449, 20%). Seventy percent of all off-label prescription events had strong evidence supporting use, and 19% of prescription events had moderate or weak evidence for use.

Conclusion: One-third of prescription events in the APCU were off-label, with majority of off-label use having a strong level of supporting evidence. Our findings highlight the need for more research in key areas such as delirium and dyspnea management.

Keywords: Drug prescriptions; neoplasms; off-label use; palliative care; therapeutics; unlabeled indication.