Context
Although off-label medications are frequently prescribed in palliative care, there are no published studies examining their use in the United States.
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% confidence interval 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%). 70% 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.