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Off-Label Medication Use in the Inpatient Palliative Care Unit
Jung Hye Kwon1, Min Ji Kim2, Sebastian Bruera3
1Department of Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA; Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea.
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.
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