J Clin Outcomes Manage
Off-label use of Ondansetron in hospitalized medical patients: prevalence, patterns, and predictors
Hartley S, Kuhn L, Valley S, Fallouh N, Dussan KB, Judd S, Murphy SL, Saint S, Chopra V
ABSTRACT Background: Ondansetron is frequently prescribed in hospitalized patients for nausea and vomiting. However, the Food and Drug Administration (FDA) has approved this agent only for prophylaxis of nausea and emesis related to chemo- and radiation therapy or postoperative states. Objective: To determine prevalence and predictors of off-label ondansetron use in hospitalized adult patients. Methods: Retrospective cohort study of 158 hospitalized medical patients who received non-FDA-approved ondansetron; treatment with promethazine or prochlorperazine in 151 patients was considered standard treatment. Patterns of non-FDA-approved use were analyzed using descriptive statistics. Multivariable logistic regression models were then fit to identify predictors of such use. Results: In hospitalized medical patients, ondansetron as first-line treatment for nausea outside of FDA-approved indications was 5 times more prevalent than standard therapy (4169 doses versus 750 doses). In a random sample, patients treated with ondansetron were older (54.6 versus 48.8 years, P < 0.01), more likely to be hypertensive (50.6% vs. 39.7%, P = 0.05), and less frequently prescribed multiple antiemetics at the time of admission (32.3% vs. 43.7%, P = 0.04). Receipt of prochlorperazine or promethazine in the emergency department (ED) was associated with decreased likelihood of receiving non-FDA-approved ondansetron therapy as the first antiemetic after admission (odds ratio 0.27, 95% confidence interval 0.11–0.66). Conclusions: Although ondansetron therapy for non-FDA approved indications is highly prevalent in hospitalized medical adults, use of standard anti-nausea treatment in the ED may curtail this practice. Implementing policies for targeting use of medications in the ED may significantly influence inpatient practice.
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