Off-Label Ordering of Systemic Drugs Up for Children

The rate of off-label ordering of systemic drugs has increased for children, according to a study published online Sept. 16 in Pediatrics.

Divya Hoon, from the Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, and colleagues studied off-label orders of systemic drugs for children aged <18 years based on U.S. Food and Drug Administration-approved labeling for age, weight, and indication using national representative surveys of office-based physicians. The top classes and diagnoses with off-label orders were characterized.

The researchers found that during 18.5 percent of visits, physicians ordered one or more off-label systemic drugs; 74.6 percent did so because of unapproved conditions. Proportionately, off-label ordering was most common in neonates (83 percent), and in absolute terms, it was most common among adolescents (322 orders out of 1,000 visits). There were correlations for off-label ordering with female sex, subspecialists, polypharmacy, and chronic conditions. There was considerable variation in rates and reasons for off-label ordering by age. Over time, the relative and absolute rates of off-label ordering increased. Off-label orders for antihistamines and several psychotropics increased over time; for several classes of antibiotics, off-label orders were stable or decreased.

"Despite legislation to generate more data on the effects of drugs in children, off-label orders have risen in recent years, most notably of antihistamines and psychotropic drugs, such as antidepressants," the authors write.

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