Off-Label Prescribing to Children in the United States Outpatient Setting

Objective The aim of this study was to determine the frequency of off-label prescribing to children at United States outpatient visits and to determine how drug class, patient age, and physician specialty relate to off-label prescribing. Methods Data from the 2001 through 2004 National Ambulatory Medical Care Surveys (NAMCS) consisted of a sample of 7901 outpatient visits by children aged 0 through 17 years in which prescriptions were given, representative of an estimated 312 million visits. We compared FDA-approved age and indication to the child's age and diagnoses. We used multivariate logistic regression to determine adjusted differences in probabilities of off-label prescribing. Results Sixty-two percent of outpatient pediatric visits included off-label prescribing. Approximately 96% of cardiovascular-renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary and dermatologic medication prescriptions were off label. Visits by children aged