A B S T R A C TOBJECTIVES: To describe the frequency of off-label drug use in 2014 as defined by the Food and Drug Administration (FDA)-approved age ranges in patients #18 years of age, to determine the rate of off-label drug use in 2014 by drug classification, and to compare current off-label medication usage rates with historical rates.METHODS: This is a retrospective cohort study of an administrative database containing inpatient resource use data from January 1, 2014, to December 31, 2014. Patients #18 years of age receiving 1 of 76 selected commonly prescribed medications are included. Off-label drug use is defined as use in a patient younger than the lower limit of the FDA-approved age range for any indication or dosage form of that drug. RESULTS:At least 1 drug was prescribed off label in 779 270 of 2 773 770 (28.1%) patient visits during the study period. Younger age, longer hospital stays, and mortality were associated with higher rates of off-label medication prescription. Off-label usage of certain medications differed between care settings. Rates of off-label medication use were higher in observational (45.5%), inpatient (53.9%), and ambulatory (54.2%) settings. CONCLUSIONS:Although off-label drug use at major US pediatric hospitals is declining, 1 out of every 4 medications is not in accordance with FDA label indications for patient age. There exists substantial variation in off-label drug use among drug categories and encounter types. Although many commonly prescribed medications are FDA-approved for use in subpopulations of pediatric patients, studies of their safety, efficacy, pharmacokinetics, and optimal dosing are ongoing.

Patients are more likely to be transferred to our tertiary pediatric facility for management of testicular torsion during the night or weekend. Transferring patients for management of testicular torsion delays definitive management and threatens testicular viability, especially in those transferred greater distances. Urologists at the facility of initial patient presentation should correct testicular torsion when able.

There is still a lot of room for improvement of pediatric pain control in US EDs. We aim to apply this information toward direct physician and nursing education interventions, including the recognition of age appropriate pain cues, and parental information and guidance to improve pediatric pain treatment in US EDs.