Affiliation:
1. Department of Emergency Medicine, University of Kentucky, Lexington, Kentucky;
2. Nationwide Children’s Hospital, Columbus, Ohio; and
3. Center for Biostatistics, The Ohio State University, Columbus, Ohio
Abstract
OBJECTIVES:
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.
Publisher
American Academy of Pediatrics (AAP)
Subject
Pediatrics,General Medicine,Pediatrics, Perinatology, and Child Health
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