Objective: This study examines off-label medication prescribing use and trends in children on Medicaid with ADHD with particular focus on the very young (under age 6 years).
Methods: This was an observational cohort study and retrospective analysis of ADHD medication prescriptions from Oregon Medicaid records (N = 83,190) in 2012. Manufacturer prescribing information was used to determine off-label designation. Children ages 3 to 18 years at the time of prescription who had continuous Medicaid enrollment of at least 10 months during the index year of 2012 were included in the sample frame.
Results: Children with ADHD were prescribed off-label medications primarily at the ages of 5 years and younger. Among children ages 3 to 5 years, 91.4% of prescriptions were off-label. After the age of 5 years, the percentage of off-label prescriptions dropped notably to 21%, reflecting the increase in availability of approved medications for the treatment of ADHD starting at age 6 years. In the 3- to 5-year-old age group, specific off-label and concerning medication-related observations included a high frequency of alpha agonist (e.g., guanfacine, clonidine) prescribing; the prescribing of untested formulations such as clonidine patches; prescribing of atomoxetine; and prescribing of large doses of stimulant medications.
Conclusions: Most ADHD drugs prescribed for very young children are off-label, which is concerning owing to lack of safety and efficacy data in this vulnerable population.
Keywords: attention deficit disorder; drug prescribing; off-label use; preschool child.