OBJECTIVES : Attention-deficit/hyperactivity disorder (ADHD) affected approximately 4% to 12% of children worldwide. Although numerous ADHD medications approved by the FDA, off-label prescribing is quite common. However, the risk and benefit of off-label drug use remain controversial especially for children. The study aimed to investigate the factors and patterns of off label prescribing in Children with ADHD.

METHODS : A retrospective population-based study was conducted by analyzing ten-year US. National Ambulatory Medical Care Survey. Patients aged 3 to 17 years with a diagnosis of ADHD were included. Weighted descriptive analyses were used to estimate the prevalence of ADHD prescriptions. A weighted logistic regression was further performed to examine the off-label drug use patterns across various patient and physician’s characteristics. Data trends were graphically plotted to visualize the change in off-label drug. All analyses utilized SAS PROC SURVEY applications and incorporated sample weights and standard errors to adjust for the complex sampling design.

RESULTS : Approximately 107.4 million pediatric visits with ADHD took place in US outpatient settings between 2007 and 2016. Males accounted for nearly twice as many ADHD visits as females (69.8% vs. 30.2%). Children aged 6-11 years had the highest frequency of visits compared with children aged 12-17 years, with the lowest visits by children aged 0-5 years (56% vs. 40.9% vs. 3.2%). 79.8% of these visits received at least one ADHD medication and 19.5% of the prescriptions were off-label uses. The logistic regression showed age, race, payment type, and physician’s specialty were significantly associated with off-label prescribing. No linear monotonic trend relation displayed the off-label drug use in the 10-year study period.

CONCLUSIONS : This study found off-label medications were commonly prescribed to the children with ADHD especially in young children. Our study findings highlight the need for more research and more effective policies to encourage pediatric drug regulation and development.