Trends in off-label use of antipsychotic medications among Texas Medicaid children and adolescents from 2013 to 2016

BACKGROUND: Antipsychotics are frequently prescribed for off-label indications in the pediatric population. However, little is known regarding this issue in Texas Medicaid. OBJECTIVES: To (1) describe off-label antipsychotic use among Texas Medicaid children and adolescents and (2) examine factors associated with off-label use. METHODS: Texas Medicaid prescription and medical claims from January 2013 to August 2016 were analyzed retrospectively among subjects aged 2-17 years with an antipsychotic prescription. Three diagnostic status groups (on-label, off-label, no diagnosis) were categorized based on FDA-approved indications. Descriptive and chi-square tests were conducted to determine if diagnostic status differed by age group (2-4, 5-9, 10-14, and 15-17 years), sex, and antipsychotic type. A logistic regression analysis was used to identify factors associated with off-label use. RESULTS: In this study, 43,792, 44,335, 37,221, and 24,879 (January-August) children with at least 1 antipsychotic prescription were identified from 2013 to 2016, respectively. The proportions with off-label use declined from 66.9% (2013) to 59.8% (2016). Among off-label users, more than one-half (51.3%-55.8%) had a diagnosis of attention-deficit/hyperactivity disorder. Less than 8% (6.0%-7.7%) of subjects had no mental health disorder diagnosis. Chisquare analyses (2015 data) revealed that the proportion of off-label and no diagnosis users combined were significantly (P < 0.01) higher among users aged 5-9 years (82.5%) than adolescents 10-14 years (61.9%) and 15-17 years (56.5%); males (67.7%) than females (65.3%); and first-generation antipsychotics (FGAs; 79.3%) than second-generation antipsychotics (66.7%) users. Logistic regression analyses revealed younger age and FGA users had higher odds of off-label/no diagnosis use. CONCLUSIONS: The proportion of off-label/no diagnosis antipsychotic use declined from 2013 to 2016. Younger children and those receiving FGAs were more likely to be off-label antipsychotic users, with attention-deficit/hyperactivity disorder being the most prevalent off-label diagnosis.