Off-label use of antipsychotic medications in Medicaid

Objectives: To determine how often antipsychotics are prescribed off-label to adults without schizophrenia or bipolar disorder who are enrolled in Medicaid, which pays for more than 70% of antipsychotic prescriptions in the United States. Study Design: Retrospective analysis of 2003 administrative data from 42 state Medicaid programs. Methods: Continuously enrolled patients with at least 1 prescription for an antipsychotic medication were identified. For these patients, inpatient and outpatient records were checked for any diagnosis of schizophrenia or bipolar disorder; those without any such diagnoses were considered to have received these medications off-label. Offlabel antipsychotic use was compared across sociodemographic groups (age, race/ethnicity, sex). Multivariate logistic regression models identified characteristics associated with off-label use. Results: Of the 372,038 individuals given an antipsychotic medication, 214,113 (57.6%) received these agents for off-label disorders. Offlabel use among patients receiving an antipsychotic was more prevalent among individuals under age 21 years (75.9%) and those 65 years and older (64.8%) than it was among those aged 21 to 64 years (49.0%). Rates of off-label use were relatively high for Hispanics (65.7%) and low for African Americans (52.3%) compared with whites (58.2%). Off-label use was most common among patients receiving risperidone and least common among patients receiving clozapine. Conclusions: Off-label use of antipsychotic medications is common, particularly among the elderly and children/adolescents. Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness off-label, they should perhaps be used with greater caution.