Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled/Off-label Status MARYLAND CENTER FOR EXCELLENCE IN REGULATORY SCIENCE & INNOVATION Background and Overview Objectives Concerns about the dramatically increased use of atypical antipsychotics (AAP) for the treatment of children and adolescents in the lay press 1 and in government reports 2,3 suggest the need for continuing research on this topic. GAO reports emphasize the much greater AAP usage in youth populations that qualify for Medicaid insurance than those who are privately insured. Medication use differences associated with private and public insurance coverage may reflect racial/ethnic disparities. This hypothesis is supported by reports of racial/ethnic disparities in both emergency department 4 and inpatient psychiatric units. 5 Consequently, there is a need to evaluate FDA approved indications for the pediatric use of AAP drugs with respect to ICD-9 diagnosis and race/ethnicity. I.To provide national population-based data on community-treated youth who receive prescriptions for AAP medications with respect to labeled/ off- label indications according to race/ethnicity and insurance payment type from outpatient visit data from federal surveys of physician office visits (NAMCS/NHAMCS) II.To assess AAP use from according to race/ethnicity and labeled use among publicly insured youth using Medicaid Administrative extract (MAX) claims data from California, Illinois, Florida and New Jersey Methods For the first objective, a cross-sectional design was applied to data extracts of physician office surveys ( ) from NAMCS and NHAMCS wherein visit was the unit of analysis. Population-based measures included % AAP use for total, labeled and off-label use and with respect to race/ethnicity and key covariates, e.g. age, gender payment type and region were calculated. For the second (future) objective, Medicaid administrative claims data comprising information on enrollment, physician visits and dispensed medications for youth less than 20 years old from four U.S. states will be analyzed, using logistic regression, for % AAP use for total, labeled and off- label use and with respect to race/ethnicity and key covariates, e.g. age, gender and region. Finally, NAMCS/NHAMCS publicly insured youth findings on labeled/off-label AAP use by race/ethnicity for will be compared with the MAX claims data findings. Results The figure illustrates total and off-label antipsychotic youth visits by visit year. It shows that the bulk of AAP visits are off-label from 1999 to Major increased AAP use began in 2007 following upon FDA AAP label changes for schizophrenia, bipolar disorder and autism. Labeled % AAP use is the difference in the two curves with a major increase beginning in The table illustrates the relationship of payment type and race/ethnicity on labeled and off-label visits. White labeled AAP visits were similar for private and public insurance enrollees (15.4% vs. 16.8%). However, non-white labeled visits were substantially lower among publicly-insured youth. These preliminary findings suggest that insurance payment type may interact with race/ethnicity for labeled/off-label use. Thus, while NAMCS/NHAMCS white youth labeled AAP visits did not differ for privately and publicly-insured youth, publicly insured non-white youth visits had greater off-label use. However, the findings are limited by low sample size and insufficient statistical power to detect a difference by race/ethnicity. Figure. Trend in labeled/off-label atypical antipsychotic use across 12 years. Conclusions Although labeled AAP use has increased in recent years, off-label use continues to dominate the use of AAPs for pediatric mental health problems (>70% of AAP visits). In the leading psychiatric conditions which have received FDA labeling on atypical antipsychotic products, there was lower labeled use in non- white than white youth pediatric visits. However, the analysis based on unstable estimates of visits resulting in inadequate statistical power for robust analysis. Consequently, research will continue to analyze administrative claims data to complete the second study objective. Differences in pediatric off-label antipsychotic use need further study to learn whether non-white youth groups are at greater risk of receiving poorly evidenced treatments. Regardless of potential disparities, laboratory monitoring is needed at baseline and periodically after initiating AAP treatment. 6 Bibliography 1.Lagnado L. U.S. Probes Psych Drug Use on Kids. Washington Post August 12, 2013;A1-A2. 2.US Government Accountability Office (GAO). Children's Mental Health: Concerns about appropriate services for children in Medicaid and foster care. GAO Report GAO-13-15, Government Accountability Office. Foster children: HHS guidance could help states improve oversight of psychotropic prescriptions, ZMuroff J, Edelsohn GA, Joe S, Ford BC. General Hospital Psychiatry 8 A.D.;30: DelBello MP, Lopez-Larson MP, Soutullo CA, Strakowski SM. J Child Adolesc Psychopharmacol 2001;11: Zito, JM, Burcu, M. Safer, DJ, Ibe, A. Psychiatr Serv 2013; 64: Dinci Pennap,MPH, Mehmet Burcu,MS, Julie Zito, PhD University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department