1. BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN

2. Pediatric Approved Antipsychotics Irritability due to autism Risperdal (risperidone)5-16 Abilify (aripiprazole)6-17 Schizophrenia Bipolar I Risperdal (risperidone)13–17 10-17 Abilify (aripiprazole)13-17 10-17 Zyprexa (olanzapine)13-17 13-17 Seroquel (quetiapine)13-17 10-17 Invega (paliperidone)12-17

3. Medicaid Insured Children 2002 - 2007 Medicaid data analyzed for 48 states and DC Youth 3-18 years old (≥10 months Medicaid eligibility) 62% increase in antipsychotic treatment over study period 2007 2.4% (N = 354,000) of all youth tx with antipsychotic 14% youth on antipsychotic tx had single diagnosis of ADHD 3.6% (N = 13,059) of antipsychotic treated youth were 3-5 years old Matone et al 2012

4. Factors increasing SGA prescribing to young children Availability of newer agents New pediatric FDA approvals Cost of aggression

5. Availability of Newer Agents 1993: risperidone 1996: olanzapine 1997: quetiapine 2001: ziprasidone 2002: aripiprazole 2006: paliperidone 2009: asenapine, iloperidone 2010: lurasidone

6. Uptake of new SGA Michigan State Medicaid Data ziprasidone treatment of pediatric patients in 2001 (first year of off-label availability) 292 ziprasidone prescriptions for youth <21 y/o 1% of prescriptions for youth <6 years old 33% - first SGA prescribed Penfold et al 2010

7. Costs of aggression Aggression Injury Family conflict Missed work Use of crisis services Child care problems Out of home

8. CONCERNS ABOUT INCREASED ANTIPSYCHOTIC PRESCRIBING TO YOUNG CHILDREN

9. Metabolic Side Effects Weight gain Increased blood sugar/diabetes Abnormal cholesterol levels Youth, particularly antipsychotic naïve, are at greater risk than adults

10. Side effect monitoring is low Pediatric treatment guidelines recommend fasting blood work (baseline, 3 months, 6-12 months thereafter) Weight and height needed to assess unhealthy weight gain Morrato et al 2010: 3 State Medicaid Programs (adult & child) Absolute rate of baseline testing low (<30% baseline glucose; <15% lipid testing) Rates of baseline testing did not increase post FDA warning Haupt et al 2009: Large, managed care database (adult and child) Baseline monitoring lowest in pediatric age group Post FDA warning: baseline testing low (21.8% glucose, 10.5% lipids)

11. SGA tx of disruptive behaviors Systematic review of RCT’s for disruptive behavior disorders in youth All published trials funded by pharmaceutical companies 8 trials (no participants <5 years old) 5 risperidone; subaverage-borderline IQ 1 risperidone; treatment resistant aggression ADHD-CD 1 quetiapine for adolescent CD Pringsheim & Gorman 2012

12. Limited psychosocial treatment Fails to utilize parent as “agent of change” Need for higher medication dose Medication treatment often provided in settings where there is no access to psychosocial treatment (e.g. primary care provider office)

13. MARYLAND MEDICAID PEER REVIEW PROGRAM

14. Baseline Medicaid Data (Off-label antipsychotic tx by age; 1/1/2010 – 12/30/10) Age# of Prescriptions# of Children 0-4*705178 5-912,9922065 10-1211,6991824 13-1719,3492875 *48% of prescriptions provided by non-mental health specialists (e.g. PCP)

15. Stakeholder team Psychiatry Pharmacy Pediatrics Medicaid MHA MD Coalition of Families for Children’s Mental Health AACAP, AAP Leadership from child mental health programs ProvidersFamilies Health Experts Child Serving Agencies

16. Program goals Improve oversight/monitoring of pediatric antipsychotic treatment Improve safe and appropriate prescribing Provide education/outreach to providers on pediatric antipsychotic treatment (e.g. monitoring guidelines) and related issues (e.g. psychosocial treatment referrals)

17. Review Process Indication for treatment (dx, target sx, recent safety concerns) Baseline side effects (labs, wt/ht, AIMS, ECG if indicated) Medication requested and dose Medication regimen Psychosocial treatment referral

18. Peer Consultation Initial review by a pharmacist with specialized psychiatric training Review by a child psychiatrist to provider to address any “red flag” clinical concerns Ongoing review of all cases (every 3-6 months)

19. Program Implementation Oct 2011: youth <5 years old Prescribers and parents to begin receiving information regarding 10-17 year old youth Prescribers will have approximately 70 days to obtain relevant information and complete authorization request Letters going out: – 10 years of age – letters to be sent June 2013 – 11 years of age – letters to be sent July 2013 – 12-13 years of age – letters to be sent August 2013 – 14-15 years of age – letters to be sent September 2013 – 16-17 years of age – letters to be sent October 2013

20. “Call me (maybe)” Pharmacy Child Psychiatry Medicaid Ray LoveGloria ReevesAthos Alexandrou Susan dosReisStephen MandelbaumLisa Burgess Heidi WehringDavid PruittDixit Shah Mark EllowMark Riddle Ilene VerovskiKristin Bussell Afua Addo-AbediSara Pirmohamed Nicole Letvin Jessa Coulter Acknowledgments: Joshua Sharfstein, Laura Herrera, Al Zachik, Gayle Jordan- Randolph, Mary Mussman