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BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN

BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN. 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

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BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN

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  1. BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN

  2. Pediatric Approved Antipsychotics Irritability due to autism Risperdal (risperidone) 5-16 Abilify (aripiprazole)6-17 SchizophreniaBipolar I Risperdal (risperidone) 13–1710-17 Abilify (aripiprazole)13-1710-17 Zyprexa (olanzapine) 13-1713-17 Seroquel (quetiapine) 13-1710-17 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

  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 Morratoet 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) *48% of prescriptions provided by non-mental health specialists (e.g. PCP)

  15. Stakeholder team

  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 Love Gloria Reeves Athos Alexandrou Susan dosReis Stephen Mandelbaum Lisa Burgess Heidi Wehring David Pruitt Dixit Shah Mark Ellow Mark Riddle Ilene Verovski Kristin Bussell AfuaAddo-Abedi Sara Pirmohamed Nicole Letvin Jessa Coulter Acknowledgments: Joshua Sharfstein, Laura Herrera, Al Zachik, Gayle Jordan-Randolph, Mary Mussman

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