BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN

Pediatric Approved AntipsychoticsIrritability due to autism

Risperdal (risperidone) 5-16Abilify (aripiprazole) 6-17

Schizophrenia Bipolar IRisperdal (risperidone) 13–17

10-17 Abilify (aripiprazole) 13-17 10-17Zyprexa (olanzapine) 13-17 13-17Seroquel (quetiapine) 13-17

10-17Invega (paliperidone) 12-17

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

Factors increasing SGA prescribing to young children

• Availability of newer agents• New pediatric FDA approvals • Cost of aggression

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

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 prescribedPenfold et al 2010

Costs of aggression

Aggression

Injury

Familyconflict

Missedwork

Use of crisis services

Child care problems

Out of home

CONCERNS ABOUT INCREASED ANTIPSYCHOTIC PRESCRIBING TO YOUNG CHILDREN

Metabolic Side Effects

• Weight gain• Increased blood sugar/diabetes• Abnormal cholesterol levels• Youth, particularly antipsychotic naïve, are at

greater risk than adults

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)

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 IQ1 risperidone; treatment resistant aggression ADHD-CD 1 quetiapine for adolescent CDPringsheim & Gorman 2012

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)

MARYLAND MEDICAID PEER REVIEW PROGRAM

Baseline Medicaid Data(Off-label antipsychotic tx by age; 1/1/2010 – 12/30/10)

Age # of Prescriptions # of Children

0-4* 705 178

5-9 12,992 2065

10-12 11,699 1824

13-17 19,349 2875

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

Stakeholder team• AACAP, AAP• Leadership from child

mental health programs

• MD Coalition of Families for Children’s Mental Health

• Psychiatry• Pharmacy• Pediatrics

• Medicaid• MHA

Providers Families

Health Experts

Child Serving

Agencies

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)

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

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)

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

“Call me (maybe)” Pharmacy Child Psychiatry MedicaidRay Love Gloria Reeves Athos AlexandrouSusan dosReis Stephen Mandelbaum Lisa BurgessHeidi Wehring David Pruitt Dixit ShahMark Ellow Mark RiddleIlene Verovski Kristin BussellAfua Addo-Abedi Sara PirmohamedNicole LetvinJessa Coulter

Acknowledgments: Joshua Sharfstein, Laura Herrera, Al Zachik, Gayle Jordan-Randolph, Mary Mussman