background: antipsychotic treatment of young children
TRANSCRIPT
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BACKGROUND: ANTIPSYCHOTIC TREATMENT OF YOUNG CHILDREN
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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
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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
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Factors increasing SGA prescribing to young children
• Availability of newer agents• New pediatric FDA approvals • Cost of aggression
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Availability of Newer Agents• 1993: risperidone• 1996: olanzapine• 1997: quetiapine• 2001: ziprasidone• 2002: aripiprazole• 2006: paliperidone• 2009: asenapine, iloperidone• 2010: lurasidone
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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
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Costs of aggression
Aggression
Injury
Familyconflict
Missedwork
Use of crisis services
Child care problems
Out of home
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CONCERNS ABOUT INCREASED ANTIPSYCHOTIC PRESCRIBING TO YOUNG CHILDREN
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Metabolic Side Effects
• Weight gain• Increased blood sugar/diabetes• Abnormal cholesterol levels• Youth, particularly antipsychotic naïve, are at
greater risk than adults
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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)
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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
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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)
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MARYLAND MEDICAID PEER REVIEW PROGRAM
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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)
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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
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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)
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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
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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)
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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
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“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