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Use of Atypical Antipsychotics In Pediatric Patients. William Golden, MD MACP Professor of Medicine and Public Health Med. Dir. Health Policy, DHS/Medicaid. Pediatric Mood Disorders. Reliable Diagnosis in Very Young Children ADHD, Oppositional Defiant Disorder, Autism

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Use of atypical antipsychotics in pediatric patients

Use of Atypical Antipsychotics In Pediatric Patients

William Golden, MD MACP

Professor of Medicine and Public Health

Med. Dir. Health Policy, DHS/Medicaid


Pediatric mood disorders
Pediatric Mood Disorders

  • Reliable Diagnosis in Very Young Children

    • ADHD, Oppositional Defiant Disorder, Autism

    • Schizophrenia, Depression

    • Sequelae of Dysfunctional Family Settings


Atypical antipsychotics
Atypical Antipsychotics

  • Limited FDA Approval Only in Older Children

    • Risperidone Approved for Autism (>Age 5)

  • Limited Data in Younger Children

    • No Safety Data

    • Long Term Neurologic Effects

    • Weight Gain, Diabetes

    • Extrapyramidal Side Effects

    • Literature Suggests Role for Aggressive Behavior


National concern
National Concern

  • Safety

  • Polypharmacy

  • Diagnosis

  • Growth in Prescribing

  • Foster Children At Particular Risk

    • Less Parental Oversight, Polypharmacy


Steven Domon, M.D.Section Chief, Adolescent ServicesArkansas State HospitalClinical Assistant ProfessorUAMS College of MedicineDepartment of Psychiatry,Division of Child and Adolescent Psychiatry


For foster kids oversight of prescriptions is scarce usa today may 2 2006
“For Foster kids, oversight of prescriptions is scarce”USA TODAY, May 2, 2006

“In California, Med-Cal prescription claims for atypicals for kids in foster care increased 77% between 2001 and 2005.”

“In Illinois, the number of children covered under the state’s public health care program—not just foster children—who had an atypical prescription went up 39% between fiscal years 2003 and 2005, to 17,746.”

“In February [2006], Florida’s health care agency ordered an independent investigation into why the number of Medicaid children taking antipsychotics nearly doubled in the past five years. The numbers jumped from 9,500 to 17,900 [from 2000 to 2005].”


Concern about psychotropic drugs and foster kids psychiatric times july 1 2008
“Concern About Psychotropic Drugs and Foster Kids”Psychiatric Times, July 1, 2008

“Concern is on the rise about psychotropic medications—especially atypical antipsychotics—given to foster children covered under Medicaid”

“Rep. Jim McDermott, M.D. (D, Washington), the only psychiatrist in Congress, has introduced legislation that requires states to improve care coordination for foster children.” [The American Academy of Pediatrics has endorsed this section of McDermott’s bill.]

Based on a review of data from Texas, Dr. Julie M. Zito “found that in 2004, 38% of the more than 32,000 foster care youth in Texas younger than 19 years received a psychotropic drug.”

[12.4% 0-5 years, 55% 6-12 years, and 66.5% 13-17 years]



Rebecca riley cont
Rebecca Riley (cont.)

  • Diagnosed with ADHD and Bipolar Disorder at age 28 months

  • Medications at age 4:

    • Seroquel

    • Depakote

    • Clonidine

      Source:

      Patricia Wen, Boston Globe, February 19, 2007

      Scott Allen, Boston Globe October 7, 2007


Rebecca riley cont1
Rebecca Riley (cont.)

During the summer of 2006 her in-home therapist expressed concerns about Rebecca’s medications to her psychiatrist and to her mother

The Massachusetts Dept. of Social Services investigated at least two reports of neglect and abuse made by Rebecca’s therapist

In October her school nurse and gym teacher described her as lethargic every day

On December 9, 2006 her parents refused to allow a concerned family member to take her to the hospital


Rebecca riley cont2
Rebecca Riley (cont.)

On December 13, 2006 she was found dead beside her parents bed

The state medical examiner determined that she died due to the combined effects of her prescribed medications and over-the-counter cold medications

She apparently died after deteriorating slowly, over the course of several days

Her parents were charged with murder and her physician surrendered her license while the state investigated the death

Soure:Dennis Tatz and Sue Reinert, The Patriot Ledger, Feb 6, 2007


Massachusetts response
Massachusetts’ Response

State officials set up an “early warning system” to identify preschoolers who may be getting excessive medication (35 were identified in the first 3 months)

The State Medicaid program began reviewing the records of all children under age 5 for those who were on at least three psychiatric medications or on an antipsychotic

The Massachusetts oversight system continues to evolve


Indications for antipsychotics
Indications for Antipsychotics

Psychotic Disorders

Bipolar Disorder

Autism and other developmental disorders

Tourette’s Syndrome and tic disorders

Aggression

Augmentation in other disorders such as severe OCD, PTSD


Fda approved pediatric indications for antipsychotics
FDA-approved pediatric indications for antipsychotics

Risperidone (Risperdal)

age 5-16 irritability associated with autism

age 10-17 bipolar disorder

age 13-17 schizophrenia

Aripiprazole (Abilify)

age 10-17 acute mania or mixed episodes

age 13-17 schizophrenia


Fda approved pediatric indications for antipsychotics cont
FDA-approved pediatric indications for antipsychotics (cont.)

Quetiapine (Seroquel) none

Ziprasidone (Geodon) none

Olanzapine (Zyprexa) none


Off label use of antipsychotics
“Off label” use of antipsychotics (cont.)

When antipsychotics are used in children, more often than not, that use is not FDA-approved (this is true of most psychiatric medications)

Off label use is often consistent with the standard of care

There may be evidence supporting the use of a medication even absent FDA approval

Off label use of many other medications is not uncommon in pediatric populations


Potential side effects of antipsychotics
Potential side effects of antipsychotics (cont.)

Weight gain

Sedation

Dry mouth and problems urinating

“Nervousness” or restlessness

Insomnia

Tremors and muscle stiffness

Movement disorders

Diabetes

Elevations in cholesterol and triglycerides

Menstrual changes and excessive breast milk production

Cardiac conduction effects and ECG changes

Neuroleptic Malignant Syndrome (fever, stiffness—potentially fatal)

Rare reports of fatalities in children treated with antipsychotics—causality not necessarily proven


Examples of potential problems with antipsychotics
Examples of potential problems with antipsychotics (cont.)

  • Olanzapine-induced diabetes.

  • Quetiapine-associated diabetes.

  • Olanzapine-induced weight gain

  • Risperidone-induced galactorrhea (breast milk production)

  • Ziprasidone-induced tardive dyskinesia


Example of a troubling case involving a preschooler on an antipsychotic
Example of a troubling case involving a preschooler on an antipsychotic

3 year-old male outpatient diagnosed with Intermittent Explosive Disorder and Autism

Records indicated he had a history of severe ear infections and only responded to conversation if he looked at the speaker’s face

No hearing evaluation was referred to or present in the records

Treated with trazadone, clonidine, lexapro, and olanzapine


Preschool psychopharmacology working group
Preschool Psychopharmacology Working Group antipsychotic

Gleason, et al., JAACAP, 46:12, December 2007

Reviewed available literature and made recommendations regarding the psychopharmacologic treatment of preschool children

Acknowledged the very limited literature in this age group

Developed algorithms for ADHD, Major Depressive Disorder, Anxiety Disorders, Posttraumatic Stress Disorder, Obsessive-Compulsive Disorder, Primary Sleep Disorders, Disruptive Behavior Disorders, Bipolar Disorder, and Pervasive Developmental Disorders

Emphasized the importance of psychosocial interventions before medications are utilized in part to better support the development of emotional and behavioral self-regulation


Preschool psychopharmacology working group cont
Preschool Psychopharmacology Working Group (cont.) antipsychotic

Disruptive Behavior Disorders Algorithm-

- psychotherapy first (involving parents)

-risperidone only if aggression is severe and psychotherapeutic interventions fail

-psychopharmacological interventions without psychotherapy is not recommended

-chemical restraints and “prn” medications are not recommended

PDD Algorithm- risperidone has an FDA indication age 5 and up

Bipolar Disorder Algorithm-

-psychotherapeutic interventions first

-risperidone should be the first medication choice

-mood stabilizers (lithium, Depakote) only if parents are highly reliable

- psychopharmacological interventions without psychotherapy is not recommended

-polypharmacy (using multiple medications) should be used with extreme caution


Arkansas medicaid data
Arkansas Medicaid Data antipsychotic

New process

Other states are beginning to do this but only a very few have published any findings (Texas and Florida)

States are beginning to band together with respect to how they examine data so that comparisons can be made


12,418 antipsychotic

* All Arkansas data for antipsychotic use excludes those with fewer than 2 claims

The number of Medicaid-covered Arkansas children aged 0-18 who were prescribed antipsychotic medications* in FY 2007:


Comparison of the number of medicaid covered children
Comparison of the number of Medicaid-covered children antipsychotic

Number of Medicaid Covered Children on Antipsychotics

Arkansas (2008): 12,418

Illinois (2005): 17,746*

Florida (2006): 18,137**

*USA TODAY, May 2, 2006

**Daytona Beach News-Journal, May 30, 2008

Population under age 18 (2006, estimated)

691,475

3,220,824

4,015,955


Medicaid covered children who received antipsychotics
Medicaid-covered children who received antipsychotics antipsychotic

FY 2007

  • 0-4 years: 472

  • 5-12 years: 6,335

  • 13-18 years: 5,611

  • 0-18 years: 12,418

FY 2008

  • 0-5 years: 893

  • 6-12 years: 5,602

  • 13-18 years: 4,909

  • 0-18 years: 11,404

    (an 8% decrease in total numbers)

    *Includes foster children


Medicaid covered children who received antipsychotics prescription rates
Medicaid-covered children who received antipsychotics (prescription rates)

FY 2007

  • 0-4 yrs: 3.4/1000

  • 5-12 yrs: 34.3/1000

  • 13-18 yrs: 45.8/1000

  • 0-18 yrs: 27.8/1000

FY 2008Florida 2005*

  • 0-5 yrs: 5.3/1000 0.9/1000

  • 6-12 yrs: 34.4/1000 16/1000

  • 13-18 yrs: 40.0/1000 25/1000

  • 0-18 yrs: 25.2/1000 12/1000

    *approximate, from graphs in Constantine and Larsen (2007)


The number of Arkansas foster children aged 0-18 who were prescribed antipsychotic medications in FY 2007 and 2008

2007: 1,104 of 6,078

2008 : 982 of 6,957


The rates of antipsychotic use in arkansas foster children aged 0 18
The rates of antipsychotic use in Arkansas foster children aged 0-18

FY 2007

  • 0-4 years: 23.6/1000

    3.4/1000*

  • 5-12 years: 225.4/1000

    34.3/1000*

  • 13-18 years: 261.6/1000

    45.8/1000*

  • 0-18 years: 181.6/1000

    27.8/1000*

    -Medicaid rates

FY 2008

  • 0-5 years: 27.1/1000

    5.3/1000*

    (2-5 years: 43.5/1000)

  • 6-18 years: 216.5/1000

    36.8/1000*

  • 0-18 years: 141.2/1000

    25.9/1000*


Comparison of rates of antipsychotic use in foster children
Comparison of rates of antipsychotic use in foster children aged 0-18

Texas (0-17 years)

FY 2005: 203.0/1000 children (approximately)*

*from a report by the Texas Health and Human Services Commission, Department of State Health Services, and Department of Family and Protective Services

Arkansas (0-18 years)

FY 2007: 181.6/1000 children

FY 2008: 141.2/1000 children


In which counties do children 0 4 years who receive antipsychotics live fy 2007
In which counties do children 0-4 years who receive antipsychotics live? (FY 2007)

1. Pulaski 64

2. Craighead 32

3. Garland 28

4. Green 26

5. Saline 22

6. Jefferson 20

7. Lonoke 19

8. Miller 18

8. Mississippi 18

10. Union 14

11. Randolph 13

12. White 12

13. Clark 11

13. Poinsett 11

15. Crittenden 9

15. Sebastian 9

17. Washington 8

18. Baxter 6

18. Benton 6

18. Clay 6

18. Crawford 6

18. Desha 6

18. Independence 6

18. Johnson 6

25. Chicot 5

25. Cross 5

25. Hot Spring 5

25. Lawrence 5

25. Polk 5

25. Yell 5



Where do atypical antipsychotic prescriptions for preschoolers in arkansas originate fy 2007
Where do atypical antipsychotic prescriptions for preschoolers in Arkansas originate?(FY 2007)

  • Pulaski County 197

  • Unknown 129

  • Craighead County 101

  • Sebastian County 25

  • Garland County 20

  • Union County 18

  • Jefferson County 16

  • Miller County 16

  • Texas 16

  • Tennessee 12

  • Lee County 11

  • White County 11

  • Benton County 10

  • Independence County 8

  • Johnson County 8

  • Saline County 6

  • Faulkner County 5

  • Mississippi County 5

  • St. Francis County 5

  • Missouri 5

    Note: some children received prescriptions from more than one county


Where do atypical antipsychotic prescriptions for preschoolers in arkansas originate fy 20071
Where do atypical antipsychotic prescriptions for preschoolers in Arkansas originate?(FY 2007)



Facts about those who prescribed atypical antipsychotics for preschoolers in fy 2007
Facts about those who prescribed atypical antipsychotics for preschoolers in FY 2007

243 providers wrote atypical antipsychotic prescriptions for 472 preschoolers in FY 2007.

Most prescriptions were written by psychiatrists.


Psychiatric diagnoses of medicaid covered 0 5 year olds receiving risperidone risperdal
Psychiatric Diagnoses of Medicaid-covered 0-5 year-olds receiving Risperidone (Risperdal)

  • ADHD 235

  • Unspecified Disturbance of Conduct 146

  • Speech/Language Disorder 113

  • Developmental Delay 112

  • Parent-Child Relational Problem 59

  • Oppositional Defiant Disorder 53

  • Autism 44

  • Adjustment Disorder 43

  • Other Emotional Disturbance 33

  • Psychosis 29

  • Bipolar Disorder 25

  • PTSD/Anxiety 17

  • Int. Explosive disorder/Impulse D/O NOS 16

  • Mental Retardation 15

  • Conduct Disorder/Childhood Antisocial Behavior 14

  • Depressive Disorder NOS 9

    Diagnoses do not necessarily represent the primary diagnosis FY2007


Psychiatric diagnoses of medicaid covered 0 5 year olds receiving aripiprazole abilify
Psychiatric Diagnoses of Medicaid-covered 0-5 year-olds receiving Aripiprazole (Abilify)

  • ADHD 86

  • Unspecified Disturbance of Conduct 59

  • Speech/Language Disorders 40

  • Oppositional Defiant Disorder 34

  • Parent-Child Relational Problem 28

  • Bipolar Disorder 24

  • Developmental Delay 26

  • Psychosis 17

  • Adjustment Disorder 12

  • Autism 8

  • PTSD/Anxiety 7

  • Depressive Disorder NOS 7

  • Mental Retardation 5

  • Conduct Disorder 4

    Diagnoses do not necessarily represent the primary diagnosis FY 2007


Why the increase in antipsychotic usage
Why the increase in antipsychotic usage? receiving Aripiprazole (Abilify)

There is currently no continuum of services in most areas of the state.

“Provider-rich” areas have limited openings.

Family’s need help “now.”

Physician’s may attempt to do something to help without proper attention to or access to psychotherapeutic services.

There have been recent changes in diagnostic patterns (Bipolar Disorder).

Sometimes they are used in a manner inconsistent with best practices.

Insufficient knowledge of psychopharmacologic issues by parents and guardians (including risk/benefit ratios and treatment options, etc.).


What is currently being done
What is currently being done? receiving Aripiprazole (Abilify)

DHS will continue to examine data from Medicaid and other sources to evaluate prescription practices and patterns for all Medicaid eligible children and compare them to data from other states’ data.

DHS is currently reviewing the profiles of preschoolers in DCFS custody who are receiving antipsychotics. Once that review is complete, profiles of 6-12 and 13-18 year-olds may be examined.


What is currently being done cont
What is currently being done? receiving Aripiprazole (Abilify)(cont.)

  • DYS is currently working with UAMS to evaluate the medications of youth in their custody.

  • As of August 18, 2008:

    • 93 youth had been evaluated

    • 10 had medications decreased

    • 9 had medications discontinued altogether


Where do we go from here
Where do we go from here? receiving Aripiprazole (Abilify)

Explore the use of a “call in” system whereby physicians may speak to a child and adolescent psychiatrist for guidance with younger and/or difficult to treat patients.

Explore the use of Telemedicine as a means of providing consultation to providers in underserved areas.


Where do we go from here cont
Where do we go from here? receiving Aripiprazole (Abilify)(cont.)

Begin training programs for DHS staff who have consent authority

Consider implementation of DHS Psychotropic Medications and Children Team Recommendations


House committee on ways and means july 19 2007
House Committee on Ways and Means receiving Aripiprazole (Abilify)July 19, 2007

Dr. Michael W. Naylor, M.D., University of Illinois-Chicago

Discussed Illinois DCFS’ “Centralized Psychotropic Medication Consent Unit”:

DCFS contracted with U of Illinois at Chicago Dept. of Psychiatry to

-provide independent medication reviews for psychotropic consents

-special consultation on difficult or complex cases

-notify DCFS when prescription patterns are suspect

-provide training for DCFS staff regarding psychotropic medication management

-disseminate information on new psychotropics and developments and/or alerts to physicians who treat DCFS wards


Dhs psychotropic medications and children team recommendations for youth in state custody
DHS Psychotropic Medications and Children Team: Recommendations for Youth in State Custody

  • Establish policies and procedures to guide the psychotropic medication management of youth in state custody including:

    a. identify parties empowered to provide consent in a timely manner

    b. develop training for child welfare, juvenile justice providers, and court personnel in addition to foster parents to help them become more effective advocates for children and youth in their custody

    c. monitor the use of psychotropic medications for both safety and effectiveness


Dhs recommendations for youth in state custody cont
DHS Recommendations for Youth in State Custody (cont.) Recommendations for Youth in State Custody

  • Design and implement oversight procedures to:

    a. examine the utilization of medications for youth in state custody

    b. review DHS medication formulary on a continual basis

    c. provide medication monitoring guidelines to practitioners who treat children and youth in the child welfare system


Dhs recommendations for youth in state custody cont1
DHS Recommendations for Youth in State Custody (cont.) Recommendations for Youth in State Custody

  • Create a program to provide consultation to the persons and agencies responsible for consenting for treatment with psychotropic medications in addition to or at the request of physicians treating children and youth who are in state custody.


Dhs recommendations for youth in state custody cont2
DHS Recommendations for Youth in State Custody (cont.) Recommendations for Youth in State Custody

  • Develop a website, under the proposed DMS Monitoring Unit, to provide ready access for clinicians, foster parents, and other caregivers to pertinent policies and procedures governing psychotropic medications management, psychoeducational materials, consent forma, adverse side effect information, reports on prescription patterns, and links to helpful, accurate, and ethical websites about child and adolescent psychiatric diagnoses and psychotropic medications.


Sources
Sources Recommendations for Youth in State Custody

Constantine, R, Larsen B (2007). The Use of Antipsychotic Medications in Children: A Comprehensive and Current View. Tampa, FL: Louis de la Parte Florida Mental Health Institute. University of South Florida.

“Use of Psychoactive Medication in Texas Foster Children State Fiscal Year 2005,” prepared by the Texas Health and Human Services Commission, Department of State Health Services, and Department of Family and Protective Services. June 2006.


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