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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. Reliable Diagnosis in Very Young Children ADHD, Oppositional Defiant Disorder, Autism

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Use of Atypical Antipsychotics In Pediatric Patients

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  1. Use of Atypical Antipsychotics In Pediatric Patients William Golden, MD MACP Professor of Medicine and Public Health Med. Dir. Health Policy, DHS/Medicaid

  2. Pediatric Mood Disorders • Reliable Diagnosis in Very Young Children • ADHD, Oppositional Defiant Disorder, Autism • Schizophrenia, Depression • Sequelae of Dysfunctional Family Settings

  3. 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

  4. National Concern • Safety • Polypharmacy • Diagnosis • Growth in Prescribing • Foster Children At Particular Risk • Less Parental Oversight, Polypharmacy

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

  6. “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].”

  7. “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]

  8. Rebecca Riley

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. FDA-approved pediatric indications for antipsychotics (cont.) Quetiapine (Seroquel) none Ziprasidone (Geodon) none Olanzapine (Zyprexa) none

  16. “Off label” use of antipsychotics 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

  17. Potential side effects of antipsychotics 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

  18. Examples of potential problems with antipsychotics • Olanzapine-induced diabetes. • Quetiapine-associated diabetes. • Olanzapine-induced weight gain • Risperidone-induced galactorrhea (breast milk production) • Ziprasidone-induced tardive dyskinesia

  19. 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

  20. Preschool Psychopharmacology Working Group 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

  21. Preschool Psychopharmacology Working Group (cont.) 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

  22. Arkansas Medicaid Data 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

  23. 12,418 * 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:

  24. Comparison of the number of Medicaid-covered children 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

  25. Medicaid-covered children who received antipsychotics 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

  26. 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)

  27. 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

  28. 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*

  29. Comparison of rates of antipsychotic use in foster children 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

  30. 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

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

  32. 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

  33. Where do atypical antipsychotic prescriptions for preschoolers in Arkansas originate?(FY 2007)

  34. Children’s Home County Prescription County of Origin

  35. 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.

  36. 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

  37. 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

  38. Why the increase in antipsychotic usage? 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.).

  39. What is currently being done? 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.

  40. What is currently being done? (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

  41. Where do we go from here? 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.

  42. Where do we go from here? (cont.) Begin training programs for DHS staff who have consent authority Consider implementation of DHS Psychotropic Medications and Children Team Recommendations

  43. House Committee on Ways and MeansJuly 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

  44. 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

  45. DHS Recommendations for Youth in State Custody (cont.) • 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

  46. DHS Recommendations for Youth in State Custody (cont.) • 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.

  47. DHS Recommendations for Youth in State Custody (cont.) • 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.

  48. Sources 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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