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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.

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Presentation on theme: "Use of Atypical Antipsychotics In Pediatric Patients William Golden, MD MACP Professor of Medicine and Public Health Med. Dir. Health Policy, DHS/Medicaid."— Presentation transcript:

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

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

3 Atypical Antipsychotics Limited FDA Approval Only in Older Children Limited FDA Approval Only in Older Children Risperidone Approved for Autism (>Age 5) Risperidone Approved for Autism (>Age 5) Limited Data in Younger Children Limited Data in Younger Children No Safety Data No Safety Data Long Term Neurologic Effects Long Term Neurologic Effects Weight Gain, Diabetes Weight Gain, Diabetes Extrapyramidal Side Effects Extrapyramidal Side Effects Literature Suggests Role for Aggressive Behavior Literature Suggests Role for Aggressive Behavior 3

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

5 Steven Domon, M.D. Section Chief, Adolescent Services Arkansas State Hospital Clinical Assistant Professor UAMS College of Medicine Department of Psychiatry, Division of Child and Adolescent Psychiatry 5

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].” 6

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% years] 7

8 Rebecca Riley 8

9 Rebecca Riley (cont.) Diagnosed with ADHD and Bipolar Disorder at age 28 months Diagnosed with ADHD and Bipolar Disorder at age 28 months Medications at age 4: Medications at age 4: Seroquel Seroquel Depakote Depakote Clonidine ClonidineSource: Patricia Wen, Boston Globe, February 19, 2007 Scott Allen, Boston Globe October 7,

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 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 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 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 On December 9, 2006 her parents refused to allow a concerned family member to take her to the hospital 10

11 Rebecca Riley (cont.) On December 13, 2006 she was found dead beside her parents bed 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 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 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 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,

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) 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 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 The Massachusetts oversight system continues to evolve 12

13 Indications for Antipsychotics Psychotic Disorders Psychotic Disorders Bipolar Disorder Bipolar Disorder Autism and other developmental disorders Autism and other developmental disorders Tourette’s Syndrome and tic disorders Tourette’s Syndrome and tic disorders Aggression Aggression Augmentation in other disorders such as severe OCD, PTSD Augmentation in other disorders such as severe OCD, PTSD 13

14 FDA-approved pediatric indications for antipsychotics Risperidone (Risperdal) age 5-16 irritability associated with autism age 5-16 irritability associated with autism age bipolar disorder age bipolar disorder age schizophrenia age schizophrenia Aripiprazole (Abilify) age acute mania or mixed episodes age acute mania or mixed episodes age schizophrenia age schizophrenia 14

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

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) 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 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 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 Off label use of many other medications is not uncommon in pediatric populations 16

17 Potential side effects of antipsychotics Weight gain Weight gain Sedation Sedation Dry mouth and problems urinating Dry mouth and problems urinating “Nervousness” or restlessness “Nervousness” or restlessness Insomnia Insomnia Tremors and muscle stiffness Tremors and muscle stiffness Movement disorders Movement disorders Diabetes Diabetes Elevations in cholesterol and triglycerides Elevations in cholesterol and triglycerides Menstrual changes and excessive breast milk production Menstrual changes and excessive breast milk production Cardiac conduction effects and ECG changes Cardiac conduction effects and ECG changes Neuroleptic Malignant Syndrome (fever, stiffness—potentially fatal) Neuroleptic Malignant Syndrome (fever, stiffness—potentially fatal) Rare reports of fatalities in children treated with antipsychotics—causality not necessarily proven Rare reports of fatalities in children treated with antipsychotics—causality not necessarily proven 17

18 Examples of potential problems with antipsychotics 1. Olanzapine-induced diabetes. 2. Quetiapine-associated diabetes. 3. Olanzapine-induced weight gain 4. Risperidone-induced galactorrhea (breast milk production) 5. Ziprasidone-induced tardive dyskinesia 18

19 Example of a troubling case involving a preschooler on an antipsychotic 3 year-old male outpatient diagnosed with Intermittent Explosive Disorder and Autism 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 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 No hearing evaluation was referred to or present in the records Treated with trazadone, clonidine, lexapro, and olanzapine Treated with trazadone, clonidine, lexapro, and olanzapine 19

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 Reviewed available literature and made recommendations regarding the psychopharmacologic treatment of preschool children Acknowledged the very limited literature in this age group 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 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 Emphasized the importance of psychosocial interventions before medications are utilized in part to better support the development of emotional and behavioral self-regulation 20

21 Preschool Psychopharmacology Working Group (cont.) Disruptive Behavior Disorders Algorithm- 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 PDD Algorithm- risperidone has an FDA indication age 5 and up Bipolar Disorder Algorithm- 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 21

22 Arkansas Medicaid Data New process New process Other states are beginning to do this but only a very few have published any findings (Texas and Florida) 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 States are beginning to band together with respect to how they examine data so that comparisons can be made 22

23 The number of Medicaid-covered Arkansas children aged 0-18 who were prescribed antipsychotic medications* in FY 2007: 23 12,418 12,418 * All Arkansas data for antipsychotic use excludes those with fewer than 2 claims

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 24

25 Medicaid-covered children who received antipsychotics FY years: years: years: 6, years: 6, years: 5, years: 5, years: 12, years: 12,418 FY years: years: 5, years: 4, years:11,404 (an 8% decrease in total numbers) *Includes foster children 25

26 Medicaid-covered children who received antipsychotics (prescription rates) FY yrs: 3.4/ yrs: 3.4/ yrs: 34.3/ yrs: 34.3/ yrs: 45.8/ yrs: 45.8/ yrs: 27.8/ yrs: 27.8/1000 FY 2008 Florida 2005* 0-5 yrs: 5.3/ / yrs: 34.4/100016/ yrs: 40.0/100025/ yrs: 25.2/100012/1000 *approximate, from graphs in Constantine and Larsen (2007) 26

27 The number of Arkansas foster children aged 0-18 who were prescribed antipsychotic medications in FY 2007 and :1,104 of 6, : 982 of 6,957 27

28 The rates of antipsychotic use in Arkansas foster children aged 0-18 FY years: 23.6/ years: 23.6/ /1000* 3.4/1000* 5-12 years:225.4/ years:225.4/ /1000* 34.3/1000* years:261.6/ years:261.6/ /1000* 45.8/1000* 0-18 years:181.6/ years:181.6/ /1000* 27.8/1000* -Medicaid rates FY years: 27.1/ /1000* (2-5 years: 43.5/1000) 6-18 years: 216.5/ /1000* 0-18 years: 141.2/ /1000* 28

29 Comparison of rates of antipsychotic use in foster children Texas (0-17 years) Texas (0-17 years) FY 2005: 203.0/1000 children (approximately)* 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) Arkansas(0-18 years) FY 2007: 181.6/1000 children FY 2007: 181.6/1000 children FY 2008: 141.2/1000 children FY 2008: 141.2/1000 children 29

30 In which counties do children 0-4 years who receive antipsychotics live? (FY 2007) 1.Pulaski64 2.Craighead32 3.Garland28 4.Green 26 5.Saline22 6.Jefferson20 7.Lonoke19 8.Miller18 8.Mississippi18 10.Union14 11.Randolph13 12.White12 13.Clark11 13.Poinsett11 15.Crittenden 9 15.Sebastian 9 17.Washington 8 18.Baxter 6 18.Benton 6 18.Clay 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 30

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

32 Where do atypical antipsychotic prescriptions for preschoolers in Arkansas originate? (FY 2007) 1. Pulaski County Unknown Craighead County Sebastian County Garland County Union County Jefferson County Miller County Texas Tennessee Lee County White County Benton County Independence County Johnson County Saline County Faulkner County Mississippi County St. Francis County Missouri 5 Note: some children received prescriptions from more than one county 32

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

34 Children’s Home CountyPrescription County of Origin 34

35 Facts about those who prescribed atypical antipsychotics for preschoolers in FY providers wrote atypical antipsychotic prescriptions for 472 preschoolers in FY providers wrote atypical antipsychotic prescriptions for 472 preschoolers in FY Most prescriptions were written by psychiatrists. Most prescriptions were written by psychiatrists. 35

36 Psychiatric Diagnoses of Medicaid-covered 0-5 year- olds receiving Risperidone (Risperdal) 1. ADHD Unspecified Disturbance of Conduct Speech/Language Disorder Developmental Delay Parent-Child Relational Problem Oppositional Defiant Disorder Autism Adjustment Disorder Other Emotional Disturbance Psychosis Bipolar Disorder PTSD/Anxiety Int. Explosive disorder/Impulse D/O NOS Mental Retardation Conduct Disorder/Childhood Antisocial Behavior Depressive Disorder NOS 9 Diagnoses do not necessarily represent the primary diagnosisFY

37 Psychiatric Diagnoses of Medicaid-covered 0-5 year- olds receiving Aripiprazole (Abilify) 1. ADHD86 2. Unspecified Disturbance of Conduct59 3. Speech/Language Disorders40 4. Oppositional Defiant Disorder34 5. Parent-Child Relational Problem28 6. Bipolar Disorder24 7. Developmental Delay26 8. Psychosis17 9. Adjustment Disorder Autism PTSD/Anxiety Depressive Disorder NOS Mental Retardation Conduct Disorder 4 Diagnoses do not necessarily represent the primary diagnosisFY

38 Why the increase in antipsychotic usage? There is currently no continuum of services in most areas of the state. There is currently no continuum of services in most areas of the state. “Provider-rich” areas have limited openings. “Provider-rich” areas have limited openings. Family’s need help “now.” Family’s need help “now.” Physician’s may attempt to do something to help without proper attention to or access to psychotherapeutic services. 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). There have been recent changes in diagnostic patterns (Bipolar Disorder). Sometimes they are used in a manner inconsistent with best practices. 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.). Insufficient knowledge of psychopharmacologic issues by parents and guardians (including risk/benefit ratios and treatment options, etc.). 38

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 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 year-olds may be examined. 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 year-olds may be examined. 39

40 What is currently being done? (cont.) DYS is currently working with UAMS to evaluate the medications of youth in their custody. DYS is currently working with UAMS to evaluate the medications of youth in their custody. As of August 18, 2008: As of August 18, 2008: 93 youth had been evaluated 93 youth had been evaluated 10 had medications decreased 10 had medications decreased 9 had medications discontinued altogether 9 had medications discontinued altogether 40

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 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. Explore the use of Telemedicine as a means of providing consultation to providers in underserved areas. 41

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

43 House Committee on Ways and Means 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 43

44 DHS Psychotropic Medications and Children Team: Recommendations for Youth in State Custody 1. 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 44

45 DHS Recommendations for Youth in State Custody (cont.) 2. 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 45

46 DHS Recommendations for Youth in State Custody (cont.) 3. 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. 46

47 DHS Recommendations for Youth in State Custody (cont.) 4. 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. 47

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


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