1. Psychotropic Medications and Their Use with Children A Web-based Educational Program for Children’s Medical Services Care Coordination Daniel Armstrong, Ph.D. Mailman Center for Child Development Batchelor Children’s Research Institute Department of Pediatrics University of Miami School of Medicine

2. Psychotropic Medications for Children: What are the Issues? Lack of access to child mental health services Inadequate numbers of mental health practitioners with training and experience with children Underserved populations (Location, Culture) Poor/non-existent empirical data on safety or efficacy of most psychotropic medications with children

3. Psychotropic Medications for Children: What are the Issues? Inadequate attention to risks associated with selected sub-groups of children Absence of guidelines for prescribing, monitoring Role of the pediatrician in addressing these problems: AAP (2001): The new morbidity revisited.

4. Lack of Access to Mental Health Services Estimated 13 million children in the U.S. have diagnosable mental, emotional, or behavioral disorders Two thirds have no mental/behavioral health treatment

5. Lack of Access to Mental Health Services These numbers do not include: – Children under 4 – Children with primary medical problems where behavioral problems are secondary (e.g. cancer, HIV) – Children with behavioral problems that do not meet disorder diagnostic criteria

6. Children’s Access to Mental and Behavioral Health Services Types of Problems Serious Mental Illness Developmental Disorders Problems associated with environmental risk – Maternal risk factors: Depression, social isolation – Exposure to violence – Poverty and homelessness Physical or Chronic Illness

7. Inadequate Number of Child Mental Health Providers Estimates: – Child & Adolescent Psychiatrists: 6,000 – Child Clinical/Pediatric Psychologists: 3,000 – School Psychologists: 3,000 – Developmental and Behavioral Pediatricians: <1000 – Clinical Social Work, Psychiatric Nurse Specialists: 2,000 Total: 15,000 or 1/866 children in need

8. Underserved Populations Lack of access to mental health services is highest among children of: – Poverty – Non-majority culture – Rural communities Underserved populations rarely have access to child mental health professional with cultural competence

9. What are “psychotropic” medications? Medications administered for the purpose of maintaining or improving behavior, emotions, mood, or thinking Other medications may have effects on behavior, emotions, mood, or thinking, but are not prescribed for that purpose

10. Psychotropic Medications Used with Children Psycho-Stimulants – Most often used in treatment of Attention Deficit Hyperactivity Disorder – Also used in treatment of behavior disabilities in children with autism and other developmental disabilities – May have some benefits to children with long- term, late consequences of chronic illnesses (e.g., brain tumors, leukemia, stroke, neurotrauma)

11. Psychotropic Medications Used with Children Stimulants (Schedule II Medications) – Methylphenidate Commercial names: Ritalin, Concerta, Focalin, Methylin, Metadate - methylphenidate in various forms of admistration – Amphetamine & dextroamphetamine Commercial names: Adderall, Dexedrine – Pemoline Commercial Name: Cylert

12. Psychotropic Medications Used with Children Stimulants Most Common Side Effects – Nervousness & Jitteriness – Insomnia – Decreased Appetite & Weight Loss – Headaches or Stomachaches – Skin Rash – Social Withdrawal

13. Psychotropic Medications Used with Children Stimulants Rare adverse events – Tachycardia, changes in blood pressure, nausea, dizziness, and palpitations Overdose symptoms – Vomiting, agitation, tremors, muscle twitching, convulsions, hallucinations, delirium, sweating, and cardiac arrhythmias – Contact Poison Control Center

14. Psychotropic Medications Used with Children Non-Stimulants (Not Schedule II) – Atomoxetine ( norepinephrine reuptake inhibitor ) Commercial Name: Strattera – Common Side Effects Excessive tiredness, insomnia Increase in heart rate & blood pressure Sexual side effects Enlarged Pupils Weight fluctuations Headache, dizziness Nausea, vomiting, stomach pain Mood swings and irritability

15. Psychotropic Medications Used with Children There is a lot of controversy about the use of stimulants with children – Recent AAP, AACAP reviews provide evidence of benefits for children with significant behavior problems/ADHD – Some children do experience side effects, some significant – Stimulants are the most studied medications used with children, so safety and efficacy information is available

16. Psychotropic Medications Used with Children Anti-depressants – Used in the treatment of Depression Anxiety/Panic Disorders Obsessive-Compulsive Disorder (OCD) – One class of anti-depressants (SSRIs) are under FDA black-box warning because of increased suicide risk

17. Psychotropic Medications Used with Children Anti-Depressants – Selective Serotonin Reuptake Inhibitors (SSRIs) Fluoxetine (Commercial Name: Prozac)-only drug currently approved for use in children by FDA) Paroxetine (Commercial Name: Paxil) Sertraline (Commercial Name: Zoloft) Citalopram (Commercial Name: Celexa) Fluvoxamine Maleate (Commercial Name: Luvox)- approved for with Obsessive Compulsive Disorder Clomipramine (Commercial Name: Anafranil) approved for use with OCD

18. Psychotropic Medications Used with Children Side Effects of SSRIs – Common Anxiety & nervousness Insomnia Mania and agitation Decreased appetite Rash or hives – Rare but significant Events Thoughts of suicide, attempted suicide Seizure

19. Psychotropic Medications Used with Children Other non-SSRI anti-depressants – Buproprion (Commercial Names: Wellbutrin, Zyban) Side effects: Agitation, anxiety, insomnia, hypertension, possible hallucinations, weight loss, dose related risk of seizure – Propranolol (Commercial Name: Inderal) Side effects: Dizziness, insomnia, tiredness, stomach pain, vomiting, diarrhea; difficulty breathing, sore throat, unusual bleeding, swelling of feet or hands, slow heartbeat, chest pain)

20. Psychotropic Medications Used with Children – Other non-SSRI anti-depressants Venlafaxine (Commercial Name: Effexor) – Side effects: Dizziness, drowsiness, sleep problems, difficulty breathing, cold hands or feet, hallucinations, irregular heartbeat, hypertension; In rare cases, fever or increased depression.

21. Psychotropic Medications Used with Children Atypical Anti-psychotics – Used in treatment of childhood schizophrenia, bipolar disorder – Beginning to be used in treatment of children with developmental disabilities, particularly autism

22. Psychotropic Medications Used with Children Atypical Anti-psychotics – Risperidone (Commercial Name: Risperdal) – Clozapine (Commercial Name: Clozaril) – Olanzapine (Commercial Name: Zyprexa) – Quetiapine (Commercial Name: Seroquel) – White blood cells checked weekly

23. Psychotropic Medications Used with Children Atypical Anti-psychotics – Common Side Effects Hyperglycemia Diabetes Mellitus Hypotension Cognitive and Motor Impairments – Rare Side Effects Serious cardiac abnormalities Serious neuromuscular effects

24. Current Prescription Patterns Approximately 80% of psychotropic medications are prescribed by primary care physicians (internal medicine, family medicine, & pediatrics) Primary pediatric patterns – Overwhelmingly stimulant medications – Some anti-depressants, anxiolytics

25. Concerns Empirical support for use with children – Extensive literature supporting use of stimulants for ADHD Primarily dexedrine & methylphenidate Limited literature on newer stimulants (long-lasting, methylphenidate/dexedrine combinations, methylphenidate patch, etc.)

26. Concerns – Despite increasing use trends, and availability of new “atypical” psychotropic medications, almost no empirical support for use of other psychotropics with children, particularly those under age 6 Efficacy Safety

27. Concerns FDA Black Box Warnings (2004)-SSRIs – Elevated risk for suicide in children At start of medication trial, at discontinuation Specific concerns for adolescents – Risk/Benefit Balance In randomized, double-blind, placebo- controlled clinical trials, SSRIs did not offer a significant benefit over placebo

28. Concerns Some concerns raised recently about several stimulants: long QT syndrome, etc. – Cardiovascular monitoring recommended for children on a number of psychotropic medications

29. Concerns External Pressure to Prescribe – Parents – Schools & Agencies – Insurance Providers External Pressure to Not Prescribe – Parents – Advocacy Groups

30. Things to Consider Before Prescribing Training & experience (Competence)? Collaborative relationship with mental health specialist?

31. Other Things to Consider Is the diagnosis accurate? What treatments are available for this problem? What is the relative effectiveness of each? Are combinations of approaches most appropriate?

32. Other Things to Consider – Empirical support for psychotropics – Empirical support for behavioral interventions Recent publications on empirically supported treatments:, Society of Clinical Child Psychology, Society of Pediatric Psychology – Empirical support for combined approaches AAP (2001) Statement on ADHD

33. Other Things to Consider What resources are available to the family? What are the risks of using a psychotropic medication compared with the risks of not using it?

34. Other Things to Consider What educational information is available for parents, teachers about the medication? What consent process is used? – Understanding of risks and benefits – Understanding of monitoring plan, as well as plan for adjusting or discontinuing meds or other concurrent treatments

35. Other Things to Consider Special Considerations – Use of multiple psychotropic medications – Use of psychotropics with other medications (e.g., in chronic illness) – Medication and dose sensitivity in children with CNS disease, treatment Increased toxicity Interference with other drug mechanisms

36. Suggestions for Use of Psychotropics with Children Establish plan for monitoring effectiveness Obtain accurate medication history – Current medications (including OTCs) – Previous medications Establish plan for monitoring adherence Establish plan for monitoring drug toxicity

37. Pitfalls to Avoid Avoid pressure to prescribe when inappropriate, or to not prescribe when appropriate Avoid pressure to use psychotropics to the exclusion of other effective and available interventions

38. Pitfalls to Avoid Avoid non-standard dosing, dose-escalation, or poly-pharmacy approaches without consultation Avoid practicing outside competence, experience, or comfort

39. Other Roles for Pediatric Care Providers Serve as a source of information about psychotropic medications for parents, schools, and communities Identify IRB approved clinical trials and make participation available to parents Advocate at community, state, and national level for increased access to child-competent mental health services

40. Acknowledgements This session is part of an ongoing training collaboration between the Florida Department of Health, Children’s Medical Services, and the Mailman Center for Child Development at the University of Miami Miller School of Medicine.

41. References and Resources NIMH. Treatment of Children with Mental Disorders. http://www.nimh.nih.gov/publicat/childqa.cfm http://www.nimh.nih.gov/publicat/childqa.cfm Florida Department of Children and Families. 2005. Ensuring informed and appropriate use of psychotropic medications with children in department custody. http://www.dcf.state.fl.us/mentalhealth/psychpres0111.ppt#407, 2,Ensuring Appropriate and Informed Use of Psychotropic Medications With Children in Department Custody The Center for Health and Health Care in the Schools. 2004. Psychotropic drugs and children: Use, trends, and implications for school. http://www.healthinschools.org/press/psych.asp