Mary Elizabeth Jones, PharmBsc , RPh Senior Pharmacist, Behavioral Health

1. Prescribing Psychotherapeutic Medication to Children: A History of Policy Development and Quality Improvementmaking floridamedicaidmanaged care work for patients Mary Elizabeth Jones, PharmBsc, RPh Senior Pharmacist, Behavioral Health AHCA Bureau of Pharmacy Services

2. Presentation Outline History of Policy Development Specific Concerns with Antipsychotic Prescribing in Children Best Practice Guidelines Second medical opinion review process Results

3. History of Policy Development 2005 legislation: Medicaid Drug Therapy Management Program (MDTMP) for Behavioral Health; administered by FMHI (Florida Mental Health Institute) at USF (University of South Florida). Original goals: Quality of psychotherapeutic drug prescribing Patient adherence to treatments and drug therapy Clinical risks Cost BUT the program focus shifted: Cost Containment Safe Medication use in Children WHY?

4. History of Policy Development Late 1990’s - 2000’s • Escalation in use of atypical antipsychotics in children • Pharma marketing issues: • Inappropriate marketing of antipsychotic medications for pediatric use to primary care providers • Promoting newer antipsychotics as being safer than older antipsychotics • Media coverage of antipsychotic (AP) use in children • Special interest groups question reimbursement of off-label medications without safety data in children

5. AHCA Requests USF Study Timeframe: July 2002 – December 2005 Criteria: Utilization trends Diagnoses of recipients (or children) Prescribers and their specialties Compare prescribing patterns of specialists and non-specialists

6. History of Policy Development USF study of AP prescribing patterns found: • Exposure to antipsychotics occurs at very early ages • Frequently combined with other psychotherapeutics • Treatment tends to persist for multiple years • Diagnoses often do not support AP treatment • Concerns about long-term health of patients warranted

7. History of Policy Development Policy recommendations from the USF study: • Intensify monitoring, quality improvement strategies currently in place • Develop and regularly update evidenced-based guidelines for antipsychotic treatment of pediatric populations • http://medicaidmentalhealth.org/ • Engage pediatricians and psychiatrists to enhance use of the guidelines • Continue to monitor prescribing practices using edits directly derived from the evidenced-based guidelines • Monitor antipsychotic prescribing for very young children

8. Specific Concerns Leading to Policy Development • Increased national attention • Media reports of severe adverse events • Antipsychotics commonly prescribed with other medication • Limited data to guide use in children • Limited FDA indications; off-label prescribing • Data from adult studies not applicable

9. Specific Concerns Leading to Policy Development (continued) • Some benefits to use of medication • Reduced symptoms • Improved ability to function • Improved quality of life • Some risks to use; safety and tolerability concerns • Side effects; children are more sensitive • Concurrent use of psychotherapeutic medication • Emerging data on long-term effects

10. Potential Adverse Effects of Antipsychotic Medications • Metabolic side effects • Weight gain, lipid dysregulation, obesity, diabetes • Neurological side effects • sedation, seizures • Motor side effects • restlessness, tremor, tardive dyskinesia • Cardiovascular side effects • hypotension, arrhythmias • Prolactin elevation • breast milk production, male breast development

11. Special Needs Populations Pose Additional Challenges • Children with developmental disorders and comorbid behavioral disorders • more sensitive to medication side effects • Many of these children are medically complex • Multiple diagnoses, multiple medications, multiple prescribers (at increased risk) • Psychotherapeutic medication management is challenging • Prescribers include non-specialist types and ARNPs that lack training, experience

12. Concerns Led to the Florida Best Practice Guideline Recommendation: “The use of antipsychotic medications in preschoolers (children less than six years of age) which is generally ‘off-label’, is not recommended and should only be considered under the most extraordinary circumstances. Disruptive aggression in autism is one such circumstance. Adequately powered studies have not been conducted in preschoolers.”

13. Monitoring Psychotherapeutic Medication Prescribing to Improve Quality of Care “There can be no keener revelation of a society's soul than the way in which it treats its children.” Nelson Mandela

14. Our Process – Creating a Draft • Collaborative • FMHI, AHCA, DCF, and State board certified child psychiatrists (academic, private and agency-based) • Driven by MDTMP Best Practice Guidelines • Proposed criteria, review process, prior authorization forms, and psychiatrist reviewer forms • Invited input from state medical societies and practitioners • Finalized in early 2008

15. Our Process: Convened Expert Panel “Best Practice Medication Guidelines” • National and Florida experts • Update every 2 years (next update Sept. 2014) • Academic psychiatrists, community mental health center psychiatrists, private practice • Others: pediatricians, developmental pediatricians, clinical pharmacists

16. Florida Best Practice Guidelines • Not an algorithm or step therapy • Options are categorized in different levels based on: • Strength of evidence • Consensus • Both safety and efficacy issues taken into consideration • Expert assigned to update a guideline: • Performs literature review • Determines strength of evidence • Determines appropriate criteria • Formulates recommendations and grading of evidence • Presents to the panel for consideration

17. Conditions Reviewed

18. Conditions Reviewed (continued) Principles of Practice Regarding the Use of Psychotropic Medications under Age 6 Level 0 Comprehensive Assessment Level 1 Psychosocial Treatment (tx) with Parental Involvement Level 2 If considering medication, reassess diagnosis If medication prescribed, start with monotherapy Except in rare cases, use monotherapy After 6-9 months stable, plan down titration to determine continued need Continue psychosocial tx during medication tx *Use of psychotherapeutic medication in child <24 months is not recommended with rare exceptions.

19. Diagnoses Associated with Antipsychotic Prescribing • Autism/Pervasive Developmental Disorders • ADHD alone and comorbid • Mood Disorders • Disruptive mood dysregulation d/o, Bipolar d/o, depressive d/o • Conduct Disorder • Oppositional Defiant Disorder • Obsessive-Compulsive Disorder • Tourette’s Syndrome • Schizophrenia and other psychotic disorders

20. Symptoms Targeted with Antipsychotic Medications • Severe aggression (impulsive) • Self-injurious Behaviors • Extreme Irritability • Extreme Impulsivity • Mood instability • Psychosis (positive symptoms) • Repetitive movements, Tics

21. Antipsychotic Prior AuthorizationReview Process • Preschool children less than 6 years of age • New prescriptions require review by a board-certified child psychiatrist • Academic psychiatrists who are also treating patients • Evaluate and treat children and adolescents enrolled in the Medicaid Program • AACAP and AAP Practice Parameter contributors • Served on the Florida expert panel to develop guidelines • Vetted by the USF program and approved by AHCA

22. Antipsychotic Prior Authorization Review Process • Guiding principles for the review • Appropriate and safe medical care is a priority • Adherence to Florida Medication Guidelines • 24 hour turnaround for review

23. Antipsychotic Review Considerations • Diagnosis • Target symptoms • Severity of target symptoms • Level of functional impairment • Previous behavioral therapies • Previous medication trials • Is the dosing appropriate? • Is the monitoring plan sufficient? • Other concurrently prescribed medications

24. Additional Specific Prior Authorization Requirements for Safety Monitoring • Vitals • Height, weight, BMI, BMI% (every visit) • Metabolic labs (baseline, every 6 months) • Fasting glucose • Fasting lipids • Other labs (as necessary) • Prolactin • Blood levels (i.e., lithium, valproic acid) • Tardive Dyskinesia screen (every 6 months, more often if symptomatic) • AIMS • DISCUS

25. Psychiatrist Feedback to Prescriber • Essentially, a second medical opinion is provided • Comments, recommendations • Requirements for approval consideration • The process requires prescribers justify the clinical and therapeutic need • Recommendations may include • Dosing/titration • Reduction of poly-pharmacy • Genetic workup • Psycho-social therapies • Coordination of care • Inpatient care

26. Early Prior Authorization Review Impact (Age < 6 years) 50% reduction in the number of requests Use of more than one antipsychotic stopped Reduction in the proposed doses Improvements in prescribing practices prompted additional initiatives in older children

27. Prior Authorization TimelineChildren and Adolescents

28. Compliance with Specific Monitoring • Initial % compliance compared to 2013 • (2008) BMI = 11% • (2013) BMI = 94% • (2010) Labs = 11% • (2013) Labs = 41% • (2010) TD screen = 6% • (2013) TD screen = 54%

29. Quality Improvements • Better adherence to guidelines • Reduction in polypharmacy • Improved metabolic monitoring • Improved tracking of BMI and BMI% • Improved Tardive Dyskinesia monitoring • Improved acceptance of child psychiatrist recommendations

30. Summary • Adherence with Evidenced-Based Practices improves care to children and adolescents prescribed psychotherapeutic medications • Ongoing monitoring of prescribing patterns and communications with prescribers • Promotes safe, effective treatments • Promotes individualized, measure-based care • Promotes family involvement and informed consent

31. Thank you

32. QUESTIONS Contact Information: Mary Elizabeth Jones, PharmBSc, RPh Senior Pharmacist – Behavioral Health Specialist Agency for Health Care Administration Bureau of Medicaid Quality Mary.Jones@ahca.myflorida.com