Prescribing Psychotherapeutic Medication to
Children: A History of Policy Development and
Quality Improvement
MAKING FLORIDA MEDICAID MANAGED CARE WORK FOR PATIENTS
Mary Elizabeth Jones, PharmBsc, RPh
Senior Pharmacist, Behavioral Health
AHCA Bureau of Pharmacy Services
Presentation Outline
• History of Policy Development
• Specific Concerns with Antipsychotic
Prescribing in Children
• Best Practice Guidelines
• Second medical opinion review process
• Results
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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?
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History of Policy Development
Late 1990’s - 2000’s
1. Escalation in use of atypical antipsychotics in children
2. Pharma marketing issues:
a)
b)
Inappropriate marketing of antipsychotic medications for pediatric
use to primary care providers
Promoting newer antipsychotics as being safer than older
antipsychotics
3. Media coverage of antipsychotic (AP) use in children
4. Special interest groups question reimbursement of off-label
medications without safety data in children
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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
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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
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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
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Specific Concerns Leading to Policy
Development
1. Increased national attention
2. Media reports of severe adverse events
3. Antipsychotics commonly prescribed with other
medication
4. Limited data to guide use in children
• Limited FDA indications; off-label prescribing
• Data from adult studies not applicable
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Specific Concerns Leading to Policy
Development (continued)
5. Some benefits to use of medication
• Reduced symptoms
• Improved ability to function
• Improved quality of life
6. 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
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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
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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
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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.”
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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
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Our Process – Creating a Draft
• Collaborative
–
FMHI, AHCA, DCF, and State board certified child psychiatrists (academic, private and agencybased)
• 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
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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
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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
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Conditions Reviewed
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Conditions Reviewed (continued)
Principles of Practice Regarding the Use of Psychotropic Medications under Age 6
Level 0
Level 1
Level 2
Comprehensive Assessment
Psychosocial Treatment (tx) with Parental
Involvement
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.
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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
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Symptoms Targeted with
Antipsychotic Medications
•
•
•
•
•
•
•
Severe aggression (impulsive)
Self-injurious Behaviors
Extreme Irritability
Extreme Impulsivity
Mood instability
Psychosis (positive symptoms)
Repetitive movements, Tics
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Antipsychotic Prior Authorization
Review 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
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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
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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
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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
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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
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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
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Prior Authorization Timeline
Children and Adolescents
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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%
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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
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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
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Thank you
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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
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