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

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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 Development2005 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’s1. Escalation in use of atypical antipsychotics in children

2. Pharma marketing issues:a) Inappropriate marketing of antipsychotic medications for pediatric

use to primary care providers

b) 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 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

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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 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.

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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 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

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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 TimelineChildren 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, RPhSenior Pharmacist – Behavioral Health SpecialistAgency for Health Care AdministrationBureau of Medicaid QualityMary.Jones@ahca.myflorida.com