B.Sahasranaman,MD

Medical Director

Henderson Behavioral Health

No conflicts of interest

No disclosures

Florida Medicaid Drug Therapy Management Program for Behavioral Health – administered by FMHI at USF

Psychotropic medication guidelines

Monitoring physical health in the context of psychopharmacology in children/adolescents: integrated care

Improve the quality of care and behavioral health drug prescribing practices, monitoring for safety and quality

Collaborative development of evidence and consensus-based psychotherapeutic medication guidelines

Collaborative development of edits to review practices through analysis of pharmacy claims

Provide educational and technological tools

to promote high quality prescribing

One in five children has a diagnosable behavioral health condition

Nearly 2/3rds get little help or treatment

Help is difficult to access

Nationwide, serious shortage of Child Psychiatrists especially in rural areas

2012 survey of 69 US children’s hospitals indicate families wait about 7.5 weeks on average to be seen by a child psychiatrist

Demand for child psychiatric services is projected to double between 1995 and 2020

PCPs are being asked more and more to manage behavioral health needs of children

There are reports that about 50% of Pediatric office visits involve behavioral, emotional, developmental, psychosocial, educational concerns

There are reports that 75% of children with psychiatric disorders are being brought to see pediatric PCPs

There are reports that between 1979 and 1996, psychosocial problems treated by Pediatric PCPs increased by 275%

Families typically have long term treatment relationships with their PCPs

Families may experience less stigma in coming to PCPs than to child psychiatrists

Primary care providers find lack of time as a challenge: At least twice as much if not more time is needed to address behavioral health needs during a PCP visit

Pediatric PCPs report lack of adequate knowledge as a challenge, only 5% of training time in pediatric residency is on Beh Health

Behavioral health issues are a leading cause of disability in children

Timely treatment and provision of Behavioral Health services is of paramount importance

Consequences of children not getting such care could be serious such as school failure, involvement with the criminal justice system, suicide etc.

Goal is to provide a guide to clinicians in the use of Psychotherapeutic medications in certain behavioral health conditions

Intended as a starting point, provide rational approaches to treatment

Cover a range of behavioral health conditions

Based on current Scientific knowledge/ thorough review of scientific literature and clinical consensus

Use of the guidelines is totally up to the clinician

The guidelines should be adapted and tailored to the individual’s treatment needs

The clinician and patient’s collaborative decision prevails in choice of treatment

◦ Convened “Expert panel”

◦ National and Florida experts

◦ Academic psychiatrists, CMHC psychiatrists, private practice

◦ Others: pediatricians, developmental pediatricians, clinical pharmacists

◦ Updated every 2 years

◦ First child guideline developed: 2008

◦ Most recent update: Sept 2014

Electronic copy –

◦ Available at http://medicaidmentalhealth.org

Paper copy –

◦ Stop by The Florida Medicaid Drug Therapy

Management booth.

OR

◦ Contact sabrinasingh@usf.edu to have copies mailed to you.

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ADHD

Aggression (Severe and Chronic, impulsive)

Anxiety Disorders

Bipolar Disorder (Acute or Mixed Mania)

Insomnia Disorder

Major Depression

OCD

PTSD

Schizophrenia

Tic Disorders

Principles of practice regarding the use of psychotropic medications under age 6

Dosing recommendations regarding use of antipsychotic medications under age 6

ADHD medications guidelines for children under age 6

Aggression (severe) under age 6

Anxiety Disorders in children under age 6

Major Depression in children under age 6

PTSD in children under age 6

ADHD

Aggression (Chronic, Impulsive)

Anxiety Disorders

Bipolar Disorder-(Acute Mania or Mixed Episodes)

Major Depression

Obsessive Compulsive Disorder

Post Traumatic Stress Disorder

Tic Disorders

Guidelines are organized by “levels” of treatment recommendations

Level 0: is comprised of a thorough clinical assessment

Subsequent Levels 1,2,3,etc are based on the strength of scientific evidence and expert consensus regarding a particular agent or treatment option

The expert panel considered both safety and efficacy when assigning a treatment option to a level

Psychotropic medications are only one component of a comprehensive treatment plan

Bio-Psycho-Social model Social: Environmental factors/family

circumstances and relationships/trauma/disrupted attachments

Do medication benefits outweigh risks? Are there alternate interventions with

possibility of a good outcome?

What is the risk-benefit relationship between psychosocial interventions alone versus adding any psychotropic medication?

Is another agent with fewer side effects a better choice in managing the child’s symptoms?

Have parents/guardians consented to the medication knowing the risks versus benefits? Has the child assented?

Treatment needs to be individualized

Treatment targets need to be precisely defined-target a clear symptom

Do no harm, manage benefit: risk

Maximize response to one medication before adding another

If possible, change one medication at a time

Monitor progression towards treatment goals

Monitor for safety, side effects and effects of medication on physical health

Form a partnership with the parent and child

Acute Phase: Initiation of treatment, dose adjustments to maximize response and to minimize side effects

Maintenance Phase: Monitor for maintenance of treatment response, monitor side effects and effects on physical health

Discontinuation Phase: Medication is successfully tapered with minimal risk for relapse/recurrence

Thorough assessment

Must incorporate information from various sources – school, previous treatment records, therapist, case manager

Pay attention to psychosocial factors

Use of appropriate rating scales: eg Vanderbilt, PHQ9, BPRS

Prevalence of childhood obesity is reaching epidemic proportions

Serious public health problem

No sign of reduced prevalence

Childhood obesity has more than doubled in children and quadrupled in adolescents in the past 30 years

The percentage of children aged 6–11 years in the United States who were obese increased from 7% in 1980 to nearly 18% in 2012

The percentage of adolescents aged 12–19 years who were obese increased from 5% to nearly 21% over the same period

In 2012, more than one third of children and adolescents were overweight or obese

Increased rates of metabolic syndrome, cardiovascular conditions

Increased rates of type 2 diabetes Diabetes was once a disease almost

exclusively in adults Increased rates of pediatric use of

antihypertensive, antidiabetic and antidyslipidemic medications

Childhood obesity goes into adulthood Individuals with mental illness have an

excess mortality, 2 to 3 X that of gen pop. 13 to 30 years shortened life expectancy

Pediatric obesity has been correlated with deficits in orbito-frontal cortical gray matter and cognitive functioning

Type 2 diabetes has been associated with additional structural white matter brain impairments

Obesity related to body image/low self esteem issues

Baseline medical assessment (thorough medical history, physical, baseline labs, height/wt, vitals)

Screen regularly for medication side effects

Monitor: use rating scales such as AIMS

Intervene: Lower dose, discontinue, treat side effects

Rapid increase in recent decades

Atypical antipsychotic prescriptions doubled among privately insured youth between 1997 and 2000 from 2.4 percent of all psychotropic prescriptions to 5.1 percent

National study of Medicaid-enrolled children found 62% increase of atypical antipsychotic prescribing from 2002 to 2007

The use of antipsychotic drugs for very young

children with behavior problems doubled between 1999-2001 and 2007.

Antipsychotic medication has tripled in last 10 to 15 years in children

Increase seems to be disproportionately higher among children with low family income and minority children

Evidence for efficacy and tolerability of AP medication in children is inadequate

Significant concern about weight gain and metabolic side effects

Greater tendency for cardiovascular changes in children than adults

Name of Atypical

Antipsychotic

Schizophrenia

Bipolar I

Disorder:Manic or Mixed

Irritability with

Autistic Disorder

Risperidone

√ (age 13-18) √ (age 10-18) √ (age 5-17)

Aripiprazole

√ (age 13-18) √ (age 10-18) √ (age 6-18)

Quetiapine

√ (age 13-18) √ (age 10-18) NO

Olanzapine

√ (age 13-18) √ (age 13-18) NO

Paliperidone

√ (age 12-18) NO NO

There is evidence supporting efficacy of single antipsychotics in youth for certain conditions

There is very limited or no evidence supporting the efficacy of using higher doses of antipsychotics or multiple antipsychotics

Severe aggression (impulsive)

Self-injurious Behaviors

Extreme Irritability

Extreme Impulsivity

Mood instability

Psychosis (positive symptoms)

Repetitive movements, Tics

Autism/Pervasive Developmental Disorders

ADHD alone and comorbid

Mood Disorders

Conduct Disorder

Oppositional Defiant Disorder

Obsessive-Compulsive Disorder

Tourette’s Syndrome

Schizophrenia and other psychotic disorders

An initiative of the ABIM Foundation

Launched in 2012

www.choosingwisely.org

Designed to Spur conversations about what medical treatments are appropriate and necessary

American Psychiatric Association joined the campaign in 2013

APA chose to address the prescription practices of anti-psychotic medication and issues 5 cautionary principles

1. Do not prescribe AP meds to patients for any indication without appropriate initial evaluation and ongoing monitoring

2. Do not routinely prescribe 2 or more AP medications concurrently

3. Do not use APs as the first choice to treat behavioral and psychological Sx of dementia

4. Do not routinely prescribe AP meds as first line intervention for insomnia in adults

5. Don’t routinely prescribe an antipsychotic medication to treat behavioral and emotional symptoms of childhood mental disorders in the absence of approved or evidence supported indications

www.choosingwisely.org

Drug (High Dose) Average Number of Patients Per Quarter – 2013

Risperidone 6-11 y/o >4mg/day 12-17y/o >6mg/day

242

Aripiprazole 6-11 y/o>15mg/day 12-17y/o>30mg/day

103

Quetiapine 6-11 y/o >400mg/day 12-17y/o>800mg/day

27

Olanzapine 6-11y/o >10mg/day 12-17y/o>20mg/day

23

Ziprasidone 6-11y/o>80 mg/day 12-17y/o>160mg/day

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Children and adolescents are more at risk for serious side effects including weight gain, extrapyramidal side effects, hyperprolactinemia, metabolic changes

These side effects may lead to increased rates of cardiovascular disease

Minimize side effects: start low/go slow, stop slowly, mono-therapy

Dystonia: A sustained muscle contraction Akathisia: A subjective feeling of motor

restlessness Parkinsonism: Tremor, rigidity, akinesia Tardive Dyskinesia: Irregular stereotypical

movements of mouth, face, jaw, tongue, choreoathetoid movements of fingers, arms, legs and trunk

Many antipsychotics increase prolactin level

Persistent prolactin elevation for up to two years has been documented in maintenance treatment with risperidone

Gynecomastia

Galactorrhea

Irregular menses, amenorrhea

Low bone density, osteoporosis

Sexual dysfunction

Some reports of associated increased risk of pituitary tumors

All antipsychotics have increased weight risk

Multiple antipsychotics further increase weight risk

Kids more susceptible to rapid and large weight gain

Some antipsychotics have weight independent direct metabolic effects

In 2003, FDA required a warning on diabetes risk for second-generation antipsychotic drugs

The American Diabetes Association and the American Psychiatric Association recommend glucose and lipid testing for all patients starting these medications

Despite this, there is documented low screening and monitoring rates in youth which is highly concerning

Initiating and continuing use of antipsychotics should be considered very carefully

Proactive cardiometabolic screening as part of routine clinical treatment

Integrated care with primary care

Ht/Wt/BMI –Every visit

BMI for age percentile in children

Pulse/BP—Every visit

Waist circumference

Labs: Fasting glucose/lipids at baseline, 3 mos, 6 mos, 6 mos thereafter

Hgb A1C

Consider more frequent monitoring if there is considerable weight gain

Reevaluate medication, risk-benefit ratio Consider alternative treatment strategies Health promotion and life style

intervention strategies: -Dietary counseling -Exercise -Lifestyle choices -Limiting electronics -Education

Younger kids are more sensitive to medication side effects than older youth

Limited evidence on efficacy of psychotropic meds in preschool children

Antipsychotic meds should be used extremely conservatively and carefully due to the potential for serious side effects

Developmental interventions e.g. speech therapy, occupational therapy; psychosocial interventions should be prioritized

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 could include non-specialists that may

lack specialized training/experience

Psychotropic Medication Recommendations for Target Symptoms in Youth with Neurodevelopmental Disorders

Program Website:

http://medicaidmentalhealth.org

Edits to identify patterns of unusual prescribing

High Dose Indicators

Polypharmacy: >2 antipsychotics/3 or more antipsychotics (for >90 days concurrently), 5 or more different classes of psychotropic medications concurrently

Intervention include communication with prescriber, psychiatrist consultant-peer to peer visits etc

Initiated in April 2008: WHY?

Once started antipsychotic treatment tends to persist for multiple years

Diagnostic information on claims often do not support antipsychotic treatment

Concerns about the long term health of recipients

Child psychiatrists: 76

General Psychiatrists: 56

Pediatric Neurologists: 67

Neurologists: 59

Pediatricians: 34

Developmental Pediatricians: 16

ARNPs: 23

Q2 2008

Q3 2008

Q4 2012

Q1 2013

Q2 2013

# Applications 500 320 146 143 128

Severe Aggression

61% 69% 88% 78% 83%

Self Injurious Behavior

27% 29% 45% 35% 31%

Severe Impulsivity

41% 64% 59% 63% 64%

Severe Irritability

0% 0% 67% 64% 59%

More than 50% reduction in the number of requests

Use of more than one antipsychotic has stopped

Reduction in the proposed doses

Better monitoring rates:

-BMI from 11% in 2008 to 94% in 2013

-Labs from 11% (2010) to 41% (2013)

-TD screen from 6% (2010) to 54% (2013)

Florida Best Practice Guidelines

Thorough evaluation, identifying target symptoms, assessing degree of functional impairment

Comprehensive treatment plan incorporating non-pharmacological interventions

Adherence to evidence-based practices for prescribing psychotherapeutic medications

Careful monitoring of medication side effects and physical health, minimize side effects

Ongoing evaluation of medication benefits versus risks

Electronic copy –

◦ Available at http://medicaidmentalhealth.org

Paper copy –

◦ Stop by The Florida Medicaid Drug Therapy

Management booth.

OR

◦ Contact sabrinasingh@usf.edu to have copies mailed to you.

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