Atypical Antipsychotics
Age 0-17, Summer 2016
Collaborative Advancement of
C A EPrescription Excellence
How young is too young?
What if one agent doesn’t work?
How do we minimize adverse
drug reactions?
When should they be used?
How should they be
monitored?
?
Atypical antipsychotic agents, also known as second-generation antipsychotics, or SGAs, are only approved for a very small number of specific indications.
They are being increasingly used off-label and for younger and younger children. They are used disproportionately for males, children in foster care, and those covered by Medicaid.
Much is still not known about the tolerability, efficacy and long-term safety of these agents, especially in children. There is considerable concern about the side effects/adverse drug reactions (ADRs) of these medications.
In particular, weight gain and metabolic effects can be significant and long-lasting. Children and adolescents also tend to experience more ADRs than adults taking SGAs.
Multiple groups have expressed
concerns over the trends in atypical antipsychotics for
children:
How young is too young?Age 0-4:
Avoid use of antipsychotics
Age 5-17:
Use with extreme caution
Pediatric patients 1996 - 2012Total Second-Generation Antipsychotic (SGA) increase: 600%
Psychotherapy increase 70%
2012: SGA use
Pediatric patients with moderate to
severe mental health impairment
2012: SGA use
Pediatric patients with less severe or no mental
health impairment
1996: SGA use
All pediatric patients
References: 1-10
• AACAP: American Academy of Child and Adolescent Psychiatry
• AAP: American Academy
• ACF: Administration for Children and Families, Department of Health and Human Services
• AAFP: American Academy of Family Physicians
• AHRQ-HEDIS: Agency for Healthcare Research and Quality: Health Plan Employer Data and Information Set
• CDC: Center for Disease Control and Prevention
• CMS: Centers for Medicare and Medicaid Services
2 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
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FDA-approved atypical antipsychotics by age: (Age 0-17: First-line treatment in combination with psychosocial interventions)
Schizophrenia Bipolar Disorder Irritability or Agression due to ASD* Tic Disorder (Tourette’s)
aripiprazole (Abilify®) 13 - 17 10 - 17 6 - 17 6 - 17
asenapine (Saphris®) not approved 10 - 17 not approved not approved
olanzapine (Zyprexa®) 13 - 17 13 - 17 not approved not approved
paliperidone (Invega®) 12 - 17 not approved not approved not approved
quetiapine (Seroquel®) 13 - 17 10 - 17 not approved not approved
risperidone (Risperdal®) 13 - 17 10 - 17 5 - 17 not approved
ziprasidone (Geodon®) not approved 10 - 17 not approved not approved
SGAs that are not approved for pediatric use include: brexpiprazole (Rexulti®), cariprazine (Vraylar®), clozapine (Clozaril®), iloperidone (Fanapt®), lurasidone (Latuda®). *ASD: Autism Spectrum Disorder
Ages 0 - 9 are less likely to: Relevance to SGA prescribing:
receive psychosocial interventions (PIs) PIs have demonstrated efficacy, with no risk of the ADRs associated with SGA use
Ages 0 - 9 are more likely to: Relevance to SGA prescribing:
experience health-related effects of poverty (e.g. obesity, dyslipidemia, cardiovascular disease)
SGA use creates additive risk of obesity, dyslipidemia, cardiovascular disease
experience placement in foster care children in foster care receive SGAs 6Xs more often than privately-insured children
experience ADRs from any medication even when taken correctly, SGA-ADRs lead to hospitalization 2.5Xs more than all other pediatric medications combined
receive more than one concurrent SGA and/or SGAs combined with other psychotropic medications
multiple SGA use and additional psychotropic medication use creates additive risk for multiple ADRs
Younger children have more risk factors than older children:
“Increasing consensus exists that antipsychotic medication should be the treatment of last resort, after parenting skills training and other behavioral treatments have failed.”
-Harrison et al, 2012, regarding preschool children
References: 1-2, 4-5, 7-8, 11-22Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
When should an antipsychotic be used?
1st and 2nd line:• Bipolar disorder• Schizophrenia• Tic disorder• Irritability or aggression due to autism
spectrum disorder (ASD)
3rd line:• Non-ASD aggression• Conduct disorder• Oppositional defiant disorder
Use an SGA in combination with psychosocial interventions:
These three disorders make up more than 75 percent of all pediatric SGA prescriptions. These disorders are most often symptomatic of another underlying disorder. Treatment of the underlying disorder usually removes the need for use of an SGA. (See Resources, pg. 20-21)
Most recent studies:• Aripiprazole (monotherapy): may help with additional ASD symptoms (lethargy, social withdrawal,
stereotypy, inappropriate speech, compulsions)• Risperidone (monotherapy): may help with Attention Deficit Hyperactivity Disorder (ADHD) that is not
responsive to stimulants• Oklahoma children covered by SoonerCare (Oklahoma Medicaid): only 6.3 percent had an appropriate
diagnosis while receiving an SGA in 2014
41% 37%
53%
67% of claims showed
quality-of-care concerns
Too young17%
Side effects
7%Taken
too long
34%
Wrong dose
23%
Wrong treatment
Too many drugs
Poor monitoring
41%53%
37%
Second Generation Antipsychotic Drug Use Among Medicaid-enrolled Children: Quality-of-Care Concerns (Office of the Inspector General, March 2015)
This report also showed:
- Multiple concerns present in 49% of claims
- Only 8% of SGAs were prescribed for medically-accepted indications and correct age
References: 1-2, 19-28, 38
4 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
5References: 1, 4, 6, 8, 29-33
What if one antipsychotic doesn’t work?
• Allow adequate trial length (4-6 weeks)
• Assess comorbid conditions and medication adherence
• Re-evaluate initial diagnosis
• Redefine targeted symptoms
• Substitute with alternate SGA
Avoid combining SGAs.
Combining two or more SGAs should only be considered after:
• failed addition of a mood stabilizer, AND
• failed trials of three individual SGAs
□ Adequate trial length
□ In combination with PI (Psychosocial Interventions)With at least 80 percent adherence
□ One of the three trials was clozapine
SGAs are a very diverse class of medications, with mutliple pharmacological mechanisms of action and varying receptor site activity. The choice of agent is often determined by its side effect profile. Adding multiple agents rarely results in additive efficacy, but nearly always results in additive side effects and decreased adherence.
In particular, obesity, diabetes, dyslipidemia and hypertension are likely to increase when multiple agents are used. These risk factors increase the likelihood of morbidity and/or mortality due to cardiovascular disease later in life.
Olanzapine and clozapine are considered to have the highest potential for causing weight gain, glucose changes, diabetes and dyslipidemia. As such, even more extreme care should be exercised before using these agents in combination with another SGA.
Addition of, or substitution with, a mood stabilizer is preferred over combining multiple SGAs. (See Resources, pg. 20-21)
“There’s a general consensus that great caution should be exercised with
antipsychotic drugs.” -Mark Olfson, M.D., MPH, Professor of Clinical Psychiatry, Columbia University, Co-director AHRQ
Center for Education and Research on Mental Health Therapeutics
Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
How do we minimize ADRs?
Emergency care: SGA-ADRsNeuroleptic Malignant Syndrome
NMS is a rare but potentially fatal ADR. It is characterized by high fever, sweating, unstable blood pressure, stupor, muscle rigidity and autonomic dysfunction. Patients who experience NMS should not be re-challenged with the same medication.
SGAs v. First-generation antipsychotics (FGAs)
Although they have similar efficacy, SGAs have a much higher risk of metabolic and weight-related ADRs. While FGAs have a higher risk of movement disorders, SGA movement risk is still present. Movement disorders are the most common ADR (47.7 percent) for children requiring emergency care related to an SGA-ADR.
SGAs v. StimulantsSGAs are 3.8Xs more likely to require emergency care.
SGAs v. AntidepressantsSGAs are 2.7Xs more likely to require emergency care.
• Use an SGA only when recommended
• Use the lowest effective dose for the shortest time possible
• Avoid multiple SGAs
• Utilize management strategies
Reducing ADRs leads to improved patient adherence.
SGA adherence for pediatric patients covered by SoonerCare is currently 27.2 percent.
Pediatric patients experience even more SGA-related ADRs than adults. • 74 percent of adult patients discontinue SGA use within 18 months.
• 20 percent of those adult patients list ADRs as the reason for discontinuing SGA use.
References: 1, 4, 8, 14, 27, 35-37
Im
prove patient adherence
Better symptomatic con
trol
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SGA Adverse Drug Reactions(always consider dose reduction or alternate SGA)
arip
ipra
zole
asen
apin
e
brex
pipr
azol
e
carip
razi
ne
cloz
apin
e
ilope
ridon
e
lura
sido
ne
olan
zapi
ne
palip
erid
one
quet
iapi
ne
rispe
ridon
e
zipr
asid
one
ADR management strategiesakasthisia add beta-blocker or
benzodiazepine
agranulocytosis/neutropenia
discontinue SGA
anticholinergic0 0 0 0 0
sugar-free gum/candy, strong oral hygeine, artificial tears/saliva, increase fluid/fiber
dyslipidemia add lipid-lowering agent
glucose changes add metformin
hepatic changes often self-limiting (dose reduction or alternate agent if not resolved)
orthostatic hypotension 0
increase hydration
prolactin changes0 0
asymptomatic: monitorsymptomatic: refer to endocrinologist
pseudo-parkinsonism 0
add anticholinergic
QTc prolongation0 0 0
450-500 Msec: refer to cardiology>500 Msec: DC SGA and refer
sedation give at bedtimeDC other sedating medications
seizures refer to neurologyconsider adding/switching to mood-stabilizing anticonvulsant
tardive dyskinesia refer to neurology
weight gain lifestyle modificationsconsider adding metformin
Clozapine: Excessive salivationQuetiapine: Risk of cataractsAripiprazole: Compulsive behaviorsOlanzapine: Risk of DVT/PE, hemorrhagic pancreatitis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
•Adaptedfrom:Evidence-basedbestpracticesfortheuseofsecondgenerationantipsychotics(SGAs)inpediatricprimarycareinSouthCarolina
•Combinationpediatricandadultdata•DC:discontinue
moderatemildminimalnone0 severe
References: 1, 8-9, 18, 27, 38-40Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
How should SGA use be monitored?
• Initial metabolic screening• Verify continuation of psychosocial
interventions
• Metabolic monitoring• Efficacy monitoring• ADR monitoring
Monitor at baseline, dose changes and regular intervals:(See Resources, pg. 10)
SGA Monitoring
family history
diabetes (type I & II, gestational), dyslipidemia, cardiovascular disease, schizophrenia, schizoaffective disorder, psychosis not otherwise specified, bipolar disorder
personal historysmoking, physical activity, screen time, sugar-sweetened beverages, all family history parameters (above)
weight-related waist circumference, height, weight, BMI
blood pressure hypertension
presence of EPS dystonia, akathisia, pseudo-parkinsonism, bradykinesia, tardive dyskinesia
metabolic (fasting)blood glucose, insulin, lipids (total cholesterol, LDL, HDL, triglycerides)
liver function AST, ALT
prolactin menstrual irregularities, gynecomastia, galactorrhea
Appropriate monitoring isthelargestdeficitin care for pediatric
patients receiving SGAs.-Office of the Inspector General, March 2015
SGA Monitoring:
47% across all parameters
SGA Monitoring:Lipids: 13.8%
Glucose: 23.9%
Oklahoma is currently well below the national
average for SGA monitoring.Primary care providers are
in an excellent position to improve SGA monitoring.
Psychiatric providers may lack equipment and staff necessary to perform SGA
monitoring.
References: 1-2, 14, 41
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SGA Resources
Collaborative Advancement of
C A EPrescription Excellence
SGA monitoring form pg. 10
Waist circumference pg. 11
BMI pg. 12-13
Systolic blood pressure pg. 14-15
Extra-pyramidal symptoms pg. 16-17
Blood monitoring pg. 18-19
Treatment recommendations pg. 20-21
SGA dosing pg. 22-23
SoonerCare tier chart and prior authorization criteria pg. 24
Daily mood chart pg. 25
Clozapine REMS fact sheet pg. 26-27
References pg. 28-29
Additional resources pg. 30-31
Summary: AACAP, HEDIS pg. 32
Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
SGA Monitoring for Pediatric PatientsPatient Name: Target symptom/dx:
M or F DOB:
SGA medication/dose: Anticipated SGA end date:
baseline 1 mo 2 mo 3 mo 6 mo 9 mo 12 mo
Date:
Patient Age:
Family/Personal History:
Height (cm):
Weight (kg):
BMI:
BMI Percentile:
Systolic BP:
HTN Stage:
Waist Circumference (cm):
Waist Circ. Percentile:
Simpson-Angus Score: X X X
S-A Severity: X X X
Fasting Blood Glucose: X X X
Fasting Insulin: X X X
A1C (stable BG control): X X X X
A1C (unstable BG control): X X
Fasting Total Cholesterol: X X X
Fasting LDL: X X X
Fasting HDL: X X X
Fasting TG: X X X
AST: X X X X
ALT: X X X X
Prolactin: X X X X X
Quetiapine: Eye Exam X X X X X
Clozapine: REMS protocol(updated 5/20/16)
Clozapine: Baseline EEG: Y or N Treatment level EEG: Y or NReferences: 1, 5, 11, 27, 42-44
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Boys’Waist Circumferenceby Age and Percentile
Girls’ Waist
Circumferenceby Age and Percentile
waist circumference (cm) waist circumference (cm)
age 10th 25th 50th 75th 90th age 10th 25th 50th 75th 90th
3 44.9 46.9 49.1 51.3 54.2 3 45.4 46.7 49.1 51.9 55.3
4 46.6 48.7 51.1 53.9 57.6 4 46.9 48.4 51.1 54.3 58.3
5 48.4 50.6 53.2 56.4 61 5 48.5 50.1 53 56.7 61.4
6 50.1 52.4 55.2 59 64.4 6 50.1 51.8 55 59.1 64.4
7 51.8 54.3 57.2 61.5 67.8 7 51.6 53.5 56.9 61.5 67.5
8 53.5 56.1 59.3 64.1 71.2 8 53.2 55.2 58.9 63.9 70.5
9 55.3 58 61.3 66.6 74.6 9 54.8 56.9 60.8 66.3 73.6
10 57 59.8 63.3 69.2 78 10 56.3 58.6 62.8 68.7 76.6
11 58.7 61.7 65.4 71.7 81.4 11 57.9 60.3 64.8 71.1 79.7
12 60.5 63.5 67.4 74.3 84.8 12 59.5 62 66.7 73.5 82.7
13 62.2 65.4 69.5 76.8 88.2 13 61 63.7 68.7 75.9 85.8
14 63.9 67.2 71.5 79.4 91.6 14 62.6 65.4 70.6 78.3 88.8
15 65.6 69.1 73.5 81.9 95 15 64.2 67.1 72.6 80.7 91.9
16 67.4 70.9 75.6 84.5 98.4 16 65.7 68.8 74.6 83.1 94.9
17 69.1 72.8 77.6 87 101.8 17 67.3 70.5 76.5 85.5 98
References: 45, 46Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Boys’ BMI
12 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
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Girls’ BMI
Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Age systolic BP (mm Hg)
height (cm) 130 133 137 141 146 150 153
10
111 112 114 115 117 119 119
115 116 117 119 121 122 123
Age systolic BP (mm Hg) 127 128 130 132 133 135 135
height (cm) 92 94 96 99 102 104 106 height (cm) 135 137 142 146 151 156 159
3
100 101 103 105 107 108 109
11
113 114 115 117 119 120 120
104 105 107 109 110 112 113 117 118 119 121 123 124 125
116 117 119 121 123 124 125 129 130 132 134 135 137 137
height (cm) 99 100 103 106 109 112 113 height (cm) 140 143 148 153 158 163 166
4
102 103 105 107 109 110 111
12
115 116 118 120 120 120 120
106 107 109 111 112 114 115 119 120 122 123 125 127 127
118 119 121 123 125 126 127 131 132 134 136 138 139 140
height (cm) 104 106 109 112 116 119 120 height (cm) 147 150 155 160 166 171 173
5
104 105 106 108 110 111 112
13
117 118 120 120 120 120 120
108 109 110 112 114 115 116 121 122 124 126 128 129 130
120 121 123 125 126 128 128 133 135 136 138 140 141 142
height (cm) 110 112 115 119 122 126 127 height (cm) 154 157 162 167 173 177 180
6
105 106 108 110 111 113 113
14
120 120 120 120 120 120 120
109 110 112 114 115 117 117 124 125 127 128 130 132 132
121 122 124 126 128 129 130 136 137 139 141 143 144 145
height (cm) 116 118 121 125 129 132 134 height (cm) 159 162 167 172 177 182 184
7
106 107 109 111 113 114 115
15
120 120 120 120 120 120 120
110 111 113 115 117 118 119 126 127 129 131 133 134 135
122 123 125 127 129 130 131 139 140 141 143 145 147 147
height (cm) 121 123 127 131 135 139 141 height (cm) 162 165 170 175 180 184 186
8
107 109 110 112 114 115 116
16
120 120 120 120 120 120 120
111 112 114 116 118 119 120 129 130 132 134 135 137 137
124 125 127 128 130 132 132 141 142 144 146 148 149 150
height (cm) 126 128 132 136 141 145 147 height (cm) 164 166 171 176 181 185 187
9
109 110 112 114 115 117 118
17
120 120 120 120 120 120 120
113 114 116 118 119 121 121 131 132 134 136 138 139 140
125 126 128 130 132 133 134 144 145 146 148 150 151 152
Boys’Systolic Blood Pressure by Age and Height
stage 2 HTNpre-HTN stage 1 HTN
(Normal SBP is less than the pre-HTN result)
References: 47
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age systolic BP (mm Hg)
height (cm) 130 132 136 141 146 150 153
10
112 112 114 114 116 118 118
116 116 117 119 120 121 122
age systolic BP (mm Hg) 128 128 130 131 132 134 134
height (cm) 91 92 95 98 100 103 105 height (cm) 136 138 143 148 153 157 160
3
100 100 102 103 104 106 106
11
114 114 116 117 118 119 120
104 104 105 107 108 109 110 118 118 119 121 122 123 124
116 116 118 119 120 121 122 130 130 131 133 134 135 136
height (cm) 97 99 101 104 108 110 112 height (cm) 143 146 150 155 160 164 166
4
101 102 103 104 106 107 108
12
116 116 117 119 120 120 120
105 106 107 108 110 111 112 119 120 121 123 124 125 126
117 118 119 120 122 123 124 132 132 133 135 136 137 138
height (cm) 104 105 108 111 115 118 120 height (cm) 148 151 155 159 164 168 170
5
103 103 105 106 107 109 109
13
117 118 119 120 120 120 120
107 107 108 110 111 112 113 121 122 123 124 126 127 128
119 119 121 122 123 125 125 133 134 135 137 138 139 140
height (cm) 110 112 115 118 122 126 128 height (cm) 151 153 157 161 166 170 172
6
104 105 106 108 109 110 111
14
119 120 120 120 120 120 120
108 109 110 111 113 114 115 123 123 125 126 127 129 129
120 121 122 124 125 126 127 135 136 137 138 140 141 141
height (cm) 116 118 121 125 129 132 135 height (cm) 152 154 158 162 167 171 173
7
106 107 108 109 111 112 113
15
120 120 120 120 120 120 120
110 111 112 113 115 116 116 124 125 126 127 129 130 131
122 123 124 125 127 128 129 136 137 138 139 141 142 143
height (cm) 121 123 127 131 135 139 141 height (cm) 152 154 158 162 167 171 173
8
108 109 110 111 113 114 114
16
120 120 120 120 120 120 120
112 112 114 115 116 118 118 125 126 127 128 130 131 132
124 125 126 127 128 130 130 137 138 139 140 142 143 144
height (cm) 125 128 131 136 140 144 147 height (cm) 152 155 159 163 167 171 174
9
110 110 112 113 114 116 116
17
120 120 120 120 120 120 120
114 114 115 117 118 119 120 125 126 127 129 130 131 132
126 126 128 129 130 132 132 138 138 139 141 142 143 144
stage 2 HTNpre-HTN stage 1 HTN
Girls’Systolic Blood Pressure by Age and Height
(Normal SBP is less than the pre-HTN result)
References: 47Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Simpson-Angus Scale (children and adults, page 1 of 2)
point value
patient score
point value
patient score
HEAD DROPPING:The patient lies on a well-padded examining table and his head is raised by the examiner’s hand. The hand is then withdrawn and the head allowed to drop. In the normal subject the head will fall upon the table. The movement is delayed in extrapyramidal system disorder and in extreme parkinsonism it is absent. The neck muscles are rigid and the head does not reach the examining table:
SHOULDER SHAKING:The subject’s arms are bent at a right angle at the elbow and are taken one at a time by the examiner, who grasps one hand and also clasps the other around the patient’s elbow. The subject’s upper arm is pushed to and fro and the humerus is externally rotated. The degree of resistance from normal to extreme rigidity is scored as follows:
The head falls completely with a good thump as it hits the table 0 Normal 0
Slight slowing in fall, mainly noted by lack of slap as head meets the table 1 Slight stiffness and resistance 1
Moderate slowing in the fall quite noticeable to the eye 2 Moderate stiffness and resistance 2
Head falls stiffly and slowly 3 Marked rigidity with difficulty in passive movement 3
Head does not reach the examining table 4 Extreme stiffness and rigidity with
almost a frozen joint 4
GAIT:The patient is examined as he walks into the examining room. His gait, the swing of his arms, his general posture, all form the basis for an overall score for this item:
ARM DROPPING:The patient and the examiner both raise their arms to shoulder height and let them fall to their sides. In a normal subject, a stout slap is heard as the arms hit the sides. In the patient with extreme Parkinson’s syndrome, the arms fall very slowly:
Normal 0 Normal, free fall with loud slap and rebound 0
Diminution in swing while the patient is walking 1 Fall slowed slightly with less audible
contact and little rebound 1
Marked diminution in swing with obvious rigidity in the arm 2 Fall slowed, no rebound 2
Stiff gait with arms held rigidly before the abdomen 3 Marked slowing, no slap at all 3
Stopped, shuffling gait with propulsion and retropulsion 4 Arms fall as though against
resistance; as through glue 4
WRIST RIGIDITY or Fixation of position:The wrist is held in one hand and the fingers held by the examiner’s other hand, with the wrist moved to extension, flexion and ulner and radial deviation:
TREMOR:Patient is observed walking into examining room and is then reexamined for this item:
Normal 0 Normal 0
Slight stiffness and resistance 1 Mild finger tremor, obvious to sight and touch 1
Moderate stiffness and resistance 2 Tremor of hand or arm occurring spasmodically 2
Marked rigidity with difficulty in passive movement 3 Persistent tremor of one or more
limbs 3
Extreme stiffness and rigidity with almost a frozen joint 4 Whole body tremor 4
EPS Monitoring
References: 48
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Simpson-Angus Scale (page 2 of 2
point value
patient score point
valuepatient score
SALIVATION:Patient is observed while talking and then asked to open his mouth and elevate his tongue:
LEG PENDULOUSNESS:The patient sits on a table with his legs hanging down and swinging free. The ankle is grasped by the examiner and raised until the knee is partially extended. It is then allowed to fall. The resistance to falling and the lack of swinging form the basis for the score on this item:
Normal 0 The legs swing freely 0
Excess salivation to the extent that pooling takes place if the mouth is open and the tongue raised.
1 Slight diminution in the swing of the legs 1
When excess salivation is present and might occasionally result in difficulty in speaking
2 Moderate resistance to swing 2
Speaking with difficulty because of excess salivation 3 Marked resistance and damping of
swing 3
Frank drooling 4 Complete absence of swing 4
ELBOW RIGIDITY:The elbow joints are separately bent at right angles and passively extended and flexed, with the subject’s biceps observed and simultaneously palpated. The resistance to this procedure is rated (cogwheel rigidity noted separately):
COGWHEEL RIGIDITY:Add 1 to total severity score.
Normal 0
Total Score:Slight stiffness and resistance 1
Moderate stiffness and resistance 2
Total Score Severity:Marked rigidity with difficulty in passive movement 3
Extreme stiffness and rigidity with almost a frozen joint 4
Normal 0 - 2GLABELLA TAP:Subject is told to open eyes wide and not to blink. The glabella region is tapped at a steady, rapid speed. The number of times patient blinks in succession is noted:
Minimal Movement Disorder 3 - 50 - 5 blinks 0
6 – 10 blinks 1
Clinically Significant Movement Disorder 6 - 1111 – 15 blinks 2
16 - 20 blinks 3
Severe Movement Disorder 12 +21 and more blinks 4
EPS Monitoring
References: 48Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Pediatric Blood Monitoring(Normal ranges shown)
Prolactinboys girls
< 18 years 5 - 20 ng/mL
18 + years 4 - 15.2 ng/mL 4.8 - 23.3 ng/mL
Boys and Girls: Blood Glucoseupper level glucose limit age 0 - 5 age 6 - 12 age 13 - 19
before meals 100 - 180 mg/dL 90 - 180 mg/dL 90 - 130 mg/dL
before bedtime/overnight 110 - 200 mg/dL 100 - 180 mg/dL 90 - 150 mg/dL
Boys and Girls: A1C Fasting Insulin age 0 - 5 age 6 - 12 age 13 - 19 boys
age 7 - 11boys
age 12 - 17girls
age 7 - 11girls
age 12 - 17
below 7.5% 5.1 - 24.3 8.8 - 27.4 6.1 - 18.1 8.3 - 25.3
AST ALTage boys girls age boys girls
1 - 13 8 - 60 U/L 8 - 50 U/L > 1 year 7 - 55 U/L 7 - 45 U/L
14 + 8 - 48 U/L 8 - 43 U/L
AST and ALT increases may occur within a few days, or may take weeks. However, elevations are usually self-limited, and often do not require dose limitation or
discontinuation of therapy.
References: 41, 49-54
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Pediatric Blood Monitoring
Boys and GirlsTotal Cholesterol and LDL Recommendations
category percentile total cholesterol (mg/dL) LDL (mg/dL)
acceptable < 75th < 170 <110
borderline 75th - 95th 170 - 199 110 - 129
elevated > 95th > 200 > 130
Boys by Age and Percentile Girls by Age and Percentile50th 75th 90th 95th 50th 75th 90th 95th
age Total cholesterol (mg/dL) age Total cholesterol (mg/dL)
5 - 9 153 168 183 186 5 - 9 164 177 189 197
10 - 14 161 173 191 201 10 - 14 159 171 191 205
15 - 19 152 168 183 191 15 - 19 157 176 198 208
age Triglyceride (mg/dL) age Triglyceride (mg/dL)
5 - 9 48 58 70 85 5 - 9 57 74 103 120
10 - 14 58 74 94 111 10 - 14 68 85 104 120
15 - 19 68 88 125 143 15 - 19 64 85 112 126
age LDL (mg/dL) age LDL (mg/dL)
5 - 9 90 103 117 129 5 - 9 98 115 125 140
10 - 14 94 109 123 133 10 - 14 94 110 126 136
15 - 19 93 109 123 130 15 - 19 93 110 129 137
References: 55Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
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, anx
iety
, de
pres
sion
, int
elle
ctua
l dis
abili
ty
• P
sych
osoc
ial i
nter
vent
ions
(PI):
□
BT,
CB
T, C
PP,
BS
FT, I
FT, M
ST,
MD
T,
PS
MS
• P
I + m
edic
atio
n:
□ris
perid
one,
arip
ipra
zole
, stim
ulan
t or
lith
ium
no ro
le
anxi
ety
(gen
eral
ized
, sep
arat
ion,
so
cial
), ob
sess
ive
com
puls
ive
diso
rder
(OC
D),
pani
c di
sord
er
• P
I □C
BT,
PD
P, IF
T
• S
SR
I
• P
I + S
SR
I•
PI +
non
-SS
RI:
□ve
nlaf
axin
e, T
CA
, bus
piro
ne o
r BZD
• ge
nera
lized
anx
iety
: que
tiapi
ne
(mod
)•
soci
al p
hobi
a: o
lanz
apin
e (lo
w)
• O
CD
: ola
nzap
ine
(low
)
ASD
-rel
ated
agg
ress
ion
or
irrita
tion
• P
I (A
BA
, CB
T) +
med
icat
ion:
□
rispe
ridon
e or
arip
ipra
zole
(add
va
lpro
ate
if pa
rtial
resp
onse
)
• P
I + a
ltern
ate
med
icat
ion:
□α-
2 ag
onis
t or v
alpr
oate
• P
I + o
lanz
apin
ela
ck o
f evi
denc
e
atte
ntio
n de
ficit
hype
ract
ivity
di
sord
er (A
DH
D)
• ag
e 4
- 5: B
T
• ag
e 6
- 11:
BT
+ st
imul
ant
• ag
e 12
- 17
+: s
timul
ant
• ag
e 4
- 5: B
T +
met
hyph
enid
ate
• ag
e 6
- 11:
BT
+ al
tern
ate
stim
ulan
t•
age
12 -
17+:
stim
ulan
t +B
T
• ag
e 4
- 5: B
T +
alte
rnat
e st
imul
ant
• ag
e 6
- 11:
BT
+ at
omox
etin
e or
α-
2 ag
onis
t•
age
12 -
17+:
alte
rnat
e st
imul
ant +
BT
• ris
perid
one
(low
)
bipo
lar d
isor
der I
: acu
te m
ania
• P
I (FF
T, IP
T, S
RT,
CB
T) +
m
edic
atio
n: □
moo
d st
abili
zer a
nd/o
r SG
A (n
ot
cloz
apin
e)
• P
I + a
ltern
ate
med
icat
ion:
□al
tern
ate
moo
d st
abili
zer a
nd/o
r al
tern
ate
SG
A (n
ot c
loza
pine
)
• P
I + a
ltern
ate
med
icat
ion:
□cl
ozap
ine
or B
ZDon
labe
l
bipo
lar d
isor
der I
: mix
ed•
PI +
alte
rnat
e m
edic
atio
n: □
alte
rnat
e m
ood
stab
ilize
r +/-
SS
RI
on la
bel
depr
essi
on, m
ajor
dep
ress
ive
diso
rder
(MD
D)
• P
I: □C
BT,
IPT,
edu
catio
n/ca
se
man
agem
ent r
ealte
d to
en
viro
nmen
tal s
tress
ors
• P
I + fl
uoxe
tine
• P
I + a
ltern
ate
med
icat
ion:
□al
tern
ate
SS
RI o
r SN
RI
• qu
etia
pine
(mod
) (p
edia
tric
stud
ies
show
no
effic
acy)
• ris
perid
one
+ S
SR
I (m
od)
• zi
pras
idon
e +
SS
RI (
low
)in
telle
ctua
l dis
abili
ty•
PI:
fam
ily o
r gro
up p
sych
othe
rapy
oppo
sitio
nal d
efian
t dis
orde
r (O
DD
), co
nduc
t dis
orde
r•
Trea
t und
erly
ing
diso
rder
□
com
mon
ly: A
DH
D, a
nxie
ty,
depr
essi
on, P
TSD
, sub
stan
ce a
buse
• P
I: □IP
T, IF
T, P
SM
S, B
T•
PI +
med
icat
ion:
□m
ood
stab
ilize
r, or
SG
A, o
r stim
ulan
tno
role
post
-trau
mat
ic s
tres
s di
sord
er
(PTS
D)
• P
I: □TF
-CB
T, E
MD
R, C
PTT
• P
I + m
edic
atio
n: □
SS
RI
• P
I + a
ltern
ate
med
icat
ion:
□cl
onid
ine,
pro
pran
olol
or m
ood
stab
ilize
r
• ris
perid
one
(mod
)•
quet
iapi
ne (l
ow)
• ol
anza
pine
(mix
)
References: 7, 19-25, 28, 30, 32, 56-60
20 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
21
Trea
tmen
t Rec
omm
enda
tion
s(S
hade
d ce
lls in
dica
te d
emon
stra
ted
evid
ence
to s
uppo
rt S
GA
use.
Dis
cont
inue
/tape
r any
med
icat
ions
initi
ated
as
first
line
bef
ore
star
ting
seco
nd li
ne/a
ltern
ate
med
icat
ion)
diag
nosi
s/sy
mpt
omfir
st li
nese
cond
line
third
line
afte
r thi
rd li
ne(o
ff la
bel a
dult
stud
ies
only
: mod
erat
e, lo
w,
or m
ixed
evi
denc
e)
aggr
essi
on
(impu
lsiv
e, m
alad
aptiv
e, n
ot d
ue to
A
SD
)
• Tr
eat u
nder
lyin
g di
sord
er
□co
mm
only
: AD
HD
, anx
iety
, de
pres
sion
, int
elle
ctua
l dis
abili
ty
• P
sych
osoc
ial i
nter
vent
ions
(PI):
□
BT,
CB
T, C
PP,
BS
FT, I
FT, M
ST,
MD
T,
PS
MS
• P
I + m
edic
atio
n:
□ris
perid
one,
arip
ipra
zole
, stim
ulan
t or
lith
ium
no ro
le
anxi
ety
(gen
eral
ized
, sep
arat
ion,
so
cial
), ob
sess
ive
com
puls
ive
diso
rder
(OC
D),
pani
c di
sord
er
• P
I □C
BT,
PD
P, IF
T
• S
SR
I
• P
I + S
SR
I•
PI +
non
-SS
RI:
□ve
nlaf
axin
e, T
CA
, bus
piro
ne o
r BZD
• ge
nera
lized
anx
iety
: que
tiapi
ne
(mod
)•
soci
al p
hobi
a: o
lanz
apin
e (lo
w)
• O
CD
: ola
nzap
ine
(low
)
ASD
-rel
ated
agg
ress
ion
or
irrita
tion
• P
I (A
BA
, CB
T) +
med
icat
ion:
□
rispe
ridon
e or
arip
ipra
zole
(add
va
lpro
ate
if pa
rtial
resp
onse
)
• P
I + a
ltern
ate
med
icat
ion:
□α-
2 ag
onis
t or v
alpr
oate
• P
I + o
lanz
apin
ela
ck o
f evi
denc
e
atte
ntio
n de
ficit
hype
ract
ivity
di
sord
er (A
DH
D)
• ag
e 4
- 5: B
T
• ag
e 6
- 11:
BT
+ st
imul
ant
• ag
e 12
- 17
+: s
timul
ant
• ag
e 4
- 5: B
T +
met
hyph
enid
ate
• ag
e 6
- 11:
BT
+ al
tern
ate
stim
ulan
t•
age
12 -
17+:
stim
ulan
t +B
T
• ag
e 4
- 5: B
T +
alte
rnat
e st
imul
ant
• ag
e 6
- 11:
BT
+ at
omox
etin
e or
α-
2 ag
onis
t•
age
12 -
17+:
alte
rnat
e st
imul
ant +
BT
• ris
perid
one
(low
)
bipo
lar d
isor
der I
: acu
te m
ania
• P
I (FF
T, IP
T, S
RT,
CB
T) +
m
edic
atio
n: □
moo
d st
abili
zer a
nd/o
r SG
A (n
ot
cloz
apin
e)
• P
I + a
ltern
ate
med
icat
ion:
□al
tern
ate
moo
d st
abili
zer a
nd/o
r al
tern
ate
SG
A (n
ot c
loza
pine
)
• P
I + a
ltern
ate
med
icat
ion:
□cl
ozap
ine
or B
ZDon
labe
l
bipo
lar d
isor
der I
: mix
ed•
PI +
alte
rnat
e m
edic
atio
n: □
alte
rnat
e m
ood
stab
ilize
r +/-
SS
RI
on la
bel
depr
essi
on, m
ajor
dep
ress
ive
diso
rder
(MD
D)
• P
I: □C
BT,
IPT,
edu
catio
n/ca
se
man
agem
ent r
ealte
d to
en
viro
nmen
tal s
tress
ors
• P
I + fl
uoxe
tine
• P
I + a
ltern
ate
med
icat
ion:
□al
tern
ate
SS
RI o
r SN
RI
• qu
etia
pine
(mod
) (p
edia
tric
stud
ies
show
no
effic
acy)
• ris
perid
one
+ S
SR
I (m
od)
• zi
pras
idon
e +
SS
RI (
low
)in
telle
ctua
l dis
abili
ty•
PI:
fam
ily o
r gro
up p
sych
othe
rapy
oppo
sitio
nal d
efian
t dis
orde
r (O
DD
), co
nduc
t dis
orde
r•
Trea
t und
erly
ing
diso
rder
□
com
mon
ly: A
DH
D, a
nxie
ty,
depr
essi
on, P
TSD
, sub
stan
ce a
buse
• P
I: □IP
T, IF
T, P
SM
S, B
T•
PI +
med
icat
ion:
□m
ood
stab
ilize
r, or
SG
A, o
r stim
ulan
tno
role
post
-trau
mat
ic s
tres
s di
sord
er
(PTS
D)
• P
I: □TF
-CB
T, E
MD
R, C
PTT
• P
I + m
edic
atio
n: □
SS
RI
• P
I + a
ltern
ate
med
icat
ion:
□cl
onid
ine,
pro
pran
olol
or m
ood
stab
ilize
r
• ris
perid
one
(mod
)•
quet
iapi
ne (l
ow)
• ol
anza
pine
(mix
)
SGA
s ha
ve node
mon
stratedeffic
acy
for
trea
tmen
t of:
subs
tanc
e ab
use
(alc
ohol
, coc
aine
or
met
ham
phet
amin
e)ea
ting
dis
orde
rs in
som
nia
Trea
tmen
t Rec
omm
enda
tion
s(D
isco
ntin
ue/ta
per a
ny m
edic
atio
ns in
itiat
ed a
s fir
st li
ne b
efor
e st
artin
g se
cond
line
/alte
rnat
e m
edic
atio
n)
diag
nosi
s/sy
mpt
omfir
st li
nese
cond
line
third
line
afte
r thi
rd li
ne(a
dult
stud
ies
only
: mod
erat
e, lo
w, o
r mix
ed
evid
ence
)
schi
zoph
reni
a•
PI +
SG
A (n
ot c
loza
pine
) □
PS
MS
, CM
T, M
T, IF
T, li
fe s
kills
• P
I+ S
GA
(not
clo
zapi
ne) +
ad
junc
t med
icat
ion:
□m
ood
stab
ilize
r, an
ti-de
pres
sant
, or B
ZD
• P
I + c
loza
pine
on la
bel
tic d
isor
der (
Tour
ette
’s)
• M
ild: P
I (C
BI)
• M
oder
ate:
PI (
HR
T)•
Sev
ere:
HR
T +
med
icat
ion:
□S
GA
(not
ola
nzap
ine)
or α
-2 a
goni
st
• M
ild-m
oder
ate:
HR
T +
med
icat
ion:
□S
GA
(not
ola
nzap
ine)
or α
-2 a
goni
st•
Mod
erat
e-se
vere
: H
RT
+ ol
anza
pine
• ris
perid
one
(low
)
Abb
revi
atio
ns:
α-2
agon
ist:
guan
faci
ne, c
loni
dine
IPT:
inte
rper
sona
l the
rapy
AB
A: a
pplie
d be
havi
oral
ana
lysi
s, e
spec
ially
Ear
ly In
tens
ive
Beh
avio
ral
Inte
rven
tion
MD
T: m
ultid
imen
sion
al tr
eatm
ent
BS
FT: b
rief s
trate
gic
fam
ily th
erap
yM
ood
stab
ilize
r: lit
hium
, val
proa
te, c
arba
maz
epin
e (r
ecom
men
d 6-
8 w
eeks
to
dete
rmin
e ef
ficia
cy)
BT:
beh
avio
ral t
hera
py (I
ncre
dibl
e Ye
ars,
Trip
le P
, Par
ent-C
hild
Inte
ract
ion
Ther
apy)
MS
T: m
ultis
yste
mic
ther
apy
BZD
: ben
zodi
azep
ine
(clo
naze
pam
, dia
zepa
m, l
oraz
epam
)M
T: M
ilieu
The
rapy
CB
I: cl
assr
oom
-bas
ed in
terv
entio
nP
DP
: psy
chod
ynam
ic p
sych
othe
rapy
CB
T: c
ogni
tive
beha
vior
ther
apy
PS
MS
: pro
blem
-sol
ving
man
agem
ent s
kills
CM
T: c
ogni
tive
rem
edia
tion
ther
apy
SN
RI:
sero
toni
n an
d no
repi
neph
rine
reup
take
inhi
bito
rs (d
ulox
etin
e,
venl
afax
ine,
des
venl
axax
ine)
CP
P: c
opin
g po
wer
pro
gram
(sch
ool-b
ased
set
ting)
SR
T: s
ocia
l rhy
thm
ther
apy
CP
PT:
chi
ld-p
aren
t psy
chot
hera
pyS
SR
I: se
lect
ive
sero
toni
n re
upta
ke in
hibi
tor (
cila
topr
am, e
scita
lopr
am,
paro
xetin
e, fl
uoxe
tine,
fluv
oxam
ine,
ser
tralin
e); m
onito
r clo
sely
due
to s
uici
dal
idea
tion,
wor
seni
ng d
epre
ssio
n, in
citin
g m
anic
epi
sode
EM
DR
: eye
mov
emen
t des
ensi
tizat
ion
and
repr
oces
sing
Stim
(stim
ulan
t): m
ethy
lphe
nida
te o
r am
phet
amin
eFF
T: fa
mily
-focu
sed
ther
apy
TCA
: tric
yclic
ant
idep
ress
ant (
amitr
ipty
line,
clo
mpi
ram
ine,
des
pira
min
e,
doxe
pine
, nor
tript
ylin
e, p
rotri
ptyl
ine)
IFT:
inte
grat
ive
fam
ily th
erap
yTF
-CB
T: tr
aum
a-fo
cuse
d co
gniti
ve b
ehav
iora
l the
rapy
HR
T: h
abit
reve
rsal
trai
ning
References: 7, 19-25, 28-30, 32, 56-60Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Ped
iatr
ic S
GA
Dos
ing
Entir
e SG
A cl
ass:
• In
ject
able
form
ulat
ions
are
NO
T ap
prov
ed fo
r ped
iatri
c us
e•
Tota
l tre
atm
ent p
rogr
am in
clud
es m
edic
atio
n an
d ps
ycho
logi
cal,
educ
atio
nal,
and
soci
al in
terv
entio
ns
• FD
A B
oxed
War
ning
: pos
sibl
e in
crea
se in
risk
of s
uici
dal t
houg
hts
and
beha
vior
in
child
ren,
ado
lesc
ents
, and
you
ng a
dults
• FD
A B
oxed
War
ning
: ris
k of
dea
th in
crea
sed
in e
lder
ly p
atie
nts
• Av
oid
abru
pt d
isco
ntin
uatio
nO
DT:
ora
lly d
isin
tegr
atin
g ta
blet
s
NTE
: not
to e
xcee
d
arip
ipra
zole
(Abi
lify®
)•
dose
titra
tion:
2m
g da
ily fo
r 2 d
ays,
then
5m
g da
ily fo
r 2 d
ays,
then
5m
g da
ily
incr
emen
ts a
t 1 w
eek
inte
rval
s•
OD
T is
dos
ed th
e sa
me
as o
ral t
able
ts•
non-
divi
ded
dose
s•
with
or w
ithou
t foo
d
ASD
agi
tatio
n (a
ge 6
- 17
)2
- 15
mg/
day
(NTE
15
mg/
day)
BPD
I: m
anic
or m
ixed
, mon
othe
rapy
(age
10
or o
lder
)2
- 10
mg/
day
(NTE
30
mg/
day)
BPD
I: a
s ad
junc
t with
lith
ium
or v
alpr
oate
(age
10
or o
lder
)2
- 10
mg/
day
(NTE
30
mg/
day)
Tour
ette
’s (a
ge 6
- 18
)<
50 k
g: 2
- 5
mg/
day
(NTE
10
mg/
day)
≥ 50
kg:
2 -
10 m
g/da
y (N
TE 2
0 m
g/da
y)
Schi
zoph
reni
a (a
ge 1
3 - 1
7)2
- 10
mg/
day
(NTE
30
mg/
day)
asen
apin
e (S
aphr
is®
)•
dose
titra
tion:
day
1: 2
.5 m
g B
ID
day
4: 5
mg
BID
d
ay 7
: 10
mg
BID
• al
low
to d
isso
lve
com
plet
ely
unde
r ton
gue
• do
not
cru
sh, c
hew
, or s
wal
low
• av
oid
eatin
g or
drin
king
for 1
0 m
inut
es a
fter a
dmin
istra
tion
• gi
ve in
div
ided
dos
es: B
ID•
perio
dica
lly e
valu
ate
need
for l
ong-
term
use
BPD
I: a
cute
man
ic o
r mix
ed,
mon
othe
rapy
or a
djun
ct w
ith li
thiu
m o
r val
proa
te (a
ge 1
0 or
old
er)
5 - 2
0 m
g/da
y (N
TE 2
0 m
g/da
y)
cloz
apin
e (C
loza
ril®
)•
safe
ty a
nd e
ffica
cy a
re n
ot e
stab
lishe
d: m
ultip
le s
tudi
es a
nd p
rofe
ssio
nal
orga
niza
tions
reco
gniz
e a
role
as
treat
men
t of l
ast r
esor
t for
refra
ctor
y di
seas
e
• do
se ti
tratio
n (a
dult)
: da
y 1:
12.
5 m
g, 1
- 2
times
dai
ly25
- 50
mg/
day
incr
emen
ts a
t dai
ly in
terv
als
Schi
zoph
reni
a (n
ot F
DA
-app
rove
d ag
e 18
and
you
nger
)ag
e 5
- 12:
150
- 30
0 m
g/da
yag
e 13
- 17
: 200
- 60
0 m
g/da
y
olan
zapi
ne (Z
ypre
xa®
)•
dose
titra
tion:
2.5
- 5m
g in
crem
ents
at d
aily
inte
rval
s•
OD
T: p
ull b
ack
foil
(do
not p
ush
thro
ugh)
; con
sum
e im
med
iate
ly a
fter r
emov
al fr
om
pack
age
• no
n-di
vide
d do
ses
• w
ith o
r with
out f
ood
BPD
I: a
cute
man
ic o
r mix
ed, m
onot
hera
py (a
ge 1
3 - 1
7)2.
5 - 1
0 m
g/da
y (N
TE 2
0 m
g/da
y)
Dep
ress
ed B
PD I:
in c
ombi
natio
n w
ith fl
uoxe
tine
20 m
g (a
ge 1
0 - 1
7)2.
5 - 1
2 m
g/da
y (N
TE 1
2 m
g ol
anza
pine
, 50
mg
fluox
etin
e)
Schi
zoph
reni
a (a
ge 1
3 - 1
7)2.
5 - 1
0 m
g/da
y (N
TE 2
0 m
g/da
y)
References: 18, 61-72
22 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
23
Ped
iatr
ic S
GA
Dos
ing
palip
erid
one
(Inve
ga®
)•
dose
titra
tion:
3 m
g/da
y in
crem
ents
at 5
day
or m
ore
inte
rval
s•
do n
ot c
rush
, che
w, o
r spl
it•
with
or w
ithou
t foo
d
Schi
zoph
reni
a (a
ge 1
2 - 1
7)<
51 k
g: 3
- 6
mg/
day
(NTE
6 m
g/da
y)≥
51 k
g: 3
- 12
mg/
day
(NTE
12
mg/
day)
quet
iapi
ne (S
eroq
uel®
); qu
etia
pine
XR
(Ser
oque
l XR
®)
• do
se ti
tratio
n (IR
or E
R)
day
1: 5
0 m
g/da
y
d
ay 2
: 100
mg/
day
the
n in
crea
se 1
00 m
g/da
y•
XR
: do
not c
rush
, che
w, o
r spl
it•
XR
: giv
e w
ithou
t foo
d, o
r sna
ck o
f 300
cal
orie
s or
less
•
XR
: giv
e in
the
even
ing
(onc
e da
ily)
• IR
: giv
e in
div
ided
dos
es, 2
- 3
times
dai
ly
• IR
and
XR
: if m
ore
than
7 d
ays
of d
oses
hav
e be
en m
isse
d, re
star
t ini
tial t
itrat
ion
sche
dule
• IR
and
XR
: pat
ient
s m
ay s
witc
h be
twee
n eq
uiva
lent
tota
l dai
ly d
oses
BPD
I: m
anic
, mon
othe
rapy
(age
10
- 17)
400
- 600
mg/
day
(NTE
600
mg/
day)
Schi
zoph
reni
a (a
ge 1
3 - 1
7)40
0 - 8
00 m
g/da
y (N
TE 8
00 m
g/da
y)
rispe
ridon
e (R
ispe
rdal
®)
• w
ith o
r with
out f
ood
• di
vide
d or
non
-div
ided
dos
es•
solu
tion:
may
be
give
n un
dilu
ted,
may
dilu
te w
ith w
ater
, cof
fee,
ora
nge
juic
e or
low
-fa
t milk
(not
com
patib
le w
ith c
ola
or te
a)
• O
DT:
do
not c
hew
, or s
plit
• O
DT:
pul
l bac
k fo
il (d
o no
t pus
h th
roug
h); c
onsu
me
imm
edia
tely
afte
r rem
oval
from
pa
ckag
e; w
ith o
r with
out l
iqui
d
ASD
irrit
abili
ty (a
ge 5
or o
lder
)
0.5
- 3 m
g/da
y (N
TE 3
mg/
day)
< 15
kg:
not
reco
mm
ende
d15
-20
kg: d
ay 1
: 0.2
5 m
g/da
y
afte
r day
5: 0
.5 m
g/da
y, m
aint
ain
at le
ast 1
4 da
ys fo
r eac
h 0.
5 m
g/da
y in
crea
se≥
20 k
g: d
ay 1
: 0.5
mg/
day
af
ter d
ay 5
: 1 m
g/da
y, m
aint
ain
at le
ast 1
4 da
ys fo
r eac
h 0.
5 m
g/da
y in
crea
se
BPD
I (a
ge 1
0 or
old
er)
0.5
- 2.5
mg/
day
(NTE
2.5
mg/
day)
adju
st 0
.5 -
1 m
g/da
y at
leas
t 24
hr in
crem
ents
Schi
zoph
reni
a (a
ge 1
3 or
old
er)
0.5
- 3 m
g/da
y (N
TE 3
mg/
day)
adju
st 0
.5 -
1 m
g/da
y at
leas
t 24
hr in
crem
ents
zipr
asid
one
(Geo
don®
)•
dose
titra
tion:
firs
t dos
e gi
ven
undi
vide
d, w
ith e
veni
ng m
eal
then
incr
ease
by
20 m
g/da
y, e
very
1 -
2 da
ys, i
n di
vide
d do
ses
(BID
)•
take
with
food
BPD
I: a
cute
man
ic o
r mix
ed, m
onot
hera
py (a
ge 1
0 - 1
7)<
45 k
g: 4
0 - 8
0 m
g/da
y (N
TE 8
0 m
g/da
y)≥
45 k
g: 8
0 - 1
60 m
g/da
y (N
TE 1
60 m
g/da
y; a
nd n
ot b
efor
e da
y 8
in ti
tratio
n sc
hedu
le)
brex
pipr
azol
e (R
exul
ti®)
c
arip
razi
ne (V
rayl
ar®
) ilo
perid
one
(Fan
apt®
)
lura
sido
ne (L
atud
a®)
safe
ty a
nd e
ffica
cy a
re n
ot e
stab
lishe
d
References: 18, 61-72Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
SoonerCare SGA Tier Chart & PA CriteriaTier-1 products are available without prior authorization for age 5 and older.Prior authorization requests for members under age 5 are reviewed by an OHCA-contracted child psychiatrist.
Tier-2 Authorization Criteria:1. A trial of two Tier-1 products (not including clozapine), at least 14 days in duration each, titrated to recommended dose, that
did not yield adequate response or resulted in intolerable adverse effects.• Pending aripiprazole move to Tier-1: One of the Tier-1 trials must include a trial with aripiprazole unless the member has a patient-
specific, clinically significant reason why aripiprazole is not appropriate or an FDA approved diagnosis not covered by aripiprazole. • Clozapine does not count towards a Tier-1 trial.
Tier-3 Authorization Criteria:1. A trial of two Tier-1 products (not including clozapine), at least 14 days in duration each, titrated to recommended dose, that
did not yield adequate response or resulted in intolerable adverse effects; AND• Pending aripiprazole move to Tier-1: One of the Tier-1 trials must include a trial with aripiprazole unless the member has a patient-
specific, clinically significant reason why aripiprazole is not appropriate or an FDA approved diagnosis not covered by aripiprazole. • Clozapine does not count towards a Tier-1 trial.
2. A trial of two Tier-2 products, at least 14 days in duration each, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.
3. A manual prior authorization may be submitted for consideration of a Tier-3 product when the member has had at least four trials of Tier-1 and Tier-2 products (two trials must be from Tier-1) that did not yield an adequate response or resulted in intolerable adverse effects.
4. Use of Versacloz® (clozapine oral suspension) and Fazaclo® (clozapine orally disintegrating tablet) requires a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation.
Approval Criteria for Atypical Antipsychotics as Adjunctive Treatment for Depression: Authorization of Abilify® (aripiprazole), Seroquel XR® (quetiapine extended-release), Symbyax® (olanzapine/fluoxetine), or Rexulti® (brexpiprazole), for a diagnosis of major depressive disorder requires current use of an antidepressant, and previous trials with at least two other antidepressants from both categories (an SSRI and duloxetine) and a trial of aripiprazole tablets (pending aripiprazole move to Tier-1) that did not yield adequate response. Tier structure applies (the member would have needed to try the Tier-2 atypical antipsychotics indicated for adjunctive treatment of MDD before trying Tier-3).
Clinical Exceptions:• Members currently stabilized on a higher-tiered medication defined by paid claim(s) for the higher tiered medication in the
past 90 days will be approved. • Members being released from a hospital and stabilized on a higher-tiered medication will be approved. • Approvals will be granted for members with clinical conditions for which lower-tiered drugs are contraindicated. • Approvals will be granted for members whose current regimen includes drugs known to adversely interact with all lowered
tiered drugs. • Lurasidone (Latuda®) may be approved for pregnant women with appropriate diagnosis.
Tier-1 Tier-2 Tier-3clozapine (Clozaril®)* aripiprazole (Abilify®, Abilify Maintena®,
Aristada®)clozapine (Fazaclo®)
quetiapine (Seroquel®) paliperidone (Invega Sustenna®, Invega Trinza®)**
iloperidone (Fanapt®)
risperidone (Risperdal®, Risperdal Consta®)
lurasidone (Latuda®) paliperidone (Invega®)
olanzapine (Zyprexa®) asenapine (Saphris®) brexpiprazole (Rexulti®)ziprasidone (Geodon®) quetiapine ER (Seroquel XR®) olanzapine/fluoxetine (Symbyax®)
clozapine oral suspension (Versacloz®)
*Does not count toward a Tier-1 trial.**In addition to tier trials, use of Invega Trinza™ requires members to have been adequately treated with the 1-month paliperidone extended-release injection (Invega® Sustenna®) for at least four months.
Second Opinion Process for Children 0-4 Years of Age and Unusual Dosing RequestsChildren less than 5 years of age will require a “second opinion” prior authorization to be reviewed by an OHCA-contracted child psychiatrist. Current users will be allowed to remain on current medication until the petition is submitted and reviewed. The second opinion process is as follows:• Clinical pharmacist reviews petition for necessary information, including diagnosis and behavioral information to submit to
on-call OHCA psychiatrist. • On-call psychiatrist at OHCA reviews submitted prior authorization request. • OHCA faxes response back within 24 hours. • Clinical pharmacist issues appropriate response for petition based on the results.
References: 37
24 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
25
Dai
ly M
ood
Cha
rt: C
ompl
ete
the
char
t at t
he e
nd o
f eac
h da
yM
onth
:•
Rat
e yo
ur m
ood:
1.
P
lace
a c
heck
in th
e bo
x th
at d
escr
ibes
the
high
est m
ood
you
felt
that
day
.(+
3 =
very
hig
h m
ood)
2.
Pla
ce a
che
ck in
the
box
that
des
crib
es th
e lo
wes
t moo
d yo
u fe
lt th
at d
ay.
(-3
= ve
ry lo
w m
ood)
3.
Pla
ce a
che
ck in
the
box
that
des
crib
es th
e hi
ghes
t lev
el o
f anx
iety
you
felt
that
day
. (+
3 =
lots
of a
nxie
ty)
4.
Pla
ce a
che
ck in
the
box
that
des
crib
es th
e hi
ghes
t lev
el o
f irr
itabi
lity
you
felt
that
day
.(+
3 =
lots
of i
rrita
bilit
y)
• H
ours
Sle
pt: W
rite
the
num
ber o
f hou
rs y
ou s
lept
with
in th
e la
st 2
4 ho
urs.
• W
eigh
t: W
rite
your
wei
ght o
n th
e 14
th a
nd 2
8th d
ay o
f eac
h m
onth
.•
Med
icat
ions
: Lis
t you
r med
icat
ions
. Inc
lude
the
nam
e, h
ow m
any
mg,
an
d ho
w m
any
times
a d
ay y
ou a
re to
ld to
take
it.
Pla
ce a
che
ck in
the
box
for t
hat d
ay if
you
took
you
r med
icin
e•
Alc
ohol
/Dru
gs: P
lace
an
“A” i
n th
e bo
x if
you
dran
k al
coho
l. P
lace
a
“D” i
n th
e bo
x if
you
took
any
dru
g no
t pre
scrib
ed b
y yo
ur d
octo
r
Day
of t
he M
onth
Rat
e yo
ur m
ood:
12
34
56
78
910
1112
1314
1516
1718
1920
2122
2324
2526
2728
2930
31
high
+3 +2 +1no
rmal
low
-1 -2 -3
anxi
ety
+3 +2 +1
irrita
bilit
y+3 +2 +1
hour
s sl
ept
wei
ght
med
icat
ions
alco
hol/d
rugs
note
s
adap
ted
from
: Nat
iona
l Ins
titut
e of
Men
tal H
ealth
’s L
ife C
hart
Met
hod
(NIM
H-L
CM
TM)
References: 73Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
CLO
ZAPI
NE
REM
SPD
A F
act
She
etTh
e Sin
gle
Sha
red
Syst
em for
Clo
zapi
neN
o Blo
od,
No
Dru
gTM
In M
ay 2
016,
the
Clo
zapi
ne R
EMS P
rogr
am la
unch
ed t
he P
re-D
ispe
nse
Auth
oriz
atio
n (P
DA).
Th
is F
act
She
et is
inte
nded
to
expl
ain
the
PDA a
nd w
hat
it m
eans
for
pre
scribe
rs a
nd p
harm
acie
s.Ph
one
844-
267-
8678
F
ax 8
44-4
04-8
876
ww
w.c
loza
pine
rem
s.co
m
BA
CK
GR
OU
ND
AN
D C
ON
TEX
TO
n O
ctob
er 1
2, 2
015,
the
sing
le s
hare
d C
loza
pine
RE
MS
Pro
gram
was
app
rove
d by
FD
A fo
r ALL
clo
zapi
ne p
rodu
cts,
repl
acin
g al
l oth
er c
loza
pine
pat
ient
regi
strie
s.
At t
he ti
me
of la
unch
, sev
eral
key
cha
nges
wer
e m
ade
to h
ow a
pre
scrip
tion
is
fille
d, n
eutro
peni
a m
onito
ring
reco
mm
enda
tions
and
the
treat
men
t gui
delin
es in
cl
ozap
ine
pres
crib
ing
info
rmat
ion:
• A
bsol
ute
neut
roph
il co
unt (
AN
C) i
s us
ed e
xclu
sive
ly fo
r pat
ient
m
onito
ring.
W
hite
blo
od c
ell (
WB
C) c
ount
s ar
e no
long
er a
ccep
ted.
• Pa
tient
s w
ith B
enig
n Et
hnic
Neu
trop
enia
(BEN
) can
be
trea
ted
with
clo
zapi
ne a
nd h
ave
a se
para
te A
NC
mon
itorin
g al
gorit
hm.
• A
NC
thre
shol
ds to
con
tinue
clo
zapi
ne tr
eatm
ent a
re lo
wer
.
For
gen
eral
pop
ulat
ion
patie
nts,
inte
rrup
t tre
atm
ent i
f neu
trope
nia
is
susp
ecte
d to
be
cloz
apin
e-in
duce
d fo
r AN
C le
ss th
an 1
000/
uL.
F
or p
atie
nts
with
BE
N, i
nter
rupt
trea
tmen
t if n
eutro
peni
a is
sus
pect
ed to
be
cloz
apin
e-in
duce
d fo
r AN
C le
ss th
an 5
00/u
L.
• Su
bsta
ntia
l dro
ps in
AN
C d
o no
t req
uire
act
ion
unle
ss th
e pa
tient
ex
perie
nces
neu
trop
enia
.
• Pr
escr
iber
s ha
ve g
reat
er fl
exib
ility
to m
ake
patie
nt-s
peci
fic
deci
sion
s ab
out c
ontin
uing
and
resu
min
g tre
atm
ent i
n pa
tient
s w
ho
expe
rienc
e m
oder
ate
and
seve
re n
eutro
peni
a.
Pat
ient
s m
ay b
e re
-cha
lleng
ed if
the
pres
crib
er d
eter
min
es th
e ris
k of
ps
ychi
atric
illn
ess
is g
reat
er th
an th
e ris
k of
sev
ere
neut
rope
nia.
In th
is
case
, a p
rovi
der c
an e
nter
a “t
reat
men
t rat
iona
le” a
utho
rizin
g th
e pa
tient
to
cont
inue
ther
apy.
• P
resc
riber
s an
d ph
arm
acie
s m
ust b
e sp
ecia
lly c
ertifi
ed in
the
new
C
loza
pine
RE
MS
Pro
gram
.
• P
resc
riptio
ns fr
om o
utpa
tient
pha
rmac
ies
will
requ
ire w
hat i
s ca
lled
a “P
re-D
ispe
nse
Aut
horiz
atio
n” o
r PD
A fro
m th
e R
EM
S P
rogr
am.
Pre
scrip
tions
from
inpa
tient
pha
rmac
ies
requ
ire a
n el
igib
ility
che
ck.
Giv
en th
e si
gnifi
cant
cha
nges
bei
ng im
plem
ente
d, a
tran
sitio
n pe
riod
was
put
in
plac
e to
allo
w p
harm
acis
ts a
nd p
resc
riber
s to
bec
ome
certi
fied
in th
e pr
ogra
m,
enro
ll pa
tient
s, a
nd b
egin
usi
ng th
e si
ngle
sha
red
syst
em to
man
age
patie
nt c
are.
In
add
ition
, pha
rmac
ies
bega
n co
nduc
ting
elig
ibili
ty c
heck
s.
Bas
ed o
n fe
edba
ck a
fter p
rogr
am la
unch
, the
Clo
zapi
ne R
EM
S P
rogr
am, i
n co
nsul
tatio
n w
ith th
e FD
A, e
xten
ded
the
dead
line
for i
mpl
emen
ting
the
outp
atie
nt
PD
A. T
he g
oal w
as to
min
imiz
e tre
atm
ent d
isru
ptio
n fo
r pat
ient
s w
hile
allo
win
g m
ore
time
for p
harm
acie
s an
d pr
escr
iber
s to
com
plet
e ce
rtific
atio
n.
NEX
T STE
PSTh
e C
loza
pine
RE
MS
Pro
gram
laun
ched
a li
mite
d ve
rsio
n of
the
PD
A in
May
of 2
016.
Thi
s w
ill e
valu
ate
the
crite
ria to
aut
horiz
e tre
atm
ent,
calle
d pr
ogra
m e
lem
ents
in th
e fo
llow
ing
man
ner:
INIT
ITA
L P
DA
LAU
NC
H: C
LOZA
PIN
E R
EM
S P
RO
GR
AM
ELE
ME
NTS
PD
A
Patie
nt is
regi
ster
edP
atie
nt re
gist
ratio
n in
the
RE
MS
will
be
eval
uate
d. If
a p
atie
nt is
not
regi
ster
ed in
the
Clo
zapi
ne R
EM
S P
rogr
am, t
his
will
pre
vent
a P
DA
.N
ot is
sued
Patie
nt A
NC
on
file
If pa
tient
doe
s no
t hav
e an
AN
C o
n fil
e w
ith th
e R
EM
S, t
his
will
pre
vent
a P
DA
.N
ot is
sued
Patie
nt h
as lo
w A
NC
• If
the
last
AN
C o
n fil
e fo
r a p
atie
nt is
a lo
w A
NC
indi
catin
g m
oder
ate
or s
ever
e ne
utro
peni
a, it
will
pre
vent
a P
DA
.•
If th
e pr
escr
iber
cho
oses
to c
ontin
ue th
e pa
tient
on
cloz
apin
e th
erap
y, a
trea
tmen
t ra
tiona
le m
ust b
e pr
ovid
ed to
the
Clo
zapi
ne R
EM
S P
rogr
am fr
om th
e pr
escr
iber
bef
ore
the
disp
ense
can
be
auth
oriz
ed; o
nce
the
treat
men
t rat
iona
le is
sub
mitt
ed, p
roce
ed w
ith
obta
inin
g a
PD
A.
Not
issu
ed
(if lo
w A
NC
)
Issu
ed(if
low
AN
C
& tr
eatm
ent
ratio
nale
su
bmitt
ed)
Patie
nt A
NC
s ar
e cu
rren
tIf
last
AN
C d
raw
dat
e is
out
side
of p
atie
nt’s
mon
itorin
g fre
quen
cy (M
F), i
t will
not
pre
vent
a
PD
A (w
arni
ng m
essa
ge w
ill b
e di
spla
yed)
.•
All
FDA
clai
m re
spon
ses
will
pro
vide
the
disp
ensi
ng p
harm
acy
with
the
last
two
AN
C
valu
es a
nd th
e as
soci
ated
blo
od d
raw
dat
es, a
s w
ell a
s th
e pa
tient
ME
.•
It is
reco
mm
ende
d th
at fo
r pat
ient
saf
ety
reas
ons,
pha
rmac
ies
cont
act t
he p
resc
riber
to
acq
uire
the
mos
t rec
ent p
atie
nt A
NC
info
rmat
ion
and/
or u
se c
linic
al ju
dgm
ent b
efor
e pr
ocee
ding
with
dis
pens
e; m
ore
rece
nt A
NC
s ca
n be
sub
mitt
ed b
y w
eb, p
hone
or f
ax.
Issu
ed
Pres
crib
ers
are
cert
ified
Pre
scrib
er c
ertifi
catio
n st
atus
will
be
eval
uate
d bu
t will
not
pre
vent
a P
DA
(war
ning
mes
sage
w
ill b
e di
spla
yed)
.Is
sued
Phar
mac
ies
are
cert
ified
Pha
rmac
y ce
rtific
atio
n st
atus
will
be
eval
uate
d bu
t will
not
pre
vent
a P
DA
(war
ning
mes
sage
w
ill b
e di
spla
yed)
.Is
sued
This
pha
sed
appr
oach
is d
esig
ned
to:
• G
ive
pres
crib
ers
and
phar
mac
ies
mor
e tim
e to
com
plet
e ce
rtific
atio
n in
the
prog
ram
.•
Allo
w p
resc
riber
s an
d ph
arm
acie
s m
ore
time
to a
djus
t to
new
pre
scrib
ing
info
rmat
ion
befo
re th
e de
finiti
on o
f a
curr
ent A
NC
is s
trict
ly e
nfor
ced.
Whe
n th
e fu
ll PD
A la
unch
occ
urs
late
r in
the
year
, if p
resc
riber
s an
d/or
pha
rmac
ies
are
not c
ertifi
ed in
th
e C
loza
pine
REM
S Pr
ogra
m, o
r a p
atie
nt’s
AN
C is
not
cur
rent
, thi
s w
ill im
pact
the
phar
mac
y’s
abili
ty to
di
spen
se c
loza
pine
, neg
ativ
ely
affe
ctin
g pa
tient
car
e.
Ada
pted
from
Clo
zapi
neR
EM
S.c
om
To
bet
ter i
nder
stan
d th
e in
itial
PD
A la
unch
in M
ay 2
016,
and
the
full
PD
A la
unch
late
r thi
s ye
ar, p
leas
e re
view
the
info
rmat
ion
on th
e ne
xt p
age.
References: 74
26 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
27
PDA F
ACT
SH
EET
WH
AT A
RE
MY
RES
PON
SIB
ILIT
IES
Initial PDA Launch (May 2106)
• Th
e in
itial
Pre
-Dis
pens
e A
utho
rizat
ion
(PD
A) w
ill b
e im
plem
ente
d in
the
outp
atie
nt e
nviro
nmen
t.•
Elig
ibili
ty c
heck
will
con
tinue
in th
e in
patie
nt e
nviro
nmen
t.•
Initi
al P
DA
and
elig
ibili
ty c
heck
m
essa
ging
will
incl
ude
indi
catio
n of
w
heth
er th
e pr
escr
iber
and
pha
rmac
y ar
e ce
rtifie
d, a
lthou
gh c
ertifi
catio
n is
no
t req
uire
d at
this
tim
e fo
r a P
DA
to
be is
sued
.•
The
initi
al P
DA
and
elig
ibili
ty c
heck
pr
oces
s w
ill e
valu
ate
whe
ther
ther
e is
a A
NC
on
file
with
acc
epta
ble
valu
es p
er th
e pr
escr
ibin
g in
form
atio
n or
a tr
eatm
ent r
atio
nale
on
file
docu
men
ting
the
pres
crib
er’s
dec
isio
n th
at th
e be
nefit
s ou
twei
gh th
e ris
ks o
f di
spen
sing
clo
zapi
ne.
• In
itial
PD
A an
d el
igib
ility
che
ck
mes
sagi
ng w
ill in
clud
e th
e la
st
two
AN
C v
alue
s on
file
and
thei
r dr
aw d
ates
. as
wel
l as
the
patie
nt’s
m
onito
ring
frequ
ency
(MF)
, alth
ough
a
curr
ent A
NC
is n
ot re
quire
d at
this
tim
e fo
r a P
DA
to b
e is
sued
Exa
mpl
e: L
ast
2 A
NC
: 510
0 01
/12/
16; 5
300
12/1
8/16
; M
F=28
d•
Bec
ause
the
initi
al P
DA
and
elig
ibili
ty
chec
k pr
oces
s w
ill n
ot e
valu
ate
whe
ther
the
AN
C o
n fil
e is
cur
rent
re
lativ
e to
the
patie
nt’s
MF,
pha
rmac
ies
are
expe
cted
to c
ontin
ue u
sing
thei
r cl
inic
al ju
dgm
ent t
o de
term
ine
if a
mor
e cu
rren
t AN
C is
nec
essa
ry to
dis
pens
e cl
ozap
ine.
PR
ES
CR
IBE
RS
CH
AIN
PH
AR
MA
CIE
SIN
DE
PE
ND
EN
T O
UTP
ATIE
NT
PH
AR
MA
CIE
S U
SIN
G
PH
AR
MA
CY
MA
NA
GE
ME
NT
SY
STE
M T
O O
BTA
IN A
PD
A
IND
EP
EN
DE
NT
OU
TPAT
IEN
T P
HA
RM
AC
IES
US
ING
W
EB
SIT
E O
R C
ALL
CE
NTE
R
TO O
BTA
IN A
PD
A
INPA
TIE
NT
PH
AR
MA
CIE
S
• C
ertif
y in
pro
gram
(one
-tim
e re
quire
men
t)•
Ens
ure
patie
nts
have
cu
rren
t AN
Cs
on fi
le w
ith
the
Clo
zapi
ne R
EM
S
Pro
gram
• U
se c
linic
al ju
dgm
ent
to d
eter
min
e if
bene
fits
of c
loza
pine
out
wei
gh
risks
if a
pat
ient
has
an
AN
C in
dica
ting
mod
erat
e or
sev
ere
neut
rope
nia;
do
cum
ent t
his
judg
men
t w
ith th
e C
loza
pine
RE
MS
P
rogr
am a
s a
treat
men
t ra
tiona
le
• U
se p
harm
acy
man
agem
ent s
yste
m
to o
btai
n a
PD
A pr
ior t
o di
spen
se o
f clo
zapi
ne•
Rev
iew
AN
C d
ata
(val
ues
and
date
of d
raw
) pr
ovid
ed w
ith P
DA
and
use
clin
ical
judg
men
t to
det
erm
ine
whe
ther
cl
ozap
ine
shou
ld b
e di
spen
sed
• W
ork
with
cha
in
auth
oriz
ed re
pres
enta
tive
to c
ertif
y in
pro
gram
(o
ne-ti
me
requ
irem
ent)
• U
se p
harm
acy
man
agem
ent s
yste
m
to o
btai
n a
PD
A pr
ior t
o di
spen
se o
f clo
zapi
ne•
Rev
iew
AN
C d
ata
(val
ues
and
date
of d
raw
) pr
ovid
ed w
ith P
DA
and
use
clin
ical
judg
men
t to
det
erm
ine
whe
ther
cl
ozap
ine
shou
ld b
e di
spen
sed
• C
ertif
y in
pro
gram
(one
-tim
e re
quire
men
t)
• U
se C
loza
pine
RE
MS
P
rogr
am w
ebsi
te a
t cl
ozap
iner
ems.
com
or
call
cent
er a
t 844
- 267
-86
7B to
obt
ain
a P
DA
prio
r to
disp
ense
of
cloz
apin
e•
Rev
iew
AN
C d
ata
(val
ues
and
date
of d
raw
) pr
ovid
ed w
ith P
DA
and
use
clin
ical
judg
men
t to
det
erm
ine
whe
ther
cl
ozap
ine
shou
ld b
e di
spen
sed
• C
ertif
y in
pro
gram
(one
-tim
e re
quire
men
t)
• U
se C
loza
pine
RE
MS
P
rogr
am w
ebsi
te a
t cl
ozap
iner
ems.
com
or c
all
cent
er a
t 844
-267
-867
8 to
con
duct
an
elig
ibili
ty
chec
k fo
r a p
atie
nt v
ia W
eb
or C
onta
ct C
ente
r bef
ore
disp
ensi
ng fo
r the
firs
t tim
e•
Cer
tify
in p
rogr
am (o
ne-
time
requ
irem
ent)
IF T
HE
ELI
GIB
ILIT
Y C
HE
CK
IS
NO
T S
UC
CE
SS
FUL
• W
ork
with
pat
ient
and
pr
escr
iber
to g
et a
n AN
C
on fi
le•
Wor
k w
ith p
resc
riber
to
dete
rmin
e if
a tre
atm
ent
ratio
nale
sho
uld
be e
nter
ed
by th
e pr
escr
iber
in th
e ca
se
of a
n AN
C th
at is
not
with
in
acce
ptab
le ra
nge
per t
he
pres
crib
ing
info
rmat
ion
• W
ork
with
pre
scrib
er to
ge
t pat
ient
enr
olle
d in
the
Clo
zapi
ne R
EMS
Prog
ram
IF T
HE
PDA
IS D
ENIE
D•
Wor
k w
ith p
atie
nt a
nd p
resc
riber
to g
et a
cur
rent
and
acc
epta
ble
ANC
on
file
with
the
Clo
zapi
ne R
EMS
Prog
ram
• W
ork
with
pre
scrib
er to
det
erm
ine
if a
treat
men
t rat
iona
le s
houl
d be
ent
ered
by
the
pres
crib
er if
an
ANC
is n
ot w
ithin
acc
epta
ble
rang
e pe
r the
pre
scrib
ing
info
rmat
ion
• W
ork
with
pre
scrib
er to
get
pat
ient
enr
olle
d in
the
Clo
zapi
ne R
EMS
Prog
ram
Full PDA Launch (Target: Q4, 2106)
Whe
n th
e P
DA
is fu
lly la
unch
ed, a
ll of
the
Clo
zapi
ne R
EM
S p
rogr
am e
lem
ents
will
be
enf
orce
d as
det
aile
d be
low
:•
Pres
crib
ers
and
phar
mac
ies
are
requ
ired
to b
e ce
rtifie
d to
pre
scrib
e an
d di
spen
se
cloz
apin
e.•
The
full F
DA
proc
ess
will
eval
uate
w
heth
er th
ere
is a
AN
C o
n fil
e w
ith
acce
ptab
le v
alue
s pe
r the
pre
scrib
ing
info
rmat
ion
or a
trea
tmen
t rat
iona
le o
n fil
e do
cum
entin
g th
e pr
escr
iber
’s de
cisi
on
that
the
bene
fits
outw
eigh
the
risks
of
disp
ensi
ng c
loza
pine
.•
The
full P
DA
proc
ess
will
eval
uate
w
heth
er th
e AN
C o
n fil
e is
cur
rent
rela
tive
to th
e pa
tient
’s M
F.If
any
of th
e ab
ove
cond
ition
s ar
e no
t m
et, d
ispe
nse
of c
loza
pine
will
not
be
auth
oriz
ed.
• C
ertif
y in
pro
gram
if n
ot
alre
ady
certi
fied
(one
-tim
e re
quire
men
t)•
Ensu
re p
atie
nts
have
cu
rrent
AN
Cs
on fi
le w
ith
the
Clo
zapi
ne R
EMS
Pr
ogra
m•
Use
clin
ical
judg
men
t to
det
erm
ine
if be
nefit
s of
clo
zapi
ne o
utw
eigh
ris
ks if
a p
atie
nt h
as a
n AN
C in
dica
ting
mod
erat
e or
sev
ere
neut
rope
nia;
do
cum
ent t
his
judg
men
t w
ith th
e C
loza
pine
REM
S
Prog
ram
as
a tre
atm
ent
ratio
nale
• U
se p
harm
acy
man
agem
ent s
yste
m
to o
btai
n a
PDA
prio
r to
disp
ense
of c
loza
pine
• W
ork
with
cha
in a
utho
rized
re
pres
enta
tive
to c
ertif
y in
pro
gram
if n
ot a
lread
y ce
rtifie
d (o
ne-ti
me
requ
irem
ent)
•Us
e ph
arm
acy
man
agem
ent s
yste
m
to o
btai
n a
PDA
prio
r to
disp
ense
of c
loza
pine
• C
ertif
y in
pro
gram
if n
ot
alre
ady
certi
fied
• U
se C
loza
pine
REM
S
Prog
ram
web
site
at
cloz
apin
erem
s. c
orn
or c
all
cent
er a
t 844
-267
-867
8 to
obt
ain
a PD
A pr
ior t
o di
spen
se o
f clo
zapi
ne•
Cer
tify
in p
rogr
am if
not
al
read
y ce
rtifie
d
• C
ondu
ct a
n el
igib
ility
chec
k fo
r a p
atie
nt v
ia W
eb o
r C
onta
ct C
ente
r•
Cer
tify
in p
rogr
am if
not
al
read
y ce
rtifie
d
IF T
HE
ELI
GIB
ILIT
Y C
HE
CK
IS
NO
T S
UC
CE
SS
FUL
• W
ork
with
pat
ient
and
pr
escr
iber
to g
et a
n AN
C
on fi
le•
Wor
k w
ith p
resc
riber
to
dete
rmin
e if
a tre
atm
ent
ratio
nale
sho
uld
be e
nter
ed
by th
e pr
escr
iber
in th
e ca
se
of a
n AN
C th
at is
not
with
in
acce
ptab
le ra
nge
per t
he
pres
crib
ing
info
rmat
ion
• W
ork
with
pre
scrib
er to
ge
t pat
ient
enr
olle
d in
the
Clo
zapi
neR
EMS
Prog
ram
IF T
HE
PD
A IS
DE
NIE
D•
Wor
k w
ith p
atie
nt a
nd p
resc
riber
to g
et a
cur
rent
and
acc
epta
ble
ANC
on
file
with
the
Clo
zapi
ne R
EMS
Prog
ram
• W
ork
with
pre
scrib
er to
det
erm
ine
if a
treat
men
t rat
iona
le s
houl
d be
ent
ered
by
the
pres
crib
er if
an
ANC
is n
ot w
ithin
acc
epta
ble
rang
e pe
r the
pre
scrib
ing
info
rmat
ion
• C
onta
ct p
resc
riber
to c
ertif
y if
they
hav
e no
t don
e so
• C
ertif
y in
the
prog
ram
if y
ou h
ave
not d
one
so•
Wor
k w
ith p
resc
riber
to g
et p
atie
nt e
nrol
led
in th
e C
loza
pine
REM
S Pr
ogra
m
References: 74Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
1. Findling RL, Druru SS, et al. Practice Parameter for the Use of Atypical Antipsychotic Medications in Children and Adolescents. American Academy of Child and Adolescent Psychiatry. 2011. Available at: http://www.aacap.org/App_Themes/AACAP/docs/practice_parameters/Atypical_Antipsychotic_Medications_Web.pdf Accessed 6/29/16.
2. Second-Generation Antipsychotic Drug Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns. Department of Health and Human Services. Office of the Inspector General. 2015. OEI-07-12-00320. Available at: http://oig.hhs.gov/oei/reports/oei-07-12-00320.pdf. Accessed 6/29/16.
3. Olfsom M, Druss BG, et al. Trends in Mental Health Care among Children and Adolescents. NEJM. 2015;372:2029-2038.
4. Kealey E, Scholle SH, et al. Quality Concerns in Antipsychotic Prescribing for Youth: A Review of Treatment Guidelines. Academy of pediatrics. 2014; 14(50):S68-S75.
5. United States Government Accountability Office: Children’s Mental Health: Concerns Remain about Appropriate Services for Children in Medicaid and Foster Care. GAO-13-15. Washington, DC: United States Government Accountability Office. Available at: http://www.gao.gov/assets/660/650716.pdf. Accessed 6/29/16
6. Gebelhoff R. Most Antipsychotic Drugs Prescribed to Teens Without Mental Health Diagnosis. The Washington Post, July 6, 2015. Available at: https://www.washingtonpost.com/news/to-your-health/wp/2015/07/06/most-antipsychotic-drugs-prescribed-to-teens-without-mental-health-diagnosis-study-says/. Accessed 6/29/16.
7. Foti ME, Harper G, et al. Antipsychotic Medication Use in Medicaid Children and Adolescents: Report and Resource Guide from a 16-State Study. Available at: http://rci.rutgers.edu/~cseap/MMDLNAPKIDS/Antipsychotic_Use_in_Medicaid_Children_Report_and_Resource_Guide_Final.pdf . Accessed 6/29/16.
8. Seida JC, Schouten JR. Pediatrics. Antipsychotics for Children and Young Adults: A comparative Effectiveness Review. 2012. Available at: https://effectivehealthcare.ahrq.gov/ehc/products/147/918/CER39_First-and-Second-Generation-Antipsychotics_execsumm_20120104.pdf. Accessed 6/29/16.
9. Linares LO, Martinez-Martin N, et al. Stimulant and Atypical Antipsychotic Medications for Children Placed in Foster Homes. Available at: stacks.cdc.gov/view/cdc/22654/cdc_22654_DS1.pdf . Accessed 6/29/16.
10. Browne S, Roe M, et al. Quality of life in schizophrenia: relationship to sociodemographic factors, symptomatology and tardive dyskinesia. Acta Psychiatr Scand 1996;94:118–124.
11. Harrison, JN, Cluxton-Keller F, et al. Antipsychotic Medication Prescribing Trends in Children and Adolescents. Journal of Pediatric Health Care. 2013;26(2):139-145.
12. Olfson M, Crystal S, et al. Trends in Antipsychotic Drug Use by Very Young, Privately Insured Children. Journal of the American Academy of Child and Adolescent Psychiatry. 2010;49(1):13-23.
13. Ekono M, Yang J, et al. Young Children in Deep Poverty. New York National Center for Children in Poverty, Mailman School of Public Health, Columbia University. Available at: http://www.nccp.org/publications/pdf/text_1133.pdf. Accessed 6/29/16.
14. Retwe DC, Greenblatt, J, et al. Antipsychotic Medication Prescribing in Children Enrolled in Medicaid. Pediatrics. 2015;135(4).
15. Olfson M, King M, et al. Treatment of Young People with Antipsychotic Medications in the United States. JAMA Psychiatry. 2015;72(9):867-874.
16. Szilagyi MA, Rosen DS, et al. Health Care Issues for Children and Adolescents in Foster Care and Kinship Care. Pediatrics. 2015; 136(4):e1142-e1166.
17. Garfield LD, Brown DS, et al. Psychotropic Drug Use Among Preschool Children in the Medicaid Program From 36 States. Available at: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2014.302258. Accessed 6/29/16.
18. Micromedex® 2.0, (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed 6/29/16.
19. McClellan J, Stock S, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Schizophrenia. Journal of the American Academy of Child & Adolescent Psychiatry. 2013;52(9):976-990.
20. McClellan J, Kowatch R, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Bipolar Disorder. Journal of the American Academy of Child & Adolescent Psychiatry. 2007;46(1):107-125.
21. Volkmar F, Siegel M, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Autism Spectrum Disorder, Journal of the American Acedemy of Child & Adolescent Psychiatry. 2014;53(2):237-257.
22. Murphy TK, Lewin AB, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Tic Disorders. Journal of the American Academy of Child & Adolescent Psychiatry. 2013;52(12):1341-1359.
23. PracticeWise: Evidence-based Child and Adolescent Psychosocial Interventions. American Academy of Pediatrics. Available at: https://www.aap.org/en-us/Documents/CRPsychosocialInterventions.pdf. Accessed 6/29/16.
24. Steiner H, Lemsing L, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Oppositional Defiant Disorder. Journal of the American Academy of Child & Adolescent Psychiatry. 2007;46(1):126-141.
25. Pappadopulos E, Macintyre JS, et al. Treatment Recommendations for the Use of Antipsychotics for Aggressive Youth (TRAAY) Part II. Journal of the American Acadamy of Child & Adolescent Psychiatry. 2003;42(2):145-161.
26. Penfold RB, Stewart C, et al. Use of Antipsychotic Medications in Pediatric Populations: What Do the Data Say. Curr Psychiatry Rep. 2013;15(12):426.
27. First- and Second-Generation Antipsychotics in Children and Young Adults-Systemic Review Update. Available at: https://effectivehealthcare.ahrq.gov/ehc/products/615/2244/antipsychotics-children-update-draft-report-160606.pdf. Accessed 6/29/16.
28. Connolly SD, Bernstein GA, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Anxiety Disorders. Journal of the American Academy of Child & Adolescent Psychiatry. 2007;46(2):267-283.
29. Shekelle P, Maglione M, et al. Efficacy and Comparative Effectiveness of Off-label Use of Atypical Antipsychotics. Available at: http://www.effectivehealthcare.ahrq.gov/repFiles/Atypical_Antipsychotics_Final_Report.pdf. Accessed 6/29/16.
30. Kondo K, Winchell K. AHRQ Systematic Review Surveillance Program: Off-label Use of Atypical Antipsychotics: An Update. Available at: https://effectivehealthcare.ahrq.gov/ehc/products/150/2061/atypical-antipsychotics-off-label-update-surveillance-160506.pdf. Accessed 6/29/16.
31. Brown MT, Bussell JK. Medication Adherence: WHO Cares. Mayo Clin Proc. 2011;86(4):304-314.
32. AHRQ Off-label Use of Atypical Antipsychotics: An Update Executive Summary. Available at: https://effectivehealthcare.ahrq.gov/ehc/products/150/786/CER43_Off-LabelAntipsychotics_execsumm_20110928.pdf. Accessed 6/29/16.
33. Simon V, VanWinkel R, et al.Are Weight Gain and Metabolic Side Effects of Atypical Antipsychotics Dose Dependent? A Literature Review. Journal of Clinical Psychiatry. 2009;70(7):1041-50.
34. Choosing Wisely. http://www.choosingwisely.org/wp-content/uploads/2015/02/APA-Choosing-Wisely-List.pdf.
35. Hampton LW, Daubresse M, et al. Emergency Department Visits by Children and Adolescents for Antipsychotic Drug Adverse Events. JAMA Psychiatry. 2015;72(3):292-294.
36. Hampton LM, Daubresse M, et al. Emergency Department Visits by Adults for Psychiatric Medication Adverse Events. JAMA Psychiatry. 2014;71(9):1006-1014.
37. Holderread, BH. (June 2016) Update on Medication Coverage Authorization Unit/SoonerPsych Program Update. Drug utilization report presented at the meeting of the Oklahoma Health Care Authority Drug Utilization Review Board, Oklahoma City, OK. Available at: https://www.okhca.org/about.aspx?id=490. Accessed 6/29/16.
38. Komossa K, RummelKluge C. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database of Sysetmatic Reviews. 2013;Volume 5. Available at: http://www.ncbi.nlm.nih.gov/pubmed/20238348. Accessed 6/29/16.
39. South Carolina Medicaid Academic Detailing Program. Evidence-
References
28 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
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Based Best Practices for the Use of Second Generation Antipsychotics (SGAs) in Pediatric Primary Care in South Carolina. Available at: https://www.sccp.sc.edu/sites/default/files/27803-SCORE%20BRO-3-13-vertical.pdf. Accessed 6/29/16.
40. VraylarTM product information. Allergan. Available at: http://www.allergan.com/assets/pdf/vraylar_pi. Last revised 9/2015. Accessed 6/29/15.
41. Hedis 2015: Safe and Judicious Antipsychotic use in Children and Adolescents. Available at http://www.ahrq.gov/sites/default/files/wysiwyg/policymakers/chipra/factsheets/chipra_1415-p011-1-ef.pdf. Accessed 6/29/16.
42. Allison D, Bergman R, et al. ADA/APA/AACE/NAASO Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes. Diabetes Care. 2004;27(2):596-601.
43. Psychotropic Medication Utilization Parameters for Children and Youth in Foster Care. Texas Department of Family and Protective Services and University of Texas at Austin College of Pharmacy. 2016. Available at: https://www.dfps.state.tx.us/Child_Protection/Medical_Services/documents/reports/2016-03_Psychotropic_Medication_Utilization_Parameters_for_Foster_Children.pdf. Accessed 6/29/16.
44. Horn M, Procyshyn RM, et al. Prescribing second-generation antipsychotic medications: Practice guidelines for general practitioners. BC Medical Journal. 2012;54(2):75-82.
45. Fernandez JR, Redden D, et al. Waist Circumference Percentiles in Nationally Representative Samples of African-American, European-American, and Mexican-American Children and Adolescents. Journal of Pediatrics. 2004;145:439-444.
46. DHHS. A Healthier You. 2005. Available at https://www.cdc.gov/healthyweight/assessing/. Accessed 12/1/16.
47. A Pocket Guide to Blood Pressure Measurement in Children. NIH. National Heart Lung and Blood Institute. Available at: https://www.nhlbi.nih.gov/files/docs/bp_child_pocket.pdf. Accessed 6/29/16.
48. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatrica Scandinavica 1970;212(Suppl 44):11-19.
49. Standards of Medical Care in Diabetes-2016: Summary of Revisions. American Diabetes Association. Diabetes Care. 2016; 39(suppl):S1-S106.
50. Standards of Medical Care in Diabetes-2015 Abridged for Primary Care Providers. American Diabetes Association Position Statement. Avaliable at: http://campuslifeservices.ucsf.edu/upload/ahi/files/ADA_Standards_of_Medical_Care_in_Diabetes_2015.pdf. Accessed 6/29/16.
51. Kurtoglu S, Mazicioglu M, et al. Insulin-Resistance in Obese Children and Adolescents: HOMA-IR Cut-Off Levels in the Prepubertal and Pubertal Periods. Journal of Clinical Research in Pediatric Endocrinology. 2010;2(3):100-106.
52. Pediatric Test Reference Values. Mayo Clinic Medical Laboratories. Available at: http://www.mayomedicallaboratories.com/test-info/pediatric/refvalues/reference.php. Accessed 6/29/16.
53. Eren E, Yapici S, et al. Clinical Course of Hyperprolactinemia in Children and Adolescents: A Review of 21 Cases. Journal of Clinical Research of Pediatric Endocrinology. 2011;3(2):65-69.
54. LiverTox. Clinical and Research Information on Drug-Induced Liver Injury. Available at: http://livertox.nih.gov/index.html. Accessed 6/29/16.
55. Daniels SR, Greer FR, et al. Lipid Screening and Cardiovascular Health in Childhood, Pediatrics. 2008;122:198-208.
56. Wolraich M, Brown L, et al. ADHD: Clinical Practice Guidelines for the Diagnosis, Evaluation, and Treatment of ADHD in Children and Adolescents. Pediatrics. 2011;105(5):128-144.
57. Rosato NS, Correll CU, et al. Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management. Pediatrics. 2012;129(6):e1577-e1589. Accessed 6/29/16.
58. Birmaher B, Brent D, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Depressive Disorders. Journal of the American Academy of Child & Adolescent Psychiatry. 2007;46(11):1503-1526.
59. Cohen JA, Bukstein O, et al. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Posttraumatic Stress Disorder. Journal of the American Academy of Child & Adolescent Psychiatry. 2010;49(4):414-430.
60. Szymanski L, King BH, et al. Practice Parameter for the Assessment and Treatment of Children, Adolescents, and Adults with Mental Retardation and Comorbid Mental Disorders. Journal of the American Academy of Child & Adolescent Psychiatry. 1999;38(12):s5-s31. (currently being updated)
61. Aripiprazole. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; September 2015. Accessed 6/29/16.
62. Asenapine. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; April 2015. Accessed 6/29/16.
63. Brexpiprazole. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; October 2015. Accessed 6/29/16.
64. Cariprazine. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; December 2015. Accessed 6/29/16.
65. Clozapine. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; October 2015. Accessed 6/29/16.
66. Iloperidone. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; May 2014. Accessed 6/29/16.
67. Lurasidone. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; December 2014. Accessed 6/29/16.
68. Olanzapine. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; April 2016. Accessed 6/29/16.
69. Paliperidone. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; July 2015. Accessed 6/29/16.
70. Quetiapine. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; May 2016. Accessed 6/29/16.
71. Risperidone. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; May 2016. Accessed 6/29/16.
72. Ziprasidone. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; April 2015. Accessed 6/29/16.
73. National Institute of Mental Health. Life Chart Method (NIMH-LCMTM). Available at http://www.cqaimh.org/pdf/tool_edu_moodchart.pdf. Accessed 6/29/16.
74. Clozapine REMS Fact Sheet. Available at https://www.clozapinerems.com/CpmgClozapineUI/rems/pdf/resources/Clozapine_REMS_Fact_Sheet.pdf. Accessed 6/29/16.
Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
Additional ResourcesFor Clinicians:1. AACAP Practice Parameters (various mental health disorders)
http://www.aacap.org/aacap/resources_for_primary_care/practice_parameters_and_resource_centers/practice_parameters.aspx
2. AHRQ Comparative Effectiveness Review: First and Second Generation Antipsychotics in Children and Young Adults (draft) https://effectivehealthcare.ahrq.gov/ehc/products/615/2244/antipsychotics-children-update-draft-re-port-160606.pdf
3. AACAP Tip Sheet: Improving Communication Between Clinician and Youthhttps://www.aacap.org/App_Themes/AACAP/docs/youth_resources/misc/Youth_Voice_Tip_Sheet_2012.pdf
4. HEDIS measures: Safe and Judicious Antipsychotic Use in Children and Adolescentshttp://www.ahrq.gov/sites/default/files/wysiwyg/policymakers/chipra/factsheets/chipra_1415-p011-1-ef.pdf
5. Clozapine REMS program: www.clozapinerems.com6. Find a Provider: Directory of Behavioral Health providers by city (SoonerCare Provider Directory)
http://www.okhca.org/individuals.aspx?id=5187. AHRQ: The Academy -- Integrating Behavioral Health and Primary Care
https://integrationacademy.ahrq.gov/playbook/about-playbook?utm_source=AHRQ&utm_medium=D-PILS&utm_term=&utm_content=3&utm_campaign=AHRQ_IAPB_2016
CME Credits Available:1. AAFP: Common Questions About Oppositional Defiant Disorder (expires 5-2-17, physicians),
available at: http://www.aafp.org/afp/2016/0401/p586.html. 2. Medscape: Do Antidepressants Really Work in Children (expires 7-15-17, physicians, nurses),
avaliable at: http://www.medscape.org/viewarticle/865395.3. Medscape: WHO Releases Report on Cost Benefits of Mental Health (expires 5-5-17, physicians, nurs-
es),available at: http://www.medscape.org/viewarticle/862452.
4. Medscape: Patient Requests for Specific Care (expires 6-21-17, physicians), http://www.medscape.org/viewarticle/865078.
5. AAFP: Primary Care Education Series 2016: Mental Health (expires 8-6-17, physicians),available at: https://nf.aafp.org/Cme/CmeCenter/Details?session=affc933a-05be-4f1f-a247-a1b9d-c97e5ee
6. AAFP: Primary Care Grand Rounds CME Series for St. Luke’s: Behavioral Health (expires 9-7-17, phy-sicians),available at: https://nf.aafp.org/Cme/CmeCenter/Details?session=ee19f008-5d6b-4706-9e8d-3ade-7a2e2768.
7. AACAP: Weight Gain and Metabolic Consequences of Ripseridone in Young Children with Autism Spectrum Disorder (expires 4-30-17, physicians), available at: http://www.jaacap.com/cme/home.
8. AACAP: Age of Onset, Duration, & Type of Medication Therapy for ADHD & Substance Use During Adolescence (expires 5-31-17, physicians), available at: http://www.jaacap.com/cme/home.
For Patients and Caregivers:1. National Alliance on Mental Illness: www.nami.org2. Austism Speaks: www.autismspeaks.org3. National Suicide Prevention Lifeline: www.suicidepreventionlifeline.org (1-800-779-0402)4. DBSA Wellness Tracker: Mental Health Wellness Tracker App (DBSA-Depression and Bipolar Support
Alliance): http://www.facingus.org/tour/tracker. (requires individual login)
5. Child Mind Institute: Parents Guide to Getting Good Care: http://childmind.org/guide/parents-guide-getting-good-care/how-do-i-know-if-im-getting-good-treatment/ (requires individual login)
6. AACAP: Psychiatric Medication: http://www.aacap.org/AACAP/Families_and_Youth/Resources/Psychi-atric_Medication/Home.aspx
7. AHRQ: Antipsychotic Medications for Children and Teens: A Review of the Research for Parents and Caregivers (draft)http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=display-product&productID=1146
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The content appearing in this educational material, prepared by the Oklahoma HealthCare Authority (OHCA), University of Oklahoma, College of Pharmacy, and Pharmacy Management Consultants is intended to provide helpful clinical information for the health professional community. It is made available with the understanding that individual clinicians will make their own choices with respect to individual patient care. The content should not be considered complete, and does not cover all diseases, ailments, physical conditions or their treatment. It should not be used in place of clinical judgement by individual providers.
Any information about drugs contained within the content is general in nature, and does not cover all possible uses, actions, precautions, side effects, or interactions of the medicines mentioned. The content is not intended as medical advice for individual patients or for making an evaluation as to the risks and benefits of taking a particular drug.
The OHCA, University of Oklahoma, College of Pharmacy, and Pharmacy Management Consultants, and the author of the content specifically disclaim all responsibility for any liability, loss, or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any of the content in this material.*adapted from: Drugs.com
The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, religion, disability, political beliefs, or status as a veteran in any of its policies, practices or procedures. This includes, but is not limited to: admissions, employment, financial aid and educational services. Inquiries regarding non-discrimination policies may be directed to: Bobby J. Mason, University Equal Opportunity Officer and Title IX Coordinator, (405) 325-3546, [email protected], or visit www.ou.edu/eoo.
This publication, printed by Pharmacy Management Consultants is issued by the University of Oklahoma. 150 copies have been prepared and distributed at no cost to the taxpayers of the State of Oklahoma.
Psychiatric Consultation ProgramWhen residents in rural Oklahoma require behavioral health care, they typically turn to their primary care providers (PCPs). SoonerCare provides these PCPs with access to free, informal telephonic consultations with board-certified psychiatrists. These professionals offer advice on psychotropic medication management issues for children, adolescents and adults.
The SoonerCare Psychiatric Consultation Program is also available to judges, Department of Human Services (DHS) and Oklahoma Juvenile Affairs (OJA) supervisors.
For more information, please visit www.okhca.org/BH
How it worksThe SoonerCare-contracted PCP contacts the OHCA Behavioral Health Unit at (405) 522-7597 to schedule a time to review the case.
We will schedule an appointment for you with an OHCA psychiatrist.
Appointments are available during business hours.OHCA board-certified psychiatrists:Brent Bell, D.O.John Raizen, M.D.
Psychiatric Consultation Hotline: (405) 522-7597
Referrals for behavioral health services: (800) 652-2010
Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
HEDIS 2015: Safe and judicious SGA use in children and adolescents
Decrease:• Use of antipsychotic medications in very young
children• Use of higher-than-recommended doses of
antipsychotics in children and adolescents• Use of multiple, concurrent antipsychotics in children
and adolescents
Increase:• Use of first-line psychosocial care for children and
adolescents on antipsychotics• Followup visit for children and adolescents on
antipsychotics• Metabolic screening for children and adolescents
newly on antipsychotics• Metabolic monitoring for children and adolescents on
antipsychotics
AADRs reduced
• Before starting: movement disorders, metabolic parameters
• Every four weeks for 3 months: BMI, BP, waist
• Every six months: AST, ALT
• Every three months: BMI, movement, glucose, insulin, A1C, lipids
• Every 12 months: prolactin• Additional monitoring: clozapine,
quetiapine, ziprasidone
• Diabetes• Hyperlipidemia• Seizure disorders
• Cardiac abnormalities• Previous response and ADRs
associated with SGAs
Develop a multi-disciplinary plan: • Follow treatment guidelines and current evidence• Continued psychosocial care• Continued screening for ADRs -- lower dose or change agent if ADRs present• Assess efficacy, at least every 90 days (4-6 weeks after dose/agent change)• Gradually discontinue/replace ineffective agents rather than adding second agent• Avoid abrupt discontinuation of SGAs except in cases of severe ADR• Plan treatment duration before treatment initiation, use short term
• Use psychosocial interventions as first-line treatment
• Avoid SGAs for age 4 and under• Avoid use of multiple SGAs• Avoid SGA use with other psychotropics
• Use low dosing for short duration• Use SGAs with appropriate diagnosis• Reduce SGA dose if ADRs occur, except
NMS (discontinue)
Clinical history evaluation for patient and family:
AACAP 2011: SGA use in children and adolescents
BBody and blood
monitoring
CClinical History
DDevelop a plan
Body size and movement, blood parameters - monitor initially and routinely:
ADR risk reduction:
References: 4, 41
Summary:
32 Pharmacy Management Consultants (managed by OU College of Pharmacy) – Rev. 4/2016
