Off-Label Drug Use in Pediatrics * 1 Page – Need in 4 hours, no extension
The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.
When treating children, prescribers often adjust dosages approved for adults to accommodate a childs weight. However, children are not just smaller adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.
Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group.
To Prepare
Review the interactive media piece in this weeks Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
Reflect on situations in which children should be prescribed drugs for off-label use.
Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.
By Day 5 of Week 11
Write a 1-page narrative in APA format that addresses the following:
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
*References attached, please only use these
J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 423www.jppt.org
RESEARCH
JPPT | Clinical Investigation
Off-label Prescribing Trends for ADHD Medications in
Very Young Children
Shannon G. Panther, PharmD; Alice M. Knotts; Tamara Odom-Maryon, PhD; Kenneth Daratha, PhD; Teri Woo, PhD;
and Tracy A. Klein, PhD
OBJECTIVE This study examines off-label medication prescribing use and trends in children on Medicaid
with ADHD with particular focus on the very young (under age 6 years).
METHODS This was an observational cohort study and retrospective analysis of ADHD medication
prescriptions from Oregon Medicaid records (N = 83,190) in 2012. Manufacturer prescribing information was
used to determine off-label designation. Children ages 3 to 18 years at the time of prescription who had
continuous Medicaid enrollment of at least 10 months during the index year of 2012 were included in the
sample frame.
RESULTS Children with ADHD were prescribed off-label medications primarily at the ages of 5 years and
younger. Among children ages 3 to 5 years, 91.4% of prescriptions were off-label. After the age of 5 years,
the percentage of off-label prescriptions dropped notably to 21%, reflecting the increase in availability of
approved medications for the treatment of ADHD starting at age 6 years. In the 3- to 5-year-old age group,
specific off-label and concerning medication-related observations included a high frequency of alpha
agonist (e.g., guanfacine, clonidine) prescribing; the prescribing of untested formulations such as clonidine
patches; prescribing of atomoxetine; and prescribing of large doses of stimulant medications.
CONCLUSIONS Most ADHD drugs prescribed for very young children are off-label, which is concerning
owing to lack of safety and efficacy data in this vulnerable population.
ABBREVIATIONS AAP, American Academy of Pediatrics; ADHD, attention-deficit hyperactivity disorder; FDA,
US Food and Drug Administration; ISMP, Institute for Safe Medication Practices
KEYWORDS attention deficit disorder; drug prescribing; off-label use; preschool child
J Pediatr Pharmacol Ther 2017;22(6):423429
DOI: 10.5863/1551-6776-22.6.423
Introduction
Attention-deficit/hyperactivity disorder (ADHD) is
currently diagnosed in approximately 11% of United
States children ages 4 to 17 years.1 From 2007 to
2011 the number of children ages 2 to 5 years taking
medication to treat ADHD increased by 2-fold.2 Prac-
tices changed significantly within the last decade to
favor pharmacologic treatment in very young children,
despite a consensus in guidelines recommending
non-pharmacologic therapy as the primary treatment
approach. In 2007, a total of 97,583 children ages 2 to
5 years diagnosed with ADHD were identified as being
untreated or treated without medication, while 51,409
children were identified as taking an ADHD medication,
a ratio of approximately 2:1 in favor of not using medica-
tion.2 By contrast, in 2011, there were 103,562 children
2 to 5 years old on medication and 49,839 diagnosed
and not receiving medication, a ratio of approximately
3:1 in favor of taking medication for ADHD.3 Also in
2011, over half of preschool-aged children diagnosed
with ADHD were not receiving behavioral therapy even
though there is significant evidence demonstrating its
effectiveness for the treatment of ADHD symptoms.3
The American Academy of Pediatrics (AAP) guide-
lines recommend behavioral therapy as first-line treat-
ment for preschool-aged 4- to 5-year-old children.4 The
American Academy of Child and Adolescent Psychiatry
recommends behavioral therapy as required adjunctive
therapy in children 3 to 5 years of age.5 If medica-
tion is indicated, methylphenidate is the treatment of
choice for young children.4 Methylphenidate should be
initiated at a small dose and titrated up slowly. Since
ADHD is a condition that often manifests most promi-
nently in the young, it is recommended that children
be frequently monitored when initiating therapy and be
evaluated at least twice a year once maintained. For
young children who are not successfully maintained
on methylphenidate, treatment alternatives used in
practice include other stimulants, the alpha agonists,
and atomoxetine.
Background
Prescribing for Children on Medicaid. Medicaid
claims data have been used to examine prescribing
424 J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 www.jppt.org
patterns for children with ADHD in multiple studies.68
Oregon Medicaid, unlike other state programs, funds
mental health medications as a carve-out, which allows
for individualized prescribing. The Oregon Medicaid
formulary system uses a preferred drug list for ADHD
medications but does not require prior authorization
for non-preferred mental health medications.9 Both on-
label and off-label prescribing patterns among Oregon
nurse practitioner prescribers and physicians (the most
prevalent type of prescribers for children on Medicaid)
are similar for the treatment of ADHD,10 and their ability
to prescribe controlled substances is similar on a state
level in scope and breadth.10
Off-label Prescribing in Children. Off-label prescrib-
ing is described by the US Food and Drug Administra-
tion (FDA) as the unapproved use of an approved drug
[] for a disease or a medical condition.11 When a new
medication is approved, the FDA-approved labeling
is based on the indication and age group treated dur-
ing clinical trials conducted for the approval process.
The labeling cannot contain suggestions for use in an
unstudied population because of lack of supporting
clinical evidence.12 In 2014, the AAP issued a policy
statement regarding the off-label use of medications
in children. It recommended prescribing decisions be
made on the basis of product labeling, clinical evidence,
expert judgment, and published literature. AAP further
stated that off-label prescribing is considered reason-
able if based on sound clinical evidence.13
Purpose. The purpose of this study was to examine
current trends of off-label prescribing practices for
children diagnosed with ADHD, with a particular focus
on very young children under 6 years of age.
Methods
This observational cohort study was deemed exempt
by the institutional review boards at Washington State
University and Pacific Lutheran University. The Oregon
Health Authority provided de-identified Medicaid en-
counter and pharmacy claims data. The period covered
by this study included records with prescribing dates
of service from January 1, 2012, to December 31, 2012.
The sample was restricted to children ages 3 to 18
years with a provider diagnosis of ADHD within the prior
730 days, and continuous Medicaid eligibility, defined
as at least 10 of 12 months in a given year. Diagnosis of
ADHD was broadly defined by using ICD-9 diagnosis
codes (314.0, 314.00, 314.01, 314.1, 314.2, 314.8, 314.9,
V62.3, 313.83). All prescription drug event records (i.e.,
pharmacy claims) with prescribing dates of service
from January 1, 2012, to December 31, 2012, were
requested. The Oregon Health Authority stores pre-
scription records by the year of the date of fill. To obtain
all prescription drug events written in 2012, pharmacy
claims records from 2012 and 2013 were requested,
allowing for capture of prescriptions written in 2012
and filled in 2013. Data about prescriptions that were
written, but not filled, were not available. Prescriptions
for non-ADHD medications were excluded.
Classification of a prescription national drug code
as an ADHD medication was based on the Healthcare
Effectiveness Data and Information Set 2013 mea-
sure for follow-up care for children prescribed ADHD
medication. ADHD medications examined included
methylphenidate, amphetamine-dextroamphetamine
mixed salts and dextroamphetamine as a combined
category, lisdexamfetamine, dexmethylphenidate
(controlled substances) and guanfacine, clonidine, and
atomoxetine (non-controlled substances). On-label and
off-label indications were determined by researcher
review of the FDA-approved manufacturer prescribing
information (Table 1).
Records available for analysis were age of the child
at the time the prescription was filled, sex, date the
prescription was written, date filled, the 11-digit National
Drug Code for the medication prescribed, supply pre-
scribed, formulation (immediate or extended release),
and the prescribing providers national provider identi-
fier taxonomies. Records were analyzed on the basis
of a 30-day supply (2831 days) being dispensed. The
unit of analysis used was the number of 30-day supply
prescriptions. A 30-day supply represents the minimum
amount for which a typical prescriber would initiate or
refill a prescription. Use of this unit of analysis allowed
for inclusion of all prescriptions written for varying num-
ber of days supply. For example, a prescription written
for a 90-day supply was counted as three 30-day supply
prescriptions. A full description of study methods has
been published previously.10
Statistical Analysis. Descriptive statistics, including
the mean, standard deviation, frequency, and percent-
age, were used to characterize all children, the subset
of children receiving at least 1 off-label prescription,
and the subset of children receiving at least 1 on-label
prescription. Frequency of off-label and on-label pre-
scription use was stratified by the age of the child at
the time the prescription was written (3 to 5; 6 to 11;
and 12 to 18 years) and by sex. Off-label prescription
use by provider type (nurse practitioner, physician,
and other) and by age group and sex of the child was
examined. We summarized off-label prescribing rates,
using 30-day supply prescriptions characterized by
active ingredient and formulation (7 ADHD medication
categories) and release (immediate or extended). Data
were summarized by using reports from a structured
query language server database.
Statistical analyses comparing off-label to on-label
prescribing by age group, sex, and provider type were
not performed. Non-unique subsets of children among
levels of the comparator groups (e.g., age group) violate
the assumptions of mutually exclusive groups required
for statistical testing of group differences. Our dataset
violated the mutually exclusive comparator group re-
quirement in several ways. For example, a child could
Trends in Off-label Prescribing of ADHD Medications Panther, SG et al
J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 425www.jppt.org
have received both off-label and on-label prescriptions,
resulting in inclusion in more than 1 subset such that
the sum of the number of children in these subsets
exceeded the total number of children. Similarly, a
child could have been counted in more than 1 age
group based on the age of the child at the time the
prescription was written, or a child could have been
prescribed both on-label and off-label medications by
different provider types.
Results
The dataset contained 197,364 prescriptions written
for children ages 3 to 18 years in 2012, of which 108,775
prescriptions were excluded because these prescrip-
tions were for non-ADHD medications, and 3892 pre-
scriptions were excluded owing to the absence of an
encounter claim with a provider within 730 days with an
ADHD diagnosis. As a result, 84,697 eligible prescrip-
tion records were available for analysis. Prescription
records were further reduced to the number of 30-day
supply prescriptions (N = 83,190) among 10,753 unique
children. A total of 721 children were treated by at least
2 providers for a total of 11,448 prescriptions (13.8%).
Prescribers. Prescribers were identified by National
Provider Identification to represent a total of 1799
providers (381 nurse prescribers, 1404 physician pre-
scribers, and 14 other [non-nurse and non-physician]
prescribers). Physicians wrote 67,346 total prescriptions
for ADHD medications and accounted for 80.9% of the
83,190 prescriptions; nurse practitioners wrote 15,408
(18.5%) of the total prescriptions; and other prescribers
wrote 436 (0.6%) of the total prescriptions. Forty-four
percent (n = 791) of the 1799 providers wrote off-label
prescriptions to children 3 to 18 years of age. Rates of
off-label prescribing by age group and sex use were
similar across provider types. In the youngest age group
(ages 3 to 5 years), 13.6% (398/2928) of prescriptions
written by nurse prescribers were classified as off-label,
while 16.2% (1834/11,308) of prescriptions written by
physician prescribers were classified as off-label.
There were no discernable differences in the rate of
off-label prescribing to children, based on the sex of
the child: 17.8% of males received off-label prescriptions
compared to 15.7% of females (Table 2). Of the 83,190
prescriptions written for a 30-day supply, 14,372 (17.3%)
were considered to be off-label. Of all the prescriptions
written for children in the 3- to 5-year-old category,
91.4% (2233/2442) were prescribed off-label (3 years of
age, 87.3%; 4 years of age, 93.8%; and 5 years of age,
Table 1. Comparison of FDA Labeling of Medications for ADHD and Guidelines for Recommended
Pharmacotherapy by Age4,5,1429
ADHD Medication FDA-Approved Age per Labeling* Guideline Recommendations
Generic (Brand) Immediate
Release
Extended
Release
Other Dosage Form AAP (2011)4, AACAP (2009)5,
Atomoxetine (Strattera) 6 yr Alternative
treatment
First line for
specific comorbid
diseases
Clonidine (Catapres,
Kapvay)
No indication 6 yr (tablet) No indication
(patches)
Extended-release
tablet is alternative
treatment
Alternative
treatment
Guanfacine (Tenex,
Intuniv)
No indication 6 yr Extended release
is alternative
treatment
Alternative
treatment
Dextroamphetamine
containing (Adderall,
Dexedrine)
3 yr 6 yr First line, no
recommendation
6 yr
First line
Dexmethylphenidate
(Focalin)
6 yr First line First line
Lisdexamfetamine
(Vyvanse)
6 yr First line First line
Methylphenidate
(Methylin, Concerta)
6 yr 6 yr 6 yr (chewable, oral
solution, patch)
First line,
recommended
4 yr
First line
AACAP, American Academy of Child and Adolescent Psychiatry; AAP, American Academy of Pediatrics; ADHD, attention-deficit/hyperactivity
disorder; FDA, US Food and Drug Administration
* Age at which the manufacturers package insert provides dosing guidance for the medication.
Medication therapy treatment recommendation per national guideline.
Age recommendation 6 yr, unless specified.
Offers no age recommendation.
Trends in Off-label Prescribing of ADHD MedicationsPanther, SG et al
426 J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 www.jppt.org
90.9%). By comparison, rates of off-label prescribing
dropped starting at age 6 years. For children in the
6- to 11-year-old category, 15.6% received off-label
prescriptions for ADHD (7259/46,396). For children in
the 12- to 18-year-old category, 14.2% received off-label
prescriptions for ADHD (4880/34,352).
Medications. The most commonly prescribed off-
label prescriptions for children ages 3 to 5 years were
methylphenidate and alpha agonist formulations (Table
3). Nine hundred sixteen of 2233 off-label prescriptions
(41.0%) were written for formulations of methylpheni-
date (immediate and extended release combined).
Methylphenidate records for 3- to 5-year-old children in
our dataset included 166 prescriptions for doses larger
than 25 mg per day and 13 prescriptions for doses as
large as 54 mg. Clonidine and guanfacine (immediate
and extended release combined) accounted for 42.6%
(952/2233) of the off-label prescriptions written for
the 3- to 5-year-old age group. Clonidine immediate-
release tablets at 97.6% (363/372) were prescribed
more often than the extended-release tablets at 1.2%
(4/372) and patches at 1.2% (5/372).
Prescribing of immediate- and extended-release
guanfacine was similar at 54.1% (314/580) and 45.9%
(266/580), respectively. Clonidine (immediate and ex-
tended release) and guanfacine (immediate release)
prescribing accounted for all off-label prescribing to
children 6 to 11 years of age (n = 7259) and to children
12 to 18 years of age (n = 4880). Not reported in Table
2, 73 of 77 off-label prescriptions (children aged 3 to
18 years) for clonidine extended release were written
for the clonidine patch. Dextroamphetamine-containing
extended-release formulations (n = 180) and atomox-
etine (n = 103) were also frequently prescribed off-label
medications for children ages 3 to 5 years (8.1% and
4.6%, respectively). The 2 other medications for which
off-label prescriptions were written for children ages 3
to 5-years included dexmethylphenidate, both imme-
diate (20/2233) and extended release (20/2233), and
lisdexamfetamine (42/2233).
Discussion
Most medications used to treat ADHD are consid-
ered off-label for children younger than age 6 years.30
Few studies exist concerning the prescribing of ADHD
medications to preschool-aged children; therefore,
current research provides limited evidence to inform
guidelines and FDA labeling. Our discussion adds
beneficial information to the currently available data
by providing insights regarding specific medications
being used off-label in this age group.
Methylphenidate. Methylphenidate is the only
ADHD medication recommended for use in children
as young as 4 years by AAP guidelines.4 Studies have
demonstrated that children ages 4 to 5 years are to
receive a weight-based dose of 0.7 0.4 mg/kg/day of
methylphenidate.31 From this dosing guidance, most
children under the age of 5 years should be receiving
doses smaller than 25 mg per day, and yet our dataset
revealed 166 prescriptions written for methylphenidate
doses larger than 25 mg per day and 13 prescriptions
written for doses as large as 54 mg per day in the 3- to
5-year-old age group. Larger doses of methylpheni-
date are associated with an increased incidence of
sleep disturbances and related issues in children.32
It is uncertain what other adverse medication-related
Table 2. Demographic Characteristics of Children (318 Years) With an ADHD Diagnosis Who Were Prescribed
ADHD Medications by FDA Label Status
ADHD Prescribing
On-label Off-label Total
Total 68,818 (82.7%) 14,372 (17.3%) 83,190
Unique children* 10,151 2628 10,753
Age, mean SD 11.0 3.2 9.6 3.7 10.8 3.3
n (%) n (%) n
Group
35 yr 209 (8.6%) 2233 (91.4%) 2442
611 yr 39,137 (84.4%) 7259 (15.6%) 46,396
1218 yr 29,472 (85.8%) 4880 (14.2%) 34,352
Sex
Male 51,134 (82.2%) 11,083 (17.8%) 62,218
Female 17,676 (84.3%) 3296 (15.7%) 20,972
ADHD, attention-deficit/hyperactivity disorder; FDA, US Food and Drug Administration
* The number of unique children by label status exceeds the total number of unique children given that children were prescribed both on-label
and off-label ADHD medications.
Descriptive statistics for age (years) are based on the minimum age for child within the calendar year.
Trends in Off-label Prescribing of ADHD Medications Panther, SG et al
J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 427www.jppt.org
events are occurring as a result of using large doses of
methylphenidate in children 3 to 5 years old. However,
studies of preschool-aged children have revealed that
30% of the children will experience side effects when
prescribed a stimulant to treat ADHD and 10% will
choose to discontinue the medication.6
Dextroamphetamine. The immediate-release formu-
lations of dextroamphetamine-containing medications
are FDA approved for use in children starting at age 3
years.20,22 However, according to the AAP, the approval
of immediate-release dextroamphetamine was made
during a time of less stringent approval processes, and
therefore the AAP does not recommend dextroam-
phetamine in 3- to 5-year-old children.4 In contrast, the
extended-release formulations of dextroamphetamine-
containing medications are not FDA approved until
the age of 6 years. If used in children younger than 6
years, general dosing recommendations made by the
prescribing information for dextroamphetamine and
amphetamine mixed salts suggest beginning with 2.5
mg/day, which is half of the starting dose for a 6-year-
old child and then titrating up to the desired effect.20,22
In our study, extended-release dextroamphetamine-
containing medications represented 8% (180/2233) of
the overall off-label prescribing in children 3 to 5 years
old and, as with methylphenidate, larger doses (2530
mg) of dextroamphetamine were noted.
Atomoxetine. In our dataset, 103 prescriptions for
atomoxetine were dispensed for children ages 3 to
5 years. The use of atomoxetine prescriptions in very
young children may be concerning owing to limited re-
search demonstrating efficacy in very young children.33
To our knowledge, atomoxetine has not been studied
in children ages 3 to 4 years and only 1 study of 101
children (80% power) has been reported investigating
the effectiveness of atomoxetine in children ages 5 to 6
years. The study concluded atomoxetine was effective
in treating ADHD, compared to placebo, in 5- to 6-year-
old children, but no other studies have been reported
that reproduce or validate this studys findings.34
Also of concern are data suggesting a potentially
higher incidence of adverse events with atomoxetine in
children younger than 6 years. A safety data extrapola-
tion analysis of the atomoxetine study in children ages
5 to 7 years found that 5 year olds are more likely than
older children to experience labile moods from the
medication. Irritability was reported 36.8% of the time
for 5-year-old children versus 3.6% in the 6 to 7 year
olds. Mood disorders such as tearfulness, mood swings,
and emotional disorders were twice as likely in 5 year
olds than in 6 to 7 year olds (less than 3% versus 6.9%,
respectively).33
Alpha Agonists. Alpha agonist medications account-
ed for 42% of the off-label prescriptions for children
ages 3 to 5 years, which was more than those written for
all methylphenidate formulations combined (41%) even
though methylphenidate is the first-line medication rec-
ommended by the AAP guidelines for use in children
starting at age 4 years. The role of alpha agonists as
adjunctive therapy and, in recent studies, monotherapy,
has brought them to the forefront of treatment plans
for ADHD in children.4,35 Extended-release oral for-
mulations of these medications are FDA approved as
monotherapy or adjunct therapy for ADHD in children
Table 3. Off-label Prescribing of ADHD Medications (N = 83,190; 30-Day Supply Scripts)
Category of Off-label Prescribing Dosage Form Scripts by Age (n)
35 yr 611 yr 1218 yr
Atomoxetine N/A 103 0 0
Clonidine IR 363 4716 3436
Clonidine ER 9 49 19
Dexmethylphenidate IR 20 0 0
Dexmethylphenidate ER 20 0 0
Dextroamphetamine ER 180 0 0
Guanfacine IR 314 2494 1425
Guanfacine ER 266 0 0
Lisdexamfetamine N/A 42 0 0
Methylphenidate IR 457 0 0
Methylphenidate ER 459 0 0
Subtotal off-label prescribing 2233 7259 4880
All ADHD scripts written 2442 46,396 34,352
Percentage off-label prescribing 91.4% 15.6% 14.2%
ADHD, attention-deficit/hyperactivity disorder; ER, extended release; IR, immediate release; N/A, not applicable.
Trends in Off-label Prescribing of ADHD MedicationsPanther, SG et al
428 J Pediatr Pharmacol Ther 2017 Vol. 22 No. 6 www.jppt.org
6 years and older and are routinely used as a treatment
for ADHD.4,35 In this study, immediate-release formula-
tions of clonidine and guanfacine were prescribed more
often for preschoolers than the extended-release forms
(363 and 314 versus 9 and 266, respectively).
The AAP guidelines (2011) note efficacy, but limited
supporting evidence for the extended-release formula-
tion of the alpha agonist medications in children older
than preschool-age, and do not support immediate-
release use for any age group and do not mention the
use of other dosage forms such as the clonidine patch.
The American Academy of Child and Adolescent Psy-
chiatry guidelines (2007) acknowledge the prevalence
of alpha agonist prescriptions for ADHD particularly
when comorbid conditions are involved, but note that
extensive controlled trials are lacking and published
data are variable in methods and outcomes.5 Regard-
less, in practice, the immediate-release alpha agonists
are often used to help counteract the side effects of
stimulant medications such as sleep disturbances.36
And, while not the focus of this research, the potential
for coprescribing of an alpha agonist with a stimulant
medication was observed and noted as occurring at
22.9% of the time for all children and 26.9% of the time
in children ages 3 to 5 years. The impact of continued
or long-term use of this medication class, originally
developed as antihypertensive medications, not for
psychiatric use, is unknown and unstudied in the pe-
diatric population.
Other Observations. One final concern observed
was the use of Institute for Safe Medication Prac-
tices (ISMP) Do Not Crush medications. Three of
the highlighted medications, atomoxetine and each
of the extended-release alpha agonists, are solid oral
dosage forms, which cannot be opened and sprinkled
on food.14,16,19,37 While some very young children can
swallow pills whole, potential administration concerns
exist for those who cannot.
Limitations. Study limitations include the following:
the dataset was processed on the basis of the diagnosis
of ADHD. It is unknown what, if any, comorbid condi-
tions existed in the children analyzed in our dataset.
The use of the alpha agonists was common for children
3 to 5 years old. Medication dosing frequency was not
available in the dataset, and medication regimens were
not connected to an individual patient. Therefore, it is
unknown if the alpha agonists were being coprescribed
to treat side effects of stimulant medications or to treat
comorbid conditions such as Tourettes syndrome.38
Prescriptions written, but not dispensed, were not
included, as these data were not available. This report
includes 1 year of data from a Medicaid population in
1 state and may not be reproducible in other states.
Finally, it is unknown which, if any, children received
cognitive behavioral counseling.
Conclusion
The practice of off-label prescribing is considered
reasonable if based on sound clinical evidence; how-
ever, the current literature, regulatory approvals, and
guidance for the use of ADHD medications in children
ages 3 to 5 years are lacking. Our findings support
prioritization of studying and appropriately relabeling
ADHD medications for pediatric patients, particularly for
the very young, while acknowledging that behavioral
therapy strategies should continue to be first-line and
adjunctive treatment in this age group.
ARTICLE INFORMATION
Affiliations College of Pharmacy (SGP, AMK), Washington
State University, Spokane, Washington, College of Nursing
(KD, TAK, TO), Washington State University, Vancouver and
Spokane, Washington, and School of Nursing (TW), Pacific
Lutheran University, Tacoma, Washington
Correspondence Shannon G. Panther, PharmD;
[emailprotected]
Disclosures The authors declare no conflicts or financial in-
terest in any product or service mentioned in the manuscript,
including grants, equipment, medications, employment, gifts,
and honoraria. The authors had full access to all the data in
the study and take responsibility for the integrity of the data
and the accuracy of the data analysis.
Acknowledgment Information contained in this manuscript
was previously presented as a symposium presentation titled
Examining Patterns in Prescribing ADHD Medications at the
Western Institute of Nursing Meeting; April 2016; Anaheim,
California.
Copyright Published by the Pediatric Pharmacy Advocacy
Group. All rights reserved.
For permissions, email: [emailprotected]
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