The document discusses the off-label use of drugs in pediatric patients and strategies to improve safety. It notes that off-label use is common in children due to a lack of pediatric drug research. While dosages are often adjusted from adult levels, children process drugs differently throughout development. As a nurse, awareness of safety issues with off-label drugs in children is important. The document provides a case study of an 8-year-old boy with depression and decision points on treating him with antidepressants.

1. PLEASE FOLLOW THE INSTRUCTIONS BELOW:
ZERO (0) PLAGIARISM
5 REFERENCES NO MORE THAN 5 YEARS, OR LESS
PLEASE SEE ATTACHED RUBRIC DETAILS AND FOLLOW
APA FORMAT.
NO RUNNING HEAD, AND PLEASE ADHERE TO THE ONE
(1) PAGE AS INSTRUCTED
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 child’s 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 week’s Resources

2. 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.
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.
Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression
BACKGROUND INFORMATION
The client is an 8-year-old African American male who arrives

3. at the ER with his mother. He is exhibiting signs of depression.
Client complained of feeling “sad”
Mother reports that teacher said child is withdrawn from peers
in class
Mother notes decreased appetite and occasional periods of
irritation
Client reached all developmental landmarks at appropriate ages
Physical exam unremarkable
Laboratory studies WNL
Child referred to psychiatry for evaluation
MENTAL STATUS EXAM
Alert & oriented X 3, speech clear, coherent, goal directed,
spontaneous. Self-reported mood is “sad”. Affect somewhat
blunted, but child smiled appropriately at various points
throughout the clinical interview. He denies visual or auditory
hallucinations. No delusional or paranoid thought processes
noted. Judgment and insight appear to be age-appropriate. He is
not endorsing active suicidal ideation, but does admit that he
often thinks about himself being dead and what it would be like
to be dead.
You administer the Children's Depression Rating Scale,
obtaining a score of 30 (indicating significant depression)
RESOURCES

4. § Poznanski, E., & Mokros, H. (1996). Child Depression Rating
Scale--Revised. Los Angeles, CA: Western Psychological
Services.
ALL THREE MEDICATIONS ARE PROVIDED BELOW AND
DECISION POINTS TO FOLLOW.
Decision Point One
Begin Zoloft 25 mg orally daily
RESULTS OF DECISION POINT ONE
Client returns to clinic in four weeks
No change in depressive symptoms at all
Decision Point Two
Increase dose to 37.5 mg orally daily
RESULTS OF DECISION POINT TWO
Client returns to clinic in four weeks
Depressive symptoms decrease by 20%. Client reports feeling a
little bit better

5. Decision Point Three
Increase to 50 mg orally daily
Guidance to Student
At this point, sufficient symptom reduction has not been
realized. Should either increase dose or consider different SSRI.
At 8 weeks post-initiation of therapy, there should have been a
significant (as defined as 50%) decrease in symptoms. This
would be considered an adequate trial of antidepressant and
change in dose or to a different agent would be appropriate.
Decision Point One
Begin Paxil 10 mg orally daily
RESULTS OF DECISION POINT ONE
Client returns to clinic in four weeks
Reduction in The Children's Depression Rating Scale by 5
points overall, but with complaints of nausea, vomiting, and
diarrhea
Decision Point Two
Change to Prozac 10 mg orally daily
RESULTS OF DECISION POINT TWO

6. Client returns to clinic in four weeks
There is a 25% reduction in symptoms, client’s side effects of
nausea, vomiting, and diarrhea have resolved. Client reports
that he is feeling a “little bit better”
Decision Point Three
Continue current dose
Guidance to Student
You have two equally compelling choices at this point. The
client has only been taking the current drug at its current dose
for 4 weeks. It would be appropriate to continue at current dose.
Additionally, you could also increase the dose to 20 mg orally
daily. A discussion of risk/benefits should be had with the
childs guardian regarding this and collaborative decision
making should occur. There is no indication at this point that
augmentation agents are required as the child is showing a
partial response to therapy.
Decision Point One
Begin Wellbutrin 75 mg orally BID
RESULTS OF DECISION POINT ONE
Client returns to clinic in four weeks

7. Child is unable to fall asleep at night
Decision Point Two
Change to Lexapro 10 mg orally daily
RESULTS OF DECISION POINT TWO
Client returns to clinic in four weeks
Child is tolerating Lexapro, and is sleeping at night. There is a
40% reduction in symptoms
Decision Point Three
Continue current dose
Guidance to Student
At this point, there is no indicating that you should change back
to Wellbutrin as the child is tolerating the current medication
without mention of side effects. Also, the child is experiencing
a reduction in symptoms. You could also increase the dose to 15
mg orally daily, but the child has only been taking the drug for
4 weeks at this point. It may be more prudent to give the current
therapy an additional 4 weeks before making any decisions to
change current dose.