NURS 6521: Week 11 Assignment

Assignment: Off-Label Drug Use in Pediatrics
● 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.

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● Photo Credit: Getty Images
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 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.

Learning Resources

Required Readings (click to expand/reduce)
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced
practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.
● Chapter 9, “Drug Therapy in Pediatric Patients” (pp. 58—60)
Corny, J., Lebel, D., Bailey, B., & Bussieres, J. (2015). Unlicensed and off-label drug
use in children before and after pediatric governmental initiatives. The Journal of
Pediatric Pharmacology and Therapeutics, 20 (4), 316–328. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557722/

This article highlights pediatric governmental initiatives to prevent unlicensed and off-
label drug use in children. Review these initiatives and guidelines and how they might
impact your practice as an advanced practice nurse.
Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A.
(2017). Off-label prescribing trends for ADHD medications in very young children. The
Journal of Pediatric Pharmacology and Therapeutics, 22 (6), 423–429.
doi:10.5863/1551-6776-22.6.423

This study examines the frequency of off-label prescribing to children and
explores factors that impact off-label prescribing. This study also examines
off-label prescribing to children with ADHD.

Required Media (click to expand/reduce)
Laureate Education (Producer). (2019i). Therapy for pediatric clients with mood
disorders [Interactive media file]. Baltimore, MD: