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.  

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( option drugs below)

· 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 Disorder

BACKGROUND INFORMATION

The client is an 8-year-old African American male who arrives 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·  Mother reports that teacher said child is withdrawn from peers in class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

§ Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.

Treatment options

1)Zoloft 25 mg orally daily, 2) Paxil 25 mg orally daily, 3) Wellbutrin 75 mg orally BID 

Resources for reference ( 3 + references)

Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’s pharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.

· Chapter 8, “Drug Therapy in Pediatric Patients” (pp. 65—67)

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: Author.