Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. How do you determine the appropriate use of off-label drugs in pediatrics?

Are there certain drugs that should be avoided with pediatric patients?

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

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 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• Mother reports that teacher said child is withdrawn from peers in class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.

 

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

Decision Point Three

 

Maintain current dose

 

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.

 

 

Write a 2-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.

 

 

 

 

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2^nd 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.