Unapproved use of approved drugs
Unapproved use of approved drugs
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. Unapproved use of approved drugs
To Prepare- Unapproved use of approved drugs
- 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.
Reminder: The School of Nursing requires that all papers submitted include a title page, introduction, summary, and references. The Sample Paper provided at the Walden Writing Center offers an example of those required elements (available at http://writingcenter.waldenu.edu/57.htm). All papers submitted must use this formatting.
Submission and Grading Information- Unapproved use of approved drugs
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Grading Criteria- Unapproved use of approved drugs
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Week 11 Assignment Rubric
Therapy for Pediatric Clients with Mood Disorders- An African American Child Suffering From Depression.
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. Unapproved use of approved drugs
You administer the Children’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)
§ Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.
Decision Point One
Select what you should do:
Begin Zoloft 25 mg orally daily
Begin Paxil 10 mg orally daily
Begin Wellbutrin 75 mg orally BID
Week 11: Pediatrics
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. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?
This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings. Unapproved use of approved drugs
Learning Objectives- Unapproved use of approved drugs
- Evaluate the practice of prescribing off-label drugs to children
- Analyze strategies to make the off-label use of drugs safer for children
- Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders
Learning Resources- Unapproved use of approved drugs
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.
Document: Final Exam Study Guide (PDF)
Required Media (click to expand/reduce)
Laureate Education (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.
This Exam covers the content you have explored throughout this course.
This exam is a test of your knowledge in preparation for your certification exam. No outside resources—including books, notes, websites, or any other type of resource—are to be used to complete this exam. You are not allowed to take screenshots or record the exam questions in any other format while taking the exam. You are expected to comply with Walden University’s Code of Conduct. Unapproved use of approved drugs
Photo Credit: Getty Images
By Day 7 of Week 11
Complete the Final Exam.
Submission and Grading Information
Complete the Exam by Day 7 of Week 11
To Complete this Exam:
Week 11 Exam