OFF-LABEL DRUG USE IN PEDIATRICS
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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.
Be sure to review the Learning Resources before completing this activity.
LEARNING RESOURCES
Required Readings
• Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.
o Chapter 9, “Drug Therapy in Pediatric Patients” (pp. 58—60)
• 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 Links to an external site.. 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
• Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disorders Links to an external site.[Interactive media file]. Baltimore, MD: Author.
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.
Write a 1-page narrative in APA format that addresses the following:
1. Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
2. 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: Essay include a title page, introduction, summary, and references.
Rubric
NURS_6521_Week11_Assignment_Rubric
Criteria Ratings Pts
This criterion is linked to a Learning OutcomeExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. 40 to >35.0 pts
Excellent
The response accurately and thoroughly explains in detail the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate and specific examples that fully support the explanation provided. 35 to >31.0 pts
Good
The response accurately explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate examples that support the explanation provided. 31 to >27.0 pts
Fair
The response inaccurately or vaguely explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes inaccurate or vague examples that may or may not support the explanation provided. 27 to >0 pts
Poor
The response inaccurately and vaguely explains the circumstances under which children should be prescribed drugs for off-label use, or is missing. … The response includes inaccurate and vague examples that do not support the explanation provided, or is missing.
40 pts
This criterion is linked to a Learning OutcomeExplain strategies to making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific. 45 to >40.0 pts
Excellent
The response accurately and clearly describes in detail strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate, complete, and detailed descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 40 to >35.0 pts
Good
The response accurately describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 35 to >31.0 pts
Fair
The response inaccurately or vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes inaccurate or vague descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 31 to >0 pts
Poor
The response inaccurately and vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, or is missing. … The response includes inaccurate and vague or incomplete descriptions and names of off-label drugs that require extra care and attention when used in pediatrics, or is missing.
45 pts
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused–neither long and rambling nor short and lacking substance. 5 to >4.0 pts
Excellent
Paragraphs and sentences follow writing standards for flow, continuity, and clarity. 4 to >3.5 pts
Good
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. 3.5 to >3.0 pts
Fair
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. 3 to >0 pts
Poor
Paragraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time.
5 pts
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation 5 to >4.0 pts
Excellent
Uses correct grammar, spelling, and punctuation with no errors 4 to >3.5 pts
Good
Contains a few (1–2) grammar, spelling, and punctuation errors 3.5 to >3.0 pts
Fair
Contains several (3–4) grammar, spelling, and punctuation errors 3 to >0 pts
Poor
Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding
5 pts
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, running head, parenthetical/in-text citations, and reference list. 5 to >4.0 pts
Excellent
Uses correct APA format with no errors 4 to >3.5 pts
Good
Contains a few (1–2) APA format errors 3.5 to >3.0 pts
Fair
Contains several (3–4) APA format errors 3 to >0 pts
Poor
Contains many (≥ 5) APA format errors
5 pts
Total Points: 100
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