The unapproved use of approved drugs, also called off-label use, with children i

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.
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.
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Mother reports that teacher said child is withdrawn from peers in class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
Select what you should do:Begin Zoloft 25 mg orally daily
Begin Paxil 10 mg orally daily
Begin Wellbutrin 75 mg orally BID
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.
For your narrative:
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Explain strategies to making 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. (Be Specific)
NURS_6521_Week11_Assignment_Rubric
NURS_6521_Week11_Assignment_Rubric
CriteriaRatingsPts
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 >35.5 ptsExcellent
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.
35.5 to >31.6 ptsGood
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.
31.6 to >27.6 ptsFair
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.
27.6 to >0 ptsPoor
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 >40.05 ptsExcellent
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.
40.05 to >35.55 ptsGood
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.
35.55 to >31.05 ptsFair
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.
31.05 to >0 ptsPoor
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 >4.45 ptsExcellent
Paragraphs and sentences follow writing standards for flow, continuity, and clarity.
4.45 to >3.95 ptsGood
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.
3.95 to >3.45 ptsFair
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.
3.45 to >0 ptsPoor
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 >4.45 ptsExcellent
Uses correct grammar, spelling, and punctuation with no errors
4.45 to >3.95 ptsGood
Contains a few (1–2) grammar, spelling, and punctuation errors
3.95 to >3.45 ptsFair
Contains several (3–4) grammar, spelling, and punctuation errors
3.45 to >0 ptsPoor
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 >4.45 ptsExcellent
Uses correct APA format with no errors
4.45 to >3.95 ptsGood
Contains a few (1–2) APA format errors
3.95 to >3.45 ptsFair
Contains several (3–4) APA format errors
3.45 to >0 ptsPoor
Contains many (≥ 5) APA format errors
5 pts
Total Points: 100
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