Off-Label Drug Use in Pediatrics Assignment
Pediatrics
Prescription of medication to children is an area that should be approached systematically due to the diverse factors affecting this demographic. The aim of off label drug use for children is to attain maximum benefit for the patient in the challenges that he or she is facing. This is a decision based on professional judgment, and decision-making should be guided by the presentation of the patient and evidence supporting the use and efficacy of the drugs in helping this particular individual (Pratico et al., 2017). One way that the use of off-label drugs can be made safer includes considering the risk and benefit ratio of medication, and disclosing such information. For instance, in the case there is an option to begin the use of Zoloft, an SSRI, in a child that is suffering from depression. In a trial that evaluated the efficacy of Zoloft in comparison to a placebo, the findings showed that after 12 weeks 55 percent of children in the study group improved in comparison to 24 percent that received the placebo (Cardy et al., 2017). Furthermore, side effects have been associated with the drug that include drowsiness, fatigue, insomnia, nausea, and dizziness. Children have also been reported to experience changes in their mental state.
Therefore, in the case presentation the first approach will be to attempt a non-pharmaceutical intervention such as cognitive behavioral therapy, which has been found to be effective in children that have depression (Yang et al., 2017). The judgment and insight of the patient are appropriate and there is no suicide ideation. Hence, CBT will help identify the source of the problem and aid in the introduction of the appropriate behavioral interventions for positive outcomes in the child.
References
Cardy, R., Dhaliwal, S., & Reddy, P. S. (2017). Antidepressant drug treatment in Child and
adolescent Psychiatry. Madridge J Intern Emerg Med, 1(1), 31-39.
Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles,
CA: Western Psychological Services
Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Leonardi,
(2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207.
Yang, L., Zhou, X., Zhou, C., Zhang, Y., Pu, J., Liu, L., … & Xie, P. (2017). Efficacy and
acceptability of cognitive behavioral therapy for depression in children: A systematic review and meta-analysis. Academic pediatrics, 17(1), 9-16.
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.
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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.
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
To submit your completed Assignment for review and grading, do the following:
Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)” as the name.
Click the Week 11 Assignment Rubric to review the Grading Criteria for the Assignment.
Click the Week 11 Assignment link. You will also be able to “View Rubric” for grading criteria from this area.
Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)” and click Open.
If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
Click on the Submit button to complete your submission.
NURS_6521_Week11_Assignment_Rubric
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Excellent
Good
Fair
Poor
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Points Range: 36 (36%) – 40 (40%)
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.
Points Range: 32 (32%) – 35 (35%)
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.
Points Range: 28 (28%) – 31 (31%)
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.
Points Range: 0 (0%) – 27 (27%)
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.
Explain 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.
Points Range: 41 (41%) – 45 (45%)
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.
Points Range: 36 (36%) – 40 (40%)
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.
Points Range: 32 (32%) – 35 (35%)
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.
Points Range: 0 (0%) – 31 (31%)
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.
Written 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.
Points Range: 5 (5%) – 5 (5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity.
Points Range: 4 (4%) – 4 (4%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.
Points Range: 3.5 (3.5%) – 3.5 (3.5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.
Points Range: 0 (0%) – 3 (3%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time.
Written Expression and Formatting – English writing standards:
Correct grammar, mechanics, and proper punctuation
Points Range: 5 (5%) – 5 (5%)
Uses correct grammar, spelling, and punctuation with no errors
Points Range: 4 (4%) – 4 (4%)
Contains a few (1–2) grammar, spelling, and punctuation errors
Points Range: 3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) grammar, spelling, and punctuation errors
Points Range: 0 (0%) – 3 (3%)
Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding
Written 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.
Points Range: 5 (5%) – 5 (5%)
Uses correct APA format with no errors
Points Range: 4 (4%) – 4 (4%)
Contains a few (1–2) APA format errors
Points Range: 3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) APA format errors
Points Range: 0 (0%) – 3 (3%)
Contains many (≥ 5) APA format errors
Total Points: 100
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