NURS 6521 WEEK 11 Assignment: Off-Label Drug Use in Pediatrics Discussion Paper

 NURS 6521 WEEK 11 Assignment: Off-Label Drug Use in Pediatrics Discussion Paper

 NURS 6521 WEEK 11 Assignment: Off-Label Drug Use in Pediatrics Discussion Paper

 Off-Label Drug Use in Paediatrics

            The use of off-label drugs among pediatric patients has increased over the years mainly because of limited clinical trials and research among this population to determine the safety and effectiveness in the management of certain conditions such as mental disorders (Yackey et al., 2019). The purpose of this discussion is to illustrate the off-label use of psychotropic agents for pediatric patients with mood disorders.

Circumstances to Consider

Physicians normally consider several factors such as the lack of standard, safe, and effective licensed therapeutic options for the management of certain conditions, before prescribing off-label medications to children and adolescents (Egberts et al., 2022). Consequently, the process of approval of certain drugs may take a lot of time, and effect, despite proven effectiveness in the management of certain conditions, such as the use of fluoxetine for depression.

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Off-Label Drug Safety among Pediatrics

            Official dosing guidelines for most drugs used among children are missing, putting the child at high risk of potential harm with the use of such drugs. However, through evidence-based practice, several pragmatic methods like Fried’s Rule, Webster’s Rule, and Clark’s rule have been proposed, as a result of their great success in arriving at the optimal dose while preventing harm to the pediatric patient (Belayneh et al., 2020).

Drugs to Handle with Extra Care

            The U.S. Food and Drug Administration has provided a list of several pharmacological agents that should be handled with extra care among pediatrics due to their increased risk of suicidal ideation among other adverse effects (Egberts et al., 2022). Such drugs include Seroquel, Zyprexa, Risperdal, and coumadin among others.

Conclusion

The use of off-label drugs among pediatric patients is common and potentially harmful. . This has largely been associated with a lack of adequate clinical trial and research to support their effectiveness and safety among this vulnerable population. Caution should however be taken when prescribing and dosing these medications to avoid adverse effects.

References

Belayneh, A., Tadese, E., & Molla, F. (2020). Safety and biopharmaceutical challenges of excipients in off-label pediatric formulations. International Journal of General Medicine, 13, 1051. DOI: 10.2147/IJGM.S280330

Egberts, K. M., Gerlach, M., Correll, C. U., Plener, P. L., Malzahn, U., Heuschmann, P., … & Romanos, M. (2022). Serious adverse drug reactions in children and adolescents treated on and off-label with antidepressants and antipsychotics in clinical practice. Pharmacopsychiatry. DOI: 10.1055/a-1716-1856

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital Pediatrics, 9(3), 186-193. https://doi.org/10.1542/hpeds.2018-0168

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NURS-6521 WEEK 11 Assignment: Off-Label Drug Use in Pediatrics DUE ON 5/13/22
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.
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.

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

Name: NURS_6521_Week11_Assignment_Rubric