NURS_6521 Off-Label Drug Use in Pediatrics Essay

NURS_6521 Off-Label Drug Use in Pediatrics Essay

NURS_6521 Off-Label Drug Use in Pediatrics Essay

Off-Label Drug Use in Pediatrics Sample Essay

The use of off-label medications is a common practice in pediatric patients. The practice is associated with increased risk of harm to the patients because of inadequate evidence-based data on their use. Therefore, this paper examines circumstances that may lead to off-label prescribing to pediatric patients and safety strategies to be considered.

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There are circumstances under which children should be prescribed off-label medications. One of them is a situation where the healthcare providers are managing unapproved disorder that does not have approved medications. In such cases, physicians prescribe medications that have proven effective among the adult populations for a similar disorder at a lower dose. The other circumstance is when the healthcare practitioners have in-depth understanding of the pediatric patients’ disease process and the effectiveness of off-label drugs. They prescribe off-label medications to benefit the patients while utilizing their professional judgment to improve the care outcomes in pediatric patients (van der Zanden et al., 2021). For example, physicians prescribe ketamine for pediatric patients admitted to the intensive care unit despite it not being a FDA-approved drug of choice for this population.

Healthcare practitioners should consider several strategies to ensure that off-label drugs are safe for children from infancy to adolescence. One of the strategies is by relying on the existing evidence when prescribing the off-label medications. Practitioners should critique the evidence obtained from high-quality studies and use them to inform their prescription decisions when treating pediatric patients. The other strategy is by considering ethics of practice. The decisions to treat pediatrics with off-label drugs should be informed by the principles of ensuring safety, justice, and quality outcomes for the patients (García-López et al., 2020; Hoekstra & Dietrich, 2022).

The other strategy is considering the influence of patient factors such as age on the pharmacological processes of the drugs prescribed to pediatric patients. The pharmacodynamic and pharmacotherapeutic processes in adult differ from that seen in pediatric patients. Therefore, practitioners should make decisions such as lowering the dosage and frequency of off-label medications as compared to adult doses to ensure safety and quality outcomes (Hoon et al., 2019). Some of the off-label drugs that should be prescribed with care for pediatric patients include hydromorphone, ketamine, and dexmedetomidine, which can be fatal is poorly used.

            In conclusion, off-label medications are largely used in pediatric patients. The use is attributable to the lack of adequate data on the efficacy of different treatments for pediatric conditions. Practitioners should consider strategies for ensuring safety in the prescription of off-label medications. In addition, they should make their treatment decisions based on evidence-based data and guidelines.

References

García-López, I., Cuervas-Mons Vendrell, M., Martín Romero, I., de Noriega, I., Benedí González, J., & Martino-Alba, R. (2020). Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study. Journal of Pain and Symptom Management, 60(5), 923–932. https://doi.org/10.1016/j.jpainsymman.2020.06.014

Hoekstra, P. J., & Dietrich, A. (2022). First do no harm: Use off-label antipsychotic medication in children and adolescents with great caution. European Child & Adolescent Psychiatry, 31(1), 1–3. https://doi.org/10.1007/s00787-022-01950-7

Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Strom, B. L., & Horton, D. B. (2019). Trends in Off-Label Drug Use in Ambulatory Settings: 2006–2015. Pediatrics, 144(4), e20190896. https://doi.org/10.1542/peds.2019-0896

van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., de Hoog, M., & de Wildt, S. N. (2021). Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework. Clinical Pharmacology & Therapeutics, 110(4), 952–965. https://doi.org/10.1002/cpt.2336

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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.

RESOURCES

Be sure to review the Learning Resources before completing this activity.

Click the weekly resources link to access the resources.

WEEKLY RESOURCES

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 College 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

Links to an external site.

). All papers submitted must use this formatting.

SUBMISSION INFORMATION
Before submitting your final assignment, you can check your draft for authenticity. To check your draft, access the Turnitin Drafts from the Start Here area.

To submit your completed assignment, save your Assignment as WK11Assgn_LastName_Firstinitial
Then, click on Start Assignment near the top of the page.
Next, click on Upload File and select Submit Assignment for review.

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Rubric

NURS_6521_Week11_Assignment_Rubric

NURS_6521_Week11_Assignment_Rubric

CriteriaRatingsPtsThis criterion is linked to a Learning Outcome

Explain 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 Outcome

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.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 ptsThis criterion is linked to a Learning Outcome

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.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 Outcome

Written Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation5 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 Outcome

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.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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