Off-Label Drug Use in Pediatrics Essay Assignment

Off-Label Drug Use in Pediatrics Essay Assignment

Off-Label Drug Use in Pediatrics Essay Assignment

Off-label use refers to prescribing a drug that is not within the terms of the product license with regard to indication, dose, route of administration, or age. Children should be prescribed drugs for off-label use only in the circumstance that there is substantial evidence from well-controlled research studies supporting the drug’s efficacy in treating a particular condition in the pediatric population (Mei et al., 2017). In addition, children should be prescribed drugs for off-label use if the indicated drugs are ineffective in treating a condition. Besides, the benefits of the drug should outweigh the potential risks. Therefore, informed consent must be obtained from the child’s parent/caregiver. The clinician should explain to the caregiver the potential benefits and risks of the drug and alternative options to off-label use (Corny et al., 2015).

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Off-label use and dosage of drugs can be safer for pediatric populations by making clinical decisions guided by the best available evidence. Besides, clinicians should prioritize the individual patient’s well-being when making clinical decisions. Clinicians should also apply their professional knowledge and judgment in determining the utilization of a drug in children (Panther et al., 2017). In situations of off-label drug use, clinicians can play a significant role in promoting the safety of the practice by publishing their experience with the drugs they prescribed for off-label use. Furthermore, drug use studies in pediatrics should be continuously conducted to establish drug use patterns in children and suggest modifications wherever needed.

Off-label drugs that need caution and attention when prescribed in children include those targeting the cardiovascular and neurological systems and sedatives. The drugs have the risk of cardiopulmonary and neurologic instability if given in low or high doses (Allen et al., 2018). The drugs include Dopamine, Milrinone, Amlodipine, Lisinopril, lorazepam, ketamine, dexmedetomidine, fentanyl, methadone, hydromorphone, and oxycodone.

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & DeLeon, S. (2018). Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783.

Corny, J., Lebel, D., Bailey, B., & Bussieres, J. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316–328.

Mei, M. E. I., Li-bo, W. A. N. G., En-mei, L. I. U., Zhi-ping, L. I., Zhuo-yao, G. U. O., Xiao-bo, Z. H. A. N. G., & Hong, X. U. (2017). Current practice, management and awareness of pediatric off-label drug use in China-A questionnaire based cross-sectional survey. Chinese Journal of Evidence-Based Pediatrics, 12(4), 289. https://doi.org/10.1186/s12887-019-1664-7

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. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423-429. doi:10.5863/1551-6776-22.6.423

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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.

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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

Learning Resources

Required Readings (click to expand/reduce)

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.
• Chapter 9, “Drug Therapy in Pediatric Patients” (pp. 58—60)

Corny, J., Lebel, D., Bailey, B., & Bussieres, J. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316–328. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557722/

This article highlights pediatric governmental initiatives to prevent unlicensed and off-label drug use in children. Review these initiatives and guidelines and how they might impact your practice as an advanced practice nurse.

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. 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.

Document: Final Exam Study Guide (PDF)

RUBRIC:

Required Media (click to expand/reduce)

Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.

Excellent Good Fair Poor
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. 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. 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. 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. 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. 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. 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. 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. 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. 5 (5%) – 5 (5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity. 4 (4%) – 4 (4%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. 3.5 (3.5%) – 3.5 (3.5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. 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 5 (5%) – 5 (5%)
Uses correct grammar, spelling, and punctuation with no errors 4 (4%) – 4 (4%)
Contains a few (1–2) grammar, spelling, and punctuation errors 3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) grammar, spelling, and punctuation errors 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. 5 (5%) – 5 (5%)
Uses correct APA format with no errors 4 (4%) – 4 (4%)
Contains a few (1–2) APA format errors 3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) APA format errors 0 (0%) – 3 (3%)
Contains many (≥ 5) APA format errors