Off-Label Drug use in Pediatrics Discussion Paper

Off-Label Drug use in Pediatrics Discussion Paper

Case Overview

The patient is a-8 year-old African male who presented to the clinic with complaints of feeling sad, withdrawing from peers, a decrease in appetite, and occasional periods of irritation. These are the symptoms of depression. Upon examination, the child seems sad and admits to thinking about his death more often. The care provider should select one drug Zoloft, Paxil, or Wellbutrin. The essay discusses the circumstances for using the off-label drug in children and describes the strategies for making use of off-label drugs. Off-Label Drug use in Pediatrics Discussion Paper

Off-Label Drugs And Their Indications

Off-label is the use of pharmaceutical drugs for a different purpose than what the FDA approved and not described in its package. A drug label consists of drug components, how it works, research studies that led to its approval, and the side effects it may cause.

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FDA ensures a drug’s safety and efficiency for a specific use (McMahon, A. W., & Dal Pan, G. 2018). The nurses may use the drug at a different dosage for treating another illness. The recommended drugs for treating the patient are antidepressants. They are not FDA-approved because of their effects on children, and there is not enough evidence of their efficiency. The reasons for using off-label drugs in this patient are lack of standard therapy, lack of alternative forms of treatment, and lack of clinical trials in certain age groups (Yackey, et al, 2019). For example, Paxil is a selective serotonin reuptake inhibitor used as an off-label for depression in children.

Strategies To Make The Off-Label Use And Dosage Of Drugs Safer For Children From Infancy To Adolescence

Off-label drugs prescribed for children with unapproved dosages exert the desired therapeutic effect, produce adverse drug reactions, or fail to produce the intended effect. Therefore, there should be an improvement in the development of medicine suitable for treating diseases. The manufacturer should not market a drug whose purpose is unapproved (Vijay, et al, 2018). Off-label drugs are given cautiously with close monitoring for side effects. For example, Paxil is an SSRI effective in treating depression (Anvari, et al, 2020). However, the pediatric dose should be lower with upward titration monitoring for tolerance and adverse effects. Additionally, the patient should be under close monitoring for a suicidal watch.

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.

The interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders:

Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression
African American Child

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. Off-Label Drug use in Pediatrics Discussion Paper

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

Assignment:

Write a 1-page narrative in APA format that addresses the following:

1. Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
2. 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). All papers submitted must use this formatting.

Resources:
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/ Off-Label Drug use in Pediatrics Discussion Paper

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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.

Rubrics:

Rubric Detail

Name: NURS_6521_Week11_Assignment_Rubric

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. Off-Label Drug use in Pediatrics Discussion Paper

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. Off-Label Drug use in Pediatrics Discussion Paper
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
Total Points: Off-Label Drug use in Pediatrics Discussion Paper