Doctors are Now at Liberty to Administer Off-Label Drugs

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(dot)waldenu(dot)edu/57.htm). All papers submitted must use this formatting.
In the United States, the FDA approves a drug for a certain set of uses after the drug has been put through rigorous studies. Once approved, the FDA and the drug manufacturer create the drug’s “label” which is an information document that details the drug’s specific approved uses. However, researchers may later discover that the drug can be used to treat other conditions. In this case, doctors may legally prescribe a drug to treat a condition not listed on the drug’s label. Thus, “off-label drug use” means to use a drug for a purpose not listed on the drug’s label. Typically, an ethical doctor will only prescribe a drug for off-label purposes when the benefits of use outweigh the risks. Credible medical evidence such as clinical trials and medical literature should also support the doctor’s decision.

Examples of off-label drugs

Drug (Brand name) Common on-label use Common off-label use
bupropion (Wellbutrin) depression bipolar
diphenhydramine (Benadryl) allergy sx, insomnia N/V related to pregnancy
escitalopram (Lexapro) depression, anxiety bipolar
fluoxetine (Prozac) depression, OCD, bipolar autism spectrum disorders
montelukast (Singulair) asthma COPD
quetiapine (Seroquel) schizophrenia, bipolar insomnia


Write a 1+ page paper 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(dot)ncbi(dot)nlm(dot)nih(dot)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.
Required Media (click to expand/reduce)
Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.
Rubric Detail

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Name: 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.
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
Total Points: 100
Name: NURS_6521_Week11_Assignment_Rubric