OFF-LABEL DRUG USE IN PEDIATRICS

Description

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.

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

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Mother reports that teacher said child is withdrawn from peers in class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.

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

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.

For your narrative:

Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Explain strategies to making 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. (Be Specific)

NURS_6521_Week11_Assignment_Rubric

NURS_6521_Week11_Assignment_Rubric

Criteria Ratings Pts

This criterion is linked to a Learning OutcomeExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.

40 to >35.5 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.

35.5 to >31.6 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.

31.6 to >27.6 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.

27.6 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 OutcomeExplain 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 >40.05 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.

40.05 to >35.55 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.

35.55 to >31.05 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.

31.05 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 pts

This criterion is linked to a Learning OutcomeWritten 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 >4.45 pts

Excellent

Paragraphs and sentences follow writing standards for flow, continuity, and clarity.

4.45 to >3.95 pts

Good

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.

3.95 to >3.45 pts

Fair

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.

3.45 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 OutcomeWritten Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation

5 to >4.45 pts

Excellent

Uses correct grammar, spelling, and punctuation with no errors

4.45 to >3.95 pts

Good

Contains a few (1–2) grammar, spelling, and punctuation errors

3.95 to >3.45 pts

Fair

Contains several (3–4) grammar, spelling, and punctuation errors

3.45 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 OutcomeWritten 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 >4.45 pts

Excellent

Uses correct APA format with no errors

4.45 to >3.95 pts

Good

Contains a few (1–2) APA format errors

3.95 to >3.45 pts

Fair

Contains several (3–4) APA format errors

3.45 to >0 pts

Poor

Contains many (≥ 5) APA format errors

5 pts

Total Points: 100

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Title of the Paper in Full Goes Here
Student Name Here
Program Name or Degree Name, Walden University
Course Number, Section, and Title
(Example: NURS 0000 Section 01, Title of Course)
Instructor Name
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(enter the date submitted to instructor)
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Title of the Paper
This is your introductory paragraph designed to inform the reader of what you will cover
in the paper. (BSN Students – Carefully follow your course-specific Grading Rubric concerning
the content that is required for your assignment and the Academic Writing Expectations [AWE]
level of your course.) This template’s formatting—Times New Roman 12-point font (other
options include Calibri 11, Arial 11, Lucida Sans Unicode 10, and Georgia 11), double spacing,
1” margins, 1/2” indentations beginning of each paragraph, page numbers, and page breaks—is
set for you, and you do not need to change it. Do not add any extra spaces between the heading
and the text (you may want to check Spacing under Paragraph, and make sure settings are all set
to “0”). The ideas in this paper should be in your own words and supported by credible outside
evidence. Cite the author, year of publication, and page number, if necessary, per APA. The
introductory paragraph should receive no specific heading because the first section functions as
your paper’s introduction. Build this paragraph with the following elements:
1. Briefly detail what has been said or done regarding the topic.
2. Explain the problem with what has been said or done.
3. Create a purpose statement (also commonly referred to as a thesis statement) as the last
sentence of this paragraph: “The purpose of this paper is to describe…”.
Level 1 Heading (Name According to the Grading Rubric Required Content)
This text will be the beginning of the body of the paper. Even though this section has a
new heading, make sure to connect this section to the previous one so the reader can follow
along with the ideas and research presented. The first sentence, or topic sentence, in each
paragraph should transition from the previous paragraph and summarize the main point in the
paragraph. Make sure each paragraph addresses only one topic. When you see yourself drifting
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to another idea, make sure you break into a new paragraph. Avoid long paragraphs that are more
than three-fourths of a page. Per our program recommendations, each paragraph should be at
least 3-4 sentences in length and contain a topic sentence, evidence, analysis, and a conclusion or
lead out sentence. See the MEAL plan (Main idea, Evidence, Analysis, and Lead out) in the
Writing Center. In your paragraphs, synthesize your resources/readings into your own words and
avoid using direct quotations. In the rare instances you do use a direct quotation of a historical
nature from a source, the page or paragraph numbers are also included in the citation. For
example, Leplante and Nolin (2014) described burnout as “a negative affective response
occurring as result of chronic work stress” (p. 2). When you transition to a new idea, you should
begin a new paragraph.
Another Level 1 Heading (Name According to the Grading Rubric Required Content)
Here is another Level 1 heading. Again, the topic sentence of this section should explain
how this paragraph is related to or a result of what you discussed in the previous section.
Consider using transitions between sentences to help readers see the connections between ideas.
Be sure to credit your source(s) in your paper using APA style. The APA Manual 7th
edition and the Walden Writing Center are your best citation resources. Writing Center resources
are available at https://academicguides.waldenu.edu/writingcenter/apa/citations. You must
appropriately and correctly cite all works used in your document.
The following paragraph provides examples of in-text citation examples. According to
Leplante (2019), employers cause burnout when employees are stressed by too much work. Or
you might write and cite in this manner: Employers cause burnout when employees are stressed
by too much work (Leplante, 2019). When paraphrasing, the author name and year of publication
in citations is required by APA to direct the reader to a specific source in the reference list.
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Personal communications are not listed in the reference page but are noted in text as (S. Wall,
personal communication, May 24, 2019). This should immediately follow the content of the
interview. Also, go to
Another Level 1 Heading (Name According to the Grading Rubric Required Content)
APA can seem difficult to master, but following the general rules becomes easier with
use. The Writing Center also offers numerous APA resources on its website and can answer your
questions via email. Prior to submitting your paper for grading, submit your draft to SafeAssign
Drafts found in the left column of your course.
And so forth until the conclusion….
Conclusion
The conclusion section should recap the major points of your paper. Do not introduce
new ideas in this paragraph; the conclusion should interpret what you have written and what it
means in the bigger picture.
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References
Please note that the following references are intended as examples only. List your own
references in alphabetical order. Also, these illustrate different types of references; you are
responsible for any citations not included in this list. In your paper, be sure every reference entry
matches a citation, and every citation refers to an item in the reference list.
Journal Article; Two Authors; DOI
Leplante, J. P. & Nolin, C. (2014). Consultas and socially responsible investing in Guatemala: A
case study examining Maya perspectives on the Indigenous right to free, prior, and
informed consent. Society & Natural Resources, 27(4), 231–248.
https://doi.org/10.1080/08941920.2013.861554
Journal Article, Two Authors; URL
Eaton, T. V., & Akers, M. D. (20007). Whistleblowing and good governance. CPA Journal,
77(6), 66–71. http://archives.cpajournal.com/2007/607/essentials/p58.htm
Journal Article, More Than Twenty Authors; DOI
Wiskunde, B., Arslan, M., Fischer, P., Nowak, L., Van den Berg, O., Coetzee, L., Juárez, U.,
Riyaziyyat, E., Wang, C., Zhang, I., Li, P., Yang, R., Kumar, B., Xu, A., Martinez, R.,
McIntosh, V., Ibáñez, L. M., Mäkinen, G., Virtanen, E., . . . Kovács, A. (2019). Indie pop
rocks mathematics: Twenty One Pilots, Nicolas Bourbaki, and the empty set. Journal of
Improbable Mathematics, 27(1), 1935–1968. https://doi.org/xxx/xxxxxx
Book; One Author
Weinstein, J. A. (2019). Social change (3rd ed.). Rowman & Littlefield.
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Book; Chapter in an Edited Book
Christensen, L. (2020). For my people: Celebrating community through poetry. In B. Bigelow,
B. Harvey, S. Karp, & L. Miller (Eds.), Rethinking our classrooms: Teaching for equity
and justice (Vol. 2; pp. 16–17). Rethinking Schools.
Professional Organization Web page
Centers for Disease Control and Prevention. (2018). Back to school.
https://www.cdc.gov/features/teens-back-to-school/index.html
Professional Organization Book
American Nurses Association. (2010). Nursing: Scope and standards of practice (2nd ed.).
Two or more works by same author in the same year
Wall, S. (2018a). Effects of friendship on children’s behavior. Journal of Social Psychology,
4(1), 101–105.
Wall, S. (2018b). Trials of parenting adolescents with deviant behaviors. Journal of Child
Psychology, 4(12), 161–167.
Government Article
National Institute of Mental Health. (1990). Clinical training in serious mental illness (DHHS
Publication No. ADM 90-1679). U.S. Government Printing Office.
Lecture Notes
Health effects of exposure to forest fires [Lecture notes]. (2019). Walden University Blackboard.
https://class.waldenu.edu
Personal Communication (Only Goes in Body of Paper and not in References)
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Video
Walden University. (2009). Title of video here [Video]. Walden University Blackboard.
https://class.waldenu.edu
Television (Audio)
Important, I. M. (Producer). (1990, November 1). The nightly news hour [TV series episode].
Central Broadcasting Service.
APA Resources
You have other several options to assist you in the formulation of your reference page.

Your American Psychological Association (APA) Manual is your best reference
resource. Use the current edition with a copyright date of 2020.

The Walden Writing Center also a great place for referencing advice at
https://academicguides.waldenu.edu/writingcenter/apa/references.

Citation and reference examples are provided in the ‘BSN TOP Ten References and
Citations” handout found in the Writing Resources tab of the course. This document
covers the 10 most commonly used reference and citation formats. You are responsible
for looking up any that are not included on this list.

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