Assignment: Off-Label Drug Use in Pediatrics

Week 11: Pediatrics Assignment: Off-Label Drug Use in Pediatrics

Assignment: Off-Label Drug Use in Pediatrics

Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?

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This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings.

Learning Objectives

Students will:

  • Evaluate the practice of prescribing off-label drugs to children
  • Analyze strategies to make the off-label use of drugs safer for children
  • Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders

Learning Resources

Required Readings (click to expand/reduce)

Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’s pharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.

  • Chapter 8, “Drug Therapy in Pediatric Patients” (pp. 65—67)

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)

Required Media (click to expand/reduce)

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

Assignment: 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.

Photo Credit: Getty Images

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.
Assignment: Off-Label Drug Use 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). All papers submitted must use this formatting.

Submission and Grading Information

To submit your completed Assignment for review and grading, do the following:

  • Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)” as the name.
  • Click the Week 11 Assignment Rubric to review the Grading Criteria for the Assignment.
  • Click the Week 11 Assignment link. You will also be able to “View Rubric” for grading criteria from this area.
  • Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)” and click Open.
  • If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
  • Click on the Submit button to complete your submission.
Grading Criteria

To access your rubric:

Week 11 Assignment Rubric

Check Your Assignment Draft for Authenticity

To check your Assignment draft for authenticity:

Submit your Week 11 Assignment draft and review the originality report.

Submit Your Assignment by Day 7 of Week 11

To participate in this Assignment:

Week 11 Assignment

Final Exam

This Exam covers the content you have explored throughout this course.

This exam is a test of your knowledge in preparation for your certification exam. No outside resources—including books, notes, websites, or any other type of resource—are to be used to complete this exam. You are not allowed to take screenshots or record the exam questions in any other format while taking the exam. You are expected to comply with Walden University’s Code of Conduct.

Photo Credit: Getty Images

By Day 7 of Week 11

Complete the Final Exam. You have 120 minutes to complete the exam. You may only attempt this exam once.

Submission and Grading Information

Complete the Exam by Day 7 of Week 11

To Complete this Exam:

Week 11 Exam

Module in Review

In this module, you evaluated the practice and circumstances of prescribing off-label drugs to children and analyzed the strategies used to make their use and dosage safer for children. After you have completed the Discussion and the Final Exam for this week, you have finished the course. Congratulations! Please complete the Course Evaluation form and submit by Day 7.

Congratulations! After you have finished all of the assignments for this week, you have completed the course. Please submit your Course Evaluation by Day 7.

Assignment: Off-Label Drug Use in Pediatrics

Casey ElBayly WK 9 Discussion
COLLAPSE

In the provided scenario, a 68-year-old male has been hospitalized with community-acquired pneumonia (CAP) for the last three days. He is receiving empiric antibiotics, including ceftriaxone 1 g IV daily and azithromycin 500 mg IV daily. His medical history includes COPD. HTN. hyperlipidemia, and diabetes. He is respiratory status is responding well to treatment, however, he is experiencing nausea, vomiting, and a poor appetite. Current guidelines for the treatment of CAP include treatment with a beta-lactam antibiotic and a macrolide antibiotic (Metlay et al., 2019) He is already receiving ceftriaxone (beta-lactam) and azithromycin (macrolide). These two antibiotics should provide the appropriate coverage for his CAP. Nausea and vomiting are common side effects of antibiotic treatment (Michigan Medicine, n.d.). Using antibiotics changes the bacterial gut flora which can lead to an imbalance, causing nausea and vomiting (Michigan Medicine, n.d.). These symptoms tend to improve over time. This patient should be provided a probiotic to help replace the normal gut flora and decrease nausea and vomiting (Heta & Robo, 2018). Having the patient eat yogurt, may be an easy way for him to consume a probiotic. I would continue both of his currently prescribed antibiotics as they fall under the current guidelines of treating inpatient CAP. It is obvious that the medication are helping him as his condition is improving. Hopefully, his nausea and vomiting will improve soon. He could be prescribed an antiemetic, such as Zofran, to help with his side effects. I would be sure to educate the patient on the need for IV antibiotics and that his side effects should ease up soon. It will be important to instruct him to finish his course of antibiotics up discharge as well. It is important for him to understand that the entire course needs to be completed in order to help prevent antibiotic resistance.

 

Casey

References

 

Heta, S., & Robo, I. (2018). The side effects of the most commonly used group of antibiotics in periodontal treatments. Medical Sciences, 6(1), 6. https://doi.org/10.3390/medsci6010006

Metlay, J. P., Waterer, G. W., Long, A. C., Anzueto, A., Brozek, J., Crothers, K., Cooley, L. A., Dean, N. C., Fine, M. J., Flanders, S. A., Griffin, M. R., Metersky, M. L., Musher, D. M., Restrepo, M. I., & Whitney, C. G. (2019). Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American thoracic society and infectious diseases society of America. American Journal of Respiratory and Critical Care Medicine, 200(7), e45–e67. https://doi.org/10.1164/rccm.201908-1581st

Michigan Medicine. (n.d.). Medicines that can cause nausea and vomiting. Retrieved July 29, 2020, from https://www.uofmhealth.org/health-library/sig56596

Rubric Detail

Select Grid View or List View to change the rubric’s layout.

Name: NURS_6521_Week11_Assignment_Rubric
Grid View
List View
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