Assignment: NURS 6521 Week 11 Discussion: Off-Label Drug Use in Pediatrics
Circumstances under which children should be prescribed drugs for off-label use: 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. 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. When it’s okay to give a child a drug that wasn’t made for that use: Off-label use, which means giving a drug to a child even though it wasn’t meant for them, happens a lot. This is because very few drugs have been studied and tested with children, so there aren’t usually any dosage guidelines for kids.
When treating children, doctors often change the doses that are meant for adults to fit the weight of the child. But children aren’t just “smaller” versions of adults. Adults and children absorb, distribute, metabolize, and get rid of drugs in different ways and in different ways. Children even act differently at different ages, from babies to teenagers. This could make it harder to know if a drug is safe for a child to take. As an advanced practice nurse, you need to know what the safety risks are of using drugs outside of their approved uses with this group of patients.
To prepare:
Review the Bazzano et al. and Mayhew articles in the Learning Resources. 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.
With these thoughts in mind:
By Day 3 of circumstances under which children should be prescribed drugs for off-label use
Post an explanation of circumstances under which children should be prescribed drugs for off-label use. Then, 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.
By Day 6
Read a selection of your colleagues’ responses and respond to at least two of your colleagues on two different days who provided a different rationale than you did, in one or more of the following ways:
Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library.
Validate an idea with your own experience and additional research.
Readings
· Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88.
Retrieved from Walden Library databases.
This study examines the frequency of off-label prescribing to children and explores factors that impact off-label prescribing.
· Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123.
Retrieved from the Walden Library databases.
This article reviews the prevalence of off-label prescribing, including its benefits and risks. It also explores issues regarding the safety of off-label prescribing and when it is unavoidable.
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Module 8: Pediatrics
As an advanced practice nurse, you provide patient care across all stages of the lifespan. While you may not necessarily specialize in pediatrics, you will likely come across pediatric patients and may be involved in developing, implementing, and recommending drug therapy plans for pediatric patients. Of special note, the proper dosing and administration of pharmacotherapeutics for pediatric patients ensures their continued growth, development, and promotion of positive health outcomes.
What’s Happening This Module?
Module 8: Pediatrics is a 1-week module, Week 11 of the course. In this module, you will examine the practice of prescribing off-label drugs to children and explore strategies for making off-label drug use safer for children. You also complete your Final Exam.
What do I have to do? When do I have to do it?
Review your Learning Resources Days 1-7, Week 11
Assignment: Off-Label Drug Use in Pediatrics Submit your Assignment by Day 5 of Week 11.
Final Exam Complete by Day 7 of Week 11.
Go to the Week’s Content
Week 11
Week 11: 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?
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. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician Helpants (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)
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. Assignment: NURS 6521 Week 11 Discussion: Off-Label Drug Use in Pediatrics
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.
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 5 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.
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 Assessment 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 Assessment by Day 7
