Posted: September 21st, 2022

NURS 6521: Off-Label Drug Use in Pediatrics

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

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Sample Answer Guide:
Circumstances under which Children Should be Prescribed Drugs for Off-Label Use

The use of drugs that are not specifically approved for children, also known as off-label use, is a common practice in pediatrics. This is because pediatric dosages are not always readily available, as very few drugs have been researched and tested on children. Despite this, when treating children, doctors often alter adult dosages to fit the weight of the child. However, this practice can be problematic as children process and respond to drugs differently than adults due to differences in absorption, distribution, metabolism, and excretion, as well as differences in responses during various stages of development from infancy to adolescence.

To ensure the safety of pediatric patients when using off-label drugs, advanced practice nurses must be aware of the potential safety implications and take necessary precautions. In certain circumstances, it may be appropriate to prescribe a drug off-label to a child. The following are some examples:

Lack of Approved Treatment Options
In some cases, there may be no approved treatment options for a particular condition in children. In these situations, off-label use may be necessary to provide relief to the child. However, it is important to carefully weigh the potential benefits and risks before making a decision.

Compassionate Use
In some instances, a child may be suffering from a life-threatening condition, and there are no approved treatments available. In such cases, off-label use may be necessary to provide relief and improve the child’s quality of life.

Evidence-Based Practice
In some cases, there may be evidence from previous studies or real-world experience that suggests that a particular off-label drug may be effective and safe for use in children. In such cases, it may be appropriate to prescribe the drug off-label to the child.

Strategies to Make Off-Label Drug Use and Dosage Safer for Children from Infancy to Adolescence

Despite the prevalence of off-label drug use in pediatrics, it is important to ensure the safety of pediatric patients. The following are some strategies that can be used to make off-label drug use and dosage safer for children from infancy to adolescence:

Dosage Adjustment
One of the key strategies for making off-label drug use safer for children is to adjust dosages appropriately. It is important to consider the child’s weight, age, and developmental stage when determining the appropriate dose. It may also be necessary to regularly monitor the child’s response to the drug to ensure that it is effective and safe.

Close Monitoring
When using off-label drugs in pediatrics, it is essential to closely monitor the child’s response to the drug. This may include regular monitoring of the child’s vital signs, as well as monitoring for any adverse effects. Advanced practice nurses should also educate parents and caregivers on the importance of monitoring their child’s response to the drug and what to look for in terms of adverse effects.

Collaboration with Specialists
In some cases, it may be necessary to collaborate with specialists, such as pediatricians, pharmacists, and other healthcare professionals, to ensure that the off-label drug is being used safely and effectively. This may involve discussing the potential risks and benefits of the drug and working together to determine the best course of action.

Evidence-Based Practice
To ensure the safety of pediatric patients when using off-label drugs, it is important to rely on evidence-based practice. This may involve reviewing the available literature and consulting with specialists to determine the best course of action.

Off-Label Drugs that Require Extra Care and Attention When Used in Pediatrics
Off-label use of drugs in pediatrics is common and often necessary due to a lack of FDA-approved options for certain conditions in this population. However, it is important to exercise caution and carefully consider the potential risks and benefits when using drugs off-label in children. Here are a few examples of off-label drugs that require extra care and attention:

Antipsychotics
Antipsychotics are commonly used off-label in children to treat conditions such as attention deficit hyperactivity disorder (ADHD), bipolar disorder, and depression. While these drugs can be effective, they can also have serious side effects, including weight gain, metabolic changes, and an increased risk of diabetes. It is important to carefully monitor the child’s weight, glucose levels, and other metabolic parameters while using antipsychotics.

Antidepressants
Antidepressants are often used off-label in children and adolescents to treat depression, anxiety, and other mood disorders. However, these drugs can have side effects such as suicidal thoughts, especially in children and adolescents. It is important to closely monitor children for any changes in mood or behavior while taking antidepressants.

Stimulants
Stimulants, such as methylphenidate (Ritalin) and amphetamines (Adderall), are commonly used off-label in children with ADHD. These drugs can have side effects such as decreased appetite, insomnia, and nervousness. It is important to carefully monitor the child’s appetite and sleep patterns while using stimulants.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
NSAIDs, such as ibuprofen (Advil) and naproxen (Aleve), are commonly used off-label in children to treat pain, inflammation, and fever. These drugs can have serious side effects, such as increased risk of kidney damage, stomach ulcers, and bleeding. It is important to closely monitor children for any signs of adverse effects while taking NSAIDs.

While off-label drug use in pediatrics can be necessary, it is important to carefully consider the potential risks and benefits before starting a child on such a treatment. Regular monitoring and close communication with the child’s healthcare provider are essential to ensure the safe and effective use of off-label drugs in this population.
References
Kimland, E. and Odlind, V., 2012. Off‐label drug use in pediatric patients. Clinical Pharmacology & Therapeutics, 91(5), pp.796-801.
Jain, S. S., Bavdekar, S. B., Gogtay, N. J., & Sadawarte, P. A. (2008). Off-label drug use in children. The Indian Journal of Pediatrics, 75, 1133-1136.
Pandolfini, C., & Bonati, M. (2005). A literature review on off-label drug use in children. European journal of pediatrics, 164, 552-558.
Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Strom, B. L., & Horton, D. B. (2019). Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics, 144(4).
Meng, M., Lv, M., Wang, L., Yang, B., Jiao, P., Lei, W., … & Li, Q. (2022). Off-label use of drugs in pediatrics: a scoping review. European Journal of Pediatrics, 181(9), 3259-3269.
van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., … & de Wildt, S. N. (2021). Benefit‐risk assessment of off‐label drug use in children: the bravo framework. Clinical Pharmacology & Therapeutics, 110(4), 952-965.

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