Posted: November 16th, 2022

Week 11: Pediatrics – prescribed drugs for off-label use

Week 11: Pediatrics

Children, like adults, face a wide range of health issues, but they also face issues that are more prevalent in their age group. The prescription of drugs for off-label use is one issue that has a significant impact on children. How do you determine the appropriate use of off-label drugs in pediatrics as an advanced practice nurse? Are there any drugs that should be avoided when treating children?
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
Explain the circumstances under which drugs for off-label use should be prescribed to children. Provide specifics and examples.
Describe strategies for making off-label drug use and drug dosage safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that, when used in pediatrics, necessitate extra caution and attention.
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.

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 School 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.
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.
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Off-Label Drug Use in PediatricsOff-label drugs Pediatric Off-Label Drug Use In pediatrics, off-label drugs are used when there is a lack of effective and approved medication to treat a specific condition. Due to the availability of evidence from clinical trials about the effectiveness of medication, healthcare practitioners may also prescribe off-label drugs (Moulis, Durrieu & Lapeyre-Mestre, 2018). Amoxicillin, for example, is used to treat ear and chest infections in children. The drug is widely used due to the availability of research evidence demonstrating the medication’s effectiveness and lack of side effects (Moulis, Durrieu & Lapeyre-Mestre, 2018). Another reason is a lack of clinical trials because researchers primarily focus on adults rather than children under a certain age. Off-label drugs have a certain percentage of health risks that clinicians must effectively manage. One method of ensuring a child’s or infant’s safety is to rely on available evidence (De Zen, Marchetti, Barbi & Benini, 2018). Peer-reviewed sources have indicated that various drugs and dosages are safe. A practitioner can also confirm a drug’s safety using the FDA Medwatch program. Consensus statements and AAP guidelines are two other reliable sources of information about the safety of off-label drugs (De Zen, Marchetti, Barbi & Benini, 2018). Other measures that clinicians can take include checking a child’s weight, medical history, and other complications. The data will aid in the safe prescription of off-label medications. Off-label drugs necessitate extra caution in order to avoid complications. One of the medications is morphine, which is used to treat pain in children. Because the drug can cause complications such as breathing problems, it must be used with caution (Gore, Chugh, Tripathi, Lhamo & Gautam, 2017). Cyclizine should also be used with caution in children because it can cause blurred vision.

References
De Zen, L., Marchetti, F., Barbi, E., & Benini, F. (2018). Off-label drugs use in pediatric palliative care. Italian Journal of Pediatrics, 44(1), 144.
Gore, R., K Chugh, P., D Tripathi, C., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current Clinical Pharmacology, 12(1), 18-25.
Moulis, F., Durrieu, G., & Lapeyre-Mestre, M. (2018). Off-label and unlicensed drug use in children population. Therapies, 73(2), 135-149.

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