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.
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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 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
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (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
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.
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.
Expert Solution Preview
Introduction: The use of drugs for off-label use in children is a common practice due to the lack of pediatric dosage guidelines. However, pediatric patients respond differently to drugs compared to adults, and this poses safety concerns. As an advanced practice nurse, it is essential to understand when it is appropriate to use drugs for off-label use in children and how to ensure their safety.
1. Circumstances under which children should be prescribed drugs for off-label use: Children should only be prescribed drugs for off-label use when there are no other approved treatment options available, or when approved medications have failed to adequately treat the condition. For example, a child with severe depression may be prescribed an antidepressant medication that has only been approved for use in adults. Another example is when a child has a rare medical condition that has no approved treatments available.
2. Strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence: To ensure the safety of children prescribed drugs for off-label use, healthcare providers should carefully monitor their response to the medication. They should also consider factors such as the child’s age, weight, and overall health status. It is also important to ensure that the dosage is adjusted correctly based on the child’s age and weight. Some off-label drugs that require extra care and attention when used in pediatrics include antidepressants, antipsychotics, and ADHD medications. Additional strategies include obtaining informed consent from parents or guardians and closely monitoring the child for any adverse reactions.
In conclusion, pediatric patients should only be prescribed drugs for off-label use when other treatment options have been exhausted, and healthcare providers should take extra care when prescribing and monitoring the use of off-label drugs in children. By following these strategies, healthcare providers can ensure the safety of pediatric patients prescribed drugs for off-label use.
