Assignment: Off-Label Drug Use in Paediatrics Essay

Assignment: Off-Label Drug Use in Paediatrics Essay

Assignment: Off-Label Drug Use in Paediatrics

            The use ofoff-label drugs among pediatric patients has increased over the years mainly because of limited clinical trials and research among this population to determine the safety and effectiveness in the management of certain conditions such as mental disorders (van der Zanden et al., 2021). The purpose of this discussion is to illustrate the off-label use of psychotropic agents for a pediatric patient with mood disorders.

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Circumstances to Consider Off-Label Use of Drugs

Physicians normally consider several factors such as the lack of standard, safe, and effective licensed therapeutic options for the management of certain conditions, before prescribing off-label medications to children and adolescents (Yackey et al., 2019). Consequently, the process of approval of certain drugs may take a lot of time, and effect, despite proven effectiveness in the management of certain conditions, such as the use of fluoxetine for depression.

Situations for Making Off-Label Drug Safe among Pediatrics

            Most pediatric medications lack official dosing guidelines making the use of such off-label drugs potentially harmful. However, through evidence-based practice, several empirical methods such as Webster’s Rule,Clark’s rule, and Fried’s Rule have been proven to promote safe dosing and prevent harm among this vulnerable population (Pratico et al., 2018).

Drugs to Handle with Extra Care

            The U.S. FDA has provided a list of several pharmacological agents that should be handled with extra care among pediatrics due to their increased risk of suicidal ideation among other adverse effects (Yackey et al., 2019). Such drugs include Seroquel, Zyprexa, Risperdal, and coumadin among others.

Conclusion

The use of off-label drugs among pediatric patients is common and potentially harmful. . This has largely been associated with a lack of adequate clinical trial and research to support their effectiveness and safety among this vulnerable population. Caution should however be taken when prescribing and dosing these medications to avoid adverse effects.

References

Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Drago, F. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207. https://doi.org/10.2174/1574886313666180619120406

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. https://doi.org/10.1002/cpt.2336

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital Pediatrics, 9(3), 186-193. https://doi.org/10.1542/hpeds.2018-0168

 

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.

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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 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.