NURS 6521 Off-Label Drug Use in Pediatrics

NURS 6521 Off-Label Drug Use in Pediatrics

Off-Label Drug Use in Pediatrics

The use of off-label medications is a common practice in pediatrics. Healthcare providers strive to ensure safety, quality, and efficiency in the use of off-label medications. Factors such as age, weight, and gender among others must be considered when prescribing these medications. Therefore, this essay examines the circumstances under which children should be prescribed off-label drugs and strategies to make off-label use and dosage safer for children.

Circumstances for Off-Label Drug Use

There are circumstances, which demand the prescription of off-label drugs for children. One of them is when there is a lack of an approved FDA drug for use in treating a condition. In this case, healthcare providers rely on the existing evidence on the effectiveness of an off-label drug for pediatric population (Guidi et al., 2022). The other circumstance is when the existing evidence supports the use of an off-label medication for pediatrics. For example, the existing evidence may demonstrate the effectiveness of antidepressants used for adults in children population, hence, informing the use of off-label drugs. Another example that may lead to the use of an off-label drug is if a pediatric patient does not tolerate an approved drug(Meng, Lv, et al., 2022; van der Zanden et al., 2022). As a result, off-label drugs are used in such cases.

Strategies for Safety in Off-Label Drug Use

One of the strategies to make off-label use and dosage of drugs safer for children is by relying on clinical guidelines and evidence to make treatment decisions. Clinical guidelines and evidence provide insights into appropriate dosage for off-label drugs used in pediatrics. The other strategy is to personalize treatment. The selected treatments should align with patient factors such as age and weight to prevent incidences of overdose and adverse drug reactions(Fung et al., 2021; van der Zanden et al., 2021). Some of the drugs that require extra care and attention when used in pediatrics include morphine, which is a strong analgesic, tramadol, an analgesic, and infliximab, which is used in conditions such as ulcerative colitis and Crohn’s disease(Meng, Zhou, et al., 2022).

Conclusion

Circumstances such as the lack of FDA approved drugs contribute to the use of off-label medications among pediatric patients. Strategies such as personalizing treatments and using clinical guidelines promote safety in the use of off-label drugs among children. Nurses and other healthcare providers should constantly explore effective strategies to ensure safety in the use of off-label drugs when treating pediatric patients in their practice.

References

Fung, A., Yue, X., Wigle, P. R., & Guo, J. J. (2021). Off-label medication use in rare pediatric diseases in the United States. Intractable & Rare Diseases Research, 10(4), 238–245. https://doi.org/10.5582/irdr.2021.01104

Guidi, B., Parziale, A., Nocco, L., Maiese, A., La Russa, R., Di Paolo, M., & Turillazzi, E. (2022). Regulating pediatric off-label uses of medicines in the EU and USA: Challenges and potential solutions. International Journal of Clinical Pharmacy, 44(1), 264–269. https://doi.org/10.1007/s11096-021-01303-5

Meng, M., Lv, M., Wang, L., Yang, B., Jiao, P., Lei, W., Lan, H., Shen, Q., Luo, X., Zhou, Q., Yu, X., Xun, Y., Lei, R., Hou, T., Chen, Y., & Li, Q. (2022). Off-label use of drugs in pediatrics: A scoping review. European Journal of Pediatrics, 181(9), 3259–3269. https://doi.org/10.1007/s00431-022-04515-7

Meng, M., Zhou, Q., Lei, W., Tian, M., Wang, P., Liu, Y., Sun, Y., Chen, Y., & Li, Q. (2022). Recommendations on Off-Label Drug Use in Pediatric Guidelines. Frontiers in Pharmacology, 13, 892574. https://doi.org/10.3389/fphar.2022.892574

van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., de Hoog, M., & 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

van der Zanden, T. M., Smeets, N. J. L., de Hoop-Sommen, M., Schwerzel, M. F. T., Huang, H. J., Barten, L. J. C., van der Heijden, J. E. M., Freriksen, J. J. M., Horstink, A. A. L., Holsappel, I. H. G., Mooij, M. G., de Hoog, M., & de Wildt, S. N. (2022). Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy. Clinical Pharmacology & Therapeutics, 112(6), 1243–1253. https://doi.org/10.1002/cpt.2736

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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.

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.

Resources

Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.

WEEKLY RESOURCES

Learning Resources

Required Readings

• 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)

• 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

• Links to an external site.. 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)

• Download Final Exam Study Guide (PDF)

Required Media

• Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disorders

• Links to an external site. [Interactive media file]. Baltimore, MD: Author.

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

Links to an external site.). All papers submitted must use this formatting.

submission information

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1. To submit your completed assignment, save your Assignment as WK11Assgn_LastName_Firstinitial
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Rubric

NURS_6521_Week11_Assignment_Rubric