NURS 6521 Week 11: Off-label Drug Use in Pediatrics Essay

NURS 6521 Week 11: Off-label Drug Use in Pediatrics Essay

NURS 6521 Week 11: Off-label Drug Use in Pediatrics

(A). Circumstances under which children should be prescribed drugs for off-label use

The US Food and Drug Administration (FDA) describes off-label drug prescription as the unapproved use of an approved drug for diseases or medical conditions. In pediatrics, off-label drugs have unauthorized indications, an unapproved age group, and unidentified dosage, or route of administration (Belayneh et al., 2022). Although prescribing off-label drugs may expose children to multiple adverse effects due to limited information regarding the drugs’ appropriate dosage and the preferred age groups, various circumstances favor the prescription of off-label drugs. According to Belayneh et al. (2022), factors that justify the proliferation of off-label drugs in pediatrics include a lack of appropriate pediatric preparations, complicated or limited scientific and ethical requirements in pediatric studies, high formulation costs, and fragmented markets. Other contextual factors that encourage clinicians to prescribe off-label medications include the failure of standard treatment options, a lack of clinical trials, and the presence of rare medical conditions in children.

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(B). Strategies to make off-label use and dosage of drugs safer for children from infancy to adolescence. Descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

Pediatric patients are susceptible to adverse reactions of high-level drugs due to organ system immaturity and ongoing growth and development (Rosenthal & Burchum, 2021). As a result, it is essential to implement evidence-based strategies to enhance the safety of off-label drugs. According to Mei et al. (2019), the recommended approaches for improving the safety of off-label drugs in pediatrics include requesting access to these medications based on supportive scholarly support, frequent assessments by expert groups, approval by an ethics committee, monitoring the drugs’ adverse reactions, obtaining consent from parents, and educating caregivers about appropriate usage of off-label drugs. Equally, establishing a database for off-label drugs can provide a platform for regular updates and information exchange regarding the utilization of these medications.

Off-label use of fentanyl in the field of anesthesia obtains justifications from its solubility and potency. According to Ziesenitz et al. (2018), fentanyl’s mechanism of action entails interactions with the opioid receptor, leading to the analgesic effect during anesthetic periods, immediate postoperative period, premedication, induction, and maintenance. However, this drug is not approved for use outside the perioperative period of pain or sedation. Consequently, its off-label use in children outside the operating room can predispose them to various adverse effects. Oshikoya et al. (2019) argue that off-label use of fentanyl can lead to respiratory depression when used in pediatric ICUs. Clinicians should monitor the pediatric patients’ progress and provide information about the safety of off-label fentanyl use in children.

References

Belayneh, A., Abatneh, E., Abebe, D., Getachew, M., Kebede, B., & Dessie, B. (2022). Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia. SAGE Open Medicine, 10, 1–9. https://doi.org/10.1177/20503121221096534

Mei, M., Xu, H., Wang, L., Huang, G., Gui, Y., & Zhang, X. (2019). Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study. BMC Pediatrics, 19(1). https://doi.org/10.1186/s12887-019-1664-7

Oshikoya, K. A., Wharton, G. T., Avant, D., Van Driest, S. L., Fenn, N. E., Lardieri, A., Doe, E., Sood, B. G., Taketomo, C., Lieu, P., Yen, L., & McMahon, A. W. (2018). Serious adverse events associated with off-label use of azithromycin or fentanyl in children in intensive care units: A retrospective chart review. Pediatric Drugs, 21(1), 47–58. https://doi.org/10.1007/s40272-018-0318-9

Rosenthal, L., & Burchum, J. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.). Saunders.

Ziesenitz, V. C., Vaughns, J. D., Koch, G., Mikus, G., & van den Anker, J. N. (2018). Pharmacokinetics of fentanyl and its derivatives in children: A comprehensive review. Clinical Pharmacokinetics, 57(2), 125–149. https://doi.org/10.1007/s40262-017-0569-6

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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.

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.

                                  Learning Resources

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

Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disorders Links to an external site.[Interactive media file]. Baltimore, MD: Author.