Off-Label Drug Use in Pediatrics Discussion Essay Paper

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Off-Label Drug Use in Pediatrics Discussion Essay Paper

Selective serotonin reuptake inhibitors (SSRIs) such as Escitalopram, fluvoxamine, fluoxetine, and sertraline are FDA-approved drugs for treating mood disorders in pediatric patients. The FDA has recommended these SSRIs due to their efficacy in reducing mood symptoms in pediatrics (Edinoff et al., 2021). Additionally, SSRIs have a high safety profile when treating mood disorders in this patient population. However, drugs for off-label use are prescribed to pediatrics with mood disorders. One situation where drugs for 0ff-label use are prescribed to pediatrics with mood disorders is when the medication is the FDA-approved treatment for mood disorders in other patient profiles. For instance, Olanzapine is the FDA-approved treatment for schizophrenia and bipolar I disorder in individuals aged 13 years and above (Monahan et al., 2022). On the contrary, Olanzapine is an off-label drug for treating schizophrenia and bipolar disorder in children aged seven years and below (Giurin et al., 2022). Off-Label Drug Use in Pediatrics Discussion Essay Paper

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The safety of drugs of off-label use and dosage in children, ranging from infancy to adolescence, can be enhanced through two primary strategies. First, the psychiatrist should consider the potential adverse of drugs of off-label use before prescribing them to the pediatric. For example, the psychiatrist should consider the safety profile when using Quetiapine as an off-label drug for treating symptoms of bipolar disorder and schizophrenia in children aged 12 years and below (Rachamallu et al., 2019). Secondly, psychiatrists should consider the dosage of an off-label drug to ensure it is appropriate before prescribing it to pediatrics with mood disorders to avoid exposing them to drug-related toxicity. Infants should be prescribed lower dosages, while teenagers should be prescribed higher ones. Lastly, psychiatrists should take extra care when using Olanzapine as an off-label treatment of mood disorders in pediatrics. Olanzapine exposes pediatrics with mood disorders to adverse drug-related side effects, including weight gain, dyslipidemia, orthostasis, and sedation (Khan et al., 2023).

Overall, (SSRIs) such as Escitalopram, fluvoxamine, fluoxetine, and sertraline are FDA-approved drugs for treating mood disorders in pediatric patients due to their efficacy and safety profiles. On the contrary, drugs of off-label use and dosage are used in treating mood disorders in this population under some circumstances. For instance, the FDA-approved treatment for other conditions in pediatric patients can be used as drugs of off-label use in managing mood disorders in this patient profile. The safety of drugs of off-label use and dosage in children, ranging from infancy to adolescence, can be enhanced by considering potential adverse of drugs and appropriate dosage. Extra care is required when using Olanzapine as an off-label treatment of mood disorders in pediatrics due to potential adverse drug-related side effects such as weight gain, dyslipidemia, orthostasis, and sedation Off-Label Drug Use in Pediatrics Discussion Essay Paper

 

 

References

 

Edinoff, A. N., Akuly, H. A., Hanna, T. A., Ochoa, C. O., Patti, S. J., Ghaffar, Y. A., … & Kaye, A. M. (2021). Selective serotonin reuptake inhibitors and adverse effects: a narrative review. Neurology International, 13(3), 387-401.

Giurin, M. S., Trojniak, M. P., Arbo, A., Carrozzi, M., Abbracciavento, G., Monasta, L., & Zanus, C. (2022). Safety of off-label pharmacological treatment in pediatric neuropsychiatric disorders: a global perspective from an observational study at an Italian third level children’s hospital. Frontiers in pharmacology, 13.

Khan, S., Diakite, S., & Kumar, A. (2023). Use of Fluphenazine in Bipolar Disorder with a History of Substance Abuse: A Report of Two Cases. Cureus, 15(1).

Monahan, C., McCoy, L., Powell, J., & Gums, J. G. (2022). Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia. Annals of Pharmacotherapy, 56(9), 1049-1057.

Rachamallu, V., Elberson, B. W., Vutam, E., & Aligeti, M. (2019). Off-label use of clozapine in children and adolescents—A literature review. American Journal of Therapeutics, 26(3), e406-e416.

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. Off-Label Drug Use in Pediatrics Discussion Essay Paper

RESOURCES

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

WEEKLY RESOURCES

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.

RESOURCES

  • Walden University, LLC. (Producer). (2019i). Therapy for pediatric clients with mood disordersLinks to an external site. [Interactive media file]. Baltimore, MD: Author.
  • 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 childrenLinks 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. Off-Label Drug Use in Pediatrics Discussion Essay Paper

 

 

BY DAY 5 OF WEEK 11

Write a 1-page narrative in APA format that addresses the following: PLEASE REVIEW THE RUBRIC. THIS IS THE LAST ASSIGNMENT BEFORE THE FINAL

  • 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