Prescription of Off-Label Medications for Children Essay.

Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression
African American Child

BACKGROUND INFORMATION

The client is an 8-year-old African American male who arrives at the ER with his mother. He is exhibiting signs of depression.Prescription of Off-Label Medications for Children Essay.

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Client complained of feeling “sad”
Mother reports that teacher said child is withdrawn from peers in class
Mother notes decreased appetite and occasional periods of irritation
Client reached all developmental landmarks at appropriate ages
Physical exam unremarkable
Laboratory studies WNL
Child referred to psychiatry for evaluation

MENTAL STATUS EXAM

Alert & oriented X 3, speech clear, coherent, goal directed, spontaneous. Self-reported mood is “sad”. Affect somewhat blunted, but child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes noted. Judgment and insight appear to be age-appropriate. He is not endorsing active suicidal ideation, but does admit that he often thinks about himself being dead and what it would be like to be dead.Prescription of Off-Label Medications for Children Essay.

You administer the Children\’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)

RESOURCES

§ Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.

Decision Point One
Select what you should do:

Begin Zoloft 25 mg orally daily
Begin Paxil 10 mg orally daily
Begin Wellbutrin 75 mg orally BID

Week 11: Pediatrics
Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?Prescription of Off-Label Medications for Children Essay.

This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings.Prescription of Off-Label Medications for Children Essay.

Learning Objectives
Students will:

Evaluate the practice of prescribing off-label drugs to children
Analyze strategies to make the off-label use of drugs safer for children
Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders
Learning Resources
Required Readings (click to expand/reduce)

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.Prescription of Off-Label Medications for Children Essay.

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.

Document: Final Exam Study Guide (PDF)

Required Media (click to expand/reduce)

Laureate Education (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.

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.Prescription of Off-Label Medications for Children Essay.

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.

Photo Credit: Getty Images

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.Prescription of Off-Label Medications for Children Essay.

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.Prescription of Off-Label Medications for Children Essay.
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.

Off-label drugs are those medications that are FDA-approved for treatment of the indicated condition in adults but not in children. They become off-label prescriptions when their dosages are tailored to a child’s weight at the discretion of the clinician because there is no safety profile data on pediatric use (Vijay et al., 2018). This short paper discusses the prescription of off-label drugs to children from a psychopharmacologic standpoint.Prescription of Off-Label Medications for Children Essay.

African American Male Child with Depression

The 8 year-old African American male child presenting with depression is a classical case of a diagnosis for which off-label prescription may be necessary. In his case, the decision that will be taken from the given choices will be to begin sertraline (Zoloft) 25 mg orally daily (Rosenthal & Burchum, 2018). Some of the circumstances in which children should be prescribed off-label drugs are (i) when the diagnosis made does not have pharmacologic agents approved for use in children but has FDA-approved ones for adults (such as depression); and (ii) when there is a threat to the child’s life (like suicidal ideation in the case of this 8 year-old) and therefore the need to uphold beneficence outweighs any potential risks to the child that may breach the principle of nonmaleficence.Prescription of Off-Label Medications for Children Essay.

Some of the strategies to make off-label use and dosage of medications safer in pediatrics from infancy to puberty include prescribing them in line with the existing pediatric prescription guidelines for other similar medications, observing the child closely in a healthcare setup for at least 24 hours after administering the first dose (to see if there is any threat to the child’s safety), and consulting widely with colleagues before making the prescription to learn from the experience of others. Some of the off-label drugs that require extra care when used in children include alprazolam (Xanax), clonazepam (Klonopin), and escitalopram (Lexapro). For instance, escitalopram carries a risk of increased suicidal thinking if used in children below the age of 12 years (Vijay et al., 2018).Prescription of Off-Label Medications for Children Essay.

Conclusion

The use of off-label medications in pediatrics is fraught with risks that must be taken into consideration by all clinicians. Close observation and extensive consultations before prescription for the inexperienced clinician are essential for patient safety.Prescription of Off-Label Medications for Children Essay.