Off-Label Drug Use in Pediatrics Assignment

Off-Label Drug Use in Pediatrics Assignment

Off-Label Drug Use in Pediatrics Assignment

Off‐label drug use is the prescription of a drug that has been authorized for marketing, but for a disease, at a dose, through a route, or for a patient’s age that is not indicated. Pediatric patients should be prescribed drugs for off-label use when there is an unavailability of standard, approved, effective, and safe pharmacological options for a particular condition for children (Unni & Joseph, 2019).

Off-label drugs can also be prescribed when the approved medication options are ineffective in achieving the desired treatment outcomes. Furthermore, drugs for off-label use should only be prescribed when concrete evidence supports the drug’s efficacy and its safety in children (Mei et al., 2018). Substantial evidence should exist supporting the use of the drug for a particular disease in a specific age group in children. Besides, the evidence should be from well-controlled studies proving that the benefits of off-label drug use outweigh the potential risks when used in children.

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Clinicians can make off-label use and drug dosage in pediatrics safer by making decisions supported by evidence-based practice (EBP). They should use peer-reviewed literature, practice guidelines, and AAP policies to source literature supporting the off-label use of a specific drug in children (Yackey & Stanley, 2019). In addition, clinicians can make off-label use safer by utilizing the drug’s information provided by the manufacturer to make decisions on the dose of the drug. Drug labels contain indications, drug-to-drug interactions, side effects, and maximum dose for each age group (Yackey & Stanley, 2019). Therefore, it can guide clinicians in determining the safest drug dose when prescribing to children and adolescents.

Off-label drugs requiring extra care and attention when prescribed to pediatrics include sedatives, oxycodone, methadone, and hydromorphone. Drugs acting on the cardiovascular system also need extra care due to hemodynamic instability (Unni & Joseph, 2019). They include Lisinopril, Dopamine, Milrinone, and Amlodipine. Besides, drugs acting on the nervous system need caution to prevent impaired cognitive development in children.

References

Mei, M. E. I., Li-bo, W. A. N. G., En-mei, L. I. U., Zhi-ping, L. I., Zhuo-yao, G. U. O., Xiao-bo, Z. H. A. N. G., & Hong, X. U. (2018). Current practice, management and awareness of pediatric off-label drug use in China-A questionnaire based cross-sectional survey. Chinese Journal of Evidence-Based Pediatrics, 12(4), 289. https://doi.org/10.1186/s12887-019-1664-7

Unni, J. C., & Joseph, R. B. (2019). Off-Label Medications in Pediatrics. The Indian Journal of Pediatrics, 86(12), 1149-1149.  https://doi.org/10.1007/s12098-019-03029-9

Yackey, K., & Stanley, R. (2019). Off-label prescribing in children remains high: a call for prioritized research. Pediatrics, 144(4).doi:10.1542/peds.2019-1571

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Assignment: Off-Label Drug Use in Pediatrics

This week is about Pediatric Issues.

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 (See below “Therapy for Pediatric Clients with Mood Disorders”.
• Reflect on situations in which children should be prescribed drugs for off-label use.
• Explain strategies for making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific.

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.

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

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.
• 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. The self-reported mood is “sad”. Affect somewhat blunted, but the child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes were 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.
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