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.

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.

Expert Answer and Explanation

Off -Label Use of Medicine in Children

There is numerous information related to the use of drugs in adults, but the same literature wit reference to children is limited. Contrary to popular belief, children are not small adults, and their attributes such as weight, age, and surface area to volume ratio have to be accounted for to inform on appropriate dosage (Frattarelli et al., 2014). The rapid growth in children can alter or change the expected results of medication dosage. Off-label drug use remains a significant public health problem for infants, young children, and adolescents, due to the massive number of medications that is yet to process labeling information to use in pediatrics.

In retrospect, various circumstances should be adhered to for children to be prescribed off-label use medicine. The main reason for off-label drug use is for the benefit of the patient. A pediatrician can use their professional judgment to assess the situation and prescribe the appropriate dosage from Off-label medication (American Academy of Pediatrics, 2014). In accordance with the American Academy of Pediatrics, the use of off-label should only be considered when the child patient in need of a critical medicine that could save their life but is yet to be labeled.

Safety of Off-Label Drugs

To compensate for the lack of labels, drug manufacturers are mandated to indicate on the packaging whether or not the drug has met the required tests approvals to be safely prescribed to infants and children. The indication can be made through the inclusion of clearly evidence-based warnings and any other form of contradiction with adult labeling (American Academy of Pediatrics, 2014). Pediatricians need to differentiate between an alert based on off-labels for children and the lack of approval by the FDA for a specific drug regimen.

References

American Academy of Pediatrics. (2014). AAP Makes Recommendations On Use of Off-Label Drugs for Children. aap.org. Retrieved 20 April 2020, from https://www.aap.org/en-us/about-the-aap/aap-press-room/pages/AAP-Makes-Recommendations-On-Use-of-Off-Label-Drugs-for-Children.aspx

Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Neville, K. A., Paul, I. M., & Van, J. D. A. (2014). Off-label use of drugs in children. Pediatrics, 133(3), 563-567. https://doi.org/10.1542/peds.2013-4060

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