NURS 6521 Week 11 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.

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.

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.

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 All papers submitted must use this formatting.

Submission and Grading Information

Off-Label Drug Use In Pediatrics Sample Paper

Major depressive disorder is a significant pediatric and adolescent health problem associated with significant morbidity. These patients suffer from impaired social functioning, school difficulties and have an increased risk of physical illness and substance abuse. It is also associated with an increased risk of mortality by suicide. Treatment should therefore be initiated with both psychotherapy and pharmacotherapy.

Choosing an antidepressant is however a challenge for pediatric patients. This is because of the smaller evidence available for antidepressant efficacy compared to adult patients. Selective serotonin reuptake inhibitors (SSRIs) are the first line antidepressants in both pediatric and adult patients with only a few of these antidepressants FDA approved to be used in pediatrics. 

The lack of FDA approval for pediatric patients is mostly attributed to the lack of sufficient testing. This means that some antidepressants used in pediatrics are prescribed off—label. Use of off-label drugs is common in pediatrics. Off-label drugs use is when drugs are used for treatment of conditions different from the ones they were originally intended for (Gore et al., 2017).

Off-label drug use is recommended in children if they do not receive adequate improvement after using first line drugs (Dwyer & Bloch, 2019). In patients with depressive disorders, improvements can be seen when switching from one SSRI to another e.g., when a switch from Prozac to Zoloft is made (Boyce et al., 2020).

However, certain considerations need to be made when drugs are used off label. These include the child’s body weight and stage of development. This is relevant because these factors can affect how the child will tolerate the drug (Collier et al.,2017). 

Metabolism is also affected by these factors and consequently the amount of drugs prescribed. Another important consideration is the side effects associated with the drugs. SSRIs, for example, are more likely to cause suicidal ideations in pediatric and adolescent patients than in adults. 


  • Boyce, P., Hopwood, M., Morris, G., Hamilton, A., Bassett, D., Baune, B. T., Mulder, R., Porter, R., Parker, G., Singh, A. B., Outhred, T., Das, P., & Malhi, G. S. (2020). Switching antidepressants in the treatment of major depression: When, how and what to switch to?. Journal of Affective Disorders, 261, 160–163.
  • Collier, H., Nasim, M., & Gandhi, A. (2017). Prescribing in obese children: how good are pediatricians?. Archives Of Disease In Childhood, 102(1), 61–62.

Dwyer, J. B., & Bloch, M. H. (2019). Antidepressants for Pediatric Patients. Current Psychiatry, 18(9), 26–42F.

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric Off-Label and Unlicensed Drug Use and Its Implications. Current Clinical Pharmacology, 12(1), 18–25.