Off-Label Drug Use in Pediatrics patients
The prevalence of pediatric depression is a significant public health concern in the United States. According to Bernaras et al. (2019), the incidence of major depressive disorder has increased dramatically among children and adolescents, increasing the percentage of this mental illness in the United States to 0.5%. Depression in children is associated with various symptoms that lead to impaired functioning. For this reason, pharmacological interventions are used in treating depression symptoms in children. This discussion focuses on circumstances under which drugs for off-label use can be prescribed to children, strategies for enhancing the safety of off-label use and dosage, and off-label drugs that need extra care.
Drugs for off-label use can be prescribed in treating depression in children if they have been approved by the FDA to be used in treating other mental illnesses in children. For instance, the FDA has approved sertraline 50-200 mg/day for treating Obsessive Compulsive Disorder (OCD) in children above 6 years. Sertraline is recommended in treating OCD in children and adolescents for a maximum of 12 weeks since its highly-effective and generally well tolerated in this patient population (Tini et al., 2022). However, this drug is used off-label in treating children with depression. Psychiatrists should consider the patient’s age when prescribing off-label drugs to children of various age brackets, ranging from infancy to adolescence. The dosage for infants should be relatively lower than that of adolescents. Prescription of paroxetine as an off-label drug in pediatrics with depression requires extra care. According to Bérard et al. (2017), paroxetine increases the risk of cardiac malformations in pediatrics significantly. Thus, pediatrics treated with this antidepressant are at a high risk of developing these conditions.
Overall, off-label drugs are used in treating depression in children if the drug has been approved by the FDA for treating other mental illnesses in pediatrics. When prescribing drugs of 0ff-label use and dosage, psychiatrists should consider the patient’s age. Mental healthcare providers should take extra care when prescribing paroxetine to pediatrics with depressive symptoms since it increases the risk of developing cardiac malformations.
Bérard, A., Zhao, J. P., & Sheehy, O. (2017). Antidepressant use during pregnancy and the risk of major congenital malformations in a cohort of depressed pregnant women: an updated analysis of the Quebec Pregnancy Cohort. BMJ Open, 7(1), e013372.
Bernaras, E., Jaureguizar, J., & Garaigordobil, M. (2019). Child and adolescent depression: A review of theories, evaluation instruments, prevention programs, and treatments. Frontiers in Psychology, 10, 543. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435492/
Tini, E., Smigielski, L., Romanos, M., Wewetzer, C., Karwautz, A., Reitzle, K., … & Walitza, S. (2022). Therapeutic drug monitoring of sertraline in children and adolescents: A naturalistic study with insights into the clinical response and treatment of the obsessive-compulsive disorder. Comprehensive Psychiatry, 115, 152301. https://doi.org/10.1016/j.comppsych.2022.152301
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.
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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.
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.