Week 11 Assignment: Off-Label Drug Use in Pediatrics/NURS 6521

Week 11 Assignment: Off-Label Drug Use in Pediatrics/NURS 6521

Week 11 Assignment: Off-Label Drug Use in Pediatrics/NURS 6521

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.

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.

A Sample Of This Assignment Written By One Of Our Top-rated Writers

Week 11 Assignment

Major Depressive Disorder (MDD) has become the most prevalent mood disorder in children in the United States. According to Mullen (2018), approximately 12.8% of the US population aged between 8 and 12 years had reported a minimum of a single incident of a major depressive episode by 2016, making the high rate of MDD among children a major public health concern. MDD in children is characterized by various clinical manifestations including reduced energy, concentration, appetite, and sleep (Mullen, 2018). Children with this mood disorder might also report irritability, agitation, and suicidal ideations or thoughts (Mullen, 2018). These symptoms impair a child’s interpersonal relationships and school performance, necessitating treatment using pharmacological interventions. This discussion focuses on the prescription of drugs for off-label use and dosage in treating depressive episodes in children, including circumstances under which drugs for off-label use are prescribed in treating depression in children, strategies for improving the safety of off-label use and dosage in children, off-label drugs that need extra care.

Under some circumstances, mental healthcare providers prescribe drugs for off-label use to children presented with depressive symptoms. First, medications that have been approved by the FDA for treating MDD symptoms in adults can be prescribed as a drug for off-label use and dosage in children presented with major depressive disorder. For instance, the FDA approved Zoloft for treating depression in adults due to its effectiveness in managing depressive symptoms in this population with minimal drug-related side effects (Lewis et al., 2019). However, psychiatrists prescribe Zoloft to children with depression as a drug for off-label dosage due to superior outcomes in adults. By prescribing Zoloft to children with depressive symptoms, mental healthcare providers aim at reducing presented depressive symptoms, and improving patients’ quality of life. In another incident, FDA-approved drugs for treating other mood disorders such as anxiety or attention deficiency hypertensive disorder (ADHD) can be used in treating depressive symptoms in children. For instance, the FDA has approved the use of Atomoxetine in treating ADHD in children in the United States and Europe (Mechler et al., 2021). However, psychiatrists prescribe this medication to children presented with depressive episodes as a drug for off-label dosage, aiming at reducing presented depressive symptoms.

Mental healthcare providers use various strategies to enhance the safety of the off-label use and dosage prescribed to children. The first strategy involves considering potential drug-related adverse reactions. Drugs with potentially severe side effects, when used in treating depressive symptoms in adults, are not prescribed to children. Secondly, psychiatrists consider the patient’s age when prescribing drugs for off-label use as a treatment for depression in children. Infants are prescribed lower dosages while adolescents are prescribed higher dosages. This strategy reduces the risk of adverse drug reactions in dosage-dependent medications. Psychiatrists should take extra care when using off-label drugs for treating depression in pediatrics. For instance, extra care is needed when prescribing Desflurane to children with depression. This drug is associated with severe side effects, including myocardial depression and peripheral vasodilation (Page et al., 2018).

Overall, drugs for off-label use and dosage are commonly used in treating depressive symptoms in children. Medications that have been approved by the FDA for treating MDD symptoms in adults can be prescribed as a drug for off-label use and dosage in children presented with major depressive disorder. Drug-related side effects and child’s age are considered to enhance the safety of drugs for off-label use and dosage.

References

Lewis, G., Duffy, L., Ades, A., Amos, R., Araya, R., Brabyn, S., … & Lewis, G. (2019). The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomized trial. The Lancet Psychiatry, 6(11), 903-914. DOI: 10.1016/S2215-0366(19)30366-9

Mechler, K., Banaschewski, T., Hohmann, S., & Häge, A. (2021). Evidence-based pharmacological treatment options for ADHD in children and adolescents. Pharmacology & Therapeutics, 107940. https://doi.org/10.1016/j.pharmthera.2021.107940

Mullen, S. (2018). Major depressive disorder in children and adolescents. Mental Health Clinician, 8(6), 275-283. Doi: 10.9740/mhc.2018.11.275

Page, R. L., O’Bryant, C. L., Cheng, D., Dow, T. J., Ky, B., Stein, C. M., … & Lindenfeld, J. (2018). Drugs that may cause or exacerbate heart failure: a scientific statement from the American Heart Association. Circulation, 134(6), e32-e69.