Examine the frequency of off-label prescribing to children and explores factors that impact off-label prescribing essay
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.
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.
This article highlights pediatric governmental initiatives to prevent unlicensed and off-label drug use in children. Review these initiatives and guidelines and how they might impact your practice as an advanced practice nurse.
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 .child is withdrawn from peers in class 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. Self-reported mood is “sad”. Affect somewhat blunted, but child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes 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 )Decision Point One Begin Zoloft 25 mg orally daily RESULTS OF DECISION POINT ONE Client returns to clinic in four weeks No change in depressive symptoms at all Decision Point Two Increase dose to 50 mg orally daily RESULTS OF DECISION POINT TWO Client returns to clinic in four weeks Depressive symptoms decrease by 50%. Cleint tolerating well Decision Point Three Maintain current dose Guidance to Student At this point, sufficient symptom reduction has been achieved. This is considered a “response” to therapy. Can continue with current dose for additional 4 week to see if any further reductions in depressive symptoms are noted. An increase in dose may be warranted since this is not “full” remission- Discuss pros/cons of increasing drug dose with client at this time and empower the client to be part of the decision. There is no indication that the drug therapy should be changed to an SNRI at this point as the client is clearly responding to this therapy. 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