Off-Label Drug Use in Pediatrics Assignment

Pediatrics

Prescription of medication to children is an area that should be approached systematically due to the diverse factors affecting this demographic. The aim of off label drug use for children is to attain maximum benefit for the patient in the challenges that he or she is facing. This is a decision based on professional judgment, and decision-making should be guided by the presentation of the patient and evidence supporting the use and efficacy of the drugs in helping this particular individual (Pratico et al., 2017). One way that the use of off-label drugs can be made safer includes considering the risk and benefit ratio of medication, and disclosing such information. For instance, in the case there is an option to begin the use of Zoloft, an SSRI, in a child that is suffering from depression. In a trial that evaluated the efficacy of Zoloft in comparison to a placebo, the findings showed that after 12 weeks 55 percent of children in the study group improved in comparison to 24 percent that received the placebo (Cardy et al., 2017). Furthermore, side effects have been associated with the drug that include drowsiness, fatigue, insomnia, nausea, and dizziness. Children have also been reported to experience changes in their mental state.

Therefore, in the case presentation the first approach will be to attempt a non-pharmaceutical intervention such as cognitive behavioral therapy, which has been found to be effective in children that have depression (Yang et al., 2017). The judgment and insight of the patient are appropriate and there is no suicide ideation. Hence, CBT will help identify the source of the problem and aid in the introduction of the appropriate behavioral interventions for positive outcomes in the child.

References

Cardy, R., Dhaliwal, S., & Reddy, P. S. (2017). Antidepressant drug treatment in Child and

adolescent Psychiatry. Madridge J Intern Emerg Med, 1(1), 31-39.

Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles,

CA: Western Psychological Services

Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Leonardi,

207. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207.

Yang, L., Zhou, X., Zhou, C., Zhang, Y., Pu, J., Liu, L., … & Xie, P. (2017). Efficacy and

acceptability of cognitive behavioral therapy for depression in children: A systematic review and meta-analysis. Academic pediatrics, 17(1), 9-16.

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.

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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 School 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 http://writingcenter.waldenu.edu/57.htm). All papers submitted must use this formatting.

Submission and Grading Information

To submit your completed Assignment for review and grading, do the following:

• Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)” as the name.
• Click the Week 11 Assignment Rubric to review the Grading Criteria for the Assignment.
• Click the Week 11 Assignment link. You will also be able to “View Rubric” for grading criteria from this area.
• Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)” and click Open.
• If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
• Click on the Submit button to complete your submission.