Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment
Prescribing Medications for Children and Adolescents with Major Depressive Disorder (MDD)
Major depressive disorder, or MDD, is a depressive disorder characterized by feelings of worthlessness, suicidality, low self-esteem, depressed mood, and a lack of enjoyment of pleasurable activities that were previously enjoyed (APA, 2022). Listings are diagnostic criteria in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or DSM-5-TR that must exist for the diagnosis. Its treatment in children and adolescents involves using pharmacotherapy and psychotherapy or other nonpharmacologic strategies (Pataki & Carlson, 2016). The pharmacologic treatment makes use of FDA-approved and non-FDA-approved (off-label) medications.
An FDA-Approved, an Off-Label, and a Nonpharmacologic Intervention for MDD
One of the FDA-approved medications for treating MDD is fluoxetine (Prozac). It is a selective serotonin reuptake inhibitor or SSRI (Stahl, 2017). It is the drug I would recommend for the treatment of MDD in children and adolescents. It is supposed to be given to children and adolescents aged eight years and above. According to Braüner et al. (2016) found that about 32.3% of all psychiatric prescriptions for children and adolescents are off-label. Sertraline (Zoloft) which is another SSRI, is the off-label medication I would recommend for treating major depression in children and adolescents.
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Nonpharmacological interventions are also evidence-based, just like medications. Usually, they include psychoeducation and psychosocial treatments. A proven psychotherapeutic modality for managing MDD in children and adolescents as in adults is cognitive behavioral therapy or CBT (Shrestha et al., 2020). It encompasses the cognitive remodeling of restructuring, which is about changing the thought process.
Risk Assessment
Figuring out the effectiveness and safety of medications, particularly those not endorsed by the FDA, is a key component of the risk analysis that will be carried out to guide therapeutic results. Additionally, in-depth discussions with peers who have used it and had greater expertise are required. The risk analysis for the FDA-approved one will include assessing the likelihood of negative effects. The FDA-approved medication fluoxetine and the off-label sertraline have the advantage of being effective at treating MDD. Its risks, together with the off-label sertraline, include the possibility of agitation and insomnia, amongst other adverse effects (Stahl, 2017). These are taken into account in the risk assessment.
Clinical Practice Guidelines
There are indeed clinical practice guidelines in the management of depression. The guidelines recommend treatment with a dual approach of medications and psychotherapy (Gautam et al., 2017). In the guidelines, SSRIs are ideal because of their low side effects, effectiveness, and tolerability. Then again, CBT is preferred because of its proven effectiveness in resolving symptoms in those on medications. However, even with the guidelines prepared, treating depression, especially in children and adolescents, still requires careful critical clinical decision-making for each patient.
Conclusion
Major depressive disorder, or MDD, is a depressive disorder with a high morbidity and mortality rate in the general population. Its treatment can occasionally be challenging, especially in children and adolescents. However, the use of off-label prescriptions and nonpharmacologic strategies on top of FDA-approved drugs has proven effective. Available clinical practice guidelines support these recommendations Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment .
References
American Psychiatric Association [APA] (2022). Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM-5-TR), 5th ed. Author.
Braüner, J.V., Johansen, L.M., Roesbjerg, T., & Pagsberg, A.K. (2016). Off-label prescription of psychopharmacological drugs in child and adolescent psychiatry. Journal of Clinical Psychopharmacology, 36(5), 500–507. https://doi.org/10.1097/jcp.0000000000000559
Gautam, S., Jain, A., Gautam, M., Vahia, V.N., & Grover, S. (2017). Clinical practice guidelines for the management of depression. Indian Journal of Psychiatry, 59(Suppl. 1), S34-S50. https://doi.org/10.4103/0019-5545.196973
Pataki, C., & Carlson, G. A. (2016). Major depressive disorder among children and adolescents. FOCUS, 14(1), 10–14. https://doi.org/10.1176/appi.focus.20150037
Sadock, B.J., Sadock, V.A., & Ruiz, P. (2015). Synopsis of psychiatry: Behavioral sciences clinical psychiatry, 11th ed. Wolters Kluwer. Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment
Shrestha, M., Lautenschleger, J., & Soares, N. (2020). Non-pharmacologic management of attention-deficit/hyperactivity disorder in children and adolescents: A review. Translational Pediatrics, 9(S1), S114–S124. https://doi.org/10.21037/tp.2019.10.01
Stahl, S.M. (2017). Stahl’s essential psychopharmacology: Prescriber’s guide, 6th ed. Cambridge University Press.
PRESCRIBING FOR CHILDREN AND ADOLESCENTS
Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.
—Agency for Healthcare Research and Quality
Psychotropic drugs are commonly used for children and adolescents to treat mental health disorders, yet many of these drugs are not FDA approved for use in these populations. Thus, their use is considered “off-label,” and it is often up to the best judgment of the prescribing clinician. As a PMHNP, you will need to apply the best available information and research on pharmacological treatments for children in order to safely and effectively treat child and adolescent patients. Sometimes this will come in the form of formal studies and approvals for drugs in children. Other times you may need to extrapolate from research or treatment guidelines on drugs in adults. Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment Each individual patient case will need to be considered independently and each treatment considered from a risk assessment standpoint. What psychotherapeutic approach might be indicated as an initial treatment? What are the potential side effects of a particular drug?
For this Assignment, you consider these questions and others as you explore FDA-approved (“on label”) pharmacological treatments, non-FDA-approved (“off-label”) pharmacological treatments, and nonpharmacological treatments for disorders in children and adolescents.
Reference:
Agency for Healthcare Research and Quality. (2015). Off-label drugs: What you need to know. https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-drug-usage.htmlLinks to an external site.
RESOURCES
Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.
TO PREPARE
- Your Instructor will assign a specific disorder for you to research for this Assignment.
- Use the Walden library to research evidence-based treatments for your assigned disorder in children and adolescents. You will need to recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating this disorder in children and adolescents.
THE ASSIGNMENT (1–2 PAGES)
- Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents.
- Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
- Explain whether clinical practice guidelines exist for this disorder and, if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
- Support your reasoning with at least three scholarly resources, one each on the FDA-approved drug, the off-label, and a non-medication intervention for the disorder. Attach the PDFs of your sources.
BY DAY 7 OF WEEK 3
Submit your Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment Assignment.
SUBMISSION INFORMATION
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Rubric
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In 1–2 pages, address the following: • Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents.
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• Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
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• Explain whether clinical practice guidelines exist for this disorder and, if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
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• Support your reasoning with at least three scholarly resources, one each on the FDA-approved drug, the off-label, and a non-medication intervention for the disorder. Be sure they are current (no more than 5 years old). Attach the PDFs of your sources.
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Written Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well-developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused—neither long and rambling nor short and lacking substance. A clear and comprehensive purpose statement and introduction are provided that delineate all required criteria.
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Written Expression and Formatting – English Writing Standards: Correct grammar, mechanics, and proper punctuation
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Written Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, parenthetical/narrative in-text citations, and reference list.
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Total Points: 100 Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment
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