For this Assignment you consider these questions and others as you explore FDA-approved (“on label”)
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.
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Expert Answer and Explanation
Prescribing for Children and Adolescents
Irritability, defiance and aggressive tendencies are some of the manifestations that are associated with the disruptive, impulse-control and conduct disorders. One of the unique attributes of the condition is that it is prevalent in individuals aged 19 and below. Children or adolescents with the disorder tend to display behaviors that violate societal norms such as hurting others, stealing items, displaying tendency towards the destruction of property, and lacking remorse (Björnsdotter, Ghaderi, & Enebrink, 2020). Effective management of the disorder requires understanding of the medications for treating it including the risks associated with the use of the pharmacological interventions.
FDA-Approved Drug, Off-Label Drug and a Non-pharmacological Intervention for Treating Children and Adolescents
The Fluoxetine is one of the medications that the Food and Drug Administration (FDA) approved for managing symptoms linked to a wide range of disorders including compulsive disorder. As an SSRI medication, Fluoxetine is good for one’s mood, and it makes one less irritable by causing the rise in their brain’s serotonin levels (O’Connor et al., 2020).
Olanzapine is also ideal for the disorder, and despite being an off-label drug, it helps regulate one’s mood by controlling the brain’s dopamine levels (Rybakowski, 2023).
The Cognitive Behavioral Therapy (CBT) is also an ideal intervention for adolescents and children who exhibit signs of impulsive and disruptive behaviors.
The Risk Assessment that Can Inform the Treatment Decisions
The Benefit Risk Assessment (BRA) provides an ideal method for determining the risks of the recommended interventions. Using this method, providers can identify the benefits of each of the proposed treatments including their respective risks, and make appropriate decisions in terms of the ideal treatment option (Masri et al., 2022).
The Risks and Benefits of FDA-Approved Drugs
Although a patient may feel drowsy, headache, experience seizures and insomnia when they are on Fluoxetine, the medication stabilizes mood. These symptoms are attributed to the rise in the amount of serotonin in one’s brain.
The Risks and Benefits of the Off-Label Drug
Despite olanzapine being an effective intervention for adolescents and children with impulsive and disruptive behaviors, it may cause sleepiness and dizziness. In certain cases, patients may develop rush on their body and sometimes add weight.
Whether the Clinical Guidelines Exist for the Disorder
While there is lack of a clinical guideline for the behavioral disorder, information is available to providers who may want to learn about the disorder including the approach to managing it. The de-escalation of the medication is one of the things that a provider should consider when working with patients with the disorder if the FDA-approved or the off-label medications cause serious clinical events.
It is also important that they consider the patient’s substance use history because using any of the recommended medications while on behavior-altering substances, can impede treatment or worsen symptoms (Baweja et al., 2021). The other information that is worth considering when using the medications is the patient’s health history, which is crucial in the sense that it minimizes the patient’s risk of developing serious complications.
Conclusion
In conclusion, the Fluoxetine and olanzapine are FDA-approved and off-label medications that a provider may use to treat disruptive, impulse-control and conduct disorder because they regulate one’s mood. Prior to prescribing these medications, a provider should ensure they assess the risks and benefits of these drugs. In addition, they should assess patients’ health status to determine how well they can respond to the medications. This is necessary to prevent the serious health events linked to the use of the drugs.
References
Baweja, R., Waschbusch, D. A., Pelham, W. E., 3rd, Pelham, W. E., Jr, & Waxmonsky, J. G. (2021). The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder. Frontiers in psychiatry, 12, 699687. https://doi.org/10.3389/fpsyt.2021.699687.
Björnsdotter, A., Ghaderi, A., & Enebrink, P. (2020). Cluster Analysis of Child Externalizing and Prosocial Behaviors in a Randomized Effectiveness Trial of the Family-Check Up and Internet-Delivered Parent Training (iComet). Journal for person-oriented research, 6(2), 88–102. https://doi.org/10.17505/jpor.2020.22403.
Masri, H. E., McGuire, T. M., Dalais, C., van Driel, M., Benham, H., & Hollingworth, S. A. (2022). Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies. Journal of the Medical Library Association : JMLA, 110(2), 185–204. https://doi.org/10.5195/jmla.2022.1306.
O’Connor, C., Downs, J., Shetty, H., & McNicholas, F. (2020). Diagnostic trajectories in child and adolescent mental health services: exploring the prevalence and patterns of diagnostic adjustments in an electronic mental health case register. European child & adolescent psychiatry, 29(8), 1111–1123. https://doi.org/10.1007/s00787-019-01428-z.
Rybakowski, J. K. (2023). Application of Antipsychotic Drugs in Mood Disorders. Brain sciences, 13(3), 414. https://doi.org/10.3390/brainsci13030414.
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FAQs
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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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