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.
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. 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.
The Assignment(1–2 pages)- Eating Disorders
Research and select ONE FDA approved medication, ONE off-label drug, and ONE therapy form. Support them with 3 references less than 5 years old.
For risks of medications, consider side effects or adverse reactions of the medications.
On the clinical practice guidelines question, research if there is one and respond if yes or no with explanation (and source).
Use the following questions as sub-headings and address all questions!
1. Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents.
2. 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?
3. 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. (TIP: Research online IF there is any “clinical practice guidelines” for management of your assigned disorder. Hence your response should be either YES or NO WITH further explanation as required on this question)
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.
LEARNING RESOURCES
Required Readings
• Hilt, R. J., & Nussbaum, A. M. (2016). DSM-5 pocket guide for child and adolescent mental healthLinks to an external site.. American Psychiatric Association Publishing.
o Chapter 14, “Psychosocial Interventions”
o Chapter 15, “Psychotherapeutic Interventions”
o Chapter 16, “Psychopharmacological Interventions”Links to an external site.
• Thapar, A., Pine, D. S., Leckman, J. F., Scott, S., Snowling, M. J., & Taylor, E. A. (2015). Rutter’s child and adolescent psychiatry (6th ed.). Wiley Blackwell.
o Chapter 43, “Pharmacological, Medically-Led and Related Treatments”
• Walden University. (n.d.). Developing SMART goalsLinks to an external site.. https://academicguides.waldenu.edu/ld.php?content_id=51901492Links to an external site.
• Zakhari, R. (2020). The psychiatric-mental health nurse practitioner certification review manual. Springer.
o Chapter 5, “Psychopharmacology”
Required Media:
• CriticalThinkRx. (2019, June 9). Module 5: Links to an external site.Specific drug classes: Focus on adverse effectsLinks to an external site. [Video]. YouTube. https://youtu.be/Gbq6RnOsGKQLinks to an external site.
• CriticalThinkRx. (2019, June 9). Module 2: Use of psychotropics with youth_prevalence and concernsLinks to an external site. [Video]. YouTube. https://youtu.be/NRef-g4Ding