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
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.
LEARNING RESOURCES
· Hilt, R. J., & Nussbaum, A. M. (2016). DSM-5 pocket guide for child and adolescent mental health Links to an external site. . American Psychiatric Association Publishing.
· Chapter 14, “Psychosocial Interventions”
· Chapter 15, “Psychotherapeutic Interventions”
· 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.
· Chapter 43, “Pharmacological, Medically-Led and Related Treatments”
· Walden University. (n.d.). Developing SMART goals Links 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.
· Chapter 5, “Psychopharmacology”
REQUIRES Media
· CriticalThinkRx. (2019, June 9). Module 5: Links to an external site. Specific drug classes: Focus on adverse effects Links 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 concerns Links to an external site. [Video]. YouTube. https://youtu.be/NRef-g4Ding
TO PREPARE
You are assigned to research on Disruptive Mood Dysregulation Disorder
· Research evidence-based treatments for your Disruptive Mood Dysregulation 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 Disruptive Mood Dysregulation 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.
MY RESEARCHED ARTICLES
Byrne, G., & Connon, G. (2021). The Use of Standard Parenting Management Training in Addressing Disruptive Mood Dysregulation Disorder: A Pilot Study. Journal of Contemporary Psychotherapy, 51(3), 259–263. https://doi.org/10.1007/s10879-021-09489-5
Winters, D. E., Fukui, S., Leibenluft, E., & Hulvershorn, L. A. (2018). Improvements in Irritability with Open-Label Methylphenidate Treatment in Youth with Comorbid Attention Deficit/Hyperactivity Disorder and Disruptive Mood Dysregulation Disorder. Journal of Child & Adolescent Psychopharmacology, 28(5), 298–305. https://doi.org/10.1089/cap.2017.0124
Tapia, V., & John, R. M. (2018). Disruptive Mood Dysregulation Disorder. Journal for Nurse Practitioners, 14(8), 573–578. https://doi.org/10.1016/j.nurpra.2018.07.007
Pan, P.-Y., Fu, A.-T., & Yeh, C.-B. (2018). Aripiprazole/Methylphenidate Combination in Children and Adolescents with Disruptive Mood Dysregulation Disorder and Attention-Deficit/Hyperactivity Disorder: An Open-Label Study. Journal of Child & Adolescent Psychopharmacology, 28(10), 682–689. https://doi.org/10.1089/cap.2018.0068
Rice, T., Simon, H., Barckak, D., Maiyuran, H., Chan, V., Hassan, Y., Tatum, J., & Coffey, B. J. (2019). Amantadine for Treatment of Disruptive Mood Dysregulation Disorder Symptoms. Journal of Child & Adolescent Psychopharmacology, 29(8), 642–646. https://doi.org/10.1089/cap.2019.29172.bjc
Le, J., Feygin, Y., Creel, L., Lohr, W. D., Jones, V. F., Williams, P. G., Myers, J. A., Pasquenza, N., & Davis, D. W. (2020). Trends in diagnosis of bipolar and disruptive mood dysregulation disorders in children and youth. Journal of Affective Disorders, 264, 242–248. https://doi.org/10.1016/j.jad.2019.12.018
Uran, P., & Kılıç, B. G. (2020). Family Functioning, Comorbidities, and Behavioral Profiles of Children With ADHD and Disruptive Mood Dysregulation Disorder. Journal of Attention Disorders, 24(9), 1285–1294. https://doi.org/10.1177/1087054715588949
Linke, J., Kircanski, K., Brooks, J., Perhamus, G., Gold, A. L., & Brotman, M. A. (2020). Exposure-Based Cognitive-Behavioral Therapy for Disruptive Mood Dysregulation Disorder: An Evidence-Based Case Study. Behavior Therapy, 51(2), 320–333. https://doi.org/10.1016/j.beth.2019.05.007
Mulraney, M., Schilpzand, E., Hazell, P., Nicholson, J., Anderson, V., Efron, D., Silk, T., & Sciberras, E. (2016). Comorbidity and correlates of disruptive mood dysregulation disorder in 6-8-year-old children with ADHD. European Child & Adolescent Psychiatry, 25(3), 321–330. https://doi.org/10.1007/s00787-015-0738-9
Lin, Y.-J., Tseng, W.-L., & Gau, S. S.-F. (2021). Psychiatric comorbidity and social adjustment difficulties in children with disruptive mood dysregulation disorder: A national epidemiological study. Journal of Affective Disorders, 281, 485–492. https://doi.org/10.1016/j.jad.2020.12.039
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