Prescribing for Children and Adolescents with Bipolar Disorder Essay

Prescribing for Children and Adolescents with Bipolar Disorder Essay

Prescribing for Children and Adolescents with Bipolar Disorder

Bipolar disorder is among the mental health disorders with considerable disease burden to patients and their families. Psychiatric mental health practitioners select evidence-based interventions to optimize outcomes in bipolar disorder. Pharmacological and non-pharmacological treatments are often utilized in the disease. Therefore, this essay examines FDA and off-label drugs for bipolar disorder and their associated benefits and risks.

The FDA has approved the use of some drugs in the treatment of bipolar disorder among children and adolescents. They include lithium, Lurasidone, Asenapine, Risperidone, Olanzapine, Aripiprazole, Quetiapine, and fluoxetine/olanzapine combination. An example of an off-label medication used in the treatment of bipolar disorder is divalproex (DelBello et al., 2021). Non-pharmacological interventions are also recommended for bipolar disorder in children and adolescents. An example is the use of family psychoeducation to increase their understanding of the disease and effective management strategies (Fadilah & Haniman, 2021; Gautam et al., 2019; Sun et al., 2019).

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I will utilize the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) to diagnose and treat a child with bipolar disorder. K-SADS is an effective tool that allows healthcare providers to timely diagnose and treat affective disorders such as bipolar disorder, depression, and anxiety disorders. The tool is highly valid and reliable in the diagnosis and determination of severity bipolar disorder symptoms (Nishiyama et al., 2020). The severity of the symptoms based on the scores will guide the treatments being adopted for the patient.

The use of FDA approved medications for bipolar disorder is associated with benefits and risks. Among the benefits include a high rate of safety and efficacy in treating bipolar disorder. FDA-approved drugs have undergone rigorous high-quality, randomized controlled studies to determine their safety and efficacy index. The drugs have a high level of efficacy against bipolar disorder symptoms. Healthcare providers prescribe them with a high level of confidence due to the minimal risk of patient harm. However, psychiatric mental health nurse practitioners should monitor the risks associated with the individual drugs (Sun et al., 2019). For example, patients should be monitored for lithium toxicity and suicidal thoughts due to the antidepressants used in the treatment.

There are also benefits and risks with the use of non-FDA approved or off-label drugs in bipolar disorder. One of the benefits is that these drugs produce the desired outcomes in cases where the FDA-approved drugs have proven ineffective. Patients may also benefit from the low costs incurred in the purchase of non-FDA approved medications. The use of off-label drugs may be associated with some risks. The safety and efficacy profile of the off-label drugs is less known. As a result, the children and adolescents treated to them due to bipolar disorder are largely at an elevated risk of developing serious side and adverse effects (Sun et al., 2019). Psychiatric mental health nurse practitioners should monitor them closely for response and potential unwanted side effects that may warrant changes in the treatment regime.

A clinical practice guideline for use in the treatment of bipolar disorder in children and adolescents in the USA does not exist. However, psychiatric mental health nurse practitioners can make their treatment decisions based on the best available evidence. Randomized controlled trials, systematic reviews, and meta-analyses provide practitioners with highly reliable and valid evidence that they can use to make informed decisions on the treatment approaches (Gautam et al., 2019). For example, studies have demonstrated the effectiveness of Lurasidone in children and adolescents with bipolar disorder, hence, informing the decisions made.

In summary, FDA-approved and off-label drugs can be used in treating bipolar disorder in children and adolescents. Non-pharmacological interventions can also be incorporated into the treatment for enhanced outcomes. Practitioners should weigh the benefits against the risks of FDA and off-label drugs in bipolar disorder management. Evidence-based data should inform the decisions made in the absence of clinical practice guidelines for use in treating bipolar disorder in children and adolescents.

References

DelBello, M. P., Tocco, M., Pikalov, A., Deng, L., & Goldman, R. (2021). Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. Journal of Child and Adolescent Psychopharmacology. https://doi.org/10.1089/cap.2021.0040

Fadilah, S., & Haniman, F. (2021). Bipolar Type 1 Disorder Comorbid with Idiopathic Epilepsy in Children: A Case Report. Scientia Psychiatrica, 2(3), Article 3. https://doi.org/10.37275/scipsy.v2i3.41

Gautam, S., Jain, A., Gautam, M., Gautam, A., & Jagawat, T. (2019). Clinical Practice Guidelines for Bipolar Affective Disorder (BPAD) in Children and Adolescents. Indian Journal of Psychiatry, 61(Suppl 2), 294–305. https://doi.org/10.4103/psychiatry.IndianJPsychiatry_570_18

Nishiyama, T., Sumi, S., Watanabe, H., Suzuki, F., Kuru, Y., Shiino, T., Kimura, T., Wang, C., Lin, Y., Ichiyanagi, M., & Hirai, K. (2020). The Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL) for DSM-5: A validation for neurodevelopmental disorders in Japanese outpatients. Comprehensive Psychiatry, 96, 152148. https://doi.org/10.1016/j.comppsych.2019.152148

Sun, A. Y., Woods, S., Findling, R. L., & Stepanova, E. (2019). Safety considerations in the psychopharmacology of pediatric bipolar disorder. Expert Opinion on Drug Safety, 18(9), 777–794. https://doi.org/10.1080/14740338.2019.1637416

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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. 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.

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.
  • 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 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.
  • 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

TO PREPARE

• Your Instructor will assign a specific disorder for you to research for this Assignment. Assigned disorder is: (BIPOLAR DISORDER)
• Use the Walden library to research evidence-based treatments for your assigned BIPOLAR 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 bipolar 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 bipolar 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.

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This criterion is linked to a Learning Outcome

In at least 2 pages, address the following:

• Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned Bipolar disorder in children and adolescents.

25 to >22.0 pts

Excellent

The response accurately and concisely explains one FDA-approved drug, one off-label drug, and one nonpharmacological intervention that would be appropriate for treating the assigned disorder in children and adolescents.

25 pts

This criterion is linked to a Learning Outcome

• 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?

25 to >22.0 pts

Excellent

The response accurately and concisely explains the risk assessment you would use to inform your treatment decision making. A concise and accurate explanation of the risks and benefits of each pharmacological intervention is provided.

25 pts

• 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.

25 to >22.0 pts

Excellent

The response accurately and concisely uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations.

25 pts

• 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.

10 to >8.0 pts

Excellent

The response provides at least three current, evidence-based resources from the literature to support the intervention recommendations. The resources reflect the latest clinical guidelines and provide strong justification for decision-making.

10 pts

 

Written Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well-developed ideas, flow logically, and demonstrate a 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.

5 to >4.0 pts

Excellent

Paragraphs and sentences follow writing standards for flow, continuity, and clarity. A clear and comprehensive purpose statement, introduction, and conclusion are provided that delineate all required criteria.

5 pts

Written Expression and Formatting – English Writing Standards: Correct grammar, mechanics, and proper punctuation

5 to >4.0 pts

Excellent

Uses correct grammar, spelling, and punctuation with no errors

5 pts

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.

5 to >4.0 pts

Excellent

Uses correct APA format with no errors.

5 pts

Total Points: 100

As stated above:

• The Assignment- Review grading rubrics for points assigned to each of the questions below!

• 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 bipolar 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 bipolar disorder.
• Attach the PDFs of your sources.