Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment

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), 5
th
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, 11
th
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, 6
th
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.html
Links 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.

WEEKLY RESOURCE

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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Rubric

NRNP_6665_Week3_Assignment1_Rubric

NRNP_6665_Week3_Assignment1_Rubric

Criteria

Ratings

Pts

This criterion is linked to a Learning Outcome
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.

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.

22
 
to >
19.0
 pts

Good

The response accurately 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.

19
 
to >
17.0
 pts

Fair

The response somewhat vaguely or inaccurately 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.

17
 
to >
0
 pts

Poor

The response vaguely or inaccurately explains interventions that would be appropriate for treating the assigned disorder in children and adolescents. Interventions may not represent the three types of interventions required, or response may be missing.

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.

22
 
to >
19.0
 pts

Good

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

19
 
to >
17.0
 pts

Fair

The response somewhat vaguely or inaccurately explains the risk assessment you would use to inform your treatment decision making. The explanation of the risks and benefits of each pharmacological intervention is somewhat vague or inaccurate.

17
 
to >
0
 pts

Poor

The response vaguely or inaccurately explains the risk assessment you would use to inform your treatment decision making. The risks and benefits of each pharmacological intervention is vague or inaccurate. Or, the response is missing.

25
 pts

This criterion is linked to a Learning Outcome
• 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.

22
 
to >
19.0
 pts

Good

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

19
 
to >
17.0
 pts

Fair

The response somewhat vaguely or inaccurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations.

17
 
to >
0
 pts

Poor

The response vaguely or inaccurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Or, the response is missing.

25
 pts

This criterion is linked to a Learning Outcome
• 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.

8
 
to >
7.0
 pts

Good

The response provides at least three current, evidence-based resources from the literature to support the intervention recommendations Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment .

7
 
to >
6.0
 pts

Fair

Three evidence-based resources are provided to support the intervention recommendations, but they may only provide vague or weak justification.

6
 
to >
0
 pts

Poor

Two or fewer resources are provided to support the intervention recommendations. The resources may not be current or evidence based.

10
 pts

This criterion is linked to a Learning Outcome
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.

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.

4
 
to >
3.5
 pts

Good

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. Purpose, introduction, and conclusion of the assignment are stated, yet are brief and not descriptive.

3.5
 
to >
3.0
 pts

Fair

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. Purpose, introduction, and conclusion of the assignment are vague or off topic.

3
 
to >
0
 pts

Poor

Paragraphs and sentences follow writing standards for flow, continuity, and clarity <60% of the time. No purpose statement, introduction, or conclusion were provided. 5  pts This criterion is linked to a Learning Outcome 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

4
 
to >
3.5
 pts

Good

Contains one or two grammar, spelling, and punctuation errors

3.5
 
to >
3.0
 pts

Fair

Contains several (three or four) grammar, spelling, and punctuation errors

3
 
to >
0
 pts

Poor

Contains many (five or more) grammar, spelling, and punctuation errors that interfere with the reader’s understanding

5
 pts

This criterion is linked to a Learning Outcome
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.

5
 
to >
4.0
 pts

Excellent

Uses correct APA format with no errors

4
 
to >
3.5
 pts

Good

Contains one or two APA format errors

3.5
 
to >
3.0
 pts

Fair

Contains several (three or four) APA format errors

3
 
to >
0
 pts

Poor

Contains many (five or more) APA format errors

5
 pts

Total Points: 
100 Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment