PRESCRIBING OFF-LABEL DRUGS FOR CHILDREN AND ADOLESCENTS
WEEK 3 ASSIGNMENT 1 (AT LEAST 3 PAGES)
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. Each individual patient’s 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
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
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. The assigned case is -Attention-Deficit Hyperactivity Disorder (ADHD)
• 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 (AT LEAST 3 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 Assignment.
SUBMISSION INFORMATION
Before submitting your final assignment, you can check your draft for authenticity. To check your draft, access the Turnitin Drafts from the Start Here area.
1. To submit your completed assignment, save your Assignment as WK3Assgn1+last name+first initial.
2. Then, click on Start Assignment near the top of the page.
3. Next, click on Upload File and select Submit Assignment for review.
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. 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 OutcomeWritten 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 OutcomeWritten 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
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