Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat
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?
Assignment 1: 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 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
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.
PLEASE TAKE NOE: My own assigned specific disorder is (PERSISTENT DEPRESSIVE DISORDER).
,
Rubric Detail
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Content
Name: NRNP_6665_Week3_Assignment1_Rubric
| Excellent | Good | Fair | Poor | |
|---|---|---|---|---|
| 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. | Points: Points Range: 23 (23%) – 25 (25%) 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. Feedback: | Points: Points Range: 20 (20%) – 22 (22%) 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. Feedback: | Points: Points Range: 18 (18%) – 19 (19%) 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. Feedback: | Points: Points Range: 0 (0%) – 17 (17%) 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. Feedback: |
| • 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? | Points: Points Range: 23 (23%) – 25 (25%) 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. Feedback: | Points: Points Range: 20 (20%) – 22 (22%) 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. Feedback: | Points: Points Range: 18 (18%) – 19 (19%) 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. Feedback: | Points: Points Range: 0 (0%) – 17 (17%) 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. Feedback: |
| • 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. | Points: Points Range: 23 (23%) – 25 (25%) The response accurately and concisely uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Feedback: | Points: Points Range: 20 (20%) – 22 (22%) The response accurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Feedback: | Points: Points Range: 18 (18%) – 19 (19%) The response somewhat vaguely or inaccurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Feedback: | Points: Points Range: 0 (0%) – 17 (17%) 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. Feedback: |
| • 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. | Points: Points Range: 9 (9%) – 10 (10%) 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. Feedback: | Points: Points Range: 8 (8%) – 8 (8%) The response provides at least three current, evidence-based resources from the literature to support the intervention recommendations. Feedback: | Points: Points Range: 7 (7%) – 7 (7%) Three evidence-based resources are provided to support the intervention recommendations, but they may only provide vague or weak justification. Feedback: | Points: Points Range: 0 (0%) – 6 (6%) Two or fewer resources are provided to support the intervention recommendations. The resources may not be current or evidence based. Feedback: |
| 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. | Points: Points Range: 5 (5%) – 5 (5%) 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. Feedback: | Points: Points Range: 4 (4%) – 4 (4%) 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. Feedback: | Points: Points Range: 3.5 (3.5%) – 3.5 (3.5%) 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. Feedback: | Points: Points Range: 0 (0%) – 3 (3%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity <60% of the time. No purpose statement, introduction, or conclusion were provided. Feedback: |
| Written Expression and Formatting – English Writing Standards: Correct grammar, mechanics, and proper punctuation | Points: Points Range: 5 (5%) – 5 (5%) Uses correct grammar, spelling, and punctuation with no errors Feedback: | Points: Points Range: 4 (4%) – 4 (4%) Contains one or two grammar, spelling, and punctuation errors Feedback: | Points: Points Range: 3.5 (3.5%) – 3.5 (3.5%) Contains several (three or four) grammar, spelling, and punctuation errors Feedback: | Points: Points Range: 0 (0%) – 3 (3%) Contains many (five or more) grammar, spelling, and punctuation errors that interfere with the reader’s understanding Feedback: |
| 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. | Points: Points Range: 5 (5%) – 5 (5%) Uses correct APA format with no errors Feedback: | Points: Points Range: 4 (4%) – 4 (4%) Contains one or two APA format errors Feedback: | Points: Points Range: 3.5 (3.5%) – 3.5 (3.5%) Contains several (three or four) APA format errors Feedback: | Points: Points Range: 0 (0%) – 3 (3%) Contains many (five or more) APA format errors Feedback: |
Show Descriptions Show Feedback
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.–
Levels of Achievement: Excellent 23 (23%) – 25 (25%) 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. Good 20 (20%) – 22 (22%) 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. Fair 18 (18%) – 19 (19%) 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. Poor 0 (0%) – 17 (17%) 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. Feedback:
• 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?–
Levels of Achievement: Excellent 23 (23%) – 25 (25%) 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. Good 20 (20%) – 22 (22%) 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. Fair 18 (18%) – 19 (19%) 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. Poor 0 (0%) – 17 (17%) 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. Feedback:
• 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.–
Levels of Achievement: Excellent 23 (23%) – 25 (25%) The response accurately and concisely uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Good 20 (20%) – 22 (22%) The response accurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Fair 18 (18%) – 19 (19%) The response somewhat vaguely or inaccurately uses either clinical guidelines (if available) or other information from the literature to justify intervention recommendations. Poor 0 (0%) – 17 (17%) 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. Feedback:
• 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.–
Levels of Achievement: Excellent 9 (9%) – 10 (10%) 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. Good 8 (8%) – 8 (8%) The response provides at least three current, evidence-based resources from the literature to support the intervention recommendations. Fair 7 (7%) – 7 (7%) Three evidence-based resources are provided to support the intervention recommendations, but they may only provide vague or weak justification. Poor 0 (0%) – 6 (6%) Two or fewer resources are provided to support the intervention recommendations. The resources may not be current or evidence based. Feedback:
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.–
Levels of Achievement: Excellent 5 (5%) – 5 (5%) 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. Good 4 (4%) – 4 (4%) 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. Fair 3.5 (3.5%) – 3.5 (3.5%) 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. Poor 0 (0%) – 3 (3%) Paragraphs and sentences follow writing standards for flow, continuity, and clarity <60% of the time. No purpose statement, introduction, or conclusion were provided. Feedback:
Written Expression and Formatting – English Writing Standards: Correct grammar, mechanics, and proper punctuation–
Levels of Achievement: Excellent 5 (5%) – 5 (5%) Uses correct grammar, spelling, and punctuation with no errors Good 4 (4%) – 4 (4%) Contains one or two grammar, spelling, and punctuation errors Fair 3.5 (3.5%) – 3.5 (3.5%) Contains several (three or four) grammar, spelling, and punctuation errors Poor 0 (0%) – 3 (3%) Contains many (five or more) grammar, spelling, and punctuation errors that interfere with the reader’s understanding Feedback:
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.–
Levels of Achievement: Excellent 5 (5%) – 5 (5%) Uses correct APA format with no errors Good 4 (4%) – 4 (4%) Contains one or two APA format errors Fair 3.5 (3.5%) – 3.5 (3.5%) Contains several (three or four) APA format errors Poor 0 (0%) – 3 (3%) Contains many (five or more) APA format errors Feedback:
| Total Points: 100 |
|---|
Name: NRNP_6665_Week3_Assignment1_Rubric
,
PLEASE FOLLOW THE INSTRUCTIONS AS INDICATED BELOW:
1). ZERO (0) PLAGIARISM
2). AT LEAST 3 or 5 REFERENCES, NO MORE THAN 5 YEARS (WITHIN 5YRS, OR LESS THAN 5YRS)
3). PLEASE SEE THE ATTACHED RUBRIC DETAILS, the assignment instructions with my assigned specific diagnosis disorder (PERSISTENT DEPRESSIVE DISORDER, inserted at the bottom) and the Writing instruction.
4). Please review and follow the grading rubric details, and include each component in the assignment as required. Also, follow the APA 7 writing rules, style/Format, Title page, Introduction, Purpose statement, Literature Review, Conclusion, References.
Thank you.
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