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What are the risks and benefits of the FDA-approved medicine?
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

Photo Credit: Getty Images/Ingram Publishing

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.

By Day 7 of Week 3

Submit your Assignment.

Submission and Grading Information

To submit your completed Assignment for review and grading, do the following:

· Please save your Assignment using the naming convention “WK3Assgn1+last name+first initial.(extension)” as the name.

· Click the Week 3 Assignment 1 Rubric to review the Grading Criteria for the Assignment.

· Click the Week 3 Assignment 1 link. You will also be able to “View Rubric” for grading criteria from this area.

· Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK3Assgn1+last name+first initial.(extension)” and click Open.

· If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.

· Click on the Submit button to complete your submission.