FDA-approved drug, one off-label drug, and one nonpharmacological intervention
• 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.
Sample Answer
General Approach to Treatment Decision-Making and Risk Assessment
1. Identify the Disorder:
- Clearly define the disorder and its specific symptoms.
- Consider the child or adolescent’s age, developmental stage, and any co-occurring conditions.
2. Assess the Severity of Symptoms:
- Evaluate the impact of the disorder on the child’s quality of life, academic performance, and social interactions.
- Determine the urgency of treatment and the potential for long-term consequences.
3. Consider the Risk-Benefit Ratio:
- FDA-Approved Drug:
- Benefits: Efficacy, safety profile, and potential for long-term improvement.
- Risks: Side effects, drug interactions, and potential for addiction or misuse.
- Off-Label Drug:
- Benefits: Potential efficacy for the specific disorder, especially when FDA-approved options are limited or ineffective.
- Risks: Lack of rigorous clinical trials, uncertainty about long-term effects, and potential for adverse reactions.