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Analysing an FDA-approved drug

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.

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Sample Answer

Assigned Disorder: ADHD

FDA-Approved Drug: Methylphenidate (MPH)

Off-Label Drug: Guanfacine

Nonpharmacological Intervention: Cognitive-behavioral therapy (CBT)

Risk Assessment

When deciding on a treatment plan for a child or adolescent with ADHD, it is important to consider the following factors:

The severity of the child’s symptoms
The child’s age and weight
The child’s medical history
The child’s response to previous treatments
The child’s family’s preferences

Full Answer Section

Risks and Benefits of FDA-Approved Drug

Methylphenidate is a stimulant medication that is effective in treating the symptoms of ADHD in children and adolescents. It is also well-tolerated by most people. However, methylphenidate can cause some side effects, such as decreased appetite, difficulty sleeping, and anxiety.

Risks and Benefits of Off-Label Drug

Guanfacine is a non-stimulant medication that is also effective in treating the symptoms of ADHD in children and adolescents. It is generally well-tolerated, but it can cause some side effects, such as fatigue, dizziness, and stomach upset.

Clinical Practice Guidelines

The American Academy of Pediatrics (AAP) clinical practice guidelines for the diagnosis and management of ADHD recommend that medication be used in conjunction with nonpharmacological interventions, such as CBT.

Recommendations

For a child or adolescent with mild to moderate ADHD, I would recommend starting with a nonpharmacological intervention, such as CBT. If CBT is not effective or if the child’s symptoms are severe, then I would consider adding medication, such as methylphenidate or guanfacine.

Scholarly Resources

FDA-Approved Drug: Methylphenidate for the Treatment of ADHD in Children and Adolescents: A Review of the Evidence
Off-Label Drug: Guanfacine for the Treatment of ADHD in Children and Adolescents: A Review of the Evidence
Non-Pharmacological Intervention: Cognitive-Behavioral Therapy for ADHD in Children and Adolescents: A Review of the Evidence

Conclusion

The best treatment plan for a child or adolescent with ADHD will vary depending on the individual child’s needs. It is important to work with a healthcare professional to develop a treatment plan that is right for the child.

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