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.
The recommended FDA-approved drug for the treatment of ADHD in children and adolescents is the dextroamphetamine sulfate (d-alpha-methylphenethylamine). Dextroamphetamine sulfate is a central nervous system stimulant majorly sold under the brand name Zenzedi. It is available in both tablets and oral solution forms and is approved for use in children aged between 3 and 16 years old (Wigal et al., 2020). It is approved for prescription to treat ADHD in children as well as in the management of narcolepsy. It works by increasing dopamine and norepinephrine levels in the brain, therefore helping control symptoms such as inattentiveness and impulsivity and improving attention and focus (Steingard et al., 2019).
Off-label Drug
Extended-release guanfacine is an FDA-approved medication for the management and treatment of high blood pressure in adult patients. However, it is recommended for off-label treatment of ADHD in children and adolescents. It is an effective alternative in children with ADHD who poorly respond to and tolerate psychostimulants (Huss et al., 2016). As an alpha-2 agonist, extended-release guanfacine helps manage ADHD symptoms by reducing sympathetic outflow from the vasomotor center centrally and increasing vagal tone. It, therefore, makes it possible for the child to relax and remain attentive. However, as a drug initially developed for blood pressure and heart rate management, it is important to monitor any heart rate- and blood pressure-related symptoms when used for treating ADHD in children.
Nonpharmacological Intervention
The recommended nonpharmacological intervention for ADHD in children and adolescents is cognitive-behavioral therapy (CBT). CBT is an evidence-based nonpharmacological intervention that has been found to effectively manage ADHD symptoms with a focus on behavioral and cognitive-related symptoms. CBT combines cognitive and behavioral strategies to identify and manage maladaptive behavioral, emotional, and behavioral responses associated with ADHD and help them cope with their condition.
Risk Assessment to Inform Treatment Decision-Making
Both FDA-approved and off-label medicines have varied benefits and risks when used to manage and treat ADHD in children and adolescents. For instance, FDA-approved medications are beneficial in that they are widely tested for effectiveness and safety when treating ADHD in children. However, such medications, as they are major stimulants, increase the risk of developing long-term side effects such as dependency on the drugs and intolerability in young children (Huss et al., 2016; Wigal et al., 2020). On the other hand, off-label drugs are beneficial as safer and more effective alternatives to stimulants and are more tolerable in children. However, they still bear the risk of developing side effects and complications as they are not initially developed for ADHD treatment. It is important to make an assessment of the child before making any treatment decisions, including choosing between using FDA-approved drugs and off-label drugs. The main assessments to inform the treatment decisions include an assessment of the child’s medical and family history of ADHD and other health conditions, current symptoms, the side-effects of the drug options, any allergies the child has, including allergies to the drug components, and any medications the child is currently using or has used previously. This will help avoid any adverse drug interactions and reactions to ensure the child’s safety.