Recommend one FDA approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents

Recommend one FDA approved drug, one off-label drug, and one nonpharmacological intervention for treating

Prescribing for Children and Adolescents

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.

Expert Answer and Explanation

Prescribing for Children and Adolescents

Irritability, defiance and aggressive tendencies are some of the manifestations that are associated with the disruptive, impulse-control and conduct disorders. One of the unique attributes of the condition is that it is prevalent in individuals aged 19 and below. Children or adolescents with the disorder tend to display behaviors that violate societal norms such as hurting others, stealing items, displaying tendency towards the destruction of property, and lacking remorse (Björnsdotter, Ghaderi, & Enebrink, 2020). Effective management of the disorder requires understanding of the medications for treating it including the risks associated with the use of the pharmacological interventions.

FDA-Approved Drug, Off-Label Drug and a Non-pharmacological Intervention for treating Children and Adolescents

One FDA approved drug recommended is Fluoxetine. Fluoxetine is one of the medications that the Food and Drug Administration (FDA) approved for managing symptoms linked to a wide range of disorders including compulsive disorder. As an SSRI medication, Fluoxetine is good for one’s mood, and it makes one less irritable by causing the rise in their brain’s serotonin levels (O’Connor et al., 2020).

Olanzapine is also ideal for the disorder, and despite being an off-label drug, it helps regulate one’s mood by controlling the brain’s dopamine levels (Rybakowski, 2023).

The Cognitive Behavioral Therapy (CBT) is also an ideal intervention for adolescents and children who exhibit signs of impulsive and disruptive behaviors.

The Benefit Risk Assessment (BRA) provides an ideal method for determining the risks of the recommended interventions. Using this method, providers can identify the benefits of each of the proposed treatments including their respective risks, and make appropriate decisions in terms of the ideal treatment option (Masri et al., 2022).

The Risks and Benefits of FDA-Approved Drugs

Although a patient may feel drowsy, and headache and experience seizures and insomnia when they are on Fluoxetine, the medication stabilizes mood. These symptoms are attributed to the rise in the amount of serotonin in one’s brain.

The Risks and benefits of the Off-Label Drug

Despite olanzapine being an effective intervention for adolescents and children with impulsive and disruptive behaviors, it may cause sleepiness and dizziness. In certain cases, patients may develop rush on their body and sometimes add weight.

Whether the Clinical Guidelines exist for the Disorder

While there is lack of a clinical guideline for the behavioral disorder, information is available to providers who may want to learn about the disorder including the approach to managing it. The de-escalation of the medication is one of the things that a provider should consider when working with patients with the disorder if the FDA-approved or the off-label medications cause serious clinical events.

It is also important that they consider the patient’s substance use history because using any of the recommended medications while on behavior-altering substances, can impede treatment or worsen symptoms (Baweja et al., 2021). The other information that is worth considering when using the medications is the patient’s health history, which is crucial in the sense that it minimizes the patient’s risk of developing serious complications.

In conclusion, the Fluoxetine and olanzapine are FDA-approved and off-label medications that a provider may use to treat disruptive, impulse-control and conduct disorder because they regulate one’s mood. Prior to prescribing these medications, a provider should ensure they assess the risks and benefits of these drugs. In addition, they should assess patients’ health status to determine how well they can respond to the medications. This is necessary to prevent the serious health events linked to the use of the drugs.

References

Baweja, R., Waschbusch, D. A., Pelham, W. E., 3rd, Pelham, W. E., Jr, & Waxmonsky, J. G. (2021). The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder. Frontiers in psychiatry, 12, 699687. https://doi.org/10.3389/fpsyt.2021.699687.

Björnsdotter, A., Ghaderi, A., & Enebrink, P. (2020). Cluster Analysis of Child Externalizing and Prosocial Behaviors in a Randomized Effectiveness Trial of the Family-Check Up and Internet-Delivered Parent Training (iComet). Journal for person-oriented research, 6(2), 88–102. https://doi.org/10.17505/jpor.2020.22403.

Masri, H. E., McGuire, T. M., Dalais, C., van Driel, M., Benham, H., & Hollingworth, S. A. (2022). Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies. Journal of the Medical Library Association : JMLA, 110(2), 185–204. https://doi.org/10.5195/jmla.2022.1306.

O’Connor, C., Downs, J., Shetty, H., & McNicholas, F. (2020). Diagnostic trajectories in child and adolescent mental health services: exploring the prevalence and patterns of diagnostic adjustments in an electronic mental health case register. European child & adolescent psychiatry, 29(8), 1111–1123. https://doi.org/10.1007/s00787-019-01428-z.

Rybakowski, J. K. (2023). Application of Antipsychotic Drugs in Mood Disorders. Brain sciences, 13(3), 414. https://doi.org/10.3390/brainsci13030414.

Alternative Expert Answer

Prescribing for Children and Adolescents with ADHD

When prescribing drugs, a clinician has to take into account the risks associated with the medications. This is important to help prevent adverse clinical events which may arise when a provider prescribes certain medications to patients with conditions such as Attention Deficit Hyperactivity Disorder (ADHD). The ADHD starts during the early stages of one’s development, and it is characterized by inability for one to control their behavior, and it may affect one’s attention (Agency for Healthcare Research and Quality, 2015). It is imperative to examine the FDA-approved and off-label drugs in terms of their risks and benefits.

Medication Recommendations

There are a number of options when it comes to the medications and interventions for ADHD in children and adolescents. The Methylphenidate is one of these options, and it is on the list of the medications which the FDA approved to treat the disorder. The off-label drug, dexmethylphenidate also treats the disorder. It works by controlling the impulses in the central nervous system, and putting the hyperactivity process under control. Both of these two medications are taken orally.

For the non-pharmacological treatment, a clinician can use cognitive behavioral therapy (CBT). The use of this intervention is to help the patient alter their behaviors and though patterns (Agency for Healthcare Research and Quality, 2015).

Risk Assessment to use

The Drug-Associated Risk Assessment tool provides a framework for examining the drug-based risks and complications. The tool incorporates self-administered questionnaire, and it assesses whether the patients have a history of drug allergies or have had adverse medication events. One of the key advantages associated with the tool is that it provides reliable details about the patient, and a provider informed by these details, can administer treatment that poses fewer side effects (Snyder et al., 2015).

Risks and Benefits of FDA-Approved Medicine

Although the use of the methylphenidate can result to significant benefits to the patient, the use of the drug can pose certain risks. When a patient with ADHD takes the drug, they can manage their behavior, be focused and attentive. Still, it yields fast results, and within two weeks, a child with the disorder may experience full recovery. However, the medication can exacerbate hypertension in patients with this cardiovascular disorder (Maneeton et al., 2015). It can also cause an increase in the heart rate, and this can be dangerous to a patient with a heart ailment.

Risks and Benefits of Off-Label Drug

Just like the FDA-approved drug, the dexmethylphenidate exhibits desirable and undesirable attributes. When one takes the medication, it stimulates their central nervous system, and if taken regularly, it can help improve one’s attention. It equally helps one to focus. However, taking the medication can cause restlessness, and headache (Briars & Todd, 2016). This means that a person with migraines can have a difficult time dealing with the side effects of the drug.

Whether the Clinical Guidelines Exist

The clinical guidelines for managing the ADHD exist. The diagnosis, treatment and evaluation should follow the required protocol, and be guided by the evidence-based practice. The child’s behavior or academic issues should inform the decision to perform ADHD assessment (CDC, 2020).

Conclusion

In conclusion, various medications can exhibit benefits as well as risks, and it is imperative that providers perform assessment to determine the degree of risks of the medications. This is vital because a provider can make changes to the intervention if they know that administering certain medication may cause serious allergic reactions. Methylphenidate and dexmethylphenidate are some of the available options for treating ADHD.

References

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.

Briars, L., & Todd, T. (2016). A Review of Pharmacological Management of Attention-Deficit/Hyperactivity Disorder. The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 21(3), 192–206. Doi: https://doi.org/10.5863/1551-6776-21.3.192.

CDC. (2020). ADHD Treatment Recommendations. https://www.cdc.gov/ncbddd/adhd/guidelines.html.

Maneeton, N., Maneeton, B., Woottiluk, P., Suttajit, S., Likhitsathian, S., Charnsil, C., & Srisurapanont, M. (2015). Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials. Neuropsychiatric disease and treatment, 11, 2943–2952. Doi:  https://doi.org/10.2147/NDT.S91765.

Snyder, M. E., Pater, K. S., Frail, C. K., Hudmon, K. S., Doebbeling, B. N., & Smith, R. B. (2015). Utility of a brief screening tool for medication-related problems. Research in social & administrative pharmacy : RSAP, 11(2), 253–264.Doi: https://doi.org/10.1016/j.sapharm.2014.08.005.

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