Assignment: Off-Label Drug Use in Pediatrics

PLEASE FOLLOW THE INSTRUCTIONS BELOW: 

ZERO (0) PLAGIARISM

5 REFERENCES NO MORE THAN 5 YEARS, OR LESS

PLEASE SEE ATTACHED RUBRIC DETAILS AND FOLLOW APA FORMAT.

NO RUNNING HEAD, AND PLEASE ADHERE TO THE ONE (1) PAGE AS INSTRUCTED

The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.

When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.

 Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group.

To Prepare
  • Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
  • Reflect on situations in which children should be prescribed drugs for off-label use.
  • Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.

Write a 1-page narrative in APA format that addresses the following:

  • Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
  • Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression

African American Child

BACKGROUND INFORMATION

The client is an 8-year-old African American male who arrives at the ER with his mother. He is exhibiting signs of depression.

  • Client complained of feeling “sad”
  • Mother reports that teacher said child is withdrawn from peers in class
  • Mother notes decreased appetite and occasional periods of irritation
  • Client reached all developmental landmarks at appropriate ages
  • Physical exam unremarkable
  • Laboratory studies WNL
  • Child referred to psychiatry for evaluation

MENTAL STATUS EXAM

Alert & oriented X 3, speech clear, coherent, goal directed, spontaneous. Self-reported mood is “sad”. Affect somewhat blunted, but child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes noted. Judgment and insight appear to be age-appropriate. He is not endorsing active suicidal ideation, but does admit that he often thinks about himself being dead and what it would be like to be dead.

You administer the Children’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)

RESOURCES

§ Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.

ALL THREE MEDICATIONS ARE PROVIDED BELOW AND DECISION POINTS TO FOLLOW. 

 Decision Point One

Begin Zoloft 25 mg orally daily

RESULTS OF DECISION POINT ONE

  • Client returns to clinic in four weeks
  • No change in depressive symptoms at all

Decision Point Two

Increase dose to 37.5 mg orally daily

RESULTS OF DECISION POINT TWO

  • Client returns to clinic in four weeks
  • Depressive symptoms decrease by 20%. Client reports feeling a little bit better

Decision Point Three

Increase to 50 mg orally daily

Guidance to Student
At this point, sufficient symptom reduction has not been realized. Should either increase dose or consider different SSRI. At 8 weeks post-initiation of therapy, there should have been a significant (as defined as 50%) decrease in symptoms. This would be considered an adequate trial of antidepressant and change in dose or to a different agent would be appropriate.

  Decision Point One

Begin Paxil 10 mg orally daily

RESULTS OF DECISION POINT ONE

  • Client returns to clinic in four weeks
  • Reduction in The Children’s Depression Rating Scale by 5 points overall, but with complaints of nausea, vomiting, and diarrhea

Decision Point Two

Change to Prozac 10 mg orally daily

RESULTS OF DECISION POINT TWO

  • Client returns to clinic in four weeks
  • There is a 25% reduction in symptoms, client’s side effects of nausea, vomiting, and diarrhea have resolved. Client reports that he is feeling a “little bit better”

Decision Point Three

Continue current dose

Guidance to Student
You have two equally compelling choices at this point. The client has only been taking the current drug at its current dose for 4 weeks. It would be appropriate to continue at current dose. Additionally, you could also increase the dose to 20 mg orally daily. A discussion of risk/benefits should be had with the childs guardian regarding this and collaborative decision making should occur. There is no indication at this point that augmentation agents are required as the child is showing a partial response to therapy.

 Decision Point One

Begin Wellbutrin 75 mg orally BID

RESULTS OF DECISION POINT ONE

  • Client returns to clinic in four weeks
  • Child is unable to fall asleep at night

Decision Point Two

Change to Lexapro 10 mg orally daily

RESULTS OF DECISION POINT TWO

  • Client returns to clinic in four weeks
  • Child is tolerating Lexapro, and is sleeping at night. There is a 40% reduction in symptoms

Decision Point Three

Continue current dose

Guidance to Student
At this point, there is no indicating that you should change back to Wellbutrin as the child is tolerating the current medication without mention of side effects. Also, the child is experiencing a reduction in symptoms. You could also increase the dose to 15 mg orally daily, but the child has only been taking the drug for 4 weeks at this point. It may be more prudent to give the current therapy an additional 4 weeks before making any decisions to change current dose.

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