Assignment: Off-Label Drug Use In Pediatrics

Assignment: Off-Label Drug Use In Pediatrics

 PLEASE FOLLOW THE INSTRUCTIONS AS INDICATED BELOW
1). ZERO (0) PLAGIARISM
2). ATLEAST 5 REFERENCES, NO MORE THAN 5 YEARS (WITHIN 5YRS, OR LESS THAN 5YRS)
3).  PLEASE SEE THE ATTACHMENT FOR RUBRIC DETAILS AND RECOMMENDED WRITING TEMPLATE AND APA 7 STYLE.
4). Please review and follow the grading rubric details, and include each component in the assignment as required. Also, follow the APA writing rules and style, Title page, summary, Conclusion, References. 
5) Please, Include the Title page, Introduction, purpose statement, Literature Review, conclusion, and reference page. 
Thank you very much.
 
 
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 the 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.
PLEASE NOTE BELOW:
I have provided all the decision points about the drugs. Decisions point one is to pick one medication to begin, either Zoloft, Paxil, or Wellbutrin. I provided all decision points under each drug to follow if any changes are to be made.
For Zoloft:
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 Zoloft 50 mg orally daily
RESULTS OF DECISION POINT TWO

  • Client returns to clinic in four weeks
  • Depressive symptoms decrease by 50%. Client tolerating well

Decision Point Three
Maintain current dose

Guidance to Student
At this point, sufficient symptom reduction has been achieved. This is considered a “response” to therapy. Can continue with current dose for additional 4 week to see if any further reductions in depressive symptoms are noted. An increase in dose may be warranted since this is not “full” remission- Discuss pros/cons of increasing drug dose with client at this time and empower the client to be part of the decision. There is no indication that the drug therapy should be changed to an SNRI at this point as the client is clearly responding to this therapy.

For Paxil:
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.

For  Wellbutrin:
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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Assignment: Off-Label Drug Use In Pediatrics

 

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