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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  • Discussion Questions (DQ)

Initial responses to the DQ should address all components of the questions asked, including a minimum of one scholarly source, and be at least 250 words. Successful responses are substantive (i.e., add something new to the discussion, engage others in the discussion, well-developed idea) and include at least one scholarly source. One or two-sentence responses, simple statements of agreement or “good post,” and responses that are off-topic will not count as substantive. Substantive responses should be at least 150 words. I encourage you to incorporate the readings from the week (as applicable) into your responses.

  • Weekly Participation

Your initial responses to the mandatory DQ do not count toward participation and are graded separately. In addition to the DQ responses, you must post at least one reply to peers (or me) on three separate days, for a total of three replies. Participation posts do not require a scholarly source/citation (unless you cite someone else’s work). Part of your weekly participation includes viewing the weekly announcement and attesting to watching it in the comments. These announcements are made to ensure you understand everything that is due during the week.

  • APA Format and Writing Quality

Familiarize yourself with the APA format and practice using it correctly. It is used for most writing assignments for your degree. Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for APA paper templates, citation examples, tips, etc. Points will be deducted for poor use of APA format or absence of APA format (if required). Cite all sources of information! When in doubt, cite the source. Paraphrasing also requires a citation. I highly recommend using the APA Publication Manual, 6th edition.

  • Use of Direct Quotes

I discourage over-utilization of direct quotes in DQs and assignments at the Master’s level and deduct points accordingly. As Masters’ level students, it is important that you be able to critically analyze and interpret information from journal articles and other resources. Simply restating someone else’s words does not demonstrate an understanding of the content or critical analysis of the content. It is best to paraphrase content and cite your source.

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For assignments that need to be submitted to Lopes Write, please be sure you have received your report and Similarity Index (SI) percentage BEFORE you do a “final submit” to me. Once you have received your report, please review it. This report will show you grammatical, punctuation, and spelling errors that can easily be fixed. Take the extra few minutes to review instead of getting counted off for these mistakes. Review your similarities. Did you forget to cite something? Did you not paraphrase well enough? Is your paper made up of someone else’s thoughts more than your own? Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for tips on improving your paper and SI score.

  • Late Policy

The university’s policy on late assignments is a 10% penalty PER DAY LATE. This also applies to late DQ replies. Please communicate with me if you anticipate having to submit an assignment late. I am happy to be flexible, with advance notice. We may be able to work out an extension based on extenuating circumstances. If you do not communicate with me before submitting an assignment late, the GCU late policy will be in effect. I do not accept assignments that are two or more weeks late unless we have worked out an extension. As per policy, no assignments are accepted after the last day of class. Any assignment submitted after midnight on the last day of class will not be accepted for grading.

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Communication is so very important. There are multiple ways to communicate with me: Questions to Instructor Forum: This is a great place to ask course content or assignment questions. If you have a question, there is a good chance one of your peers does as well. This is a public forum for the class. Individual Forum: This is a private forum to ask me questions or send me messages. This will be checked at least once every 24 hours.

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