NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

Sample Answer for NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS Included After Question

NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

OFF-LABEL DRUG USE IN PEDIATRICS 

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. 

RESOURCES 

NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS
NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.  

WEEKLY RESOURCES 

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. 

BY DAY 5 OF WEEK 11 

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. 

Reminder: The College of Nursing requires that all papers submitted include a title page, introduction, summary, and references. The Sample Paper provided at the Walden Writing Center offers an example of those required elements (available at http://writingcenter.waldenu.edu/57.htm Links to an external site.). All papers submitted must use this formatting. 

SUBMISSION INFORMATION 

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  1. To submit your completed assignment, save your Assignment as WK11Assgn_LastName_Firstinitial 
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Rubric 

OFF-LABEL DRUG USE IN PEDIATRICS Rubric 

NURS_6521_Week11_Assignment_Rubric 
Criteria  Ratings  Pts 
This criterion is linked to a Learning OutcomeExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. 
40 to >35.0 pts 

Excellent 

The response accurately and thoroughly explains in detail the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate and specific examples that fully support the explanation provided. 

35 to >31.0 pts 

Good 

The response accurately explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate examples that support the explanation provided. 

31 to >27.0 pts 

Fair 

The response inaccurately or vaguely explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes inaccurate or vague examples that may or may not support the explanation provided. 

27 to >0 pts 

Poor 

The response inaccurately and vaguely explains the circumstances under which children should be prescribed drugs for off-label use, or is missing. … The response includes inaccurate and vague examples that do not support the explanation provided, or is missing. 

 

40 pts 
This criterion is linked to a Learning OutcomeExplain strategies to making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific. 
45 to >40.0 pts 

Excellent 

The response accurately and clearly describes in detail strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate, complete, and detailed descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 

40 to >35.0 pts 

Good 

The response accurately describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 

35 to >31.0 pts 

Fair 

The response inaccurately or vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes inaccurate or vague descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 

31 to >0 pts 

Poor 

The response inaccurately and vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, or is missing. … The response includes inaccurate and vague or incomplete descriptions and names of off-label drugs that require extra care and attention when used in pediatrics, or is missing. 

 

45 pts 
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused–neither long and rambling nor short and lacking substance. 
5 to >4.0 pts 

Excellent 

Paragraphs and sentences follow writing standards for flow, continuity, and clarity. 

4 to >3.5 pts 

Good 

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. 

3.5 to >3.0 pts 

Fair 

Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. 

3 to >0 pts 

Poor 

Paragraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time. 

 

5 pts 
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation 
5 to >4.0 pts 

Excellent 

Uses correct grammar, spelling, and punctuation with no errors 

4 to >3.5 pts 

Good 

Contains a few (1–2) grammar, spelling, and punctuation errors 

3.5 to >3.0 pts 

Fair 

Contains several (3–4) grammar, spelling, and punctuation errors 

3 to >0 pts 

Poor 

Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding 

 

5 pts 
This criterion is linked to a Learning OutcomeWritten Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, running head, parenthetical/in-text citations, and reference list. 
5 to >4.0 pts 

Excellent 

Uses correct APA format with no errors 

4 to >3.5 pts 

Good 

Contains a few (1–2) APA format errors 

3.5 to >3.0 pts 

Fair 

Contains several (3–4) APA format errors 

3 to >0 pts 

Poor 

Contains many (≥ 5) APA format errors 

 

5 pts 

 

 

 

A Sample Answer For the Assignment: NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

Title: NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

NURS 6521 Off-Label Drug Use In Pediatrics  

Off-label drug use entails prescribing medications for indications other than those approved by the FDA. It also involves using a dose or dosage form not approved by the FDA. Off-label drug use has become common because the FDA does not regulate clinical practice. The purpose of this paper is to discuss off-label prescribing in pediatrics. 

Prescribing Children Drugs for Off-Label Use 

Off-label drug prescribing in pediatrics should only be practiced if no drug is approved to treat a specific condition for that age group. van der Zanden et al. (2021) explain that a specific and unmet medical need should inform off-label drug use in children.  

In addition, off-label prescribing should be done in the face of a life-threatening or terminal medical illness, where the clinician prescribed any logical and available treatment, approved by the FDA or not. Off-label drug use can also be practiced if one drug from a particular class has FDA approval.  

Strategies to Make The Off-Label Use and Dosage of Drugs Safer For Children 

Off-label prescribing can be made safe for pediatrics by conducting a risk-benefit assessment of the intended medication and using age-appropriate dosing recommendations. Besides, alternative treatment options should be compared to identify the safest yet most effective drug for a specific age and condition (van der Zanden et al., 2021). Off-label drugs that should be prescribed with caution in pediatrics include cardiovascular medications like Amlodipine and Lisinopril since they risk causing hemodynamic instability in under or overdose (Rusz et al., 2021). Sedatives like ketamine and lorazepam also need caution since they have long-term adverse effects on the CNS in children.  

Conclusion 

Off-label drug use in children is indicated when a medical condition requires drug treatment for which no licensed medications are available or for which treatment with approved drugs is not effective or suitable. A risk-benefit assessment of an off-label drug can make off-label drug use safer for pediatrics. Cardiovascular drugs and sedatives should be used with caution in pediatrics.  

 

References 

Rusz, C. M., Ősz, B. E., Jîtcă, G., Miklos, A., Bătrînu, M. G., & Imre, S. (2021). Off-Label Medication: From a Simple Concept to Complex Practical Aspects. International journal of environmental research and public health, 18(19), 10447. https://doi.org/10.3390/ijerph181910447 

van der Zanden, T. M., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., … & de Wildt, S. N. (2021). Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework. Clinical Pharmacology and Therapeutics, 110(4), 952-965. https://doi.org/10.1002/cpt.2336