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Sample Answer for NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS Included After Question
NURS 6521 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.
Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.
- 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.
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OFF-LABEL DRUG USE IN PEDIATRICS Rubric
|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.
|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.
|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.
|This criterion is linked to a Learning OutcomeWritten Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation
|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.
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.
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.
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