Assignment: Off-Label Drug Use in Pediatrics
Assignment: Off-Label Drug Use in Pediatrics
The circumstances for prescribing drugs for off-label use by children
Off-Label Use of drugs occurs when patients are given drugs by doctors without the approval of the Food and Drugs Administration (FDA). A patient is sometimes given drugs that were approved to treat another condition that is different from theirs. According to research, three-fourths of prescribed drugs do not have pediatric use information (Frattarelli et al., 2014).In most cases, children are the main victims of off-label drugs prescription due to unavoidable reasons. One of the reasons is that doctors tend to think that a specific drug is effective to a child even if it is not yet approved by the FDA. This mainly happens because information on drug use in children is rarely found, and therefore this gives health workers a hard time. Off-label drugs are useful in saving children’s lives (Jain et al., 2017). Some diseases like Asthma and Allergies do not have a specific medication for curing the patient but, doctors have prescribed some children to off-label use of drugs in such cases, and the patients tend to show much improvement. For example, there was evidence that showed that aspirin could prevent a second heart attack, and doctors prescribed it as off-label. It was effective, but it took a long time before it was approved.
Strategies for making off-label drugs safer for Children
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Off-label drugs are commonly used by many pediatrics in the world, and so there is a need to make them safer for use. There are various strategies that can be used to make off-label drugs safer. One of the strategies is by controlling and managing the promotion of drugs such as prazosin. When it is controlled, the drugs will be used in a minimal number. Another way of making the off-label drugs safer is by creating awareness about the drugs, telling people the advantages and the disadvantages of using the drugs (Pandolfini & Bonati 2016). Another strategy is by reducing the promotion of off-label drugs at the manufacturer level; this is effective because if they are not manufactured, they will not be available in the market for consumption. The restriction is always another way of dealing with off-label drugs such as clomiphene; for example, if strict safety measures are used, people will not use the drugs (W’t Jong et al., 2015). The government also can help in this by banning the use of off-label memantine drugs and enacting laws that can help to address this issue; nothing tends to be more effective than law.
References
Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Neville, K. A., Paul, I. M., & Van,
- D. A. (2014). Off-label use of drugs in children. Pediatrics, 133(3), 563-567.
Jain, S. S., Bavdekar, S. B., Gogtay, N. J., & Sadawarte, P. A. (2017). Off-label drug use in
children. The Indian Journal of Pediatrics, 75(11), 1133.
Pandolfini, C., & Bonati, M. (2016). A literature review on off-label drug use in
children. European journal of pediatrics, 164(9), 552-558.
W’t Jong, G., Vulto, A. G., de Hoog, M., Schimmel, K. J., Tibboel, D., & van den Anker, J. N.
(2015). A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics, 108(5), 1089-1093.
Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?
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This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings.
Learning Objectives
Students will:
- Evaluate the practice of prescribing off-label drugs to children
- Analyze strategies to make the off-label use of drugs safer for children
- Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders
Learning Resources
Assignment: 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.
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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.
Assignment: Off-Label Drug Use 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). All papers submitted must use this formatting.
Submission and Grading Information
To submit your completed Assignment for review and grading, do the following:
- Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)†as the name.
- Click the Week 11 Assignment Rubric to review the Grading Criteria for the Assignment.
- Click the Week 11 Assignment link. You will also be able to “View Rubric†for grading criteria from this area.
- Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)†and click Open.
- If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
- Click on the Submit button to complete your submission.
Grading Criteria
To access your rubric:
Week 11 Assignment Rubric
Check Your Assignment Draft for Authenticity
To check your Assignment draft for authenticity:
Submit your Week 11 Assignment draft and review the originality report.
Submit Your Assignment by Day 7 of Week 11
To participate in this Assignment:
Week 11 Assignment
Final Exam
This Exam covers the content you have explored throughout this course.
This exam is a test of your knowledge in preparation for your certification exam. No outside resources—including books, notes, websites, or any other type of resource—are to be used to complete this exam. You are not allowed to take screenshots or record the exam questions in any other format while taking the exam. You are expected to comply with Walden University’s Code of Conduct.
Photo Credit: Getty Images
By Day 7 of Week 11
Complete the Final Exam. You have 120 minutes to complete the exam. You may only attempt this exam once.
Submission and Grading Information
Complete the Exam by Day 7 of Week 11
To Complete this Exam:
Week 11 Exam
Module in Review
In this module, you evaluated the practice and circumstances of prescribing off-label drugs to children and analyzed the strategies used to make their use and dosage safer for children. After you have completed the Discussion and the Final Exam for this week, you have finished the course. Congratulations! Please complete the Course Evaluation form and submit by Day 7.
Congratulations! After you have finished all of the assignments for this week, you have completed the course. Please submit your Course Evaluation by Day 7.
Assignment: Off-Label Drug Use in Pediatrics