NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Walden University NURS 6521 Assignment: Off-Label Drug Use in Pediatrics-Step-By-Step Guide
This guide will demonstrate how to complete the Walden University NURS 6521 Assignment: Off-Label Drug Use in Pediatrics assignment based on general principles of academic writing. Here, we will show you the A, B, Cs of completing an academic paper, irrespective of the instructions. After guiding you through what to do, the guide will leave one or two sample essays at the end to highlight the various sections discussed below.
How to Research and Prepare for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Whether one passes or fails an academic assignment such as the Walden University NURS 6521 Assignment: Off-Label Drug Use in Pediatrics depends on the preparation done beforehand. The first thing to do once you receive an assignment is to quickly skim through the requirements. Once that is done, start going through the instructions one by one to clearly understand what the instructor wants. The most important thing here is to understand the required format—whether it is APA, MLA, Chicago, etc.
After understanding the requirements of the paper, the next phase is to gather relevant materials. The first place to start the research process is the weekly resources. Go through the resources provided in the instructions to determine which ones fit the assignment. After reviewing the provided resources, use the university library to search for additional resources. After gathering sufficient and necessary resources, you are now ready to start drafting your paper.
How to Write the Introduction for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
The introduction for the Walden University NURS 6521 Assignment: Off-Label Drug Use in Pediatrics is where you tell the instructor what your paper will encompass. In three to four statements, highlight the important points that will form the basis of your paper. Here, you can include statistics to show the importance of the topic you will be discussing. At the end of the introduction, write a clear purpose statement outlining what exactly will be contained in the paper. This statement will start with “The purpose of this paper…” and then proceed to outline the various sections of the instructions.
How to Write the Body for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
After the introduction, move into the main part of the NURS 6521 Assignment: Off-Label Drug Use in Pediatrics assignment, which is the body. Given that the paper you will be writing is not experimental, the way you organize the headings and subheadings of your paper is critically important. In some cases, you might have to use more subheadings to properly organize the assignment. The organization will depend on the rubric provided. Carefully examine the rubric, as it will contain all the detailed requirements of the assignment. Sometimes, the rubric will have information that the normal instructions lack.
Another important factor to consider at this point is how to do citations. In-text citations are fundamental as they support the arguments and points you make in the paper. At this point, the resources gathered at the beginning will come in handy. Integrating the ideas of the authors with your own will ensure that you produce a comprehensive paper. Also, follow the given citation format. In most cases, APA 7 is the preferred format for nursing assignments.
How to Write the Conclusion for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
After completing the main sections, write the conclusion of your paper. The conclusion is a summary of the main points you made in your paper. However, you need to rewrite the points and not simply copy and paste them. By restating the points from each subheading, you will provide a nuanced overview of the assignment to the reader.
How to Format the References List for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
The very last part of your paper involves listing the sources used in your paper. These sources should be listed in alphabetical order and double-spaced. Additionally, use a hanging indent for each source that appears in this list. Lastly, only the sources cited within the body of the paper should appear here.
Stuck? Let Us Help You
Completing assignments can sometimes be overwhelming, especially with the multitude of academic and personal responsibilities you may have. If you find yourself stuck or unsure at any point in the process, don’t hesitate to reach out for professional assistance. Our assignment writing services are designed to help you achieve your academic goals with ease.
Our team of experienced writers is well-versed in academic writing and familiar with the specific requirements of the NURS 6521 Assignment: Off-Label Drug Use in Pediatrics assignment. We can provide you with personalized support, ensuring your assignment is well-researched, properly formatted, and thoroughly edited. Get a feel of the quality we guarantee – ORDER NOW.
Sample Answer for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Situations When Off-Label Medications May be Used in Pediatrics
There are specific situations when medications in the regard of off-label medications can be given to children. For instance, whenever a drug which is meant to manage a particular condition has been used without demonstrable success, a physician can choose a different alternative to save the day (“Off-Label use of Medicines in Children,” n.d.). A physician may be compelled to prescribe a drug to a pediatric when a particular formulation is available in a different country in another possible scenario. Yet there are acute shortages in their areas of jurisdiction. On the other hand, the physician can make an importation request for a drug used in another country for adults but for children in their country (Allen et al., 2018). Examples of the off-label medications used in children include amoxicillin, used for different conditions, including otitis media. There are specific medications which are high risk and should be used with caution in paediatrics, including dopamine, hydromorphone, oxycodone and lorazepam (Czaja et al., 2015). The medication could cause pronounced psychological effects or even unforeseen death.
Strategies for Off-label Medications for Pediatrics
Whenever off-label medications are used in children, there ought to be strategies to ensure they attain the best possible outcomes with minimal adverse effects. More clinical trials should be considered but within the safety and ethical parameters in children to establish the efficacy of medications (Tefera et al., 2017). The healthcare providers, the nurses, physicians and pharmacists should have efficient reporting methods and address the occurrence of adverse effects in children, which would then enhance the use of the medications.
References
Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … DeLeon, S. (2018). Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/31379392
Czaja, A. S., Reiter, P. D., Schultz, M. L., & Valuck, R. J. (2015). Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research. Journal of Pediatric Pharmacology and Therapeutics, 20(3), 186–196. https://doi.org/10.5863/1551-6776-20.3.186
OFF-LABEL USE OF MEDICINES IN CHILDREN | INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH. (n.d.). Retrieved February 2, 2021, from https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext
Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off-label drug use in hospitalized children: A prospective observational study at gondar university referral hospital, northwestern Ethiopia. Pharmacology Research and Perspectives, 5(2), 304. https://doi.org/10.1002/prp2.304
Sample Answer 2 for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Circumstances under which children should be prescribed drugs for off-label use
Off-label prescribing is common in pediatrics due to the unavailability of standard therapeutic options for a specific condition or disease for children. Off-label drugs should be used in children if they are experiencing a serious condition for which there is no alternative approved by the FDA and there is evidence on the safety and efficacy of the drug. According to Hoon et al. (2019), off-label prescribing is legal and can be a representation of the best practice based on clinical experience along with supporting evidence of efficacy and safety, especially if labeled alternatives do not exist. For example, enalapril is approved by FDA for heart failure and hypertension in adults and only for hypertension in children. Nevertheless, enalapril is frequently utilized in the treatment of heart failure in pediatrics.
Children should be prescribed off-label drugs when the benefits of using the medications exceed the risks. According to Shanshal and Hussain (2021), when proscribing off-label drugs to children, physicians must examine all information about the medication, determine risk tolerance, and ensure the promising benefits exceed the potential risks for the individual child. Strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, Off-label usage and dosage can be made safe for children by conducting comprehensive drug development studies to evaluate optimal dosing, safety, pharmacokinetics, and efficacy of medications in pediatric patients. Allen et al.92018) pointed out that more age-specific research in children is essential to provide children with adequate drug efficacy and safety. Until more data is available, clinicians should base their decisions on the best available evidence.
Also, practitioners should be encouraged to perform due diligence about the use of off-label use drugs in pediatrics and report adverse drug events. Shanshal and Hussain, (2021) allege that physicians must be aware of the frequently prescribed off-label medications in pediatric patients and be wary of the known potential adverse reactions and side effects. Off-label drugs that require extra care and attention when used in pediatrics Off-label drugs that cause serious adverse drug events need extra attention and care when utilized in pediatric patients. According to Oshikoya et al.(2019), serious adverse events refer to an adverse drug experience that occurs at any dosage that leads to a life-threatening condign, death, significant incapacity or disability, or other event necessitating intervention. Fentanyl and azithromycin are used off-label in pediatric patients in ICUs but they can cause respiratory depression. Practitioners caring for children utilizing these drugs in ICUs must closely watch and monitor children, notably for respiratory events.
References
Allen, H. C., Carbe, M. C., Lees, J., Aiz, N., Chaaban, H., Miller, J. L, Johnson, P., & DeLeon, S. (20118). Off-Label Medications use in Children, More Common that We Think: A Systematic Review Of the Literature. Oklahoma State Medical Association, 111(8), 776-783. Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Storm, B. L., & Horton, D. B. (2019). Trends in Off-Label Drug Use in Ambulatory Settings: 2006-205. Pediatrics, 144 (4) e20190896. https://doi.org/10.1542/peds.2019-0896 Oshikoya, K. A., Wharton, G. T., Avant, D….McMahon, A. W. (2019). Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A retrospective Chart Review. Pediatric Drugs, 21, 47-58. https://doi.org/10.1007/s40272-018-0318-9 Shanshal, A. M. & Hussain, S. A. (2021). Off-label Prescribing Practice in Pediatric Settings: Pros and Cons. Systematic Reviews in Pharmacy, 12(1), 1267-175.
Sample Answer 3 for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
The use of off-label medications is a common practice in pediatric patients. The practice is associated with increased risk of harm to the patients because of inadequate evidence-based data on their use. Therefore, this paper examines circumstances that may lead to off-label prescribing to pediatric patients and safety strategies to be considered.
Circumstances
There are circumstances under which children should be prescribed off-label medications. One of them is a situation where the healthcare providers are managing unapproved disorder that does not have approved medications. In such cases, physicians prescribe medications that have proven effective among the adult populations for a similar disorder at a lower dose. The other circumstance is when the healthcare practitioners have in-depth understanding of the pediatric patients’ disease process and the effectiveness of off-label drugs. They prescribe off-label medications to benefit the patients while utilizing their professional judgment to improve the care outcomes in pediatric patients (van der Zanden et al., 2021). For example, physicians prescribe ketamine for pediatric patients admitted to the intensive care unit despite it not being a FDA-approved drug of choice for this population.
Strategies
Healthcare practitioners should consider several strategies to ensure that off-label drugs are safe for children from infancy to adolescence. One of the strategies is by relying on the existing evidence when prescribing the off-label medications. Practitioners should critique the evidence obtained from high-quality studies and use them to inform their prescription decisions when treating pediatric patients. The other strategy is by considering ethics of practice. The decisions to treat pediatrics with off-label drugs should be informed by the principles of ensuring safety, justice, and quality outcomes for the patients (García-López et al., 2020; Hoekstra & Dietrich, 2022).
The other strategy is considering the influence of patient factors such as age on the pharmacological processes of the drugs prescribed to pediatric patients. The pharmacodynamic and pharmacotherapeutic processes in adult differ from that seen in pediatric patients. Therefore, practitioners should make decisions such as lowering the dosage and frequency of off-label medications as compared to adult doses to ensure safety and quality outcomes (Hoon et al., 2019). Some of the off-label drugs that should be prescribed with care for pediatric patients include hydromorphone, ketamine, and dexmedetomidine, which can be fatal is poorly used.
Conclusion
In conclusion, off-label medications are largely used in pediatric patients. The use is attributable to the lack of adequate data on the efficacy of different treatments for pediatric conditions. Practitioners should consider strategies for ensuring safety in the prescription of off-label medications. In addition, they should make their treatment decisions based on evidence-based data and guidelines.
References
García-López, I., Cuervas-Mons Vendrell, M., Martín Romero, I., de Noriega, I., Benedí González, J., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: A prospective observational study. Journal of Pain and Symptom Management, 60(5), 923–932. https://doi.org/10.1016/j.jpainsymman.2020.06.014
Hoekstra, P. J., & Dietrich, A. (2022). First do no harm: Use off-label antipsychotic medication in children and adolescents with great caution. European Child & Adolescent Psychiatry, 31(1), 1–3. https://doi.org/10.1007/s00787-022-01950-7
Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Strom, B. L., & Horton, D. B. (2019). Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics, 144(4), e20190896. https://doi.org/10.1542/peds.2019-0896
van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., de Hoog, M., & de Wildt, S. N. (2021). Benefit-risk assessment of off-label drug use in children: The bravo framework. Clinical Pharmacology & Therapeutics, 110(4), 952–965. https://doi.org/10.1002/cpt.2336
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.
Also Read:
NURS 6521: Basic Pharmacotherapeutic Concepts
Resources
Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the 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
Before submitting your final assignment, you can check your draft for authenticity. To check your draft, access the Turnitin Drafts from the Start Here area.
- To submit your completed assignment, save your Assignment as WK11Assgn_LastName_Firstinitial
- Then, click on Start Assignment near the top of the page.
- Next, click on Upload File and select Submit Assignment for review.
Sample Answer 4 for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Strategies to safely use Drugs Off-label as well as Drugs that require attention when used in Pediatrics
When prescribing pediatric drugs, especially for off-label prescription use, strict guidelines are necessary to protect patient safety. For this reason, different approaches are needed. Physicians must use a safety plan that maximizes adverse effect monitoring by only administering the medication to in-patients and reporting side effects to the relevant authorities in accordance with the code of conduct (Yackey & Stanley, 2019).
Safe drug provision requires an understanding of the variations in pediatric dose calculations such as the pharmacokinetic impact on the prescribed medication. It would be better to engage with experts, use data from various sources to inform practice, and assess the accepted norms of evidence-based medicine utilizing previously available resources. Following the recommendations of reliable publications is another strategy to consider, as these will offer the most up-to-date information on different medications. The WHO and UNICEF Better Medicines for Children Programme is one such resource that could be useful in this (Yackey & Stanley, 2019).
Off-label medications that have been found as being contraindicated or should be used cautiously in pediatric settings include:
- Guanfacine, an alpha-agonist that can produce drowsiness, bradycardia, hypotension, or heart block in which with this drug caution should be taken. As a result, it is important to check pulse and blood pressure in order to rule out congenital cardiac disease. (Rosenthal & Burchum, 2021).
- The FDA advises against using promethazine in pediatric instances because there is a considerable risk of severe respiratory depression, particularly in children under the age of two (Allen et al., 2018).
- Phenobarbital is another medication that should be given cautiously to children since it may result in behavioral abnormalities and developmental delays (Panther et al., 2017).
- Additionally, tetracycline should be contraindicated in children under 8 years old as hypoplasia could occur (Rosenthal & Burchum, 2021).
Conclusion
Prescriptions for off-label usage of drugs are common in pediatric settings. This may be the result of the different bodily compositions of children and adults, which makes it necessary to utilize some medications for purposes other than those for which they were designed. As a result, finding the appropriate medication for a certain age group might be challenging. A thorough understanding of the drugs could improve the safety of this drug when used outside of the prescribed use. This can be achieved by identifying the circumstances in which using specific pharmaceuticals off-label is acceptable and the strategies to take to improve safety in such circumstances (Allen et al., 2018).
References
Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & DeLeon, S. (2018). Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. The Journal of the Oklahoma State Medical Association, 111(8), 776-783
Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423-429.
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.
Yackey, K., & Stanley, R. (2019). Off-Label Prescribing in Children Remains High: A Call for Prioritized Research. Pediatrics, 144(4), e20191571. https://doi.org/10.1542/peds.2019- 15
Sample Answer 5 for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Off-label drug use is the use of pharmaceutical drugs for indication, age group, dosage, route of administration not approved by the relevant authorities. This is particularly prevalent among pediatric patients owing to their age group and restricted pharmaceutical research. The most common reason that physicians prescribe off-label drugs is due to the absence of drugs for a particular indication that is safe for pediatric patients that has sufficient pediatric research. Indication of sildenafil for pulmonary hypertension in children is a classic case.
There are also cases of failure of standard therapy and the need for alternative therapy. High doses of amoxicillin indicated for otitis media in children is of relevance to failure of standard therapy. The lack of alternative forms of therapy, for example use of intranasal desmopressin for nocturnal enuresis, has also been attributed. The lengthy course of obtaining FDA approval has also been implicated. Further, insufficient clinical trials among pediatric age group has also contributed to the challenge due to the stern protection offered from the federal government. The need to increase the efficacy of treatment is also a cause of particular emphasis to salbutamol used for 12 times a day and is only licensed for 4 times daily. Most drugs prescribed for very young children are off label due to a lack of safety and efficacy data among this age group.
Special attention and research have been undertaken and strategies provided to combat off-label drug prescriptions. Implementation of electronic medical records to help track off-label prescription. Written instruction should be provided by the physician to reinforce any verbal conversion. Further, mass information of patients of unlicensed and off-label prescription drugs through medical charts, Online ADR forms is also an effective strategy. Therefore, standardization of research and prohibition of off-label older drugs and current promotion off-label drugs respectively are required. A demonstration should be provided by the clinician appropriately on the route of administration.
Sufficient compensation should be advised to the caregiver in case of spillage as they common with children thus much a need to avoid inaccurate dosing. Multiple dosing can be avoided by strictly sticking to drug administration charts and adherence to finishing the stipulated dose.
Drugs such as Aspirin require special attention when indicated for pediatric patients since they are contraindicated in patients with previous viral infections. Promethazine should also not be administered to children younger than 2 years old due to pronounced respiratory depression. Glucocorticoids should only be indicated for a shorter period due to their growth suppression effects. Androgens are contraindicated in pre-pubertal males due to premature closure of epiphyseal plates. Tetracyclines are contraindicated for pediatric patients due to their teeth staining. Therefore, the use of off-label drugs should be only considered when it the only option left and special attention is taken into account for pediatric patients.
References
Corny, J., Lebel, D., Bailey, B., & Bussières, J. F. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The journal of pediatric pharmacology and therapeutics, 20(4), 316-328.
Lee, G. (2018). Lehne’s Pharmacotherapeutics for Advanced Practice Providers, Laura D. Rosenthal, Jacqueline Rosenjack Burchum, Elsevier, eBook ISBN: 9780323376631, Paperback ISBN: 978-0-323-44,783-6.
Mir, A. N., & Geer, M. I. (2016). Off-label use of medicines in children. International Journal of Pharmaceutical Sciences and Research, 7(5), 1820.
Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423-429.
Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Drago, F. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207.
Rubric
| Criteria | Ratings | Pts | ||||
|---|---|---|---|---|---|---|
|
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. |
|
|||||
|
Explain 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. |
|
|||||
|
Written 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. |
|
|||||
|
Written Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation |
|
|||||
|
Written 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. |
|
|||||