NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

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NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics – Step-by-Step Guide

The first step before starting to write the NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics, it is essential to understand the requirements of the assignment. The first step is to read the assignment prompt carefully to identify the topic, the length and format requirements. You should go through the rubric provided so that you can understand what is needed to score the maximum points for each part of the assignment. 

It is also important to identify the audience of the paper and its purpose so that it can help you determine the tone and style to use throughout. You can then create a timeline to help you complete each stage of the paper, such as conducting research, writing the paper, and revising it to avoid last-minute stress before the deadline. After identifying the formatting style to be applied to the paper, such as APA, you should review its use, such as writing citations and referencing the resources used. You should also review how to format the title page and the headings in the paper.

How to Research and Prepare for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

The next step in preparing for your paper is to conduct research and identify the best sources to use to support your arguments. Identify the list of keywords from your topic using different combinations. The first step is to visit the university library and search through its database using the important keywords related to your topic. You can also find books, peer-reviewed articles, and credible sources for your topic from PubMed, JSTOR, ScienceDirect, SpringerLink, and Google Scholar. Ensure that you select the references that have been published in the last words and go through each to check for credibility. Ensure that you obtain the references in the required format, for example, in APA, so that you can save time when creating the final reference list. 

You can also group the references according to their themes that align with the outline of the paper. Go through each reference for its content and summarize the key concepts, arguments and findings for each source. You can write down your reflections on how each reference connects to the topic you are researching about. After the above steps, you can develop a strong thesis that is clear, concise and arguable. Next you should create a detailed outline of the paper so that it can help you to create headings and subheadings to be used in the paper. Ensure that you plan what point will go into each paragraph.

How to Write the Introduction for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

The introduction of the paper is the most crucial part as it helps to provide the context of your work, and will determine if the reader will be interested to read through to the end. You should start with a hook, which will help capture the reader’s attention. You should contextualize the topic by offering the reader a concise overview of the topic you are writing about so that they may understand its importance. You should state what you aim to achieve with the paper. The last part of the introduction should be your thesis statement, which provides the main argument of the paper.

How to Write the Body for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

The body of the paper helps you to present your arguments and evidence to support your claims. You can use headings and subheadings developed in the paper’s outline to guide you on how to organize the body. Start each paragraph with a topic sentence to help the reader know what point you will be discussing in that paragraph. Support your claims using the evidence conducted from the research, ensure that you cite each source properly using in-text citations. You should analyze the evidence presented and explain its significance and how it connects to the thesis statement. You should maintain a logical flow between each paragraph by using transition words and a flow of ideas.

How to Write the In-text Citations for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

In-text citations help the reader to give credit to the authors of the references they have used in their works. All ideas that have been borrowed from references, any statistics and direct quotes must be referenced properly. The name and date of publication of the paper should be included when writing an in-text citation. For example, in APA, after stating the information, you can put an in-text citation after the end of the sentence, such as (Smith, 2021). If you are quoting directly from a source, include the page number in the citation, for example (Smith, 2021, p. 15). Remember to also include a corresponding reference list at the end of your paper that provides full details of each source cited in your text. An example paragraph highlighting the use of in-text citations is as below:

The integration of technology in nursing practice has significantly transformed patient care and improved health outcomes. According to Smith (2021), the use of electronic health records (EHRs) has streamlined communication among healthcare providers, allowing for more coordinated and efficient care delivery. Furthermore, Johnson and Brown (2020) highlight that telehealth services have expanded access to care, particularly for patients in rural areas, thereby reducing barriers to treatment.

How to Write the Conclusion for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

When writing the conclusion of the paper, start by restarting your thesis, which helps remind the reader what your paper is about. Summarize the key points of the paper, by restating them. Discuss the implications of your findings and your arguments. End with a call to action that leaves a lasting impact on the reader or recommendations.

How to Format the Reference List for NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics

The reference helps provide the reader with the complete details of the sources you cited in the paper. The reference list should start with the title “References” on a new page. It should be aligned center and bolded. The references should be organized in an ascending order alphabetically and each should have a hanging indent. If a source has no author, it should be alphabetized by the title of the work, ignoring any initial articles such as “A,” “An,” or “The.” If you have multiple works by the same author, list them in chronological order, starting with the earliest publication. 

Each reference entry should include specific elements depending on the type of source. For books, include the author’s last name, first initial, publication year in parentheses, the title of the book in italics, the edition (if applicable), and the publisher’s name. For journal articles, include the author’s last name, first initial, publication year in parentheses, the title of the article (not italicized), the title of the journal in italics, the volume number in italics, the issue number in parentheses (if applicable), and the page range of the article. For online sources, include the DOI (Digital Object Identifier) or the URL at the end of the reference. An example reference list is as follows:

References

Johnson, L. M., & Brown, R. T. (2020). The role of telehealth in improving patient outcomes. Journal of Nursing Care Quality, 35(2), 123-130. https://doi.org/10.1097/NCQ.0000000000000456

Smith, J. A. (2021). The impact of technology on nursing practice. Health Press.

NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics Instructions

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.

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.

NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics Sample Paper 1

Major depressive disorder is a significant pediatric and adolescent health problem associated with significant morbidity. These patients suffer from impaired social functioning, school difficulties and have an increased risk of physical illness and substance abuse. It is also associated with an increased risk of mortality by suicide. Treatment should therefore be initiated with both psychotherapy and pharmacotherapy.

Choosing of antidepressant is however a challenge for pediatric patients. This is because of the smaller evidence available for antidepressant efficacy compared to adult patients. Selective serotonin reuptake inhibitors (SSRIs) are the first line antidepressants in both pediatric and adult patients with only a few of these antidepressants FDA approved to be used in pediatrics.

The lack of FDA approval for pediatric patients is mostly attributed to the lack of sufficient testing. This means that some antidepressants used in pediatrics are prescribed off—label. Use of off-label drugs is common in pediatrics. Off label drugs use is when drugs are used for treatment of conditions different from the ones they were originally intended for (Gore et al., 2017).

Off-label drug use is recommended in children if they do not receive adequate improvement after using first line drugs (Dwyer & Bloch, 2019). In patients with depressive disorders, improvements can be seen when switching form one SSRI to another e.g., when a switch from Prozac to Zoloft is made (Boyce et al., 2020).

However, certain considerations need to be made when drugs are used off label. These include the child’s body weight and stage of development. This is relevant because these factors can affect how the child will tolerate the drug (Collier et al.,2017). Metabolism is also affected by these factors and consequently the amount of drugs prescribed. Another important consideration is the side effects associated with the drugs. SSRIs, for example, are more likely to cause suicidal ideations in pediatric and adolescent patients than in adults.

References

Boyce, P., Hopwood, M., Morris, G., Hamilton, A., Bassett, D., Baune, B. T., Mulder, R., Porter, R., Parker, G., Singh, A. B., Outhred, T., Das, P., & Malhi, G. S. (2020). Switching antidepressants in the treatment of major depression: When, how and what to switch to?. Journal of Affective Disorders, 261, 160–163. https://doi.org/10.1016/j.jad.2019.09.082

Collier, H., Nasim, M., & Gandhi, A. (2017). Prescribing in obese children: how good are paediatricians?. Archives Of Disease In Childhood, 102(1), 61–62. https://doi.org/10.1136/archdischild-2016-310603

Dwyer, J. B., & Bloch, M. H. (2019). Antidepressants for Pediatric Patients. Current Psychiatry, 18(9), 26–42F. https://pubmed.ncbi.nlm.nih.gov/31511767/

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric Off-Label and Unlicensed Drug Use and Its Implications. Current Clinical Pharmacology, 12(1), 18–25. https://doi.org/10.2174/1574884712666170317161935

NURS 6521 Week 11 Assignment: Off-Label Drug Use in Pediatrics Sample Paper 2

The use of an approved drugs for unapproved purposes is referred to as off-label use. The U.S. Food and Drug Administration (FDA), an organization in charge of the approval of medication use in the USA, regulates the use and applications of medications. The off-label use of medications is legal and common practice in the United States. This practice is risky in pediatric management because there is limited evidence-based data on the efficacy and safety of certain medications in the pediatric population (Allen et al., 2018). Various research studies have been done by pharmaceutical companies and the department of health to fill the knowledge gap in the past three decades.

Circumstances Under Which Children Should be Prescribed Drugs for Off-Label Use

Off-label prescription happens in the management of pediatrics for various reasons. When a standard, safe, and efficacious therapeutic agent for a particular condition is unavailable, an off-label prescription may be allowed. In pediatrics, this is common with the use of most antibiotic medications. The use of ceftriaxone has been used for most febrile conditions for which its use is not approved by the FDA.

The use of sildenafil for pulmonary hypertension in infants is another example of off-label use of medications (Kelly et al., 2017). In other circumstances off-label prescription in children occurs when the clinical trials in the specific age groups are not available, the standard therapy fails, and when the alternative forms have shown more efficacy and effectiveness than the standard therapy in treating the same condition.

Strategies to Make the off-label Use and Dosage of Drugs Safer

Occasionally, clinicians may carry out off-label prescriptions because the approval process by the FDA takes longer or is quite expensive for a particular medication for which evidence-based trials and studies have shown substantial efficacy. The best strategy to promote medication safety in children can be achieved through improving the process of approval and clinical trials of such medications (Mir & Geer, n.d.).

This mainly applies to chemotherapeutic agents. Various neoplastic conditions common in childhood can also occur in adults. In such cases, the same agents used to manage adults are used in children because there is no approved medication in children (Gore et al., 2017). Pharmacists and physicians should regularly monitor and report adverse reactions in children on off-label prescriptions. Approving the clinical trials of medications in children and neonates makes the overall process of approval faster and efficient.

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. https://www.ncbi.nlm.nih.gov/pubmed/31379392

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current Clinical Pharmacology, 12(1), 18–25. https://doi.org/10.2174/1574884712666170317161935

Kelly, L. E., Ohlsson, A., & Shah, P. S. (2017). Sildenafil for pulmonary hypertension in neonates. Cochrane Database of Systematic Reviews, 8, CD005494. https://doi.org/10.1002/14651858.CD005494.pub4

Mir, A. N., & Geer, M. I. (n.d.). Off-label use of medicines in children. International Journal Of Pharmaceutical Sciences And Research. Retrieved February 10, 2021, from https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext