NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

Walden University NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS– Step-By-Step Guide

This guide will demonstrate how to complete the Walden University NURS 6521 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 OFF-LABEL DRUG USE IN PEDIATRICS

Whether one passes or fails an academic assignment such as the Walden University NURS 6521 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 OFF-LABEL DRUG USE IN PEDIATRICS

The introduction for the Walden University NURS 6521 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 OFF-LABEL DRUG USE IN PEDIATRICS

After the introduction, move into the main part of the NURS 6521 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 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 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.

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Sample Answer for 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 

Sample Answer 2 for NURS 6521 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 3 for NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

Off-label drug use refers to the practice of prescribing medications for an unapproved age group, dosage, or condition. While this practice is legal and often backed by scientific evidence, it’s particularly prevalent in pediatrics due to the lack of clinical trials involving children.

Circumstances for Off-Label Drug Use in Children

Off-label drug use in children is often necessary when:

1. No approved pediatric medication exists: Many diseases affect both adults and children, but not all medications used to treat these diseases in adults are approved for pediatric use. For example, Prozac, an antidepressant, is often used off-label to treat depression in children and adolescents.
2. Approved pediatric medication is ineffective: Sometimes, a child may not respond to an approved medication, necessitating the use of an off-label alternative. For instance, Gabapentin, originally developed for treating epilepsy in adults, is sometimes used off-label to manage pain in children.
3. The child has a rare condition: Rare diseases often lack specific approved treatments, making off-label use necessary. For example, Rituximab, a drug approved for certain types of cancer, is used off-label to treat rare autoimmune diseases in children.

Strategies for Safer Off-Label Drug Use in Pediatrics

To ensure the safety of off-label drug use in children, the following strategies can be employed:

1. Thorough review of available literature: Before prescribing an off-label drug, clinicians should review all available scientific evidence to understand the potential risks and benefits.
2. Close monitoring: Children taking off-label drugs should be closely monitored for side effects. This is particularly important for drugs like Clonidine, an adult hypertension drug often used off-label to treat ADHD in children, which can have serious side effects if not properly monitored.
3. Informed consent: Parents or guardians should be fully informed about the reasons for off-label use, potential risks, and alternative treatments.
4. Dose adjustment: Dosages should be carefully adjusted to suit the child’s weight and age. This is crucial for drugs like Warfarin, an anticoagulant used off-label in children, where the dosage must be carefully calibrated to prevent bleeding complications.

In conclusion, while off-label drug use in children is sometimes necessary, it should be approached with caution. Clinicians must make evidence-based decisions, closely monitor patients, and ensure parents or guardians are fully informed.

Reference:

Meng, M., Zhou, Q., Lei, W., Tian, M., Wang, P., Liu, Y., Sun, Y., Chen, Y., & Li, Q. (2022). Recommendations on Off-Label Drug Use in Pediatric Guidelines. Frontiers in pharmacology, 13, 892574. https://doi.org/10.3389/fphar.2022.892574

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.

Bazzano, A. T., Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic pediatrics, 9(2), 81–88. https://doi.org/10.1016/j.acap.2008.11.010

Sample Answer 4 for NURS 6521 OFF-LABEL DRUG USE IN PEDIATRICS

When a medication is used for a reason that is not one of its permitted uses, administration routes, indications, patient ages, or intended purposes, this is referred to as using the medication off-label (Hengartner, 2020). For instance, most antidepressants have only been approved for adult use, hence being used off-label in children. The purpose of this paper is to discuss the use of off-label drugs in the treatment of pediatric patients.

Reasons for Children’s Off-Label Drug Use

Most practitioners have cited several circumstances as grounds for utilizing off-label pediatric medications (Solmi et al., 2020). Examples of such situations include the absence of pediatric dosage instructions, the inadequateness of juvenile formulations, and the lack of updates or modifications for juvenile indications (Egberts et al., 2022). Prozac has been authorized by the FDA for the management of pediatric depressive symptoms in patients older than 8 years (Hoon et al., 2019).

Techniques to Improve the Safety of Children Using Off-Label Drugs

When off-label medications are utilized by children, regardless of the rationale, serious adverse side effects may occur. To increase the safety of young children using off-label drugs, further clinical studies are required (Hengartner, 2020). Before administering a medicine to a kid, its benefits and hazards must be evaluated. It is advised that prescribers employ evidence-based dosing approaches, such as the Clarks rule, to make sure kids receive the right dose and frequency to prevent side effects (Egberts et al., 2022). As suggested by the FDA, it is advisable to avoid medications with substantial side effects, such as SSRIs, which are known to induce suicidality in young children (Solmi et al., 2020). Due to the higher risk of self-harm and suicidal ideation in this age range, escitalopram, fluoxetine, fluvoxamine, and paroxetine, among others, should be taken with care in children (Hoon et al., 2019).

Conclusion

Due to the lack of information about drug dosage, effectiveness, and safety for children, practitioners often recommend medications that are off-label for this age group. Most drugs given to kids aren’t meant for them, and most of these prescriptions haven’t been tested enough on kids. Given the lack of pediatric evidence, practitioners may end up giving out medicines that could be dangerous to the child hence the need for continuous research on this age group. 

References

Egberts, K. M., Gerlach, M., Correll, C. U., Plener, P. L., Malzahn, U., Heuschmann, P., Unterecker, S., Scherf-Clavel, M., Rock, H., Antony, G., Briegel, W., Fleischhaker, C., Häge, A., Hellenschmidt, T., Imgart, H., Kaess, M., Karwautz, A., Kölch, M., Reitzle, K., & Renner, T. (2022). Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice. Pharmacopsychiatry. https://doi.org/10.1055/a-1716-1856

Hengartner, M. P. (2020). Editorial: Antidepressant Prescriptions in Children and Adolescents. Frontiers in Psychiatry, 11. https://doi.org/10.3389/fpsyt.2020.600283

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). https://doi.org/10.1542/peds.2019-0896

Solmi, M., Fornaro, M., Ostinelli, E. G., Zangani, C., Croatto, G., Monaco, F., Krinitski, D., Fusar‐Poli, P., & Correll, C. U. (2020). Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications, and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects. World Psychiatry, 19(2), 214–232. https://doi.org/10.1002/wps.20765