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

Sample Answer for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics Included After Question

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.

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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). All papers submitted must use this formatting.

Submission and Grading Information

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Click on the Submit button to complete your submission.

A Sample Answer For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Title: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Off-label drug use refers to prescribing an FDA-approved drug for non-indicated use. Clinicians usually prescribe a drug for an unapproved use after they deem it medically appropriate for a specific patient. The purpose of this paper is to explore off-label drug use in pediatrics.

Circumstances to Prescribed Drugs for Off-Label Use in Children

Drugs should be used for off-label use in children if there is evidence supporting the drug’s efficacy and safety in treating the specific condition in pediatrics. The drug should have been evaluated by the expert group on off-label drug use and approved by the pharmacy administration committee (Meng et al., 2022). Most importantly, the benefits of off-label use should outweigh the risk for pediatric patients. For instance, the clinician should assess the potential benefits and risks of prescribing the drug to a child and ensure that the benefits outweigh the risks (Rusz et al., 2021). The clinician should also prescribe a drug for off-label use after obtaining informed consent from the caregiver and making a plan for monitoring adverse drug reactions (ADRs).

Strategies to Make the Off-Label Use and Dosage of Drugs Safer For Children

Off-label use can be made safer for pediatrics by ensuring that their recommendations in pediatric guidelines are founded on a reliable methodological framework. An off-label drug database can be established and updated regularly, where clinicians can refer to it before prescribing to identify potential benefits and ADRs, promoting patient safety (Meng et al., 2022). Providing information on the risks of off-label drugs can encourage health providers to appropriately prescribe and use off-label medications for pediatrics. Off-label medications requiring extra care and attention in pediatrics include cardiovascular system drugs (Amlodipine, dopamine), sedatives (lorazepam, ketamine), fentanyl, oxycodone, and hydromorphone (Allen et al., 2018).

Conclusion

Drugs for off-label use should be prescribed in children if they are supported by evidence, evaluated by the expert group, and if the benefits outweigh the risks. Off-label use can be made safe in pediatrics by having a reliable methodological framework and a regularly updated database. Sedatives and CVS drugs should be used with caution in off-label use in children.

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.

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

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

A Sample Answer 2 For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Title: 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

A Sample Answer 3 For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Title: 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

Grading Rubric

Performance Category	100% or highest level of performance 100% 16 points	Very good or high level of performance 88% 14 points	Acceptable level of performance 81% 13 points	Inadequate demonstration of expectations 68% 11 points	Deficient level of performance 56% 9 points	Failing level of performance 55% or less 0 points
Total Points Possible= 50	16 Points	14 Points	13 Points	11 Points	9 Points	0 Points
Scholarliness Demonstrates achievement of scholarly inquiry for professional and academic topics.	Presentation of information was exceptional and included all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information was good, but was superficial in places and included all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information was minimally demonstrated in all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in one of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in two of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in three or more of the following elements Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information
	16 Points	14 Points	13 Points	11 Points	9 Points	0 Points
Application of Course Knowledge Demonstrate the ability to analyze and apply principles, knowledge and information learned in the outside readings and relate them to real-life professional situations	Presentation of information was exceptional and included all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information was good, but was superficial in places and included all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information was minimally demonstrated in the all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in one of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from and scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in two of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in three of the following elements Applies principles, knowledge and information and scholarly resources to the required topic. Applies facts, principles or concepts learned scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.
10 Points	9 Points			6 Points	0 Points
Interactive Dialogue Initial post should be a minimum of 300 words (references do not count toward word count) The peer and instructor responses must be a minimum of 150 words each (references do not count toward word count) Responses are substantive and relate to the topic.	Demonstrated all of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.	Demonstrated 3 of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.			Demonstrated 2 of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.	Demonstrated 1 or less of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.
8 Points	7 Points	6 Points	5 Points	4 Points	0 Points
Grammar, Syntax, APA Points deducted for improper grammar, syntax and APA style of writing. The source of information is the APA Manual 6th Edition Error is defined to be a unique APA error. Same type of error is only counted as one error.	The following was present: 0-3 errors in APA format AND Responses have 0-3 grammatical, spelling or punctuation errors AND Writing style is generally clear, focused on topic,and facilitates communication.	The following was present: 4-6 errors in APA format. AND/OR Responses have 4-5 grammatical, spelling or punctuation errors AND/OR Writing style is somewhat focused on topic.	The following was present: 7-9 errors in APA format. AND/OR Responses have 6-7 grammatical, spelling or punctuation errors AND/OR Writing style is slightly focused on topic making discussion difficult to understand.	The following was present: 10- 12 errors in APA format AND/OR Responses have 8-9 grammatical, spelling and punctuation errors AND/OR Writing style is not focused on topic, making discussion difficult to understand.	The following was present: 13 – 15 errors in APA format AND/OR Responses have 8-10 grammatical, spelling or punctuation errors AND/OR Writing style is not focused on topic, making discussion difficult to understand. AND/OR The student continues to make repeated mistakes in any of the above areas after written correction by the instructor.	The following was present: 16 to greater errors in APA format. AND/OR Responses have more than 10 grammatical, spelling or punctuation errors. AND/OR Writing style does not facilitate communication
0 Points Deducted					5 Points Lost
Participation Requirements	Demonstrated the following: Initial, peer, and faculty postings were made on 3 separate days					Failed to demonstrate the following: Initial, peer, and faculty postings were made on 3 separate days
0 Points Lost					5 Points Lost
Due Date Requirements	Demonstrated all of the following: The initial posting to the graded threaded discussion topic is posted within the course no later than Wednesday, 11:59 pm MT. A minimum of one peer and one instructor responses are to be posted within the course no later than Sunday, 11:59 pm MT.					Demonstrates one or less of the following. The initial posting to the graded threaded discussion topic is posted within the course no later than Wednesday, 11:59 pm MT. A minimum of one peer and one instructor responses are to be posted within the course no later than Sunday, 11:59 pm MT.