OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

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

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

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.

A Sample Answer For the Assignment: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

Title: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

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 therapeutics20(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 Research7(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 Therapeutics22(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 safety13(3), 200-207.

Click here to ORDER an A++ paper from our Verified MASTERS and DOCTORATE WRITERS: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

(Sánchez-Salvatori, & Vidrio, 2003). Another possibility is that with the patient’s

OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521
OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

impaired renal function, that her kidneys were not able to metabolize the drug
properly, causing the half life of hydralazine to be increased. I was able to find a
case study which states, “Following a single 50 mg dose of hydralazine (Apresoline)
in 13 patients with impaired renal function, a decrease in glomerular filtration rate
(GFR) was correlated with an increase in serum half-life (T1/2) of the drug (r=-0.69;
p less than 0.01)” (Talseth, p.1, 1976).

 

A Sample Answer 2 For the Assignment: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

Title: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

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: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

Title: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

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 Association111(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 Pharmacology13, 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 Health18(19), 10447. https://doi.org/10.3390/ijerph181910447

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.