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Assignment: Off-Label Drug Use In Pediatrics

Assignment: Off-Label Drug Use in Pediatrics Walden

Off-Label Drug Use in Pediatrics

Despite the lack of approval by the FDA on drugs to be prescribed for pediatric patients, the off-label drug is still used in healthcare. Therefore, the off-label drug is important for health issues among children, infants, and adolescents and is used for medical conditions that are not approved to treat (Scolle et al., 2021). The paper examines the rate at which the off-label drug is prescribed in children and explains the factor that influences its prescription for children with ADHD.

The Circumstance under which Children need Off-Label Prescription

Various circumstances are likely to cause off-label prescriptions for children, including a lack of clinical trials in special age groups (Garcia-Lopez et al., 2020). A child is also likely to be given an off-label drug prescription when the standard therapy fails (Garcia-Lopez et al., 2020). The drug helps in offering relief of the

Assignment Off Label Drug Use in Pediatrics Walden
Assignment Off Label Drug Use in Pediatrics Walden

symptoms and cure a specific disorder.

Therefore, the circumstances leads to the violation of the pharmacological algorithm of medication. However, it is recommended that a practitioner be cautious with the medication profile before prescribing the off-label drug to children with ADHD (Scolle et al., 2021). The first step should be to evaluate the

evidence-based research study of the off-label drug. If the evidence supports that the off-label drug is efficient for the children, the practitioner should proceed with the prescription.

Assignment: Off-Label Drug Use in Pediatrics WaldenFor instance, the off-label drug that can treat children with ADHD is guanfacine and clonidine. Guanfacine is absorbed orally and is eliminated within 17 hours of half-life (Okada et al., 2019). Guanfacine helps in regulating the behavior of the prefrontal cortex. It also enhances the network connection needed to boost the cognitive experience (Okada et al., 2019). 50 % of the drug is excreted in Renal excrete.

Clonidine is also an off-label drug that can be prescribed to children with ADHD. It helps stimulate the alpha-adrenoceptors in the brain (Joo & Kim, 2018). This leads to decreased peripheral resistance and the sympathetic outflow from the central nervous system (Joo & Kim, 2018). It is excreted through urine. The estimated half-life is 30 minutes which occurs after epidural administration.

Strategies for Making Off-Label Use and Dosage of Drug Safe for Children

The first step to making the off-label drug safer for children is by ensuring the approval of clinical trials. The clinical trials help identify the safety of off–label drugs for pediatric patients (Rosenthal & Burchum, 2021). It is also essential to evaluate the off-label drug’s side effects and advise the patient to immediately report in case of experiencing any harmful effects (Rosenthal & Burchum, 2021). It is also needed that the pharmacy sector comes up with a solution for calculating the dosage of the off-label drug for children with ADHD.

Conclusion

Some off-label drugs require extra care before prescribing them to a patient. They possess a potency to affect a child’s liver and brain, thus requiring that nurses be extra careful when prescribing off-label medication. Therefore, despite the prescription of the off-label medication counting as a prevalent practice, it is essential to ensure that one is mindful that it can cause a serious effect on a patient. The best way to make the practice safe is by conducting a clinical trial and looking for the drug’s evidence-based practice.

References

García-López, I., Vendrell, M. C. M., Romero, I. M., de Noriega, I., González, J. B., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: a prospective observational study. Journal of Pain and Symptom Management60(5), 923-932. https://www.sciencedirect.com/science/article/pii/S0885392420305297

Joo, S. W., & Kim, H. W. (2018). Treatment of children and adolescents with attention deficit hyperactivity disorder and/or Tourette’s disorder with clonidine extended release. Psychiatry Investigation15(1), 90. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5795037/

Okada, M., Fukuyama, K., Kawano, Y., Shiroyama, T., Suzuki, D., & Ueda, Y. (2019). Effects of acute and sub-chronic administrations of guanfacine on catecholaminergic transmissions in the orbitofrontal cortex. Neuropharmacology156, 107547. https://www.sciencedirect.com/science/article/pii/S0028390819300620

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants. Elsevier.

Scholle, O., Kollhorst, B., Riedel, O., & Bachmann, C. J. (2021). First-time users of ADHD medication among children and adolescents in Germany: an evaluation of adherence to prescribing guidelines based on claims data. Frontiers in Psychiatry12, 430. https://doi.org/10.3389/fpsyt.2021.653093

Click here to ORDER an A++ paper from our Verified MASTERS and DOCTORATE WRITERS: Assignment: Off-Label Drug Use in Pediatrics Walden

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

Assignment: Off-Label Drug Use in Pediatrics Walden
Assignment: Off-Label Drug Use in Pediatrics Walden

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.

Resources

Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.

WEEKLY 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

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  1. To submit your completed assignment, save your Assignment as WK11Assgn_LastName_Firstinitial
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Excellent Good Fair Poor
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
36 (36%) – 40 (40%)

The response accurately and thoroughly explains in detail the circumstances under which children should be prescribed drugs for off-label use.

The response includes accurate and specific examples that fully support the explanation provided.

32 (32%) – 35 (35%)

The response accurately explains the circumstances under which children should be prescribed drugs for off-label use.

The response includes accurate examples that support the explanation provided.

28 (28%) – 31 (31%)

The response inaccurately or vaguely explains the circumstances under which children should be prescribed drugs for off-label use.

The response includes inaccurate or vague examples that may or may not support the explanation provided.

(0%) – 27 (27%)

The response inaccurately and vaguely explains the circumstances under which children should be prescribed drugs for off-label use, or is missing.

The response includes inaccurate and vague examples that do not support the explanation provided, or is missing.

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.
41 (41%) – 45 (45%)

The response accurately and clearly describes in detail strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.

The response includes accurate, complete, and detailed descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

36 (36%) – 40 (40%)

The response accurately describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.

The response includes accurate descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

32 (32%) – 35 (35%)

The response inaccurately or vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.

The response includes inaccurate or vague descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

(0%) – 31 (31%)

The response inaccurately and vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, or is missing.

The response includes inaccurate and vague or incomplete descriptions and names of off-label drugs that require extra care and attention when used in pediatrics, or is missing.

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.
(5%) – 5 (5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity.
(4%) – 4 (4%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.
3.5 (3.5%) – 3.5 (3.5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.
(0%) – 3 (3%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time.
Written Expression and Formatting – English writing standards:
Correct grammar, mechanics, and proper punctuation
(5%) – 5 (5%)
Uses correct grammar, spelling, and punctuation with no errors
(4%) – 4 (4%)
Contains a few (1–2) grammar, spelling, and punctuation errors
3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) grammar, spelling, and punctuation errors
(0%) – 3 (3%)
Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding
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.
(5%) – 5 (5%)
Uses correct APA format with no errors
(4%) – 4 (4%)
Contains a few (1–2) APA format errors
3.5 (3.5%) – 3.5 (3.5%)
Contains several (3–4) APA format errors
(0%) – 3 (3%)
Contains many (≥ 5) APA format errors
Total Points: 100