Assignment: Off-Label Drug Use in Pediatrics Walden

Assignment: Off-Label Drug Use in Pediatrics Walden

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 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.

For 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

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