Assignment; Off-Label Drug Use in Pediatrics

Assignment; Off-Label Drug Use in Pediatrics

Assignment; Off-Label Drug Use in Pediatrics 

Assignment; Off-Label Drug Use in Pediatrics  Sample Paper

The term “off-label usage” refers to the use of a medicine for purposes, administration methods, indications, patient ages, or intended objectives that are not officially approved or authorized (Hengartner, 2020). For example, the majority of antidepressants have received approval only for adult populations, necessitating their off-label use in pediatric patients. The purpose of this paper is to examine the many categories of non-FDA-authorized medications used in the treatment of mood disorders among pediatric populations.

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Reasons for Children’s Off-Label Drug Use

According to Solmi et al. (2020), there are certain circumstances when the prescription of medications for off-label usage in pediatric patients is deemed permissible. An illustrative instance occurs when a pediatric patient presents with a rare medical condition without any therapy alternatives authorized by the Food and Drug Administration (Egberts et al., 2022). Another illustration arises when a youngster presents with a prevalent ailment, although the treatment sanctioned by the Food and Treatment Administration (FDA) proves to be ineffective or poorly tolerated (Hoon et al., 2019).

Improve Safety

Regardless of the justification, children using off-label drugs run the risk of experiencing major unfavorable side effects. Additional clinical research is necessary to improve the safety of pediatric patients using off-label medications (Hengartner, 2020). The benefits and risks of a medication must be considered before giving it to a child. Prescribers are recommended to adopt evidence-based dosage approaches, like the Clarks rule, to guarantee that the children get the right quantity, route of administration, and frequency of the drug to prevent adverse effects (Egberts et al., 2022). The FDA warns against taking medications with serious side effects, like SSRIs, that can cause suicidal ideation in pediatric patients (Solmi et al., 2020). Due to the increased likelihood of suicidal ideation and self-injurious behaviors in this age range, children should be careful when taking medications like fluoxetine, and paroxetine (Hoon et al., 2019).

Conclusion

Practitioners frequently prescribe off-label medications for children due to insufficient data on drug dosage, efficacy, and safety in this population. The majority of medications administered to children are not specifically formulated for pediatric use, and a significant proportion of these prescriptions lack sufficient testing in pediatric populations. Due to the limited availability of pediatric evidence, healthcare professionals may administer medications that pose potential risks to children. Therefore, it is imperative to conduct ongoing research specifically focused 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

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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.
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736254/

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Criteria	Ratings				Pts
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.	40 to >35.5 pts Excellent 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.	35.5 to >31.6 pts Good 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.	31.6 to >27.6 pts Fair 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.	27.6 to >0 pts Poor 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.	40 pts
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.	45 to >40.05 pts Excellent 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.	40.05 to >35.55 pts Good 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.	35.55 to >31.05 pts Fair 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.	31.05 to >0 pts Poor 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.	45 pts

 

Criteria	Ratings						Pts
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 to >4.45 pts Excellent Paragraphs and sentences follow writing standards for flow, continuity, and clarity.	4.45 to >3.95 pts Good Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.	3.95 to >3.45 pts Fair Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.			3.45 to >0 pts Poor Paragraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time.	5 pts
Written Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation	5 to >4.45 pts Excellent Uses correct grammar, spelling, and punctuation with no errors	4.45 to >3.95 pts Good Contains a few (1– 2) grammar, spelling, and punctuation errors	3.95 to >3.45 pts Fair Contains several (3–4) grammar, spelling, and punctuation errors		3.45 to >0 pts Poor Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding		5 pts
Written Expression and Formatting – The paper follows correct APA format for title page, headings, font,	5 to >4.45 pts Excellent Uses correct APA format with no errors	4.45 to >3.95 pts Good Contains a few (1– 2) APA format errors	3.95 to >3.45 pts Fair Contains several (3–4) APA format errors			3.45 to >0 pts Poor Contains many (≥ 5) APA format errors	5 pts

 

Criteria	Ratings				Pts
spacing, margins, indentations, page numbers, running head, parenthetical/in- text citations, and reference list.
Total Points: 100