Off-Label Drug Use In Pediatric

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Apr 3, 2024

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1 Assignment 11: Off-Label Drug Use In Pediatric Walden University DNRS 6521C: Advanced Pharmacology Circumstances where off-label drugs are prescribed for children

2 As an advanced practice nurses, we have to be aware of the safety implications of the off- label use of drugs with the pediatric group. Since children respond differently during stages from infancy to adolescence, this poses potential safety concerns when prescribing drugs to pediatric patients. While off-label medication use in children is prevalent and sometimes dangerous (Belayneh et al., 2020), several circumstances call for their use. These circumstances include when conventional, FDA-approved treatment choices for a particular ailment are unavailable or when alternative forms of treatment for a specific age group are unavailable. For example, suppose a child is in critical care and needs an off-label sedative for a traumatic procedure. In that case, clinicians will be concerned about the drug's effect on the developing brain but will prescribe it to save the child from excruciating pain (Hoon et al., 2019). Other circumstances that warrant the prescription an off-label treatment include the failure of standard targeted therapies to handle certain conditions. There is overwhelming evidence of the usefulness and safety of a particular off-label drug in managing such a situation (Hagemann et al., 2019). Strategies to make the off-label drugs safer for children Although off-label prescription is neither illegal nor unethical in most situations, it is done routinely without full consideration of benefit and risk (Zandenet al., 2021). Notably, optimal dosage selection is frequently overlooked, exposing children to unknown toxicity and, as a consequence, impairment. To render off-label medications safer for children and adolescents, the prescription must consider patient factors such as age, gender, and treatment history (Mukattash et al., 2018). The care provider would need to apply an empirical dose adjustment algorithm to determine appropriate doses. Prescriptions must be correctly labeled, with proper dosages for each age group, to save patients from the dangers of overdose. Drug-drug

3 interactions must be explored, registered, and made available to healthcare providers (Balan et al., 2018). Potential side effects of the medications should be observed and reported so that urgent action may be taken if they emerge. These medications include the antibiotic chloramphenicol, Solfoton, Zoloft, and oxygen therapy. Chloramphenicol, in particular, is effective in treating bacterial meningitis in the infant (Oong & Tadi, 2021), but if overdosed can result in grey baby syndrome (Das & Bothra, 2021). It is noted that prolonged oxygen supplementation is linked to retrolental fibroplasia in an infant (Higgins, 2019); hence should be administered with caution. Conclusion In conclusion, advanced practice nurses need to ensure the safety of pediatric patients. Understanding that some off-label drugs have been recognized as harmful when used in children necessitates extra caution.

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4 References Balan, S., Hassali, M. A. A., & Mak, V. S. (2018). Two decades of off-label prescribing in children: a literature review. World Journal of Pediatrics, 14(6), 528-540. https://link.springer.com/article/10.1007/s12519-018-0186-y Belayneh, A., Tadese, E., & Molla, F. (2020). Safety and biopharmaceutical challenges of excipients in off-label pediatric formulations. International Journal of General Medicine, 13, 1051. https://dx.doi.org/10.2147%2FIJGM.S280330 Das, S., & Bothra, A. (2021). Babies in dermatology. Indian Journal of Dermatology, Venereology and Leprology, 1-4. doi:10.25259/IJDVL_485_20 Hagemann, V., Bausewein, C., & Remi, C. (2019). Drug use beyond the licence in palliative care: A systematic review and narrative synthesis. Palliative medicine, 33(6), 650-662. https://doi.org/10.1177%2F0269216319840602 Higgins, R. D. (2019). Oxygen saturation and retinopathy of prematurity. Clinics in Perinatology, 46(3), 593-599. https://doi.org/10.1016/j.clp.2019.05.008 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. Paediatrics, 144(4). https://doi.org/10.1542/peds.2019-0896 Mukattash, T. L., Alkhaldi, S., Alefan, Q., Jarab, A. S., Abu Farha, R. K., & Al-Azayzih, A. (2018). Off-label medicine use in children, a study of community pharmacists in Jordan. Journal of Pharmaceutical Health Services Research, 9(4), 407-411. https://doi.org/10.1111/jphs.12271 Oong, G. C., & Tadi, P. (2021). Chloramphenicol. In StatPearls [Internet]. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK555966/ van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., ... & 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.

Off-Label Drug Use In Pediatric

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