Assignment: Off-Label Drug Use in Pediatrics

Assignment: Off-Label Drug Use in Pediatrics

Assignment: Off-Label Drug Use in Pediatrics

            Age-appropriate formulations are usually required when manufacturing medication for the pediatric population. Drug development for children is normally encountered several challenges because of complicated scientific requirements and ethical standards for pediatric studies, high formulation costs, lack of financial assistance, and a small and fragmented market (Schrier et al., 2020). Due to these challenges, only a few studies have attempted to promote the production of medications that meet pediatric needs. Researchers have also failed to conduct clinical trials with pediatric participants on several drugs, for approval and incorporation into treatment guidelines, due to the high risks of adverse events that can even lead to death (Pratico et al., 2018). Healthcare providers are thus left to utilize their clinical judgment and prescribe adult drugs to pediatric patients in an off-label manner. This is normally when there is no medication for pediatric use in the treatment of the child’s condition or case of treatment failure and a lack of alternative medication for the same condition.

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            Due to the increased risks of adverse events with the use of adult drugs off-label among pediatric patients, clinical trials on this vulnerable population should be encouraged to improve drug safety. Optimization of drug administration through electronic support and sustainable intervention can also help promote the safe use of off-label drugs among children. for instance, a recognized national standard for dosing should be implemented in a computerized prescriber order entry system for evidence-based pediatric dosage calculation (Hoon et al., 2019). However, the use of some off-label drugs such as fentanyl is associated with serious adverse effects like respiratory depression, hence should be used with extra caution among the pediatric population. Selective serotonin reuptake inhibitors like sertraline are also associated with increased suicidal ideation when used among children (Zanden et al., 2021). Drugs from this class should thus be used with caution in children as recommended by the FDA.

References

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

Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., Salvo, V., Falsaperla, R., Vitaliti, G., La Rosa, M., Leonardi, S., Rotondo, A., Avola, N., Sgarlata, D., Damiano, A., Tirantello, M., Anzelmo, G., Cipolla, D., Rizzo, A., & Russo, A. (2018). Off-Label Use of Drugs and Adverse Drug Reactions in Pediatric Units: A Prospective, Multicenter Study. Current Drug Safety, 13(3), 200–207. https://doi.org/10.2174/1574886313666180619120406

Schrier, L., Hadjipanayis, A., Stiris, T., Ross-Russell, R. I., Valiulis, A., Turner, M. A., Zhao, W., De Cock, P., de Wildt, S. N., Allegaert, K., & van den Anker, J. (2020). Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European Society for Developmental Perinatal and Pediatric Pharmacology. European Journal of Pediatrics. https://doi.org/10.1007/s00431-019-03556-9

Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., Hoog, M., & 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

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