Off-Label Drug Use in Pediatrics Essay

Off-Label Drug Use in Pediatrics Essay

Off-Label Drug Use in Pediatrics Essay

            Off-label drugs are medications used without adhering to the mandatory test for their safety and effectiveness for precise dosage and approval for clinical use by the United States Food and Drug Administration (Costa et al., 2018). This paper seeks to delve into off-label use in pediatrics.

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Circumstances under Which Children should be Prescribed Drugs for Off-Label Use

            Off-label drugs can be prescribed to children under certain circumstances such as where there exists no safe, efficient, standard, and certified therapeutic options for a particular disease in pediatrics (Costa et al., 2018). The other circumstance where off-label medication can be utilized is where there is a lack of or contradicting medication information on the treatment of a given condition in pediatrics. Off-label drugs can also be used in circumstances where there are no clinical trials in pediatrics, failure in standard therapy, and the existence of proper evidence about the safety and effectiveness concerns of the approved medications for pediatrics (Allen et al., 2018). For instance, albuterol can be prescribed as an off-label medication for pediatrics to manage asthma because there is no alternative medication for managing asthma in pediatrics.

Strategies to Make the Off-Label Use and Dosage of Drugs Safer for Children

            Healthcare providers and pharmacists should perform proper clinical trials to augment the medication efficacy and safety in pediatrics. The drug regulatory authority should also ensure the provision of a defined safety, efficacy, and suitable off-label medication dosages and route of administration. Also, universal national standards should be created to guide medication dosing and enable healthcare providers to formulate evidence-based practice for off-label drug dosages in pediatrics to enhance health outcomes in this population (Yackey & Stanley, 2019).

               Off-label drugs that require extra care and attention when used in pediatrics include propofol because it is associated with high toxicity levels. Prednisolone is also associated with sepsis in pediatrics. Albuterol should also be prescribed with extra care because it causes extreme pulse rates and pediatrics may become cyanotic, suffer respiratory arrests, and turn black.   

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … & DeLeon, S. (2018). Off-label medication use in children, more common than we think: a systematic review of the literature. The Journal of the Oklahoma State Medical Association, 111(8), 776. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268/

Costa, H. T. M. D. L., Costa, T. X., Martins, R. R., & Oliveira, A. G. (2018). Use of off-label and unlicensed medicines in neonatal intensive care. PloS one, 13(9), e0204427. https://doi.org/10.1371/journal.pone.0204427

Yackey, K., & Stanley, R. (2019). Off-label prescribing in children remains high: a call for prioritized research. Pediatrics, 144(4). https://doi.org/10.1542/peds.2019-1571

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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.

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.