NURS 6521 Week 11 Discussion: Off-Label Drug Use in Pediatrics
Circumstances under which children should be prescribed drugs for off-label use: 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.
Review the Bazzano et al. and Mayhew articles in the Learning Resources. 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.
With these thoughts in mind:
By Day 3 of circumstances under which children should be prescribed drugs for off-label use
Post an explanation of circumstances under which children should be prescribed drugs for off-label use. Then, 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.
By Day 6
Read a selection of your colleagues’ responses and respond to at least two of your colleagues on two different days who provided a different rationale than you did, in one or more of the following ways:
Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library.
Validate an idea with your own experience and additional research.
· Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88.
Retrieved from Walden Library databases.
This study examines the frequency of off-label prescribing to children and explores factors that impact off-label prescribing.
· Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123.
Retrieved from the Walden Library databases.
This article reviews the prevalence of off-label prescribing, including its benefits and risks. It also explores issues regarding the safety of off-label prescribing and when it is unavoidable.
Off-Label Drug Use in Paediatrics
The use of off-label drugs among pediatric patients has increased over the years mainly because of limited clinical trials and research among this population to determine the safety and effectiveness in the management of certain conditions such as mental disorders (Yackey et al., 2019). The purpose of this discussion is to illustrate the off-label use of psychotropic agents for pediatric patients with mood disorders.
Circumstances to Consider
Physicians normally consider several factors such as the lack of standard, safe, and effective licensed therapeutic options for the management of certain conditions, before prescribing off-label medications to children and adolescents (Egberts et al., 2022). Consequently, the process of approval of certain drugs may take a lot of time, and effect, despite proven effectiveness in the management of certain conditions, such as the use of fluoxetine for depression.
Off-Label Drug Safety among Pediatrics
Official dosing guidelines for most drugs used among children are missing, putting the child at high risk of potential harm with the use of such drugs. However, through evidence-based practice, several pragmatic methods like Fried’s Rule, Webster’s Rule, and Clark’s rule have been proposed, as a result of their great success in arriving at the optimal dose while preventing harm to the pediatric patient (Belayneh et al., 2020).
Drugs to Handle with Extra Care
The U.S. Food and Drug Administration has provided a list of several pharmacological agents that should be handled with extra care among pediatrics due to their increased risk of suicidal ideation among other adverse effects (Egberts et al., 2022). Such drugs include Seroquel, Zyprexa, Risperdal, and coumadin among others.
The use of off-label drugs among pediatric patients is common and potentially harmful. . This has largely been associated with a lack of adequate clinical trial and research to support their effectiveness and safety among this vulnerable population. Caution should however be taken when prescribing and dosing these medications to avoid adverse effects.
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. DOI:
Egberts, K. M., Gerlach, M., Correll, C. U., Plener, P. L., Malzahn, U., Heuschmann, P., … & Romanos, M. (2022). Serious adverse drug reactions in children and adolescents treated on and off-label with antidepressants and antipsychotics in clinical practice. Pharmacopsychiatry. DOI: 10.1055/a-1716-1856
Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital Pediatrics, 9(3), 186-193.