NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Circumstances under which children should be prescribed drugs for off-label use 

Off-label prescribing is common in pediatrics due to the unavailability of standard therapeutic options for a specific condition or disease for children. Off-label drugs should be used in children if they are experiencing a serious condition for which there is no alternative approved by the FDA and there is evidence on the safety and efficacy of the drug. According to Hoon et al. (2019), off-label prescribing is legal and can be a representation of the best practice based on clinical experience along with supporting evidence of efficacy and safety, especially if labeled alternatives do not exist. For example, enalapril is approved by FDA for heart failure and hypertension in adults and only for hypertension in children. Nevertheless, enalapril is frequently utilized in the treatment of heart failure in pediatrics.

Children should be prescribed off-label drugs when the benefits of using the medic

NURS 6521 Assignment Off Label Drug Use in Pediatrics

NURS 6521 Assignment Off Label Drug Use in Pediatrics

ations exceed the risks. According to Shanshal and Hussain (2021), when proscribing off-label drugs to children, physicians must examine all information about the medication, determine risk tolerance, and ensure the promising benefits exceed the potential risks for the individual child. Strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, Off-label usage and dosage can be made safe for children by conducting comprehensive drug development studies to evaluate optimal dosing, safety, pharmacokinetics, and efficacy of medications in pediatric patients. Allen et al.92018) pointed out that more age-specific research in children is essential to provide children with adequate drug efficacy and safety. Until more data is available, clinicians should base their decisions on the best available evidence.

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Also, practitioners should be encouraged to perform due diligence about the use of off-label use drugs in pediatrics

NURS 6521 Assignment Off-Label Drug Use in Pediatrics

NURS 6521 Assignment Off-Label Drug Use in Pediatrics

and report adverse drug events. Shanshal and Hussain, (2021) allege that physicians must be aware of the frequently prescribed off-label medications in pediatric patients and be wary of the known potential adverse reactions and side effects. Off-label drugs that require extra care and attention when used in pediatrics Off-label drugs that cause serious adverse drug events need extra attention and care when utilized in pediatric patients. According to Oshikoya et al.(2019), serious adverse events refer to an adverse drug experience that occurs at any dosage that leads to a life-threatening condign, death, significant incapacity or disability, or other event necessitating intervention. Fentanyl and azithromycin are used off-label in pediatric patients in ICUs but they can cause respiratory depression. Practitioners caring for children utilizing these drugs in ICUs must closely watch and monitor children, notably for respiratory events.

References Allen, H. C., Carbe, M. C., Lees, J., Aiz, N., Chaaban, H., Miller, J. L, Johnson, P., & DeLeon, S. (20118). Off-Label Medications use in Children, More Common that We Think: A Systematic Review Of the Literature. Oklahoma State Medical Association, 111(8), 776-783. Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Storm, B. L., & Horton, D. B. (2019). Trends in Off-Label Drug Use in Ambulatory Settings: 2006-205. Pediatrics, 144 (4) e20190896. Oshikoya, K. A., Wharton, G. T., Avant, D….McMahon, A. W. (2019). Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A retrospective Chart Review. Pediatric Drugs, 21, 47-58. Shanshal, A. M. & Hussain, S. A. (2021). Off-label Prescribing Practice in Pediatric Settings: Pros and Cons. Systematic Reviews in Pharmacy, 12(1), 1267-175.

The use of off-label medications is a common practice in pediatric patients. The practice is associated with increased risk of harm to the patients because of inadequate evidence-based data on their use. Therefore, this paper examines circumstances that may lead to off-label prescribing to pediatric patients and safety strategies to be considered.


There are circumstances under which children should be prescribed off-label medications. One of them is a situation where the healthcare providers are managing unapproved disorder that does not have approved medications. In such cases, physicians prescribe medications that have proven effective among the adult populations for a similar disorder at a lower dose. The other circumstance is when the healthcare practitioners have in-depth understanding of the pediatric patients’ disease process and the effectiveness of off-label drugs. They prescribe off-label medications to benefit the patients while utilizing their professional judgment to improve the care outcomes in pediatric patients (van der Zanden et al., 2021). For example, physicians prescribe ketamine for pediatric patients admitted to the intensive care unit despite it not being a FDA-approved drug of choice for this population.


Healthcare practitioners should consider several strategies to ensure that off-label drugs are safe for children from infancy to adolescence. One of the strategies is by relying on the existing evidence when prescribing the off-label medications. Practitioners should critique the evidence obtained from high-quality studies and use them to inform their prescription decisions when treating pediatric patients. The other strategy is by considering ethics of practice. The decisions to treat pediatrics with off-label drugs should be informed by the principles of ensuring safety, justice, and quality outcomes for the patients (García-López et al., 2020; Hoekstra & Dietrich, 2022).

The other strategy is considering the influence of patient factors such as age on the pharmacological processes of the drugs prescribed to pediatric patients. The pharmacodynamic and pharmacotherapeutic processes in adult differ from that seen in pediatric patients. Therefore, practitioners should make decisions such as lowering the dosage and frequency of off-label medications as compared to adult doses to ensure safety and quality outcomes (Hoon et al., 2019). Some of the off-label drugs that should be prescribed with care for pediatric patients include hydromorphone, ketamine, and dexmedetomidine, which can be fatal is poorly used.


            In conclusion, off-label medications are largely used in pediatric patients. The use is attributable to the lack of adequate data on the efficacy of different treatments for pediatric conditions. Practitioners should consider strategies for ensuring safety in the prescription of off-label medications. In addition, they should make their treatment decisions based on evidence-based data and guidelines.


García-López, I., Cuervas-Mons Vendrell, M., Martín Romero, I., de Noriega, I., Benedí González, J., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: A prospective observational study. Journal of Pain and Symptom Management, 60(5), 923–932.

Hoekstra, P. J., & Dietrich, A. (2022). First do no harm: Use off-label antipsychotic medication in children and adolescents with great caution. European Child & Adolescent Psychiatry, 31(1), 1–3.

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), e20190896.

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