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 medications 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.
Also, practitioners should be encouraged to perform due diligence about the use of off-label use drugs 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. https://doi.org/10.1542/peds.2019-0896 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. https://doi.org/10.1007/s40272-018-0318-9 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,
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