The use of an approved drugs for unapproved purposes is referred to as off-label use. The U.S. Food and Drug Administration (FDA), an organization in charge of the approval of medication use in the USA, regulates the use and applications of medications. The off-label use of medications is legal and common practice in the United States. This practice is risky in pediatric management because there is limited evidence-based data on the efficacy and safety of certain medications in the pediatric population (Allen et al., 2018). Various research studies have been done by pharmaceutical companies and the department of health to fill the knowledge gap in the past three decades.
Circumstances Under Which Children Should be Prescribed Drugs for Off-Label Use
Off-label prescription happens in the management of pediatrics for various reasons. When a standard, safe, and efficacious therapeutic agent for a particular condition is unavailable, an off-label prescription may be allowed. In pediatrics, this is common with the use of most antibiotic medications. The use of ceftriaxone has been used for most febrile conditions for which its use is not approved by the FDA.
The use of sildenafil for pulmonary hypertension in infants is another example of off-label use of medications (Kelly et al., 2017). In other circumstances off-label prescription in children occurs when the clinical trials in the specific age groups are not available, the standard therapy fails, and when the alternative forms have shown more efficacy and effectiveness than the standard therapy in treating the same condition.
Strategies to Make the off-label Use and Dosage of Drugs Safer
Occasionally, clinicians may carry out off-label prescriptions because the approval process by the FDA takes longer or is quite expensive for a particular medication for which evidence-based trials and studies have shown substantial efficacy. The best strategy to promote medication safety in children can be achieved through improving the process of approval and clinical trials of such medications (Mir & Geer, n.d.).
This mainly applies to chemotherapeutic agents. Various neoplastic conditions common in childhood can also occur in adults. In such cases, the same agents used to manage adults are used in children because there is no approved medication in children (Gore et al., 2017). Pharmacists and physicians should regularly monitor and report adverse reactions in children on off-label prescriptions. Approving the clinical trials of medications in children and neonates makes the overall process of approval faster and efficient.
Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & 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), 776–783. https://www.ncbi.nlm.nih.gov/pubmed/31379392
Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current Clinical Pharmacology, 12(1), 18–25. https://doi.org/10.2174/1574884712666170317161935
Kelly, L. E., Ohlsson, A., & Shah, P. S. (2017). Sildenafil for pulmonary hypertension in neonates. Cochrane Database of Systematic Reviews, 8, CD005494. https://doi.org/10.1002/14651858.CD005494.pub4
Mir, A. N., & Geer, M. I. (n.d.). Off-label use of medicines in children. International Journal Of Pharmaceutical Sciences And Research. Retrieved February 10, 2021, from https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext
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