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Posted: October 21st, 2023
Pediatrics prescribe medication for off-label drug use for a lack of specific medication to treat a certain ailment. This practice is particularly common in neonatal and pediatric intensive care units. Healthcare providers also prescribe drugs for off-label use due to a lack of adequate clinical trials on children (Gore et al., 2017). Lack of clinical trials presents a challenge of a lack of standard therapy to treat certain health conditions in children. Therefore, pediatricians will rely on sufficient research showing that certain medications can be used and positively impact a child’s health without negative effects (Gore et al., 2017). For instance, bupropion (Wellbutrin) is commonly used to treat depression, but it can be used to treat bipolar in off-label use (Gore et al., 2017). The decision to use it is due to the unavailability of effective alternatives and the positive impact of the drug on children. Pediatricians must carefully weigh the potential benefits against the risks, considering factors such as the child’s age, weight, and overall health status when prescribing off-label medications.
The approaches to ensure safety of off-label use drugs is relying on evidence-based practice from clinical trials. Rigorous monitoring and documentation of outcomes are crucial in these cases. They should acquire information from AAP policies, consensus statements, and clinical trials (Moulis et al., 2018). Other safety measures include checking the weight, health, and medical history of children (Moulis et al., 2018). The purpose is to take precautions to avoid adverse effects that may compromise the recovery process. Pediatricians often collaborate with pharmacists and other specialists to develop individualized treatment plans, ensuring the most appropriate and safest use of off-label medications for each child.
Pediatricians are aware that some medications require extra care to avoid adverse effects. Careful dosage adjustments and patient education are critical in these situations. One of the medications that require extra care is Quetiapine (Seroquel). The drug lead to a spike in blood pressure (Saiyed et al., 2017). Healthcare workers take precaution by checking blood pressure levels while administering the drug. Close monitoring is also necessary. Another medication is Montelukast (Singulair) that treats asthma. Children should start with a low dosage of the drug and get regular checkups (Saiyed et al., 2017). Pediatricians should ensure the benefits are more than the adverse effects that may affect the health of patients. They often work closely with families to educate them about potential side effects and the importance of follow-up appointments to monitor the child’s response to the medication.
References
Gore, R., K Chugh, P., D Tripathi, C., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current Clinical Pharmacology, 12(1), 18-25.
Moulis, F., Durrieu, G., & Lapeyre-Mestre, M. (2018). Off-label and unlicensed drug use in children population. Therapies, 73(2), 135-149.
Saiyed, M. M., Ong, P. S., & Chew, L. (2017). Off‐label drug use in oncology: a systematic review of literature. Journal of Clinical Pharmacy and Therapeutics, 42(3), 251-258.
Andrade, S. R. A., Santos, P. A. N. D. M., Andrade, P. H. S., & da Silva, W. B. (2020). Unlicensed and off‐label prescription of drugs to children in primary health care: A systematic review. Journal of Evidence‐Based Medicine, 13(4), 292-300.
Nir-Neuman, H., Abu-Kishk, I., Toledano, M., Heyman, E., Ziv-Baran, T., & Berkovitch, M. (2018). Unlicensed and off-label medication use in pediatric and neonatal intensive care units: No change over a decade. Advanced Therapy, 35(11), 1874-1883.
Gazarian, M., Horton, D. B., Carleton, B., Kinlaw, A. C., Bushnell, G. A., Czaja, A. S., … & dosReis, S. (2023). Optimizing therapeutic decision‐making for off‐label medicines use: A scoping review and consensus recommendations for improving practice and research. Pharmacoepidemiology and Drug Safety, 32(11), 1200-1222.
Nydert, P. (2020). Off-Label Drug Use, Medication Errors and Adverse Drug Events: Among Swedish Pediatric Inpatients (Doctoral dissertation, Karolinska Institutet (Sweden)).
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