Off-Label Drugs Use in Pediatrics
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While our local study was not focused primarily on the neonate population, we did find a significant number of off-label prescriptions were due to patient age and the risk of receiving an off-label prescription decreased as age increased.Finally, none of the studies we reviewed addressed the issue of parental consent for off-label use despite two studies reporting an adverse drug reaction secondary to off-label medication use. This may in part be secondary to the above-referenced American Academy of Pediatrics adopted policy that specifically states providers do not need parental consent if the medication use is supported by current evidence in the literature or a practitioners experience with the medication. Additionally, there may be a lack of knowledge among prescribers about the on label indications for commonly used pediatric medications. Practitioners should be aware of the off-label medications they commonly use in children and be mindful of known potential adverse reactions and side effects but also be wary of possible new unreported drug reactions or side effects.
The most frequent category of off‐label use in our study was inappropriate dosing and/or frequency (42.3%). Similar findings were reported from the survey in pediatric ward of European countries, Germany, Brazil and Scotland (Conroy et al. 2000; Daukes et al. 2004; Porta et al. 2010; Hildtraud 2013). Off‐label medicine use, such as under‐ and/or overdosing, could bear the risk of potential health hazards. Inappropriate dosing is of particular concern for antibiotic use with respect to the development of resistances. If medication is underdosed, there may be no therapeutic benefit but carries a risk for ADRs. Among all pediatric patients surveyed, those receiving care for the most frequent diagnosis, which is community acquired pneumonia (CAP), are the leading recipients of off‐label medicines.
Implementing evidence based approach can significantly improve rationality of pediatric pharmacotherapy.
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