Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics

European Journal of Pediatrics 168:1473-1478 (2009)
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Abstract

Off-label drug use in paediatrics is associated with an increased risk of adverse drug reactions. Any risk-benefit analysis has to be based on value judgments that should include parents' views. However, nothing is known so far about the parents' perspective on this critical issue. Therefore, a quantitative survey with parents of healthy and chronically ill children was carried out (n=94). Knowledge about the practice of off-label use is generally poor in both groups. Surprisingly, this is also true for the parents of children with chronic disease. 9.3% of the parents of chronically ill children and 19.6% of the parents of healthy children would refuse treatment with an off-label drug. Parents who have poor knowledge about the practice of off-label use tend to refuse to volunteer their child for study participation. Therefore, the information of parents on the off-label use of drugs is important to meet ethical standards and to increase the parents’ acceptance of medical studies with children.

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