A quantitative survey study found that the parents of many children, including those with chronic illness, were unaware of the practice of 'off-label' medicines use in children; when asked, significant proportions would not accept such use.

The authors note that off-label drug use is common in paediatrics, because companies do not routinely carry out clinical studies of drug effects and adverse effects in children for those drugs less commonly used in this group. They suggest that it is so frequent in some areas that it may not be highlighted to parents. To discover parents knowledge of and views on this subject, they carried out a questionnaire survey of the parents of 94 children: these were parents of children with renal disease identified through the paediatric departments in two German hospitals, and parents of children identified at a local soccer club (on the basis that they would normally be healthy).

Participants were asked how much knowledge they wanted on medicines given to their children, how much knowledge they had about off-label use, and whether they would volunteer their child for a clinical study of a drug if they were ill.

Overall, parents' knowledge was poor: in the healthy group, 28% were aware that medicines may be given to children off-label, and 33% were convinced that this did not occur; the largest group (39%) did not know. In the chronic illness group, where a better knowledge was expected, the proportions were 35%, 26%, and 37% respectively.

Parents were not keen on off-label medicines being given to their children: 20% of the healthy group would refuse such medicines, as would 9% of the chronic illness group. Most of the remainder would only accept when such use was essential. Consent to a child's participation in a clinical study varied according to the study design, however those who were more knowledgeable about the practice were more likely to consent.

The authors conclude that in their study group of German parents, knowledge about off-label use of medicines in children was poor. They suggest that it is necessary to improve this, both for ethical reasons and to increase parents' acceptance of clinical trials in children.