Post-marketing surveillance is needed for off licence use of drugs in children

Editor—Sutcliffe's editorial on the issue of testing pharmaceutical products in children addresses a longstanding problem for which there has been much talk but no solution.¹ Although not likely to produce the quality of data that would come from formal trials in children, an alternative approach is to develop a well structured programme of post-marketing surveillance for drugs that are used off licence in children. This could look at both efficacy and side effects.

Pharmaceutical companies have developed some effective methods of post-marketing surveillance and could be asked to help with the development of such a programme. This could be strengthened by involving pharmaceutical services, which could ensure that prescriptions for specified products dispensed for children are registered with a central registry that could cross check with reports from clinicians.

This approach would be less expensive than the alternative formal trials, and it would resolve many of the ethical issues involved, assuming that a clinician has made the decision that prescription off licence is justified for clinical reasons in a particular child.

Paediatricians have an excellent track record in supporting the British Paediatric Surveillance Unit, and I anticipate that they would give equally strong support to a programme of pharmaceutical surveillance if a similar easy to use approach to data collection were developed.

As the cost for this would be comparatively low, the pharmaceutical industry might be prepared to support establishing such a programme through a supplement to the licensing fees for new preparations.