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

doi:10.1136/bmj.326.7391.712/a

BMJ 2003;326:712 ( 29 March )

Letters

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

The first 150 words of the full text of this article appear below.

EDITOR $---$ Sutcliffe's editorial on the issue of testing pharmaceutical products in children addresses a longstanding problemfor which there has been much talk but no solution.¹ Althoughnot likely to produce the quality of data that would come fromformal trials in children, an alternative approach is to developa well structured programme of post-marketing surveillance fordrugs that are used off licence in children. This could look atboth efficacy and sideeffects.

Pharmaceutical companies have developed some effective methods of post-marketing surveillance and could be asked to help withthe development of such a programme. This could be strengthenedby involving pharmaceutical services, which could ensure thatprescriptions for specified products dispensed for children areregistered with a central registry that could cross check withreports fromclinicians.

This approach would be less expensive than the alternative formal trials, and it would resolve many of the ethical . . . [Full text of this article]