ABSTRACT

Most drugs used in adults are high quality products with a licence for their use. In children however, we often need to use medicines that are unlicenced (UL), or licenced medicines in ways not covered by the licence (off label) (OL). We cannot guarantee the safety, efficacy or quality of these drugs, as they have not been tested in clinical trials in the paediatric population for the indications and methods by which they are used. Many reasons are given by the pharmaceutical industry for not testing drugs in children, e.g. difficulties in studying drugs in children, ethical problems and consent issues. However, the real reason is that it is time consuming and expensive to perform trials in children, and without a legal obligation and/or financial incentives to do so then they are unlikely to happen.