EMEA consults on guidance for medicines used in children

The European Agency for the Evaluation of Medicinal Products (EMEA) has launched a six-month consultation on a draft guideline on pharmacovigilance for medicines used by those under 18 years of age.

This is the first guideline to focus exclusively on the issues of safety of medicines in children and it covers the reporting of adverse drug reactions in children and also on the possible need for studies designed to follow the long-term safety of medicines in children. It aims to strengthen the pharmacovigilance system for all medicines used in children.

According to the European Commission (EC), more than 50% of medicines used to treat children are prescribed on an unlicensed or 'off-label' basis because they have not been adequately tested or formulated and authorised for use in children.

Differences in age and development during childhood mean that children may experience different adverse drug reactions from those in adults. There is also concern children are less able to communicate adverse events than adults leading to an under-reporting of reactions. Off-label use may also increase the occurrence of adverse drug reactions.

The EC proposed legislation back in September 2004 that aims to stimulate the research, development and authorisation of medicines to treat children. The EMEA draft guideline is in preparation for when this comes into force and is open for consultation until 31 January 2006.