European Medicines Agency consulting on a draft guideline on pharmacovigilance for medicines used in children

The European Medicines Agency (EMEA) has launched a six-month consultationperiod on a draft guideline on the conduct of pharmacovigilance formedicines used by the paediatric population, children from birth to 18 yearsof age. This is the first guideline to focus exclusively on the issues ofsafety of medicines in children. The EMEA is consulting not only onreporting of adverse drug reactions in children, but also on the possibleneed for studies designed to follow the long-term safety of medicines inchildren.

According to the European Commission, more than 50 percent of medicines usedto treat children are prescribed on an unlicensed or 'off-label' basisbecause they have not been adequately tested and/or formulated andauthorised for use in children.

Differences in age and the stage of growth and development during childhoodmean that children may experience adverse drug reactions that vary innature, type and severity from those seen in adults. The systems fordetecting adverse drug reactions in children may not be as effective as foradults. Children may be unable to communicate adverse events or may not beaware that they experience an adverse event. In addition to under-reportingof reactions, off-label use may increase the occurrence of adverse drugreactions. The guideline aims at strengthening the pharmacovigilance systemfor all medicines used in children, whether specifically authorised for suchuse or not.

The European Commission proposed new legislation in September 2004 that aimsto stimulate the research, development and authorisation of medicines totreat children. The proposed regulation also contains a number of provisionsfor pharmacovigilance and the EMEA draft guideline is preparatory work witha view to implementing the regulation once it comes into force.

The European Medicines Agency in particular welcomes comments on thisguideline from healthcare professionals looking after paediatric patients.