A novel scheme for the reporting of adverse drug reactions

Background-The safety of medicines used in children is of considerable publ ic interest, yet available data to monitor the safety of medicines in child ren is limited. Aims-To raise awareness and stimulate reporting of adverse drug reactions ( ADRs) in children in the Trent region. Methods-A pilot Paediatric Regional Monitoring Centre (PRMC) has been estab lished in the Trent region. The scheme operates as an extension of the UK's spontaneous reporting scheme, the Yellow Card Scheme run by the Medicines Control Agency and the Committee on Safety of Medicines. Proactive interven tions including a monthly reminder letter and presentations to staff in the identified hospitals have been made. Results-During the first year of the PRMC, 95 reports were received from th e Trent region compared to 40 for the previous year. Twenty four of these r eports were for medicines used "off label". The 95 reports involved 105 dru gs and 171 suspected ADRs. Twenty six of the ADRs (15%) were considered med ically significant. Conclusions-The number of ADR reports from the Trent region has increased c onsiderably in the first year of the scheme. The results show that intensiv e education and promotion of ADR reporting can result in a major increase i n reporting. This initiative will increase our knowledge about the safety o f medicines used to treat children and so help protect public health.