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Simpler rules for reporting ADRs in children

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Simpler rules for reporting ADRs in children

The Medicines and Healthcare products Regulatory Agency (MHRA) has simplified its guidance for reporting suspected adverse drug reactions (ADRs) in children via the Yellow Card scheme.

The changes follow feedback from healthcare professionals and patient groups, which concluded that reporting every suspected ADR in children was impractical and potentially acted as a barrier to reporting. The updated guidance urges healthcare professionals to report only suspected ADRs that are ‘serious, medically significant or result in harm’, as well as those that are associated with newer medicines and vaccines identified by the black triangle symbol.

The guidance also places greater emphasis on the importance of reporting ADRs in children that result from medicines errors. MHRA director of vigilance and risk management of medicines Dr June Raine said: “The effects of medicines in children can be different to adults and in order to widen our knowledge on any possible side effects in this young age group for existing and new drugs, it is vital that we receive reports”.

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