(2) what assessment she has made of the implications of the technical problems experienced by the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme on the MHRA’s commitment to pharmaco-vigilance and the provision of information to the general public on adverse drug reactions.
Drug Analysis Prints (DAPs) are reports that collect together information on suspected adverse drug reactions submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) through the yellow card scheme. The programme for resolving the technical and data issues relating to the production of DAP on the MHRA website is ongoing. This is a high priority for the Agency and full resolution is planned by the end of the 2007-08 business year. The Agency does provide anonymised information on suspected adverse drug reactions upon request to the general public, health professionals, and pharmaceutical companies, interim measures are in place for providing these data ad-hoc in an equivalent, non-automated, format to the DAP.
The MHRA continue to have total commitment to its pharmacovigilance function and the provision of data on adverse drug reactions. The technical issues experienced at the MHRA have however had an impact upon the format in which these data are presented. The resolution of these issues and full utilisation of the future Sentinel system will enable the Agency to further enhance the pharmacovigilance capabilities and continue to be a world leader in the provision of authoritative, high quality drug safety information by maximising the best technologies available.