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Electronic Yellow Card Scheme

Volume 405: debated on Tuesday 13 May 2003

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To ask the Secretary of State for Health how many reported adverse drug reactions via the electronic yellow card scheme there have been in each of the last five months; and what assessment he has made of the scheme. [111132]

[holding answer 7 May 2003]: The Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) launched a new electronic yellow card on 31 October 2002. During 2002, 15 electronic reports of suspected adverse drug reactions were received in November and 16 reports in December. During 2003, 25 reports were received in January, 10 reports in February, 20 reports in March and 10 reports in April.A working group of the CSM and its subcommittee on pharmacovigilance has been formed to advise on strategies for electronic reporting and the criteria for the evaluation of its contribution to pharmacovigilance. The working group has proposed a questionnaire for electronic reporters to obtain their opinions on the usefulness of the electronic yellow card. Reporters are invited to complete this electronic questionnaire after completing an electronic report. An evaluation will be carried out in November 2003, in order to assess the impact of and the nature and quality of information received on electronic yellow cards. The CSM will consider the findings of the evaluation, to inform future enhancements to the electronic yellow card.The capability for early action on emerging safety issues is reflected in the MCA's high level and operational targets. These reflect the time taken to make newly received spontaneous adverse reaction reports available for review and analysis by pharmacovigilance assessors. The MCA's performance against targets is published annually and in 2001–02 all targets were met or exceeded, against a background of a 55 per cent. increase in spontaneous adverse reaction reports.