Headlines: May 5th, 2004

NHS patients are to be able to report unexpected effects of drugs directly to the medicines watchdog using a series of methods, including the Internet. The Medicines Healthcare and products Regulatory Agency is planning to pilot different systems of patient reporting, which will also include forms available in GPs surgeries.The proposal is one of a series of recommendations which have been made by experts following a review of the Yellow Card scheme, which has been in use for 40 years. The other recommendations will be put out for consultation but the idea of direct patient reporting is to be rolled out immediately.

Health Minister Lord Warner said the Yellow Card System was recognised as one of the best spontaneous reporting schemes for adverse drug reactions in the world. Direct patient reporting would improve the scheme even further. He said systems would be set-up to allow patients to report unexpected effects of medication easily and quickly to the experts monitoring drug safety.

The independent review was set up last year, under the leadership of Dr Jeremy Metters, to look at the implications of allowing greater access to Yellow Card data and to examine how better use could be made of the data itself. In addition to the direct patient reporting the group’s recommendations include academics and researchers being able to access data, providing their proposals are approved by a scientific and ethics committee, that the MHRA should publish anonymous, aggregated data on its website on a regular basis and that it should raise the awareness of health professionals about the importance of reporting adverse reactions.