(2) what assessment she has made of the merits of introducing a requirement for doctors to report adverse reactions to (a) licensed and (b) unlicensed drugs;
(3) what assessment she has made of the merits of extending the remit of the Medicines and Healthcare products Regulatory Agency in order to allow it to monitor adverse reactions to unlicensed drugs.
The Yellow Card Scheme is used to collect reports of suspected adverse drug reactions (ADRs) associated with any marketed medicinal product, including those available on prescription or purchased from a pharmacy, or a general retail outlet. The scheme encompasses unlicensed as well as licensed products, including herbal products.
The Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) are continually working to increase the quality and quantity of reports received via the Yellow Card Scheme.
The following table shows the number of reports received in the past three years.
Number of reports 2006 23,992 2005 22,127 2004 20,037
In 2003, an independent review of the Yellow Card Scheme strongly endorsed the value and importance of the Scheme for public health and the benefit of patients. The MHRA is currently developing a strategy in consultation with the CHM to build on these recommendations in order to further strengthen reporting to the Yellow Card Scheme.
It is recognised that voluntary spontaneous reporting systems such as the Yellow Card Scheme are associated with an unknown level of under-reporting. It has been estimated that 10 per cent. of serious ADRs and between 2 and 4 per cent. of non-serious ADRs are reported and that serious reactions are five times more likely to be reported than non-serious reactions.
The value of introducing mandatory reporting of suspected ADRs by healthcare professionals has been considered on several occasions, most recently during the independent review of the Yellow Card Scheme. Available evidence indicates that there is no clear increase in rates of reporting in countries with mandatory reporting when compared with those where reporting is voluntary. Furthermore there would be practical difficulties in enforcing mandatory reporting. The Independent Review did not recommend a mandatory system for suspected ADR reporting in the United Kingdom.