§ Tim LoughtonTo ask the Secretary of State for Health what assessment he has made of the future development of direct patient reporting of adverse drug reactions. [178659]
§ Ms Rosie WintertonThe yellow card scheme is the United Kingdom system for collecting and monitoring information on suspected adverse drug reactions (ADRs). The scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Committee on Safety of Medicines (CSM) and currently depends on voluntary reporting of suspected ADRs by health professionals. The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.
Following an independent review of access to the yellow card scheme, it was announced on 4 May 2004 that the recommendation that patients should be able to report suspected adverse drug reactions directly to the CSM/MHRA had been accepted in principle.
The MHRA is currently developing proposals to pilot different arrangements for patient reporting to gauge effectiveness. The Licensing Authority will reach a decision on the proposals, taking into account the advice of the CSM.