§ Mr. WeirTo ask the Secretary of State for Health what assessment he has made of the structures in place to ensure that adverse drug reactions in patients are picked up at the earliest possible stage in situations where there are concerns about potential side-effects of a drug. [60788]
§ Ms BlearsThe Medicines Control Agency (MCA) is responsible for monitoring the safety of medicines on the UK market, and has well-developed procedures in place for pharmacovigilance, enabling early identification and prompt action in relation to drug safety issues.
The yellow card scheme, introduced in 1964 after the thalidomide tragedy, has a world-wide reputation for effectiveness in detecting previously unidentified drug safety hazards. All newly introduced medicines are monitored intensively for at least two years, during which time the safety profile of the medicine is frequently reviewed to ensure that it is appropriately reflected in the product information for health professionals and patients. In addition to spontaneous reports of suspected adverse reactions, the MCA evaluates data on drug safety from a range of sources. In 1999, MCA acquired the general practice research database and its post-licensing division is now evaluating its potential in contributing to effective pharmacovigilance.
297WThe capability for early action on emerging safety issues is reflected in the MCA's high level and operational targets. These measure performance in terms of the time taken to make newly received spontaneous adverse reaction reports available for review and analysis by pharmacovigilance assessors. 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.
The committee on safety of medicines (CSM) has a statutory role in advising the licensing authority on promotion of the collection and investigation of adverse reactions. CSM regularly reviews the effectiveness of the yellow card scheme, and on advice of the CSM in 1999 the scheme was widened to include pharmacists. Following a successful pilot in relation to the meningitis C vaccination programme, the CSM has advised that the scheme should be extended to nurses.