Tuesday, October 25, 2005

Plans by the government medicines watchdog to encourage and study patient reports of side effects have met with strong approval from the Association of the British Pharmaceutical Industry (ABPI).

Currently the Medicine and Healthcare products Regulatory Agency (MHRA) gathers data on possible side effects from doctors and other health professionals through the long established ‘Yellow Card’ scheme. A UK-wide pilot scheme is now being rolled out to welcome reports from patients and carers.

The increased amount of data resulting from extending the scheme should help companies identify unexpected side effects sooner. Patients may have difficulty distinguishing such side-effects from disease symptoms and other unrelated health problems, so careful analysis will be critical. The ABPI would also welcome steps to improve reporting by health care professionals through better training.

ABPI Director of Medicine, Dr Richard Tiner said: “Spontaneous reporting is a vital part of monitoring medicine safety and the ABPI welcomes this extension. Direct reporting of patients and carers experiences of side effects from medicines will add a valuable new source of information for the MHRA and manufacturers.”