Patients using psychiatric drugs able to report unexpected side-effects directly to drug regulator

January 17, 2005
by Adam James

Patients using psychiatric drugs are to be able to report unexpected side-effects directly to the drug regulator, ministers announced today.

The move represents a bid to improve how the safety of all medication - including psychiatric drugs - is monitored by the drugs regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA)

There have, in particular, been huge concerns that the MHRA was failing to effectively monitor the safety of SSRI antidepressants. Critics had claimed the MHRA was dominated by the commercial interests of pharmaceutical firms.

Up to now only doctors - via the "Yellow Card" system - have been able to report adverse drug reactions (ADRs) to the MHRA.

Health Minister Lord Warner said: "The Yellow Card System is recognised to be one of the best spontaneous reporting schemes for adverse drug reactions in the world. The measures I have announced today will help make it even better.

"Enabling patients to directly report unexpected drug reactions allows them to play their part in making medicines safer and help the experts better monitor drug safety and protect public health".

Lord Warner also announced today that the MHRA will publish Yellow Card data - including the (anonymous) data submitted by patients - on its website.

He said: "The data generated through the scheme can be used to further research and improve drug safety in the UK - patients can see the information used to make decisions about medicines safety and researchers can use this important resource to aid research."

Lord Warner said every request to the MHRA from a researcher will be reviewed by an independent committee to make sure it is ethically and scientifically sound and protects patient confidentiality.

The first pilots of patients directly reporting ADRs to the regulator were also launched today.

Forms to report ADRs are to be available in 4000 GP surgeries across the UK. Patients will also be able to make reports online.

Chairman of the MHRA, Sir Alasdair Breckenridge, said: "Research based on Yellow Card data could have enormous public health benefits and by enabling researchers to access the data we will be playing our part in promoting this important research."

* The Report of an Independent Review into Access to the Yellow Card Scheme, which preceded Lord Warner's announcement, is available at www.tso.co.uk/bookshop.

* www.yellowcard.gov.uk

See also:
Jan 17: People on psychiatric drugs should report side effects directly to drug safety watchdog, says pharmaceutical lobby group.
Dec 6, 2004: No evidence that SSRI antidepressants likely to increase suicidal behaviour, watchdog announces - guidelines also issued for treatment of depression
Nov 16: Reform of system for regulating psychiatric drugs outlined by ministers - Commission for the Safety of Medicines members can not have interests in pharmaceutical industry.
Oct 21: Professor of psychological medicine claims half of journal articles written by those with interest in selling researched drugs - health select committee also told drug firms bribe doctors and "ghostwrite" articles

Add your comments
What do you think? Email your comments on the above
article to the editor using the form below. Selected comments will be displayed.

© 2001-7  Psychminded Limited. All rights reserved