Measures to improve the drug side effect reporting system - the Yellow Card Scheme

Patients and researchers will be able to look at data on the safety of different medicines announced Health Minister, Lord Warner today. The move is part of a series of measures to further improve the drug side effect reporting system - the Yellow Card Scheme, which is used by the medicines watchdog (MHRA) to monitor the safety of medicines in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) will publish anonymous data on suspected adverse drug reactions on their website. Researchers will also be able to access more detailed data and measures will be put in place to prevent potential abuse of the information. Every request will be reviewed by an independent commitee to make sure it is ethically and scientifically sound and protects patient confidentiality.

The first pilots of patients directly reporting unexpected effects of drugs to the regulator were also launched. Forms to report unexpected drug reactions will available in 4000 GP surgeries across the UK and patients will also be able to make reports online.

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. I hope we can expand the scheme being piloted nationally later in the year.

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. 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".

The new measures are key recommendations made by experts who reviewed the yellow card scheme last year and a public consultation. The Chair of the review, former deputy Chief Medical Officer, Dr Jeremy Metters has agreed to chair the group advising the MHRA on setting up these new measures.

Chairman of the MHRA, Sir Alasdair Breckenridge said:

"The Yellow Card Scheme is an important way that the MHRA monitors drug safety. It is only right that others can also benefit from the data. 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. I am also delighted that Dr Metter's has agreed to help advise on opening access to the scheme".

http://www.dh.gov.uk/

 
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