Patients set to benefit from better access to medicines safety data, UK

Main Category: Public Health
Article Date: 17 Jan 2005 - 13:00 PDT

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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 - theYellow 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".

Notes to editor

1. The main recommendations made in the Report of an Independent Review into Access to the Yellow Card Scheme have been accepted, except for those made about Regional Monitoring Centres. These recommendations are the subject of further consideration.

2. The full report is published by the Stationary Office and is available online at the link provided:

3. Recommendations for direct patient reporting of suspected adverse drug reactions (ADRs) were immediately accepted on the publication of the Report of an Independent Review into Access to the Yellow Card Scheme. The MHRA is committed to building a direct patient reporting scheme that will satisfy the needs of patients and the public. Pilot patient reporting schemes are currently underway, and these will inform the development of a permanent patient reporting scheme.

4. Patients are welcome to lodge a report through the Yellow Card website (www.yellowcard.gov.uk), or by completing a paper-based 'Patient Yellow Card', available in over 4000 GP surgeries across the UK. Alternatively, these forms are also available directly from the MHRA by telephoning 020 70842000. Patient reports will be put directly onto the MHRA Yellow Card website.

3. The Yellow Card Scheme was set up in 1964 following the Thalidomide tragedy to provide a system for early detection of emerging drug safety hazards and the routine monitoring for all medicines in clinical use. Suspected adverse reactions to marketed medicinal products are reported to the Committee on Safety of Medicines (CSM) and MHRA, which are jointly responsible for running the scheme. Until now, reports have been primarily submitted voluntarily by GPs, hospital doctors, dentists, coroners, pharmacists and nurses. Reports are also received via the pharmaceutical industry, which has a statutory obligation to report suspected serious ADRs.

5. In July 2002 Health Minister Lord Warner announced the start of an independent review of the Medicines and Healthcare products Regulatory Agency's (MHRA's) drug side effect reporting system - the Yellow Card Scheme.

6. The CSM is an independent Committee of experts that advise Government on the safety, quality and effectiveness of medicines, including vaccines. It is also responsible for encouraging the collection and investigation of reports on suspected adverse reactions to medicines already on the market.

The MHRA is the executive arm of the UK's Drug Licensing Authority and is responsible for all aspects of the regulation of medicines in the UK.

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