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Last Updated: Tuesday, 4 May, 2004, 10:54 GMT 11:54 UK
Patients to report drug problems
Patients will be able to report unexpected reactions to drugs
Patients will be able to directly report unexpected side effects of prescription drugs to a medicines watchdog, the government has said.

The Medicines Healthcare and products Regulatory Agency (MRHA) is to pilot different ways of submitting reports.

Patients may be able to use the Internet or forms in their GP's surgery to register comments.

The existing Yellow Card scheme which monitors adverse drug reactions is based on reports from doctors.

The data generated through the scheme can be used to further research and improve drug safety in the UK
Alasdair Breckenbridge, Medicines Healthcare and products Regulatory Authority
The proposal to add patient reports to the information drug experts have is one of a series of recommendations made by experts reviewing the scheme.

It was set up in 1964, following the Thalidomide scandal, to provide a system for the early detection of emerging drug safety hazards and the routine monitoring of all medicines in clinical use.

Direct patient reporting will be rolled out immediately.

But other recommendations, including widening access to Yellow Card data to academics and researchers, and for the MHRA to publish anonymised data on their website for the public to view, will be put out for consultation.


Launching the proposals, health minister Lord Warner said: "Patients want and deserve to play their full part in making medicines safer.

"The Yellow Card System is recognised as of the best spontaneous reporting schemes for adverse drug reactions in the world.

"By introducing direct patient reporting we will improve the scheme even further."

Alasdair Breckenbridge, chairman of the MHRA, added: "The Yellow Card Scheme has been the cornerstone of monitoring drug safety for 40 years.

"The data generated through the scheme can be used to further research and improve drug safety in the UK. These proposals will help to ensure that the full potential of this data is realised."

Melinda Letts, chairwoman of the Long-term Medical Conditions Alliance: "We welcome this because it does give patients the power to report these reactions.

"In doing so, it contributes to a growing sense that patients have got more of a relationship with their own medication and making their own decisions."

But Richard Brook, chief executive of mental health charity Mind, added: "We need to ensure that the MHRA, the people charged with regulating medicine in Britain, will act upon the evidence they hear, in a decisive and wholly impartial manner.

"At present the MHRA listens far too closely to the concerns of major pharmaceutical companies and not nearly close enough to people experiencing side effects from drugs that should be making them better, not worse."



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