will be able to directly report unexpected side effects of
prescription drugs to a medicines watchdog, the government has said.
Patients will be able to report unexpected
reactions to drugs
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 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
"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
"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."