using psychiatric drugs able to report unexpected side-effects directly
to drug regulator
by Adam James
using psychiatric drugs are to be able to report unexpected side-effects
directly to the drug regulator, ministers announced today.
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)
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
to now only doctors - via the "Yellow Card" system - have
been able to report adverse drug reactions (ADRs) to the MHRA.
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.
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.
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."
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.
first pilots of patients directly reporting ADRs to the regulator
were also launched today.
to report ADRs are to be available in 4000 GP surgeries across the
UK. Patients will also be able to make reports online.
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
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