UK to publish adverse drug reaction data

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Britain is to overhaul and open up its drug safety monitoring system, already viewed as one of the better schemes worldwide, in the wake of recent scandals over the side effects of some medicines. Patients will in future be able to view anonymous data on suspected adverse drug reactions on the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Web site, Health Minister Lord Warner said Monday.

Researchers will be able to access more detailed information.

In addition, the government has launched pilot schemes that will allow patients to report suspected bad reactions direct to the medicines watchdog.

The global withdrawal of Merck & Co Inc.’s Vioxx in September and warnings over Pfizer Inc.’s similar painkiller Celebrex last month have highlighted the problems of drug safety monitoring around the world.

In contrast to the United States, where monitoring largely relies on doctors reporting problems to manufacturers, who then inform the regulator, Britain has a long established vigilance scheme overseen by independent safety experts.

Under the so-called Yellow Card system, suspected bad reactions are spontaneously reported straight to the Committee on Safety of Medicines and the MHRA by healthcare professionals, pharmacists, coroners and drugmakers.

From now on, however, forms to report unexpected drug reactions will also be available to the public in 4,000 doctors’ surgeries around the country and patients will also be able to make reports online.

“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,” Warner said.

Britain’s Yellow Card system was set up in 1964 in the wake of the thalidomide tragedy, which led to the birth of children without limbs among women who took the drug while pregnant. 

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