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Drug side effects

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A UK-wide pilot scheme allowing people to report suspected medicine side effects directly to the health watchdog has been welcomed by Which?.

In 2001, we called for such a system after highlighting that doctors were often failing to pass on information about suspected adverse reactions to drugs. One study, in 1998, found just 9 per cent of all possible adverse reactions associated with ten new drugs were reported by GPs to the regulator.

Under the new scheme, patients will be able to flag up problems to the Medicines and Healthcare products Regulatory Agency (MHRA) through its Yellow Card reporting scheme.

It wants to hear about adverse reactions caused by prescribed and over-the-counter medicines as well as complementary and herbal remedies.

Report online, by form, by phone

Which? Senior Health Policy Advisor Kate Webb said: ‘Which? has called for direct patient reporting of side effects to the Yellow Card Scheme for some time and we welcome this launch by the MHRA.

‘It is important now that the scheme is widely publicised and that patients are aware that they can report side effects they experience directly to the medicines regulator.’

Reporting forms will be available in pharmacies, GP surgeries and other NHS outlets across the UK from the last week of October. Reports can also be made on the Yellow Card website or by calling a free hotline: 0808 100 3352.

The MHRA wants people particularly to report side effects not mentioned in the patient information leaflet that comes with the medicine. It also wants to know about adverse reactions causing problems bad enough to interfere with everyday activities. No timescale for the pilot has been announced.

The Yellow Card scheme was set up in 1964 following the Thalidomide tragedy, in which babies were born with deformities to mothers who had taken the drug during pregnancy. The aim was to provide a system for early detection of dangerous drugs.

Since then there have been more than 500,000 reports of suspected side effects, enabling the MHRA to identify and take action on a range of previously unrecognised medicines safety issues.

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