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MHRA clear on side-effects

A new method for patients to report potential drug-related side-effects direct to the MHRA came into operation from today.

A new method for patients to report what they think could be potential drug-related side effects direct to the UK medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), came into operation from today.

As the furore surrounding the regulator's role in drug safety continues to gather momentum, the MHRA has overtly extended its 40-year-old Yellow Card system for reporting adverse drug reactions (ADRs) to include reports from patients, parents and carers.

Anyone who feels they may have suffered, or be suffering, an adverse effect due to their prescription medicine can register an ADR by filling in a paper form (supplied to around 4,000 GP's surgeries across the country) or submit a concern online, via The MHRA's website will display the number of yellow cards raised for specific drugs, as well as the nature of the problems.

“The point is that patients can see the information on which the MHRA makes decision on the drugs people take. People are interested in their medicines and what the possible side-effects are,” said an MHRA spokesperson.

She admitted, however, that the MHRA “doesn't know” whether the system will become inundated with large numbers of side-effect reports that may well be irrelevant to the patient's medication.

However, a new expert committee, the Patient Reporting of Adverse Drug reactions Working Group, has been set up to evaluate each potential ADR before any information appears on the MHRA website.

“There will be a time lag of around three to six months between the MHRA receiving reports and them appearing on the wesbite as part of the anonymous data sets,” the MHRA told

“It is important to remember that the inclusion of a particular reaction does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account in assessing the likelihood that a drug has caused a reaction, including other medications the patient may be taking, and the underlying condition of the patient.”

The MHRA declined to make a direct comment on whether the timing of the new scheme was anything more than a coincidence with respect to the increasing political pressure from the government's Health Select Committee.

“It's not as if we've quickly put it together in two weeks. We said in May that we would introduce direct patient reporting, The move is to try and give patients even more information on which to make decisions.”

Yet, some industry critics remained sceptical. One told the Financial Times: “This has all the hallmarks of a rush job, trying to fit a round peg into a square hole.”

30th September 2008


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