Healthy Skepticism Library item: 1315

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Publication type: news

Medicines watchdog under fire
BBC NEWS 2003 Jun 26
http://news.bbc.co.uk/2/hi/health/3021082.stm

Full text:

The government’s medicines watchdog has been attacked by MPs for failing to do enough to protect patients.
The Commons public accounts committee said the Medicines Control Agency’s efforts to improve patient safety was lacklustre.

It accused the agency of failing to gather information on the side-effects of drugs and not doing enough to inform patients about the risks.

The report follows an investigation by the National Audit Office earlier this year which also criticised the MCA.

Under fire

It found that the MCA is only told of one in four adverse drug reactions and failed to examine how effective its safety warnings were.

It urged the agency to step up its efforts to tell doctors and patients about the possible side-effects of drugs.

The whole emphasis of the newly formed MHRA needs to change.
Wendy Garlick,
Consumers Association

The agency is responsible for regulating the safety, quality and effectiveness of medicine.
It was recently merged with the Medical Devices Agency to form the Medicines and Healthcare products Regulatory Agency (MHRA).

MPs said the agency must do more to protect patients.

Conservative MP and chairman of the public accounts committee Edward Leigh, chairman of the committee, said: “It is simply unacceptable that the agency’s efforts to drive improvements in the protection of public health have been so lacklustre.

“The level of reporting by health professionals of adverse reactions to medicines is far too low.

“And the leaflets and labels on medicines designed to provide patients and doctors with important information on potential risks are poor.

“The agency must do more to tackle these issues, for example, by developing training for doctors on medicines’ safety monitoring, and working with manufacturers to comply with good practice on patient information.

“There is also a clear need for an effective communications and awareness strategy to enable the agency to put across safety messages to the public and health practitioners alike.”

The Department of Health said the new agency was stepping up its efforts to inform patients and doctors about the risks associated with certain medicines.

“A key priority for the new agency will be taking an early look at how to further improve communications to achieve this,” said a spokesman.

“There are a number of initiatives that MHRA already has in place to develop and improve all aspects of medicine safety, along with its work in Europe.

“Work is in hand to improve patient information leaflets and labels of medicines.

“The agency is playing a leading role in laying the ground for making sure that more medicines are available for children within the licensing framework, both in the UK and Europe.”

The Consumers Association welcomed the MPs’ report.

Wendy Garlick, its principal policy advisor, said: “The whole emphasis of the newly formed MHRA needs to change.

“A complete shift in approach is needed so that the public becomes the agency’s key stakeholder and not the pharmaceutical industry, as suggested by the public accounts committee.”

Liberal Democrat spokesman Dr Evan Harris said: “The MHRA must now undertake a major communications exercise to raise awareness of what it does.

“It must reach out to patients and clinicians to tackle adverse drug reactions and put across safety messages.”