Medicine warnings 'not working'

The MCA regulates medicines in the UK

Doctors and patients may not be getting the information they need on the risks associated with medicines.

A National Audit Office report has said the Medicines Control Agency (MCA), the UK's medicines watchdog, must improve the way it communicates to doctors and patients.

The chairman of the Commons Public Accounts committee called the report's conclusions "worrying news".

The MCA regulates the safety, quality and effectiveness of medicine.

The public are in many cases having to deal with poorly labelled medicines and make sense of unhelpful and confusing information

Edward Leigh, Public Accounts Committee

The NAO's report praises the MCA for its monitoring of the safety of licensed medicines and for its inspection of the development and distribution of medicines.

But it calls for improvements in the reporting of so-called adverse reactions, where doctors should tell the MCA if a patient has, or could have been, made ill by the drug.

The report says the MCA is only told about a quarter of fewer suspected reactions to drugs under the existing voluntary scheme.

But the NAO says the MCA does not routinely monitor the effectiveness of its safety warnings, which are based on the adverse reaction reports, although it is planning some improvements to the system.

'A good record'

The report adds communication to patients also needs to be improved.

It welcomes the MCA's plan to tell patients and consumers as well as doctors about adverse drug reactions through NHS Direct from later in 2003.

But the NAO said: "Patient information leaflets enclosed with medicines are often found by the public to be unhelpful and confusing.

"Many consumers read only part of the information provided, and around one in 10 never read the leaflet at all."

Not enough is being done to proactively collate critical drug safety information or to ensure that it is communicated quickly and effectively enough to those that need it

Jackie Glatter of the Consumers' Association

Sir John Bourn, the head of the NAO, said: "The MCA has a good record and its work is highly respected around the world and forms a model in many countries.

"But it needs to do more to communicate directly with health professionals and the public and improve the effectiveness of its safety messages."

Dr Gordon Munro, acting chief executive of the MCA, defended the agency's work.

He said: "The MCA has been an important player in the regulation of medicines on the European and international scene since its creation.

"It continues to build on its scientific and regulatory expertise, protecting public health through a range of activities which ensure that medicines in the UK meet high standards of safety, quality and efficacy, while continuing to improve its overall performance."

He added: "We are actively considering the findings and recommendations of the report."

Information

The NAO compiled its report for the Commons Public Accounts Committee, which is looking at the work of the MCA.

Edward Leigh, chairman of the Committee of Public Accounts, said: "This report reveals the worrying news that the medical profession and the public are not always getting the information they need about medicines and the risks associated with their use, including possible adverse reactions.

"Safety warnings do not always get through to those in the medical profession, including clinicians and nurses, who need them.

"And the public are in many cases having to deal with poorly labelled medicines and make sense of unhelpful and confusing information."

'Not enough done'

Mr Leigh said this caused particular concern as more and more medicines were being made available without prescription.

Jackie Glatter of the Consumers' Association said: "The NAO report confirms what we have found time and time again - not enough is being done to proactively collate critical drug safety information or to ensure that it is communicated quickly and effectively enough to those that need it."

She warned that patient information was suffering because of a conflict between the MCA's public and industry objectives.

Ms Glatter said as long as that was the case, it was difficult to see "how it can effectively prioritise its responsibility in the area of public health".

Paul Burstow, Liberal Democrat Health spokesman, said: "This report must set alarm bells ringing in the Department of Health."