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Saturday, 1 December, 2001, 00:34 GMT
GPs fail to report drug problems
Problems with new medicines should be reported
GPs are failing to report possible adverse reactions from newly marketed drugs, research has found.

The study found that only about 10% of adverse drug reactions are reported by GPs to the Committee on Safety of Medicines (CSM).

However, over 50% of serious adverse reactions are reported.

GPs are being asked to do the impossible in the eight minutes they spend with each patient

Dr Chaand Nagpaul
Newly marketed drugs in the UK are marked with a black triangle.

All suspected adverse drug reactions involving these drugs are supposed to be reported to the CSM through a system known as the yellow-card scheme.

However, a team from the Drug Safety Research Unit in Southampton has found that under-reporting is frequent.

The researchers analysed prescription data obtained for 15 newly marketed drugs.

Small number

Definition of serious adverse reaction
Results in death
Is life-threatening
Requires hospital admission or prolongation of stay in hospital
Results in persistent or great disability or incapacity
They found that only 9% (376) of adverse drug reactions were said to have been reported to the CSM.

However, 53% (27) of the events classified as serious adverse drug reactions were reported.

The researchers acknowledge that reporting of serious suspected adverse reactions has improved since a previous study done in 1998.

Researcher Dr Saad Shakir said: "Our results suggest that family doctors are five times more likely to report serious events on black-triangle drugs than non-serious labelled events.

"This finding raises the question of whether doctors are fully aware of the meaning of the black triangle, whereby all suspected adverse drug reactions should be reported to the CSM."

No time

Dr Chaand Nagpaul, a GP in Stanmore, Middlesex, and a member of the British Medical Association's prescribing sub-committee, told BBC News Online that doctors simply did not have enough time to complete every administrative task asked of them.

However, he was confident that serious side effects were being properly reported.

Dr Nagpaul said: "GPs are being asked to do the impossible in the eight minutes they spend with each patient.

"In a short, hurried consultation there is not going to be enough time for patients to discuss all side effects, and for GPs to check the product data sheet to ascertain whether it is a side effect and fill in the necessary administration forms to report it.

"A lot of short cuts take place in a consultation because GPs have such limited time. They must concentrate on treating the patient, and inevitably administrative tasks fall behind."

Dr Nagpaul said extra resources were needed to give GPs more time for patients. He also said patients should be given forms to report side effects directly to the CSM.

The research is published in The Lancet medical journal.

See also:

21 Mar 01 | Health
GPs call for prescription changes
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