Healthy Skepticism Library item: 4910

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

ADRs 'significantly under-reported', says BMA
PM Live.com 2006 May 11
http://www.pmlive.com/pharm_market/news.cfm?showArticle=1&ArticleID=4606

Notes:

Ralph Faggotter’s Commnets:

In the UK- “… only about 10 per cent of adverse reactions are formally reported.”

In some other countries the figure is much lower.

If doctors reported every ADR they came across, they would never get any work done!

Full text:

ADRs ‘significantly under-reported’, says BMA

Adverse drug reactions are `significantly under-reported’ in the UK and doctors are often confused about how to inform regulators of suspected side effects, according to a new British Medical Association (BMA) report.

The study, Reporting Adverse Drug Reactions: A guide for healthcare professionals says that at least 250,000 UK patients are admitted to hospital suffering from adverse drug reactions at a cost of some £466m a year.

It also calls on health professionals to inform the Medicines and Healthcare products Regulatory Agency (MHRA) when a medication has an unwanted effect.

Dr Vivienne Nathanson, head of BMA ethics and science, said doctors had a professional duty to report all adverse drug reactions, especially if children or the elderly are involved.

“Unfortunately too many health professionals are confused about reporting procedures,” she said. “Doctors must make sure they report any suspected ADR and at the same time increase awareness among their patients about the reporting process.”

She added that only about 10 per cent of adverse reactions are formally reported.

According to a 2004 study, 6.5 per cent of people admitted to a hospital had suffered an ADR and in 80 per cent of these cases, the reaction was the cause of the admission.

The report says reporting rates must be increased and cites how in 2003, ADR reporting of its effects on the liver caused the herbal drug kava kava to be withdrawn.

The report also recommends ways in which health professionals can increase reporting rates. These include stricter vigilance of so-called `black triangle’ labelled drugs, which are under intensive monitoring, and making patients aware that they should immediately inform their doctor if they suffer any reaction to a medicine.

While ADR reporting has traditionally been the domain of doctors, pharmacists and nurses, at the tail end of last year the MHRA announced a scheme whereby patients were able to report drug side effects to the regulator.

‘Yellow card’ forms were placed in GP practices and other NHS sites; patients are also able to report suspected side effects online at www.yellowcard.gov.uk.

Date published: 11/05/2006