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BMJ. 2007 November 3; 335(7626): 907.
PMCID: PMC2048869

Agency urges researchers to make more use of yellow card data

Researchers are being urged to make more use of yellow card data on reported adverse reactions to drugs in the United Kingdom.

The call from the Medicines and Healthcare Products Regulatory Agency comes after the publication of the first annual report by its independent scientific advisory committee. The committee reviews the scientific merit of proposals for using data from the card scheme and the general practice research database in research.

“The potential of the data we hold for public health research is unparalleled, and I am delighted that the launch of this first report shows that this is increasingly recognised by researchers,” said Alasdair Breckenridge, chairman of the agency.

“Although general practice research database data have been available for some time, opening up access to the yellow card scheme database was a new venture.”

The advisory committee was set up in 2006 to give advice on research related requests to access data from the general practice research database and yellow card scheme. The research database can provide data from anonymised longitudinal medical records in primary care, and the yellow card scheme was set up in 1964 to collect reports on suspected adverse drug reactions.

The annual report says that with increasing amounts of data being stored on databases in the UK and Europe, the importance of rigorous scientific review to safeguard data held by the agency has never been greater.

The report shows that most of the new database applications (62%) were from academia, with 17% from the drug industry and 13% from government.

It also highlights reasons why applications for data from the yellow card scheme may be rejected, including research hypotheses that are not specific enough and those about reactions to drugs that are already known. It also says that commercial use of data could not be approved where it has been freely and voluntarily supplied for the public good.

The committee chairman, Brian Gennery, welcomed the diversity of applications: “I am pleased that applications for yellow card data have been received from a variety of different applicants, both large organisations and individual researchers. It is important that data are widely accessible to benefit public health research, and the initial feedback we have received from applicants and their enthusiasm to access data has been encouraging.”

But there have been critics of the yellow card system. Andrew Herxheimer, a clinical pharmacologist and former editor of the Drug and Therapeutics Bulletin, who now works at the international Cochrane Collaboration, said, “There is a problem in the brevity and anonymity of the data. They are keen to protect the confidentiality of the patients and the doctors, which is right and proper, but the reports are so thin, just a few sentences, and you cannot understand what is happening without going back to patient or doctor.

“The problem is that there is nowhere on the yellow card forms for the patient or doctor to say they agree to being contacted if further information is needed. It means all the data in there are blocked because you cannot get beyond them.”

Notes

The report is available at www.mhra.gov.uk.


Articles from The BMJ are provided here courtesy of BMJ Publishing Group