MHRA to let patients report side-effects online

The new forms, which are being set up at www.yellowcard.gov.uk, will allow medication users to report any ADRs they encounter, as part of an extension of the existing Yellow Card reaction reporting scheme. According to the Medicines and Healthcare products Regulatory Agency (MHRA), this will help them “better understand the patient’s own experience and perspective of adverse drug reactions".

Data from clinicians and patients will also be available online in an anonymised format, along with guidance on interpretation, in the form of a drug analysis print (DAP). Less commonly viewed data will be available on request through the Freedom of Information Act 2000.

More detailed reports for scientific and research purposes will require accreditation by an independent committee, who will review whether the study meets standards of patient confidentiality.

The changes come after the DH implemented recommendations from the May 2004 report, ‘Report of an Independent Review of Access to the Yellow Card Scheme’, ordered by Lord Warner in July 2002.

Chair of the MHRA, Sir Alasdair Breckenridge, said: “The Yellow Card Scheme is an important way that the MHRA monitors drug safety. It is only right that others can also benefit from the data. Research based on Yellow Card data could have enormous public health benefits and by enabling researchers to access the data we will be playing our part in promoting this important research."

Although DAPs have been publicly available on request since the inception of the Yellow Card scheme, the report recommended that the MHRA make them available online without people having to specifically ask for them.

The report also recommended online reporting by linking pharmacies and GPs to the system, and possibly through integrating electronic health record. It suggests this could be done through improving links to NHSnet at pharmacies.

When asked how this would be done, a spokesperson for the DH told E-Health Insider: "The MHRA is developing a communications strategy to increase awareness of the Yellow Card Scheme amongst professional and patient stakeholder groups.

“This will include tailored communications and promotion, education and training for health professionals, including links to the NHS locally. The Committee on Safety of Medicines (CSM) will be reviewing proposals shortly and these will be reported on the MHRA website when available."

Other options introduced for patients include filling out yellow forms at their GP’s surgery in 4000 pilot projects across the UK. Alternatively, forms can be ordered by phone. Any patient-reported data will be kept separate from that reported by health professionals, until a way of linking them cleanly is worked out.

The Yellow Card scheme was set up in 1964 after thalidomide caused widespread birth defects. It is jointly run by the MHRA and the CSM. Before the announced changes, Yellow Cards were solely filled in by clinicians when they identified possible side-effects in patients on medication. Pharmaceutical companies also have a statutory obligation to file serious suspected ADRs.

Health Minister Lord Warner said: “The Yellow Card system is recognised to be one of the best spontaneous reporting schemes for adverse drug reactions in the world. The measures I have announced today will help make it even better."

Yellow Card scheme
Medicines and Healthcare products Regulatory Agency