Yellow Card Scheme simplifies reporting drug side effects

A spokesman for the MHRA said integrated reporting of suspected side effects, known as adverse drug reactions (ADRs), to the Yellow Card Scheme has been rolled out in 4000 GP practices across England.

The agency said Yellow Card reports act as an early warning of previously unrecognised ADRs, while providing valuable information on already recognised ADRs, helping to ensure that medicines are acceptably safe.

Healthcare professionals can use the website or app to access the latest safety information from the MHRA about medicines and medical devices on the Newsfeed.

They can also search for medicines to see details of Yellow Card reports others have made. Medicines of interest can also be added to a Watch List to receive news and alerts about new side effects and safety advice as it emerges.

The reporting system also ensures patient details are anonymised, which provides an easier, faster and more secure method for healthcare professionals to report suspected ADRs through a few simple steps.

Much of the information needed is automatically populated from the patient and reporter record. This mean that reporters only need to complete a few additional pieces of information. A copy of the report is also held on the patient’s record.

The MHRA’s vigilance and risk management of medicines’ head of pharmacovigilance strategy, Mick Foy, said:

‘This is an important milestone for the Yellow Card Scheme.

‘All Yellow Card reports can be a source of potential new safety information. Expanding the availability of easy-to-use routes of reporting is invaluable towards increased reporting and protecting patient safety.’

Dr Jez McCole, GP at Sheffield Gleadless Medical Centre, said he believes the system could ‘massively improve’ the reporting of ADRs:

‘I haven’t reported a Yellow Card in years, and it was completely coincidental that a significant issue presented itself in consultation the day before the EMIS Yellow card integration switch-on went live.

‘It was a very straightforward process and I think will massively improve the reporting of ADRs with enough advertising.’

Dr Shaun O’ Hanlon, EMIS Group chief medical officer, said: ‘Clinical safety is EMIS Group’s number one priority.

‘Integrating Yellow Card reporting into EMIS Web is another way that clinicians that use our systems can contribute to preventative healthcare, enabling the MHRA to gather information to continue their work to improve medication safety.’

The MHRA said it will continue to work with suppliers and NHS Digital to expand integrated reporting in a range of healthcare settings.

Recent examples of Yellow Card reports that contributed to identifying important safety issues are available from the Yellow Card website.

Reporting guidance for EMIS Web users can be found on EMIS Now.

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