Medicines information pharmacists at five NHS hospitals are currently involved in evaluating a new system for reporting adverse drug reactions (ADRs) electronically to the Yellow Card Scheme.
The new system, which will enable the capture of information about each ADR and the automatic production of a Yellow Card from that data, will be deployed nationwide once the pilot is successfully completed.
The study is being led by Southampton University Hospitals NHS Trust on behalf of the UK Medicines Information service (UKMi), and is being supported and monitored in the five centres by the Medicines and Healthcare products Regulatory Agency (MHRA) targeted research programme.
Introduction of the system will be integrated into the MiDatabank system, which is already used in medicines information centres across the UK for documenting, researching and answering enquiries.
Commenting on the study, the MHRA’s director of vigilance and risk management of medicines Dr June Raine said: “medicines information pharmacists provide important support on individual pharmaceutical care of patients and advice about medicines management in the NHS.The integration of Yellow Card reporting into this system will allow information to be more easily shared with the MHRA for effective drug safety monitoring.”
“Reporting suspected ADRs via the Yellow Card Scheme is a vitally important way of monitoring medicines for potential drug safety issues. Easier access to the Yellow Card Scheme enables the earlier detection of any potential drug safety issues, allowing the MHRA to take prompt action to protect public health,” she added.
Spontaneous ADR reporting is the commonest source for identification of drug safety issues, and often provides an early warning of possible hazards, notes the MHRA. There is a legal requirement for pharmaceutical companies to report suspected ADRs to their drugs when these come to their attention, while the Yellow Card Scheme, run by the MHRA on behalf of the Commission on Human Medicines (CHM), allows health professionals and patients to report suspected ADRs on a voluntary basis.
The Scheme acts primarily as an early warning system for the identification of previously unrecognised suspected ADRs. It also provides valuable information on recognised ADRs, allowing the MHRA to identify and refine the understanding of risk factors that may affect the clinical management of patients. The Scheme’s value has been demonstrated many times and it has helped to identify numerous important safety issues; however, is associated with an unknown and variable level of under-reporting, says the Agency.
The MHRA’s strategy to strengthen use of the Scheme focuses strongly on making reporting as convenient and easy as possible. Yellow Card reporting forms have been made more accessible and easy to complete, and an introduction of online reporting form for reporting via the Internet has been developed at www.yellowcard.gov.uk.
The Agency has also been looking at ways of integrating electronic Yellow Card reporting into GP systems to make reporting as easy as possible to address this. Since the start of July, many GPs are now able to report suspected ADRs to the Scheme directly using their GP practice software. Work to develop similar features within other software systems are continuing with a number of other IT system providers, it adds.