Patient reporting helps highlight serious side effects of drugs

19 May, 2011

New research has shown that patient reporting of suspected adverse drug reactions (ADRs) is richer in detail and better at describing the impact on their daily lives than information provided by health care professionals.

The study, led by Tony Avery, Professor of Primary Care at The University of Nottingham and carried out between October 2007 and June 2010, has shown that the introduction of patient Yellow Card reporting can help to identify important side effects of medicines including serious adverse reactions and reactions that had not been previously included in pharmaceutical product literature (‘Summaries of Product Characteristics and Patient Information leaflets’).

Tony Avery, Professor of Primary Health Care in the School of Community Health Sciences at The University of Nottingham, said: "Our study has shown that patient reports of suspected adverse drug reactions add value by highlighting problems that are not commonly reported by healthcare professionals, and by providing detailed information about adverse reactions, including the impact on patients’ lives. Also, patient reports are just as likely as those from healthcare professionals to concern reactions that are considered serious."

Monitoring of suspected ADRs is vital for patient safety. The Yellow Card Scheme (YCS) run by the Medicines and Healthcare products Regulatory Agency (MHRA) is the system for reports submitted from patients and healthcare professionals on a voluntary basis.

Although the patient voice is clearly important for pharmacovigilance a survey carried out by this study found that of over 2,000 members of the public only one in 12 had heard of the Yellow Card Scheme. The surveys and a series of focus groups indentified ways in which publicity and reporting methods might be improved.

Until 2005 ADR Yellow Card reports were only accepted by the MHRA from health care professionals — after that patients were also included in the scheme. Until now there have been few studies on the views and experiences of patients on the reporting of suspected ADRs.

The study, funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme, concludes that patients could have a more significant role to play in the reporting of ADRs and more should be done to encourage them to participate in the YCS.

Patient  reporters who returned questionnaires to the research team provided important insights into patients’ experiences "Actually, no one knows better than the patient how it feels" and the YCS: "I feel it's important that medicines and their side effects are monitored.  If people who suffer the side effects report them, it's the only way the MHRA will be made aware of the problems and effects some people are experiencing from certain medications".

Researchers from The University of Nottingham, the University of Aberdeen, Keele University, the Drug Safety Research Unit in Southampton, Liverpool John Moores University and the University of Leicester looked at the characteristics of patient reports, the types of drug and suspected ADR reported and the seriousness of reports and their contents. They sought the views and experiences of over 1,300 patient reporters and found that 93 per cent found it fairly easy or very easy to make a Yellow Card report.

Claire Anderson, Professor of Social Pharmacy, School of Pharmacy said "Raising public awareness of the scheme should be prioritised.  Our study showed that the public had often stumbled across the Yellow Card Scheme either in a pharmacy, a doctor’s surgery or via the media."

A major report on the work is published on-line by NIHR Health Technology Assessment ( on Wednesday May 17, and is packed with information about the project, including a large number of illustrative quotes from patients.

MHRA’s Director of Vigilance and Risk Management of Medicines, Dr June Raine said, "Medicines have important benefits; however, they may also have side effects. We welcome the results from this important study which confirm the MHRA’s experience that patients make an important contribution to monitoring the safety of medicines through Yellow Card reporting.

"The findings from this study will help us continue to strengthen the role of patients as reporters to the scheme. The more reports the MHRA receives about suspected adverse drug reactions, the sooner we can relay important safety messages to the public and healthcare professionals — everyone benefits from better information"..

Source: University of Nottingham