Thursday, May 26, 2011

UK patients’ reports of adverse reactions are more detailed than doctors’ -- Mayor 342 --

UK patients’ reports of adverse reactions are more detailed than doctors’

  1. Susan Mayor

+ Author Affiliations

  1. 1London

Patients’ reports of adverse reactions to drugs are richer in detail and better at describing the impact of suspected side effects on their daily lives than information provided by healthcare professionals, shows a UK study.

Researchers assessed the effect of inviting patients or their representatives to report to the United Kingdom’s yellow card scheme for reporting adverse reactions. Healthcare professionals have reported side effects to this voluntary scheme since 1964, but it was opened up to patients in October 2005. Yellow card reports are submitted to the Medicines and Healthcare Products Regulatory Agency by post or telephone or through the internet.

The study compared 26 129 yellow card reports made by patients (20% of the total) and health professionals (80%) between 1 October 2005 and 30 September 2007 (Health Technology Assessment, doi:10.3310/hta15200). It was funded by the health technology assessment programme of the National Institute for Health Research.

Analysis showed that patients’ reports of suspected adverse drug reactions were more likely to include information about symptoms (93%) than reports made by health professionals (78%) and to describe their extreme nature (47% versus 17% of reports). They were also more likely to explain the effect of the reaction on the patient’s life (47% versus 12%).

Patients commonly reported on temporal associations, with 61% stating that the suspected reaction had followed administration of the drug, 26% that it had improved on stopping the drug, and 7% that it had recurred on restarting the drug.

Qualitative analysis showed that patients’ descriptions of suspected adverse drug reactions were more detailed. They also gave information on reasons for the drug being prescribed, how patients identified the adverse reaction, and responses from health professionals.

“Our study has shown that patient reports of 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,” said Tony Avery, the study’s lead author and professor of primary healthcare in the School of Community Health Sciences at the University of Nottingham.

He noted that reports made by patients were just as likely to be about serious reactions as those from healthcare professionals.

A sixth (15%) of the total reports by patients and healthcare professionals described adverse drug reactions not listed on the drug’s summary of product characteristics, so potentially providing new information.

The researchers concluded that patients could be given a more important role in reporting of adverse drug reactions and suggested that more should be done to encourage them to participate in the yellow card scheme. A survey of more than 2000 members of the public showed that only one in 12 had heard of the scheme.

June Raine, director of vigilance and risk management of medicines with the Medicines and Healthcare Products Regulatory Agency (MHRA), 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.”


Cite this as: BMJ 2011;342:d3160

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