UK patients invited to report side-effects
pharmafile | October 28, 2005 | News story | Sales and Marketing |
Members of the public will now be able to report adverse events in medicines direct to the UK watchdog through reporting forms online, in pharmacies and by telephone hotline.
Patients had once been considered unable to accurately report adverse events, but controversies over serious side-effects in antidepressants such as Seroxat and the now withdrawn painkiller Vioxx have brought about the change.
A number of witnesses who gave evidence to a recent health select committee inquiry claimed the exclusion of patients from the system meant warning signals had gone unnoticed.
Now a nationwide pilot programme extending the Yellow Card to patients will be launched, with a permanent system expected to be introduced some time next year.
The UK medicines regulator the MHRA (and its predecessor the MCA) was heavily criticised by the health select committee's report, which recommended the introduction of the scheme.
Chairman of the regulator's Committee on Safety of Medicines Prof Gordon Duff commented: "The benefits of encouraging patients to complete Yellow Card reports are becoming evident. Patients provide a different and extremely useful insight into suspected side-effects that we cannot easily get from Yellow Card reports from health professionals."
Industry association the ABPI has welcomed the news, and says the resulting increased amount of data should help companies identify unexpected side-effects sooner.
The association did warn, however, that patients may have difficulty distinguishing such side-effects from disease symptoms and other unrelated health problems, and said careful analysis would therefore be critical.
The ABPI said health professionals also needed better training to improve their reporting.
Mental Health charity Mind has been one of the most vocal supporters for extending the system.
Alison Cobb, policy officer at Mind, said: "The extension of the Yellow Card reporting scheme is something for which Mind has been lobbying and campaigning for several years.
"Now that the problems encountered by people prescribed drugs such as Seroxat have been publicly recognised, it is important that people have access not only to alternative support such as talking therapies but also to appropriate assistance when coming off their medication."
Recent research by Mind in its Coping with coming off report showed that many mental health service users do not receive adequate support from medical professionals when trying to come off their medication.
The MHRA has also recently updated its website, providing information previously not easily available, including complete drug-by-drug records of adverse drug reactions.
The database contains a time lag which means only information up to January 2004 is available, a measure which the MHRA says will allow it to investigate any safety concerns and take necessary action.
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