Yellow card scheme is “chaotic and misconceived”
The yellow card scheme is chaotic and misconceived in some important respects, say the authors of a new study.
Charles Medawar, of the campaign group Social Audit, and Dr Andrew Herxheimer,
department of primary health care, University of Oxford, have published
what they say is the first critical appraisal of the yellow card scheme
in monitoring the safety of marketed medicines.
The study is a follow up to an earlier analysis of paroxetine (Seroxat)
users’ experiences (done by analysing e-mails sent in response
to a BBC Panorama programme and posted to a discussion board on the Social
Audit website).
The researchers reviewed anonymised yellow card reports of suspected
reactions to paroxetine that had been provided by the Medicines and Healthcare
products Regulatory Agency. They found that most yellow card reports
lacked important information, such as patient history, dosage and outcome
of reaction. Furthermore, the researchers suggest that miscoding and
flawed analyses of the cards have led to an underestimation of the risk
of suicidal behaviours associated with paroxetine use.
The researchers also attempted to compare the value of reports from patients
with those from health professionals. They conclude that reports from
patients, despite their limitations, communicate essential information
that professional reporters can never be expected to provide. “Our
analyses suggest that direct patient reporting may complement yellow
cards, and have an important part to play in pharmacovigilance,” they
say. However, they add that it would be a mistake to try to fit patient
reports into the system established for professional reporting.
In response to the researchers’ concerns, a spokeswoman for the
MHRA said: “Monitoring of drug safety in the United Kingdom does
not rely solely on ADRs being reported. The value of spontaneous reporting
schemes in early detection of drug safety issues is universally recognised,
but so too are the limitations, which is why the yellow card scheme is
but one part of the rigorous system of pharmacovigilance in the UK.” She
added that the MHRA recognised the important contribution that patients’ views
and experiences can make.
A spokesman for GlaxoSmithKline, manufacturer of Seroxat, told The
Journal that the company takes all reports of adverse events seriously, whether
they come from health care professionals or patients. “While we
read this latest paper with interest, it is important to note that the
safety profile of paroxetine has been well characterised,” he added. |
