Psychiatric Bulletin (2007) 31: 191-192. doi: 10.1192/pb.31.5.191c
© 2007 The Royal College of Psychiatrists
Medication side-effects - informing the MHRA
June Raine, Director of Vigilance and Risk Management of Medicines
Medicines and Healthcare Products Regulatory Agency (MHRA), London SW8
5NQ, email:
press.office{at}mhra.gsi.gov.uk
Lyall et al (Psychiatric Bulletin, January 2007,
31, 16-18) described how two patients with psychotic illnesses
developed stuttering while being treated with clozapine. The
Governments Medicines and Healthcare Products Regulatory Agency (MHRA)
is responsible for ensuring that medicines are acceptably safe. It takes
action in relation to safety concerns and changes in the balances of risks and
benefits. There is no mention by Lyall et al of informing the MHRA
about the stuttering side-effect. I would like to urge readers of
Psychiatric Bulletin to report to the MHRA any side-effects,
suspected or otherwise, caused by a medicine through the Yellow Card Scheme.
This scheme plays an essential role in protecting public health by helping the
MHRA to monitor the safety of medicines on the market. Psychiatrists and other
healthcare professionals can complete a form online at
www.yellowcard.gov.uk,
or on a Yellow Card available in the British National Formulary, or
directly from the MHRA (by telephoning 0800 731 6789). I would also urge
readers to encourage patients to report any side-effects. With these reports,
we can actively look for signs of potential safety issues requiring further
investigation.
Reporting of adverse drug reactions is the professional duty of all
healthcare professionals. The continued success of the Yellow Card Scheme
depends on the continued support of health professionals and patients in
completing Yellow Cards. We encourage Yellow Card reports from patients, but
it is also vitally important that we continue to receive reports from
psychiatrists and other health professionals.