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Letters to the Editor
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Ampoule labelling
Beware similarity of labels in Anectine and Zofran injections
From Mr T. Delaney, MPSI
Hospital pharmacists, anaesthetists and operating theatre nursing staff
need to be aware of a potential hazard associated with the redesigned
labelling of the ampoule of Zofran 5mg/2ml injection by GlaxoSmithKline.
Operating room nursing staff reported this labelling via our medication
safety incident reporting system as a serious hazard.
The new Zofran ampoule label is plastic, translucent and tinted yellow,
and bears the usual product details. Unfortunately, the new design is
similar to that of GSK’s Anectine 100mg/2ml ampoules. This is also
of yellow-coloured plastic, although in this case the label is opaque
and there is a white component at the bottom.
As regards other distinguishing marks, Anectine has two stripes, one
red and one blue, on the neck of the ampoule; Zofran has two blue strips
on the neck of the ampoule. However, in practice, few staff rely on such
markings to identify products. It is preferable that the label on the
ampoule is as clear and distinctive as possible.
Because of the way operating room staff use medicines such as suxamethonium,
there is a risk of error in this setting. The risk is minimal in any
other setting where, even if Anectine were stocked, it would be refrigerated
and therefore in a different place from Zofran. However, in operating
theatres, ampoules of Anectine are often stored temporarily alongside
other medicines to facilitate work flow during a theatre session.
We have contacted GSK about the labelling problem. The company has indicated
that it would be likely to change the Anectine labelling as a result
of this problem. However, the Anectine labelling has been satisfactory
for some time whereas the new Zofran label, with its translucent plastic,
is more difficult to read than an opaque label and our preference and
that of our theatre staff would be for the Zofran label design to be
changed.
Label changes take months or even years to pass through regulatory bodies.
Meanwhile, hospital pharmacists and operating theatre staff need to be
aware of the current hazard and to take appropriate steps to prevent
mishap.
When designing or redesigning packaging and labelling, pharmaceutical
manufacturers should always engage the help of users of their products
for the purposes of minimising the likelihood of errors as a result of
design changes. Regulatory agencies should make such measures a mandatory
requirement.
Tim Delaney
Head of Pharmacy
Adelaide & Meath Hospital,
Dublin,
Ireland
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The
Pharmaceutical Journal