Anaesthesia, 1996, Volume 51, pages 1-2

Editorial
Ampoule labelling
Neither doctor checked the labels of the contents . . .
with fatal results [I]. However well an ampoule is
labelled, the clinical outcome of any injection depends
on the correct drug being administered and the only
certain way of achieving this is for the label to be read
and reread if necessary.
In 1953, a subcommittee of the National Health
Service (NHS) Central Health Services Council looked
at the reported accidents and near accidents relating to
injection of the wrong drug and stated, infer aha, that
the most important cause of accidents is the failure on
the part of the person giving the injection to read or
check the label on the ampoule or other container [2].
The Medico-Pharmaceutical Forum in 1979 set up a
working party To review the problems encountered by
anaesthetists in identifying dispensed medicines and to
advise possible courses of action. They divided error
into two categories: First is the failure of communication of the spoken or written word and second is the
failure to read labels accurately [3]. Both groups made
recommendations for improved labelling, but there is no
evidence of any positive action being taken to implement
the recommendations.
In 1987, the Association of Anaesthetists of Great
Britain and Ireland asked the Centre of Responsibility
for the NHS Procurement of Pharmaceuticals to
examinue standards of ampoule labelling. The services
of a typographer were obtained. This work culiminated
in the publication in 1991 of a n N H S specification for
ampoule labelling, incorporating many of the recommendations of earlier reports. Background to this
work and the medical/pharmaceutical considerations
were described in The Pharmaceutical Journal [4]. The
publication of an NHS specification was welcomed by
the medical profession as a significant step forward [5, 61.
For the first time the pharmaceutical industry had been
presented with a definitive statement of user needs.
The NHS specification divides the information on an
ampoule label into three categories, namely information
essential to the user at the point of use, other
information required by law and commercial information. The essential information is required to be
printed in a standard format on the long axis of the
ampoule in a san serif type face, black on an opaque
yellow background, a colour combination that has been
used in other areas since it affects conspicuity to a
surprising degree [7]. The type size selected must make
optimum use of the space available. The traditional
labelling of ampoules has been by ceramic printing on
clear glass, but this results in all ampoules appearing
similar. Although the ampoules still appear similar, the
use of colour in the new labelling improves legibility of
the essential information, draws the users eye to that
part of the label and achieves maximum legibility in poor
light. The NHS specification requires that, for labels on
plastic containers, the black/yellow colour combination
should be reserved for injectable products; this has been

0003-2409/96/010001

+ 02 $12.00/0

agreed between the NHS Regional Pharmaceutical

Quality Controllers and certain manufacturers.
A specification for small volume parenteral drug
containers (D4267) was published in 1989 by the
American Society for Testing and Materials [8]. The
basic requirements are very similar to the NHS
specification, the main difference being that the
American version includes a legibility test (20 foot
candles illumination readable at 500 mm by a person
with 20:20 vision).
Mistakes or near-mistakes are usually followed by a
clamour for devices such as colour coding or differential
sourcing (use of a specific product from a different
manufacturer). The most common request is for the
introduction of colour coding. The major problem with
colour coding is that it can be the easiest mental
short-cut of all in the assumed identification of the
contents of an ampoule without reading the label. It is
therefore both fallible and dangerous to ascribe a value
to colour. A more mundane problem with colour coding
is that there is a large imbalance between the number of
ampoules marketed and the six or seven easily
distinguishable colours. A further problem with colour
is the need for a convention and nowhere is this more
apparent than with the user applied drug labels currently
available to anaesthetists. The American standard
(D4774) [9] and the labels available in the UK specify a
total of 16 different colours for a similar range of
therapeutic classes of drug, but at no point is there any
agreement between colour and therapeutic class.
Differential sourcing, like colour coding, offers a false
sense of security. It is highly likely that the differentiated
product selected forms part of a range of similarly
labelled ampoules from the same manufacturer. The
supply of another product in the same livery is therefore
a distinct possibility-an error waiting to happen. There
is no safe alternative to reading ampoule labels.
In practice, products are often selected initially by
their location, overall appearance, size, shape, colour,
style of lettering or length of words., The labels
recommended in the NHS specification have been
designed to make the essential information so clear that
misinterpretation becomes difficult.
Use of the correct substance does, however, depend on
the label being read. When an error occurs it is unusual
for parties to admit to not reading the label. The usual
excuse is that the product looked like the one normally
used. The classic error involving adrenaline and atropine
is probably the only case where such a defence might be
considered. Although adoption of the International
Non-proprietary Name (INN) of epinephrine instead of
adrenaline may avoid such a look alike confusion it has
been suggested that epinephrine might be confused with
ephedrine. A more recent criticism [personal communications] has been the possible confusion between heparin
and protamine sulphate; here the words are so different
that if the label is read properly there can be no excuse

@ 1996 The Association of Anaesthetists of G t Britain and Ireland

Editorial

for error. Similarly, confusion between potassium

chloride and sodium chloride cannot be excused if the
labels have been read properly.
A number of critical incidents and even fatalities have
been reported following erroneous administration of
strong potassium chloride injection [lo]. In the U K this
preparation, with a black plastic cap attached to the
ampoule or, in the case of a plastic ampoule, with black
cross hatching at the top of the ampoule to simulate a
black cap, can be obtained if ordered. There is no
measure of the effectiveness of this device in the U K . In
the USA more than 70 errors, most of which were fatal,
involving potassium chloride were reported prior to the
introduction of black capped containers. The product
name has also been changed to Potassium chloride for
injection; concentrate and a warning, must be diluted,
is printed on the cap. No report of death relating to a
look-alike container has been received since the change
to this presentation [ 1 11.
Having introduced a product labelled as clearly as
possible the only area for error is in the reading process.
It has been shown [I21 that many of the mistakes made
in recognising the names of substances occurred because
people read, not as one might suppose, character by
character to form words but by the contour of the word
and its idosyncrasies as a structure. Reading by such
method produces the classic confusion between the
words adrenaline and atropine. Since reading is a skill
learned in early childhood there is an assumption that all
adults can read and this assumption is all the stronger
when professionally qualified persons are concerned;
having learned the rudiments at an early age the
individual takes this ability for granted.
Recognition of words and characters will also depend
on the individuals background. An injectable product
that was labelled LV to designate low volume was
challenged immediately by Pharmacists who recognised
the danger of confusion with IV [13]. A limited piece
of local research showed that pharmacists, doctors and
nurses all made the anticipated error but persons with no
medical or pharmaceutical background read the letters
correctly. The company rapidly changed the labelling.
Such a potential danger should have been apparent not
only to the company, but also to the Medicines Control
Agency who had approved the labelling aspect of the
Product Licence. This example illustrates that, despite
extensive and expensive procedures designed to promote
product safety, the authorities may not perceive the

words o r abbreviations beyond their immediate accuracy and relevance to the particular product they are
addressing.
While there are a number of steps that might be taken
to lessen the possibility of errors, for example restricting
the availability of strong potassium chloride injection,
the only infallible way of knowing what is in an ampoule
is by the words o n the label. If we are giving an injection
we must continually retrain ourselves to read the words.
We should ensure we d o not read what we expect, but
inspect what we read.
Formerly Senior Executive,
D.S. NUNN
National Medicines Sourcing,
North Thames Regional Health Authority,
London W2 3QR
Consultant Anaesthetist

W.L.M. BAIRD

Royal Injrmary,
Glasgow G4 OSF

References
[I] BRAHAMSD. Doctors and manslaughter. Lancet 1993;
341: 1404.
[2] NHS Central Health Seroices Council Report for 1953.
London: HMSO, 1954.
[3] Dangerous mistakes in drug administration. London:
Medico-Pharmaceutical Forum, 1979.
[4] NUNNDS. Ampoule Labelling-the way forward. The
Pharmaceutical Journal 1992; 248: 361-3.
[5] GURATSKY
BP. Labelling drug ampoules. British Medical
Journal 1993; 307: 1211.
[6] JAMES RH. Labelling drug ampoules. British Medical
Journal 1993; 307: 1211.
[7] KINNEAR
J. Words and buildings. The art of public lettering.
London: The Architectural Press. 1980.
[8] Standard Specification for Labels for Small- Volume
(100 ml or less) Parenteral Drug Containers, 04267-89,
Annual Book of ASTM Standards. Philadelphia: American
Society for Testing and Materials.
[9] Standard Specification /or Users Applied Drug Labels in
Anaesthesiology, 04774-88, Annual Book of ASTM
Standards. Philadelphia: American Society for Testing
and Materials.
[lo] HILL
G . The KCI killer. Journal ef The Medical Defence
Union 1990; Spring: 10-1.
[I I] COHENMR. Drug product characteristics that foster
drug-use-system errors. American Journal of HeallhSystem Pharmacy 1995; 5 2 395-9.
[I21 TINKERMA. Legibility of prinl. Iowa: Iowa State
University Press, 1963.
[I31 Depixol LV-Fears over name choice. The Pharmaceutical
Journal 1992; 24& 184.

Editorial notices
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Anaesthesia, Volume 51, January 1996