Design for patient safety/Crown Copyright 2005
An image from “Design for patient safety” illustrates
different font styles
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For many, the word “design” will conjure up images of iMac
computers or the latest Volkswagen Beetle. Design giants, such as Philippe
Starck, Ron Arad and the Bauhaus may spring to mind — names far
removed from pharmacy. But the two disciplines are not so alien. Last
week saw the launch of a book, ‘Information
design for patient safety’, a collaboration between the National Patient Safety Agency
and the Helen Hamlyn Research Centre at the Royal College of Art (RCA)
(PJ, 15 October, p472). And, in fact, how good design can improve health
care is something that the Government has been thinking about for some
time.
In 2003, the Department of Health, working with the Design Council, published
a report “Design for patient safety”, which suggests that
a well-designed environment can prevent errors in the health service.
Also in 2003, the National Patient Safety Agency created a new NHS role
and appointed Colum Menzies Lowe as head of design and human factors.
According to Mr Lowe, who has 14 years’ experience as a designer
in the private sector, there are three elements of design: usefulness,
usability and desirability.
Packaging
One of the most prominent design issues in pharmacy is that of drug
packaging and patient information leaflets (PILs). Many letters have
appeared
in The Journal’s letters pages over the years from pharmacists
dismayed at the designs of packaging that are “accidents waiting
to happen”.
Packaging design in the pharmaceutical industry is handled by either
in-house teams or design agencies. Designs for over-the-counter medicines,
where characteristics such as attractiveness and distinguishability are
regarded as significant, are usually commissioned from design agencies.
A marketing team will prepare a brief and the designers will come up
with perhaps six or seven designs. These are whittled down to two or
three that might be tested on a consumer group. In contrast, most designs
for prescription-only products are created in-house. In some cases, this
may simply involve applying a company’s house design (ie, logo,
colour, font, etc). The chosen design is then handed over to design engineers
who work out how the packaging will be produced.
“Good design is about understanding your user,” says Mr Lowe.
The problem with drug packaging, however, is that there are many users
in
the chain, from operations staff who have to store and distribute the
products, to pharmacists and patients. It is not just about keeping your
product fresh, making it easy to transport and stack, and getting the
consumer to buy. Added complications include ensuring safety and compliance.
And because many medicines are used by the elderly, packaging should
take into account users who are visually impaired or suffer from poor
manual dexterity. Design considerations
The designer will consider elements such as print size, font, colour
and layout. A designer’s aim is to meet the brief. Design company
MosleymeetsWilcox redesigned the packaging for Nice’nClear headlice
lotion. Steven Mosley told The Journal that the target consumers were
parents. “We chose green to make the product appear natural.
Green communicates this in the UK,” he said. A rounded font was
chosen to convey friendliness. Branding is significant, especially
for OTC products, so what the box looks like on pharmacy shelves is
also considered. “Some shelves have a lip and would obscure the
logo if it was at the bottom of the box,” he explained.
The author of the recently published ‘Information design for patient
safety,’ Thea Swayne, tracked the journey of a medicine from manufacturing
plant, through distribution warehouses, pharmacies and hospital wards,
to patients’ homes. Her book highlights a multitude of design problems
with current packaging, such as look-alikes and sound-alikes, small type
sizes and glare on blister foils. Situations in which medicines are used
include a parent giving a cough medicine to a child in the middle of
the night and a busy pharmacist selecting one box from hundreds. It is
argued that packaging should be designed for moments such as these. “Manufacturers
are not aware of the complex situations into which products go. As designers,
we are interested in not what is supposed to happen in [hospital] wards,
but what happens in the real world,” Ms Swayne said. Safety and compliance
Incidents where vincristine has been injected intrathecally instead
of intravenously are a classic example of how poor design can contribute
to harm. Investigations following these tragedies have attributed some
blame to poor typography on ampoules.
Child protection is another area that gives designers opportunities
to improve safety. According to the Child Accident Prevention Trust,
seven
out of 10 children admitted to hospital with suspected poisoning have
swallowed medicines. Although child-resistant closures have reduced the
number of incidents, they are not fully child proof. The definition of
such a closure is one that not more than 15 per cent of children aged
between 42 and 51 months can open within five minutes. There is scope
for improving what is currently available, according to Richard Mawle,
a freelance product designer. “Many child resistant packs are based
on strength. They do not necessarily prevent a child from access, but
may prevent people with a disability,” he told The Journal. “The
legal requirements are there for a good reason, but they are not good
enough in terms of the users,” he said. “Older people, especially
those with arthritis, may have the same level of strength as a child,” he
explained, and suggested that better designs could rely on cognitive
skills (eg, making the opening of a container a three-step process) or
be based on the physical size of hands.
Mr Mawle worked with GlaxoSmithKline on a project to improve compliance
through design, which involved applying his skills to packaging and PILs.
Commenting on the information presented, he said: “There can be
an awful lot of junk at the beginning of PILs. For example, why are company
details towards the beginning of a leaflet when what might be more important
for the patient is that the medicine should not be taken with alcohol?” Design principles and guidelines
The intricacies of design and visual information are too complex to
cover sufficiently in this article but, suffice to say, people receive
information
from packaging in sophisticated ways. Most designers will work according
to basic principles, for example, for a single word sans serif fonts
are clearer than serif fonts and lower case letters are easier to read
than capitals or italics. Similarly, the use of too many colours is
confusing so it is better to keep to two or three.
Look-alike boxes present a potential for picking errors and an obvious
solution would be to use colours to highlight different strengths. However,
according to Ms Swayne, colour differentiation needs to be approached
with care. Not only should strong colour contrasts be used, but designating
a colour to a particular strength (colour coding) is not recommended
because this could lead to the user not reading the text on a box.
For medicines packaging, rules exist in the form of legislation (eg,
EU Council Directive 2001/83/EC) and Medicines and Healthcare products
Regulatory Agency guidance (“Best practice guidance on labelling
and packaging of medicines”). Legislation has resulted in some
improvements, for example, particulars such as manufacturer’s details
should now be placed lower down in PILs. On the other hand, the rules
can be vague in some places. For example, article 54 of directive 2001/83/EC
says that particulars required to appear on packaging should be “easily
legible, clearly comprehensible and indelible”. The MHRA guidance
reflects this, but neither specifies a minimum font size, unlike Royal
National Institute of the Blind guidelines, which recommend a minimum
font size of 12 point. ‘Information design for patient safety’ recommends
that generic names should be at least 16 point to avoid confusion in
patients who are dispensed different brands of the same drug. However,
what the minimum size should be has not been tested. Evidence
Design features can provide the basis for lengthy debates. For example,
one argument is that if all packaging is white with black lettering,
people would have no choice but to read every box carefully. The problem
is that trials of drug packaging design are few — common studies
of legibility and comprehensibility concern road traffic signs and
visual display units. Although some designers take results from such
studies into account, proving that a particular feature is beneficial
can be difficult. For example, EU legislation requires that packaging
must now include the name of the medicine in Braille but, according
to Karel van der Waarde, a design consultant to the pharmaceutical
industry, “it is not known how much visually impaired patients
will benefit nor how much the reading of visually able patients will
be impaired”.
More evidence might, however, soon be available. EU legislation requires
PILs to reflect consultations with target patient groups to ensure they
are legible, clear and easy to use. This implies that industry will have
to start conducting tests. Dr van der Waarde has performed readability
studies on boxes and PILs for industry. A typical study involves showing
a leaflet or package to a small group and asking them questions to test
understanding. Results and comments are used to modify the material,
which is then tested on a larger group. A third group is used to show
that any further changes made are an improvement. Dr van der Waarde is,
however, sceptical about the legal requirements and says that many regulatory
authorities do not have the resources to handle packaging information
properly. “They do not look at the use of packaging in a practical
context — they only see one box at a time and not several together
as pharmacists would do,” he said. Making a difference
‘Information design for patient safety’ emphasises that
design does not have to be breathtaking and improvements need not be
complicated.
Something as simple as including drug name and strength above the space
provided for a dispensing label would support the checking process. But
if such small changes could make a difference, why are they not made?
Five years ago, community pharmacist Idris Hughes set up a website (www.patientpacks.com)
to campaign against the shortcomings of drug packaging. Mr Hughes criticises
industry for its “abysmal lack of care in pharmaceutical product
labelling and packaging design,” adding that “some packaging
has not changed in decades.”
Atenolol packaging from Almus |
Not all companies deserve such criticism.
Almus Pharmaceuticals has focused on using design strategically. Launched
over two years ago, it recognised
a gap in the market and used this to differentiate its range of generics. “We
understood the difficulties that pharmacists faced with the poorly designed
generic packs available at the time,” Careen Sneddon, technical
director at Almus, told The Journal. The brief Almus gave to the design
agency included avoiding medication errors and it worked closely with
the agency to ensure the designers understood what was needed. The result
was an innovative distinctive design. Moreover, good design does not
always mean higher costs. “We spent a lot working with the design
agency, but our packs are predominantly produced using a three-colour
process so there is no justification [for poor design] on grounds of
cost,” Ms Sneddon said.
One possible way to encourage change was suggested by Wendy Harris, senior
pharmacist at the NPSA: if pharmacists report all dispensing errors caused
by bad design the NPSA could build up a database and approach the industry
with a persuasive case. Mr Hughes agrees: “There are at least two
victims of a dispensing error — the patient and his or her relatives
and the pharmacist. It takes some courage but I encourage people to step
into the no blame culture and report every error.” In addition,
pharmacists could consider how they might exacerbate matters. Ms Harris
points out that if similar packaging is unsafe, the common dispensing
practice of repackaging into white cartons and brown glass bottles might
cause elderly or confused patients to make a selection error themselves.
Perhaps the answer lies in the hands of purchasers. According to Mr Lowe, “the
NHS has got to provide the carrot — it can buy what we know to
be safer products”. Pharmacists can apply a similar principle.
Jonathan Westlake, product manager at IVAX Pharmaceuticals, which has
also focused on safer design, advises pharmacists concerned about problems
arising from identical packaging of different drugs “to only dispense
products from manufacturers who have taken time and trouble to listen
and support pharmacists with patient packs that are stylish, functional
and easy to recognise”.
Others are less optimistic about what it will take to procure change.
According to Mr Mawle, designers can come up with a perfect solution
but this has to work within the existing framework. “There are
many conflicting issues, for example, improved compliance must be balanced
with higher costs and unless some higher power says ‘forget the
cost, we will buy this new system because it will save money in the long
run’ change will be slow,” he commented. Dr van der Waarde
believes that the fundamental problem is based in legislation, which
treats all medicines identically. “This makes it difficult to design
information suitable for use in specific contexts and it will take time
for legislation to change,” he said. Innovations
Almus Pharmaceuticals believes that it has acted as a catalyst for
better design of generic packaging. The company’s continued pursuit
of improvement has led it to include a picture of tablets on its boxes
as an identification aid and, most recently, it has acquired rights
to a patented packaging form that prevents PILs being separated from
medicines.
The RCA innovation exhibition this year revealed designs for a number
of innovative objects. “The popper”, by Hugo Glover, aims
to help arthritis sufferers remove tablets from blister packs, and “pluspoint”,
by James Cobb, is an adrenaline auto-injector that aims to overcome the
fact that many patients do not carry their auto-injectors due to their
prohibitive size. The aim of good design, according Roger Coleman, professor
of inclusive design at the RCA, is to try to make things more user friendly
as well as safer. Surely, in a patient-centred health system, that can
only be a good thing. ‘Information design for patient safety’ is
not intended to be mandatory. Rather, its purpose is to create a basic
design standard and to stimulate innovation. The challenge for the pharmaceutical
industry, as a whole, is to adopt such a standard. |
The
Pharmaceutical Journal