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Duncan Jenkins and Raj Gokani are directors of MORPh
consultancy Ltd, Worcester |
Whose responsibility is it to ensure that the way a product is packaged
does not hinder accurate dispensing? Any pharmacist will tell you that
the packaging of medicines can have an influence on dispensing errors.
Most of us have been in a situation where products that look or sound
similar have been confused resulting in a near miss or a dispensing error.
This perception is supported by error reporting data which shows that
look-alike and sound-alike drugs are implicated in a third of dispensing
errors made in NHS hospitals.1
So whose responsibility is it to ensure that the right product is dispensed
and administered? Clearly pharmacists and other health care professionals
should read the label and not simply rely on the appearance of a product.
End of story? Well, not quite. This view is like saying that if all motorists
drive carefully, there will be no road traffic accidents and therefore
no need for seat belts. Safe dispensing and administration of medicines
should rely on more than vigilance alone.
Several pharmaceutical manufacturers have redesigned their packaging
with a view to aiding product differentiation and reducing the risk of
selection error. However, a quick glance around any dispensary will show
that these companies are in the minority. The use of corporate livery
across entire product ranges is far too common.
So what has motivated the pioneers of safe packaging? An altruistic desire
to protect professionals and patients? This is undoubtedly a factor,
but there are other, more tangible influences emerging.
The Medicines and Health care products Regulatory Agency (MHRA) published “Best
practice guidance on the labelling and packaging of medicines” (PDF 230K) in 2003. This makes recommendations for the positioning and presentation
of information, the use of innovative design to aid identification of
the correct product and user-testing to support packaging and labelling
risk assessment. However, although the guidance makes good sense, it
is only guidance and not regulation. Furthermore, user-testing of packaging
and labelling is not clearly defined, although work is being undertaken
by MORPh Consultancy and others to develop suitable methodology. However,
in the absence of full regulatory clout, will there be sufficient incentives
for the industry? Recent precedents suggest these incentives may exist.
Targeted action
Clinical governance is now embedded in clinical practice and the National
Patient Safety Agency (NPSA) is a household name to health professionals.
The agency published the first report of the National Reporting and Learning
System and the Patient Safety Observatory this July. It may come as no
surprise that medicines feature prominently in the report. Of the 67,334
errors reported from acute hospitals, 8.6 per cent were associated with
medicines.
The reporting system drew attention to selection errors associated with
two childhood vaccines (Repevax and Revaxis) which resulted in 93 children
receiving the wrong product. A safer practice notice was issued by the
NPSA and the MHRA in April this year, drawing attention to this issue
and providing action points for NHS staff in England and Wales to reduce
the risk of further errors. The bulletin also announced that manufacturers
would be redesigning the packaging of one of the vaccines to aid differentiation.
Although the interaction between NPSA, MHRA and the manufacturers is
not known in this case, the NHS made its intentions for England known
in “Building a safer NHS for patients” (Department of Health,
2001) with the statement: “The identification of trends and patterns
of avoidable adverse events will allow targeted action to avoid risk.
In some circumstances action will be taken directly with pharmaceutical
companies.”
Incentives
Although the NPSA and MHRA are influential, capacity to engage industry
in a reactive fashion may limit impact. In any case, prevention is better
than cure. So what other incentives exist? For big pharmaceutical companies
with high volume, high margin brands, investment in packaging and labelling
risk assessment is likely to be small compared with the millions invested
in product development. However, several smaller companies who manufacture
generic medicines have also undertaken packaging designs with safety
in mind. An important consideration for them is whether or not the NHS
is willing to pay for safer packaging.
In a market where competition has mainly been exerted by price, it might
be considered a brave move to introduce packaging and labelling design
into the equation. However, if the NHS wants to improve patient safety,
organisations must be willing to pay for it. Reassuringly, NHS procurement
processes are now starting to take account of safety of packaging, labelling
and other aspects of product design as part of the tender assessment
process.
Returning to the original question of whose responsibility it is to ensure
that product packaging does not hinder accurate dispensing, it remains
the direct responsibility of the health professional. However, others
have a role to play in a developing a multi-faceted approach to patient
safety. The NPSA plays a vital role in providing intelligence and professional
leadership, although other influences include manufacturers, the MHRA
and procurement professionals. Considerations include packaging and labelling
design as well as safe systems of working.
References
1. Roberts DE, Spencer MG, Burfield R, Bowden S. An analysis of dispensing
errors in NHS hospitals. International Journal of Pharmacy Practice 2002;
10(Suppl):R6 (PDF 45K) |
Hospital Pharmacist