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Pharmaceutical Packaging and Labelling for Use by Blind and Partially Sighted People

John Gill

 

People with a visual impairment often experience problems in differentiating packets with the increased standardisation of packaging sizes and shapes.  They can also have problems with reading the instructions since they are often printed in a small typeface with poor visual quality.  To alleviate these problems the European Commission have issued a directive requiring suppliers to incorporate braille labels and produce information leaflets in alternative formats.  However the associated standard has yet to be published which leaves uncertainty about the detailed implementation of the directive.

 

Packaging poses significant problems for many older people.  This is often due to an inability to read the label, understand its meaning or open the package without damaging the contents.  Failure to take medicine correctly has been estimated to cost the US economy $100 billion per year [1].

About 1.5% of the population has vision such that they could be registered as 'blind' or 'partially sighted', of these about 0.4% have to rely on non-visual methods to access information [2].  Within these groups there are considerable variations from one individual to the next.  For instance people with low vision includes those with:

 

(a)     Macular degeneration

Macular degeneration accounts for about half of all registerable blindness in the UK; it is particularly common among the older population.  Typically it results in the loss of central vision.  This group often benefits from larger than normal print.

 

 



(b)     Cataracts

A cataract is an opaqueness of the lens at the front of the eye.  It has similarities to driving a car with a dirty windscreen; if the sun is in your eyes, it is difficult to see anything, but with the sun behind you there are relatively few problems.  Fortunately cataracts can usually be operated on successfully, with the lens being replaced by a plastic lens.

 

 



(c)      Diabetic retinopathy

Haemorrhages occur on the retina at the back of the eye.  This is the single most common eye disease among the 16 to 64 age group.  One effect of diabetes tends to be a very poor sense of touch; therefore few people with diabetic retinopathy can read braille.

 

 

(d)     Tunnel vision

Tunnel vision can be associated with some forms of retinitis pigmentosa or a late stage of glaucoma.  Retinitis pigmentosa (RP) is the name for a group of conditions which are genetic and result in night blindness.  Glaucoma is from increased pressure in the eye; if detected early enough, then it can be treated by taking pills.  People with tunnel vision can find it easier to read small print rather than large print.

 

Note:  If you want the above pictures to show a pharmaceutical package, then Chris Sharville (Tel 01342 841666) has the masks to do the job.

 

In addition total colour blindness affects about 0.0025% of the population.  However about 8% of males and 0.5% of females have problems distinguishing red and green.

 

Suggest insert a picture showing an example ofa pharmaceutical package, and then modified to show what it might look like for someone with red-green colour blindness

 

The ageing process affects vision.  In a sixty year old only about one third of the light reaches their retina compared to when they were twenty.  There is also a decline in visual accommodation (the ability of the eye to change focal distance) coupled with a deterioration in the speed of adapting to changes in illumination.  In addition many older people have a combination of impairments.

More than half of people with a visual disability have a significant additional impairment.  This number is increasing since more people are living to an older age.  However it is difficult to predict the effect of multiple impairments since two individuals who appear to have the same combination of impairments may function very differently. 

For partially sighted people it is essential to design the labelling to maximise legibility.  It is recommended that designers should [3]:

The choice of typeface is of particular significance since misreading the dosage quantity could have serious consequences.  It is most important to use a font with 'open' numerals, and avoid fonts such as Arial with 'closed' numerals (see Fig 1).

 

Closed numerals        6 8 9
Open numerals     6 8 9

Fig 1  Comparison of 'closed' and 'open' numerals

Various types of information needs to be included on the packaging:
Primary            Product name, dosage
Secondary       Do not take if …
Tertiary            Advertising

The size of the print for the primary information on packaging should be at least 14 point.  Ideally secondary information should be in 12 point since most older users would benefit from a large print size, but there is finite space on the packaging and increasing regulation requiring more and more information to be included.

A European Directive (2004/27/EC) requires braille labelling for medicinal products introduced after 30th October 2005 [4].  The braille should be on the outer, or secondary, packaging and should include:

Braille characters consist of one to six embossed dots which can have 64 different configurations (see Fig 2). 
 

 

 

 

 

 

 

 


Fig 2  Braille characters consist of 1 to 6 embossed dots

One problem with braille is the lack of redundancy, in that a damaged or missing dot can completely change the meaning of the text (see Fig 3).  Therefore it is very important that the braille dots do not get damaged between the time they are embossed and the time the package reaches the patient.  This will necessitate some changes in how the packages are handled in the supply chain.

 

 

 

 

 

 


                        Fig 3  Only one dot differentiates '£75' from 'large'

 

Another problem with braille labelling is the relatively small number of people who can read it.  Out of about 1 million people in the UK whose vision is such that they could be registered as blind or partially sighted, between ten and twenty thousand can read braille [2].

There are various methods for adding braille to packaging including:

Whichever method is used there is a problem of space on smaller packets such as used for eye drops.  The dimensions for braille (see Fig 4) cannot be scaled up or down.  Therefore to include even a short name like 'Ibuprofen 200' in braille requires a space of over 500 mm2, but the guidance notes to the directive specify that the underlying printed text has to be easily legible.  This implies that the underlying text has to be in a large bold typeface otherwise the embossed braille dots will significantly erode the legibility of the text.

The practicalities of finding space for the braille will probably require manufacturers to use larger packaging.  An alternative would be a fold-out label, but this is likely to be difficult to integrate into the production process.

 

 

 

 

 


                            Horizontal dot to dot (a)               2.5 mm
Vertical dot to dot (b)                   2.5 mm
Cell to cell (c)                                6.0 mm
Line to line                                  10.0 mm

                        Fig 4   Braille cell dimensions

However the dimension which is likely to be the most problematic is the dot height.  In a braille book this is normally between 0.45 and 0.5 mm [6].  On packaging it could be significantly less subject to the constraint that an appropriate dot profile is used.  With lower dot heights the radius of curvature at the top of the dot (r in Fig 5) should decrease.  However the radius of curvature at the bottom of the dot (R in Fig 5) determines the strength of the dot; if R is too large then the dot can easily be squashed, but if it is too small then the material becomes too thin and will burst.  Using long fibre card and high humidity can improve the embossing characteristics of the material.  It is possible to spray a reinforcing agent on the back of the card to improve the durability of the dots.


 

 

 

 

 

 

 


                                                Fig 5   Braille dot profile

 

The directive also requires patient information leaflets to be available in alternative formats which could include:

However there will be a problem with the timely delivery of this information.  When a patient collects their medication from a chemist, they do not want to wait a few days to receive the patient information leaflet in a form they can read.  Therefore there needs to be a system for delivering this information within hours, but it will not be viable for the chemist to stock the whole range of leaflets in all the alternative formats.

Therefore it is likely that patients will opt for the audio information over the telephone because it will be the only format they can have immediately.  The problem will be to design an easy to use service.  It may not be practicable to have a different telephone number for each pharmaceutical product, but many older patients will decline to use an interactive voice response system.

If all information leaflets are produced in alternative formats, the cost to the pharmaceutical industry is likely to be considerable, whilst take up of the service could be modest.

The European Commission has funded a project, Medi-Voice, which addresses the problems of non-compliance and miss-dose by people who have a visual impairment or are illiterate.  Further information at http://pera.projectcoordinator.net/~medi-voice

The new European directive was implemented before work had even started on preparing the associated European standard which will define precisely the requirements such as dot height and required alternative formats for the patient information leaflets.  This will leave a period of uncertainty where manufacturers run the risk of implementing systems which subsequently do not meet the specifications in the European standard, and will therefore have to be changed.  The European Commission might want to consider not requiring compliance with the directive until the associated standard is published.

 

References
1.         Compliance and Persistence with Medication Therapy.  Managed Care Supplement, Vol 19, No 9, September 2000, p 7.
2.         Bruce I, McKennell A & Walker E  Blind and Partially Sighted Adults in Britain.  HMSO, ISBN 0 11 701479 6, 1991.
3.         Information in Alternative Formats www.tiresias.org/guidelines/alternative_formats.htm
4.         European Commission Directive 2004/27/EC Medicinal Products for Human Use.
5.         Guidance Concerning the Braille Requirements for Labelling and the Package Leaflet  pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/04_05/Braille_text20050411.pdf
6.         Braille Cell Dimensions  www.tiresias.org/reports/braille_cell.htm

 

 

 



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