Security and safety at your fingertips, Braille on medicinal products

For sighted persons, and likewise for those with low vision, text in Braille very seldom pops up in their everyday activities and lives. They see and use printed information, be it in ordinary or enlarged fonts.

However, stemming from an EU directive from 2004, it became mandatory that all medicinal packages and containers should be labelled with Braille, indicating the name of the product and basic indications such as important information about the strength of active substances. This has led to a quite unique exposition of Braille on close to all medicinal products, visible for sighted users and touchable for Braille users.

This has several positive implications. Firstly those who are able to use / read Braille to at least a practical extent, can now make distinctions between various medicinal products without necessarily having to ask for help from sighted people in their vicinity, and without inventing various home-made ways to remember which package contains what pills or lubricants. Previously, people used all sort of tricks, rubber bands, clips, pieces of tape etc. to make the tactile distinctions. Now they can read the name etc on the package with their fingers.

Secondly, this leads to increased security, safety and independence. A Braille user can now at any time identify the desired product on his/her own.

Thirdly, this is one way to prove how great and useful Braille marking is. The idea that where there is Braille there is an obvious reason to use it, becomes clear. The more Braille is present, the more reasons there are to get to know and use Braille to enhance independence, which again leads to a sense of satisfaction. Obviously, the medicinal industry and the packaging industry did not at first consider the EU requirements about Braille as a way of becoming Braille crusaders, but as time passed, they have become increasingly aware of the independence and security issues that were some of the basic reasons behind the directive’s provisions.

It is worth looking back at the work that lead to this Directive, and a good way of doing this is to check out a modified version of a presentation that I delivered at a so-called Braille Medicine Forum event which took place in London on October 27-28 2006. The rationale behind the meeting was the need for the pharmaceutical industry to get to grips with recently adopted EU legislation which makes it mandatory to provide Braille labelling on medicinal products. There seemed to be a lot of technical limitations that prevent crisp and easy-to-read Braille on the packaging.

In the dialogue and standardization work which took place, there was considerable interest to arrive at something reasonable, but was necessary for the blind movement to constantly formulate their needs, demands and check any draft solutions to reach the highest possible Braille quality. My presence at this BMF and my work in the CEN arena with colleagues from Germany, the UK and Spain were ways of acting as watch dogs, in the most positive sense of the word.

To present myself briefly, I had at this time for two years been chairing and propelling the European Blind union work on designing guidelines for Braille on pharmaceutical packaging, Patient Information Leaflet requirements and validation issues. I represented the visually impaired together with colleagues in a CEN working Group dealing with Braille on medicinal packaging and chaired two so-called task forces dealing with detailed segments of this quite complex issue.

Lets start by quoting a simple, well-worn but extremely valid principle that we should really all support: nothing about us without us. I believe that for you, dear audience, not one single individual would accept that events, possibilities, decisions etc. affecting you, were undertaken or carried out without yourself or representatives for you having had the opportunity to make your assessment or concerns known. The same goes for us, the blind, or any other minority group. It seems meaningless and worthless if people, so-called experts, technocrats or professionals make decisions on our behalf without giving us the opportunity to speak, use our expertise and experience as the end-users who know where the shoe pinches. In the name of equality, respect and dignity, but at the same time to make shortcuts in involving the end-users at the design phase, money will be saved, decisions will be more sound and chances are that the degree of satisfaction will be much higher than if we as a group are left out of the planning, evaluation and decision-making chain.

It is important to note that this event took place around the same time as the negotiations leading the creation of the United Nations Convention on the Rights of People with Disabilities (CRPD) Article 9 of which (on accessibility) states;

"To enable persons with disabilities to live independently and participate fully in all aspects of life, States Parties shall take appropriate measures to ensure to persons with disabilities access, on an equal basis with others, to the physical environment, to transportation, to information and communications, including information and communications technologies and systems, and to other facilities and services open or provided to the public, both in urban and in rural areas. These measures, which shall include the identification and elimination of obstacles and barriers to accessibility, shall apply to, inter alia: Information, communications and other services, and promote the design, development, production and distribution of accessible information and communications technologies and systems at an early stage, so that these technologies and systems become accessible at minimum cost."

Although this text is phrased in somewhat general terms, I believe it leaves no doubt in our minds that access to information on medicinal packages is but one example of how the world can and should be made accessible to blind persons.

When looking at the magnitude of the minority in question, it is estimated that 1 out of every 30 Europeans have a visual impairment, taking the varying definitions of blindness into account. With this in mind, and with assessments rather than hard statistics available, there are approx. 30 million blind or partially sighted Europeans of which 1/8 or 3.75 million Europeans are blind, which, for this practical purpose means that the persons in question have a visual deficiency that implies that sight for reading is excluded.

Nowadays, the picture of how this group acquires information is very different from the situation say 20 years ago. Internet, audio media, information recorded on tapes and most recently on disc and other digitized media in mp3 formats adapted to the so-called DAISY format, is preferred by many blind persons who have become late blind. The prevalence of blind computer users that are able to access information on the web is growing and does not necessarily restrict itself to the young generation.

Nevertheless, this way of storing and offering information to the blind requires technology and is not readily accessible at the snap of a finger. Also this information is not directly attached to the product it is meant to describe. The situation is different for Braille, which, when written or produced, is right there at your fingertips, if it can be read, that is. Braille on a carton, a container or a box is associated directly to the contents therein.

The ability to read Braille by sense of touch, and transfer the information through the fingers to create understanding, recollection or simple factual recognition requires:

  1. That the Braille is fully legible,
  2. That the user/reader masters the Braille characters and
  3. That the tactile sense on the part of the blind user is intact so as to be able to sense what is written on the product.

Braille itself, having been developed to its full extent in 1825 by a young Frenchman Louis Braille, basically consists of a base set-up of 2 dots horizontally and 3 vertically. This gives a total of 2 times 3 namely 6 dots which from simple calculation gives 2 to the 6th power dot combinations, 64 in all. As one of the 64 combinations is all zeros, no dots present, this is considered as a space rather than a real Braille character.

Actually, nowadays, outside the literary Braille system, there exists an eight dot Braille system in many countries which is used for all those many special characters such as percent, Greek letters, backslash, vertical bar (under-score), bullets and so on. Mathematical wizards will understand, that 8-dot combinations gives 255 choices of Braille combinations. Although some of you might think that this could solve representative problems offering a unified symbol for characters such as the Micro sign as in microgram, the percentage sign and so on, I must disappoint you. Firstly, only a fraction of blind users/readers know the specific national 8 dot systems. Secondly, hardly anyone is able to grasp the much more complex dot patterns in 8 dot configurations. Thirdly, it is a system mainly used for computer manipulation and, finally, even this 8 dot code varies from country to country.

Linguistic particularities such as the amount and type of accented letters, affects the national Braille representation vastly. Braille has developed nationally, i.e. within a structured or more casual environment and almost without coordination between nations. Sometimes, more through coincidence than coordination, different letters that sound the same, are represented in the same way: The Danish-Norwegian æ (or ash) and the Swedish-Finnish a umlaut, which sounds the same but is to be found at different places in the ANSI tables, are represented by the same three dots, 345. The same goes for the o slash and the o umlaut, both are represented with dots 246, as this has been decided upon in the respective countries independently.

While the Scandinavian alphabets all have 3 accented characters, the Spanish language has 7 such characters and French even more. Every time a letter occurs in a language, it calls for representation by one of the 63 Braille signs. The ‘i’ acute in Spanish Braille is represented with the dots 34, while in English and Danish, the same dot combination indicates the slash.

Across Europe, the variety of representations within the literary Braille system of the percentage sign, how to write micro in microgram, the slash etc. is vast and national Braille authorities generally guard their countries' Braille tables like lions.

I could go on with examples but this seems quite unnecessary. Another aspect or peculiarity in the most neutral sense of the word is to be found when writing numbers. Most countries around the World and in Europe use the number sign (dot 3456) to indicate that the Braille signs to follow, the letters a through j, should be interpreted as digits 1 through 0. As for the Francophone countries, however, and with French legislation underpinning the stance, it has been decided to apply a particular and very different number system when writing literary Braille: Dot 6 followed by the first letters in the alphabet with a dot 6 added, zero being a very special case. So, a French digit 1, dot 6 followed by dots 16, would be the same Braille sign as the Scandinavian Braille symbol for a ring. And in the UK and Denmark, digit 1 would be written as dots 3456 followed by dot 1, a. This French system is called Antoine. As peculiar and national as it might seem, it is sure to create headaches amongst many producers that prefer universality.

I will end this presentation by talking about specifications and validation procedures. The conclusions might seem vague and far from exact and concise. One reason is the fact that there is no existing accepted standard to go by, hardly any research to use as an outset for specifications and also, this area becomes quite subjective and dependant on existing technology.

Visualize yourself using spectacles and sitting in your cosy parlour with a long expected letter. You have poured the gin and tonic appropriate for accompanying the reading. You sit down, tear the envelope open to indulge into the contents, and you then experience this irritating phenomenon that your glasses are sticky, covered with some milky substance that makes your vision unclear. You keep on wiping and drying your spectacles, but you can hardly sense the meaning and only decipher a few words. You get angry and end up spilling your drink all over your clothes.

Now what does this have to do with our topic? Well, I wanted to give you a sort of analogy to the experience blind people have, when they are confronted with poor, low quality, faint Braille. I know that my comparison is not fully valid, because the sticky glasses and a barrier between the eye and the text rightly should be compared with say a person with rough finger tips or very freezing cold hands trying to read legible Braille. However, my point is that the frustration blind people encounter when being confronted with faint Braille due to insufficient dot height is the same that you would feel in my letter example above.

From the launch of the directive and until a technical standard was agreed upon, several years passed with regular meetings between standardization bodies and organizations of the blind and the EBU as the target group stakeholder representatives, people from the pharmaceutical industry and people from the packaging industry. It was an interesting and educative process, where we from the blindness movement became aware of a lot of technical issues that we had never thought about, including the aspects of harmonization of useful Braille signs. During the process there arose a need to determine standards on minimum height of the Braille dots, both from a readability and a safety perspective: Could a good and even a "poor" Braille user read the Braille signs and feel comfortable that what he/she sensed was the right information? How low could the dots be without losing a sense of security? What was the margin for faulty dots (meaning that for instance a missing dot or a faint dot would mean that a Braille user might think that the content of a certain substance was different than was the actual fact, since for instance one dot less could turn a 6 into a 9 or a 7 into a 0).

For this reason, a joint research project was initiated with the University of Birmingham under Ms. Sarah Morley Wilkins' supervision and financed partially by the industry and partially by the participating organizations of users to validate some dot height values that we could be satisfied with and that the industry should be obliged to work towards.

One last word about validation. Validation of Braille text is as important as any quality control to honour responsibility, avoid liability and prevent damage. Braille can be checked through comparing graphic/pdf representations against the Braille dots on the actual packages. But as for the user-interface, to ensure that the Braille is really correct and fully legible, the Braille protocol requirements must contain user panel provisions to secure that not only the objective, but also the subjective checking is applied.

These were complicated issues and not something that was determined and described within a few weeks. The work, however, was vital to the directive, and I believe that this may offer wider interest and guidance to other industrial areas than the pharmaceutical one, for instance within the food packaging sector.

How many of you have tried to pour orange juice on a breakfast bowl of cornflakes?

By John Heilbrunn, Danish Association of the blind, Vice-President.

More information on this topic is available on the EBU Website