Compliance Column

Seeing the problem

Have you noticed that the print size on product labels seems to be getting smaller? I must confess that I have asked my 11 year old son on numerous occasions to read the dosage instruction printed on the back of over-the-counter (OTC) medicines – and I have good eyesight! For the blind and the partially sighted, the inability to read labels on their medicines represents a serious health risk. Throughout Europe this problem affects an estimated 7.4 million people out of a general population of about 385 million and these estimates don’t include individuals like me who just find the type face too small. A report from the Royal National Institute of the Blind (RNIB) states that one in five of the general public could be at risk because they cannot read the small print on medicine labels. Hopefully assistance is now at hand. As a result of successful lobbying by the European Blind Union (EBU) and others for over two years Directive 2004/27/EC will now include provision for the blind and partially sighted. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amends Directive 2001/83/EC on the Community code relating to medicinal products for human use and must be implemented by 30th October 2005.

Put simply, from the end of October it will be mandatory for all pharmaceutical products for human use throughout Europe to include Braille on the outer packaging. The marketing authorization holder also has the responsibility to ensure that a package information leaflet is made available in formats appropriate for the blind and partially sighted.

What’s required?

According to the new European Union legislation the name of the medicinal product followed by its strength must be put in Braille on the packaging of all human medicinal products. Pharmaceutical companies are also encouraged to express further information such as pharmaceutical form, and if appropriate the intended population in Braille on bigger volume packages. For medicinal products authorized in a single strength, only the name in Braille needs to be included on the packaging. For blisters packs, ampoules and bottles, the name in Braille has to appear only on the outer/secondary packaging. No exemptions are made for multilingual packaging. Parallel importer/distributor have to ensure that the Braille text is provided in the language(s) of the Member State of destination and that the original Braille text will not cause confusion. Under the directive the package leaflet should be provided on request for partially sighted people in a suitable print, taking into consideration all aspects determining the readability. One exception is that it will not be necessary to use Braille on product packaging which are intended for administration by health care professionals.

Braille or rubber bands?

Currently visually impaired individuals employ a wide variety of methods to help them identify their medicines. These methods include placing pieces of tape or rubber bands around the bottles, transferring the medicines to different shaped containers and often storing their medicines in different places. While all these methods are cues that prompt the memory they also depend on the individual being in control of their environment. If someone comes along and changes the system the visually impaired person has a real and potentially dangerous problem on their hands.

These mandatory European requirements represent a giant improvement for people with vision impairments as they will soon be able to determine by themselves information pertaining to pharmaceutical products, whether it be prescribed and provided by a pharmacy or sold OTC. Critics are quick to argue that many partially sighted and blind individuals are unable to read Braille. Whereas it is true that many may not be able to read long amounts of text in Braille, it should be a relatively easy process for some to distinguish between different medical products with a small amount of training. Indeed many visually impaired already depend on Braille to gain information on signs, directions, food etc. even though they would not claim to be proficient in reading Braille. Certainly Braille must be a more satisfactory method than placing a rubber band around a bottle or transferring it to another container.

Get packing!

Many groups across the pharmaceutical industry will be affected by this new directive namely: product development managers, parallel importers and distributors, drug information personnel, labeling experts, regulatory affairs groups and quality control and assurance departments but perhaps the biggest impact will be on the pharmaceutical packaging industry.

Adding relief dots to folding carton packaging and labels is technically not difficult; it’s just another element in the set of die-shapes. Other ways to provide Braille labelling on the medicine package include using special fonts on printers that emit a substance that makes up dots on the surface of the carton and also separate embossed labels may offer a solution when attached to the medicine carton.

However there are a number of difficult issues with the implementation of the directive including: higher operational costs that will ultimately be met by the customer and the fact that there is currently no real industry standard established for Braille. Two centuries after its introduction, the Braille system exists in many forms including:

American Literary Braille;
British Braille;
Computer Braille;
Grade 1 Braille;
Literary Braille (Grade 2);
Music Braille;
Nemeth Code Braille.

Developments are already afoot to try and standardize the type of Braille that will be used throughout the pharmaceutical industry. The Spanish association Aspack, together with the Spanish National Blind Association (ONCE) and Farmindustria (the Spanish Pharmaceutical industry umbrella) has launched an industry standard for Braille on carton board packaging that had been offered for adoption at a pan European Level. The European Carton Makers Association (ECMA) has also established a working party charged with the objective of collecting, analyzing and distributing documentation about legislative requirements and to check the availability and of harmonizing Braille standards. The German Association FFI has also released the first draft of their technical guidelines for blind scripture in folding carton manufacture.

The National Council for the Blind of Ireland has offered the following detailed instructions that may be practical and operational transnationally.

Height of dot (Ideally): 0.5 mm + / - 5 %
Diameter of the base of the dot: 1.3 mm + / - 1.5 %
Horizontal spacing between dots in a cell: 2.5 mm + / - 4 %
Vertical spacing between dots in a cell: 2.5 + / - 4 %
Spacing between cells (between identical dots): 6.0 mm + / - 10 %
Spacing between lines (between identical dots): 10.1 mm + / - 9 %
All names must be written in full (grade 1) Braille, meaning that no contractions are to be used.
Uppercase indicators are omitted.
The letters a-z are represented in Braille in the same way in all countries covered by the directive.
Accented characters have to be written in Braille according to the national standard in the country / countries in which such accented characters are parts of the alphabet.

Values given as numbers are to be given as follows:

Number sign: dots 3456 (indicating that the next character(s) are interpreted as digits) followed by any or more of the letters a-j, which will be interpreted as 1-0.
The period, full stop or point (as indicating a decimal value) is given by the use of dot 3.
The percentage sign is given as a two character sign: dot 5 followed by the letter p (dots 1234).

It is also important to ensure that the legibility of the existing print is not distorted by the addition of the Braille lettering and that the Braille can withstand the production process, packaging method and storage.

Hi-tech alternatives

Access to information is a basic right, and one that is particularly important for people with disabilities. The addition of Braille on medicine containers is just one step in allowing blind and partially sighted people to handle medicines with more confidence in the home and allow them to enjoy greater independence. Braille labeling is far from the ultimate solution and many more high tech methods are available or under investigation. These include:

ScriptTalk which is a portable handheld electronic device used to identify prescription information stored in the memory of a RFID microchip embedded with a self-adhesive smart label on the medication bottle;
ALOUD and Talking RX which are essentially talking prescription containers;
Speaking bar code readers such as ScanTELL.

People with disabilities - particularly those with visual impairments may find it hard or impossible to access information others take for granted. Hopefully the appearance of Braille on packaging will also play an important role in raising the general awareness of the difficulties faced by blind people and the partially sighted.

Fiona Jones

P.I.L.S Compliance Columnist