Packaging
In association with Mondi Packaging
Read what’s on the pack PDF Print E-mail
Written by Peter Sevenoaks, Director, PGM Consulting Ltd   
For just over a year our company has been assisting a major international pharmaceutical company address the forthcoming requirements for the inclusion of Braille on medicines packaging, whilst taking into account the EC Directive rulings, guidelines and their fuller implications.

Many well-intentioned UK and EC ministers, charities, lobby groups and various private individuals have championed and pressed for the proper inclusion of the blind and partially-sighted in society. Part of this inclusion has been the delivery of relevant communications to this sector of the population – specifically with the inclusion of Braille on medicines packaging.

It is only right and proper that the resulting EC Directive and Guidelines (Article 56a of EC Directive 2001/83/EC) were to be progressed quickly. But in truth, for a multitude of reasons, few of the markets have been able to meet and supply the necessary information to enable this to happen smoothly. As a result of this laudable intent, the key stakeholders and more specifically the pharmaceutical industries themselves have been heading for turbulent and ‘expensive’ times – across Europe, and around the world – in trying to achieve this end.

This article demonstrates some of the real-world problems encountered to date. Why problems? The brief appears elementary: just the addition of Braille to a medicines pack! That doesn’t sound like rocket science – especially in 2006 with all our technology and sophistication.

What do we require to implement Braille on a pack?

  • The Braille content;
  • A compliant Braille marking system;
  • Suitable specifications for both the pack and Braille components;
  • The necessary market approvals from regulatory and blind authorities/associations. It sound so simple – hey presto, you should have suitable-quality Braille on a pack – but it isn’t.

The Braille

The first problem encountered is that the Braille alphabet itself is not common across the EC, let alone across the world. When Louis Braille invented the six-dot, domino-style tactile communication system, it worked well for him in France and for people elsewhere.

It was adopted widely and adapted around the world over time, to suit local country requirements. The resultant Braille alphabets have been in the custody of hard-pressed charitable organisations, discretely serving their local blind and partially-sighted communities. When a new character or notation was required – if there weren’t existent Braille cell sets to borrow from – it was invented. This was pragmatic, and satisfactory at the time.

To date, unmanaged Braille evolution has resulted in an array of misaligned “Braille dialect alphabets” – sharing a common heritage and many cells, but often, by market, different in subtle ways.

At one extreme, countries have been aware of this up-and-coming legislation and this misalignment; they have been hard pressed to bring their Braille alphabets to some degree of commonality – but they have been experiencing difficulties co-ordinating this activity with proper authority, and in getting EC-wide buy-in and consensus.

At the other extreme, we encounter countries shifting themselves decisively towards their very own discreet affirmed Braille alphabet version, albeit with some of the same heritage commonality, but they are also different.

There is to be no Braille sharing in this approach – so every market will have to use its specific alphabet and notation. The upshot is a great deal of confusion about Braille alphabets, and a certain added complexity and costs to the ultimate implementation.

So the Braille alphabets themselves are a problem – but these will be sorted out eventually and when they are, the market-specific artworks can readily be created and we would be hopeful of being one step closer to providing the solution.

All that is now needed is for the pack graphics to be revised for Braille placement – into artworks.

Whilst this might appear not to be a problem, the Brailling process must not render existing pack texts illegible. It is highly likely many packs will require to be redesigned graphically to accommodate this restriction – at no insignificant cost. Will we now be ready to execute Braille on packaging? Possibly!

The compliant Braille marking system


Next, we need to agree a suitable Braille marking system and provide a satisfactory packaging specification – and remember, we are talking about pharmaceutical packaging, where a missing or a wrongly placed Braille dot might kill someone. At the very least, an incorrect or missing dot would require a product recall – a very costly and damaging commercial exercise.

As you would expect Good Manufacturing Practice (GMP), the stalwart practice of the pharmaceutical businesses will apply here in order to control and minimise such mishaps. Very well, choose a Braille marking system that immediately and readily meets GMP requirements. Carton embossing seems to be the first choice system, already proven and much used in Italy, Spain and other world markets. Of course there are other Braille options like labelling, direct and indirect screen printing etc., but these may or may not be fully GMP-compliant. For simplicity, let’s not be hung up about the Braille marking system, particularly for the moment, and accept that embossing should achieve a relatively cost-effective GMP-compliant solution.

Suitable compliant specifications


So, now we just need a set of suitable specifications. These should embrace standards, tolerances and such details; which of these apply to pharmaceutical packaging – and Braille in particular? The Directive in this instance usefully identified some recommendations – these are broadly encompassed within the definition of the Marburg Medium Spacing specification.

Several European professional packaging organisations have evolved this recommendation into usable focused specifications, but only for limited use within their business sectors. In most instances no definition of a meaningful, blind-readable Braille dot height was included!

This being said, much of this diligent work has helped enormously to champion a way forward. The lack of sustainable dot height data is an area of grave concern, as this will be bound totally to the chosen material and Braille marking process/system (e.g. it is possible to achieve excellent dot height with screen printing processes – but possibly not necessarily the same height with the carton board embossing process).

The lack of critical understanding on this topic alone has demonstrated a deep flaw in the root of the Directive’s good intentions and the various attempts at providing a suitable, readily accepted specification. This situation has been further exacerbated by the various

leading EC charities, who have not yet fully embraced this aspect. Their recommendations for minimum dot heights hover between 0.46–0.50mm; these are not viable presently on most high-speed packaging lines and materials.

So, for the moment let’s assume a meaningful consensus related to dot height and materials will be accepted and consistently achievable.

Market approvals, regulatory and blind authorities/associations


What we need now is clarity of intent from the various markets with support from their regulatory and blind authorities.

With all of the above, it is understandable that many of these markets do not yet have answers to some very simple questions, such as: When will your market implement retrospective requirements? What alphabets are officially recognised in your market? Who are the officially recognised Braille authorities and custodians of your Braille alphabet?

Conclusion


The above elements clearly demonstrate some of the many difficulties that have been experienced by many pharmaceutical businesses and the packaging professionals trying to meet the Directive’s requirements.

On a constructive and positive note, how is Braille to be implemented across the EC with this maelstrom of sometimes lacking, conflicting specifications and requirements?

The pharmaceutical companies and bodies such as the BSI, MHRA, ABPI, EBU, RNIB etc. have grasped the metal, and are driving for the delivery of a common Braille Standard for Europe. Company standards are in many instances going their own way in order to meet compliance requirements, so as to be able to launch new product (the area where Braille compliance is already mandatory throughout Europe). They are also readily able to react to those markets who have been mapping and declaring their requirements.

In the interim, the likely standards to be implemented by the pharmaceutical companies will be of their own specification, and these are probably going to be in excess of the eventual European Standard – yet to be evolved through the BSI and CEN.

There are a plethora of other areas that are raising challenges: GMP processes, small packs and long Braille ‘translations’, differing pack form etc. – in short, a multitude of production, quality, checking, artwork and processes issues.

Behind all this work is a second stream to the Directive – this applied to the package leaflet, which has to be supplied in alternative formats: large text, Braille and electronic sound formats. This in itself is an area devoid of standards and specifications, and as I write, these are in formulation. As an independent consultant, I cannot applaud enough the commitment given by the industry to implementing and driving for conformance against severe negative pressures and timeframes.

As a whole, the companies have not only embraced the requirements of the Directive and Guidelines, they have with their unique ethical self-regulatory discipline exceeded and striven to communicate the restrictions of their special business operations to the relevant regulatory and specifying authorities.

Everyone in this work, without exception, has listened and tried to meld their requirements with the legislation and the many obstacles presently in the pathway, but with some 25 countries involved, the process it is going to take some time.

In the end, approved, Braille-legible dots, at meaningful heights, in the correct market alphabets, on a GMP marking system, will be on all pharmaceutical products. We will also have available the alternative formats package leaflet, but the road is long. The objective will ultimately be met, and the blind and partially-sighted will be able to read what’s on and inside the pack.
 
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