However in recent years legislation has greatly impacted the pharmaceutical packaging industry in a number of ways whether its the performance (in the case of child resistance or tamper evidence) or the graphics (in the case of information, warnings, font sizes and more recently Braille). This trend looks set to continue.

In the European Union, in addition to national legislation, the European New Medicines Legislation (NML) now covers a broad range of products. This means that Patient Information Leaflets, Track, Trace and Authenticate, Child Resistance, Compliance (with on pack storage requirements as well as patient dosing) and Waste – all have to be addressed.

A quick example can be used to illustrate the problem of how Legislative factors can impact on a typical product:

A small product (above the minimum stipulated size requirement for Braille – e.g. an eye-care or topical cream) requires Braille on pack. But when sizing the pack against the required Braille characters, there is found to be insufficient space. The solution may be to increase the pack size.

The “waste element” of the packaging component is immediately impacted. Similarly, if you require a larger Patient Information Leaflet, will it fit in the existing carton? Again Legislation has an impact. It is easy to see how Track and trace and other legislative elements may similarly cause problems.
 

In an ideal world, legislation would merely endorse industry practice by formalising standards. However, in many cases regulation and legislation is driven to meet needs not yet addressed by the respective industries. This leads to many challenges.

Braille packaging legislation

A topical example of the impact of legislation is the requirement to place Braille on pharmaceutical and OTC (over the counter) medicine packs on all new products registered after October 2005 (See Article 56 2001/83/EC as amended by Article 56a Directive 2004/27/EC.)
 
In the absence of National and European Standards this, for much of the Pharmaceutical industry, has been an extremely challenging and costly exercise. In this instance the EU Legislation preceded the industry’s capability to implement a standard solution. There was also a significant lack of basic Braille information and knowledge (such as National characters) as well as production “dot height” limitations on packaging formats and supplier capability issues

Implications for the manufacturer

Manufacturing and producer companies are often affected by legislation change, be this the brand owners or the licence holders. These manufacturers independently try and find solutions to legislative challenges resulting in broad swathes of industry attempting to find a multitude of individual solutions. Whereas, it might be more cost and time effective to coordinate and jointly develop industry-wide solutions.

A historical example of this scenario is neck finishes when PET bottles were first introduced to the UK market in the late 1970s. These were developed to become industry standards by a leading packaging manufacturer on behalf of the soft drinks industry with test data shared with all the parties funding the joint development. Once the solution was accepted, it soon became the industry standard. The alternative would have been for each packaging manufacturer to develop their own solution and then recommend their own solution over others, which would have only created more confusion.

If industry could pre-empt or better anticipate legislation requirements then maybe their findings could be plugged into the development of the legislation standards, which would smooth the introduction of the required improvements.

Late Stage Customisation (LSC)

Innovative technologies have opened up new opportunities to meet the challenges of packaging legislation.. A good example of this is Late Stage Customisation (LSC), which has allowed businesses to implement effective strategies for a wide range of products that may have had long lead times or high costs if produced by conventional technologies.

New LSC technology permits businesses (particularly those dealing with pharmaceutical products or high numbers of SKUs) to have the benefits of medium to long production runs  combined with the flexibility to produce low volume orders – exactly matching market’s specific needs and customisation requirements demanded by their regulatory authorities.

Dynamic digital artworking systems can be used in LSC which allows for varied text and coding systems (2D datamatrix codes) as well as dynamic sequential numbering of packs. This in turn can lead to improved track and trace and product authentication capabilities. Lesson’s garnered from adopting an LSC strategy can be aplied to higher volume products. So, in the case of the pharmaceutical industry, the developing technology of digital art working is facilitating the alignment of packaging with specific legislative requirements while assisting in building supply efficiencies and access to medicine.

Different packaging markets means different requirements

Legislation now requires more information to be included with pharmaceutical products. In the EU the ‘Centralised Procedure’ for registering certain products often means that more than one language might be included or that the full licence holder address needs to be shown for each country that the product is marketed in the EU. This could mean 27 different addresses. Change an address and all the leaflets across the EU for that product need to be changed. Given the order sizes of many products this could be a production and procurement nightmare.

Network Rationalisation in the pharmaceutical industry has resulted in specialist manufacturing centres supplying global markets. The variations required to meet local regulations has increased packaging complexity. As an example, in the ‘old’ Central and Eastern European markets (CEE), the same medication may need to be packed to meet 25 different market requirements. Not only may language vary but so might the approved indications.

Some countries such as Belgium also require leaflets in three languages. A strategy to have more multi-lingual patient information leaflets to ease supply logistics adds to this demand.

Text size and type face considerations

Product liability requires the Pharmaceutical Industry to ensure the integrity of all information passing into the hands of the patient.

Regulators are concerned that an aging population is able to both read and understand all patient information. However, more product data, larger type faces and more user friendly layouts all increase the size of leaflets. Recently EMEA has advocated that leaflets have the minimum font size increased from 8 point to 12 point, with headings being 14 point.

Packaging supply sites are being requested by the markets to insert increasingly larger leaflets into the packs.  Some supply sites are resorting to hand packing, due to the limitation of their packing equipment. In addition, leaflet suppliers are reaching the maximum print capability on their conventional printing equipment.

The shape of the type, in the case of numerals, can also be an issue. In certain ‘closed’ font types, numerals such as 6, 8 and 9 can be confusing. In text 1 and l can also be confusing, or 0 and O. Hence careful consideration must be given to communicating information to the intended reader.

Providing increasing patient information with each pack is driving the quest for alternative solutions to conventional leaflets. Meeting these challenges can lead to many innovative solutions and some added value at the same time, which may also drive patient compliance.

Solutions to legislative requirements

With the rapid development of digital systems the range of opportunities is enormous.

When the much heralded implementation of RFID at pack levels occurs this will further open up communication standards.
Both the United State’s FDA and Europe’s EFPIA are both recommending the implementation of technologies which allow products to be tracked through the supply chain and used to verify that the correct product is being administered to the patient. Whereas RFID might have been nominated as the preferred solution both authorities have chosen to outline the performance requirements rather than the technology itself.

The increasing use of the 2D datamatrix code will enable more packs to carry sequential numbers (or encrypted codes) providing digital imaging technology is used to apply the code. Using such codes will depend upon the use of suitable data management systems and having the full supply chain saturated with coded products. It may take the full shelf life of some products before the pipeline is completely coded.

Whatever the coding system used global supply networks will have the challenge to develop global coding which can be defined at the time of application and read with meaningful results at the point of administration.

Codes which mean something to the administrator of the medicine need to be applied to the patient pack. This is done on the filling and packing line which has no visibility of the end user. So, asking the filling plant to apply such coding data or coding technologies would seem to add production ‘hassle’. However, if one could include data and coding technologies which enable a more efficient production cycle and effective supply chain network then these benefits can fund the patient level requirements which on their own would not justify the financial case, even though legislation may demand it.

Such an example is the use of RFID to monitor the temperature an individual pack is subjected to. Often this is a contentious issue in that no business wants it’s consignment rejected because the transit temperature exceeded that specified.

Conclusion

It is doubtful whether any product can be packed to be truly ‘anti-counterfeitable’. All products can be copied in some form to look similar to the original. These similarities can often confuse the end user into believing they have the real product. The challenge is to allow the end user to check if the product is real for themselves
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By the use of appropriate coding systems and having suitable readers available through the supply chain those who are of a responsible disposition could verify that the product is from the right source and is in the correct place. This would require a ‘secure’ supply chain a challenge in itself.

There is a developing market for coding systems and particularly readers with RFID. The real challenge for any system is to have a globally consistent coding process and a suitable data management system.

PGM Consulting delivers innovative, creative solutions to real-world packaging and related Supply Chain problems. For more information please visit www.pgmconsulting.co.uk