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Falsified Medicines Directive

August 2013

THE TURBO

Blister machine B 1660.Innovative machine technologyfor dynamic packaging.

Blister machine B 1660.

• High speed for the mass production

of solid dose products

• Up to 750 blisters per minute

• With platen or rotary sealing

• 1, 2 or 3-lane operation

• Direct blister transfer to the cartoner

Uhlmann UK Ltd.

6 Lakeside Business Park

Swan Lane, Sandhurst,

Berkshire GU47 9DN

Great Britain

www.uhlmann.de

Harry Thomason at Travtec Ltd

Code WordThe European Falsified Medicines Directive offers manufacturers the opportunity to invest in effective anti-counterfeiting measures, with the potential to implement a global standard. However, successful systems will depend on the accuracy of the code printed on the product packaging

Counterfeit medicines pose a serious threat to public health and safety, and they remain a growing problem throughout the European Union (EU). In the last five years, over 40 million have been seized by customs at EU borders, while in 2010 alone the number seized at outer borders was 11.5 million. Just as worrying, given the huge increases in online purchases in recent years, is that the percentage of drugs ordered over the internet that turn out to be counterfeit is estimated at between 50 per cent and 80 per cent.

Part of the problem up until now has been that counterfeit medicines were previously regarded as a low priority for many governments. This was not helped by the lack of a coordinated approach, with governments acting alone and often with weak regulatory structures and inadequate penalties, which made counterfeit medicines a much safer option than narcotics for many criminals. Counterfeit medicines could be more profitable too – one recent case highlighted a two-man wholesaler in the UK that made £57.6 million in the four years prior to the arrest of the owners.

It is hardly any wonder, therefore, that the World Health Organization estimated that the counterfeit pharmaceutical market was worth $75 billion in 2010.

Tackling the Issue

It is against this background that, in July 2011, the EU sought to strengthen the protection of patients and consumers through the introduction of the

Figure 1 (above): 2D close-up: the 2D Datamatrix code contains a huge amount of information in a concise format

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Figure 2: Screenshot of a Lixis Vision system ensuring efficient quality control

code, a randomised unique serial number, expiry date and batch number.

With this information, every pack that is produced by each manufacturer has to be ‘checked in’ to a pan-European medicines system. At the point of dispensing, it is then ‘checked out’ and the information cross-referenced to confirm that: the pack is still correct and valid; there have not been any alerts raised against the code; the batch number is correct; and the product is still within its expiry date. The system also includes an optional check while the pack is at the wholesalers.

This system was tested at a national level through a successful pilot project from September 2009 to February 2010 in Sweden, and work is continuing on the national interface with the securPharm project in Germany this year.

Common System

It is clear that a Europe-wide system at the very least – and ideally a global standard – will be of tremendous benefit in today’s international markets, particularly since several countries have already begun to do their own thing. Turkey, for example, was the first country in Europe to implement a track-and-trace system for the pharmaceutical industry which, after a few false starts, went live in 2010. A 2D coding system has also been implemented in France, with the CIP 13 coding requirement in place since January 2011.

There are financial justifications for a single approach too. It is estimated that 25,000 packaging lines will need to be converted in pharmaceutical plants globally, and at an estimated €150,000 per line, this will already cost the industry around €3-4 billion to put in place. Nevertheless, if each country has its own preferred system, this cost could increase substantially, rather than benefiting from the economies of scale from a common system.

At this stage, it is clear that manufacturers will be required to participate in a systems-based, Europe-wide medicines verification process.

Falsified Medicines Directive (FMD). The Directive defines measures that increase the reliability of the medicinal supply chain, with manufacturers having to apply safety features to provide verification of authenticity and allow identification of individual packs.

The deadline for pharmaceutical manufacturers to meet the mandatory compliance to the FMD is expected in 2017. In meeting these requirements, it is important that any system put in place is both cost-effective and able to integrate effectively into existing supply chain processes.

Indeed, even before the publication of the Directive, the pharmaceutical industry in Europe was already moving in the direction of a safe, cost-effective and partnership-based pan-European medicines verification system.

2010 saw the establishment of the European Stakeholder Model (ESM), a partnership of organisations involved in the pharmaceutical supply chain: the European Association of Euro-Pharmaceutical Companies; the European Federation of Pharmaceutical Industries and Associations; the European Association of Pharmaceutical Full-line Wholesalers; and the Pharmaceutical Group of the European Union.

This partnership approach has developed a European end-to-end system to enable medicines to be verified at the point of dispensing to

the patient. Importantly, it has been devised by the stakeholders who will use it in day-to-day operations, so while demonstrating their commitment to the process it will also ensure that the system is workable.

The reason this is important is that as part of the process of implementing a Directive, member states delegate powers to the European Commission (EC) for ‘non-essential elements’ of the legislation – these are referred to as ‘Delegated Acts’. For the FMD, a proportion of this will focus on the technical details of ensuring verification and identification of medicines.

Industry Implications

While the exact outcome of the Delegated Act is not yet clear – it is due to be published next year – there are already indications of what it is likely to contain. An EC consultation carried out between November 2011 and April 2012 showed emerging alignment on areas such as harmonisation through regulation; establishing international standards; using 2D barcode technology; the inclusion of national numbers where necessary (giving some flexibility at national level); and a mandatory point-of-dispensing check with optional random verification by wholesalers.

This is broadly in line with the system the ESM has developed, which uses the 2D Datamatrix code to contain four key data elements: the manufacturer’s product

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Figure 3: Packs need to be completely controlled during the printing process

needs should also be taken into account, ensuring that any coding and marking solution is able to meet the demands of tomorrow as well as today.

Printing Options

Laser offers high-quality permanent codes without putting any additional substances on the product and can be as visible or discreet as required, with no drying time or risk of smudging. However, it is highly dependent on the nature of the material to be coded, as some materials are difficult to mark by laser – which can affect printing speeds – and some cannot be marked at all.

Inkjet printing, on the other hand, is supremely versatile and can print on almost any substrate. It can print one or multiple lines of text and simple graphics at high speeds, while a wide range of inks offering different colours, removable inks, fluorescent, colour-change and ultraviolet further adds to

In particular, the system capabilities that need to be put in place, such as serialisation, are already known. The bottom line is that if these are not acted upon in good time, there is a real danger that pharmaceutical companies will not be able to trade in Europe after 2017. Delaying is clearly not an option. Manufacturers need to start thinking very quickly about making sure they have the equipment and systems to meet this requirement.

Datamatrix Codes

Central to this will be the need to print the 2D Datamatrix code. This provides greater flexibility and accuracy, and is able to include a huge amount of information in a concise format. The 2D Datamatrix code can also contain a greater amount of information than conventional EAN 128 versions, which enables it to be more easily included on primary packs or labels as well as outer cases. One thing to

remember when specifying equipment to produce this code is that it does require a coding system with a print resolution of at least 600dpi.

The first consideration is to select an appropriate printer. With the array of specialist and high-tech coding systems now available, choosing the right piece of equipment can be a daunting task. On the simplest of levels, companies will often be choosing between inkjet and laser technologies. However, within each technology there are further choices that can be made – for example, between thermal inkjet and continuous inkjet, or between carbon dioxide laser and steered beam (scribing) lasers.

Before making any decision, it is vital that a company accurately assesses its requirements in terms of substrate, code content, line speed and factory environment, in addition to the available budget. Future business

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Conclusion

The FMD provides a great opportunity for pharmaceutical companies to introduce comprehensive and effective worldwide anti-counterfeiting systems. Nevertheless, while the focus of these systems is on data collection and exchange, it is essential that the project is not regarded solely as an IT issue. Ultimately, the future success of the Directive will depend on the accuracy of the code printed on the pack – and if too little regard is placed on the engineering aspect, problems will continue to arise in the supply chains.

A fully integrated system is therefore required, and pharmaceutical companies should take great care in selecting the appropriate partner with the relevant experience. Undoubtedly, coding will play a crucial role in helping to ensure the safe manufacture and distribution of pharmaceutical products across the world and to effectively tackle the dangers of counterfeiting. Equally, pharmaceutical manufacturers will find that by working with the right suppliers these new systems will quickly prove a hugely valuable investment. But the time available to find these suppliers and implement the right systems is fast running out – if manufacturers want to be completely ready for FMD compliance in 2017, it is definitely a case of now or never.

its appeal. A recent innovation has been the introduction of specialist inks that can now print directly onto foil blister packs, further enhancing the versatility of this technology.

Nevertheless, selecting the right printer is only the start of finding an appropriate coding solution. While today’s high-resolution printing technologies can deliver the quality of barcode necessary for automated verification systems, it must be understood that they will not always be printing in ideal conditions. For a verification system to work effectively, it will be necessary not only to have

an easily readable code, but also to ensure that it is placed correctly on the pack.

With this in mind, it is equally important that the pack is completely controlled during the printing process. This requires an appropriate feeding and handling system. For efficient quality control purposes, a vision system needs to be incorporated as well. The most sophisticated of these will be able to offer a number of quality checks in addition to barcode accuracy. For example, character recognition software can read both pre-printed and in-line printing, and automatically detect shift or rotation variations. Colour verification can also be monitored, as well as checking the accuracy of logos and artwork, or for the presence and position of labels, caps and other items.

Since none of these pieces of equipment works in isolation, it is vital that they are also fully integrated and able to communicate with each other as part of a seamless operation. In other words, the effective coding of the pack becomes part of a specialised product handling solution comprising all these elements, along with a fail-to-safety reject system.

There are further advantages of such a system, for example in enabling the provision of late-stage

customisation where standard packs

are customised at the last minute with particular information for specific end markets. This helps to minimise origination costs,

while enabling packs to be tailored

to meet different legislative requirements in different countries, or allowing supply to be concentrated towards markets where demand is heaviest.

About the authorAfter serving a five-year apprenticeship, Harry Thomason qualified as a mechanical engineer and trade union representative. Since 2005, he has been Managing Director of

Travtec Ltd, an engineering-based company manufacturing specialised product handling systems for the pharmaceutical, food and cosmetics industries. Harry is also a Director of Sunala Ltd, distributor of Wolke Thermal Inkjet Printers in the UK and Irish pharmaceutical market, and a Director of Nutec Systems Inc, a US-based supplier of pharmaceutical track-and-trace systems. Email: hthomason@travtec.co.uk

Figure 4: Effective coding of a pack needs to be part of a specialised product handling solution

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