Tags tag counterfeits

As counterfeiting methods become increasingly sophisticated, ever more advanced technologies are needed to fight back. Rob Karsten examines the options

Pharmaceutical manufacturers have a major problem. Once a box of tablets has been closed or a bottle of pills sealed, they can't know for certain exactly what is inside.The exterior packaging might indicate that a batch of antibiotics, made in Italy on 28 October 2002 and destined for the US marketplace, was the original contents but, without handcuffing the box or bottle to a company agent for the journey to the eventual end user, the manufacturer cannot be 100% sure that the same pills are still in there when they are sold to the customer.

Protecting pharmaceutical packaging is a vital weapon in the fight against counterfeiting, but it can only ever provide a solution to one part of the problem. If the pharmaceutical industry is to pose serious barriers to the counterfeiter it needs to identify and implement solutions that both protect exterior packaging and also allow the authentication of the contents inside.

However, there isn't an anticounterfeiting solution in existence that can't be copied; the objective is to make it as difficult as possible by providing functionality in two main areas (table 1).

tagging solutions

Anticounterfeiting solutions fall into two distinct categories: overt tagging systems such as holograms and digital printing techniques; and covert tagging systems like electromagnetic tags, Radio Frequency Identification (RFID) and bio-molecular taggants.

Holograms are the most commonly used overt tagging system. They provide a visual mark of authenticity that can be referred to when purchasing goods so are backed by significant consumer confidence. Before the proliferation of holographic production technologies they were also sufficiently difficult to copy that officials and agents could also use them to prove a product's authenticity.

Printing technologies, based on sophisticated image generation techniques, are being marketed as solutions for product authentication. However, as the resolution of scanners increases, the ability of such techniques to provide a barrier to the counterfeiter diminishes.

Covert tagging solutions offer a hidden - and therefore highly difficult to replicate - means of assigning an identity to a product. Designed to impart an indisputable means of authenticating a product and spotting a fake, most are also capable of being read very quickly from a short distance with a hand-held scanner, meaning that inspectors and agents can work effectively in less than ideal situations. Some also offer track and trace capabilities.

Taggants are a relatively new addition to the anticounterfeiting toolkit. One example is a coding system based on the use of complex biomolecules that are introduced into the packaging or product. Taggants provide a high level of security and are proving to be extremely difficult to copy, although their use is held back by their detection method, which is highly specific and usually forensic, involving wet chemistry.

RFID is the most sophisticated covert tagging solution on the market, utilising small chips that store information about a product and transmit this data to a local receiver. The technology fulfils both the product identification and track and trace needs of the manufacturer, is easy to use and offers a high level of security, but it is relatively expensive.

Electromagnetic tags, characterised by Flying Null's EMID solution, use a small laminate tag containing magnetic elements that can be embedded into the product or its packaging. The magnetic elements give off a signal when interrogated by a special scanner and the position of these elements within the tag gives each tag a unique identity, thus offering both product authentication and track and trace capabilities.

secondary protection

Flying Null's tags typically measure 2 x 30mm and are about 0.02mm thick. They have been specifically designed for covert incorporation into product or packaging, making them difficult detect and duplicate. Additionally the use of the tags can be arranged to indicate tampering or combined with a tamper evident outer seal such as a hologram. As a less complicated technology than RFID, EMID tags offer significant costs savings of up to 90% per application.

As it is becoming more and more difficult to protect secondary packaging from the determined counterfeiter, attention is turning to covert anticounterfeiting technologies as they represent a much higher level of security than overt technologies.

Of the three technologies identified, taggants offer the highest level of security, but don't provide compatibility with existing systems nor ease of use. RFID and EMID tags provide reduced security levels but satisfy the compatibility and ease of use requirements.

The usefulness of RFID and EMID tags becomes clearer when we look past the exterior packaging. If it is becoming more difficult to protect product from counterfeiting by tagging the secondary packaging, it makes logical sense to look towards the end product.

cost-effective

What if pharmaceutical manufacturers were able to assign an identity or mark of authenticity to the product?

Any solution would need to be accessible without opening the box and breaking the tamper evident seal. Both RFID and EMID technologies are machine-readable and are capable of being read from a distance, without line of sight and therefore offer this functionality. The solution must be deployed as close to the product as possible, so the tag must be embeddable in the primary packaging, typically either the blister packaging or the induction seal of the bottle containing the product, without the material disrupting the reading.

RFID manufacturers have traditionally struggled to find a cost-effective tag that can be successfully embedded in aluminium foil, as found on blister packs and in induction seals, because the metal interferes with the signal from the chip. Only advanced, more expensive, RFID tags can overcome this problem so Flying Null began exploring the possibility of embedding its tags into aluminium foil laminated packaging.

During tests at one of the major global pharmaceutical manufacturers, the EMID tags were successfully embedded between the plastic and aluminium layers of blister packaging and proved capable of being reliably read through the secondary packaging. Further trials also established the viability of embedding the tags within the induction seals commonly found on pharmaceutical product bottles and containers.

unique identities

With a price point much below that of RFID, electromagnetic tags can provide a cost-effective solution to the problem.

With an EMID tag, company agents or government officials could establish the authenticity of both contents and secondary packaging by simply scanning the box or bottle. If unique identities are assigned to the tags on the contents and packaging, they could also cross-reference the two tags to ensure that the product is in its original packaging and that it has moved through the correct channels to the correct marketplace.

This would provide an accountability trail from point of manufacture to point of sale or administration to alleviate problems with the grey market or diverted drugs.

Being able to tag the contents of a box or bottle also opens up the possibility of manufacturers offering a means of authentication at the point of sale. Combining two machine-readable anti-counterfeiting technologies, one on the product and one on the packaging, that relate in some way to each other could lead to the introduction of simple scanning devices for distribution to pharmacies and healthcare providers.

The scanner would read the identities of both packaging and product, compare their identities and provide a simple yes, both packaging and product are genuine and relate to each other, or no, one or the other is not authentic or they don't relate to each other.

Given their high levels of security and functionality, RFID and EMID tags represent the future of anticounterfeiting and logistics technologies for the pharmaceutical industry. Both have their benefits and drawbacks, RFID is more expensive to deploy but can be read from a greater distance, EMID tags are cheaper to deploy, can be read through films and foils, but don't offer the same reading range.

Typically RFID tags are more suitable for track and trace applications that require a relatively small number of tags on reusable or high value items, where the cost of the tag can be offset against the fact that the tag has a longer lifespan or the product has a higher value. On the other hand, EMID tags are probably more appropriate in product authentication applications where there are a large number of tags on items that are destined for single use.

Technologies are rarely implemented for their own sake and any decision should be made following an evaluation of costs and required functionality.