It is estimated that counterfeit drugs are currently worth more than US$75bn in global trade and criminals are becoming increasingly competent in packaging their products. Detecting that a product is counterfeit is not straightforward. In some cases, it results from basic mistakes made by the counterfeiter; for example, something as obvious as a spelling error on packaging is quite common. Counterfeiters spend a lot of money on sophisticated packaging and labels and then simple errors are often overlooked.
Other indicators can be more subtle; for example, bottle shapes may not be perfectly matched or the colour shade of a bottle may be slightly incorrect – perhaps a simple difference between amber and a light brown. Odours from the pills themselves may also be unusual or the pills may leave an unusually high level of powder residue because they have been formulated incorrectly with the use of chalk. Labels are another key indicator: if a label comes off too easily then this can be a sign of counterfeit activity and will be sent back to a pharmaceutical company for inspection.
One method adopted by many pharmaceutical companies to prevent counterfeit problems is to integrate security within the product packaging. In the healthcare market this can include a variety of technologies that can be integrated into the product packaging – be it a carton, label, overwrap or specialised tear tape. Bespoke packaging solutions can carry a variety of sophisticated brand protection devices, including layering overt and covert authentication and tamper-evidence technologies alongside the brand design features.
Overt technologies
Overt features enable instant authentication of packaging through visual inspection by the user without requiring expert knowledge. Optically variable features such as holographic devices and colour-shift inks are some of the most common and effective overt security features, enabling packaging to be validated quickly and easily.
Holographic devices such as easily identifiable holograms are primarily used as first-level identification devices
Holographic devices such as easily identifiable holograms are primarily used as first-level identification devices and are designed to enable successful authentication at the point of inspection. Secure holograms have been used successfully on a number of customers’ products for many years for brand protection purposes and are supplied on a variety of carriers, including self-adhesive formats. There are many different holographic technologies, including fully metallised, de-metallised and high-refractive index (HRI).
Essentra, for example, carries out its own in-house holographic design, then works to achieve the very highest levels of security design using a wide range of origination techniques. To enhance the security of the hologram further, a variety of features can be included in the design enabling the hologram to be built up using a combination of these features depending on the level of security required.
Another overt technology involves colour-shift inks, which appear as two or more distinct colours when seen from different viewing angles. Such features are easily verified by tilting the item to enable the different colours to be seen. Different colour combinations are available and both strong opaque and subtle transparent effects can be created to complement the existing design of the document or product. Colour-shift pigments are highly specialised and require specific technical knowledge and bespoke equipment. The supply of colour-shift inks is carefully controlled and they are only used in genuine circumstances under strict codes of conduct and including end-use agreements.
Covert technologies
Covert techniques such as infra-red (IR) and ultra-violet (UV) inks, microtext and microscopic tagging are invisible and difficult to detect and replicate without specialist detection equipment. Forensic solutions including molecular markers, and biological tracers offer another level of authentication, but these features can only be identified using laboratory equipment.
Taggants can also be placed onto packaging, with the most effective being completely invisible and detectable only with a special reading device
Images printed with UV inks are visible only under a UV light. UV inks are available in different frequencies, so depending on the formulation of the ink, the investigators will need to use either a long-wave or short-wave UV light to enable the printed images or text to become visible. In addition to this, covert technologies such as taggants can also be placed onto packaging, with the most effective being completely invisible and detectable only with a special reading device. As with other covert technologies, taggants can be identified only by the brand owner or people they equip with the appropriate knowledge and technology, to provide conclusive verification.
Tamper-evidence
Many companies want packaging that will demonstrate whether a product has been tampered with, and in certain parts of the world legislation now demands this. The Falsified Medicines Direcive 2011/62/EU (FMD), enacted in 2011, highlights in Article 54, the need ‘..to verify the authenticity of the medicinal product and identify individual packs’. This has led to a focus on serialisation within the industry. However, Article 54 also requires ‘..a device allowing verification of whether the outer packaging has been tampered with’.
Authentication solutions used to ensure tamper-evidence can be overt, covert, forensic – or any combination. They can protect against tampering, refilling, counterfeiting and diversion and assist in meeting the requirements of the FMD.
Holographic labels seal cartons and provide authentication to users
Tampering can often render products unsafe, dangerous or in some cases even fatal. Tamper-evident seals provide a clear indication that tampering has occurred and can protect your customers and brands from potentially harmful interference. Tear tape is an ideal medium to incorporate easy-opening, tamper-evidence and security into product packaging efficiently and cost-effectively. Essentra currently produces more than 31 million kilometres of tear tape each year to achieve these objectives. Ten colour gravure printing and sophisticated slitting lines ensure tape products meet exacting print and quality standards and can be applied to a wide range of packs, from flexible overwraps and sleeves to cartons, boxes and even hermetically sealed packs.
Engaging with the issue
So how engaged are companies currently with the challenges presented by the FMD and possible solutions to overcome these? Polls taken at a recent Essentra webinar entitled ‘Meeting the Packaging Needs of the EU Falsified Medicines Directive & Beyond’, showed that only 50% of the companies represented were already taking steps towards meeting the serialisation requirements of the FMD. Also, when asked if they had undertaken activity to meet the tamper-evidence requirements of the FMD, just 58% replied positively.
These results showed that although many of the webinar attendees were actively addressing the requirements of the FMD and looking for packaging products to help achieve this, there was still a way to go for many. Polling also highlighted that the preferred products to achieve tamper-evidence included closure labels, glued cartons and perforations as the top solutions being considered or implemented.
Integrated approach
When looking to maximise security it is important to use both overt and covert features that complement each other and are integrated into the design of the carton, label or tear tapes. Packaging companies’ design studios can provide design capability for customers, adding value and delivering customised design concepts and artwork creation for packaging, building in security as part of the overall pack design. This enables a wide variety of features to be integrated into products to meet the overall brand security needs.
When looking to maximise security it is important to use both overt and covert features that complement each other
With the use of increasingly sophisticated counterfeit methods, drug counterfeit criminals continue to advance and profit at the cost of public safety and company revenue. It is essential to implement overt, covert and forensic technologies to ensure that criminals are unable to re-use, copy or misappropriate pharmaceutical drugs or drug packaging.
Anti-theft, tamper-evidence and authentication solutions enable inferior and potentially harmful counterfeit products to be reliably intercepted and stolen genuine products recovered. By implementing the new packaging security techniques, robust and reliable protection from tampering, copying and brand infringement is enabled and counterfeiting will become a less profitable and more challenging process.
