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Keeping it real - anti-counterfeiting technology

Pharmaceutical packaging is a hot topic at the moment, as companies weigh up the likely consequences of regulatory efforts to protect supply chains from counterfeiting, diversion and theft

Keeping it real - anti-counterfeiting technologyIn Europe, last year's introduction of the Falsified Medicines Directive has focused attention on the use of serial numbers to give a unique identity to pharmaceutical packages, an initiative covered in depth in the article 'Safety in numbers'.

Meanwhile, other developments such as the US Food and Drug Administration's (FDA) pronouncements on standardised numerical identifiers (SNIs) for medicines, as well as the forthcoming 2015 deadline in California for an electronic pedigree system, have made some sort of serialised coding system almost inevitable in the US.

The question many are asking at the moment is whether a serialised coding system to verify a pack, coupled with tamper-evidence to safeguard the integrity of its contents, is sufficient protection against counterfeiting in relatively well-regulated markets, such as the EU.

“The Falsified Medicines Directive – and its use of terms such as unique identifiers and safety features almost as synonyms – has persuaded some companies to think that coding may be enough,” says Mark Davison of brand protection consultancy Blue Sphere Health, who recently authored a book called Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs. “Coding clearly goes a long way towards protection,” he states, “but the systems are not going to become ubiquitous, or even widespread, in the supply chain overnight.”

And, of course, the codes themselves are only effective if systems and infrastructure are in place to check them at appropriate intervals in order to prevent duplicate serial numbers being allowed to circulate for any length of time.

“It is a wise precaution to have some form of authentication layer in addition to digital information on a pack – even if it is just a code printed with some form of verifiable ink,” Davison continues. This helps to reduce the vulnerability to copying, as well as to identify when this has occurred in the field.

Many concur that the most robust anti-counterfeiting strategy for packaging would rely on a combination of tamper-evidence, serialisation and authentication technologies to provide layers of protection.

There is a bewildering array of authentication technologies to choose from, many of which have a long heritage in other settings, such as protecting bank notes from forgery.

Overt technologies that can be detected by eye, smell or touch, such as raised printing, colour-changing inks, watermarks and holograms, are commonly used, albeit generally for higher-value, higher-vulnerability products, according to Davison.

Covert features rely on the use of some form of scanning or visualisation equipment to be read, and include microtext, microthreads, taggants – such as a radio-frequency microchips – and invisible or luminescent inks and can be detected in the supply chain by those with access to the specialised equipment.

Finally, forensic technologies, such as molecular markers and biological tracers, require laboratory testing and are kept secret by brand owners to help assist investigations and legal proceedings.

“All the bigger pharma companies, and certainly those in the top 20, have security features of one form or another on most of their products,” Davison asserts.
That is not generally the case for smaller companies, however. While they may make use of unique packaging or printing features on their products, many are not using additional authentication features.

Gaps in the supply chain
That leaves gaps in the supply chain, which could be exacerbated by the proposed use of 'white lists' in the EU Falsified Medicines Directive to exclude from the safety feature requirements prescription products that are not deemed at risk of counterfeiting. Similarly, over-the-counter products are specifically excluded, unless they are high-risk and therefore added to a black list.

“Counterfeiters don't have to fool everyone all of the time; they just have to fool enough people some of the time to make money,” says Davison, who believes that a white- or black-listing approach will simply drive counterfeiters to target products that are required to have less protection.

What seems clear is that while the European Commission may issue pronouncements on the coding strategies that should be used via the delegated acts procedure, authentication technologies are likely to be left to the discretion of the manufacturer.

Meanwhile, efforts to provide guidance to industry on securing the supply chain continue outside the EU. For instance, the US Pharmacopeial Convention (USP) published a draft document on supply chain integrity in January 2012 that endeavours to bring together the disparate information that is currently distributed across a range of sources, including USP's own publications, FDA guidance, trade organisation recommendations and others.

The draft, which is intended to replace the current general chapter on good storage and shipping practices in the US Pharmacopeia, notes that the combined use of layered packaging technologies such as tamper-evidence, serialisation and authentication features are an 'integral part of brand protection'.

“USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in,” according to Praveen Tyle, USP's chief scientific officer.

“There is incentive for all players in the pharmaceutical industry – large and small companies, regulators and standards-setting bodies – to come to some agreement on hot-button issues such as track-and-trace technology.”

USP is planning to hold a Workshop on Supply Chain Integrity to discuss the proposed chapter, currently scheduled for 22-23 May, at its headquarters in Rockville, Maryland.

Emerging economies
Meanwhile, outside the well-regulated markets in the EU and US, the picture is very different. One of the key limitations of any coding system is that it has to be online: no broadband means no reliable means to verify the code on a pack.

In many other parts of the world, reliable internet connection is not the norm, so an EU-style coding-based system becomes largely unworkable. There has, however, been a phenomenal investment in mobile phone networks in Africa, for example, and this has provided a conduit to allow verification of medicine packs via text messaging.

Africa is now the second-largest mobile phone market in the world in terms of users, with more than 600 million subscribers, more than five times the number with access to the internet.

Companies such as Sproxil, PharmaSecure and mPedigree have developed systems that are based on printing a simple alphanumeric code on the primary and/or secondary packaging of a product, which can be texted to a central SMS number. Within seconds, a return message indicates whether the code is genuine. These have already started to roll out in Nigeria, Ghana and India, as well as other countries around the world where the background level of drug counterfeiting is relatively high.

The systems are not completely secure. For example, pilot testing in Nigeria revealed cases where fake and genuine blisters were included in a coded secondary pack, although the greater visibility over the supply chain helped the brand owner identify the retail outlets where this activity was occurring. Overall, they can have a significant effect where there is a lot of counterfeiting.

Davison believes that, in time, there may be potential in adapting the systems emerging in Europe and the US, which look likely to rely on 2D datamatrix codes, to allow consumer-level verification using mobile phone networks. That would also reduce the complexity for manufacturers and avoid a situation in which a different array of technologies needs to be applied and verified, depending on the end-market for a product.

“The more we can do with what is actually printed on the pack, the better,” he notes. “Complexity kills these systems.”

Davison also believes that some of the best approaches to authenticating products rely on the intrinsic properties of the medicine itself, rather than the addition of an extra security feature.

Handheld Raman spectroscopy scanners can be used to check the spectra of a drug, for example, and this can be a great way to identify counterfeits on shop shelves and at various points of entry into the supply chain. Other approaches being used involve recording the intrinsic pattern of fibres in cardboard packaging for a product, which can then be verified in the field using a simple office scanner.

On-dose technologies
One advantage of handheld scanners is that they can be used to authenticate the dosage form itself through the primary and secondary packaging. This is important as there have been numerous cases in which counterfeit medicines have been placed within genuine packaging in order to make it easier to penetrate the supply chain.

Last October, the US FDA published its final guidance on in-dose markers, known as physico-chemical identifiers (PCIDs), for use in solid oral dosage forms such as tablets and capsules. This document provided advice on the supporting information that drugmakers need to provide in order to secure approval for using PCIDs in their products.

Drugmakers have already started to look at incorporating PCIDs into their pharmaceutical products and, in 2010, technology supplier NanoGuardian said it was within months of its first pharmaceutical customer bringing a product to market using its PCID technology. Other key players include excipient specialist Colorcon and its partner ARmark, which, in 2010, agreed to work together on an authentication technology that can be incorporated into the film coatings of solid oral dosage forms.

Davison believes that companies are increasingly willing to apply PCIDs to new products, although there is a reluctance to 'retrofit' these features, not least because of the regulatory issues that can be presented by changing a medicine's formulation.

Meanwhile, he believes one of the simpler things that companies can do is simply shore up their internal processes; for example, by taking more spectra of their products, which can be used for reference when samples of suspected counterfeits come back to the lab for testing.

“Unfortunately, many pharmaceutical companies don't have good connectivity between the quality management of the outgoing product and the response to counterfeits,” says Davison, adding that, in many companies, spectral data is taken, but is not made available to the personnel doing investigatory work.

“Improving linkages between existing data sources is one of the improvements that industry can make without investing in new technologies,” Davison concludes.

Phil Taylor
The Author
Phil Taylor
is a freelance journalist specialising in the pharmaceutical industry.

24th February 2012


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