‘How do we know it is what it claims to be?’ is a question which is fundamental to authentication and the ways in which it might be answered are the basis of the authentication business. Hitherto, effort has been concentrated on the packaging of the product since that is what is most conveniently examined by enforcement agencies and the end user. But recent conferences on authentication and anti-counterfeiting have indicated that some new trends may be emerging.

At the recent Global Forum on Pharmaceutical Anti-Counterfeiting, three trends in authentication were thrown into stark relief and one had the feeling of history in the making as a paradigm shift was enacted. The Forum, held in Miami, Florida (24-26 February, 2010) was the fifth of its kind and brought together experts in all aspects of pharmaceutical safety from around the world. Because we all take medication at some stage in our lives, the topic of product safety is highly personal and never more so than when our lives, or those of loved ones, depend on the accuracy and potency of the product.

Just as the incidence of counterfeit, or other types of product abuse, increases exponentially and the skill of the counterfeiter in accurately reproducing packaging also increases, the rationale that if the package is genuine so must the product be, has been undermined.  So we observe a palpable move towards validating the product itself with less attention placed on its packaging.

For years, there have been covert technologies available for tagging or marking products but their use has been held back because they require some detector device and they have not been considered ‘mainstream’. All that began to change on 13th July, 2009 when the US Food and Drug Administration (FDA) issued its Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting. This cumbersome title belied the importance of its content. It relates to what are now becoming known as PCIDs - Physical-Chemical Identifiers which can be incorporated into tablets and capsules ingested orally.
These often take the form of extremely small particles or taggants with microprinted text or logos which can be seen under a microscope. Microscopic examination might not be the most convenient way of checking the authenticity of a product but it is unambiguous and leads to a reliable result short of chemical analysis. But, here again, technology has made rapid advances such that small analytical laboratories can now be packed in a user friendly form so inspectors and law enforcement officers can use them in the field. In pharmaceutical counterfeit detection, for example, portable Raman spectrometers have been adopted in Nigeria and by some pharma companies. These are handheld devices that can detect the fingerprint of a chemical substance even through its packaging.  Often during raids on suspected counterfeit stocks, officers have only a very limited time (30-60 minutes) in which to make an unambiguous determination on the suspect material. After this time it must be either seized or released.

There is no reason why this approach should be restricted to pharmaceutical products, although the imperative to prevent fake pharmaceuticals reaching patients and the heavily regulated nature of the business. The issue is much broader and so it is reasonable to suppose that manufacturers of other saleable, branded products, will similarly see the merits of marking and inspecting their products at the microscopic and/or molecular level.

But there are other ways of increasing confidence in products that can engage the help of the consumer (who may not have a microscope or portable Raman spectrometer). Principal amongst these is the concept of ‘track and trace’ which is now beginning to emerge from a fog of confusion, misrepresentation and inflated expectation.

After the hype surrounding RFID abated, the view persisted that if one could track a product from point of manufacture to point of sale, all would be well. There is ample evidence that the idea was flawed on two counts: regardless of the technology used for tracking, the amount of data generated as the product passed through all touch points in the distribution chain would be completely unwieldy and, more critically, sensitivities arise about who has access to the information. We have often warned that the so-called electronic pedigree (e-pedigree) is impractical and no substitute for more tried and tested methods and at the Global Forum, ample evidence for this view was presented.

So, the second trend we noticed was the move away from such terms as ‘track & trace’ and ‘e-pedigree’ and towards ‘end-to-end’ verification. Recognizing the difficulty in getting distributors and shippers to record the lot numbers and identity of all the products passing through their hands, not to mention a general reluctance to make this information available, the thought is now to focus on the book ends and ignore the books in between. In practical terms, this means recording pertinent details of the product at manufacture and allowing the end user access to that information as a way of verifying that what s/he has is correct and has not exceeded its expiry date. All information relating to the distribution channels is ignored.

And the third trend is the method of connecting the end user to the product manufacturer. 2D data matrix bar-coding is definitely gaining ground. The means for printing such codes is becoming more available, their information content is significantly higher than linear barcodes and reader technology (together with appropriate software applications) are now making their presence felt. As Coventry demonstrates, even cell phones are shaping up to become effective 2D readers, thus putting digital verification into the hands of millions.

It may be too soon to sound the death knell of e-pedigree but what seems to be emerging is a practical alternative made attractive by its simplicity. A trial of 2D bar-coded pharmaceutical products was carried out in Europe under the auspices of the European Federation of Pharmaceutical Associations (EFPIA). In this scheme, a pharmacy, equipped with data matrix reader, scans the 2D barcode at the point of sale. It was noted that the whole process would be so much simpler if a single code and a single scanner could be used. Nevertheless, the advantages of having this code in addition to the conventional linear barcode seemed to outweigh any drawbacks such that it is widely predicted that most European pharmaceutical products will have 2D bar codes within five years. Drug manufacturers are already gearing up in anticipation.