Counterfeit drugs are a huge global problem—in 2010 the revenue generated by this faking business was estimated to be $75 billion by the National Associate of Boards of Pharmacy (NABP). However taking out the financial impact on the pharma industry as a whole, which is clearly commercially devastating even for global blue chips, the bottom line is that these fake drugs can kill. Preventing the production of these products is practically impossible—however, creating a mechanism whereby the patient and/or physician can easily determine if a product is a fake, is an area of much furtive R&D activity.

Anti-counterfeit packaging has been in development for over a decade. A problem that started out in developing countries has now infiltrated all countries across the globe including the U.S. and the EU. It doesn’t matter if your handle falls off your fake handbag—it may hurt your purse and your pride—but if the tablet you take contains antifreeze and brick dust, not only will it not cure you, it can potentially kill you. Ultimately buying drugs from the internet without a prescription is always a dangerous business, but for pharmacies ordering legitimate drugs there needs to be labelling and packaging in place to ensure that it’s possible to differentiate between a fake and authentic medication.

Pharma companies, research groups, and packaging development companies are constantly working to develop the technology and materials that are available to prevent fraudsters from marketing products in ‘look-a-like’ packaging. In terms of print on boxes, often the fake can be of very high quality; therefore as engineers and scientists, we need to look beyond the packaging.

There are various mechanisms of protecting packaging from counterfeiters, which categorically includes overt features (visible to the naked eye), covert features (not visible to the naked eye), forensic technology (embedded in the material and requiring scientific verification) and ‘Track & Trace’ techniques. Each of these has its advantages and disadvantages. Generally overt options are lower tech and cheaper to apply. These packaging additions include holograms and optically variable devices (OVD).
These two are similar in appearance, however holograms have a 3D appearance whereas OVDs are normally 2D. The most effective protection using overt techniques are directly applied to the packaging such as blister foil, or as part of a tamper evident feature, however counterfeiters have managed to duplicate holograms quite expertly.

Covert features on packaging may be a more effective deterrent, however the main disadvantage of hidden protection is that it’s of very little use to the general public. Invisible printing and embedded images require lighting and filters in order to verify authentication. Anti-copy and anti-scan designs can reveal latent images when copied, but the average person would not necessarily know to check for this.

Forensic markers are an effective form of covert technologies that require either kit tests to prove authenticity or lab test. They can use chemical or biological markers that ‘tag’ the packaging and are highly secure against counterfeiting. Unfortunately, they aren’t appropriate for public use and generally have a high cost attached to them.

The final alternative is a ‘Track and Trace’ system, which facilitates specific marking of each specific package. The unique identification mark stays with the package throughout the supply chain and information is maintained on a database that effectively allows complete traceability. Serialization is a similar method of product marking, which if carried out using random and non-sequential numbering, can provide a high level of security. If packs are copied they will be highlighted on the database when verified or could be flagged for expiry—fraudsters supplying out-of-date medication—and cancelled batches. Confirmation of authenticity can be verified by various mechanisms including via the use of mobile phones and text confirmation to validate the product.

Radio Frequency Identification (RFID) tagging is a newer arrival on the market, and is a marker carrying an antenna alongside a microchip. The tag can carry various items of information relating to the product and can be detected at a distance. This has distinct advantage over barcodes, which can do the same thing but require line of sight and scanning for verification. There is a cost issue associated with RFID tags as well as the fact that most people wouldn’t be able to authenticate the information held on them, however as developments move forward these markers may become widely used. With the advent of QR Code (Quick Response) and widespread mobile phone usage, this may provide a happy medium between the RFID tag and bar code. QR Codes can carry authentication data that would allow the general public to determine authenticity. Since most smart phones have the ability to read QR codes, it’s feasible that direct printing to either packaging or tablet may become the norm.

However, in an ideal world, the most effective deterrents for counterfeiters must be complex and inexpensive to apply and also easy to identify and interpret.

One of the more recent developments in packaging protection was demonstrated by scientists at the University of Michigan using an image of Marilyn Monroe. Researchers at the university developed labels that reveal an image when breathed upon to demonstrate its effectiveness. The process of creating the label itself requires highly technical equipment, however once a template has been created the manufacturing process is cheap and as simple as making plastic cups. The technology involves creating microscopic pillars, which effectively hide an image imprinted onto a material underneath. When breathed upon the moisture is trapped by the pillars and the image becomes revealed. Up to this point, creating nano-pillars for this type of use was difficult, as they tended to adhere to the mold rather than the material. The research team developed a new polymer using a blend of polyurethane and an adhesive to create a liquid polymer, which facilitated the mini-pillars to release from the mold. As a result, this covering for various materials has been created and the polymer provides a certain amount of protection, meaning that the labels are relatively robust, which is important for surviving transit and storage.

Should this type of labelling be applied to pharmaceutical packaging, it would be possible to determine whether the drug inside is the ‘real thing’ simply by breathing on it. Seemingly, it’s a highly technical solution to a complex problem that can easily be interpreted by almost anyone and potentially affordable to boot. The research team has been able to demonstrate that the polymer can adhere to plastics, fabric, paper and metal, and is preparing to demonstrate that it will also work with glass and leather. This means that the techniques can potentially be used across a spectrum of drug products. The process is commercially scalable and labels can be produced relatively inexpensively, however for counterfeiters, they will be practically impossible to copy.

Clearly we need to keep moving forward with mechanisms to prevent counterfeit pharmaceuticals making it to market—it’s a cat and mouse game to be one step ahead of the fraudsters. With the combination of new technologies, such as the ‘breath revealing label’ and established identification methods, we stand a better chance of stemming the flow of lethal counterfeit drugs.