Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN June 2005
Track & Trace
What Do You Really Need?
Risk analysis should play a role in any track-and-trace initiative.
by Gadi Honig
General Manager
Tadbik Advanced Technologies
 |
| Thermochromatic ink on security labels changes color when heated by a person’s thumb. |
Counterfeiting is taking an increasing share of the market in many industries. Pharmaceuticals are especially hard-hit by counterfeiters—a 2002 article in Die Zeit, a highly respected German news magazine, estimated that counterfeit pharmaceutical products accounted for $48 billion, or around 15% of the market. In India, the magazine estimated that 20% of the pharmaceuticals on the market were counterfeit. To make matters worse, counterfeiting, tampering, and theft of pharmaceuticals are increasing by 15% each year.
Counterfeit pharmaceuticals may contain no active ingredient, insufficient quantities of active ingredients, or inappropriate or dangerous ingredients. With the boom in Internet trading, reputable-looking Web sites may sell counterfeit or gray-marketed products—with your company name on the label. The liability and public relations nightmares aren’t hard to imagine.
Analyze Risk
What does your company stand to lose from counterfeiting or gray marketeering/product diversion? Some common risks include:
• Market share lost to counterfeiters.
• Lost trust among consumers and physicians.
• Liability for damages caused by authentic-looking counterfeit products.
• Legal ramifications of diverted pharmaceuticals sold off-label in certain countries.
• High cost of seeking out and prosecuting counterfeiters.
Further exploration of the counterfeiting or gray-market challenge focuses on the extent of the problem. At this stage, risk analysis is an important tool, helping establish a budget that keeps the track-and-trace efforts profitably in-line with the scope of the problem.
Risk analysis includes a thorough and honest assessment of:
• Market share.
• Counterfeit market share (this may be done by market or region).
• Distribution—where are the trouble spots? Where does your company or its allies control product movement?
• Packaging—where could track-and-trace technologies be applied?
Battle Plan
 |
| Latent images are very hard to counterfeit, and polarizers are inexpensive decoders. |
With the insight gained from risk analysis, you can answer the most pressing question in the track and trace arena: do you want to employ overt or covert technologies?
• Covert methods are visible on a “need-to-know” basis—they are kept secret from consumers (and counterfeiters) but can be detected by laboratories, company personnel, or allies in the distribution chain. Most covert technologies employ laboratory processes, decoders, or detectors to pick up hidden materials that identify authentic product. Some examples include taggants that may be detected in the lab or with specially tuned light emitters.
• Overt technologies are much more easily apparent—they are often visible to the naked eye or may be decoded with inexpensive tools. Examples include hologram tags, special inks that react to light or heat, or visible inclusions in label stock that are hard to duplicate by printing.
A key question at this stage is who should be able to authenticate your product. There are three levels of inspection: the naked eye or a decoder inexpensive enough to distribute to consumers; an inspector with a semi-expensive decoding device, such as a laser pen or an RFID reader; and a laboratory with expensive equipment that can decode track-and-trace technologies for forensic evidence.
On a practical level, the question comes down to whether company sales reps should be the only ones to check product at the distributor, pharmacy, or retail level, or whether consumers should participate. Do you want customers to know your product is being protected from counterfeiters? Some companies don’t want to publicize the fact that counterfeits are available; others see overt protection as a way of assuring customers that the products they purchase are indeed authentic, and may even recruit their customers as aides in fighting counterfeiting. In fact, some companies use authentication efforts as a marketing advantage, touting peace of mind for customers.
The next important question is budget. How much are you willing to spend on track and trace in general? How much is a single product check worth? Obviously, a laboratory test on a sample is far more expensive than a scan with a decoder on the shelf.
Not surprisingly, the best way to protect a product is to employ a combination of overt and covert technologies to ensure that even if some are copied, others are still effective.
It’s like protecting your home with a good lock, a loud dog, and a burglar alarm system. The U.S. $100 bill employs more than 10 security features; the Swiss 100-franc note uses even more.
Budget Considerations
Speaking of $100 bills, budget is obviously a key factor in choosing an appropriate technology. As noted above, a risk assessment could provide alarming evidence that track-and-trace tactics are an important investment. Cost is impacted at several points in the track-and-trace process:
• The cost of the technology itself (e.g.: X cents per label).
• The cost of inspection (naked eye? A $100 decoder for every sales rep? A lab test?)
• The cost of training.
• The cost of enforcement and litigation when counterfeit product or gray marketeering is discovered.
Overt features may also be advertised to the public—a way to build trust and even cachet, but an investment that requires advertising and marketing communications budgeting to ensure that consumers know what they are looking for.
Options Abound
With a better sense of need, a look at packaging, and a quick calculation of your budget, we can outline key categories of technologies.
Security substrates include watermarks, threads, fibers, or planchettes (like tiny dots or confetti) incorporated into the paper or plastic substrate of the label. They are easy to see and relatively challenging to counterfeit without access to the same substrate stock.
Inks and varnishes can be selected for features such as color change in reaction to visible or UV light, optically variable inks that change color when viewed at different angles, thermochromatic inks that change color when exposed to different temperatures (for instance, when an inspector holds a thumb on the label for a few seconds). Like security substrates, these are easy to detect and challenging to counterfeit with conventional inks.
Security graphics challenge the printing skills of counterfeiters by employing extremely tiny printing, intricate graphics, or geometric patterns (guilloche), like those in U.S. currency. Digital watermarks can be embedded into graphics and detected by sophisticated software.
Taggants are microscopic particles blended into inks or varnishes. Ranging from odor capsules to samples of specific DNA, taggants require some sort of detection. The tool could be a handheld decoder or a laboratory chromatograph. Taggants are outstanding covert tools.
Holograms are by far the most widely used authentication technology. Visible to the naked eye and also machine readable, holograms are cost-effective and highly attractive. However, they can be counterfeited. That can be especially problematic, because consumers generally assume that any hologram is a good sign, and it takes an expert to know what to look for.
Latent images use a highly secret process to embed an image in a plastic substrate. Viewed through an inexpensive decoder—a piece of polarizing plastic or lenticular material or a magnifier—the latent image is eye catching and has not yet been counterfeited.
Other technologies include laser engraving, consecutive numbering, RFID and EMID (electromagnetic identification) measures, and a range of emerging products.
Counterfeiting will continue to grow as a challenge to manufacturers of pharmaceutical and medical products—the prevalence of Internet marketing, the continuing globalization of trade, and the growing sophistication of printing and computer-generated graphics will see to that. As a result, employing a well-designed track and trace strategy—and revising it every two to three years—will continue to be of extraordinary value to the industry.
Gadi Honig is general manager of Tadbik Advanced Technologies in Petach Tikvah, Israel. Tadbik Advanced Technologies and its U.S.-based sister company, Logotech, offer track-and-trace technologies for pressure-sensitive labels.
For more information, contact Gadi Honig at gadi@tadbik.co.il.
Copyright ©2005 Pharmaceutical & Medical Packaging News
