Three Technologies To Battle Bogus DrugsBy Jim Rittenburg, Ph.D.
When a consumer goes to a bookstore and picks up a paperback book, he expects the title on the cover and the contents on the pages in between to match. When he heads to the grocery store and buys a can of chicken noodle soup, he trusts that when the can is opened he’ll see chicken noodle soup—not tomato or anything else. U.S. consumers trust labels, and even more important, they have faith in the brands. They expect the item they purchase to be what the label says it will be. What’s more, consumers in the United States don’t expect the product in the packaging to be harmful, much less deadly. Increasingly, that’s not the case when it comes to pharmaceuticals.
In 2004, the Federal Drug Administration (FDA) launched 58 drug counterfeiting investigations1. That’s a sharp increase from the 30 cases launched in 2003 and a dramatic increase when compared to the handful of drug counterfeit investigations launched annually in the late 1990s. The FDA considers fakes, diluted drugs or drugs that have been stolen or diverted from the legitimate supply chain to be counterfeits.
Some consumers assume that only drugs purchased online or across international borders are risky, but many suspected counterfeit drugs were purchased by consumers who had their prescriptions filled at their neighborhood pharmacy.
The Huge Jump In Pharmaceutical CounterfeitingDrug counterfeiting is a low risk, highly profitable activity that has attracted the attention of organized crime. Computer technology – including high-quality scanners, printers and copiers – allows counterfeiters to easily create packaging that looks like the real thing. Counterfeits are often such good imitation that it’s hard for experts, much less consumers, to tell they’re fake.
Many counterfeiters have profited from the sales of bogus or watered-down versions of expensive medications. Some of the costliest drugs are sold in very small quantities; therefore it doesn’t take much product to generate sizeable profits for counterfeiters. Finally, the penalties associated with trafficking in counterfeited drugs are light compared with penalties assessed for other felonies.
In 2004, the FDA responded to the emerging threat in a report entitled, “Combating Counterfeit Drugs.” The report states that the implementation of new technologies is crucial when it comes to protecting the U.S. drug supply. The report tasks drug companies with putting solutions into place and it champions the use of authentication, electronic pedigree systems, and radio frequency identification (RFID) as effective methods of curbing drug counterfeiting. The FDA has called RFID a “cornerstone technology” 2 and maintains that it will be feasible for RFID to be in use by 2007. For the time being, the FDA is allowing market forces to drive the development and use of RFID technology, however as this technology matures we can expect regulations to follow.
No Silver BulletRFID is still very much a young technology, and while it will eventually be part of the solution, RFID alone can’t stop drug counterfeiting or diversion. RFID is a technology that is poised to deliver huge efficiencies through the supply chain; however, it will not become a primary technology for authenticating products or stopping drug diversion. RFID is not foolproof and a range of near- and long-term issues makes RFID a technology that’s better suited for supply chain management than safeguarding the U.S. drug supply.
First, there is a question of standards. No uniform RFID standard has been finalized, nor has one been successfully tested. There are also technical hurdles regarding RFID’s workability across the range of typical pharmaceutical packaging. Radio waves that operate well with solids operate much differently in metallic or liquid environments. Liquid medication or foils used in pharmaceutical packaging can easily interrupt the signal traveling between an RFID tag and RFID reader and distort the accuracy of the reading. Achieving reliable read rates at the unit level remains a significant technical challenge. Another barrier to the widespread use of RFID is its current cost; tags typically cost 30 cents or more and readers start at $100 apiece3.
RFID has also raised privacy concerns; critics are concerned that RFID could jeopardize a consumer’s privacy by allowing remote tracking of the items a consumer is carrying, items a consumer had bought and items a consumer owns. Another serious concern, particularly once counterfeiters and diverters focus their attention on the tags, is the integrity of the data stored in RFID tags. Hackers can break into RFID tags and reprogram key information about the contents of a package, its whereabouts, etc., or the RFID tag can be disabled or destroyed so that tracking information is lost. Tags can also be removed from original packaging and subsequently associated with other products with the intent to deceive. The combination of tainted information and medicine could prove harmful to unwitting consumers, retailers and drug makers.
The Authentication 3-StepThe most effective defense drug makers can rely on to fight drug counterfeiting involves a three-pronged strategy that emphasizes authentication, tracking, and surveillance. Manufacturers will need to incorporate multiple layers of anti-counterfeiting technologies into a drug’s packaging and the drug itself; utilize electronic product code (EPC) based tracking systems; and monitor drugs as they travel through the supply chain.
Overt security features are the first element of a solid anti-counterfeiting arsenal. Polychromatic inks (similar to the ink used on U.S. $20 and $50 bills) can be used on labels and packaging. Color shifting inks change colors depending on the angle from which they are viewed. These inks are difficult to manufacture and hard for counterfeiters to copy. Holograms are another visual element that can be used as a security feature; they can be affixed to closure seals or packaging. Visual security features like polychromatic inks and holograms serve two purposes, they act as counterfeiting deterrents and give inspectors and consumers a method to easily distinguish whether a product is authentic or suspect.
Covert security features comprise the next level of authentication security. Special markers can be added to inks and coatings; these markings remain invisible under normal conditions, but are illuminated when exposed to very specific wavelengths of light. Covert markers can also be incorporated into packaging materials including tears, closures, blister foils, seals, and even used in holographic packaging elements.
Pharmaceutical authentication can be taken even deeper, down to the forensic level. Various types of ingestible markers can be inserted into the dosage form (e.g., tablets and capsules) during the manufacturing process. These FDA-accepted markers are in commercial use and are being designed into pipeline products. Ingestible markers are inactive, odorless, colorless and tasteless. They do not impair the finished product in any way, but are useful when it comes to authenticating pharmaceuticals. Field testing kits and lab analysis are both used to detect the presence of markers in genuine pharmaceutical products.
Overt, covert and forensic level authentication features can easily be incorporated into products and packaging at the point of manufacture without disrupting product manufacturing and packaging processes already in place. Inserting authentication technologies into products at the manufacturing level makes them more difficult to detect and harder for counterfeiters to reverse-engineer.
Layering multiple authentication features from a variety of technologies makes it difficult for counterfeiters to successfully copy a product. Even if counterfeiters manage to duplicate a single authentication feature, there would still be many other features left in place to authenticate and ultimately protect the product.
Once drugs leave their manufacturing site, tracking these units as they move through the supply chain is critical to preventing theft and counterfeiting. Drug companies can serialize product units at the manufacturing site with overt electronic product codes (EPC.) Stations employed at various points along the supply chain scan the codes when the product arrives, capture the data, and put it into a database that allows authorized personnel to track the product’s whereabouts via the Internet. It’s a process similar to tracking a FedEx® package.
Inspectors provide in-the-field surveillance of drugs in their journey from the factory to store shelves. A field inspector uses special equipment to check for various authentication features during spot checks throughout the supply chain. Field inspectors sound the alarm if counterfeit products are found in the distribution system and the presence of inspectors is also a deterrent for drug distributors who might otherwise consider buying drugs from questionable sources.
In the past, drug manufacturers have utilized anti-counterfeiting tactics in response to counterfeiting situations that demanded immediate attention. During the past few years, the rise in the number of pharmaceutical counterfeiting cases, the danger these cases pose, and increased public awareness of the problem has necessitated a different approach. Now companies are starting to proactively put anti-counterfeiting strategies into place. Drug companies are assessing risks globally, across product lines, and throughout their brands.
Just as tamper-evident seals became the norm in the 1980s following a major drug tampering crisis, pharmaceutical products with built-in anti-counterfeiting technologies are becoming the norm in drug stores in the United States and around the world.
References1 Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update. Food and Drug Administration. May 18, 2005.
2 Crawford, Lester, Ph.D. Speech before Pharmaceutical Education Associates. March 22, 2005.
3 Hamrick, Lee. InternetWeek. RFID Readers: Read Right.
About the Author: Jim Rittenburg, Ph.D. is Vice President, Pharmaceuticals for Dallas-based Authentix. His company provides authentication solutions for pharmaceuticals, consumer goods, industrial goods, petroleum, and spirits.