Keeping It Real - Pharmaceutical Executive


Keeping It Real

Pharmaceutical Executive

On-Drug, Out of Mind

A more future-forward approach to anti-counterfeiting is on-dosage security—the ability to add a layer of protection to the actual drug.

Four years ago, the idea of on-dosage security was still in the hypothetical, neat-but-expensive stage of development. In Iselin, NJ, at a meeting of the International Society for Pharmaceutical Engineering, excipient manufacturer Colorcon hosted a forum about the benefits of designing tablets that are distinctive and can be protected by trademarks.

One of the first tools Colorcon brought to market was high-definition printing using pharmaceutical-grade inks. Some companies investigated using of the process to print pills with 2-D barcodes that would be scannable and serialized—giving every individual tablet a distinct number.

"Our technology is very useful for search-and-seizure evidence," says Mary Ann Hegedus, business development manager for brand-enhancement services at Colorcon. "If [the authorities] find a 55-gallon drum loaded with loose tablets, right there on the spot, the investigator can get the evidence he or she needs to say, 'Yes, this is counterfeit.'"

Colorcon also pioneered work in color-shifting pigments that have a pearlescent effect and subtly change color when held at various angles to the light. Hegedus says that the advantage of the pigment is that it is difficult to reverse-engineer. "Because it is applied on top of a base coat, anybody who's looking to copy it must know the composition of the base coat, the weight gain of the base coat, the composition of the pearlescent top coat, and the composition of it," she explains. "It's easier to counterfeit a round white pill."

And the idea of individually coding tablets is far from dead. An Illinois-based company called NanoGuardian is using a form of nanoencryption to add overt, covert, and forensic security markings to the tablet coating or the capsule gel. The technology offers three levels of protection, including a visible marking to authenticate the pill, a hidden marker for added authentication and protection, and a series of modifiable codes at the nanoscale level that can contain everything from the ingredients of the drug to the address of the plant that manufactured it.

NanoGuardian also allows pharma companies to use different codes for different market segments. For example, if a particular distribution channel has been identified as corrupt, they can set up a special code for that particular sting, send the product through the channel, and then verify the product when it makes its way into the supply chain.

"Not only can I tell if this product is real, but also if this product was diverted from a country where I sold it for X dollars, and now it's being [put] into authentic bottles and returned to me for US dollars," says NanoGuardian's Dean Hart.

End Game: Education

In the end, no matter what security is used to safeguard a drug, it all comes down to educating the consumer. "If there's no market out there for purchasing these products, then these folks will probably go ahead and counterfeit something else," FDA's Bernstein says. "But the market is out there, and the consumers and patients need to really understand how risky this is."

In June, FDA published a list of red flags consumers should be aware of when purchasing medication, as well as a long list of fake cancer cures that are being touted on the Internet. In addition, with the passing of the Internet Pharmacy Consumer Protection Act in October, online pharmacies must register with the government in order to be able to sell drugs on the Web. If the companies aren't on the list, Internet hosting services have the go-ahead to shut down the sites without a warrant.

Between the push by the government for more online security and the addition of new anti-counterfeiting tools, pharma is making headway in the war against brand-jackers and counterfeiters. But it still has a way to go.

"I don't think that anybody is nave enough to believe that with advances in technology we are ever going to be able to keep criminals from duplicating our [products]," Mages says. "In the long term, we just need to be flexible and always be ready to reinvent ourselves and introduce new technologies that they have not yet been able to compromise. Hopefully, we will be able to stay ahead of the counterfeiters."

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