Evaluating Pharma Security Labeling Options

Combining multiple technologies yields optimum protection for high-risk situations

By John Bennett, vice president, Product Identification Business Team, FLEXcon and Christian Liebl, senior innovations and process manager, Schreiner MediPharm

Most people are aware of the problems associated with illegal drugs, but there is another type of drug problem that rarely makes the news: the sale of counterfeit medications. The World Health Organization (WHO) estimates that counterfeit drug sales nets more than $45 billion annually, and accounts for nearly 10 percent of the international legal drug market.

But the impact on lost revenues can pale when compared to the risk to unsuspecting consumers, who may take suspect medications for life-threatening conditions, only to discover that the drugs are less potent, or do not work at all. Even more frightening is the fact that the WHO predicts that this problem will only continue to grow for the foreseeable future.

Assessing Risk
So what can a drug manufacturer do to protect itself from falling prey to this insidious problem? In many cases, the answer lies in effective security labeling. However, to ensure that you are creating a solution that works best for your situation, you first need to diagnose where your risks lie. Consider, when you visit a doctor the first question asked is, “What is your problem?” The same is true when a label manufacturer talks with an end user about security labeling.

In essence, a security solution is only useful when it is directed at a specific problem. To do this, you need to understand where the issues exist, or could exist. Further, your solution should be commensurate with the risk. For example, a high-end biotech medication that costs $5,000 for a round of treatment will likely be more attractive to counterfeiters than a private label OTC medication. As a result, you should plan on spending more on your security for the drugs that represent the largest value to would-be thieves.

For these more expensive medications, a multi-layer security system is going to provide the highest level of protection. This involves a variety of overt (obvious) and covert (hidden) measures designed to safeguard your medication at every step of the production, packaging, and distribution processes. This type of system may cost more than a less aggressive labeling defense, but it is important to weigh the cost of such features against the potentially catastrophic cost of doing nothing.

Identifying Vulnerabilities
The most appropriate type of security labeling depends on the nature of the threat. For example, drug counterfeiters will sometimes re-use empty containers of your product, filling them with counterfeit medication. To combat this, you could use a selectively destructible labeling material that leaves a VOID pattern behind when the package is opened. In this case, the label has become an integral part of the package, making it a challenge to reuse the container.

Then there is the possibility that the counterfeiters will create a fake label that mimics the appearance of the authentic markings. One solution here is to utilize a colored label made with a dyed substrate on which the label content is printed. A counterfeiter is much more likely to flood coat a white or clear substrate with color to produce which may seem like an identical label, however a simple scratch with a knife will reveal the fake.

Another tool to help thwart fake labeling involves creating a customized holographic label with a purposeful defect. A counterfeiter is unlikely to pick up on the imperfection, such as one misspelled word in an otherwise repeated pattern. This again allows for easy identification. On the covert side, a KeySecure or BitSecuretracking element can be embedded into the label. Totally invisible to the naked eye, the decryption key for this type of tracking device lies only with corporate headquarters and the relevant policing authority.

For manufacturers experiencing supply chain issues, there are a variety of tracking mechanisms available. Adhesive and film components such as charms, taggants, security pigments, color-shifting inks, and holograms can be tracked throughout the transportation process and can help ensure the integrity of your supply chain, or identify where it is less secure. The same may be said for 2D barcodes and radio frequency identification (RFID) labels, which can be scanned and logged to safeguard compliance.

Differentiation Is Key
An old adage suggests that if a bear attacks your campground, you do not necessarily have to be faster than the bear. You do, however, need to be faster than the slowest camper. The same may be said of the pharmaceutical industry, where counterfeiters will look for the easiest targets and attempt to mimic the one with the lower level of security. Using a higher level of security than your competition makes your product less attractive to would-be thieves. The cost of failure is what will determine the level of security you choose. By combining multiple technologies, it is possible to create optimum protection for situations where risk is high, justifying the expense. Doing so involves working collaboratively with experienced and trusted converters and film suppliers to develop customized labels that target the threat specifically and provide enough layers of protection to keep your product secure and your customers safe.

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