Tech Beats Security Breach

There is a growing need for creative out-of-the-box technologies that prevent a rift in patient safety while keeping a company’s investments and reputation in good standing. Counterfeiting, diversion, the resale of expired products, and complexities within the supply chain are forcing the healthcare industry to seek ahead-of-the-curve security packaging.

The packaging quality of counterfeits has soared in recent years with protections being thwarted in as little as six months. A recent collaboration between FDA and the World Health Organization provides evidence of the need for information technology aimed at combating counterfeits. According to Desmond Hunt, Ph.D., senior scientific liaison, general chapters, U.S. Pharmacopeial Convention, there are three categories of technologies being used to thwart counterfeiters: overt, covert, and forensic.

“The most successful approach to ensuring packaging authenticity has been to incorporate a combination of the three methods to produce several layers of security,” Hunt says.

The Federal Trade Commission and the World Customs Organization in Interpol estimate the overall global counterfeiting problem to be about $600 billion per year. Aside from lost revenues, counterfeits threaten brand and product integrity, corrupt supply chains, taint product pedigree, and increase liability risk for brand owners.

Overt methods like holograms or color-shifting inks can be used on product packaging. Covert solutions like infrared and ultraviolet pigments and microtext are not immediately obvious and require the use of specialized equipment to examine or read the feature, while forensic technologies like molecular markers and biological tracers can only be identified through laboratory testing. A molecular marker can be integrated into a drug product, and knowledge of its presence would rest solely with a manufacturer that can test to determine the authenticity of a package.

According to Steve Delepine, vice president, business development, BrandWatch Technologies (brandwatchtech.com), the use of a single security solution to secure and validate is no longer enough. BrandWatch incorporates overt, covert, track and trace, and forensic security systems with a unified secure chain of custody.

“A multilayered brand protection program not only combats fraud and provides the ability to validate product authenticity, but also adds the capability to integrate push-pull marketing efforts—for OTC—that enhance customer engagement and reduce costs associated with product recalls and fraud,” Delepine says.

InkSure Technologies (inksure.com) offers three different solutions that can be used separately or together in the pharmaceutical supply chain, which include taggants, forensic-level readers, and track and trace technology.

InkSure’s TagSure product is an invisible machine-readable taggant that is integrated into a company’s products and packaging. The company also provides forensic-level readers that are programmed to read only predetermined taggant combinations. The company’s track and trace combines taggants with bar codes to help managers protection against diversion and expiration throughout the supply chain.

Vast counterfeiting issues reportedly exist in many of the emerging markets like India, Africa, China, and Russia, however, the threat is growing globally. According to Nathan Sigworth, CEO, PharmaSecure Inc. (pharmasecure.com), one market that is a particular focus is the Indian market. In December, India-based Unichem Laboratories Ltd. (unichemlabs.com) purchased 70 million of PharmaSecure’s SMS-based authentication codes to apply to several brands, including the anxiety drug Trika and the high blood pressure and hypertension brand Losar. The codes will be integrated into existing manufacturing processes at two plants in the region.

This is the only technology reportedly in use in the Indian market that empowers consumers themselves to check the authenticity of their medicines. Consumers are able to check whether a drug is authentic in real-time via text message using a mobile phone. Customers text the unique identifier on the individual strip to a phone number that is printed alongside the code and then receive an authentication text message from Unichem in response.

In Europe, rules require that patient inserts be printed in the local language. According to Sharon Flank, Ph.D., CEO, InfraTrac (infratrac.com), this poses a challenge to a package-security plan.

“You can wrap up the package as nicely as you want, but when somebody rips it off in order to write the insert in Dutch, it’s gone,” Flank says. “So you’ve got to pay again to put something else on it.”

InfraTrac’s patent-pending FDA- and EU-friendly method of spectroscopy gets beneath the package to tag the product itself by comparing optical components to a chemical library. InfraTrac establishes a covert near-infrared spectral signature for each lot of a pharmaceutical formulation by making FDA SUPAC Level 1 composition changes.

In the case of FDA-regulated drugs, about 5% of the inactive ingredients can be changed after the drug is approved and on the market. In Europe, that is 10%. InfraTrac is witnessing more companies wanting to incorporate this technology early in development when formulations are finalized as part of their Quality by Design efforts.

“FDA likes to see anticounterfeit and antidiversion measures as part of the proposed REMS plan, particularly for products in categories known to be prone to problems, like pain management,” Flank explains.
Companies in the area of lifestyle drugs are particularly interested in implementing anti-counterfeiting solutions. Because of consumer marketing, there is much more brand awareness surrounding these products, and, in some cases, there is a shame factor in purchasing some of these brands at the local pharmacy. This dynamic results in consumers seeking illicit purchasing channels to avoid conventional channels.

“That opens up a significant opportunity for the counterfeiter to engage in fraud,” says Adam Scheer, senior director, business development and strategic marketing within the Advanced Optical Technologies segment of JDS Uniphase Corp. (jdsu.com). JDS Uniphase provides multilayer security techniques for overt and covert document authentication; product verification; and brand integrity, including color-shifting pigment and holographic technologies.

Cost concerns still plague many pharmaceutical marketers within the healthcare industry, however, security-packaging experts urge brand owners to evaluate how much revenue is being lost and the extent to which an enterprise could be compromised. According to Tal Gilat, president and CEO, InkSure, companies cannot afford to let their customers be put in danger by look-alikes.

“If the public believes that a company cannot control the products sold under their name, people will stop buying the product,” Gilat says.

Gilat adds that many clients report positive return on investment from implementing InkSure’s technology and have been surprised by the revenue losses they were sustaining before instituting an anti-counterfeit program. The Ukraine government and Turkish Telecom, which use the same technology as the company’s pharmaceutical and wellness clients, have reported substantial revenue increases since implementing InkSure technology solutions.

According to Delepine, brand security can actually be a profit center when used appropriately.

“Integrating security with marketing and customer loyalty programs can move brand security into value-added payback, spurring additional customer interaction that can enhance customer loyalty,”  Delepine says.

Supply-chain security challenges comprise diversion, third-shift productions, expired products, and cargo theft. Although these are not counterfeiting issues, a company’s products can still be used wrongfully to obtain a profit.

While diversion includes people buying products cheaply and smuggling them across borders to sell in areas where they are more expensive, third-shift productions occur when a company’s contractors produce products under the company IP and then sell and distribute the products through unauthorized channels. In addition, those who have access to expired products may try and sell them with a new label on an old product.

According to Gilat, while these are not counterfeiting in the traditional sense, they still rob the company of income and often results in dangerous and sub-par products. “The challenge of diversion, third-shift production, and reselling expired products is that these products are not technically counterfeit and it is very hard to detect that anything is wrong,” Mr. Gilat says.

Track and trace technologies, while typically implemented as distribution chain management tools, can also combat counterfeiting by providing data on product diversion and developing market intelligence. According to Hunt, when combined with additional identification tools, track and trace technologies can help slow down counterfeiters by highlighting distribution discrepancies or disturbances.

FreightWatch International (freightwatchintl.com) provides customized logistics security solutions to prevent cargo theft throughout the supply chain. FreightWatch’s Geo F2 Tracker, which launched on December 10, is an embeddable tracking device available to the market for tracking and monitoring cargo, identifying its whereabouts, preventing cargo theft, or recovering shipments if a load is stolen. The F2 Tracker, when layered with FreightWatch’s suite of security services, prevents cargo theft and secures corporate supply chains.

The F2 Tracker simultaneously allows for real-time visibility into a shipment and disruption management of the supply chain. The F2 Tracker is so small that it can be inserted inside packaging as small as a pill bottle, which can then be placed directly in a box as a part of the shipment. The device is entirely embedded in the shipment, allowing FreightWatch to covertly track in real-time the shipment’s whereabouts versus tracking just the truck or trailer location. This is important if a theft occurs and a shipment is separated from the truck.

As counterfeits become advanced, the technology to hinder them is becoming faster and more accurate with a heavier emphasis on overt technologies. In the pharmaceutical industry, one expert anticipates that more generic companies will be implementing anti-counterfeiting solutions.

Gilat explains that while conventional wisdom used to be that counterfeiters went after big names and big profits. The industry, however, is realizing that counterfeiters will imitate any brand they can make money from.

“With the weak economy, demand for generic drugs is on the rise, meaning more money can be made from exploiting these brands,” Gilat says.

In the coming year, InkSure will be releasing ScanSure, a reader that offers track and trace abilities and product authentication. ScanSure detects taggants and also reads a product’s bar code and can determine whether a product is genuine, diverted, or expired. ScanSure does this by assessing the presence of the correct taggant, the authenticity of the bar code, the bar code information, and whether the bar code has been read previously.

PharmaSecure has new technologies in the works, such as the application of traceability throughout the supply chain that serves low-margin manufacturers; the improvement of tools in the hands of consumers to make informed pharmaceutical decisions; protection against international drug diversion; and the monitoring of health needs and health problems regionally aimed at ensuring compliance to life-saving drug regimens.

In the area of covert technologies, JDS Uniphase is encountering clients who are increasingly becoming burdened by the need for multiple readers. This is because covert technologies tend to require specialized readers.

“We’re looking at innovating covert technologies that use commonly commercially available readers,” Scheer says.
 

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