The new year has kicked off with yet another near-assault on the biopharma market with counterfeit product: GSK’s finding that its OTC weight-loss product, alli, had been counterfeited and sold through Internet sites to the American public. GSK was quick to cite FDA’s statement that “no evidence at this time that counterfeit alli product has been sold through other channels, such as retail stores.” But while it has long been known that Internet “pharmacy” sales are rife with counterfeits, when a widely advertised product like alli, sold at a brand-name website like Ebay, is found to be fake, the consequences are painful for the brand owner.
One of the significant details of the alli incident is that GSK testing of the fake product showed that it contained a different active ingredient, sibutramine, which happens to be the active ingredient in another weight-loss product, Meridia. Meridia is an Abbott Laboratories product sold on a prescription basis and with warnings about risks to people with certain cardiovascular conditions. In many counterfeit incidents, the product is simply water (in the case of injectables) or chalk or other fillers—but some counterfeiters actually make products with active ingredients that they then expect will bring back return customers (provided, of course, that they don’t kill them first).
Like the heparin scandal of 2008 (Pharmaceutical Commerce Product Security Supplement, Sept. 2008), which involved contaminated API rather than counterfeit, packaged product, and like numerous instances of fraudulent products available on websites, the alli incident is an assault on legitimate distribution of pharmaceuticals, but not an actual intrusion. Outside the US, millions of dosages of fake products are being quarantined around the world. Advocates of strong security measures such as drug track-and-trace systems and pedigrees emphasize the need to reinforce the pharma supply chain. Critics complain of the cost and maintain the basic integrity of the supply chain as it is now. But individual pharma brand owners are left to their own devices.
“Brand owners want to do what’s right for their brand,” says Adam Scheer, marketing manager at JDSU. “In the absence of comprehensive legislation, we believe that we can provide solutions that can be implemented in a way that provides good protection.”
More countermeasures arrive
One thing the biopharma industry can count on is a steady stream of new anti-counterfeiting measures becoming available. Longtime followers of the anticounterfeiting scene maintain that most techniques can be replicated (or at least rendered ineffectual) by the counterfeiters themselves, who are adept at simulating or sidestepping many of the the techniques. But in an ongoing, escalating war, new techniques keep the brand owner ahead of the crooks.
In the past several months, some of the more notable new introductions include:
Catalent Pharma Solutions (Somerset, NJ) is making available the DigiTrack technology of DigiMarc Corp. (Beaverton, OR), which involves imposing an invisible (to the unaided eye) watermark in printed surfaces—and which can be read by either a purpose-built handheld reader or even a Web-enabled smartphone. Catalent says that unit-specific coding (i.e., a serial number) can be included.
Schreiner MediPharm (Blauvelt, NY) is rolling out technology developed by a sister company in Germany, Schreiner ProSecure, called the Transparent-Hologram-Seal, which combines tamper-evident sealing with an intricate, 2D holograph design
AlpVision (Vevey, Switzerland) introduced an optical-surface-analysis technique, called Fingerprint, at last year’s Interphex show; the technology depends on a surface scan of a package (or even a tablet) and then a comparison to stored data and signal-processing software. The technique can identify packages based on the tool marks from printing or die-casting—even when the surface is “read” using an office scanner. The technique has been upgraded with a combination of microdots that can be introduced into printed surfaces and then recognized; this is called Cyptoglyph. Another component of the system is an online Web service to download the code or surface-recognition data, called Krypsos. Pharma packager Rondo-Pak (US HQ in Norristown, PA), and reportedly Alcan Packaging (Bethlehem, PA), are licensing the technology.
Verify Brand(Minneapolis) has released version 2.0 of VB Enterprise, a system to generate, record and then track (or authenticate) barcodes or proprietary symbology at the unit level. The company says that it is developing its system (which is really a comprehensive track-and-trace system) in compliance with the evolving GS1 standards for tracking supply-chain movements.
Convectra (Southborough, MA; formerly named Pharmorx Security) has linked up with a contract packager (MSO Packaging; Belfast, Ireland) along with Sun Chemical Security (Parsippany, NJ), a maker of security inks, to provide a one-stop-shop solution for both securing packages, even at the item level, and for tracking them across trading partners by employing Covectra’s “Authentitrack” IT system.
To these can be added a host of related or alternative techniques, including holograms (Kurz Transfer Products, HW Sands), specialty inks (JDSU, Sun Chemical Security, Kodak), taggants (JDSU, Authentix, ARmark) and various types of microprinting (on paper) or etching (on glass or other surfaces). Constantia Hueck Foils (Blythewood, SC) incorporates anticounterfeiting designs into foils and films for unit-dose packaging. Label converters like Nosco (Gurnee, IL) or CCL Label (Hightstown, NJ) use specialty inks and other technologies with the labels they produce.
“Our security-coded foils and films have been included in a number of projects over the past few years,” says Fred Lutz, sales director at Constantia Hueck Foils. “They provide a significant measure of security at relatively low cost, while being customizable to very specific customer needs.”
An alternative approach is “on-product” authentication, which involves some manipulation or treatment of tablet surfaces. Dean Hart, EVP of NanoGuardian (Skokie, IL), one of the vendors in this technology, notes that all the package-security techniques in the world don’t authenticate the actual product inside the package or container. NanoGuardian’s technology, a surface treatment that doesn’t add any physical material to a tablet, has been refined from something that required a laboratory for authentication to a method that can use a handheld optical scope, in the field.
JDSU and Armark have developed micro-taggants—small bits of inert material that can contain a number or symbol on their surface, which can be added to tablet coatings (or packaging inks, for that matter). FDA came out with guidance in mid-2009 allowing for use of such technologies, as long as the components are either inert and non-interacting with the formulation, or meet GRAS (generally recognized as safe) rules for pharmaceutical ingredients. Colorcon (Harleysville, PA), a contract provider of tablet coatings and excipients, offers taggants and color-shifting inks for coatings and other surface treatments for brand protection.
A handful of companies, including Ahura Scientific (Wilmington, MA) have developed in-field spectroscopic analyzers that can do a quick read of the composition of a product, precise enough to identify specific production lots. (Ahura has just been purchased by Thermo Fisher Scientific, of Waltham, MA).
Connecting with patients
Although the breadth of physical features available for authentication and brand protection is large and growing, there seems to be an evolution in the field toward security as a data and communications technology as much as a printing or tagging one. The problem of authenticating product in the field (as opposed to bringing it into a laboratory for analysis) has been a constant hurdle; field investigators don’t want to wait days or weeks for the lab analysis to be completed. Many of the vendors have adapted their technologies so that some type of field device can be used for a simple “good/no good” signal; often, these are dependent on stored information on product composition or encoding.
But the authentication systems of vendors like Verify Brand, AlpVision, or Covectra, as well as several companies in the brand-security business like SICPA and Authentix, are being extended into the track-and-trace world of pedigrees and supply-chain business processes. Even more intriguing, some of these vendors are looking at their techniques (when they involve the patient or end consumer authenticating a package via a phone call or Internet look-up) as a method of connecting with customers and providing educational or promotional messaging.
Covectra says that it has lined up a pharma client for just that goal, with a “Brand Loyalty and Integrity Service” (BLIS) based on AuthentiTrack, that is currently being implemented. Catalent Pharma, working with Digimarc (which can involve authentication via a smartphone connection), expects to offer similar connectivity.
“Clearly we have a fit in brand authentication and security, says Eric Caro, business development manager at Catalent Printed Solutions. “The Digimarc technology has been deployed successfully in a number of consumer markets. But we see a bigger play for providing ‘media enhanced packaging’ for enabling the consumer to communicate directly with the manufacturer.”
As Caro envisions it, consumers (or pharmacists, as part of an internal security check) can take a picture of a product carton with a smartphone, then verify the package’s authenticity by sending that picture to a dedicated website. Once there, the consumer can opt in to additional services, such as obtaining a coupon for the next refill, answering a questionnaire, or engaging in a host of programs such as compliance schedules, exercise or diet programs or other health-related services.
The concept of ‘media enhanced packaging’ has been suggested in the past, such as with cartons with embedded RFID tags whose data can be relayed via a phone connection to another location. But what was lacking in the past was widespread experience in using personal digital devices (like a cellphone) for this kind of connectivity. The wild popularly of the Apple iPhone and similar technologies is changing that dynamic with the development of downloadable “smart apps” that turn the handheld device into a data center.
These purpose-built IT systems can be expected to be compliant with the infrastructure around e-pedigree and RFID that is being established by the GS1 organization, which continues to evolve coding and information-exchange systems for trading partners. Currently, GS1 is conducting a series of supply-chain workshops among its members to test “use scenarios” for trading-partner transactions (of which authentication is only one piece). GS1 standards also figured in a major test conducted in Europe by the EFPIA organization (see p. 8). There, upwards of 100,000 packages were encoded with 2D barcodes, then shipped through conventional distribution channels to a network of retail pharmacies in Sweden. Individual pharmacists were able to authenticate each unit as they were handed over to customers with an IT system involving SAP, Siemens and Hewlett Packard.
RFID, the technology of embedding a chip in packaging that can be read via a radio signal, continues to make some progress in the industry, although most pharma manufacturers are talking about using 2D barcodes in place of RFID tags. Cephalon is going live with an RFID system for several of its pain medicines, using a packaging-line serialization system from Systech International, and RFID-embedded cartons from Nosco. Communication of pedigree information is accomplished by technology originally developed by SupplyScape (now TraceLink).
At the November HDMA Track and Trace meeting (National Harbor, MD, Nov. 30-Dec. 2), a series of major pharma companies, including Abbott and Pfizer, talked about how they are progressing with the development of serialization and drug-tracking projects even though the deadline for having systems in place to meet California schedule is years away. (Meanwhile, technology vendors in this space note that it will take many months to implement a reliable serialization system, so there’s no value in waiting to get started.)
Next month, FDA is scheduled to come out with a set of recommendations on how pharmaceutical products should carry “serialized numerical identifiers” (SNIs) that will be a critical steppingstone to e-pedigree or track-and-trace systems. Many industry observers expect that FDA will simply accept that the GS1 system, now being implemented by healthcare providers for their own inventory-management purposes, will be adopted in whole or in part. What will be interesting to handicap is whether the slow-moving GS1 organization will be passed by as individual technology vendors race to establish their own systems. PC