Medical Device Link.

SECURITY PACKAGING SUPPLEMENT

The pharmaceutical industry is on the verge of significantly changing the way it identifies and tracks its products. State and federal interest in unique product identification to fight counterfeiting is driving the concept of mass serialization.

Stakeholders, however, appear hesitant to move forward without mandates or standards. Many have been studying the use of serializing radio-frequency identification (RFID) and bar codes in pilots for some time, yet only a few are using such technologies on products distributed to the market. At a recent meeting on developing electronic pedigrees to comply with California’s pending law, several manufacturers implied that they were hesitant to invest fully in one technology without knowing what their supply-chain partners were doing or what FDA may require.

Other security packaging technologies are also viable solutions. Regulators point out the promise of nanotechnology, encryption, and other track-and-trace or authentication technologies.

Industry activity suggests that product security could exist on multiple levels that could be classified into two separate camps: public and private. For example, supply-chain participants could use overt tools such as serial numbers (encoded in a bar code or an RFID tag) to convey drug pedigree, while auditors or inspectors could use covert and or even forensic tools for private authentication.

THE ROLE OF PACKAGING

Security tech firm SICPA divides the different layers of security packaging and labeling offerings as follows:

• Overt security: for the public.
• Semicovert security: for retailers.
• Covert security: for inspectors.
• Forensic security: for legal procedures.
• Track-and-trace security: for production and distribution control by the authorities or brand owners.

“A selection of these technologies can be combined to yield a unique, multiple-layered security solution, combining material- and information-based security into a highly secure yet industrially viable, robust, and scaleable system,” says Jack Henderson, pharmaceutical sales director for SICPA. “Furthermore, the different layers of the solution are designed to address different users, giving them a tool to authenticate and/or identify secure items.”

West Pharmaceutical Services (Lionville, PA) has layered security features into its vial closures. West’s Flip-Off seals consist of a plastic button heat staked to an aluminum shell. “The method of assembling the plastic button to the shell provides evidence of tampering,” says Carol Mooney, market manager, strategic product initiatives, for West. “When the button is removed, a portion of the aluminum shell tears away and stays attached to the plastic. Buttons that have been removed cannot be reattached properly to the portion of the aluminum shell that remains on the vial.” West has enhanced its Flip-Off seals with West Spectra technologies, which include seals with brand identification and other identifying marks molded into or printed onto the seals. Spectra can also include RFID.

Mooney estimates that “at any given time, there are more than 250 million vials using West Spectra seals in the global pharmaceutical supply chain. Pharmacists and healthcare providers can verify the packages’ authenticity by checking the color schemes against the manufacturer’s published educational materials related to packaging.”

Figure 1. Source PMP News’s 2007 Security Packaging Survey.

Packaging continues to be an attractive means of securing healthcare products. More than 60% of respondents to PMP News’s annual Security Survey are using or considering using packaging technologies to enhance product security. “Our product and application is the first of its kind,” writes one respondent serving the veterinary medicine market. The company is currently standardizing packaging and labels. “We want to corner the market and identify fraudulent or gray market product. We also need to control mass identification and product flow.”

However, some companies do not see a need to employ packaging in a security program. “[It] has not been an issue at this point,” writes one respondent. Say others: “Our products are not in a [high]-profile area of the market” and “Product is a low- to no-risk device.”

Henderson has experienced similar reluctance. “Brand owners are reluctant to add proven technology, seeing security as an expense, rather than a long-term investment,” he says. “The issue of standards and RFID as a security tool are still questions that linger. Companies are afraid to jump without knowing what possible standards may be implemented by FDA, etc.”

Some survey respondents haven’t found it easy to introduce security into existing processes. Packaging changes are often only initiated after a problem arises, rather than in anticipation of one. “Packaging [is] only subject to change due to an event or observation,” writes one respondent. Technologies may also have limitations: One company has not “found one easy for us to incorporate into our device manufacturing, is functional, and [that] doesn’t add cost.”

And survey respondents are most concerned with tampering, ranking it higher than theft, counterfeiting, and diversion threats. “The only issue is tampering with the product,” wrote one respondent.

MOTIVATING FACTOR: REGULATION

More than two-thirds of the survey respondents work for companies whose products have never fallen victim to counterfeiting, diversion, tampering, or theft. Why, then, would such companies change their packaging as part of a product security program?

California. The industry is focusing heavily on California’s rules for serializing each saleable unit, currently slated to take effect January 1, 2009.

“Many manufacturers won’t do anything until mandated by state or federal legislation,” says Ellen Reilly, managing director of supply chain solutions with BearingPoint’s Life Science practice. “The California epedigree legislation is the focus and is placing time-bound pressure on manufacturers.”

Many have publicly asked the California State Board of Pharmacy’s (BoP) enforcement committee for a delay; the committee has asked industry to put all such requests in writing before it will consider them.

FDA has also been charged with developing standards by congressional act H.R. 3580, signed by President Bush in late September 2007. The agency must standardize a numerical identifier for industry to use for drugs from the point of manufacturing and repackaging by March 2010. (See the sidebar on page 50.)

FDA opened 54 cases investigating counterfeit drugs in 2006. This was up from 32 cases in 2005, and down from 58 cases in 2004, the year FDA published its “Combatting Counterfeit Drugs” report.

Legislation regarding the application of security features will become more prevalent in the United States and abroad, predicts Scott Denley, global product manager, Alcan Packaging Kreuzlingen. However, “in the United States, public policy initiatives addressing counterfeit drugs at both the federal and state level (CA, FL, NV, etc.) appear to be sending conflicting messages to the pharma industry. Compliance with one piece of federal legislation would be easier than the resulting complexity of differing policies at state levels.”

BAR CODING VERSUS RFID

Figure 2. Technologies used by or of interest to healthcare product packagers. Source PMP News’s 2007 Security Packaging Survey. (click here to enlarge)

Bar coding has inched ahead of RFID in terms of industry buzz. More than two-thirds of survey takers are currently using or considering using bar coding of lot or date codes, compared with 13% of those using or considering using RFID to tag items. (See Figure 2.) However, 28% are interested in learning more about RFID item tagging, while 40% would like to learn more about bar coding date or lot codes.

Interest in mass serialization, however, which the pending laws will require, is lagging. Only 14% of respondent companies are employing or considering mass serialization using bar codes; only 5% are employing or considering mass serialization using RFID. Interest in further education on mass serialization using bar codes or RFID is 12% across the board.

Cost is definitely a deterrent, no matter the technology. “Even though companies have identified counterfeiting issues in the past, they have not been pursued because of the costs and logistics [involved] in pursuing these,” says James Butcher of Claricom. “This is why brand protection solutions must be practical and cost effective.”

Claricom is working with Griffin-Rutgers Company, Inc. (Ronkonkoma, NY), to bring its solution to the United States. Claricom produces software for serializing items as well as software that enables a user to gain complete plantwide control of all digital coders and printers from a single PC, reports Peter Umbdenstock of Griffin-Rutgers. Numerous different coder technologies (ink-jet, desktop label printers, thermal-transfer coders, OEM print engines) can be operated on one all-encompassing software system.

“We think that a combination of Claricom print design and coder control software along with CounterFight product security software employing true random mass serialization may have real, cost-effective application to the California 2009 mandate for product serialization and ePedigree tracking,” says Umbdenstock. “We think we may be looking at a much lower-cost alternative to RFID that may give users everything that California has defined, except for non-line-of-sight code scanning.”

CounterFight’s Secure Product Profile (SPP) won a PISEC Award in November.

Automated Packaging (Streetsboro, OH) uses in-line print-and-pack systems with bar code printing directly on the bag of contents, with database verification for pharmacy fulfillment applications. “We are seeing a growing demand for security packaging applications, using dynamic bar code printing and scanning technology,” says Tim Groff. “A lot of people are talking about the problems of counterfeiting, but easing implementation is the issue.”

Figure 3. Packaging levels to be protected with security features. Source PMP News’s 2007 Security Packaging Survey. (click here to enlarge)

However, how can 2-D bar codes be the solution if much of healthcare distribution involves sending mixed totes to retail pharmacies? “You need non-line-of-sight technology, like RFID,” says Narendra Srivatsa of Cortegra. “When used correctly, RFID works well. UHF Gen 2 works well. Tag reading is faster, and performance with liquids and metal has been addressed with UHF in the near field.” Evaluation will be ongoing, he says, but the industry should take cues from entities like the Department of Defense, which utilizes UHF readers. Cortegra is working with pharmaceutical companies as they evaluate UHF RFID.

Nosco (Gurnee, IL) has introduced 2-D Data Matrix mass serialization production capability that includes the use of Hewlett-Packard’s Security Publishing Solutions. Nosco 2-D Data Matrix codes can help biologic drug producers meet ePedigree requirements at the item level, and can be used as a “bridge” or provide “redundancy” for RFID for pharmaceutical manufacturers, reports Joe Tenhagen, vice president of marketing for Nosco. Serialized 2-D codes are produced on labels and folding cartons and managed with a database infrastructure. 2-D codes on labels are provided with data
certification.

“Drug makers are using 2-D codes and RFID options to meet ePedigree laws. We are seeing roughly 50% of producers utilize 2-D codes at the item level for biologics, or as a way to get started,” he says.

AUTHENTICATION

Respondents are interested in other technologies. Although only 4% of respondents are currently using or considering holography, 21% would like to learn more about it. Forty-six percent currently use or are considering using printing technologies, and 18% would like to learn more.

Bayer Healthcare redesigned its packaging for Kogenate FS and Kogenate FS with Bio-Set to include specialty printing features. Microprinting text “often too small to read with the naked eye” is used, says a company spokesperson, making it “very difficult to accurately reproduce during counterfeit attempts.” Ink that is only visible under ultraviolet light is also employed.

Figure 4. Degree of challenge in implementing security packaging technologies, with 5 representing a very strong challenge and 1 representing a not-so-strong-at-all challenge. Source PMP News’s 2007 Security Packaging Survey. (click here to enlarge)

Med-Health Pharma LLC (Rochester, NY), a prescription drug repackager, is using Kodak’s Traceless anticounterfeiting technology to place an invisible marker on its packages to distinguish genuine prescription drugs from dangerous fakes. Med-Health Pharma delivers medications for point-of-care dispensing at physicians’ offices.

“Using the Traceless System allows Med-Health Pharma to give physicians confidence in the prescriptions they provide their patients,” says Sam Haddad, vice president of operations, Med-Health Pharma. “This solution enables us to quickly and easily verify the authenticity of the medications we package and deliver to physicians.”

“Layering is very effective,” says Donald J. Dobert, president, ATL Pharma Security Label Systems. “Multiple anticounterfeiting techniques are very dynamic.”

ATL has just launched its SecurBook labels. Multiple-panel booklet labels are available with features such as Pharma-Void, Secur-Detek, and Secur-Mark. “ATL Pharma utilizes IDGLOBAL technology,” says Dobert, which he calls fail-safe. “It consists of unique forensic markers with digital data for tracking. Specific ATL SecurBook labels contain an invisible and nondegradable forensic marker. When applied to pedigree documentation, packaging, and containers, a customer’s supply channel becomes secure, because all digital data scans must be identical. If they match, brand authentication and anticounterfeiting are ensured.” An invisible forensic code can be placed in the ink, varnish, paper, mylar, etc. 

ARmark Authentication Technologies LLC offers covert markers for authentication of products across the healthcare industry. Made from excipient materials or food-based materials, these covert markers can be added into the label or applied directly into the blister film, bottle, or foil laminate, reports Jeff Robertson, director and general manager. “Each covert maker contains brand owner–specific information, chosen by the brand owner which provides the brand owner a method for authentication against counterfeiting and diversion.” In addition, these covert taggants can be applied directly on tablets via traditional tablet-coating methods or applied to medical devices using an aerosol. In the last year, Robertson says that ARmark has been able to increase the amount of “custom information contained on the covert marker as well as the numerous materials of composition that provide flexibility in applications served.”

Alcan Pharmaceutical Flexible Packaging has expanded its range of overt, covert, forensic, and track-and-trace solutions. In addition, Alcan has strengthened its global security supply pedigree, extending its family of security packaging solutions to the pharma supply chain. A combination of technology, security of supply, innovation, and service provide a range of options.

Topflight is designing security elements into various tamper-evident labels. “Printing adhesives and multiple-layer converting, along with more recent developments in hologram, taggant, and indicating-ink technologies, have allowed us to add features to meet customer needs or simply provide a more cost-effective means of production,” says Dave Becker, marketing and communication manager. “We are currently using several new items such as covert markers, multilevel holograms, and self-destructing labels for brand security and brand protection. We often combine technologies for maximum effect. Destructible designs indicate either product tampering or an attempt to remove the label.”

Stardust Materials LLC produces ceramic powder that can be integrated in other materials like plastic film, ink, and even glass. “The ceramic powder is an inorganic material that is tenacious—extremely stable,” says Vitaly Talyansky, partner. “Our security is built on limited access to the material—we control the stuff.”

Engineered with specific optical properties that can be tailored to individual users, the ceramic powder can withstand thousands of degrees in temperature. “As a physicist in the Soviet Union, my father, Edward Talyansky, designed the powder to tag military vehicles so that they could be authenticated with scanners from a distance. After the empire crumbled, he thought it could be used for brand protection.” Talyansky reports that the powder is currently being used to protect apparel and postage stamps.

Such covert technologies can be layered into (or around) bar codes. Talyansky says that bar codes themselves can be printed with ceramic-containing pigments. Latent images (invisible screens) can also be printed over standard bar codes without interfering with traditional scanning.

Nosco has also demonstrated the use of a unique pattern of color tiles framing a 2-D Data Matrix, explained Gregg Metcalf, Nosco’s industry manager, at a California Express Solution Workshop on electronic pedigrees. The tiles offer even more options for unique item identification. The bar code and tiles can be produced as a single-image composite cluster, said Metcalf.

No one technology is prevailing, says Cortegra’s Srivatsa. He still sees security-minded pharma companies layering different technologies.

Denley of Alcan says that the way security technologies are being applied is evolving. “Instead of solutions that are applied to one brand, we see a move towards more flexible, cross-brand solutions.”

PATIENT PERCEPTION

“If the consumer doesn’t feel safe using the product 100% of the time, total sales of a company can suffer,” says Becker. “The added danger and previous crises involving pharmaceuticals simply magnify those concerns. In reality, a single instance of product tampering has the potential to ruin a company.”

Developing tamper-evident packaging may be the simplest way to assure patients. Bayer Healthcare introduced tamper-evident packaging for Kogen­ate FS “to help ensure product integrity and show evidence of tampering,” says a company spokesperson. In addition, a distinctive “K” is “featured on all packages to let users know the
carton includes new anticounterfeiting features,” she says.

In general, “customers see the advantages of having their products tamper-evidently sealed,” says Marta Berger, sales and marketing for Dividella. NeoTOP and NeoWallet lines are designed with this in mind and offer a solution, she says. “The Dividella top-loading and top-opening so- lutions have offered tamper evidence for the last 30 years by means of one to four hot-melt glue points on the carton lid, so the package cannot be opened without visible damage.”

MAINTAINING SECURITY

Technology providers understand that maintaining product security extends well into their realm. “There is a huge cost investment and learning curve to assuredly provide security labeling,” says Becker of Topflight Corp. “In the strictest security environment, labelers must be able to verify [the lack of] tampering of raw materials and processes from receipt to shipment, 24 hours a day. In order to provide multiple-layer security, a variety of processes must be combined which sometimes extend the capabilities of existing equipment, require investing in new equipment, or demand innovative product development to make designs even feasible.”

Robertson of ARmark says that one of the biggest challenges to incorporating any authentication product is “the control of the supply chain after it has been applied and before it has been combined with the target article. Without proper supply chain controls, the whole solution could become compromised.”

ARmark offers supply-chain audits for all healthcare customers to help them understand where there could be weaknesses and to provide solutions, says Robertson. “It is not enough to just supply a technology to a brand owner. You have to become part of a bigger solution for them.”

Paper can also serve as a stand-alone item for providing safe products, says Richard Murach, product manager, pharmaceutical papers, Fraser Papers. Although “lightweight opaque paper used for inserts and Medication Guides is more a medium for special inks, taggants, RFID, and other security devices, the specific fiber blend used is unique to each paper mill, specifically Fraser Papers.” The fiber is manufactured on site at pulp mills using specific tree species native to the northeast. When made into lightweight opaque paper on individual machines, the paper has characteristics unique to the facility and manufacturing machine. It is “similar to a fingerprint,” he says.

Each pharmaceutical company can specify a particular brand of paper. “When it is specified only to use a particular product, the pharmaceutical company now has control over the raw materials used rather than generic lightweight opaque papers,” he says. “If counterfeit drugs are coming to market, the insert paper can be an additional means of providing authenticity without additional cost to the packaging.”

Grades specifically manufactured by Fraser Papers for use in the inserts and outserts are Pharmopaque, Snowbrite Pharm, Circular Bond, and Gorham Pharm. These grades are designed for and used by pharmaceutical printers for pharmaceutical leaflet end use. Fraser Papers can also provide additional security features to the product, similar to what might be done on the printing press, such as adding taggants, special fibers, etc.

Manufacturers will need assurances that security is maintained. Although 68% of survey respondents indicated that technologies will be applied in house, 28% wrote that they will be applied by a contract packager and 27% by a distribution center.

WRAPPING UP

At PISEC in November 2007, one speaker said that “the largest competitors in the market are the counterfeiters.”

Some see counterfeiting as a worldwide threat. “Counterfeit prescription drugs represent a global crisis that has serious consequences for the entire healthcare industry,” says Steve Powell, general manager and director, security solutions, Kodak’s Graphic Communications Group.

“Because counterfeiters are constantly trying to beat the technology, it is advisable to change solutions or at least features of a specific solution periodically, staying one-step ahead at all times,” advises Henderson from SICPA. “Too many changes, however, is an ineffective option.”

Adds Robertson of ARmark: “I wouldn’t say that it is important to continually change the technology used, but it is important to at least have the ability to change what information is present so that a brand owner can stay ahead of the counterfeiters.”

Denley recommends that companies consider next-generation solutions. “The timing of change is more likely tied to actual market events than arbitrary changes at preset time intervals. Alcan Packaging has committed the necessary R&D resources to identify and validate next-generation solutions.”

And security packaging technologies do work. Denley reports that a counterfeit product was caught in connection with the company’s technology. “An Asian customer submitted multiple printed blisters for authentication. Our R&D print team was able to discern the authentic from the counterfeit blisters,” he says.

Despite the current lack of consensus or standardization, some manufacturers are protecting products at high risk of counterfeiting and diversion with sophisticated packaging. Working in private, they are waging a battle with criminal competitors that others deny threaten the supply chain.