Packaging for Protection
FDAï¿½s anticounterfeiting task force has helped raise awareness of the need for security packaging.
|Safety Syringes Inc. has combined a tamper-evident
feature with a passive
needlestick prevention method for prefilled glass syringes.
Now more than ever, the American publicï¿½s health is at risk due to counterfeit drugs. FDA has recognized this problem and has taken action. The agency has formed a task force to explore new technologies and other methods to ensure the safety of the drug supply. In October 2003, FDA held a public meeting, inviting attendees to share information about technologies, education, and regulatory issues related to the anticounterfeiting initiative. The response from vendors was huge. A host of technologies are available, and suppliers are ready to help protect drugs from counterfeiters. Those interviewed for this article felt that the initiative has played a vital role in raising industryï¿½s awareness of the problem. They also felt the public meeting drew attention to FDAï¿½s willingness to work with industry to find a solution.
During the public meeting, FDA commissioner Mark B. McClellan emphasized that a multilayered approach will help ensure the security of prescription drugs. He acknowledged that there is no magic bullet to solve the problem. Rather, a combination of overt and covert technologies is needed to thwart counterfeiters.
McClellan believes that it is important for consumers, pharmacists, and other healthcare professionals to recognize when anticounterfeiting technology is used so that they can identify counterfeit drugs.
Sidebar: Dispensing Safety
Gregg Metcalf agrees. ï¿½An informed end-user is going to be the pharmaceutical industryï¿½s best weapon,ï¿½ he says. Metcalf is the national accounts representative for security products at Kurz Transfer Products (Charlotte, NC). Overt technologies can be used to help the public determine whether a drug is original or counterfeit. Optical variable devices (OVDs), such as holograms and Trustseals, are popular overt features. Additionally, overt features are combined with covert features to enhance the degree of protection. Covert features usually require the use of magnification equipment or special readers to verity their location and existence. OVDs and technologies such as color-shifting inks can increase the level of protection by layering the technologies together, making a product more costly for the counterfeiter to produce, says Metcalf. A popular security option is transparent or see-through OVDs, he says. These can be used over copy where real estate is scarce, such as on vial labels. The transparent OVDs are more subtle in appearance and allow important information to be verified through the security device. Kurz is also testing a new flip-top cap technology that incorporates the hologram into the mold. This allows the OVD to be an integral part of the package.
Hueck Foils (Wall, NJ) offers holograms that can be applied to different substrates. ï¿½We introduced Medica Protec about six months ago in Europe,ï¿½ says Angela Roggenhofer, healthcare marketing manager of Hueck Foils. The identical holographic feature can be applied to the blister foil and as a hot-stamping strip on the carton and on the leaflet, she explains. ï¿½This provides additional security because counterfeiters do not necessarily have the different technologies available to apply the hologram to three different substrates.ï¿½
Overt features allow the consumer to play an active role in determining whether or not a drug is counterfeit. But they are not enough.
Scott Denley advises customers to find solutions that can be used with existing packages. Denley is the marketing manager of Alcan Packagingï¿½s pharmaceutical flexibles business unit in the pharmaceutical and personal care sector (Shelbyville, KY). The company has developed a platform of market-ready overt and covert technologies for blister packaging called Nï¿½Crypt. These are easily combined with existing packaging, says Denley. There is no need for customers to make any changes to their production line.
Overt technologies, such as line embossing and microtext, can be combined with covert technologies, such as taggants and security inks, that are read with an optical reader. Alcan Packaging is investigating the application of these and other technologies across the entire pharmaceutical sector for all of its materials, for example folding cartons, glass tubing, plastics, and contract packaging. With all the high-profile incidents of counterfeiting, such as those involving Lipitor and Viagra, Denley has noticed an increased interest in security packaging over the past 6 to 12 months.
Joe Pleshek has also noticed the pharmaceutical sector showing more interest in the companyï¿½s products. Pleshek is brand protection market manager for Appleton Security Products (Appleton, WI). The companyï¿½s TechMark taggant papers are a high-security covert technology that can be used for labels. Ultraviolet particles embedded in the paper can be read with a handheld scanner. For a lower level of security, the companyï¿½s new AssurMark product offers the added benefit of tamper evidence. ï¿½If someone tries to remove the AssurMark label, it comes off in small pieces,ï¿½ explains Pleshek. This addresses the problem of remarking, in which counterfeiters remove the authentic label and replace it with a counterfeit label. ï¿½In many cases, criminals will try to put the fake label over the existing label,ï¿½ says Pleshek. ï¿½So we added covert features to the product.ï¿½ Ultraviolet fibers are added to the paper base stock. When a UV light is shined over the threads, they fluoresce.
Tursso (St. Paul, MN), a manufacturer of pressure-sensitive labels, has worked with Appleton. The company markets its security products under the trade name Tursso Security Solutions. In the past, ï¿½customers havenï¿½t been as willing to incorporate security features into their packaging as we would have thought,ï¿½ says David Gray, vice president sales and marketing. ï¿½Until theyï¿½ve been in a situation where theyï¿½ve been directly impacted by diversion or fraudulent activity, it hasnï¿½t been a front burner issue,ï¿½ he says. But he believes this will change.
|Identical holographic features from Hueck Foils can be applied to
cartons, leaflets, and blister foil.
Deciding where to apply security features to your packaging is as important as deciding what technologies to use. Gray advises companies to examine their packaging liability. ï¿½Where are the holes in your supply chain? If you see areas that are vulnerable, research the various technologies and materials that are available to add security.ï¿½
Don McMillan, vice president of marketing for West Pharmaceutical Services (Lionville, PA), notes that many companies are using security features on their cartons and labels. But there are also technologies that bring the solution closer to the product. The companyï¿½s D-I-D (decoration-identification-differentiation) system, for example, customizes the aluminum seal and plastic button that make up the closures on vials. These can be printed, embossed, or debossed with the manufacturerï¿½s name, logo, instructions for use, and other information. Incorporating the security feature into the closure creates a more tortuous path for the counterfeiter, says McMillan. Without this feature, discarded vials can be refilled, resealed, and released into the supply chain. J&J Ortho Biotech started using custom-colored seals to indicate the various strengths of Procrit after counterfeiters acquired lower-strength vials and relabeled them as higher-strength vials. The company now also prints the strength of the product on the aluminum under the plastic cap. This remains hidden until the point of use.
Another example of an anticounterfeiting solution being incorporated into a parenteral package is the Tamper Evident UltraSafe Passive Delivery System from Safety Syringes Inc. (Carlsbad, CA). According to Erik Miller, director of marketing, this is the first time a tamper-evident feature has been combined with a passive needlestick prevention method for prefilled glass syringes. The feature consists of a tear tab, which is removed to expose the rubber needle shield. ï¿½Once the tab is removed, it is impossible to replace,ï¿½ Miller says. There is also a feature that prevents the plunger from being removed without visible and permanent damage.
These overt deterrents help prevent attempts to counterfeit or adulterate the contents of the prefilled syringe.
Miller believes blister packs can provide a certain level of tamper evidence, but they are relatively easy and inexpensive to copy and replace. And once the syringe is taken out of the blister, it may be intercepted prior to administration. Therefore, he says, blister packs should be layered with other technologies, such as the UltraSafe syringe. ï¿½With the UltraSafe system, the tamper-evident feature remains in place until the drug is administered. In that way it adds real value and is unique,ï¿½ says Miller.
Much has been said about the use of radio-frequency identification (RFID). Some see RFID as one of the most promising solutions for securing the supply chain and deterring counterfeiters. Others feel that the cost of RFID tags is prohibitive. The technology is still emerging, and issues of privacy are also a concern. Also, RFID tags cannot be easily read through liquids. Nevertheless, FDAï¿½s public meeting revealed that many are in favor of implementing RFID solutions.
According to a study by The Freedonia Group (Cleveland), the U.S. demand for smart labels is expected to grow more than 14% annually through 2007 to reach $460 million. According to the report, ï¿½by far the best gains are expected in the nascent RFID label segment.ï¿½
RFID tags contain the electronic product code (EPC), a number that uniquely identifies a product. To oversee and develop commercial and technical standards for the EPC, the Uniform Code Council together with EAN International established EPCGlobal (formerly the AutoID Center), a not-for-profit standards organization.
Jon Borschow, chairman of the Healthcare Distribution Management Association (HDMA), said that HDMA believes RFID holds the most promise. ï¿½In the case of EPC, we are encouraging our manufacturing partners to put this technology in their product packaging and to commit to early adoption,ï¿½ he said.
Wal-Mart has already led the way with a mandate for its top 100 suppliers to use RFID tags at the case and pallet level by January 1, 2005. The retailer has also asked about 24 pharmaceutical companies to begin tagging its bulk containers of Class 2 drugs shipped to a distribution center in Betonville, AR. This is slated to start in March 2004.
For industry to derive the most benefit from RFID, some feel that it must be applied at the unit level. Liz Churchill, director of marketing for Matrics Inc. (Columbia, MD), sees smart packaging, using EPC RFID tags, being used at the unit-of-use level on vials to track them throughout the supply chainï¿½the first goal being at the pharmacy level. The company offers a line of passive ultra high-frequency smart inlays and tags, Visibility Manager data mangement software, and multiprotocol advanced readers designed and packaged ready to interface with EPC-compliant Class 0 and Class 1 tags that comply with specifications defined by EPCGlobal.
Vince Reese, business development manager for Appleton, also believes that the pharmaceutical industry is one of the few markets that could support item-level tracking in the short term. ï¿½There are some cancer drugs that sell at more than $1000 a vial. And they are known to disappear,ï¿½ he says. ï¿½Tracking of that type of drug will happen beyond the pallet and case level.ï¿½ The company is designing a label product for RFID smart label applications. At press time, the product was scheduled to launch in the first quarter of 2004. The label is designed to address problems of reliability and print quality, explains Reese. Some smart labels require a no-print zone. This is the area where the antenna and chip are located. Appletonï¿½s label media features a cushioning layer in this zone, which provides a flat printing surface. The layer also protects the antenna and chip connection. In addition, an antistatic coating protects the chip from electrostatic discharge, which can render the chip unreadable.
Despite some of the challenges of RFID technology, suppliers like Appleton are looking at RFID solutions more closely. CCL Label (Framingham, MA) is expanding its RFID and security label printing operations to a second facility in Highstown, NJ. The site is strategically located to serve pharmaceutical customers. At press time, the company was scheduled to begin manufacturing labels incor-porating RFID and other security features this month.
FDAï¿½s final report is due in early 2004. While there is speculation on what FDAï¿½s recommendations will be, one thing is certain: Pharmaceutical companies cannot afford to overlook security packaging. In his comments, Westï¿½s McMillan emphasized that there are many companies that provide anticounterfeiting technologies. It is important to ensure that these technologies are appropriate for the industry. In addition to choosing the right technology, experts advise drug companies to review and change their solutions often to stay ahead of counterfeiters.
These individuals interviewed for this article were pleased that FDA is working closely with industry to find a solution. ï¿½FDA has always been viewed as a watchdog,ï¿½ says McMillan. ï¿½Now FDA is on the same side as the companies it audits, and the common enemy is the [counterfeiters].
It may be a real evolution in FDAï¿½s relationship with the marketplace.ï¿½