by Ursula Jones
When you think about your products' labeling, do you feel anxious? Are you frustrated by the need to get more information on your labels without changing the design of the package? Do you worry about your products being stolen, counterfeited, or misused? If you're a healthcare manufacturer, chances are you've answered yes to one or more of these questions.
Today's pharmaceutical and medical device manufacturers are faced with stringent regulations, a competitive global marketplace, complex distribution systems, and profit losses from theft or counterfeiting. To get an edge in this environment, many healthcare companies are looking to their labels. And thanks to new designs and technological advances, today's labels can offer a solution to just about any problem.
One of the biggest labeling issues facing today's healthcare manufacturers is the ever-increasing amount of information that must be printed on labels. Between FDA regulations and the need to print in multiple languages, manufacturers are finding that their existing labels are simply too small. This often results in a complete redesign of the label—or worse, of the package itself.
One way to avoid redesigning the existing package is to use expanded-content labels (ECLs). ECLs combine traditional product labels with loose, folded outserts for a more cost-effective, secure, and user-friendly system. By combining the loose outsert with the roll-form label, all components are applied in a continuous form. One clear advantage to using this process is the elimination of secondary visual inspections required by FDA for printed, non-roll-form materials. Other advantages include reduced start-up, shut-down, and changeover times; in-creased production rates and line flexibility; reduced packaging line labor costs; and faster, more-accurate reconciliation.
"The versatility of ECLs is the main selling point," says Chris Schaefer, marketing manager for CCL Label (Rosemont, IL). "They also help meet multilingual requirements. And printing one label with 12 languages eliminates the need for individual single-language labels and results in reduced inventory for the manufacturer," she adds. CCL offers a number of ECL formats including leaflets or booklets, laminated or nonlaminated formats, zipper perforations, and single-print constructions.
"Our customers often need to add copy on their labels without changing the size of the label or bottle," says Claudia Mace of The Control Group (Norwood, NJ). Mace's company offers a wraparound label that utilizes existing bottle sizes, creating additional space by overwrapping using a special process. The label is lifted up, allowing the consumer to read the copy underneath.
Moss Printing (Chicago) also offers ECLs. Its Fix-a-Form is a multipanel foldout label/leaflet combination attached to a pressure-sensitive base label that can replace boxes, inserts, shrink-sleeves, and hangtags. Bar codes can also be printed onto the label for added security.
Tom Pugh, marketing manager for Bell-Mark (Pine Brook, NJ) says that the need to print in several languages and to print bar codes directly onto the primary packaging is a challenge for both medical and pharmaceutical manufacturers. "Thermal-transfer printers that can handle these requirements in a programmable fashion have a real advantage since they make for easy changeover," says Pugh.
ECLs can also provide a distinct marketing advantage. "An ECL makes for a cleaner-looking container," says Lance Vanden Brook, marketing manager for New Jersey Packaging (Fairfield, NJ). "And because it eliminates a step in the manufacturing process, there's one less thing that can go wrong," he adds. "They are more expensive than traditional label-onsert combinations, but because pharmacists (or consumers) can't throw the onsert away, it stays with the bottle." All of these advantages are making ECLs the choice of many manufacturers.
PATIENT PACKAGE INSERTS
Another type of expanded labeling is also taking off. Now that FDA allows direct-to-consumer advertising for prescription drugs, manufacturers are seizing the opportunity to communicate with their customers. One of the best ways to do this is through patient package inserts.
"Our primary research shows that this will be the hottest growth area in packaging of both Rx and OTC medications," says Tony Kapsaskis, director of marketing and sales for The Challenge Printing Co. (Wallington, NJ).
HoloSecure materials from Van Leer Metallized Products incorporate covert holograms.
Challenge Printing's Expand-A-Text design combines a pharmacist's brochure with several patient inserts, all printed on the same sheet. The company can also print separate patient inserts and glue them together. The benefit from this type of construction is that the pharmacist's insert is kept with the original package, while separately designed inserts can be given to each patient. This allows the maker to provide more information to patients than was previously possible, which helps increase compliance with drug regimens.
"Drug companies lose a lot of money when patients don't take their medicine properly," says Kapsaskis. "Because when the drug doesn't work as it should, the patient will choose not to take it again." Manufacturers can also face lawsuits when drugs are not taken properly. To avoid these scenarios, drug companies are stepping up their efforts to get as much information to the patient as possible. Doing so also helps increase customer loyalty, which translates directly into increased sales.
A growing problem in the pharmaceutical industry is counterfeiting. Some counterfeited products look exactly like the real thing, even down to the brand name. A primary concern for drug companies is liability. If a consumer becomes sick after taking a counterfeited drug, the brand-name manufacturer could be the target of a lawsuit.
"With an estimated $275 billion worth of worldwide goods counterfeited last year and $6 billion in pharmaceutical drugs, there is a growing need to protect products and packages with security-label materials," says Jim Macuga, business development manager for Avery Dennison, Fasson Roll North America (Painesville, OH).
According to Frank Shea of Van Leer Metallized Products (Franklin, MA), "The World Health Organization estimates that 6—;7% of pharmaceuticals sold worldwide are counterfeited." If these figures are accurate, then drug manufacturers—and the general public—have a serious problem on their hands.
One way for drug manufacturers to protect their product's authenticity is to use holograms in the labeling. "Holograms have become the number-one consumer-recognized anticounterfeiting device," says Macuga. "When consumers see a hologram on a product, they believe they're getting the real thing."
Crown Roll Leaf (Paterson, NJ) specializes in the design and manufacture of holograms for a variety of industries. According to Stu Glazer, marketing manager, the use of holograms will continue to grow in popularity because the cost of producing them is going down. "As the technology has improved, the economies of scale have also improved," Glazer says. Holograms are usually embossed onto a polyester film with an adhesive backer, metallized, and then sold to a converter.
For manufacturers that don't want a visible hologram on their package, Van Leer has developed holographic security papers that integrate covert holograms into the paper itself. The holograms are invisible under normal lighting, but are revealed using a laser pen or other light source. The HoloSecure product is unique because it is paper based, rather than film or foil based. This offers a number of benefits. First, the hologram can serve as a tamper-evident feature. Second, it can't be replicated like film-based holograms. And, it's easier and more cost-effective to convert.
For some drug companies, chemical taggants are becoming increasingly popular. A chemical is embedded in the label, where it remains undetectable. Oftentimes, only a few people at the drug company even know it's there. If a lawsuit is ever filed, the manufacturer can prove the absence of the chemical taggant, thereby indicating that the product is not theirs.
In response to these needs, Macuga's company has developed a line of security film products especially for the pharmaceutical and medical industry. Integrated into the label base stock are security technologies including voidable polyesters that leave a custom message or the word Void behind when the label is removed. Films with chemical taggants and holograms are also available.
Another way to prevent counterfeiting is to make the labeling hard to duplicate. "We're printing higher-end graphics and as many as nine colors per label," says New Jersey Packaging's Vanden Brook. "Doing so helps assure physicians and pharmacists that the product is real."
ANTITHEFT AND ANTIDIVERSION MEASURES
Even if product authenticity is not a problem, product theft certainly is. Theft of OTC drugs—particularly vitamins, nutraceuticals, pain relievers, and expensive products like Rogaine—is common in the retail marketplace. To combat this, many drug retailers are placing antitheft devices, such as electronic article surveillance (EAS) tags, onto the outside of packages. Unfortunately, these tags are obvious to would-be thieves, who can simply tear the device off the package.
This has caused some retailers to turn to drug packagers for help. A popular solution is "source tagging." In source tagging, the EAS tag is embedded into the package and under the label where it is hidden from view. Other suppliers can provide labels that integrate RF circuits. The circuits are not visible to consumers, so they cannot be removed.
Pick-n-Place labels from Pharmagraphics aid in product tracking.
Of even greater concern to drug and device manufacturers is unauthorized distribution. Distributors are usually given the rights to sell a specific product in a specific region or, in some cases, one country. These products are purchased by the distributor and sold at a predetermined price. If price differentials exist between countries, however, a distributor could sell the product into an unauthorized area for greater profits.
Manufacturers can combat this by using product-tracking devices. A radio-frequency identification device (RFID), which comprises a computer microchip and antenna, is embedded into the label stock. The microchip can store vast amounts of information including distribution channels, quality control data, warranty and expiration dates, and even the location at which the product is ultimately purchased. Certainly, having access to all of this information would be extremely useful for manufacturers. It would also allow them to know which, if any, of their distributors are selling products in unauthorized areas.
According to Avery Dennison's Macuga, however, a system such as this is still costly. "The technology is here today, but large-scale implementation is still a number of years away," he says. "Currently, the cost for the tag is approximately $1 to $2 per label. Then there's the additional expense of updating the company's systems to read and process the information. Costs would have to be around $0.25 per label to make it more widely accepted," he adds.
Medical device manufacturers could use such a system in another way. Avery Dennison is currently working with a device company that wants to place RFID tags in two separate devices that are intended to be used together for a particular procedure. If the devices are used improperly by the healthcare provider, the manufacturer could offer proof via data contained in the RFID tags, thereby limiting its liability in case of a patient injury.
"RFID has great potential in the future," says Macuga. "Ultimately, as low-cost, disposable RFID tags become available, they will replace visible and bar code labeling in specific applications." Applications that can benefit from RFID include those requiring non-line-of-sight scanning or multiple-tag reading in a single pass. RFID is also suitable for applications where data need to be included directly with the labeled product or article. "The transition will be a long-term process, but this technology truly has the capability to revolutionize the product-tracking industry," he says.
Besides tracking products through distribution chains, healthcare manufacturers are increasingly concerned with tracking their products once they've been delivered to the patient. Pharmagraphics (Greensboro, NC) has developed a product that provides guaranteed tracking for patient records and diagnostic testing.
According to John Pacific, vice president, marketing and sales, the Pick-n-Place labels offer manufacturers several advantages. "For example, consecutive and 100% accurate bar code verification is now possible, affording manufacturers and healthcare providers complete confidence that the correct prescribed medicine is being dispensed to the correct patient every time," he says.
The labels can be custom printed in a variety of bar codes and sizes. A portion of the die-cut bar code has a custom removable adhesive that allows it to be easily removed from the master container and affixed to the patient's medical records. The first series of numbers are identical on every master container of the same prescription, identifying the product. The second series of numbers sequentially change, identifying the patient who received the medicine.
For manufacturers going through clinical trials, Almedica (Parsippany, NJ) has developed a software program that automates the clinical label—;printing process. The ADLS system is a simple, fast method to capture and document protocol-specific information, produce labels, and reconcile clinical materials. High-quality open and blinded labels can be produced in a variety of sizes with embedded graphics and bar codes. The system operates in a Windows-based environment and can share data with other corporate systems.
Given all these innovations, healthcare manufacturers can use their labeling in ways never before perceived possible. And with more developments on the horizon, the potential uses for labels seem endless. For now, such manufacturers can rest easy knowing their products aren't being stolen, counterfeited, or used improperly.
Photo courtesy of CCL Label