Specialty Labels Add Function to Form

Pharmaceutical companies are turning to multifunctional labels to serve varied needs.

Kassandra Kania, Managing Editor
Photo of a resealable label courtesy of Weber Marking Systems Inc.

The function of labels in the pharmaceutical industry extends far beyond product and brand identification. Recent FDA regulations dictate that over-the-counter (OTC) drug labels must include a Drug Facts panel, challenging drug manufacturers to find creative ways of expanding labeling space. And many of these manufacturers are beginning to request multifunctional labels that not only comply with FDA regulations but also play an increasingly important role in addressing a variety of needs, such as promoting patient compliance, attracting and retaining customers, providing marketing opportunities, and increasing security.


The volume of text that appears on pharmaceutical labels has grown, but the size of the package often has not. Therefore, drug makers are faced with the challenge of accommodating more information in a limited amount of space. "Customers are asking for inserts that are able to accommodate more text," says Ernie Chaplin, vice president of sales, marketing, and product licensing at Pharmagraphics (Itasca, IL). "It's a key issue in the package insert and outsert business—the ability to take large pieces of paper and fold them into small glued inserts or outserts. We're being asked to do this because the industry is seeing their inserts grow."

Alternatively, some companies are doing away with cartons and inserts altogether in the interest of cutting costs and incorporating the insert information onto a label that stays with the product. "Our pharmaceutical customers need to put more information in a smaller area, but at the same time they want to eliminate boxes because there's a cost savings," says John Edwards, owner of Edwards Label (Ventura, CA). The company specializes in booklet labels that can be attached to the outside of a round container and opened using a pull tab. These labels provide 40 sq in. of real estate in an area measuring 4 sq in. on a product, says Edwards.

Pharmaceutic Litho & Label Co. (Chatsworth, CA) also manufactures booklet and extended text labels that increase real estate space. "Customers need to provide more information to the public," says Tom Moore, president. He also notes that the point size of the text has increased so that the elderly can read it more easily. "With our process, we can apply a 40-page booklet to a label," he says.


Edwards also cites the support of patient compliance as an important consideration when choosing a label that remains with the product and can be resealed. "Instead of having booklets fold out in a z-fold," he says, "we've padded them so that when it opens, it opens as if you're turning the pages of a book," thereby reducing the chance of the label being torn or destroyed. That way, patients can refer to the instructions each time they take their medication.

Tom Michalsen, media products manager at Weber Marking Systems Inc. (Arlington Heights, IL), agrees that requests are growing for labels that help promote patient compliance with drug regimens. "There's a trend moving away from cartons because the label stays with the product; instructions get tossed away with the box," he says. Weber Marking Systems makes extended booklet labels as well as resealable one-ply labels that contain text on both sides so that the patient can peel back the label, read both sides, and then reseal it.

Labels can be peeled back to reveal additional text. (Photo courtesy of Impaxx Corp.)

Both types of labels are becoming more popular, says Michalsen, as the need to supply consumers with more precautionary statements about the product increases.

But using labels to keep information with the product is not the only method of helping patients take their medication correctly. Some companies are adding a graphic element as well as color to their labels to make it visually easier for patients to follow instructions.

Robin Henfling, president of the Impaxx Arlington Press Pharmaceutical Packaging Group (Brooklyn, NY), says that the use of color in pharmaceutical labeling is becoming more prevalent, and the company has invested in a large color press to meet this demand. "Typically, package inserts would be black type, and that would be it," he says. "But now we're getting into colors geared toward patients. For example, the advantages of color are evident in an asthma drug. The insert might show a photo of a person holding the inhaler, and we'll do that in full-color processing, rather than working the six-point type and trying to describe it.

"Often, the reason drugs aren't effective is because they're not taken properly, particularly with inhalers," he continues. "Now, [pharmaceutical companies] are figuring out that they want to make sure the consumers take the drugs properly so they won't switch."


Generally, OTC drug manufacturers are more concerned than prescription drug makers with creating labels that attract and retain customers. Whether or not a manufacturer wants a product with shelf appeal has a major effect on what types of labeling materials are used. Today, most prescription drug makers use pressure-sensitive labels, favoring paper over plastic. However, the use of films is also on the rise, particularly with OTC drug labels. "There's much more film used in the pharmaceutical industry than there used to be," says Luciano Chiovitti, North American account manager for Label-Aire (Fullerton, CA), "but the majority of [labels] are still on paper."

According to a study on world labels by the Freedonia Group (Cleveland), plastic labels will cut more deeply into the traditional paper-applications market, capturing 27% of the world market by 2005. One reason for the increase, says Chiovitti, is the fact that the cost of films has decreased. Also, "you can do more interesting things with film materials, such as achieving the no-label look," he says, "and they can handle more abrasive environments."

One of the most enticing qualities of heat-shrinkable labels is the "brilliant label finishes and the ability to shrink and conform to shape," says Ed Farley, director of sales at Axon Corp. (Raleigh, NC). Highlighting the shape of a bottle with a full-body shrink sleeve not only draws attention to the product but also allows for 360° graphics, says Impaxx's Henfling.

Although the use of full-body shrink sleeves in the pharmaceutical industry is still rare, one company has taken the plunge and discarded its carton in favor of a colorful full-body shrink sleeve to promote the new hourglass shape of its bottle: Allergan's Rocket Bottle for contact lens solution. "Because the bottle has so many complex curves, we were unable to use a pressure-sensitive label on it," says Rodney Terwilliger, senior engineer for Allergan (Irvine, CA). "We had to have something that would form to the shape of the bottle. We tried screen-printing directly onto the bottle with inks, but we couldn't get full coverage. We couldn't display as much information. With the shrink sleeve, we were able to completely cover the bottle with a label of whatever color we wanted."

In addition to attracting customers, labels are being used as a marketing tool to cross-sell products and promote new brands. Labels that peel back to reveal instant coupons and mail-in rebates can help companies increase sales, say experts. Edwards calls this "using your product like a billboard." By offering consumers an incentive, companies can obtain their names and addresses, which allows them to develop a database for a direct-mail program.


Although full-body shrink sleeves are uncommon in the pharmaceutical industry, the market for tamper-evident shrink labels is expanding. According to a study of shrink labels conducted by Huston Keith of Keymark Associates (Marietta, GA), 70% of bottles used for OTC drugs use tamper-evident labels, and this number is expected to grow about 6% annually.

Some pharmaceutical companies interviewed for the study indicated that they might consider using a full-body sleeve label to meet needs for providing additional information, especially if they already had a machine to apply a tamper-evident band that could be easily modified to apply sleeves. In these instances, says Axon's Farley, "the label can be configured so that part of it provides a tamper-evident feature that can be removed via perforation while leaving the label intact."

Label Express Inc. (Orem, UT), a business unit of Impaxx, has developed a tamper-evident version of its Reveal Estate extended-text label. Hidden face slits in the label cause it to tear if there is an attempt to remove it. The design is bidirectional so regardless of the direction of removal, pieces of label will be left on the product. "Our pharmaceutical customers were looking for ways to use an extended-text label but were struggling with the fact that they did not want the label to lift off the product completely," says Henfling. "We came up with this new approach to give companies the added space they need on a label while maintaining product identification."


Despite the variety of labeling options available to pharmaceutical manufacturers, many of them are reluctant to take advantage of them because they fear that consumers who are accustomed to a certain label might think that the product has changed if the label changes. Therefore, "manufacturers may cling to a package that they do not need, like a carton," says Keith.

Another reason some companies are hesitant to introduce changes is the increase in costs. "A lot of pharmaceutical companies have already invested in pressure-sensitive label applicators," says Keith. Therefore, they are reluctant to make changes to their labels that may result in additional investment. Should they wish to introduce a new line, however, exploring new labeling options might be feasible.

"The industry is incredibly stable and growing," says Michalsen. "There are always new products coming out, and [manufacturers] are challenging label suppliers to do more. You challenge yourself from a converting standpoint to come up with something new to make a label that's more functional."

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