Medical Device Link.

Originally Published PMPN January 2004

Labeling

Lori Bryan

Ampersand Label’s EasyTab labels feature a larger recessed pull tab that makes it  easier to open the extended-text label.

Manufacturers know best all the ins and outs of their latest drug or device. What isn’t always so clear-cut is how to communicate this information to patients effectively. Limited space for printed data can make it tough for healthcare packagers to meet FDA labeling requirements, let alone educate patients on the importance of their drug regimen or brand. But going the distance is easier now than ever before thanks to advancements in label technologies. 

Make More type Fit 

Companies may find that new insert capabilities meet their needs for supplying patients with large amounts of printed information. Creative Press (Evansville, IN), for example, is designing an insert for a client that accommodates 1232 sq in. of copy on 100 panels. Investing in new technology—in this case, a new Vijuk folding machine—makes such innovation possible, says John McKay, Creative Press’s vice president–business development. The machine “takes a 381¼2-in. wide ¥ 16-in. tall [sheet of] paper and folds it down to 13¼4 ¥ 37¼8 in.,” McKay says. The client will affix the insert as a side mount to a bottle.

Labels like the TwinSerts products from J H Bertrand (Buffalo, NY) also support lots of data. The TwinSert consists of two outserts that packagers and patients seem to love. “This product doubles the amount of copy space,” says the company’s president, Jeff Bertrand. “Most manufacturers of booklet labels don’t have the modifications we’ve made to be able to put two pieces together with a special overwrap and affix it to the base label so [the packager] can put it in roll form and affix it to the product.” The product is bulky and may require modifications to a packager’s labeler. However, it can be applied, Bertrand says. “If we can put it in roll form, [packagers] ought to be able to automatically apply it. And we’re able to successfully do it.” For patients, he adds, “the strength of the [TwinSerts] is that it provides two pamphlets that they can take away with them. They’re delivered in a neat and clean way, so there’s no sticky edges or anything. The [patient] can put it in a purse or a pocket” and retain it for later reference, he says. 

Margaret Polt, marketing manager for The Challenge Printing Co. (Wallington, NJ), has also noticed an increase in mulitpack outserts. “These are outserts that are folded and then glued together in bundles,” she says. “This allows pharmacists to give information directly to the consumer from the manufacturer.”

Make It Intelligible

“FDA hasn’t moved to that 8-point type yet, but it’s imminent,” McKay says. Packagers gearing up to comply are doing so not solely for the sake of regulatory compliance, but also to provide more-legible text. This, in turn, may do a better job of promoting brand and improving patient compliance. “The bigger font is probably the biggest [request] we’re getting,” McKay says. 

Packagers today are also interested in multicolor printing, according to McKay. “We’re starting to see more and more of that, where we do more than one color so it accents type to stand out. 

Such multicolor printing may do more than enhance readability for patients. It may improve quality. Bertrand explains: “Some kind of color coding might make visual inspection easier. Because a lot of phar- maceutical companies are making labels that are black-and-white and [nearly] identical, the difference [being] maybe a code number or something like that, it’s virtually impossible to inspect the process. If there were some kind of designation showing the difference between labels, not only would that help the patient, it would help the inspection process.”

Color or not, legible text is irreplaceable when it comes to giving patients comprehensible product infor- mation. But pictures can be worthy supplements. A new unit-dose package called PharmaDial from Colbert Packaging (Lake Forest, IL) promotes patient compliance with language that reminds patients to take their medication and pictures that show them how to remove the medication from the circular blister. “We have three large photos showing each of the steps,” says Glen Grosskopf, Colbert Packaging’s vice president of product development. “Pictures seem to work a little bit easier than the wording on the package.” PharmaDial recently received the F=1 child-resistance rating, which is the highest child safety rating, from the Consumer Product Safety Commission. 

Keep It Together

Keeping product information with its dispensed prescription drug is another way pharmaceutical companies are helping to protect patients. Labels that allow patients to read pages of data and then reseal them to the primary container are more than a convenience. Such labels can also improve regimen compliance. Patients also avoid potentially serious drug interactions, since warnings and other product information are readily accessible. 

The Challenge Printing Co.’s two-ply MultiPly label and its PharmaScript extended-content label are both designed to provide more space for patient information. “The real benefit of these labels for the consumer is that the information stays attached to the bottle for future use,” says Polt. 

The patented EasyTab label, part of the MultiVision line of extended-text labels from Ampersand Label (Garden Grove, CA), incorporates a resealable upper panel. This enables patients to “open and close it several hundred times,” says Ampersand Label’s Andrew Vale, vice president, general manager, East Coast division. “And instead of having [the label] fold out in an accordion fashion, which makes it very awkward to fold back in place, we glue the sheets so they open and close like the pages of a book.” 

Feedback from clients has enabled Ampersand Label to improve on EasyTab’s patient-friendliness. “If you have a look at one of our early EasyTab labels and then look at our more-recent ones, you’ll notice two things in particular,” Vale says. “First, you’ll notice that the pull tab is much bigger than it was in the past.” The larger size gets patients’ attention, Vale says. It is especially user-friendly for seniors, who can slide a finger underneath it quite easily. “And secondly, we recessed the pull tab slightly, so that it stays in one place,” he says.

The smallest prescription drug packages, however, may not be candidates for EasyTab. “On the prescription side of things, we have to pick and choose our applications. The really small packages are a challenge,” says Vale. For instance, “you may have a small 60-cm3 bottle, and you’ve got information that FDA mandates that might take up a 10 ¥ 17-in. sheet. We could make the product, but [packagers] could never machine apply it at any speed that makes sense.” And, Vale says, the label would be too big and bulky for such a tiny finished product.

What to Watch For

Finding innovative ways to get more information onto packages is a trend that promises to continue. 

Embedding RFID (radio-frequency identification) tags in booklet labels is a technology to track, says Bertrand. “We’re getting a lot of requests for RFID and using it creatively in the process,” says Bertrand. “In the next four years or so, that’s going to be an enormous thing. If [RFID] can store a lot of information, maybe there’ll be [information] stored for the pharmacist.” With a reader, he says, the pharmacist could access “information that maybe could never fit in the booklet or that complements the booklet.”

The Challenge Printing Co. is also looking at RFID for enhancing the security and integrity of the drug information that the patient received through the packaging. The company has developed a security authentication protocol that governs the use of both overt and covert packaging authentication features. Part of this protocol is the use of RFID. “We have already started RFID implementation projects with several of our customers, assuming an active role in procuring tags, facilitating the testing process, ensuring the tags are programmed and tested, and finally incorporating them in packaging components such as labels and inserts,” says Polt. “In doing so, we are also helping our customers meet the recent request from Wal-Mart to several pharmaceutical 
companies to incorporate RFID tags, as far down as the individual bottle level.” 

Manufacturers should also follow FDA in regard to providing consumers with useful written prescription drug information. The Pharmaceutical Printed Literature Association (PPLA; Falls Church, VA) is encouraging FDA to amend the current voluntary system which relies on pharmacies (not drug manufacturers) to print and dispense such literature. Presently, “pharmacists rely on a network of vendors to produce the information, which is printed in the pharmacy, and nobody has regulatory authority over this network of vendors. Also, since it’s a voluntary system, there is no requirement that pharmacies dispense any information at all, and recent research suggests that 10% of pharmacies don’t,” says Peter Mayberry, PPLA’s executive director. 

“Another big shortcoming,” Mayberry says, “is that most pharmacies that do dispense literature rely on single-pass systems, whereby the information has to be printed on one side of one sheet of paper. There’s only so much information you can get in that amount of space. We contend it would be better for the [drug] manufacturers to write a leaflet for the drug, have it approved by FDA, and then adhered directly to the drug container. This type of system is used in Europe and other parts of the world, and should be adopted in the United States.”

Mayberry says the PPLA would like to see the day when all prescription drugs are accompanied by the now-voluntary PPI (patient-prescribing information)—one developed by the [drug] manufacturer and distributed with the drug when it’s dispensed. “That way,” he noted, “you’d have uniform quality of printed information that is universally available to patients. Each time a prescription is filled, it would be accompanied by manufacturer-prepared, FDA-approved information. This would be a tremendous benefit for patients and would definitely help minimize some of the inherent risks associated with prescription drug products.” 

Copyright ©2004 Pharmaceutical & Medical Packaging News