Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN July 2005
Specialty Labeling
Labels with Multiple Layers
As they help companies meet the latest label content requirements, expanded-content labels also serve as platforms for promotions and security features.
by David Vaczek
Senior Editor
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| A two-panel label from John Henry Packaging Group features print on both sides. |
In recent years, FDA, healthcare professionals, and consumers have focused more attention on drug safety. To encourage the safe use of pharmaceuticals, manufacturers have been asked to provide more, and more readily accessible, drug labeling information.
Interest in expanded-content labels (ECLs) has grown as a result. These labels can encompass added content in an efficient and user-friendly way. Multipanel labels allow companies to fit more information on bottles and packages without having to reengineer packaging or give up graphic and branding elements. ECLs can be a convenient and less-expensive choice for expanding labeling space when packaging lines are not set up to place inserts into cartons.
ECLs are also being used as promotional vehicles. And, as more companies are exploring incorporating security features into labels, multipage constructions may serve as platforms for authentication elements or product codes.
“We are seeing an increased demand for ECLs, or multi-ply or multilayer constructions in general. Manufacturers are seeking to put more information at the same font size into the same packaging dimensions,”says Rob Rykman, vice president of sales, healthcare group, CCL Label Inc. (Hightstown, NJ).
Printers have geared up to meet the latest requirements with new folding machines and thinner paper and film. Solutions include ECLs, larger inserts and outserts, and expanded-content cartons with fold-out panels.
Increasing Drug Safety
Last October, FDA said that manufacturers of all antidepressant drugs will have to distribute Patient Medication Guides (MedGuides) with each prescription, and revise labeling to include boxed warnings and expanded warning statements.
In April, the agency asked manufacturers of prescription nonsteroidal anti-inflammatory drugs (NSAIDs) to include MedGuides and boxed warnings alerting patients to an increased risk of cardiovascular and gastrointestinal events when those drugs are used. And labels for OTC NSAIDs will need to include more-specific information on the drugs’ potential risks.
Meanwhile, the final rule on the proposed overhaul of the format for package inserts (PIs), required for all prescription drugs, is expected soon. The proposed rule calls for font sizes no smaller than eight points and the inclusion of a summary box that would highlight important information such as side effects and contraindications. This would boost insert size requirements by 30 to 50%.
Pharmaceutical companies have been strongly opposed to the summary box feature. Some have argued that if lawsuits are brought, they could be held liable for failing to highlight certain information, says Peter Mayberry, executive director of the Pharmaceutical Printed Literature Association.
Mayberry says the final rule could be issued midsummer. “Just because FDA has proposed an eight-point font, that doesn’t mean the final rule will include that requirement. Our position as an industry is, we are ready to do whatever we have to,” he says.
Labeling Options
Companies are looking at alternatives for delivering MedGuide information with unit-of-use packaging, which FDA is promoting. By integrating the information into labeling, manufacturers can ensure that consumers will receive the critical copy.
“FDA wants to know that patients are getting that information. Just recently, manufacturers have started to switch to unit of use so they can go directly to the patient without the pharmacist being involved. It becomes obvious that including labels that have patient instructions tucked under them will become increasingly popular as a method to deliver such instructions to end-users,” says Margaret Polt, marketing manager at The Challenge Printing Co. (Clifton, NJ).
The company’s solutions for unit-of-use packages include its resealable MultiPly label that features three printable label surfaces. It provides as much as 300% more space than the base label. Its PharmaScript design incorporates a fold-out brochure under the label, for when MedGuide requirements are more extensive.
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| The MultiPly label from The Challenge Printing Co. offers three printable surfaces. |
Arlington Press Inc. (Lake Success, NY) has worked with a manufacturer of an antidepressant drug on alternatives for providing MedGuides with a 30-count unit-of-use bottle. The vendor has considered using a base label paired with an overlaminated folded insert containing 150 square inches of copy on both sides, with a peel or tear-off corner. The top of the ECL shows the same copy as the base label, says Thomas Henderson, vice president of sales and marketing, Arlington Press.
Henderson notes that the MedGuide format typically covers patient package insert information (PPI), so a PPI may not be needed when a MedGuide is used.
“The new labeling requirements will drive ECL use in some instances. Most MedGuides contain a reasonable amount of copy. An ECL can be a terrific solution if you have a relatively modest requirement for the MedGuide in terms of square inches of copy,” Henderson says.
Arlington also uses multiserts to deliver MedGuides, pairing a PI to one PPI or MedGuide, or to multiple consumer inserts. Challenge Printing delivers MedGuides with bulk packaging as part of an outsert or a separate brochure attached to an outsert. For printing the compliance labeling for some NSAID drugs, Pharmagraphics LLC (Greensboro, NC) has combined two folded glued leaflets, one for the pharmacist and one for the patient, attached to the container, says Pharmagraphics’ CEO, Carl Treleaven.
In many cases, OTC drugs have been able to meet Drug Facts requirements with a few additional panels and still retain packaging graphic elements that are critical for maintaining shelf presence and conveying brand identity.
“People are giving up real estate to add Drug Facts. But they don’t have to. You can add labeling space instead,” says Jim Yonge, technical sales manager, Nosco (Gurnee, IL).
John Henry Packaging Group (Lansing, MI) offers ECL solutions including two- and three-panel labels and digitally printed booklets of 2 to 48 pages, affixed to pressure-sensitive labels or delivered as stand-alone inserts. Its two-panel label features text printed on the back of the primary label and is resealable. It has been popular with companies requiring minimal added space and for use with smaller bottles, says John Henry Packaging’s marketing director, Dan Welty.
“Frequently, people just need a little extra space. From an aesthetic standpoint, they do not want to increase the size of their label and give up graphics.” The two-panel label increases space by as much as 80%, with adhesive covering 20% of the back panel.
John Henry used an ECL to convey Drug Facts in cross-promotional twin packs for Vicks DayQuil and NyQuil cold medicines in two different configurations. In one case, it affixed an ECL with three Drug Facts panels to a sleeve label holding two single cartons. In the other, the facts were printed on an SBS boardstock construction holding two bottles without cartons.
Chaucer Press Inc. (Wilkes-Barre, PA) has come out with a two-ply, three-panel label with a cut-out corner window on the top page to allow companies to print the lot and expiration number box on the base label, instead of on the top label. The resealable label can be supplied as a pressure-sensitive label, or in cut-label form.
Most ECLs constructed with an overlaminate usually do not allow for the lot and expiration date to remain on the bottle, since the data are stamped on the top page. “Manufacturers want the lot and expiration date to remain on the bottle at all times,” says Patricia Frances, vice president, Chaucer Press.
Pfizer is using the label on all of its 250-ml Advanced Listerine products to accommodate Drugs Facts. On the larger-size Listerine bottles, the company was able to fit in the added information by redesigning its single-ply labeling.
“People are looking for less-expensive and efficient solutions for FDA’s Drug Facts mandate. Chaucer’s label is cost-effective because it is a seamless construction produced in one flow on one piece of equipment,” Frances says.
Building In Security
Manufacturers are exploring ECLs as conveyors of security-authentication features and codes, including bar codes or RFID tags. Companies are not adopting ECLs to feature security features, but rather considering options in cases where they are already being used. ECLs, for example, could support a strategy of rotating a portfolio of authentication features. Consumer concern about RFID tags compromising patient privacy could be addressed by embedding the tag in an ECL layer where it could be easily removed.
CCL Label customers have inserted security features into ECL base labels and booklet pages. “You don’t need an ECL for
this, but in a lot of cases, manufacturers are currently using a multipage label,” says Ryckman.
“If they are going to use an ECL, that opens the door as to how we can supply the security features. If the security is overt, it’s good to have the additional real estate,” says Nosco’s Yonge.
Yonge describes one possible scenario where an ECL, such as Nosco’s Fix-a-Form multipanel label, might be used to deliver security features and product codes that could be torn out or peeled off a liner and saved as the product moves through the supply chain. Labels could include features such as color-shifting ink and holograms or mass-serialization numbers. A pharmacist, for example, would put one label into his records and a second label on the patient’s amber bottle. “The pharmacist and the consumer have records that a safe and secure product was dispensed. A distributor could use the same strategy, designating points within the distribution channel where a person removes the feature and adds it to their records.”
By providing more surface area for graphics or promotion copy, ECLs become a selling tool that can increase loyalty with self-treating consumers. Product benefits may be detailed or graphically illustrated, and companies can cross-promote. CCL Label offers solutions for resealing multi-ply labels, making it convenient for consumers to check the label content in the store when considering a purchase. “An ECL won’t make you pick up a product. But it helps sell it after you pick it up,” says Yonge.
Johnson & Johnson Merck has featured a seven-panel, fold-out-page ECL on Pepcid Complete acid reducer and antacid. Two panels present Drug Facts. One page delivers a buy-three-get-one-free mail-in offer with survey questions on the back.
The mail-in offer is advertised on the top label. Two panels including the base label provide advice on controlling heartburn, as well as clinical study results.
Cost Concerns
ECLs are often cost-effective solutions, though some companies are electing to purchase base labels and inserts separately as a less costly alternative to ECLs.
“The cost of buying them separately tends to be substantially less than if you buy the combined construction. Companies are focusing on costs, and some are saying the reason to combine them just isn’t compelling. You could buy a pressure-sensitive label and an onsert or outsert that would glue closed and attach to the cap or the backside of the container,” says Treleaven.
Ryckman notes that products already using an ECL can add additional plies without making major changes in the packaging line. An ECL might cost 50% more than the separate components. But graduating to an ECL from a single-ply label can be a less costly route than adopting a carton-and-insert method if lines are not set up with insertion and carton- erector equipment, he says. ECLs obviate the chance for a mix-up such as putting the wrong insert with the wrong label. “It depends on what equipment you have. (And) the more pieces of equipment you have in-line, the more downtime you have. If you look at total applied cost, in a lot of cases, the ECL will be less expensive,” Ryckman says.
CCL Label has invested $25 million a year for the past three years installing presses that can work with thinner-gauge film and a lightweight 27-lb paper stock. The thinner paper allows adding more pages without increasing the thickness of the label.
“If I can use two thinner plies to make one label that is about the same thickness as the original single-ply label, I can save money. We are putting more and more information into a smaller space by adding layers and increasing the size of the insert,” says Ryckman.
The arguments for using ECLs are compelling. As FDA continues to mandate more labeling information, and ECLs provide solutions for incorporating elements such as promotions and security features, ECLs look attractive, as long as their costs are reasonable. Cost has become an increasingly important in labeling decisions, as manufacturers drive costs out throughout the supply chain.
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