Medical Device Link.

Originally Published PMPN July 2003

Labeling

by Jenevieve Blair Polin
Contributing Editor

Merck redesigned the blister card for Fosamax with the patient in mind.

To truly serve patients and healthcare providers, drug labeling information must be accessible. In other words, pharmacists, physicians, nurses, patients, and other healthcare consumers need access to information that is both current and easy to read. FDA has long suggested this, even encouraged it, and is once again interested in enforcing it. Proposed regulations and guidelines on label readability, as well as an interest in electronic labeling, show that FDA senses a lack of easy-to-grasp, pertinent information.

The pharmaceutical industry is also working to provide more information, with the help of printed literature providers. Efforts involve some drug makers extending their labeling space with longer inserts and expanded-
content labels.

PATIENT INFORMATION

The information FDA considers to be critically lacking in pharmaceutical packaging is the information that is written specifically for patients in language they can understand. 

Since 1968, FDA has required that manufacturers of just a handful of drugs supply a Medication Guide written in layman’s language with each unit dispensed. In 1980, FDA published a rule mandating the distri-bution of FDA-approved patient information for a much larger group of prescription drugs, but the agency rescinded this rule almost immediately. 

In the mid-1990s, FDA again proposed to require Medication Guides for an expanded number of drug products, but Public Law 104-180 was an end run around this 1995 proposal. This law actually prohibited FDA from requiring uniform, FDA-approved content for patient information, provided that the private sector—pharmaceutical manufacturers—achieved the following milestone: by the year 2000, 75% of persons receiving new prescriptions must receive “useful written information.”

That milestone has not been met. In June 2002, FDA announced results of a study finding that, while 89% of patients received written information with their prescriptions, only 50% of the information met FDA’s criteria for “useful” (visit www.fda.gov/cder/reports/prescriptioninfo/default.htm for more information). The agency has therefore announced a meeting to be held July 31 to address the issue of Medication Guides. (See the sidebar on the opposite page.)

According to Bill Mitchell, executive vice president, printed components, for the packaging services business of Cardinal Health (Philadelphia), “Medication Guides represent a significant growth area for printed component manufacturers due to FDA’s continued interest in this issue. To help our customers meet patient needs, Cardinal Health’s Moorestown facility is investing significant dollars to purchase state-of-the-art printing equipment to produce Medication Guides and other pharmaceutical marketing pieces.”

Printed items to be tested are placed inside the Lockhart Legibility Instrument on an easel, where they are illuminated by two 25-W incandescent floodlights. The subject turns a handle, which rotates a polarizing filter inside the viewing screen, until he or she can read the text. The filter controls the amount of light that reaches the subject’s eyes. Messages that are difficult to read require more light.

The Challenge Printing Co. (Wallington, NJ, and Broadway, NC) has also invested heavily in equipment used to print multicolor inserts in anticipation of demand for Medication Guides, says Challenge’s marketing manager Margaret Polt. “We foresee color use becomingly increasingly important as the trend toward making inserts more patient friendly continues,” she says. 

LEGIBILITY

One of the cornerstones of usefulness is the consumer’s ability to read the information at all. “Labeling choices are often made based on subjective evaluation,” says Hugh Lockhart, PhD, professor at Michigan State University School of Packaging (MSU; East Lansing, MI). “Color choices for shelf packages are based more on the emotional impact of the color on the decision maker than on the measurable mechanical ability to read the type printed in that color,” he adds. Lockhart has developed the Lockhart Legibility Instrument, a device that allows objective comparison of the legibility of various printed materials (see the photo on page 28). No objective standard has been adopted yet by regulatory authorities to define legibility, so the device can be used solely for comparisons of legibility at this time. ASTM subcommittee D10.32, working with Lockhart, has drafted a standard practice for use of this device to measure the ease of reading printed matter in package labeling. 

Font size is, of course, a major factor affecting legibility. FDA proposed a rule almost three years ago that would, among other things, mandate a minimum font size of 8 points for type in package inserts (PIs) (FR December 22, 2000, Vol. 65, No. 247, p. 81,081–81,131). This rule has yet to be finalized. 

THE BIGGER, THE BETTER?

Some pharmaceutical manufacturers are specifying larger fonts to accommodate visually impaired and elderly end-users. “We’re seeing on the PI side the rapid increase of demand for larger font size, because of an aging population. And drug companies are asking us to figure out a way to keep the prescribing information insert on the existing bottle or in the existing carton,” says Ernie Chaplin, vice president of sales, marketing, and product licensing for Pharmagraphics (Greensboro, NC). 

To answer this challenge, larger PI layouts and new folding and bulk reduction methods can be used. Chaplin says Pharmagraphics has recently upgraded its folding equipment from Vijuk Equipment (Elmhurst, IL) to handle insert paper up to 14 ¥ 30 in. in overall size and still fold it to function in existing packages. The firm has improved the foldability of the 1.25 ¥ 1.25–in. closure-mounted outsert for use as a right-angle outsert by reducing paper basis weight and employing bulk reduction methods in folding.

Christopher T. Bolin, vice president, sales, for The NOSCO Printing Group (Gurnee, IL), says his company has also upgraded its equipment. “It gives us the ability to go well beyond the standard 90 panels that had always been the maximum,” he says. 

Challenge has also invested heavily in custom-made folding equipment to fold large-format inserts from a size of 500 sq in. to 1 1¼4 in. sq, says Polt. 
In early 2003, JH Bertrand Inc. (Buffalo, NY) introduced its Outserts on Rolls concept. “It is a right-turn- angle pamphlet, folded by a Vijuk unit, glued closed, and affixed to a two-ply dry release base label,” says president Jeff Bertrand. “We use a dry release to make it easy for the patient to peel off the information without leaving any sticky edges. From that product, we developed our Twin-Serts on Rolls concept, named after my one-year-old twin girls. Twin-Serts are two Vijuk-folded pieces, each glued closed, shrink-wrapped, and affixed to a base label. This doubles the copy space on even the most sophisticated pharmaceutical folds. After you get beyond the most sophisticated fold and ultra thin papers, what do you do next to get more copy space? Coupling pamphlets, whether on labels or as outserts, is going to be a wave of the future.” 

New labeling technologies may also be able to overcome the challenge of updating print. Thom Luinenburg, project development manager for Altwood Roll Label (Elmwood Park, NJ), describes the challenges presented by printed-paper PIs and ways that packaging innovations can address them. “Our client had a product contained in a carton with an insert. A change was made to the insert. They had a million pieces, and they were looking at having to open up the boxes, take out the existing insert, and put in the new replacement insert.” The client received FDA clearance to use Altwood’s onsert product instead. The onsert consists of a replacement insert folded and sandwiched between two layers of clear film with an adhesive back. These onserts are then supplied in the same form as a roll of labels. 

USER-FRIENDLINESS?

Can a 30-inch-long sheet of paper filled with 8-point type and folded into 120 tiny squares be considered user- friendly? How far will the user delve into this printed matter before losing interest? Laura Bix, an assistant professor working with Lockhart at MSU, says they have used eye-tracking instruments from Applied Science Laboratories (Bedford, MA) to begin to answer questions about these issues. These eye trackers can be used to determine in what order a reader examines different textual elements and to identify areas that catch the reader’s eye. For printed information to be effective, Bix says, four steps proposed by the noted visual psychologist GK Rousseau must take place: The information must be (1) noticed, (2) decoded [read], (3) comprehended, and (4) acted upon [complied with]. Bix and Lockhart have recently studied the noticeability and legibility of two warnings on labels: the child-resistant closure warning and the tamper-evident warning. 

EXPANDED-CONTENT LABELS

The Challenge Printing Co. offers its RemovaTab label with peel-off bar codes for individual unit coding and its MultiPly label to expand labeling area.

Expanded-content labels (ECLs) are also allowing drug makers to provide more information to patients. In some cases, ECLs are even replacing inserts. “With a few major products, the customer is eliminating the insert and incorporating the insert into the label,” says Des Laffan, general manager for Pharmalabel (Greensboro, NC), a division of The John Henry Packaging Group (Lansing, MI). “It’s a multi-ply, saddle-stitched ECL. They are spending more money on the new package than they were for the label and the insert combined, but because they’re able to eliminate the inserting operation and the personnel involved, the total cost for them is lower.”

Barry Park, senior account executive for New Jersey Packaging (Fairfield, NJ), says that the amount of information that must be included at the desired font size determines whether an ECL is possible. The company’s Seam Glued Booklet Plus product can accommodate 10–20 pages, depending on stock thickness, and its Folded Booklet Plus can handle 14–28 panels. “If you have a booklet that’s the maximum size it can be, adding more pages to it is not an option, and then you also get to the point where it becomes so thick that it will no longer wrap around a bottle. I’ve actually seen some customers who have gotten out of ECLs and gone back to the primary label with two inserts glued together, and in some cases have even gone back to using a folding carton,” he explains. Instead, he says, New Jersey Packaging has seen increasing use of ECLs for Drug Facts and patient information.

ECLs are “a continuing area of growth,” says Brent Chorneyko, general manager for the Sioux Falls, SD, plant for CCL Label. CCL produces more multipanel labels for FDA-regulated products than any other domestic supplier. The company offers a variety of configurations for ECLs and can adapt them to conform to most requirements. 

Whatever solution a drug manufacturer chooses, it should be designed with the patient, or practitioner, in mind. After all, the drug information is meant to encourage safe and proper use of a drug. If that information is too obscure, too buried in text, and possibly unavailable, patients, and products, will suffer. 

Copyright ©2003 Pharmaceutical & Medical Packaging News