Medical Device Link.

Originally Published PMPN June 2003

Compliance Packaging

by Daphne Allen

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

First and foremost, compliance packaging is all about the patient. With regimens broken down into individual doses, compliance packaging is designed to make drug therapy easy to follow. The idea is that if patients better understand and follow their regimens, therapy is more likely to work. 

Compliance packaging can also help drug manufacturers. Take Pfizer’s Zithromax. It is often provided in the Z-Pak. The fold-over carded blister helps patients start antibiotic therapy correctly with two pills, then one each day thereafter. The ease of this regimen, made so mostly through packaging, sticks in patients’ minds. It makes them more likely to ask for the Z-Pak again should they need it. And those requests translate into increased sales, perhaps more than requests prompted by direct-to-consumer advertising, because patients have already been convinced of the drug’s effectiveness. 

“Compliance packaging has taken on a life of its own,” says Renard Jackson, executive vice president, contract services North America, of Cardinal Health’s packaging services business (Philadelphia). For instance, “Z-Pak, not Zithromax, has almost become the brand’s name.” 

Jackson is also chairman of the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA). In both capacities he says he has seen more drug companies each year recognizing the marketing benefits of the compliance package. “Companies are not only looking for a functional compliance package that will help the patient, but also a package that stands out and enables the product to be recognized,” he explains.

Such an increased interest can be seen in the winners of HCPC’s 2002 Compliance Package of the Year awards. The program’s winners are GlaxoSmithKline’s (GSK) titration-therapy physician sample pack for Lamictal, Merck’s regimen package for Fosamax, and AstraZeneca’s physician sample for Nexium. In addition to promoting compliance, which is good in and of itself for a brand, the winning packages feature several elements that help market the brand. These include brand colors, repeated and enhanced use of the drug’s brand name, and prescription stickers. Even such features as weekly calendars and unique opening features contribute to branding, as they can differentiate the package from that of a competitor.

PATIENT BENEFITS

HCPC’s winning packages were designed—or redesigned, in two cases—with the patient in mind. The overall winner, Lamictal, for instance, uses a four-panel carded blister to present a complicated regimen. It is a physician’s sample that helps patients begin a five-week titration of the antiepileptic drug. GSK handles blister packaging, while Caraustar Custom Packaging Group (Clifton, NJ) heat seals the blisters into the paperboard folders, supplied by MeadWestvaco (Mebane, NC). Jeff Robb, vice president of marketing for MeadWestvaco, says the firm’s Printkote EasySeal Plus is used as the paperboard.

The package is a redesign of the previous sample, which comprised five individual blister units in one carton. “We wanted to get everything into one unit,” explains Judy Gibbs, senior packaging engineer. In addition to the carded blisters, the new packaging features a prescription sticker, a pocket for a patient insert and a physician insert, and an area on which doctors can write instructions.

All of these elements work together to “escalate patients up to a prescription dose,” says Gibbs. For instance, for the first two weeks of a particular Lamictal therapy, patients take one 25-mg tablet every other day. Then, for the third and fourth weeks, patients take one 25-mg tablet every day, and finally, for the fifth week, two 25-mg tablets every day.

GSK’s redesign goal was to make “initiation of Lamictal simpler,” says David Ballesteros, product director, Lamictal. “With the previous sample, there was always the concern that patients would get the individual blisters out of order. Now, the order is crystal clear.” In addition, each day of the week is represented, even days that do not call for a dose—they simply bear the word “none.” Finally, Ballesteros says, new colors and text that is “crisper, cleaner, and more direct” translate into a clearer presentation.

Med-ic Electronic Compliance Monitor from Information Mediary Corp. uses thin-film electronics and sensors to record patient dosing.

HCPC judges agree. Packaging was a “difficult challenge for this drug,” says one judge. The new design is “outstanding,” with “easy-to-follow instructions.” The judges also found Lamictal’s insert to be an effective communication tool, says Peter Mayberry, HCPC’s executive director. 

Fosamax’s package is also tailored to patients’ needs. The once-a-week osteoporosis regimen is provided in a bifold design with a patented child-resistant, senior friendly (CR/SF) zipper-back feature, reports Mayberry. “Compliance is enhanced by the inclusion of a seven-day calendar to document the patient’s starting date, along with four calendar reminder stickers to mark the initial and subsequent dosing dates,” he explains. To supplement Merck’s internal packaging operations, Sharp Corp. (Conshohocken, PA) also performs blister packaging and carding, using materials from Klöckner Pentaplast of America (Gordonsville, VA) and Alcan Packaging Pharma Center (Shelbyville, KY). MeadWestvaco’s Robb reports that Printkote EasySeal Plus is used as the paperboard, and Klöckner’s Kent Sides says 10-mil Pentapharm PH-M570/01 is used as the blister film. 

Stephen Hess, director of packaging for Merck, says that Merck had received patient feedback on the original packaging’s child-resistant (CR) opening features and decided to improve them with a new package. In addition to including easy-to-use peel-back CR strips, which impressed HCPC judges, the package features the use of pictograms to demonstrate the CR opening features, says Hess. 

Other patient-friendly features are reminder stickers, graphics that remind patients of the dosing day, and information to help answer questions on dosing and schedule, Hess reports.

HCPC’s final winner, AstraZeneca’s Nexium, helps patients manage their regimen for acid reflux disease. The physician’s sample is a 14-day carded foil blister pack enclosed in a tamper-evident carton, says Mayberry. Instructions are printed on the foil itself. The judges found it to be a “fine design that saves space while serving as an effective patient reminder.” Jones Packaging (London, ON, Canada) performed the packaging. 

MANUFACTURER BENEFITS

Easy-to-follow regimens like these increase the chance that a drug therapy will benefit the patient. That means prescriptions are more likely to be refilled. “Compliance packaging can encourage brand loyalty,” says Allan Wilson, MD, PhD. “Doctors often switch a patient from one drug to another because of complaints or no effects. But noncompliance—not the wrong drug—may be to blame.” He says noncompliance can lead doctors to “take potential revenue from one company and give it to another.” 

Cofounder and president of Information Mediary Corp. (Ottawa, ON, Canada), Wilson has invented Med-ic Electronic Compliance Monitor. Its patented sensor circuitry records when each dose is removed from a blister card, creating a compliance diary. Wilson is currently promoting Med-ic for use in clinical trials, where he says patient compliance is critical for a beneficial drug study. But Med-ic may one day find its way into the market, especially for applications in which healthcare practitioners must closely monitor pharmaceutical use, such as for controlled substances. 

GSK’s Ballesteros believes that regimen compliance can benefit a drug manufacturer. “If a patient gets the best drug outcomes, manufacturers and products benefit, too.” In Lamictal’s case, he says, “How one starts taking the drug is incredibly important to outcomes,” and therefore drug success. So patient compliance is “huge.” 

BRAND APPEAL

In addition to features that encourage proper regimen use, compliance packaging usually offers another element—billboard space. “Marketing departments love the room for instructions,” says Cardinal Health’s Jackson.

Rick Sury agrees. Sury is vice president for strategic partnerships for the contract packaging and specialty cartons business unit of Alcan Packaging (Bethlehehm, PA, and Baie D’ Urfé, QC, Canada). He says that “Marketing loves descriptive packaging that jumps out at the doctor, pharmacist, and patient. Marketing likes the fact that when patients open this package, they will get something more than just the drug. They’ll get detailed inserts, booklets, and calendars.” 

A compliance package may also help a drug compete. Cardinal Health’s Jackson points to the packaging for Amnesteem, the trade name for isotretinoin, from Mylan’s subsidiary, Bertek Pharmaceuticals Inc. Bertek offers Amnesteem in both 30-capsule and 100-capsule packages containing either three or ten blister packs of 10 capsules each. Amnesteem competes with Roche Laboratories’ Accutane. Jackson says that at the HCPC’s National Symposium on Patient Compliance in May, speaker Bob Dufour, director of pharmacy for Wal-Mart, cited the Amnesteem packaging as an example of good packaging. “Not only does it aid in compliance, but it communicates the warnings associated with this product,” Jackson says. 

Child resistance and senior friendliness may also give drug products a competitive edge. “Patients want to know they have taken a drug, but they don’t want to struggle with the package,” says Alcan’s Sury. “And no one wants children to get into the package.” 

The new package for Lamictal from GlaxoSmithKline outlines a five-week regimen in a compact carded blister.

Sury’s colleague Tim Saarinen, manager, sales and marketing for Alcan Packaging Pharma Center, sees a lot of interest in senior friendliness. “Patients need to be able to open compliance packaging easily. Innovative solutions are those that do not require a lot of physical strength.”

Fosamax’s package was redesigned with CR/SF features in mind, says Merck’s Hess. He spoke about the challenges of designing a child-resistant blister card that women aged over 50 could access easily at HCPC’s symposium. “Some CR features can be a significant barrier to patient acceptance and adherence to dosing requirements,” he said. But “don’t lose the benefit of unit-dose packaging,” he advised attendees. “Look for solutions.” 

BETTER OUTCOMES

Both Jackson and Sury acknowledge the significant investments required to produce a compliance package. But there are economic benefits. “If you can keep 10% more patients on a regimen, you will justify the cost of the compliance package,” Jackson says. “The benefits far outweigh the costs.”

Companies like Cardinal Health, Alcan Packaging, Howell Packaging (Elmira, NY), and others say they can help make a compliance package affordable, even cost-effective. Joseph Lally, marketing manager, packaging for pharmaceuticals at Howell, recounts a recent example. “A major pharmaceutical manufacturer asked us to create a patient starter compliance package that would house both a 10-mg and a 20-mg blister of product along with a patient insert and a patient information brochure. The unit needed to be compact and yet contain all elements. We came up with a design and process in two dedicated, adjacent contract-packaging suites. Our client had a new package with minimal investment and a line that could be terminated at the end of the program with no disruption to its internal operations.”

And, just as Wal-Mart’s Dufour liked Bertek’s compliance package for its new product, Sury says other pharmacists appreciate compliance packaging. “Now more than ever pharmacists prefer compliance packaging—no counting, no possibility for mistakes.”

Finally, for drug companies with no new chemical entities set to launch, a compliance package can create market opportunity. “Drug pipelines are at a 20-year low,” says Jackson. “Some drug companies are therefore taking currently marketed products and combining them in a compliance package to create combination therapies.” 

Copyright ©2003 Pharmaceutical & Medical Packaging News