As Demand Increases, So Do Options

By Christina Elston

Howell Packaging produced a starter kit to encourage regimen compliance with Hoffmann-LaRoche�s Pegasys treatment for Hepatitis C. Copyrighted by Hoffmann-La Roche Inc. All rights reserved.

While some pharmaceutical categories—especially oral contraceptives—have long taken advantage of packaging that promotes patient compliance, most products have been slower to catch on. But as the research comes in, and as the benefits of and demand for compliance packaging have become clear, the options are increasing.

“Awareness grew, so the demand grew,” says Pete Belden, vice president of sales at contract packager Anderson Packaging Inc. (Rockford, IL). He adds that during the past five years, the company has invested heavily in equipment and process development to help meet this demand in a cost-efficient way.

MORE-EFFICIENT PACKAGING PROCESSES

Anderson was instrumental in developing a packaging process that helped bring down—by more than half—the unit cost of the Dosepak by MeadWestvaco Healthcare Packaging (New York City). This was the result, says Belden, of collaboration with MeadWestvaco and with pharmaceutical partners to bring automation and process improvements to the Dosepak packaging lines.

The company has also had increased business, and increased efficiencies, in the area of carded blisters. “We’ve done a lot of things to meet the market’s need for adding features to the pack,” says Belden. The company, he says, can affix and insert instructional CD or DVDs, mirror stickers, medication guides, or patient feedback cards very efficiently.

Efficient packaging can be more challenging with complex dosing regimens, such as therapies that require a specific “ramping-up” of product strength over time. “At Howell Packaging (Elmira, NY), we have designed and produced many titration starter packages,” says marketing manager Joe Lally.

For one customer, the company engineered a high-speed production line for a product that required the patient to start the first week with a 10-mg daily dose, then increase to a 20-mg dose. The package housed both the 10-mg and 20-mg blister of product, along with a package insert and a patient information brochure. The line ensured initial segregation of the two product doses during assembly and final verification that both were contained in the same package.

COMPATIBILITY WITH EXISTING LINES

Though compliance packages have begun to include many value-added elements, the push has increasingly been to incorporate those elements via standard manufacturing processes. One example is the compliance-tracking Med-Ic Digital Package from Information Mediary Corp. (IMC; Ottowa, ON, Canada). The Healthcare Compliance Packaging Council (HCPC) honored the product as the 2005 Compliance Package of the Year.

The Med-Ic uses a paper label printed with a grid of conductive ink. When the medication is pushed through, the broken connection prompts a microchip in the package to record the time and date. The label goes right into the heat-sealed blister pack. “It’s really no different from the standard way of assembling a blister pack,” says product manager James Neilson.

Designs and products that make compliance packaging child resistant and senior friendly are also being folded in to existing processes. The Kid Key—a carton with a tear-away portion that becomes the “key” to open the package, made by Chesapeake—features a glued-end format that could theoretically be used with a customer’s existing cartoner, says Chesapeake Pharmaceutical Packaging North America product development manager Matthew Ramsdell.

Information Mediary Corp.’s Med-Ic Digital Package won Compliance Package of the Year in the Healthcare Compliance Packaging Council’s annual competition.

The company acquired Arlington Press in September 2005, changing the name of Arlington to Chesapeake Pharmaceutical Packaging North America. “Our focus is on bundling items together that maintain automation,” Ramsdell says. “These products can use existing equipment in the pharmaceutical customer’s manufacturing facilities. The purchase of new capital equipment isn’t always an easy thing to do these days.”

Using existing equipment can help make compliance packaging cost-effective. “Some of the F=1 packages tend to be very expensive, which means it has to be a blockbuster drug to afford them,” says William J. Walker, vice president of sales and marketing at Sharp Corp. (Allentown, PA). “Our pharmaceutical customers are asking for more compliance packaging, at a lower cost.”

The company’s goal in designing its AdvantagePak was to engineer a senior-friendly package that could be made on Sharp’s existing equipment. The package received an HCPC compliance package award in a new category for 2005: Innovative Design. “It was important to eliminate the need for specialized equipment that would require extensive capital and a new operational learning curve,” Walker says. “That is important to our customers, who are concerned about longer lead times, higher pricing, and difficult validation issues.”

PROCESS AND VOLUME FLEXIBILITY

Packaging options flexible enough for manual—as well as high-speed automated—operations are entering the market. Chesapeake offers a child-resistant option flexible enough for high-speed or manual operations, says Ramsdell of Chesapeake. The company’s Kid Stop product is a label-based application that adheres to blister pack foil, providing a secondary level of support on a blister card. The company offers an off-line application system for use in smaller-volume projects. The product has been available in the European market for some time and is now being offered to the U.S. market, says Ramsdell. Kid Stop has achieved an F=1 rating in child-resistance testing.

FLEXIBILITY WITH DOSING REGIMENS

To maintain F=1 ratings in the face of variable dosing regimens, the new Stora Enso Pharma SHR pack, which TestPak (Whippany, NJ) started marketing in April, separates child resistance from inner packaging. Developed by paperboard producer Stora Enso and Bosch Packaging Technology, the Pharma SHR system complements TestPak’s FamilyPak compliance products, says vice president of sales and marketing Bill Eveleth.

“Because the system achieves full F=1 child-resistance performance on the outer carton alone, packaging system designers will have a degree of flexibility not previously available in reclosable systems,” Eveleth says. “Virtually any blister can be enclosed, and with no requirement for a second child-resistant barrier on the contained blister. The implications of this are huge from the standpoint of design and development lead time, flexibility, tooling, platform consistency, and cost.”
Sharp’s Advantage Pak also offers dosing flexibility. “We wanted to design a solution that would be flexible for any basic blister format and would maintain an F=1 child-resistance rating at each dosing level,” says Walker. “Our design is not dependent on outer packaging, and it can be used for compliance at any child-resistance level as well. It is equally well suited for tablets, caplets, and capsules.”

When packaging its Altace antihypertensive medication in a MeadWestvaco Dosepak, one goal that King Pharmaceuticals sought to achieve was to give patients a degree of flexibility. The firm wanted to “enable the patient to interact with the package and to have the package provide feedback to the consumer,” says MeadWestvaco’s director of marketing Larry Blake. An interactive label featuring days of the week is tipped into the insert in the inner package, allowing the patient to highlight the first day of therapy and track accordingly. “We want to give the patient as many visual cues as we can,” Blake says. The package was honored by HCPC as a second runner-up for 2005.

NEW PATIENT RELATIONSHIPS

The IMC Med-Ic represents one way that compliance packaging is being used to build relationships with patients. When a patient’s package is scanned, clinicians can retrieve each time a dose was removed. A scattergram, with data points plotted across the horizon, makes it readily apparent whether the doses are being taken at regular intervals, and at about the same time each day. This allows the doctor to intervene with patient education if doses are being missed or delayed. Data can also be exported to Excel spreadsheets or output as an XML document for analysis.

Patient education is also a factor in programs created at Howell. “There is a real effort in the pharmaceutical industry toward relationship marketing,” says Lally. The company recently produced such packaging for a self-injected product. The compliance package was a training kit that contained tools and materials to teach the self-injection technique, plus patient compliance logs.

“This package was personally delivered by the sales representatives and gave them an opportunity not only to detail their product and build brand equity, but also to leave behind material that supported patient compliance strategies,” Lally explains. Howell also produces packages that encourage patients to register at secure Web sites containing compliance strategies and information.

In designing packaging for Seasonale, by Barr Labs, one challenge for PharmaDesign (Warren, NJ) was to preserve existing and prospective patient relationships with the product by preserving the basic look of the package.

Oral contraceptives (OC) have had the same basic packaging for decades, and women know and accept the look. “If we were to make a radically new system for dispensing these pills,” says Matthew Coe, PharmaDesign vice president of industrial design, “it would seriously endanger the acceptance of the drug in the market.”

This made the design more of an engineering challenge than a conceptual one. The company’s solution was honored as first runner-up for 2005 by HCPC. “It’s using the traditional OC pack, and just stacking two more pages below it,” Coe says.

The benefits of platform consistency should not be underestimated, says TestPak’s Eveleth. Market research has shown that one reason consumers have preferred bottles is because they are familiar with them,” he says. “The same applies to a reclosable carton system.”

Thus, the company designed a platform that patients could get to know. “The Pharma SHR system makes it possible to use a single platform that is flexible enough to handle a wide range of blistered products,” he says. “This is a big boost for patient familiarity.”

A VALUE-ADDED LOOK

The look of the package can also be important to patients in terms of perceived value, says Coe. He says this is why PharmaDesign and other companies working with compliance packaging are doing more and more with plastic. Plastic, says Coe, can be manufactured at costs similar to or lower than costs for cards. It also offers better durability (in the case of Seasonale, the package must last three months). “People are relating to that durability of the plastic,” Coe says.

With injection molding, compliance packaging can be as high-end and pleasing to the senses as other consumer packaging, explains Coe, noting that many drug companies share packaging technology with their consumer product divisions, “and they’re not doing a lot of cardboard engineering in their consumer product divisions.” Because the Seasonale package hinge is injection molded in one piece, minimal assembly is required, and production costs are kept low.

PHARMACEUTICAL BRAND DIFFERENTIATION

There are other potential cost benefits to compliance packaging as well. “The pharmaceutical industry as a whole is under great pressure to reduce prices and lower costs,” says Blake.

R&D costs are skyrocketing, and generally the pipeline for new products is shrinking. “Pharmaceutical marketers have to do more with their current brands, and compliance packaging is a proven method that allows them to do so,” he explains.

Companies can use compliance packaging to refresh existing products, either by changing the physician sample and offering a new way to present the product to physicians, or by changing the trade packaging and offering consumers a new way to interact with the product.

“It’s a very concise and clear way to change the way customers interact with their medication as well as a way to drive persistence and potentially create better brand loyalty,” Blake says. It can help differentiate a brand from its competitors.

Currently, there are only a handful of packaging types meeting the need for compliance packaging with high-level child resistance, reports Belden. But companies are pouring effort into developing new and innovative products. “It’s good for the industry,” he says. “There’s a lot of creativity and a lot of effort focused on it.”
This work, Belden adds, could bring us some “new wrinkles on the wallet,” as well as other types of compliance-prompting solutions that will bring even more options to packagers, pharmaceutical companies, and patients.