Compliance packaging: On the right track

Compliance packaging is making inroads into the pharmaceutical industry. 

by Daphne Allen
Editor

Interest in compliance packaging continues to grow. Even more attention is likely, given the favorable results from a recent study on its use and a major retail pharmacy’s interest in such packaging. 

The latest behind-the-scenes work in package design and development shows that effort is being made to drive costs out of compliance packaging. This is important, as drug companies are often driven by the bottom line, says Rick Sury, vice president of sales, contract packaging and specialty cartons, Alcan Packaging (Bethlehem, PA). 

As suppliers look for ways to ease manufacturer costs, they are also adding more value to such packages. Innovations are targeting patient and pharmacy needs, which could reduce costs for other players in healthcare.
 
A STUDY IN SUCCESS

Ohio State University (OSU) recently finished its study of the use of pill calendars to aid patients taking lisinopril, a treatment for chronic high blood pressure. In this study, the pill calendars were Slide Pack blisters from Cardinal Health. Merck & Co. provided the lisinopril. The Centers for Medicare and Medicaid Services provided financial support for the study.

Results suggest that the blisters succeeded in encouraging patients to follow drug regimens and to refill prescriptions. Interestingly, “diastolic blood pressure was reduced in nearly half of the patients who received the drug in a blister package, compared with fewer than 20 percent of those participants who received bottles of medication,” a press release on the study reports.

“This suggests that a better system of packaging for medications helped people take their medications properly,” says Philip Schneider, the study’s lead author and a clinical professor of pharmacy at OSU. Helping Schneider conduct the study were Craig Pedersen, an associate professor of pharmacy, and John Murphy of the University of Arizona.

The study showed that 14 percent more patients who received blister-packed medication refilled their prescriptions on time. Forty-eight percent of the patients who received blisters had lower diastolic blood pressure after 12 months, compared with only 18 percent of the patients who received bottles.

“Although blister packs are slightly more expensive than a bottle, people often forget to take their bottled medications, or get confused on how to take them properly,” said Schneider. “Offering long-term medications in this type of packaging could ultimately save millions of dollars.”

Larry Blake, director of marketing for MeadWestvaco Healthcare Packaging, expects the OSU study results to have a big impact. “Pharmaceutical marketers like hard data to support any change in packaging,” he says. “The OSU study gives them evidence of increased persistence and better outcomes. Both of these should help to expand the market for compliance packaging.”

INNOVATION AWARDED 

Taro Pharmaceuticals and Wal-Mart hope to improve compliance for Warfarin. As noted by Taro during the 13th annual National Symposium on Patient Compliance, sponsored by the Healthcare Compliance Packaging Council (HCPC), Wal-Mart asked Taro to design prescription drug packages that help Wal-Mart customers adhere to drug regimens. (Easing pharmacy operations was also a requirement.) Taro worked with American Health Packaging (Columbus) to find a portable carded blister design that would fit a 30-tablet regimen. After more than one year in development, the two finalized a concept that American Health calls the Track Pack. Tablets are arranged in a racetrack design, allowing patients to begin the regimen on any day of the week. 

Able to fit into a man’s shirt pocket or a woman’s purse, the package features thorough instructions in large type, explains Rachelle Goto, Taro’s vice president of pharmacy services and generic prescription marketing. “The package was designed for the geriatric patent,” she says. “This package adds value to our product, helping patients take products exactly as instructed.”

The package was recognized as the Compliance Package of the Year by HCPC. Competition judges noted: “The fact that such an outstanding design is being used with a generic drug is especially praiseworthy.” Another judge’s comment pointed to the package’s overall impression. “Exciting graphics, clear instructions, and a knock-out compliance-prompting design make this the best package I’ve seen this year.”

Goto says that Taro and Wal-Mart’s efforts don’t stop with the 5-mg Warfarin. “The concept will move to other dosage strengths of Warfarin and then on to other products,” she says. “Wal-Mart is looking for as many products as possible to be supplied in compliance packaging.” For Warfarin, packages will be color coded to match strengths.

The other winners of HCPC’s competition are the Namenda Patient Starter Kit by Forest Pharmaceuticals, which placed as first runner-up, and GlaxoSmithKline’s Imitrex 9-count package. The Namenda package holds a titrated regimen for Alzheimer’s therapy. The step-up in dosage strength is cued through color-coded bars that distinguish the 5-mg tablets from the 10-mg tablets. The box wallet package design is a product of Dividella AG (Switzerland), part of the Körber Pharmaceutical Packaging Division (Clearwater, FL). 

GlaxoSmithKline’s Imitrex 9 count is provided in MeadWestvaco’s Perfpak. Not only does the Perfpak give GSK the space to provide product information and a large-type insert, it also leaves room for patients to record dosing time and date. There is also a designated space for the pharmacy label. According to HCPC, GSK chose the Perfpak for its design, which lends quick and easy access, promotes ease of reading, and provides a compact delivery for the 9-count foil blister pack. Judges were also extremely impressed with the unique child-resistant Perfpak feature, which achieved an F-3 rating during the children’s portion of CPSC-protocol testing but is still easy for even senior adults to use properly.

OPTIMIZING DESIGN TO CONTROL COSTS

Using compliance packaging usually means significant packaging costs. Material, machinery, and service can all add up. But some say that taking the trial and error out of package design may help ease the investment.

Klöckner Pentaplast of America Inc. (Gordonsville, VA) is helping drug companies optimize design through the use of finite elements analysis (FEA). The company’s BlisterPro service helps users explore options for blister cavity geometry by using FEA software instead of actual forming tools, explains Steven Warakomski, technical manager, pharmaceutical films, for Klöckner Pentaplast. “Users can know what barrier performance to expect when thermoforming films,” he says. “They can screen for pitfalls and correct errors before making tooling.” Klöckner Pentaplast is offering the service to customers at its Pharmaceutical Packaging Technology Center in Gordonsville, where it works one-on-one with drug companies.

Studying cavity geometry is important, Warakomski says, because it tends to be one of the most important factors in thickness distribution. “Geometry problems are harder to deal with than are sealing and forming temperature problems,” he says. “This predictive analysis tool allows us to outline what the package could be. We could design a new package to meet a particular footprint, design around a particular shape, and explore options in depth, perforation, and thickness.”

Time and money spent on making and remaking tooling could be saved. In addition, “you could make material decisions and get through stability faster,” says Warakomski. 

Kent Sides, business manager, pharmaceutical films, for Klöckner Pentaplast, says that toolmakers have been receptive to the service. For instance, toolmakers always ask where to place venting areas in the blister tooling. “This helps drug companies answer that question,” he says.

Earlier this year, Montesino Associates LLC (Wilmington, DE) announced its own work with FEA software. The consultancy is marketing blister-simulation software from Amcor Flexibles Healthcare Inc. (Mundelein, IL). Black Box, which helps firms project barrier performance, joins Montesino’s other marketed scanning service, 3-D Smart, which predicts blister tooling performance. Black Box predicts finished blister thickness at multiple points within each cavity. 

According to Montesino’s founder, Peter Schmitt, “This service is of increasing importance, as high-barrier materials are used in greater frequency and volumes in response to demanding product requirements.” Schmitt anticipates that such software could “help pharmaceutical companies complete packaging studies more quickly and accurately, speeding up new drug launches and reducing testing costs.” 

On another cost note, Alcan Packaging’s Sury reports that efforts to reduce contract packaging costs require a close study of operations. Alcan Packaging, for instance, is using six sigma to ensure that internal processes are operating as efficiently as possible. “We are looking at the time and labor it takes for a process to generate an end-product. Our team is searching for ways to increase efficiency and to transfer that savings to customers while still developing good packages.” 

MeadWestvaco is also analyzing ways to lower the total cost of compliance packaging, says Blake. “We are looking at how the primary packaging component integrates with secondary packaging. Also, MeadWestvaco tries to assess commercial packaging machinery in order to best design its packages. For example, the Shellpak F-1 compliance package was designed to run on commercial cartoners with a thermoformed blister, lowering the total cost of production.”

END-USER NEEDS

Two of the latest designs in compliance packaging focus on helping both patients and pharmacists. At Interphex in New York City, Clear-Vu Pharma (Westbury, NY) introduced a design the firm calls the Reel Dispenser. The product is an injection-molded square housing that can hold strips of blister-packaged drugs wound in a roll. The housing, which can be child-resistant and can incorporate tamper evidence, can open blisters upon dispensing. A wheel counter keeps track of dosing, and RFID can be added seamlessly.

David Mroczka, director of marketing and sales, reports that the Reel Dispenser can be designed to hold enough blisters for multiple regimens for pharmacies, or it can be designed to hold just one regimen for patient use. “It has the ease and flexibility of a bottle, but it distributes strips of blisters,” he says. “We are putting the blister into a format people can use.” Flat sides give both manufacturers and pharmacists room for product instructions. 

Sharp Corp. (Allentown, PA) is interested in getting more drug information to the patient with drug sample packaging. The company’s new Flow Wrap package is a blister used for samples that are flow wrapped in a clear or printed material, reports Bill Walker, Sharp’s vice president of sales and marketing. “Patient inserts and Med Guides can be wrapped along with the blister, as opposed to being placed into a carton,” he says. “This way, manufacturers can be assured that patients are getting that information with their samples, no matter how these samples are stored at the physician’s office. Many of our customers have become more concerned about compliance information reaching the end-user. Our Flow Wrap package solves that issue.”