Compliance packaging tackles chronic illness and cost concerns

Pharmaceutical & Medical Packaging News staff

Cost-effective, senior-friendly innovations push the industry forward.

By Maximillian Del Rey

Assistant Editor

Compliance packaging for drugs targeting the chronically ill presents challenges as many ailments such as cancer transition from episodic to chronic diseases that require continuous treatment. Packaging converters must also balance child security with elder friendliness. A child resistance of F=1 must be accompanied by ease of use for weaker and older patients.

For instance, the NextBottle, designed by One World Design & Manufacturing Group Ltd. (Warren, NJ), promotes access for seniors in addition to compliance. The product, which won the 2007 Healthcare Compliance Packaging Council (HCPC) Innovative Design award, used familiar elements, such as the push-and-twist mechanism of a prescription bottle, to make it easy for patients to learn how to operate it.

“At OneWorld we designed the NextBottle to take all the good features of a common, normal amber-vial medicine bottle and address some of its shortcomings,” says Marty Mason, One World’s director of marketing. “Let’s look at the cap: We increased the size to make it easier for seniors and harder for children to grasp.”

One World will ally with Aylward Enterprises LLC (New Bern, NC) and Catalent Pharma Solutions (Somerset, NJ) to develop a line to fill the Next- Bottle, Mason says. The automated production line will be unveiled at 2008 Pack Expo in November in Chicago.

“Aylward is making the funnel feeder, Catalent is investing in the line, and One World is supplying the Next- Bottles,” Mason says.

The alliance creates a cost-effective solution for producing the NextBottle, says Mason.

Fighting Costs

Advancing compliance packaging from early stages of development to full-scale production lines can create a stumbling block for contract packagers.

“You want something good,” says Justin Schroeder, marketing manager of Anderson Packaging (Rockford, IL). “But you also want it to be cost-effective. A lot of people come out with package designs that are innovative, but aren’t easily manufactured.”

With pharmaceutical companies hesitant to shoulder costs associated with transitioning to unit-dose compliance packages, conversion has moved slowly in some sectors.

Another product in the development pipeline is the AlertPak compliance blister, produced by Colbert Packaging (Lake Forest, IL) in cooperation with Anderson Packaging.

“It’s really for any kind of regimen that needs to be taken for five to 10 days or more,” says Lon Johnson, Colbert Packaging’s vice president of sales. “Companies are making combination medications that treat acid-reflux, blood pressure, and prostate growth.”

Accommodating the Elderly

Johnson says this process challenges contract packagers to produce a package that promotes adherence to such a regimen. Compliance packaging manufacturers face challenges in assembling drug cocktails for patients.

“What we’re seeing is that contract manufacturers have to increase controls to segregate the drugs,” says Johnson. “It started out with the cocktail, which was less effective with an amber bottle. You couldn’t rely on a patient’s memory to take more than two or three drugs multiple times per day.

“In addition, what we’ve discovered is that in those therapies, a lot of the times, the critical drug needs to be enhanced by a supplement, sometimes a vitamin,” he says.

Colbert Packaging has developed the ComplyPak blister designed to accommodate two or three drugs within a compliance package, Johnson says. “We’re trying to get away from the amber bottle.”

According to an Ohio State University study, Johnson points out, hypertension patients had 10–15% better compliance with a compliance package instead of amber bottles.

Oncology patients are another group that has turned up surprising compliance testing results, says Ralph Mendoza, Stora Enso (Morris Plains, NJ) sales manager.

“I think that oncology seems to be the next area within compliance unit-dose packaging that we’ll start to see a change in. Oncology rates are surprising; adherence rates range from 50 to 75 percent. You’d feel that there’d be greater numbers. But now there are more oncology products in the pipeline to promote adherence.”

Colbert Packging, for example, has redesigned its PharmaDial package, despite its F=1 rating, to be more friendly to the weak and elderly. Colbert made a modification that eliminated one of its three operating steps while maintaining an F=1 rating. The redesign made the product easier for the elderly to handle.

“[Elderly-friendly compliance] is a constant struggle,” says Johnson. “We’ve done some senior testing. PharmaDial, a three-step product, was too challenging as a senior-friendly device. The retro modification made the product smaller by sheer physics. It allowed us to take some of the air out of it.”

“If they’re taking the meds themselves, they need as much support as possible,” says Bill Desmond, Permalith Plastics LLC’s (Pennsauken, NJ) vice president, sales and marketing. “You don’t want people to have to open a prescription bottle and count the pills to see whether they’re on schedule.”

Permalith has also redesigned its oral-contraceptive blister to achieve F=1 compliance. While the oral-contraceptive blister had been a successful product in terms of adherence, the device wasn’t designed to be child resistant, since the drugs aren’t harmful.

But a new design was needed for medications intended to be used as part of regimented care, for patients who need a particular drug for an extended period. The PermaSafe package sandwiches a blister between two plastic cards, requiring the user to align the blister core to an exit position where perforations enable the user to extract a pill.

In addition, the PermaSafe blister card can be modified for the weak and elderly.

“We can adjust the perforation depth on the blister so that we can have the poundage of force that patients need to break the blister to be elderly-friendly,” Desmond says. “Poundage depends on the surface size and shape of the pill. If you have a big tablet, three pounds of force would work; but for a small pill, one pound might be appropriate.”

Moving Forward

“The pharma companies want to sell products in bulk. They want to let [packaging] types of decisions [be made] more downstream,” Desmond says. “We’ve sold [compliance with blister cards] in a number of areas, but when the decision went through upper-level marketing, they nixed it.

“It will take a social change for them,” he says. “It’s already done in Europe and it’s coming here. When it happens, it’ll happen on a wide scale.”

Desmond believes the nature of the American healthcare system will ultimately leave the decision up to the insurance companies.

“Insurance companies specify these types of things and pay for them. If it costs 4 cents more per prescription, fine; we have to prove that a unit-dose compliant package is [used] more correctly than a package that isn’t unit-dose.”

Mendoza, however, believes more testing on adherence must be done for change to quicken.

“From what we’ve found, there’s still not enough data in the area segmented into compliance packaging and adherence. Many pharma companies believe in the need for unit-dose products to increase rates of persistence and adherence, but there’s still not enough data to support this.”