Packaging Improves Compliance

Although patient compliance problems have been receiving attention for at least a decade, many medications are still dispensed in bottles that contain a supply intended to last days or weeks and require considerable effort on the part of the patient or caregiver to keep track of the dosing schedule. As a result, when it comes to consistently taking the right dose at the right time for the duration of a prescription, many consumers don't do a very good job.

Hallie Forcinio

The failures add up to millions of dollars in unnecessary healthcare costs and lost work time, as well as nursing home admissions and patient illnesses and death. Packaging designed to help patients follow proper dosage regimens could reduce or even eliminate many noncompliance problems.

Compliance packaging is especially important for regimens that require frequent doses, multiple medications, or titrated doses. But it also can help patients remember simple regimens such as once-a-week doses.

For pharmaceutical manufacturers looking for new ideas in compliance packaging, a review of 10 years of winners of the Compliance Package of the Year competition sponsored by the Healthcare Compliance Packaging Council (HCPC, Falls Church, VA, www.unitdose.org) is instructive. The winning concepts often are based on blister cards, generally in combination with plastic compacts or paperboard cartons or sleeves, but they also may take other forms.

One example of a nonblister format is the "Medistick" from Merck & Co. (Whitehouse Station, NJ, www.merck.com), which won the first Compliance Package of the Year Award competition in 1995. It consists of a narrow, rectangular container with cavities to hold individual doses. Cavities are sealed with printed, peelable film or foil-laminate lidstock. The lidstock is printed with the days and/or times when doses should be taken. To access the medication, the patient or caregiver simply peels away the appropriate section of the lidstock. An injection-molded, flanged cover makes the container child-resistant and protects the lidstock if the package is carried in a pocket or purse. The number of tablets per stick and the number of sticks per package may vary according to the dosage regimen. Sticks generally are injection molded from low-density polyethylene, but any thermoplastic resin may be used. In addition, wall thickness can be increased to reinforce the barrier without resorting to complex multilayer structures. Filling occurs on automated equipment that drops a tablet or capsule, on edge, into each cavity. A jogging seal jaw then seals the lidstock in place.

The 2002 Compliance Package of the Year also won a Medical Design Excellence Award in 2002. The design was based on prefilled syringes. The "SimpleJect Auto-Injector System," developed by Amgen Inc. (Thousand Oaks, CA, www.amgen.com) and Owen Mumford Ltd. (Woodstock, UK, www.owenmumford.com), is designed to make the administration of the drug "Kineret" easy, comfortable, and accurate in the treatment of rheumatoid arthritis (RA). When designing the SimpleJect device, Amgen worked with patients, healthcare professionals, and design experts to ensure the product would increase compliance by overcoming the often limited dexterity of RA patients, their fear of needles, and their lack of skill in administering injections. Without the SimpleJect system, many RA patients would have to rely on family members or friends every day to receive needed injections—a circumstance that would certainly cause many people to miss treatments periodically. In addition, the system automatically removes the needle cover and shields the needle from patient view during the injection process, a blessing for needle-phobic patients. A clearly written patient booklet accompanying the SimpleJect Auto-Injector system presents easy-to-understand instructions, colors, and diagrams.

As noted previously, the majority of compliance designs are based on blister cards. The "Helidac Therapy Kit" from Procter & Gamble Pharmaceuticals (Cincinnati, OH, www.pg.com), the winner of the 1997 Compliance Package of the Year award, simplifies the complex, multipill, frequent-cycle regimen used to treat the Helicobacter pylori infections responsible for most stomach ulcers. The kit organizes the regimen into 14 daily-dose blister cards, each divided into four, four-pill dosing units for breakfast, lunch, dinner, and bedtime. Each blister card contains eight round, pink bismuth subsalicylate tablets; four white, round, 250-mg metronidazole tablets; and four orange and white 500-mg tetracycline tablets. The design development is based on a packaging, education, reminders, and motivation concept created after the Helidac development team analyzed patient behavior.

The "Prempro/Premphase EZ DIAL" dispenser from Wyeth-Ayerst Laboratories, now Wyeth Pharmaceuticals (Collegeville, PA, www.wyeth.com), relies on a 28-count blister card housed inside a dispenser. It was recognized as the 1998 Compliance Package of the Year for its exceptional user-friendliness in delivering hormone replacement therapy to menopausal women.

An increasingly popular version of blister-card compliance packaging is the wallet pack, which typically positions a blister card or cards in a paperboard folder. One winner in this style of compliance package is a wallet pack for a physician's titration-therapy sample of "Lamictal," an anti-epileptic drug from GlaxoSmithKline (Research Triangle Park, NC, www.gsk.com). The wallet pack is contract packaged in Clifton, New Jersey, by Caraustar Industries, Inc. (Austell, GA, www.caraustar.com). Initially, Lamictal was packaged as a five-week regimen on four separate cards. The wallet pack assembles the same number of doses on one card that folds into a compact package. The arrangement of the medication, graphics, and instructions help physicians explain how to take the changing doses of medication.

Figure 1: The "Dosepak" design for once-per-week Actonel features a pull-out blister card and a fold-out panel for additional product information.

The "Dosepak" design from MeadWestvaco (New York, NY, www.meadwestvaco.com) marries a folding carton with a blister card to deliver compliance, tamper evidence, child-resistance, and senior-friendliness (see Figure 1). A concept of this package design won the top prize in the HCPC competition in 2000. It featured a slim carton with a diecut tab that released a paperboard-encased blister card. The carton–card combination provides a large surface area on which to print dosage instructions.

It didn't take long for the Dosepak to be adopted for an actual product. Procter & Gamble Pharmaceuticals chose the Dosepak design for the 35-mg dose of "Actonel," a once-per-week osteoporosis drug. It not only won the 2003 Health Care Compliance Package of the Year Award, but also won the Best of Show Award in the 2003 AmeriStar competition sponsored by the Institute of Packaging Professionals (Naperville, IL, www.iopp.org) and was a contender for the President's Award in the 2003 WorldStar Competition sponsored by the World Packaging Organisation (Stockholm, Sweden, www.worldpackaging.org). The interior of the Actonel package offers more space than a bottle label to print three-step dosing instructions in type large enough to facilitate reading by postmenopausal women, the product's primary market. The four-tablet package also provides space for patients to mark the day of the week she chooses to take the once-per-week medication. An integral pocket holds additional information and protects it from damage.

Figure 2: The "Track Pack" blister card design simplifies dispensing of warfarin for pharmacists, clearly shows the proper dosage schedule, and provides a refill alert.

Arranging tablets in a racetrack design proved to be the answer Taro Pharmaceuticals USA, Inc. (Hawthorne, NY, www.taropharma.com) was seeking when Wal-Mart Stores, Inc. (Bentonville, AR, www.walmartstores.com) asked for a package that would help improve compliance for 5-mg warfarin, an anticoagulent, and at the same time simplify pharmacy operations. Taro worked with a contract packager to find a pocket-size carded blister design that would accommodate a 30-tablet regimen. The oval "Track Pack"design by American Health Packaging (Columbus, OH, www.healthpack.com) permits patients to begin the regimen on any day of the week (see Figure 2). The large, printable area on the compact package permits larger type for instructions, which improves readability. The package was recognized as the 2004 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 described the package's overall impression: "Exciting graphics, clear instructions, and a knockout compliance-prompting design make this the best package I've seen this year."

A decade of awards shows there's no lack of good ideas for compliance packaging. These concepts serve as the starting point for new packaging innovations that will make it easier for even more patients to take their medications properly.

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com