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, http://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, http://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, http://www.amgen.com) and Owen Mumford Ltd. (Woodstock, UK, http://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.