Package design deters counterfeiters when it is distinctive, difficult to duplicate, and incorporates features such as
holographic labels, microprinting, color-shifting ink, or radio-frequency identification (RFID).
The "Clonidine" wallet pack combines child-resistant, senior-friendly, and compliance features.
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Yet another way packaging enhances patient safety is by preventing medication mistakes. Simple design techniques such as color
coding can flag crucial information such as dosage strength and administration method. The Association of Anaesthetists of
Great Britain and Ireland (London) and three related organizations have developed guidelines for color coding self-labeled
syringes used in critical-care areas to help identify drug and drug type at a glance.
In addition, FDA has mandated unit-of-use barcoding on the packaging of prescription and OTC drugs dispensed in hospitals.
The barcode carries the product's National Drug Code and may also include a lot number and expiration date. Scanning with
a barcode reader identifies the product and provides an automated means to confirm that the correct dose is being given to
the right patient at the proper time through the correct administration route. If patient wristband information and caregiver
identification is scanned, the system also can help automate record keeping and billing (4).
More than half of all prescriptions are not taken correctly (5). Reasons include difficulty remembering when to take a dose
and whether a dose was taken. Creatively printed blister cards and presentations like wallet packs arrange medication in an
organized fashion. Patients who take their medicine on schedule tend to experience more positive outcomes and lower healthcare
costs. Increased compliance also generates sales for pharmacies and drugmakers because it encourages the prompt refill of
prescriptions and the restocking of OTC drugs in the medicine cabinet (6).
Item-level radio-frequency identification tagging is moving from pilot projects to daily use, especially for commonly counterfeited
products. Shown here are item-level tags and a reader from Impinj, Inc. (Seattle, WA).
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One example of a sophisticated compliance package is a CR, senior-friendly wallet pack for "Clonidine" from Mylan Pharmaceuticals
Inc. (Morgantown, WV) and UDL Laboratories, Inc. (Rockford, IL). The package was recently recognized in an annual competition
sponsored by the Healthcare Compliance Packaging Council (Falls Church, VA). The design features a plastic housing with a
slide-out drawer that holds a push-through blister card with 30 tablets arranged in four rows. Pressing a button unlocks the
drawer so it can be pulled out to grant access to the medication. Precisely registered printing on the blister card indicates
when each dose should be taken ("Shellpak" compliance package, MeadWestvaco Healthcare Packaging, New York).
Advances in materials and containers
Material and container advances help make design innovations a commercial reality, ensure products are adequately protected
to maintain potency until the end of their expected shelf lives, simplify administration, minimize the chances of mislabeling
or misdosing, discourage counterfeiting, and reduce the environmental impact of packaging.
Various materials can protect a product's shelf life. New combinations that offer good protection or low cost appear on the
market constantly. Some innovations rely on familiar barrier materials such as "Aclar," ethylene vinyl alcohol, and polyvinylidene
chloride. Others such as cyclic olefin copolymer (COC) and cyclic olefin polymer (COP) are newcomers to the pharmaceutical
industry (7). COC replaces barrier-coated polyvinyl chloride (PVC), is capable of 5-in. draws, and forms on the same tooling
as PVC. COP is compatible with injection-molded containers and flexible packaging, provides compatibility with ethylene oxide
and gamma sterilization, and contains extremely low residual-metals content.
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