Unit-Dose Packaging: An Easy Pill to Swallow

By Carro Ford Weston

The trend toward unit-dose packaging goes well beyond pills in blister packs, and Cardinal Health developed this foam applicator with a frangible seal.

Unit-dose, or single-dose, packaging is not that widespread in the U.S. market, but that won't be the case for long. FDA-mandated compliance is driving adoption, and unit dose packaging (UDP) also has a profound influence on patient compliance and reduction in medication errors. Although UDP costs more to manufacture than bottles, it's hard to argue with something that contributes to better patient health and safety.

"In medicine, there is a renewed focus on patient safety and compliance," notes Renard Jackson, executive vice president, business development for packaging services at Cardinal Health. "This is the main force behind the FDA mandate for unit-dose packaging in clinical trials. There is about 50% compliance now as far as people correctly taking their medications, so a one or two percent increase is huge for pharmaceuticals, and people in turn will get healthier."

"Single-dose packaging leads to better patient compliance for several reasons," says Keith Kiedinger, vice president of pharmaceutical and healthcare products for Shorewood Packaging. "It is far more transportable and convenient than a bottle of pills. It is also easier for a patient or caregiver to tell if pills have been taken and how many are left. This reduces confusion and lessens the chance that the prescription won't be refilled on time."

Insurance companies and HMOs also stand to gain. "If you get people to take their meds more consistently and reduce medical costs, everyone benefits," says Kiedinger. "The packaging is beneficial in managed health care because you visually see the medication, and it cuts down on misdoses."

Safe but easy

As the market moves to more blister packaging for medications, two opposing requirements must be met. Packages must be hard to open to meet child resistant (CR) standards, yet they must be easy to open to be considered senior-friendly (SF). As medications become more potent and potentially more toxic, packaging must provide different levels of security. This is a tough balancing act, yet one that manufacturers are diligently addressing.

"The goal of the unit-dose format is to protect that individual unit and also pass child-resistant testing. As drugs become more potent, you have to design packaging that passes CR testing, which is more rigorous. You have to protect to F1 specifications, the most stringent level, which basically means zero failure," Jackson explains.

"As we move to blister packs, we recognize the need to deliver medication safely, but also have ease of use," says Kiedinger. "There are many good packages; many are complex, but we try to use as simple an approach as possible, like our new bend and peel technology." As more drugs shift to OTC availability, he adds that CR packaging will become more prevalent.

Unit-dose packages are the best way to get patients to take medications every day and on time.

As products become more potent, they are often more light sensitive and susceptible to degradation from moisture and need more vigorous packaging materials. Shorewood Packaging is working on a variety of different substrates and paper, such as blister board that works well with a variety of plastics for better sealing. "Moisture is a concern," Kiedinger says, "and blister packaging doesn't expose all the contents at the same time."

From a manufacturing standpoint, web-based technology has an advantage over sheetfed as a more most cost-effective process for blister packaging. "From paper roll to printing to die cut, web is a more cost-effective way to go, and in general the industry is shifting to that," explains Kiedinger.

A dose of convenience

In a mobile society that thrives on convenience, single dose blister packaging has strong appeal. "The ability to carry one dose in a purse or pocket, instead of having to take the entire bottle of 100 is something people like a lot," says Jackson. UDP is also more discrete.

UDP can conveniently house individual doses of medications to be used in combination. "You see that in clinical trials and titration packs," says Kiedinger. "Certainly in HIV treatment, there is a prevailing need. Users can easily see if they have taken all the pills. Blister packaging lends itself to this better than a bottle, and we have been working on some projects in this area."

There's also no reason UDP need be limited to pills, tablets, or capsules. "One area that holds promise is unit dose packaging of creams and ointments," says Jackson. "Cardinal Health has developed DelPouch? delivery system, which allows unit of use applications of these medications."

The U.S. market may already be more familiar with UDP than it realizes, through consumer and OTC products like gum and cold remedies. Again, it's the

convenience factor. UDP is also quite commonly seen in medication sample packs of one or two doses. Combine this with the advantages of compliance and patient safety, and UDP is well on its way to becoming an established packaging format.

A blister pack alone doesn't deliver the full potential of UDP; but combined with barcoding, it really comes into its own. Barcoding lets providers and caregivers easily and accurately check information such as medication pedigree and inventory. Jackson explains: "Wanding and other verification technology can help reduce medication errors by reading barcode information to ensure the right patient receives the right drug and dosage, and that the medication is not expired. Eventually there will be bedside capabilities like wanding a patient's bracelet and the package for a match."

In fact, this is already beginning to happen in the real world. John Roberts, director of channel management at the Uniform Code Council, reports that patients at V.A. hospitals are beginning to expect this type of drug verification. This level of sophistication is being driven by the FDA, which is requiring pharmaceutical companies to have unit-dose bar coding for pharmaceuticals and biologics in place by April 2006.