Unit-dose Packaging - More regulations may not be necessary

You don't usually see the pharmaceutical industry happy about these efforts. It's not because its members have anything against unit-dose packaging. It's because they don't want to be more regulated than they already are. And they don't want to change practices that are already well established and acceptable to regulators.

But if a pharmaceutical company is shown the benefits it could reap by putting more products in unit-dose packaging, and it is left to make its own decision, the unit-dose format might gain more acceptance. That is what Bob Dufour, R.Ph., director of pharmacy, third party, and government relations for Wal-Mart Stores Inc. (Bentonville, AR), is finding out. More regulations may not be necessary.

Dufour says he has developed a "real passion" for unit-dose packaging because of the benefits it brings to the customer. "The customer should be informed and should understand the medications they are taking," he says. "This type of packaging accomplishes that." The amber vials that consumers get when their drugs are repackaged from bulk packaging do a disservice in several ways, he explains.

One, the labels on amber vials are hard to read and often don't provide much drug information.

Two, such vials provide no indication as to whether the patient has already taken a dose.

Three, if a patient has several vials, the patient may have trouble telling the difference between them. Mistaking one for another could lead to medication errors like an overdose or underdose.

On the other hand, he says, most unit-dose packages made by the drug's manufacturer prominently display the drug name and provide clear information and instructions. Such packages also have the exact lot number and expiration date, helping consumers in case of a recall or an expired product.

"Helping customers understand the medications they are taking helps prevent misadventures. [Unit-dose] packaging reminds you that you are not compliant," says Dufour, who was scheduled to speak at the November 19 annual meeting of the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA) but instead will talk at the HCPC's annual symposium in May 2003. All of these characteristics, Dufour says, seem like logical extensions of a brand loyalty campaign, which is an important part of marketing in the era of direct-to-consumer advertising for prescription drugs.

"What do people think of when they see Claritin?" he asks. "Blue skies and white clouds, which they remember from the commercials. When you have that sort of thing on the package, brand loyalty is tremendous. And when the drug moves to over-the-counter status, as Claritin is doing now, that brand loyalty is an advantage to the manufacturer because consumers will recognize the product on the shelves. You don't get that with an amber vial. It does not make sense that manufacturers don't take their packaging to a higher level."

With this message, Dufour and colleagues from other chain drug stores have been visiting a number of pharmaceutical companies to talk up the benefits of unit-dose packaging. "We are successful," he says. "We've talked with senior people at several manufacturers and many 'get it.' "

As a result, some manufacturers are taking a harder look at unit-dose packaging for new products. They are focusing on new products because of regulatory hurdles to changing the package of an existing product and because of reimbursement issues that may come up if doctors started writing prescriptions for something other than 30-counts from bulk packages. With new products, he says, the pharmaceutical companies just need to educate doctors from the start to prescribe the amount in the unit-dose package, preferably by telling them to write "one pack."

Dufour and his colleagues understand that pharmaceutical companies may be more likely to respond to reason than to compulsion.

"While this is a huge advantage to consumers, we have not discussed it with patient groups or government groups," he says. "We think the pharmaceutical companies will come along on their own."

Of course, there may be another reason why Dufour's argument has been so well received. Retailers help pharmaceutical companies make profits and pay bills, while government agencies, packaging suppliers, and trade publications do not. But what matters is not the messenger but the message. And if the message benefits both consumers and industry, it makes sense to heed it.