The next chapter: Unit-of-use packaging

In an effort to reduce dispensing errors, the U.S. Pharmacopeia encourages pharmacists to dispense drugs in unit-of-use packaging. But can manufacturers support the call?

 Daphne Allen, Editor 

A new voice has just been added to the call to reduce medical errors. The United States Pharmacopeia (USP) now suggests that dispensing medications in original manufacturers' containers may eliminate many of the dispensing errors that occur at pharmacies. The organization has proposed a new General Chapter, <1136>, to the United States Pharmacopeia 27 and the National Formulary 22 (USP 27 and NF 22, 2004 annual edition) on unit-of-use packaging. The chapter was published in the preview section of the July/August issue of Pharmacopeial Forum, titled "Packaging—Unit of Use."

USP believes that when pharmacists are freed from the tedious—and error-prone—job of counting out pills from bulk supplies, repackaging them in generic bottles, and printing and applying labels to the bottles, dispensing and labeling errors will be reduced. Pharmacists will then be able to spend more time with patients, helping them understand and adhere to their drug regimens.

"Considering changes in drug distribution systems, professional care paradigms, consumer needs and expectations, and our economic environment, now is the time to introduce a general informational chapter on this issue," says Claudia C. Okeke, PhD, a USP scientist who serves as liaison to the USP Expert Committee on Packaging, Storage, and Distribution. "With a significant number of medication errors being reported and a call for bar coding of medication packages even for single-unit containers, this chapter can provide positive support to pharmacy practitioners."

Pharmacists, however, may need more than just a USP chapter to dispense prescription drugs in unit-of-use packaging. Most prescription drugs are supplied in bulk to pharmacies, not in unit-of-use packaging, which USP defines as "a container-closure system that is designed to hold a specific quantity of a drug product for a specific use." Pharmacists, therefore, have little choice but to repackage them.

For pharmacists to put USP's new chapter to wide use, drug manufacturers are going to need to supply unit-of-use packaging. While USP is not making any recommendations to manufacturers, Okeke does say that manufacturers should consider unit-of-use packaging, and she even suggests other packaging aids to reduce errors, like adding bar coding to allow automatic product identification. "These are just suggestions. Our goal is to reduce errors and increase efficiency. We also want to free pharmacists up from counting so they can spend more time counseling patients."

A NEW CHAPTER IN PACKAGING

USP points out that dispensing prescriptions in the manufacturer's original unit-of-use packaging offers several advantages for pharmacists. These include:

Okeke says that USP expects little disagreement on whether unit-of-use packaging offers these benefits. For instance, pharmacists should welcome the initiative, says Jeff Robb, vice president, marketing, of MeadWestvaco's Global Pharmaceutical Healthcare Packaging Group (Mebane, NC). "One of the top three pharmacies is trying to move the industry out of amber vials. Amber vials are not effective at building compliance, and their tiny labels have no information on indications. Manufacturers can present their products in unique, identifiable packaging that helps patients adhere to dosing regimens."

Peter Mayberry, executive director for the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA), welcomes the chapter, and he hopes that USP's support of unit-of-use packaging will influence manufacturers. "It's encouraging that USP has recognized the benefits of packaging that comes directly from the manufacturer—or its agent—to the patient. Unit-of-use packaging has been a long time coming, and it can improve safety and increase compliance."

Ed Hancock, president of American Health Packaging (Columbus, OH), commends USP for "its continuing work to ensure that pharmaceuticals are dispensed in packaging that ensures the efficacy of the drug through the dispensing process. The benefits as described in the 'Briefing' preamble are intuitive as well as factual, and correctly encourage the adoption of unit-of-use packaging for dispensing rather than pharmacist counting and repackaging. "

UNIT DOSE OR UNIT OF USE?

The proposed new General Chapter outlines the different packaging options available for prescriptions, defining and explaining materials of construction, package closure types, repackaging and reprocessing, and labeling. It mentions blisters and bottles, but again, USP does not recommend one over the other. "Such a decision is up to the manufacturer," Okeke says. "It depends on the drug and the regimen."

While Mayberry agrees, he stresses that "unit-dose packaging, such as a blister or strip package [in which each dose is separate and identified], is much more effective in achieving patient safety and compliance than unit-of-use bottles."

Shawn Reilly, vice president of marketing for Anderson Packaging Inc. (Rockford, IL), which offers both blister and bottle packaging services, advocates any solution that best achieves the practice, "the right medicine, at the right dose, at the right time, to the right patient."

Larry Blake, marketing manager for contract packager Sharp Corp. (Conshohocken, PA), says that the format manufacturers choose most likely depends upon three things: marketing preferences, number of tablets for a particular unit of use, and economics. "A carded blister is good, because you can print detailed directions. You can even print different copy for different indications. But if a particular regimen requires more than 36 tablets, it would be difficult to package it in a carded blister. The package would be too large."

Bottles may also be more economical. Mohan Sasthav, MeadWestvaco's market planning analyst, says that bottling lines are easy to set up and run, while blister lines are more complicated and may also be more expensive.

And because of the cost of customization, a carded blister could be too expensive for some drug companies. "A more cost-effective alternative would be to put multiple blister foil units into a carton," Blake says.

But blisters, even the more expensive carded blisters, can pay off. "Blisters help reduce overdosing and missed dosing, and they are tamper evident, reassuring patients of safety," Blake adds. "If you can make the regimen easier to follow, patients will comply, potentially reducing costs to the whole healthcare system."

Bill Sharpless, healthcare market specialist for Honeywell Specialty Films (Morristown, NJ), agrees. "Healthcare costs are out of control in America, and one contributing cause is the number of deaths and hospitalizations due to poor medication compliance. Repackaging drugs into smaller dispensing units [at the pharmacy] does not promote compliance."

Information printed on a carded blister may also make up for any shortfalls in doctor instructions. "Medication errors can also be attributed to doctors not communicating dosing instructions properly," says Paul Mangano, Hueck Foil's (Wall, NJ) healthcare account manager. "Pharmacists have no time to check with patients to make sure they understand how to take their medications."

Sasthav also recommends the carded blister. "Not only does it encourage compliance, but it helps pharmaceutical companies develop brand equity because of its billboard space for logos, graphics, product details, and other elements that can distinguish a product from its competitors."

And Robb says research shows that a 28-day blister may be more appropriate for the pharmacist to dispense, and that day count suits most patient regimens and refill schedules. Carded blisters may even be easier to store on pharmacy shelves than bottles holding the same number of tablets.

Blister packaging, carded or not, offers another benefit that bottles do not—each dose may carry its own bar code for automatic identification. While not specifically pushing unit-dose bar codes, Okeke explains that USP believes that bar coded unit-of-use packaging may also reduce dispensing errors by facilitating automatic product identification.

Unit-of-use codes could be placed on either bottle or blister, but only blisters can offer unit-dose codes. Recent projects have shown that data-dense codes are feasible, like Reduced Space Symbology and Datamatrix. These can encode the National Drug Code, expiration date, and lot code, critical for identification. Several firms have introduced coding solutions this year, like printer providers Griffin-Rutgers Inc. (Ronkonkoma, NY) and Adolph Gottscho Inc. (Union, NJ); printing plate manufacturer Quint Co. (Philadelphia); and printer The NOSCO Printing Group (Gurnee, IL). And other coding solutions providers like Product Identification & Processing Systems Inc. (New York City), Barcode Technology Inc. (New York City), and The Rack Design Group Inc. (Madison, NJ) also promote unit-dose coding.

OTHER PLUSES

Blister or bottle questions aside, an investment in unit-of-use packaging will be a significant one for manufacturers, whether they set up their own operations or hire a contract packager.

But Reilly raises other benefits to manufacturer unit-of-use packaging, namely unit-dose packaging. "Packaging to the unit-dose level is best and most securely done at a primary packaging site, either at a drug company or a dedicated contract packager. It is only at these sites where packaging occurs under strict CGMP compliance, nearly eliminating potential errors in product or dosage mix-up. Product can then carry full expiration dating, which could be one, two, or three years. If pharmacy repackaging is done, the product can only carry a six-month to one-year expiration date, adding costs to the supply chain and increasing the chance that outdated product may be used."

While packaging providers like Howard Thau, president of Sonic Packaging Industries (Westwood, NJ), argue that "packaging is best left to the professional," Thau says he has the utmost respect for the pharmacist. "It's just that pharmacists don't have the time to run a packaging operation with the necessary quality controls. The pharmacist is being asked to be a pharmacist, a packager, and a quality control person, all in one. How long can one person do three jobs?" Instead, pharmacists should have ready-to-dispense packages that could be scanned for automatic identification, he adds.

Also, unit-of-use packaging ensures that the drug is protected until the point of use, says Nic Hunt, global business director for Rexam Pharma Flexibles. "Seniors frequently unpack drugs from bulk containers and store them in day-by-day units, exposing the drugs to ambient conditions before use. If the senior does this on a weekly or monthly basis, drugs could be exposed to ambient moisture for sufficient time to affect the active ingredient. Keeping tablets in unit-of-use packs retains efficacy."

And, adds Sharpless, "Keeping medications in their original containers and using individually blistered unit-of-use packaging provides parents and grandparents a package that has demonstrated child resistance."

Some even say that unit-of-use, child-resistant blisters promote public health. "They increase product compliance, which benefits everyone. They increase security and accountability, showing which dose was taken last or whether one was missed. Their advantages to society are tremendous," says Chris Madison, sales and marketing manager for Graphic Packaging Corp.'s healthcare business.

Lastly, when pharmacists no longer spend time counting products to fill prescriptions, they may get prescriptions to patients faster. Angela Roggenhofer, Hueck's sales manager, relates a recent experience she had as a patient. "I had to take some medication for three days. In Germany, where all drugs are prepacked in blisters, I would have walked into a pharmacy and left with my medication in two minutes. Here in the United States, it took the pharmacist 20 minutes to fill my six-tablet prescription. That's a long time, especially when you're sick!"

Comments on the proposed new chapter should be sent to Dr. Okeke at USP, 12601 Twinbrook Pky., Rockville, MD 20852. Questions on unit-of-use packaging can be e-mailed to [email protected].