Bar Coding Unit-Dose Blisters
New requirements for bar coded unit-of-use packages could lead to requirements for unit-dose packaging. But is industry prepared?
Daphne Allen, Editor
Bar coding unit-dose blisters for hospital use isn't a new idea. In February 1990, the Pharmaceutical Manufacturers Association (now known as the Pharmaceutical Research and Manufacturers of America or PhRMA) put together a bar code technical committee and interest group to research the feasibility of printing bar codes on hospital unit-dose blister packs and other small pharmaceutical packages. The group determined that it could be done, given some specifics in code and code placement, materials, machinery, and processes.
Twelve years have since passed, and yet few drug manufacturers place their drugs into bar coded, unit-dose blisters for hospital use. Instead, explains Peter Mayberry, executive director of the Healthcare Compliance Packaging Council, "the existing paradigm for drug distribution in the United States involves manufacturers shipping drugs in bulk [to hospitals], where the drugs are then repackaged in the pharmacy, then often repackaged again by the person responsible for dispensing the drug in an in-patient setting." He calls such a system "seriously flawed" because it "results in thousands of medication errors and patient mistakes each year."
Bruce Cohen, a PhRMA member who worked on the 1990 bar code committee and is also director of packaging technology of GlaxoSmithKline, chalks up the lack of manufacturer bar coded hospital blisters mainly to high implementation costs with little return on investment and to the risk of choosing a code that could become obsolete.
Recent efforts to reduce medical errors at hospitals, however, may encourage manufacturers to bar code unit-dose packages. In December, FDA announced in the Federal Register that it would draft a proposal that all human drug and biologic products carry bar codes. Days after the announcement, two group purchasing organizations—Novation (Irving, TX), the supply company of VHA Inc. and University HealthSystem Consortium (UHC), and Premier Inc. (Chicago), an alliance owned by not-for-profit health systems—announced new requirements for bar coded unit-of-use packages.
While these requirements do not specifically call for bar coded unit-dose blisters, an interest in reducing medical errors could lead groups like these to conclude that unit-of-use packages such as bottles, pouches, blisters, or boxes that carry only one bar code per course of therapy, not per dose, may not be as effective as unit-dose blisters for solid-dose oral pharmaceuticals. "Unit-dose blisters can help practitioners administer the correct drug to the correct patient at the proper time," explains Renard Jackson, executive vice president of domestic contract services for PCI Services, a Cardinal Health Co. (Philadelphia).
And when these unit doses each carry their own bar code, each dose can be verified and recorded as it is administered, reducing the chance of mix-ups or missed doses. The ultimate safeguard is a bar coded unit-dose package provided by the manufacturer or its agent. "Drug manufacturers or contract packagers should supply hospitals with unit-dose products, as long as it can be done cost-effectively," argues Jackson. "This would limit possible product mix-ups associated with dumping out and repackaging products."
On December 10, 2001, Novation executives explained that, effective with its 2004 pharmacy portfolio renegotiations, all Novation-contracted pharmaceuticals will be required to carry bar codes on unit-of-use packaging. John Riddick, director of quality assurance and regulatory affairs, says that "Novation recognizes the critical role that unit-of-use bar coding plays in fostering a safer environment for healthcare workers and patients. As a result, we want all unit doses to carry bar codes."
On December 20, Premier announced that, starting in 2003, it will require all new and existing suppliers to provide unit-of-use bar coding. "By requiring scannable bar codes for hospital pharmaceutical products, we are convinced that medication errors will be reduced with more assurance that patients get the right medicine at the right time in the right dosage," says Premier executive Howard E. Sanders, responsible for group purchasing. Ken Inchausti, a spokesperson for Premier, adds the group is "looking for bar codes down to the unit level, so when [nurses] break open a pack, the products within have bar codes on them."
While the purchasing power of Novation and Premier may prompt some drug manufacturers to implement unit-dose bar coding, FDA's announcement may have greater effects. In a December 3, 2001, notice, FDA said that it would propose requiring bar codes on all drugs and biologics in order to curtail medication errors. (For more details, see the Regulatory Focus column on page 66.) Jerry Phillips, FDA's associate director of the office of drug safety, explains that the agency believes that every drug dose should carry a bar code. "Once hospitals have the infrastructure, bar codes will enable nurses to scan medications prior to administration, which should help reduce errors at the point of use," says Phillips. Whether FDA will require that each dose carry a bar code, and what exactly will be required in those codes, though, remains to be seen. In its notice, FDA stated that requiring bar codes on unit doses might scare some away from unit doses and into bulk containers because unit-dose packaging is more costly, and a bar code requirement could increase costs further.
PhRMA's Cohen believes that FDA regulations regarding bar coding are needed to push industry toward bar coding unit-dose blister packages for hospital use. "Yes, bar coding unit-dose packages is the right thing to do, and yes, it will save lives. But it is not cheap. So most drug manufacturers aren't going to do anything until FDA devises regulation and chooses a bar code standard that everyone in industry will have to use." At press time, Cohen said that PhRMA members were planning to meet in mid-January to lay the groundwork for complying with FDA's upcoming bar code requirements.
While blisters help consumers follow regimens at home, they play a different role in hospitals. "Blister packaging itself is an error prevention tool. If doses get separated from a regimen, you still know the drug's identity from its label and lot and expiration date," says Dominick Alese, associate administrator, clinical systems analysis, Good Samaritan Hospital Medical Center. "With loose tablets or capsules in a vial, you don't always have these details."
When you add a bar code to each unit dose of a blister, you can automate drug identification and administration at the bedside. "Systems are needed to tie the patient to drug administration, and bar coding is a very good way to do that," explains Paul Mangano, healthcare account manager for Hueck Foils LLC (Wall, NJ), a converter of blister foils and films. "A handheld computerized system that can identify the patient and medication at the point of administration is what is needed."
Bill Sharpless, healthcare market specialist for Honeywell (Morristown, NJ), manufacturer of Aclar, agrees that bar coded unit-dose packaging can promote safe drug delivery. "When administering medication to a patient in these settings, it is paramount that you dispense the correct medication to the correct patient. Packaging can assist, and bar coding medications is one tool. This is best accomplished by the use of blister packs in hospital unit-dose format."
The cohort of bar coded, unit-dose medications is a computerized system designed for use at the patient bedside. Bridge Medical Inc.'s (Solana Beach, CA) solution is MedPoint, a software system that accepts data from handheld scanners used by nurses. As nurses scan bar coded drugs, the patient's identification bracelet, and their own badges at administration, the system verifies the five rights of administration—right patient, right drug, right dose, right time, right route of administration—and more. It logs and checks the administration and notifies nurses of potential interactions, under or overdoses, drugs with similar names or appearances for which the administered drug could be mistaken, or other problems.
The system is receiving accolades. "Our Medication Errors Workgroup identified bar code–enabled point-of-care (BPOC) technology effective in decreasing medication errors and enhancing patient safety at the medication administration phase," says Lee H. Perlman, executive vice president and COO of the Greater New York Hospital Association. It has endorsed MedPoint and is promoting its use to members.
However, for MedPoint, and other BPOC technologies like it, to really be able to bring down the number of medical errors nationwide, most drugs used in hospitals need to be bar coded, says Rusty Lewis, Bridge's senior vice president and chief operating officer.
To make up for the lack of manufacturer bar coded unit-dose drugs, many hospitals repackage drugs in their own pharmacies. "We buy anything available in unit-dose formats, but most blister packages don't have bar codes, and we are even seeing manufacturers cutting back on blisters," says Alese. "So we are looking at repackaging drugs ourselves with a tabletop system."
But some say that pharmacy repackaging isn't always ideal. "Far too many hospitals are having to repack items into unit dose," says Steve Mead of FuturePak. "Many packages are substandard and may be done with less regard for product stability than is mandated for repackaging or manufacturing."
Howard Thau, president of Sonic Packaging (Westwood, NJ), agrees, saying "the focus of the pharmacy staff is to dispense the medication, while the professional contract packager is trained and managed to handle the responsibility of repackaging product."
So, to provide hospitals with bar coded unit-dose blisters, repackagers and some contract packagers are picking up where manufacturers are leaving off. For instance, FuturePak specializes in unit-dose and unit-of-use solid-dose packaging and often works with repackagers like Hospak, which buys generic pharmaceuticals, has them repackaged, and sells them to hospitals in specialized formats.
Another repackager, UDL Laboratories Inc., has captured a significant market share in hospital unit-dose formats, says Jodi Eichelberger, national accounts manager. Owned by Mylan Laboratories, a developer, manufacturer, and marketer of generic and branded pharmaceutical products, UDL Labs repackages Mylan's drugs and other generic drugs purchased from other manufacturers into its own private-label line of unit-dose formats specifically for institutional use. The firm currently offers more than 300 SKUs, and only nine of those are not in bar coded unit-dose formats.
Despite PhRMA's 1990 findings and UDL Labs' success, many in industry say bar coding unit-dose packages simply cannot be done affordably. At least not yet. Sharpless says the problem with bar coding blisters occurs when healthcare professionals request information that can't fit on a single blister.
To put bar codes onto hospital blisters, Cohen says most manufacturers will have to make blister packages bigger. Such an increase in real estate means much more than an increase in materials. "Because you need more labeling space for each dose, you end up with fewer doses per blister. This means that some companies will lose up to 60% capacity of their blister packaging lines. In addition, you will need new tooling and in-line printers. This [endeavor] is no small cost."
Another challenge is determining a code. The 1990 PhRMA bar code committee recommended using Code 128 Subset C with a 10-mil or larger narrow bar width and printing the code in the seal area between blister cells, splitting the code longitudinally with the perforation. Peter Umbdenstock of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY), one of the vendors that participated in the 1990 study, says the code holds about 10 characters. He and his brother Jim Umbdenstock still recommend this code, saying that it can be printed easily with in-line printers mounted on blister-forming machines. Adolph Gottscho Inc. (Union, NJ) also participated in the 1990 study, and some of its systems have been mounted on blister lines from Uhlmann Packaging Systems LP (Towaco, NJ).
Stephen Hess, director of packaging technology for Merck & Co., agrees that finding real estate for codes can be difficult. However, Merck has been marketing bar coded hospital unit-dose packaging for years, encrypting the National Drug Code (NDC) into Code 128, so its challenge is a different one. FDA's proposal will require codes to include the NDC, just like Merck already does, but the agency is considering requiring lot numbers and expiration dates per the advice of several groups. Including such variable information in bar codes means that manufacturers may need to choose a code other than Code 128 because the bar code might be too long.
Instead, smaller, more data-dense codes may help manufacturers fit the NDC, lot number, and expiration date. Several have evolved since the study, such as Reduced Space Symbology codes from the Uniform Code Council Inc., two-dimensional Data Matrix codes, and some other proprietary codes. "You can get a lot of characters into Data Matrix formats," says Peter Umbdenstock. "These two-dimensional codes have enough room for an NDC, lot number, and expiration date." He adds that PDF-417 and some stacked codes can also work. And an invisible code readable with only ultraviolet light holds promise, too, but requires further investments. However, until FDA sets a standard, Cohen believes that manufacturers are reticent to invest time and capital in a code that may not be used widely in years to come.
Rich Hollander of Pfizer adds that industry needs to evaluate the other label copy already required on hospital unit-dose packaging. "Does a drug manufacturer's or distributor's name and address need to appear if the NDC is there in human and machine readable format and is already present on the outer packaging labeling?" he asks. "Adding the requested information to already crowded labeling may easily compromise the human-readable differentiation between products/strengths that is essential when there is no automatic identification at the dispensing level. We need to be careful and cognizant that if more copy is to be added to already crowded labeling, we may need to remove other copy."
MAKING IT HAPPEN
Manufacturers can enlist the help of equipment providers like Uhlmann, Griffin-Rutgers, Gottscho, and others to help them print in-line. They can also seek out a contract packager that has invested in equipment and let them eke out some labeling space for bar codes.
American Health Packaging (Columbus, OH), which offers both repackaging and contract packaging operations, is in a unique position in that it works with both manufacturers and hospitals. "We see the full range of what manufacturers are struggling with as well as how users are interfacing with packaging," explains president Ed Hancock. "Hospitals would prefer not to repackage drugs, so there is a competitive advantage for products in unit-dose formats." Hancock admits that fitting a bar code that includes an NDC, a lot code, and an expiration date onto the typical unit-dose blister is not easy, so his firm is working on a solution.
Demand for bar coded blisters is likely to continue to increase, especially when hospitals begin to see other benefits beside patient safety. "Blisters can be bar coded to automate dispensing, which can also automate drug inventory control and billing as well," explains PCI's Jackson.
And, "when the manufacturer (or its hired contract packager) supplies hospitals with unit-dose packaging, hospitals are able to save through increased prescribing efficiencies. These savings can be realized through decreased handling and transfering of medications from one package medium to another," says Jeff Robb, vice president of marketing, technology, and strategic alliances at Mebane Packaging, a Westvaco Packaging Resource (Mebane, NC).
Not only would coded unit-dose packaging save hospitals money and labor, but it would also limit their liability. "It is becoming clearer [to hospital administrators] that compliance is an issue both in terms of cost of healthcare provision and personal liability for dispensers and administrators of the drugs," explains Nic Hunt, global product director for Rexam Pharma Flexibles (Mundelein, IL).
Hospitals and their buyers may soon begin shopping for bar coded unit-dose pharmaceuticals. If manufacturers want to secure contracts with group purchasing organizations like Novation, says Riddick, "they are going to have to bar code unit doses." Otherwise, repackagers like UDL Labs will have the competitive edge.