Medication errors caused more than 7,000 deaths in 1993, according to a landmark report published in 1999 by the Institute of Medicine (Washington). Most medication errors are preventable, but efforts to reduce errors have not been particularly successful. The U.S. Food and Drug Administration (FDA, Washington) is hoping to turn this situation around by requiring bar codes on packaging for prescription and over-the-counter drugs dispensed at patient bedsides in hospitals. The final rule was published in February 2004 and takes effect on April 24, 2006, except for new drugs, which must comply within 60 days of approval. The idea is to have the care giver scan the bar code on the package and, perhaps, the patient wristband, as well as their own identification badge. This information would link back to a database to confirm the right drug is being given to the right patient at the right dose at the right time by the right administration route. Hospitals with such systems already in place have experienced dramatic reductions in medication errors. The bar code must encode the product's National Drug Code (NDC), and it may include the lot number and expiration date. "We try to encourage our customers to include lot number and expiration date capability or plan for it in their online printing systems," says Debbie Murphy, global life sciences practice leader at thermal-transfer bar code printer supplier Zebra Technologies (Vernon Hills, IL). Encoding lot number and expiration date information helps customers manage inventory-related processes. It also can be useful to drug manufacturers. "By reading unit-of-use codes, instead of just printing them for customers, [manufacturers] can gain supply chain visibility and improve the quality of their information," notes a white paper from Zebra Technologies, "Beyond Point of Care: Benefiting from Unit-of-Use Bar Code Traceability in the Life Sciences Supply Chain." This can enhance batch traceability and support brand protection and anti-counterfeiting efforts, as well as use of radio frequency identification (RFID) technology. The paper goes on to explain that "a major benefit to data entry by scanning will be sharply reduced labor and effort required to comply with the myriad regulations covering the transport and storage of controlled substances including the FDA's Good Manufacturing Practices, 21 CFR Part 11 Electronic Signatures Rule and the Safe Medical Devices Act." It can also improve production, record keeping and distribution operations. "Variable information at the unit-of-use level closes the loop between enterprise and supply chain traceability systems," the paper concludes. UP TO SNUFF
Any linear bar code that meets the standards of the Uniform Code Council (UCC)/EAN International (Lawrenceville, NJ/Brussels, Belgium) and is capable of accommodating the NDC may be used. This gives drug makers and their customers many options, the most likely being Code 128 or Code 39, which are already commonly used in the healthcare industry, or the Reduced Space Symbology (RSS) family of codes, which were designed to fit in the limited area available on most unit-dose packages. For a drug maker accustomed to filling pills into bottles with counts of hundreds or even thousands, the transition to bar coded unit-dose packages is a big change. Even companies using blister card packaging, which arranges pills in a series of pockets covered by peelable or push-through lidstock, will need to make some changes. Assembling a unit-dose bar coding system requires integration of numerous components. Preprinted labels may be purchased, but, more likely, drug makers will add an existing line or install a secondary off-line coding process. With the potential for different symbologies being required by different customers, system flexibility is paramount. Quick changeover on the production line is also essential because production runs tend to be relatively short. Other important features include crisp print reproduction to ensure scannable codes, ability to handle variable data and connectivity with upstream systems. The type of material being printed also may impact printer selection, and consumable costs related primarily to ink or ribbons must be considered. Keep in mind also that printing technologies for packaging pills in blister cards is much different than printing processes for pill bottles. Printing on blister card lidstock generally is done by a unit mounted on the blister packaging machine. Options include flexographic platen printers, which use a flat rubber mat to transfer ink to the material being printed, flexographic ultraviolet (UV) printers, inkjet and thermal-transfer overprinters. For wider material widths, printheads may be ganged or mounted on a traversing device. The 800 Series of In-Line Platen Printers from Adolph Gottscho Inc. (Union, NJ) includes units compatible with most blister packaging machine models. Removable print mat plates reduce plate changeover time to less than 60 seconds and allow for variable coding. UV inks reduce the release of volatile organic compounds and cure quickly with exposure to UV light to produce smear-resistant bar codes, alphanumeric characters and graphics. As a result, "UV systems can be easier to maintain and clean and offer higher overall quality and reliability," says Christopher Anderson, director of sales and marketing at Adolph Gottscho. The DataFlex thermal-transfer overprinter from Videojet Technologies Inc. (Wood Dale, IL) mounts on blister packaging or thermoform-fill-seal machines, which seal products into plastic containers they create, and prints codes two at a time. Software reproduces RSS codes, and a clutchless, bidirection ribbon drive maintains ribbon tension, backtracks after printing so nearly all of the ribbon is used and prevents breaks. The digital system relies on a standard Windows operating system with ethernet to code in real time, simplifying the programming of date and time rollovers and offsets and communications with other systems. A color touch screen with a graphical user interface makes the system easy to learn and simple to operate, according to the vendor. Another option is the GottJet Series of inkjet coders from Adolph Gottscho, which are extremely flexible and able to print across wide expanses of lidstock. They rely on standard industrial ink cartridges from HP (Palo Alto, CA) and address shortcomings related to creating an image via a pattern of ink droplets to produce consistently scannable codes. Label printers can be installed off-line or integrated with applicators online. Thermal-transfer is popular because of its high print quality, but inkjet, laser and hot-stamp coders are also used. Whatever printing method is selected, manufacturers must verify codes are scannable and correct. "You want to make sure you have the highest level of readability possible," says Diane Hund, global marketing director at Videojet Technologies. Often a laser scanner and/or camera-based vision system is integrated with the printing system. The camera verifies the human-readable data via optical character recognition/verification software while a laser scanner confirms bar code readability. It may even grade print quality based on standards administered by the American National Standards Institute (Washington). Additional scanners may be located at various points downstream to capture data and enable product tracking from the packaging line to the dock door. For this data to be truly useful, readers and printers must connect to, and communicate with, related systems. Ideally, this connectivity reaches all the way back to the enterprise resource planning system. SAP AG (Walldorf, Germany), for example, makes it possible to bundle processes from manufacturer to patient via its Adaptive Business Network, which allows software systems to communicate even if some of the systems aren't SAP based. "The resulting visibility provides a lot of traction in product recall situations," says Jim Sabogal, a U.S.-based solution manager in SAP's Life Sciences and Pharmaceutical industry business unit. That's because knowing exactly what product is affected and where it is in the supply chain minimizes the size of the recall and eliminates the recall of large numbers of good product. Yet another consideration when assembling a unit-dose labeling operation is material handling. Although designed for sample packaging, the stainless steel Blister Packaging Station from AutoPak Engineering Corp. (San Juan, PR) also can be used for unit-dose applications. In action, blisters are conveyed from the outfeed of the blister packager through a gap transporter to a stop where a pre-set number of blisters are automatically counted and dropped into a waiting display tray. Once the count is complete, the flaps are manually closed, it's placed on an exit conveyor for case packing and an empty tray is set up. The modular system can be configured with multiple stations as needed. MERGED TECHNOLOGIES
With implementation of unit-dose labeling paralleling growing demand for anticounterfeiting tools and supply chain interest in RFID, it's likely that the use of the three complimentary technologies will converge sooner rather than later since each can contribute to product visibility and record keeping for electronic pedigrees. Supporting this hypothesis is the fact that the FDA has described RFID as a leading technology to fight the growing problem of counterfeit drugs and is strongly committed to reducing the number of fake products in the supply chain, which is estimated at about 10% globally and as high as 50% in some countries. Technology vendors are hard at work, too. Gottscho, for example, is partnering with DNA Technologies (Boston) to add DNA taggants to its ink, and several companies including HP are developing ways to apply codes to individual pills. As these technologies mature, analysts assure, both patients and manufacturers will benefit as medication errors decline and counterfeit products are blocked from the supply chain.