Originally Published March 2000
BAR CODE SUPPLEMENT
Using Bar Codes to Reduce Medical ErrorsBy placing bar codes on individual, unit-of-use packages for medical devices and pharmaceuticals, manufacturers can take part in a movement intended to reduce the number of errors caused in hospitals and pharmacies.
by Daphne Allen, Editor
Errors at medical facilities have reached alarming numbers. The Institute of Medicine (IOM) reports that medical errors kill between 44,000 and 98,000 people a year in hospitals alone. A 1997 article in the Journal of the American Medical Association cites a study at two prestigious teaching hospitals that showed that 2 out of every 100 admissions involved a preventable adverse drug event. While not all of these errors resulted in death or disability, the study reported that they increased hospitals' costs by an average $4700 per admission, or about $2.8 million annually for a 700-bed teaching hospital. And IOM feels these estimates are modest.
A number of solutions have been suggested. Develop more-user-friendly medical devices and drug delivery systems. Institute a no-fault policy for adverse-event reporting. Automate hospital processes in order to minimize the possibility of human error.
Healthcare product packagers have an opportunityand perhaps an obligationto participate in this last solution. One of the staples of automation is automated identificationhaving a computer decipher product identitythrough the use of bar codes.
Most master cartons of medical products bear bar codes today. Photo courtesy Weber Marking Systems Inc.
Manufacturers already bar code most shipping cases and bulk packages or master packs. According to a 1997 report commissioned by the Supply Chain Committee of the Health Industry Distributors Association (HIDA) on the status of bar code use and implementation in the medical/surgical industry, nearly 70% of all cases and 77% of all master packs bear industry-standard bar codes.
However, the percentages for individually packed products, typically called unit-of-use packs, unit-dose packages, or eaches, lag far behind those of cases and master packs. Only 26% of eaches bore industry-standard bar codes in 1997. HIDA will release a new report this year. The Health Industry Business Communications Council (HIBCC) puts the current percentage of bar coded unit doses at 40%, most of which are solid oral dosages in blister packs.
While coding cases and master packs has helped manufacturers, distributors, and healthcare facilities effectively and efficiently track orders and manage inventory during distribution, these bar codes will do little to help automate product identification at the point of care. Instead, bar coded unit-of-use packages are needed so that each drug dose or each medical device use for each patient and each situation is verified and recorded, say some industry participants. With slightly more than a quarter of individual packages coded, healthcare product manufacturers have a lot of coding to do before they can truly help reduce medical errors.
WHY CODE EACHES?
In 1998, IOM formed the Quality of Health Care in America Committee to improve healthcare quality over the next 10 years. While admitting that no one organization or approach will represent a complete solution, the committee devised recommendations specific to certain industry players. Following are summarized points from the committee's report that apply to packaging.
- FDA should increase attention to the safe use of drugs in both pre- and postmarketing processes
through . . .the development and enforcement of standards for the design of drug packaging and labeling that will maximize safety in use.
- The healthcare industry should use order-entry systems that provide real-time alerts if a medication order is out of range for weight or age or is contraindicated.
- The healthcare industry should use bar coding for positive identification and detection of misidentified patients, records, and so forth.
- The healthcare industry should produce unit-dose packages, which can reduce calculation, measurement, preparation, and handling errors and provide a fully labeled package that stays with the medication up to its point of use.
Bar coding unit-of-use packages could help industry meet all of these requirements. "One approach to preventing medication errors at a patient's bedside is to implement a system for bar code scanning of every dose to check for right medication, right patient, right dose, right time, and right route before administration," says Paul Seelinger, RPh, managerpharmacy logistics products for Pyxis Corp. (San Diego), a subsidiary of Cardinal Health. Pyxis markets several automated medication systems, including MedStation, a point-of-care drug dispensing system, and Homerus, a centralized pharmacy system that packages and bar codes products for use in hospitals and other healthcare facilities.
Ann Marie Cook, director of marketing at Weber Marking Systems Inc. (Arlington Heights, IL), also believes that the use of bar codes can reduce medical errors. With bar codes, healthcare practitioners can rely on "more than just visual checking," she explains. "They can avoid errors caused by bad writing on patient charts and mistakes in drug dosing."
Finally, "bar code scanning can take the place of data entry," which is fraught with error, says Craig Hopkins of CyberLogic, a reseller of bar coding systems from Tharo Systems Inc. (Brunswick, OH).
John Roberts, director-healthcare at the Uniform Code Council Inc. (UCC), feels that controlling medical errors may soon be the key for payment. "The IOM study should be a clarion call to healthcare. The rate of medication mistakes at an alleged 10% is too high. Congress is studying legislation. Major corporations that are paying the healthcare bill have read the report and see methods to reduce costs," he says. "Once a medical malpractice carrier or a health maintenance organization compares a hospital with a 100%bar code product policy, like St. Alexius Medical Center in Bismarck, ND, which has a less than one tenth of a percent medication error rate, with a medical center that does little or no bar code verification and has a much higher error rate, funds and patients will flow to the better-managed, more-efficient, more-productive, and in the end, better-for-the-patient, institution."
At St. Alexius Medical Center, CEO Dick Tschider is a staunch advocate of this technology and supports all efforts to implement technology wherever possible to improve patient care. Anything that enters a patient's room at St. Alexius is bar coded, either by the manufacturer or by employees at St. Alexius. The added cost is offset by error prevention and accurate documentation, both for the chart and billing. This frees up nursing time to focus on the patient. This detailed information on actual procedural costs allows decisions to be made on supplies and pharmaceuticals based on actual history and allows the medical center to work with the medical staff to point out inefficiencies or increased costs when comparing peers.
Unit doses of certain medications can be bar coded for point-of-care scanning. Photo courtesy Accu-Chart Plus healthcare Systems Inc.
Al Schwindt, director of pharmacy at St. Alexius, indicates that "robotic technology was implemented to assist in virtually eliminating dispensing errors, since the robot assists in product identification at the point of dispensing drugs. Because manufacturers do not prepare all their products in robot-ready packaging, which is bar coded and includes product identification, lot number, and expiration date, the medical center prepares its own packaging, because of the risk management program in the institution." According to Frank Kilzer, directormaterials, the hospital's central supply and purchasing, with bar code technology, has reduced lost charges and improved documentation to the point that inventory losses are less than 1%, compared with a national average of 1520%.
The financial impetus for bar coding products may affect demands placed on the drug and device manufacturing industries. "We would like manufacturers to put standard bar codes on everything," explains Roger Pierce, director of the Department of Veterans Affairs's (VA) consolidated mail outpatient pharmacy (CMOP) in Los Angeles. Pierce's CMOP facility, which fills about 17,000 prescriptions for refills and maintenance drugs per day, relies upon bar codes to move products through the prescription-filling process. "Because we are operating at such high volumes, we need mechanisms for reducing errors. Bar code scanning verifies that the right product is being channeled to the right customer through our automated systems. Humans can take shortcuts, especially when working quickly and for long hours. The use of bar codes reduces the possibility of those errors."
VA's prime vendor, AmeriSource, has agreed to work toward putting bar codes containing universal product number (UPN), expiration date, and lot code on everything it supplies to the VA, says Pierce. "The CMOP directors would like them to do it even if the manufacturers don't." But he says that he'd prefer it if manufacturers were to place standard bar codes on unit-of-use packages from the very beginning.
The VA has also brought bar coding right into its hospitals. The first hospital in the VA system to implement a bar code scanning system at the point of care was the Topeka, KS, Colmery-O'Neil VA Medical Center five years ago. "Nurses, patients, and products are all bar coded," says Pierce. "Anything that doesn't match sounds an alarm." Tracy Eddy, the pharmacy supervisor on staff at the hospital, states that the hospital ideally purchases unit-dose liquids or controlled substances already bar coded from the manufacturer or distributor. "But for solid oral-dose medications and some liquids, we still need to bar code the unit doses," she says.
Also, the state of California now requires a UPN on all of its Medi-Cal purchases. If the bidder does not have a UPN, the bidder must supply its UPN implementation plan. "With group purchasing organizations and now California demanding the UPN on all products, UPN marking has been given a big boost," says Roberts.
Key Web sites for manufacturers interested in bar coding their products include:
HIBCC OR UCC/EAN?
The healthcare industry has two bar code standards to choose fromeither HIBCC's health industry bar code labeler identification code (HIBC-LIC) primary data structure or UCC's and EAN International's UCC/EAN universal product code (UPC) primary data structure. While the HIBC-LIC is an alphanumeric code, the UPC is all numeric. Each standard defines the information required and the order of that information. The UCC/EAN standard uses a version of the symbology Code 128, and the HIBC-LIC standard uses either Code 39 or 128. Code 128 is widely used because it takes up less space, says HIBCC's president Robert Hankin, PhD.
Despite the type of coding standard a manufacturer chooses to use, hospital scanners should be able to read both of these two standards. Today's scanners have an automatic discrimination feature that enables them to determine whether a bar code conforms to either the UCC/EAN standard or the HIBCC standard, explains UCC's Roberts.
HIBCC's Hankin points out that the HIBC-LIC standard was developed specifically for the healthcare industry and took into consideration healthcare provider requests to make the code alphanumeric. "The alphanumeric code enables healthcare providers to link it to other alphanumeric items, like patient names," says Hankin.
Bar codes, text, and logos can be produced by thermal-transfer printers.
The benefit of the UCC/EAN standard, however, is that it is designed for retail distribution in addition to healthcare distribution, explains Karen Longe, a healthcare bar coding consultant based in Lake Bluff, IL.
The nature of the unit-of-use package presents a problem. Usually small, the packages often contain product name, maker, strength, lot number, expiration date, National Drug Code (NDC), use instructions, and any warnings. Other products, like medications removed from bulk bottles, often don't even have a package. Such a situation does not make it easy to apply a label with a bar code.
"The real issue is the amount of real estate on these small drug containers. FDA wants in human-readable form the NDC, lot number, and expiry date, and the manufacturer wants its name and address. This does not leave a lot of room for a bar code," explains Roberts. "That is why the UCC has been working so hard to produce reduced-space and composite symbology."
Last year UCC and EAN International introduced multiindustry symbology standards for space-constrained applications: reduced-space symbology (RSS) and composite symbology.
Even single tablet packs can be bar coded. Photo courtesy Accu-Chart Plus Healthcare Systems Inc.
The RSS is the most compact linear symbol to date and is available in four symbologies: RSS-14, RSS-14 Limited, RSS-14 Expanded, and RSS-14 Stacked. (See "Cracking the Bar Code Quandary" on page 6 in the October 1999 issue of PMP News.) The partnership's other solution, composite symbology, consists of a linear symbol that encodes UCC/EAN primary item identification. The linear symbol is associated with an adjacent two-dimensional composite component that encodes supplementary application identifier element strings, such as a batch number or expiration date.
UCC has set up a healthcare RSS implementation team composed of about 15 members to develop an application guide for the use of the RSS on small vials and bottles. Two manufacturers, Abbott and Alcon, have agreed to test the RSS by bar coding it on some of their smallest products, and St. Alexius will attempt to read it at the ward level. "This will help us prepare a guideline for use for both the manufacturer and provider," says Roberts.
"RSS is viable for the healthcare product industry," says RSS team participant Tom McInally, director of logistics and distribution services for Bergen Brunswig (Orange, CA), a healthcare product distribution firm. "You can get down to the smallest footprint possible." He admits that hardware to read it is not in wide use, but often "it only requires users to reprogram their scanning software."
Recently, HIBCC has been moving to adopt the two-dimensional data matrix. "It is about one-third to one-half the size and can contain twice the data as the traditional-sized Code 128," explains Hankin. In addition to product and manufacturer information, the code can contain lot numbers, expiration dates, and other information hard to fit into linear codes.
"We have finished the technical work on specifications for the use of a data matrix carrying the HIBC data on surgical instruments and the use of PDF-417 or a data matrix for pharmacy-packaged medications and patient identification. PDF-417 is the most widely supported two-dimensional symbology and is especially useful for labeling cylindrical-shaped containers such as vials and syringes. Work is also under way on the use of data matrix and/or PDF-417 on unit-dose packages and, most significantly, on the use of optical character recognition (OCR) for the coding of lot and expiration date information on unit doses and other small packages, says Hankin. "OCR will enable the automatic capture of text information just as bar codes are read today. In this way, the manufacturer can avoid the costs of implementing two-dimensional bar code printing for the coding of lot/batch and expiration date information, which has been shown to be a barrier to the implementation of two-dimensional bar codes on unit doses."
COST AND EFFICIENCY
As Hankin points out, for medical device and pharmaceutical product makers, perhaps the biggest obstacle to bar coding each individual medical device and pharmaceutical package is cost. "It is hard to quantify a return on investment when bar coding unit-of-use packages," says Weber's Cook.
To bar code individual products or medication doses, many manufacturers may need to first adopt unit-of-use packaging instead of bulk packaging. Device manufacturers usually do place devices into individual packages to maintain the sterility of each item, so these firms may only need to redesign their labeling. But for pharmaceuticals, a sizable portion of drugs shipped to pharmacies and hospitals are supplied in large bottles with 1000 counts or more. Drug manufacturers will then most likely need to switch to blister packages, which hold each dose in its own package. The change will undoubtedly bring substantial costs in terms of package redesign and validation, but the benefits of unit-dose packaging include far more than a contribution to automatic identification. Unit-dose packaging also aids in regimen compliance and may increase product shelf life.
If a firm chooses to bar code its products, there's really no way for it to avoid the capital investment, unless it is prepared to employ a label-printing firm and to deal with inventory replenishment issues. Equipment suppliers, however, have made it easier and more efficient to place bar codes on small packages in-house, which can translate into labor and time savings.
Adolph Gottscho (Union, NJ), a firm that has been advocating the use of bar codes on unit-dose packages for more than a decade, supplies platen printers for printing bar codes on a wide variety of substrates. For instance, the printers can impart codes onto foil, film, paper, and metallized paper and film. Such capabilities allow users to bar code individual pill blisters as well as larger blisters.
By linking the labeling software that runs thermal-transfer printers to company databases that produce and maintain the bar codes for each product, manufacturers can switch from one bar code to another without changing machine hardware. Weber and Bell-Mark (Pine Brook, NJ) both offer such systems. "Bar codes for each product vary, even if slightly, and many companies are using the same packaging line for multiple products," explains Tom Pugh, vice president of sales and marketing for Bell-Mark, whose EasyPrint thermal-transfer printer was designed to replace hot-stamp coders. Rather than buying separate lines and printers for each product, companies can simply use one thermal-transfer printer. "Thermal-transfer printers are better equipped to produce variable codes than other systems," Pugh says. In addition, Weber can even customize its Legitronic software to meet specific needs.
The quality of printing equipment has also improved tremendously over recent years, enabling healthcare product manufacturers to produce clear, scanner-friendly codes with little waste. "It is easy to bar code unit-of-use packages now," says Pete Umbdenstock, vice president of sales and marketing for Griffin-Rutgers Company, Inc. (Ronkonkoma, NY), a provider of ink-jet and flexographic printers. "Years ago, we relied on platen printers to produce codes, but it was difficult to maintain registration. Also, the systems relied on solvent-based inks, which over time would lose some of their vibrancy through solvent evaporation."
"Now," says Umbdenstock, "we offer technologies like roller flexography presses with ultraviolet-curable inks. There are no problems with registration and the printed ink is a vibrant black. For instance, we just set up a system for printing small codes and print on silver foil and the outcome was amazing."
In addition to thermal transfer and flexography, ink jet can also be used to produce codes. Weber has developed a high-resolution ink-jet coder that can print scannable bar codes directly onto both porous and nonporous surfaces. Similar ink-jet systems are also supplied by Marconi Data Systems (formerly Videojet Systems International; Wood Dale, IL), Domino Amjet (Gurnee, IL), and Griffin-Rutgers.
According to Ed Atwell, business manager for Marconi Data Systems, the firm's ink-jet technology has been used to apply bar codes since the early 1970s. "The use of ink-jet equipment for bar codes has always been driven by several important factors. One main driver is the extremely low cost of the bar code itself when applied by ink-jet equipment. For example, the cost for an ink-jet bar code can be as low as $0.000006 each," he says. "Additionally, being able to apply bar codes using a noncontact technology such as ink jet tends to make integration into existing production systems easy. Also, ink-jet print speeds easily and reliably keep up with the highest of production line speeds."
"By far the most versatile and compact ink-jet coding format is the two-dimensional or data matrix code," says Domino Amjet's Ken Stephenson. "Aesthetically more pleasing, it blends well with label graphics and for a given area can contain many times the data of conventional bar codes. Codes as small as 3/16-sq-in. can be printed and scanned equally well using either visible or invisible ultraviolet inks."
Dave Schuh, vice president of sales and marketing at MGS Machine (Minneapolis), says that while he has seen the pharmaceutical packaging industry predominately rely on preprinted bar codes applied by the packaging material providers, MGS does get some requests for bar code printing equipment. "We have been supplying bar code printing equipment on our case packers for quite some time. Up to this point, application requests to move this capability upstream to the point-of-use package have been few and far between. We do have the capability to respond, should the trend to print in-line on the point-of-use package emerge further," he says. MGS can either integrate bar code printing equipment like ink-jet, thermal-transfer, and laser printers right onto packaging lines or supply the bar code scanning devices used to verify that the right product is being packaged with the right preprinted bar code.
Manufacturers that are still undecided about what type of printing technology to use can visit UCC's Web site for a complete overview of the major technologies and their strengths and weaknesses. (See box above for a listing of UCC's site and other Internet resources for bar coding products.)
Invisible Codes Save Time and Money
Recently, Searle R&D (Skokie, IL) developed a new drug that required an efficient mechanism for product tracking between the U.S. manufacturing plant and a labeling location in Europe. Ideally the tracking mechanism should not interfere with the market appearance of the product.
Because the vials needed to be shipped nude from the United States to Europe for country-specific labeling, it was originally thought that the vials needed to be sealed in a coded box for lot code and expiration date identification after they reach their European destination. However, if the boxes were opened or damaged during transit, the European packaging site would be forced to discard the entire contents of the compromised box because they could no longer be certain of the vials' authenticity and lot code. "We couldn't be sure that the vials hadn't been tampered with," explains Ralph Dillon, international manufacturing engineering for Searle. "But we weren't set up to label the products according to individual European country requirements in the United States, so consequently we need to ship them nude."
That's when Dillon's team decided to print a two-dimensional data matrix code, a compact code that takes up little space, on the bottoms of the nude vials in an invisible ultraviolet ink. Domino Amjet (Gurnee, IL) provided the ink-jet equipment for applying the code as well as the invisible ink. "The data matrix code gives us more digits or bits of information encoded in the same space as a traditional bar code," he says, "which is helpful because the 2-ml vials are very small."
Domino Amjet's A300 ink-jet printer has built-in data matrix software.
Also, the invisible code does not interfere with the labeling being applied in Europe, so it "does not become a marketing appearance concern," Dillon adds. Vial contents can therefore be inspected easily.
Because data matrices do not need to be oriented to any particular position for scanning, Searle saves money by eliminating the need for an orienting device. "We were able to eliminate a capital cost." Using bar code scanning equipment from Systech (Cranbury, NJ), Dillon was able to automatically check every vial for proper identification quickly and cost-effectively. To keep costs down or to stay on schedule, "other companies perform lot sampling as a means of verification. We are able to implement 100% inspection."
Able to verify the authenticity of each of its vials upon arrival in Europe, Searle is able to avoid discarding valuable vials of its new injectable drug, which is currently in clinical trials. "We have automatic authentication technology," Dillon explains, "and it gives us confidence in our packaging facility operation."
Dillon feels that other companies could realize similar benefits more easily than they may think. "This is a proven, reliable, and easily validated technology in that ink-jet coders and vision systems are already common in most plants," he says. "And data matrix is a proven, reliable code. Since it is used extensively in electronics, it will be supported for many years to come. This is no Sony Betamax."
TAKING THE FIRST STEP
In some ways, the healthcare industry is at an impasse. Hospitals, which are often struggling just to survive in an era of managed care, reduced reimbursement, and increased services demand, are reluctant to spend the money it takes to implement an automated system, especially if most of the devices and drugs they receive do not carry bar codes at the unit-of-use level. Many hospitals and pharmacies have implemented their own bar coding systems, using systems from Pyxis or Accu-Chart Plus Healthcare Systems Inc. (Hoffman Estates, IL). Tim Cloninger, president of Accu-Chart, strongly suggests that hospitals carefully examine all of the operational costs associated with each system that is being evaluated. "The benefits of a true unit-dose system with bar code technology are great. Every medicationsolid, liquid, injectable, etc.needs to be in a unit-dose form with a bar code on each item to achieve maximum accuracy and efficiency. If all of the drugs are not bar coded, you open the door for mistakes to be made."
On the other hand, healthcare product makers hesitate to spend the money it takes to place bar codes on individual products that most likely will be used in a nonautomated setting. Bar coding unit-dose packages may require manufacturers to redesign packages and labeling just to accommodate the codes.
UCC's Roberts feels that the responsibility lies first with hospitals. "The manufacturers want to hear from the customers. If the primary customer is not demanding bar codes, why should the manufacturer place them on the product?"
Instead, Roberts believes that healthcare providers such as hospitals "should develop the policies that will allow the best use of this technology, before it is mandated. Hospitals should look to their peers that are efficient in this area, benchmark themselves against them, and stay in business."
However, the work of the healthcare product manufacturer is not over. More unit-of-use products need to be bar coded for scanning at the point of care. Until most individual packages bear bar codes, product identification and delivery will remain a manual process, subject to human error.
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