Bar codes have made a difference in healthcare, but they have materialized slowly on unit-of-use packages.
On October 7, 2012, the bar code celebrated its 60th anniversary. And while PMP News is only celebrating its 20th anniversary in 2013, much of our reporting over the years has been on this automatic identification enabler.
In June 1994, PMP News called bar coding “one of the fastest growing technologies in the healthcare industry.” In the article, “Bar Coders Manage the Data Boom,” PMP News reported that “the flock of new bar codes compresses more data in less space, opening a world of opportunities for imprinting information on a package.” The article described “the 2-D Data Matrix Code . . . to encode data in a redundant, ‘checkerboard-like’ format.”
In-line printing has advanced to support variable coding, such as those produced by Bell-Mark’s Intellijet printer.
And today, in 2013, manufacturers in both the pharmaceutical industries and medical device industries are turning to bar codes to position themselves to apply unique identification to saleable or unit-level packages, which many in the 1990s called “eaches.” Pharmaceutical manufacturers are currently preparing to meet California’s electronic pedigree regulation, under which at least 50% of a manufacturer’s pharmaceutical products will need to bear a serial number at its lowest saleable level by January 1, 2015; the remaining 50% will need to do so by January 1, 2016. While there is currently no federal requirement for serialization, FDA has provided for guidance for adding what it calls Standardized Numerical Identifiers (SNIs) in it’s March 2010 guidance.
FDA is also finalizing its proposed rule for Unique Device Identification (UDI), which would require most medical devices distributed in the United States to bear unique device identifiers. The final rule, expected this summer, will most likely spell out coding requirements based on device class.
Interestingly, while regulations and standards are taking shape today, in the early days, bar coding efforts may have been driven by utility and application, rather than regulation.
“Over the past 20 years, the role of bar coding for the pharmaceutical and medical device industries has seen a slow but steadily rising growth,” explains Bill Croisetiere, technical key account manager, Bell-Mark. “The focus for the early part of the past 20 years had been primarily a cost versus value proposition. In the mid-1990s, most companies implementing bar codes had started doing so as they identified value within their own four walls. Over the last 5 to 10 years, there has been a much higher focus outside of those walls due to an awareness of patient safety. This awareness has been enhanced with the development of federal, global, and local regulations and standards.”
Further, “end users have been utilizing bar codes over the last 10-plus years in their efforts to identify patient data, devices, and medication to streamline their processes and minimize patient risk,” continues Croisetiere. “In most cases, they have needed to develop internal bar code standards relevant to their business systems to achieve any value. These programs/projects completed by end-users have been tracked to show how they have been able to improve their businesses ability to execute work daily while lowering operating costs in many instances.”
For instance, in July 1994’s “What Hospitals Want from Bar Codes,” features editor Melissa Larson wrote: “More and more healthcare center administrators are realizing that bar codes can help in everything from product inventory to avoiding patient/drug mixups.”
In May 1994’s “Hospital Packaging Trends,” PMP News quoted Al Schwindt, then director of pharmacy for St. Alexius Medical Center, as saying, “We can minimize errors with bar coding.” Bar coding also “allows us to charge everything the patient uses to the patient’s account. We [used] to have lost charges of 12 to 16 percent. We are now down under 1 percent.”
St. Alexius has continued to benefit from bar coding. Frank Kilzer, who actually helped Schwindt’s department implement bar codes, reports that before 1985, when they had started using bar codes, about 35% of their stock was “lost—we didn’t know where it went. But when we started scanning bar codes, the average loss across all departments was reduced to less than 3%, and in several key areas, such as our Cath Lab Department, the losses were completely eliminated by scanning 100% of everything they use.”
Videojet has produced the text “Pharmaceutical and Medical Packaging News” in a Code 128 bar code above, and the same data in a DataMatrix symbol. Both symbols are printed with the same size bars and elements, but the DataMatrix symbol is much smaller and easier to fit on packaging of all shapes and sizes.
Kilzer has been a strong, continuous advocate for healthcare product bar coding. He has spoken at numerous industry conferences and to regulators, even hosting FDA’s Jay Crowley to demonstrate how UDI would work in a hospital setting.
Kilzer has slowly seen bar coding of pharmaceuticals and medical device increase over the years. He estimates that about 50 to 60% of the items that his hospital receives carry bar codes at the unit-of-use level, so his team continues to apply their own bar codes to 100% of the incoming items to be sure that every item can be scanned throughout the system. “It means that much to us. We can track utilization. Now more than ever you need to know where your costs are.”
Why Bar Codes?
As Kilzer observes, more and more healthcare products are carrying bar codes. Why?
In October 1997, PMP News reported that “bar codes are used by healthcare providers for their internal applications, including patient specific samples, patient tracing, automated systems, stock picking, order and reordering. . . . Coding and marking just makes good business sense.” And “Traceability is important to allow the manufacturer to track the product back to a certain point in time; to pinpoint the product to a specific shift,” Erik Brainard of Graseby Allen was quoted saying in the issue.
Today’s hospitals and manufacturers are reaping those very same benefits and more. “In the last 20 years, bar coding of pharmaceutical products has enabled manufacturers, packagers, distributors, retailers, and users to easily trace basic information such as lot numbers, batch numbers, and expiration dates,” says Chris Palmer, global strategic account manager, life sciences, Videojet. “A unique National Drug Code (NDC) bar code is assigned to each manufactured drug and is marked on each package enabling fast and accurate identification of products throughout the supply chain.”
Manufacturer uptake has been gradual. While “there has been little change over the previous 15 years, with recent legislation in France, India, China, and Turkey, we are now starting to see a massive shift in the global introduction of machine readable codes—bar codes—in pharmaceuticals and medical devices,” observes Craig Stobie, global life sciences sector manager for Domino. “One of the reasons behind this is the global proliferation of falsified medicines and the need for manufacturers to protect its brand and its patients from these medicines. We are seeing a shift—underpinned by various pieces of global legislation—from batch to item level coding, to facilitate traceability and enable item authentication. There is also an emerging objective from hospitals to reduce the number of medical errors by scanning machine readable codes, at the bedside, during dispensation or in theatre, on pharmaceutical products and medical devices.”
Smaller, more data-dense bar codes that have emerged over the two decades have suited pharmaceutical and medical device packages, first with DataMatrix, then Reduced Space Symbology, later renamed GS1 DataBar. Siobhan O’Bara, senior vice president, Industry Engagement, GS1 US, says that “GS1 US is observing increasing use of smaller bar codes such as GS1 DataBar and GS1 DataMatrix that can hold more product information, in less space, and on smaller packages. This supports automatic capture of the product information in hospital systems from receipt to the EHR. This extended information will be easily adaptable to the next wave of technology adoption, RFID, especially with EPC-enabled RFID which is backwards compatible with the GS1 bar codes.”
Explains Robert A. Hankin, PhD, President & CEO, the Health Industry Business Communications Council (HIBCC): “The most significant role shift has been from what was a predominately warehouse and cash register–based logistics process to a critical and broadly applicable patient safety tool. This was spurred in part by advances in technology that allow for small package labeling, i.e., unit or patient-dose labeling, thereby bringing it to the bedside and the individual. The parallel reductions in scanner hardware costs made the technology more feasible for both large and small hospitals to implement. In terms of understanding the importance and applicability of these advancements, the industry has been garnering collective uptake and growing support for many years. Important events have included the 1999 Institute of Medicine (IOM) report which cited bar coding as a potential method to reduce medical errors, and the subsequent Food & Drug Administration (FDA) regulations on pharmaceutical labeling in 2006 and on medical device UDIs more recently.”
Palmer concurs: “Healthcare providers and hospital systems are focused on keeping end-users safe. This has translated into the creation of the 5 Patient Rights where hospitals accurately identify and administer patient medication by scanning a bar code to ensure that the right medication is given to the right patient, in the right dosage, from the right route and at the right time. At the same time, healthcare providers scanning the patient medication bar code are able to create an automatic billing entry to account for the medication delivered to the patient.”
Adds Hankin: “The healthcare industry’s acknowledgment of the importance of alphanumeric capability in labeling led to the creation of the Health Industry Bar Code Standards (HIBC) early on. Twenty years ago HIBCC was celebrating its 10th anniversary as an organization and of our work developing standards specifically for providers and their suppliers. We were tasked with this mandate by our founding organizations, including the American Hospital Association, and since that time the alphanumeric Supplier Labeling Standard (SLS) and the Provider Application Standard (PAS) have achieved global integration, as well as recognition from ANSI, CEN, and ISO.”
So why has it taken pharmaceutical and medical device manufacturers so long to implement unit-of-use bar coding. Why is St. Alexius still only seeing 50 to 60% of incoming stock with unit-of-use bar codes?
Stobie says there “was very little change in the last twenty years with most companies using often very poor embossed, human readable as the only form of identification on products. Unlike the FMCG environment, which has seen wide-scale use of bar codes since the first product (Wrigley’s chewing gum) was scanned in 1974, the pharmaceutical and medical device sectors have seen little and isolated use of bar codes other than for use with pallets.”
Legislation has encouraged manufacturers to push forward. The minimal use of bar coding “changed with the legislation in animal health products (IFAH) back in 2008, which introduced batch level at item level including a 2-D code,” says Stobie. “We have subsequently seen similar legislation initially introduced in Turkey (Jan 2010), France (Jan 2011), and South Korea (Jan 2012). The legislative requirements for the adoption of bar codes, often unique at item level, have now become widespread with the United States, China, India, and Europe all in the process of ratifying requirements.”
Thankfully, technology has improved steadily over the two decades. Palmer explains that a “variety of technologies are required to mark various pharmaceutical packaging materials including pouches, blister packs, syringes, vials, bottles, cartons, cases, and more. Videojet’s portfolio of marking and coding solutions has grown to match this challenge—offering many solutions within each product family—thermal ink jet, continuous ink jet, case coding, thermal transfer offset printing, laser marking, and printed and applied labels.”
Croisetiere says that a major development in the last 20 years “is the technology available to support printing valid quality bar codes. Prior to 300-dpi or higher resolution printers being available it was very difficult to gain the amount of space required on a package to print a valid bar code. Now with 300-, 400-, and 600-dpi technologies available, this can be accomplished in a smaller area at high quality for packages. These improvements have also allowed for more data to be encoded within the bar codes thus allowing more benefits for business use. The introduction of the 2-D bar code for the industries in combination with the high resolution of the printing equipment has also created many opportunities for including relevant data for industry/business use on packages.”
And the last 10 years has seen the “development of high speed/quality printing and scanning technologies enabling organizations to consider printing the bar codes as part of their manufacturing process,” continues Croisetiere. “Today, you can print directly on packages in-line or offline at print resolutions of 600 dpi that will allow you to minimize the number of printing technologies needed to complete this task. In essence you can print the entire artwork and the bar codes including variable data with a single printing solution.”
The current trend, says Palmer, “is to pack quite a bit of data into a machine-readable code or bar code, including the lot/batch number, time stamp, expiration date, NDC, or GTIN code to identify the manufacturer and the product. Additionally, the codes may include some newer data additions such as the package type [bottle, carton, case, pallet] as well as a unique serial number that is assigned to ONLY that one product. The purpose of including the serial number on the product is to provide improved traceability throughout the entire supply chain.”
Ulrike Kreysa, vice president healthcare, GS1 Global Office, says that “bar coding of pharmaceuticals and medical devices has advanced in the healthcare industry. We are beyond the ‘hen and the egg’ situation where both end of the supply chain did not want to move ahead before the other side would start implementation. It can be expected that bar coding will be as omnipresent in healthcare as it is in other sectors. Due to the important issues that can be resolved with the implementation of bar coding and related processes, we will see AIDC probably also progressing in developing countries.”
Next page: Bar coding milestones
Milestones in Bar Coding
1952—Invention of the bar code.
1974—The Uniform Code Council (UCC) is established in the United States as a not-for-profit standards organization.
1974—On April 26, a pack of Wrigley’s gum becomes the first product to be scanned with a GS1 bar code in a supermarket in Ohio, GS1 reports.
1996—The Data Matrix symbol was accepted as an AIM standard.
1999—The Institute of Medicine (IOM) report, which cited bar coding as a potential method to reduce medical errors, reports HIBCC.
2003—Pfizer introduces 2-D bar codes on hospital unit-dose packages.
2004—U.S. FDA’s Bar Code Rule requiring the National Drug Code to be encoded in linear bar codes for all pharmaceuticals issued pursuant to a physician’s orders.
2005—GS1 Global Healthcare User Group created, followed by local GS1 healthcare implementation groups in 30 countries including the United States.
2007—FDA Amendments Act signed into law by President George W. Bush. The act states that “the secretary shall promulgate regulations establishing a unique device identification system for medical devices.”
2010—FDA guidance on Standardized Numerical Identification (SNI) for prescription drug packages.
2011—The Global Harmonization Task Force (GHTF) draft guideline on UDI and medical devices to achieve greater uniformity between national medical device regulatory systems around the world, reports GS1.
2012—The U.S. FDA Unique Device Identification (UDI) proposed regulation that would require unique identification marking on most medical device items.
2012—CDC uses GS1 DataMatrix to mark and control the Vaccines Information Sheets (VIS), reports GS1.
2015—California’s Electronic Pedigree law takes effect, under which at least 50% of a manufacturer’s pharmaceutical products will need to bear a serial number at the lowest saleable level by January 2015, and the remaining by January 2016.