The FDA begins bar code requirement on most drugs used in hospitals

Bar coding has earned its stripes
Up Close with Symbol’s Ken Kleinberg
by Rick Dana Barlow
Affixing tiny labels printed with vertical stripes of varying widths onto product packages historically has met considerable resistance from healthcare providers.

Early on, hospitals dismissed bar coding as simply too costly from administrative, financial and operational perspectives, requiring behavioral changes that even affected the clinical perspective. Then newer and flashier alternative technologies caught fire – like radio frequency identification (RFID) tags, for example – and then bar coding simply sounded quaint by comparison. Sort of like a bicycle to a motorcycle.

Most of it, experts agree, merely stems from stereotypical avoidance issues. In short, it’s bunk at worst, sour grapes at best but probably more about fear than anything else. Vendors in the manufacturing and retail industries, and even in healthcare, already have proven for more than three decades that bar coding works. Now the U.S. Food and Drug Administration is pushing the issue, albeit with some cautionary restraint, by requiring healthcare vendors to use bar codes on products. Will providers face the same challenge? It’s possible.

Healthcare Purchasing News Senior Editor Rick Dana Barlow managed to catch Ken Kleinberg, senior director, Healthcare Solutions Division, Symbol Technologies Inc., fresh from a national bar coding conference and trade show to shed some light on the continual tug-of-war about bar coding’s benefits and outlook.

HPN: Why are so many different bar coding standards needed and used for drugs and devices? Why should they be so different from the UPC symbols used in the manufacturing and retail industries outside of healthcare?
Kleinberg: Different types and standards for bar coding in healthcare have sprung up over the years to fill various needs – usually to serve the manufacturer and the supply chain. Different bar code symbologies (data carriers) have different strengths, depending on how much information must be encoded in the bar code (e.g., 1-D, 2-D or composite), whether the bar code will be read while the package is in motion (e.g., on a conveyer belt), whether the bar codes are read from near or close range, and the packaging size, etc. For example, Reduced Space Symbology (RSS) codes are used for labeling small packages.

In addition, there are different bar code structures (data formats) in use. While some are manufacturer-specific, others conform to such organizational standards as the Health Industry Business Communications Council (HIBCC). Unfortunately, there is no one group driving overall standards in the healthcare market, especially at the bedside, although there are exceptions. For example, the FDA bar code rule for medications requires a UCC.EAN- or HIBCC-standardized linear bar code with the drug National Drug Code. There is currently a push for standardized nomenclature and labeling of medical devices. However, given the challenges of assembling the case to show effects on patient safety, it may take a number of years to accomplish.

Everyone seems to be abuzz about RFID, and to a lesser extent, infrared and ultrasound (the latter two primarily for tracking assets and people), relegating bar coding almost to relic status. But bar coding, in a number of areas, offers some key advantages over its newer competition or younger siblings. What are those advantages?

Bar coding is a mature and affordable technology in use in most industries. Bar code symbologies and scanning equipment continue to improve and will remain in use through this decade and the next.

RFID does have some major advantages over bar coding, such as omni-directional reading of tags, simultaneous reading of multiple tags and the ability to write/update tags. These advantages make RFID a particularly useful technology for asset management and supply chain management. When compared to such technologies as Infrared (IrDA) for ‘locationing,’ RFID has the advantage of passing through walls – the Achilles heal of IrDA – when, for example, a medical device is misplaced.

However, RFID technology is still somewhat nascent – standards are still being established and costs remain relatively high. As such, RFID is seeing its greatest early use for larger packaging, such as pallets and cases. Although RFID has seen some use for item-level tagging (especially for securing the pharmaceutical supply chain against counterfeiting), the line-of-sight requirement of bar coding actually makes it a better fit at the bedside for unit dose medications where there must be 100 percent confirmation of what object is in hand.

On April 26, the FDA began requiring bar codes on most drugs used in hospitals. Because many hospitals are not equipped to use bar codes, nor has the FDA required hospitals to set up systems to use the mandatory bar codes, drug companies may be motivated to minimize their expenses and invest in the cheapest and lowest quality bar codes available. How do the forward-thinking bar code-enabled hospitals deal with this?Although there has been evidence that drug companies have backed off in some cases from unit-dose packaging to save the expense of having to bar-code label smaller packages, the cost to the manufacturer of adding a bar-code label is relatively inexpensive. The FDA and the purchasing hospitals will be monitoring the presence and quality of these bar codes and, although the FDA was not explicit in the final regulation, it’s expected that the bar codes should at least meet a C quality.

However, there are some gray areas that exist within this rule. For example, if a company attempts to meet the regulation by placing a bar code on a transparent IV bag, the bag would have to be placed against a solid background (such as a wall or piece of paper) to enable the bar code to be read – and most would say that this should not be acceptable to the intent of the regulation. In fact, some manufacturers have taken a leadership role to solve this problem, such as Baxter with reverse contrast labels on IV bags.

Over time, it’s likely that market pressures will make it possible for hospitals to readily purchase the majority of their meds in unit-dose bar-code-labeled packaging – if not from the manufacturers, than from the ecosystem of repackers, labelers, distribution companies and other niche players.

For those hospitals or hospital systems that don’t want to have to shop around or be subject to market whims, many will decide to invest in their own packaging and labeling equipment. This route has some challenges, as some of this equipment, particularly the larger robot systems, can be quite expensive and whenever repacking/relabeling is done, there is always the possibility for error. However, this approach does have the advantage of the hospital creating a more uniform label that could be easier to scan than the manufacturer’s labels and could contain extra information that the hospital deems important (i.e. lot and expiration date – some hospitals have opted for using 2-D in their own labeling efforts).

It should also be noted that when it comes to pediatric doses, special cocktails and some injectables, most hospitals that wish to approach 100 percent bar-coded meds at the bedside will have to do some packaging and labeling themselves for accurate results.

How do hospitals handle crumpled, faded, smeared or otherwise damaged bar codes on products that show up at their docks or on their shelves?
Such damaged bar codes are a fact of life and can be a real hindrance to effective supply chain and asset management. Hospitals can protect themselves in a number of ways, such as requesting manufacturers to use higher quality bar code labels and to use bar code symbologies with check digits or more inherent redundancy. The hospital can also invest in more advanced scanner equipment, such as those with fuzzy logic algorithms that are specially designed to deal with just such problems.

With the FDA requiring drug manufacturers to apply the very basic one-dimensional bar codes on products, what will it take for this to migrate to the device manufacturers and finally to the healthcare providers themselves, which, by and large, have resisted bar code adoption for decades? The FDA did the healthcare industry a great service by breaking the longstanding logjam where manufacturers did not place bar-code labels on unit-dose drugs because they did not see the hospitals investing in scanning equipment to read them, and hospitals not investing in scanners because the drugs were not arriving with bar codes.

With that major barrier removed, many hospitals can now invest with confidence in standardized scanning technology for medication administration applications. Once that infrastructure is in place, it can be leveraged by manufacturers and users alike for additional equipment and applications. For example, a medical device company would benefit from placing a bar-code label on its devices and having the equipment label scanned when the hospital is reporting a problem. Also, the hospital could better manage its own assets if the devices were bar-code labeled. Hospitals with the bar coding infrastructure for medications and medical devices would then be able to consider programming and monitoring their medical devices wirelessly. Additional applications that also take advantage of bar-code labeling such as specimen collection, blood transfusion verification and nurse call (using VoIP) could also readily follow.

For years healthcare providers have heard the numbers – bar coding could prevent adverse events from medication errors during a 20-year period and can increase administrative, financial and operational efficiencies, all of which translates into cost savings and enhances profitability. Are they still skeptical? Cynical? If they’re not convinced by any of this what will it take to win them over and get them to invest in and implement bar coding systems?

There have been many reasons that have prevented hospitals organizations from investing in healthcare IT in general. High cost, lack of standards, concerns about performance and security are a few. In addition, healthcare IT must compete with other capital expenditures and competing business initiatives. For example, should the hospital build a new surgery center, or purchase a new MRI (both of which are readily linked to revenue)?

Although medical errors are expensive, there is no line item that can be identified to point to the cost savings of reducing medication errors. Bar coding technology, in comparison to larger electronic medical record systems and computer physician order entry systems, is relatively inexpensive and delivers considerable bang for the buck – with paybacks usually within the first year. The FDA bar code regulation, by standardizing on UCC and/or HIBCC approved linear bar codes, gives healthcare organizations the confidence to invest in scanning equipment.

Although many larger healthcare systems, like the VA and HCA, have led the charge in bar coding at the bedside, there are smaller hospitals that have also used the technology successfully and have been willing to share their experiences – both from a patient safety perspective as well as a financial and operational perspective. In addition, although there have been a number of well-publicized failures when it comes to CPOE and larger EMR initiatives, there are as of yet no examples of organizations that have failed with bar code scanning technology.

CMS recently indicated it wants to link DRG reimbursement to costs, rather than charges. It’s no secret that bar coding can help facilities track and manage their costs. Should this be enacted and managed care companies and private insurers follow suit, will that financial change be enough to ignite interest in, adoption and implementation of bar coding systems? Why?
There are a number of ways for payers such as CMS and other insurers to reimburse and incentivize providers, including capitation, pay for service, pay for use of technology, and pay for performance (e.g., outcomes). All methods eventually hinge on the payer and provider understanding what was wrong with the patient, what care was given, what did it cost and how long did it take. Tracking the patients, caregivers, medical equipment, assets and procedures are all necessary to fully answer these questions and bar coding is an excellent technology to help in that regard.

Unlike improving the safety of medication administration, however, where bar coding was considered by many to be the most practical and cost effective solution, tracking and improving care is a broader problem with many applicable solutions and technologies. For example, active tag technology in combination with a real-time locationing system could be used for tracking and locating patients, caregivers, and medical equipment. And while reimbursement for costs might drive greater adoption of bar coding, reimbursement for outcomes would likely drive broader use of technology and innovation – and reward those companies that improve processes and reduce overall costs (not just reward hospitals that can prove they spent more). HPN
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