Road to RFID Paved with Bar Codes

Aug. 11, 2005
Bar codes are the short-term answer, as long as manufacturers strive to understand FDA guidelines at all levels of packaging, says George Wright IV, vice president of Product Identification & Processing Systems, Inc.
RFID adoption has lagged in pharma and other industries for a number of reasons, including the cost of implementing systems, ongoing changes in global standards and the still-unacceptable-to-many failure rate of RFID tags. Supporting those not rushing to embrace RFID is George Wright IV, vice president of Product Identification & Processing Systems, Inc. He asserts, "The road to RFID is paved with bar codes." spoke with Wright to ascertain the view from his particular mountaintop.PM: You say the road to RFID is paved with bar codes. What’s the main reason?GW: There are several reasons. The simplest is that RFID chips still fail at a significant rate and when that happens, you need a backup system, a means of capturing the information that cannot be read from the RFID data carrier. 2D bar codes are the backup system. Even for mass serialization and track and trace applications, bar code technology can do the job.Another fundamental reason is that the total cost to implement an RFID system in both time and money is significant — much higher than most prospective users realize. As is the case with most productivity-enhancing technologies, RFID systems will be deployed gradually, where the ROI warrants it. As system costs decline over the coming decade, more applications can justify the investment. During this period, bar codes will continue to play their historical item-identification role and will also be called upon to do even more in the way of track and trace.PM: You’ve also said that 2D matrix bar codes such as Data Matrix will be the technology of choice for the foreseeable future among pharmaceutical packagers. Why?GW: Well, I don’t think made quite such a sweeping statement. I said if pharmaceutical manufacturers were free to choose, I do believe this would be the case — over the long term — because 2D matrix codes are easier to print (and print well); have the advantage of built-in error correction, which makes them more robust and resistant to a certain amount of physical damage; and byte for byte are much smaller than traditional linear bar codes. The fact is, however, they are not free to choose, except in certain limited applications, whether because pharmaceuticals move through national supply chains regulated by governments or simply because the choice is constrained by the installed base of scanners, both in their own manufacturing/packaging facilities, at the distribution centers and ultimately at the point of sale and point of care.In the U.S., where FDA has now mandated that the NDC be encoded in standardized bar code data structures and symbologies and printed on the package or label of 1) all human Rx products and 2) OTC products packaged for institutional use, the use of 2D bar codes was specifically excluded because FDA determined that the added cost to hospitals of 2D scanners/imagers over the less expensive 1D or linear scanners would be prohibitive. In addition, the global marketplace — saturated with 1D scanners everywhere — would still require the traditional linear U.P.C./EAN or other standard 1D symbol.That said, manufacturers do seem to be migrating toward the use of 2D symbols (and particularly Data Matrix ECC200) for component identification and we see manufacturers evaluating the possible addition of GS1 Data Matrix (also ECC200) bar codes to packaging and labeling as a supplemental symbol (typically, encoding addition secondary data such as expiration date, lot number and possibly even serial number), over and above what the FDA or the current supply chain may minimally require. The idea is that this additional symbol will be “invisible” to traditional linear bar code scanners but would be beneficial to those users who deploy 2D imagers sooner rather than later. To me this is an excellent idea that provides a seamless migration path for the future and it is one that I think you will see formally endorsed in the pharmaceutical supply chain very soon.PM: The effectiveness of bar codes, while good, can be better. What steps need to happen for  open bar code systems such as the GS1 system to provide everything they are capable of?GW: There are four main elements of most any bar code scanning system, open or otherwise. With reference to the GS1 system and others, these are: 1) the manufacturer/labeler’s assignment of unique identification numbers at every level of packaging and the communication of that information (and related product attribute data) within the organization and to trading partners; 2) the bar code itself printed on the package or the label; 3) the scanner that reads the bar code; and 4) the application software that handles the scanned data. To start with, manufacturers need to closely control the assignment of unique item identifiers for all of their products at all levels of packaging. Such assignments must conform to the relevant guidelines, knowledge of which is too often woefully lacking at many manufacturers. Once that is done, this information needs to be published internally to the affected departments such as manufacturing/packaging, distribution, sales, marketing and customer service. The information also needs to be communicated to trading partners.When it comes to printing bar codes, the correct data needs to be encoded in the right symbology and the symbol must be well printed. ANSI and/or ISO standards have been in place for more than 15 years detailing how bar code print quality is to be assessed reported and most every industry bar code application guideline and vendor compliance guideline specifies a minimum print quality grade. The marketplace offers a wide array of quality bar code print quality verification tools (and unfortunately some others that are not) and the choices are growing in number and in capability. In most retail markets, the cost of verification is more than paid for in savings from avoiding supplier charge-backs for poor quality bar codes. In healthcare, where patient safety is often a big part of the cost/benefit equation, the benefits of quality are even more manifest, particularly when quality is mandated under cGMP, as with the FDA bar code rule.As for scanners, the major scanner manufacturers have excelled at providing excellent scanners and portable data collection terminals that will readily read even many very poor quality symbols. So item number 3 is not really an issue. In my opinion, the single most significant impediment to achieving the full benefits of bar code scanning — particularly in healthcare — is the lack of understanding on the part of application software developers (whether manufacturing, distribution or clinical) of how to properly handle the diverse mix of data structures and symbologies that a single application will encounter. The endless refrain is “We need a standard!” Well, the fact is we have a standard, maybe not a single standard in a given supply chain but usually no more than two. In healthcare, these compatible and even complimentary standards (GS1 and HIBCC) have existed and been used for decades and the logic to differentiate the various data formats, to validate and parse the different strings and to capture and send the relevant date elements to their respective fields (or to ignore or discard those not needed) is not a secret. It may not be common knowledge, but the experts in the field are out there. Application software should not be hamstrung by a simplistic and limited ability to handle only a small subset of the modest and limited universe of symbologies and data structures that are standardized and in widespread use in the given supply chain. All too often, however, this is the case. In my opinion, rectification of this situation would do more to achieve the full potential of our current global bar code systems and to extend their life than any other single improvement.PM: You’ve said FDA has indicated that they are not going to be the “bar code police.” Who or what then, should police bar code quality?GW: The short answer is “the marketplace.” In the “Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule,” FDA said, “As we noted in the preamble to the proposed rule, various bar code standards exist, as do standard procedures for bar code verification…Given these standards and other documents, as well as the comparatively greater expertise of standards organization …we do not intend to audit or monitor bar code quality aggressively. We believe that our GMP requirements and the drug Quality Reporting Systems provide additional safeguards to ensure bar code quality.”They also said, “If an individual encounters a problem scanning the bar code, and the problem is due to the bar code’s [poor] quality, then such scanning problems can be reported to FDA through the Drug Quality Reporting System, [which] encourages health care professionals to voluntarily report observed or suspected defects or quality problems with marketed drug products. The agency receives reports through the MedWatch Program.”Thus far, the evidence suggests that “the marketplace” is doing the job. I know of a few problems that have already cropped up with hospital pharmacies trying to scan the new Reduced Space Symbology (RSS) symbol now being printed on unit dose blisters and other packages. These problems have been reported by the hospital directly to the manufacturers, who have been eager to identify the cause and to assist in resolving the problem. Most often, the cause has been due to the scanner itself not being equipped to read this new symbology. In some cases the scanner could read RSS if the symbology were “turned on” in the scanner. Other times, the application software cannot handle the 16 digits encoded in this standard GS1 format, having been programmed to handle only the more established 12-digit U.P.C. data stream. Yet both data formats are equally valid and must be handled seamlessly.I believe (and hope) that individuals and institutions in healthcare will be strongly motivated to police bar code quality. The evidence to date suggests that most manufacturers are responding aggressively to meet the new FDA rule, including the provisions for bar code quality and are responding likewise to feedback from the supply chain. This will certainly not always be universally true, however, and there will no doubt be cases in the future where this becomes a significant issue. PM: What’s your general take on FDA’s bar code guidance? Is it, in fact, misguided?GW: No, I wouldn’t say that at all. I think most people affected by this new rule believe FDA wrote an amazingly intelligent rule, one actually asked for by most all the stakeholders in the pharmaceutical supply chain. I believe they did it responsibly, responsively and with great care. Still, there are certainly a few points that could have been made more succinctly and with greater clarity, the principal one being a precise definition of what it means to be compliant by the effective date of 4/26/06.In the draft guidance they recently published in a Q&A format, they provided clarification and guidance on a few issues on which they had received comment. Although one of those areas was the meaning of “compliance by 4/26/06,” they still failed to sufficiently clarify what they intend to have happen by that date. PM: There are two camps — users and vendors — with two opposing interpretations of what FDA’s guidance means. How did this come about?GW: Your question goes to the heart of the matter mentioned above. The original proposed rule called for a three-year implementation period before the rule would take full effect. The final rule reduced that to 2 years. The confusion comes about because nowhere did it say precisely what was meant. The manufacturers, mindful of the time it takes to reengineer drug labeling and packaging and the sheer number of products affected, interpreted the meaning of compliance by 4/26/06 to be that all drugs packaged on or after that date would have to be in compliance.Certainly there are other possible interpretations as well, though none in my opinion that is as sensible. If the meaning is not packaged on or after 4/26/06, then it could be shipped by the manufacturer on or after that date; or shipped by the distributor on or after that date; or received by the hospital on or after that date; or even administered to the patient on or after that date.Admittedly, packaged on or after 4/26/06 is the most favorable to the manufacturers in that it gives them the most time to be compliant. And while there are reports that some pharmacy people and/or their trade groups would like to see a “stricter” interpretation, meaning one that would put bar coded unit dose drugs in their hands sooner, the fact of the matter is that there will still be a only a small minority of hospitals capable of point of care scanning even by 4/26/06. So in my mind, to push for something most hospitals will not be able to use and beyond what manufacturers could reasonably attain, seems pointless and to deny the reality. PM: How can the rift be repaired? Or which interpretation will win out?GW: I wouldn’t call it a rift. Certainly there is an ambiguity that FDA has yet to clarify. My opinion is that “packaged on or after 4/26/06” will ultimately be what is called for. Even then, there are going to be manufacturers who come up short, some probably very short. As incredible as it may seem, I’m not sure some manufacturers believe this is “for real.”PM: How concerned should manufacturers be about April 26, 2006? Will they be considered compliant?GW: As a healthcare consumer, I want them to be very concerned and I want them to be working diligently to have all covered drugs compliant when they are packaged on or after 4/26/06. For any company that started an implementation program when the final rule was issued (and many of the largest manufacturers had started at least a year before) packaged on or after 4/26/06 is not an unreasonable deadline. And those manufacturers who have acted in good faith and invested the time and money to be compliant by 4/26/06 are to be applauded. Those who are not compliant by 4/26/06 and who have blatantly ignored the rule for too long should be punished. I won’t mince words on this point; patient lives are at stake. FDA should make it plain now that they will not be tolerant of “slackers” in this regard and penalties should be levied against egregious offenders.PM: Once all covered drugs are bar code according to the rule, will the system have all the pieces in place to prevent the thousands of annual in-hospital patient deaths in the U.S. alone attributed to medication errors? GW: Unfortunately, no. There is still no mandate for hospitals to invest in point of care bar code-based medication administration systems. This is an expensive and disruptive deployment under the best of circumstances; budgets are tight and IT and other expert human resources are also limited. And although Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has floated a trial balloon proposing to mandate such systems, nothing has been done. Liability insurers may be able to play a more prominent role in that such systems will reduce errors and should thereby reduce fatalities, which one would think would have a significant impact on payouts and premiums. In addition, GPO’s may become more actively involved and could help their members by developing one or more standardized implementation models for their members to use as a starting point.There are an incredible number of talented and dedicated people in this country and around the globe who are working every day to bring this vision to fruition. Some work day-to-day as healthcare providers or managers. Others run or work for associations whose goal is to improve patient care and reduce healthcare costs. And still others work in healthcare manufacturing and distribution, in pharmacies or in the automatic identification business. The necessary standards are in place, the technology is capable, the desire to implement these life-saving systems is clear, and the need is manifest. It is time to simply do it!George Wright IV is a “second-generation” bar code expert with nearly 25 years of experience in the field. A tireless supporter of bar code standards and education in a number of industry sectors, George is a frequent speaker and recognized champion of Auto ID technology, particularly in healthcare. He is a longstanding member of key healthcare bar code standards development organizations, including the Uniform Code Council (now GS1 US) and the Health Industry Business Communications Council (HIBCC) Automatic Identification Technical Committee. In addition, he is currently serving as revision editor and sub-group chair on the HDMA Automatic Identification Work Group, the industry group charged with revising and updating the 2001 HDMA Bar Code Guidelines.