This podcast examines issues surrounding current requirements for barcodes on unit-of-use medication packages and provides insight into the opportunities available for utilizing updated barcoding practices. Speakers discuss what is needed from vendors, federal agencies, and pharmacies to facilitate a change in current practices.
The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
(upbeat music) - Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy. - Thanks for joining us in this episode of Informatic Spites. Podcasts where we talk with our members about innovative pharmacy topics and informatics and new technology. Brought to you by ASHP section of the Pharmacy Informatics and Technology. And these podcasts cover topics on innovation and pharmacy, hot topics and informatics and new technology. My name is Madeleine Camahoe, and I'm the Vice President and Chief Pharmacy Officer of Baptist Health, South Florida, and a member of the section of Pharmacy Informatics and Technology section, Advisory Group on Operations and Automations. And today, we're gonna talk with Kevin Marvin and Mark Newinschwander. Kevin is an informatics pharmacist leader with significant experience in working for and consulting for multiple large academic medical centers. Pharmaceutical companies and healthcare technology vendors. Kevin is an ASHP and hemsfellow and has received the Distinguished Service Award from ASHP Informatics section. For three decades, Mark Newinschwander has been a medication safety advocate. He is the founding director of the Thrive Coalition of IV Accuracy. And in 2010, he received ISN's Peace 10th Lifetime Achievement Award for champion barcode medication administration and his leadership in advocating for FDA regulations regulating to medication barcodes. So today, we're gonna talk about medication barcodes, the current standards, and the changes needed for the future. So thanks for joining us. Welcome, Kevin, let's start with you first. - Thank you, Madeleine, it's great to be here. So June 26th marks the 50th anniversary of barcode scanning at retail point of sale, which occurred in 1974. 25 years passed before scanning at the point of care would be introduced to hospitals. Today, over 95% of medication administrations in the US hospitals use barcode medication administration technology or BCMA. A thin majority but growing majority of these hospitals also use barcode medication preparation technologies for IVs. We are certain that ubiquitous adoption will happen. - Mark will recap the barcode's history and the medication use process and the FDA's role. - Yeah, you bet, I'd love to. You know, it's interesting, I met, I had the privilege of becoming friends with George Lauer who invented the UPC product code whose 50th birthday of scanning we celebrate this month. And it was interesting, George and his colleagues had no idea how their invention of barcode changed the rule and especially no idea that it would change healthcare and provide for medication safety. And I left to see him experience the benefits of barcoding himself with his wife and with him. And so it was a beautiful experience for me. I also met his colleague at the time, Bill Selmaier, who realized that if retail barcoding was going to succeed, they would have to get the manufacturers to apply barcodes on product packaging at the source. So when they started, they had to put barcode labels on everything in the back of grocery stores. It was Bill Selmaier who talked the industry into barcode labeling at the source. And I think that will come to play in some of my comments, the significance of that. It was in the late '90s on her way home from a nursing conference here in Seattle that an RN named Sue Kennick returned her rental car. And the Hertz agent scanned the barcode on her windshield, read it back to her name from his handheld and asked if she wanted to charge that to her card on file. Her daughter told me they nearly missed the plane or Sue's grilling of the agent about the technology. And during the flight home to Kansas, she envisioned how nurses might one day scan patient wristbands and medications to ensure they match at the point of administration. Well, Sue's vision was enthusiastically received back in Topeka at her VA hospital by the IT department. And together, they developed a homegrown system that so impressed Ken Kaiser, who was head of the VA at the time, that he mandated a system-wide implementation. And shortly after the turn of the millennium, not only was BCMA born, but it was soon to be in every VA hospital. - So Mark, wasn't there a significant problem in this? Labels on drug packages that arrive in hospitals at that time did not have barcodes? - Yes, that's right. At the time, FDA regulations required drug companies to list manufacturer drug strength, which we've come to know as the NDC number, as well as lot number and expiration date, all inhuman readable print on all immediate packages. So there was no machine readable print, but it was NDC lot number expiration date in human readable print on all immediate drug packages. - Okay, so Mark, some listeners may not be familiar with that term, immediate drug package. Can you explain on that? - Yes, I agree. The immediate drug package was then and still is the term used in FDA regulations involving drug packages. Packages produced for hospitals, as opposed to retail prescriptions and over-the-counter medications sold directly to patients. The FDA defines an immediate package as any container that touches the drug. So that means if you have a blister with one pill in it, that blister is the immediate package. If you have a bottle with 50 pills in it, the bottle is the immediate package. And then regardless of the volume, any ampule, vial, syringe, bag of any size because it touches the drug is an immediate package. So the FDA shies away from the ambiguous unit of use. And we don't need to go into that except to say they don't use the term very often. And they also shun the term unit dose. We often refer to a single pill in a package as a unit dose package. But that's really a misnomer because the manufacturer doesn't determine doses. It's the physicians order that determines the dose. So a dose might be two immediate drug packages or it might be half the contents in an immediate package. - That's an important term that an immediate package. It's a package that touches the drug. So initially the VEA in their process had to generate and apply their own barcodes in-house. - They did and it was incredibly time consuming and it was dangerous compared to packaging and labeling done under good manufacturing practices in manufacture and repackaging houses. They used refrigerator-sized pill packaging machines or tabletop pill packaging machines for single items, for quote, their immediate packages, going from bulk down to the individual. And then for ampoules, vials, syringes, bags and all that, all of those had to be over labeled. And the first VA hospital I visited that was successfully doing bedside barcoding was a little bit alarming to me. In a back room of a pharmacy, rather dimly lit room, there was a gentleman who was a war veteran and of course I'm grateful for his service. I was grateful for his service, but he was well into his 80s. He had very high prescription glasses and he was squinting and one by one applying barcode labels to the various ampoules, vials and syringes. And you can imagine what went through my head. Nevertheless, responsible VA studies demonstrated BCMA's dramatic impact on reducing medication errors at the point of care. And this then prompted a handful of technology companies to develop and market similar technologies in the private world for public consumption. However, despite significant interest, you can understand why hospitals were reluctant to buy the technology. They argued, why would we purchase BCMA technology if manufacturer medications don't have barcodes? So few hospitals were interested in returning to the packaging and labeling business as the VA had. If the manufacturers weren't gonna provide it, they weren't gonna buy the technology. Well, appeals to the drug companies to print barcodes on packages at the source were dismissed. They argued, why would we go to the trouble and cost if hospitals didn't have scanning technology? And the whole thing reminded me of a three-stooges episode I saw once where the guys were standing in front of a door, an open door each saying, after you, no after you, no after you. Now, I became part of an informal, though intense coalition, appealing to the FDA to require manufacturers to apply barcodes on immediate packages. It took a few years, but our persistence contributed to the agency's understanding of BCMA's value and to the importance of manufacturers barcoding labels at the source. Still though, the FDA felt compelled to let the market drive that decision. We were not sure. As a matter of fact, we were certain manufacturers would not barcode medications voluntarily. Our research revealed that market demand was insufficient to move them. Regulation would be necessary. So we remained unrelenting and were, of course then, you can imagine beside ourselves when the FDA convened a meeting of stakeholders in Chicago to discuss the possibility of a rule that would require barcode labeling. And at that meeting, it was interesting. There was just one question asked of the attendees. And it was this. If the FDA does issue a barcode rule requiring manufacturers include barcodes on all immediate drug packages, what data do you believe should be encoded in that barcode? The consensus among providers, not among drug companies, but among providers, was that the FDA should require in machine readable print exactly what they already required in human readable print. NDC, lot number, and expiration date. Well, fast forward. Now you can imagine how giddy we were when the Undersecretary of Health and Human Services announced, and I don't know if it was in 2002 or 2003, but he announced that the FDA would issue a barcode rule mandating NDC numbers in linear codes on all immediate drug packages. - That's interesting, Mark, but not lot numbers or expiration dates on those packages? - That's right, no lot or expiration. And there's a good reason for that. At the time, barcode symbologies were limited to one-dimensional linear codes, and not unlike the barcodes we still have on boxes of Cheerios today, which are capable of containing limited data sets. There simply was not enough bars in a linear code or enough real estate on a package to handle as many bars in a barcode as it would take to add lot number and expiration date. And so even though 2D barcodes that could carry all this data were on the horizon, they were not standardized, they were not ready, hospitals didn't have the technology for scanning them. And so we got a linear code with just the NDC number. - Well, that must have been disappointing. - Yeah, it was disappointing, but we had to own up to the reality that they couldn't do it at that time. And if they would have said we needed all that data, it would have kicked the can down the road and we never would have got barcoding at the point of care off the mark. And so it was disappointing, but there were a couple of things that mitigated our disappointment. The first was that the FDA noted in the federal registry that they would consider whether to accept other automatic identification technologies as they became more mature and accepted. And in my conversations with the FDA off the record, I was told by an FDA official that he anticipated they would really visit the role in five years when consideration would be giving to adding lot number and expiration date, if symbologies had progressed to accommodate such at that point. And so we felt we could wait five years. Nevertheless, come on, we want a great victory in getting barcodes with NDCs. The NDC is the critical factor when we're trying to verify that the right patient is getting the right drug at the right time. And that cleared the log jam, which had been preventing drug companies and hospitals and automation vendors from walking through the BCMA door together. And interestingly, by 2006, that's just two years after the rule, virtually all manufacturing media packages arrived at hospitals with NDC embedded barcodes. And we steadily made our way to the ubiquitous adoption of bedside barcoding we have today. The NDC proved not only to be the camel's nose in the tent, but I argue a couple of homes as well. - Yeah, and perhaps better than half of these hospitals are also using barcode medication preparation technology or IV workflow management systems, which were introduced in 2007. The Thrive Coalition, which you direct, is championing this effort and universal adoption and faithful utilization of these systems for preparing all IVs. - Yeah, it just makes sense to us that if we require nurses to scan patient wristbands and medications to assure a match, then why when we are following a recipe for making an IV medication, do we not require scanning, diluents and drugs to ensure that we are putting in those bags, what belongs in there, bags that are gonna go into the patients. And if we get the bag wrong, there's nothing that BCMA can do to identify that or fix that. So we've gone upstream and said we need to apply what has proven at the bedside back into the medication preparation process. Now, of course, we wanna get the rest of the camel in the tent back to lot number and expiration date. We want them to be added to barcodes so that with the same scans that we use for handling medications, we can automatically identify and intercept drugs that have been recalled or out of date. Now, all of that to say, still two decades later, the FDA barcode rule has not been amended to require lot numbers and expiration dates. Well, Mark, and many believe that the 2013 Drug Supply Chain Security Act addressed and solved this problem. We've heard in talks and read an article, certainly I have in recent months that the FDA requires that labels on manufactured packages include barcodes embedded with NDC, lot and expiration data. Is this right? - Yeah, that is right. And they require 2D data matrix codes to do that, which are fully capable of carrying all that data. And that is wonderful. The DSCSA is a wonderful app with many benefits. However, the requirement applies to packages down to the lowest sellable units, not down to the immediate packages that are inside those units. So it's valuable for traceability and counterfeit prevention, but immediate packages when they are removed from these lowest sellable units, still have linear barcodes embedded only with NDC, no lot numbers, no expiration dates. That means that in effect, we have two packaging rules from the FDA. The new one, DSCSA, is for bulk products arriving on hospital docs in lowest sellable units and then the old rule for the immediate packages inside those lowest sellable units. And so we still have linear codes with no lot number and expiration. - That's interesting. So I've heard that some drug manufacturers argued you don't need lot and expiration data on barcodes if you already have them in human readable print on the packages. Oh man, I've heard that one before. Plenty of people argued back in the day that why do we need NDC data in machine readable package since it's already on the packages in human readable print? And the same arguments needed that we gave for needing a machine readable of the NDC apply to a machine readable of lot number and expiration date. - So we persist in asking the FDA to finish the drug barcode rule, which would require manufacturers to include lot numbers and expiration dates with current required NDC numbers in one barcode on all immediate drug packages. - Yep, one barcode containing NDC lot number and expiration date. - Okay, Mark. So let's spend our remaining minutes outlining the compelling reasons for asking the FDA for this one barcode containing NDC lot and expiration date. - Good, I'll give you two game-changing reasons. The top two reasons. First of all, if we have lot number and expiration date in the barcode, whenever we scan medications in the handling in their handling process in a hospital, we can automatically identify and intercept expired and recalled drugs. That is if we are filling storage bins or filling automated dispensing cabinets and scanning the pocket and scanning the drugs so there's a match so that we won't get adult heparin in an infant heparin pocket or if we're loading carousels or if we are preparing IVs, if the products we're scanning or out of date are recalled, we can intercept them or if we are administering it to patients. At that point, we can intercept and there are three things that come out of this that are worth thinking about. The first is this promises to improve safety. We're protecting patients from potential harm that may happen to them from receiving recalled meds or expired meds. And then there's the quality of care ensuring that patients receive the full potency of drugs prescribed, not out of date drugs. And then the third is this promotes legal compliance. I mean, it is after all the law or its regulation or code that prohibits the use of using outdated and recalled drugs, being able to identify and intercept these drugs at any point of scanning helps with legal compliance. So number one, identifying expired and recalled medications before they reach the patient. And then the next one is pretty exciting to me. Lot number and expiration date in the bar code enables simultaneous documentation of lot numbers and expiration dates of all billions and drugs scanned during IV preparation. And that's required by USP chapter 797, 795, 800 that lot numbers and expiration dates are recorded for each ingredient used. And this results in four things. Number one, consistency. So we're preventing preparers from intentionally or accidentally skipping documentation fields. There's accuracy, eliminating errant entries, which too often result when using prone to error handwriting or manual key entry. There's efficiency by simultaneously populating required lot and expiration dates. There's no redundancy, there's no interruption. And finally, sterility. Data entry scanning requires few passes of product in and out of the sterile field. And so if we are doing that documenting without any extra activity on the part of the technician, we're reducing opportunities for touch contamination. So there's some pretty compelling reasons to have lot number and expiration date. And it seems to me there needs to be a lot of explanation for why we wouldn't do it if we're not going to do it. - Well, thank you, Mark, that certainly sold it to me. In summary, I see several takeaways from this discussion. The first is that immediate packages are the packages touching the medication and are the packages used within hospitals. These packages have a barcode, which only encodes the NDC. And by FDA rule, they are linear barcodes and have been required since 2004. Next is that the TubeD barcodes, which are required by the 2013 Drug Supply Chain Security Act, contain the NDC lot number and expiration date, in addition to other fields, but they do contain that information. And they only exist on packages for saleable units and therefore are not available for internal hospital use. After all these years, it is time for the next step. We want and need to have immediate products containing barcodes with NDC, lot and expiration date. Thank you, Mark. I'm going to hand off to Madeline. - Well, that's all the time we have today. We have for our broadcast. And I want to thank Kevin and Mark for joining us today for the first part of our discussion on barcodes on unit of use medication packages. And please join us for the second part where we can discuss the future of barcode information on unit dose medication packaging. Thanks for tuning in on this session of Informatic Bites. And if you haven't before, I encourage you to check out ASHP informatics resource. You can find member exclusive offerings in the informatics resource center, including articles, standards, and guidelines as well as practice tool for pharmacy informatics and health technology related topics. Be sure to follow at ASHP official podcasts for more episodes and informatics bites from the section of pharmacy informatics and technology. And in our next podcast, we'll get out of the clouds and into the weeds regarding the critical need for and the benefits of having lot and expiration barcodes on all immediate drug packages. Thank you for listening to ASHP official, the Voice of Pharmacists Advancing Healthcare. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate or leave a review. Join us next time on ASHP official. (upbeat music) (upbeat music) (upbeat music) (upbeat music) [BLANK_AUDIO]
