Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain. I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is. It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back. So let me show you.
SERIALIZATION
THE DAWN OF ^ CIVILIZATION
No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.
Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs. Whether you agree to the benefits or not you certainly must accede to the fact that serialization in pharma supply chains is being mandated by more and more governments around the world, and that trend is not likely to reverse but will likely increase. Serialization mandates are currently in place for 2015-2016 in the state of California and they are under consideration by the two largest pharmaceutical markets in the world: The E.U. and the U.S.
Serialization is upon us and there is no turning back. While this is the foundation for why the industry must move away from linear barcodes, it is not the complete reason.
ADDING SERIAL NUMBERS TO PHARMACEUTICALS
Serialization mandates in countries around the world vary quite a bit but the more recent the regulation, the more likely they are to specify the use of GS1 standards, either as part of the mandate or as an example of one way to comply. GS1 linear barcodes are the most common type of product identifier barcode in use today in the larger markets so when you need to add a serial number to a drug, the addition of a GS1 serial number makes a lot of sense.
In a recent essay, “Depicting An NDC Within A GTIN”, I showed how to depict a U.S. Food and Drug Administration (FDA) National Drug Code (NDC) with an GS1 Global Trade Item Number (GTIN) for both over-the-counter (OTC) drugs and prescription drugs. Then, in my essay “Anatomy of an FDA SNI” I explained how to use GS1 standards to produce an FDA-compliant serialized NDC, or sNDC. An sNDC is what is necessary if you want to (voluntarily today) add a serial number to any drug that has an NDC assigned to it for the U.S. market according to the FDA’s Standardized Numeric Identifier (SNI) document from 2010 (see also my essay “FDA Aligns with GS1 SGTIN For SNDC“). At the end of my “Anatomy of an FDA SNI” essay I used the FDA’s own example (from their SNI Guidance document) to create the GS1 string of elements that would be encoded into a barcode and placed onto the drug package:
01003555556667762111111111111111111111
What I didn’t say in that essay is that you can’t encode this or any other sNDC in the GS1 Universal Product Code-A (UPC-A) barcode symbology that is used today for depicting NDC’s in linear barcodes on many of the pharmaceuticals in the U.S. supply chain. The UPC-A symbology itself does not support the addition of the serial number. For that you have to switch to another GS1 linear symbology known as GS1-128 (formerly known as UCC-128 and EAN-128).
Without the serial number, the linear UPC-A barcode for the NDC in the FDA’s example would look like this (all barcode images in this essay are courtesy of Terry Burton’s website):
That’s what the NDC barcode would look like today depicted as a GS1 GTIN-12 without the serial number. Here is what the full NDC and the serial number from the FDA’s example sNDC would look like depicted as a GTIN-14 plus serial number and rendered in the GS1-128 symbology:
Look at these two examples and you will see why serialization triggers the need to abandon linear barcodes. The linear barcodes that result after adding a serial number to NDCs are too long to fit onto most drug labels in a way that allows them to be scanned properly. Yes, this example uses U.S.-specific data and requirements but the same principles will apply to almost all countries and similar results will occur. Yes, the serial number in the FDA’s example is an extremely long one that probably exceeds the needs of 99% of companies, but the technology must accommodate the extremes or it is not usable.
And that’s not even the most extreme serial number I can think of. Serial number “YESTHISISAVALIDSRNUM” (yes, this is a valid serial number) is the most extreme serial number I can think of, and this is what it would look like as an sNDC in the GS1-128 symbology:
That’s even less workable.
SO WE NEED TO MOVE TO 2D BARCODES, RIGHT?
2-Dimensional barcode symbologies, like GS1’s DataMatrix, will solve this problem, yes. For example, here is what the previous two examples would look like encoded in GS1 DataMatrix:
(01)00355555666776
(21)11111111111111111111
(01)00355555666776
(21)YESTHISISAVALIDSERNM
Both of these symbols take up less space than the original UPC-A barcode that only contains the NDC. Even if we now add a lot/batch (AI=”10) and an expiration date (AI=”17) as I recommended in my essay “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”, and we do so using the maximum lengths possible, these two become:
(01)00355555666776
(21)11111111111111111111
(17)160701
(10)22222222222222222222
(01)00355555666776
(21)YESTHISISAVALIDSRNUM
(17)160701
(10)YESTHISISAVALIDLOTNM
Whoa! What happened with the “extreme” example to make it blow up so big? There are two things that just happened. First, the DataMatix symbology is highly compressed and it automatically adjusts to accommodate the type and size of the data being encoded. Notice that the length of the lot number and the serial number in the two images above are the same, but the type of the data in the lot and serial numbers are not the same. When only digits are used the symbology can compress the image into a smaller space than it can when alphanumerics are used. In both examples I am using the maximum number of characters allowed, but in the extreme example I am using all alphas in both the serial number and in the lot number. That is the worst-case scenario and, as you can see, it takes up more space.
Second, the GS1 DataMatrix symbology will split into multiple segments (four in this case) once you cross a technical boundary related to the number of bits being encoded. Alphanumeric characters require more bits to encode them than numeric characters and in this example we crossed that boundary so the image generator split it into four segments. This helps readers decode larger symbols without significantly lowering reliability.
Considering the fact that it required me to come up with a pretty unrealistic extreme example of both serial number and lot number before the symbols made the leap to four segments I think it is unlikely that most drugs will require more than one segment. That’s because most drugs require many fewer than 20 characters for their lot/batch and serial numbers and most companies will probably stick with numeric-only characters in their serial numbers.
WHAT ABOUT RFID?
The pharma industry could move to Radio Frequency Identification (RFID) instead of 2D barcodes where regulations allow, but I believe that is unlikely except where the overseeing regulatory body actually requires it for all drugs in that jurisdiction. The explanation I documented for that in my essay “RFID is DEAD…at Unit-Level in Pharma” still applies. On the other hand, RFID would also solve the space problem that we have seen results with linear barcodes and the addition of serialization. In fact, most RFID tags would likely be placed under the product label so they would not take up any label real estate at all, but I don’t think manufacturers will view that savings as enough to offset the cost of the tags themselves.
THE TIME IS NOW
If you are a global pharma manufacturer or repackager and you haven’t yet figured out a plan for moving away from linear barcodes on your product labels, now is the time to start. Whether you choose 2D barcodes or RFID, the existence of serialization mandates around the world is the reason you need to take action and the time is now.
If you are a distributor, pharmacy or dispenser of pharmaceuticals in parts of the world where serialization has arrived or is coming, you need to develop a plan for reading the product codes and serial numbers using technologies that drug manufacturers and repackagers will move to. Now is the time to find out how many different technologies you will have to deal with. Now is the time to influence those manufacturers who are considering technologies that you don’t want and steer them toward those you do want.
Now is the time.
NOW IS THE TIME…EXCEPT FOR ONE THING!
Except, the FDA currently requires that drugs sold into the U.S. market be identified with their NDC specifically in a linear barcode. That means that in the U.S. today, you cannot move away from linear barcodes on your drug product, even when you need to add serial numbers to them for compliance with the California pedigree law in 2015-2017. As I show above, it doesn’t make sense to add serial numbers in linear barcodes so you are left with the probable decision to put the NDC and serial numbers in a 2D barcode or RFID tag in addition to the existing linear barcode that contains the NDC by itself. That’s pretty space inefficient.
The FDA is aware of this unfortunate situation as indicated by their recent request for comment on eliminating the requirement for the use of linear barcodes containing the NDC on drugs. Click here to read the responses they have collected so far. You have until February 23, 2012 to submit your own comments to the FDA through www.regulations.gov, docket number FDA-2011-N-0719.
Pay close attention to what the FDA does with this issue. More than likely it will impact everyone in the U.S. pharmaceutical supply chain.
Dirk.
Thank you to George Wright IV of PIPS for catching an embarrassing error in my construction of the GTIN-14’s encoded into the sample barcodes. I have now corrected and updated them.
Oh, it would be so easy if technical barriers were the only problem! I’ll add another big barrier: The pharmacy industry remains opposed to track-and-trace.
NCPA, which lobbies for smaller pharmacies, testified to Congress on February 1, 2012, as follows:
“Our view on such a system is that it should be: 1) used sparingly – for example, only in cases of recalls; 2) allow for human readable identifiers on the saleable unit; 3) not be used by manufacturers as a prerequisite for the ability of
pharmacists to purchase their products, or return recalled or outdated products; and 4) and not impose significant burdens and hardships on certain sectors of the supply chain or serve as an
unfunded mandate at a time when small businesses, such as independent pharmacies, are already struggling under a crushing burden of federal and state regulations.”
Translation: Mind your own business. We don’t need no stinkin’ bar codes.
And don’t forget that the pharmacy associations funded a bogus Accenture study asking for millions per store to implement T&T. (http://www.drugchannels.net/2008/06/accentures-track-and-trace-straw-man.html).
The FDA has no authority over pharmacies, so good luck with that track-and-trace implementation!
Adam,
As always, thanks for your comments and thanks for the link to your essay about that old Accenture study. It will be interesting to see what happens with track & trace and/or ePedigree at the federal level, but my current essay is talking about only the barcode used on drugs. Of course, if a country like the United States decides not to add serialization to drug packages then there would be no reason to move away from linear barcodes. Although now that I think about it, if the U.S. decides against serialization but decides to add lot and expiration date to the barcode, then there would still be a reason to switch from linear to 2D barcodes.
I wonder what would happen in each state board of pharmacy if the federal government mandated serialization on drug packages? Do you think the states would refuse to require their pharmacies to make use of it? I suppose some might, but I know at least one state that would require it!
Dirk.
The same issues relate to medical devices. Consider, please: the savings from AIDC in retail sales and distribution, the need for US companies to compete abroad where regulations requiring AIDC are being implemented, that the refusal to adopt technology in healthcare administration is a key reason US healthcare costs are disproportionately higher than many other countries and still out of control. Thanks.
Well said Napoleon. I wonder why pharmacies aren’t leading the charge toward greater information in the barcodes on drugs and devices. I would think that the addition of lot/batch and expiration date at least would help streamline some of the 5-R’s (Right dose, Right patient, Right medication/device, Right time, Right route) that a pharmacist needs to pay attention to on every dispense. Those data elements would help the pharmacist be confident that the Right Medication/Device is being dispensed because a computer could confirm that the drug/device hasn’t expired and isn’t involved in a recall. That would happen almost instantaneously without the need to read the human readable that is printed on the side of the drug/device package. Serialization would also ensure that the Right Medication/Device is being dispensed because it would help detect suspicious supply chain history that may indicate that the drug/device isn’t real.
I also wonder why insurance companies aren’t out there leading the charge. It seems like it would help their profitability without eliminating any services or coverages.
Dirk.
Agree 100%. Always enjoy your posts.
Here are a few more factoids which may be of interest:
MAJOR: FDA re-authorization is a chance to DO SOMETHING to further legislation on both pharma and devices FDAAA! You can’t track outcomes or populate an EMRs and PMRs without AIDC!
MINOR: HDMA has led in resolving the pharma issues for distributors. AIM Global has recently formed a healthcare focus group. US customs also pushing AIDC to stop counterfeits at the border. DoD wants AIDC to track mission critical healthcare supplies with an interoperable system. The NEHI has scheduled a Hill briefing on 1 March on tracking outcomes. Senator Kay Hagan has Medication Therapy Management legislation in the House. I’ve asked the Dental Trade Alliance to hold off on any system because they should not go off in a new direction.
Disclosure: I have a HIDA seat on the HIBCC BoD and several patents in the area of medication management. For context, please see: http://www.newdirectionsconsulting.net . Thanks.
You asked about insurance companies. That deserves a separate comment. Insurance companies are largely pass through entities. They follow and earn their profits from the pay for procedure system which is widely known to be a cause of the healthcare mess. Health reform, controversial as it is, has a logic at its base. This is “pay for making people better.” This is known as paying for outcomes or accountable care if you agree with it; and socialism or Obama Care (Previously Hillary Care and or capitation.) if you oppose. The government may screw up the idea. But…
Employers, patients, caregivers and CMS, not insurance companies ultimately pay healthcare bills. The ultimate payers are now encouraging wellness demanding that they pay for outcomes. The insurance companies are coming along because of the logic and the demands of those who ultimately pay the bills. Some have got the idea and are actively helping the payers. Some seem to be conflicted and basically stuck in the paperwork churn of their broken, legacy cost-plus-and-pass-cost-on systems.
As noted before you can’t write down all the information needed to maintain an EMR of PMR to know what care has been given. What drug? what device? What outcome?
Thanks for the opportunity to weigh in.
One of the key issues in getting universal adoption will be to have the same requirement across all packs. The potentially crazy situation in Europe under the Falsified Medicines Directive, as currently written, will be that Rx products which are white-listed as “safe” will not need to carry a serialized code. In fact, they will be specifically prohibited from carrying a code. This white list process is to appease lobbyists from the generics industry, primarily, who view their products as too cheap to fake. Any trip to Africa disproves that theory. In industrial systems, complexity creates cost so the simpler the coding environment the better. A uniform, universally-applied traceability identifier for drugs should not be beyond the wit of man but we seem to be making pretty heavy weather of it.
Beyond the impracticality of fitting long barcodes onto product, Chinese regulations (which *mandate* a linear barcode) have highlighted another equally serious problem with linear barcodes. Inline printing of such barcodes is far more difficult/costly than of Datamatrix, in large part due to the much poorer error correction afforded by this older technology. This strongly motivates some companies to switch to pre-printed labels, which in turn can be a more costly and complex pathway to compliance.