I was a little surprised at how heated the discussion was at the breakfast table back during last year’s Healthcare Distribution Alliance (HDA) Traceability Seminar. I chose an open seat at a table with people from multiple drug manufacturers and someone from GS1 US. Our conversation at the table started out typically—the weather, the previous day’s speakers—the usual. I had recently been thinking about the human readable portion of the Product Identifier mandated by the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages”), so I asked everyone what their company was planning to do?
My main question was about their company’s interpretation of the DSCSA requirement to include the Standardized Numerical Identifier (SNI) in the human readable portion (see “Anatomy Of An FDA SNI”). It’s in the barcode too, but exactly how to encode it there is fairly well understood. But the human readable seems to have some variability in interpretation.
The SNI is composed of the combination of the drug package’s 10-digit National Drug Code (NDC) and a serial number, which can be up to 20 alphanumeric characters long. I’ve spent considerable time and effort researching and writing to explore the question “Is a GS1 GTIN really usable in the human readable as an NDC for DSCSA compliance?” (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1” and “…Part 2”). The trail of facts is surprisingly lengthy so I won’t repeat them here. Read the essays referenced above if you want the full explanation.
Listen to the ContractPharma webinar:
Featuring Peter Sturtevant of GS1 US,
Joseph Lipari and Dirk Rodgers of Systech
Thursday, February 22, 2018
Listen to the recording
In the end, I concluded that only the FDA can tell us the true answer, but I think it is a bad idea to use a GS1 GTIN as an NDC for DSCSA human readable compliance. It’s a bad idea because of who is likely to rely on the printed human readable the most.
WHICH HUMANS WILL ACTUALLY READ THE HUMAN READABLE CONTENT?
Workers in the pharma supply chain will do everything they can to never look at the human readable content of a package. They are going to want to scan the 2D barcode to collect the data needed about the package in their hand. That’s because they need the entire contents of the DSCSA Product Identifier so they can treat it as a single block—a single unique identifier. They need it electronically–formatted exactly as the manufacturer, their trading partners and regulators will recognize it: exactly the way it is encoded within the 2D barcode. And only a barcode reader can reliably extract that block of data perfectly every time–electronically–as data.
If the barcode is unreadable, after November 27, 2023, companies in the supply chain are very unlikely to read the human readable text and type the 30 to 50 characters into their computer so they can sell even a single unit (unless there is a life-saving immediate need or if perhaps the product is valued on the high end). The odds of reading and typing that many characters and getting them all entered right in the first pass is not very high. And without an overall check digit, you won’t even be able to tell if you might have made a typing error. And errors like that could result in the appearance of illegitimate activity (if you mistakenly duplicated a different, legitimate unit, for example). In my view, very few situations in the supply chain will justify typing a DSCSA Product Identifier into a computer.
More than likely, in the instance of a barcode that is unreadable the unit will be considered unsalable and returned to the seller. When the seller gets it back, if they can’t read the barcode, they will return it too, until it arrives at the original manufacturer. Let them try to read the human readable.
So if repackagers, 3PLs, wholesale distributors and dispensers aren’t likely to read the human readable, who is? It will probably be patients, when handling drugs that their pharmacist did not repackage on dispense, and who don’t have a barcode reader or smartphone; and emergency medical professionals, like first responders, who may also not have a barcode reader and computer or smartphone handy when they need it. In most cases, they won’t need the entire DSCSA Product Identifier. They will just need to confirm the NDC, and that the drug is not expired. The serial number and lot number data will probably be meaningless to them.
Fortunately, the NDC will probably be printed elsewhere on the package, but in most cases, the expiration date will probably only be visible in the DSCSA Product Identifier human readable text.
YOU DECIDE(D): CONSCIOUSLY, WILLFULLY
In the absence of guidance from the FDA, drug manufacturers must consciously make the decision. How should we format the human readable text? Should we follow the letter of the law and print the SNI as the 10-digit NDC plus the serial number? Or should we print what is encoded in the barcode, a GS1 GTIN plus a serial number?
By now, that decision has probably already been made by most companies marketing drugs in the United States. So at breakfast at the HDA Traceability Seminar, I wanted to know. What is everybody doing? My “poll” wasn’t scientific. It wasn’t even really a poll. I just asked around. I found one multi-national company who said they had evaluated their alternatives, just as I did in my essays, and they concluded that they should print the NDC in the DSCSA Product Identifier human readable text. All of the others I asked are printing only the GS1 GTIN there, because that’s what’s in the barcode.
Some of those who are printing the GTIN didn’t like hearing questions about the appropriateness of that choice. That’s why the discussion got a little heated at my breakfast table. The representative from GS1 US expressed the opinion that printing the NDC instead of the GTIN in the human readable next to a GS1 barcode violates GS1 rules, and so he felt that companies printing the GTIN were doing the right thing. I wasn’t trying to calm anyone down when I asked whether companies should be more afraid of potentially violating federal law or violating GS1 standards?
THE ROOT PROBLEM
It was a great discussion, and I hope I didn’t cause too much indigestion. The root problem the conversation exposed is that there is a difference between the regulatory identifier and the practical identifier of the same product. The NDC is the regulatory identifier, and the GS1 GTIN is the practical identifier. And it’s even worse than that. Dispensers and payers use a third identifier I call an “NDC-based reimbursement code” for drugs too.
Yes, each one of these is easily relatable to the other (if you know how), but an NDC does not equal a GTIN, and a GTIN is not an NDC. If you do a search in a database, you have to know in advance if your index is an NDC or a GTIN, or an “NDC-based reimbursement code”, and convert your search key to match.
All three identifiers have been used to identify drug products in the US for decades without too much difficulty. And yes, drug companies have been printing the GS1 GTIN below the NDC linear barcodes for decades, and the FDA hasn’t said anything about it.
What is new, is the emphasis on the SNI and its use in tracing documentation and reporting. And it’s not just supply chain. Over the last 10 years something known as “Health IT” has grown significantly, and it will continue to grow going forward. Having three different identifiers for every drug—even if they are relatable—is bound to be a problem that slows things down.
The solution isn’t to let everyone choose one identifier or another. The solution is to move forward with a single identifier for drugs. That was precisely the topic of my open letter to the FDA back in 2016 (see “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”). Make the GTIN the official FDA identifier for drugs (following the Unique Device Identifier, UDI, approach, see also “UDI And The Approaching End Of The NDC”). That would eliminate the decision companies are currently faced with for the DSCSA human readable, thus making drugs much easier to identify, which makes their use by patients safer, not to mention more accurate reimbursements, and on and on.
There is even another problem that is induced by this ugly swirling set of identifier systems. I will explore that problem in the near future. The longer the FDA delays transforming the NDC system the longer it will take for everyone to benefit from the changes imposed by the DSCSA. So what are we waiting for?