Its not often that one or more things happen in one week that make me want to break the once-a-month blog pattern. This week was one of those weeks. And this is one of two blogs that arose from it.
I happened to review a string of comments from the SOPIT community on ASHP connect about IV solution bar codes that wouldn't read within in a certain BCMA product.
30338100702 (Dobutamine) - doesn't scan
0100304097809226 (Dobutamine) - scans
30338107702 (Dopamine) - doesn't scan
0100304093724325 (Dopamine) - scans
Now anyone who has been around bar codes as long as I have can look at these and tell that the ones that don't scan are a classic 12-digit UPC encoding and the ones that do scan represent a special format of GTIN that our friends at GS1 built specifically for encoding an NDC.
The UPC encoding starts with a 3 (which means its a drug), followed by the NDC in its unformatted 10-digit format, followed by a single-character check digit. (e.g 3, followed by 0338100702, followed by a check digit, which appears to be missing).
The GTIN encoding starts with 01003, followed by the 10-digit unformatted NDC followed by a single-character check digit. (e.g., 01003, followed by 0409780922, followed by a check digit of 6).
By the way, one can also commonly encounter a GTIN encoding that starts with 01103, followed by the 10-digit unformatted NDC, followed by a check digit.
These are so common, that I would consider any BCMA system who couldn't recognize and parse them to be seriously unaware of the market in which it has to live, and the software constructs needed to handle this are so elementary that it is amazing to me that any BCMA system couldn't just handle them. Further, these products have been around for so long, it seems highly unlikely that the BCMA system (or the pharmacy system that drives it) would be unaware of the NDCs for them.
Yet, if you follow the thread that caught my attention, you see discussions of making certain that all the right databases have the right data in them, and about mapping formats to be certain that it can be correctly parsed, and so on.
Why would anyone set up a system that way?
Some of the problem, of course, is that the FDA has no standards it requires. So, in the 5 years since bar coding on pharmaceutical containers was mandatory, I have seen bar codes that contain the above formats, or just the 10-digit unformatted NDC, or the literal text "NDC:" followed by the 10-digit NDC. But even then, the number of alternative formats that need to be supported (even if you include HIBCC) doesn't reach double-digits and the formats are mutually exclusive (and therefore easily identified).
ASHP has long been pushing for the ability to also capture lot and expiration in a single scan; if we want to go there, we are going to have to insist on standards that permit the identification of this information (my vote is the GS1 standard) and the FDA is considering arguments to permit the use of 2-D bar codes, so it is time that they also land on a standard that they insist everyone uses.
But wait!!!! Most BCMA systems don't parse the bar code; they just read it as a glyph. So, if the FDA were to permit 2-D bar codes, and those bar codes were to contain variable information like lot, expiration and/or serial number, most BCMA systems couldn't handle them!!!
Again, why would someone set up a system to work that way?
As some of you know, John Poikonen and I have been managing a running point-counterpoint argument about BCMA and its lack of an evidence base. It is a friendly discussion; John and I are old friends. But how can anyone expect a useful evidence base around BCMA when the implementations are so thoughtless? How can anyone expect it to make a difference?
The answer seems pretty clear to me:
1. The FDA needs to land on, and enforce a standard encoding
2. The BCMA vendor community needs to agree to properly parse it
3. The FDA (or someone else) needs to produce a reliable and timely database of NDC's that BCMA systems can rely on
Given this, we can actually finally know whether or not BCMA is worth its cost. I suspect, given these three things that the evidence base will appear.
What do you think?
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