Dirk Rodgers of rxtrace.com writes "It’s August and that means it is time to check in on the progress
toward full serialization of drugs in the U.S. supply chain. This is an
annual look I’ve been doing for five years now. For my previous
essays, see:
- “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
- “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.
In each essay I produced a graph of my own personal estimate
of the likely rise in the percentage of drugs that I thought would
result, based on the deadlines that were in place at the time. Of
course, things changed last year because the Drug Supply Chain Security
Act had preempted the California Pedigree law the previous November, so
last year I made a new estimate that took into consideration the DSCSA
dates.
One of the problems making guesses like this is that there is not
much data out there about what is actually happening, or what companies
are planning to do. By now, all drug manufacturers and repackagers should
have a solid project plan for meeting the 2017 deadline, but no one has
collected data about when those companies plan to begin shipping their
products with those serial numbers.
I have done an unscientific survey for the last two years, both times sponsored by Frequentz (see “DQSA: Did The Authors Get The Timeline Right?” and “2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!”),
in which I tried to find out when we will see a big rise in the
percentage of drugs with serial numbers on them entering the supply
chain. What I found
is that companies are making progress in adding serial number
capabilities to their packaging lines, but many are choosing not to turn
those systems on until sometime in mid- to late-2017—just prior to the
deadline. If true, that will result in a rise that is in line with my
predictions over the years.
A few years ago the Center for Healthcare Supply Chain Research, an independent research “partner” of the Healthcare Distribution Management Association
(HDMA), began including some questions about serialization in the
supply chain in their annual survey of wholesale distributors. This is
close to what I have been looking for. They have been asking U.S.
wholesale distributors to report the percentage of SKU’s received
inbound from manufacturers with 2D bar codes on them. It is safe to
assume that any drug in the U.S. that has a 2D barcode on it is
serialized.
In 2012 their respondents reported that only 1.1% had them. In 2013,
the year with the most recent data, that percentage “leaped” to 2.6%.
That is a big jump over a single year, but the numbers are still very
small and I’m not sure you can trust these companies to report such
numbers accurately. I assume these responses come from someone at the
corporate office who is mostly just guessing at what is actually
happening in the distribution centers. I would be very surprised if
anyone is actually measuring this number scientifically. They should,
but I doubt they are. Correct me if I am wrong.
I am including the graph of my prediction again this year, with no
modifications because the HDMA’s “actual” numbers are within my
predicted range for 2012 and 2013. That gives me at least some
minimal confidence that my prediction from last year will reflect the
eventual reality. If my estimates are accurate, then right at this
moment wholesale distributors should be receiving Rx drugs with serial
numbers on more than 10% of their Rx SKUs.
Does anyone think this is what’s happening? Are there any wholesale
distributors out there who would like to anonymously tell us what you
are seeing right now? Feel free to respond through the “Contact Dirk” link, or just send me an email.
Going forward, I am going to move this annual look at the rise to
sometime right after the HDMA publishes their annual survey results so
my analysis of their data is fresher. I think they publish in December
or January. Watch for that. Dirk." - For more on item serialization from Dirk Rodgers visit www.rxtrace.com
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