In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached. Click here to read my first essay on the topic which explains the concept. Click here to read my 2011 essay and click here to read my 2012 essay. These are not estimates of the actual percentage today. Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future. My plan was to revisit my prediction each year at this time to see how it is faring. (click the drawing to enlarge it.)
Each year I’ve said I would need to update my prediction if anything in the legal landscape changes. These include:
- California changes their pedigree deadlines, or certain other requirements
- The Federal Government (Congress and/or the FDA) imposes a nationwide pedigree law/regulation
- Some other state adds a serialization-based pedigree requirement to their regulations
- “The Big One” happens and the State of California slides into the Pacific Ocean
Only the second one has a very high likelihood, but so far, even that hasn’t happened (see “Federal Pedigree: Caught In A Web Of Politics“) so nothing yet would lead me to change my prediction. So here again is my graph with no changes to the data since 2010. I have simply updated the year and placed an arrow on the X-axis to show the current point in time.
As I have pointed out in the past, it will be kind of hard to tell how well my prediction is doing if some authority with the means to measure the actual percentage does not step up and make it public. In the last 12 months no entity has stepped up to do that so we don’t have any way to accurately tell how much progress has been made. And to be honest, my personal observation does not really count because it is totally unscientific and because I no longer have any view into what is happening across the entire supply chain like I had in the past when I worked for Cardinal Health. But, I think we can all be fairly confident that the trend is still upward and still accelerating over previous years. Just like last year it still feels like we are probably somewhere between my low and high lines on the graph but, again, probably closer to the low line than the high line.
And over the last few years I have learned that some (many/most?) manufacturers who have installed the systems necessary to print/apply serial numbers in barcodes on their drug packages have chosen not to turn them on just yet, preferring instead to do limited pilots to test their capability and then shutting the systems off for now, awaiting the effective date of the California regulation. Depending on how widespread that approach is, any numbers collected would be on the low side of reality.
There have been some interesting articles published over the last year that looked into how companies are doing with their programs. From Pharmaceutical Commerce last month: “Preparing for a serialized supply chain”, from Life Science Leader in last fall: “The Business Case For Pharmaceutical Serialization”, and from Healthcare Packaging in May: “Pharmaceutical serialization: Should you wait?”. OK, I wrote that last one, but the very compelling data behind it was collected by the folks at the magazine.
Another year has passed with an apparent uptick in the number of drugs serialized in the U.S. market. If we’re going to get to 100% by January 2016 in California we’ll need to see a marked increase in the rate in the next two years as my prediction graph shows. Keep watching for that.