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. 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 is 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. Nothing of significance to progress has changed in the last year that 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’ve 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 doesn’t 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. My personal observation doesn’t really count because it is totally unscientific, but, like last year, as an anecdotal observation I can say that I am aware of a few more products on the market with serial numbers on them this summer than I was last summer, so the trend is still upward. 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.
That’s probably not as significant as it might sound. What might be happening is that manufacturers are still testing their initial experimental deployments and working on improving the reliability of the new processes before they replicate their systems to all of their production lines. If that’s true then we may yet see my older theory come true that the actual percentage would leap from the low line on the graph towards the high line at some point. A few companies may also be adding serialization capabilities but holding off on actually turning them on until the California dates get closer as a cost containment move.
There have been some interesting articles published over the last year that looked into how companies are doing with their programs. From Pharmaceutical Commerce in February 2012: “Manufacturers are reviving their serialization plans”, from Life Science Leader in March 2012: “The Long Road To Serialization And Track-And-Trace”, and from Life Science Leader in July 2012: “Serialization And The Outsourcing Decision”.
Another year has passed with only an apparent small increase 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 few years as my prediction graph shows. Keep watching for that.