Last Friday I attended the first annual Partnership For Safe Medicines (PSM)Interchange 2010 event. PSM is a coalition of organizations that are committed to the safety of prescription drugs and protecting consumers against unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines. PSM was started a few years ago to help educate healthcare professionals and the public about the dangers of counterfeit and other illegitimate drugs. It is based in Vienna, VA but focuses on the problem globally. The membership is made up of professional organizations from industry, universities and government.
I don’t get paid for endorsements. I don’t sell my opinion. No one has my thoughts under their control. So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion. This year, the event will be held on November 8-10 in National Harbor, MD (just south of Washington DC).
BTW, This opinion wasn’t solicited and I am paying full (member) price to attend the event. This isn’t an advertisement. It’s what I believe.
GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market. Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders. With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government. If they can get the government to reference GS1 standards in their laws, their work is much easier.
This isn’t unique to GS1, or course. All standards organizations know this and they all have various approaches to getting the attention of each country’s government. There is nothing wrong with this. In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.
DPMS has many benefits. It results in a self-contained, self-secure electronic document that clearly shows the chain of ownership and/or custody of a given drug package (or a set of packages if they all have the same history). It works equally well with serialized and non-serialized products. The security of DMPS documents comes from within the electronic documents themselves rather than just from a security layer wrapped around a given server. A self-contained, self-secure document model should work well as evidence in a criminal trial.
GS1 EPCglobal ratified and published the most recent version of the Tag Data Standard (TDS), 1.5. I have always been a fan of TDS, but earlier versions served as much to expose embarassing disconnects in GS1 standards as they did to explain how to apply GS1 identifiers in an Radio Frequency IDentification (RFID) context. Earlier versions of TDS tightly bound the concept of the Electronic Product Code (EPC) to RFID, and that’s just wrong. “EPC”, even as defined in those earlier versions of TDS, is a way of uniquely identifying objects on a global basis. It’s purely a globally unique identifier standard. That’s a hugely important and relatively new concept. RFID–a simple data carrier technology that’s been around for many years–is almost insignificant in comparison.
Even the name “Tag Data Standard” reflects this wrong-headed binding of EPC to RFID by seeming to place the RFID “Tag” at the center of the “standard”. Yes, there is a need for a “Tag Data Standard”, to show how to encode an EPC into an RFID tag, but it is wrong to Continue reading Masterpiece: GS1 Tag Data Standard 1.5→
I received news last night that my friend and co-worker, Ivan Shen, passed away on Sunday after losing a five month battle with cancer. During his career Ivan worked for serialization and pedigree companies including Oat Systems, Reva Systems and SupplyScape (now TraceLink). Many RxTrace subscribers are current or former co-workers or former customers of Ivan. Continue reading Yifan “Ivan” Shen (1962–2010)→
Back in 2005 I created a line graph of my personal prediction of the percentage of pharmaceuticals in the U.S. supply chain that would be unit-level serialized by the manufacturer and I circulated it among my co-workers at the time. I based it purely on guesses that were “supported”–very flimsily–by the number of large pharmaceutical manufacturers who were participating in the GS1 EPCglobal Healthcare and Life Sciences (HLS) Business Action Group (BAG) (the group is now defunct), and the existence of an early version of the California Pedigree Law. The graph included a high and low line that formed a band that I thought would be where the reality would fall. In that prediction I didn’t think most manufacturers would achieve 100% serialization of their products until sometime between 2010 (high) and 2015 (low).
In my analysis at that time, I theorized that the actual percentage would start out following my “low” estimate line, but at some unpredictable point, something would happen that would cause the percentage to jump up to the “high” estimate line. At the time, I assumed the event that would cause that jump would be the U.S. Federal government issuing some kind of pedigree regulation that included a unit-level serialization requirement.
As it turned out, things moved slower than I had guessed. Here it is 2010 and the percentage of drugs in the supply chain with unit-level serial numbers on them is so small that it’s tough to give it a percentage. But I think my estimate from way back in 2005 was not bad for its time (but notice I’m not publishing the actual graph). After all, the California Pedigree deadline has been pushed out at least three times since then (from 2007 to 2009, to 2011, to 2015/1016).
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.