The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation. Take careful note of this one. It could be the one that finally makes it. Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate
Tag Archives: pedigree laws
The Significance of the Abbott, McKesson and VA Pilot
Last month I had the opportunity to see the presentation by Abbott Labs, McKesson, the U.S. Department of Veterans Affairs (VA) and GHX about their recent and ongoing Network Centric ePedigree pilot. [NOTE: GS1 removed the PDF file from their website after my essay was published. See the comments below this essay for more. – Dirk.] I see that a presentation on the same topic is on the agenda for this week’s HDMA Track & Trace Technology Seminar. If you are attending that event, don’t miss that presentation because this pilot is an important one. I normally like to attend the HDMA event but I won’t be there this year due to a long-scheduled vacation.
The pilot implemented a “Centralized” Network Centric ePedigree (NCeP) system. Continue reading The Significance of the Abbott, McKesson and VA Pilot
More Thoughts On The Congressional Discussion Draft
You now have less than one week to provide a group of Congresspeople with your thoughts on their latest discussion draft for a bill that would attempt to make our U.S. drug supply chain less susceptible to criminal attacks and errors. See my two earlier essays, “The Congressional Draft Proposal to Improve Drug Distribution Security” and “Congressional Legislation Development: Mad Libs Edition!” for more specifics.
Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is. That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences. I don’t know what you’ve been up to, but this is my third essay about it. 😉
There are still a few things that I wonder about. Continue reading More Thoughts On The Congressional Discussion Draft
Congressional Legislation Development: Mad Libs Edition!
I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security. As promised last Thursday, here is my analysis. Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.
But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs. Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept. The problem is Continue reading Congressional Legislation Development: Mad Libs Edition!
The Congressional Draft Proposal to Improve Drug Distribution Security
Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress. That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee. Download it in PDF form from Senator Harkin’s website.
I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay. Stay tuned for that.
The email I received included the following explanation from Kathleen Laird of the HELP Committee: Continue reading The Congressional Draft Proposal to Improve Drug Distribution Security
Who Will Decide Which Pedigree Model You Will Invest In?
[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 15, 2010. See “Return Of Two Classics” for an explanation.]
In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers. I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.
Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice. If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages. I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.
But what about the pedigree model that the supply chain will use for compliance? Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is? Yes we can! And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In?
The Built-in Protections Of The U.S. Pharma Supply Chain
Last week we learned that 11 people were charged with the record-breaking $75 Million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010 (see the excellent article by Jay Weaver in the Miami Herald, including a copy of one of the multiple indictments). Importantly, all of the stolen drugs from the Lilly warehouse were apparently recovered before they could be re-introduced into the legitimate supply chain. But this investigation and the charges go well beyond the infamous Lilly warehouse theft. They include other pharmaceutical, liquor, cigarette and cell phone cargo thefts around the country, allegedly perpetrated by members of the same criminal organization. Cracking this organization could end up disrupting the most prolific source of cargo theft in the United States over the last five years.
Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges. They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.
This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world. In this case, it is strong and cooperative law enforcement organizations. While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world? I don’t think you would (unless you’re one of the Villa brothers or their associates!).
But what are the other components that result in the safest drug supply chain in the world? It’s certainly doesn’t occur by accident, so what are the built-in protections? Continue reading The Built-in Protections Of The U.S. Pharma Supply Chain
GS1 Standards – Betcha Can’t Use Just One!
The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.
So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One!
