I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain). It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply.
The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.” And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”
In the California language, a “dangerous drug” is Continue reading Certifications In A California-Compliant Drug Pedigree
In the U.S., the initials FOB stand for “Freight On Board”. “FOB…” is used here to establish which party, the buyer or seller, pays the shipping costs. FOB terms are typically either “FOB Shipping Point“, which means the buyer must pay the shipping, or “FOB Destination“, which means the seller must pay the shipping costs. The “FOB” terms of a given shipment of goods must be agreed to by the buyer and seller, either through a pre-negotiated contract, or through the seller’s acceptance of the terms spelled out in the buyer’s purchase order (PO).
If someone had told me even six months ago I’d be writing an essay about FOB terms I wouldn’t have believed them. It seems like the most boring topic imaginable. So what has led me to this boring topic? Have I finally run out of things to write about? Continue reading Pedigree Will Change FOB Terms
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.
PSM is led by a distinguished panel of leaders and directors. The leaders are Continue reading Partnership For Safe Medicines Interchange 2010
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.
It’s an event that is intensely focused on Continue reading Terminology: Track and Trace, and Pedigree
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.
But what happens when those governments are too big to sway easily? What if it costs too much and takes too long to get them to see the light? This is when a standards adoption organization needs to get creative. In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”. It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards. Let me explain. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This
Four years ago the GS1 EPCglobal Software Action Group (SAG) Drug Pedigree Messaging Work Group was wrapping up the standard specification for the GS1 Drug Pedigree Messaging Standard (DPMS, aka GS1 Pedigree Ratified Standard). That standard was developed through collaboration between U.S. pharmaceutical supply chain members, industry associations, solution providers and GS1. DPMS 1.0 was ratified by the EPCglobal Board in early January 2007.
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.
But even before DPMS was ratified people were raising questions and concerns about it. Those concerns were Continue reading A Semi-Centralized, Semi-Distributed Pedigree System Idea
There was a flurry of discussion last week over a recent Wall Street Journal blog by their “Numbers Guy”, Carl Bialik, regarding the often quoted “estimate” that 10% of drugs worldwide are counterfeit. On September 10, Bialik posted an essay titled, “Dubious Origins for Drugs, and Stats About Them“. The next day he published an article on the topic called “Counterfeit Drug Count Is Tough to Swallow“. Both essays call into question the origins and the accuracy of the “estimate”. On September 13, Dr. Adam Fein posted an essay titled, “The Counterfeit Counterfeit Drug Count” on his DrugChannels blog, citing the WSJ essays and providing some additional insight.
Don’t miss the many comments left by readers of Bialik and Fein’s postings. It’s surprising how Continue reading Stop Claiming that 10% of Drugs Worldwide are Counterfeit
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