Buried deep inside the complaint filed in federal court last month by TraceLink against the Healthcare Distribution Alliance (HDA) is the heart of the issue (see “Tracelink vs. HDA”). It’s about the sharing of product master data throughout the supply chain—that is, “Supply Chain Master Data” (SCMD) (see “Supply Chain Data Synchronization and Patient Safety”). According to TraceLink’s complaint, the closed nature of HDA’s Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”) is causing problems for vendors of DSCSA compliance solutions, and that will cause end-user companies in the supply chain to pay more for their overall solution. Continue reading What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data
There is a not-so-secret situation that has been festering for years in the internal IT systems of many companies in the U.S. pharma supply chain. In the past, nobody liked to admit it, but most would, because the full extent of the problem was hidden away from public view. It was an internal problem mostly affecting only internal systems.
The problem was that the quality of the local master data was poor. Master data is the data that companies hold in internal databases to describe their trading partners (customers and suppliers), products (their own and those of other companies), contract parameters (pricing, authorization, terms and conditions, etc.), and facilities, etc.
Companies get lulled into thinking this data Continue reading DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee. It is definitely worth watching closely, but don’t let it take your eye off of the California regulations. Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law. That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.
Last week I wrote about the new draft regulation on certifications in California e-pedigrees. In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference. This draft regulation is Continue reading California’s Draft Inference Regulation
During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on. The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees. Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees
GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide. The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.
This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”). Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance
A lot of things related to ePedigree in the U.S. supply chain are cooking right now but they seem to be happening a little too slowly, so it will be interesting to see where it all ends up in the next few years. After developing the Drug Pedigree Messaging Standard (DPMS) in 2006-2007, GS1 is now taking only the initial steps toward adding network-centric ePedigree capabilities to their EPCIS and related standards. The California Board of Pharmacy says they would like to be able to accept a semi-centralized network centric approach as long as it includes all the stuff listed in their pedigree law. For nearly 18 months, GS1 U.S. has been “nearing publication” of a draft guideline—six years in the making—that is supposed to help companies who want to use EPCIS to meet the California law. Congress considered passing a Federal track & trace regulation that would have preempted the California law last year but failed from lack of agreement between the parties. Some companies are making good progress on meeting the serialization requirement but the number who have the pedigree part figured out are those who have settled on DPMS. All the while the California pedigree deadlines are rushing toward us like a bus-sized asteroid heading straight toward Earth. Not surprisingly, the asteroid is moving faster than the efforts to divert or absorb it.
I’ve written about my theory that the date of impact won’t be pushed out again, no matter what happens (for a full explanation of that theory, see “Will The California ePedigree Dates Slip Again?”).
What can be done? In my view, it’s going to be determined by Continue reading California ePedigree Uncertainty
Currently, we know that companies can use GS1’s Drug Pedigree Messaging Standard (DPMS) to comply with the California pedigree law. That’s been known for a long time now. But many companies have been hoping to use GS1’s more general purpose Electronic Product Code Information Services (EPCIS) standard instead for almost as long. For just as long, it has been known that a number of problems arise when you try to figure out exactly how to apply EPCIS to California compliance.
The problem is, EPCIS was originally envisioned by its creators to share supply chain “visibility” data. That is, event data that was to be collected automatically based on Radio Frequency IDentification (RFID) reads picked up by readers that were to be spread around the supply chain by each of its members. The collection of RFID readers were to form a kind of “visibility” of each RFID tag applied to the products in the supply chain. From this visibility would come benefits. One of those benefits was to be Continue reading “The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance
For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard. The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”. According to the call-to-action:
“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data. Standards will also address data confidentiality and security. This MSWG will create
A) standard for security framework applicable to EPCIS and,
B) pedigree checking services.”
This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards?