Tag Archives: EPCIS

California Pedigree Law

“The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

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Magoo_christmas_futureImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 →

California Pedigree Law

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

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“The Californians”

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.As I indicated last week, I wanted to write about a specific dialog that occurred at the December 4, 2012 California Board of Pharmacy Enforcement Committee meeting.  The important exchange came at the end of the meeting during the catchall agenda item called “General Discussions” when topics that are not on the agenda can be raised by Board members or the general public in attendance.

As soon as the Chair opened that agenda item, Michael Ventura of GlaxoSmithKline rose and strode to the microphone.  The exchange that followed was captured on the meeting video.  I transcribed the exchange below as it happened because I think it provides a number of important clarifications about  Continue reading California Board of Pharmacy Clarifies Use Of GS1 EPCIS →

Board of Pharmacy

How To Make The Semi-Centralized Track & Trace Model A Reality

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Last week I attended the Enforcement Committee meeting of the California Board of Pharmacy.  The value of attending these meetings is hard to extract.  It helps to have a solid knowledge of the language of the pedigree law, understanding of the standards and technology being considered to meet it, and the history of how we got where we are today.  Even with all that on your side it takes a lot of concentration during the meeting and after it is over to put it all into perspective and find the value.

I will provide you with my thoughts on what Continue reading How To Make The Semi-Centralized Track & Trace Model A Reality →

Network Centric ePedigree Models

The Significance of the Abbott, McKesson and VA Pilot

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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 →

IBM, track and trace

Could It Be The Cloud? More Thoughts On IBM’s Divestiture Of Its EPCIS And E-Pedigree Suite

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At times like these I often think of an old movie from 1981 called “Modern Problems” which starred Chevy Chase as a hapless air traffic controller who faced problem after problem, some of which wouldn’t even have existed 20 years earlier.  For some reason I can’t explain, I sometimes think of that movie when I’m about to click the “Publish” button on an essay.  As soon as that button is clicked, my thoughts are instantly transmitted to the world (hundreds of people in the case of RxTrace) in a neat little package.

Almost immediately after clicking the Publish button on last Friday’s essay, “IBM Divests EPCIS and ePedigree Suite” I had thoughts of another possibility that IBM’s recent action might explain.  Too late.  My thoughts were already being read by people.  A “modern problem”.  Fortunately I can send this follow-up.

Like a commenter to my Friday essay, I wondered why IBM would chuck their entire traceability repository product if the problem were simply that ePedigree only makes sense for boutique solution providers?  They could have just sold off the ePedigree application and kept the more generally marketable ITS product.  There has to be more to it than that. Continue reading Could It Be The Cloud? More Thoughts On IBM’s Divestiture Of Its EPCIS And E-Pedigree Suite →

pedigree software

IBM Divests EPCIS and ePedigree Suite

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According to the IBM website, IBM has sold its Infosphere Traceability Server (ITS) product to Frequentz, a company based in Los Altos, CA.

The IBM ITS webpage now states:

“Frequentz acquired the IBM InfoSphere Traceability Server in Oct 2, 2012. All future information regarding the InfoSphere Traceability Server products will be available from Frequentz.”

No other information about the sale was included.

This is stunning news considering the history of the ITS product, and because Continue reading IBM Divests EPCIS and ePedigree Suite →

GS1

Should GS1 Continue Developing ePedigree Standards?

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Photo by immrchris

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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? →

WMS

The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores.  A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma.  That’s so that the WMS vendor can maximize their sales.  The more industries, the more sales and the more profitable it is.  Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades.  In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations.  I include Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization →