Tag Archives: NCeP

The New GS1 Healthcare US Track & Trace Guidance

 

GS1 Healthcare US
GS1 Healthcare US

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.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

California ePedigree Uncertainty

Pedigree law approaches CaliforniaImportant 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.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 lawFor 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

Data Ownership In The Track & Trace Cloud

Cloud over IllinoisImportant 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.Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository?  I met one potential future repository service provider who seemed to think that they would own that data.  Imagine their excitement.  All the data about where drugs go throughout the supply chain!  Think of the value they could mine from that.

Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS).  And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud

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

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

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

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

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

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

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

Reliance on Trust in the U.S. Pharma Supply Chain

Trust plays a big role in today’s U.S. pharmaceutical supply chain.  Patients trust that their doctors know what they are doing when they prescribe a medicine and they trust their pharmacist to fill their prescriptions with real medicines that were:

  • manufactured to tight quality specifications,
  • are well within the expiration date,
  • have not been tampered with,
  • have always been kept within recommended environmental tolerances,
  • and have been in the control of companies who have a strong interest in supply chain integrity and in the safety of the drugs within the supply chain.

When we receive our little amber bottles of repackaged drugs from our pharmacist, we aren’t given any way to check on any of those things ourselves.  We trust that the pharmacy has done something to ensure all that.  And fortunately in the U.S., we are almost always justified in that trust.  We enjoy the safest supply chain in the world.

A WHOLE LOT O’ TRUSTIN’ GOIN’ ON

But, now if the pharmacy doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler will supply them with drugs that have those characteristics too.  And if the pharmacy’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler’s wholesaler provides them with drugs like that too.  And if the pharmacy’s wholesaler’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that Continue reading Reliance on Trust in the U.S. Pharma Supply Chain