Tag Archives: pedigree laws

InBrief: FDA To Publish Track & Trace Standard By Year End

March 28, 2012 Dirk Rodgers

I stumbled across the FDA’s recently published “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012” while surfing the PharmTech website late last week. The guide is published each year in the spring to provide a “heads-up” on which guidance documents the FDA thinks they will be able to complete and publish by the end of the calendar year.

I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said Continue reading InBrief: FDA To Publish Track & Trace Standard By Year End →

Federal Pedigree

What If RxTEC Isn’t Adopted?

March 19, 2012 Dirk Rodgers 5 Comments

I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA). In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working on drafting an actual proposed bill until their discussion draft (dated February 27, 2012) appeared on the internet about 10 days ago. I first saw it on Ed Silverman’s Pharmalot blog.

I also saw a presentation by one of the members of the PDSA last week that touched on the RxTEC proposal. It was characterized as a “stepping-stone” to full traceability in the U.S. supply chain someday down the road. In other words, the PDSA apparently means that their RxTEC proposal isn’t the final destination but it is only the first step toward that ideal. At least, that’s how I interpreted that “stepping-stone” comment.

PLATEAUS OF SECURITY

Now this is a concept that is familiar to me. In fact, as an idea stripped of all of the RxTEC-specific details, it is identical to the idea beneath the approach I proposed in a pair of RxTrace essays last May and June called “Plateaus of Pharma Supply Chain Security” and “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”.

This single underlying idea originates, on both accounts, from the fact that the amount of illegitimate activities within the U.S. supply chain is really quite small compared with the rest of the world (see my essay, “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”), and to reduce it further will take Continue reading What If RxTEC Isn’t Adopted? →

California Pedigree Law, Florida Pedigree Law

The Surprise Consequence of the California Pedigree Law

March 5, 2012 Dirk Rodgers 10 Comments

The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state. I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states. Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide. That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not. Voila! Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.

AFTER 2015: ALL DRUGS IN THE U.S. SUPPLY CHAIN ARE SERIALIZED AND PEDIGREED BY THE MANUFACTURER

That will be a big change, even outside of California. Here are some of the things I think we will see happen: Continue reading The Surprise Consequence of the California Pedigree Law →

Barcodes

Why NOW Is The Time To Move Away From Linear Barcodes

February 13, 2012 Dirk Rodgers 9 Comments

Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain. I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is. It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back. So let me show you.

SERIALIZATION
THE DAWN OF ^ ~~CIVILIZATION~~

No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.

Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs. Whether you agree to the benefits or not you certainly must accede to the fact that Continue reading Why NOW Is The Time To Move Away From Linear Barcodes →

Repackaging

Repackaging Drugs Under A Serialization Regulation

February 6, 2012 Dirk Rodgers 1 Comment

The California ePedigree law goes into effect for manufacturers in 2015/2016. In mid-2016 distributors and repackagers will need to comply. The California pedigree law includes the need for manufacturers and repackagers to serialize drugs at the smallest level of distribution to pharmacies. That’s just one of the requirements, they also need to make reference to those serial numbers in the ePedigrees that they create (manufacturers) or update (repackagers, distributors and pharmacies). (For more on the full pedigree regulation see my essays “The California Pedigree Law” and “California Pedigree Law: Historic Change To Commerce”). The implications of this to repackagers are unique. Let’s explore why. Continue reading Repackaging Drugs Under A Serialization Regulation →

Pedigree models

Could This Be Your Future Track & Trace/ePedigree Exchange Solution?

December 5, 2011 Dirk Rodgers 10 Comments

In a recent essay I discussed GS1 Healthcare’s proposed Network Centric ePedigree (NCeP) models that are currently available for review and discussion by the industry. By the way, GS1 is giving everyone until December 15 to respond to a survey to provide them with your thoughts on the various NCeP models. To review the videos and respond to the survey click on this link.

In a somewhat related news item, Pharmaceutical Commerce recently published an online article by Nick Basta about the Global Healthcare Exchange’s (GHX) project to build a new prototype for a track and trace data exchange hub called “GHX updates progress on a prototype data exchange for track-and-trace“. That article was an update to a more in-depth article by Nick about the project from last April in the same online magazine called “Healthcare Exchange Bids for Prototyping a Track-and-Trace System“. Combined, the two very interesting articles describe the prototype that is now complete and ready for piloting.

In fact, the GHX prototype implements Continue reading Could This Be Your Future Track & Trace/ePedigree Exchange Solution? →

pedigree laws

Should Regulations Dictate Technology?

November 28, 2011 Dirk Rodgers 4 Comments

In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations? This question arises whenever a new regulation is considered by any of these bodies or agencies. It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer. Let’s review the history first.

EXAMPLE: EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information. Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives? Is it a paper pedigree? Can it be electronic? What is the format? Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Continue reading Should Regulations Dictate Technology? →

Pedigree models

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2

November 14, 2011 Dirk Rodgers

There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.

In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.

The NCeP group published a very interesting recording of a presentation that explains the details of their work. It is called “NCeP – Technical Analysis Sub-Group, Event Based Pedigree”. The purpose of this recording is to help people outside of the close-knit NCeP group to learn about the pedigree models developed there, evaluate them and provide feedback to the group about which model(s) should be Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2 →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance