Posts Tagged ‘track and trace’

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 Read the rest of this entry »

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? Read the rest of this entry »

Every couple of years it seems that someone introduces a bill into the U.S. Congress that would one way or another legalize the reimportation of prescription drugs into the U.S. from other countries.  In December of 2009, right around the time that the Patient Protection and Affordable Care Act was being debated intensely Senator Byron Dorgan (D-ND) introduced a bill to do just that. 

You may recall that there was a dustup about how Senator Barack Obama had introduced a similar bill only a few years before that, but now as President, he made a deal with the drug industry that supposedly assured that drug reimportation wouldn’t be added to the Healthcare Reform bill in exchange for the industry supporting the Reform bill.  Senator Dorgan’s bill did not pass but Healthcare Reform did (See Dr. Adam Fein’s coverage of the failure of Senator Dorgan’s bill, “Drug Importation: Dead Again”).

The reason I’m thinking about reimportation this week is that I came across an interesting document that was published last week by the Partnership for Safe Medicines (PSM) called “A Risky Proposition:  How Opening The U.S. To Foreign Medicines Poses A Risk To Chronically Ill Americans”, a second edition.  I’m not sure why it was released now—maybe someone is thinking about introducing another reimportation bill again (I guess it’s not Senator Dorgan anyway!)—but I have an opinion about the topic Read the rest of this entry »

Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs.  This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security.  For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores.  You can get a copy of the full report PDF, view the associated webcast and graphic here:  After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs.  I’ll have more to say about the webcast in a subsequent essay.

According to the “Introduction and Background”,

“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses.  This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”

The report is 77 pages of text with 24 additional pages of references.  The text is peppered with numbered references for those who want more details on a particular topic.

There are three Chapters.

1. Pharmaceutical Manufacturing:  Globalization and Quality Management
2. Barriers to FDA Oversight
3. Pharmaceutical Distribution

Chapter 1 contains Read the rest of this entry »

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment.   Previously, all segments had to comply with the regulation by January 2011.   Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017.   As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses.   Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.

This staggered start pleased a lot of people—particularly distributors and pharmacies.   However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.

I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”.   I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system.   On its own, the U.S. pharma supply chain is naturally complex.   A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost.   As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain.   That adds a lot of complexity.

THE PLATEAUS OF SECURITY

No matter which model the industry implements, starting it up will have its own complexities.   In my view, regulators and industry should Read the rest of this entry »

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store (Click on image).

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy.  The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.

At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.

FOUR VIEWS OF THE U.S. SUPPLY CHAIN

In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy.  That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.

Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Read the rest of this entry »