Tag Archives: pharmaceutical supply chain

The Viability of Global Track & Trace Models

At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates.  I want to explain that statement in a future essay (soon), but before I do I want to explore some of the track and trace models that are being considered by both GS1 and the FDA.  I particularly want to look at the viability of each model because I think we will find that some just aren’t (viable), and that will help narrow the search.

I’ll look at the three basic models that the FDA mentioned in their recent workshop:  Centralized, Semi-Centralized and Distributed (or Decentralized as the FDA called it).  There are others, but it seems that they can all be either based on, or reduced to, one of these three basic models.

In this essay I am looking at track & trace models from a global viewpoint, which is something that GS1 is doing but the FDA may not.  Attacks on the pharma supply chain are a global problem and global problems demand global solutions or gaps will be left for criminals to exploit.

GS1’s goal is to develop standards that apply globally as much as possible and the FDA will likely find that Continue reading The Viability of Global Track & Trace Models

Lessons from “Drug Theft Goes Big”

If you are a regular reader of RxTrace but you still haven’t read Fortune Magazine’s recent article, “Drug Theft Goes Big” by Katherine Eban, then I suggest that you stop reading this essay right now and spend the next 15 minutes absorbing her article carefully.  And then return here for my analysis.  It’s that good and that important.

Many of you will remember Katherine Eban as the author of the excellent book “Dangerous Doses, A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply”.  See my comments on the book here where I point out that a lot has changed since the events that are documented so well in the book.

The new Fortune article is a great update on what drug supply chain criminals have been up to since “Dangerous Doses” was published back in 2005.  The greatest thing about the article is Continue reading Lessons from “Drug Theft Goes Big”

Attributes Of A Global Track & Trace Application

In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view.  I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting.  Instead, I’m going to talk about the attributes of a track & trace application from the viewpoint of any global pharma manufacturer who is facing the regulatory mandates for serialization and traceability in a growing list of countries around the world, and from the viewpoint of any solution provider who is thinking about what they need to include in their solution offering so that those global pharma companies find it attractive enough to buy.

To those kinds of companies, the potential for new non-binding guidance from the U.S. is important, but perhaps less so than an increasing number of binding regulations from around the world.  Whatever the FDA—and especially the U.S. Congress—may do in the future will be important when selecting a track & trace solution, but the U.S. is only one of the countries in the world and pharma companies that do business in those other countries do not have time to wait for the U.S. to figure out their approach before making investments.

The goal is to make investments today that will be Continue reading Attributes Of A Global Track & Trace Application

Pharma Serialization ROI

Over the last few years I’ve taken part in many conversations that touched on the question of how to achieve a Return On Investment (ROI) with serialization in the pharmaceutical supply chain.  It seems intuitive that there should be an ROI because serial numbers provide increased data granularity and accuracy, but those characteristics in themselves do not guarantee a positive return.

For that, you must figure out a way to take advantage of those things in a way that increases productivity through decreased errors and reduced physical handling.  Serialization might do that if you can increase the amount of automation in supply chain operations within your own facilities.  Without automatic serial number reading and material handling, dealing with serial numbers will likely have the opposite effect on productivity.

Another way to take advantage of mass serialization of pharmaceuticals in the supply chain is to use it to help automate certain existing business processes between trading partners.  Whenever it is valuable to Continue reading Pharma Serialization ROI

Do We Even Need To Mandate Drug Pedigrees Anymore?

  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.

 

Drawing by Zsuzsanna Kilian

A CHALLENGE TO THE CURRENT CONVENTIONAL WISDOM

 

Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature.  No two laws are exactly the same.  That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law.  For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.

Many of these entities are in favor of replacing those state laws with one administered by the U.S. Food and Drug Administration (FDA).  I don’t challenge that.  In this essay, I’m challenging the very need for any U.S. pedigree requirement at all.  Let me explain. Continue reading Do We Even Need To Mandate Drug Pedigrees Anymore?

Pedigree Will Change FOB Terms

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.

fobIn the U.S., the initials FOB stand for “Freight On Board”.  “FOB…” is used here to establish which party, the buyer or seller, pays the shipping costs.  FOB terms are typically either “FOB Shipping Point“, which means the buyer must pay the shipping, or “FOB Destination“, which means the seller must pay the shipping costs.  The “FOB” terms of a given shipment of goods must be agreed to by the buyer and seller, either through a pre-negotiated contract, or through the seller’s acceptance of the terms spelled out in the buyer’s purchase order (PO).

If someone had told me even six months ago I’d be writing an essay about FOB terms I wouldn’t have believed them.  It seems like the most boring topic imaginable.  So what has led me to this boring topic?  Have I finally run out of things to write about? Continue reading Pedigree Will Change FOB Terms

Partnership For Safe Medicines Interchange 2010

Last Friday I attended the first annual Partnership For Safe Medicines (PSM)Interchange 2010 event.  PSM is a coalition of organizations that are committed to the safety of prescription drugs and protecting consumers against unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines.  PSM was started a few years ago to help educate healthcare professionals and the public about the dangers of counterfeit and other illegitimate drugs.  It is based in Vienna, VA but focuses on the problem globally.  The membership is made up of professional organizations from industry, universities and government.

PSM is led by a distinguished panel of leaders and directors.  The leaders are Continue reading Partnership For Safe Medicines Interchange 2010

A Semi-Centralized, Semi-Distributed Pedigree System Idea

Four years ago the GS1 EPCglobal Software Action Group (SAG) Drug Pedigree Messaging Work Group was wrapping up the standard specification for the GS1 Drug Pedigree Messaging Standard (DPMS, aka GS1 Pedigree Ratified Standard).  That standard was developed through collaboration between U.S. pharmaceutical supply chain members, industry associations, solution providers and GS1.  DPMS 1.0 was ratified by the EPCglobal Board in early January 2007.

DPMS has many benefits.  It results in a self-contained, self-secure electronic document that clearly shows the chain of ownership and/or custody of a given drug package (or a set of packages if they all have the same history).  It works equally well with serialized and non-serialized products.  The security of DMPS documents comes from within the electronic documents themselves rather than just from a security layer wrapped around a given server.  A self-contained, self-secure document model should work well as evidence in a criminal trial.

But even before DPMS was ratified people were raising questions and concerns about it.  Those concerns were Continue reading A Semi-Centralized, Semi-Distributed Pedigree System Idea