The Congressional Draft Proposal to Improve Drug Distribution Security

October 25, 2012 Dirk Rodgers 2 Comments

Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress. That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee. Download it in PDF form from Senator Harkin’s website.

I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay. Stay tuned for that.

The email I received included the following explanation from Kathleen Laird of the HELP Committee: Continue reading The Congressional Draft Proposal to Improve Drug Distribution Security →

Drug recalls

We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

October 22, 2012 Dirk Rodgers 5 Comments

That’s right. We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it. I will explain, but first, what is a drug recall?

Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it. The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).

Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls →

Conferences

How To Maximize The ROI Of Attending A Conference

October 17, 2012 Dirk Rodgers 2 Comments

I’ve been doing a lot of traveling in the last few months since I left Cardinal Health. Right now my wife and I are just finishing up a visit to Culver City, CA where we arrived just in time for the birth of our first grandchild. This was a non-business trip, of course, but all of my other recent travels have been to attend conferences or public meetings of one kind or another.

One of the ways I maximize the return on investment (ROI) of attending conferences is to take lots of notes and then publish internally an analysis of the things that I thought had some important significance to my company. This technique has resulted in a searchable record of my impressions of every speaker and networking contact that struck me for any reason in almost every Continue reading How To Maximize The ROI Of Attending A Conference →

IBM, track and trace

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

October 8, 2012 Dirk Rodgers 7 Comments

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

October 5, 2012 Dirk Rodgers 4 Comments

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 →

Barcodes, RFID

InBrief: RFID and Barcode Interoperability

October 2, 2012 Dirk Rodgers 2 Comments

There is a new and valuable resource available for anyone who needs to make use of both GS1 RFID and GS1 barcodes–or even just one or the other–on any product or shipping container and in any supply chain. It is called “RFID Bar Code Interoperability, GS1 Guideline” and it is available as a free PDF download here on the GS1 website.

This is a guidance document, which means that it isn’t a standard itself but draws contents from GS1 standards documents to better explain the subject. In this particular case it draws primarily from the GS1 General Specifications and the Tag Data Standard. Both of those source documents are huge and so you will find this new guidance document a relative joy to read if you need this kind of information.

Even if you are already familiar with GS1’s RFID and barcode standards, intermingling them so that they are fully interoperable in a single application isn’t Continue reading InBrief: RFID and Barcode Interoperability →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice

September 24, 2012 Dirk Rodgers 1 Comment

Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release. He was also required to hand over $55 million, which represents the proceeds from his crimes.

What was his crime? He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009. In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.

This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice →

GS1

Should GS1 Continue Developing ePedigree Standards?

September 17, 2012 Dirk Rodgers 2 Comments

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? →

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