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

January 7, 2013 Dirk Rodgers 1 Comment

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 →

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

December 17, 2012 Dirk Rodgers 2 Comments

mick-jagger-steve-martin-snl-californians — “The Californians”

As I indicated last week, I wanted to write about a specific dialog that occurred at the December 4, 2012 California Board of Pharmacy Enforcement Committee meeting. The important exchange came at the end of the meeting during the catchall agenda item called “General Discussions” when topics that are not on the agenda can be raised by Board members or the general public in attendance.

As soon as the Chair opened that agenda item, Michael Ventura of GlaxoSmithKline rose and strode to the microphone. The exchange that followed was captured on the meeting video. I transcribed the exchange below as it happened because I think it provides a number of important clarifications about Continue reading California Board of Pharmacy Clarifies Use Of GS1 EPCIS →

Sad News

Robert J. “Bob” Bergantino (1960-2012)

December 10, 2012 Dirk Rodgers 4 Comments

I received very sad news last night of the loss of another friend and co-worker in the serialization and track and trace industry. Bob Bergantino, most recently of Excellis Health Solutions, worked for SupplyScape at the same time I did. We didn’t work on any projects or sales together but Bob was such a cheerful and inviting person that I couldn’t help but know and love him. Bob had a magnetic personality and was full of wit, charm and love for everyone around him. We will all miss him. Continue reading Robert J. “Bob” Bergantino (1960-2012) →

Board of Pharmacy

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

December 10, 2012 Dirk Rodgers 6 Comments

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 →

standards

Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

December 3, 2012 Dirk Rodgers 6 Comments

I was recently asked to help a small medical device manufacturer switch all of their medical device-related product codes from Health Industry Business Communications Council (HIBCC) Universal Product Numbers (UPN) to GS1 Global Trade Item Numbers (GTIN). Historically, the pharmaceutical supply chain has used GS1 GTINs but the medical device supply chain has predominantly used HIBCC UPNs, so a switch like that seemed to be against the grain. I asked them, “Why are you abandoning HIBCC codes for GS1 codes?”

The answer was a little startling Continue reading Can HIBCC Withstand The GS1 Tide In Medical Device Identification? →

Anti-counterfeiting, serialization

The Different Goals of Anti-Counterfeiting Technologies and Serialization

November 26, 2012 Dirk Rodgers 6 Comments

While writing last Monday’s RxTrace essay I ran out of time before I could get to the point I originally intended to make, so here is the conclusion to my thoughts on the topic.

The point I wanted to make is that there is a big difference between the goal of serialization and that of most other anti-counterfeiting technologies. Most anti-counterfeiting technologies covered in Mark Davison’s essential book on the topic, “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs“, are technologies that a given manufacturer chooses to place in or on their drug, or on their drug’s packaging so that they can later differentiate it from potential counterfeit versions. That is, so that they can later “authenticate” only the drugs that they truly manufactured.

The decision a given manufacturer makes about which anti-counterfeiting technology(ies), if any, to use for a given drug for a given market is Continue reading The Different Goals of Anti-Counterfeiting Technologies and Serialization →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice, Part 2

November 21, 2012 Dirk Rodgers

Ed Silverman has just raised my awareness in his Pharmalot blog for today that the Wall Street Journal is reporting that the first physician has pleaded guilty to purchasing illegal foreign drugs in the counterfeit Avastin series of crimes from earlier this year. That’s swift justice and I love it. Apparently there are more to come. Hopefully it will serve to remind all physicians that they need to only buy from licensed and legitimate sources. Their patient’s lives depend their knowledge and skills… but also on their pharmaceutical buying practices

Rather than repeat Ed and WSJ, just go read the articles yourself by clicking here:

Pharmalot article: A Doc Pleads Guilty To Buying Counterfeit Meds
WSJ article: U.S. Fake-Drug Probe Puts Spotlight on Role of Doctors

Continue reading InBrief: Pharma Supply Chain Criminals Get Justice, Part 2 →

Anti-counterfeiting, serialization

Pharma Anti-Counterfeiting and Serialization

November 19, 2012 Dirk Rodgers 1 Comment

Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world. The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national. What we need now more than ever before is a multi-national approach to fighting these crimes.

That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina. See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.

The dispute is Continue reading Pharma Anti-Counterfeiting and Serialization →

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