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.
Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is. That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences. I don’t know what you’ve been up to, but this is my third essay about it. 😉
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 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,
Over the last year in GS1, in many of the members of the U.S. pharma supply chain and even in the FDA, the focus has turned to the analysis and discussion of three classes of electronic pedigree models:
One of the characteristics included in many of these discussions is the “points of failure” of each model. For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem. In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.
The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.
But at least one news source seemed to do some additional investigating. Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday. In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.
And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.
HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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