Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain. Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now. Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.
My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill. I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I. If that is what brought you here, sorry, look elsewhere.
The California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present. The first of these occurred on Monday of this week. The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments. I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action. It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting. All that seemed to happen since that meeting Continue reading Hey California Board of Pharmacy: Your Time Is Running Out!→
During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on. The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees. Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees→
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
There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.
In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.
Within conversations held during the development of standards for electronic pedigrees it is sometimes common to hear people apply the following test to any pedigree proposal:
“A state inspector arrives at your facility without prior warning, enters the warehouse, picks up any random package of drugs and asks to see ‘the pedigree’ for this package.”
The point being made is that, according to the California Pedigree Law, at the very least, supply chain members will need to be capable of producing a full pedigree for any and every package of drugs in their possession at any time in case of a surprise inspection.
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.