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!
There was a particularly interesting public dialog that occurred during the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy. I have been waiting for the official video recording of the meeting to be posted by the State of California but something seems to be holding it up. Fortunately, I recorded the audio myself.
UPDATE: Apparently the video has been out there for almost 3 weeks. I was looking for it in the wrong place. Find it here.
The dialog was between Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy, and Bob Celeste, Director, GS1 Healthcare US. Mr. Celeste had just finished presenting an update to the Committee on the recently published GS1 US Guideline (see “The New GS1 Healthcare US Track & Trace Guidance”) when Mr. Room asked him to remain at the front of the room to serve as a foil for an experiment he wanted to try. Mr. Room had
Continue reading The Board of Pharmacy Must Respond To Ideas For Making EPCIS Work
I attended the California Board of Pharmacy Enforcement Committee meeting last week and several topics came up that I want to write about. Unfortunately I’ve been doing a lot of traveling since then and all of a sudden I started having computer problems a few days ago. My youngest daughter is getting married next month and so the family met up in Chicago this past weekend for several of the events leading up to the big one. There is more travel scheduled for this week.
Travel doesn’t normally interfere with my ability to write on a deadline, but Continue reading The Best Laid Plans…
GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide. The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.
This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”). Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance
Digital electronic messages can be transmitted from one party to another using a wide range of communications technologies. Today, businesses that make use of the internet to transmit their business messages to and from their trading partners make use of standards-based Electronic Data Interchange (EDI) message formatting.
EDI messages are typically transmitted point-to-point, from one business to one other business. There are a large number of EDI message types defined but in the pharmaceutical supply chain the most common messages are purchase orders, purchase order acknowledgments, invoices and advance shipment notices (ASN’s). (While I have the chance, I’d like to point out that ASN’s are not pedigrees for multiple reasons that I will not cover in this essay.)
In the U.S. pharma supply chain AS2 is the most common communications protocol in use for EDI message exchange. AS2 provides generalized message security to ensure that the messages cannot be understood or tampered with by unauthorized parties during movement from sender to recipient. According to Wikipedia, these are achieved through the use of digital certificates and encryption. Messages can optionally be digitally signed by the sender to provide non-repudiation within the AS2 payload context.
Electronic pedigrees as defined by the states of Florida and California are messages that contain fairly complex legal documentation which describe the chain of custody or ownership of a given package of drugs, but they also contain several types of legally required certifications. Continue reading Electronic Message Security and More on Certifications