EPCglobal & Prescription Drug Tracking

Andrew Pollack authored an article in the New York Times on March 26, 2008 entitled California Delays Plan to Track Prescription Drugs.

"In a reprieve for the pharmaceutical industry, California regulators agreed on Tuesday to delay by two years a requirement that all prescription drugs be electronically tracked as a means of thwarting counterfeiting.....

The California plan would require that drugs be tracked electronically from the manufacturer through the wholesaler to the pharmacy. Each bottle of pills sold to a pharmacy would have to have a unique serial number, encoded in a bar code or a radio-frequency identification tag.....

Pharmaceutical manufacturers [said that] putting a unique serial number on each container would require changing their packaging lines, which would cost millions of dollars and take years. […] Pharmacies and wholesalers, meanwhile, said they could not install the software and the equipment needed to read the serial numbers until they knew what systems the drug manufacturers would use."

Though not directly identified in Pollack's article, EPCglobal is a leader in establishing standards in the area of drug tracking. EPCglobal is a private, standards setting consortium governed by very large organizations like Cisco Systems, Wal-Mart, Hewlett-Packard, DHL, Dow Chemical Company, Lockheed Martin, Novartis Pharma AG, Johnson & Johnson, Sony Corporation and Proctor & Gamble. EPCglobal is architecting essential, core services for tracking physical products identified by unique electronic product codes (including RFID tags) across and within enterprise systems controlled by large organizations.

I submitted a comment to EPCglobal on January 22, 2008 about EPCglobal's Architecture Framework. You will see that the comment is addressed to Mark Frey who courteously and immediately responded that he had forwarded it to EPCglobal's Architectural Review Committee.

This is a 10 page comment (including exhibits) about broader data ownership issues than just those relating to electronic pedigree documentation for use by pharmaceutical supply chain. But see the first full paragraph on page 5 where I said:

“[W]hile EPCglobal has begun establishing forward-looking standards relative to electronic pedigree documentation for use by pharmaceutical supply chain participants [see EPCglobal Pedigree Ratified Standard Version 1.0 as of January 5, 2007], it has yet to include these standards within the EPCglobal Architecture Diagram.

With this comment I am proposing, by way of an illustrative example, that the methods developed by Pardalis within its IP may be used to derive essential specifications for connecting the current EPCglobal (EPCIS) Architecture with its ePedigree standards for the pharmaceutical industry."

The illustrative example referred to above is a mock Common Point Authoring (CPA) informational object. This illustrative example has a reference point beginning with a granular EPCglobal ePedigree document. The represented CPA informational object is the EPCglobal ePedgiree document that has been further granularized with mock XML tagging containing unique identifiers pointing to a CPA registered data element database.

My point is that EPCglobal has yet to develop standards for ePedigree document exchange that may be efficiently, flexibly and cost-effectively applied to the pharmaceutical supply chains for helping to reduce counterfeiting. Given the players who comprise EPCglobal, it is reasonable to presume that California regulators have essentially backed off enforcing their anti-counterfeiting regulations because EPCglobal has yet to catch up to the California plan. The plan was to take effect January 1, 2009. Now it has been pushed back to 2011.

Update on Thursday, May 29, 2008 at 1:54PM by Steve Holcombe

From the Economist's Economic & Financial Indicators section:

"Custom seizures of counterfeit goods rose by 17% in the EU last year, according the European Commission."

Source: The Economist crediting European Commission

"The number of cases has grown rapidly since 2003, but fewer fake articles were confiscated last year than in 2006—perhaps because internet sales have boosted the number of small consignments. Indeed, 70% of cases involved air-express courier or mail. Cigarettes and clothing accounted for more than half the sham gear seized. China was the source of almost 60% of dodgy goods. Switzerland and India account for three-quarters of the trade in fake drugs, which rose by 51% last year. Treatments for erectile dysfunction—phoney Viagra pills—were the most common counterfeit medicines." [emphasis added]

Update on Sunday, April 4, 2010 at 9:07PM by Steve Holcombe

"Discovery services" (See the EPCGlobal Standards Overview at http://www.epcglobalinc.org/standards) has been gray in color for the two years since I published this blog entry. And I am informed by a knowledgeable source that it will probably be another two years before they arrive at any definitive standards (if then). 

Granularity & Semantic Trust

I have received, and continue to receive, some quizzical looks and comments when I speak about Common Point Authoring in terms of granularity or granular information ownership.

Here's a wonderful parable about granularity taken from an excerpt of Automated Trust Mechanisms and the One World Market by Greg FitzPatrick. This paper was submitted to XML Europe 2001.

"Granularity .... means the breaking up [of] ideas, processes, products and services into fragments. The makeup of a set of fragments is dynamic and aspectual to ever-changing utility and circumstance. Each set represents new and unique combinations. The backside of granularity is complexity and the costs involved in extending distributed trust. Unlike Humpty-Dumpty, a granular set must be able to function as effectively as any pre-granular whole.

Imagine a group of children in a playroom. Each child has come to the room with a thousand pieces of their privately owned and highly valued collections of Lego. A teacher says to the children. "Put all your Lego pieces in the middle of the floor and build a great city." The children balk, since once the Lego is removed from their immediate possession, they can no longer identify it as their own. The teacher tells them," I will keep track of each piece and remember whose is whose. If the children trust the teacher's ability to do this they will begin to build.

To match their trust the teacher would need almost supernatural powers since Lego is known for the precision modularity of its product, mostly indistinguishable plastic blocks. The value of playing together and having so much Lego to build with is the value of the network, but the effort to maintain trust regarding individual ownership is the transaction cost.

End-to-end markets are capable of creating a considerable amount of complexity. Through Semantic trust they will admit a swarm of participants (fragments) into one and the same transaction. [....] The complexity is further exacerbated by the existence of exploratory negotiation. Agents trying to evaluate their participation in a deal would need the same transaction mechanisms as those of a firm deal. The trust mechanisms must be in place regardless."

The image of a teacher assuring these kids that they will get back 'their' exact Lego pieces is powerful.

Tim Berners-Lee in addressing XML 2000 is said to have described the Semantic test for such trust as being that "... which is passed if, when you give data to a machine, it will do the right thing with it".