FDA

FDA Aligns with GS1 SGTIN For SNDC

March 29, 2010 Dirk Rodgers 3 Comments

Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages. This was right on time since the FDA Amendments Act of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later. Well done.

The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC →

standards

So a customer demands that you use GLN’s and GTIN’s. What next?

March 22, 2010 Dirk Rodgers 2 Comments

In the healthcare supply chain a significant number of hospital group purchasing organizations (GPO’s) have stipulated, to varying degrees, that their suppliers begin making use of GS1 Global Location Numbers (GLN’s) in all of their trade with their member hospitals by the end of 2010 (Sunrise 2010) and GS1 Global Trade Item Numbers (GTIN’s) by the end of 2012 (Sunrise 2012). Here are the announcements from Novation, Premier, MedAssets and Amerinet. From the wording of their announcements it appears that Continue reading So a customer demands that you use GLN’s and GTIN’s. What next? →

standards

WAR: GS1 Vs. HIBCC

March 15, 2010 Dirk Rodgers 3 Comments

That’s right. GS1 and HIBCC are in a multi-year fight over the dominance of their standards within the U.S. healthcare supply chain. Continue reading WAR: GS1 Vs. HIBCC →

supply chain security

Supply Chain Data Synchronization and Patient Safety

February 22, 2010 Dirk Rodgers

Does the supply chain itself make any contribution to patient safety? The legitimate pharmaceutical supply chain is that complex web of companies that move drugs from the manufacturers to the pharmacies that dispense them to patients. The supply chain always includes both of those end points (manufacturer and pharmacy) and, in the U.S., normally also includes at least one wholesaler. The supply chain is typically viewed as “Manufacturer to Wholesaler to Pharmacy”, whether the pharmacy is within a hospital, clinic, retail independent, chain store, grocery store, or mail order. The great majority of prescription drugs arriving in the hands of U.S. patients have passed through this supply chain.

So what contribution does this chain make toward the safety of those patients? In my view, it comes in three ways: Continue reading Supply Chain Data Synchronization and Patient Safety →

discovery serivces, Uncategorized

Will The Pharma Supply Chain Find Any Value In GS1 Discovery Services?

February 8, 2010 Dirk Rodgers 8 Comments

I’m pretty excited about the kickoff this Wednesday of the GS1 EPCglobal Software Action Group (SAG) Discovery Services Work Group which will take the business and technical requirements that were collected by an earlier group and turn them into an actual standard. This will be the first new major technical standard GS1 has started for quite a few years. The most recent kickoff I can remember was the GS1 Drug Pedigree Messaging Standard (DPMS) which kicked off back in late 2005 and completed in January 2007. The GS1 Electronic Product Code Information Services (EPCIS) standard effort kicked off in late 2004 and completed in April 2007. That gives you an idea of how long these things take.

The effort to create the business and technical requirements for Discovery Services started just about two years ago and completed this past December. How long will it take to get to a ratified standard? The GS1 Discovery Services Work Group Charter predicts it will be done in June of 2011, but predictions in charter documents are notoriously optimistic. The EPCIS Charter predicted that standard would be ratified in August of 2005, for example—one third the time it actually took.

This is not a bad thing in my opinion. A Charter document needs to estimate how long the effort will take, but once things get rolling, GS1 EPCglobal takes as long as needed to get the standard right. So how long will this one take? Based on how long the requirements took, I’m guessing Continue reading Will The Pharma Supply Chain Find Any Value In GS1 Discovery Services? →

legitimate pharmaceutical supply chain

The Deputized Supply Chain

January 31, 2010 Dirk Rodgers 1 Comment

Several people I know from the traceability solution provider community like to tout the similarities between the food supply chain and the pharmaceutical supply chain. They see similar track and trace regulation in the futures of both chains. After all, both supply chains are regulated by the same agency (FDA, although food is also regulated by the USDA) and they see them as having similar problems. But I don’t buy all that. My friends see the use of common tools (their products, of course) and I might give them that, but these two problems only seem similar on the surface and so, if track and trace regulation is needed for both, the two regulations ought to have only high-level similarities.

THE FOOD SUPPLY CHAIN

The increasing frequency of the scariest problems in the food supply chain are related to accidents—like unintended contact with surfaces or organic matter that contaminate the food with nasty things like E. coli or salmonella—or food that has spoiled as the result of improper storage somewhere in the supply chain—like refrigerators or freezers that aren’t doing their job. Consumers would benefit from the use of food track and trace in situations like these only when the contamination or spoilage isn’t detected until after the product is split up and distributed down multiple paths. The track and trace system would improve the speed of the recall and the confidence in its completeness.

Generally, food is distributed to retail outlets inside containers that are packed by the manufacturer or processor. I’m not an expert here so those of you who are, please correct me, but I don’t think food distributors normally break down cases and ship individual saleable units to retailers. I think they normally ship full cases, bins and pallets. For this reason, item-level serialization is not critical to end-to-end track and trace. However, container-level serialization-based track and trace would be a major benefit to this supply chain.

There is one more thing about the food supply chain that I think is significant for this discussion. Many of the trading partners at the start of the supply chain are small, independent and technically unsophisticated. Most of the trading partners at the end of the supply chain are just the opposite: large corporations with big IT budgets.

THE PHARMACEUTICAL SUPPLY CHAIN

On the other hand, the scariest problems in the pharmaceutical supply chain Continue reading The Deputized Supply Chain →

standards

“Why the rush for GS1 standards?”

January 19, 2010 Dirk Rodgers 4 Comments

In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”. The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc. In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards. Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States. It’s well worth reading.

I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry. There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another. In effect, it’s a patchwork, yet each user can claim to be using a standard. This was exactly the case with the railroads 150 years ago as Mike’s analogy implies. Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard? I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard. That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.

Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR). He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI). He calls for the use of part of the federal economic stimulus money to be used for standards development. Continue reading “Why the rush for GS1 standards?” →

Sad News

Charles “Chuck” Schramek (1945 – 2010)

January 16, 2010 Dirk Rodgers

Chuck Schramek passed away on January 9 after losing his battle with cancer. See his obituary here. As I understand it, he spent most of his career working in IT at McNeil Consumer Healthcare, a Johnson & Johnson company, eventually serving in the role of Executive Director of Information Architecture for J&J. He spent the last few years of his career as an executive-on-loan to GS1 EPCglobal from J&J. In that capacity he filled the role of facilitator of work groups related to pharmaceutical supply chain integrity/security. That’s where I met him.

Chuck was a very humble, friendly person who had Continue reading Charles “Chuck” Schramek (1945 – 2010) →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance