HDMA

GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance

January 31, 2011 Dirk Rodgers 1 Comment

Earlier this month the Healthcare Distribution Management Association (HDMA) published newly updated guidance documents for the use of Accredited Standards Committee (ASC) X12 Electronic Document Interchange (EDI) messages in the U.S. healthcare supply chain. This is a very important update that supply chain participants should take notice of because it includes new information about how to properly communicate GS1 identifiers, including GLN’s, GTIN’s, and Electronic Product Codes (EPC’s) like SGTIN’s and SSCC’s, within the four document types that are in common use for Order-to-Cash transactions.

The EDI document types included in the updated guidance includes: Continue reading GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance →

pedigree certification, security

Electronic Message Security and More on Certifications

January 24, 2011 Dirk Rodgers

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 →

serialization

Pharma Serialization ROI

January 3, 2011 Dirk Rodgers 1 Comment

Over the last few years I’ve taken part in many conversations that touched on the question of how to achieve a Return On Investment (ROI) with serialization in the pharmaceutical supply chain. It seems intuitive that there should be an ROI because serial numbers provide increased data granularity and accuracy, but those characteristics in themselves do not guarantee a positive return.

For that, you must figure out a way to take advantage of those things in a way that increases productivity through decreased errors and reduced physical handling. Serialization might do that if you can increase the amount of automation in supply chain operations within your own facilities. Without automatic serial number reading and material handling, dealing with serial numbers will likely have the opposite effect on productivity.

Another way to take advantage of mass serialization of pharmaceuticals in the supply chain is to use it to help automate certain existing business processes between trading partners. Whenever it is valuable to Continue reading Pharma Serialization ROI →

Uncategorized

Happy Holidays 2010

December 17, 2010 Dirk Rodgers 5 Comments

I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR. Due to our family party schedule I don’t expect to post any more essays this year.

I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law. One of our favorite holiday activities is to debate which ones to see. Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).

So drive carefully, don’t drink and drive and don’t eat too much. On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity. And, OK, you can eat too much just once.

See you next year.

pedigree laws

Do We Even Need To Mandate Drug Pedigrees Anymore?

December 6, 2010 Dirk Rodgers 2 Comments

pedigree drag — Drawing by Zsuzsanna Kilian

A CHALLENGE TO THE CURRENT CONVENTIONAL WISDOM

Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature. No two laws are exactly the same. That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law. For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.

Many of these entities are in favor of replacing those state laws with one administered by the U.S. Food and Drug Administration (FDA). I don’t challenge that. In this essay, I’m challenging the very need for any U.S. pedigree requirement at all. Let me explain. Continue reading Do We Even Need To Mandate Drug Pedigrees Anymore? →

Writing

Writing Is Thinking. For Example, Ken Traub

November 29, 2010 Dirk Rodgers 3 Comments

Noted writer, editor, literary critic and teacher, William Zinsser, is known for the quote “writing is thinking on paper”. Today I don’t think paper has much to do with it, but what I think he means is, the very process of writing something forces a person to think about the thing they are writing about, and then embody that thinking clearly in the written output (paper or electronic). As you might imagine, I agree with this. I like to write and I believe that my own experience with writing has greatly improved my thinking. For a really great essay on the topic of writing and thinking, see The Secret About Writing That No One Has The Balls To Tell You by Pete Michaud…and don’t miss the many excellent comments below his essay.

I’ve been writing about ideas surrounding my professional experience much longer than the year and a half I have been writing RxTrace. In fact, I have written some pretty legendary emails and other essays over my career. Legendary because they raised ideas that were either unpopular or otherwise not wanted by the recipient(s). If you know me very well then chances are you’ve read one or two of those.

In a previous job, I did a fair amount of Continue reading Writing Is Thinking. For Example, Ken Traub →

EPCIS

The Future of Traceability Repositories and Inventory Management Systems

November 8, 2010 Dirk Rodgers 1 Comment

I think there is a significant difference between the traceability repositories we see on the market today and those that I think we are likely to see in the future. Today, traceability repositories are typically implemented by software suppliers as standalone applications or modules that we end users refer to as “an EPCIS”. We call it that because the most defining characteristic of these modules is that they implement GS1’s Electronic Product Code Information Services (EPCIS) standard. Today, traceability repository vendors expect customers to buy their traceability module and integrate it with existing applications. For a long time now I have felt that this approach was less than optimal and I think we will eventually see a switch occur in the software market toward existing application vendors adding traceability repositories and EPCIS interfaces as new features added to their existing functionality. Let me explain. Continue reading The Future of Traceability Repositories and Inventory Management Systems →

Digital Signatures

Certifications In A California-Compliant Drug Pedigree

October 26, 2010 Dirk Rodgers 7 Comments

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain). It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply.

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.” And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Continue reading Certifications In A California-Compliant Drug Pedigree →

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