Monthly Archives: January 2011

HDMA

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

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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

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

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

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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 →