Tag Archives: HDMA

HDMA

Standards and Guidance For U.S. Pharma Supply Chain Technology

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[This essay is one of two long lost essays that have now been restored on RxTrace.  It was originally published on November 22, 2010.  See “Return Of Two Classics” for an explanation.]

In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours.  So where can you get better information?  I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology →

standards

Depicting An NDC Within A GTIN

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In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“.  Now let’s put them all together.  Why would we need to do that?  Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package.  Pure and simple.  To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard.  You have two realistic choices for standard approaches to this problem:  HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare.  Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay.  If you want more information Continue reading Depicting An NDC Within A GTIN →

HDMA

Updated HDMA Bar Code Guidance: A Must Read

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In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain.  The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”.  The guidance is aimed mostly at pharma manufacturers and repackagers who place barcodes on their drug packages, cases and pallets.  The last time the guide was published was in 2005 and this new edition includes some significant changes that everyone in the supply chain who deals with product and shipping container labeling should be aware of.

The updated document can be downloaded from the HDMA Marketplace web page.  It is free to HDMA members.  Non-members will need to pay a fee but don’t let that stop you from downloading a copy if you have any Continue reading Updated HDMA Bar Code Guidance: A Must Read →

FDA

Anatomy Of The National Drug Code

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The U.S. Food and Drug Administration (FDA) created the concept of the National Drug Code (NDC) in 1969 to “…provide an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals, and insurance companies” (from 34 FR 11157, July 2, 1969).  (I can’t find a copy online of the original Federal Register article from 1969 so I’m relying on a more recent article that references it.)   Those of us in the U.S. pharma supply chain make use of NDC’s every day, but very few of us know the history of their development, exactly how the numbers are composed and what they mean.  I’ll try to explain all of that and provide sources for further reading.

HISTORY OF THE NDC

The NDC was initially a voluntary identifier (see references at the end of this essay).  We all know how that would have turned out (for more on that thought, see my recent essay “Should Regulations Dictate Technology?“) so in 1972 the FDA made the NDC mandatory for all prescription and over-the-counter (OTC) drugs.  Manufacturers were required to obtain a “Labeler Code” from the FDA, construct their NDC’s using that code as the base and print the NDC number on drug packages.  Barcodes were not required by the FDA back then.

From the quote in the first paragraph above you can see that the FDA intended the NDC to be Continue reading Anatomy Of The National Drug Code →

cargo theft, pedigree

Lessons from “Drug Theft Goes Big”

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If you are a regular reader of RxTrace but you still haven’t read Fortune Magazine’s recent article, “Drug Theft Goes Big” by Katherine Eban, then I suggest that you stop reading this essay right now and spend the next 15 minutes absorbing her article carefully.  And then return here for my analysis.  It’s that good and that important.

Many of you will remember Katherine Eban as the author of the excellent book “Dangerous Doses, A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply”.  See my comments on the book here where I point out that a lot has changed since the events that are documented so well in the book.

The new Fortune article is a great update on what drug supply chain criminals have been up to since “Dangerous Doses” was published back in 2005.  The greatest thing about the article is Continue reading Lessons from “Drug Theft Goes Big” →

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 →

HDMA

Terminology: Track and Trace, and Pedigree

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I don’t get paid for endorsements.  I don’t sell my opinion.  No one has my thoughts under their control.  So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion.  This year, the event will be held on November 8-10 in National Harbor, MD (just south of Washington DC).

BTW, This opinion wasn’t solicited and I am paying full (member) price to attend the event.  This isn’t an advertisement.  It’s what I believe.

It’s an event that is intensely focused on Continue reading Terminology: Track and Trace, and Pedigree →

supply chain security

Supply Chain Data Synchronization and Patient Safety

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 →