HDMA

Updated HDMA Bar Code Guidance: A Must Read

January 9, 2012 Dirk Rodgers 1 Comment

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

January 3, 2012 Dirk Rodgers 1 Comment

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 →

Pedigree models

Could This Be Your Future Track & Trace/ePedigree Exchange Solution?

December 5, 2011 Dirk Rodgers 10 Comments

In a recent essay I discussed GS1 Healthcare’s proposed Network Centric ePedigree (NCeP) models that are currently available for review and discussion by the industry. By the way, GS1 is giving everyone until December 15 to respond to a survey to provide them with your thoughts on the various NCeP models. To review the videos and respond to the survey click on this link.

In a somewhat related news item, Pharmaceutical Commerce recently published an online article by Nick Basta about the Global Healthcare Exchange’s (GHX) project to build a new prototype for a track and trace data exchange hub called “GHX updates progress on a prototype data exchange for track-and-trace“. That article was an update to a more in-depth article by Nick about the project from last April in the same online magazine called “Healthcare Exchange Bids for Prototyping a Track-and-Trace System“. Combined, the two very interesting articles describe the prototype that is now complete and ready for piloting.

In fact, the GHX prototype implements Continue reading Could This Be Your Future Track & Trace/ePedigree Exchange Solution? →

pedigree laws

Should Regulations Dictate Technology?

November 28, 2011 Dirk Rodgers 4 Comments

In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations? This question arises whenever a new regulation is considered by any of these bodies or agencies. It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer. Let’s review the history first.

EXAMPLE: EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information. Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives? Is it a paper pedigree? Can it be electronic? What is the format? Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Continue reading Should Regulations Dictate Technology? →

Anti-counterfeiting, cargo theft

STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict

November 21, 2011 Dirk Rodgers 1 Comment

Last Thursday a bipartisan group of U.S. Senators and Representatives jointly introduced a bicameral bill that would significantly increase the criminal penalties for drug counterfeiting to as much as 20 years in prison, as reported by Phil Taylor in SecuringPharma (see the article for the details). The house bill is called H. R. 3468, The Counterfeit Drug Penalty Enhancement Act. The group of legislators include U.S. Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Michael Bennet (D-CO), and Richard Blumenthal (D-CT) and U.S. Representatives Patrick Meehan (R-PA) and Linda Sánchez (D-CA). Not surprisingly the responses from the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer were swift and supportive.

Raising the penalties for counterfeiting drugs to the point where they adequately reflect the widespread harm they can cause the public is a very good thing. It should have the effect of making people think twice about selling counterfeit drugs to Americans through the internet or attempting to introduce them into the legitimate supply chain (brick-and-mortar and legitimate internet pharmacies). It may even cause more people in the legitimate supply chain to Continue reading STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict →

Pedigree models

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2

November 14, 2011 Dirk Rodgers

There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.

In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.

The NCeP group published a very interesting recording of a presentation that explains the details of their work. It is called “NCeP – Technical Analysis Sub-Group, Event Based Pedigree”. The purpose of this recording is to help people outside of the close-knit NCeP group to learn about the pedigree models developed there, evaluate them and provide feedback to the group about which model(s) should be Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2 →

PDMA, RxUSA Lawsuit

Impact of RxUSA v. HHS On Future Pedigree Legislation

November 7, 2011 Dirk Rodgers 5 Comments

I attended the Partnership for Safe Medicines (PSM) Interchange 2011 conference on October 27 in Washington DC. (I’ll cover that event more fully in a future essay.) For me, the event couldn’t have been better, but I measure events like this perhaps a little differently than most people. The agenda is important and the quality of the speakers is absolutely important, but in my view those are simply the things that lead to the one thing that can transform a merely good conference into a great conference: the quality of the attendees.

(The quality of the attendees is exactly why I like the HDMA Track and Trace Seminar. BTW, this year’s HDMA event starts this Thursday).

In the case of this year’s PSM event, I rate the quality of the attendees very high, and that’s because I had a number of great conversations with some very knowledgeable people during the breaks and at the social event the evening before. That was my interaction with the attendees, not the speakers. One of the topics of conversation surrounded the question of what exactly it was the led to the successful challenge to the Prescription Drug Marketing Act (PDMA) pedigree provisions in the RxUSA v. HHS court case and appeal and whether or not the same thing might occur with other drug pedigree laws.

AN IMPORTANT QUESTION GOES UNANSWERED

One of the first speakers at the PSM event was U.S. Representative Jim Matheson (D-UT), sponsor of H.R.3026, the “Safeguarding America’s Pharmaceuticals Act of 2011” which was introduced into the House of Representatives on September 22, 2011. There are some differences, but the core of this new bill is basically the same as Continue reading Impact of RxUSA v. HHS On Future Pedigree Legislation →

California Pedigree

Inspecting An Electronic Pedigree

October 31, 2011 Dirk Rodgers 6 Comments

Within conversations held during the development of standards for electronic pedigrees it is sometimes common to hear people apply the following test to any pedigree proposal:

“A state inspector arrives at your facility without prior warning, enters the warehouse, picks up any random package of drugs and asks to see ‘the pedigree’ for this package.”

The point being made is that, according to the California Pedigree Law, at the very least, supply chain members will need to be capable of producing a full pedigree for any and every package of drugs in their possession at any time in case of a surprise inspection.

This scenario is an important one when selecting a pedigree model, but it often causes me to think about exactly what the company being inspected would show the inspector, and how they would do that. Continue reading Inspecting An Electronic Pedigree →

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