Should Regulations Dictate Technology?

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.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?

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

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

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

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.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

Impact of RxUSA v. HHS On Future Pedigree Legislation

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

Inspecting An Electronic Pedigree

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

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

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.For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard.  But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard.  The  misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.

In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.

There are probably several reasons that this misconception persists.  First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula.  The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.

Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law.  The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.

Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements.  Let me show you how Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

Safe Prescription Drug Reimportation: An Oxymoron

Every couple of years it seems that someone introduces a bill into the U.S. Congress that would one way or another legalize the reimportation of prescription drugs into the U.S. from other countries.  In December of 2009, right around the time that the Patient Protection and Affordable Care Act was being debated intensely Senator Byron Dorgan (D-ND) introduced a bill to do just that.

You may recall that there was a dustup about how Senator Barack Obama had introduced a similar bill only a few years before that, but now as President, he made a deal with the drug industry that supposedly assured that drug reimportation wouldn’t be added to the Healthcare Reform bill in exchange for the industry supporting the Reform bill.  Senator Dorgan’s bill did not pass but Healthcare Reform did (See Dr. Adam Fein’s coverage of the failure of Senator Dorgan’s bill, “Drug Importation: Dead Again”).

The reason I’m thinking about reimportation this week is that I came across an interesting document that was published last week by the Partnership for Safe Medicines (PSM) called “A Risky Proposition:  How Opening The U.S. To Foreign Medicines Poses A Risk To Chronically Ill Americans”, a second edition.  I’m not sure why it was released now—maybe someone is thinking about introducing another reimportation bill again (I guess it’s not Senator Dorgan anyway!)—but I have an opinion about the topic Continue reading Safe Prescription Drug Reimportation: An Oxymoron

Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource

Earlier this summer J. Wiley & Sons published a new book called “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs” by Mark Davison, CEO of Blue Sphere Health, a pharmaceutical consultancy.  I pre-ordered it on Amazon.com in the spring and it was finally delivered in July.  You may have noticed the image and link I added to the left margin under “RxTrace Recommends” shortly after I started reading it.  The hardbound book is 400 pages, including the main text, notes, references, glossary and index, but it took me until now to finish reading it.  I’ve been so busy lately that I could only read a few pages at a time, that is until my vacation when I finally had time to sit down and read the whole book.

The book is broken up into five parts.  Part 1, General Themes, provides an in-depth examination of the problem of drug counterfeiting around the world including its formal definition, the origins, costs, risks, and the contrast (and controversy) between intellectual property and anti-counterfeiting.  In the last chapter of Part 1, Davison explains the difference between “Traceability” and “Authentication”.  He points out that the term “Traceability” is sometimes known as “digital authentication”, where the term “Authentication” by itself is usually used to Continue reading Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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