Tag Archives: free

Dirk Rodgers Consulting LLC

Announcing, Dirk Rodgers Consulting, LLC

11 Comments

After a month of intensive preparations I can now finally announce that I will leave my current employer on July 27, 2012, and on the following Monday I will open the books on Dirk Rodgers Consulting, LLC.  As many of you know, I have filled the role of Sr. Consultant in an full-time internal position at my employer for the last 3 1/2 years.  I will now be able to help clients navigate the same intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance that I have written about for the last three years.

Over those three years I have been approached by a number of companies who were looking for quality help with their special problems in this realm but I was forced to turn them down or refer them to other consultants because I already had a full time job.  From now on I will be able to offer my own expertise instead.

I have pulled together a new website to market my services at www.DirkRodgers.com.  So far it is pretty minimal but through the fall I intend to expand the information it contains and establish more formal offerings.  If you know of someone in need of help with knowledge and strategy in the areas I write about, please refer them to either RxTrace.com or DirkRodgers.com.

SO NOW WHAT BECOMES OF RxTRACE?

The creation of Continue reading Announcing, Dirk Rodgers Consulting, LLC →

RxTrace, Writing

Three Years of Heat and Light

2 Comments

I published my first essay on RxTrace three years ago on July 4, 2009 (see “Welcome to rxTrace”).  It took just two days after that first essay became visible on the internet before people were finding it through search engines and Google Alerts, a remarkable feature of self-publishing.  Since then I have published over a hundred essays on a wide range of topics exploring the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance.

This past year the number of people reading RxTrace regularly have more than doubled (see “The Abrupt Surge of Interest in Serialization and ePedigree Topics”).  That is a reflection of the steady march of time toward the effective dates of the California Pedigree law and other serialization mandates around the world, but it is also, I hope, a reflection of the type of writing about these subjects and perspectives that you can’t find anywhere else.

This year the most popular essay was “How Counterfeit Avastin Penetrated the U.S. Supply Chain”, which is the first essay to Continue reading Three Years of Heat and Light →

Writing

Summer Writing

3 Comments
A fine summer vacation!

It’s summer and for whatever reason, readership tends to go down in the summer.  People are busy with vacations and vacation planning.  After work hours and weekends are dedicated to family and outdoor fun.  That’s the way it should be.

I do have some specific essays that I want to write this summer but I intend to be a little less regular until the end of August when I will return to my weekly publishing schedule.  I may also post one or two essays this summer that are not directly related to my normal subject matter.  Call it summer recreational thinking/writing.  Watch for those and let me know what you think about them.

There are a couple of big changes coming up Continue reading Summer Writing →

California Pedigree Law

PDUFA Will Not Include RxTEC

4 Comments

Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee.  That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill.  See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates.  The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal.  The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC →

Counterfeit Drugs, Reimportation

Some People Actually WANT To Buy Counterfeit Drugs

It’s hard to imagine why people would actually prefer to buy drugs from internet websites that are obviously not licensed legitimate pharmacies.  That is, those that do not require proof of a valid prescription from a legitimate prescriber, and/or do not carry an online pharmacy certification (especially from the National Association of Boards of Pharmacy, NAPB, VIIPS program).  In an earlier essay I said this about people who would buy drugs from these illegitimate sources:

“Most of the criminal activity has moved out of the legitimate supply chain, mostly onto the internet.  You know, the internet, where criminals can sell drugs directly to the few consumers who are dumb enough to think that someone will sell them legitimate prescription drugs, but do so illegally by not requiring a prescription.  That is, they think that some faceless company would be willing to knowingly break one law, but could then be trusted to provide real pharmaceuticals at below market prices.  In the age of the internet, how do you protect people who are that gullible?”

A few weeks after writing that rather disparaging passage I met one of those gullible people Continue reading Some People Actually WANT To Buy Counterfeit Drugs →

California Pedigree Law

The Preemption Provisions Built Into The California Pedigree Law

10 Comments

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 this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption.  As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017.  It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.

Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law →

Data Quality

Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program

Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN).  Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN.  That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).

In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN.  That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high.  As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.”  I couldn’t agree more.

The GS1 Data Quality program is centered on the “Data Quality Framework”, which is Continue reading Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program →

GDSN

An Open Letter to GS1, RE: GDSN Marketing

5 Comments

Dear GS1,

How have you been?  I’ve been fine, done a bit of writing since we last met and gotten a little greyer.  How are the kids?  My two kids are doing great but I have to admit, after raising two I don’t know how you do it with 125 kids, or whatever the number of M.O.s there are today.

The reason I’m writing to you today is to offer you my thoughts on your Global Data Synchronization Network (GDSN) Marketing campaign.  That campaign would be more effective if it focused on demonstrating the distinction between internal master data (and programs associated with improving its quality), and externally shared master data (and the significantly different kinds of programs needed to improve its quality).  And especially to show that many (most?) of company master data is, in reality, externally shared master data, either incoming or outgoing.  That’s the step that I see missing from your campaign.

Companies who are already familiar with the kind of programs that are designed to improve their internal master data need to be taught to see the special characteristics of Continue reading An Open Letter to GS1, RE: GDSN Marketing →