Archive for 2010

I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR.  Due to our family party schedule I don’t expect to post any more essays this year.

I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law.  One of our favorite holiday activities is to debate which ones to see.  Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).

So drive carefully, don’t drink and drive and don’t eat too much.  On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity.  And, OK, you can eat too much just once.

See you next year.

Drawing by Zsuzsanna Kilian

A CHALLENGE TO THE CURRENT CONVENTIONAL WISDOM

Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature.  No two laws are exactly the same.  That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law.  For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.

Many of these entities are in favor of replacing those state laws with one administered by the U.S. Food and Drug Administration (FDA).  I don’t challenge that.  In this essay, I’m challenging the very need for any U.S. pedigree requirement at all.  Let me explain. Read the rest of this entry »

Ken Traub

Noted writer, editor, literary critic and teacher, William Zinsser, is known for the quote “writing is thinking on paper”.  Today I don’t think paper has much to do with it, but what I think he means is, the very process of writing something forces a person to think about the thing they are writing about, and then embody that thinking clearly in the written output (paper or electronic).  As you might imagine, I agree with this.  I like to write and I believe that my own experience with writing has greatly improved my thinking.  For a really great essay on the topic of writing and thinking, see The Secret About Writing That No One Has The Balls To Tell You by Pete Michaud…and don’t miss the many excellent comments below his essay.  

I’ve been writing about ideas surrounding my professional experience much longer than the year and a half I have been writing RxTrace.  In fact, I have written some pretty legendary emails and other essays over my career.  Legendary because they raised ideas that were either unpopular or otherwise not wanted by the recipient(s).  If you know me very well then chances are you’ve read one or two of those. 

In a previous job, I did a fair amount of Read the rest of this entry »

Figure 1.

I think there is a significant difference between the traceability repositories we see on the market today and those that I think we are likely to see in the future.  Today, traceability repositories are typically implemented by software suppliers as standalone applications or modules that we end users refer to as “an EPCIS”.  We call it that because the most defining characteristic of these modules is that they implement GS1′s Electronic Product Code Information Services (EPCIS) standard.  Today, traceability repository vendors expect customers to buy their traceability module and integrate it with existing applications.  For a long time now I have felt that this approach was less than optimal and I think we will eventually see a switch occur in the software market toward existing application vendors adding traceability repositories and EPCIS interfaces as new features added to their existing functionality.  Let me explain. Read the rest of this entry »

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain).  It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply. 

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.”  And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Read the rest of this entry »

From "The Principles of Accounting"

In the U.S., the initials FOB stand for “Freight On Board”.  “FOB…” is used here to establish which party, the buyer or seller, pays the shipping costs.  FOB terms are typically either ”FOB Shipping Point“, which means the buyer must pay the shipping, or “FOB Destination“, which means the seller must pay the shipping costs.  The “FOB” terms of a given shipment of goods must be agreed to by the buyer and seller, either through a pre-negotiated contract, or through the seller’s acceptance of the terms spelled out in the buyer’s purchase order (PO).

If someone had told me even six months ago I’d be writing an essay about FOB terms I wouldn’t have believed them.  It seems like the most boring topic imaginable.  So what has led me to this boring topic?  Have I finally run out of things to write about? Read the rest of this entry »