Five Years of Pharma Supply Chain Analysis

Led_Zeppelin_-_Houses_of_the_HolyLast Friday was the five year anniversary of RxTrace and this is the 255th essay.  I started RxTrace on July 4, 2009 as an outlet for ideas (see my very first essay, “Welcome to rxTrace”).  The results of the last five years have been very rewarding.

Rather than looking back this year, let’s look to the future.  What is coming next?

I always maintain a fairly informal RxTrace list of ideas I want to explore when I get the chance.  With the switch in attention from the California pedigree law to the new Federal Drug Supply Chain Security Act (DSCSA) in the last year, my list grew pretty long and continues to grow.  Here is a list of things I’ve been thinking about and may end up exploring in full RxTrace essays in the coming twelve months:

  • More surprises contained within the DSCSA Verification language
  • Analysis of the forthcoming GS1 Healthcare US DSCSA Guidance
  • Analysis of the forthcoming HDMA Updated EDI ASN Guidance for DSCSA
  • Implications of various market strategies leading up to some of the DSCSA effective dates
  • More thoughts on aggregation data and its proper value and use
  • The likely effects of various DSCSA provisions on the progression of data exchange technology use
  • What exactly does “electronic” mean in the DSCSA data exchange requirements?
  • Why RFID still doesn’t make sense in the pharma supply chain
  • What the manufacturers/wholesale distributors/pharmacies “won” with the passage of the DSCSA
  • How the DSCSA fills the “hole” in the PDMA that led to the RxUSA lawsuit
  • Contrast the Unique Device Identification (UDI) regulation with the DSCSA legislation
  • A closer look at the… / implications of the DSCSA on…:
    • grandfathering features
    • Human Readable information requirements
    • Quarantine Requirement
    • the distribution of certain types of drugs and combination products
    • the CMO, 3PL and authorized distributor contracts
    • standard operating procedures (SOPs)
    • the distribution of drug samples
    • Record-Keeping requirements
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Over the past twelve months I have experimented with interviews (Kosta Tsavaras, Ken Traub) and a guest blogger (Mark Davison).  I think those experiments were a success and I hope to do more of the same kind of thing in the coming year.  I also published a few “off-topic” essays (see this, and this) and I may do it again.  My summer advertising program to benefit cancer research has been a big success.  So far the program has raised about $6,500 for the Pelotonia cancer research fundraiser.  Make sure you thank these special advertisers whenever you are working with them, and watch for this fundraiser each summer (see “One Goal: End Cancer.”).

WHAT IS MISSING?  TELL ME AND WIN!

But what is missing from the list above?  What do you want to see in RxTrace?  What do you like/dislike about RxTrace?  Take the brief 2014 RxTrace Reader’s Survey and help set its direction.  Enter your contact information at the end of the survey to be entered into a drawing to win a free single user license to “The Drug Supply Chain Security Act Explained” by Dirk Rodgers!  Good luck, and thanks for the support over the last five years.

Dirk.

3 thoughts on “Five Years of Pharma Supply Chain Analysis”

  1. Thanks for the informative essays. 3 suggestions.
    “The distribution of certain types of drugs and combination products” ….. Pharma is investing heavily in these and DSCSA enables tracking patient compliance. See Bayer’s Bluetooth enabled injector approved in Europe.
    What roles for HIBCC?
    How to control NGO costs? (GS-1, GMDN, HIBCC)

  2. Congrats! Dick. Rxtrace has been a great source for industry information, and your commentary and insights have been valuable.
    Our best wishes for the next 5…

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