The Different Goals of Anti-Counterfeiting Technologies and Serialization

While writing last Monday’s RxTrace essay I ran out of time before I could get to the point I originally intended to make, so here is the conclusion to my thoughts on the topic.

The point I wanted to make is that there is a big difference between the goal of serialization and that of most other anti-counterfeiting technologies.  Most anti-counterfeiting technologies covered in Mark Davison’s essential book on the topic, “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs“, are technologies that a given manufacturer chooses to place in or on their drug, or on their drug’s packaging so that they can later differentiate it from potential counterfeit versions.  That is, so that they can later “authenticate” only the drugs that they truly manufactured.

The decision a given manufacturer makes about which anti-counterfeiting technology(ies), if any, to use for a given drug for a given market is Continue reading The Different Goals of Anti-Counterfeiting Technologies and Serialization

InBrief: Pharma Supply Chain Criminals Get Justice, Part 2

Ed Silverman has just raised my awareness in his Pharmalot blog for today that the Wall Street Journal is reporting that the first physician has pleaded guilty to purchasing illegal foreign drugs in the counterfeit Avastin series of crimes from earlier this year.  That’s swift justice and I love it.  Apparently there are more to come.  Hopefully it will serve to remind all physicians that they need to only buy from licensed and legitimate sources.  Their patient’s lives depend their knowledge and skills… but also on their pharmaceutical buying practices

Rather than repeat Ed and WSJ, just go read the articles yourself by clicking here:

Continue reading InBrief: Pharma Supply Chain Criminals Get Justice, Part 2

Pharma Anti-Counterfeiting and Serialization

Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world.  The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national.  What we need now more than ever before is a multi-national approach to fighting these crimes.

That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina.  See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.

The dispute is Continue reading Pharma Anti-Counterfeiting and Serialization

The Significance of the Abbott, McKesson and VA Pilot

Last month I had the opportunity to see the presentation by Abbott Labs, McKesson, the U.S. Department of Veterans Affairs (VA) and GHX about their recent and ongoing Network Centric ePedigree pilot.  [NOTE:  GS1 removed the PDF file from their website after my essay was published.  See the comments below this essay for more. – Dirk.]  I see that a presentation on the same topic is on the agenda for this week’s HDMA Track & Trace Technology Seminar.  If you are attending that event, don’t miss that presentation because this pilot is an important one.  I normally like to attend the HDMA event but I won’t be there this year due to a long-scheduled vacation.

The pilot implemented a “Centralized” Network Centric ePedigree (NCeP) system. Continue reading The Significance of the Abbott, McKesson and VA Pilot

Will The California ePedigree Dates Slip Again?

Coastline near Laguna Beach California, November 2009. Photo by Dirk.
Click to enlarge image.

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.Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”.  I don’t have any special or inside knowledge but, as usual, I do have a theory about that.  I offer it to you here as one possible outcome.  You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again?

More Thoughts On The Congressional Discussion Draft

You now have less than one week to provide a group of Congresspeople with your thoughts on their latest discussion draft for a bill that would attempt to make our U.S. drug supply chain less susceptible to criminal attacks and errors.  See my two earlier essays, “The Congressional Draft Proposal to Improve Drug Distribution Security” and “Congressional Legislation Development: Mad Libs Edition!” for more specifics.

Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is.  That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences.  I don’t know what you’ve been up to, but this is my third essay about it.  😉

There are still a few things that I wonder about. Continue reading More Thoughts On The Congressional Discussion Draft