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 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 refer to the “…process of determining whether or not the product and packaging are real or fake, regardless of their apparent transaction history…”.

Part 2, Authentication, is an overview of the full spectrum of sensory authentication techniques and technologies.  The coverage is so complete that it doesn’t make sense to list them all here, but a partial list includes authentication of bulk products, on-dose and in-dose authentication, analytical detection of counterfeit dosage forms using many different technologies, each explained in easy to understand sections.  Part 2 continues with sensory authentication techniques and technologies on drug packaging including coverage of many different printing technologies, security labels, holograms and other diffractive optically variable image devices (DOVIDs), specialty inks and covert taggants and forensic markers.  Part 2 wraps up with a series of chapters on the security of primary and secondary packaging.  The variety of technologies Davison covers is incredibly comprehensive.

Part 3, Product Tracking, is an overview of track and trace technologies and related topics including (again, too many to list here…this is just a partial list) serialization (serial numbers, randomization, etc.) data carriers (linear barcodes, matrix codes, RFID,etc.),  data formats (ePedigree, “fingerprinting”, etc.) and management of packaging hierarchy (inference, “bookend” approaches, batch level traceability vs. full serialization, digital signatures, etc.).  Part 3 includes a chapter on “Geographical Perspectives” which explains the current thinking on pharmaceutical track and trace in various countries around the world.  Davison includes a chapter on product tracking in other industries which highlights approaches that are working, to varying degrees, in other industries like tobacco, alcohol, food and toys.  Part 3 wraps up with a chapter on general supply chain security processes and one that discusses practical issues for implementing an anti-counterfeiting initiative.

Part 4, Conclusions and the Future, is where Davison provides his thoughts on where the technology, the criminal and the legislative activities are likely to lead us from a global perspective.

Part 5, Further Resources, contains a single essay called “A Patient’s Guide to Avoiding Counterfeit Drugs“.

In writing this book Davison has made a great contribution to the global fight against counterfeit drugs.  For the first time we have a single reference that collects explanations of every significant anti-counterfeiting technology and approach used around the globe, including both sensory authentication and traceability technologies.

This book is aimed at people who need to have a full understanding of approaches being taken or considered to combat drug counterfeiting around the world.  This includes executives and other corporate leaders in pharmaceutical supply chain organizations including security, sourcing, manufacturing, packaging, distribution, supply chain, marketing, risk management, legal, government affairs, compliance and IT.  Technology solution providers, policy-makers, legislators, media, educators and students will also find this to be a valuable reference.  I found this book to be very complete and easy to read.  If you are interested in the topics that RxTrace covers regularly then you should read this book.  I recommend it highly.

Full disclosure, Davison references three RxTrace essays as sources, but these represent a very small fraction of the hundreds of references he includes in the back of the book–a great resource in and of itself.


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