Could Blockchain Technology Be Used For DSCSA Compliance?

c4scs-logoIf your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare.  I recently attended a very interesting day-long workshop on that very topic. 

So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies?  I’ll tell you what I think.  But first, a little background.

Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information.  It’s all about adding trust to information that is shared between parties.  Trust is just one of the many components of security.

There are many ways to apply blockchain technology.  The most famous application of it is in the virtual currency known as “Bitcoin”.  The Pharma Blockchain Bootcamp I attended last month, organized by DisruptiveRx, included a mix of speakers, some of whom were experts in the technology, but were not very familiar with the pharma industry, and, some who were experts in various aspects of the pharma industry and were excited about the potential use of blockchain to solve a challenge within their area of healthcare expertise.  These areas included:

  • Bio/Pharmaceutical R&D
  • Clinical trials
  • Anti-counterfeiting
  • Supply chain regulatory compliance (particularly the DSCSA)

That is a diverse set of potential applications.  My interest is in the last two, and particularly its potential use in meeting the Drug Supply Chain Security Act (DSCSA).  Fortunately, DisruptiveRx had lined up the foremost authority on ideas for applying technology to meet the DSCSA, Bob Celeste, as a speaker. 

Mr. Celeste is Founder of the Center for Supply Chain Studies (C4SCS), a non-profit organization dedicated to helping trading partners collaboratively study specific applications of technology that might improve their supply chain.  Of course, blockchain has caught their interest.  Mr. Celeste spoke about a new study that his company is currently organizing and will kick off soon, centered around the potential application of blockchain technology by the U.S. pharma supply chain to meet the requirements of the DSCSA in 2023.  At the time, the new study was in the “pre-launch” state, which means anyone can join their calls without charge and without commitment.  Pre-launch for the “DSCSA & Blockchain” study will continue through the end of this month when the final participants will be established and they will move forward with the actual study in the new year.

In his presentation at the Pharma Blockchain Bootcamp, Mr. Celeste demonstrated a solid understanding of the 2023 DSCSA requirements, and enough understanding of blockchain technologies that he effortlessly showed what makes it such a compelling potential solution to those requirements.  More than any other speaker, he was able to show both the problem, and the potential application of blockchain to a solution within his area of expertise.

HOW BLOCKCHAIN MIGHT SOLVE THE DSCSA TH PROBLEM IN 2023

Starting on November 27, 2023, companies in the U.S. pharma supply chain will no longer be required to pass Transaction Histories (TH) to their customers.  But, from that time on, they must have “…systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer…”.  The act of gathering the various Transaction Information (TI) documents back to the manufacturer would only be necessary whenever an investigation into suspect or illegitimate product would be conducted [see DSCSA Section 582(g)(1)(D)].  This would presumably be rare.  When something so complex is needed so rarely, its complexity is actually compounded.

Here is how Mr. Celeste depicts the resulting problem:

c4scs-dscsa-2023-problem
Drawing courtesy of Center For Supply Chain Studies. Click on image to enlarge.

Upon being contacted by a government agency, the hospital at the end of this supply chain will be asked to gather the TI’s for a given set of product going back to the manufacturer.  The request to the manufacturer will likely raise the questions shown.  The manufacturer might legitimately ask, “Who are you?”, “Are you a legitimate member of the supply chain?”, and “How do I know that you own the drug you requested information about?”.  These are questions of trust.  The manufacturer should not respond to anyone asking for this kind of information unless these questions can be answered satisfactorily.  But if the hospital and the manufacturer have no existing direct business relationship, it may take more time than the law allows to establish the trust necessary to provide the answers.  The same problem may exist between the hospital and the first wholesaler, in this example.

In this slide, Mr. Celeste summarizes the problems and what it is that makes blockchain technology so attractive:

Drawing courtesy of Center For Supply Chain Studies. Click on image to enlarge.
Drawing courtesy of Center For Supply Chain Studies. Click on image to enlarge.

Into this problem, blockchain would introduce a way of trusting the party making the original request, that they have a legitimate reason to ask such a question, and that they actually do own the product in question.  The technology does not impose a need for a central repository, but would work weather a centralized or distributed architecture is used.  It would work with information packets that are composed of any format, including GS1 EPCIS events.

Now, even after Mr. Celeste’s presentation, I am not convinced that blockchain is the right solution for the industry to align behind to meet the 2023 DSCSA requirements, but I have a better understanding of the potential, and I agree that it is a worthy thing for the industry to investigate.  His study is well-timed, and his organization appears to be exactly what is needed for the industry to take an in-depth, unbiased look at this potential solution.  Most RxTrace readers are well aware that Mr. Celeste has a long and successful history of facilitating exactly this kind of work when he worked at GS1 US.  But as I pointed out back in 2013, GS1 US is incapable of leading the investigation of solutions to the DSCSA because they are too GS1-specific (and for other reasons…see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”).  It is not surprising that any potential solution component that lies outside of GS1 standards is not something they want to put their heart into.  Now that Mr. Celeste is running an organization that is independent of any potential solution, he can lead the group anywhere it ends up needing to go.  He will not need to stop at the domain boundary of GS1 standards.  That bodes well, not only for this particular study, but his company and the pharma supply chain overall.

In its barest form, blockchain can be used to quickly establish trust between two or more parties who do not already know each other.  But there are lots of different ways it could be implemented.  Each way of implementing blockchain brings along its own set of restrictions and benefits.  If blockchain technology is going to be used to solve these particular trust problems, the industry will need to determine exactly how it will be applied and what those resulting restrictions and benefits would be.  I hope the study that C4SCS is about to undertake will begin to do just that.  To join the C4SCS study, visit their website:  www.c4scs.org.

Dirk.

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