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The Future of Healthcare Supply Chain Security

Businessman looking through binocularsLet’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future.  Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period.  In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years.  These include:

Most of these laws and regulations deal, at least in part, with the identification of drugs and devices in a security context in the two largest markets for those product in the world.  Author Mark Davison recently discussed transatlantic alignment (see “Transatlantic Alignment”) in the near term as the result of some of these new laws, but I want to look even farther out.  By 2024, all of these laws will be fully operational.  What will these supply chains look like?

Here are my predictions.

REAPING THE BENEFITS OF STANDARDS

Drug and device manufacturers will be able to harmonize the identification of their products using standards that are recognized in a large portion of the world.  The application of GS1 standards in pharma extends well beyond just the U.S. and the E.U. so that supply chain will experience the greatest harmonization.  The mix of GS1 and HIBCC standards in the device supply chain will likely continue in some parts of the globe but at least companies should be able to choose one or the other for all of their products based on where those products are marketed.  So even though the world may not harmonize around one set of standards, a given company should be able to.

martin_cooper-200x200By 2024, everything in these two markets should be marked by a 2D barcode and the linear barcode placed on healthcare packages today will be a distant bad memory—like comparing today’s smartphone with the first “portable” mobile phone.  The higher density of the 2D information graphic  will leave more label space available for other uses.  Less obvious, the ability to add extra data elements within the barcode without rendering the regulated data elements unreadable will allow manufacturers to provide increasingly diverse special information to downstream trading partners about each product, on both cases and units.

If current trends continue, by 2024, China will likely become the second largest market in the world for drugs and devices.  I suppose China will remain the one hold-out regarding the use of global identification standards, but we can hope by then they are starting to see the light.

COUNTERFEITERS AND CARGO THIEVES WILL BE BLOCKED

Counterfeiters and cargo thieves will be forced to move on to other types of products because dealing in pharmaceuticals and devices will become too risky.  With the addition of serial numbers to drugs in both the U.S. and E.U., plus the tracing that will be required in the U.S. market and the point of dispense (PoD) authentication that will take place in Europe, it will be very difficult for these criminals to introduce their illegitimate products into the legitimate supply chain without detection.  Why would they bother risking their freedom with healthcare products when less secure supply chains are available.

RECALLS WILL EXECUTE FLAWLESSLY

Thanks to lot/batch numbers and serial numbers—increasingly referred to as “production identifiers”—encoded in every drug and device unit barcode and standardized, electronic recall notices (not widely used today), warehouse and inventory management system will be able to monitor for recalled lots and serial numbers at every read point.  Recalled units will automatically be blocked from continuing down the forward logistics stream the instant the recall notice is received by a member of the supply chain (see “We Should Be Ashamed Of The U.S. Approach To Pharma Recalls“).

RECOGNITION OF GS1 GTIN BY GLOBAL PHARMA REGULATORS
I believe that in the next 10 years, regulators around the world as a group (except maybe China) will recognize the value of using the same way of identifying drugs and devices everywhere, and the most likely approach is GS1’s Global Trade Identification Number (GTIN).  Today a number of large countries assign national numbers to drug makers, like the National Drug Code (NDC) in the U.S., the Drug Identification Number (DIN) in Canada, and the Pharma-Zentral-Nummer (PZN) in Germany.  Not only do these different identification schemes cause difficulty for drug manufacturers, they also reduce the effectiveness of global supply chain security because it makes tracking and tracing across international borders more difficult.  I believe that in the next 10 years, countries will begin to adopt the approach first taken by the U.S. FDA UDI rule as a replacement for national numbering systems for healthcare products (see “FDA Proposed UDI: A Revolution In Number Assignment”).  That approach is to let the manufacturer register their chosen product identification number using one of several numbering standards, including GS1’s GTIN.

Globe

DRUG SERIALIZATION GOES GLOBAL

I think the driver to standardize the product codes globally (above) will be the desire by smaller countries to serialize their drugs.  But serialization within such a small area as Columbia, for example, would be very impractical, unless the same product code and serialization schemes are applied throughout Central and South America.  The same goes for Africa and Asia.  Once smaller countries realize this, I think we will see them banding together and aligning around GS1 standards as a group so that manufacturers will be happy to supply serialized and traceable product across entire regions, not just within the borders of single countries.  Once serialized by the manufacturer, local regulations can impose track and trace or authentication regulations based on those serial number on internal distribution of those drugs.  Everyone wins.

WILL RFID HAVE AN IMPACT IN 10 YEARS?

I predict that RFID will still not be widely used in healthcare supply chains for tracking and tracing products at the unit level (see “RFID is DEAD…at Unit-Level in Pharma“).  But I am equally confident that other use cases will be found that will tolerate the lower read reliability of non-line-of-sight technologies so RFID will play a role in our supply chain by 2024 in one way or another.  Tag and reader prices should continue to drop slowly over that time and perhaps manufacturers will begin to use RFID on their cases where tunnel and portal readers can isolate the intended target product and can use higher power antennas.

What are your predictions?  Leave a comment below.  Any way you look at it, the supply chain will be significantly more secure and more efficient in 10 years, thanks to today’s legislation.

Dirk.

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2 Responses to “The Future of Healthcare Supply Chain Security”

  • Peter Norton says:

    Hi Dirk,

    I agree entirely but I think you overlooked one key region – China/Asia. In June last year the Chinese FDA also introduced a new regulation which virtually mirrored the EU version and in some areas is a little more focused on preventing falsified medicines from entering the supply chain.
    The trend that I have seen is that many of these new regulations, no matter which region you look at, are getting closer and closer to resembling one another which I believe is a very positive trend.
    All we need to do now is get the standards for identification and traceability locked down and this will be big leap forward.
    Also in regards to RFID, when you consider cold chain products linked to traceability the options are endless with RFID for real time monitoring of location and condition, but possibly not at the unit level, more so at the case or pallet level.

  • Anonymous says:

    Predict pressure for the US to also authenticate at point of dispense and the EU to secure the supply chain prior to point of dispense.

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About The Author
Dirk Rodgers

Dirk is an independent consultant and founder of RxTrace. He has contributed to many of the industry groups that have been formed over the last 10 years to investigate solutions to the problem of counterfeit and other illegitimate drugs in the legitimate supply chain. He served as co-chair of a number of key technical work groups in GS1 and GS1 US. These include the original GS1 EPCglobal Drug Pedigree Messaging work group that created the DPMS pedigree standard, the Network Centric ePedigree (NCeP) work group and the RFID Barcode Interoperability Guideline work group. Dirk holds a BS in Electrical and Computer Engineering from the University of Wisconsin-Madison.

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