improved the ways in which data is shared in the industry, keeping
it connected to its associated product is a huge paradigm shift. Fortunately, stakeholders are already testing programs in anticipation
of 2023’s requirements and producing promising results.
For example, we partnered with a variety of organizations to
create and test strategies for complying with the regulation’s full
implementation. We executed a four week pilot program to test
the serialization of individual products with multiple pharmaceutical manufacturers. Beginning at the point of manufacture, a
DataMatrix barcode—or 2D barcode printed as a square or rectangle—containing a serialized Global Trade Item Number (GTIN),
batch/lot number and expiration date was applied to each individual product. At different points throughout the supply chain,
automated vision systems or manual barcode scanners read the
barcode to capture the GTIN, serial number, batch/lot number and
product expiration date. Once AmerisourceBergen placed an order
and that order shipped, the pharmaceutical manufacturers issued
an Electronic Product Code Information Services (EPCIS) message containing the serialized GTINs for the products in the order, which provided our distribution center with the details of the
products that were in transit. When the shipment arrived, the EPCIS events allowed us to confirm receipt without opening a single
case. This trial provided valuable learnings that lead to a template
for future pilots, all while giving us the ability to pinpoint a solution
that works across product types and manufacturers.
ACTING LOCALLY BUT STANDARDIZING GLOBALLY
Global sourcing needs a global system. The health care industry
must take a worldwide view and think about establishing common core business practices that work across the spectrum. Even
an independent pharmacy operating in a remote location is part
of the global supply chain—the medication dispensed by that
pharmacy comes from manufacturers, wholesalers and repackagers that operate around the world.
Just like identifying key points of contact, education and data
security proved to be challenges when implementing DSCSA in
the U.S. Countries around the world each have a unique set supply chain that functions for their country, and this presents challenges for global companies. As a collaborative partner with GS1,
we are on the ground in countries all over the world, helping to
shape their regulations to fit with the needs of today’s global supply chain and providing insight on best practices.
When countries don’t align with GS1 barcode standards, the
ability for therapies to move from country to country safely and
efficiently is threatened and implementation timelines and patient access to medication can be impacted. For example, Brazil
enacted legislation that was not aligned with the standard method to use serial numbers in combination with a GTIN, they wanted the serial number to be unique by manufacturer versus unique
by product. Manufacturers realized that under the Brazilian law,
they would run out of unique number combinations within a
shorter amount of time, and also they would have to modify the
way that they managed their global data. With the help of GS1,
the industry worked with Brazilian authorities to amend their law
to align with globally recognized standards.
China was another county where the industry has worked
closely with GS1 to move them towards using global standards.
China was operating within a closed system that moved data in
a non-standardized manner. This caused difficulties in importing or exporting medication, and caused manufacturers to have a
completely different strategy to meet China’s requirements. China is now working closely with GS1 to implement new tracking
and tracing legislation that will benefit not only manufacturers
but also patients, as it will open up greater access to therapies
coming in and out of the country, while also better servicing their
More education is needed to create widespread success.
Stakeholders need to educate a variety of key groups, from regulators to manufacturers, on the benefits of standardized supply
chain operations. For regulators, it takes outreach from manufacturers, wholesalers and dispensers to begin to understand what
a globally secure supply chain looks like and what organizations
like GS1 do to help achieve those goals. From there, the industry
needs to showcase the benefits of complying with global regulations, such as access, efficiency and safety for all products.
Once regulators are on board, a timeline for global implementation must be developed with manufacturers. Secure supply chain standards, while vital, take a significant amount of time
and resources to implement properly. If regulators do not allow
enough time for implementation, they run the risk of limiting
manufacturers’ ability to comply. At the same time, the pharmaceutical industry needs to work with regulators to discuss what
timelines are realistic. Sometimes, moving a deadline back by one
year is the best way to ensure safe compliance and continued access for patients.
PROTECTING THE FUTURE OF THE SUPPLY CHAIN
Ultimately, developing a consistent supply chain for countries
around the world is imperative for ensuring patients have better access to the therapies they need. Requiring manufacturers,
wholesalers, distributors and repackagers to serialize product for
several different supply chains and individual country regulations is both costly and puts patients at risk if it does not work
smoothly. Using global standards to implement serialization systems protects the product and patients.
The more industry members learn from and communicate
with each other, the more all of us can anticipate success in
implementing global secure supply chain standards. Countries
around the world are looking to the U.S. for insight on how to
craft their own regulations as we work through realizing the benefits of DQSA, DSCSA and other legislation. Together, we must
be forward-thinking and communicative with regulators, manufacturers, wholesalers, repackagers, distributors, health systems
and pharmacies as, regardless of the countries in which we operate, we share one common goal: to deliver safe, efficient and
accessible patient care. CP
HEATHER ZENK is vice president, secure supply chain at AmerisourceBergen Corporation. In this role, she is responsible for
developing and implementing traceability business processes
and technology that will enhance patient safety, further secure
the pharmaceutical supply chain and create broader service offerings to manufacturer partners and AmerisourceBergen customers.