Serialization Director, SEA Vision U.S.
Companies throughout the U.S. are on the final home stretch towards serialization compliance. By November 2017, the U.S. Drug Supply Chain Security Act (DSCSA)
requires that all pharmaceutical manufacturers serialize products
down to the item level, including a product identifier on labels
and cases. Information on product transactions as drugs make
their way through the supply chain must also be recorded.
As the deadline approaches, it’s clear that some organizations
are under-prepared and unlikely to achieve compliance, which
may have an impact on the supply of vital medicines. This article
discusses some of the key learnings that companies supplying
drug products in Europe should take from the U.S. as they prepare for the 2019 introduction of the European Falsified Medicines Directive (FMD). It also explores Turkey as a best practice
example of serialization in operation.
STATE OF PLAY:
THE GLOBAL SERIALIZATION LANDSCAPE
More than 40 countries across the globe have guidelines for item
level pharmaceutical serialization and traceability, yet no two
countries have the exact same requirements. Serialization regulations are currently in place in countries such as Turkey, Argentina,
Saudi Arabia, China, South Korea and India, while the EU, U.S.
and Brazil are in the deployment stages. For global pharmaceutical manufacturers operating in multiple geographies, this means
a complex web of technical and operational challenges.
Turkey, which has one of the longest standing track and
trace systems in place, having introduced its requirements in
2010, is an example of a country that has adapted well to serialization requirements.
As Turkey’s key goal when launching its serialization guidelines was to reduce the occurrence of pharmaceutical reimbursement fraud, the Turkish Ministry of Health (MOH) mandates the
placement of 2D data matrix barcodes on all unit-level items that
require reimbursement. From July 1, 2010, all pharmacists in the
country’s serialization scheme İlaç Takip Sistemi (ITS) were unable to gain reimbursement for medicines without a 2D data matrix barcode.
Manufacturers, or those responsible for packaging such as
contract packaging organizations (CPOs) imprint the item’s
identity using a GS1 GTIN, a unique serial number, a packaging
lot number and expiration date in both human readable form and
a machine readable GS1-encoded data matrix symbol. Information is then posted into the ITS centralized government database.
A number of lessons have been learned through preparing
for Turkish regulations, including the need to build as much flexibility as possible around installation and validation to assist in
reducing qualification and overall downtime of packaging lines.
In addition, there is a clear need to develop new standard operating procedures (SOPs) prior to qualification and go-live to ensure
effective internal processes. Training of personnel is also critical
to run, manage and address challenges when serialized lines become operational.
All major markets appear to be aligned in their view of the importance of serialization, however the specific requirements and
philosophies behind the regulations can vary significantly from
country to country and even state to state. Across the Americas,
the emphasis is on track and trace and the ability to associate
cartons with cases so that products can be identified throughout
the distribution network.
In Europe, however, the focus is on authenticating drugs at the
point they are dispensed to patients, known as Point of Dispense
Authentication (PoDA). There will be no traceability throughout
the distribution network until the product is scanned and verified
at the pharmacy.
Despite these differences, there are still a number of lessons
that companies throughout the pharmaceutical supply chain in
Europe can learn from those that have faced similar challenges
in the U.S.
1. Complacency is counterproductive
At this stage in Europe’s journey towards serialization compliance, complacency is the single biggest cause of potential failure.
Not making decisions or issuing purchase orders for the necessary serialization technology is going to have serious repercussions when you find your efforts are too late. The worst thing
any company can be is idol. There was a time and a place as long
ago as ten years where smaller organizations could sit back and
let the larger pharmaceutical players become the early adopters.
That time has passed. Those companies that remain reactive instead of proactive in their serialization preparations are destined
2. Mindset over matter
On the whole, companies in the U.S. have taken a solid project management approach to meeting the new requirements.
From Global Serialization
A look at some key findings leading up to Europe’s 2019 FMD