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.

Lessons learned
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 for failure.

2. Mindset over matter
On the whole, companies in the U.S. have taken a solid project management approach to meeting the new requirements. This mindset, which recognizes the importance of detail and forward planning, is crucial to navigating the complexities of serialization. A thorough approach that considers the entire lifecycle of the implementation is more likely to succeed. Companies in Europe should look to the U.S. project management practices and consider taking the same approach to maximize success.

3. Communication is critical
As the U.S. deadline looms closer, many companies are realizing the importance of involving their entire organization in serialization preparations. For example, quarterly meetings with representatives from validation, quality, supply chain, IT, manufacturing and marketing have become more commonplace and should be adopted in Europe. In fact, as the deadline is now less than six months away, larger organizations are finding that weekly discussions have become necessary. Perhaps the most important piece of advice is to look internally and build a recurring model of communication so all relevant parties have full project visibility. 

4. Don’t underestimate the complexity
In practice, lot level compliance in the U.S. has required a more substantial investment in IT infrastructure and staff resources than first anticipated. Companies that need to meet the EU requirements should look to the U.S. as a blueprint for what needs to be done, including guidance on necessary timeframes, level of investment and resources to achieve compliance. Taking the time to scope out your program, including how many sites, production lines and products will be affected by regulatory changes will help to limit surprises along the way. Formulating a user requirement specification (URS) prior to project kick-off will help to focus your efforts. It’s also important to develop a comprehensive program roadmap, outlining timelines, key milestones and deliverables.

5. People power
Establishing a dedicated taskforce to drive your serialization project forward makes sense for most organizations and clearly defining who will lead the group is critical to ensuring proper governance. Ensure team members understand their role and how much time they need to dedicate to the program outside their core job functions. Determine if you have a serialization subject matter expert (SME) in place and if not, seek out an SME from a consulting company. Remember to engage vendors and implementation partners as part of your serialization team, leveraging their track record and expertise. This will maximize collaboration and implementation effectiveness.
 
6. Future proof your serialization set-up
From November 27, 2017, manufacturers supplying drug products in the U.S. must affix or imprint a human interpretable and unique standardized numeric identifier (SNI), packaging lot number and expiration date on each drug package and maintain records of this data for six years. However, this is just one step in securing the pharmaceutical supply chain and protecting against counterfeit medicines, with subsequent updates to guidelines to follow.

From November 2018, repackagers must also encode drugs in the same way as manufacturers. From November 2019, wholesale distributers will only be able to engage in transactions involving pharmaceutical products that are encoded with the SNI, packaging lot and expiration date required of manufacturers and the same requirements will apply to dispensing organizations from November 2020. In fact, it is not until November 27, 2023, ten years after the enactment of the DSCSA, that full track and trace requirements will come into force.

The message here is to be prepared for evolving regulatory requirements and take a forward-thinking view. Many companies in the U.S. are already taking the 2023 deadline into consideration and implementing technologies and processes with the flexibility to adapt to new requirements. For example, it is likely that aggregation will become mandatory in some markets, creating more complex data exchange challenges. Build this capability into your solution now, to save time and money in the future.

Conclusion
In the U.S. it’s likely that only 70% of small contract manufacturing organizations (CMOs) and CPOs will be ready for the DSCSA requirements. As such, it’s important that companies preparing for the EU FMD don’t make the same mistakes. Prioritizing serialization within your business is critical to meeting the 2019 deadline and key learnings from the U.S. include the importance of internal communication, a comprehensive project management approach to implementing changes and the need to think to the future. Those organizations that take a short-term view when implementing new technologies and processes risk not maximizing the return on investment. Take the opportunity to refine and improve your business operations and you’ll experience the benefits of your serialization efforts for years to come. 

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Carlos Machado is serialization director for EA Vision U.S. where he is responsible for sales, operations, implementation and post project support services in North America. As part of the serialization initiatives, Carlos is leading the partnership between Sea Vision and Zenith Technologies implementing its serialization product suite, focusing on speed to deliver, engineering excellence and a superior customer experience.