Serialization has been an industry hot topic for a long time and despite the extensive build up, a lack of readiness among supply chain companies has led to the Drug Supply Chain Security Act (DSCSA) enforcement being delayed by a year. But what does this new deadline mean for the industry? And, what opportunities does it offer pharmaceutical companies?

This article will discuss what those who were underprepared should be doing to implement a suitable solution before the new enforcement date arrives and how well-prepared companies can utilize this time to achieve wider business benefits.

A second chance
The announcement that the enforcement of the DSCSA regulations will be delayed did not come as a complete surprise. Many companies failed to recognize both the urgency and the scope of the task at hand and as a result have been unable to meet the requirements in time.

Serialization is not as simple as it sounds. The scope of implementing serialization across packaging lines goes far beyond introducing a barcode. Solutions need to be fully integrated across business operations to ensure minimum disruption to supply and with varying market regulations to contend with successfully implementing serialization is a steep learning curve.

Beyond this, each individual drug product will have its own unique identifier, as well as other product information, such as expiry dates, within its barcode and all of this data needs to be recorded in a level 4 system. Companies then need to be able to transfer the mass amounts of data generated because of serialization, safely and securely.
In short, the considerations surrounding serialization are extensive and it is essential that those involved in the supply chain recognize this. While this extra time is a welcome reprieve for a lot of supply chain partners, implementing serialization remains a time sensitive task. Companies should now seize the opportunity this delay offers to ensure they are fully compliant come the new enforcement date and the looming EU Falsified Medicines Directive (FMD) deadline.

Time to act: the vital steps CMOs should be taking
The European Stakeholder Model (ESM) suggests that four to five years is a realistic timeframe to establish and implement a robust solution. So, with just over a year until the new enforcement date in the U.S. and then the EU deadline shortly afterwards, a lot of pharmaceutical companies are now looking for alternative ways to meet serialization requirements.

Outsourcing serialization to a third-party provider is becoming increasingly popular. Selecting a contract manufacturing organization (CMO) that is well-prepared for serialization and potentially already delivering these to services to some territories will no doubt speed up the time it takes to ensure a suitable solution is in place, as well as mitigate the need for substantial upfront investment and extensive staff training.

Cost is still a huge concern for a lot of industry players, particularly small and mid-sized pharmaceutical companies. The initial upfront investment required to equip packaging lines and develop an end-to-end solution is substantial and as a result many have found outsourcing to partners who can build the cost into new or existing supply agreements a more viable option.

The delay to the enforcement deadline should not be a reason to become complacent about the matter at hand. For those CMOs who are just starting out on their serialization journey, the time to act is now. Serialization presents a huge opportunity for contract partners and those who can offer a tried and tested solution combined with a comprehensive knowledge of market requirements will find themselves at the forefront of the industry.

A unique opportunity
While the majority of CMOs are still in the early stages of developing and implementing serialization,¹ those who have adopted a proactive approach are now in the ideal position to offer pharmaceutical companies an alternative to investing in internal resource to meet serialization requirements.

For those who were ready for the serialization deadlines, this delay may seem unfair. While the disruption to their deployment and delivery plan will be minimal, the extra time will mean a delay in receiving payment fees from customers to cover the costs of equipping its lines and implementing a wider solution. Nevertheless, these delays should be a positive thing as those who have spent considerable time developing a solution now have the luxury of being able to further test their lines to minimize the risk of any mistakes once serialization becomes compulsory.

In addition, CMOs who are already on track to meet the deadlines can add further value to their offering by exploring the wider business benefits that can be achieved because of these new systems and processes, such as improved operational efficiencies.

While patient safety must be the focus of track and trace solutions, there is also a whole host of other opportunities that can be gained by introducing serialization. For example, implementing a solution that requires such a high level of data management and exchange capability could help to improve data transfer in other areas of the business.

End-to-end supply chain visibility could also offer a host of benefits beyond eradicating counterfeit medicines from the market. Greater visibility will help to improve order management and in turn reduce the amount of medicines being wasted, as well as allowing companies to spot any potential supply shortages before they happen. It can also make the logistics surrounding product recalls simpler. For example, if a certain batch has been exposed to the wrong conditions, a supplier can easily identify exactly which products need to be recalled, even after they have reached the market, and ensure all the effected drugs are accounted for.

Serialization has been gravely underestimated by a lot of pharmaceutical companies and CMOs meaning many simply aren’t in a position to implement a suitable solution in time for the deadlines. As a result, well-prepared CMOs are now ideally placed to offer an outsourced serialization solution. The delays to the DSCSA enforcement should be taken as a valuable lesson by the industry. It’s now imperative that all members of the supply chain act now to help ensure full compliance and avoid any future delays. 

References

1. NEXUS 17 polls, TraceLink, Barcelona, June 2017

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Erik Haeffler is the Vice President of Manufacturing Services and the Head of CSR at Recipharm. He is responsible for the group’s sustainability work, as well as its focus on operational and commercial excellence. As part of his role, Erik is continuously developing a model for working with multi-site projects and is accountable for operations development across the company, including elements such as project management resources, corporate IS and project/product sourcing decisions.