Savvy pharma companies will use the U.S. DSCSA enforcement postponement for enhanced — not deferred — implementation of track and trace systems.
Procrastination is human nature. All of us hem, haw, and actively avoid responsibilities at times. This is especially true for things we are told to do, rather than those we choose to do. And when there’s plenty of time to do something, it’s easy to justify putting it off another day.
Until it isn’t.
In a nutshell that is why, in late June, the U.S. FDA announced a one-year postponement on enforcing the Drug Supply Chain Security Act — a regulation which, among other mandates, necessitates printing unique product identification codes on all Rx units of sale and homogenous cases distributed domestically. Simply put, the FDA’s hand was forced: an alarmingly high number of pharmaceutical manufacturers and CMOs did not have serialization solutions in place sufficient to meet the original deadline of Nov. 27, 2017.
This shouldn’t happen again — and it won’t. Note the term “enforcement postponement.” FDA isn’t delaying the law’s enactment — it is still slated to become official U.S. law this November (changing the law would, in fact, require a formal act of Congress). Rather, it is extending a penalty-free grace period for those in violation of the law. Make no mistake: unit-level serialization is here to stay, and laws inevitably tend to…well… get enforced.
Coincidentally, the U.S. enforcement postponement places pharma companies in the U.S. and Europe — who, of course, frequently produce products distributed in each other’s markets — in roughly the same boat. The deadline for serialization implementation in the EU is Feb. 9, 2019, about two months after the DSCSA will start being formally enforced by FDA here in the States. That said, track and trace solutions meant to address the newly practicable U.S. deadline of November 2018 should also conform to the EU’s similar standards, and vice versa.
With the clock still ticking, it’s time for the pharmaceutical industry to quickly recover from its collective sigh of relief. Need some anti-procrastination motivation? How’s this: with the extra time, pharma companies can stop, catch their breath after a mercifully paused sprint to compliance, and move toward implementing forward-thinking serialization solutions that actually help their business rather than merely allow them to stay in business.
In other words, pharma companies have a golden opportunity to introduce track and trace systems that are truly remarkable rather than restrictively remedial.
The need for this next-level thinking is becoming increasingly evident. As awareness grows of the complexity and interconnectivity of the serialization process, pharma manufacturers are realizing the importance of modularity and flexibility in the solutions they choose. The enforcement postponement provides valuable time for pharmaceutical manufacturers to look beyond short-term compliance needs and consider long-term solution viability.
Considering what remains a muddied landscape, idyllic systems now trend toward more flexible, hardware-agnostic serialization solutions that can adapt or scale up to meet future track and trace mandates, as well as help improve business practices. For those who had been rushing toward compliance, then, the postponement affords time to rethink the overall process, such as incorporating tools that can better utilize — for the sake of production improvements and personnel allocation — the troves of data that serialization mandates be tracked and stored for reporting purposes.
To help pharma companies and CMOs take full advantage of the DSCSA enforcement suspension, here are three considerations toward implementing a more comprehensive, beyond-compliance serialization system.
Be Honest about Buyer’s Remorse
The DSCSA postponement provides a chance for those spearheading serialization initiatives to reassess their overall strategy. For those companies who’d been rushing toward compliance via the most basic, expedient routes available, the time is now for some honest soul-searching.
The big question is this: Is the solution you’ve been working to implement a marriage of convenience, or a truly happy one? Scenarios like these exemplify the adage that “speed kills.” Amidst the sprint to meet the original November 2017 deadline, did you feel the need to do some “settling” in terms of what was achievable in a fast-narrowing timeframe?
In my experience, the most common flaw with many serialization solutions currently being embraced is that they are inherently shortsighted and, as a result, will be obsolete sooner rather than later. It is worth remembering that the initial DSCSA mandate for unit-level serialization will be followed, in subsequent years, by increasingly stringent requirements ending with full supply chain traceability in 2023.
Why invest in a technology that will need to be replaced in five years? The yearlong enforcement suspension gives pharma companies and CMOs enough time to reimagine their serialization solutions into scalable systems that can address rolling deadlines with phased-in requirements … if they don’t procrastinate.
Consider Lessons You’ve Learned
Fact: As someone charged with implementing a workable track and trace solution — and with the entire viability of the business at stake, no less — you know more about serialization now than at the inception of the process. The postponement gives you the opportunity to employ that newfound knowledge.
A real world example: One of my customers needed to add bundling operations on seven packaging lines. A huge problem arose when they realized that a few of the lines couldn’t be updated using the existing serialization solution they’d been utilizing. I won’t name names, but that’s alarmingly inadequate, and the customer is fortunate to have discovered this limitation early enough to correct it — an onerous exercise involving costly downtime and the requisite validation that any system used in the pharma industry must complete.
Another typical issue here lies with cyber-security. As we move toward enterprise-level serialization, solutions will need to be interconnected in a way that, in our age of the Internet of Things, can expose vulnerabilities. As the widespread grief caused by the aptly named WannaCry ransomware attacks exemplifies, it’s become all too easy for criminals to take the cyber-backdoor into the networks of large companies and, once inside, wreak havoc.
For those pharma companies considering, for example, forgoing a previously planned transactional-only (Level 2) serialization system in favor of a more flexible enterprise-level solution (Level 4), the importance of proper encryption and virus protection cannot be overstated.
Operational Costs and Beyond-Compliance ROI
It’s inevitable: the vast majority of serialization solutions are going to reduce overall productivity. Whenever a new step is introduced to an extended process, such as pharma packaging, there will be some degree of slowdown.
The important question is this: To what degree? In my experience, too many pharma companies have realized too late that their chosen serialization solutions are significantly diminishing production output, and are expressing an urgent need to mitigate this drop-off.
Unfortunately, some are already in too deep, having installed on a multi-site, company-wide basis systems that, in order to be significantly improved upon in terms of speed or other matters of import, essentially need to be ripped out and replaced. That’s tens of millions of dollars in infrastructure alone — an investment simply not possible for many manufacturers.
Here, two key buzzwords (or shall we say “buzz phrases”) are “hardware-agnosticism” and “beyond-compliance return on investment.”
Simply put, hardware-agnostic solutions are less likely to become obsolete, and are more suited to making adjustments as production needs change or evolve. A process as intricate as serialization requires an outsized number of components to “play nice” with each other; these sorts of ongoing transactional relationships are best mediated by software.
Finally, beyond-compliance ROI alludes to ways of utilizing the massive amount of data generated by serialization efforts to improve business practices (including the potential to reduce or even eliminate production slowdown caused by the system’s line incorporation). Solutions now exist that open up new horizons beyond regulatory compliance in terms of data analysis and machine learning tools, among other capabilities.
Indeed, the data pharma companies are required to gather, store, and report to regulatory authorities can be as valuable as they choose to make it. For example, tools exist that monitor overall equipment efficiency (OEE) to pinpoint potential production bottlenecks. Associated systems track and predict production scenarios that allow companies to allocate the proper personnel for specific projects, maximizing individual fortes while limiting unnecessary overtime.
The DSCSA enforcement postponement gives pharma companies an opportunity to address both current and emerging regulations while also minimizing impact on production processes and productivity. The time is now to move toward solutions that are flexible, scalable, and relatively painless to deploy. Often, this means hardware agnostic systems compatible with a wide range of equipment, and “smart factory” solutions that allow for data-driven business practice improvements.
About the Author
Dave Harty is Head of Professional Services for Adents, a provider of serialization solutions for unique product identification and traceability. Adents serializes pharmaceutical products for the top global pharma companies to help them and their CMOs adapt to market changes and comply with regulations on drug traceability.