Our team is spending much of the summer on the road, talking to pharmacy owners and operators at events like Cardinal Health's RBC Boston 2023, AmerisourceBergen & Good Neighbor Pharmacy's ThoughtSpot 2023, and DiversifyRx's Pharmacy Profit Summit.
We love being at these events; aside from the pleasure of spending time with so many dedicated pharma professionals, this gives us a chance to talk through the DSCSA compliance challenges they're facing. (Also, everyone gets a kick out of our now-famous scan game.)
However, this is also where we hear many of the misconceptions about DSCSA that are cycling through the pharmaceutical industry. There are persistent and potentially dangerous arguments, some rooted in misinformation, others in ways of thinking that just don't apply anymore; either way, they present a very real risk.
So, let's take them on:
It might be tempting to buy into the notion that things will continue more or less as before when the deadline hits, or that DSCSA can be treated as some sort of surface formality or paperwork. Nothing could be further from the truth. DSCSA serialization is transformational, and its measures are in place to ensure that suspect, illegitimate, diverted, or recalled medications don't make their way through the supply chain to patients. As such, industry cooperation is essential and will be enforced, both by regulators and by your trading partners.
Yes, your trading partners will expect you to comply with DSCSA. (If they don't, they're part of a major problem for you.) In fact, some take the deadline so seriously that they're enforcing their own penalties for not meeting onboarding deadlines far in advance of November. This is because failing to comply will seriously disrupt business, and compliance is a team effort. Product that arrives without EPCIS data must go into quarantine, and if you can't send or receive the data, you can't send or receive any product. So, it's understandable that some trading partners take such measures to protect their business — they need to know who's going to be ready and who's going to be a problem.
And, as an expert from law firm Arnold & Porter told Regulatory Focus, you can expect FDA inspections to cover DSCSA compliance, including trading with Authorized Trading Partners, having interoperable data connections, exchanging data ahead of transactions, and using product identifiers.
There has been no indication that the FDA will grant enforcement discretion for DSCSA.
This is because it’s become quite easy to comply with DSCSA. The industry has had time to process and understand the requirements (given that the final deadline marks the end of a decade-long process!) and there are now accessible, affordable solutions.
When trading partners across the pharmaceutical industry have the information and resources available to adopt DSCSA, there’s no regulatory rationale to accommodate businesses that don’t take these steps. Anyone who's serious about protecting your business will advise you to be compliant well ahead of the deadline.
Many wholesale distributors who have already onboarded EPCIS took the step of creating portals for their dispenser trading partners. These allow them to track orders, exchange EPCIS data, and investigate potential problems. This is a fantastic step, making numerous elements of DSCSA collaboration easy and quick.
A distributor portal helps a pharmacy do business with them, but that solution really just covers the distributor's DSCSA responsibilities, not the pharmacy's.
For example, DSCSA requires dispensers to be able to verify serialized data, confirm Authorized Trading Partners, and investigate and report suspect products. If you don’t have these capabilities, not only are you vulnerable to regulatory audits, you’re making the security of your business and the health of your patients completely reliant on someone else’s system working perfectly. When problems occur, you won’t have the visibility or tools to resolve them.
We can't address this point without reiterating, for context, that noncompliance is a literal threat to your ability to do business. Being unable to legally receive prescription drug products is, by definition, an existential risk for any pharmacy. Even if there were no other chance of complications and delays (as there always is), it wouldn't be a good idea to put off dealing with an issue this serious.
So, please take note that interoperability is not something to rush — partner onboarding can take weeks even under good conditions. And think about the fall timeline, leading up to November 27.
This is not a period during which you want to deal with new shipping procedures or problems, as it also precedes a national holiday (Thanksgiving) and a massively popular shopping holiday (Black Friday), and marks the beginning of the winter holidays, when many people are harder to reach, take time off, or are laser-focused on meeting their end-of-year business objectives.
Put simply: we all know how projects go when they're rushed, particularly ones that are meant to serve a long-term goal. You’re more likely to spend far more time and money all told, and take much greater risks, on a last-minute solution than one done with adequate time to communicate with trading partners and find the processes that make DSCSA flow smoothly with your operations.
This is almost certainly going to mean a money sink rather than savings. Here are just some of the ways that trying to do DSCSA without a solution will actually increase your costs:
In addition to preventing losses from all of the above, a comprehensive DSCSA solution can save you money by increasing efficiency and automating time-consuming elements such as trading partner management, expiration management, exceptions alerts, and more.
In short, the choice here isn't between working smarter and working harder; it's between working smarter and letting your job become nigh-impossible (and at incredible risk).