Last week, LSPedia held its first DSCSA Deadline webinar, a thorough look at what pharmaceutical trading partners are responsible for now and in the future, how to best use the FDA’s “stabilization period,” how the law will be enforced, and what steps to take to safeguard against regulatory actions.
In our previous post, we detailed Tish Pahl's presentation on what trading partners already need to be doing to comply, and clarified that businesses still need to have systems in place for the Enhanced Security requirements before November 27, 2023, to ensure that the following year can be used to refine and polish them – including collaborating with trading partners to ensure a smooth exchange of transaction data. Further, Pahl cautioned that the FDA’s stabilization period is not “enforcement discretion,” as trading partners will be at risk of enforcement action if they aren’t in compliance, or if they're stopping or slowing their efforts to get there.
The session included a few polls for viewers, to better understand the landscape and their goals for attending. First, we asked the role of attendees; there was an even split between manufacturers and wholesale distributors, each representing more than a third of attendees.
Then, we asked how they'd describe their progress in implementing DSCSA compliance. The good news was that most attendees said their organizations were, with some level of progress, at least working on implementing EPCIS data exchange. But only a combined 24 percent had fully implemented EPCIS, which is concerning, since trading partners need to have systems in place by November 27, 2023 for stabilization to begin.
Finally, we asked attendees whether they had processes for testing the accuracy of the data they exchanged. Just under half said they did; the rest were split between those who didn't, or didn't know. So, this looks like an area where greater clarity and communication within organizations might be beneficial, in addition to pushing ahead with the vital work of getting these systems in place.
Now, let’s move on to the panel discussion. (Responses are edited for brevity; click here to view the entire session.) The panel was moderated by LSPedia's Daniel MacKinnon, Vice President of Sales & Marketing.
Rose Campasano: Most service providers are in a position to exchange data, and that’s exactly what needs to happen. From a provider’s standpoint, we can’t be successful if we’re not all successful. LSPedia’s made great strides with its outreach program and in its ability to communicate with other providers, so data is accurate and succinct.
I’ve been working in this industry for a long time, and the FDA doesn’t joke around. While its statements are labeled as "guidance," it puts your company at risk when you don’t follow it. They’ve been clear, saying “this is not a time to lay back, take your foot off the gas.” You’ve got to keep moving forward, because you don’t want to give anyone in the FDA an excuse to say, “Well, you’re not taking this seriously, let’s see what else you’re not taking seriously.”
Jay Gilbreath: Our group is moving forward no matter what, and that’s what all dispensers should be doing at this moment: working towards full compliance with everything now and in the future. Read the guidance documents, and make sure you’re moving toward the end product. You need to be working now because you don’t want to be waiting until the last minute.
Clayton Dickson: Morris & Dickson believes that we all need to be working toward the guidance, to become compliant by [November 27,] 2023. Use that 1-year period as stabilization of those processes. We gotta keep full steam ahead to work through all the bugs that will arise.
Daniel MacKinnon: We don’t know what we don’t know – and a main point of the stabilization period will be working through all the bugs that will be uncovered. There’s so much to learn, and that’s why we need to have systems in place this year.
Tish Pahl: I agree with my colleagues here. At the HDA Traceability Seminar, Dr. [Connie] Jung and [Dr. Leigh] Verbois were appalled to learn that there were trading partners who were trying to cancel their contracts, take their foot off the gas until August or September 2024.
They were appalled since that is not the message that should be taken away from their stabilization policy. So they were interested in learning who those people were. They were very curious. If you are one of those people – FDA refers to them as “recalcitrant” – then tell them the FDA is looking for them.
Rose Campasano: The most difficult challenge is making sure that everyone in your organization understands what their role is in compliance and can document the process. If you don’t have good policies, if you don’t have SOPs in place, you’re gonna fall, you’re gonna fail, and it’s gonna cost you.
You need to make sure everyone is well trained and that new people coming into your organization can be trained rapidly. It’s a matter of making sure you don’t have product that’s gonna sit in quarantine and cause you to not be able to sell that product. It’s policy, procedure, documentation, and training, and that takes time to get through your organization and get it right. And you have to prove that people are being trained continuously.
Jay Gilbreath: How are you going to make sure your employees maintain their knowledge base and document it, even through timeframes when you don’t see or practice certain issues? You need to do competency checks, for just one example.
Clayton Dickson: From a distributor standpoint, the most important thing is to begin and continue to receive aggregated data from all trading partners. During stabilization, we can test that data and our processes. Our key focus is working with upstream trading partners so that we can provide accurate data to the dispensers; we can’t leave the dispensers high and dry come 2024. Improving processes around receiving accurate and complete data is the key for our organization.
Daniel MacKinnon: And serialization provides so much more than compliance, especially on the dispenser level. Having this influx of data on products can improve business efficiencies, and enables you to promote better processes or make better business decisions on products.
Tish Pahl: All the issues you've identified about compliance, procedures, and documentation – that’s what got Safe Chain in so much trouble. I encourage trading partners to take a look at that warning letter and see all the ways FDA found those verification systems to be inadequate. You train on these systems, and then you follow it, and then you document that you followed it.
Rose Campasano: The biggest risk is partners that are slow to comply. You have to decide quickly what to do when your partners, the companies you’re buying from, say “I’m not ready to be compliant yet.” That is a problem for you. If you don’t get the appropriate data, guess what? You can’t sell the product.
Every business needs to decide how they’re going to handle this. I can see that there’s going to be a lot of hurt feelings, but you can’t risk your business because the partners you buy from are slow to comply or won’t comply at all.
The second problem is knowing who your trading partners are. They have to be Authorized Trading Partners; you have to do your due diligence. There are tools out there that can help you – LSPedia’s tools can help you. If your partners are not authorized to do business in your state, it will come out, and it’s not a minor issue. Those are the things that will cause blockages or stalls because companies are not used to verifying data, or not taking a strict approach to their trading partners.
Daniel MacKinnon: Nobody wants to have their company be the topic of discussion for the next webinar.
Jay Gilbreath: One, make sure your employees know what’s required of them. Two, you have to make the decision to say no, you’re not going to use a trading partner because they are not in compliance. I know that’s a rough situation, but it is required. You have to say, “I’m sorry, but I just cannot use you,” even from the dispenser side.
A major thing for dispensers to consider is dropship items, because even though you may be ordering through your wholesaler, they are not responsible for the track and trace information since they never had ownership of those dropshipped items. You have to be able to prove that the company you’re buying dropship items from is actually authorized. You need a system like LSPedia [that can automatically keep track of trading partner licenses] or do your own legwork, and if you’re going to do your own legwork, document where you’ve done it and decide how often you’re going to review it.
Clayton Dickson: The obvious risk is the shortages we could see in the supply chain if our manufacturing partners and distributors don’t keep pushing. Especially for the patients, this creates a lot of risk. We could be delaying treatment for patients due to a data issue, when the product is in quarantine. It really emphasizes the need to keep pushing.
Rose Campasano: If you have a serialization partner, put the pressure on them. You now have key metrics in that system, you can see your inventory [and] shipments. You can use systems like LSPedia and take advantage of the data it can provide, [and] faster turnaround times on managing exceptions. So, if you have a provider, push on them to get value beyond reports.
Jay Gilbreath: If you have a central pharmacy that all things are sent through [to be] pared out to other pharmacies, or a central warehouse to send out to pharmacies, you can know exactly where products are going, all the way to the exact bottle. So that’s a very positive thing.
Daniel MacKinnon: LSPedia has a Pharmacy Pro solution, and using that with BI, we can create product expiration management. That’s so crucial – so many pharmacies that we speak with on a daily basis spend so much time daily, weekly, monthly, annually going through every single item on every shelf to look at the expiration date of every single product. Now, that can be done in just minutes by pulling a report that says which products you have right now that are expired.
Clayton Dickson: There’s gonna be some immediate benefits [to] recalls and returns. We have a new, meaningful way to communicate up and down the supply chain through interoperability, which we didn’t have before. And that transparency could create new areas where we’re all gonna see value.
Tish Pahl: We cannot currently track a prescription drug – one of the most important and valuable things that moves in the US supply chain – at the item level right now, only at the lot level. There is greater traceability in a host of other products. I heard someone tell me it’s possible to trace golf balls, but not prescription drugs. So this is huge. And yes, it’s painful and awkward and difficult and it’s required an enormous investment, but there are huge benefits to supply chain security, patient safety, accountability, transparency.
Rose Campsano: Just one short thing: don’t stop, don’t delay, we’ve got to keep moving.
Jay Gilbreath: Don’t rest on your laurels, go forward, don’t stop. Even dispensers, remember, we’re in this just as much as the wholesalers and the manufacturers.
Clayton Dickson: We’ve gotta keep moving, keep pushing ahead.
Tish Pahl: Same.