The Pharma Industry Isn’t Ready for the November 2023 DSCSA deadline and the FDA isn’t Budging.

I attended the Healthcare Distribution Alliance (HDA) 2022 Distribution Management and Expo Conference in Austin, TX a couple weeks ago. The HDA is an industry association comprised of leaders from all aspects of the pharma supply chain. Their goal is to work together to implement regulations and provide feedback to regulatory bodies such as the Food and Drug Administration (FDA).

Zebra set up a booth, and I attended several sessions regarding each supply chain segment’s readiness for the final milestone of the Drug Supply Chain Security Act (DSCSA) which is due November 27, 2023. I learned that the industry must have the required data to accompany a shipment of pharmaceuticals between trading partners or face shipping stoppages, fines, and other consequences that no one wants.  Wholesalers are onboarding each of their 500+ manufacturers to ensure they can receive the EPCIS formatted data cleanly into their systems one year ahead of the deadline. (Yes, just a few months from now.) If you think that goal is ambitious, it is.

In fact, my Zebra colleague, Carrie Angelico, summed it up best when she said, “I’ve never seen such a look of panic in the room as I saw at this conference.”

The Situation – and Stipulations

The message was clear from manufacturers at the conference that they are not just selling products anymore. The regulation requires that accurate data must also accompany every shipment.

However, I attended a panel session that focused on wholesaler readiness for DSCSA, and the big three wholesalers said they are finding this to be more difficult than expected due to data cleanliness issues at the source as well as data transmission errors. Some wholesalers estimate that roughly 40% of transactions have data errors that may represent stoppages to the supply chain under DSCSA. Moreover, a large portion of trading partners haven’t started preparing for this aspect of the looming milestone, which can easily take 6-9 months to achieve.

Here’s the kicker: clean and accurate data must accompany each shipment, during each movement within the supply chain, or the shipment stops.  

No one can afford there to be bottlenecks in the pharma supply chain. Three-in-10 patients who responded to Zebra’s Pharmaceutical Supply Chain Vision Study in 2021 say they are already having trouble getting the medications they need due to out-of-stocks or limited product availability.

That’s why trading partners are trying to get these data connections established and tested at least one year prior to the November 2023 deadline; they must do everything they can to avoid shipment stoppages, which means allowing ample time for data cleanups and for inventory to cycle through to a compliant state. If shipments stop between trading partners, the impacts are felt by the patients and other supply chain entities, such as the hospitals, clinics, non-government organizations (NGO) and pharmacies serving those patients. Patients will experience delays getting their prescriptions and vaccines. Manufacturers, wholesalers, and pharmacies will lose revenue from delays, spoilage, and loss in market share as those affected take their business to more prepared providers. (Pallets could be sitting outside on trucks and loading docks, unable to be received.) And that’s just the start.

With the FDA making it clear during the conference that the November 27, 2023 milestone date will not be delayed, all segments of the pharma supply chain must act today to ensure data accuracy and increase worker efficiency so product distribution can be maintained under DSCSA.

The Options

Organizations are hiring data specialists to mitigate the data integrity issue, but shipment aggregation accuracy is another story.

The regulation requires that all sellable units be serialized. This has already been accomplished in an earlier DSCSA milestone. Pharma products now have a 2D barcode that contains the product number, unique serial number, expiration date, and lot number. The other shoe that is falling in November 2023 is the challenge of aggregation. 

Aggregation requires that the EPCIS file reflect the hierarchy of what serialized product is physically in which carton, which carton is in which case, and which case is in which pallet or tote throughout each supply chain movement. This is a significant lift and leads to throughput delays and inaccuracies with current barcode-based tools.

The industry is looking to increase staffing to accommodate for the increased number of scans and to attempt to mitigate human error. Unfortunately, due to the labor market, adding headcount really isn’t an option. That’s a problem in and of itself. So, the industry is looking for technology solutions to help increase efficiencies.

I talked with wholesalers and manufacturers at the conference and discovered that these organizations are open to exploring Intelligent Edge Solutions (IES) such as RFID, fixed industrial scanning and machine vision, robotics automation, and artificial intelligence in order to reduce data errors and ensure their current workforce is as efficient as possible.

Now, if you’ve been following the pharma industry for a while, you might be surprised to see some of those technologies listed. For many years – decades, really – barcode-based track and trace was the gold standard. In fact, many pharma companies were afraid to try anything else given how risk averse they must be (for the reasons previously mentioned). They tested RFID several years ago, but it wasn’t quite mature enough at that time to consistently read tags on pharma products and packaging.

So, when I told them RFID was worth reconsidering, they wanted proof. Fortunately, I had it.

Zebra conducted proof of concept level testing with a major pharmaceutical company in July 2021 and proved that RFID is a viable option to address aggregation of difficult pharmaceuitcal properties such as prefilled vials, pre-filled syringes, foil blister packs, dry tablets, and heavy liquids. Indeed, RFID technology has greatly improved in the last 2-3 years, and tag prices have come down to a fiscally responsible level. We have demonstrated in real-world settings that this technology solution is a fast and accurate complimentary addition to a product’s existing barcode label. Yes, it helps that Zebra is an industry leader in RFID label conversion and can create RFID inlays that fit into existing label footprints at the sellable, package, case, and pallet levels to meet aggregation requirements. But this solution is bigger than one company’s expertise and capabilities.

Achieving DSCSA compliance demands a team effort. Every supply chain stakeholder is impacted by upstream and downstream decisions and actions. It’s not just about tagging at the source – though that is going to be where the solution ultimately starts. Distributors can’t take advantage of RFID if manufacturers aren’t tagging products and pallets before shipping them.

How We Can Prepare (Together) for a November 2022 “Go-Live” of New Technologies, so the Pharma Industry is Ready for DSCSA in November 2023

Zebra has joined the pharma consortium led by The Axia Institute to explore the validity and value proposition of leveraging RFID and GS1 standards. There is growing support for this option, but in order to become a viable solution, manufacturers will need to tag their products at the source of manufacturer as I just mentioned. Given the impact of inaccurate shipment data, and the current rate of inaccurate data using only barcode-based reporting and tracking solutions, the value proposition for RFID is becoming more attractive to manufacturers, wholesalers, 3PLs and pharmacies.

What’s great about this consortium is that pharma supply chain members can send their products directly to the Axia lab for third-party RFID tag testing and aggregation use case validation. The Axia Institute, via its close affiliation with Michigan State University, has FDA approval to receive and store pharmaceuticals in the facility. Zebra is providing equipment and best practice guidance to support RFID testing, adherance to GS1 standards, and case study publication to the industry.

The more pharma companies test RFID in real-world settings, the lower the risk rating and higher the likelihood that the industry will have a way to consistently capture clean data by the time November arrives – this year and next. Decision-makers will get the insights they need to justify the business case and spend.

At the same time, Zebra will continue to gain critical insights to the business outcomes of the pharma industry through engagement with different decision-makers and managers at the operational level. We as consortium members now have a clear set of industry pain points to address and the connections we need across the industry to engage in a meaningful and mutually-beneficial way. 

Zebra’s next step is to move forward with the industry consortium to explore RFID and other IES solutions with pharma’s industry leaders, so we can help them reach their destination on time.

If you’d like to learn more about the RFID proof of concept we conducted last year, how RFID could work in your environment, or how some of the other technologies I mentioned fit into the DSCSA solution mix, let’s find some time to talk. You can email me at john.wirthlin@zebra.com or connect with me via LinkedIn.

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Related Read:

• We Must Urgently Rethink How Pharmaceutical Supply Chains are Managed and the Role RFID Plays
• Have You Been Keeping Track of GS1 Traceability Standards?