Drug traceability labels: almost as important as the drug itself

Drug traceability labels: almost as important as the drug itself

As the pharmaceutical packaging community scrambles to comply with the home stretch of DSCSA regulations that come into effect in November 2023, many are focused on “what’s digital”: interoperable systems, storage, formatting and data sharing.

But experts reminded attendees of the recent AIM Virtual Summit panel about aautomatic identification technologies and supply chain traceability without forgetting something more tangible: the label of the case itself. [Editor’s note: some responses were edited for brevity. 



As Brian Schmidt, principal IT generalist at McKesson, explained, pharma manufacturers spend a lot of time making sure that the unit of use bottles are good-looking and durable last to test the time to avoid disruptions, but they often pay little attention to the case labels. “As the cases or pallets of cases move through the supply chain, each one of those case labels is just as significant as the label that’s printed on the unit of use bottles,” he said. (The full panel video, including discussion of auto ID technology will be available for viewing soon here.)

Currently, if they’re not able to read those labels, they can place an internal label on the package to move that package through the supply chain. He said, “But going forward, if we’re not able to read those serial numbers and the information on the case, there’s a disruption. That product needs to be quarantined, researched, and looked at. That’s the next thing that we’re going to need to pay attention to as an industry.”

He said there have been conversations about what happens when this label falls off, and not only will this prevent them from moving product, but they’ve even had instances where the color fades. “You have marketing get involved with some of the packaging labels—and they’re really innovative with special colors of pink and light sienna and other colors—and we’ve seen packages that have been serialized early on that their labels are starting to fade and we just can’t read them anymore. These kinds of things are what we, as an industry, need to continue to keep at the forefront, and to improve upon as we move forward.”

Lori Bitar, market development manager, medical device and pharma at FLEXcon (global manufacturer of pressure-sensitive film products) has discussed the important issue of label failure with a colleague, particularly with regulations and changes in materials and container types. “It’s very important to identify all of that upfront, because that’s the trunk of the tree that holds all of this other great technology,” she said.

SpotSee’s president and CEO Tony Fonk agreed that while the label has historically been a bit of an afterthought, it’s now becoming the “center of everything” as a result of track-and-trace requirements and new technologies coming online.

“What’s amazing to me is it’s not only identification, it’s verification. There’s a lot of other information that you can get from it. It’s no longer just the printing of a serial number,” he said. He highlighted the use of QR codes for patients, who can scan a code and get information all the way down to dosage for their particular product and videos on appropriate administration. “There’s just so much more power in what we describe as a label beyond just identification and track-and-trace.”

Looking forward, Fonk gets most excited about where technologies can be applied to help manufacturers identify whether the cold chain remained intact, where excursions took place, etc. “We’ve talked about beyond the wholesaler, it gets really fragmented really fast. There’s a lot of variables when it comes to temperature, time, traffic, etc., that can cause a problem. We want to bring that intelligence to the label, as well. The label is becoming this wonderful brain of any shipped item-level device or pharmaceutical. And I think there’s plenty more to be discovered.”

Echoing the sentiments above, Fonk added that with DSCSA regulations, if you lose a product’s identification label, it’s as good as gone. “You really can’t do much with that medication if you can’t turn around and re-verify that. So, [the label] is as important as the drug itself, which is quite amazing.

Where does the data go?

Ultimately, the goal is for the data to be used in an interoperable database. As Fonk noted, simply put, it’s like creating a highway. “I envision this highway that stretches from the manufacturer to the wholesaler through 3PL and all the way to the dispensary, and ultimately into the hands of the patient. Of course, DSCSA is limited – it doesn’t go to the patient, but it’s illogical to think that we can’t go there. We have to go, especially with more and more home deliveries.

He said the highway has two layers: the confidential layer and what he called “benign but useful” data. He added, “There will be many kinds of useful information that can be shared across this whole supply chain that makes us better.

He highlighted the extension beyond DSCSA and regulations, especially with 75% of pharmaceuticals shipped globally covered by some form of track and trace or evolving track and trace legislation. “When you start thinking about information this way, you start thinking about how we get pharmaceuticals to developing countries and people in developing countries,” Fonk said. “This super data highway…we’re going to be able to say, ‘Well, what’s the most efficient way to get there? Where do we see the most problems? All of this will help us be much more efficient and accurate in terms of accessing healthcare around the world, not just in the United States. »

In the United States, the manufacturer is solely responsible for serialization and labeling. “Coming back to relabelling, we are not able to relabel as a wholesaler to move product through the supply chain because we no longer have the authority to do so,” Schmidt said. Speaking from the wholesaler’s point of view, he explained that they have to check that the information they receive from the manufacturer is correct – that’s no small task with around 1.4 billion serial numbers, a he noted – but they also need to break these cases down into individual units and be able to tell distributors that they received, say, a hundred different products in their shipment and here are their unique serial numbers. Next, the distributor must ensure that these numbers are correct. “This is only part of the challenges with the United States [regulations]. But I think what’s good is that it brings the industry together to really understand how we can work together to achieve a common goal. The law was very specific and each supply chain partner has a very specific requirement to meet,” he explained.



From counterfeit identification to quality excursions

Reflecting on what data does for industry and for patients, panelists mentioned a range of benefits.

Reminders: Beyond the primary task of a serial number to track products and communicate with downstream partners, Schmidt said recalls are an obvious pursuit. “When we’re looking at recalls right now, they’re done at the batch level. At this level, it could be a batch of hundreds of thousands of bottles or millions of bottles, depending on the run of the product. Unfortunately, these have impacts on the supply chain today,” he explained. “In the future, the industry is considering recalling not just one lot, but very specific serial numbers. So the manufacturer has reason to say, ‘Hey, this anomaly only happened for these serial numbers. series in the lot”. Presumably in the future with FDA approval, of course, we may limit the recall to those specific serial numbers.

Diverted product: Beyond product quality recalls, Schmidt noted that drugs can be stolen, sometimes by truckloads. In this scenario, they could identify the individual serial numbers they got away with and report them to the FDA and trading partners if necessary, to let them know that those numbers should be marked as suspect.

The cold chain: Fonk said that for cold chain monitoring today, the most effective method of monitoring a truck or pallet may be with a data logger monitoring a corner of the truck. This may mean that the product is affected in one area of ​​the truck but not the rest. Depending on the location of the recorder, this monitoring may indicate that all of the product in the truck is bad because it looks at it as a whole.

“These tools, this highway, this information and new methods allow us to monitor down to the single pharmaceutical level. The reason I share this is that it starts to combine the benefits – we see DSCSA as a benefit to be able to make the whole supply chain more efficient,” Fonk said. Instead of throwing or return an entire pallet of drugs, a company could identify the affected serial numbers and the recipient could only collect those. Then the supply chain continues to function.” So there’s a lot of value in being able to monitor and again, these technologies allow us to do that, but allow us to monitor up to that level. And when I say technologies, beyond the individual label, [it’s also] the readability of everyone in and throughout the supply chain. So really exciting stuff.

The online seminar has been recorded and will soon be available on the OBJECTIVE YouTube channel here.

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