Why you Need to Take Unit-level, Lot-level and Package-level Identifiers More Seriously!

Enough has been said about the importance of serialization in eliminating the counterfeit drug from the pharmaceutical supply chain, but the way it functions is yet to be decoded. Now that we have realized that serialization is a necessity, it requires our attention at the minuscule level to understand the multiple layers of serialization a supply chain has to deal with.

But why does serialization essentially have to be complicated?

It’s because of the complexity in the way the most dynamic industry in the world- the pharmaceutical supply chain- functions. The fact that counterfeit drugs do not infiltrate from a single point of entry is clear when we see the demographic expanse of a drug supply chain. With India and China (the most notorious when it comes to counterfeit drugs) being the global drug manufacturing hub, Africa (another big player in the counterfeit market) being the hub of repackagers, and the European Union being the global distribution of drugs, stakeholders in the drug supply chain have to be very particular about the steps they follow to secure the quality of the drugs reaching the end users.

The Role of Aggregation

Aggregation, the serialization underdog has till now been ignored by most of the stakeholders in the supply chain because of the sheer fact that it has not been mandated by DSCSA. The price of implementation is another factor that has often got them hesitated. However, the fact that aggregation can really enhance the outcome of serialization processes is gradually being realized.

Now how does that work?

Describing the unit-level, lot-level and package-level identifiers and the way they form the ‘child-parent’ relationship with each other would help you understand the way serialization gets leverage from aggregation.

The national serialization requirements by FDA forces a pharmaceutical company to print a unique serial number on the drug package as it moves down the packaging line, and then link that number to the carton and then link those individual and carton numbers to the pallet as it leaves the production facility on its way to the wholesaler.

During product recalls or the VRS process, these identifiers provide instant information pertaining to the product origins, often not requiring the wholesaler to send a request and wait for a response to take the next steps. Some of the other advantages attached to using aggregation or maintaining a ‘parent-child’ identifier include:

-Easy tracking when products of the same lot are sold at different places: Although serialized and screened for the multi-level identifiers, it is possible that the warehouse selling them may sell one part of the lot to one dispenser and the other part to another dispenser. In such cases, the unit-level product identifiers help in tracing the origins of the items back to the manufacturer without any hassle.

-Easy determination of FDA approved or unapproved drugs: On second thoughts, product or unit level identifiers are the best way to determine whether or not the product is approved by the FDA. FDA interprets the definition of “labelling” in section 201(m) of the FD&C Act to include the product identifier. Accordingly, as part of registration and listing under 21 CFR part 207, a manufacturer of any prescription drug for commercial distribution must submit a copy of all current labelling as specified under 207.49 (a)(15)(i), independent approval status. In other words, the absence of this identifier in the first place indicates that the product is unapproved or not registered.

-Ease of traceability: FDA prefers using the sNDC as the package-level SNI for most prescription drugs because that allows the different stakeholders in the supply chain to add their own unique identifiers or SNIs in front of the NDC number. These SNIs can be linked to databases containing product attributes such as lot or batch numbers, expiration dates, distribution/transaction history, and other identifiers related to the product. This domain is still evolving and is expected to include more features to further strengthen the integrity of the product.

The above can be better explained with a pictorial description of a product timeline in the supply chain. The image (by GS1) shown above clearly explains how the unit-level (the bottle), the case or lot (the box) and the pallet (the group of boxes) are connected to each other in each phase of transition. So, the item from GLN 1(green) reaches GLN 4( Orange) to the consumer, the unique identifier will have 4GLNs+2 GTINs+2 SSCCs, all of them sharing the information in the picture above.

[To know more about unit-level packaging, read: Why is Pharma Aggregation the Future of Traceability? An Inside Story]

Challenges to be considered in unit-level, lot-level and package-level drugs

So, if the multi-level identifiers are so important, why aren’t they being adopted at a massive scale? Here’s exploring the challenges that stakeholders, mainly dispensers face when it comes to accepting the process.

-Additional investments: The case of healthcare centers and hospitals is just a case in point. Hospitals receiving consignments from wholesalers, who have already mobilized the DSCSA requirements when it comes to GS1 barcoding, are hesitant to invest in AR-enabled multiscanners required to read the GS1 codes- one because of the cost and two because of the training hours required for learning to operate them.

Hospitals, therefore, prefer sticking to the simpler NDC codes on the packages, indirectly failing the purpose of the unit, lot and package level identifiers. This, in turn, forms a vantage point for the counterfeit drug suppliers who can easily infiltrate the system here without being detected.

Sticking to the 2D label with a linear scanner turns out to be cumbersome and expensive en masse. While the cost of the investment in advanced machinery worry hospitals, they end up spending more time, labour and capital in printing 2D barcodes either on-site or via contract packagers- on drugs coming into central pharmacies from drug wholesalers and group purchasing organizations. Hospitals must use the 2D to get the NDC number in a bar code and while doing so add the expiration date and lot number, which makes it easier for them to track the drugs’ origin. While that’s a lot of work, hospitals still continue to do it because they believe they are saving money here, which is not true.

Interestingly, getting them to understand the importance of unit level, lot-level and package-level identifiers for serialization is a task that would meet failure 90% of the time. Prejudice or a practice, that’s the hard reality.

-Data discrepancy: Fear of Having to address an additional issue of the discrepancy is another reason why stakeholders are yet to warm up to the idea of affixing multi-level product identifier. Say, for instance, Warehouse 1 has the technology and the eagerness to implement the identifiers and creating a child-parent connection for data sharing, but Warehouse 2 is a small player, not having the required infrastructure to maintain the same. This will lead to a gap in data sharing by the time the product reaches the end of the line. The stakeholder right after Warehouse 2 will be clueless about the data collected by its predecessor because of this gap, which will continue to be there till the end. Tracing such packages creates additional tracking pressure on the supply chain, thus demotivating participants from implementing the process in the first place.

A word of advice

For those who already realize the importance of multi-level packaging identifiers, it is important to understand that using the right technology at the right juncture can only speed up the process of pharmaceutical tracking and serialization. AR-enabled technologies like multiscanners and insta-verification software, coupled with Traceability suites can help organize data and the product in the supply chain. So be it data sharing during saleable returns or identifying a “suspect” product in a given consignment, references are available right away.

It must be remembered that the FDA recommends warehouses to produce VRS audit reports within 24 hours of a product being returned for verification and re-sale. With the help of unit-level packing and advanced technology together, data sharing is transparent, faster and accurate, leaving warehouse with more productive efforts in the supply chain, while saving them man-hour too.

And for those who are still unsure of the process, it is worth mentioning that the one-time investment it calls for is worth trying out. It will definitely add value to the overall capital and man-hour savings in as labour-intensive work as serialization and traceability.

But above all, it must be acknowledged that this barcoding process strengthens the integrity of an essential commodity such as medicine, which is the main aim of pharma companies. One may argue that serialization is enough for the purpose. But, would that be enough in case of global drug circulation? It is a sad reality that we must accept and acknowledge that the counterfeit market is growing across borders, even infiltrating countries like the United States that have stringent internal laws for medicine supply. Unit-level packaging is the only solution here.

Why TrackTrace RX?

We are world’s only VRS that offers AR-driven insta-verification scanners that cannot just do the job, but do the job well for you to go ahead and sort the documents you need to send to FDA in minutes. Our Traceability portal helps you identify the drugs across the timeline, throughout its journey in the supply chain, and also help you manage data by detailing each and every step of the verification. So, you have all the details right in front of you when you send the audit report.

Our RX-driven multiscanners and traceability together ensure accurate verification, lesser cost of verification implementation, lesser man-hour cost required for manual verification, easy data-management, and faster traceability. Our API-first software engineering approach does not require spending extra hours or money in restructuring your operational framework to accommodate our software. A little patch that would take you minutes is enough to get connected to all the LDs related to the supply chain.

Responsiveness is a pre-requisite of VRS-compliance, but we take you a step further in making you responsibly compliant too. Just a few weeks ahead of the November 27, 2020 deadline, your last chance of avoiding a penalty is here. We could partner you for VRS-readiness affordably and quickly.