EDDS, 2023 DSCSA compliance and why we need to prepare from now!

Enough has been said and realized about the importance of a secured supply chain. We have spoken a lot about the way serialization plays an important role in the traceability of drugs and enhancing its visibility in a supply chain.

[Read: Mere traceability is not enough for VRS-compliance; Here’s what you need]

Everything is part of the process of reaching a greater goal- making traceability interoperable and DSCSA compliant. Our final destination has been set in 2023, when the entire process of traceability will be visible and interoperable. In other words, the supply chain will be completely automated. The Enhanced Drug Distribution Security (EDDS) phase by November 27, 2023, will have fully interoperable data system in place to identify and track drugs as they pass through each stage of the pharmaceutical supply chain.

Is this possible? It is only if stakeholders realize the importance of deploying mobile-edge technology and stakeholders wake up to the clarion call for action to act swiftly ad effectively. But before taking a deep-dive into the operational technicalities, it is first important to first understand what EDDS is?

EDDS definition

As the full-form implies, the day EDDS is put in place, the security chain will be entirely secured from the drug counterfeit market. And November 27, 2023, would be the first day when the US pharma supply chain will start operating fully with numbers. To put it simply, serial numbers in the machine and human-readable format will be there on every drug packaging after November 2023.

One major difference in the functioning of the drug supply chain is understood, but there would be a lot more transformations happening over time, for instance, the way T3 information is shared.

For instance, the Transaction Information (TI)document must include the full DSCSA Unique Identifiers- including the serial numbers for the first time, that is physically included in the shipment. The Transaction History need not be exchanged anymore. So, with the TH gone, the only documents that need to be shared include the Transaction Information and the Transaction Statement.

                       -The data exchange changes, as defined by DSCSA

“The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued [by the FDA]…”

The way data is exchanged, after the EDDS is achieved and implemented, will change in a gradual and progressive manner, requiring time and a lot of doing and undoing. It is best to be prepared ahead in time to avoid the last-minute hustle. To start with, the FDA has to prepare a final guideline for the EDDS implementation.

Moreover, the following requirements will come into effect:

• Everyone must be able to promptly respond with the TI and TS for drugs when requested by government regulatory bodies like the FDA.
• Every stakeholder in the supply chain must be able to facilitate gathering the information necessary to produce TI for each transaction for a given drug package going back to the manufacturer when the request comes from a government regulatory body.

Working toward a change

Since DSCSA aims at effortless communication and the development of a standardized system for drug identification, the big pharma is gradually shifting toward serialization process as per the Global Trade Item Number (GTIN).

Easily traceable, without the need for a Transaction History stating the time and location of a drug, the GTIN will not only enhance DSCSA compliance but will also reduce paperwork.

For instance, if a product with a GTIN at a dispenser shows it has been returned, it essentially means the product was returned for verification to a distributor who after authenticating it has sent it back to the dispenser. Now the GTIN number will have the entire timeline and the location of the product in the supply chain till the time it reaches the dispenser.

This is particularly useful for tracking complex shipments with multiple medicines too. The serial number is enough to communicate the TI and the TS requirements. Moreover, the advanced protocols required by the DSCSA reduces the loss of products, penalties for losing them and the possibility of landing with a counterfeit product.

-What 3PLs need to do?

After ensuring that all the trading partners in the supply chain are DSCSA-compliant, should the manufacturers change the way they interact with the others? Here are certain things that need to be done by the manufacturers:

• Provide product tracking information at par with new guidelines
• Be familiar with the protocols for handling illegitimate or suspicious drug packages
• Check the authenticity of the trading partners from the FDA database. Also, confirm the report and the licensure.

Why is it necessary to change?

Trading partners are halfway through the compliance protocols, establishing the right process, equipment and software for a faster and seamless data transition whenever drugs change hands. Hereon, changing for the changing requirements of the EDDS would be just a small necessary step forward.

Consider this, as DSCSA compliance becomes more important to the industry, those with best practices, experience and data behind every transaction they make will be in a position to lead the industry. More valuable and profitable partnerships will be gained, staying ahead of the competition.

And in order to do that, it is important to initiate the process required for EDDS right now! Remember, it will take time to find the right partner and stakeholders to be able to handle an interoperable system. The fact that all the trading partners have to be on the same page should be verified. Unless that’s done, forget business profitability, penalties and fines would add on to the capital loss. Add to it the reputation damage, which might diminish the brand value.

So, it’s time to make changes to the warehouse management system and delivery tracking software as soon as possible. As far as serialization is concerned, experts advice to pilot a serialization program with a few serials to test and troubleshoot the systems and operations. Re-checking if you have the right systems in place and getting new ones that are compliant with the 2023 deadline is the next important step stakeholders should consider.

Support your system with the right technology

Aligning the entire supply chain process with data interoperability of 2023 is THE job at hand. It is best to start by revamping the existing systems and software or replace them with AR-enabled scanning machines, traceability suites and RX-enabled insta-verification system. Because one thing needs to be remembered- DSCSA 2023 demands high speed of supply chain operations and compromising with that would only deplete your revenue returns.

TrackTraceRX’s mobile-edge tracking technology is flexible and can scale with a growing business and automate the processes in an effective and error-free manner. API-first design is the foundation of all the software we have designed, which makes them easily integrable and navigable.

Our system capture information fast and communicate with other traders (whatever systems they are using) with the utmost ease. No tedious workflow management or an external IT team is required to get our software integrated.

With the right solution, eliminate the counterfeit drug from the supply chain, while minimizing negative returns during the VRS process. Think ahead of time and do what it takes to make your system compliant ahead of 2023 so that you are left with enough time to test the system you have put in place.

Remember, EDDS is the future of traceability and without this, your supply chain will be dysfunctional beyond 2023.