Curating DSCSA compliance data for 80,000 US pharmaceutical trading partners and counting
Maintaining a high-quality, current database enabling Drug Supply Chain Security Act (DSCSA)-relevant compliance checks across the US supply chain to ensure that only authorized trading partners are involved, thereby reducing the risk of counterfeit or harmful products reaching patients
The US Drug Supply Chain Security Act (DSCSA) requires that only trading partners that are duly authorized interact with each other. Think about it along the same lines as creditworthiness management by financial institutions. Your bank has checked your level of financial reliability before handing you a card that allows you to make purchases. Vendors then rely on your bank’s due diligence.
In the same vein, Spherity and Legisym support the industry to enable seamless electronic communication that is restricted to Authorized Trading Partners (ATPs). The joint product, Credentialing Service CARO, is designed to reduce the time-consuming manual effort required to verify ATPs in a decentralized supply chain. This digital process is highly secure and enables supply chain actors to prove and verify the ATP status in accordance with DSCSA requirements. HDA recognized our tireless work on credentialing with the prestigious HDA Distribution Management Award in 2023.
High-quality data is the backbone
Using original source data from every US State Board of Pharmacy and the Food and Drug Administration (FDA), data for approximately 80,000 trading entities are being curated daily by Legisym’s team of experts.
Through CARO, Legisym’s high-quality database is leveraged to transform the data into electronically verifiable credentials. These credentials are effectively the basic tools that automate compliance within the Verification Router Service (VRS) and other systems designed for the exchange of sensitive electronic data.
“We can credentialize each and every Authorized Trading Partner. No matter the size, location, or specialty of the Authorized Trading Partner, the credentialing process can verify their identity and validate their status. This is crucial for maintaining the integrity of the pharmaceutical supply chain and ensuring patient safety.”
— David Kessler, President, Legisym LLC
Thanks to Spherity’s and Legisym’s joint effort, every dispenser, wholesaler, manufacturer, and even state board, can have access to credential-backed electronic profiles with CARO and plug these into their DSCSA solution for seamless electronic product verification and tracing. By integrating credentialing into existing solutions, every participant in the supply chain is enabled to be electronically authenticated and authorized.
Why credentialing is important for patient health
The importance of credential validation and verification in the pharmaceutical supply chain cannot be overstated. Just as credit card owners need to protect their identity to prevent theft, ATPs in the pharmaceutical supply chain need to own and verify their credentials to prevent unauthorized transactions that allow fake drugs to harm patients.
The Gilead case in 2021 is a prime example of the risks involved. In this case, counterfeit versions of the HIV drugs Biktarvy and Descovy were found in the US. The counterfeit drugs were sold throughout the US from licensed pharmacies to American patients. This was a massive breach in the US drug supply chain involving $250 million in counterfeit HIV drugs. The case highlights the importance of due diligence in verifying products when onboarding new suppliers to ensure product safety and legitimacy.
This incident underscores not only the reputational risk for wholesalers and pharmacies who do not verify the products and associated supplier credentials, but also tarnishes manufacturers whose brand receives bad press. It is crucial for all entities in the supply chain, from manufacturers to wholesalers to pharmacies, to understand the importance of credential validation and verification. Education and awareness are key to ensuring the integrity of the supply chain and protecting the health and safety of patients.
What do credit cards and ATP credentials have in common?
In short: thorough due diligence.
Just as financial institutions validate the creditworthiness of an entity or person before credit card issuance, ATP credential issuers, such as Legisym, assess the legitimacy of a pharmaceutical identity during the credentialing process. In both industries, these standardized checks are crucial in establishing trust, mitigating risk, and facilitating seamless electronic interactions.
Pharmaceutical license and registration checks are no mean feat. Data resides in various databases that are formatted differently and updated at different frequencies. To keep up to date, these data sources need to be checked regularly. This is what our integration partner Legisym does day in, day out. They diligently aggregate high-quality data on 80,000 US pharmaceutical trading partners, that is, dispensers, wholesalers, and manufacturers.
In the context of DSCSA compliance, continuous monitoring of ATPs is a critical aspect. Just as a credit card company monitors an individual’s credit limit to prevent fraud and ensure financial health, the continuous monitoring of ATP credentials ensures that only entities with a valid ATP status remain in the game. This ongoing verification process is crucial in maintaining the integrity of the pharmaceutical supply chain, thereby reducing the risk of counterfeit or harmful products reaching patients.
How to get ATP credentials
To use credentialing for ATP requirements under DSCSA, trading partners need to claim their corporate profiles in a one-time onboarding process. Once the trading partner profiles are claimed and verifiable credentials are issued, they are stored and monitored in a secure account in Spherity’s Credentialing Service CARO.
CARO is connected to every VRS and tracing service provider currently active on the market to ensure that communication between trading partners across different service providers is validated and ATP checks are logged for compliance audits.
Industry standards enable an open market
Interoperability between credentialing service providers is enabled by the open standards defined by the Open Credentialing Initiative. Read more in our previous blog post or tune in to hear why industry-wide standards matter in fulfilling the intent of DSCSA. Drummond Group certified both Spherity and Legisym as OCI-compliant service providers.
The described technology enables U.S. pharmaceutical supply chain actors to interact instantly with digital trust, as they can digitally verify their ATP status in every interaction.
Last but not least: Contact our experts at atp@spherity.com.
Feel free to reach out with any question or to set up a demo to see how these tools work. If you just want to stay sphered join Spherity’s Newsletter List or follow us on LinkedIn and Twitter.
