As the pandemic rages on and challenges like drug counterfeiting and supply chain disruptions continue, digital intelligence is the one thing that life sciences industry leaders can count on for competitive advantage. IDC predicted that by 2023, 75% of life sciences manufacturers will invest in intelligent supply chain solutions to enable resilience and prevent future disruptions during health emergencies such as COVID-19.

Increasing regulations are also sparking digital innovation across life sciences. For example, organizations are required to share updated supply chain data with trusted partners for compliance with the final phased-in regulations of the U.S. Drug Supply Chain Security Act (DSCSA). Initially passed in 2013, the latest batch of requirements from this act will require pharmacies, wholesalers, and manufacturers to track and report drug shipments for legitimacy between authorized trading partners. That’s where Spherity Credentialing Service CARO comes in, an app that provides updated information proving a dispenser’s trading partner status.

“When a pharmacist in a tiny dispensary in North Dakota has suspicions about a received drug shipment, they send a verification request to a global pharmaceutical manufacturer that has numerous wholesalers in between them and the pharmacy,” said Dr. Oliver Nuernberg, chief product owner of Life Sciences at SAP. “Automating the credentialing process builds transparency and trust between indirect partners, immediately surfacing the pharmacy’s credentials as an authorized trading partner. This saves time and costs with greater information accuracy and fewer delays, strengthening an organization’s ability to meet DSCSA regulations.”

Available on SAP Store, Spherity Credentialing Service CARO is integrated with SAP Information Collaboration Hub for Life Sciences, a cloud-based network solution that helps organizations comply with other provisions of the U.S. DSCSA. For example, drug traceability is another U.S. DSCSA mandate. Pharmaceutical manufacturers can also use the information hub to help law enforcement trace drug shipments by serial numbers, supporting audits that help keep counterfeit medications out of the supply chain.

Intelligent Automation Strengthens Health of Drug Supply Chain

Spherity functions as a digitally encrypted wallet that captures and stores a dispenser’s, or any other trading partner’s, verified identity data, including address, notarized documents such as articles of incorporation, as well as updated U.S. state and DEA license information. By digitizing previously manual data collection and distribution tasks between systems, the app eliminates historical time lags that often resulted in outdated information.

“In the past, information about trading partner status was manually imported on a monthly basis from spreadsheets provided by third parties. An order might come from a wholesaler or dispenser whose license expired or was revoked weeks or even months ago,” said Nuernberg. “Electronic credentialing surfaces accurate information much faster, helping organizations automatically prove compliance with regulations, including license type as required to dispense various drugs.”

Once a pharmacy’s identity is verified in their digital wallet, pharmaceutical companies would also be informed on an ongoing basis if the state or federal agency didn’t renew that license or revoked it for any reason.

Verified Partner Identity for Supply Chain Safety

Verifying a dispenser’s identity isn’t as easy as it sounds. Drug supply chains are complex, involving manufacturers, wholesale distributors, re-packagers, and logistics companies long before the goods reach pharmacies for dispensing. Having an app that automatically verifies a dispenser’s identity in real or near real time is designed to support regulatory compliance and help make drug supply chains more secure. Anticipating the 2023 regulations, some global pharmaceutical manufacturers and wholesalers have been testing the app with measurable results.

“Using the app, organizations have told us that they can securely and more easily verify trading partners and generate audit-ready records,” said Georg Jürgens, manager of Industry Solutions at Spherity. “With electronic interactions, they can trust that a trading partner is legitimate because due diligence has been conducted that proves identity. The app is easy to get up and running and has already increased efficiencies.”

Jürgens added that the app’s interoperability with different systems is designed to help meet regulatory mandates around electronic data sharing, easing collaboration between trusted partners along the clinical supply chain.

Digitalized Business Innovation

Eliminating counterfeit drugs in the legitimate supply chain is just the beginning of what’s possible in a fully digitalized life sciences supply chain. Pharmaceutical companies will be able to bring in and ramp up new, trusted suppliers faster. Intelligence will only grow with greater automation for business and patient value.

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