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The purpose of the U.S. Drug Supply Chain Security Act (DSCSA) is to help prevent harmful drugs from entering the U.S. drug supply chain, and to detect harmful drugs if they do infiltrate the supply chain.
The U.S. DSCSA outlines steps to achieve an interoperable and electronic process to identify and trace prescription drugs as they move through the supply chain.
Dispensers have responsibilities to protect patients from receiving harmful drugs such as counterfeit or illegitimate drugs.
The law requires drugs to be traced as they move through the supply chain:
- Only accept prescription drugs that are accompanied by product tracing documentation.
- Store product tracing documentation received for six years.
- Generate and provide all product tracing documentation with a transaction if a prescription drug is sold to a trading partner.
To help customers comply with the regulations of the act, which protects consumers from fake, counterfeit, contaminated or stolen medication, SAP has expanded the SAP Information Collaboration Hub for Life Sciences.
SAP Information Collaboration Hub for Life Sciences is an SAP Cloud Service that facilitates exchange of traceability data across the pharma supply chain network. This SAP cloud service provides connectivity to supply chain partners through B2B messaging, a Web App portal and through third party serialization providers.
SAP added a verification repository to authenticate pharmaceutical items returned from hospitals and pharmacies to wholesalers before the products are resold. This repository allows wholesalers to verify the product code, lot, expiration date and a unique serial number embedded in the barcode against the manufacturer’s data.
The most recent addition to SAP Information Collaboration Hub for Life Sciences covers regulatory collaboration between participants of the pharmaceutical supply chain of prescription medicine.
The option for regulatory collaboration provides onboarding, integration, and messaging capabilities, including the possibility to onboard a high number of business partners to exchange fully standardized messages in the DSCSA context. The service also provides capabilities to address tracing requests and contains an exception management capability.
Since the network has grown to tens of thousands of partners, a key limitation emerged: There was no simple way for business partners, acting as network end users and who are not SAP customers, to directly interact with SAP Support in case of critical issues. Without the direct access to the SAP support system, network end users had to contact the SAP customer who in turn contacted SAP to resolve issues.
To address this situation, SAP added Built-In Support to SAP Information Collaboration Hub for Life Sciences to provide direct, seamless assistance to life science companies and their partners acting as network end users.
Network end users can now resolve issues independently without involving SAP customers in the resolution process. Users can efficiently search for relevant product information to resolve issues, and if necessary, create support requests directly with SAP Support.
The Network End-user simply selects the Built-In Support icon on the web app screen:
The user then can ask a question resulting in a search of documentation, SAP Knowledge Base Articles, and other relevant helpful content.
If the user cannot find a suitable answer, there is the option to create a request which the SAP support team receives and acts on.
In conclusion, the integration of Built-In Support within the SAP Information Collaboration Hub for Life Sciences marks a significant step forward in enhancing user experience and support efficiency. When network end users directly access support resources and resolve issues independently, we not only streamline the support process but also reinforce SAP's commitment to improving lives through better Life Sciences solutions.
Are you interested in more information on SAP Information Collaboration Hub for Life Sciences? Find here my blog "Saving Lives one Serial Number at a Time" which describes the journey of SAP Information Collaboration Hub for Life Sciences from the beginning in 2017 until 2021 - the next chapter, which then includes the most recent enhancements for U.S. DSCSA until 2024 will follow in the very near future.