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Saving Lives one Serial Number at a Time - US DSCSA update 2024

martin_janssen
Associate
Associate
‎2024 Oct 18 9:09 AM
631

These days counterfeit medications are a real threat for consumers. An example is described in the Reuters article The extraordinary demand for Novo Nordisk’s Ozempic and other drugs used for weight-loss is fueling ...

Statistics are available on the total number of counterfeit incidents concerning pharmaceuticals worldwide from 2002 to 2023. In 2002, 196 incidents of pharmaceutical crime were reported by the Pharmaceutical Security Institute. However, the annual number of such incidents increased significantly, up to 6,900 by 2023. (Source: Statista – Health, Pharma & Medtech – Pharmaceutical Products & Markets)

As a reminder: counterfeit designer bags, watches or sneakers cause economic harm to impacted companies whose products are copied, but do no real harm to consumers. That is very different when it comes to counterfeit medication. Using counterfeit medication causes health risks, or even worse, death.

All kinds of medicine can be counterfeited: expensive lifestyle or anti-cancer medicine, antibiotics, medication for hypertension, cholesterol lowering drugs, hormones, steroids, antihistamines, and inexpensive generic versions of basic pain killers.

In response to this, governments world-wide have enacted directives that require members of the pharmaceutical supply chain to serialize their items, which enables the identification of counterfeit products through track and trace or verification.

Since 2018, the business network SAP Information Collaboration Hub for Life Sciences facilitates exchange of traceability and serialization data across the supply chain, enabling each customer to connect once and only once to share data with all partners and regulatory bodies.

In 2021, I wrote about the history and the evolution of SAP Information Collaboration Hub for Life Sciences as a standard offering to the Pharma Industry. This standard cloud service is built on the SAP Business Technology Platform and is offered as Software as a Service through subscription.

SAP Information Collaboration Hub for Life Sciences started with serial number request and response between Market Authorization Holders (MAH) and Contract Manufacturer Organizations (CMO), and serialization event message exchange between Market Authorization Holders (MAH), Contract Manufacturer Organizations (CMO) and 3rd Party Logistics provides (3PL).

In 2019, SAP added the capability for Regulatory Reporting, starting with reporting in the European Union. Regulatory reporting for the EU Falsified Medicine Directive (FMS) was the first capability within that scope.

SAP enlarged this offering by addressing additional regulatory reporting scenarios, based on a new generic reporting interface between SAP Advanced Track and Trace for Pharma and SAP Information Collaboration Hub for Life Sciences.

Today the seven largest pharmaceutical companies globally, 16 out of the top 20 pharmaceutical companies, and two of the three largest U.S. pharmaceutical wholesalers are using SAP Information Collaboration Hub for Life Sciences to connect their ecosystem.

In 2019, SAP Information Collaboration Hub for Life Sciences, together with SAP Advanced Track and Trace for Pharmaceutical won the Frost & Sullivan “Visionary Innovation Leadership Award”.

In August 2021, SAP Information Collaboration Hub for Life Science won a Golden Stevie Award in the 18th Annual International Business Awards cycle in the “Business-to-Business Products” category.

SAP Information Collaboration Hub for Life Science also won the Hasso Plattner Founders´ Award 2021 in the category Products & Technology.

 

The U.S. Drug Supply Chain Security Act (U.S. DSCSA) is a federal law that defines requirements that must be followed by all companies involved in the pharmaceutical supply chain to enhance tracing at the unit level of prescription drugs. This law protects patients from fake, contaminated, or stolen medication.

The law requires wholesalers to verify prescription drugs that are returned and intended for resale.

SAP added a verification repository to SAP Information Collaboration Hub for Life Sciences, to authenticate pharmaceutical items returned from hospitals and pharmacies to wholesalers before the products are resold. This scenario allows wholesalers to verify the product against manufacturer data stored in the repository and is in productive use by our customers (Manufacturers and Wholesalers) for a number of years.

Since 2015, lot-level product tracing information, including transaction information (TI), transaction history, and transaction statement (TS) must be provided in paper format to a subsequent purchasing trading partner. Since November 27th, 2023, electronic-based approaches are required for all trading partners to meet enhanced drug distribution security requirements, including electronic product tracing at unit level.

In November 2023, the FDA announced it does not intend to act on the enforcement of U.S. DSCSA until November 27th, 2024. While the U.S. DSCSA law is in effect since November 27th, 2023, this created a one-year stabilization period that allowed all stakeholders additional time to refine systems and processes necessary to maintain compliance under U.S. DSCSA.

The FDA has issued an additional exemption for connected trading partners with respect to the U.S. DSCSA. “This exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.”

SAP already delivered the necessary capabilities to fulfill U.S. DSCSA requirements as part of SAP Information Collaboration Hub for Life Sciences. Through the option for regulatory collaboration, SAP provides onboarding, integration, and messaging capabilities, including self-onboarding for a high volume of business partners who can then exchange fully standardized messages in a regulatory context.

The service also provides:

  • Invitation initiation from SAP customers to business partners who are not SAP customers
  • Self-onboarding of invited business partners
  • Transmission of standardized notifications in legislation-specific formats using a generic reporting framework
  • Receiving standardized regulatory notifications from business partners
  • Trace management.
  • Exception management

The new services of SAP Information Collaboration Hub for Life Sciences help our customers and their business partners become compliant and remain compliant. 

The most recent release of SAP Information Collaboration Hub for Life Sciences is release 2408 available since August 24th, 2024.

Find the first post which describes the journey of SAP Information Collaboration Hub for Life Sciences from the beginning in 2017 via the following link: https://community.sap.com/t5/sap-for-life-sciences-blogs/saving-lives-one-serial-number-at-a-time/ba...