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MediLedger Product Verification System

Sector: Tertiary sector · Industry: Health technology · Organisation: Chronicled, Inc. (seit 2023 unter NABP) · Maturity level: Production

The MediLedger Product Verification System is a blockchain-based solution for the US pharmaceutical supply chain, developed by Chronicled in 2019 and acquired by the National Association of Boards of Pharmacy in 2023. The system enables tracking and verification of medications throughout the entire supply chain and supports compliance with US Drug Supply Chain Security Act regulations. Since launch, the platform processes transactions between manufacturers, distributors and pharmacies and has been integrated into NABP's Pulse platform since 2023.

Documentation status

Description

The US Drug Supply Chain Security Act (DSCSA, 2013) mandates electronic traceability of all prescription medicines. Chronicled developed MediLedger — a blockchain network for DSCSA compliance based on Hyperledger Fabric. From November 2023, full interoperable electronic traceability is mandatory. NABP took over the Chronicled tool in June 2023 as a patient protection instrument.

Counterfeit medicines are a global problem: WHO estimates that 10% of all medicines worldwide are counterfeit, with an estimated 200,000 deaths per year. In the US, Congress responded in 2013 with the DSCSA, which mandates phased implementation of prescription medicine traceability. MediLedger (Chronicled, San Francisco) is the leading blockchain platform for this: it uses Hyperledger Fabric in a permissioned network where manufacturers, wholesalers, pharmacies and regulators have access. Each package receives a serial number; every transaction (shipment, receipt, return) is recorded on the blockchain. In case of suspected counterfeiting, a pharmacy can immediately query the full transaction history of the package. Partner network: Pfizer, Gilead, AmerisourceBergen, McKesson, Cardinal Health, Walmart, CVS Health and 100+ others. The FDA endorsed MediLedger as part of its DSCSA Pilot Program. In June 2023, NABP acquired the Chronicled tool to continue it as a non-profit patient protection instrument.

Perspectives

B2B — organisations perspective

Pharmaceutical manufacturers, wholesalers and pharmacies can demonstrate DSCSA compliance via MediLedger — with blockchain-based serialization, automatic verification and interoperability across all trading stages.

B2C — consumers perspective

Patients and pharmacists can verify the authenticity of any prescription medicine within seconds — a direct protection against counterfeit drugs, some of which are life-threatening.

Employees perspective

Employees in pharmacies and distribution centres benefit from automated verification processes that reduce time-consuming manual checks. The system supports compliance teams in meeting regulatory requirements more efficiently and focusing on more strategic tasks.

Benefits

General

B2B — organisations

B2C — consumers

Employees

Challenges

General

B2B — organisations

Employees

Technology foundation

The MediLedger system uses a decentralized blockchain infrastructure specifically developed for the life sciences industry and is considered an industry-leading solution. Blockchain technology enables every medication transaction to be immutably recorded and grants all authorised participants in the supply chain transparent access to verification data.

Implementation examples

NABP Integration into Pulse Platform

The NABP wanted to support its members in meeting DSCSA requirements while simultaneously enhancing patient safety through improved medication verification. Integration into the existing Pulse platform was intended to accelerate adoption and maximise benefits for regulators and pharmacies.

In 2023, the NABP took over the MediLedger system and integrated it into their Pulse platform for enhanced compliance support.

After acquiring Chronicled in June 2023, the National Association of Boards of Pharmacy integrated the MediLedger product verification system into its existing Pulse platform. This integration enabled state regulators and pharmacies to gain expanded access to verification services and improve DSCSA compliance. The system now supports a broader user base and offers enhanced features for monitoring drug safety.

The acquisition resolved the issue of sustainable funding and further development of the system. At the same time, access was improved for smaller pharmacies and regulatory authorities that previously might not have had the resources for direct integration.

Tags

Supply chain, Pharmaceuticals, Compliance, Verification, DSCSA

Sources

  1. NABP Acquires Patient Safety Tool From Chronicled Inc.
  2. NABP Acquires Patient Safety Tool From Chronicled Inc.
  3. FDA DSCSA Pilot Project Report