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Blockchain-based Prescription Drug Supply Chain Tracking

Sector: Tertiary sector · Industry: Pharmaceutical sales and services · Organisation: Walmart · Maturity level: Pilot

Walmart participates in an FDA pilot project for blockchain-based tracking of prescription drugs and vaccines, based on the Drug Supply Chain Security Act of 2013. The project aims to identify and remove counterfeit, stolen or contaminated medications from the supply chain. The electronic, interoperable track-and-trace system enables real-time monitoring of medications and accelerates the tracking and tracing of inventory.

Documentation status

Description

Monitoring prescription medicines through blockchain closes a critical safety gap: counterfeit opioid tablets from unknown sources have claimed tens of thousands of lives in the US opioid crisis; contaminated medicines have led to mass recalls.

DSCSA implementation: pharmaceutical manufacturers must label every single pack with a GS1 serial number; wholesalers and pharmacies must scan and document this at every change of ownership. The blockchain model: instead of a central database (single point of failure and attack), MediLedger and similar systems use Hyperledger Fabric as a permissioned blockchain — only authorised actors can write, everyone can perform compliance checks. Walmart Pharma Tracking Initiative: Walmart used the experience from IBM Food Trust (mango traceability reduced from 6 days to 2.2 seconds) as a blueprint for pharmaceutical tracking in its 5,000+ pharmacies. Special challenge of the opioid crisis: stolen or diverted prescription medicines not documented in DSCSA-compliant fashion could be immediately identified as counterfeits or illegal diversions.

Perspectives

B2B — organisations perspective

Pharmacy networks and pharmaceutical wholesalers can instantly verify with blockchain-based DSCSA systems whether the serialization chain is complete for every incoming medicine — automated counterfeit protection.

B2C — consumers perspective

Patients benefit from increased safety of their medicines and a reduced risk of receiving counterfeit or contaminated products. Improved traceability can also help identify the cause more quickly in cases of allergic reactions or side effects.

Employees perspective

Pharmacy and healthcare staff receive better tools to verify the origin of medicines. Automated verification processes reduce manual checks and increase the efficiency of daily workflows.

Benefits

General

B2B — organisations

B2C — consumers

Employees

Challenges

General

B2B — organisations

Employees

Technology foundation

The project uses a shared, permissioned blockchain network based on proven blockchain technologies such as Hyperledger Fabric. This technology is particularly suitable for the pharmaceutical supply chain as it enables secure, immutable records of all transactions while meeting privacy and regulatory requirements.

Implementation examples

FDA pilot project for pharmaceutical supply chain tracking

The project addresses the critical need to remove counterfeit and contaminated medicines from the supply chain and increase patient safety. At the same time, it aims to improve compliance with FDA regulations and increase the efficiency of supply chain tracking.

Walmart participates in an FDA pilot project for blockchain-based tracking of prescription medicines and vaccines. The project aims to identify and remove counterfeit, stolen or contaminated medicines from the supply chain.

The pilot project is based on the Drug Supply Chain Security Act of 2013 and develops an electronic, interoperable track-and-trace system. The system enables real-time monitoring of medicines, accelerates tracking and tracing of inventories, and monitors temperature control as well as product integrity. Walmart brings its experience from the successful blockchain implementation in the food supply chain. The project was planned for completion in Q4 2019 with results in an FDA DSCSA programme report.

The system solves problems of lack of transparency in pharmaceutical supply chains and difficult traceability in product recalls. It also addresses the challenge of interoperability between different systems of supply chain participants.

Tags

Supply chain, Medicine safety, FDA compliance, Track and trace, Counterfeit protection

Sources

  1. FDA: DSCSA Blockchain Interoperability Pilot Project Report (IBM, KPMG, Merck, Walmart), Februar 2020
  2. Merck: IBM, KPMG, Merck and Walmart collaborate as part of FDAs blockchain program
  3. Ledger Insights: Walgreens, Walmart join MediLedger FDA blockchain pharma pilot