Blockchain-Based Pharmacovigilance Framework: Enhancing Drug Safety Through Distributed Ledger Technology

Abstract

The study proposes a blockchain-based framework to overcome the challenges of data silos, privacy risks, and interoperability limitations in pharmacovigilance systems, focusing on the refinement of adverse drug reaction (ADR) data collection, storage, and analysis. Incorporating blockchain's transparency, immutability, and security, the framework comprises four core components: a data collection layer for multi-source ADR reporting, a standardization layer for data integration and validation, a blockchain network layer for tamper-proof storage and secure sharing, and a data analysis layer for real-time risk detection and visualization. The framework's efficacy in drug safety monitoring and regulatory efficiency is exemplified by the MediLedger and Merck's SAP Pharma Blockchain Proof of Concept case studies. The proposed resolution shows remarkable potential for advancing global pharmacovigilance practices.