Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study.

JMIR Research Protocols
Madison Milne-IvesEdward Meinert

Abstract

Adverse drug event reporting is critical for ensuring patient safety; however, numbers of reports have been declining. There is a need for a more user-friendly reporting system and for a means of verifying reports that have been filed. This project has 2 main objectives: (1) to identify the perceived benefits and barriers in the current reporting of adverse events by patients and health care providers and (2) to develop a distributed ledger infrastructure and user interface to collect and collate adverse event reports to create a comprehensive and interoperable database. A review of the literature will be conducted to identify the strengths and limitations of the current UK adverse event reporting system (the Yellow Card System). If insufficient information is found in this review, a survey will be created to collect data from system users. The results of these investigations will be incorporated into the development of a mobile and web app for adverse event reporting. A digital infrastructure will be built using distributed ledger technology to provide a means of linking reports with existing pharmaceutical tracking systems. The key outputs of this project will be the development of a digital infrastructure, including a backen...Continue Reading

References

Feb 18, 2011·Pharmacoepidemiology and Drug Safety·David J McLernonUNKNOWN Yellow Card Study Collaboration
Apr 28, 2011·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Claire AndersonUNKNOWN Yellow Card Study Collaboration
Jan 23, 2018·Integrated Pharmacy Research & Practice·Muhammad Abdul HadiEjaz Cheema
Sep 13, 2018·Journal of Clinical Pharmacy and Therapeutics·Andrew ThompsonMunir Pirmohamed
May 28, 2019·Pharmacoepidemiology and Drug Safety·Mary Louise Hughes, Marjorie Weiss

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Software Mentioned

Vigilance Hub
Farmatrust
Yellow
RADR2
WEB

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