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VOLUME 2 , ISSUE 1 ( January-June, 2018 ) > List of Articles


Big Data Analytics and Pharmacovigilance—An Ethical and Legal Consideration

Rahat Kumar, Pratyush Sharma, MaheshInder Singha

Keywords : Adverse drug reactions (ADRs), Big data analytics, Ethical considerations, Pharmacovigilance.

Citation Information : Kumar R, Sharma P, Singha M. Big Data Analytics and Pharmacovigilance—An Ethical and Legal Consideration. Curr Trends Diagn Treat 2018; 2 (1):58-65.

DOI: 10.5005/jp-journals-10055-0040

License: NA

Published Online: 01-06-2018

Copyright Statement:  NA


Drug side effects become once the drugs enter the market. Such type of side effects also called adverse drug reactions (ADRs). ADRs are a major cause of morbidity and mortality among people and present a major health problem worldwide. Thus, what we need is effective post-marketing safety surveillance (or called as pharmacovigilance). In pharmacovigilance, adverse events are obtained from various sources such as drug manufacturers, healthcare professionals, and patients/people consuming these drugs but this presents a problem of lesser reporting as reporting is voluntary amongst these groups. The solution to this problem is the use of big data analytics. Big data” has become a more and more cited term in health care, for the potential use of the huge amount of data collected from digital medical records or administrative data (e.g., drug prescriptions, hospital dismissal forms, healthcare services, etc. and also as a support for regulatory decisions, pharmacovigilance included. Big data also references artificial intelligence, infrastructure, and services, as well as automated processing operations that facilitate the collection, storage, and analysis of data gathered and being produced in ever-increasing quantities. Big data obtained via social media is analyzed using statistics might have considerable errors and biases for individuals not conforming to group characteristics. Utilization of big data in Pharmacovigilance will bring in the potential to complement traditional spontaneous reporting systems, by allowing an epidemiological approach to determine the incidence of adverse events in the population.

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