Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.
OBJECTIVE
Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance.


METHODS
Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage.


RESULTS
The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework.


CONCLUSIONS
This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.
['Koutkias|Vassilis G|VG|', 'Lillo-Le Louët|Agnès|A|', 'Jaulent|Marie-Christine|MC|']
D016907:Adverse Drug Reaction Reporting Systems D014150:Antipsychotic Agents D066126:Cardiotoxicity D002543:Cerebral Hemorrhage D003024:Clozapine D064420:Drug-Related Side Effects and Adverse Reactions D065427:Factor Xa Inhibitors D006220:Haloperidol D006801:Humans D016247:Information Storage and Retrieval D060735:Pharmacovigilance D011720:Pyrazoles D011728:Pyridones
computational framework case studies Adverse drug events bibliographic databases emerging data sources for pharmacovigilance heterogeneous public data joint exploitation social media spontaneous reporting systems