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.
a Institute of Applied Biosciences , Centre for Research & Technology Hellas , Thermi , Thessaloniki , Greece.|b INSERM, U1142, LIMICS , F-75006 , Paris , France.|c Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS 1142, LIMICS, F-75006 , Paris , France.|d Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142) , F-93430 , Villetaneuse , France.
Vassilis G
VG
Koutkias
e Centre Reìgional de Pharmacovigilance, Hôpital Européen Georges-Pompidou, AP-HP , F-75015 , Paris , France.
Agnès
A
Lillo-Le Louët
b INSERM, U1142, LIMICS , F-75006 , Paris , France.|c Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS 1142, LIMICS, F-75006 , Paris , France.|d Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142) , F-93430 , Villetaneuse , France.
Marie-Christine
MC
Jaulent
D016907:Adverse Drug Reaction Reporting Systems; D014150:Antipsychotic Agents / Q000009:adverse effects; D066126:Cardiotoxicity / Q000209:etiology; D002543:Cerebral Hemorrhage / Q000139:chemically induced; D003024:Clozapine / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D065427:Factor Xa Inhibitors / Q000009:adverse effects; D006220:Haloperidol / Q000009:adverse effects; D006801:Humans; D016247:Information Storage and Retrieval; D060735:Pharmacovigilance; D011720:Pyrazoles / Q000009:adverse effects; D011728:Pyridones / Q000009:adverse effects
D014150:Antipsychotic Agents; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D003024:Clozapine; D006220:Haloperidol
Adverse drug events; bibliographic databases; case studies; computational framework; emerging data sources for pharmacovigilance; heterogeneous public data; joint exploitation; social media; spontaneous reporting systems