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Open AccessJournal ArticleDOI

Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project

TLDR
The results clearly suggest that broad-ranging statistical signal detection in Twitter and Facebook, using currently available methods for adverse event recognition, performs poorly and cannot be recommended at the expense of other pharmacovigilance activities.
Abstract
Social media has been proposed as a possibly useful data source for pharmacovigilance signal detection. This study primarily aimed to evaluate the performance of established statistical signal detection algorithms in Twitter/Facebook for a broad range of drugs and adverse events. Performance was assessed using a reference set by Harpaz et al., consisting of 62 US Food and Drug Administration labelling changes, and an internal WEB-RADR reference set consisting of 200 validated safety signals. In total, 75 drugs were studied. Twitter/Facebook posts were retrieved for the period March 2012 to March 2015, and drugs/events were extracted from the posts. We retrieved 4.3 million and 2.0 million posts for the WEB-RADR and Harpaz drugs, respectively. Individual case reports were extracted from VigiBase for the same period. Disproportionality algorithms based on the Information Component or the Proportional Reporting Ratio and crude post/report counting were applied in Twitter/Facebook and VigiBase. Receiver operating characteristic curves were generated, and the relative timing of alerting was analysed. Across all algorithms, the area under the receiver operating characteristic curve for Twitter/Facebook varied between 0.47 and 0.53 for the WEB-RADR reference set and between 0.48 and 0.53 for the Harpaz reference set. For VigiBase, the ranges were 0.64–0.69 and 0.55–0.67, respectively. In Twitter/Facebook, at best, 31 (16%) and four (6%) positive controls were detected prior to their index dates in the WEB-RADR and Harpaz references, respectively. In VigiBase, the corresponding numbers were 66 (33%) and 17 (27%). Our results clearly suggest that broad-ranging statistical signal detection in Twitter and Facebook, using currently available methods for adverse event recognition, performs poorly and cannot be recommended at the expense of other pharmacovigilance activities.

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Pharmacovigilance - The next chapter

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The Impact of the COVID-19 "Infodemic" on Drug-Utilization Behaviors: Implications for Pharmacovigilance.

TL;DR: The rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people’s behavior, and the responses of some influential regulatory authorities are analyzed in an attempt to minimize the actual or potential risks arising from this behavior are analyzed.
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Artificial Intelligence Within Pharmacovigilance: A Means to Identify Cognitive Services and the Framework for Their Validation.

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Journal ArticleDOI

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

TL;DR: The Innovative Medicines Initiative WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues.
References
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Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports

TL;DR: The process of generating ‘signals’ of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack but statistical approaches to the data have been underutilised.
Journal ArticleDOI

A Bayesian neural network method for adverse drug reaction signal generation

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TL;DR: The role of Bayesian shrinkage in screening spontaneous reports, the importance of changes over time in screening the properties of the measures and some suggestions as to where emerging research is likely to lead are given.
Journal ArticleDOI

Social Media Analytics and Intelligence

TL;DR: This special issue samples the state of the art in social media analytics and intelligence research that has direct relevance to the AI subfield from either an methodological or domain perspective.
Journal ArticleDOI

VigiBase, the WHO Global ICSR Database System: Basic Facts

TL;DR: The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible pharmacovigilance signals, and the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities.
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