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Accepted for/Published in: JMIR Public Health and Surveillance

Date Submitted: Apr 10, 2020
Date Accepted: Jun 25, 2020

The final, peer-reviewed published version of this preprint can be found here:

Complementing the US Food and Drug Administration Adverse Event Reporting System With Adverse Drug Reaction Reporting From Social Media: Comparative Analysis

Zhou Z, Hultgren KE

Complementing the US Food and Drug Administration Adverse Event Reporting System With Adverse Drug Reaction Reporting From Social Media: Comparative Analysis

JMIR Public Health Surveill 2020;6(3):e19266

DOI: 10.2196/19266

PMID: 32996889

PMCID: 7557434

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Complementing the FDA Adverse Event Reporting System with Adverse Drug Reaction Reporting on Social Media

  • Zeyun Zhou; 
  • Kyle Emerson Hultgren

ABSTRACT

Background:

Adverse drug reactions (ADRs) can occur any time that someone uses a medication. ADRs are systematically tracked and catalogued, with varying degrees of success, in order to better understand their etiology and to develop methods of prevention. The Food and Drug Administration (FDA) has developed the FDA Adverse Event Reporting System (FAERS) for this purpose. FAERS collects information from myriad sources, but the primary reporters have traditionally been medical professionals and pharmacovigilance data from manufacturers. Recent studies suggest that information shared publicly on social media platforms related to medication use could be of benefit in complementing FAERS data in order to have a richer picture of how medications are actually being used, and the experiences that people are having across large populations.

Objective:

To validate the accuracy and precision of research methodology and conduct evaluations of social media ADRs reporting via tweets for multiple commonly used pharmaceutical agents.

Methods:

ADR data from the ten most prescribed medications according to pharmacy claims data were collected from both FAERS and Twitter. In order to obtain data from FAERS, the SafeRx database, a curated collection of FAERS data, was used to collect data from March 1, 2016 to March 31, 2017. The Twitter data was manually scraped during the same time period to extract similar data using an algorithm designed to minimize noise and false signals in social media data.

Results:

A total number of 40,539 FAERS ADRs reports were obtained via SafeRx and more than 40,000 tweets containing the drug names as were obtained from Twitter’s Advanced Search engine. While the FAERS data was specific to ADRs, the Twitter data was more limited. Only five drugs had sufficient volume of ADR content for review and comparison. FAERS and Twitter shared similarities in types of data reported and a few unique items to each data set as well.

Conclusions:

Utilization of social media as an ADR pharmacovigilance platform should continue to be studied as a unique and complementary source of information rather than a validation tool of existing ADR databases.


 Citation

Please cite as:

Zhou Z, Hultgren KE

Complementing the US Food and Drug Administration Adverse Event Reporting System With Adverse Drug Reaction Reporting From Social Media: Comparative Analysis

JMIR Public Health Surveill 2020;6(3):e19266

DOI: 10.2196/19266

PMID: 32996889

PMCID: 7557434

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