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Descriptions of Adverse Drug Reactions are Less Informative in Forums than in the French Pharmacovigilance Database but Provide More Unexpected Reactions

Abstract : Background: In the past years, social media have drawn attention for their potential use in Pharmacovigilance. Recent work showed that it is possible to extract adverse drug reactions (ADRs) in users’ posts on social media. The main objective of the Vigi4MED project is to evaluate the relevance and quality of the information shared by patients on web forums about drug safety, and its potential usefulness for pharmacovigilance. Methods: After selecting websites of interest, we manually evaluated the relevance of posts’ content for pharmacovigilance related to 6 drugs (agomelatine, baclofen, duloxetine, exenatide, strontium ranelate and tetrazepam). We compared forums to the French pharmacovigilance database (FPVD) in order to (1) evaluate if they contained relevant information to characterize a pharmacovigilance case report (patient's age and sex; treatment indication, dose and duration; time-to-onset (TTO) and outcome of ADR) and (2) patients’ age and sex; ADRs’ nature, seriousness, unexpectedness and outcome; drug dechallenge and rechallenge. Results: The cases in the FPVD were significantly more informative than the posts in forums for patient description (age, sex), treatment description (dose, duration, TTO) and the outcome of the ADR, but indication of the treatment was more often found in forums. Cases were more often serious in the FPVD than in forums (46% vs 4%) but contained more often an unexpected ADR in forums than in the FPVD (24% vs 17%). Moreover, 197 unexpected ADRs identified in forums were absent from the FPVD and the distribution of the MedDRA System Organ Classes (SOCs) was different between both data sources. Discussion: To our knowledge, this study is the first to evaluate how patients’ posts may qualify as potential and informative case reports to support the pharmacovigilance classical workflow compared to case reports in a pharmacovigilance database. The posts were less informative (except for the indication) and focused on less serious ADRs than the FPVD’s cases, but we found more unexpected ADRs in forums than in the FPVD and their SOCs were different. Thus, web forums should be considered as a secondary but complementary source for pharmacovigilance.
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https://hal.archives-ouvertes.fr/hal-01831145
Contributor : Limsi Publications <>
Submitted on : Thursday, July 5, 2018 - 4:22:04 PM
Last modification on : Monday, February 10, 2020 - 6:14:07 PM

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  • HAL Id : hal-01831145, version 1

Citation

Pierre Karapetiantz, Florelle Bellet, Bissan Audeh, Jérémy Lardon, Damien Leprovost, et al.. Descriptions of Adverse Drug Reactions are Less Informative in Forums than in the French Pharmacovigilance Database but Provide More Unexpected Reactions. Frontiers in Pharmacology, Frontiers, 2018, pp.23. ⟨hal-01831145⟩

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