Pilot evaluation of adverse event reports in PatientsLikeMe database
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Background: Post-marketing surveillance is very important because many adverse events (AEs) are detected only when a drug is used in more diverse populations and for a longer period of time. The current AE reporting system has certain limitations including high underreporting rates. Hence, there is a need to supplement this system with other methods of AE reporting. Previous research has shown that social media and direct patient reporting may be effective in collecting AE reports. Objective: To explore the utility of a patient centered social networking site, PatientslikeMe (PLM), in AE reporting and assess the validity of the AEs reported. Design: Observational retrospective study Methods: To determine the potential of PLM to be used as an AE reporting tool we examined for - completeness of the data, credibility of the AEs reported and the rate of reporting in a subset of the PLM population who reported taking one of eight selected drugs. Results: Of the 2249 subjects, 80% were female. A total of 1625 AEs were reported by 267 subjects. Only 35% of these 1625 AE reports were found to be related to the drug. We could not make a judgment on the credibility due to lack of adequate information in more than 50% of these reports. More than half of the commonly expected AEs were not reported even once and the rate of reporting was found to be very low. Conclusion: PLM is not ready to be utilized as an AE reporting tool. Improvement in the quality and completeness of the data is needed to make a judgment about the validity of AEs generated from such AE data sources, so that the FDA and others engaged in pharmacovigilance can fully utilize these AE reports.
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