Thesis (M.A.)--Boston University
PLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you. / 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.
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/12528 |
| Date | January 2012 |
| Creators | Mody, Kinjal |
| Publisher | Boston University |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
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