Indexed on: 21 Jan '17Published on: 21 Jan '17Published in: BMJ open
Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products.Our review conduct will follow the Joanna Briggs Institute scoping review methods manual. Literature searches were conducted in MEDLINE, EMBASE and the Cochrane Library from inception to 13 May 2016. Additional sources included searches of study registries, conference abstracts, dissertations, as well as websites of international regulatory authorities (eg, Food and Drug Administration (FDA), the WHO, European Medicines Agency). Search results will be supplemented by scanning the references of relevant reviews. We will include all publication types including published articles, editorials, websites and book sections that describe use of social media and crowd-sourced data for surveillance of adverse events associated with health products. Two reviewers will perform study selection and data abstraction independently, and discrepancies will be resolved through discussion. Data analysis will involve quantitative (eg, frequencies) and qualitative (eg, content analysis) methods.The summary of results will be sent to Health Canada, who commissioned the review, and other relevant policymakers involved with the Drug Safety and Effectiveness Network. We will compile and circulate a 1-page policy brief and host a 1-day stakeholder meeting to discuss the implications, key messages and finalise the knowledge translation strategy. Findings from this review will ultimately inform the design and development of a data analytics platform for social media and crowd-sourced data for pharmacovigilance in Canada and internationally.Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/).