title: Online reporting of adverse drug reactions: a study from a French regional pharmacovigilance center.
abstract: BACKGROUND
  In France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrénées Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate.
  
  
  OBJECTIVE
  To assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports.
  
  
  METHODS
  In a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, "seriousness" and nature of ADRs) of online notifications reported to the RPVC between July 7(th), 2010 (first online notification) and December 31(th), 2011. We performed comparisons to a random sample of "conventional" notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period.
  
  
  RESULTS
  The total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26 days) earlier than "conventional" ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19 days with the new tool). In comparison to "conventional" notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for "seriousness" of ADRs.
  
  
  CONCLUSIONS
  It is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting period and file processing, which is essential to generate early safety signals.
authors.forename: Delphine
authors.initials: D
authors.lastname: Abadie
authors.forename: Leyla
authors.initials: L
authors.lastname: Chebane
authors.forename: Max
authors.initials: M
authors.lastname: Bert
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D030881:Disclosure / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005602:France / Q000453:epidemiology; D006282:Health Personnel / Q000706:statistics & numerical data; D006801:Humans; D020407:Internet; D060735:Pharmacovigilance; D011364:Professional Practice / Q000706:statistics & numerical data; D012189:Retrospective Studies