title: Informativeness of patient initial reports of adverse drug reactions. Can it be improved by a pharmacovigilance centre?
abstract: OBJECTIVE
  Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports.
  
  
  METHODS
  A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor.
  
  
  RESULTS
  Overall, 240 reports concerning 522 ADR and involving 278 drugs were reported over this 4-year period. Mean number of available key elements of information in initial reports was increased from 11/16 to 15/16 after review of reports by the PVC. Time to onset and duration of the ADR were respectively available in only 51 and 58% of the reports before review compared to 83 and 90% after review. Medical history and concomitant medication were missing in 75% of the initial reports compared to less than 30% of the reports after review. Contacting the reporter enabled an increase of informativeness of most elements of information for more than 90% of the reports.
  
  
  CONCLUSIONS
  Patient reports often need to be completed on key elements of information that are required to assess reports. Both upstream education of patients and downstream intervention of a pharmacovigilance assessor to complete missing information could help to enhance the informativeness of such reports.
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.|Aix Marseille Université, Institut de Neurosciences Timone, CNRS, 7289, Marseille, France.
authors.forename: F
authors.initials: F
authors.lastname: Kheloufi
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.|Aix Marseille Université, Institut de Neurosciences Timone, CNRS, 7289, Marseille, France.
authors.forename: A
authors.initials: A
authors.lastname: Default
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.|Aix Marseille Université, Institut de Neurosciences Timone, CNRS, 7289, Marseille, France.
authors.forename: F
authors.initials: F
authors.lastname: Rouby
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.
authors.forename: D
authors.initials: D
authors.lastname: Laugier-Castellan
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.
authors.forename: M
authors.initials: M
authors.lastname: Boyer
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.
authors.forename: B
authors.initials: B
authors.lastname: Rodrigues
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: Ponte-Astoul
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.
authors.forename: M J
authors.initials: MJ
authors.lastname: Jean-Pastor
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France.|Aix Marseille Université, Institut de Neurosciences Timone, CNRS, 7289, Marseille, France.
authors.forename: O
authors.initials: O
authors.lastname: Blin
authors.affiliation: Regional Pharmacovigilance Centre of Marseille Provence Corse, Department of Clinical Pharmacology and Pharmacovigilance, Assistance Publique - Hôpitaux de Marseille, 270 boulevard Sainte Marguerite, 13009, Marseille, France. joelle.micallef@ap-hm.fr.|Aix Marseille Université, Institut de Neurosciences Timone, CNRS, 7289, Marseille, France. joelle.micallef@ap-hm.fr.
authors.forename: J
authors.initials: J
authors.lastname: Micallef
mesh_terms: D000328:Adult; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D057566:Self Report / Q000592:standards*
keywords: Adverse drug reactions; Consumer; Direct patient reporting; Health democracy; Informativeness; Patients; Pharmacovigilance; Quality; Spontaneous reporting