title: Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system.
abstract: OBJECTIVE
  Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying whether the registries could be useful tools for a safer use of innovative drugs.
  
  
  METHODS
  All ADR reports included in the Italian Pharmacovigilance Network database from January 1st2013 to December 31st2015 (vaccines and literature cases excluded) were analysed. We compared the ADR reports of MR and non-MR drugs with the same ATC class at III level.
  
  
  RESULTS
  The percentage of ADR reports with a completed 'Section 7' was significantly lower for MR compared to non-MR drugs (2.0 versus 6.2, p < 0.001). The difference concerned in particular the ADR reports related to abuse/misuse, medication errors and overdose. These reports, more strictly related to inappropriate use, were less frequent for MR drugs in all the considered ATC classes.
  
  
  CONCLUSIONS
  Our study suggests that monitoring registries could be a useful tool for the reduction of frequency of ADRs related to inappropriate use, besides the control of pharmaceutical budget.
authors.affiliation: a Department of Diagnostics and Public Health, Section of Pharmacology , University of Verona , Verona , Italy.
authors.forename: Lara
authors.initials: L
authors.lastname: Magro
authors.affiliation: a Department of Diagnostics and Public Health, Section of Pharmacology , University of Verona , Verona , Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Arzenton
authors.affiliation: a Department of Diagnostics and Public Health, Section of Pharmacology , University of Verona , Verona , Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: Moretti
authors.affiliation: b Italian Medicines Agency , Pharmacovigilance Office , Rome , Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Sottosanti
authors.affiliation: b Italian Medicines Agency , Pharmacovigilance Office , Rome , Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Potenza
authors.affiliation: a Department of Diagnostics and Public Health, Section of Pharmacology , University of Verona , Verona , Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Leone
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D062787:Drug Overdose / Q000453:epidemiology / Q000517:prevention & control; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008508:Medication Errors / Q000517:prevention & control / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D063487:Prescription Drug Misuse / Q000517:prevention & control / Q000706:statistics & numerical data; D012042:Registries
keywords: Adverse drug reactions; Italian monitoring registries; Italian pharmacovigilance system; abuse; misuse; off-label use; overdose