title: Campania Region (Italy) spontaneous reporting system and preventability assessment through a case-by-case approach: a pilot study on psychotropic drugs.
abstract: OBJECTIVE
  We conducted the first pilot Italian study to assess the preventability of adverse drug reactions involving psychotropic drugs reported through spontaneous reporting system from 01/07/2012 to 31/12/2014 in Campania Region.
  
  
  METHODS
  Preventability was assessed, case-by-case, using an adapted version of the P-method. The evaluation was performed only for those reports that had, as suspected drug, antipsychotics, mood stabilizers, antidepressants, anxiolytic and/or sedative-hypnotic.
  
  
  RESULTS
  Eighty-one cases (19.2%) out of 421 reported during the study period were preventable. In seventy-seven (95.1%) out of 81 preventable cases, the underlying mechanism of the adverse drug reactions was dose-related, in four (4.9%) preventable cases the underlying mechanism of the adverse drug reactions was respectively susceptibility- (1; 1.2%), unknown- (1; 1.2%) and time-related (2; 2.5%). In the 81 preventable cases, 97 critical criteria were detected of which 29/97 (29.9%) related to healthcare professionals' practices, 0/97 (0.0%) to drug quality and 68/97 (70.1%) to patient behaviour.
  
  
  CONCLUSIONS
  We proved that it was possible to apply and adapt the P-Method to assess the preventability of the adverse drug reactions involving psychotropic drugs, analysing individual case safety report sent through Campania Region spontaneous reporting system. Information acquired will be used to organize educational activities for both physicians and patients to promote a more appropriate drug use.
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sessa
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Mascolo
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Scavone
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Maccariello
authors.affiliation: b Department of Psychiatry , Second University of Naples , Naples , Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Iannaccone
authors.affiliation: b Department of Psychiatry , Second University of Naples , Naples , Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Fabrazzo
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Liberato
authors.initials: L
authors.lastname: Berrino
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology , Second University of Naples , Naples , Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011619:Psychotropic Drugs / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D011619:Psychotropic Drugs
keywords: Adverse events; drug safety; drug-drug interactions; pharmacovigilance; preventability; psychotropic drugs