title: Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.
abstract: OBJECTIVE
  The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation.
  
  
  METHODS
  All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach.
  
  
  RESULTS
  From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment.
  
  
  CONCLUSIONS
  Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sessa
authors.affiliation: b Department of Internal and Experimental Medicine, 'Magrassi-Lanzara,' Institute of Radiology , Second University of Naples , Naples , Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Rossi
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Mascolo
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Cimmaruta
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Scavone
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Fiorentino
authors.affiliation: b Department of Internal and Experimental Medicine, 'Magrassi-Lanzara,' Institute of Radiology , Second University of Naples , Naples , Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Grassi
authors.affiliation: b Department of Internal and Experimental Medicine, 'Magrassi-Lanzara,' Institute of Radiology , Second University of Naples , Naples , Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Reginelli
authors.affiliation: b Department of Internal and Experimental Medicine, 'Magrassi-Lanzara,' Institute of Radiology , Second University of Naples , Naples , Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rotondo
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Second University of Naples , Naples , Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; 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; D060735:Pharmacovigilance
chemical_list: D003287:Contrast Media
keywords: Adverse events; Campania region; contrast media; preventability; spontaneous reporting system