Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions.

ABSTRACT: Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method. Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs we

SUBMITTER: Sessa M 

PROVIDER: S-EPMC5445158 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature