Advances in Pharmacoepidemiology and Drug Safety

Abstract

Systematic Approach to Pharmacovigilance beyond the Limits: The Southern Network on Adverse Reactions (SONAR) Projects

Marcos Cardoso Rios, Evelyne de Andrade Mota, Layana Tyara Sandes Fraga, Saulo Makerran Loureiro, Tereza Virgínia Silva Bezerra Nascimento, Ângelo Roberto Antoniolli, Divaldo Pereira de Lyra-Junior, Alex Franca, Ramie Leibnitz, John Restaino, Whitney Maxwell, LeAnn B Norris, Zaina P Qureshi, Linda Martin, Bryan L Love, Brandon Bookstaver, Scott Sutton, Raja Fayad, Sony Jacob, Peter Georgantopoulos, Oliver SaOliver Sartorrtor, Paul RYarnold, Dinah Huff1, William Hrusheshky, Dennis W Raisch RPh, Richard Ablin and Charles L Bennett

As of 2013, the Southern Network on Adverse Reactions (SONAR) team described 50 significant adverse drug reactions (sADRs) associated with FDA approved drugs. The team also investigates policy issues surrounding pharmacovigilance. Herein we describe the systematic approach to pharmacovigilance taken by the Southern Network on Adverse Reactions and discuss major findings from the group. By 2015, the team hopes to have identified 20 additional sADRs focusing on biologics, biosimilars, and biobetters. The ultimate goal of SONAR is to decrease the timescale between ADR detection and the dissemination of information regarding the sADR