On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.
Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.
Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics in Adverse Drug Reaction (ADR) reports and self-reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.
Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.
View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.