Why Are We Still Creating Individual Case Safety Reports?

Abstract

The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind other fields and industries and has been slow to adapt to new approaches. The main aspect holding it back has been a focus on the administrative and adherence side of creating individual case safety reports (ICSRs) and distributing these reports to the various stakeholders per strict regulatory requirements. Now, in 2018, we are more behind the curve than ever, and the field seems to be at a breaking point, calling for urgent and drastic changes. The question at hand is whether in this era of an abundance of electronically available data and technological advancements, which allow the application of automation, this process still makes sense. Is there still a place for creating and redistributing ICSRs from marketed use in a current, state-of-the-art safety system? Artificial intelligence, deep machine learning, and related technologies are already in place in many other industries. Swift and rigorous change is necessary for the discipline of pharmacovigilance to keep up with what is happening in the world at large.

Keywords: adverse event reporting; case processing; drug safety; drug safety profiles; individual case safety reports; information technology; pharmacovigilance.