JULY, 20228 TRANSFORMING PHARMACOVIGILANCE USING TECHNOLOGY ­ HELP OR HYPE?By Sebastian Horn, Vice President, Head of Global Patient Safety & Pharmacovigilance, Teva PharmaceuticalsFor decades, companies have tried to solve the same problems in Pharmacovigilance (PV): improve compliance, reduce costs, increase employee engagement. Approaches have typically included- Simplification - Off-shoring - "Patient first" mantrasHow can technology help?With advancements in computing power and user interface design, including touchscreens and voice control, automation and robotics are becoming more common in the PV space. Projects are labeled "digital" to make them look attractive and innovative, yet many initiatives have failed to deliver on their promises. Even the most operational areas such as case processing have not been able to develop fully compliant computerized systems over decades of work on them.Here we take a closer look at IT advancements that could possibly substantially change the future of patients, PV departments, and healthcare companies.Case processingCurrent: Every company and every Health Authority has its own Pharmacovigilance database.Future: What if... there was ONE global database, "Globovigilance?"No more excessive focus on "15-day reporting timelines," but clear data entry standards, ensuring a consistent data set, with any case to be entered in, let's say, 30 days. No more "ping-pong" of cases between databases, no duplicates, no more need for PV agreements, reconciliation, data migration, serious or non-serious complexities. All cases globally -- which no database offers today in the current fragmented approach, by the way -- would be directly available for scientific purposes of cumulative signal detection and evaluation.Most of the headcount (and money) in PV is still spent on case processing mainly because of the need to turn unstructured data, i.e., human language, into structured data, i.e., fields in the database. So automating case processing in PV requires to structure the data input; replacing e-mails and phone calls with touch screen user interfaces with drop-down menus, for example. This would remove the need for large data entry teams and make the process quicker IN MY OPINIONSebastian Horn
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