The implementation of KPI (key performance indicators) to manage the Pharmacovigilance System of a public vaccine producer in Brazil

Background Pharmacovigilance (PV) is a critical science aimed at enhancing patient safety. For a pharmacovigilance system (PVS) to be effective, it must be robust, efficient, and regularly evaluated to ensure ongoing improvement. Key Performance Indicators (KPIs) are essential quantifiable measures that evaluate the performance of companies, processes, and systems, including pharmacovigilance. Aim This study aimed to implement and evaluate KPIs for the PVS of a public vaccine producer in Brazil, identifying improvement areas and supporting continuous enhancement. Methods KPI selection for Instituto Butantan's PVS was guided by a systematic review and benchmarking with pharmaceutical representatives, followed by validation through expert consensus. A dashboard was created for KPI implementation, with goals, measurements, and evaluation frequency detailed in the institution's Standard Operating Procedure (SOP). Results The review identified one KPI for a Marketing Authorization Holder (MAH) PV process. Interviews with pharmaceutical company representatives led to 25 additional KPIs, with one overlapping. After expert review, all KPIs were approved after adjustments, and 10 were piloted, including metrics like the number of individual case safety reports (ICSR), ICSR per product, and serious adverse events (SAE) per product. A dashboard tracked these KPIs monthly in 2022 and 2023. Conclusion Over two years, KPI evaluations proved valuable, prompting improvements in PV processes and tools. Results indicated that expanding to the remaining KPIs would further enhance Instituto Butantan's PVS.