Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study

• DOI: 10.1007/s40264-023-01353-w
• Publication Date: 2023-10-07T15:01:47Z
• Authors: Oskar Gauffin; Judith S. Brand; Sara Hedfors Vidlin; Daniele Sartori; Suvi Asikainen; Martí Català; Etir Chalabi; Daniel Dedman; Ana Danilovic; Talita Duarte-Salles; Maria Teresa Garc...; Saara Hiltunen; Annika M. Jödicke; Milan Lazarevic; Miguel A. Mayer; Jelena Miladinovic; Joseph Mitchell; Andrea Pistillo; Juan Manuel Ramír...; Carlen Reyes; Annette Rudolph; Lovisa Sandberg; Ruth Savage; Martijn Schuemie; Dimitrije Spasic; Nhung T. H. Trinh; Nevena Veljkovic; Ankica Vujovic; Marcel de Wilde; Alem Zekarias; Peter Rijnbeek; Patrick Ryan; Daniel Prieto-Alh...; G. Niklas Norén
• Keywords: Prioritization

Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is first stage after detection and aims to determine if there sufficient evidence justify further assessment. Throughout management, a prioritization of signals continually made. Routinely collected health data can provide relevant contextual information but primarily used at later pharmacoepidemiological studies assess communicated signals.The aim this study was examine feasibility utility analysing routine from multinational distributed network support reflect on key user requirements for these analyses become an integral part process.Statistical performed VigiBase, WHO global database individual safety reports, targeting generic manufacturer drugs 16 prespecified adverse events. During 5-day study-a-thon, were using regulatory documents scientific literature alongside descriptive 10 partners European Health Data Evidence Network (EHDEN). Databases included UK, Spain, Norway, Netherlands Serbia, capturing records primary care and/or hospitals.Ninety-five statistical subjected validation, which eight considered data. Design, execution interpretation results took up few hours each (of 15-60 minutes execution) informed decisions five out signals. The impact insights varied possible alternative explanations, potential public clinical follow-up studies. Three selected assessment, two supported by Standardization analytical code, availability event phenotypes including bridges between different source vocabularies, governance around access use identified as important aspects future development.Analyses feasible given time limits inform decision making. cost-benefit integrating management requires research.