The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine
Charles Khouri, Alex Hlavaty, Michele Fusaroli, Nitin Joshi, Francesco Salvo, Andrew Bate, Antoine Pariente, Emanuel Raschi
Abstract
In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user-friendly dashboards. This has led to a large increase in low-quality, poorly reported research using adverse event reporting databases (e.g., FDA's Adverse Event Reporting System [FAERS]). Such publications producing thousands of statistical associations erroneously presented as "safety signals" can create unscientifically grounded alarm with considerable impact on healthcare provider practices and patient behaviors.
Topics & Concepts
PharmacovigilanceAdverse Event Reporting SystemEvent (particle physics)Adverse effectMedicineMedical emergencyAdverse drug eventUnder-reportingHealth careMEDLINEMandatory reportingALARMEvent dataFamily medicinePatient safetyHealth professionalsBusinessPublic healthRisk assessmentAlternative medicineEmergency medicinePharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcareMeta-analysis and systematic reviews