Epidemiology and economic burden of “serious” adverse drug reactions: Real-world evidence research based on pharmacovigilance data

Abstract

Serious adverse drug reactions account for 3.6% of French hospital admissions. Of these, 48.5% are, at least potentially, preventable. The first aim of post-marketing pharmacovigilance is to detect adverse drug reactions as a safety signal to improve patients' safety. Thus, this study describes the epidemiology of "serious" adverse drug reactions reported between 2015 and 2018 to a regional pharmacovigilance centre and assesses their economic burden.All "serious" adverse drug reactions reported to a regional pharmacovigilance centre during the four-year study period were collected and cost associated. Only congenital anomalies related to "serious" adverse drug reactions were excluded.All 2585 "serious" adverse drug reactions reported are related to 1242 "serious" individual case safety reports. Among 58.1% of them, patients required hospital admission or a visit to the emergency room with a median cost estimated to €3725 per "serious" individual case safety report. The most "serious" adverse drug reactions reported involved gastrointestinal disorders. Fifteen percent of the imputed drugs had a narrow therapeutic index and the most frequently drug was fluindione. Finally, high relationships with an economic burden were observed for ages over or equal to 65, and imputed drugs from "Blood and Blood-Forming Organs" and "Anti-infectives for systemic use" therapeutic groups.This study provides news data on epidemiology and cost of "serious" adverse drug reactions completing the existing literature. On a regional scale, pharmacovigilance real world data could be interesting for pharmacist clinicians in common practice to improve the good use of drugs.