Reporting ADR as a Citizen: Analysis of Data from Sardinian Region: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: European legislation on pharmacovigilance was amended with the adoption of EU Regulation 2010/1235 [1], which introduced significant changes in the active participation of patients and healthcare professionals to the Adverse Drug Reaction (ADR) reporting process. In recent years a new trend has established worldwide, allowing patients to directly report ADRs to national pharmacovigilance authorities [2]. A consumer, defined as a nonhealthcare professional, is now also considered as a source of information on the safety of a medicinal product [3]. Objective: To identify numerosity and level of the involvement of citizens in ADR reporting in Sardinia. Methods: We extracted data using Vigisegn platform from the Sardinian Region, from 2013 to 2021, for ADRs, stratified by year and qualification of the signaler. ADRs were also analyzed by severity, outcome, SOC (System Organ Classification) and ATC2 (Anatomical Therapeutic Chemical Classification System, level 2). Results: In Sardinia, from 2013 to 2021, 6.591 ADR reports were recorded, 1093 (17%) of which were by citizens. Among those reports, 75% were classified as "not serious" and 37% had resolved completely. From 2013 to 2021, citizen participation in ADR reporting changed significantly, from 1 to 26% (Table). In this period, most SOCs reported by citizens were "General pathologies and conditions related to site of administration" (596), "Pathologies of nervous system" (421), "Pathologies of musculoskeletal system and connective tissue" (328). As for SOC "Pathologies of reproductive system and breast", a significant increase in reporting was recorded from 0% in 2013 to 73% in 2021. In this period, citizen reporting of pathologies of reproductive system and breast constituted 49% of the total reports. In absolute terms, the ATC J07 Vaccine was the most reported by citizens with 799 reports (2737 in 2021). Reports by citizens for homeostatic calcium drugs (H05) account for 81% (48 ADRs) of the total reports for this ATC. Conclusion: Increase in citizen reporting in 2017 and 2021 can be traced back to the information activities of the Regional Center following the introduction of mandatory vaccination and the awareness campaign for Covid-19 vaccines. Such increase reflects the growing importance of pharmacovigilance among citizens, meaning that an increasing number of citizens have now acquired the necessary tools to ADR reporting, thus becoming a significant source of information on the safety of drugs and vaccines.