title: A plea for a more epidemiological and patient-oriented pharmacovigilance.
abstract: The present work has the main objective of summarizing the history of pharmacovigilance and the associated methods and legislation and of showing how it could/should be reformulated in terms of a transition from a drug-centered to a patient/population-centered approach. The recurrent emergencies associated with new drug molecules raise many questions about the efficacy and efficiency of methodological tools as well as the role of regulatory systems. Drugs cannot be considered as an independent variable: the evaluation of all their effects must take into account the real contexts in which they are used and which affect not only their efficacy but also their tolerability and safety. Specific emphasis is given to recent and promising developments focused on the participation of patients and populations as key actors in producing knowledge that could technically integrate what has been produced so far and allow the evolution of surveillance from a role of controlling severe adverse reactions attributable to individual molecules to one of promoting a comprehensive assessment of the benefit/risk profile of drugs as they are utilized in society.
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Centro Studi SIFO, Consorzio Mario Negri Sud, Via Nazionale 8/a, 66030, S. Maria Imbaro, Italy. scurti@negrisud.it
authors.forename: Veronica
authors.initials: V
authors.lastname: Scurti
authors.forename: Marilena
authors.initials: M
authors.lastname: Romero
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
mesh_terms: D035843:Biomedical Research; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use; D014943:Global Health; D006291:Health Policy; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007880:Legislation, Drug; D060735:Pharmacovigilance; D057285:Precision Medicine / Q000266:history* / Q000379:methods*; D056737:Safety-Based Drug Withdrawals / Q000266:history
chemical_list: D015507:Drugs, Investigational