Evaluation of risk factors associated with the use of potentially inappropriate psychotropic drugs in the older people, based on reports of adverse reactions to the Agência Nacional de Vigilância Sanitária, EudraVigilance and VigiBase

• Grant number: 24/21112-6
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate (Direct)
• Start date: March 29, 2025
• End date: September 23, 2025
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Patricia de Carvalho Mastroianni
• Grantee: Geovana Schiavo
• Supervisor: Maria Teresa Ferreira Herdeiro
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
• Institution abroad: Universidade de Aveiro (UA), Portugal
• Associated to the scholarship: 22/14307-0 - Performance and applicability of triggers tools for detection of adverse drug events in hospitalized older people: a retrospective and prospective analysis, BP.DD

Abstract

Introduction: The use of potentially inappropriate psychotropic drugs in older adults is associated with adverse drug reactions (ADRs) and, consequently, an increase in hospital admissions. Although pharmacovigilance systems help generate signals of ADRs, there is still limited evidence regarding the reporting of potentially inappropriate psychotropic drugs in older populations within international and national databases. Objective: The aim of this study is to identify the risk factors associated with adverse reactions to potentially inappropriate psychotropic drugs in older adults, as reported to three health agencies. Methods: A cross-sectional study will be conducted, with retrospective data collection and analysis from the pharmacovigilance databases of the National Health Surveillance Agency (ANVISA), EudraVigilance, and VigiBase. Reports of suspected ADRs related to potentially inappropriate psychotropic drugs in individuals aged 65 years and older (¿65) from December 2018 to December 2024 will be included. Data on sex, age or birth date, suspected ADR (including the drug and clinical manifestations), location, seriousness, and outcome of the ADR will be extracted using a computer algorithm. Logistic regression models will be used to identify risk factors associated with ADRs. Disproportionality analyses will be performed to assess potential associations between the use of psychotropic drugs and the occurrence of ADRs. Expected Results: The analysis of ADR data from international and national pharmacovigilance databases is expected to provide valuable insights to health professionals. These insights will support the development of clinical protocols to detect, avoid, and manage adverse reactions to psychotropic drugs in older adults, thereby contributing to improved drug safety for geriatric patients.