Characterization of suspected patient safety incidents related to the use of clonazepam and zolpidem notified to the National Health Surveillance Agency (Anvisa) between 2018 and 2024

• Grant number: 24/03007-0
• Support Opportunities: Scholarships in Brazil - Master
• Start date: April 01, 2025
• End date: January 31, 2026
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Fabiana Rossi Varallo
• Grantee: Lara Riboli Bortolato
• Host Institution: Faculdade de Ciências Farmacêuticas de Ribeirão Preto (FCFRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Introduction: Advances in computer science have contributed to increasing the ability to extract information on the safety of drug use and generate pharmacovigilance signals that can impact on public health policies, regulation of the pharmaceutical market and clinical decision-making. Currently, benzodiazepines and Z-drugs are indicated for the treatment of insomnia, and chronic use is not recommended due to the risk of adverse drug events. Objectives: Therefore, this study aims to characterize the suspected safety incidents related to the use of clonazepam and zolpidem that were reported to VigiMed from December 10, 2018 to December 31, 2024. Method: This will be an observational, analytical, retrospective and descriptive study. The research will be conducted in two stages. In the first stage, a computer algorithm will be developed to screen the database for notifications that meet the inclusion criteria (suspected incident related to the use of clonazepam and zolpidem, from well-documented reports, according to the vigiGrade criteria). In the second stage, the variables of interest will be extracted: a) demographics; b) suspected drug; c) notification; d) notifier and; e) suspected notified incident. The prevalence of suspected safety incidents notified to Anvisa will be compared in two periods: before (t0) and after (t1) the publication of the regulatory for medicines subject to special control (RDC No. 357 of March 24, 2020). Expected results: It is hoped that this study will identify the potential risks associated with the use of clonazepam and zolpidem and to contribute to the issuing of safety alerts and to promote the safe and appropriate use of these health technologies. In addition, the evaluation of reports of suspected incidents will favor the feedback for Anvisa itself, since it will make it possible to detect weaknesses, especially with regard to the quality of the reports, providing an opportunity to development of strategies to mitigate risks and crises associated with the use of these medicines.