Use of triggers on characterization of adverse drug events in Pediatric Intensive Care Unit

• Grant number: 14/08174-0
• Support type: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): September 01, 2014
• Effective date (End): July 31, 2015
• Field of knowledge: Health Sciences - Collective Health - Public Health
• Principal researcher: Nicolina Silvana Romano Lieber
• Grantee: Carolina Dagli Hernandez
• Home Institution: Faculdade de Saúde Pública (FSP). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Chart review using triggers has been considered one of the most efficient methods for adverse drug events (ADE) detection. Recently, a list of pediatric-specific triggers has been developed. However, there still are few studies using this tool, especially with children hospitalized in Pediatric Intensive Care Unit (PICU), which are more likely to have ADE. Therefore, it is necessary to study the incidence of ADE in this population with reproducible, efficient and easy-to-use methods. Objectives: 1) To test the applicability of chart review based on triggers in PICU on Hospital Universitario of University of Sao Paulo (HU-USP); 2) To quantify and characterize adverse events on PICU. Materials and Methods: This prospective study will be carried out with children hospitalized in PICU of HU-USP. Suspected ADEs will be detected by voluntary reporting and chart review using triggers, which will be conducted by a primary reviewer. A secondary reviewer will be responsible for validating and confirming the suspected ADE found. In order to verify the applicability of this method, a critical analysis based on hospital context and practicality and speed of execution of the method will be performed. For characterization of ADE, patient's age and sex, ADE description and severity, suspected drug, dose, route of administration and clinical outcome will be collected. Medication errors will be classified by type of error and suspected adverse drug reactions (ADR) causality will be defined by Naranjo algorithm. Expected results and contribution: We aim to analyze the ADR detection method through triggers as a tool to be used routinely on PICU of HU-USP, as well as obtaining information related to ADR occurring in this unit, identifying higher-risk groups and drugs involved, to establish intervention measures.