Development and validation of an online form for active search for adverse drug reactions
Vigil Sanit Debate, Rio de Janeiro, 2025, v.13: e02359 | Published on: 10/01/2025
DOI:
https://doi.org/10.22239/2317-269X.02359Keywords:
Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions, Patient Safety, Validation StudyAbstract
Introduction: Pharmacovigilance is a science related to the early detection and prevention of events associated with the use of drugs, such as adverse drug reactions (ADR). Active surveillance methods are increasingly being used to detect ADRs. Although the use of triggers is recommended, active Search tools for suspected ADR are scarce in the literature. Objective: To develop an active search tool for suspected ADR using triggers. Method: This methodological development study was conducted and divided into two stages: i) a literature review to build a list of triggers and the first version of the instrument; ii) content validation using the Delphi technique with the participation of professionals involved in Pharmacovigilance and Patient Safety at the institution. Instrument sessions were considered valid when the Content Validity Index (CVI) ≥ 0.80. Results: An online form was developed on the Google Forms platform containing three sections: review of medical records, patient and hospitalization data, and identification of suspected ADR. The final version has 28 questions, including 16 objective and 12 subjective. The material was evaluated by seven experts in two Delphi rounds, and the total CVI was 1. Conclusions: The instrument shows evidence of validity in terms of objective, structure, relevance, appearance, and content, representing another Pharmacovigilance tool for the hospital. It can be used by healthcare professionals from different backgrounds and is easily adaptable to the reality of other institutions. Future work should be carried out to validate the tool with the target audience.
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Ana Clara Garcia Marton, Laboratório de Inovação para o Cuidado em Saúde, Departamento de Ciências Farmacêuticas, Universidade Federal do Espírito Santo (UFES), Vitória, ES, Brasil
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Dyego Carlos Souza Anacleto de Araújo, Laboratório de Inovação para o Cuidado em Saúde, Departamento de Ciências Farmacêuticas, Universidade Federal do Espírito Santo (UFES), Vitória, ES, Brasil
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Rita de Cássia Ribeiro Gonçalves, Departamento de Ciências Farmacêuticas, Universidade Federal do Espírito Santo (UFES), Vitória, ES, Brasil
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Cândida Caniçali Primo, Programa de Pós-Graduação em Saúde Coletiva (PPGSC), Universidade Federal do Espírito Santo (UFES), Vitória, ES, Brasil
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