Triggers of drug-related bleeding events: a systematic review

Mariana Balhego Rocha; Kathleen Asturian; Lidia Ensfeld; Ana Helena Dias Pereira dos Santos Ulbrich; Diogo Pilger

doi:10.1590/s2175-97902026e24622

Authors

Mariana Balhego Rocha Programa de Pós-Graduação em Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil , Federal University of Rio Grande do Sul
Kathleen Asturian Programa de Pós-Graduação em Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil , Federal University of Rio Grande do Sul
Lidia Ensfeld Programa de Pós-Graduação em Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil , Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brasil , Federal University of Rio Grande do Sul
Ana Helena Dias Pereira dos Santos Ulbrich Instituto de Inteligência Artificial na Saúde, Porto Alegre, Rio Grande do Sul, Brasil
Diogo Pilger Programa de Pós-Graduação em Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil , Federal University of Rio Grande do Sul

DOI:

https://doi.org/10.1590/s2175-97902026e24622

Keywords:

Drug-related side effects and adverse reactions, Quality indicators, Health care, Hemorrhage, International normalized ratio, Pharmacovigilance

Abstract

Adverse drug events (ADEs), such as drug-related bleeding (DRB), represent a serious public health issue and highlight the role of triggers in pharmacovigilance. This study aimed to identify the triggers used to detect inpatient DRB. A systematic review was conducted and registered in PROSPERO (CRD42023440337). The search included the databases PubMed, LILACS, Cochrane Library, Embase, and Web of Science, covering published studies on ADEs in hospitalized adults focused on DRB triggers, with no language restrictions, up to September 2024. Methodological quality was assessed using the Joanna Briggs Institute tool, and trigger performance was evaluated by Positive Predictive Value (PPV). Twenty-three studies were included, identifying 28 triggers for DRB with PPV ranging from 0% to 100%. Prolonged INR and PTT were the most high-performing laboratory triggers, while textual triggers have demonstrated their potential, despite requiring adjustments to avoid false positives. A multimodal approach of laboratory and textual triggers combined emerges as beneficial to ADEs surveillance. Standardized and rigorous methodologies are recommended to strengthen evidence and guide clinical interventions.

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References

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Triggers of drug-related bleeding events: a systematic review

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