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Causality assessment of adverse drug reactions detected in a Brazilian public hospital: interrater agreement using a global introspection method
  • +4
  • Renata Menezes,
  • Maria das Dores Silva,
  • Antonio Ribeiro,
  • Marcelo Filho,
  • Glaucia Martinho,
  • Luna Ferreira,
  • Maria Martins
Renata Menezes
Hospital das Clinicas da Universidade Federal de Minas Gerais
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Maria das Dores Silva
Hospital das Clinicas da Universidade Federal de Minas Gerais
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Antonio Ribeiro
Hospital das Clinicas da Universidade Federal de Minas Gerais
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Marcelo Filho
Hospital das Clinicas da Universidade Federal de Minas Gerais
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Glaucia Martinho
Hospital das Clinicas da Universidade Federal de Minas Gerais
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Luna Ferreira
Fundação Hospitalar do Estado de Minas Gerais
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Maria Martins
Universidade Federal de Minas Gerais Faculdade de Medicina
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Abstract

Adequate categorization of adverse drug reaction (ADR) causality may contribute to its early recognition in the assessment of ADR. The method proposed by World Health Organization and Uppsala Monitoring Center (WHO-UMC system) is universally used for causality assessment. We sought to evaluate ADR causality in hospitalized patients using WHO-UMC system. ADR preventability was also evaluated in this study. We reviewed cases of ADR identified in a Brazilian university hospital. Three healthcare professionals adjudicated, independently, each ADR reported using WHO-UMC method. Overall, 90 ADR involving 64 patients were evaluated and adjudicated as possible in 47 (52.2%) cases. Slight concordance was found in the agreement analyses, with kappa range of 0.10-1.18, indicating poor reproducibility of WHO-UMC system. Our results suggest the involvement of interdisciplinary teams could improve the quality of the monitoring process of ADR. A great number of preventable ADR reinforce the need for improvements in pharmacovigilance strategies in hospital settings.