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Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool

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Abstract

Background

Algorithms for causality assessment of adverse drug reactions (ADRs) in a neonatal intensive care unit (NICU) are important in the management of adverse events, however, it is inconclusive which tool best suits pharmacovigilance in neonates.

Aim

To compare the performance of the algorithms of Du and Naranjo in determining causality in cases of ADRs in neonates in a NICU.

Method

This observational and prospective study was conducted in a NICU of a Brazilian maternity school between January 2019 and December 2020. Independently, three clinical pharmacists used the algorithms of Naranjo and Du in 79 cases of ADRs in 57 neonates. The algorithms were evaluated for inter-rater and inter-tool agreement using Cohen's kappa coefficient (k).

Results

The Du algorithm showed greater ability to identify definite ADRs (≈ 60%), but had low reproducibility (overall k = 0.108; 95% CI 0.064–0.149). In contrast, the Naranjo algorithm showed a lower proportion of definite ADRs (< 4%), but had good reproducibility (overall k = 0.402; 95% CI 0.379–0.429). The tools showed no significant correlation regarding ADR causality classification (overall k = − 0.031; 95% CI − 0.049 to 0.065).

Conclusion

Although the Du algorithm has a lower reproducibility compared to the Naranjo, this tool showed good sensitivity for classifying ADRs as definite, proving to be a more suitable tool for neonatal clinical routine.

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Acknowledgements

We are grateful to all the members of the Neonatal Intensive Care Unit and the pharmacy of the Januario Cicco Maternity School for providing us with electronic medical records and other patient records that were important for the development of this work.

Funding

This study was financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brasil (CAPES)—Finance Code 001.

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Authors and Affiliations

  1. Graduate Program of Pharmaceutical Science, Health Science Center, Faculdade de Farmácia, Centro de Ciências da Saúde, Universidade Federal Do Rio Grande Do Norte UFRN, Av. General Gustavo Cordeiro de Farias, Petrópolis, Natal, RN, 59012-570, Brazil

    Ramon Weyler Duarte Leopoldino, Antonio Gouveia Oliveira & Rand Randall Martins

  2. Pharmacy Department, Health Science Center, Federal University of Rio Grande Do Norte, Natal, Brazil

    Lucas Vinicius Silva de Oliveira, Antonio Gouveia Oliveira & Rand Randall Martins

  3. School Maternity Januário Cicco (MEJC/EBSERH), Health Science Center, Federal University of Rio Grande Do Norte, Natal, Brazil

    Flávia Evelyn Medeiros Fernandes

  4. Municipal Health Department of the City of Natal, Natal, RN, Brazil

    Haline Tereza Matias de Lima Costa

  5. Children’s Hospital Varela Santiago, Natal, RN, Brazil

    Letícia Martins Pereira Vale

Authors
  1. Ramon Weyler Duarte Leopoldino
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  2. Lucas Vinicius Silva de Oliveira
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  3. Flávia Evelyn Medeiros Fernandes
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  4. Haline Tereza Matias de Lima Costa
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  5. Letícia Martins Pereira Vale
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  6. Antonio Gouveia Oliveira
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  7. Rand Randall Martins
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Correspondence to Rand Randall Martins.

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Leopoldino, R.W.D., de Oliveira, L.V.S., Fernandes, F.E.M. et al. Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool. Int J Clin Pharm 45, 1007–1013 (2023). https://doi.org/10.1007/s11096-023-01595-9

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  • DOI: https://doi.org/10.1007/s11096-023-01595-9

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