J Appl Biomed 21:59-66, 2023 | DOI: 10.32725/jab.2023.010

Pallavi Pradhan1, 2, Maude Lavalle2, 3, Samuel Akinola4, Fernanda Raphael Escobar Gimenes5, Anick Brard6, 7, Julie Mthot2, 3, Marie-Eve Pich2, 8, Jennifer Midiani Gonella5, Lyne Cloutier9, Jacinthe Leclerc2, 3, 9, * 1University of Quebec at Trois-Rivieres, Department of Anatomy, Trois-Rivieres, Canada 2University Institute of Cardiology and Pulmonology of Quebec - Laval University, Centre of Research, Laval, Canada 3Laval University, Faculty of Pharmacy, Laval, Canada 4University of Pecs, Faculty of Health Sciences, Department of Nursing, Pecs, Hungary 5University of Sao Paolo, Nursing School of Ribeirão Preto, Sao Paolo, Brazil 6University Hospital Center, Research Center of Sainte-Justine, Montreal, Canada 7University of Montreal, Faculty of Pharmacy, Montreal, Canada 8Laval University, Faculty of Medicine, Laval, Canada 9University of Quebec at Trois-Rivieres, Department of Nursing, Trois-Rivieres, Canada

Background: The core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted.

Objective: To provide an up-to-date overview of the different causality assessment tools.

Methods: We conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool's ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context.

Results: Twenty-one eligible causality assessment tools were retrieved. Naranjo's tool and De Boer's tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding "ease-of-use" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo's tool, Jones's tool, Danan and Benichou's tool, and Hsu and Stoll's tool appeared to be the easiest to implement into various clinical contexts.

Conclusion: Among the many tools identified, 1981 Naranjo's scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.

Keywords: Adverse drug reactions; Adverse events; Causality assessment; Healthcare quality; Pharmacovigilance Grants and funding:

This research was funded by the Department of Nursing of Universit du Qubec à Trois-Rivières, and the Fondation de l’Institut universitaire de cardiologie et de pneumologie de Qubec-Universit Laval.

Conflicts of interest:

The authors have no conflict of interests to declare.

Pradhan P, Lavalle M, Akinola S, Escobar Gimenes FR, Brard A, Mthot J, et al.. Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings. J Appl Biomed. 2023;21(2):59-66. doi:10.32725/jab.2023.010.