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Drug-Induced Liver Injury: Why is the Roussel Uclaf Causality Assessment Method (RUCAM) Still Used 25 Years After Its Launch?

Danan, Gaby, Teschke, Rolf·2018·Drug Safety
DOI 10.1007/s40264-018-0654-2
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Abstract

Launched in 1993 and partially based on the results of an international consensus meeting organized under the auspices of the Council of International Organizations of Medical Sciences (CIOMS), the Roussel Uclaf Causality Assessment Method (RUCAM) is the most used causality assessment tool worldwide for the diagnosis of drug-induced liver injury (DILI) and herb-induced liver injury (HILI) in a large number of epidemiological studies, case reports, and case series. The 25-year experience of RUCAM use confirmed that the success was due to its objective, standardized, and liver-injury-specific approach structured with defined key elements derived from a series of DILI cases with positive rechallenge. Using this series, the validation procedure avoided arbitrary definitions and confirmed scores to key items. The algorithm provides a quantitative causality grading of highly probable, probable, possible, unlikely, or excluded relationship between the liver injury and the suspected product(s). Despite challenges, prospective use of RUCAM fosters case data completeness and transparent causality adjudication in real time, as opposed to subjective opinion resulting from several rounds by experts lacking defined key elements and scores. In 2016, RUCAM was updated with specification of alcohol use and Hepatitis E Virus (HEV) biomarkers and simplified item handling to further reduce inter-observer variability. RUCAM-based probable and highly probable DILI and HILI cases are essential for…

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Metadata

Authors
Danan, G., & Teschke, R.
ORCID
Danan, Gaby
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2018-03-03
Volume
41
Issue
8
Pages
735-743
ISSN
  • 0114-5916
  • 1179-1942
DOI
10.1007/s40264-018-0654-2
Cited by
75
References
1
Language
en
Licence
www.springer.com/tdm (tdm)

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