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Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future.
Front Pharmacol. 2019; 10:853.FP

Abstract

Among the causality assessment methods used for the diagnosis of drug-induced liver injury (DILI), Roussel Uclaf Causality Assessment Method (RUCAM) remains the most widely used not only for individual cases but also for prospective and retrospective studies worldwide. This first place is justified by the characteristics of the method such as precise definition and classification of the liver injury, which determines the right scale in the scoring system, precise definition of the seven criteria, and the validation approach based on cases with positive rechallenge. RUCAM is used not only for any types of drugs but also for herbal medicines causing herb-induced liver injury, (HILI) and dietary supplements. In 2016, the updated RUCAM provided further specifications of criteria and instructions to improve interobserver variability. Although this method was criticized for criteria such as the age and alcohol consumption, recent consensus meeting of experts has recognized their value and recommended their incorporation into any method. While early studies searching for DILI in large databases especially in electronic medical records were based on codes of diseases or natural language without causality assessment, the recommendation is now to include RUCAM in the search for DILI/HILI. There are still studies on DILI detection or the identification of biomarkers that take into consideration the cases assessed as "possible," although it is well known that these cases reduce the strength of the association between the cases and the offending compound or the new biomarker to be validated. Attempts to build electronic RUCAM or automatized application of this method were successful despite some weaknesses to be corrected. In the future, more reflections are needed on an expert system to standardize the exclusion of alternative causes according to the clinical context. Education and training on RUCAM should be encouraged to improve the results of the studies and the day-to-day work in pharmacovigilance departments in companies or in regulatory agencies. It is also expected to improve RUCAM with biomarkers or other criteria provided that the validation process replaces expert opinion by robust standards such as those used for the original method.

Authors+Show Affiliations

Pharmacovigilance Consultancy, Paris, France.Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University, Frankfurt, Germany.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31417407

Citation

Danan, Gaby, and Rolf Teschke. "Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future." Frontiers in Pharmacology, vol. 10, 2019, p. 853.
Danan G, Teschke R. Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future. Front Pharmacol. 2019;10:853.
Danan, G., & Teschke, R. (2019). Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future. Frontiers in Pharmacology, 10, 853. https://doi.org/10.3389/fphar.2019.00853
Danan G, Teschke R. Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future. Front Pharmacol. 2019;10:853. PubMed PMID: 31417407.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future. AU - Danan,Gaby, AU - Teschke,Rolf, Y1 - 2019/07/29/ PY - 2019/05/14/received PY - 2019/07/04/accepted PY - 2019/8/17/entrez PY - 2019/8/17/pubmed PY - 2019/8/17/medline KW - DILI KW - RUCAM KW - Roussel Uclaf Causality Assessment Method KW - drug-induced liver injury KW - pharmacovigilance KW - prospective studies SP - 853 EP - 853 JF - Frontiers in pharmacology JO - Front Pharmacol VL - 10 N2 - Among the causality assessment methods used for the diagnosis of drug-induced liver injury (DILI), Roussel Uclaf Causality Assessment Method (RUCAM) remains the most widely used not only for individual cases but also for prospective and retrospective studies worldwide. This first place is justified by the characteristics of the method such as precise definition and classification of the liver injury, which determines the right scale in the scoring system, precise definition of the seven criteria, and the validation approach based on cases with positive rechallenge. RUCAM is used not only for any types of drugs but also for herbal medicines causing herb-induced liver injury, (HILI) and dietary supplements. In 2016, the updated RUCAM provided further specifications of criteria and instructions to improve interobserver variability. Although this method was criticized for criteria such as the age and alcohol consumption, recent consensus meeting of experts has recognized their value and recommended their incorporation into any method. While early studies searching for DILI in large databases especially in electronic medical records were based on codes of diseases or natural language without causality assessment, the recommendation is now to include RUCAM in the search for DILI/HILI. There are still studies on DILI detection or the identification of biomarkers that take into consideration the cases assessed as "possible," although it is well known that these cases reduce the strength of the association between the cases and the offending compound or the new biomarker to be validated. Attempts to build electronic RUCAM or automatized application of this method were successful despite some weaknesses to be corrected. In the future, more reflections are needed on an expert system to standardize the exclusion of alternative causes according to the clinical context. Education and training on RUCAM should be encouraged to improve the results of the studies and the day-to-day work in pharmacovigilance departments in companies or in regulatory agencies. It is also expected to improve RUCAM with biomarkers or other criteria provided that the validation process replaces expert opinion by robust standards such as those used for the original method. SN - 1663-9812 UR - https://www.unboundmedicine.com/medline/citation/31417407/Roussel_Uclaf_Causality_Assessment_Method_for_Drug_Induced_Liver_Injury:_Present_and_Future_ L2 - https://doi.org/10.3389/fphar.2019.00853 DB - PRIME DP - Unbound Medicine ER -
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