A concept for causality assessment and causal inference of adverse events cases-Reference-Cited by-同舟云学术

A concept for causality assessment and causal inference of adverse events cases

Published:2022-11-02 Issue: Volume: Page:
ISSN:2284-0230
Container-title:Journal of Biological Research - Bollettino della Società Italiana di Biologia Sperimentale
language:
Short-container-title:J Biol Res

Author:

Al-Imam Ahmed^ORCID,Sami Ahmed,Lane Samantha,Younus Manal

Abstract

Dear Editor, Causality assessment of adverse drug events is essential in pharmacovigilance to assess the relationship between the medicine and the event.1,2 Regulatory authorities recommend using standardized methods for causality assessment.3,4 The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system offers generalized criteria for establishing causal relationships.3 In contrast, the Roussel Uclaf Causality Assessment Method (RUCAM) provides a specialized system to assess Drug-Induced Liver Injury (DILI) cases. We systematically reviewed the literature and verified that these systems are among the best tools currently available for signal detection and causality assessment. [...]

Publisher

PAGEPress Publications

Subject

Biochemistry (medical),Plant Science,General Biochemistry, Genetics and Molecular Biology

Reference13 articles.

1. Adverse drug reactions: definitions, diagnosis, and management

2. Spatiotemporal Mapping of Online Interest in Cannabis and Popular Psychedelics before and during the COVID-19 Pandemic in Poland

3. The World Health Organization. The use of the WHO-UMC system for standardised case causality assessment [Internet]. Who.int. 2013.Accessed 1 July 2022. Available from: https://www.who.int/publications/m/item/WHO-causality-assessment

4. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012. Roussel Uclaf Causality Assessment Method (RUCAM) in Drug Induced Liver Injury. Updated 2019 May 4. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548272/

5. Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting. A consensus by a CIOMS Working Group. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2020.

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