Related Experiment Video
Updated: Jan 11, 2026
Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Pharmacist-Led Assessment of Drug-Induced Liver Injury in Hospitalized Patients
Gabriela Xavier Ortiz1, Karin Hepp Schwambach2, Ana Helena Dias Pereira Dos Santos Ulbrich3
1, MSc, was, at the time of this study, a student in the Master's program at the Universidade Federal de Ciências da Saúde de Porto Alegre (Federal University of Health Sciences of Porto Alegre), Porto Alegre, Rio Grande do Sul, Brazil. She has since graduated and is a Pharmacist at Mãe de Deus Hospital, Porto Alegre, Rio Grande do Sul, Brazil.
Background:
Drug-induced liver injury (DILI) is an important but underdiagnosed adverse drug reaction in hospitalized patients. The complexity of diagnosis, under-reporting, and a lack of standardized assessment tools contribute to underestimation of its prevalence.
Objectives:
To estimate the prevalence of DILI in a tertiary care hospital and to discuss the role of clinical pharmacists in using the Roussel Uclaf Causality Assessment Method (RUCAM) to detect, assess, and manage DILI.
Methods:
This cross-sectional study included patients who were admitted between January and June 2022 to a tertiary care hospital in Porto Alegre, Brazil. All hospitalized patients with alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal at any point during the hospital stay were screened. Suspected cases of DILI were evaluated by trained pharmacists using the RUCAM. Data were collected retrospectively from electronic medical records and analyzed using descriptive and inferential statistics.
Results:
Of 56 014 patients admitted to the hospital during the study period, 1274 had elevated ALT, of whom 38 were classified by the RUCAM as having DILI. Among these, 33 (87%) experienced development of DILI during the hospital stay. Most of the patients (n = 29, 76%) were in general hospital wards, and this factor showed a significant association with occurrence of DILI. Anti-infectives were the most commonly implicated drugs (69%), specifically the combination of rifampicin, isoniazid, pyrazinamide, and ethambutol and various β-lactams. Simvastatin was also commonly implicated. None of the DILI cases were reported to the institutional pharmacovigilance system.
Conclusions:
DILI remains under-recognized and under-reported in hospital settings. This study reinforces the potential role of clinical pharmacists in active surveillance using RUCAM and highlights the need for institutional strategies prioritizing the monitoring of liver function in high-risk patients, particularly on general wards.
Related Concept Videos
01:22Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
01:26Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow
01:14Effect of Hepatic Disease on Pharmacokinetics: Active Drug, Metabolite and Fraction of Metabolized Drug
01:08Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:26Therapeutic Drug Monitoring: Drug Analysis Methods