Abstract
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.