Towards safer medication practices: a retrospective analysis of adverse drug reactions

Under-reporting of adverse drug reactions (ADRs) to regulatory authorities remains a major challenge for pharmacovigilance, despite the substantial patient safety and financial implications of ADRs encountered in clinical practice. Reporting by healthcare professionals is persistently low; in 2017, only 19% of reports submitted to the Therapeutic Goods Administration (TGA) originated from healthcare professionals, largely due to time constraints and limited reporting knowledge. This study evaluated ADR reporting patterns and impact following implementation of an automated ADR reporting tool embedded within the electronic medical record (eMR). A retrospective study was conducted at Blacktown and Mt Druitt Hospitals after integration of an automated ADR reporting tool into the eMR in 2022. The tool captured all data required for regulated TGA reporting. Monthly ADR reports were compiled by the hospital’s medication safety committee and submitted to the TGA. ADRs were categorised using the Medical Dictionary for Regulatory Activities (MedDRA), and causality was assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria. Prior to implementation, no ADR reports were submitted to the TGA from Blacktown and Mt Druitt Hospitals in 2018–2019, with only 3 reports in 2020 and 19 in 2021. Following implementation of the automated reporting tool, 1,632 ADR reports were submitted between March 2022 and March 2025. Most ADRs were reported retrospectively (57.6%), and 15% of patients experienced two or more ADRs. Antibacterials for systemic use were most frequently implicated (43.8%), followed by analgesics (16.5%) and anti-inflammatory and antirheumatic products (6.9%). Most ADRs were classified as unassessable/unclassifiable (57.3%), with fewer deemed possible (19.4%), probable (13.3%), or certain (8.2%). Only 4.6% of ADRs were considered preventable. ADR‑related costs totalled A$800,391 over the study period, predominantly attributable to hospital admissions and excess bed‑days. Preventable ADRs accounted for A$36,783 in potentially avoidable costs. Embedding automated ADR reporting within clinical workflows markedly increased reporting rates, with automated pre-population of clinical fields designed to reduced clinician burden. Incorporating similar functionality into the forthcoming statewide digital health system in New South Wales may strengthen pharmacovigilance, enhance data completeness, and improve early detection of unsafe medicines.