Evaluation of Adverse Drug Reactions at Hospital Besut: A 5-year Retrospective Study

Objectives: An adverse drug reaction (ADR) is an unintended and harmful response to a medicinal product and is a significant cause of morbidity and mortality. Despite its importance, no prior systematic ADR evaluation has been conducted at Hospital Besut. This study aimed to analyze ADR patterns reported within 5 years (2019 to 2023) in Hospital Besut, focusing on affected organ systems and types of drugs involved, causality, severity, outcomes, and identifying associations between demographics, severity, and reaction onset. Methods: A retrospective observational study was conducted using all ADR reports recorded in the Pharmacy Information System (PhIS) and submitted to the National Pharmaceutical Regulatory Agency. Data from January 2019 to December 2023 were collected and analyzed from June to November 2024. The descriptive and statistical analyses, including the Chi-square test, were used to present the findings, with significance set at P < 0.05 using SPSS software version 27. Findings: A total of 289 ADR forms with 413 reactions were analyzed. The occurrence of ADRs was common among females ( n = 151, 52.2%), followed by males ( n = 138, 47.8%). The average mean age of patients was 36 ± 21.9 years. Most ADRs involved the skin ( n = 280, 67.8%) and respiratory system ( n = 44, 11.6%). The drug–reaction relationships were mostly classified as probable and possible, which were 114 (39.4%), respectively. In addition, most of the onset of ADR occurred within minutes ( n = 117, 40.5%), and the reactions were mild ( n = 171, 59.2%), with 181 (62.6%) of patients recovering from the ADR. Antibiotics ( n = 94, 32.5%) and analgesics ( n = 55, 19.03%) were responsible for most ADRs. Only age was significantly associated with the reaction severity ( P = 0.037). Conclusion: This study emphasizes the importance of pharmacovigilance in identifying common ADR patterns and promoting safer medication practices in Hospital Besut.