Adverse drug reactions reporting: Five years analysis from a teaching hospital

Abstract

Background: Adverse drug reactions (ADRs) are important cause of morbidity and mortality. Despite its known importance, rate and quality (completeness score) of ADR reporting is not satisfactory. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years. Material and Methods: In this retrospective study, ADRs reported between 2017 to 2021 were analyzed according to year, gender, age-group, pharmacological class and department. The completeness score of ADRs was calculated. The number of sensitization programs conducted over 5 years and its impact on the completeness score was also evaluated. Results: A total of 104 ADRs were reported among 61 (58.6%) female and 43 (41.4%) male patients. Adults (18-65 years) comprised the most affected age group, accounting for 82 (79%) patients. Out of all, 35.5% ADRs were reported in 2018, whereas 27% were reported during 2021. Except during 2017, percentage of females with ADRs was more. Department of pulmonary medicine and dermatology contributed to maximum extent in ADR reporting. Antibiotics [23 (22.11%)], antitubercular drugs (AKT) [21 (20.19%)], and vaccines [13 (12.4%)] represented the most common agents with which ADRs were reported. ADR reporting was very low in 2017 (4/104). Percentage improvement in completeness score in 2021 vs. 2018 was 11.95% (P < 0.05). Positive trend in the improvement of average completeness score with number of sensitization programs was observed. Conclusion: Incidence of ADRs was more common in females. AKT and antimicrobials are commonly implicated in ADRs. Increase in awareness of ADR reporting through sensitization programs can help to improve rate and quality of reporting.

Keywords

• healthcare professionals
• pharmacovigilance activities
• safety reporting