Adverse Drug Reaction & Reporting in A Tertiary Care Teaching Hospital in Bangladesh

Abstract

Background: An adverse drug reaction (ADR) is a common clinical problem while treating a patient. Adverse drug reaction (ADR) is the undesirable effect of medicine that occurs beyond its known therapeutic effects. This study aimed to obtain information about the detection of ADR and the status of ADR reporting in a tertiary care teaching hospital. Methods: This observational study was conducted at the Department of Pharmacology, Dhaka Medical College, Bangladesh, from July 2019 to June 2020. A total of 600 patients were selected by purposive sampling technique as per inclusion and exclusion criteria. Collected data were analyzed using descriptive statistics. Continuous data were expressed as mean ± SD (standard deviation) and the nominal data were expressed as percentages. Analysis of data was carried out by using a statistical package for social science (SPSS) 22.0 for Windows. Result: Among the three departments, the highest number of patients with ADR was detected in the pediatric department (56.3%), followed by the dermatology department (31.3%), and the lowest (12.5%) in the medicine department. Among 16 ADRs (who developed ADRs) only 1 (6.30%) patient was reported to the relevant authority which was the pediatric department and 15 patients with ADRs were underreported.  Conclusion: Most of the detected ADRs were underreported. In Bangladesh, the importance of ADR is still underestimated with inadequate reporting, inappropriate data collection, storage, and analysis. Thus, adverse drug reaction reporting systems need to be robust to be able to detect new drug alerts and improve pharmacovigilance.