Adverse drug reaction prevalence pattern among drugs and its correlation with causality assessment in ADR monitoring centre in Kerala over 6 months

Sunil Nettath


Background: Prevalence of adverse drug reactions had been studied extensively in the past to find out the drug pattern distribution of ADR. In this study, authors tried to find out the prevalence pattern and its correlation with the WHO causality assessment over the 6 months.

Methods: This study was done in Govt Medical College Palakkad Kerala as an observational study. Without revealing the identity of the patients as is done in ADR reporting in pharmacovigilance program, a retrospective data collection was done by collecting different types of ADR reported in this hospital for the previous six months. Only data of inpatients was collected and tabulated for different group of drugs. Then using the WHO scale of causality assessment, the ADR individually was classified to probable, possible, or certain and tabulated.

Results: In this study, the prevalence pattern of drugs causing ADR was evaluated over six months in a tertiary care centre. Out of the 45 cases reported, major ADR were for antibiotics (55.5%) and anticancer agents (18.2%) and the least reported ADR were for vaccines and supplements (2.2%). In causality assessment WHO scale only one case was certain (2.2%). Here the majority Causality assessment was found to be probable (44.45%) and possible (51.2%).

Conclusions: From this study it is concluded that the antibiotics has the major ADR pattern. It’s also known that the probable and possible causalities are more common when ADR are reported.


ADR-Adverse drug reactions, Causality assessment, Pharmacovigilance

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