Causality assessment and pattern of adverse drug reactions in a tertiary care hospital

Dinesh K. Badyal, Bimal Kanish, Gaurav Gulrez


Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.

Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.

Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).

Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.


ADR monitoring, Causality assessment, India, Tertiary hospital

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