A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India

Mahesh N. Belhekar, Sweta B. Tondare, Prasad R. Pandit, Kiran A. Bhave, Tejal C. Patel


Background: The present study was undertaken to evaluate the incidence and pattern of adverse drug reaction (ADRs), causality, severity and preventability of ADRs.

Methods: Data was collected and analyzed with the information such as patients’ demographic details, associated co-morbid conditions and detailed drug related information gathered from ADR reporting forms. World Health Organization (WHO) scale was used for assessing causality, modified Hartwig scale was used for assessing severity and modified Schumock and Thorntons scale were used for assessing preventability of ADRs. Data was analyzed using descriptive statistics.

Results: Total 154 ADRs were reported in a period of one year (August 2016- July 2017). Out of 154 ADRs analyzed, 120 (77.9%) were in adults, 33 (21.4%) pediatric and 01 (0.7%) in geriatric patients. The most common ADR recorded was cutaneous reactions (43.5%) and the most common causative class of drugs for the same was found to be antimicrobials (46.7%) followed by non-steroidal anti-inflammatory drugs (15.6%). Causality assessment scale indicated 68.8% ADRs possible and 24% ADRs as probable. Severity assessment revealed that 45.5 % were mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 84.4% of the cases were probably non-preventable.

Conclusions: In this study it was found that, most of the ADRs were of possible category with mild to moderate severity and majority being non-preventable. Antimicrobial drugs being the most common offending drug class causing ADRs. Strategies targeting appropriate and cautious use of this class of drugs may benefit in reducing the number of ADRs and therefore the cost involved in the treatment.


Causality, Preventability, Pharmacovigilance, Severity

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