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Causality, severity, preventability assesment of adverse drug reactions in a tertiary are NABH accredited hospital

Dhanraj - Chaudhary, Balakeshwa Ramaiah, Raju Koneri




The aim of the study was to assess for adverse events and to analyze, monitor and report the pattern and distribution of adverse events associated with drugs, at an Indian NABH accredited hospital. The secondary objectives were to assess the preventability, incidence, and severity of the reported adverse drug reactions.


The information such as patient details, patient medication therapy details including non-prescription drugs, alternative treatments and recently ceased medication, comprehensive adverse reaction details including description of the reaction, time of onset and duration of the reaction and treatment given with relevant investigation reports were collected. The overall process was done to ensure safety of drugs and minimize ADRs. The PVPI-CDSCO form was used for data collection.


During the period of six months study, we found total number of ADRs was 135 out of them 112 were preventable, 23 were non preventable, incidence and crude rate among all ADRs was 1.6983 and 0.774. Considering outcome of ADRs, among all the fatal was 4.44%, fully recovered was 62.22%, recovering was 23.70% and unknown was 9.62%. Similarly, causality assessment by Naranjo scale showed definite 50.37%, probale 29.62%, possible 15.55% and unlikely 4.44%. The severity of ADRs was upto Level 7.


The present study used as intensive monitoring method to detect and estimated an incidence of adverse reactions in the monitored group. The causality, severity, predictability, preventability and treatment of ADRs were studied and assessed.





Pharmacovigilance, Causality, Severity, Preventability


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WHO Causality Assessment Scale the recommendation by the WHO Uppsala Monitoring Center System.

Modified Hartwig’s and Siegel Adverse Drug Reactions Assessment Scale; Mild, Moderate, Severe With their Level up to 7.

Criteria for determining preventability scale of an ADRs; Section A, Section B, Section C assessed by using Modified Shumock and Thomton criteria.

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