Background: Pharmacovigilance (PV) System is an integral part of drug therapy which helps in detection,
monitoring and designing strategies to minimize the occurrence of adverse drug reaction (ADRs). Present study was
planned to study the patterns of ADRs in a tertiary care government hospital.
Methods: The present study was carried out for a period of one year. Suspected adverse drug reaction reports due to
medications submitted to the Department of Pharmacology under the Pharmacovigilance Programme of India were
included. The reports were analyzed for their type, severity, organ system involvement, and the causality assessment was
performed using Naranjo Probability Scale.
Results: A total of 520 ADRs were received. The highest percentage (66.2%) of ADRs was seen in adult patients. Female
patients experienced more (57.5%) ADRs. 95% of ADRs occurred in patients receiving 5 or more drugs. Medicine
department reported the maximum number (38.46%) of ADRs. Antimicrobial agents (AMA) (35.7%) were the
commonest group of drugs causing ADRs. Amongst the organ systems affected, skin constituted a major component
(40.4%). Causality assessment revealed that 55% of the ADRs were possible. Majority of the ADRs were non-serious and
only 7 cases were serious and required hospitalization.
Conclusion: The results suggest that healthcare professionals (HCP) at this institution are cognizant of PV. However a
closer liaison between the HCPs and the hospital PV centre, periodic reinforcement of the HCPs regarding the need for
PV can further improve spontaneous reporting. The data will also help in designing strategies for framing policies towards
safer use of drugs in future.
Keywords: Pharmacovigilance, polypharmacy, antimicrobial agents, causality assessment, adverse drug reaction, adverse drug
events, Naranjo Probability Scale, closer liaison, causality, Pharmacopeia
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