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An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center, Nalgonda

Shivaraj B Patil, Ramani Gade, Raghuveer B, Venkatarao Y, Yamini V.


Background: Adverse drug reaction (ADR) monitoring is important for risk benefit analysis and for patient’s safety. ADR monitoring helps in maintaining the database which is specific to Indian population.

Aims and Objectives: This study aims to analyze the pattern of ADRs, drug implicated, organ system affected, severity of ADRs, and their causality assessment.

Materials and Methods: It was a retrospective analysis of all the ADRs reported to ADR monitoring center, Nalgonda, from January 2019 to December 2019. Prior ethics committee approval was obtained. ADRs were collected using suspected ADR forms provided by National Coordination Center-Pharmacovigilance Programme of India (NCC PVPI). All the ADRs were reported to NCC PVPI through VigiFlow software.

Results: A total of 273 ADRs were reported of which 59% were female and 41% were male. According to the age group, 30–39 years were the most common age group affected about 26%. The most common drug class implicated for ADRs was antimicrobials. Skin was the most common system affected. Most of the ADRs belonged to probable category according to the WHO causality assessment scale. Only 9 (3%) ADRs were of serious nature.

Conclusion: Pharmacovigilance is important for identification of ADRs due to drugs. Still, lot of awareness about pharmacovigilance needs to be created among health-care professionals to improve the reporting of ADRs. This, in turn, will improve the drug safety among patients.

Key words: Adverse Drug Reactions; Pharmacovigilance; Adverse Drug Reaction Monitoring Center

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