Background: Pharmacovigilance is an important element of evidence-based medicine generating data for rational use of drugs.
Aims and Objectives: The aims and objectives of the study are to describe the pattern of adverse drug reactions (ADRs) reported to an ADR monitoring centre (AMC).
Materials and Methods: This was a retrospective analysis of ADRs reported to an AMC in South Kerala for a period of 3 years from October 2017 to September 2020 after obtaining Institutional Ethics Committee clearance. The data were entered in Excel and analyzed using SPSS 16.
Results: During the period under study, 634 ADRs were reported with a mean age of 48.75 ± 19.25 years. The most common organ affected was skin and appendages followed by the hepatobiliary system. The most common ADRs reported were itching, maculopapular rash, and elevated liver enzymes. Antimicrobials accounted for the maximum ADRs of which beta-lactams were the most common. The median time for occurrence of ADRs was after 4 days (interquartile range: 1.30). The majority of ADRs were probable, preventable, had moderate severity, and non-serious. Skin and integumentary followed by hepatobiliary system were the most common ADRs and isoniazid was the most common drug associated with ADRs.
Conclusion: Antimicrobials accounted for the maximum number of ADRs which were dominated by beta-lactams and antituberculosis drugs. Prospective studies on the development of ADRs will give better understanding of the temporality as well as outcome and management of ADRs.
Key words: Adverse Drug Reactions; Pharmacovigilance; Causality; Preventability; Temporality; Severity
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