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Adverse drug reactions: An analysis of spontaneous reports

Sameer Uz Zaman, Ramesh L, Vishnu Priya B, Ravindra S Beedimani, Manikanta M.


Abstract

Background: Adverse drug reactions (ADRs) are among the top causes of morbidity and mortality in both hospitalized and ambulatory patients worldwide. The Pharmacovigilance Programme of India was initiated with the goal that the benefits of drugs should outweigh the risks.

Aim and Objective: The purpose of this study was to analyze and evaluate the incidence and the patterns of ADRs from reports collected at our ADR monitoring center (AMC).

Materials and Methods: A total of 187 suspected ADR forms which were submitted to our AMC were evaluated for demographics, reporting department, causative drug(s), and organ system involvement. Causality, severity, and preventability assessments were also carried
out.

Results: Most ADRs (43.31%) were found in the 31–60 years age group, with health centers (63) reporting the maximum number followed by the dermatology department (34). The leading causal therapeutic class of drugs was anti-infective agents (36.73%) followed by antiparasitic products (14.79%). Skin and subcutaneous tissue disorders (47.39%) and gastrointestinal disorders (26.04%) were the organ systems with most ADRs. In causality assessment, the probable cases had a higher incidence (78.57%) than the possible (21.42%) ones. Based on the severity, most of the reactions were categorized as moderate (83.95%), 14.97% were mild, and only 1.06% were severe. Most of the ADRs were not preventable (99.5%).

Conclusion: Despite most ADRs being not preventable, regular awareness programs should be conducted and a system of rewarding those who consistently report ADRs may be implemented. This will increase reporting and also improve patient safety.

Key words: Adverse Drug Reactions; Pharmacovigilance Programme of India; Causality Assessment; Severity Assessment






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