Evaluation of Pharmacovigilance Reporting Patterns and Adverse Drug Reactions in a Tertiary Care Teaching Hospital.

BACKGROUND: Pharmacovigilance is crucial in the safety of drugs and it is here that adverse drug reactions (ADRs) are observed, especially in a tertiary care environment where polypharmacy is prevalent. This paper set out to assess the patterns of pharmacovigilance reporting and examine the nature of ADRs in a tertiary care teaching hospital. METHODS AND MATERIALS: The study was prospective observational and was carried out after 12 months involving 250 patients with suspected ADRs. The sources of data included the spontaneous reporting forms, patient records, and laboratory results. The World Health Organization (WHO) causality assessment scale was used to determine ADRs. Descriptive statistics were presented in the form of mean ± standard deviation and percentages, and Chi-square and t-tests were used in the inferential statistics. RESULTS: The average age of the patients was 47.8 (18.5) years, and the patients were mostly male (58%). The largest percentage of ADRs reported was in the medicine department (42%), then surgery (22) and pediatrics (16). The most commonly involved classes of drugs were antibiotics (36%) and antiepileptics (18%). Type A reactions were found in 64 percent of the cases, whereas Type B reactions were found in 36 percent. WHO causality assessment indicated that 52% of ADRs were possible, 34% probable, and 14% certain. ADRs were serious in 28% of the patients. Underreporting was observed and only 68 percent of ADRs were reported in writing. The incidence of ADRs was significantly greater in patients who were on polypharmacy (five or more drugs) than in those on fewer drugs (P = 0.01). CONCLUSION: The article identifies some gaps in pharmacovigilance reporting and presents the necessity to involve better awareness, training, and regular reporting systems to improve drug safety in clinical practice.