Prevalence and Spectrum of Adverse Drug Reactions in a community hospital of North India
METHODS: The study was conducted on more than 1500 patients attending a community hospital during 6 months. The information on each patient was collected prospectively in a structured format. Patients attending OPDs and wards were included following a cluster sampling procedure. WHO-UMC causality assessment system was followed for classification of severity and causality. Prevalence and 90% CI was estimated and presented.
RESULTS: Out of 1501 patients included in the study 139 cases of ADRs were reported. Overall prevalence of ADR was 9.3% (CI 8.3%-10.4%). ADR rate was higher in females (10.59%) than in males (8.36%). All the age-groups had almost equal distribution of ADRs. ADRs were classified in various specialities depending upon the place of treatment of the patient. In General Medicine prevalence was 6.4%, followed by skin 15.2%, psychiatry 16.7% and oncology 31.5%. The most common organ system involved was skin (40.3%) followed by metabolic and endocrine manifestations (15.8%). Most common class of drug implicated was antibiotics (19.4%) followed by anti-cancer drugs (12.9%), steroids (10.8%), anti-epileptics (9.4%), anti-Tubercular drugs (8.6%) and anti-hypertensives including diuretics (7.9%). The causality assessment of ADRs revealed that 42.4% ADRs were ‘probably/likely’ and 39.6% ‘possible’, rest were of ‘certain’ causality.
CONCLUSION: The estimated prevalence of ADR in this study is lower than the global estimate based on meta-analysis of Lazarou et al, which showed 15.1%. There is no gender or age-specific ADRs, however differentials based on specialty and drug class were observed in ADRs.