PATTERN, CAUSALITY ASSESSMENT AND SEVERITY OF SUSPECTED ADVERSE DRUG REACTIONS REPORTED AT TERTIARY CARE TEACHING HOSPITAL

Background: Present study was conducted to evaluate pattern, causal association and severity of suspected Adverse Drug Reactions (ADRs) at a tertiary care teaching hospital in western India. Materials & Method: Spontaneous collection of suspected ADRs was done over a period of one year. Demographic data, suspected drug group/s, causal association, severity & preventability scale from the reported ADRs were analysed. Results: 150 suspected ADR reports were collected. Adult patients (14-50 years) experienced 109 (72.66 %) ADRs followed by elderly patients (>50 years) experienced 29 (19.33%) ADRs and paediatric patients (<14 years) experienced 12(8%) ADRs. On the causality scale 62.67% were probable ADRs and on severity scale 63% were moderately severe ADRs. According to MeDRA classification of ADR, Skin and subcutaneous tissue disorders were most common (47.67%), followed by Gastrointestinal disorders (23 %) and Nervous system disorders (13.95%). ADRs were most commonly seen due to antimicrobial drugs (44.3%) followed by Non steroidal anti-inflammatory drugs (NSAIDs) (17.8%). Conclusion: Our study findings showed underreporting in spontaneous ADR reporting system. Continuous efforts through training, sensitization & awareness programmes of all the stakeholders of health care system should be done to improve ADR reporting.