OBJECTIVE: To detect the adverse drug reactions (ADRs) through spontaneous reporting system in IGGMC&H, Nagpur and analyze them using World Health Organization (WHO) assessment scales. METHOD: An observational, prospective study was conducted based on ADRs reported between 1st June '05 to 31st May '09 to the ADR reporting unit of the hospital. The ADRs reported by spontaneous reporting system were from patients attending outpatient department (OPD), in-patient department (IPD) and casualty of IGGMC&H Nagpur. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality and severity. RESULT: Total 2639 ADRs were reported with in the period from 1st June '05 to 31st May '09. Antimicrobial agents (AMA) were the drug class most commonly involved and Non Steroidal Anti-inflammatory Drugs (NSAIDs) were next to AMA. Cotrimoxazole a well established agent was the individual drug most frequently reported in this study. Upon causality assessment, majority of the reports were rated as probable (55.89%). CONCLUSION: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. AMAs were causing maximum ADRs. This study provides a database of ADRs due to common drugs used in our hospital, which will help clinicians for optimum and safe use of these drugs. Hence strict vigilance is required for the use of these likely drugs and their safety assessment.
OBJECTIVE: To detect the adverse drug reactions (ADRs) through spontaneous reporting system in IGGMC&H, Nagpur and analyze them using World Health Organization (WHO) assessment scales. METHOD: An observational, prospective study was conducted based on ADRs reported between 1st June '05 to 31st May '09 to the ADR reporting unit of the hospital. The ADRs reported by spontaneous reporting system were from patients attending outpatient department (OPD), in-patient department (IPD) and casualty of IGGMC&H Nagpur. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality and severity. RESULT: Total 2639 ADRs were reported with in the period from 1st June '05 to 31st May '09. Antimicrobial agents (AMA) were the drug class most commonly involved and Non Steroidal Anti-inflammatory Drugs (NSAIDs) were next to AMA. Cotrimoxazole a well established agent was the individual drug most frequently reported in this study. Upon causality assessment, majority of the reports were rated as probable (55.89%). CONCLUSION: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. AMAs were causing maximum ADRs. This study provides a database of ADRs due to common drugs used in our hospital, which will help clinicians for optimum and safe use of these drugs. Hence strict vigilance is required for the use of these likely drugs and their safety assessment.