Profile of Adverse Drug Reactions in Patients Admitted to General Surgical Wards of a Rural Tertiary-Care Hospital in India

Abstract

Aim To find the incidence rate of adverse drug reactions (ADRs) and investigate its various aspects in patients admitted to surgery wards of a rural tertiary-care hospital in India. Methodology A prospective observational study, involving 800 patients over a period of 1.5 years, was carried out to find the incidence rate of ADRs, and various aspects of such events (e.g. causality, severity, preventability, causative drugs, organs/systems involved, and management strategy with outcome). A structured and pre-tested form was used to compile the data. Results An ADR was reported in 3.9 % of patients. Neither the age nor gender of the patients influenced incidence rate. Type A (augmented) reactions accounted for 83.9 % of ADRs. Causality assessment, using the WHO-UMC method, revealed that 58.1 and 41.9 % of ADRs fell into the ‘probable’ and ‘possible’ categories, respectively, whereas the corresponding proportions were 71.0 and 29.0 % using the Naranjo ADR probability scale. As the number of drugs per patient increased, the incidence of ADRs also increased. The majority (77.4 %) of ADRs were associated with antimicrobial drugs, followed by analgesics, with 71 % of ADRs involving the gastrointestinal system. No ADRs were fatal. Suspected drugs were discontinued in 64.5 % of patients and 96.8 % patients had fully recovered at the time of discharge.