A Prospective Analysis of Adverse Drug Reactions in a South Indian Hospital

Adverse drug reactions are a great cause of concern to the medical profession, the patients and the pharmaceutical industry. However ADR reporting and monitoring is yet to catch up in India. Hence we undertook a study to record and analyze adverse reactions among all patients admitted to the medical wards of a tertiary care. Centre patients admitted to all medical wards over one year were assessed for ADRs throughout their admission. Suspected ADRs were recorded and analyzed for i) the type of reaction ii) severity iii) Consequence on treatment that is if the drug was continued, or stopped, or needed to be treated with other drugs, iv) Physiological system involved and the v) group of the drugs associated with ADRs. Among 1250 patients admitted during the study period, 250 adverse events were observed. Majority (76.8%) were of mild type, 66% were severe requiring intensive care and 3 patients died. Antimicrobials were responsible for maximum (42.4%) ADRs followed by drugs acting on CNS (20%). When we analyzed the systems affected, CNS side effects were more common in our study. While in many other studies Cardiovascular and gastrointestinal side effects were the most common. Combination of drugs was responsible for a large percentage of ADRs. Inadvertent use of antipsychotics with sedatives led to respiratory failure in 4 patients of which 1 died. Contaminated IV fluids are suspected to be the cause of death in another fatal ADR. In conclusion there is a need for vigilant ADR monitoring to be done by all doctors to prevent morbidity and mortality from ADRs