A profile of adverse drug reactions with risk factors among geriatric patients in a tertiary care teaching rural hospital in India

Abstract

Aims & Objective: To study the adverse drug reaction profile, its causality, severity, associated risk factors and preventability in geriatric patients in a tertiary care teaching rural hospital. Materials and methods: Four hundred geriatric patients from various inpatient and outpatient departments were observed for occurrence of adverse drug events (ADEs) during August 2007 to October 2009. ADEs were either spontaneously reported or elucidated from personal interviews and analyzed. Results: In forty seven (11.75%) patients, 57 events occurred of which 75.43% occurred in indoor and 24.56% in outdoor patients. Most patients (74.46%) were in the age range of 65 to 74 years. The male to female ratio was 1.47: 1. Majority of ADEs involved gastrointestinal system (43.85%), followed by cardiovascular system (14.03%), endocrine system (12.28%) and skin and mucous membranes (12.28%). 142 drugs were suspected to cause these ADEs. Chemotherapeutic agents were the most commonly suspected drugs followed by cardiovascular drugs, drugs acting on CNS and steroids. On assessing causality, majority of events were rated as ‘possible’ by both WHO-UMC (66.66%) and Naranjo’s criteria (68.42%). Severity assessment (Hartwig scale) showed that 19.29%, 68.42% and 12.28% ADEs were severe, moderately severe and mild respectively. Risk factors for ADR development found were socioeconomic status (p=0.000), number of diseases suffered (p=0.002), number of medicines taken per day (p=0.000), compliance (p=0.048) and inappropriate prescribing (p=0.004). 36.84% ADRs were definitely preventable and 17.54% were probably preventable by modified Schumock and Thornton scale. Conclusion: ADRs is a major problem prevalent in geriatric patients and is significantly associated with socioeconomic status, number of diseases, number of medicines consumed per day, compliance to therapy and inappropriate prescribing.