Spontaneous Reporting of Adverse Drug Reactions in Geriatric Patients in India.

Background: In India, spontaneous reporting of adverse drug reactions (ADRs) by healthcare professionals was initiated in 2010. The drug safety issues for geriatric population are critical due to age-related physiological changes, pharmacodynamics and pharmacokinetics changes. Objective: Our objective was to assess the spontaneous reports of adverse drug reactions, observed in geriatric patients (over 65 years of age) in India during the period from 1 July 2011 to 31 June 2013. Method: The spontaneous reports of 4357 elderly patients (≥65 years) were retrieved at national pharmacovigilance centre from the database containing all ADR reports from 90 ADR Monitoring Centres (AMCs) in India under Pharmacovigilance Programme of India (PvPI) for the period of two years. These reports were analysed for various characteristics of patients, drugs and ADRs using a search and analysis tool. Results: Of the 4357 geriatric Individual Case Safety Reports (ICSRs), more ADRs were reported from the male (57.77%) than the female patients (41.38%). The ADRs from 1120 (25.71%) patients of the total geriatric patients were found to be serious of which 8 (0.71%) were fatal. Cisplatin, carboplatin, cyclophosphamide, acetylsalicylic acid and insulin were the common drugs prescribed to the elderly patients and the commonest ADRs reported were vomiting, diarrhoea and constipation. The ADRs in geriatric population mostly affected Gastro-intestinal system and Skin & appendages system. Conclusion and implications of key findings: This study from spontaneous reporting indicates the common ADRs in the geriatric patients in India which will help healthcare professionals in better understanding of the drug safety issues in elderly.