Pharmacovigilance in Geriatrics: Exploration of Etio-Clinical Profile and Severity of Adverse Drug Reactions at a Tertiary Hospital in South India.

Abstract

Background: The increasing geriatric population worldwide necessitates focused attention on medication management due to altered physiological and pharmacokinetic profiles. This study aims to explore the etio-clinical profile of Adverse Drug Reactions (ADRs) in geriatric patients and their severity, providing insights into the prevalence, severity, and contributing factors to enhance pharmacovigilance efforts.

Methodology: A prospective observational study was conducted over two years, from July 2016 to September 2018, at a 1700-bed tertiary care private teaching institution in South India. ADRs were primarily collected through active surveillance, supplemented by spontaneous reporting. The collected ADRs were categorized based on gender, age, comorbidities, and the affected physiological systems to facilitate a detailed analysis. Causality assessment was performed using the WHO-UMC scale, and severity was evaluated using Hartwig and Siegel's criteria. Statistical analysis was conducted using SPSS software version 16.0, with data presented in percentages and proportions.

Results: A total of 206 ADRs were documented during the study period, with 55 cases reported within the geriatric population. Among the geriatric, 32 (58.1%) were females and 23 (41.9%) were males. The causality assessment, performed using the WHO-UMC causality assessment scale, revealed that the majority of the ADRs fell into the 'likely' category, accounting for 69% (n=38) of the cases. Cutaneous manifestations were the most prevalent, observed in 38 patients. Beta-lactam antimicrobials, such as piperacillin-tazobactam, ampicillin-sulbactam, and ceftriaxone, were the most commonly involved. The severity of the ADRs was assessed using the Hartwig and Siegel severity criteria. Additionally, 48 cases were classified as mild, corresponding to levels 1 and 2 on the Hartwig and Siegel scale. Furthermore, 6 cases were classified as moderate, corresponding to levels 3 and 4 on the scale, and one was severe.

Conclusion: The study highlights the critical need for vigilant pharmacovigilance in the geriatric population to prevent and manage ADRs effectively. By identifying the etio-clinical profiles of ADRs, healthcare providers can develop targeted interventions to improve therapeutic outcomes and ensure safer medication practices in this vulnerable demographic. Enhanced patient education and meticulous history-taking are pivotal in reducing the incidence of ADRs, thereby promoting better health outcomes for elderly patients.