Pharmacovigilance in Geriatric Patient- A Prospective Observational Study Done in a Tertiary Care Hospital of Odisha, India

Introduction: Geriatrics is a speciality that focuses on healthcare of elderly people. Geriatric population is defined as people above 60 years of age. Geriatric population constitute 8.14% of total population in India. They have diverse physiological and pathological profiles which have an impact on the pharmacokinetic and pharmacodynamic properties of the administered drug. Very often they are under polypharmacy due to multisystem involvement and thereby subjected to numerous drug interactions and Adverse Drug Reactions (ADRs). There are few studies conducted in India regarding ADRs in Geriatric Patients and none in Odisha, India.

Aim: Pharmacovigilance study in Geriatric patients was taken up in a tertiary care hospital to assess the spectrum, cause, severity and preventability of ADRs.

Materials and Methods: This prospective, observational study was conducted in Department of Pharmacology in collaboration with Departments of Geriatric Medicine, Medicine and Skin and Venereal Disease (VD) of SCB Medical College and Hospital, Cuttack, Odisha, India. All geriatric patients (aged ≥60 years) diagnosed with ADR, from September 2016 to September 2018, were included. The detailed information of type of ADR and its characteristics were filled up in Suspected ADR Reporting Form. The prevalence and profile of ADRs in geriatric patients were studied. Their causality, severity and preventability were assessed by World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) System, Modified Hartwig’s Severity Scale and Schumock and Thornton Preventability Scale, respectively.

Results: A total of 236 geriatric ADRs were reported in two years, out of which, the most common ADRs were cutaneous 100 (42.4%), followed by metabolic 68 (28.8%) and Gastrointestional (GI) involvement 26 (11%). Out of the geriatric ADRs, 128 (54.2%) ADRs were possible, 65% were moderate in intensity and 70.3% ADRs were probably preventable.

Conclusion: Cutaneous and metabolic ADRs were most common in geriatric patients in present study. Majority of ADRs were possibly caused due to the drug used, were of moderate intensity and probably preventable.