Pharmacovigilance in clinical practice: a retrospective observational study of spontaneously reported adverse drug reactions among patients at a tertiary care hospital

Giriraju Eswar Meher; Rashmi B. Kharde; Palak Agrawal; Rahul Kunkulol

doi:10.18203/2319-2003.ijbcp20263777

Authors

Giriraju Eswar Meher Department of Pharmacology, Pravara Institute of Medical Sciences, Loni, Maharashtra, India
Rashmi B. Kharde Department of Pharmacology, Pravara Institute of Medical Sciences, Loni, Maharashtra, India
Palak Agrawal Department of Pharmacology, Pravara Institute of Medical Sciences, Loni, Maharashtra, India
Rahul Kunkulol Department of Pharmacology, Pravara Institute of Medical Sciences, Loni, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20263777

Keywords:

Pharmacovigilance, Adverse drug reactions, Spontaneous reporting, VigiFlow, PvPI, WHO-UMC causality, MedDRA, Drug safety

Abstract

Background: Adverse drug reactions continue to cause problems in day-to-day practice. They increase hospital stay, add to treatment cost, and sometimes can lead to significant morbidity. Pharmacovigilance helps in detecting, assessing, and preventing these reactions. In India, spontaneous reporting through VigiFlow under the Pharmacovigilance Programme of India (PvPI) is the main source of real-world safety data. We analysed all complete ADR reports received at our centre during the year 2023.

Methods: A total of 436 complete spontaneous ADR reports containing 907 reactions were reviewed. Reactions were coded using MedDRA system organ classes. Suspected drugs were coded using the WHO Drug Dictionary, and causality was assessed by the WHO-UMC scale. Only frequencies and percentages were calculated.

Results: Most reports came from adults (282, 64.7%) and elderly patients (123, 28.2%). Females accounted for 295 reports (67.7%). Paclitaxel was the most commonly suspected drug (66 reports), followed by cisplatin (30) and carboplatin (28). The intravenous route was responsible for 292 reports (67%). Gastrointestinal disorders formed the largest group (362 reactions, 39.9%), followed by nervous system (161, 17.8%) and skin disorders (152, 16.8%). The majority of the reactions were non-serious (95.6%) and had recovered (95.4%).

Conclusions: Adult female patients and anticancer drugs dominated the reports. Gastrointestinal, neurological and skin reactions were most frequent. Although most reactions were non-serious and recovered, the serious cases still highlight the need for continuous monitoring.

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