Home|Journals|Articles by Year

Directory for Medical Articles
 

Original Research



Spontaneous reporting of adverse drug reactions in geriatric patients in India

V Kalaiselvan, Sakshi Gakhar, Prasad Thota, SK Gupta, GN Singh.


Abstract

Background: In India, spontaneous reporting of adverse drug reactions (ADRs) by health-care professionals was initiated in 2010. The drug safety issues for geriatric population are critical due to age-related physiological, pharmacodynamic, and pharmacokinetic changes.

Aims & Objective: To assess the spontaneous reports of ADRs observed in geriatric patients (over 65 years of age) in India from 1 July 2011 to 31 June 2013.

Materials and Methods: 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 2 years. These reports were analyzed for various characteristics of patients, drugs, and ADRs using a search and analysis tool.

Results: Of the 4357 geriatric individual case safety reports, more ADRs were reported in the male (57.77%) than in the female (41.38%) patients. Of the total geriatric patients, ADRs reported from 1120 (25.71%) 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 most common ADRs reported were vomiting, diarrhea, and constipation. In geriatric population, ADRs mostly affected gastrointestinal system and skin and appendages system.

Conclusion: This study from spontaneous reporting indicates the common ADRs in the geriatric patients in India, which will help health-care professionals to better understand the drug safety issues in elderly.

Key words: Adverse Drug Reaction; Geriatric; India; Spontaneous Reporting






Full-text options


Share this Article



Online Article Submission
• ejmanager.com







eJManager.com
Review(er)s Central
About BiblioMed
License Information
Terms & Conditions
Privacy Policy
Contact Us

The articles in Bibliomed are open access articles licensed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (https://creativecommons.org/licenses/by-nc-sa/4.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.