Journal of Pharmacovigilance

A study on incidence and clinical characteristics of Adverse Drug Reactions at a private tertiary care hospital in north Karnataka

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Binu Mathew, Abhinandana U, Vishnu Prasad, Ashok Malpani and Hiremath Doddayya

Accepted Abstracts: J Pharmacovigilance

Abstract:

It is important to identify the risks for ADRs, henceforth the common drugs causing ADRs, their therapeutic class, demographic data of patients suffered from ADRs and concomitant medications used should be known. Also ADR specific data such as type of reaction, system affected and probable causes will be of great help to minimize the ADRs. It was a prospectiveobservational study. Nine patients (13. 8%) were admitted due to an Adverse Drug Reaction compared to 56 (86. 15%) who were affected by ADR after hospital admission. The majority of patients who suffered from ADRs were of 30-59 years 41 (63. 2%). Systems most commonly affected were dermatological in 18 (24. 8%) patients, gastro Intestinal in 14 (20%) patients, central nervous system in 11 (19. 2%) patients followed by respiratory system in 9 (17. 6%) patients. The drug class mostly associated with ADR was NSAIDS in 10 (13. 6%) cases, followed by antibiotics in 9 (11. 2%) cases. In 6 (9. 6%) cases the drug was withdrawn, dose altered in 9(11. 2%) and no change was made in 45 (79. 2%) patients. Adverse reactions encountered were treated and the final outcome was measured. About 63 (98. 4%) patients recovered, while in 2(1. 6%) cases the ADR decreased. No fatal cases were reported. Intervention was required in all ADRs as it indirectly contributed to affect the patient?s quality of life. Our ability to anticipate and prevent such ADRs can be facilitated by the establishment of standardized approaches and active reporting o f suspected ADRs. Our study shows that ADRs are a significant problem in hospital in-patients contributing to morbidity and resulting in considerable financial burden. Over half are definitely at potentially avoidable and steps should be taken to introduce strategies to reduce their impact.