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Comparative Study
. 2008 Feb;65(2):210-6.
doi: 10.1111/j.1365-2125.2007.02993.x. Epub 2007 Jul 27.

Adverse drug reaction monitoring in a secondary care hospital in South India

R Arulmani  1 , S D Rajendran, B Suresh
Affiliations
Comparative Study

Adverse drug reaction monitoring in a secondary care hospital in South India

R Arulmani et al. Br J Clin Pharmacol. 2008 Feb.

Abstract

What is already known about this subject: The benefits of adverse drug reaction (ADR) monitoring are well-known. Poor awareness and nonavailability of a central co-ordinating body resulted in lack of ADR monitoring in India. The National Pharmacovigilance Programme was recently initiated, encouraging ADR monitoring in selected centres, including our centre.

What this study adds: This is the first study of its kind at GHQH, Ootacamund that has provided insight into the burden of ADRs here. The incidence and severity of ADRs documented in our study is lower than those reported in comparable populations in Western studies but more than those reported in India.

Aims: To ascertain the current burden of ADRs at a Government hospital in Ooty and to assess the severity of reported ADRs and the additional financial burden associated with ADRs.

Methods: A prospective, spontaneous reporting study was conducted over a period of 9 months of inpatient admissions to the medical wards, co-ordinated by clinical pharmacists. The WHO definition of an ADR was adopted. The Naranjo algorithm scale was used for causality assessment. Confirmed ADRs were classified according to the Wills & Brown method and assessed for severity and patient outcomes. The average cost incurred in treating the ADRs was calculated.

Results: Of the total of 187 adverse drug events (ADEs) reported, 164 reports from 121 patients were confirmed as ADRs, giving an overall incidence of 9.8%. This included 58 (3.4%) ADR related admissions and 63 (3.7%) ADRs occurring during the hospital stay. About two thirds of the reactions (102, 62.2%) were classified as probable. The majority of the reactions (88, 53.7%) were mild. Most patients (119, 72.6%) recovered from the incidence. The majority of the reactions were of type H (100, 61%) which indicates that they were not predictable and not potentially preventable. An average cost of 481 rupees ( pound 6) was spent on each patient to manage ADRs.

Conclusions: The incidence and severity of ADRs documented in our study are lower than those reported in comparable populations in Western studies but more than those reported in India.

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