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Observational Study
. 2017 Nov-Dec;49(6):432-437.
doi: 10.4103/ijp.IJP_781_16.

Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year

Preeti Singh  1 , Manju Agrawal  2 , Rajesh Hishikar  2 , Usha Joshi  2 , Basant Maheshwari  2 , Ajay Halwai  2
Affiliations
Observational Study

Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year

Preeti Singh et al. Indian J Pharmacol. 2017 Nov-Dec.

Abstract

Background: India is a developing country and adverse drug reactions (ADRs) influence most of the diseases in our population, and monitoring is required due to the paucity of ADRs. The present study was done to analyze the ADRs at the ADR monitoring center (AMC) of tertiary care hospital in Raipur during 1 year.

Materials and methods: Study of ADR monitoring of outpatient and inpatient was a prospective and observational study carried out between September 2015 and August 2016. The ADRs in the form of Individual Case Safety Report (ICSR) was sent to the Indian database (Vigiflow®).

Results: Total ICSRs reported to Vigiflow® were 232 during 1 year. Among them, 63.79% were found to be nonserious and 36.21% were serious. Nearly 45% of ADRs were implicated only due to antimicrobials, which is highest among all other groups of drugs. A maximum number of ADRs were observed in 31-60 years of age group (52.15%). In causality assessment, the probable cases had a higher incidence (67.24%), followed by possible (27.58%) and certain (4.74%). The frequency of ADR reporting at our AMC was low (0.043%) compared to national average. Our AMC shared 0.35% of total ICSRs, which is insignificant (P < 0.001) compared to the JSS, Mysore and PGIMER, Chandigarh, AMCs, which have shared most of the ICSRs in Vigiflow®.

Conclusions: The frequencies of ADRs reporting in our study are less compared to those reported with other similar studies. Underreporting is a very serious concern in Raipur, and Pharmacovigilance Programme of India must intercede to pick up ADRs across the country.

Keywords: Adverse drug reaction monitoring center; Pharmacovigilance Programme of India; Vigiflow®; adverse drug reactions; individual case safety reports.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Number of adverse drug reactions submitted since September 2015 to August 2016
Figure 2
Figure 2
Adverse drug reactions reported by various departments
Figure 3
Figure 3
Pharmacological classes of drugs implicated to cause adverse drug reactions
Figure 4
Figure 4
Comparative performance to our adverse drug reaction monitoring center with leading medical college's adverse drug reaction monitoring centers in India. Contribution of individual case safety reports to National Coordination Centre, Ghaziabad, through Vigiflow® since September 2015 to August 2016
See this image and copyright information in PMC

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