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. 2011 Jan;16(1):16-25.

Prevalence of adverse drug reactions at a private tertiary care hospital in south India

Shanmugam Sriram  1 , Ali Ghasemi, Rajeswari Ramasamy, Manjula Devi, Rajalingam Balasubramanian, Thengungal Kochupapy Ravi, Ali Mohammad Sabzghabaee
Affiliations

Prevalence of adverse drug reactions at a private tertiary care hospital in south India

Shanmugam Sriram et al. J Res Med Sci. 2011 Jan.

Abstract

Background: Adverse Drug Reactions (ADRs) constitute an enormous burden for the society. The aim of the present study was to detect, document, assess and report the suspected ADRs and preparation of guidelines to minimize the incidence of ADRs.

Methods: A prospective-observational study was conducted in the Department of General Medicine of a tertiary care hospital for 12 months from April 2008 to March 2009. Detected and suspected ADRs were analyzed for causality, severity and preventability using appropriate validated scales and were reported. ADR alert card was prepared and given to patients. Therapeutic guidelines were prepared and given to the relevant departments.

Results: A total of 57 ADRs were detected, documented, assessed and reported during the study period the incidence was found to be 1.8%. Assessment of severity of the suspected ADRs revealed that 12% of suspected ADRs were severe and 49% of ADRs were moderate in severity. Causality assessment was done which revealed 63% of ADRs were possibly drug-related. The majority of patients who had suffered from ADRs were above 60 years (56%). Gastrointestinal system was most commonly affected (37%) and the drug class mostly associated with ADRs was antibiotics (23%). Preventability of ADRs was assessed; and the results revealed that 28% of ADRs were definitely preventable.

Conclusions: Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient's safety. In this way, hospital/clinical pharmacists play the cornerstone role.

Keywords: Adverse Drug Reactions (ADR); India; Prevalence.

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Figures

Figure 1(a)
Figure 1(a)
Adverse Drug Reaction monitoring card (front view)
Figure 1(b)
Figure 1(b)
Adverse Drug Reaction monitoring card (backside view)
Figure 2
Figure 2
Adverse Drug Reaction alert card (front view)
Figure 2(b)
Figure 2(b)
Adverse Drug Reaction alert card (backside view)
Figure 3
Figure 3
Causality assessment of suspected Adverse Drug Reactions (WHO scale)
Figure 4
Figure 4
Predisposing factors for adverse drug reactions
See this image and copyright information in PMC

References

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