A pharmacovigilance study in the department of medicine of a university teaching hospital

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Himanshu Sharma
Mohammed Aqil
Faisal Imam
Mohammad S. Alam
Prem Kapur
Krishna K. Pillai


Adverse Drug Reaction Reporting Systems, India


The aim of the present study was to monitor adverse drug reactions (ADRs) in the Medicine out patient department (OPD) of a University Teaching Hospital.

Method: A prospective evaluation of the ADRs reported in the Department of Medicine of our University Teaching Hospital over a period of 4-months was conducted.

Results: During the study period, a total of 600 patients visited the Medicine OPD and 122 ADRs were reported.  Out of 122 reports that were identified, a higher percentage of ADRs in males (52.4%) was observed as compared to females (47.5%). Of the 122 ADRs, 50 were found to be mild (41.0%), 49 moderate (40.2%), and 23 severe (18.2%). A total of 71 (58.0%) ADRs were observed in patients receiving 4 or more medications concurrently. Conversely 46 (37.7%) ADRs were detected in patients using 3 or less medicines. The largest number of reports were associated with antihypertensive therapy (39.3%), followed by antimicrobials (31.1%) and antidiabetics (10.7%). Amongst the organ systems affected, gastrointestinal ADRs constituted a major component (24.7%) followed by skin reactions (22.2%). On causality assessment, nearly 29.5% ADRs were considered as probable, 33.6% possible and 6.6% could not be categorised and were placed under unassessable.

Conclusion: The present work is the maiden pharmacovigilance study conducted at our university teaching hospital. The data presented here will be useful in future, long term and more extensive ADR monitoring in the hospital and in promotion of rational prescribing and drug use in the hospital.


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