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.
