Evaluation of Adverse Drug Reactions – A Prospective Analysis in a Tertiary Care Teaching Hospital
Objective: To identify and assess theAdverse Drug Reactions(ADRs) in patients who are admitted in a tertiary care teaching
hospital (SRM MCH & RC) in Potheri.
Methods: A prospective spontaneous reporting was carried out in various departments of the tertiary care teaching hospital,
Potheri from August 2015 to Febraury 2016, after obtaining Institutional Ethics Committee approval. Descriptive analysis of
the ADR data collected is done by Microsoft Excel software and isexpressed as percentage comparison.
Results: A total number of 55 ADRs were reported during this seven months of period(August 2015 – February 2016) of
which 27 were males and 28 were females. There is no significant difference between genders. The department of medicine
reported the highest number of ADRs (27.2%) followed by general surgery (21.8%). The maximum number of patients
(69%) was reported with dermatological manifestations. Majority of ADRs were due to antibiotics(63.6%). According to the
Naranjo’s causality assessment scale, 85% of the ADRs were probable and 15% were possible. Severity assessment by
Modified Hartwig and Siegel scale revealed 43.6% ADRs to be moderate, 36.3% were mild and 1.8% was severe.
Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to
the increased hospital stay. The reporting of ADRs to regional pharmacovigilancecentres should be encouraged to ensure