Analysis of Adverse Drug Reactions Reported at the Adverse Drug Monitoring Centre of the Tertiary Care Hospital

Abstract

Introduction: The drugs developed during the recent
years lead to incredible benefits for the patients but causes
increased incidence of adverse drug reaction (ADR). ADR is an
undesirable, unintended consequence of drug administration.2
It is well known that “No drug is absolutely void of side effects”,
so to monitor such ADR, we have AMC at the tertiary care
hospital. Aim of our studywas to analyzeADRs reported at the
AMC centre of the tertiary care hospital.
Material & Methods: This retrospective study was carried
out at the AMC of Shri Ram Murti Smarak Institute of Medical
Sciences, Bareilly, for a period of 3 years. Patients of all ages
and either sex were included. Adverse drug reactions were
reported by the healthcare professionals and patients were
included in our study. The reported ADRs were analyzed
according to the demographic profile, department-wise, class
of drug and system organ class involved. Data collected was
analyzed and expressed in percentages.
Results: Total 197 ADRs were reported from various
departments. Most of the adverse drug reactions were observed
in females in the age group of 18 to 65 years. A maximum number
(29) of ADR’s were reported from the oncology department,
followed by Orthopedic, paediatric and voluntary reporting by
the patients. Most of the ADRs were reported from antibiotics
72 (36.54%). The causality assessment of ADRs were assessed
according WHO-UMC causality assessment scale, according
to which the maximum were probable,116 (58.8%) followed by
possible, 75 (38.07%) and certain, 6 (3.04%).
Conclusion: The study concluded that the spontaneous
reporting of ADR’s is satisfactory. Reporting from HCP’s
needs to be enhanced by sensitization and creating
awareness by imparting training and conducting workshops
on pharmacovigilance.