Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India

Amita Jindal; Raj Kumar; Sumir Kumar; Amandeep Kaur; Kiranjit; Rakesh Tilak Raj

doi:10.18203/2319-2003.ijbcp20231113

Authors

Amita Jindal Department of Pharmacology, GGS Medical College and Hospital, Faridkot, Punjab, India
Raj Kumar Department of Pharmacology, GGS Medical College and Hospital, Faridkot, Punjab, India https://orcid.org/0000-0001-9604-6596
Sumir Kumar Department of Skin and VD, GGS Medical College and Hospital, Faridkot, Punjab, India
Amandeep Kaur Department of Pharmacology, GGS Medical College and Hospital, Faridkot, Punjab, India
Kiranjit Department of Chest and TB, GGS Medical College and Hospital, Faridkot, Punjab, India
Tilakraj Rakesh Department of Skin and VD, Govt. Medical College, Amritsar, Punjab, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20231113

Keywords:

Adverse events, ADRs causality, Preventability, Severity, Adverse drug monitoring centre, Pharmacovigilance, WHO causality scale

Abstract

Background: The aim of the present study was to determine the pattern of adverse drug reactions (ADRs) reported at ADR monitoring centre (AMC) in Punjab.

Methods: This observational retrospective study was done in department of Pharmacology, GGS Medical College and Hospital, Faridkot from September 2020 to August 2021. A total of 148 ADRs were reported during the study period. Each ADR was analyzed for demographic data and characteristics of ADR. Assessment of causality, severity and preventability was done according to WHO UMC scale, modified Hartwig and Siegel scale and Modified Schumock and Thornton Preventability Scale respectively.

Results: A total of 148 ADRs were reported from both outpatients and in patients of various departments. Most of the ADRs were found in males (55%) and patients of age group 31-45 years (33%). Majority of ADRs were reported from dermatology department (40%). Overall, 38% of ADRs were due to antimicrobial drugs. Most of the ADRs were reported as possible (57%), followed by probable (41%) as per WHO causality assessment. Most of the ADRs were moderate severity (83%). 97% of the ADRs were found to be definitely preventable type.

Conclusions: We concluded that most of the ADRs were reported from antimicrobial drugs, so it is advisable to have close monitoring of the antimicrobial drug therapy to prevent ADRs in the patients. Although the majority of ADRs were moderate in nature but mostly were recovered. The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

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