A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital

Smita Shenoy; Mohit Gupta; Sadhana Holla; Madhurima Home; Harish Thanusubramanian

doi:10.18203/2319-2003.ijbcp20195770

Authors

Smita Shenoy Department of Pharmacology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
Mohit Gupta Department of Surgery, Jagadguru Sri Shivarathreeshwara Medical College, Mysuru, Karnataka, India
Sadhana Holla Department of Pharmacology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
Madhurima Home Mayo Clinic, 5777 East Mayo Boulevard, Phoenix, USA
Harish Thanusubramanian Pfizer India Ltd, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20195770

Keywords:

Cancer, Hematological, Causality, Predictability

Abstract

Background: Serious adverse drug reactions (ADRs) cause physical, psychological and economic harm to patients and society. This study was undertaken to understand serious ADRs in a tertiary care hospital and risk factors associated with it.

Methods: The serious adverse reactions that occurred over a one-year period were assessed. The serious adverse drug reactions, action taken, outcome, predictability, suspect drug, causality, patient demographics and risk factors for the reaction was collected. Chi-square test was applied for observing relationships of predisposing factors for serious ADRs.

Results: Out of a total of 984 reported adverse drug reactions, 94 (9.55%) were serious. Hematological disorders (41.05%) were the common serious ADRs followed by electrolyte disturbances (18.94%). Anticancer agents were the suspect drugs for majority of serious ADRs. Serious ADRs contributed to 39 (0.05%) admissions in the hospital. Recovery occurred in 97.87% of the patients. The causality was possible in 91.48% (n=86) and probable in 8.51% (n=8) of the serious adverse drug reactions. Males, patients even with a single concomitant disease and those with more than 2 concomitant medications were at increased risk (p<0.05) for developing serious ADRs.

Conclusions: Serious ADRs are a significant problem in health care. Measures should be taken to detect and treat them at the earliest to reduce suffering of the patient.

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