ASSESSMENT OF MANAGEMENT OF ADVERSE DRUG REACTIONS REPORTED IN A TERTIARY CARE HOSPITAL IN CALICUT

Aim: Adverse drug reactions are a serious problem with increasing incidence as more medicines become available and more people become exposed to them. Detection and management of adverse drug reaction is one of the major areas in the medication process, where the management is not emphasized much. This study was done to determine the difference in the management of adverse drug reactions reported in the study site with the evidence based management.

Method: Retrospective cross- sectional observational study design was followed for a period of five years. Inpatient related suspected ADRs reported by physician-in-charge or other healthcare professionals directly involved with the patient care was included as the observed. Parameters such as causality, type of reaction, severity, management given were assessed. Further the management given in the hospital was compared with standard treatment guideline or available evidence-based treatment for ADRs.

Results: Out of 59 patients 57.6% were male and 42.3% were female. As per Naranjo’s causality assessment 66.1% of reactions were probable, 28.8% were possible, 5.08% were definite. As per Modified Hartwig and Siegel severity assessment majority of the ADRs were moderate (50%) and mild (46.6%). Wills and Brown classification showed Type A (augmented) 64.4%, Type H (hypersensitivity) 30.5%, Type C (chemical) 3.38% and Type D (delivery) 1.7% reactions. Most of the patients with ADR (56.3%) completely recovered after treatment and 33.4% were recovering process. The management followed for stopping the suspected medication was 27.1% of cases and in 10.2% cases the suspected medication was stopped as well as an antidote/antagonist was also prescribed.

Conclusion: The major portions of management were not reported and many cases the outcome of management was not specified. The clinical pharmacy department should give more emphasis on the reporting standards so the that in future the references and interventions will have more clarity.

Keywords: Adverse drug reaction, Causality, Classification, Severity, Management, Evidence based medicine.