Prospective Study On Adverse Drug Reactions: A Step Towards Patient Safety
Bilgy Babu1*, Amitha P Marla2
1.Clinical Pharmacy department, A J Hospital and Research Centre, Mangalore
2. Director of Medical Administration, A J Hospital and Research Centre
To identify the adverse drug reactions in the patients. To increase the reporting and awareness among the staffs. To evaluate the causality assessment and severity of ADRs. A prospective study was conducted for a period of one year from February 2019 to January 2020 in the Inpatients of AJ Hospital and Research Centre. Identified and reported ADRs were analyzed. ADR reporting questionnaire was provided to healthcare professionals to assess the knowledge about ADR. ADR causality assessment was carried out using WHO probability scale. Severity assessment of ADRs was done using modified Hartwig and Siegel severity scale. Paired t-test was applied to find the association between the two phases. A total of 100 ADRs were identified from 1120 patients.Causality assessment indicated that most of the ADRs were probably (85%) drug related. Severity of 79% reactions were reported as moderate. Study was categorized into two phases; Phase I and Phase II. Knowledge rate among respondents was found to be 67% in phase-I which had a remarkable increase in phase-II (92%). Common barrier for underreporting of ADR was lack of knowledge regarding ADR. The study concluded that interventions such as implementation of well-established reporting process and continuous training will help to reduce the current underreporting crisis.
Keywords: Adverse drug reactions, Causality assessment and severity, underreporting, interventions