Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients.

ABSTRACT: Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the m

SUBMITTER: Sundaran S 

PROVIDER: S-EPMC6306913 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature