The Association between Potential Factors and Seriousness Level of Adverse Drug Reactions (ADRs) at King Narai Hospital: a cross-sectional study

Abstract

Objectives To determine factors associated with seriousness level of adverse drug reactions (ADRs) occurred among patients. This study also aimed to propose recommendations for evidence-based practices to reduce occurrences ADRs at serious level. This study was a cross sectional analysis of all ADR occurrences in King Narai hospital during 1 January 2014 to 31 December 2018. All reports were collected retrospectively and deidentified data were extracted from the ADRs reports. Statistical analyses were performed using IBM SPSS Statistical software package version 25.0.

             Results: A total of 924 ADR events were reported, 254 (27.5 %) events were serious level and three Quarters of events (n=670, 72.5%) were reported as non-serious level. The mean age of study population was 48±20.5 years and majority of population were female (n=557, 60.3 %). In general, there was no statistically significant differences in characteristics between patients who had ADRs at serious level and those who had non-serious ADRs. However, ADRs reported from the Internal Medicine were more likely to be serious level than non-serious level (82.6% vs 58.4 respectively, p <0.001). Conversely, Surgery departments reported serious ADRs less than non-serious level significantly (4.5% vs 12.9% respectively p<0.000). There was a relationship between some chief complaints and serious level of ADRS. Patients with Injury, poisoning had a greater proportion of serious ADRs than non-serious level (23.2% vs 7.8% respectively p<0.001). ADRs caused by using musculo-skeletal system medication were more likely to be serious ADRs compare to non-serious (20.1% vs 11.8% respectively p<0.001), whereas using anti-infective drugs caused ADRs at serious level less than non-serious level (44.9% vs 60.3% respectively, p<0.001). ADRs from internal medicine department were 3.75 time (95% CI; 2.24, 6.28, p<0.001) more likely to occur at serious level. ADRs caused by using medication from other health professional were 3.28 time (95% CI; 1.72, 6.28, p<0.001) to be serious ADRs.