Adverse Drug Reaction profile in hospitalized patients: a network analysis approach
Adverse drug reaction; Risk factors; Pharmacovigilance; Risk score.
Introduction: RAMs have a significant incidence among hospitalized patients. An important step in reducing the incidence of adverse reactions would be to identify those patients who are at increased risk of developing an RAM from individual risk factors. Objective: Develop a tool to predict adverse drug reactions in hospitalized patients. Methodology: Observational, analytical, case-control study in a 1: 2 ratio of all patients admitted during the period from June 2016 to December 2017 at Hospital Universitário Onofre Lopes, Brazil. For the identification of the variables of the patients associated with the occurrence of RAM, the univariate analysis of each patient variable by conditional logistic regression was performed initially with the entire study population. For the multivariate analysis were included the variables that in univariate analysis showed a significant association with the occurrence of RAM at a level of significance <0.10. The statistical program Stata 12 was used. Results: The proportion of patients with one or more RAMs was 4.43% (95% CI 4.00 to 4.90%). The most common adverse reactions were hypoglycaemia (26.4%) and hypotension (15.2%). Univariate analysis identified 27 variables that were associated with the occurrence of RAM. Twelve variables were statistically related to the occurrence of RAM, such as female (adjusted OR, 1.61, 95% CI, 1.18-2.21), previous history of RAM (ORA 1.97 CI 95 (ORA 1.63 95% CI 1.13- 2.34) and with target organ damage (ORA 6.49, 95% CI, 3.56-11.83) and intravenous drug prescription (ORA 1.60, 95% CI, 1.14-2.24). Conclusion: The prevalence of RAM was observed in 3.97% of the patients, with emphasis on dose-dependent hypoglycemia and hypotension reactions. Twelve independent risk factors for RAM development were identified, with diabetes with target organ damage being the most impacting factor. Based on these factors, the risk assessment tool for the development of RAM was developed and validated.