Medication safety incidents: characterization of voluntary reports in an oncology hospital in Porto Alegre

Abstract

Objective: To characterize and quantify the medication security incidents reported in a specialized hospital in oncology, located in Porto Alegre, in addition to identifying the profile of the patients most affected by them. Methods: Cross-sectional study with retrospective data collection. Spontaneous notifications of pharmacovigilance, related to drug incidents from 2018 to 2020, were analyzed through an active search in the institutional system, through documents previously prepared by the pharmacy service and electronic medical records. Duplicate notifications were excluded. The collected data were grouped in variables related to notificated incidents and patient characteristics, with a descriptive analysis and the Chi-square test being performed to check whether there was an association between observed frequencies of the years of the study (categories) and the classification of notifications of security incidents. Results: 861 notifications were analyzed, 313 referring to 2020, 327 referring to 2019 and 221 to 2018. Incidents with damage were the prevalent classification, corresponding to 87.3% (n=752) of the reported occurrences. Among them, adverse drug reactions (ADRs) were the type associated with the years 2018 and 2019, often related to the use of antineoplasic agents. The classification of incidents varied according to the years of study, with statistically significant difference. There was a significant difference between the occurrences of drug-related incidents over the years. The mean age of the patients observed was 57.3 years (± 14.1), with a predominance of females and digestive system neoplasms as the main diagnosis. Antineoplasic agents were the most reported drugs, especially paclitaxel. Conclusions: The occurrence of incidents with damage in oncology centers, especially ADRs, is similar to findings in the literature. The results obtained allow an overview of safety issues and serve as a basis for directing pharmacovigilance actions within health services.