Implementation of pharmacovigilance and analysis of adverse reactions in oncology at a philanthropic hospital in Brazil

Abstract

Introduction: Pharmacovigilance in oncology (oncovigilance) aims to detect adverse drug reactions (ADR)
associated with antineoplastic treatment, being a necessity to reduce morbidity and mortality associated with ADRs in cancer patients, as they are more prone to ad-verse drug events (EAM). Objective: To evaluate and
characterize the occurrence of ADRs in the oncology sector of a philanthropic hospital in Brazil after training
health professionals and implementing a pharmacovigilance service. Methodology: Training was carried out
for health professionals, emphasizing the need to report different ADEs. Subsequently, the ADRs reported by
patients were recorded by professionals on a form and transferred to the researchers who, together with CEFAL
(UNIFAL-MG Pharmacovigilance Center), were responsible for reporting to the regulatory body. A descriptive
analysis of patients and ADRs was carried out, classifying themaccording to severity and mechanism of action.
Results: Training in pharmacovigilance significantly increased the number of notifications. In total, 45 patients
presented ADR, corresponding to 30 women (64.58%), aged between 43 and 78 years, with different neoplasm
diagnoses. The 15 men (35.42%) were aged between 39 and 78 years. 65 ADRs were recorded, including those not
provided for in leaflets that were classified as mild and type A. Conclusion: The implementation of oncovigilance
with the notification of different ADEs can contribute to their avoidability and severity, implementing safety in the
use of antineoplastics and quality of life of cancer patients.