Eventos adversos envolvendo medicamentos antineoplásicos no Brasil.

Abstract

Antineoplastic agents have high toxicity, a narrow therapeutic range, are classified as high-alert medications and are associated with the occurrence of several Adverse Drug Events (ADE). To monitor these and other ADEs involving medicines and vaccines, the National Health Surveillance Agency (Anvisa) provided the VigiMed system for reports. The objective of this study was to describe reports of suspected ADE involving antineoplastics in Brazil. This is a descriptive study of ADR reports made in the VigiMed system, between 01/01/2019 and 03/31/2023, involving antineoplastics. All data was collected in the public domain of Anvisa. Descriptive statistics was used to characterize the reports (by month, type of report, type of entry, type of notifier and origin of the report); the patients involved (gender, age group, pregnant and breastfeeding); reactions (outcome, severity, System Organ Class – SOC and medication errors) and antineoplastics (most involved drugs and route of administration). The completeness of the data was also evaluated according to the type of notifier. Finally, the profile of reports involving antineoplastics registered for rare conditions in Brazil was evaluated. A total of 29,656 reports involving some antineoplastic drug were identified (18.0% of the total reports in the period), with the majority being spontaneous reports (85.5%), provided by health services (59.0%) and originating in the southeast region (37.0%). The pharmacist was the main notifier (48.0%; n=14,767), with notifications being more complete when the notification involved this professional (69.5%). The patients involved in ADEs were, for the most part, adults (48.1%) and females (63.0%). There was a predominance of non-severe reactions (47.8%). The most common reactions involved general disorders and clinical conditions at the site of administration (15.0%). Medication errors (n=1,121) were mainly related to the administration stage (47.1%). The antineoplastic drug most frequently involved in ADEs was paclitaxel (n= 4503; 10.4%). It was also observed a predominance of parenteral presentations (45.1%) among ADEs. In relation to antineoplastic drugs registered for rare conditions between 2018 and 2022 (n=29), there were reports of suspected ADE involving 22 of these drugs, the majority of which were supplied by a “Pharmaceutical Company” (66.2%) and containing at least one severe reaction (61.5%). It is concluded that antineoplastic drugs are frequently related to suspected ADEs, demonstrating the importance of implementing safety barriers and carrying out adequate monitoring of cancer patients. In relation to VigiMed, there is a trend towards an increase in registered notifications, although it is still necessary to carry out initiatives to educate and engage notifiers to improve the completeness and quality of the reports.