Eventos adversos notificados ao sistema nacional de notificação (VigiMed) envolvendo medicamentos antineoplásicos no Brasil: Adverse events reported to the National Reporting System (VigiMed) involving antineoplastic medications in Brazil

Juliana de Oliveira Gomes  Ramos; Adriano Max Moreira  Reis; Helaine Carneiro; Cristiane de Paula Rezende; Mário Borges  Rosa; Mariana Martins Gonzaga do  Nascimento

doi:10.17765/2176-9206.2024v17n4.e12816

Authors

Juliana de Oliveira Gomes Ramos Federal University of Minas Gerais https://orcid.org/0009-0005-1813-7982
Adriano Max Moreira Reis Federal University of Minas Gerais https://orcid.org/0000-0002-0017-7338
Helaine Carneiro University of Brasília https://orcid.org/0000-0002-5438-7963
Cristiane de Paula Rezende Federal University of Minas Gerais https://orcid.org/0000-0001-7457-4187
Mário Borges Rosa Institute for Safe Medication Practices https://orcid.org/0000-0002-6922-8367
Mariana Martins Gonzaga do Nascimento Federal University of Minas Gerais https://orcid.org/0000-0003-2183-4365

DOI:

https://doi.org/10.17765/2176-9206.2024v17n4.e12816

Keywords:

Antineoplastic agents, Drug-related side effects and adverse reactions, Medication errors, Adverse drug reaction reporting systems, Pharmacovigilance

Abstract

Objective: to describe suspected adverse drug events (ADEs) involving antineoplastics reported in Brazil. Methods: descriptive study of reports to the VigiMed system between 01/01/2019 and 03/31/2023. Results: 29,656 reports involving antineoplastics were identified, most were spontaneous (85.5%) and came from health services (59.0%). Adults (48.1%) and females (63.0%) were more involved in the reports, with a large number of unreported data on age and sex. The most common antineoplastic medicines were paclitaxel (10.4%) and oxaliplatin (7.6%), with emphasis on parenteral presentations (45.1%). A reduced number of medication errors involving antineoplastics were identified (1.3%) and the Reporting Odds Ratio (0.22; 95% CI 0.21-0.23) demonstrated they were less frequent for this class than for other products. Conclusion: reports of ADE involving antineoplastics are frequent in Brazil, and it is important to improve safety barriers and monitor cancer patients, in addition to promoting education and engagement to improve notifications.

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Author Biographies

Juliana de Oliveira Gomes Ramos, Federal University of Minas Gerais

Graduated in Pharmacy with emphasis on Hospital Pharmacy and Health Services from the Federal University of Minas Gerais. Specialist in Clinical Pharmacy and Pharmacology Applied to Clinical Practice from the Faculty of Medical Sciences. Master's degree in Medicines and Pharmaceutical Assistance from the Federal University of Minas Gerais. Currently, he is part of the Clinical Pharmacy sector of the company Far.me Farmacoterapia Otimizada and works as a professor in postgraduate courses.

Adriano Max Moreira Reis, Federal University of Minas Gerais

PhD in Science from the Fundamental Nursing Program of the University of São Paulo, Ribeirão Preto Campus (2009). Master in Pharmaceutical Sciences from the Federal University of Minas Gerais (1998). He is currently Associate Professor IV at the Faculty of Pharmacy of the Federal University of Minas Gerais. He has experience in the area of Pharmacy, working mainly in the following areas: pharmacotherapy of the elderly, pharmacovigilance, study of drug use, patient safety, pharmaceutical assistance in hospitals and in health services.

Helaine Carneiro , University of Brasília

Assistant Professor in the Department of Pharmacy at the School of Health Sciences at the University of Brasília (UnB), having recently served as Pharmacovigilance Manager at the National Health Surveillance Agency (Anvisa). She is currently a postdoctoral fellow in the area of Public Oncology Policies at the University of Nova Lisboa, Portugal. At UnB, she develops the teaching-research-extension triad in the areas of Management, Economics and Health Surveillance. She holds a PhD in Sciences from the Ribeirão Preto School of Nursing - USP, a Master's in Pharmaceutical Sciences from the Ribeirão Preto School of Pharmaceutical Sciences - USP, an MBA in Marketing from FUNDACE/FEARP - USP, a Specialist in Hospital Pharmacy and Clinical Pharmacy from SBRAFH, a degree in Industrial Pharmacy from the Federal University of Ouro Preto, and a course in Clinical Pharmacy from the University of Chile.

Cristiane de Paula Rezende, Federal University of Minas Gerais

Pharmacist, graduated from the School of Pharmacy of the Federal University of Ouro Preto. PhD in Medicines and Pharmaceutical Assistance from the Federal University of Minas Gerais. Master in Pharmaceutical Sciences from the Federal University of Ouro Preto. Specialist in Preceptorship in the Unified Health System from the Sírio-Libanês Institute of Education and Research (IEP/HSL). Serves as a member of the scientific council of the Institute for Safe Practices in the Use of Medications (ISMP Brazil) and works as a professor in postgraduate courses.

Mário Borges Rosa, Institute for Safe Medication Practices

Pharmacist at the Hospital Foundation of the State of Minas Gerais since 1990. President of the Institute for Safe Practices in the Use of Medications (ISMP-Brazil), since 2006. President of the Latin American Network for the Safe Use of Medications 2014. Coordinator of the Sentinel Network of the João XXIII Hospital of Fhemig carrying out Pharmacovigilance and Technovigilance activities since 2010. He has experience in the area of Pharmacy working mainly in the following topics: Pharmacovigilance, Hospital Pharmacy, Epidemiology, Patient Safety, Medication Errors, Prescription Errors, Adverse Events related to Medications, high alert medications/potentially dangerous medications.

Mariana Martins Gonzaga do Nascimento, Federal University of Minas Gerais

Assistant Professor of the Department of Pharmaceutical Products - School of Pharmacy, Federal University of Minas Gerais (PFA/FAFAR/UFMG), Post-doctorate from the Postgraduate Program in Medicines and Pharmaceutical Assistance, Center for Studies in Pharmaceutical Care (CEAF/PPGMAF/FAFAR/UFMG). PhD in Health Sciences from the Oswaldo Cruz Foundation/René Rachou Research Center (FIOCRUZ/CPqRR). Master in Health Sciences from the Federal University of São João del Rei (UFSJ). Specialist in Hospital Pharmacy and Health Services from the State University of Montes Claros/Minas Gerais Pharmacists Association (UNIMONTES/AMF). Graduated in Pharmacy with a degree in industry from FAFAR/UFMG. Serves as a member of the scientific council of the Institute for Safe Practices in the Use of Medications (ISMP Brazil). She worked as a professor in several undergraduate and postgraduate courses (2007 to 2017), as a supervising pharmacist at Hospital Risoleta Tolentino Neves and as a pharmacist at SES-MG.

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Adverse events reported to the National Reporting System (VigiMed) involving antineoplastic medications in Brazil