Pharmacovigilance knowledge in Brazil: perception of participants of oncology patient advocacy group on adverse events reporting

ABSTRACT

Objective: Pharmacovigilance revolves around the maintenance and understanding of drug safety through detection and evaluation of spontaneous adverse events (AE) reporting. However, underreported phenomenon occurs often due inefficient spontaneous reporting by patients, physicians, healthcare professionals and caregivers. Therefore, the aim of this survey was to evaluate the knowledge and perception related to pharmacovigilance in Brazil.

Methods: From February to March 2015, 260 respondents answered an internet-based survey related to knowledge on pharmacovigilance from Oncoguia Institute, an independent non-profit cancer patient advocacy group. Descriptive analyses were performed according to answers frequency.

Results: Among the respondents, 40.7% were diagnosed with breast cancer, followed by hematological malignancies (6.5%). Reported treatment included chemotherapy (35.9%), surgery (28.7%), and radiotherapy (16.4%). Most of the respondents were not aware of the importance of a pharmacovigilance AE report (51.7%). In fact, 21.3% of the respondents were not aware of what AEs are. In 65% of the cases, physicians have described the main AE expected to the prescribed treatment. Respondents reported nausea (23.6%), hair loss (22.8%), weight gain (14.5%) and vomiting (13.2%) as the most common AEs. Only 7.2% and 4.2% of the respondents were aware that AEs could be reported to pharmaceutical industry and ANVISA, respectively.

Conclusions: This survey demonstrates that knowledge and perception regarding AEs and pharmacovigilance activities are very poor among overall population, including cancer patients. Therefore, there is an enormous demand for educational awareness of AEs reporting importance in overall population, patients, and physicians, especially in oncology.

RESUMO

Objetivo: A farmacovigilância gira em torno da manutenção e compreensão da segurança de medicamentos por meio da detecção e avaliação de relatos de eventos adversos espontâneos (EA). No entanto, o fenômeno da subnotificação ocorre frequentemente devido à notificação espontânea ineficiente por parte de pacientes, médicos, profissionais de saúde e cuidadores. Portanto, o objetivo desta pesquisa foi avaliar o conhecimento e a percepção relacionada à farmacovigilância no Brasil.

Métodos: De fevereiro a março de 2015, 260 entrevistados responderam a uma pesquisa na Internet relacionada ao conhecimento sobre farmacovigilância do Oncoguia Institute, um grupo independente de defesa de pacientes com câncer sem fins lucrativos. Análises descritivas foram realizadas de acordo com a frequência de respostas.

Resultados: Entre os entrevistados, 40,7% foram diagnosticados com câncer de mama, seguidos por neoplasias hematológicas (6,5%). O tratamento relatado incluiu quimioterapia (35,9%), cirurgia (28,7%), radioterapia (16,4%). A maioria dos entrevistados não estava ciente da importância de um relatório de EA farmacovigilância (51,7%). De fato, 21,3% dos entrevistados não sabiam o que são os EAs. Em 65% dos casos, os médicos descreveram o principal EA esperado para o tratamento prescrito. Os entrevistados relataram náuseas (23,6%), perda de cabelo (22,8%), ganho de peso (14,5%) e vômitos (13,2%) como EAs mais comuns. Apenas 7,2% e 4,2% dos entrevistados sabiam que os EAs poderiam ser comunicados à indústria farmacêutica e à ANVISA, respectivamente.

Conclusões: Esta pesquisa demonstra que o conhecimento e a percepção sobre os EAs e atividades de farmacovigilância são muito pobres na população geral, incluindo pacientes com câncer. Portanto, há uma enorme demanda por conscientização educacional dos EAs que relatam importância na população geral, pacientes e médicos, especialmente em oncologia.

Keywords:

Health Surveys - Medical Oncology - Drug-Related Side Effects and Adverse Reactions - Pharmacovigilance

Descritores:

Pesquisas de Saúde - Oncologia Médica - Efeitos colaterais relacionados às drogas e reações adversas - Farmacovigilância

Publikationsverlauf

Eingereicht: 17. August 2018

Angenommen: 01. Oktober 2018

Artikel online veröffentlicht:
26. Februar 2025

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