Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

Abstract

The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs) in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.Uniterms: Pharmacovigilance. Oncovigilance. Drugs/adverse reactions. Adverse drug reactions/underreporting. Adverse drug reactions/Spontaneous notification. Clinical pharmacy.Estudos de farmacovigilância são imprescindíveis em oncologia, pois os antineoplásicos possuem alta toxicidade e estreita janela terapêutica. Os objetivos deste estudo foram analisar o perfil das notificações espontâneas de reações adversas a medicamentos (RAM) em pacientes oncológicos e a incidência de RAM ao tratamento antineoplásico em um hospital terciário e universitário. Para compor o perfil de RAM, revisaram-se os formulários de notificação de reações em pacientes oncológicos do ano de 2010 e classificaram-se as reações conforme o medicamento envolvido, mecanismo, causalidade e gravidade. Para avaliar a incidência de reações, aplicou-se um questionário no momento da quimioterapia e a gravidade foi classificada pelos Critérios Comuns de Toxicidade. Apenas 10 reações foram notificadas ao Setor de Farmacovigilância, cujo perfil encontrado foi tipo B, grave, possível, e foram principalmente relacionadas aos compostos de platina e taxanos. Na análise da incidência das reações, observou-se que náusea, alopecia, fadiga, diarreia e distúrbio do paladar foram as reações mais frequentes relatadas por pacientes oncológicos, e as reações grau 3 e 4 não foram notificadas. De acordo com essas análises, propõe-se que os profissionais da saúde sejam treinados quanto às notificações e que farmacêuticos clínicos sejam cada vez mais inseridos neste contexto para redução da subnotificação de RAM.Unitermos: Farmacovigilância. Oncovigilância. Medicamentos/reações adversas. Anti...

Conhecimento de farmacovigilância no Brasil: percepção de participantes de um grupo de advocacy de pacientes de oncologia sobre informes de eventos adversos

“…However, HCP-centered reporting could be an issue, as HCPs may not be properly familiarized with PV and drug safety, with a poor rate of AEs reporting, (12,(30)(31)(32) including in Brazil. (8,33) Our study demonstrated that most of survey respondents were not aware that patients and HCPs are allowed to report AEs to manufacturers and government health agency (ANVISA). In addition, most participants did not know the meaning of PV and the importance to report AEs.…”

“…This finding is in agreement with the literature. (8) However, under-reporting AEs by patients is not limited to the Brazilian scenario, as even developed countries still present decreased awareness on AE reporting. (34) However, it may be aggravated in our scenario due to lack of public policies/campaigns to minimize these barriers for AE reporting.…”

“…AEs are very frequent in oncology treatments, and usually underreported, due to different barriers, including not enough and inefficient spontaneous reporting by patient. (8) Defined by WHO as the science to detect, assess, understand, and prevent of adverse effects, (9) pharmacovigilance (PV) is a key area to reduce adverse events and ensure the patient safety. To be effective, PV have to be supplied by reports of AEs, especially spontaneous reports from different sources, including patients.…”

Evidências do cuidado farmacêutico na prática clínica da oncologia

“…13 No âmbito da farmacovigilância, a detecção e identificação de reações adversas, além da proposta de medidas de intervenção e prevenção, otimizam a terapia e minimizam a ocorrência de internações. 14 Numa pesquisa qualitativa de Eduardo et al 1 , para os profissionais entrevistados, sua atuação na equipe multidisciplinar se faz indispensável, pois é esse profissional que tem mais conhecimento a respeito do tratamento farmacoterapêutico a ser feito e de farmaeconomia. Relata um profissional farmacêutico entrevistado: "Importante e indispensável, já que completa a equipe multiprofissional com seus conhecimentos sobre quimioterápicos, diluição e parte administrativa."…”

<p>Chemotherapy-Related Adverse Drug Reaction and Associated Factors Among Hospitalized Paediatric Cancer Patients at Hospitals in North-West Ethiopia</p>

“…12,13 One of the most common treatment modalities is chemotherapy, which is extremely useful for the treatment of cancer. [14][15][16] As a result, it controls the spread of cancer cells, relieves tumor-related symptoms, improves the quality of life and prolongs patient survival. 14,17 Although cancer treatment options exist, patients become vulnerable to ADR due to various reasons, including poor adherence to drugs and clinical conditions.…”