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Provedor de dados:  BJPS
País:  Brazil
Título:  Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting
Autores:  Visacri,Marília Berlofa
Souza,Cinthia Madeira de
Pimentel,Rafaela
Barbosa,Cristina Rosa
Sato,Catarina Miyako Shibata
Granja,Silvia
Marialva,Mécia de
Lima,Carmen Silvia Passos
Mazzola,Priscila Gava
Moriel,Patrícia
Data:  2014-06-01
Ano:  2014
Palavras-chave:  Pharmacovigilance
Oncovigilance
Drugs/adverse reactions
Adverse drug reactions/under-reporting
Adverse drug reactions/Spontaneous notification
Clinical pharmacy
Resumo:  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.
Tipo:  Info:eu-repo/semantics/article
Idioma:  Inglês
Identificador:  http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200411
Editor:  Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação:  10.1590/S1984-82502014000200021
Formato:  text/html
Fonte:  Brazilian Journal of Pharmaceutical Sciences v.50 n.2 2014
Direitos:  info:eu-repo/semantics/openAccess
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