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

Marília Berlofa Visacri,Silvia Granja,Mécia De Marialva,Patrícia Moriel,Cristina Rosa Barbosa,Carmen Silvia Passos Lima,Catarina Miyako Shibata Sato,Rafaela Pimentel,Priscila Gava Mazzola,Cinthia Madeira De Souza

doi:10.1590/s1984-82502014000200021

Marília Berlofa Visacri, Silvia Granja + Show 8 more

Open Access

https://doi.org/10.1590/s1984-82502014000200021

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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.

Highlights

Pharmacovigilance is defined as a set of activities designed to identify and evaluate the effects of the acute and chronic use of pharmacological treatments in the population or subgroups exposed to specific treatments (Laporte, Carné, 1993)
The primary objectives of the current study was to analyze the pattern of spontaneous notification of suspected adverse drug reactions (ADRs) affecting oncology patients at a tertiary care teaching hospital, integrated with the Pharmacovigilance Program from the Brazilian National Health Surveillance Agency (ANVISA) during 2010, and to assess the incidence of ADRs related to antineoplastic treatment and the degree of toxicity reported by patients at the Chemotherapy Clinic
The current study demonstrated that notifications of ADRs per year in oncology patients are a very small number, especially considering the toxicity of chemotherapy, characterizing the under-reporting

Summary

Introduction

Pharmacovigilance is defined as a set of activities designed to identify and evaluate the effects of the acute and chronic use of pharmacological treatments in the population or subgroups exposed to specific treatments (Laporte, Carné, 1993). Pharmacists involved in pharmacovigilance have played an important role in the notification of suspected ADR by providing information and instructions on the safe and appropriate use of medicines, in addition to reducing the prevalence of ADRs and underreporting (Van-Grootheest, Jong-Van Den Berg, 2005). This is possible because the pharmacists who directly advise patients, especially within the context of pharmaceutical care, are more likely to detect ADRs

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