CÍNTHIA MADEIRA DE SOUZA, MARÍLIA BERLOFA VISACRI, GRAZIELE BALDAN FERRARI, ANNA PAULA LOURENÇO COSTA, CARMEN SILVIA PASSOS LIMA, PRISCILA GAVA MAZZOLA, PATRICIA MORIEL
Faculty of Medical Sciences, State University of Campinas, Brazil
Adverse drug reactions (ADRs) are common in oncology patients, predictable and, at least, probably preventable in many instances. The improved use of preventive measures has the potential to contribute to reducing the incidence and severity of ADRs. The aim of this study was to assess frequency and severity of ADRs in oncology patients. This is a quantitative, descriptive and exploratory study in drug-vigilance.
The patients, during and after chemotherapy sessions at a University Hospital in Brazil from august 2011 to June 2012, were selected for interviews about symptoms related to their chemotherapy. A clinical pharmacist investigated ADRs and their severity was classified by Common Terminology Criteria of Adverse Events (version 4.0) (grade 0 to 4). A total of 100 patients were interviewed, (54.0 % men, 46.0% women; age: 56.8 ± 12.1). The most frequent kinds of cancer were gastrointestinal cancer (n=76; 76.0%), head and neck cancer (n=8; 8.0%) and gynecological cancer (n=4; 4.0%).
The most prevalent treatment protocols were: fluorouracil + leucovorin + oxaliplatin (FLOX, n=24; 24.0%), irinotecan + fluorouracil + leucovorin (IFL-SALTZ, n=17, 17.0%) and fluorouracil + leucovorin (MACDONALD, n=16, 16.0%). Oncology patients had 10.5 ± 4.9 ADRs (range 2-26). The three most incident ADRs were nausea (66.2%; 55.3% grade 1), xerostomia (59.2%; 68.4% grade 1) and fatigue (57.8%; 43.1% grade 1). It was found that 69.3% of symptoms presented grade 1 of severity, 25.0% grade 2, 4.9% grade 3 and 0.8% grade 4.
The effects with grade 3 and 4 should have been notified to the drug-vigilance system, but these were not consistently reported, contributing to under-reporting. Therefore, pharmaceutical follow-up is essential to characterize the ADRs, and to assist in prevention, detection, notification and resolution of these events. Supported by: Pibic/CNPQ; Funcamp.
Rev.Bras. Farm. – 94 (4); 2013
Faculty of Medical Sciences, State University of Campinas, Brazil
Adverse drug reactions (ADRs) are common in oncology patients, predictable and, at least, probably preventable in many instances. The improved use of preventive measures has the potential to contribute to reducing the incidence and severity of ADRs. The aim of this study was to assess frequency and severity of ADRs in oncology patients. This is a quantitative, descriptive and exploratory study in drug-vigilance.
The patients, during and after chemotherapy sessions at a University Hospital in Brazil from august 2011 to June 2012, were selected for interviews about symptoms related to their chemotherapy. A clinical pharmacist investigated ADRs and their severity was classified by Common Terminology Criteria of Adverse Events (version 4.0) (grade 0 to 4). A total of 100 patients were interviewed, (54.0 % men, 46.0% women; age: 56.8 ± 12.1). The most frequent kinds of cancer were gastrointestinal cancer (n=76; 76.0%), head and neck cancer (n=8; 8.0%) and gynecological cancer (n=4; 4.0%).
The most prevalent treatment protocols were: fluorouracil + leucovorin + oxaliplatin (FLOX, n=24; 24.0%), irinotecan + fluorouracil + leucovorin (IFL-SALTZ, n=17, 17.0%) and fluorouracil + leucovorin (MACDONALD, n=16, 16.0%). Oncology patients had 10.5 ± 4.9 ADRs (range 2-26). The three most incident ADRs were nausea (66.2%; 55.3% grade 1), xerostomia (59.2%; 68.4% grade 1) and fatigue (57.8%; 43.1% grade 1). It was found that 69.3% of symptoms presented grade 1 of severity, 25.0% grade 2, 4.9% grade 3 and 0.8% grade 4.
The effects with grade 3 and 4 should have been notified to the drug-vigilance system, but these were not consistently reported, contributing to under-reporting. Therefore, pharmaceutical follow-up is essential to characterize the ADRs, and to assist in prevention, detection, notification and resolution of these events. Supported by: Pibic/CNPQ; Funcamp.
Rev.Bras. Farm. – 94 (4); 2013
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