Abstract
Spontaneous reporting systems may generate a large volume of information in real world conditions with a relatively low cost. Disproportionality measures are useful to indicate and quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality), based upon differences compared to the background reporting frequency. This cross-sectional study (2008 to 2013) aimed to analyse the feasibility of detecting such signals in the Brazilian Pharmacovigilance Database comprising suspected adverse drug reactions related to the use of doxorubicin, cyclophosphamide, carboplatin, trastuzumab, docetaxel, and paclitaxel for breast cancer chemotherapy. We first accessed overall database features (patient information and suspected adverse drug reactions) and further conducted a disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% in order to identify possible signals of disproportionate reporting, only among serious suspected adverse drug reactions. Of all data reports of adverse reactions (n = 2603), 83% were classified as serious, with the highest prevalence with docetaxel (78.1%). The final analysis was performed using 1,309 reports with 3,139 drug-reaction pairs. The following signals of disproportionate reporting, some rare or not mentioned on labels, were observed: tachypnea with docetaxel; bronchospasm, syncope, cyanosis, and anaphylactic reaction with paclitaxel; and anaphylactic shock with trastuzumab. Structured management of spontaneous adverse drug reaction reporting is essential for monitoring the safe use of drugs and detecting early safety signals. Disproportionality signal analysis represents a viable and applicable strategy for oncology signal screening in the Brazilian Pharmacovigilance Database.
Highlights
Pharmacovigilance activities—aimed at monitoring the safe use of medicines—are important in oncology due to the inherent toxicity of antineoplastic agents (Baldo and De Paoli, 2014)
We carried out a cross-sectional study related exclusively to spontaneous adverse drugs reactions (ADRs) reported in Notivisa from 2008 to 2013 during breast cancer treatment with doxorubicin, cyclophosphamide, carboplatin, trastuzumab, docetaxel, and paclitaxel—which are the preferred regimens according to National Comprehensive Cancer Network and Brazilian guidelines (National Comprehensive Cancer Network., 2017; Brasil, 2018)
Of all serious ADRs, the majority (78.1%) were associated with docetaxel, with the greatest prevalence of those classified as general disorders (Table 1)
Summary
Pharmacovigilance activities—aimed at monitoring the safe use of medicines—are important in oncology due to the inherent toxicity of antineoplastic agents (Baldo and De Paoli, 2014). Prevalence and mortality of breast cancer in the worldwide female population (International Agency for Research on Cancer., 2014), knowledge of the toxicity profile of the main drugs used in its treatment is important strategically for prevention, detection and early management of suspected adverse drugs reactions (ADRs) related to chemotherapy. Reports of ADR screening from the national surveillance system may offer data pertaining to different drug-event combinations (or drug-event pairs). These include methods of disproportionality analysis (DPA) that represent the main class of analytical methods for spontaneous report systems (SRS) data analysis in pharmacovigilance (Harpaz et al, 2012; European Medicines Agency., 2016)
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