Background Oncology drugs feature multiple adverse effects, however, physicians often consider toxicity acceptable and focus on the outcome, providing tools to deal with unavoidable side effects. The threshold of evaluation of adverse drug reactions (ADR) is different from other areas and many adverse effects are so predictable that are not even considered.
Purpose To record the toxicity reported in our hospital for patients receiving cancer treatment, to perform a quantitative evaluation, and to estimate the culture of pharmacovigilance in this field.
Material and methods We analysed ADR reports included in the National Network of Pharmacovigilance in 2014, and then sorted the ADR reports by category: antineoplastic agents and immunomodulators. We identified: the type of drug, active ingredients most reported, seriousness of the symptoms experienced and their resolution.
Results During the reporting period, there were 67 ADRs. 74% involved injectable drugs and more than half (61%) related to generics/biosimilars. Major toxicity was reported for: oxaliplatin (10), paclitaxel (9), filgrastim (7, 5 non-response to treatment), carboplatin (6), Afinitor and docetaxel (5). 81% were non-serious reactions. All were known and reported in drug leaflets. Most adverse reactions occurred during drug administration or the following days. Regarding outcome, 48% completely resolved (reversible toxicity in a short period), 27% improved and only 3% had a resolution with sequelae. There were no drug related deaths. 1 ADR was caused by a medication error and 1 involved an off-label use.
Conclusion Data collected showed ADR reporting related to injectable drugs and generics/biosimilars. ADRs were mostly not serious, did not become chronic and were known; we can therefore suspect an important phenomenon of under reporting. In onco-haematology there have been many new drugs launched on the market (many oral), and for many of them the safety profile needs to be further evaluated: pharmacovigilance is an important resource. The pharmacist has a key role in raising awareness of the problem, but also in encouraging appropriate reporting.
No conflict of interest.
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