Introduction: The foundations of pharmacovigilance are the monitoring of drug safety in real-world medicine, and identification of new adverse effects, unknown at the time of market approval. Cancer patients are prone to adverse drug reactions due to the complexity of the neoplastic disease and its treatment. Pharmacovigilance of anti-cancer medicines is further complicated because patients have comorbidities, as for elderly patients. It is even more challenging when complete safety and risk data for a drug are lacking, as may occur for new molecules or when it comes to drugs for children.
Areas covered: This article introduces the field of pharmacovigilance of anti-cancer drugs, describing the various layers of complexity that make the recognition of adverse drug events in oncology particularly problematic, including the type of medicines, the phenomenon of underreporting and polypharmacy. Finally, it reviews new digital tools to help pharmacovigilance activities in oncology.
Expert opinion: The authors outline some crucial challenges and opportunities that can be useful for pharmacovigilance to keep up with the times and follow the current technological and scientific progress. In addition to the evaluations made by researchers, it will, of course, be necessary to have an equality important concrete response from the institutions and regulatory bodies.
Keywords: Pharmacovigilance; adverse drug reaction; clinical oncology; patient reported outcomes; under-reporting.