Pharmacy Unit, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS , Aviano, Italy.
Hospital Pharmacy Unit, Institute for Maternal and Child Health "IRCCS Burlo Garofolo" , Trieste, Italy.
Expert Opin Drug Saf. 2020 Jul;19(7):849-860. doi: 10.1080/14740338.2020.1772751. Epub 2020 Jun 18.
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.
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.
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.
药物警戒学的基础是在现实医学中监测药物安全性，并发现新的不良作用，这些作用在获得市场批准时是未知的。由于肿瘤疾病及其治疗的复杂性，癌症患者容易发生药物不良反应。由于患者存在合并症，如老年患者，抗癌药物的药物警戒工作更加复杂。当完全缺乏药物的安全性和风险数据时，情况甚至更加具有挑战性，这种情况可能发生在新分子药物或儿童用药上。
本文介绍了抗癌药物药物警戒领域，描述了使肿瘤学中不良药物事件识别变得特别成问题的各种复杂情况，包括药物类型、漏报现象和多种药物并用。最后，它回顾了有助于肿瘤学药物警戒活动的新数字工具。
作者概述了一些关键挑战和机遇，这些挑战和机遇对药物警戒跟上时代步伐并跟踪当前技术和科学进展非常有用。除了研究人员的评估外，当然还需要从机构和监管机构获得同样重要的具体回应。
