Pharmacovigilance of anti-cancer medicines: opportunities and challenges

ABSTRACT

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

Acknowledgements

The authors thank Valerie Matarese, PhD, of UpTo infotechnologies for providing medical writing support.

Article highlights

• Pharmacovigilance still involves many challenges in oncology.

• Implementation of international electronic reporting systems means not that also clinical management of ADRs is well-known and standardized.

• Underreporting of adverse drug reactions in oncology is a major problem.

• Safety of newer targeted cancer drugs must be strictly monitored, to implement individual toxicologic profiles and expand knowledge.

• Modern pharmacovigilance in oncology must proceed in the direction of risk prediction and personalization of ADR management.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.