Structured Benefit-Risk Assessments: An Illustrative Case Study of Paracetamol.

This paper aims to provide an overview of the steps in developing a structured benefit-risk assessment, along with a simple, salient, and timely example of its implications. Using the time-tested, non-prescription drug paracetamol (a.k.a. acetaminophen) as an example, we demonstrate the fundamental role a well-structured benefit-risk assessment may play in clarifying the safety profile of even well-established medicinal products. The benefit-risk balance assessment performed by drug manufacturers and others involved in keeping drugs on the market is integral to a non-stop drug safety assessment continuum throughout a product’s lifecycle. This provides further reassurance that, as the world grapples with new diseases, pharmacovigilance systems with robust tools such as structured benefit-risk assessments can evolve and adapt by developing essential preventive and mitigative strategies. All these examples and practices contain the through-line of consideration for the protection of public health, a foundational cornerstone of pharmacovigilance practice. While a wealth of information may be explored on each aspect of the presented topics, the authors aim to give even those readers with only minimal background in pharmacovigilance an appreciation for the value of structured benefit-risk assessments.