Structured Benefit-Risk
Assessments: An Illustrative Case Study of Paracetamol Open
Access
Rosa A. Piccirillo, MD and Jennifer Parish, MD MPH
October 17, 2022
DOI: 10.36316/gcatr.04.0046.
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.
Keywords
Pharmacovigilance;
Benefit-risk assessments; Paracetamol (acetaminophen); COVID-19
Copyright©2022 by the author(s). Licensee Global Clinical and
Translational Research. This is an open-access article distributed under
the terms and conditions of the Creative Commons Attribution License (CCBY4.0, https://creative-commons.org/license/by/4.0/),
which permits unrestricted use, distribution, and reproduction in any medium
provided the original work is properly cited.
How to cite this article. Piccirillo R and Parish J. Structured
Benefit-Risk Assessments: An Illustrative Case Study of Paracetamol. Glob Clin Transl Res. 2022; 4(4): 8-15. DOI:10.36316/gcatr.04.0046.
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