Three methods for integration of environmental risk into the benefit-risk assessment of veterinary medicinal products

• Published in: The Science of the total environment Vol. 605-606; pp. 692 - 701
• Main Authors: Chapman, Jennifer L., Porsch, Lucas, Vidaurre, Rodrigo, Backhaus, Thomas, Sinclair, Chris, Jones, Glyn, Boxall, Alistair B.A.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 15.12.2017
• Subjects: Animalia; Animals; Benefit-risk assessment; Comparative evaluations; Decision support; Decision supports; Earth and Related Environmental Sciences; Environmental engineering; Environmental Pollutants - analysis; Environmental risk; Environmental risks; European Union; Geovetenskap och miljövetenskap; Humans; Integrated decision makings; Policy development; Pollution; Product authorization; Risk assessment; Risk Assessment - methods; Therapeutic benefits; Veterinary Drugs - analysis; Veterinary medicinal products; Benefit-risk assessment; Veterinary medicinal products; Environmental risk; Product authorization; Decision support
• ISSN: 0048-9697; 1879-1026
• DOI: 10.1016/j.scitotenv.2017.06.205

Veterinary medicinal products (VMPs) require, as part of the European Union (EU) authorization process, consideration of both risks and benefits. Uses of VMPs have multiple risks (e.g., risks to the animal being treated, to the person administering the VMP) including risks to the environment. Environmental risks are not directly comparable to therapeutic benefits; there is no standardized approach to compare both environmental risks and therapeutic benefits. We have developed three methods for communicating and comparing therapeutic benefits and environmental risks for the benefit-risk assessment that supports the EU authorization process. Two of these methods support independent product evaluation (i.e., a summative classification and a visual scoring matrix classification); the other supports a comparative evaluation between alternative products (i.e., a comparative classification). The methods and the challenges to implementing a benefit-risk assessment including environmental risk are presented herein; how these concepts would work in current policy is discussed. Adaptability to scientific and policy development is considered. This work is an initial step in the development of a standardized methodology for integrated decision-making for VMPs. [Display omitted] •Benefit-risk assessment of veterinary medicines considers environmental risk.•Three methods to categorize and compare benefits and risks are presented.•The developed methods are flexible, adaptable and transparent.•Further development and implementation would support authorization decisions.