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

TY - JOUR

T1 - Three methods for integration of environmental risk into the benefit-risk assessment of veterinary medicinal products

AU - Chapman, Jennifer L

AU - Porsch, Lucas

AU - Vidaurre, Rodrigo

AU - Backhaus, Thomas

AU - Sinclair, Chris

AU - Jones, Glyn

AU - Boxall, Alistair B A

N1 - © 2016 Elsevier B.V. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy.

PY - 2017/12/15

Y1 - 2017/12/15

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1016/j.scitotenv.2017.06.205

DO - 10.1016/j.scitotenv.2017.06.205

M3 - Article

C2 - 28675879

SN - 0048-9697

VL - 605-606

SP - 692

EP - 701

JO - Science of the Total Environment

JF - Science of the Total Environment

ER -