The Risk Assessment of Pharmaceuticals in the Environment: EU and US Regulatory Approach

TY - JOUR

T1 - The Risk Assessment of Pharmaceuticals in the Environment

T2 - EU and US Regulatory Approach

AU - Walter, Shona

AU - Mitkidis, Katerina

PY - 2018/6/1

Y1 - 2018/6/1

N2 - The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.

AB - The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.

KW - Pharmaceuticals

KW - Environmental impacts

KW - risk assessment

U2 - 10.1017/err.2018.33

DO - 10.1017/err.2018.33

M3 - Journal article

SN - 1867-299X

VL - 9

SP - 527

EP - 547

JO - European Journal of Risk Regulation

JF - European Journal of Risk Regulation

IS - 3

ER -