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What is Ecopharmacovigilance?

Ecopharmacovigilance can be defined as science and activities concerning detection, assessment, understanding, and prevention of adverse effects or other problems related to the presence of a pharmaceutical product or by-product in the environment.

Environmental risk assessment of medicines

Assessment of the environmental impact of medicinal products is a legal obligation, and must be performed to evaluate and limit potential adverse effects of medicines on the environment.

When is an environmental risk-assessment performed?

The environmental risk-assessment (ERA) of medicinal products is to be performed by companies during the development of new medicines.
The results are submitted to the European Medicines Agency for evaluation in conjunction with the scientific data on quality, safety and
efficacy required to support the request for marketing authorisation of medicinal products intended for human or veterinary use via the
centralised procedure.

How is an ERA performed?

An ERA is performed in a stepwise approach, which starts with an initial screening phase (Phase I), aimed at identifying the environmental exposure of pharmaceuticals based on their potential for bioaccumulation and persistence in the environment.
If following this preliminary assessment, significant environmental exposure is anticipated, or if specific risks are identified due to compound-specific characteristics, a number of studies should be performed (Phase II).

The Phase II tests identify the fate of medicinal products in the environment and their potential effects on representative organisms (e.g. fish or
daphnids, for the aquatic environment). For this purpose, the results of various widely accepted test methodologies (laid down mainly
by the Organisation for Economic Co-operation and Development, OECD) form the basis of the risk-assessment process, which may be further
extended on a case-by-case basis, depending on the outcome of the assessment.

 

What are the outcomes of the ERA?
The outcome of an ERA will serve as the basis for:
• minimising the amount of medicinal product released into the environment by appropriate measures;
• identification of specific risk-minimisation activities to be taken by the user of the medicine;
• appropriate labelling, to facilitate the correct disposal of the medicinal product by patients/healthcare professionals (e.g. ensure that the medicine is disposed of in special containers or returned to a pharmacy).

 

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