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Comparative Study
, 36 (7), 533-46

Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities

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Comparative Study

Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities

Gisela Holm et al. Drug Saf.

Abstract

Ecopharmacovigilance (EPV) is a developing science and it is currently very unclear what it might mean in practice. We have performed a comparison between pharmacovigilance (PV) and EPV and have identified that there are similarities, but also some important differences that must be considered before any practical implementation of EPV. The biggest difference and greatest challenge concerns signal detection in the environment and the difficulty of identifying cause and effect. We reflect on the dramatic vulture decline in Asia, which was caused by the veterinary use of diclofenac, versus the relative difficulty in identifying the specific causes of intersex fish in European rivers. We explore what EPV might mean in practice and have identified that there are some practical measures that can be taken to assess environmental risks across product life cycle, particularly after launch of a new drug, to ensure that our risk assessments and scientific understanding of pharmaceuticals in the environment remain scientifically and ecologically relevant. These include: Tracking environmental risks after launch of the product, via literature monitoring for emerging data on exposure and effects Using Environmental Risk Management Plans (ERMPs) as a centralized resource to assess and manage the risks of a drug throughout its life cycle Further research, testing or monitoring in the environment when a risk is identified Keeping a global EPV perspective Increasing transparency and availability of environmental data for medicinal products. These measures will help to ensure that any significant environmental issues associated with pharmaceuticals in the environment (PIE) are identified in a timely way, and can be managed appropriately.

Figures

Fig. 1
Fig. 1
AstraZeneca’s Environmental Risk Management Plan (ERMP) concept: the ERMP is initiated during drug development to provide an early indication of any potential risks and to design an appropriate environmental testing programme for the Active Pharmaceutical Ingredient (API) in support of the Environmental Risk Assessment (ERA). After launch, the ERMP is updated as necessary if any new or emerging risks are identified as part of AstraZeneca’s internal Ecopharmacovigilance (EPV) process
Fig. 2
Fig. 2
Published Measured Environmental Concentrations of propranolol in surface waters. PEC predicted environmental concentration, PNEC predicted no-effect concentration

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