Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities

作者: Gisela Holm , Jason R. Snape , Richard Murray-Smith , John Talbot , David Taylor

DOI: 10.1007/S40264-013-0049-3

关键词:

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

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