Title |
Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities
|
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Published in |
Drug Safety, April 2013
|
DOI | 10.1007/s40264-013-0049-3 |
Pubmed ID | |
Authors |
Gisela Holm, Jason R. Snape, Richard Murray-Smith, John Talbot, David Taylor, Pernilla Sörme |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Malaysia | 1 | <1% |
Chile | 1 | <1% |
Ecuador | 1 | <1% |
United Kingdom | 1 | <1% |
Canada | 1 | <1% |
Unknown | 144 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 25 | 17% |
Student > Ph. D. Student | 18 | 12% |
Researcher | 17 | 11% |
Student > Bachelor | 17 | 11% |
Student > Postgraduate | 9 | 6% |
Other | 19 | 13% |
Unknown | 44 | 30% |
Readers by discipline | Count | As % |
---|---|---|
Pharmacology, Toxicology and Pharmaceutical Science | 17 | 11% |
Environmental Science | 17 | 11% |
Medicine and Dentistry | 14 | 9% |
Agricultural and Biological Sciences | 10 | 7% |
Biochemistry, Genetics and Molecular Biology | 8 | 5% |
Other | 36 | 24% |
Unknown | 47 | 32% |