title: Implementing ecopharmacovigilance in practice: challenges and potential opportunities.
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.
authors.affiliation: AstraZeneca, Safety Health and Environment, 151 85 Södertälje, Sweden. Gisela.holm@astrazeneca.com
authors.forename: Gisela
authors.initials: G
authors.lastname: Holm
authors.forename: Jason R
authors.initials: JR
authors.lastname: Snape
authors.forename: Richard
authors.initials: R
authors.lastname: Murray-Smith
authors.forename: John
authors.initials: J
authors.lastname: Talbot
authors.forename: David
authors.initials: D
authors.lastname: Taylor
authors.forename: Pernilla
authors.initials: P
authors.lastname: Sörme
mesh_terms: D000818:Animals; D001208:Asia; D004008:Diclofenac / Q000009:adverse effects; D004784:Environmental Monitoring / Q000379:methods*; D006801:Humans; D008018:Life Cycle Stages / Q000187:drug effects; D060735:Pharmacovigilance; D011634:Public Health / Q000379:methods*; D018570:Risk Assessment
chemical_list: D004008:Diclofenac