Skip to main content

Table 1 Summary of some of the similarities and differences between ecopharmacovigilance (EPV) and pharmacovigilance (PV)

From: Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities

Similarities between EPV and PV Differences between EPV and PV
Aims to identify any adverse environmental impacts including the indirect impact on humans Identifies the nature and frequency of ADRs in patients Not subject to regulation Highly regulated
Adverse environmental impact may be missed as ERA is conducted in highly controlled exposures in the laboratory, to a limited range of species that act as surrogates for all wildlife ADRs in the wider patient populations may be missed as preclinical safety assessment is conducted within a limited range of species with defined endpoints and clinical trials represent selected patient populations under controlled conditions Potentially all species in all environmental compartments could be exposed. This includes indirect exposure to humans Exposure of prescribed drugs is restricted to identifiable individuals and a target population (human or veterinary)
EPV is captured in the ERMPs PV is captured in the RMPs Dose is unknown but environmental concentrations can be predicted or measured. Actual exposure levels are unknown without sophisticated biological monitoring work Dose is known and defined by medication regimen. Exposure levels can be measured.
EPV issues identified for any drug are documented within the ERMP and action plans are agreed within AstraZeneca RMPs ensure a robust assessment of the potential risks with a response plan to minimize or mitigate them for patients using AstraZeneca products No routine monitoring is in place; however, some fish plasma levels are being monitored for scientific studies Exposed populations are under regular supervision and routine monitoring could be in place
ERA procedures can learn from EPV and be refined to increase future levels of environmental protection. PV updates the drug development programme and safety assessments Not possible to identify adverse environmental impacts directly through discussion with the species of concern. Human intervention is required to assess impacts on the environment In most cases it is possible to discuss and clarify issues with the patient directly.
   If adverse environmental impacts are seen it is difficult to attribute these to one particular cause. May or may not be easy to attribute ADR to one particular drug or a sub-population of patients
  1. ADR adverse drug reaction, ERA Environmental Risk Assessment, ERMPs AstraZeneca Environmental Risk Management Plans, RMPs AstraZeneca Risk Management Plans