Oral Presentation SETAC Asia-Pacific Virtual Conference 2022

Pharmaceuticals in the Environment; the AstraZeneca approach to EcoPharmacoVigilance. (#17)

Irene Bramke 1 , Samuel K Maynard 2 , Jason R Snape 3 , Stewart F Owen 3
  1. Global Sustainability, AstraZeneca BV, Den Haag, SOUTH HOLLAND, Netherlands
  2. Global Sustainability, AstraZeneca , Cambridge, United Kingdom
  3. Global Sustainability, AstraZeneca UK, Macclesfield, United Kingdom

Ecopharmacovigilance (EPV), a science akin to pharmacovigilance (PV) in many aspects, is concerned with developing and establishing scientifically sound and practicable ways to ensure that environmental issues associated with pharmaceuticals in the environment (PiE) are identified in a timely manner and can be managed appropriately.

In this presentation we will share the current state of implementation of EPV at AstraZeneca, based on the 5 pillars identified by Holm et. al in 2013;

  1. Tracking environmental risks after launch of the product, via literature monitoring for emerging data on exposure and effects
  2. Using Environmental Risk Management Plans (ERMPs) as a centralized resource to assess and manage the risks of a drug throughout its life cycle
  3. Further research, testing or monitoring in the environment when a risk is identified
  4. Keeping a global EPV perspective
  5. Increasing transparency and availability of environmental data for medicinal products.

A key part of the EPV process at AstraZeneca is the routine (quarterly) search of the published scientific literature for any data concerning ecotoxicological effects or compound properties that may affect the environmental fate (degradation, partitioning, distribution) of an active pharmaceutical ingredient (API), and for reports of measured environmental concentrations (MECs) of APIs. We will introduce our publicly available interactive EPV dashboard (https://www.astrazeneca.com/sustainability/environmental-protection/pharmaceuticals-in-the-environment.html) which contains the aquatic exposure information gathered over the course of our conducting EPV for nearly a decade. We will demonstrate the utility of this resource to derive nuanced insights into geographical and temporal patterns of environmental concern from PiE.

  1. Holm, G., Snape, J. R., Murray-Smith, R., Talbot, J., Taylor, D., & Sörme, P. (2013). Implementing ecopharmacovigilance in practice: challenges and potential opportunities. Drug safety, 36(7), 533-546.