May 10, 2013 by David Taylor
When a new drug is placed on the market it is universally recognised that all the potential side-effects, both positive and adverse, will not have emerged during the extensive clinical trials. Consequently patients who take the new drug are kept under surveillance. This procedure is known as pharmacovigilance. The recognition, at the end of the last century, that most drugs will leave detectable residues in the aquatic environment, following use by the patient, has led to an appreciation that some form of ecological pharmacovigilance might also be desirable.
My former colleagues and I at AstraZeneca have just published a paper in the journal Drug Safety that addresses some of the challenges that this represents.
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.