The rate at which modern medicine is progressing is astonishing. Production and usage of medicines across the globe continue to grow substantially. The global pharmaceutical market is estimated to exceed USD 1.5 Trillion in the coming years. No doubt these new medicines have improved quality of life and saved lives for some of the most terrible diseases and conditions, however their unwanted presence in the environment is raising alarm bells. As a result, a concept combining pharmacovigilance and environmental pharmacology, was first introduced as Pharmaco Environmentology in 2006 by Syed Ziaur Rahman.
This concept has slowly evolved into Ecopharmacovigilance which is defined as “the science and activities concerning detection, assessment, understanding and prevention of adverse effects or other problems related to the presence of pharmaceuticals in the environment, which affect both human and the other animal species”.
Ecopharmacovigilance aims to ensure that significant environmental issues associated with pharmaceuticals in the environment are identified in a timely way and addressed appropriately. Ecopharmacovigilance is of significant concern these days since the unwanted presence of even trace amounts of active pharmacological ingredients in the environment may pose a risk.
There are various ways by which pharmacological pollutants may end up in the environment, such as in the patients’ excreta in the sewerage system and via release into the waste waters by manufacturers or hospitals and the terrestrial depositions. The largest release of medicines into the environment comes from the humans or animals taking them. Medicines are excreted from the body either in their unchanged form or as metabolites in faeces and urine and find their way into sewers or sewage treatment plants.
Several studies have documented the effects of pharmaceutical pollution on various animal species, such as vultures and fish. Ecopharmacovigilance is emerging as a promising approach to prevent the environmental risks posed by unwanted pharmaceutical agents ending up in the environment. However, it is impractical to implement rigorous EPV processes for all the pharmaceutical substances with complex and diversified chemical, biological or toxicological properties. Consequently, the concept of “targeted EPV” has evolved and is aimed at targeted detection, evaluation, understanding, and prevention of adverse effects of high-priority hazardous pharmaceuticals in the environment.
“Targeted EPV” implementation focusses on targeted monitoring of the presence of high-risk agents in the environment, targeted reporting of over-standard discharge, targeted management of main emission sources, targeted legislation and conduct of research on high-priority pharmaceutical pollutants, as well as targeted educational strategies for specific areas and key populations.
Although the detected concentrations of pharmaceuticals in the environment are generally low, (ng/L to μg/L) potential direct and indirect risks for human and animal populations do exist and hence should be carefully monitored. This is of further importance in the case of special populations including pregnant women, children and older patients, who may be vulnerable to even very low concentrations of medicines.
Addressing issues related to pharmaceutical pollution is one of the key current aims of Ecopharmacovigilance in managing the environmental safety of medicines. Environmental safety of medicines will be another challenge that regulators and researchers will need to face and work on collaboratively to address this vital issue and develop new strategies to minimise environmental risks.
The US, EU and Canada is already regulating in this area and undertaking Environmental Risk Assessment (ERA) in pharmaceuticals. At present there are no specific guidelines for ERA of pharmaceuticals in Japan, Australia and many other countries.
It will be important to watch this space and stay abreast of developments in this area and see what challenges and opportunities present themselves.
1. Silva LJG, Lino CM, Meisel L, Barceló D, Pena A. Ecopharmacovigilance. In: Barcelo D, editor.
The Handbook of Environmental Chemistry. Germany: Springer-Verlag Berlin and Heidelberg
GmbH & Co. KG; 2012. pp. 213–42.
2. Holm, G., Snape, J. R., Murray-Smith, R., Talbot, J., Taylor, D., and Sörme, P. (2013). Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities. Drug Saf. 36 (7), 533–546. doi:10.1007/s40264-013-0049-3
3. Wang, J., He, B., Yan, D., and Hu, X. (2017). Implementing Ecopharmacovigilance (EPV) from a Pharmacy Perspective: A Focus on Non-steroidal Anti-inflammatory Drugs. Sci. Total Environ. 603-604, 772–784. doi:10.1016/j.scitotenv.2017.02.209