Pharmaceuticals in a Globalized Environment

By: Saurabh Mamtani

Source: Photo by Lisa Fotios from Pexels

Approximately 150 United Nations (UN) member nations, in their respective constitutions, have inculcated the fundamental right to a clean and healthy environment.¹ However, for a long time these rights have been violated by various industrial sectors. The pharmaceutical industry is no exception, as it has been a significant contributor of anthropogenic pollutants since the 1970s.² Over the past 30 years, international organizations and the pharmaceutical industry have begun to notice the detrimental impact of pharmaceutical products on the environment globally.³

Terminus a quo

Pharmaceutical products enter the environment at various stages of their life cycle. By far the largest contribution to pharmaceutical pollution is patient use, in which drugs pass through our bodies and enter into waterways. The second largest source is the improper disposal of drugs, such as throwing leftover drugs in the sink or down the toilet. The third largest source is pharmaceutical waste from manufacturing facilities.³ (See Figure 1 below)

Figure 1: Circulation of pharmaceutical pollutants in the environment.³

A flaw in the system

Conventional water treatment plants, in both developed and developing countries, are simply not designed to remove pharmaceutical products. A 2017 United Nations Educational, Scientific and Cultural Organisation (UNESCO) study found that only nine out of 118 assessed pharmaceuticals were removed from wastewater with an efficiency of over 95%, and nearly half of the compounds were removed only partially with an efficiency of less than 50%.⁴

Apart from incapacitated water treatment plants, there are regulatory guidelines (i.e. Good Manufacturing Practice guidelines) that have excluded the environmental pollution clause.⁵ As a consequence, some drug manufacturing facilities have been releasing active ingredients into nearby waterways, creating localized hotspots of pharmaceutical pollution.

The general public has made their contribution as well, primarily by practising improper disposal techniques for decades. Commonly, when people fail to complete a prescription or clean out their medicine cabinet, they throw the leftover drugs in the sink or down the toilet, and eventually these drugs end up in water treatment plants.⁶

Evidence of Threat

Pharmaceutical pollution significantly affects aquatic life. For example, male fishes downstream of some wastewater outfalls produce vitellogenin (VTG), a protein normally synthesized by females during oocyte maturation and early-stage eggs in their testes. This feminization has been attributed to the presence of synthetic estrogen used in birth-control pills.⁷ The effects of pharmaceutical pollution are not limited to aquatic life. According to a report by Nature, overuse of the anti-inflammatory drug diclofenac in cattle brought vultures to the brink of extinction in Asia, as the drug was highly toxic to vultures who may have consumed it while feeding on the carcass of dead cows.⁸ Pharmaceutical pollutants in the environment have also been found to expedite the process of antimicrobial resistance (AMR), which is a major public health threat predicted to cost 10 million lives a year by 2050.⁹

In November 2016, German scientists found that water bodies in the direct environment of bulk drug manufacturing facilities in Hyderabad and nearby villages known as the Patancheru-Bollaram zone in India, were contaminated with antimicrobials or their active metabolites. This discovery became more worrying when the scientists found high levels of antimicrobial-resistant bacteria and fungi in various water bodies within that particular area. This situation comes to little surprise given the fact that the Patancheru-Bollaram zone has approximately 170 operational pharmaceutical companies, producing 50% of India’s pharmaceutical export.¹⁰

Current Efforts and the Way Ahead

One early initiative in the fight against pharmaceutical pollution was the European Commission’s Environmental Risk Assessment of Pharmaceuticals (ERAPharm). ERAPharm tracked the fate and effect of pharma products in the environment to educate and inform legislators.¹¹ However, despite recognition of the destructive impact the pharma industry has on the environment, the U.S. Food and Drug Administration and European Medicines Agency have not moved to include environmental standards in their good manufacturing practices guidelines.

Conversely, the UN and the World Health Organisation (WHO) have initiated a program called Green Procurement in the Healthcare Sector, which takes into consideration environmental pollution while procuring and delivering medicines. In Sweden, the Stockholm County Council implemented a classification system for pharmaceuticals that classifies drugs based on their environmental hazards and risks.¹² Furthermore, in 2016 the International Pharmaceutical Federation (FIP) introduced a document on Green Pharmacy Practice that takes responsibility for the environmental impact of medicines.¹³

Pharmaceutical industries have also taken initiative to create a circular economy. For example, Novo Nordisk has adopted a policy to minimize waste and pollution, keep products and materials in use, and regenerate natural systems. The company aspires to have zero environmental impact and to reach a point where the industry produces zero landfill, water, energy and material waste.¹⁴

Given the complexity of the challenge, the constant stream of new drugs on the market, and the growing demand for pharmaceuticals, it will be a long time before the issue of pharmaceuticals in the environment can be considered under control. We need to adopt green chemistry solutions, raise awareness, promote prudent drug use, improve waste-water treatment, and reduce emissions from pharmaceutical industries. A quote from an Indian woman freedom fighter has become highly relevant, vis-à-vis the global issue of pharmaceutical pollution:

“For a time, science and machinery may fetch huge returns for mankind, but ultimately will come desolation. We have got to study Nature’s balance, and develop our lives within her laws, if we are to survive as a physically healthy and morally decent species.”

-Mira Bhen, 1949.

References:

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8. Green, R. E., Donázar, J. A., Sánchez‐Zapata, J. A., & Margalida, A. (2016). Potential threat to Eurasian griffon vultures in Spain from veterinary use of the drug diclofenac. Journal of Applied Ecology, 53(4), 993–1003.
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11. Pharmaceuticals and Environment. (n.d.). European Commission. Retrieved 2020, from https://ec.europa.eu/health/human-use/environment-medicines_en
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13. International Pharmaceutical Federation. Green pharmacy practice: Taking responsibility for the environmental impact of medicines. The Hague, the Netherlands: FIP, 2015. http://fip.org/files/fip/publications/2015-12-Green-Pharmacy- Practice.pdf
14. Zero Environmental Impact. (n.d.). Novonordisk/Sustainable Business. Retrieved August 10, 2020, from https://www.novonordisk.com/sustainable-business/zero-environmental-impact.html