Express Pharma

From pills to pollution: Need for eco-pharmacovigilance to safeguard environmental sustainability

John Praveen, Associate VP - Pharmacovigilance and Medical Writing Portfolio Delivery Lead & PV/MW Shared Services Offering Lead, Accenture highlights strategies needed to protect our environment and biodiversity

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In today’s world, pharmaceuticals are integral to modern medicine, saving lives and improving the quality of life for millions. However, the environmental footprint of these drugs is often overlooked, despite increasing evidence that pharmaceutical residues in the environment have harmful and far-reaching effects on ecosystems. An emerging field called eco-pharmacovigilance is tackling this issue, focusing on understanding, and mitigating the environmental impact of pharmaceutical pollutants. In this article, we explore why eco-pharmacovigilance is vital, the risks associated with pharmaceutical pollution, and the strategies needed to protect our environment and biodiversity.

What is eco-pharmacovigilance?

Eco-pharmacovigilance is a multidisciplinary field that combines pharmacology, toxicology, and environmental science to assess the effects of pharmaceutical residues on wildlife, ecosystems, and environmental health. While traditional pharmacovigilance is concerned with monitoring the safety of drugs for human populations, eco-pharmacovigilance expands this focus to include the impact of these substances on humans (indirect exposure), non-human species and natural systems. The rapid global consumption of pharmaceuticals has led to their widespread presence in natural environments—water bodies, soils, and sediments. Drugs can enter the environment through a variety of pathways: improper disposal of unused medications, agricultural runoff, wastewater treatment plant effluent, and the excretion of unmetabolised drugs by humans and animals. Over time, these pharmaceutical residues accumulate in the environment, posing serious risks to biodiversity, contributing to the rise of antimicrobial resistance (AMR), and disrupting delicate ecological balances.

Pathways of pharmaceutical pollution

Pharmaceuticals enter the environment through several main routes, each exacerbating the growing issue of contamination in our water, soil, and air. The sources of pharmaceutical pollution include:

  1. Wastewater and sewage: When people and animals excrete medications, these compounds end up in sewage systems. Traditional wastewater treatment plants (WWTPs) are not designed to remove pharmaceutical residues effectively, allowing drugs such as antibiotics, painkillers, and hormones to flow into rivers, lakes, and coastal waters
  2. Agriculture and veterinary use: Pharmaceuticals used in farming, particularly antibiotics and hormones for livestock, also contribute to environmental pollution. These substances enter ecosystems through agricultural runoff, fertilizers, and irrigation. The overuse of veterinary antibiotics is particularly concerning as it promotes the development of AMR, a growing global health threat. 
  3. Improper disposal: A significant but often ignored source of pharmaceutical pollution is the improper disposal of unused or expired medications. Flushing pills down the toilet or tossing them into the trash can result in these drugs contaminating water and soil, spreading across vast areas and entering aquatic food chains.
  4. Pharmaceutical manufacturing: Pharmaceutical factories, especially in countries with weaker environmental regulations, can release untreated or inadequately treated waste into nearby water sources, leading to local pollution that harms ecosystems and wildlife.

The human health risks of pharmaceutical pollution

While the environmental consequences of pharmaceutical residues are alarming, they also pose direct threats to human health. These risks primarily stem from exposure to low levels of pharmaceutical pollutants in drinking water, food, and soil. Some of the most pressing public health concerns include:

  1. Antimicrobial resistance (AMR): One of the most serious risks linked to pharmaceutical pollution is the rise of AMR. Antibiotics and other antimicrobial drugs that enter the environment contribute to the spread of resistant bacteria. These drug-resistant microbes can thrive in contaminated water and soil, potentially leading to serious infections in humans that are harder to treat with existing medications. The World Health Organization (WHO) has identified AMR as one of the greatest threats to global health, and pharmaceutical pollution is a significant driver of this issue.
  2. Endocrine disruption: Certain pharmaceutical residues, such as hormones and antidepressants, can act as endocrine-disrupting chemicals (EDCs). These substances interfere with the hormonal systems of both humans and wildlife, leading to a range of health problems. For example, exposure to synthetic estrogens in birth control pills or hormone replacement therapies has been linked to reproductive issues, cancer risks, and altered sexual development.
  3. Chronic low-level exposure: Even low levels of pharmaceutical residues can have cumulative, long-term health effects. Prolonged exposure to medications like antidepressants or nonsteroidal anti-inflammatory drugs (NSAIDs) has been associated with neurological disorders, kidney damage, and gastrointestinal issues. Although individual doses may be harmless, long-term exposure through food or drinking water could have serious consequences.
  4. Bioaccumulation: Pharmaceutical pollutants can bioaccumulate in the food chain, particularly in aquatic organisms. Fish that ingest contaminated water can accumulate pharmaceutical residues in their tissues, which are then passed on to humans when consumed. This bioaccumulation can lead to chronic health problems, especially if the drugs persist in the environment and accumulate at higher trophic levels.

Environmental impact on flora and fauna

The environmental impact of pharmaceutical residues on flora and fauna is significant and increasingly concerning. Pharmaceuticals, when released into the environment through wastewater, agricultural runoff, or improper disposal, can disrupt ecosystems in various ways:

  1. Aquatic organisms: Exposure to pharmaceuticals, especially estrogen-like compounds, can have severe effects on aquatic life. For example, research has shown that male fish exposed to substances like ethinylestradiol, a synthetic estrogen found in birth control pills, become feminised. This leads to skewed sex ratios and reduced fertility, threatening fish populations. A notable case occurred in the UK’s River Aire, where fish populations showed signs of feminisation due to the presence of synthetic hormones.
  2. Soil microbes: Antibiotics in soil can disrupt microbial communities essential for nutrient cycling. For instance, the antibiotic ciprofloxacin has been found to reduce microbial diversity in soil, impairing nutrient uptake by plants and diminishing soil fertility. This can affect plant health, crop yields, and the overall productivity of ecosystems.
  3. Terrestrial wildlife: Animals that consume contaminated plants or prey risk bioaccumulation of pharmaceutical substances. For example, predatory birds consuming fish exposed to pharmaceuticals may accumulate harmful levels of toxins, affecting their health and reproduction. A study of bald eagles in the Great Lakes found that exposure to PCBs and other pollutants, including pharmaceuticals, led to thinning eggshells and reproductive failure. 

These examples underscore the cascading effects of pharmaceutical pollution on ecosystems, highlighting the need for better waste management and pollution control measures.

Monitoring and surveillance: Key to eco-pharmacovigilance

Monitoring pharmaceutical contamination is critical for understanding its extent and impact. Current monitoring efforts use a variety of techniques, but challenges persist due to the complexity and widespread nature of pharmaceutical pollutants.

  1. Detection methods: Advanced techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS) can detect pharmaceutical residues at very low concentrations. However, these methods are expensive and require specialised equipment and expertise.
  2. Biomonitoring: Using living organisms, such as fish, algae, and invertebrates, as bioindicators can help assess ecosystem health. These organisms are often the first to be affected by pharmaceutical pollution, making them valuable tools for early detection.
  3. Global surveillance: Organisations like the US EPA and the European Union have established monitoring guidelines, but surveillance remains inconsistent across regions. Greater international cooperation and better data-sharing platforms are needed for more effective tracking of pharmaceutical pollution.
  4. Data integration and modelling: Tools like Geographic Information Systems (GIS) and environmental modelling can help predict the spread of pharmaceutical contaminants and their long-term effects. These models can guide regulatory decisions and mitigation strategies.

Eco-pharmacovigilance: A strategy for regulation and risk assessment

As pharmaceutical pollution continues to grow, a coordinated approach to eco-pharmacovigilance is essential. This includes: 

  1. Environmental risk assessment (ERA): ERA evaluates the potential risks of pharmaceuticals to the environment, considering factors like drug persistence and bioaccumulation. Regulatory authorities can use ERA to develop guidelines for pharmaceutical use, disposal, and regulation.
  2. Data collection and surveillance: Ongoing data collection and monitoring are essential to track pharmaceutical contamination and its impacts. Collaborative, long-term surveillance programs can identify trends, emerging pollutants, and potential ecological risks.
  3. Public awareness: Public education campaigns can help raise awareness about the environmental risks of improper pharmaceutical disposal and encourage responsible waste management practices.

Mitigation strategies: Reducing pharmaceutical pollution
Several strategies can help reduce pharmaceutical pollution and its harmful effects:

  1. Improved waste management: Educating consumers about proper pharmaceutical disposal and investing in advanced wastewater treatment technologies can reduce the amount of pharmaceutical waste entering the environment. 
  2. Green chemistry and sustainable drug development: Pharmaceutical companies can adopt sustainable manufacturing practices, using biodegradable compounds and energy-efficient processes to minimise environmental harm. 
  3. Stronger regulations: Governments must enforce stricter regulations on pharmaceutical testing and manufacturing, ensuring that environmental impact assessments are part of the approval process for new drugs.

Eco-pharmacovigilance is essential for understanding and mitigating the environmental risks of pharmaceutical residues. As the global demand for pharmaceuticals continues to rise, we must take proactive steps to ensure that the benefits of modern medicine do not come at the expense of our planet’s health. By improving monitoring, regulation, and public awareness, we can reduce the environmental footprint of pharmaceuticals and work towards a more sustainable future where human health and environmental preservation go hand in hand.

 

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