Big Pharma’s Drugs in Our Water Supply, A Big Problem
Papers published in scientific journals describe fish and birds responding with altered behavior and reproductive systems to antidepressants, diabetes medication and other psychoactive or hormonally active drugs at concentrations found in the environment.
They report on opioids, amphetamines and other pharmaceuticals found in treated drinking water; antibiotics in groundwater capable of altering naturally occurring bacterial communities, and over-the-counter and prescription drugs found in water leeching from municipal landfills.
Studies are now examining the countless pharmaceuticals being found just about everywhere scientists have looked for them in our environment.
Just how many drugs are in use and how many may be detectable in the environment is difficult to know. But, according to the US Centers for Disease Control and Prevention (CDC), US healthcare providers order or provide millions of drugs each year.
Regulatory and health authorities, including the US Environmental Protection Agency, the FDA and the World Health Organization (WHO), have claimed that levels of individual pharmaceutical compounds being measured environmentally, typically in water have not been shown to harm human health.
But, many individual scientists, as well as the European Commission (EC) and other groups, are expressing concern about potential effects of the mixture of pharmaceutical chemicals present in the environment.
The USGS has been studying pharmaceuticals since the 1990’s, and is concerned about the consequences; for plants, animals and naturally occurring bacteria as well as human health, of long-term, low-level exposure to the various types of compounds being detected.
About 90% of pharmaceuticals found in the environment arrive there after being excreted from humans and livestock.
The Big Q’s: Where are these compounds coming from? How do we know if they pose hazards to people or the natural systems on which we depend? What’s being done to address concerns about the ubiquitous presence of so many drugs in the environment?
Of these excreted compounds, antibiotics are a particular source of growing concern given the rise of antibiotic resistance
The recent rapid increase in antibiotic use in humans and on livestock has reduced these drugs’ effectiveness as bacteria evolve to tolerate frequently used antibiotics, a problem that can be compounded by their presence in the environment.
Another 10% of the pharmaceuticals in the environment come from discarded medicine and effluent releases at pharmaceutical manufacturing sites. Many of those discards and much of that effluent also ends up in water, either as runoff from landfill or discharge from factories.
While most of the world’s urban wastewater goes to treatment plants, typical waste and drinking-water treatment methods are not designed to remove pharmaceuticals.
In a Y 2011 report, WHO estimated that depending on the method, conventional water treatment plants might remove anywhere from less than 20 to more than 90% of the pharmaceuticals compounds present.
That treatment plants do not target drugs is actually not surprising in the United States, where there are no drinking water quality standards for pharmaceuticals.
Only about 10 drugs are included on the EPA’s “contaminant candidate” list of pollutants being considered for possible regulation.
But none is regulated, meaning there are no set limits on what’s considered a safe level in drinking water. This makes it very hard when local water utilities report on pharmaceuticals they find in their systems to know what the reporting actually means or what to do about it.
The use of pharmaceuticals is growing worldwide, so it is no surprise that scientists are finding more of them in our environment, and detection is also on the rise.
As increasingly sophisticated environmental testing methods have become available in recent years, what have come to be called micro-pollutants and emerging contaminants, a category that includes pharmaceuticals have started to be detected with precision.
Analytical chemistry has progressed from being able to detect parts per million to parts per billion to parts per quadrillion.
Pharmaceuticals being measured in the environment in small concentrations can produce biological effects when those levels are tested in controlled experiments.
Yet impacts at infinitesimal levels are increasingly what studies are finding. Pharmaceuticals being measured in the environment in small concentrations can produce biological effects when those levels are tested in controlled experiments.
University of Wisconsin researchers recently discovered that levels of the antidiabetic drug metformin comparable to those found environmentally caused male fathead minnows to develop intersex gonads.
Scientists in the UK have found that concentrations of the antidepressant fluoxetine (sold under various names, including Prozac) found in environmental samples altered behavior of starlings in an experimental study. Others in Sweden found similar results when fish were exposed to levels of another psychoactive drug, oxazepam, at levels found in wastewater samples.
Government regulators stress the lack of evidence that such levels are harming human health on an acute basis some scientists note that monitoring drugs at low levels is important for understanding possible long-term effects.
Having as much detailed data as possible will help scientists figure out what might be happening at a population level, rather than only to isolated individuals.
This type of detailed information about individual drugs also will help pinpoint which pharmaceuticals to target for removal. Additional studies are needed to guide regulators toward improving monitoring and treatment.
This is a big problem that is getting bigger.
What is needed is a more comprehensive grasp of exactly what’s out there and how big of a problem various pharmaceuticals pose in terms of human and environmental health impacts.
As the Natural Resources Defense Council noted in a Y 2009 white paper that there are large data gaps in this area, exact volumes of drugs used, relative contributions from humans and livestock and a full accounting of what drugs are in the environment.
Many studies document the presence of drugs, but so far in the US no data yet yield an overall picture. New studies forthcoming from USGS and the EPA may begin to fill in those blanks.
When it comes to assessing a drug’s environmental impacts, things get complex.
To understand what the environmental and health ramifications of a particular pharmaceutical may be, regulatory agencies in both the US and Europe rely on information that comes from drug manufacturers.
In the US, pharmaceutical manufacturers must submit this information to the FDA as part of the drug registration process.
This environmental assessment (in Europe called an environmental risk assessment) includes information about the drug’s ecotoxicity at various concentrations and about its effects on various aquatic organisms. The information is then correlated with manufacturers’ projections of production, sales and use volume to estimate what potential environmental impacts will be.
A study by a group of Swedish and UK researchers found 83% of ERA’s produced in Y’s 2011 and 2012 to be either lacking in data or incomplete.
To improve efficiency in understanding potential problems, the study suggested grouping risk assessment for similar compounds rather than relying on the current compound-by-compound approach. Among its other recommendations is the inclusion of information about a drug’s potential contribution to antibiotic resistance.
Drug categories receiving particular attention from the FDA are hormonally active compounds, antibiotics and what the FDA calls “high volume” drugs — those used frequently. In April the FDA proposed guidelines about whether manufacturers will have to submit environmental assessments with applications for new drugs with hormonal effects. This points to the concern with hormonally active drugs.
What is being proposed wouldn’t necessarily prevent such compounds or their breakdown products from ending up in local water sources.
Given the demonstrated and potential impacts on our environment, unused and unneeded drugs should go into take-back programs. In the EU, take-back and collection programs are required by law, not so in the US.
In the US, the Drug Enforcement Administration (DEA) has offered 2X-yearly collections that since Y 2010 have collected more than 4.8-M pounds of prescription drugs.
But there are logistical challenges for both recipients and contributors:
- Collectors of unwanted drugs, typically healthcare facilities, pharmacies and law enforcement offices, must be authorized by the DEA and arrange for proper handling of the unwanted drugs, and such facilities may not be conveniently located for drop-off.
- Drug manufacturing offers another opportunity for reducing release of pharmaceuticals to the environment. Although manufacturing’s contribution to pharmaceutical pollution is comparatively small, it can create “hot spots” of pollution. For example, near Hyderabad, India, a major production site for generic drugs, researchers testing wastewater treatment plant effluent found levels of several antibiotics that Zorzet described as being comparable to those that would be prescribed for treatment.
- Pharmaceutical companies are also working to improve their manufacturing processes’ environmental footprint, not just at the end of the pipe but also by moving to Green chemistry solutions. To reduce such emissions, the industry is working to develop and implement what are being called “Ecopharmacostewardship” guidelines.
The goal is to work with facilities and suppliers around the world to achieve the general standard of ‘no discharge of APIs (active pharmaceutical ingredients) in toxic amounts.
The US FDA notes that pharmaceutical companies are also working to improve their manufacturing processes’ environmental footprint, not just at the end of the pipe but also by moving to “Green Chemistry” solutions.
Those include both more efficient drug production and designing drugs that will bio-degrade more efficiently or that are effective as intended but minimize by-products that will be excreted and end up in our environment.
Meanwhile, wastewater treatment plants are exploring possibilities for boosting their ability to remove pharmaceuticals from sewage.
Concerted and substantial work also is underway in the pharmaceutical industry to make manufacturing processes more efficient given that, historically, the industry was known for inputs like raw materials and energy at volumes that dwarfed the volume of the finished product.
Options range from treating water with ozone to enlisting the assistance of microbes.
But, as the 2011 WHO report cautions, “Advanced and costly water treatment technology will not be able to completely remove all pharmaceuticals to concentrations less than the detection limits of the most sensitive analytical procedures at all times.”
Have a terrific week.