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The problem
Since the mid-1990s, news headlines about “drugs in the water” have alerted the public to an unsettling public health risk. Trace amounts of pharmaceuticals have been detected in Canada’s lakes, rivers, streams and tap water. Other chemicals from food and drug products -- including food additives and the ingredients of toiletries -- have also been detected, as have veterinary and agricultural chemicals.
New biologics, genetic therapies and genetically modified foods are more recent-comers that could end up in this “chemical soup”. The health impacts on humans are not known, but deformities in the reproductive systems of marine life show that some chemicals contaminating the environment are not benign, despite the very low concentrations that have been detected.
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Full Circle: Drugs, the Environment and Our Health
24,000 drugs are approved for human and veterinary use in Canada - some of these are being found in wastewater and agricultural runoff .
A wide variety of substances contained in pharmaceuticals and personal care products have been found in the environment, as documented in recent studies in Europe and the United States.
Municipal sewage and agricultural and aquaculture wastes have been identified as sources of pharmaceuticals and personal care products, such as antibiotics, blood lipid regulators, analgesics, anti-inflammatories, antiepileptics, natural and synthetic hormones, fragrances (musks), nonylphenol ethoxylates, disinfectants and antiparasiticides.
Environment Canada
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The ubiquitous worldwide use of pharmaceuticals has led to the first realization that the seemingly minute contributions from multitudes of individuals can combine to result in measurables levels of newly recognized pollutants in the environment.
The active ingredients from medications and other pahrmaceutical preparations can pose risks beyond those associated with their intended uses in therapy, diagnosis or prophilaxis.
These unintended risks comprise two major categories(1) introduction to the environment as trace pollutants by the combined actions and activities of individuals resulting in chronic low-level exposure for wildlife and humans(e.g. via recycling in drinking water) and (2) their involvement in exposure to wildlife and humans at acute doses, primarily from special situations involving imprudent disposal and from accidental or purposeful ingestion by individuals for whom the medications were never intended. (e.i., drug diversion).
Each of these two major categories comprises several sources or origins. Active pharmaceutical ingredients (APIs) enter the environment by way of: (1) the excretion of unmetabolized API ( as well as bioactive metabolites), (2) release from the skin during bathing ( form medications applied dermally or from residues excreted through the skin via sweat [Daughton and Ruhoy 2008 submitted], (3) disposal to sewerage or trash of unwanted, unused, leftover medications, and (4) animal carcasses containing high levels of certain drugs (these tainted carcasses can contain high levels of APIs that are acutely toxic to animal scavengers [Daughton 2007].Drug Use and Disposal- Daughton, November 2008
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The Eco-Solution
According to Halifax-based researcher and health activist, Sharon Batt, the most health-promoting, cost-effective strategy for everyone is prevention: reducing inappropriate use, over-use and abuse are strategies that would improve health and mortality while also saving money.
Similarly, reducing the vast quantity of unused drugs and disposing of any unavoidable excess safely is more ecological and economical than trying to filter them from the water after the fact. These “upstream” approaches also have the advantage that they can be implemented almost immediately. Other approaches, such as improved filter systems and redesigned products, will take time and resources.
This approach is also proposed by Christian Daughton, Chief, Environmental Chemistry Branch, EPA, in his study Drug Usage and Disposal.
Long overlooked in the debate surrounding drug disposal is the larger imperative to reduce or eliminate the need for disposal in the first place. Drugs accumulate unused for a wide variety of reasons, each of which presents opportunities for reducing the need for disposal. These reason that range from patient non-compliance ( which itself has a plethora of causes), inefficient oversight of the prescription process by physicians, imprudent dispensing pratices by the retail pharmacy and insurance industry, and wasteful packaging by manufacturers.
To minimize or eliminate the occurence of leftover drugs represents a much more efficient way to deal with the many problems faced by the need for drug disposal. Preventing the need for disposal in the first place not only eliminates the resources required for environmentally sound drug disposal programs, but also serves to conserve and make more efficient use of medications for their intended purpose.
The Red Tape
Canada
In September 2001, Health Canada launched the Environmental Assessment Regulations Project (EARP), under the auspices of its Office of Regulatory and International Affairs. Designed to address the health and environmental effects of PPCPs, the program has three parts: 1) regulations to protect the environment from PPCPs; 2) a scientific research program; and 3) best practices and public education programs.
EAR Project documentation suggests a vision which meets many of the criteria for a model public health initiative. The project is to interpret health protection broadly, including harmful effects on the environment or its biological diversity, as well as direct human health impacts. The proposed decision-making strategy will incorporate the precautionary principle, which means protective action can be taken before harm has been demonstrated with scientific certainty.
Prevention is to take precedence over mop-up, “avoiding the creation of pollutants rather than trying to manage them after they have been created.”9A commitment to open discussion invites the public’s participation in solving the problem.
To date, much of the government’s work falls short of these ideals. Smiling faces of Canadians adorn EARP documents, yet the program lacks a “big picture” vision that would engage the public and put the components in perspective. A key discussion paper closes non-specialists out of the dialogue with technical language and a legalistic emphasis on a regulatory framework.
The proposed scientific program is narrowly toxicological, aimed at measuring substances and their effects, rather than preventing them from entering the environment. The highly technical research agenda also limits opportunities for public participation. The public consultation process has been dominated by the pharmaceutical and biotech industries, a fact reflected in the concerns stakeholders most often expressed: that the regulations will slow down the introduction of new substances onto the Canadian market and affect international trade.
Full Circle
At the moment, only British Columbia, Alberta and Saskatchewan have comprehensive programs that encourage consumers to return unused drugs to pharmacies. Other provinces should follow suit. The National Association of Pharmacy Regulatory Authorities (NAPRA) has shown leadership on this issue, but in order to succeed, programs need support from industry groups, medical associations and federal and provincial governments.
United States
The focus in the US has remained on how to best dispose of drugs using ecologically sound disposal practices.
To date, this has been done with relatively inefficent one-time community collection events or in-place local programs that vary in their scope and design across geoggraphic locales.
The EPA is currently evaluating a pilot demonstration of one approach that may prove more sustainable and could be implemented nationwide - designed to make use of the US Postal Service. A second pilot program involves the return of consumer medications through a pharmaceutical reverse distribuotr via UPS. While consumer take-back programs are a relatively new concept in the U.S., they have been in place in Europe for over 30 years.
To shift the emphasis of the discussion away from disposal and toward the many aspects of pollution prevention will require an open dialog between experts from the healthcare communities and from the environmental science community.
The Healthcare Dimension
In hospitals, pharmaceutical waste is generally discarded down the drain or landfilled, except chemotherapy agents, which are often sent to a regulated medical waste incinerator. These practices were developed at a time when knowledge was not available about the potential adverse effects of introducing waste pharmaceuticals into the environment.
Proper pharmaceutical waste management is a highly complex new frontier in environmental management for healthcare facilities. A hospital pharmacy generally stocks between 2,000 and 4,000 different items, each of which must be evaluated against state and federal hazardous waste regulations. Pharmacists and nurses generally do not receive training on hazardous waste management during their academic studies and safety and environmental services managers may not be familiar with the active ingredients and formulations of pharmaceutical products.Practice Green Health
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Few of the country's 5,700 hospitals and 45,000 long-term care homes keep data on the pharmaceutical waste they generate. Based on a small sample, though, the AP was able to project an annual national estimate of at least 250 million pounds of pharmaceuticals and contaminated packaging, with no way to separate out the drug volume.
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One thing is clear: The massive amount of pharmaceuticals being flushed by the health services industry is aggravating an emerging problem documented by a series of AP investigative stories — the commonplace presence of minute concentrations of pharmaceuticals in the nation's drinking water supplies, affecting at least 46 million Americans.USA Today
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The Water Treatments
While scientists have not definitively established that people are harmed by these drugs, laboratory tests have shown tiny amounts can have ill effects on human cells. And the fact that they are being consumed in combination, over many years — at any level — worries some researchers.
If those fears are borne out by future studies, it could lead communities and water providers to spend hundreds of millions of dollars on more advanced treatments to improve on the commonplace regimen of filtration and disinfection with chlorine.
A large-scale reverse osmosis system is expensive. It costs Orange County about one-eighth of a penny per gallon — or $15 month for the 12,000 gallons used by a typical family of four, a price that doesn’t include overhead charges, such as construction, salaries and maintenance.
Officials at the Greater Cincinnati Water Works say their granular activated carbon filtering system costs 93.6 cents per month for the typical family of four.
Following a parasitic outbreak, the Southern Nevada Water Authority in Las Vegas — which processes up to 900 million gallons daily at two treatment plants — invested millions of dollars in a different advanced system that dissolves ozone gas into water to destroy micro-organisms.
The cheaper ozonation process isn't designed to remove pharmaceuticals, though it does take care of many compounds.
Tests at the Nevada authority have shown that tiny concentrations of the tranquilizer meprobamate and an anti-epileptic drug regularly resist the treatment, as on occasion has carbamazepine, another anti-convulsant.
At the Metropolitan Water District of Southern California, which serves 18.5 million people, tests at one of its five plants show that ozonation failed to remove a tranquilizer and an anti-epileptic drug from the finished drinking water, according to an ongoing study.
That district and the Southern Nevada Water Authority both draw from the Colorado River, which, tests show, can contain several hundred parts per trillion of pharmaceuticals, including the active ingredients in medicines to treat depression and anxiety.
The drugs get there because wastewater plants that drain into the river use basic treatments designed to remove microbes and industrial contaminants, not pharmaceuticals — the same scenario in many rivers nationwide.
Even in Europe, where governments have gone much further in addressing trace levels of pharmaceuticals in the environment, there’s scant political will to invest broadly in advanced wastewater treatment.
“The cost isn’t acceptable right now,” Yves Levi, a pharmacist and professor of public health at Paris-South 11 University, said in an interview in French. “No one knows if the risk is considerable or not.”
Another advanced process at drinking water treatment plants, the use of carbon filters, also lets some pharmaceuticals through.
Some of the most detailed testing was done at the Passaic Valley Water Commission in Northern New Jersey, where a drinking water treatment facility downstream from numerous sewage treatment plants chemically removes sediments from water, then disinfects it with chlorine and runs it through the extra filtering step.
Although the treatment decreased pharmaceutical concentrations, some samples heading into drinking water pipes contained all or some of the following: the painkiller codeine, an anticonvulsant drug, the remnants of a drug to reduce chest pains and caffeine.
Lead researcher U.S. Geological Survey hydrologist Paul Stackelberg said he expected tests at the same type of treatment plant anywhere in the nation would produce similar results.
“It’s very easy to use all of the products that we use in our daily lives and not think twice about it,” Stackelberg said.
Stackelberg also raised an X-factor: Rather than obliterating some pharmaceuticals, chlorination could chemically transform them into compounds that are even more toxic.
In one lab study, scientists found that acetaminophen, after undergoing chlorination, reacted to form tiny amounts of two known toxic compounds — 1,4-benzoquinone and N-acetyl-p-benzoquinone imine, the latter being associated with acetaminophen overdoses.Free Drinking Water
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