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The effects of pharmaceutical products in the water supply are not wholly known. This emerging risk must be assessed and mitigated. “Take two glasses of water and call me in the morning.” STEVE KNUTSON, A.V. RISWADKAR, JÜRG SCHMID, made contaminants that may be found in drinking water. US EPA, states, and water systems then work Recent investigations of drinking water samples from several cities and wastewater treatment facilities by the Associated Press national together to make sure that these standards are met. investigative team and other sources have detected What stands out in the Associated Press investiga-trace quantities of over 100 different pharmaceuticals tion — first published in March 2008 — is the focus and chemicals in drinking water supplies, including on trace amounts of several active pharmaceutical lakes and reservoirs all over the world.1 ingredients (API), ranging from antibiotics and con- Trace chemicals and pesticides have been detected traceptives to veterinary drugs and over-the-counter in water supplies in the United States for many years, pain medications. and drinking water standards regulate them. The Safe Research studies on the potential threat of a Drinking Water Act authorizes the United States group of contaminants originating from API and Environmental Protection Agency (US EPA) to set “pharmaceuticals and personal care products” (col-national health-based standards for drinking water lectively designated as PPCPs) to human health and to protect against both naturally occurring and man- the environment are limited. However, evidence from controlled experiments on fish and data taken reclaimed waste water from waste sites, demonstrat-from the wild raise a concern. Existing sewage and ing the widespread diversity of this problem in the waste treatment systems are not equipped to remove environment.
certain groups of PPCPs effectively. Since treatment Although PPCPs are a very diverse class of con- of drinking water is not able to eliminate these trace taminants, the following chemicals are of particular effluent streams from wastewater treatment plants, concern, as reported by EPA:PPCPs are entering the nation’s drinking water sup-plies. This has resulted in the launching of additional • antibiotics, investigations by several regulatory bodies, such as • antimicrobials, the US EPA.
Although the degree of risk has not been quan- • antidepressants, tified, the detection of trace quantities of PPCPs • calcium-channel blockers,raises concerns about the long-term consequences • cholesterol-reducing drugs,on human health. This article attempts to raise the • anti-epileptic drugs (e.g., phenytoin, valproate, awareness of this emerging risk arising from PPCPs in water resources and to encourage a collaborative • multi-drug transporters (efflux pumps), dialog between various stakeholders to seek practical • musk fragrances, and risk management solutions to this challenge. Mitiga- • genotoxic drugs.4 tion actions will need to balance the risks with the societal benefits.
Sources of PPCP Contaminants
Identification of PPCP in Water
There are many sources that contribute to the entry of PPCPs into water supplies. Some are associated “Pharmaceuticals and Personal Care Products in with drug and personal care products manufactur- the Environment: Agents of Subtle Change?”, pub- ing sites, while others arise from a diverse range of lished in Environmental Health Perspective in December end-use sources. 1999, was the first to label a group of contaminants EPA and other equivalent regulatory bodies regu- found in water as “pharmaceuticals and personal care late the waste streams from drug manufacturing sites products” or PPCPs.2 through permit issuance and monitoring protocols. Some examples in this large, diverse group of Yet the Associated Press investigation estimated that PPCPs include over-the-counter, prescription, and at least 271 million pounds of pharmaceutical waste veterinary drugs such as: are released into water streams for disposal. End-use sources, on the other hand, may be many known and unknown waste streams from household and institutional sources. The impact of these sources on the overall problem may be harder to quantify. • biopharmaceutics,• nutraceuticals and sweeteners, • unused and expired medications and personal care products improperly disposed of by households, • contraceptives and sex hormones.
hospitals, nursing homes, pharmacies, and other healthcare service providers, and The U.S. Geological Survey (USGS) conducted a national benchmark survey in 1999–2000 target- • unabsorbed medications and metabolites excreted ing the presence of 95 pharmaceuticals, hormones, through human and animal livestock bodies into and other chemical contaminants in the nation’s drainage and sewage treatment systems.
streams in 30 states.3 Eighty percent of the streams tested positive for one or more contaminants. USGS PPCPs may eventually enter water treatment also found pharmaceuticals in soils irrigated with plants. However, due to their extremely low con- centration and wide range of chemical and physical centrations of PPCPs, individually or in combination, properties, they may not be completely eliminated over time cannot be discounted. The ultimate risks by wastewater treatment processes and may leave may be dependent upon both the type and amount the plants with the effluent streams, and eventually, of specific chemicals. enter groundwater.5 There are other subtle, uncontrollable risk variables Other sources are industrial wastewater streams and with potential for adverse effects. Chemicals may leak water from waste deposits and defective munici- undergo structural changes when under the influ-pal sewage systems. PPCPs may also be eluted into ence of sunlight, oxygen, microorganisms, and other surface and groundwater from contaminated sludge environmental conditions, leading to metabolites from wastewater treatment plants that is disposed of with significantly differing properties. Synergistic on agricultural land. changes may occur due to a random combination of chemicals. Adverse consequences arising from PPCPs have already occurred. For example, it is known that fish living close to effluent streams of wastewater treat- ment plants undergo sex changes under the influence quantities of drugs and chemicals of ethinyl estradiol found in contraceptives. Another example is the effect on salmon of the insecticide diazionon, which has an impact on their signaling pathway and homing behavior with implications for Reportedly, a mass poisoning that killed millions of vultures may have indirectly claimed the lives of Veterinary drugs are another important source. an estimated 50,000 people in India.7 The cause is Dung from animals treated by pharmaceuticals is used suspected to be a veterinary drug called diclofenac, as fertilizer on agricultural land. After disposal, the which was routinely given to cattle. Although now ingredients can be eluted from the dung into surface banned for veterinary applications in India, diclofenac water or penetrate the soil to reach the ground- is still in use to some extent. Diclofenac is also re-water. Similarly, discarding dipping bath water used ported to damage liver, kidneys, and the immune for treatment of animals against parasites can lead system of trout at typical concentrations detected to locally high concentrations of active ingredients in surface waters.8in soil and water.
Resistant bacteria strains formed in soil, water, and host animals are points of concern. For example, birds, Threat to Health and Environment
which are natural influenza carriers, are exposed to trace amounts of Tamiflu in surface waters. Tamiflu’s The physiological, toxicological, and dose-response active form, oseltamivir carboxylate, is suspected properties of many of the bioactive chemicals in to support the formation of drug-resistant strains of specific pharmaceuticals are well known. However, influenza.9the actual risk to humans and to the ecosystem from In addition to the threat of adverse impacts to trace quantities of those same drugs and chemicals in human health, damages to ecosystems, such as drinking water sources is currently unknown.6 dimunition of biodiversity, can be considered a Recent calculations have shown that consuming major loss scenario with potentially strong financial several liters of water contaminated with typical con- consequences.
centrations of PPCPs over a person’s lifetime results
in an ingestion of significantly smaller amounts than Regulatory Agencies and PPCP Contaminants
consuming a daily dose of the corresponding drugs. The actual effects of long-term exposures ver- Various federal and state agencies are involved in sus small concentrations over time are unknown. regulation and research regarding the effects of con-Therefore, cumulative adverse impacts of low con- taminants in water on people and the environment.
Pharmaceuticals
advises consumers to take advantage of community Environmental risk analyses are part of the approval drug take-back or other household hazardous waste process for new drugs in regions such as the European collection events conducted by city or county local Union, the United States, and Canada. However, government. due to the very complex nature of ecosystems, such
environmental risk analyses can be challenging and Future Research
of limited value, diminishing their significance. The human health effects and ecotoxicity risks Within the European Union, environmental analyses from a majority of PPCPs in the environment have are required for the approval of both veterinary and not been studied systematically. Compared to any other classes of PPCPs, more data exists for the use Although the result of the environmental analysis and effect of antibiotics.
is part of the risk-benefit consideration for veterinary Future research will utilize the analytical ability to drugs in the European Union, it is not for human drugs. make measurements and dose estimations to determine Therefore, the approval of new drugs can be expected the effects of PPCPs in the water supply on the general even if possible risks to the environment are shown. population, but more importantly, on the most suscep- Such approval may include special requirements or tible groups: children, elderly, and immunosuppressed restrictions to mitigate the risks to some extent. individuals. In addition to the impact of PPCPs on safety and efficacy, the drug research and regulatory Environment
processes will also have to consider life-cycle impact The US EPA regulates “waste water” discharges as part of new drug clinical trials and approval.
into rivers and streams from point sources such as waste treatment plants, but does not regulate the presence of PPCPs in “treated water” discharges.10 Ensuring proper disposal of Drinking water supplies from intake points con- nected to drinking water reservoirs and from sources unused and expired drugs and in close proximity to discharge points of waste treat- pharmaceutical products in ment facilities are likely to contain PPCPs. Although surface water sources are more likely to have PPCP household waste continues contaminants, underground sources such as rural wells may not be immune.
In the United States, the Resource Conservation and Recovery Act (RCRA) regulates management
and disposal of solid and hazardous waste based on Risk Mitigation Strategies
ignitibility, corrosivity, reactivity, and toxicity and regulates disposal of pharmaceutical waste gener- Mitigation strategies for this emerging risk will ated by drug manufacturers and the health-care require cooperation and efforts at many levels that will help address sources of disposal of PPCPs into The RCRA does not regulate household waste. the waste stream, improvements in wastewater Ensuring proper disposal of unused and expired drugs treatment, and treatment of drinking water. 12 and pharmaceutical products in household waste
continues to be a challenge because there is no ef- Improving Wastewater Treatment
fective and convenient way for households to dispose Because effluents from wastewater treatment of unused and expired pharmaceutics and personal plants are a source of PPCPs flowing into the envi- ronment, optimization of the treatment processes The White House Office of National Drug Control could help reduce or prevent bioactive chemicals Policy released its first consumer guidance (“Proper from entering surface water streams and, finally, Disposal of Prescription Drugs”) in 2007 and updated spreading to groundwater. the guidelines in 2009.11 It discusses restrictions Classic wastewater treatment processes usually do on flushing prescription drugs down the toilet and not lead to a complete elimination of all dissolved PPCPs because of the contaminants’ wide range age and associated adverse health consequences of properties. Establishing additional physical or can provide an impetus for changes in disposal chemical steps to be taken following the usual practices and public expectation. At the consumer biological treatment may improve the elimination level, efforts must focus on education as well as on process. Such steps include charcoal treatments and finding effective and convenient ways to encourage ozonation. Charcoal treatments are already used in communitywide drug take-back programs. This will the chemical industry, but are not common in public probably require support of drug manufacturers and wastewater treatment plants. Ozonation is reported as pharmacies. The consumer guidance document pub-being an efficient method to reduce residual amounts lished by the White House Office of Drug Control of several chemicals and pharmaceuticals in bio- Policy is a first important step in the right direction. logically pretreated water. However, the formation Much more focused efforts will be needed.
of possibly toxic oxidation byproducts following Hospitals and health-care providers will have to ozone treatments is not currently understood. ensure segregation of PPCPs in their waste streams To remove even persistent contaminants, such as and proper disposal in compliance with RCRA regu- some contrast agents, a combination of additional lations. This also applies to veterinary drug sources,
treatments may be necessary. Lack of reliable in- including veterinarians and livestock operations.
formation about investments and operating costs
of these methods will require further investigation Expectations
Contamination of water with PPCPs is expected to become an increasingly adverse exposure due to a growing, aging world population and the increasing use of prescription and over-the-counter drugs.
arising from drugs in water is of Of special concern are urban areas with a high- density population that are discharging wastewater into small channels or rivers and regions with major livestock farming operations. However, the problem of PPCP contamination of drinking water customers, and other stakeholders. sources is much more widespread in most parts of Greater awareness of the problem, research on Improving Drinking Water Treatment
adverse health effects, and analytical ability to Since the current treatment of drinking water is measure low levels of PPCPs in drinking water are not able to eliminate the trace effluent streams from likely to present serious risk management challenges wastewater treatment plants effectively, the risk to many stakeholder groups, including the drinking of spreading PPCPs with consequential damage to water, wastewater treatment, pharmaceutical, and ecosystems is ineffectually mitigated. health-care segments. In addition to the impact on On the other hand, direct impact on the health of human health, damage to the ecosystem will also consumers by long-term exposure to contaminated be a cause of concern.
drinking water should be significantly reduced by Although removal of many of the contaminants current treatment methods. Several physical and in wastewater and drinking water may be possible chemical treatment processes are known to efficiently from a technical point of view, many constraints remove residual amounts in drinking water. Informa- will have to be taken into consideration. In many tion concerning operating costs and investments to areas of the world, insufficient wastewater treatment be made in establishing these methods on a full scale capacities, the absence of advanced drinking water is unavailable.
filtration capabilities, and the lack of willingness or capabilities for capital expenditures are significant End Users
limiting factors requiring a balanced and practical Greater awareness of potential ecological dam- solution for long-term risk management. Conclusion
Endnotes
The evolution of the issue of contaminants in 1. Donn, Jeff, Martha Mendoza, and Justin Pritchard, “AP water as a risk management challenge is largely in the IMPACT: Tons of Released Drugs Taint U.S. Water,” ABC early stages. PPCP impacts on health and the envi- News (April 19, 2009), available at http://abcnews.go.com/ ronment are not fully understood, and the potential for litigated allegations of negligence is subject to 2. Daughton, Christian G., and Thomas A. Ternes, “Pharma-conjecture. Yet the potential adverse impact arising ceuticals and Personal Care Products in the Environment: from drugs in water is of such significance as to war- Agents of Subtle Change?” Environmental Health Perspectives rant consideration by insurers, their customers, and Supplements 107, no. S6 (December 1999), available at http:// ehp.niehs.nih.gov/members/1999/suppl-6/907-938daughton/ Stakeholders can greatly influence outcomes through the implementation of strategies that mitigate 3. U.S. Geological Survey, “Toxic Substances Hydrology the adverse ingress of PPCPs to water resources, facili- Program: National Stream Reconnaissance” (updated May tate technological innovations in removing PPCPs 8, 2008), available at http://toxics.usgs.gov/regional/emc/ from water resources, and encourage improved end- user behaviors in the disposal of PPCPs. Mitigation 4. U.S. Environmental Protection Agency, “Pharmaceuticals actions will need to balance the risks with societal and Personal Care Products (PPCPs): Frequent Questions” benefits and will require a concerted effort among (updated October 8, 2009), available at http://www.epa.gov/ a wide range of industry groups and government at 5. Daughton and Ternes, id.
6. Ibid.
Resources
7. Walker, Matt, “Rabies tragedy follows loss of India’s vultures,” New Scientist 2668 (August 12, 2008), available at http://www.
1. U.S. Environmental Protection Agency, “Phar- newscientist.com/article/mg19926684.400-rabies-tragedy- maceuticals and Personal Care Products (PPCPs)” (updated October 8, 2009), available at http:// 8. Hoeger, Birgit, Bettina C. Hitzfeld, Bernd Köllner, Daniel R. www.epa.gov/ppcp/.
Dietrich, and Michael R. van den Heuvel, “Sex and low-level sampling stress modify the impacts of sewage effluent on the 2. U.S. Environmental Protection Agency, “Phar- rainbow trout (Oncorhynchus mykiss) immune system,” Aquat- maceuticals and Personal Care Products (PPCPs): ic Toxicology 75, no. 1 (October 5, 2005): 53–64, available at Frequent Questions” (updated October 8, 2009), http://kops.ub.uni-konstanz.de/volltexte/2008/4987/.
available at http://www.epa.gov/ppcp/faq.html.
9. Ghosh, Gopal C., Norihide Nakada, Naoyuki Yamashita, and Horoaki Tanaka, “Oseltamivir Carboxylate —the Active 3. Massachusetts Department of Environmental Metabolite of Oseltamivir Phosphate (Tamiflu), Detected in Protection, “Origins and Fate of PPCPs” (March Sewage Discharge and River Water in Japan,” Environmental 2006), available at http://www.mass.gov/dep/tox- Health Perspectives (September 28, 2009), available at www.
ehponline.org/members/2009/0900930/0900930.pdf.
10. By authority of the Clean Water Act and National Pollutant 4. U.S. Environmental Protection Agency, “Unused Discharge Elimination System (NPDES).
Pharmaceuticals in the Health Care Industry: 11. Office of National Drug Control Policy, “Proper Disposal Interim Report (August 2008), available at http:// of Prescription Drugs” (October 2009), available at www.
www.epa.gov/waterscience/guide/304m/2008/hsi- whitehousedrugpolicy.gov/publications/./prescrip_disposal.
12. Velagaleti, Ranga R., and Martin W. Winberry, “Risk As- 5. U.S. Geological Survey, “Toxic Substances Hydrol- sessment of Human and Animal Health Drugs in the ogy Program: National Stream Reconnaissance” Environment: A Chemical Fate — and Environmental (updated May 8, 2008), available at http://toxics.
Effects — Approach,” Environmental Toxicology and Risk As- sessment: Seventh Volume, ASTM STP 1333, eds. E.E. Little, A.J. DeLonay, and B.M. Greenberg (American Society for Jürg Schmid has been a senior risk engineer working for Zurich Testing and Materials, 1998). Risk Engineering in Switzerland since 2003. He has a Ph.D. in molecular biology from the University of Zurich (Switzerland). Steve Knutson, First Vice President and Director of Emerging He worked for several years at The Salk Institute (USA) and Issues, Zurich North America, has extensive experience in the then at the Swiss Federal Institute of Technology Zurich (ETH, commercial insurance industry. He currently directs Zurich North Switzerland) before joining Zurich Risk Engineering. America’s emerging issues management team consisting of Zurich North America’s most talented claims, legal, underwriting, and Florian Hiller is a senior risk engineer for Zurich Risk Engineer-risk engineering executives. He also serves on Zurich’s global ing in Switzerland. He has a Ph.D. in organic chemistry from emerging risk group. Both of these organizations develop and the Technische Universität Dresden (Germany). He worked for execute strategies and positions to address emerging issues.
several years in the chemical industry before joining Zurich Risk Engineering in Switzerland.
A.V. Riswadkar is a product liability director for Zurich Ser-
vices Corporation. He holds a B.S. in mechanical engineering Disclaimer:
and an M.S. in industrial engineering. He has extensive con-
The information in this article was compiled from sources be- sulting experience in product safety and liability loss control lieved to be reliable for informational purposes only. Any and and prevention. His areas of expertise include identification all information contained herein is not intended to constitute and assessment of emerging risks for product and process legal advice and accordingly, you should consult with your own safety, product warnings, and instruction manuals. Riswadkar attorneys. We do not guarantee the accuracy of this information has published numerous articles on matters related to product or any results and further assume no liability in connection with safety and liability in publications such as Best’s Review, Profes- this article, including any information, methods or suggestions sional Safety, Food Quality, Machine Design, and The John Liner contained herein. The subject matter of this publication is not Review. Riswadkar is a certified quality engineer (CQE) and tied to any specific insurance product nor will adopting these certified quality auditor (CQA). He is also a certified safety policies and procedures ensure coverage under any insurance professional (CSP) and holds the Associate in Risk Manage- policy. Risk engineering services are provided by Zurich Services Reprinted with permission from The John Liner Review, Copyright 2010, Standard Publishing Corp., Boston, MA.

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