Pharmaceuticals are Redefining the Environment

Pharmaceuticals are Redefining the Environment
July 6, 2020 No Comments Brave New World Apara Sharma

You Are Polluting Your Water: How Pharmaceuticals are Redefining the Environment 

By Tanmayee Talla

Pharmaceutical pollution in water is a widely known pressing issue but a less often acknowledged one. Pharmaceutical drugs help humans, animals, and aquatic life overcome the most deadly diseases. Yet, the improper disposal of these pharmaceuticals is what is posing a huge threat to society. When Pharmaceuticals enter into the waterways, they are destroying aquatic life and have the potential to very seriously affect humans. This paper is written in an attempt to restart research, conversation, action on this pressing issue of pharmaceutical pollution in our water. This paper will present factual information on how pharmaceuticals are getting into the water, who is contributing to the pollution, systematic monitoring practices and filtration methods, and regulations on pharmaceuticals. Ethical dilemmas of personal responsibility regarding pollution, responsibility for educating society, and access to clean water without pharmaceuticals will be analyzed and discussed throughout this paper.


Table of Contents


Abstract

Pharmaceutical pollution in water is a widely known pressing issue but a less often acknowledged one. This paper will focus on the ethical implications of pharmaceutical pollution in water and aims at the overlooked aspects of this pressing topic. Pharmaceutical drugs help humans, animals, and aquatic life overcome the most deadly diseases, yet they are coming back to harm life. However, they are a part of what is causing water, a finite resource, to become more polluted day by day. But, how are these pharmaceuticals getting there? Not only are pharmaceutical companies dumping thousands of tons of pharma waste into waterways annually, but consumers, physicians, and many more also contribute to this pollution. While in drinking water, there is only a small amount of pharmaceutical pollution, it is not nonexistent. It’s only a matter of time until the ramifications of drinking tainted water begin to show in human health. 

The root of this issue of pharmaceutical pollution is that there is a lack of regulation in pharma waste disposal– the federal government has not yet defined pharmaceuticals as pollutants. So, in the absence of legal standards defining pharmaceutical products as pollutants, who is responsible for the destruction of biodiversity in water as a result of pharmaceutical pollution? Should the individual consumer or patient who receives medicine be held responsible? If changes are made to water filtration systems to filter out pharmaceutical chemicals, who has access to clean water? Should they have to choose between the present issues or future consequences regarding pharma? 

Furthermore, having access to water is a fundamental human right. So regardless of the amount of pharmaceuticals in water, at any given concentration, do we truly have access to clean water? These complex questions and their nuances will be discussed in this paper. The problems and impending problems of pharmaceutical pollution are still looming, and no changes have been made. This paper is being written as an attempt to restart research, conversation,  and action on this pressing issue of pharmaceutical pollution in our water.


Pharmaceuticals in the Waterways

How Pharmaceuticals Enter the Waterways

Pharmaceuticals enter the water in various ways. The most prevalent and potent form of pharmaceutical pollution in the waters is when the companies dump large amounts of pharmaceutical waste drugs into the sewers or nearby small waterways. A study done from 2004 to 2009 by the United States Geological Survey, USGS, showed that wastewater treatment plants receiving a discharge from pharmaceutical manufacturing companies had 10 to 1,000 times higher concentrations of pharmaceuticals than those that had not received PMF (Pharmaceutical Manufacturing Facilities) discharge (USGS). In the absence of legal standards, the levels of uncontrolled pharmaceutical pollution have reached very high levels. One recent news article reported that companies, including pharmaceutical manufacturers, have legally released 271 million pounds of pharmaceuticals into various water bodies, and some of the water bodies serve as drinking water sources (Leitman). Without strict regulations on waste disposal, the pharmaceutical industry has free reign on how they choose to dispose of their medication– and most often, this disposal happens into the waterways. 

Pills Being Dumped  Author: Arek Socha 

  Also, in America, there is a widespread practice of flushing pharmaceuticals (drugs) down the toilet when they expire, or the owner wants to dispose of them. Through the sewage system, the medicines then enter into local waterways. Moreover, humans and their metabolizing of pharmaceuticals is another contributor to pharmaceutical pollution in the waterways. Drugs taken by people are not entirely metabolized. So when humans excrete, they are expelling parts of the metabolized drugs, but also the non metabolized drugs. These drugs and metabolites end up in the sewage system and wastewater plants and make their way into the waterways. A study published in The Journal of Xenobiotics found that there were significant amounts of pharmaceuticals making their way into the waterways through non-metabolized forms in human waste. 

” According to an investigation, the consumption of pharmaceuticals, i.e., 836 ton of acetylsalicylic acid [non-steroidal anti-inflammatory drugs (NSAIDs)], 622 ton of paracetamol (NSAIDs), 517 ton of metformin (antidiabetic), 345 ton of ibuprofen (NSAIDs), 88 ton of carbamazepine (antiepileptic) was found in Germany, whereas 35 ton of naproxen (NSAIDs) was observed in England in the year 2001. However, due to incomplete metabolism, these drugs excrete through defecation and urinary systems as unchanged forms and still remain insufficient concentration levels. The discharge of treated, partially treated and untreated effluents of pharmaceutical industries in open areas as well as into the streams and unacceptable dispose of unused (i.e., expired drugs) ultimately contaminate various compartments of the environment”

Vikas Chander, Researcher at DAV (PG) College, Uttarakhand India 

Many other uncontrollable factors are hard to trace in this issue of metabolizing drugs. A person’s age and health can impact how much of a given drug will metabolize, as can timing of dose and formulation of the drug itself. After these non-metabolized drug particles enter the water, Federal law has no regulations on them. 

 “Federal law does not impose any monitoring requirements upon sewage treatment facilities that receive pharmaceutical-contaminated excrement. Furthermore, municipalities do not design municipal sewage treatment plants to remove these unregulated pharmaceutical contaminants, thus complicating any attempts to control [the pollution]”

– Melanie Leitman, An attorney in the Labor & Employment and Administrative Law & Regulatory Compliance Groups.

Most Prevalent Pharmaceuticals in Water

The most common or prevalent drugs found in waterways and drinking water throughout the United States are antibiotics, anti-inflammatory drugs, drugs for diseases like diabetes and epilepsy, antidepressants, and steroids. Now, with the opioid crisis in full effect, the dangers of opioids and other medicine in waterways pose an immense threat to the people in society.

Other USGS studies found that water receiving runoff from a livestock center contained acetaminophen, caffeine, cotinine, diphenhydramine, and carbamazepine (USGS). With all these different types of pharmaceuticals in the water, it poses a threat to overall water safety and cleanliness. 

In the United States, currently, there are no regulations labeling pharmaceuticals as pollutants making it illegal to dump, flush, or dispose of them in uncontrolled manners. Also within the waterways several different types of medications are found posing a threat to water cleanliness. So in the absence of regulations, should companies and consumers in the United States and other countries be responsible for preventing the introduction of pharmaceutical waste (including unused/expired medications) into the water supply? How does accountability play a role in this issue. Should these stakeholders take accountability for their previous actions that led to pharma pollution by preventing further pollution? Furthermore, the main issue with this type of pollution is that most wastewater filtration plants are not equipped or cannot detect pharmaceuticals in water, leading to problems of access to this type of technology, which I will discuss later in the paper.


Effects of Pharmaceuticals in Waterways on Aquatic Life and Humans

Effects on Aquatic Life

The prevalence of these drugs in the waterways has an inevitable effect on the biodiversity in the water. In  the study, “Ecological effects of pharmaceuticals in aquatic systems — impacts through behavioral alteration,” the researchers found that antidepressants were present in waterways and reported their effects on fish behavior. The most commonly used antidepressants are SSRIs, selective serotonin reuptake inhibitors, and SNRIs, serotonin-norepinephrine reuptake inhibitors, which act on the serotonin and norepinephrine reuptake transporters and interact with other parts of the serotonin system (Brodin). In fish, serotonin plays a significant role in reproductive behaviors and aggressive activities. There has been a negative correlation between serotonin levels and levels of aggression, meaning that the serotonin levels are being reduced and levels of aggression are increasing.

 “In addition to the effects reported on aggression, feeding rate, and activity, several studies have explored how SSRIs and SNRIs affect other behaviors such as courting, schooling, and shelter seeking”

– Tomas Brodin, Professor of Aquatic Ecology at the Department of Wildlife, Fish and Environmental Studies, Swedish University of Agricultural Sciences (SLU – Umeå)).

Another pertinent problem with pharmaceuticals in the waterways is the evidence of feminized male fish or intersex fish. The occurrence of feminized fish has been associated with pharmaceutical pollution of birth control. A main synthetic component found in birth control, called Ethinyl estradiol (estrogenic, or estrogen-based chemicals), is responsible for the feminizing of fish. The US Fish and Wildlife Service found that in 19 national wildlife refuges in the Northeast that 60-100 percent of studies bass (smallmouth bass) had intersex characteristics (Ivanowicz). This irregular change in fish is disrupting biodiversity in waterways all across the nation, and the world, causing a change in behavioral patterns, breeding patterns, and defense patterns of fish. Several comprehensive studies in the past decade have highlighted this issue of pharmaceutical pollution. Yet, society and pharmaceutical companies continue to dispose of their pharmaceutical waste into waterways despite the apparent destruction of biodiversity in aquatic environments.

Potential Effects on Humans

What is most concerning are the potential effects of pharmaceuticals in the water on humans. Pharmaceuticals can potentially make their way into humans primarily through drinking water. People can be exposed to pharmaceuticals in several other ways through water exposures such as swimming, bathing, and showering (Eckstein and Shrek). However, there have been fewer studies on pharmaceuticals actually being found in drinking water (and water that will come into contact with humans according to the World Health Organization, “[c]oncentrations in surface waters, groundwater and partially treated water were typically less than 0.1 µg/l (microgram/liter) (or 100 ng/l (nanogram/liter)), whereas concentrations in treated water were generally below 0.05 µg/l (or 50 ng/l). These investigations suggested that pharmaceuticals are present, albeit at trace concentrations, in many water sources receiving wastewater effluents” (WHO). In the past decade in treated water tests, the presence of pharmaceuticals in water is not very prevalent.

These small amounts of pharmaceuticals are called “trace pharmaceuticals.” However, just because they are trace, can we say with certainty that there will not be any adverse effects on humans?

As of right now, there are very few systematic monitoring practices or studies that are available on human exposure to pharmaceuticals from drinking water or being exposed to water that is tainted with pharma. But, pharmaceutical companies and people are continuing to dump pharmaceuticals into the water, despite the possibility of harmful effects on humans.

This idea of the “unknown” ruining biodiversity, including humans, can be seen in Rachel Carson’s Silent Spring. Throughout her book, she reiterates the concept of how chemicals could slowly build up in people’s fat reserves.

When they drew upon these reserves, the body would be bombarded with an overflow of chemicals. The overflow of chemicals throughout the body may cause cancer and other diseases. Again there is a large amount of uncertainty in the issue; perhaps something like what Carson described in her book could happen to humans as a result of pharmaceuticals in waterways. 

Another potential threat of this pollution is to those who have allergies. For those with severe allergies, sometimes even trace amounts of pharmaceuticals such as antibiotics can cause severe reactions that range from hives and wheezing to anaphylactic shock. Also, antibiotic resistance as a result of pollution in the water will be explored in a case study later. These potential issues may come from continuously drinking water with pharmaceuticals in it.

In summary, pharmaceuticals in the water significantly affect the biodiversity of fish. Although much is not known about pharma in drinking water, the chemicals have potentially deadly effects even on humans potentially severely affecting those with medicinal allergies. 


Current Water Filtration Systems and Regulations on Pharmaceuticals

Water Filtration Systems

To understand this issue of water filtration systems, it is necessary to consider this study published in “Chemistry World” called. Something in the Water (Burke). A portion of this study analyzes a report made by the Southern Nevada Water Authority, SNWA. It published a report last November that analyzed raw and treated drinking water from 20 full-scale drinking-water utilities and six water-reuse plants. When examining water samples from all of the plants, the team found that conventional coagulation, flocculation, and filtration (all forms of water purification) removed few of the target compounds when used at full scale. Other standard treatments such as disinfection with ultraviolet light, at typical drinking water dosages, and ion exchange are also largely ineffective However Shane Snyder, an environmental toxicologist at SNWA had a say on this issue as well. 

“Whether a chemical is detected in a wastewater effluent depends on the analytical methods’ detection capability. In the US, there are no standard methods for analyzing pharmaceuticals in water. So, we can’t be certain that our compounds are really eliminated, or simply reduced to a concentration that is less than the current detection limits”

Shane Snyder, Researcher

The effectiveness of the treatments depends on the type of drug. If a drug is hydrophobic, it can be removed through a process of oxidizing free chlorine, while a hydrophilic drug can be removed through absorption. One treatment may work for one type of medication, but not the other, leaving it to contaminate the water. Furthermore, in the United States, only a handful of water filtration utilities use advanced methods to filter out pharmaceuticals.

So should companies and governments assume the substantial technological and financial burden of implementing new water filtration systems to reduce pharmaceutical waste levels in water given the current state of somewhat minimal knowledge about risk and exposure for biodiversity, animals, and, more specifically, humans?

However, even if there is minimal knowledge about the risk of drinking tainted water on humans, if there is any given concentration of pharma in this water, are these people able to have access to “clean water”? How do we determine what concentration of pharma in the water indicated not “clean water”? 

Regulations

In the United States of America, the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and overall the federal government itself require that pharmaceutical industries must require regular monitoring and enforcement of laws for proper disposal of pharmaceutical wastes for preventing environmental degradation. Currently, from an environmental perspective the regulations made by the federal government regarding this issue are not effective. 

“Federal law does not effectively regulate the disposal of pharmaceuticals. Our current legal and regulatory regime recognizes pharmaceuticals as either a health concern or an environmental concern, but never both. Thus, current statutes at best address the problem in a piecemeal manner.”

– Melanie Leitman,  An attorney in the Labor & Employment and Administrative Law & Regulatory Compliance Groups.

Also, the federal government has adopted three different environmental Statures:  the Resource Conservation and Recovery Act (RCRA), the Clean Water Act (CWA), and the Safe Drinking Water Act (SDWA), which are applicable to certain pharmaceutical wastes in water.  Also, the National Environmental Policy Act (NEPA) analyzes the manufacturing of drug products concerning their potential to reach the natural environment. However, what is ineffective about most of these clauses are that they weren’t explicitly designed with pharmaceuticals in mind.

“ [To this day the statures]  have proven inadequate to resolve the challenges posed by pharmaceutical pollutants in the environment.”

– Gabriel Eckstein, Professor of Law and Director of the Energy, Environmental, and Natural Resource Systems Law Program 

In summary, detecting pharmaceuticals in the water is not an easy task, and many factors need to be in place (such as technologically advanced filters or filtration methods) in order for the drugs to be effectively filtered out.  The attempts to make positive changes in this issue have largely been ineffective thus far even though a few statures have been passed. In order to begin to make effective and positive change in this problem, the issue of pharmaceutical pollution needs to be looked as both a health and environmental issue, so then adequate measures can be taken.


Case Study: Pharmaceuticals in the Water in the U.S (Michigan Great Lakes Case Study)

Background and Testing the Water

The Great Lakes provides water to over 40 million people from both the United States and Canada. In this study several different water collections were examined to see if there was a pattern of a presence of pharmaceuticals in water sources and if so how much. 

As described in this study, The Milwaukee Water Works was one of the first utilities in the U.S. to test for endocrine disrupting compounds in 2003  and pharmaceuticals and personal care products in 2006, in their source and drinking water. The staff in this project  found small amounts of cotinine, 2 parts per million,  and gemfibrozil, 6 parts per million, in its Lake Michigan drinking water supply” (Alliance for the Great Lakes). 

Another drinking water test from Lake Erie Water Works was examined. The Erie Water Works “detected ibuprofen, a common painkiller, (2.5 parts per million),  gemfibrozil, a cholesterol-lowering drug, about 2.5 ppt; carbamazepine, an anticonvulsant, 2 ppt; caffeine at 21 and 60 ppt and cotinine, a nicotine derivative, at 4 ppt” (Alliance for the Great Lakes). 

Another study in Michigan in 2006 looked for the presence of pharmaceuticals, personal care products, and endocrine disrupting compounds in the municipal water supplies of Ann Arbor, Grand Rapids, and Monroe. To test to see if any treatments would be able to get rid of these chemicals from the water, the researchers “used a combination of gas chromatography, mass spectrometry, and liquid chromatography” (Alliance for the Great Lakes). From these chemical tests, “While each waste treatment plant had its strengths and weaknesses, no single decrease in a contaminant could be “correlated to a particular treatment process since individual components of the process were not analyzed” (Alliance for the Great Lakes).

Measures Taken

An Alliance in the Great Lakes Michigan area formed which worked together to reduce pharmaceutical pollution in the great lakes. They placed an emphasis on the collection and safe disposal of unwanted medications. However with the growing number of pharmaceutical users and prescriptions given out every year, the Alliance made an effort to curb prescription production trying to stop pharmaceutical pollution at its source by trying to change the design and prescription stages of medicines. They felt that this would be the most effective way to reduce pharmaceutical pollution because they can work to get this process under control.  The alliance preferred to attack this issue from the root of the issue because just focusing their efforts on encouraging responsible prescribing and disposal is beneficial for the community, but they have no guarantee and no control over whether or not people flush their medications down the toilet.  

 “Already many opportunities exist at the design stage to reduce the environmental risks posed by pharmaceuticals, and improving health care practices may reduce the amount of waste from existing drugs as well as new drugs”   

– Alliance for the Great Lakes Team, Researches at the Alliance for the Great Lakes 

This team also supported further research about the effects of pharmaceutical pollution on the environment and the people. The Alliance put forth a few ideas about what policy changes should be made: 

“1. Pharmaceutical manufacturers could be required to include toxicity information on drugs they produce. 2. FDA can improve their drug approval process by requiring manufacturers to provide more information on the toxicity of pharmaceutical waste products and potential issues from combinations with other waste pharmaceuticals. 3. The FDA drug approval process could require a life-cycle management at the time a drug is approved and also requires a closer look at end-of-cycle waste management”.

(Alliance for the Great Lakes)

The Alliance did put forth a comprehensive and effective list of policy changes they believed should be made. However, change is slow when dealing with the federal government  organizations like the FDA. Although this case study did shed more light onto the pressing issue of Pharma pollution, the actual change brought forth from these demands into the Michigan area or even throughout the nation remains unknown. 

Life cycle management is the development of a new medicine or drug from creation/identification to selling it.

In Summary, in the early 2000’s it was found that in The Great Lakes of the United States are polluted with pharmaceuticals. This was especially concerning because they provide water to so many people. When this information was found, the Alliance of Great Lakes took initiative and tried to make changes in the way in which pharmaceuticals were treated and disposed of. However the positive changes and measures taken after the publication are unknown.


Case Study: The Water in Hyderabad, India

Background Issues in Hyderabad

Hyderabad, India is known as the pharmaceutical capital of India. There are numerous research laboratories manufacturing facilities, corporate offices of companies, and plants in hyderabad dedicated to creating life saving medications. However, the pharmaceutical industry is also labelled as the most polluting industry in Hyderabad.There are a wide range of Active Pharmaceutical Ingredients (API’s) and finished medications that are manufactured there. Another reason that India has become the manufacturing hub of pharmaceuticals is because costs to produce medicine is 30-40% lower than those in the US and western Europe and with labor costs that are one-seventh that of the United States.

As mentioned in the case study, the “costs of running an FDA-inspected manufacturing plant in India are 50% lower than in ‘developed’ countries”.

(Nordea and Changing Markets).

In essence, making pharmaceuticals in India is much more affordable than other countries, which inherently made the demand very high for pharma production in India (Washington Post). Since high production of medications is very central to Hyderabad, many components of these medications that are produced make their way into the water around the facilities. Most of the research on this issue in Hyderabad has focused on the pollution from antibiotics production because it is  particularly problematic: it fuels the spread of Antimicrobial Resistance” (Nordea and Changing Markets).

Illegal/Unsafe Dumping of Pharmaceuticals into the Water by Pharma Companies

An article in The Hindu in November 2017 noted that “illegal dumping of effluent remains common practice in the pharmaceutical industry” and also highlighted cost as a motivating factor.  Pharmaceutical companies in Hyderabad claim to have “zero liquid discharge” and should be directing their effluents to common treatment plants such as the Patancheru Effluent Treatment Plant (PETL), “in reality they ‘don’t always toe the line” (The Hindu).

Potential Effects on People

An account from the case studies effectively highlights the seemingly small but potentially immense consequences of pharmaceutical pollution in water. Antibiotic manufacturing is a large industry in Hyderabad, so inherently the pollution that comes from antibiotic manufacturing has been a concern for many. In 2016 an academic study was published that identified that concentrations of antibiotics in the Hyderabad area, in rivers and other water bodies, have concentrations of antibiotics that are 1,000 times higher than the expected concentrations in developed countries. These extremely high levels of  antibiotics can be attributed to the improper disposal of industrial effluent.  The case study highlights the issue that can come from the high concentration of antibiotics. 

 “This is particularly problematic, as these high concentrations of antibiotics in the environment are contributing to the development of drug resistance in bacteria, as demonstrated by two reports published in the last year, further described below”

– Nordea and Changing Markets Team, A Team of Researchers from Hyderabad, India 

Unfortunately as a result of the pollution in Hyderabad, people are developing AMR (Antibiotic Resistance) due to the high levels of Antibiotic ingredients in water. This widespread AMR could lead to a difficult way to deal with outbreaks of diseases that require antibiotics to cure.

Effects on the Environment

As examined in this study, the water in the Lakes around Hyderabad has been frothing for almost two decades now. However, the Telangana State Pollution Control Board (TSPCB) published a report in October states that the frothing of the local lakes, where chemical waste rises to tops of lakes in the form of foroth, has been occurring as a result of detergents used by the residents and the sewage waste systems which are released into the waterways. However local people deny that just detergents are causing this frothing because they report “pungent smells, rashes on [their] skin and fever and disease that they suffer during each foam outbreak (Nordea and Changing Markets). Instead the people strongly believe that pharmaceutical companies’ wastewater effluents are causing the frothing.

The Reported Effects on Aquatic Life

Throughout the areas around Hyderabad, aquatic life has been suffering immensely. This case study particularly looked at the frequency reports on fish kill. Fish kill is a localized but large amount of fish being killed. In Edulabad Lake in Hyderabad there were frequent reports of fish kill as a result of toxic contamination. 

“In October 2017, thousands of dead fish washed ashore as a result of toxic contamination”

– Nordea and Changing Markets Team, A Team of Researchers from Hyderabad, India 

After this particular fish kill report in October 2017, the locals began to become concerned. There was no action to remove the dead fish even after several days had passed after the incident. Locals were even more almared about the potential impact on the health of the children who attended a school next to Edulabad lake. Also hundreds of families in the nearby towns of this lake were dependent on fishing from this lake as their sole source of livelihood; with the fish gone from the lake due to toxic contamination they were worried about how they would sustain themselves for the coming year.  

“[Fisherman in this area] have been rendered jobless for at least a year-and-a-half”

– P. Krishna, General Secretary of the Edulabad Gangaputra Sangam 

Not only are the fish being killed, but Children are also at a high risk of being exposed to these polluted waters because there are several schools near these waterways” (Nordea and Changing Markets). 

Measures Taken

Five pharmaceutical companies and their 6 corresponding water bodies/wastewater plants were tested for concentrations of heavy metals and solvents used in pharmaceuticals:  “Many samples showed the presence of volatile synthetic organic compounds(SOC), and most frequently several SOCs were found” (Nordea and Changing Markets).

Volatile organic compounds are chemical solvents or cleaners (and their byproducts) that are derived from petroleum products. They are man-made contaminants that arise from industrial processes. These contaminants can leach into ground water from chemical spills or wastewater discharges from industrial activities.

“The resultant compounds are often found from industrial discharges or waste materials. Chlorinated solvents, including break-down products, were noted. These chemicals have a significant human toxicity/cancer risk, both from ingestion and inhalation. The levels indicate little treatment of the solvents is occurring, or very heavy burdens of these solvents are overwhelming the waste treatment technology in use. The presence of mixtures of chemicals shows a lack of adequate water treatment prior to discharge (or potentially no treatment whatsoever). Depending on the water flow in receiving water bodies, and the distance from the effluent source, the actual concentrations of these chemicals from the discharge source could be many magnitudes greater than the concentrations detected in samples (Nordea and Changing Markets).”

The Need For More Change the Industry

Although significant findings about the harmful effects of pharmaceutical pollution have been made public in Hyderabad, only a small amount of the necessary change was made: A “Declaration on Combating Antimicrobial Resistance” was signed by over 100 companies in the Hyderabad area. This declaration, however, only mentioned that the companies who signed it would “support measures to reduce environmental pollution from antibiotics” (Nordea and Changing Markets). In September 2016, a group of smaller companies (including AstraZeneca, GSK, and Pfizer) and some major companies (including Wockhardt Cipla) came together to create a publication of an  Industry Roadmap for Progress on Combating Antimicrobial Resistance, which sted measures to reduce the environmental impact from the production of antibiotics as its first priority.

(Diagram from Nordea and Changing Markets Case Study: Hyderabad’s pharmaceutical pollution crisis, pg. 25)

Like discussed, many industry players in India acknowledge that they hold a share of responsibility for the impact of pharmaceuticals in the environment (most notably in relation to AMR) and have made a commitment to begin tackling the issue. However as this case study reported, “the self-policing approach has not as yet been successful in tackling the challenge of such magnitude. Additionally, these initiatives do not, for the most part, represent the generics industry which produces a substantial share of our pharmaceuticals (Nordea and Changing Markets)”.  

In summary, Hyderabad, India is one of the worlds largest pharmaceutical hubs. There are not many legal restrictions in place by the Indian FDA, which increases the excessive pollution of pharma in the waters. There were visible signs of distress to aquatic life, and after research, the group found significant amounts of chemicals related to pharmaceuticals in the water. This has posed an issue to people, causing dangerous amounts of AMR. The main pharma companies in Hyderabad said that they were willing to make change, but nothing major has changed yet.


Are you aware that you are responsible for polluting the waters with unused medicine?

As discussed throughout the beginning of this paper, pharmaceutical companies and manufacturers indeed play a significant role in pharmaceutical pollution. However, the common practice of flushing medicine down the toilet when the owner wants to dispose of it may seem like an insignificant action.  But when it is a common practice, like in America, there is a serious potential for flushing medicine to become a major factor in pharmaceutical pollution. Even though pharmaceutical companies are the main polluters in this issue, we individuals also play a role in this form of pollution. As the consumers of medicine (and the reason medicine is created), we have the responsibility to ethically dispose of our medicine. We have to be responsible but we also have to be accountable for our actions, and be willing to stop flushing medicine down the toilet. 

However, how will the masses know the consequences and their contribution to pharmaceutical pollution without education? So, who is responsible for raising awareness?  Who is responsible for the damage? Where is this untrue (that it is ethical to dispose of pharmaceuticals down the toilet or sink) information coming from?

Who is responsible for the destruction of aquatic life from the polluted waters?

Aquatic life has been proven to be suffering due to pharma pollution, as well as an unprecedented disruption of biodiversity in its most fundamental form. Pharma companies have substantial responsibility for the state of the waterways, but individual consumers also have a role in keeping water safe and pure. However, many questions arise in this issue.  What will happen to humans as they continue to be exposed to tainted water? Right now, the answer is not comprehensive, but one can only imagine what routinely ingesting chemicals must be doing to the body. So what can and should individuals do about it? 

People indirectly pollute the waterways by routinely dumping their unused, often expired prescriptions for an array of conditions ranging from acne to zoster. 

In October 2019, on Take Back Day (a national day when people are urged to go and safely dispose of their unwanted medications), about 442 tons of medicine was collected nationwide.

Now, one can imagine how many thousands of tons of unwanted medications are sitting in houses of millions of Americans. The most common way people dispose of their unwanted drugs is down the toilet or the sink. Yet what is the most unfathomable yet predictable part of this scenario, people genuinely think that this way of disposing of pharmaceuticals into the sewage system through the toilet or sink is correct. They believe that rather than throwing out their medication in the trash where a child, animal, or drug addict can get a hold of it, they should dispose of it into the sewers. One way this mindset evolved was improper education and instruction from hospitals and governments.

“For many years, hospitals and nursing homes disposed of their excess pharmaceuticals by flushing them down the drain.”

Leitman

“In fact, until as recently as 2002, this was the recommended method for disposing of unwanted pharmaceuticals  because it ensured that the pharmaceuticals did not end up in the wrong hands (i.e., children or the illicit drug trade). State and local governments recently began to launch massive informational campaigns in an effort to minimize or eliminate this method of pharmaceutical disposal” (Leitman). 

 “But old habits die hard, and many people still believe that flushing is the best method of disposal for unwanted pharmaceuticals”

–  Melanie Leitman,  An attorney in the Labor & Employment and Administrative Law & Regulatory Compliance Groups

People don’t realize is that they are indirectly drugging themselves and the animals and people they wanted to keep “safe.” So one can argue that it is not the general people that are just indifferent to the consequences of their actions. Still, it’s that they don’t know any better– society, government, and hospitals included,  that has not informed its people about their “incorrect ways.” 

Another major branch of polluters is the physicians that prescribe the pharmaceuticals (drugs) to the consumers. Over the past few decades, there has been an opioid epidemic. Millions of people around the country and the world have fallen into the trap of opioid addiction. According to the National Institute on Drug Abuse, “2018 data shows that every day, 128 people in the United States die after overdosing on opioids (National Institute on Drug Abuse).  As for the reason for the practice and culture of overprescribing opioids, it is unclear. However, a study done by Psychology Today looks at the psychological motives of overprescribing:

“Studies identified a phenomenon called “small-area variation” in healthcare practice, which refers to the fact that doctors in similar communities make treatment decisions simply based on the habits and practices of those in their immediate vicinity. These studies suggest that physician behavior is influenced by social signals and is not always governed by evidence, best practice, or guidelines. It’s highly likely that patterns of both antibiotic and opioid prescriptions are similarly subject to this same kind of social network effect. In the case of opioid overprescription, in particular, there are also a few unique systemic and cultural reasons why doctors persist in this behavior. Some have argued that a cultural shift in the way medicine conceives of pain over the past few decades has contributed to the opioid epidemic and, in particular, to doctors’ over-dependence on opioids to manage chronic pain. At some point, organized medicine began espousing the view that ‘all pain is treatable.’ In this view, the patient’s subjective experience of pain governs the doctor’s decision to utilize conventional medical modes of treatment, most notably pills. It came to be considered a routine part of a doctor’s duty to assess and ultimately to completely eliminate any significant pain, as determined by the patient. This kind of approach has likely led to a situation in which it becomes the expectation that a patient experiencing more than mild discomfort should be treated with pills and that the goal is to be completely pain-free. In fact, it is rarely possible to completely eliminate pain; trying to do so often results in excessive administration of opioids”

(Psychology Today). 

Knowing this information, in some cases, many people who have surgery or have mild chronic pain refuse to take opioids in fear of becoming addicted to them due to the overprescription done by their doctors. Whether it is with overprescription and or a  fear of getting addicted to opioids, people tend just to flush entire pill bottles down the toilet (they think “out of sight, out of mind”) to avoid the possibility of becoming hooked on opioids. This culture of mass personal disposing of opioids is a major contributor to the pharma pollution of waterways. However, this leads back to the idea that the physicians are the ones overprescribing, which can, in some cases, prompt people to dump their medicine into the toilets. Furthermore, pharma companies often give incentives (not specified) and subliminal psychological pressure (that it is okay to overprescribe)  to physicians who then, therefore, overprescribe leading to this issue.  

Moreover, other a person getting rid of unwanted medication and overprescription of medication, there can be many other reasons as to why pharmaceuticals may be flushed. Patients may be non-compliant to treatment; patients may experience adverse events and stop taking products; patients may pass away and their unused medications need disposal; patients taking oral contraceptives may decide to start having children and suspend birth control. These are just the few of many other circumstances which could lead to improper disposal of medication. 

In summary, along with pharma companies, consumers and physicians contribute to pharmaceutical pollution. However with factors such as a lack of education on the correct means of waste disposal and incentives for over prescription, we individuals are indeed major players in this form of pollution.

Who has the duty and responsibility to correct the ways of the people?

These facts about the effects of pharma pollution in the water on aquatic animals are known and have been known for almost two decades, so why are people today, 20 years later, still contributing to the obliteration of our biodiverse planet? This can be explained through the bystander effect.

According to psychologists, “The term bystander effect refers to the phenomenon in which the greater the number of people present, the less likely people are to help a person in distress. When an emergency occurs, observers are more likely to take action if there are few or no other witnesses.”

Today, people continue to sit back and watch our environment be destroyed because they think that other people are going to help the environment. Since everyone believes this, no change is actually being made. 

Ever since the late 2010s, there has been a decline in research into this pressing matter. Why? Maybe it is society’s or large corporations’ lack of awareness or meaningful attempts to cover up this destruction. Who was responsible for shutting this information and research out? 

Now for the future, who is responsible for re-educating society? I believe it is time for the government to step in and take control. Most Pharmaceutical companies will most likely never come forward and explicitly admit that they are polluting waters, which is leading to fundamental changes in biodiversity. If they were to do so, their company would be vulnerable under attacks, and they would have to change their entire system of disposing of waste, which would potentially lead to profit losses. One can argue that Pharma companies do indeed have the most substantial responsibility to the environment because they are directly harming the ecosystems and have a duty to preserve the earth.

But remember, Pharma companies are “for-profit,” and more than anything, they are trying to run a business to make money.

So one can argue that the Pharmaceutical companies who provide the world with life-saving medicine do not need to value being ethical and good members of society as much. However, today, there is a minimum expectation that companies will be good citizens of the planet. So, the companies’ dilemma is how much they should constrain themselves in the absence of regulation and the absence of current evidence of direct harm to humans.

Should and can public companies that have a responsibility to maximize shareholder profits, as a for-profit business, justify the substantial expenditures of time and money required to try to reduce pharma waste – even if there is no regulatory framework to measure effectiveness against it?

I believe that trying to make significant changes in an industry that is mainly focused on profit will be very hard, and in the end, ineffective. Of course, every company must focus on being good citizens of the planet, but to what extent they are good citizens is up to them (and this idea is often based around money and their profits). So although pharma companies do play a significant role in pharma pollution, the amount of change we may be able to make within this industry is potentially limited unless there are legal restrictions passed by the government. 

 The lack of regulation on pharmaceutical waste disposal in this space reflects the successful lobbying of the government on the part of pharma companies. 

[In 2018,] the lobbying group for the pharmaceutical industry spent about $27.5 million on lobbying activities in 2018, federal filings show.”

Susan Scutti, Writer and Reporter for CNN Health 

The governments tolerate the lobbying of pharma companies, which then gives these companies the idea that they have the freedom to do many things, including the unethical disposal of their waste. However, one can argue that the government, which is usually or not supposed to be affiliated with these private pharmaceutical companies, would make an effective center of education. Governments also have a wider reach, which would be integral in changing a heavily ingrained idea in society that dumping your pharmaceuticals down the toilet is the best way. 

However, if Governments begin re-educating society, then they will be expected to make changes to the public water utility systems in order to protect people and aquatic life. Even if some amount of people stop flushing their medicine down the toilet, not everyone will stop. For those people who become educated on this issue, they will begin expecting the government to protect the people from the already existing chemicals in the water but also the ones that may be entering the waterways. So, therefore, the government will need to upgrade or replace the existing wastewater plants’ filtration systems. This act and process of updating the water filtration systems will undoubtedly cost a significant amount of money, which makes the question arise “who will pay for these water filtration systems”? Perhaps, through taxes. But, then, some socioeconomic statuses will be able to afford the rate hikes, and some won’t. Who should the resources go to then? This idea of Utilitarianism and allocation of resources will be discussed later in the paper. 

In summary, along with pharma companies, consumers and physicians play a large role in polluting the environment. It is all a circle of destruction: pharma companies incentivize overprescription, physicians over-prescribe, and people dump pharma, which happens repeatedly.

Governments have the duty and responsibility to change society because they have the basis of power to make policy changes.

However, while we wait for change to be made, over-prescription of medicine, for a more extended period, causes excess medicine to pile up in millions of households around America who end up flushing this medicine down the toilet. Ecosystems all around the world are suffering, and inherently, we will suffer too. So the role of the individual and your role as a consumer of medicine and how you dispose of it is critical to our water and earth.


Who gets access to water that is free of pharmaceuticals? Can we choose not address this issue now?

Issue of the Allocation of Resources

If governments begin to make changes in society to prevent pharmaceuticals from being disposed of into the waterways, they will inevitably need to place new technology in the water plants to protect people from the already pre-existing pharmaceuticals in the water and drinking water. If governments spend money on improving water filtration systems in public water plants, they are losing money they could spend on other areas. Perhaps, they could have used that money to pay for students’ free lunches or help the homeless. One could argue that since the exact effects of pharmaceuticals in the water are not known in humans, the governments should focus on more pressing issues that would help the greater good now. Also, they could argue that aquatic life is not as important as human life; therefore, the immediate needs of humans should be tended to rather than the needs of fish and other aquatic life. However, it is not effective to think that way. This is because any functioning ecosystem, which every human lives in, every part of the ecosystem needs to be in balance if humans want to continue to survive. So, although valuing humans over aquatic life may provide the people’s immediate betterment, in the long term, the life around humans will suffer, and humans will suffer too.

Issues of Access

Governments only have a set amount of money a year to pay for the upkeep of public water utility sectors. So if Governments will choose to place the new and improved water filtration in areas of higher socioeconomic statuses because they know that people will be able to afford the rate hikes (that come with the upkeep of a more expensive water plant) and that the taxes will get paid. 

This leads to the overarching idea of Consequentialism. Consequentialism is an ethical theory that judges whether or not something is right by what its consequences are. So if the consequences outweigh the benefits, with this principle, one would not decide to go with the option that poses the “negative” consequences. So within this idea, the question of “is it ethical to deny a group of people access to clean water” arises. Isn’t this denying people access to a fundamental human right? But opposers will argue that since the effects of pharmaceuticals on humans are not known yet, that arguably, all waters with and without the pharmaceutical filters are clean to drink. Or governments can equally allocate the money for water filtration systems to all socioeconomic groups. Still, then these filters may not be the most effective to filter out pharma in the water. By doing this, people would still be ingesting small amounts of pharma in the water (less than normal because of the “sub-par” filtration systems). However, by doing this, aren’t we just putting off the inevitable destruction of human health and biodiversity (since there are still pharma particles in the water, the overall accumulation of the chemicals will just take longer).

Divide Between the Classes

If new and improved water filtration systems are selectively implemented, this will lead to the issue of the divide between the classes. Higher socioeconomic classes will be able to afford to pay for new pharma centered water filtration systems. They will be able to be safe from ingesting chemicals and have access to truly clean water. In turn, in the future, when it is proved that there are effects of drinking pharmaceuticals on humans, these groups of people will be free from the potential consequences of ingesting tainted water (therefore, they presumably wouldn’t have medical expenses associated with treating the resulting conditions). For people who are gaining antibiotic resistance from drinking polluted water, they will have adverse but just as concerning effects. These people will not be able to be cured from simple antibiotics when they get sick.

Lower socioeconomic classes will not be able to afford to pay for the new pharma centered water filtration systems, and therefore they will continue to ingest drugged waters.

In the future, when the effects of continuously drinking drugged water show up in humans, these groups of people (who are already at an economic disadvantage) will now have to pay for expensive medicine and doctor visits, which will further increase the socioeconomic divide between society. With AMR issue, the consequences perhaps may even be direr (based off of current problems with AMR). These populations may develop illnesses that can’t be effectively treated with low strain antibiotics. 

With this knowledge, another pressing question arises: Is it ethical to knowingly preserve and aid one socioeconomic through the issues of pharma pollution while willingly not helping another group of people? Should we make one group superior or destroy society as a whole? Under John Rawl’s concept of justice, the first principle guarantees the right of each person to have the most extensive basic liberty compatible with the liberty of others. The second principle states that social and economic positions are to be (a) to everyone’s advantage and (b) open to all. With the issues of pharma filtration, aren’t we violating the idea that the financial ability to pay for the filtration, will inherently not be open to those who can’t pay for it? Is it ethical to violate a strand of justice to fulfill the greater duty of utilitarianism/justice? 

In summary, under the ethical questions of “ Is it ethical to choose who gets access to water that is free of pharmaceuticals?” and “ Is it ethical to choose to not address this issue now?”, many societal nuances arise. 

The government can buy more technologically advanced water filters equipped to filter out pharma– where will the money come from? If water filtrations systems are implemented, tax rates will go up– who can and can’t afford to pay for this new cleaner water? A group of people will have access to pharma water filters and not the other– will divide between the classes will arise in terms of access to clean water and potential health issues?


Conclusion

Since water is essential to human survival, it is inevitable that we are or will soon be drinking water with pharmaceuticals in it, so we and everyone else in society must understand the severity of this issue and stop polluting our waterways. 

My Personal Ethical Perspective

Under the ideas of justice, I believe that the government should be responsible for making change. The governments tolerate the lobbying of pharma companies, which then gives these companies the idea that they have the freedom to do many questionable things. These companies often provide incentives and provide psychological pressure to physicians who then tend to overprescribe medication. In one of many ways, these medications end up in the environment/water. Although personal responsibility is a major factor here, pharma companies play a substantial role in pollution. Yet they are for-profit, private companies who cannot be coerced to do anything unless legally forced to. Governments have a duty to change the course of our planet. 

Since there needs to be a fundamental re-educating of society, I believe that governments should take responsibility for educating the public on the safe, environmentally friendly, and ethical ways of disposing of their unwanted medical supplies. They can spread information across all different areas. Since they are unaffiliated with the main polluters, pharma companies, people will be likely to believe/understand that their information is unbiased.

Pharmacies should also implement better waste disposal programs. Pharmacies can set up drop of “bins” in which the dropped of medicine is sent back to pharmaceutical return companies where it is disposed of properly.  Pharmacies perhaps can maybe even offer an incentive (such as a discount or gift card) for the customers that come back and properly dispose of their unwanted medicines. The extra money for the incentives should be given to the pharmacies from governments through monthly grants (that are required to go to offering incentives to consumers). Although taxes will go up because the government will need to pay for the incentives, spreading this cost across thousands of people will not make a significant difference in people’s taxes. 

However, for meaningful and substantial progress to be made, the government must classify pharmaceuticals as pollutants. By doing this, people will become more aware of their actions, and it will force pharmaceutical companies to find other legal ways to dispose of their waste. For other states to follow as an example, recently(1/1/19), California began requiring pharmaceutical waste stewardship further to prevent PIE (pharmaceuticals in the environment). 

Also, for significant change, there should be legislation passed that completely bans the dumping of pharmaceuticals into the waterways by the pharma companies (also people) and make them find other ways of disposing of them. However, with this comes several implications. Burning of pharmaceuticals causes air pollution and exposes people to dangerous chemicals in the air. Storing waste is essentially a waste of resources because the waste will still be present on the planet. Burying waste in the ground means that sooner or later, the chemicals will seep through the containers and contaminate the soil and groundwater (what are the implications for the people that may move onto these lands where pharma waste is buried). 

Although through this paper, I have identified many stakeholders and groups of people in society that should take the responsibility to curtail and potentially end pharmaceutical pollution, we cannot directly or immediately control the governments or companies. However, who can make a difference in this pressing matter is us, the consumers of medicine. While we wait for the needed but slow policy and corporate change to happen, ecosystems all around the world are suffering, and inherently we will suffer too. 

“ Remember, in nature nothing exists alone.” 

– Rachel Carson, Marine Biologist and Environmentalist 

So the role of the individual and your role as a consumer of medicine and how you dispose of it is critical to help save our water and earth.



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