With heightened awareness for the adverse impacts of industrial waste and pollution on human health and the environment, we must recognize the active role pharmaceuticals play in this crisis. The issue is twofold, with high rates of harmful byproducts and active pharmaceutical ingredients (APIs) appearing in manufacturing waste and traces of the drugs themselves making it into sewage and waterways through waste disposal or improper biological treatment.
A recent comprehensive study measured the concentration of 61 APIs at more than 1,000 sites along 258 rivers in 104 countries — only two sites studied were found to be uncontaminated. Widespread pollution of water sources can lead to negative consequences for humans and the environment including but certainly not limited to increases rates of antibiotic resistance, unintentional hormone exposure, and disruption of fish mating and migration behaviors.
Globally, pharmaceutical companies research, develop, test and manufacture medicines — many of which have lifesaving implications for patients. This is incredibly important work and the positive end result of these efforts, including improving the quality of life for millions of people each day, tends to overshadow the lesser known negative impacts of releases of pharmaceutical compounds into the environment.
Pharma companies need to lead the way to address this monstrous problem — but they can’t do it alone. The solution will require changes in the business models and processes, as well as the adoption of new, modern era, sustainable waste management technologies. Embracing sustainable waste practices will also help pharmaceutical companies achieve ambitious sustainability goals. As with many environmental problems, the solution requires collaboration with stakeholders representing the industry, consumers, government and technology providers.
Pharmaceuticals in the environment
Patients are the most significant source of API releases into the environment. The primary pathway is through the excretion of unabsorbed portions of a drug in urine and feces. A secondary pathway is disposal of either unwanted or expired medicines into sinks and toilets. The APIs dumped in this manner make their way into septic systems and public wastewater treatment plants, and potentially back to our drinking water and food.
A third pathway is through pharmaceutical manufacturing. API manufacturing generates many waste streams including spent solvents, aqueous wastes and wastewater. These waste streams may contain unreacted pharmaceutical reagents and intermediates, raw material impurities and reaction byproducts and unrecovered isolated intermediates and APIs. The spent solvents streams can be either recovered and reused, sent off-site for incineration or used as fuel in cement kilns. But the aqueous and wastewater streams are more difficult to manage because of high organic content, refractory compounds and low heat content, making them difficult to treat using conventional treatment methods.
APIs are typically potent, biochemically active substances that can cause toxic effects even at low doses. Many are non-biodegradable, and thus, refractory to natural biological and man-made wastewater treatment systems (i.e., septic systems, activated sludge) because of their molecular structure and physicochemical properties. Uncontrolled discharges of such APIs can negatively impact biotreatment systems, beneficial reuse of sludge and biosolids, the ecology of the receiving stream and ultimately, human health.
The hazards posed to the environment by the release of APIs are a function of the exposure of the environment, the toxicity of the compounds and the time of exposure. These hazards can be viewed as either immediate (acute) or long term (chronic). Acute hazards are associated with the shock loading of the substance, where the exposure time is relatively short and the dose is at lethal concentrations. Chronic hazards are the exposure of an organism to sublethal doses for extended periods of time (i.e., the organism's life cycle). The effects are much more subtle, such as changes in reproductive habits, disruption of hormonal activity, genetic mutations and bioaccumulation.
Limits of current waste treatment technology
Lack of on-site infrastructure to treat and eliminate waste containing APIs and other emerging contaminants is one of the biggest issues companies must grapple with. Pharmaceutical companies predominately ship their waste off-site for treatment and disposal. Not only is this costly, but it also contributes to greenhouse gas emissions.
Conventional wastewater treatment technologies are ineffective at breaking down and eliminating complex API molecules. APIs are toxic to microorganisms in the activated sludge systems of conventional and advanced wastewater treatment plants, inhibiting microbial respiration and reducing or upsetting treatment performance. Reduced performance could lead to the discharge of partially treated or untreated wastewater to receiving streams causing an oxygen deficiency. A fish kill could occur if the oxygen deficit is significant. APIs can also pass through treatment systems to a receiving water, contaminating the water column and sediment.
Wastewater sludges can also become contaminated with APIs. Conventional methods of sludge treatment such as aerobic and anaerobic digestion are incapable of breaking down APIs. Therefore, contaminated sludge land applied as fertilizer contains these toxic compounds, and can exert adverse effects on terrestrial organisms at land application sites, expose humans in landscaping applications and lead to bioaccumulation up the food chain.
To protect human health and the environment, reduce risk to shareholders and to satisfy stakeholders focused on sustainability goals, the pharmaceutical industry must rethink their current processes and address inherent flaws in their waste management practices. There are emerging technology solutions that can be deployed today to break the endless circle of generate, ship, burn and bury. The time to act is now.
Lead by example
Pharmaceutical leaders must view pressure from stakeholders, investors and consumers to adopt more comprehensive ESG practices as an opportunity to lead change. This starts with taking responsibility for the complete life cycle of pharmaceutical products and wastes.
The lasting impacts of these chemicals and byproducts once released from a manufacturing facility or excreted into a sewage system cannot be ignored.
Conventional management methods (e.g., landfilling, incineration, cement kilns) have been the only viable options for the last 50+ years. These methods may be cost effective, but they are no longer adequate in terms of pollution elimination. Pharmaceutical companies should be adopting complete, decentralized solutions that can treat waste and wastewater before it leaves a facility and reaches the environment. Thermophysical processes such as supercritical water oxidation (SCWO) have existed for decades and are now commercially-viable, scalable solutions for eliminating aqueous and non-aqueous organic waste and wastewater streams contaminated with drugs, microplastics, pathogens and other contaminants of emerging concern.
Companies that successfully deploy solutions like SCWO at their manufacturing facilities will be leaders, promoting the benefits and measurable results to industry peers. Putting competition aside, industry collaboration across the entire value chain is paramount to improve how pharmaceuticals are produced and used across global populations.
There’s also the more insurmountable challenge of reducing pharmaceutical pollution that stems from human consumption of drugs. While there are many programs and campaigns focused on driving awareness for responsible use and disposal of drugs in households, drugmakers cannot directly influence behavior at the individual level. What drugmakers can do, however, is prioritize greater bioavailability and more efficient delivery during drug development to limit wasted resources when drugs are eventually consumed. Doctors must also be more thoughtful in the amount and frequency of medicines they prescribe. These may seem like lofty goals, but when prescription and OTC drugs are more prudently consumed and better absorbed into the body, less of their chemicals and byproducts make it into patients’ waste and, eventually, our environment.
Incentives and regulations designed to cut waste in the pharmaceutical industry will continue to be introduced at federal, regional and local levels. Whether these are put forth by industry organizations, advocacy groups or the communities in which a company operates, all pharmaceutical companies in the industry must not only comply but go beyond compliance. The industry must focus more on sustainability initiatives that improve public health and the environment.
Realize & share benefits
The circular economy has also become a hot topic within manufacturing circles. When decentralized, sustainable waste management technologies are deployed on-site at pharmaceutical manufacturing plants, the cost of, and greenhouse emissions from, waste transportation are effectively eliminated. Furthermore, technologies like SCWO can recover valuable resources that are typically discarded during manufacturing. Heat and energy created during the SCWO reaction can also serve as a low-carbon power source. Compared to the traditional approach of incineration and land disposal, SCWO is a more efficient and cleaner, greener solution for addressing pharmaceutical wastes containing APIs.
All these benefits can reduce future liabilities for pharmaceutical companies. Stakeholders who have their eye on pharma’s ability to achieve sustainability goals and ESG reporting requirements will realize measurable progress against pollution and environmental hazards. Companies who are transparently communicate their efforts will be beacons to others, demonstrating how to mitigate pollution, optimize manufacturing, and improve products. The pharmaceutical industry will be viewed more positively by consumers, the medical industry and the communities in which they operate.
Where the industry will go next
Researchers are already eyeing ‘mega trends’ at a generational level and discovering vast instances of consumer exposure to opioids, hormones and other drug classes through their drinking water and food. Even with changes in processes occurring in real time, it is likely that the pharmaceutical industry will experience heightened scrutiny for shortcomings in waste management practices over the next several years. Advancements in water testing will bolster increased interest and concern over the unwanted substances that make their way from manufacturing operations into the environment.
Waste management companies themselves must also adopt these newer, cleaner innovative technologies. This will create a wrap-around impact in industries like pharma, where the potential for environmental pollution from waste is high. By treating manufacturing byproducts directly on-site and then sending waste to a treatment facility that also uses sustainable, waste management methods, the burden of contamination will be greatly reduced.
It behooves the pharmaceutical industry and its leaders to lead these conversations to avert future crises by committing to long-term changes in manufacturing, doctor and consumer behavior. Accountability will be the name of the game. This means investing in new waste management technologies and committing to sharing the impact of these efforts publicly, so consumers and stakeholders can assess progress for themselves. In addition, more targeted approaches to drug use and delivery will have a trickle down impact on pollution. With more focus placed on decreasing unnecessary use and increasing the effectiveness of a drug so less ends up in waste, pharmaceutical companies can fight chemical pollution on multiple fronts.
Each company must first own and acknowledge its role in this problem and commit to technologies, processes and strategies that prioritize reducing drugs in the environment. The time to act is now. Pharma’s focus must address the effects of their products on the environment and public health. Increased awareness and research into these issues is an opportunity to drive global change for the benefit of all.
