Covid-19 has provided the impetus and catalyst for further acceleration in the growth of pharmaceutical industries leading to high-risk pollution across the world
BY JASON LOH
AND JACHINTHA JOYCE
Although not as well-publicised as the other pollutants, pharmaceutical or drug pollution is rapidly becoming a policy concern for their degrading and toxifying impact on the environment, particularly via water sources, especially freshwater (rivers, lakes, water catchments), as “aquatic micropollutants”.
For example, according to the Cary Institute of Ecosystem Studies, “pharmaceutical pollution in freshwater [among others] is largely unstudied”.
Covid-19 has provided the impetus and catalyst for further acceleration in the growth of pharmaceutical industries leading to high-risk pollution across the world (see, e.g., “A critical review on the environmental presence of pharmaceutical drugs tested for the Covid-19 treatment”).
Worldwide revenue of the pharmaceutical industry reached US$1.4 trillion in 2021, according to ResearchandMarkets.com (see “Analyzing the US$1.4 trillion Global Pharmaceutical Industry 2022”, Business Wire, Nov 30, 2022).
But the tide is shifting and the “crustal displacement” in the policy discourse is that there’s been growing awareness and consciousness regarding the ecological impact of pharmaceutical and what’s known as active pharmaceutical ingredients’ (API) disposal, discharge and release over the years now. This is due to the global reconnaissance and findings precipitated by the off-shoring, outsourcing, and relocation of the pharmaceutical industries’ production networks to the so-called “Third World” countries.
APIs are any substances or compounds that are designed to be utilised in the production of a pharmaceutical dosage form and, when so used, becomes an active component that helps to diagnose, treat or prevent different diseases (World Health Organisation/WHO Technical Report Series No.970,2012, as quoted by the National Pharmaceutical Regulatory Agency/NPRA, Ministry of Health/MoH, Malaysia).
In addition to freshwater sources, APIs and finished pharmaceutical products (FPPs) infiltrate/enter the environment via ocean, underground water, and landfills.
Contaminants of emerging concern
Due to the nature of the role that they play, wastewater and sewage treatment plants (STPs) host pharmaceutical pollutants via urine, faeces and wastes from body wash (see, “A critical review on environmental presence of pharmaceutical drugs tested for the Covid-19 treatment”, Process Safety and Environmental Protection, Vol. 152, August 2021).
Besides medical and drug products, personal care products (PCPs) – such as toothpastes and shampoos – are counterpart elements that contribute to pharmaceutical pollution.
The Fourth Session of the International Conference on Chemicals Management (ICCM 4) nominated what’s termed as, “environmentally persistent pharmaceutical products” (EPPP) – which contain APIs – as an emerging policy issue at 2015. These pollutants are also classified as contaminants of emerging concern (CECs).
Even where the concentration is low, APIs/EPPPs/CECs can cause an inimical effect on living organisms and don’t degrade easily, and persist for longer periods in the environment due to their stable structure (“Pharmaceutical Wastewater as Emerging Contaminants (EC): Treatment technologies, impact on environment and human health”, Energy Nexus, Volume 6, June 2022).
Traces of pharmaceutical components from antidepressants, antibiotics, painkillers and birth control pills are some of the common pollutants found in freshwater sources, and considered as the leading environmentally dangerous drugs (see, “Drugs flushed into the environment could be cause of wildlife decline, The Guardian, Oct 13, 2014).
Additionally, pharmaceutical pollution is highly associated with risks in human and aquatic organisms’ endocrine (or hormonal) systems – as endocrine disrupting chemicals (EDCs).
Endocrine systems release hormones into the bloodstreams of humans and animals, which is critical in controlling mood, physical growth and development, energy level, reproductive capacity, etc.
For instance, based on a study, birth control pills have a high level of progestogens to which frogs are very sensitive. Female tadpoles that inhabit polluted areas are subjected to reproduction issues resulting from infertility (see, “Sterility in frogs caused by environmental pharmaceutical progestogens, study finds”, Science Daily, Feb 16, 2011).
Pharmaceutical pollution in rivers
Globally, 25 per cent of the rivers are impacted whereby this is inclusive of not only urban but also remote areas (see, “25 per cent of global rivers have significant pharmaceutical pollution”, Open Access Government, Feb 17, 2022).
Developing and less developing countries are more exposed (to pharmaceutical pollution) – reflecting the wider disparities arising from the North-South divide.
A study published by the Proceedings of the National Academy of Science/PNAS – “Pharmaceutical Pollution of the World’s Rivers” (Feb 14, 2022) – shows that parts of South America, sub-Saharan Africa and South Asia are highly rated pharmaceutical pollutant hubs (“Global study finds the extent of pharmaceutical pollution in the world’s rivers”, University of York, 2022). The study “monitored 1,052 sampling sites along 258 rivers in 104 countries of all continents, thus representing the pharmaceutical fingerprint of 471.4 million people” to “measure the presence of 61 pharmaceuticals.
In turn, these pharmaceuticals such as carbamazepine (a highly teratogenic substance, i.e., causing congenital disorders in a developing embryo or foetus and life-threatening allergic reactions such as Stevens-Johnson Syndrome/SJS) or toxic epidermal necrolysis/TEN), metformin and caffeine [as the three most frequently detected APIs]”.
It’s found (among other things) that:
• There’re strong correlations between the levels of socioeconomic inequality of a country and higher pollution of pharmaceuticals in the rivers;
• high levels of pharmaceutical pollution were most positively associated with regions of high local unemployment and poverty rates;
• the most pharmaceutically polluted countries and regions of the world are the ones that have been researched the least in the past – as alluded to, namely parts of sub-Saharan Africa, South America and South Asia.
These regions have a high presence of multinational pharmaceutical companies (MNCs) – as subsidiaries of the parent companies based in developed countries. By extension, the same regions and hotspots have high levels of pharmaceutical pollutant concentration.
For example, “the highest mean cumulative concentration was observed in Lahore, Pakistan at 70.8 µg/L, with one sampling site reaching a maximum cumulative concentration of 189 µg/L … This was followed by La Paz, Bolivia (68.9 µg/L mean, 297 µg/L maximum) and Addis Ababa, Ethiopia (51.3 µg/L mean, 74.2 µg/L maximum).
“The most polluted sampling site was located in the Rio Seke (La Paz, Bolivia) and had a cumulative API concentration of 297 µg/L … This sampling site was associated with both untreated sewage discharge and disposal of rubbish along the bank of the river”.
Unlike North America and the Western hemisphere, lack of sophisticated waste removal technologies (natural, e.g., via micro-organisms and industrial via, e.g., peracetic acid) and lax enforcement of regulations to mitigate pharmaceutical pollution are common in developing and less developing countries, particularly in the regions concerned.
In conclusion, we need to be more aware and mindful of the harm from pharmaceutical pollution and go the extra mile in tackling these emerging challenges. – The Health
Heightened risk of groundwater contamination
In Malaysia, the focus on pharmaceutical pollution has often been neglected.
The pharmaceutical industry here is controlled by the Drug Control Authority (DCA) of the Ministry of Health (MoH) with the NPRA as the secretariat and technical body. The DCA’s executive and legal role (as delineated/provided for under the Control of Drugs and Cosmetics Regulation, 1984) is to ensure that every pharmaceutical product marketed in the country is safe and of sound quality.
The National Pharmaceutical Regulatory Agency (NPRA) provides technical support by testing the pharmaceutical products’ quality and safety (quality control (QC) and performance evaluation.
Currently, Malaysia’s core legislation on the environment is the Environmental Quality Act (1974). No laws specifically target pharmaceutical pollution as a discrete category in its own right.
Many Malaysians in less developed states source water from groundwater sources. Kelantan, Terengganu, Kedah, Perlis, Pahang, Sabah and Sarawak are the highest users of groundwater as a source of drinking water.
But the federal government has been keen to tap into groundwater as a viable alternative source for the nation as a whole (see, “Tapping into groundwater is the way forward, says PM, New Straits Times, March 26, 2022).
If this is implemented, Malaysians might be at a heightened risk of groundwater contamination if pharmaceutical pollution isn’t definitively tackled.
Already in what could be deemed as a “rare” finding as contained in “Detecting Human Pharmaceutical Pollutants in Malaysian Aquatic Environment: A new challenge for water quality management” (chapter in Contemporary environmental quality management in Malaysia and selected countries, UPM Press, 2011), results show that the Hulu Langat River has been polluted by APIs, and sewage treatment don’t totally remove these pollutants.
Mefenamic acid, salicylic acid and glibenclamide are the most common pharmaceutical residues found in the Hulu Langat River (“The occurrence of human pharmaceuticals in wastewater effluents and surface water of Langat River and its tributaries, Malaysia”, International Journal of Environmental Analytical Chemistry, 93(3), 2011).
The ineffectiveness of our conventional sewage treatment plants (STPs) is confirmed by Dr Nurfaizah Abu Tahrim from Universiti Kebangsaan Malaysia (UKM) – which aren’t designed to treat pharmaceutical waste (See “Environmental implications of pharmaceutical waste, Borneo Post Online, Jan 27, 2021).
Regular inspections and audits important
EMIR Research would like to recommend that due attention be afforded to upgrading our STPs to ensure that they deploy the latest waste removal technology – natural and industrial – such as solar photolysis (conversion of photon energy comprising of waves of electromagnetic radiation by which the contaminants are exposed – process of irradiation) and advanced oxidation processes/AOPs (e.g., thermal plasma – increasing reactive oxygen and nitrogen species to dissolve in water and break down contaminants), respectively, which specifically targets at pharmaceutical-based/driven pollution.
The government at all three levels (federal, state, local) should be more committed to tackling river and landfill pollution by rigorously and uncompromisingly enforcing the legislation (primary) and regulations (secondary) on the pharmaceutical industries.
Regular inspections and audits should be carried out at all three levels and these activities should be coordinated and synchronised, accordingly. At the same time, the pharmaceutical industries should be assessed by private auditors in compliance to the ESG (environmental, social and governance) due diligence. Independent, non-executive directors should be empowered and trained to scrutinise and monitor pharmaceutical polluting activities.
At the micro-level, every pharmacist, medicine administrator in hospitals and clinics, and pharmacies should educate and inform patients to dispose of expired or unused drugs properly. This will prevent patients from disposing of the prescribed and non-prescribed (i.e., “over the counter or OTC) drugs improperly (e.g., flushing down the toilet bowl). This is to ensure pharmaceutical wastes from contaminating the STPs – as pre-emptive and precautionary measures. – The Health
Jason Loh and Jachintha Joyce are part of the research team at EMIR Research, an independent think tank focused on strategic policy recommendations based on rigorous research.