Year : 2019 | Volume
: 24 | Issue : 1 | Page : 13--16
The persisting environmental problem of disposal of expired and unused medicines
Abin Mani1, Vijay Thawani2,
1 Centre for Scientific Research and Development, People's University, Bhopal, Madhya Pradesh, India
2 Department of Pharmacology, People's College of Medical Sciences and Research Centre, Bhopal, Madhya Pradesh, India
Dr. Vijay Thawani
Department of Pharmacology, People's College of Medical Sciences and Research Centre, Bhanpur, Bhopal - 462 037, Madhya Pradesh
India continues to have the persisting environmental problem of disposal of expired, unused, unwanted medicines. Since this has not been studied well, the exact repercussions, therefore, are not hitherto known fully. There are no laws in country worthy of handling this problem. The municipal corporations handling the waste have not been sensitized to it. The media are insensitive to it, and populations are disorganized to take up the issue. Hence, the environment continues to suffer and will end with higher complication of human life and environment.
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Mani A, Thawani V. The persisting environmental problem of disposal of expired and unused medicines.J Mahatma Gandhi Inst Med Sci 2019;24:13-16
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Mani A, Thawani V. The persisting environmental problem of disposal of expired and unused medicines. J Mahatma Gandhi Inst Med Sci [serial online] 2019 [cited 2019 Oct 23 ];24:13-16
Available from: http://www.jmgims.co.in/text.asp?2019/24/1/13/254129
Pharmaceutical products assure potency and safety of the contained medicine till the expiry date which is mentioned on the medicine pack. At the time of expiry, the medicine is expected to have at least 90% of its original potency, under recommended storage conditions. The expiry date does not indicate that the medicine will lose its potency completely and will be no longer effective or become harmful after the expiry date. Usually, expiry date for medicines is 2–5 years from the date of production. If the medicines are stored under optimal conditions, many retain 90% of their potency for up to 5 years after the declared expiry date, and in some cases even longer. Even 10 years after the expiry date, some medicines have their original potency. In case of certain medicines like antibiotics; using long-expired medicines can contribute to increased antibiotic resistance and treatment failures., Hence, expiry dates are in benefit of the medicine consumers. The expired medicines cannot be recommended for human consumption since there will be no legal support for compensation of any side effect or adverse drug reaction occurring as the manufacturer cannot be blamed for it. The disposal of the expired and unused medicines is a vital issue because it has direct impact on environment, on all life forms, including humans.
Disposal of the Medicines
According to the recommendation of the United States Food and Drug Administration (USFDA), some selected medicines can be disposed by flushing in sink or toilet. Flushing such medicines removes this risk of retaining the expired medicines at homes. Accidental exposure to these medicines could be harmful or sometimes deadly, even in a single dose. The USFDA recommends taking back expired and unused medicines from homes and authorized collection sites in retail pharmacies, hospitals, or clinic pharmacies. In US, locations are available through authorized collectors of US Drug Enforcement Agency (USDEA) where expired medicines are collected and subsequently disposed safely.
Expired Medicine Disposal, Guidance, and Monitoring
The problem of unused or expired medicines may occur in homes, hospitals, distributors, retail pharmacies, or at the manufacturing sites. In India, common medicine disposal practices include direct disposal in the environment – in land-fill site or at isolated place, or by burning. Pharmacies incinerate the unused and expired medicines. Many municipal corporations are not aware of and hence lack medicine disposal facilities. People are totally unaware of the consequences of the unsafe disposal practice of medicines. Even the health-care professionals are ignorant about the medicine disposal practices. In India, the medicine disposal is under the narcotics department which is more concerned with controlling the misuse of addiction-causing medicines, and medicine disposal does not seem to be their priority. The unused and expired medicines are considered as municipal solid waste. Burning is considered similar to burning of plastic waste due to the physical appearance of its packaging. In India, there is no regulatory body, monitoring system, or functioning guidelines for the disposal of the expired medicines. The direct disposal of medicines by pharmacies is practiced in case of generic medicines. The quantum of generic medicine purchase, stocking, and use in public health system is higher than private pharmacies. Branded medicines are taken back by the pharmaceutical companies from the sellers, the disposal of which then is responsibility of the company.
Repacking Expired Medicines With Fresh Date: A Common Myth
There is widespread apprehension that the expired medicines taken back by the manufacturer's representatives may be repacked and resupplied. However, there is no conclusive evidence to back this fear, but many continue to harbor this opinion.
Safe Disposal of Medicines
The most environmentally safe disposal method for pharmaceutical products is community medicine take-back programs that collect medicines at a central location for proper and safe disposal. Several local public health departments in the US have initiated pharmaceutical take-back programs. In addition, the USDEA periodically promotes local take-back programs as well as a program called the National Take-Back Initiative. The proposition that pharmaceutical companies should be responsible for their products “from the cradle to the grave” has support. This philosophy suggests that the manufacturers should fund the proper disposal of pharmaceutical products manufactured by them. The process of proper treatment of disposed medicines should be done with minimal environmental impact. Water treatment should minimize or eliminate the amount of these pollutants by using sorption where suspended solids are removed by sedimentation. Another method used is biodegradation through microorganisms where bacteria feed on or break down these pollutants, thus eliminating them from the contaminated media.
Environmentally safe disposal of pharmaceutical products has not been sufficiently addressed yet. The natural consequence of the product development for patient usage is that some products will inevitably remain unused, or will be damaged, or get expired. World Health Organization, World Bank, European Union (EU), and FDA have developed guidelines for safe disposal of pharmaceuticals. There is a dire need to develop proper disposal guidelines in India with a monitoring mechanism. Expired medicine take-back programs should be started in India and should be popularized through public awareness.
The Environmental Impact
The impact on environment of disposing the expired medicines in the open, land fill, or by burning has not been studied extensively. The indoor wards of cancer patients do not have a separate sewage system. Untreated radioactive waste from the clinics and hospitals with cancer patients directly goes in the municipal drains and may percolate to the soil, thereby contaminating the water sources which further contaminate the land mass and pass to the food chain. If the medicine disposal practices are improper, the health of the exposed population is certainly at risk.
The direct impact of medicine to the wild life is responsible for the decline of vulture population in South Asia by diclofenac through cattle. Pharmaceutical products used for humans, animals, and birds have been detected in water bodies. The waste water treatment plants are not designed to manage the pharmaceutical deposits passed in the water because of human consumption and excretion. Improper waste disposal and ineffective treatment of waste water pollute the fresh water that pollutes the environment.
Between 1999 and 2009, in US alone, the use of pharmaceuticals and personal care products (PPCPs) has increased from 2 billion to 3.9 billion annually. The PPCPs enter into the environment through human activity. In Europe, the input of pharmaceutical residues via domestic waste water is estimated to be 80%, whereas 20% comes from hospitals. Individuals may add PPCPs to the environment through waste excretion, bathing, and by direct disposal of unused medications to septic tanks, sewers, or trash. The PPCPs dissolve easily in water and do not evaporate at normal temperature, and finally end up in soil and water bodies. Some PPCPs are broken down in human or animal body or degraded in the environment. However, others do not break down or degrade easily.
Detectable quantities of one or more chemicals were found in 80% of a sampling of 139 susceptible streams in 30 states of US. The most common pharmaceuticals detected were nonprescription medicines, detergents, fire retardants, pesticides, natural and synthetic hormones, antibiotics, and prescription medicines. Pharmaceutical compounds detected in sewage treatment plant effluents, surface water, and sediment include antibiotics, analgesics, anti-inflammatories, lipid regulators, beta-blockers, anticonvulsants, and steroid hormones at low concentrations, uncertainties remain about the levels at which toxicity occurs and to the risk of bio-accumulation. A study conducted in Taiwan rivers also detected the presence of Ecstasy, ketamine, caffeine, and acetaminophen. Investigations in Germany, France, and Scotland found traces of PPCPs in the upstream of waste water treatment plant effluents to rivers. Besides the human input, there is also diffused pollution from pharmaceuticals used in agriculture.
The exposure to the PPCPs depends on the concentration, type, and distribution of pharmaceuticals in the environment; the pharmacokinetics; the structural transformation of the chemical compounds either through metabolism or natural degradation processes; and the potential bio-accumulation of the medicine. In addition to the growing concerns about human health risks from pharmaceuticals via environmental exposure, their potential for inducing antibiotic resistance has been suspected.,, The EU has included pharmaceutical residues with the potential of contaminating water and soil together with other micropollutants under “priority substances.”
Estradiol concentrations in surface water may cause vitellogenin production and structural change of sex organs. These observations on feminization of fish by estrogenic compounds in sewage treatment plant effluents have been observed in many countries, and in other species like frogs, alligators, and mollusks. Propranalol was found to cause significant decrease in egg production in Medaka fish. Gemfibrozil lowered the blood levels of testosterone in fish. Fluoxetine affected swimming activity in shellfish. High levels of antibiotics in the water are a cause for alarm as there is an increased risk of selecting resistant bacteria.
In India, the bacteria resistant to ciprofloxacin have been found downstream of a pharmaceutical factory, genes for antimicrobial multiresistance have been found in drinking water, and multiresistant Salmonella have been identified in water sprayed on vegetables. The epidemic with multiresistant enterohemorrhagic E. coli at Europe originated from water-sprayed vegetables. The tetracyclines and quinolones are not metabolized in the human body and can be toxic to other animals, microorganisms, and fish. In India, several broad-spectrum antibiotics were found in concentrations toxic to microbes, animals, and plants, with enterococci resistant to all known antibiotics. Several pharmaceuticals have been found in goat, cow, and human milk. The bio-accumulation of pharmaceutical products in aquatic animals, plants, and animals significantly affects the human life in turn.
Laws and Regulations
The environmental pharmaceutical pollution is yet to be managed during entire chain of the product. To reduce the environmental impact, there should be administrative governess in authorization, market regulation, and legislation. The disposal behavior of the individuals and the waste management and treatment have to be legally regulated. The laws and regulations have to be developed regarding the disposal products based on their chemical characteristics. Impact of medicines on the environment will provide an analysis of the relevance and effectiveness of the current legislative framework in protecting the aquatic environment and human health via the aquatic environment.
The EU has added chemicals in the watch list of substances for monitoring and control in EU surface water which includes pharmaceuticals. The contamination of water and soil with pharmaceutical residues is an omnipresent environmental concern. The EU has developed disposal practices since 2004. Its directive for human pharmaceuticals requires all member states to establish collection systems for unused or expired medicines. Such systems were already in use in several member states at the time the legislation went into action in 2004. The disposal regulations in the EU differ. Incineration is practiced in Germany, Luxembourg considers the unused or expired pharmaceuticals as hazardous waste; in France, the take-back program enables people to bring back unused or expired pharmaceuticals back to the pharmacies. The disposal of the unused and expired medicines in sinks or toilets is a major problem in EU. A study from Germany showed that 24% of liquid pharmaceuticals and 7% of tablets or ointments are disposed through the toilet or sink. In 2012, about 1200 pharmaceutical substances were identified to be potentially relevant for an environmental monitoring.
In India, good manufacturing practices (GMPs) and requirements of premises, plant, and equipment for pharmaceutical products laid down in Schedule M of the Drugs and Cosmetics Rules, 1945, prescribe the requirements for disposal of waste including the rejected drugs.
The disposal of sewage and effluents (solid, liquid, and gas) from the manufactory shall be in conformity with the requirements of environment pollution control boardAll bio-medical waste (BMW) shall be destroyed as per the provisions of the BMW (management and handling) rules, 1996Additional precautions shall be taken for the storage and disposal of rejected drugs. Records shall be maintained for all disposal of wasteProvisions shall be made for the proper and safe storage of waste materials awaiting disposal. Hazardous, toxic substances and flammable materials shall be stored in suitably designed and segregated, enclosed areas in conformity with central and state legislations.
One of the conditions of drug-manufacturing license granted under the Drugs and Cosmetics Rules, 1940, is that the licensees shall comply with the GMP requirements prescribed in Schedule M of the said Rules. State-licensing authorities appointed by the respective state governments are empowered to take action in case of any violation of above requirements.
The government has taken various regulatory measures to curb the misuse of antibiotics. However, no report/incidence of growing of antimicrobial resistance of drugs due to discharge of drugs and chemicals into environment has been brought to notice of this ministry.
Monitoring and detection of pharmaceutical impact on environment has to be done on priority. India is facing multidrug-resistant bacterial infections which are only the visual impact of our doing–undoing. Environmental impact of other medicines has not been well studied as their disposal is not regulated. Currently, no methods exist to assess the negative environmental impact in the long- and short-term exposure to synthetic medicines.
Since there are not many medical activist pressure groups in the country, such issues do not find much space in the media. The ignorant populations continue to suffer the exposure because the monitoring agencies are not vigilant. None wants any additional work to control the medicine disposal. Concern for public health is at low ebb, and the medicine disposal in the country certainly needs a re-think.
The government should take active steps and initiate measures to reduce pharmaceuticals in the environment. Emission of pharmaceuticals should be essentially incorporated in GMP, and the characterization of chemical content of medicines should be revealed along with the best disposal practice so that environmentally safe disposal can be adopted. India will do well to leap-frog and adapt the take-back policy of unused and expired products and then initiate the effective disposal through incineration or deep burial. In India, awareness programs have to be conducted regarding the disposal of pharmaceuticals. Currently, the distribution of medicines is not regulated, and the quantum of medicine going to environment is surely much higher than anticipated. If nothing is done, a huge impact of the environmental consequences is waiting for us. Beware.
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Conflicts of interest
There are no conflicts of interest.
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