INTRODUCTION:

Medicines, a chemical compounds used to treat diseases, are essential in our daily lives. However, advancements in the medical industry have led to a rise in medicine waste due to over prescriptions and increased patients. This waste has negative environmental effects, biological diseases, and ethical issues. It's crucial to educate people on proper disposal of unused and expired medications¹. The healthcare system relies on medicines, which are often discarded after recovery.

A survey in Delhi found that many people dispose of unused medications in the garbage, which can end up in landfills, eroded into soil, combined with rainwater, and polluted air. This waste is then returned to us in a more hazardous form. Human, cow, and goat milk contain pharmaceuticals, which can negatively impact human mental health due to the bioaccumulation of pharmaceutical compounds in aquatic plants and animals. Therefore, it is crucial to reduce the disposal of unused medicines and promote responsible disposal practices². The degradation of medicines can take years and persist in the environment, causing potential contamination of local sources like water supply. Proper disposal of medicines as general waste is crucial to avoid unnecessary environmental contamination. Disposing medicines in an unsecured landfill is not safe, as flushing them down the toilet or spilling them down the sink is not safe³. Drug disposal is crucial for maintaining safety and preventing misuse. Proper disposal of unused medications prevents abuse and pollution. Inappropriate disposal can lead to drug pollution and loss of potency. In India, new medications are introduced daily to treat various illnesses, and when they decompose, they can become poisonous. Despite the USFDA's 'drug take back campaign' to prevent drug pollution, it is ineffective in India. Inappropriate drug disposal practices, such as flushing drugs down the bathroom sink, burning them, and disposing of them in wastebaskets, can lead to water contamination. Organizations should provide consumers with consistent information on drug disposal to ensure a safe and environmentally friendly approach. Inappropriate disposal practices can lead to issues such as contaminating water sources and causing harm to the environment⁴. The investigation aimed to raise awareness about safe medication disposal in communities and government organizations, examining global methods and understanding the level of community understanding on this crucial issue⁵. Expiration of drugs can compromise their efficacy, safety, and potency, leading to health risks. Unused or expired medications can cause antibiotic resistance, carcinogenicity, and therapeutic failure. Proper disposal procedures are crucial to prevent misuse and unintentional poisonings. Additionally, expired drugs may collect moisture, change their physico-chemical characteristics, and develop microbial contamination⁶. Expiratory or outdated medications pose potential hazards and require careful handling to prevent the build up of toxic drugs in the environment⁷. Polar compounds, commonly used as active pharmaceutical ingredients (APIs), are often referred to as "micro pollutants" due to their presence in aquatic habitats. The detection of trace amounts of human and veterinary pharmaceutical compounds and their metabolites in water surface areas allows for environmental pollution⁸. Pharmaceuticals and their byproducts pose a threat to the environment, causing water buildup, increasing antibiotic resistance, and exposing populations to medications, aquatic creatures, and personal hygiene items. Pesticides also enter ground and surface waters, eventually affecting the food chain⁹. The pharmaceutical industry is rapidly growing due to increased global use of medicines, particularly in countries like China and India. India ranks sixth in the world's pharmaceutical markets based on volume production. However, many products go unused or expired, and half of patients do not follow their prescribed dosages. Additionally, 50% of medications are improperly sold, administered, or prescribed, leading to wasted and unused products¹⁰.

PURPOSE OF DRUG DISPOSAL:

Using this guideline, you can effectively dispose of unwanted pharmaceuticals in a safe and responsible manner. From an environmental point of view, the optimum choice for the destruction of pharmaceuticals is a high temperature burning method combined with proper flue gas purification. However, it should be mentioned that there are other ways to dispose of garbage effectively besides this one. Despite Sri Lanka having this high-tech facility, there are still some marginally less safe disposal and treatment methods available as well. In the country, the NMRA is solely responsible for disposing of pharmaceuticals with the help of the national and provincial health authorities. We also consult with other government agencies as needed³. The purpose of this quantitative cross-sectional investigation was to investigate consumer knowledge regarding recommended disposal methods, actual disposal habits, and the consequences of disposing of pharmaceuticals on the environment and public health¹¹.

SOURCES AND DRUG DISPOSAL'S IMPACT:

Pharmaceutical waste, produced from various activities, produces organic pollutants that harm biota and public health. It comes in chemical, non-hazardous, and hazardous forms and sources include various industries. Sources of medication waste are:

(1) Improper handling of medications that have expired;

(2) Disposal of unused/unwanted drugs in hospitals, clinics, pharmacies or households;

(3) Materials containing chemotherapy drug residues;

(4) Medicine packaging material;

(5) Waste generated by pharmaceutical companies;

(6) Improper and direct disposal of unneeded or expired medications in the garbage, sink, or through pee or feces;

(7) Discharge from molecular farming and pesticides.^10,12

STEPS TO BE TAKEN:

The actions that will be performed when we dispose of unused medications are briefly outlined here.

1) Decision: Unneeded pharmaceuticals accumulate in healthcare facilities, provincial health departments, buyers, health campaigns, and private organizations. Approved officers, supervising pharmacists, and other responsible agents determine when action is necessary to dispose of collected pharmaceutical waste, with the pharmacy business or medical facility deciding when to do so.

2)Approval: Pharmaceutical disposal must be authorized and sanctioned by the National Medicines Regulatory Authority (NMRA). The relevant authorities must grant permission to dispose of pharmaceutical waste.

3) Planning: Planning for disposal involves determining resources like cash, knowledge, human capital, specialist time, location, tools, and disposal choices. Utilizing a tape measure and converting volume to weight using 0.2 metric tons per cubic meter as the density factor is crucial for ensuring the availability of necessary resources.

4) Forming work teams: Pharmaceutical warehouses should employ teams of pharmaceutical technicians and general medical workers, whose size and composition depend on the quantity and composition of teams and the working environment.

5) Health and safety of work teams: Workers must wear protective equipment like overalls, boots, masks, gloves, and caps at all times. Masks are essential to prevent powder liberation during crushing and disposal, and special care is needed when handling antineoplastics.

6) Sorting: Pharmaceuticals are sorted into subcategories requiring different disposal methods, including controlled substances like opioids, antineoplastics, and antibiotics. Identifying and separating medications can be time-consuming and require significant human resources, making it a complex task.

7) Disposal: It is not always possible to achieve the ideal solution because disposal options differ greatly between situations. These guidelines are intended to make recommendations that are the simplest, safest, and most practical.

8) Security: Narcotics and psychotropic drugs require strict security and supervision to prevent diversion and theft from landfills. Immobilization is the most effective solution, and pharmaceuticals should be covered with municipal waste when discarded.

OUTCOME OF IN APPROPRIATE DISPOSAL OR NON-DISPOSAL:

In general, there is no significant risk to the environment or public health from outdated medications. If an incorrect disposal contaminates local sources or water supplies that other towns utilize, it might be dangerous. Insecure landfills have the potential to give up outdated medications to kids and If expired medications are taken from a stockpile of leftover medications or during sorting, they may be resold and used improperly. Almost all pharmaceuticals become less effective after their expiration date, and some may develop adverse reactions.

1. Drug abuse and poisoning:

Insecure landfills or home storage of expired drugs can lead to accidental poisonings, overdoses, and theft of pharmaceuticals. 95% of unintentional medicine is unknowingly consumed without parental knowledge, and stolen pharmaceuticals can end up on the market for resale and abuse.

2. Antimicrobial resistance:

Over the past 50 years, millions of metric tonnes of antibiotic chemicals have been dumped into the environment, leading to antibiotic resistance. This resistance results in an annual death toll of around 700,000 due to antibiotic treatment failure. Studies show that bacteria evolve and become more resistant due to antimicrobial substances discharged from pharmaceutical facilities, healthcare facilities, and agricultural runoff. In Hyderabad, water bodies contain high levels of drug residues, while, in Delhi's STPs, researchers from the Indian Institute of Technology discovered large concentrations of bacteria resistant to carbapenem and the extended spectrum efflux pump (ESBL). It appears from these two cases that improper drug disposal may also be a factor in treatment failure.

3. Contaminated food:

India's drinking water contains antimicrobial multi-resistant genes, leading to bacteria resistant to ciprofloxacin and Salmonellae. This is believed to be responsible for the E. coli epidemic in Europe. Drinking water also contains harmful substances, including multi-resistant Salmonella in Indian water used to irrigate crops, and waste water is used to irrigate nearly 80% of Pakistan's produce.

4. Cytotoxicity:

Drugs used to treat cancer are cytotoxic, killing both healthy and cancerous cells. Incorrect disposal of these medications can lead to mental retardation, cancer, and infertility. Research shows that antineoplastic medications are mutagenic and carcinogenic. In Finland, offspring of mothers working with anticancer drugs were found to have a higher frequency of spontaneous miscarriages and abnormalities.

5. Impact on animals:

South Asia's cattle use of diclofenac has led to vulture population decline. Pharmaceuticals used for humans, animals, and birds are found in water bodies. Estrogens in industries cause feminization and demasculinization of male fish. Tetracyclines and quinolones can be poisonous to animals and microorganisms. In India, some antibiotics are poisonous to microorganisms, animals, and plants. Medicines in goat, cow, and human milk can negatively impact human health.

6. Genotoxicity:

Chemical agents damage genes, leading to mutations and potential cancer. Environmental pollution from genotoxic waste has severe ecological impacts on land, air, and water. WHO reports 20% of hospital wastes are hazardous, while 80% are non-hazardous. Hazardous wastes contain mutagenic, carcinogenic, or teratogenic substances^2,3.

RECOMMENDATIONS FOR SECURE DISPOSAL:

Guidelines for safe pharmaceutical disposal offer suggestions for unwanted or expired medications without exceeding federal, state, or municipal regulations. These secure disposal techniques are suitable for situations with limited equipment and resource availability, ensuring public health and the environment, and addressing limited advice.

1) Contamination of the water must be prevented. The location and design of a landfill need to reduce the chance that leachate may seep into an aquifer or groundwater system.

2) It is not advisable to dispose of disinfectants, antibiotics, antineoplastics that are not biodegradable in wastewater systems since they have the potential to destroy essential microorganisms for sewage treatment. When antineoplastics are discharged into watercourses, they can harm aquatic life and pollute drinking water.

3) Disinfectants shouldn't be discharged in large quantities into sewer systems or watercourses, but can be introduced when well diluted.

4) Burning medications in open containers or at low temperatures can be hazardous due to the discharge of dangerous chemicals. Avoiding this as much as possible is advised.

5) If unwanted pharmaceuticals are stored in dry conditions and no suitable disposal sites are available, there is no risk posed by their disposal if they are stored securely. Pharmaceuticals should be stored in drums with their pharmaceuticals immobilized rather than in their original packaging to prevent diversion.

6) Diluted liquid medications such as syrup and intravenous (IV) fluids— can be flushed down the sewage system without posing health or environmental risks. Small amounts of medications or well-diluted antiseptics can also be flushed into watercourses. Assistance from hydro geologists or sanitary engineers may be needed for dilapidated or damaged systems.

7) Genotoxic and Cytotoxic drugs should be disposed of chemically as directed by the manufacturer, burned at high temperatures, or returned to the original source through a take-back program.The secondary chamber with gas-cleaning equipment must be heated to 1200°C in order to destroy all cytotoxic substances.

8) Manufacturers are responsible for disposing of solid, liquid, and gas effluents in accordance with environmental regulations.

9) All biomedical waste has to be eliminated in accordance with the 1996 Bio-Medical Waste (Handling and Management) Rules.

10) It is important to take additional precautions when storing and disposing of rejected drugs. It is mandatory to maintain records for all waste disposals^2,3,13.

METHODS FOR SAFE DISPOSAL:

People often discard expired or unused medicines in dustbins, posing risks to children and pets. This can lead to serious toxicity or poisoning. Additionally, these medications end up in landfills with other solid materials, posing a significant environmental and public health risk. Proper disposal of medicines is crucial for maintaining public health. According to WHO some methods are given:

1. Landfill: Landfills are places where waste is disposed of directly under soil without any prior treatment. Solid waste is most commonly disposed of at landfills, which is the earliest and most widely used method of disposal. Landfills are of two types:

• Engineered landfill: The landfill has safeguards to prevent toxins from seeping into the aquifer, and the second-best option for disposing of medications is directly dropping them into the landfill with immobilized pharmaceutical debris.

• Engineered sanitary landfill: Landfill sites for pharmaceutical waste disposal should be developed and maintained correctly, with a focus on protecting the aquifer. Ideal landfills should be filled, elevated above groundwater, and away from streams. Solid trash is compacted daily for hygienic disposal.

2. Return to donor or manufacturer: The general public cannot safely dispose of drugs, so it's recommended to return unusable drugs to their manufacturer or authorized person. This is necessary for high-risk drugs like antineoplastics, and donations can be returned if unwanted or unrequested, especially near expiration dates.

3. Immobilization waste: encapsulation: Pharmaceuticals are encapsulated in steel or plastic drums, which must be cleaned to prevent explosives. 75% of these containers are filled with cement, cement/lime mixes, bituminous sand, or plastic foam. Before filling, cut the lids open and bend them back. A 15:15:5 mixture of lime, cement, and water is poured, and more water may be needed. Steel drum lids should be welded or seam welded. Cover the drums with municipal solid waste and place them at a landfill^2,14.

4. Waste immobilization: inertization: Separate precursors and restricted compounds from packaging materials. Remove pills and capsules from blister packets, grind using a grinder, and mix pulverized powder with lime, cement, and water in a 65:15:15:5 ratio. Add water if needed, and set in a pit or drum.

5. Sewer: Liquid medications, such as syrups and IV fluids, can be diluted into sewers over time without posing environmental or public health risks. Diluted doses can also be flushed into rivers. Broken or disrepair sewers may require hydro geologist or sanitary engineer assistance.

6. Open container burning: Burning medications in open containers at low temperatures can emit toxic chemicals into the air. Paper and cardboard packaging cannot be recycled, and burning polyvinyl chloride or PVC material is not recommended. Burning pharmaceutical waste is a common method, but only for small amounts.

7. Incineration in medium temperature: In emergencies, expired solid medications can be treated using a two-chamber incinerator at 850°C, with a minimum combustion retention duration of two seconds. Medium temperature incinerators are recommended for temporary disposal. Pharmaceutical waste should be diluted with municipal garbage. Thermal treatments destroy pathogens and toxins in clinical and hazardous wastes.

8. High temperature incineration: Furnaces are commonly used in high-temperature industries like cement kilns, coal-fired thermal power plants, and foundries. They operate at temperatures above 850°C, have a long combustion retention period, and release exhaust gases into high altitude chimneys. Cement kilns are suitable for medicine disposal due to their high temperatures, allowing organic waste components to decompose efficiently.

9. Chemical decomposition: Chemical decomposition is a method for disposing of antineoplastic medications without a suitable incinerator, followed by landfilling. However, this method is not recommended if chemical expertise isn't available. Chemical inactivation involves several steps and chemicals must be available at all times. Chemical degradation is not viable for large quantities like over 50 kg^2,3,14,15.

ROLE OF PHARMACIST IN DRUG DISPOSAL:

A survey reveals that a majority of pharmacists in Kuwait dispose of unwanted medicines in trash, with only 23% disposing of drugs. However, 82% of respondents acknowledged the environmental harm caused by inappropriate disposal and 97% believed it was their duty to preserve it. In the future, 86-88% of pharmacists will agree to collect prescription drugs from government hospitals and polyclinics for take-back schemes. Only 5% of pharmacies regularly advise consumers on drug disposal, and 25% only answer customer inquiries. In India, 25% of pharmacists admitted to throwing away solid dosage forms, and 89% of them believe pharmacy school did not teach proper disposal. 58% believe there is a link between drug disposal and environmental damage, with 69% preferring incineration of unneeded or expired medications¹⁶.

Environmental Impacts of Improper Disposal of Unused / Expired Pharmaceuticals:

Unwanted medications end up in municipal wastewater treatment facilities, including those flushed down toilets or thrown into sinks. Wastewater treatment plants in industrialized and developing nations handle wastewater using suspended particles or nitrogen and phosphorus compounds. Currently, no regulations exist in the European Union to eliminate micro pollutants, including pharmaceuticals, from wastewater. Council Directive 91/271/EEC requires member states to ensure treated wastewater meets requirements for total suspended solids, oxygen demand, and phosphorus and nitrogen content. Aquatic life is at risk due to micro pollutants like medicines and their metabolites entering water bodies. In the Baltic Sea, medications are mostly released into marine and freshwater ecosystems through wastewater treatment plants. Many medications have poor solubility on sludge, forming liquid phases. Many chemicals found in wastewater can break down and interact with other substances in the environment. Many African villages lack modern sewage and wastewater treatment facilities, leading to the release of medications and their metabolites into groundwater and soil. Landfills are used to dispose of most household trash, and a 2016 study found that 15 chemicals were found in leach ate from municipal landfills. These drugs can cause biological reactions even at low dosages, potentially causing harm to aquatic life. However, there is still much to learn about the ecotoxicological consequences of medications, as 88% of human drugs lack thorough data on their toxicity to the environment. Additionally, identifying which organisms are negatively impacted by medications is challenging due to their presence in mixtures. Antibiotic-resistant genes and bacteria have grown due to the discharge of antibiotics into the environment, leading to antibiotic resistance. This can cause antibiotic resistance to propagate from environmental elements to drinking water sources, posing a threat to human health. Groundwater supplies drinkable water to 75% of the European population, and pharmaceuticals have been found in drinking water and groundwater worldwide. In 2015, the World Health Organization approved a worldwide action plan on antibiotic resistance, aiming to optimize consumption and raise public awareness of resistant microbes. The European Union launched the European One Health Action Plan against antibiotic resistance in 2017. The COVID-19 pandemic has led to a rise in the use of medications, particularly antibiotics, and a corresponding increase in their concentration in sewage systems. Antiviral medications, antimalarial medications, antibiotics, pain medications, and a combination of these medications were tested due to the lack of specific medications to combat the SARS-CoV-2 virus. Studies show that antibiotics used in COVID-19 therapy have higher concentrations in aquatic environments during the pandemic¹⁸. FDA environmental assessment specialist Raanan Bloom, Ph.D., warns of drug residues in surface water and municipal drinking water systems, possibly due to natural bodily processes associated with medication use. Many drugs are not fully absorbed or digested in the human body and can end up in the environment after waste water treatment facilities¹⁹. Pharmaceuticals are disposed of in wastewater treatment plants using biological, chemical, and mechanical methods. Biodegradation and sorption are the two processes. Examples of medications with little sorption include rosuvastatin, metoprolol, tramadol, diclofenac, and carbamazepine. The Secure and Responsible Pharmaceutical Disposal Act of 2010 modified the prohibited drugs Act (CSA) to limit distribution, importation, manufacturing, possession, and use of prohibited drugs. This amendment was passed due to the rise in non-medical prescription drug usage and accidental overdose fatalities^19,20.

Secure disposal of unutilized and unwanted medicine in household:

1) Pills, capsules or other solid wastes:

To prevent people from eating medication, pour it into an unappealing container, such as an empty can or bag, and mix it with cat litter, seal with opaque tape, double-bag, and dispose of.

2) Liquid Medications:

If you have kitty litter or coffee grounds, you can add them to the mixture. Make sure that all personal information on the container has been removed. You will need to seal the container with duct tape or other opaque tape to prevent leakage, then double-bag it and place it in the trash.

3) Unused vials, ampoules and IV bags:

Disposing of medication waste at home involves burning, tossing in the ground, flushing into the toilet, or sending to pharmacy or medical facilities. Proper disposal is a global challenge, as improper management can have irreversible environmental effects. Combining medications with urban waste poses a threat to human health, the environment, and biodiversity. Toxic byproducts, particularly antibiotics, estrogen, antineoplastics, and immunosuppressant agents, can have teratogenic, mutagenic, and carcinogenic effects on animals and humans. Rural households often dispose of waste by fire, posing health and environmental risks due to pollution and toxic gases. ANVISA implemented RDC 222 in 2018 to regulate good practices for managing health services residues in Brazil. However, there is no national policy regulating how pharmaceuticals are collected and disposed of by households^20,21.

Expert opinion for safe disposal at home:

The World Health Organization provides guidelines for safe disposal of medications, including land filling, flushing, and incineration. However, these methods are not suitable for the general public. The author proposes a simple solution: immobilizing medications in their original packaging or mixing them with cement or ceramic materials. This creates solid bricks or flower pots, preventing them from mixing with water or air. This simple method allows people to dispose of medications at home instead of discarding them in the garbage².

Take-Back program:

Before the medication take-back program in America, the FDA had reported over thirty cases of children being exposed to fentanyl patches, with children below two being the most affected. Incorrect disposal was responsible for around 23,783 of the 255,732 cases linked to inappropriate prescription usage. Prescription drug misuse is more common among Americans than the combined use of cocaine, hallucinogens, heroin, and inhalants. In response, the US FDA and the Drug Enforcement Administration launched a drug take-back program in 2010 to provide a secure and responsible means of disposing of prescription pharmaceuticals and educate the public about misuse and disposal. Authorized collectors have collected over 200 kilograms of unwanted drugs over the last three years, keeping them out of the environment. In India, other ineffective mechanisms include mail drop and drug drop boxes. However, there is no effective way to dispose of narcotics from every home or teach individuals how to dispose of them safely²².

Pharmaceutical Waste:

Different legal systems have different definitions of trash, with Directives 2008/98/EC of the European Parliament and Council stating that unused and expired medications are considered waste. Due to safety concerns, only licensed pharmacies can sell leftover medications. Most drugs become unwanted or remain unused due to various reasons.

(1) The dose of the drug should be changed or the drug itself should be changed;

(2) Patient death;

(3) Using drugs inappropriately (especially antibiotics) or not completing therapy;

(4) A side effect that leads to discontinuation of therapy.

Prescribed medication use is a significant issue in various countries, with 59% of Ghanaian participants ending their medication as soon as they felt better. Reasons for discontinuing medication include recovering from or improving their disease or symptoms, forgetting to take drugs, and worsening symptoms. In Malaysia, 76.9% discontinued medication after feeling better, while Tanzania had 82.2% getting better before treatment. Indonesian respondents stopped using medication due to better health, prescription changes, negative effects, doctor-ordered drug changes, lack of therapeutic effectiveness, and transitioning to natural therapies²⁴.

Waste Management and waste water treatment:

Pharmaceutical residue disposal and wastewater treatment are crucial for various nations, as many dispose of unwanted medications through trash or toilets. Some countries use ozone and granulated activated carbon in sewage treatment plants to eliminate micro-pollutants like medications. However, many lack wastewater treatment infrastructure, leaving pharmaceutical contaminants in water. Research on pharmaceutical residues in wastewater is essential for the industry, and photo catalytic techniques, such as TCPP with Bi₁₂O₁₇C_l2, are promising for removing organic pollutants¹⁶. Unwanted or outdated medications are becoming a major environmental issue, with unused and expired medications ending up in landfills, septic tanks, and sewers. Groundwater contaminated with undesirable medications is also found in ponds and groundwater due to septic systems' inability to degrade pharmaceutical compounds. Medication dissolved in water is often not removed during wastewater treatment, which aims to eliminate solids, organic matter, and nutrients like nitrogen and phosphorus. Water is treated in one, two, or three phases, depending on the plant's complexity and community demands. Primary treatment removes solids and bacteria, while secondary treatment extracts nutrients and organic compounds from bacteria in aerated tanks. Tertiary treatment options include chemicals to remove nitrogen and phosphorus, with chlorine killing any germs left behind¹⁷.

Effect of pharmaceutical contamination in aquatic life:

A 2013 European study found that 29 small waterways in 10 EU countries were contaminated with veterinary drugs, mainly antibiotics. These substances can remain in drinking water and leach into natural water systems, affecting aquatic organisms and animals. Studies have shown that pharmaceutical agents can have cumulative effects on microorganisms in contact with contaminated water. A limited understanding exists of how pharmacologically active chemicals interact with ecosystems to select for antibiotic resistance²⁵.

CONCLUSION:

In India, improper medication disposal is causing environmental issues and causing confusion among the public. A campaign should be launched to educate the public on proper disposal methods and the negative effects of improper drug disposal. NGOs, civil society organizations, and drug regulatory authorities should be involved in implementing these measures. Education from pharmacists and medical experts can also help in proper disposal.

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Received on 20.04.2024 Modified on 25.05.2024

Asian Journal of Management. 2024;15(3):283-290.

DOI: 10.52711/2321-5763.2024.00045