Académique Documents
Professionnel Documents
Culture Documents
83]
Review Article
Abstract
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.
Keywords: Environmental consequences, medicine disposal, medicine take‑back policy, pharmaceuticals and personal care products
DOI: How to cite this article: Mani A, Thawani V. The persisting environmental
10.4103/jmgims.jmgims_43_18 problem of disposal of expired and unused medicines. J Mahatma Gandhi
Inst Med Sci 2019;24:13-6.
© 2019 Journal of Mahatma Gandhi Institute of Medical Sciences | Published by Wolters Kluwer - Medknow 13
[Downloaded free from http://www.jmgims.co.in on Friday, October 11, 2019, IP: 180.251.174.83]
manufacturing sites. In India, common medicine disposal of the product development for patient usage is that some
practices include direct disposal in the environment – in products will inevitably remain unused, or will be damaged,
land‑fill site or at isolated place, or by burning. Pharmacies or get expired. World Health Organization, World Bank,
incinerate the unused and expired medicines. Many municipal European Union (EU), and FDA have developed guidelines
corporations are not aware of and hence lack medicine disposal for safe disposal of pharmaceuticals.[10] There is a dire need to
facilities. People are totally unaware of the consequences of develop proper disposal guidelines in India with a monitoring
the unsafe disposal practice of medicines. Even the health‑care mechanism. Expired medicine take‑back programs should
professionals are ignorant about the medicine disposal be started in India and should be popularized through public
practices.[6] In India, the medicine disposal is under the awareness.
narcotics department which is more concerned with controlling
the misuse of addiction‑causing medicines, and medicine The Environmental Impact
disposal does not seem to be their priority. The unused and
The impact on environment of disposing the expired medicines
expired medicines are considered as municipal solid waste.
in the open, land fill, or by burning has not been studied
Burning is considered similar to burning of plastic waste due
extensively. The indoor wards of cancer patients do not have
to the physical appearance of its packaging. In India, there
a separate sewage system. Untreated radioactive waste from
is no regulatory body, monitoring system, or functioning
the clinics and hospitals with cancer patients directly goes in
guidelines for the disposal of the expired medicines. The
direct disposal of medicines by pharmacies is practiced in the municipal drains and may percolate to the soil, thereby
case of generic medicines. The quantum of generic medicine contaminating the water sources which further contaminate the
purchase, stocking, and use in public health system is higher land mass and pass to the food chain. If the medicine disposal
than private pharmacies. Branded medicines are taken back by practices are improper, the health of the exposed population
the pharmaceutical companies from the sellers, the disposal of is certainly at risk.
which then is responsibility of the company. The direct impact of medicine to the wild life is responsible for
the decline of vulture population in South Asia by diclofenac
Repacking Expired Medicines with Fresh Date: through cattle.[11] Pharmaceutical products used for humans,
animals, and birds have been detected in water bodies. The
A Common Myth waste water treatment plants are not designed to manage the
There is widespread apprehension that the expired medicines pharmaceutical deposits passed in the water because of human
taken back by the manufacturer’s representatives may be consumption and excretion. Improper waste disposal and
repacked and resupplied. However, there is no conclusive ineffective treatment of waste water pollute the fresh water
evidence to back this fear, but many continue to harbor this that pollutes the environment.[12]
opinion.
Between 1999 and 2009, in US alone, the use of pharmaceuticals
and personal care products (PPCPs) has increased from
Safe Disposal of Medicines 2 billion to 3.9 billion annually.[13] The PPCPs enter into the
The most environmentally safe disposal method for environment through human activity. In Europe, the input of
pharmaceutical products is community medicine take‑back pharmaceutical residues via domestic waste water is estimated
programs that collect medicines at a central location for proper to be 80%, whereas 20% comes from hospitals.[14] Individuals
and safe disposal. Several local public health departments in may add PPCPs to the environment through waste excretion,
the US have initiated pharmaceutical take‑back programs.[7] bathing, and by direct disposal of unused medications to septic
In addition, the USDEA periodically promotes local take‑back tanks, sewers, or trash. The PPCPs dissolve easily in water and
programs as well as a program called the National Take‑Back do not evaporate at normal temperature, and finally end up in
Initiative.[8] The proposition that pharmaceutical companies soil and water bodies. Some PPCPs are broken down in human
should be responsible for their products “from the cradle to or animal body or degraded in the environment. However,
the grave” has support. This philosophy suggests that the others do not break down or degrade easily.
manufacturers should fund the proper disposal of pharmaceutical
Detectable quantities of one or more chemicals were found
products manufactured by them. The process of proper
in 80% of a sampling of 139 susceptible streams in 30
treatment of disposed medicines should be done with minimal
states of US. The most common pharmaceuticals detected
environmental impact. Water treatment should minimize or
were nonprescription medicines, detergents, fire retardants,
eliminate the amount of these pollutants by using sorption where
pesticides, natural and synthetic hormones, antibiotics,
suspended solids are removed by sedimentation.[9] Another
and prescription medicines.[15] Pharmaceutical compounds
method used is biodegradation through microorganisms where
detected in sewage treatment plant effluents, surface water, and
bacteria feed on or break down these pollutants, thus eliminating
sediment include antibiotics, analgesics, anti‑inflammatories,
them from the contaminated media.
lipid regulators, beta‑blockers, anticonvulsants, and steroid
Environmentally safe disposal of pharmaceutical products has hormones at low concentrations, uncertainties remain
not been sufficiently addressed yet. The natural consequence about the levels at which toxicity occurs and to the risk of
14 Journal of Mahatma Gandhi Institute of Medical Sciences ¦ Volume 24 ¦ Issue 1 ¦ January‑June 2019
[Downloaded free from http://www.jmgims.co.in on Friday, October 11, 2019, IP: 180.251.174.83]
bio‑accumulation.[16] A study conducted in Taiwan rivers disposal products based on their chemical characteristics.
also detected the presence of Ecstasy, ketamine, caffeine, Impact of medicines on the environment will provide an
and acetaminophen.[17] Investigations in Germany, France, analysis of the relevance and effectiveness of the current
and Scotland found traces of PPCPs in the upstream of waste legislative framework in protecting the aquatic environment
water treatment plant effluents to rivers. Besides the human and human health via the aquatic environment.
input, there is also diffused pollution from pharmaceuticals
The EU has added chemicals in the watch list of substances
used in agriculture.
for monitoring and control in EU surface water which includes
The exposure to the PPCPs depends on the concentration, pharmaceuticals. The contamination of water and soil with
type, and distribution of pharmaceuticals in the environment; pharmaceutical residues is an omnipresent environmental
the pharmacokinetics; the structural transformation of the concern. The EU has developed disposal practices since
chemical compounds either through metabolism or natural 2004. Its directive for human pharmaceuticals requires all
degradation processes; and the potential bio‑accumulation of member states to establish collection systems for unused or
the medicine.[18] In addition to the growing concerns about expired medicines. Such systems were already in use in several
human health risks from pharmaceuticals via environmental member states at the time the legislation went into action in
exposure, their potential for inducing antibiotic resistance has 2004. The disposal regulations in the EU differ. Incineration
been suspected.[16,19,20] The EU has included pharmaceutical is practiced in Germany, Luxembourg considers the unused
residues with the potential of contaminating water and or expired pharmaceuticals as hazardous waste; in France, the
soil together with other micropollutants under “priority take‑back program enables people to bring back unused or
substances.” expired pharmaceuticals back to the pharmacies. The disposal
of the unused and expired medicines in sinks or toilets is a
Estradiol concentrations in surface water may cause
major problem in EU. A study from Germany showed that
vitellogenin production and structural change of sex organs.
24% of liquid pharmaceuticals and 7% of tablets or ointments
These observations on feminization of fish by estrogenic
are disposed through the toilet or sink.[22] In 2012, about 1200
compounds in sewage treatment plant effluents have been
pharmaceutical substances were identified to be potentially
observed in many countries, and in other species like frogs,
relevant for an environmental monitoring.[23]
alligators, and mollusks. Propranalol was found to cause
significant decrease in egg production in Medaka fish. In India, good manufacturing practices (GMPs) and
Gemfibrozil lowered the blood levels of testosterone in fish. requirements of premises, plant, and equipment for
Fluoxetine affected swimming activity in shellfish. High levels pharmaceutical products laid down in Schedule M of the
of antibiotics in the water are a cause for alarm as there is an Drugs and Cosmetics Rules, 1945, prescribe the requirements
increased risk of selecting resistant bacteria. for disposal of waste including the rejected drugs.
In India, the bacteria resistant to ciprofloxacin have been i. The disposal of sewage and effluents (solid, liquid, and gas)
found downstream of a pharmaceutical factory, genes for from the manufactory shall be in conformity with the
antimicrobial multiresistance have been found in drinking requirements of environment pollution control board
water, and multiresistant Salmonella have been identified in ii. All bio‑medical waste (BMW) shall be destroyed as per
water sprayed on vegetables. The epidemic with multiresistant the provisions of the BMW (management and handling)
enterohemorrhagic E. coli at Europe originated from rules, 1996
water‑sprayed vegetables. The tetracyclines and quinolones iii. Additional precautions shall be taken for the storage and
are not metabolized in the human body and can be toxic to disposal of rejected drugs. Records shall be maintained
other animals, microorganisms, and fish. In India, several for all disposal of waste
broad‑spectrum antibiotics were found in concentrations toxic iv. Provisions shall be made for the proper and safe storage
to microbes, animals, and plants, with enterococci resistant of waste materials awaiting disposal. Hazardous, toxic
to all known antibiotics. Several pharmaceuticals have been substances and flammable materials shall be stored in
found in goat, cow, and human milk.[21] The bio‑accumulation suitably designed and segregated, enclosed areas in
of pharmaceutical products in aquatic animals, plants, and conformity with central and state legislations.
animals significantly affects the human life in turn. One of the conditions of drug‑manufacturing license
granted under the Drugs and Cosmetics Rules, 1940, is
Laws and Regulations that the licensees shall comply with the GMP requirements
prescribed in Schedule M of the said Rules. State‑licensing
The environmental pharmaceutical pollution is yet to be
authorities appointed by the respective state governments
managed during entire chain of the product. To reduce
are empowered to take action in case of any violation of
the environmental impact, there should be administrative
above requirements.
governess in authorization, market regulation, and legislation.
The disposal behavior of the individuals and the waste The government has taken various regulatory measures to curb
management and treatment have to be legally regulated. The the misuse of antibiotics. However, no report/incidence of
laws and regulations have to be developed regarding the growing of antimicrobial resistance of drugs due to discharge
Journal of Mahatma Gandhi Institute of Medical Sciences ¦ Volume 24 ¦ Issue 1 ¦ January‑June 2019 15
[Downloaded free from http://www.jmgims.co.in on Friday, October 11, 2019, IP: 180.251.174.83]
16 Journal of Mahatma Gandhi Institute of Medical Sciences ¦ Volume 24 ¦ Issue 1 ¦ January‑June 2019