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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

Pharmaceuticals as pollutants: A threat for pharmacy profession

Apeksha Shrivastava1*, K. S. Rathore1, N. S. Solanki1 and A. K. Shrivastava2
1
Bhupal Nobles’ Girls’ College of Pharmacy, Udaipur (Rajasthan) India
2
School of Pharmacy, Suresh Gyan Vihar University, Jaipur(Rajasthan) India
Introduction: condition, health and sanitation. However,
Pharmaceuticals and health care products a very few studies have been performed in
(PHCPs) are the day to day need of this direction but situation seems to be
common man everywhere. These alarming in South Asia detailed data is not
substances as xenobiotics are excreted to available, therefore, the present discussion
the nature. Due to dense population and will be based on the data from other part of
inadequate disposal of sewage PHCPs the world.
have made their way into our waters and Sources of pharmaceutical
are starting to attract negative attention. contaminants:
Pharmaceutical residues from humans and Pharmaceutical products refer to a group
animals, personal care products, and their of chemicals used for the diagnosis,
metabolites are continually introduced to treatment, or prevention of health
the aquatic environment as complex conditions. Pharmaceuticals and their by-
mixtures. They can enter the water from products enter the environment as
discharge of treated domestic wastewater, pollutants in a variety of ways, including:
treated industrial wastewater, commercial discharge from wastewater treatment
feeding operations, and surface application plants or private septic systems, leaching
of manure1. The discovery of a variety of from landfills, agricultural runoff, and
pharmaceuticals in surface, ground, and from local hospitals.
drinking waters around the country is Pharmaceuticals do not usually persist in
raising concerns about the potentially the environment but continuous inputs
adverse environmental consequences of have the potential to keep concentrations
these contaminants. There is increasing relatively constant, even if at very low
concern that the PHCPs detected in our levels. Medications, when administered to
nation’s waters could cause adverse the individual can have beneficial results,
environmental effects, including, but not but once the active ingredients enter the
limited to; endocrine disruption in aquatic environment as an unknown interacting
life and (or) increased antibiotic resistance. cocktail of different compounds they can
A study by the United States Geological produce unwanted effects.
Survey (USGS) published in 2002 brought Pharmaceuticals initially enter wastewater
this issue into the limelight. A sampling of treatment plants from two key sources as
139 streams across 30 states found that 80 depicted in following figure. The active
percent had measurable concentrations of pharmaceutical compounds and their
prescription and non-prescription drugs, metabolites are excreted from the body;
steroids, reproductive hormones, and their and from the disposal of unused or expired
by-products2. The observations are being medications down the toilet or drain. If
supported by other studies detecting disposed of in household waste,
PHCPs in surface, ground, and drinking compounds end up on landfill sites where
waters across USA are raising concerns they may enter the landfill leachate3.
about public safety and the potentially Human and Veterinary Excretion vs.
adverse environmental consequences of Drain Disposal:
these contaminants. India and other Excretion of PHCPs and/or their
countries of South Asia are also prone to metabolites from humans and animals
such kind of contamination are supposed (Pets and Dairy) can vary anywhere from 0
to be even more due to worse living to 100% of the active compounds. Some
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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

compounds are almost completely may include percent in faeces, usually in

metabolized before they are excreted, less than 24 hours. All numbers are
while others are only moderately or poorly approximate.
metabolized and others yet again, such as Occurrence and Distribution:
contrast media, are excreted completely Pharmaceuticals in the environment,
intact. The individual’s diet, age, gender, initially hormones, first came into view in
metabolism, and various additional factors the 1970’s4. Since then scientists seem to
may play a role in the amount of be finding pharmaceutical compounds
metabolites produced. These metabolites nearly wherever and whenever they take a
may also be active compounds in and of close enough look. It was not until
themselves. recently that researchers developed
It is nearly impossible to determine the methodologies to detect these chemicals
general ratio of pharmaceutical inputs present at very low concentrations, well
from human excretion vs. the direct below therapeutic doses. The ubiquity of
flushing of expired medication. This active pharmaceutical compounds, and the
calculation is complicated by the vast fact they are constantly and increasingly
number of active pharmaceutical introduced to the environment as
compounds present, possible by-products pollutants are significant to their
produced through metabolism and waste occurrence and distribution. The
water treatments, potential synergistic nationwide United States’ Geological
interactions, and incomplete drug disposal Survey study published in 2002 found the
method data. Attempts to illustrate the most frequently detected compounds in
complexity of this issue by displaying the surface waters were coprostanol (faecal
average human excretion rates of the top steroid), cholesterol (plant and animal
drugs prescribed in 2005 are enlisted in steroid), N,N-diethyltoluamide (insect
Table 1. Each pharmaceutical is different, repellent), caffeine (stimulant), triclosan
particularly in terms of how they behave in (antimicrobial disinfectant), tri(2-
the human body. Virtually every drug has chloroethyl)phosphate (fire retardant), and
a different metabolic process, excretion 4-nonylphenol (non-ionic detergent
rate, and cascade of bio-active metabolites metabolite)2. Seven (Site 1- Merrimack
that can complicate the picture. The list in River below the Concord River, Site 2-
Table 1 is driven by market share and does Charles River above the Watertown Dam,
not take into account OTC drugs which Site 3- Laundry Brook at Watertown, Site
may be sold in significant amounts. 4- Faneuil Brook at Brighton, Site 5-
The list only representative in nature, Muddy River at Brookline, Site 6- Stony
however, apart from them many more Brook at Boston, and Site 7- Charles River
therapeutic agents along with ingredients at Boston Science Museum.) of the 139
and metabolite of health care products are total sites sampled in this study were in
also in use in substantial amount, their Massachusetts and of the ten most
contributions are combined in the waste frequently detected compounds six were
stream cannot be ignored. It is then measured at concentrations below the
difficult to distinguish the individual national average at these sites (Table 2).
contributions from each medication to The selection of sampling sites was biased
determine which compounds have the towards streams susceptible to
greatest impact. contamination, as in dense urban areas.
Percent excreted obtain either from The high overall frequency of detection for
www.rxlist.com or taken from patient organic wastewater contaminants, in over
product inserts. The percent excreted most 80% of the streams studied was likely
often equals percent found in urine though influenced by the design of this study
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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

which focused on susceptible streams. most abundant contaminants as a national

Table 2 displays the concentrations of the
Table 1: Human excretion rates of some drugs of 2005 by number of prescriptions
dispensed.
Drug Therapeutic Category % Drug excreted* unchanged
Paroxetine hydrochloride Antidepressant < 3%
Escitalopram oxalate Antidepressant 8%
Alprazolam Anxiety disorders No data available
Tramadol Analgesic 30%
Hydrocodone Opioid Analgesic Very small amount

Paracetamol Antipyretic Very small amount

Pregabalin Anti-seizure 90%

Oxycodone hydrochloride Opioid Analgesic 19%
Lisinopril Hypertension treatement 75%
Duloxetine hydrochloride Antidepressant < 1%
Atorvastatin calcium Cholesterol < 2%
Oxycodone, acetaminophen Opioid Analgesic 8-12%
Sertraline hydrochloride Antidepressant 14%
Metformin hydrochloride Type 2 diabetes 90%
Venlafaxine hydrochloride Antidepressant 34%
*Top Drug Prescription Sales for 2005 (latest year available) [Available: www.rxlist.com] (Last Visited June
12, 2007).

Table 2: Compound Concentration Comparison (Original data from USGS study)

Compound Primary Use Max Median MA Rivers MA Rivers
Name (µg/L) (µg/L) max (µg/L)a median (µg/L)
Coprostanol Steroid 150b 0.088 4.09 (6) 0.19

Cholesterol Steroid 604 0.83 5.22 (4) 1.03

N,N-diethyltoluamide Insect repellent 1.1 0.06 0.1 (4) 0.07
Caffeine Stimulant 5.7 0.1 1.6 (6) 0.13
Triclosan Antimicrobial 2.3 0.14 0.16 (4) 0.09
disinfectant
tri(2-chloroethyl) Fire retardant 0.54 0.1 0.07 (4) 0.05
phosphate
4-nonylphenolc Detergent 40 0.8 1d (7) 0.5
metabolite
Ibuprofen Anti- 1.0 0.2 0.45 (4) 0.018
inflammatory
Acetaminophen Antipyretic 10 0.11 0.94 (6) 0.009
Trimethoprim Antibacterial 0.30 0.013 0.014 (all) 0.014

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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

a
River number corresponding to highest value is egg yolk precursor protein) by male fish,
designated within parentheses. and other changes that may affect
b
Concentration estimated – value greater than
highest point on calibration curve.
reproduction or overall health6-8.
c
Concentrations estimated – reference standard Concentrations at which these effects were
prepared from a technical mixture. observed were lower than concentrations
d
Estimated value detected in some surface waters sampled
by the USGS2. Aquatic environments are a
average compared to the streams sampled major concern because organisms in this
in Massachusetts. This list gives some environment are subject to continual low-
insight into what is likely to be detectable dose exposure1.
in the MWRA system, not necessarily With respect to pathogen resistance, the
what is present or even biologically World Health Organization (WHO) warns
active. Simply because you can test for that increasing drug resistance could
something does not make it relevant and if significantly reduce our ability to cure
a compound was not detected it does not illness and stop epidemics. Curable
mean it is not present or significant. diseases, varying from sore throats to
Impacts and effects: tuberculosis and malaria, may become
There is limited documentation regarding incurable as our once-effective medicines
the direct cause and effect relationships of become increasingly ineffective9. Possibly
pharmaceuticals in the environment. The development of antibiotic resistance is a
major concerns to date have been the result of active pharmaceutical compounds
promotion of pathogen resistance to present in wastewater.
antibiotics and disruption of endocrine For humans, consumption of potable water
systems, but many other active that may contain trace amounts of various
pharmaceutical compounds make their pharmaceuticals has been identified as one
way into the water and have unknown of the primary potential routes of
consequences. To date, most of the exposure2. While some pharmaceuticals
research of pharmaceuticals as pollutants have been measured in drinking water10-11,
has been focused on aquatic environments. a number of scientists believe that
The possible effects of these substances on pharmaceuticals at the low levels detected
aquatic life are currently not well do not pose an appreciable risk to human
understood. Potential adverse aquatic health12. Sensitive populations, particularly
effects in field populations are usually pregnant woman and children, are believed
predicted from laboratory acute and to be more susceptible to any negative
chronic toxicity data in species such as effects, but studies have not shown any
algae, crustaceans, and fish5. These tests impacts on human health as of yet. The
generally look at one organism’s response exposures found thus far are well below
to one particular chemical, but in the therapeutic levels for human consumption.
environment organisms are simultaneously Because of the trace concentrations of
exposed to a host of different chemicals these drugs, it would take a significant
over multiple generations making the period of time, consuming approximately a
extrapolation from the laboratory to the gallon of water a day, to achieve a single
field exceedingly difficult. therapeutic dose of most chemicals:
Current research suggests endocrine consuming the equivalent of one tablet of
disrupting chemicals (EDC), mainly Diazepam would take 3.5 years; a capsule
synthetic steroids and other hormones, can of diphenhydramine 14.5 years; and one
lead to changes in sex ratios in fish and tablet of Tylenol 58 years13. However, the
other aquatic organisms, “feminization” of potential effects from continuous low dose
male fish, production of vitellogenin (an chronic exposure to active pharmaceutical
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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

compounds in humans are not clearly report15 on how expired medications are
understood. being disposed of found that 1.4% of
Solutions ahead: residents returned medications to a
It is true to say that a pharmacist is not pharmacy, 54% disposed of medications in
legally bound to take any action for the garbage, 35.4% flushed medications
minimizing the pharmaceutical affluent in down the toilet or sink, 7.2% did not
environment. However, as the citizen he/ dispose of medications, and 2% related
she is supposed to make environment they used all medication before expiration
clean. In only a few countries such (See Figure 2 below).
measures have been taken place sooner or Studies have reported that approximately
later such actions will also be implemented one third of the total volume of
in about all the countries of the world. pharmaceuticals sold in Germany and
Here we strict ourselves to the discussion about 25% of that sold in Austria are
pertaining to pharmacists and patient only. disposed of with household waste or down
Disposal of Unwanted Pharmaceuticals: the drain16. This significant contribution
Consumer pharmaceutical wastes are from private individuals turns the focus
created from prescription drugs for a from industry to the activities, actions, and
variety of reasons, e. g., a change in behavior of consumers on their
prescription; patient’s health improves surrounding environment. Some consider
before finishing treatment, patient death, flushing unwanted medications down the
and patient non-compliance. OTC toilet preferable to throwing medications
medicines are often sold in bulk and may in the trash where children or illicit drug
contain more than is needed before the users might get a hold of them, but
expiration date or the consumer may flushing in particular may be more closely
switch brands or prescriptions. Many of associated with causing environmental
these expired of unwanted medications are damage. By recommending the
disposed of in the trash or down the drain. medications be crushed, combined with
With few exceptions, countries do not another substance, and placed in the trash
have clear and consistent guidelines on reduces the poisoning risk but it has the
how to properly dispose of unwanted potential to enter the water through land
pharmaceuticals, especially when it comes fill leaching. Even pharmaceuticals
to the general public. In February 2007, captured in leachate at lined landfills are
the White House Office of National Drug typically transported to wastewater
Control Policy released the Federal treatment plants, where some pass through
regulations on the Proper Disposal of untreated.
Prescription Drugs14. These general Prescription Drug Abuse and Poisoning:
recommendations suggest unused Prescription and OTC drugs can be safe
pharmaceuticals be mixed with coffee and helpful to people when used in the
grounds or kitty litter, placed in an right way, but many can also be abused
impermeable bag, and thrown out in the and remain a serious public health
trash. They also recommend certain drugs concern. Medications account for the most
be flushed down the toilet. Coming in last common poison exposure category in the
on their list, they suggest taking unused United States17. They can cause addiction,
medications to a community increased blood pressure and heart rate,
pharmaceutical take-back program. seizures, organ damage, and even death.
Incineration is now regarded as the best The massive number of medications
disposal option for expired or unwanted available presents a substantial accidental
medications, but it is not a commonly poisoning risk if they are not properly
available option for the general public. A stored or disposed. Unsecured disposal to
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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

the garbage or using improper facilities sell or use. The returns industry (or
increases the risk of drug abuse or reverse distribution) was created to
poisoning. facilitate the return of unwanted or expired
Hospital Survey Summary: medications to the manufacturer for
In hospitals and nursing homes, credit. The unwanted or expired
pharmaceutical waste is generally medication remains a product until the
discarded down the drain or land filled, decision is made to dispose of it, therefore
except chemotherapy agents, which are the pharmacy or medical distributor can
often sent to a regulated medical waste potentially return them and receive credit
incinerator. Pharmacies and drug for them without the product being
providers usually send unused or expired considered hazardous waste18. Licensed
pharmaceuticals back to the manufacturer, reverse distributors are permitted by the
in other cases they use a reverse DEA (USA) to handle and dispose of
distribution company which disposes of controlled pharmaceuticals to be sure that
the products that are non-returnable17. all controlled substances are accounted for
Pharmaceutical Take Back Measures: from their creation until their consumption
Improper management of unwanted or or destruction.
expired residential pharmaceuticals poses The general public does not traditionally
hazards to both human health and the have access to a reverse distributor for the
environment. Some medicines may enter disposal of their unwanted or expired
the environment from human excretion, medications and many of the services are
but others enter the environment from the too expensive for smaller facilities. A
direct disposal of unused or expired reverse distribution scheme for a
products through the waste water stream pharmaceutical take back program
that could have been disposed of in a more executed at a local pharmacy appears
responsible way. ideal, but pharmacists are unable to accept
In certain countries like USA, Canada, controlled substances for return and are
Australia, EU etc. take back programs often unwilling to bother with setting up a
provide the legal framework and the non-controlled pharmaceutical return
logistic resources required to allow health program due to high costs.
care facilities, patients, and the general Waste and Drinking Water Treatment
public to return unused or expired of Pharmaceuticals:
pharmaceuticals so that they can either be Pharmaceuticals primarily enter
reused or disposed of safely in incineration wastewater treatment plants from
facilities. However, in India such households through excretion or improper
Programme run in the goodwill of disposal, but also through inputs from
pharmacist patient relationship, no hospitals and industry sewers. Existing
concrete legal binding has yet been wastewater treatment processes are
imposed. Over two dozen different optimized to reduce human waste which is
initiatives in USA are either studying the primarily biological in origin, not
problem or implementing ways to solve it, pharmaceutical waste. Currently the major
including take back initiatives at pollutants of concern in domestic waste
pharmacies or other collection points. solids are nitrates, phosphates, dissolved
Reverse Distribution: organic carbon, and pathogens. Treatment
Drug manufacturers, in an effort to facilities do not traditionally monitor or
encourage pharmacies or medical centers measure organic microcontaminants such
to purchase their new medications, may as pharmaceutical residues.
offer to buy back certain drugs the Influent and effluent waters can be tested
pharmacy or medical center is not able to for active pharmaceutical compounds, but
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 Apeksha Shrivastava et al / Journal of Pharmaceutical Science and Technology Vol. 2 (3), 2010, 163-170

there are many complications. It has only still other compounds may be completely
been in the past few years that continually degraded in the treatment process.
improving chemical analysis Other factors, besides biological treatment,
methodologies have lowered the limits of affecting removal of substances from the
detection to allow researchers to identify waste stream include weather related
these compounds and their metabolites at incidents such as wet-weather overflow or
very low levels, particularly in a mixed the opposite, low inflow during dry
waste stream matrix. Consequently, conditions, which leads to higher
extensive extraction, cleanup, and concentrations due to a low volume of
sophisticated instrumentation are usually water. As a result, some portions can be
required to analyze these complex directly released into the environment via
compounds and mixtures. Because of wastewater effluent due to vary levels of
these advanced methodologies required, treatment and may have adverse
samples can only be sent to a limited set of ecotoxicological effects.
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