Investigating Emergent Contaminants Pharmaceutical impacts and possible solutions By: Leah Bowe Abstract



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Investigating Emergent Contaminants

--Pharmaceutical impacts and possible solutions--

By: Leah Bowe

Abstract

Studies in many countries have demonstrated the presence and in some cases negative effects of pharmaceutical products at trace levels in surface and groundwater. The major inputs of pharmaceuticals come from households and hospitals, due to excretion and improper disposal of unwanted or expired medications. Even though the environmental impact of pharmaceuticals in the environment at trace levels has not been clearly determined preventative action should be taken in the face of uncertainty.

The purpose of this paper is to analyze the current disposal practices of unused/unwanted or expired pharmaceutical products, their studied environmental impacts, and some possible solutions. A survey of local hospitals and nursing homes was conducted to determine direct pharmaceutical inputs. This paper examines some of the actions that could be taken to decrease the amount of pharmaceuticals that are released into the environment.


Table of Contents

Abstract Page 2


Introduction Page 5

Section 1 - Background
1. Pharmaceuticals as Pollutants Page 9

1.1 Pharmaceutical Inputs Page 10

1.2 Human Excretion vs. Drain Disposal Page 12

1.3 Occurrence and Distribution Page 14

1.4 Impacts and Effects Page 16
2. Regulations and Boston Harbor Historical Overview Page 18

2.1 Clean Water Act Page 18

2.2 Safe Drinking Water Act Page 20
3. Disposal of Unwanted Pharmaceuticals Page 21

3.1 Prescription Drug Abuse or Poisoning Risk Page 23

3.2 Survey Summary Page 24

Section 2 – Take Back Programs
4. Pharmaceutical Take Back Measures Page 28

4.1 Massachusetts Take Back Options Page 29

4.2 United States Take Back Programs Page 30

4.3 International Take Back Programs Page 38

4.4 Reverse Distribution Page 41
5. Regulatory Issues Page 41

5.1 Controlled Substances Act Page 42

5.2 Resource Conservation and Recovery Act Page 43

5.3 Mailing of Controlled Substances Page 44

5.4 Health Insurance Portability and Accountability Page 44

Section 3 – Waste and Drinking Water Treatment
6. Waste and Drinking Water Treatment of Pharmaceuticals Page 46

6.1 MWRA Current Waste and Drinking Water Treatment Page 47

6.2 Possible Waste and Drinking Water Treatment Options Page 50

6.3 Implications for Wastewater Treatment and Water Suppliers Page 53


7. MWRA Influent and Effluent Wastewater Samples Page 54

7.1 Methods Page 54


Section 4 - Results
8. Recommendations Page 56

8.1 Regulatory Page 57

8.2 Individuals Page 59

8.3 Pharmacists and Health Care Providers Page 60

8.4 Public Agencies Page 61

8.5 Research Page 62


Conclusion Page 63

Section 5 - References

Appendices



  1. Acronyms Page 67

  2. Hospital–Nursing Home Survey Copy Page 68

C- Pharmaceutical Collection Sites in Massachusetts Page 69

D- Proposed Testing: Compounds and Methods Page 73

Endnotes Page 74

Acknowledgements Page 80


Introduction

Developed to promote human health and wellbeing, certain pharmaceuticals and personal care products (PPCPs) have made their way into our nation’s waters and are starting to attract negative attention. Pharmaceutical residues from humans and animals, personal care products, and their metabolites are continually introduced to the aquatic environment as complex mixtures. They can enter the water from discharge of treated domestic wastewater, treated industrial wastewater, commercial feeding operations, and surface application of manure.1 The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. There is increasing concern that the PPCPs detected in our nation’s waters could cause adverse environmental effects, including, but not limited to; endocrine disruption in aquatic life and (or) increased antibiotic resistance.

A study by the United States Geological Survey (USGS) published in 2002 brought this issue into the limelight. A sampling of 139 streams across 30 states found that 80 percent had measurable concentrations of prescription and nonprescription drugs, steroids, reproductive hormones, and their by-products.2 This and other studies detecting PPCPs in surface, ground, and drinking waters across the country are raising concerns about public safety and the potentially adverse environmental consequences of these contaminants.

The presence of these compounds in surface waters is an emerging issue in environmental science. The USGS broadly defines emerging contaminates as “any synthetic or naturally occurring chemical or any microorganism that is not commonly monitored in the environment but has the potential to enter the environment and cause known or suspected adverse ecological and (or) human health effects.”3 Some of the pharmaceuticals in question are not new but our ability to look for and measure them is ever increasing. It has only been in the past few years that continually improving chemical analysis methodologies have lowered the limits of detection to allow researchers to identify these compounds and their metabolites at very low levels, in the parts-per-billion (ppb) and parts-per-trillion (ppt) range.

PPCPs consist of a incredibly expansive, diverse collection of thousands of chemical substances, including prescription and over-the-counter (OTC) therapeutic drugs, perfumes, cosmetics, sun-screen agents, diagnostic agents, and many others. This broad collection of substances refers, in general, to any product intended to be consumed or applied externally by individuals for personal health or cosmetic reasons. All PPCPs have the potential to be excreted, disposed of, or washed into sewage systems and from there discharged to aquatic or terrestrial environments.

The steady increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated. While many of these PPCPs are present at very low levels they are continually released into the environment. Others remain in the environment because they are resistant to breakdown. Continual, multi-generational exposure of aquatic life in the environment to multiple PPCPs has unknown consequences. Laboratory studies have demonstrated that various pharmaceuticals can elicit responses in aquatic organisms at relatively low levels.4,5 Human exposure also has unknown consequences, but even if there are no current risks, there may be problems derived from the perception of risk. Pharmaceuticals are designed to induce specific biological effects at specific targets for a limited period of time. The continuous, wide spread, long-term exposure of PPCPs to the environment, although at low concentrations, may result in gradual almost undetectable changes.

The two largest sources of pharmaceuticals entering the sewer systems are believed to be from hospitals and households; including both human excretion and drain disposal of pharmaceuticals. Most often unused or expired medications are either flushed down the toilet or thrown in the garbage where they pose a threat to the environment. If flushed, pharmaceuticals may pass through treatment facilities and end up in surface and groundwater. If landfilled, they have the potential to leach from the landfill into groundwater. Alternately, without a safe and effective method for disposal, prescription drugs may be left indefinitely in medicine cabinets where they pose a threat of potential prescription drug misuse or abuse.

Currently, municipal sewage treatment plants are not engineered specifically for PPCP removal as most were built before PPCP became part of the equation. Removal efficiencies from treatment plants vary from chemical to chemical and among individual sewage treatment facilities. Sewage treatment plants are designed to reduce nitrates, phosphates, dissolved organic carbon, and pathogens, which have been the major pollutants of concern in domestic waste. Some PPCPs are not affected by sewage treatment processes, others may be degraded, and still others may be converted to “daughter” compounds.

Further steps need to be taken to understand the potential risk and if necessary to help protect our environment and human health. To determine the best policy from which to proceed, this paper examines in detail the disposal of pharmaceuticals and their daughter compounds to establish their presence, effects, and major inputs to the aquatic environment. That will be followed by an overview of the current research initiatives, pharmaceutical take back programs, and regulatory challenges in the United States and abroad.

The next part of the paper focuses on waste and drinking water treatment of pharmaceuticals, current options and influent and effluent sample measurements. Finally, policy recommendations and possible future steps will be provided with conclusions. This paper will focus primarily on human pharmaceutical inputs, excluding for the most part the inputs from personal care products, industrial and commercial manufacturing waste, animal husbandry products, and runoff which are beyond the scope of this paper.



Section 1 - Background

1. Pharmaceuticals as Pollutants

During the last three decades, the impact of chemical pollution has focused almost exclusively on the conventional “priority” pollutants (e.g. pesticides); however this is just one piece of the larger puzzle.6 The occurrence of pharmaceutical products in the environment has gained attention since the 1980s; however their occurrence has become more widely evident since the 1990s because of the continual improvement in chemical analysis methodologies.7 Not only are pharmaceuticals in the environment of special interest with respect to the original compounds introduced, but also because of the differences in their occurrence, their fate, and their effects on target organisms or on non-target organisms in the environment.

Pharmaceuticals are intended to help cure disease and to make people feel better, but the consistent increase in potency and number of prescriptions used, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated. These drugs that are improving health outcomes and quality of life, replacing surgery and other invasive treatments, and quickening recovery for patients who receive these treatments are making their way into our nation’s waters as pollutants.

With the population of the United States increasing at the rate of one person every 10 seconds and with the average individual filling over 10 prescriptions per year,8 pharmaceutical waste is a growing concern. Massachusetts only holds roughly 2%9 of the population, but per capita fills over 12 prescriptions per year. According to the Kaiser Family Foundation's Prescription Drug Trends10 report, from 1993 to 2003, the number of prescriptions purchased nationwide increased 70 percent (from 2 billion to 3.4 billion), compared to a U.S. population growth of only 13 percent.


1.1. Pharmaceutical Inputs

Pharmaceutical products refer to a group of chemicals used for the diagnosis, treatment, or prevention of health conditions. They are usually classified as either over the counter (OTC) or prescription-only medications (POM) then further classified according to their therapeutic purpose.11 Pharmaceuticals and their by-products enter the environment as pollutants in a variety of ways, including: discharge from wastewater treatment plants or private septic systems, leaching from landfills, agricultural runoff, and from local hospitals.

Pharmaceuticals do not usually persist in the environment but continuous inputs have the potential to keep concentrations relatively constant, even if at very low levels. Medications, when administered to the individual can have beneficial results, but once the active ingredients enter the environment as an unknown interacting cocktail of different compounds they can produce unwanted effects.

Pharmaceuticals initially enter wastewater treatment plants from two key sources (Figure 1): the active pharmaceutical compounds and their metabolites are excreted from the body; and from the disposal of unused or expired medications down the toilet or drain. If disposed of in household waste, compounds end up on landfill sites where they may enter the landfill leachate.



The MWRA provides wholesale water and sewer services to 2.5 million people and more than 5,500 large industrial users in 61 metropolitan Boston communities.12 Within those large industrial users, 9 are pharmaceutical industries, 62 hospitals and 10 long term care facilities that all have the potential to contribute elevated, concentrated doses of pharmaceuticals to their wastewater which will be discussed further in the survey section of this paper.



Figure 1: Possible routes of exposure to environment from medications.13

1.2. Human Excretion vs. Drain Disposal

Many pharmaceuticals are biotransformed once they enter the body. Excretion rates of active pharmaceuticals in humans can vary anywhere from 0 to 100% of the active compounds. Some compounds are almost completely metabolized before they are excreted, while others are only moderately or poorly metabolized and others yet again, such as contrast media, are excreted completely intact. The individual’s diet, age, gender, metabolism, and various additional factors may play a role in the amount of metabolites produced. These metabolites may also be active compounds in and of themselves.

It is nearly impossible to determine the general ratio of pharmaceutical inputs from human excretion vs. the direct flushing of expired medication. This calculation is complicated by the vast number of active pharmaceutical compounds present, possible by-products produced through metabolism and waste water treatments, potential synergistic interactions, and incomplete drug disposal method data.

Table 1 attempts to illustrate the complexity of this issue by displaying the average human excretion rates of the top drugs prescribed in 2005. Each pharmaceutical is different, particularly in terms of how they behave in the human body. Virtually every drug has a different metabolic process, excretion rate, and cascade of bio-active metabolites that can complicate the picture. The list in Table 1 is driven by market share and does not take into account OTC drugs which may be sold in significant amounts.

Many pharmaceuticals, even some on this list have the same active ingredient(s) and their contributions are combined in the waste stream. It is then difficult to distinguish the individual contributions from each medication to determine which compounds have the greatest impact.
Table 1: Human excretion rates of top drugs of 2005 by number of prescriptions dispensed.14


R

a

n



k


Drug

Name


Active ingredients


Primary

Use


% Parent compound excreted

1

Paxil®

Paroxetine hydrochloride

Antidepressant

< 3%

2


Lexapro®

Escitalopram oxalate

Antidepressant

8%

3

Hydrocodone

Hydrocodone, acetaminophen

Narcotic Analgesic

Very small amount

4

Xanax®


Alprazolam

Anxiety disorders

No data available

5

Ultram®


Tramadol

Analgesic

30%

6

Vicodin®

Hydrocodone, acetaminophen

Opioid Analgesic

Very small amount

7

Lyrica®


Pregabalin

Anti-seizure

90%

8

Oxycodone

Oxycodone hydrochloride

Opioid Analgesic

19%

9

Prinvil®

Lisinopril

Hypertension treatement

75%

10

Cymbalta®

Duloxetine hydrochloride

Antidepressant

< 1%

11


Lipitor®

Atorvastatin calcium

Cholesterol

< 2%

12

Percocet®

Oxycodone, acetaminophen

Opioid Analgesic

8-12%

13

Zoloft®

Sertraline hydrochloride

Antidepressant

14%

14

Metformin

Metformin hydrochloride

Type 2 diabetes

90%

15

Effexor

Venlafaxine hydrochloride

Antidepressant

34%

1.3. Occurrence and Distribution

Pharmaceuticals in the environment, initially hormones, first came into view in the 1970’s.15 Since then scientists seem to be finding pharmaceutical compounds nearly wherever and whenever they take a close enough look. It was not until recently that researchers developed methodologies to detect these chemicals present at very low concentrations, well below therapeutic doses. The ubiquity of active pharmaceutical compounds, and the fact they are constantly and increasingly introduced to the environment as pollutants are significant to their occurrence and distribution.

The nationwide USGS study published in 2002 found the most frequently detected compounds in surface waters were “coprostanol (fecal steroid), cholesterol (plant and animal steroid), N,N-diethyltoluamide (insect repellant), caffeine (stimulant), triclosan (antimicrobial disinfectant), tri(2-chloroethyl)phosphate (fire retardant), and 4-nonylphenol (nonionic detergent metabolite).”16 Seven17 of the 139 total sites sampled in this study were in Massachusetts and of the ten most frequently detected compounds six were measured at concentrations below the national average at these sites (see Table 2 below).

The selection of sampling sites was biased towards streams susceptible to contamination, as in dense urban areas. The high overall frequency of detection for organic wastewater contaminants, in over 80% of the streams studied was likely influenced by the design of this study which focused on susceptible streams. Table 2 displays the concentrations of the most abundant contaminants as a national average compared to the streams sampled in Massachusetts. This list gives some insight into what is likely to be detectable in the MWRA system, not necessarily what is present or even biologically active. Simply because you can test for something does not make it relevant and if a compound was not detected it does not mean it is not present or significant.



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

Compound

Name

Primary Use

Max

(µg/L)

Median

(µg/L)

MA Rivers max (µg/L)18

MA Rivers median (µg/L)

Coprostanol

Steroid


15019

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

disinfectant



2.3

0.14

0.16 (4)

0.09

tri(2-chloroethyl) phosphate

Fire retardant

0.54

0.1

0.07 (4)

0.05

4-nonylphenol20

Detergent metabolite

40

0.8

121 (7)

0.5

Ibuprofen

Anti-inflammatory

1.0

0.2

0.45 (4)

0.018

Acetaminophen


Antipyretic

10

0.11

0.94 (6)

0.009

Trimethoprim


Antibiotic

0.30

0.013

0.014 (all)

0.014

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