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RUNNING HEAD: Disposal of Unused Pharmaceuticals !

Disposal of Unused Pharmaceuticals: Obstacles and Opportunities for Reform


Rachel Cox
University of San Francisco










Disposal of Unused Pharmaceuticals 2
Disposal of Unused Pharmaceuticals: Obstacles and Opportunities for Reform

I. INTRODUCTION
Environmental pollution via pharmaceutical products has recently received
increased attention from the public and scientists alike. Across the United States, trace
levels of pharmaceutical components have been found throughout the environment,
including waterways, soil, and treated drinking water. While the research is limited,
there is evidence that pharmaceutical compounds may negatively impact human health
through exposure to antibiotics
1
and endocrine-disrupting substances
2
, among others
(Fent et al., 2006). Although some pollution via pharmaceuticals is inevitable as a result
of human excretion, public health risks arising from unsafe disposal, including flushing
and trashing, are becoming more apparent. Furthermore, the presence of unused
controlled substances
3
in homes is likely contributing to increased rates of prescription
drug abuse (Department of Health and Human Services, 2005).
Despite the evidence demonstrating increased pollution and potential human
health effects, the federal government and most state and local governments have
failed to take action, largely because there are a number of laws and regulations that
limit the scope and reliability of unused drug take-back programs. The Controlled
Substances Act (CSA) and Drug Enforcement Agency (DEA) are the most significant
barriers in the movement to promote proper disposal. The CSA and DEA prohibit

1
Medications that destroy or slow the growth of bacteria
2
Chemicals that may interfere with the bodys endocrine system and produce
developmental, reproductive, neurological, and immune effects in both humans and
wildlife.
3
Drugs that are regulated by state and federal law that aim to control the danger of
addiction, abuse, physical and mental harm, and trafficking by illegal means.
Disposal of Unused Pharmaceuticals 3
pharmacies, providers, and hospitals from collecting controlled substances (Controlled
Substances Act, 1970). While law enforcement officers are exempt from this restriction,
most take-back programs and events do not ensure the presence of law enforcement
and therefore cannot accept controlled substances at their sites. Additionally, the U.S.
Postal Service does not allow individuals to mail prescription drugs; only DEA-registered
entities are allowed to do so (USPS, 2011). With these regulations in place, take-back
programs are unable to offer simple, comprehensive collection, often resulting in unsafe
pharmaceutical disposal by consumers.
In order to improve the efficacy of take-back programs, reduce the level of
pharmaceutical pollution and health risks, and control the potential for controlled
substances abuse, reforms at all levels of government are necessary. The federal
government has the potential to remove the most significant barriers facing consumers
today. Reform that allows pharmacies, providers, and hospitals to collect all substances
will significantly increase the scope of take-back programs and allow ease for
consumers. Allowing consumers to mail all prescription drugs to a designated take-back
program will facilitate return and ensure substances are disposed of in an approved,
environmentally friendly manner. Once these obstacles are addressed, state and local
governments will be able to adopt more efficient and practical solutions for take-back
programs that speak to the needs of all stakeholder groups.
The DEA is currently drafting regulations to be implemented under the Secure
and Responsible Drug Disposal Act (2010). New regulations will allow expansion of
take-back and mail-in programs and give states the ability implement comprehensive
collection of all pharmaceutical substances with the potential to harm human health.
Disposal of Unused Pharmaceuticals 4
Once regulations are passed, states should implement programs funded by all relevant
stakeholders, including pharmaceutical manufacturers, retailers, and consumers, to
ensure equal representation, convenience, and economic feasibility of program
continuation.

II. SOURCES & DISPOSAL OF UNUSED MEDICATION
Recent collection efforts suggest that consumers do not use nearly 45 percent of
the prescriptions drugs they are prescribed. This may be for a number of reasons,
including allergic reactions, symptom or dosage change, reluctance to finish a regimen
due to improved condition, and death. Of those prescriptions returned, opioids and other
controlled substances account for only 2.15 percent (Teleosis Institute, 2010). While the
number of unused medications is high, the frequency of return remains low, with many
consumers keeping drugs, because they do not know how to properly dispose of them,
or disposing of them in an unsafe manner.
Research has found that consumers primarily use three disposal methods:
flushing them down a toilet or sink, throwing them into the trash, and returning them to a
pharmacy. A 2006 survey of outpatient pharmacy customers found that fewer than 20
percent had received information about proper disposal from their providers and more
than half had flushed unused medication down the toilet (Seehusen and Edwards,
2006). An earlier study found that 35.4 percent of consumers flushed unused
medication down a sink or toilet, 54 percent disposed of unused medication in the
garbage, and only 1.4 percent returned unused medication to the pharmacy
(Glassmeyer et al., 2009).

Disposal of Unused Pharmaceuticals 5
Figure 1: How US consumers dispose of medications




Flushing is the most convenient method for pharmaceutical disposal, but raises
the potential for environmental concerns. In 2002, the U.S. Geological survey found
human and veterinary drugs in 80 percent of wastewater streams tested. Among those
found, antibiotics and prescription drugs were detected most frequently. Throwing
prescription drugs in the trash is also convenient but not without risks. Research
indicates that pharmaceuticals present in landfills may leach into groundwater and
waterways, eventually reaching humans through drinking water (Bain, 2010).

Figure 2: How
pharmaceuticals
enter the water
supply
(Source: Bound
and Vouvoulis,
2005)
Disposal of Unused Pharmaceuticals 6
III. HEALTH RISKS FROM IMPROPER DISPOSAL
Pharmaceuticals are intended to cause biological reactions in the patients for
whom they are prescribed. However, once free in the environment, these reactions
have the potential to affect unintended persons and induce cumulative effects such as
increased antibiotic resistance. In some cases, the pharmaceutical concentrations found
in water are equal to or higher than the biologically effective dose (Fent et al. 2006).
Studies have shown that environmentally persistent pharmaceutical pollutants
(EPPP)
4
have resulted in compromised reproductive function and endocrine disruption
in aquatic organisms and their presence is suspected to contribute to a lowered average
age for puberty initiation (Kime, 1999; Christen et al., 2010). Additionally, Zhang et al.
(2009) found that wastewater effluent
5
actually had a higher prevalence of antibiotic-
resistant
6
strains than influent, suggesting that treated wastewater bound for human
consumption may pose a significant risk to human health. While the full impact of
pharmaceutical pollution in our environment is not yet understood, these studies and
others similar to them indicate the potential for widespread and serious health effects.






#
Compounds that are resistant to environmental degradation through biological and
chemical processes
$
Wastewater treated or untreated that flows out of a treatment plant, sewer, or
industrial outfall. Generally refers to wastes discharged into surface waters.
%
Bacteria that have evolved with the ability to resist treatment by certain classes of
antibiotics.
Disposal of Unused Pharmaceuticals 7
Table 1: Risk indicators of various pharmaceutical groups












(Source: Bound and Voulvoulis, 2005)

IV. COLLECTION MODELS
Current environmental indicators demonstrate the need for immediate
improvement of disposal practices. While risks are currently significant, they are also
changeable through improved practices. With the increased attention devoted to
pharmaceutical pollution, consumers are concerned and insisting on the expansion of
collection programs. Daughton et al. (2003) found that questions about proper disposal
are among the top inquiries practitioners receive about pharmaceuticals in the
environment. Two collection models, in addition to pharmacy return, are becoming more
Disposal of Unused Pharmaceuticals 8
popular, but are currently limited by laws and regulations, ultimately resulting in
incomplete collection practices.
Drop-off programs operate as both permanent collection sites and one-day
events. Permanent collection programs are often run by nonprofits, counties, and state
boards of pharmacy and provide drop-off services at predefined locations. The locations
generally include pharmacies, household hazardous waste facilities, and police stations,
which are the only locations that can accept controlled substances under the Controlled
Substances Act. One-day take-back events are typically community- or city-wide and
bring together pharmacies, health agencies, and law enforcement to allow the collection
of controlled substances.
In a mail-back program, consumers send unused prescriptions to a disposal
location via the U.S. Postal Service (USPS). Because the USPS only allows DEA-
registered entities to mail prescription drugs, mail-back programs are pilot studies and
few currently operate. In order to comply with USPS standards, the destination must be
registered with the DEA and prescriptions must be mailed in a specified mailer. In order
to return controlled substances in compliance with the Controlled Substances Act,
consumers must mail prescriptions directly to the Drug Enforcement Agency.

V. AGENCIES THAT REGULATE PHARMACEUTICALS
While the idea of expanding these programs in gaining traction, the frequency of
their implementation is incredibly low, in large part because of the various government
agencies and regulations relating to pharmaceutical disposal. The Food and Drug
Administration (FDA), Environmental Protection Agency (EPA), and Drug Enforcement
Disposal of Unused Pharmaceuticals 9
Agency (DEA) all have conflicting, environmentally unsound, and limiting
recommendations and regulations regarding consumer disposal. In addition, the U.S.
Postal Service (USPS) regulates the mailing of unused pharmaceutical products.
Historically, the FDA suggested flushing all unused pharmaceuticals in order to
avoid poisonings. While they no longer advise flushing all pharmaceuticals, they do still
provide a list of drugs that consumers are advised the flush. The Medications
Recommended for Disposal by Flushing list currently includes many narcotics and pain
relievers that consumers are advised to mix with undesirable substances such as coffee
grounds. The FDA has been reluctant to set drug disposal standards and prefers that
states address this issue. However, their lack of action has delayed effective
implementation of adequate disposal practices (Daughton, 2003).
The EPA is responsible for implementing the Resource Conservation and
Recovery Act (RCRA), which regulates the disposal of hazardous wastes, including 4-
10 percent of pharmaceutical products (Lauer, 2010). Because the percentage of
pharmaceuticals considered hazardous waste is so small, most hazardous waste
facilities do not accept medications at all, with many citing the inability to effectively
categorize and store medications (Glassmeyer, 2009). Additionally, because RCRA
does not include household-generated hazardous waste, this key regulation often
misses the majority of hazardous pharmaceutical waste pollution.
The DEA regulates controlled substances through the Controlled Substances Act
(CSA). The CSA mandates that any person who manufactures, distributes, or dispenses
a scheduled pharmaceutical be registered with the DEA (Glassmeyer, 2009), which
prohibits third parties from taking back controlled substances. The one exception
Disposal of Unused Pharmaceuticals 10
allowed by the CSA is for law enforcement officials, who are allowed to receive and
handle controlled substances. However, this process often requires time and resources
that patients, care facilities, and take-back programs do not have.
USPS regulations are among the most widely talked about and limiting
restrictions pertaining to take-back programs. The USPS prohibits the mailing of any
controlled substance unless both the mailer and recipient are registered with the DEA,
are exempt from DEA registration, or are a practitioner mailing directly to the patient.
Non-controlled substances are also subject to similar guidelines requiring direct
practitioner-to-patient mailing (USPS, 2011).

VI. STAKEHOLDER PERSPECTIVES
When it comes to possible solutions regarding unsafe pharmaceutical disposal
and the regulatory changes necessary, stakeholders have differing opinions. In order to
improve the efficacy of take-back programs, the stances of manufactures and
pharmacies must be explored.
Pharmaceutical manufacturers often maintain that drugs predominantly appear in
drinking water as a result of human excretion and, despite research suggesting
otherwise, not from flushing or trashing. For this reason, the industry does not see take-
back programs as appropriate strategies for pollution reduction and even educates
consumers that flushing and trashing are safe, effective methods of disposal. In
addition, manufacturers argue that industry programs are not as convenient to
consumers as community programs (SMARxT; Oregon, 2007). Pharmacists, on the
other hand, encourage proper disposal of unused medications; however, their chief
Disposal of Unused Pharmaceuticals 11
concern is cost and how it will likely be passed on to the consumers (Lis Houchen,
2008). In order to address the concerns of these two groups, certain factors are critical:
convenience and economic feasibility. Both concerns can be addressed through
changes to regulations that currently limit the scope of drop-off and mail-back models
and funding that includes all stakeholder groups.

VII. A TWO-FOLD APPROACH TO REFORM
1. Federal Reform
I. Controlled Substances Act
The CSA creates a very restricted system that limits opportunities for
collection of controlled substances. Once dispensed and outside the system,
controlled substances are hard to track and even more difficult to collect. By
prohibiting the transfer of medication from consumer to pharmacist, doctor, or
hospital, the CSA is contributing to opportunities for pollution and prescription
abuse. Currently, only two exceptions exist for this rule: 1) consumers may return
controlled substances in case of recalls or dispensing errors ( 1307.21); 2)
controlled substances may be collected by law enforcement officials ( 1301.24).
Because law enforcement officers must be present, many take-back programs
have opted not to collect controlled substances at their locations.
If no programs with law enforcement presence exist near consumers, they
are forced to either dispose of the medication in an unsafe manner or follow
provision 21 CFR 1307.21, which requires consumers to transfer medication to
a DEA registrant, deliver it to the nearest DEA office, or destroy it in the presence
Disposal of Unused Pharmaceuticals 12
of a DEA agent. While this provision includes safe means for disposal, it is simply
unrealistic for the majority of consumers.
Amending the CSA to allow for more disposal options and locations will
facilitate expansion of take-back programs and reduce the amount of
pharmaceuticals disposed of improperly. By no means should the DEA allow any
location to collect pharmaceuticals, however expansion of collection allowances
to trusted DEA-registered reverse distributors, pharmacies, hospitals, and
practitioners will ensure that all drugs, not just non-controlled substances, are
sent directly to disposal.

II. USPS Regulation of Prescription Mailings
The USPS does not currently allow for the mailing of prescription drugs,
except by manufacturers, pharmacies, and authorized dispensers; consumers
are prohibited from mailing unused pharmaceuticals back to their source.
Allowing consumers to freely send pharmaceuticals in designated envelopes to
DEA-approved entities would greatly improve the ease of collection.

Although neither of these avenues has been fully explored at the federal level,
both the DEA and USPS have begun to explore the possibility of these reforms through
state-run pilot programs. State-run programs are essentially a Band-Aid for a lack of
national reform, but are providing valuable evidence that reform is the most feasible
route to expanded, uncomplicated pharmaceutical collection.

Disposal of Unused Pharmaceuticals 13
2. State Reform Facilitating Take-back Programs
The state of Maine had an operational test agreement with the DEA and USPS
and began a mail-back program that accepted all pharmaceuticals, including controlled
substances. Pharmaceuticals were mailed from consumers to the Maine DEA through
the Safe Medicine Disposal for ME (SMDME) program. SMDME was created in 2004
through a state bill, LD 411 An Act to Establish a Pilot Program for the Return of
Unused Prescription Drugs by Mail. All received medications were sorted by the Maine
DEA and sent to the appropriate disposal site (University of Maine, 2010). Although the
program has since ended due to a lack of funding, as of December 2012, SMDME had
properly disposed of over 8,00 pounds of unused medications (University of Maine,
2012).







VIII. REFORM FEASIBILITY THROUGH FUNDING
As witnessed in the state of Maine, prescription collection reform is a safe,
effective means of reducing improper medication disposal, yet funding such programs
remains a challenge. Historically, the pharmaceutical industry has been vehemently
opposed to funding clean-up or take-back systems. However, manufacturer product-
Disposal of Unused Pharmaceuticals 14
stewardship programs that fund disposal programs have gained support in New York
and Washington
7
.
Extended producer responsibility (EPR) is both fair and feasible. Producers of
toxic substances that pollute the environment have been responsible for clean-up in
other industries, including mercury thermostats and electronic waste, for years and it is
time for pharmaceutical manufacturers to take the same responsibility (Product Policy
Institute, 2011). It should not be the responsibility of the public, especially in a struggling
economy, to pay for the totality of disposal programs. However, if pharmaceutical
companies were to be responsible for all disposal funding, the cost would likely be
redistributed to the consumer anyway. For this reason, collaboration between the
pharmaceutical industry, retailers, and consumers is likely the best approach. By
involving all stakeholder groups, programs will be able to induce the best possible levels
of compliance and participation.

IX. MERGING STATE AND FEDERAL REFORM
Complete reform, particularly for large industries, is never an easy task and often
calls for the involvement of many agency levels. For successful pharmaceutical disposal
reform, this remains true. While the federal government retains control of the most
limiting regulations regarding pharmaceutical disposal, states are better equipped to
implement individual programs. For this reason, a reform system involving federal
leadership and state execution is likely the most effective approach. Maine successfully
implemented this practice for 8 years with impressive results and imitation of their

&
New York State Assembly Bill A840; Washington House Bill 2600
Disposal of Unused Pharmaceuticals 15
program at the national level is promising. In 2010, the federal government began the
process of loosening restrictions pertaining to controlled substance collection and
consumer mail-back programs.
The Secure and Responsible Drug Disposal Act was enacted in 2010 and the
DEA is currently drafting the regulations to be implemented under the act (EPA, 2012).
Regulations will allow the public to more easily dispose of unused pharmaceuticals in a
secure, environmentally friendly manner. In December 2012, the DEA issued proposed
regulations under the Secure and Responsible Drug Disposal Act. The proposal would
expand collection options to include take-back events, mail-back programs, and
collection receptacle locations; certain registrants will be designated as collectors for
mail-back programs. Passage of these regulations will give states the ability to
implement more comprehensive and appropriate pharmaceutical collection programs.
As such, states should be sure to implement programs that take into account
stakeholder concerns of convenience and economic feasibility.

X. AN INCOMPLETE APPROACH
While the nation waits for DEA reforms under the Secure and Responsible Drug
Disposal Act, some states and counties are taking action. The state of Washington has
introduced a program advocated for by Take Back Your Meds, a focus group comprised
of all stakeholder groups including environmental and health organizations, pharmacies,
and law enforcement agencies. The group is working to pass legislation that would
introduce a permanent, rather than pilot, program to the state. However, the program,
which would be funded solely by pharmaceutical manufacturers, has been met with
Disposal of Unused Pharmaceuticals 16
harsh criticism by the industry (How Medicine Take-Back Works, 2010). The same is
true for a program introduced in Alameda County, California, which was recently found
constitutional by the U.S. District Court for the Northern District of California. California
also introduced S.B. 727, which was canceled at the request of the author, Senator
Jackson (Karst, 2013). While all of these programs address legitimate concerns, they all
have one thing in common: they are funded solely by manufactures, rather than sharing
the burden among all stakeholder groups.

XI. NEXT STEPS: STATE POLICY RECOMMENDATIONS
Focus Group Formation
Successful, statewide environmental programs have historically been developed
under the guidance of an established, diverse group of stakeholders. For example, the
Rhode Island Climate Change Commission was formed to study projected impacts of
climate change, identify strengths and weaknesses of current systems, and review
amendments to existing regulations (State of Rhode Island, 2010). States interested in
expanding pharmaceutical collection programs, following DEA approval, should form a
focus group to take on similar responsibilities and inform program establishment.

Program Establishment
Successful programs such as Maines Safe Medicine Disposal for ME are
composed of clear guidelines, designate legally-responsible collectors, and maintain
supplies to deliver all necessary sufficient services. In addition, programs comply with
all state regulations, which vary widely across the nation.
Disposal of Unused Pharmaceuticals 17
Program Funding
States should introduce legislation mandating EPR programs for pharmaceutical
manufacturers providing products within the state. In addition to EPR funding, states
should implement a fee system for retailers and consumers alike to fund a balanced
collection program for all stakeholders. Pharmaceutical manufacturers are not the only
party responsible for improper disposal, and should not be asked to fund programs as if
they were.

XII. CONCLUSION
State and local communities have begun to implement programs for collecting
and disposing of unused pharmaceuticals, however these programs are currently very
limited in scope. Take-back and mail-in programs have become accepted strategies to
prevent pharmaceutical pollution due to flushing and controlled substance abuse.
However, the barriers currently in place by federal regulations restrict programs from
offering comprehensive collection of all medications.
The DEA has already started the process of reforming the most limiting factors
the Controlled Substances Act and mail-in requirements. Following reform, states will
need to lead the way and produce programs that include widespread, easily accessible
collection strategies and engage all stakeholder parties in funding and participation to
ensure convenience and economic feasibility. Without these two critical components,
consumers will likely fail to reduce the amount of pharmaceutical pollution taking place
and continue to increase human health risks.

Disposal of Unused Pharmaceuticals 18
References
Bain, K. (2010). Understanding the public health implications of household
pharmaceutical waste in the US- part one. Medical Waste Management, July-
September 2010, 4-14.
Bound, J. & Voulvoulis, N. (2005). Household disposal of pharmaceuticals as a pathway
for aquatic contamination in the United Kingdom. Environmental Health Perspectives
113 (12), 1705-1711.
Christen, V., Hickmann, S., Rechenberg, B., & Fent, K. (2010). Highly active human
pharmaceuticals in aquatic systems: a concept for their identification based on their
mode of action. Aquatic Toxicology, 96, 167-181.
Daughton, C. (2003). Cradle-to-cradle stewardship of drugs for minimizing their
environmental disposition while promoting human health. II. Drug disposal, waste
reduction, and future direction. Environmental Health Perspectives, 111 (5), 775-783.
Results from the 2005 National Survey on Drug Use and Health: National Findings.
Department of Health and Human Services. SAMHSA. Office of Applied Studies.
Fent, K., Weston, A., & Caminada, D. (2006). Ecotoxicology of human pharmaceuticals.
Aquatic Toxicology, 76: 122-159.
How Medicine Take-Back Works. Take Back Your Meds. Retrieved November 12,
2013. http://www.takebackyourmeds.org/why/how-medicine-take-back-works.
Glassmeyer, S., Hinchey, E. Boehme, S., Daughton, C., Ruhoy, I., Conerly, O., Daniels,
R., Lauer, L., McCarthy, M., Nettesheim, T., Sykes, K., & Thompson, V. (2009).
Disposal practices for unwanted residential medicines in the United States. Environment
International, 35, 566-572.
Kime, D. (1999). Environmentally induced endocrine abnormalities in fish. The Royal
Society of Chemistry: Issues in Environmental Science and Technology, 12, 27-48.
Lauer, L. (2010). RCRA and pharmaceutical waste management: a brief federal
overview. (PowerPoint Presentation by the EPA). Retrieved November 10, 2013,
http://www.epa.gov/aging/resources/presentations/2010_0112_rcra_psi_call.pdf
Letter from Lis Houchen, National Association of Chain Drug Stores to Janet Gillaspe,
Oregon Association of Clean Water Agencies, April 21, 2008.
Oregon Pharmaceutical Take Back Stakeholder Group. Final Report. July 1, 2007. p.
78.
Product Policy Institute. (2011). What is extended producer responsibility? Economic
benefits. Retrieved on November 11, 2013, http://www.productpolicy.org/content/define-
epr.
Disposal of Unused Pharmaceuticals 19
Safe Medicine Disposal for ME. Research. Retrieved on November 11, 2013.
http://www.safemeddisposal.com/Research.php
Seehusen, DA and J. Edwards. Patient practices and beliefs concerning disposal of
medications. Journal of the American Board of Family Medicine 19 (2006):542-547.
SMARxT Disposal: A Prescription for a Healthy Planet. www.smarxtdisposal.net/.
State of Rhode Island. (2010). The Rhode Island climate risk reduction act of 2010. RI
State Legislation, Title 23, Chapter 84, section 3. Retrieved on November 11, 2013,
http://www.rilin.state.ri.us/statutes/title23/23-84/23-84-3.htm.
Teleosis Institute. (2010). Bay Area medication disposal study 2009: an inventory of
household pharmaceutical waste. Final report, version 2.1. Retrieved November 10,
2013, http://www.teleosis.org/
University of Maine, Center on Aging. (2010). Safe medicine disposal for ME: a
handbook and summary report. Retrieved on November 10, 2013,
http://www.safemeddisposal.com/documents/MailbackProgramReportFINAL.pdf.
US Environment Protection Agency (2012). Notice of proposed rulemaking. Federal
Register, 77(246).
US Postal Service. (2011). Publication 52- hazardous, restricted, and perishable, mail.
Retrieved October 28, 2013, http://pe.usps.com/cpim/ftp/pubs/pub52/pub52.pdf
Zhang, Y., Marrs, C., Simon, C., Xi, C. (2009). Wastewater treatment contributes to
selective increase of antibiotic resistance among Acinetobacter spp. Science of The
Total Environment, 407(12), 3702-3706.

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