Unused Pharmaceuticals in
the Health Care Industry:
Interim Report
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FOREWORD
EPA is committed to taking action and working with our partners to ensure clean and safe
water. The Agency is concerned about the detection of Pharmaceuticals and personal care
products in our water. EPA has been actively working with federal agencies and state and
local partners to better understand the implications of emerging contaminants such as
Pharmaceuticals, endocrine disrupting chemicals, and personal care products detected in
drinking water, wastewater, surface water and ground water. We continue to evaluate
routes of exposure, levels of exposure, and potential effects on public health and aquatic
life.
EPA is responding to emerging contaminants with a four-pronged approach aimed at
improving science, improving public understanding, identifying partnership and
stewardship opportunities, and taking regulatory action when appropriate. Over the last
few years, EPA has increased its work in a number of areas to better understand
Pharmaceuticals and personal care products. This interim report on "Unused
Pharmaceuticals in the Health Care Industry" is an important part of that effort.
Benjamin H. Grumbles
Assistant Administrator for Water
USEPA
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The Focus ofEPA's Study
EPA initiated the study of unused pharmaceutical disposal practices at health care
facilities with the goals of understanding one way in which pharmaceuticals enter our
waterways and also understanding what factors contribute to pharmaceuticals entering
through water. While EPA understands that there are many factors influencing the
handling and disposal of pharmaceuticals by the health care industry, the focus of EPA's
study is on disposal into water. EPA decided to study medical facilities because the
Agency believes that these facilities dispose of a large quantity of unused
pharmaceuticals. Thus far, EPA has only evaluated hospitals and long-term care facilities,
so the information in this interim report pertains only to hospitals and long-term care
facilities. Recently EPA decided to expand the scope of its study to include hospices and
veterinary facilities and intends to issue a nationwide information collection request to
gather better, representative data (see "Next Steps").
Hospitals include general and medical surgical hospitals, psychiatric and substance abuse
hospitals, and specialty hospitals, such as those treating cancer. Long-term care facilities
include nursing care facilities, residential mental retardation facilities, and continuing
care retirement communities.
Figure 1 shows the distribution of the over 50,000 facilities in each of the six categories
assessed for this report.
Figure 1: Number of Health Care Facilities,
2005
General Medical and
Surgical Hospicals
Continuing Care ,. ,„,
Retirement Communities / '
Psychiatric and Substance
Abuse Hospitals
722
Specialty (except
Psychiatric and
Substance Abuse)
Hospitals
973
Source: U.S. Census, 2005
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For many years, a common practice at many health care facilities has been to
dispose of unused Pharmaceuticals by flushing them down the toilet or pouring them
down the drain. Through this study, EPA has sought answers to the following questions:
• What are the current health services industry practices for disposing of unused
Pharmaceuticals?
• Which Pharmaceuticals are being disposed of and in what quantities?
• What are the options for disposing of unused Pharmaceuticals other than down the
drain or toilet?
• What factors influence disposal decisions?
• Do disposal practices differ across health services industry sectors?
• What Best Management Practices (BMPs) could facilities implement to reduce
the generation of unused Pharmaceuticals?
• What are the costs of current disposal practices compared to the costs of
implementing BMPs or alternative disposal methods?
Upon completion of the health services study, EPA hopes to understand what
factors contribute to unused pharmaceutical disposal methods at health service facilities
and which disposal methods represent best practices to minimize environmental impacts.
Unused Drugs at Nebraska Veterans Home, Grand Island, NE © 2007
To date, EPA has found little readily available information in EPA databases to
answer these questions. Consequently, EPA has researched industry trends and practices
by examining federal and state laws; meeting with federal and state officials, health care
stakeholder groups, and industry; holding a number of teleconferences; conducting site
visits to understand industry practices; attending conferences; and gathering data from a
number of secondary sources. Details of our data collection are contained in the more
detailed technical report, "Health Services Industry Study, Management and Disposal of
Unused Pharmaceuticals (Interim Technical Report)," which will be available at
http://www.epa.gov/guide/304m/ in Summer 2008.
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Pollutants of Concern
Pharmaceutical waste is generated at health care facilities before, during, and after patient
treatment, and includes expired Pharmaceuticals. How much pharmaceutical waste is
disposed of into our sewer systems is unknown. A 2007 publication by researchers at the
Bren School of Environmental Science and Management in California indicated that
drain disposal in Santa Barbara by hospitals, long-term care facilities, and pharmacies is
infrequent. In contrast, a 2008 publication by Kansas State University researchers
concluded that 59 local long-term care facilities disposed of pharmaceutical down the
drain 46 percent of the time.
For the most part health care facilities discharge their wastewater to publicly owned
treatment works (POTWs). This means that discharge information normally generated by
permitted, direct dischargers is not available. Moreover, traditional wastewater treatment
implemented in the 1970s and 1980s at POTWs is designed to remove conventional
pollutants such as suspended solids and biodegradable organic compounds—not
Pharmaceuticals. While many POTWs have since added advanced treatment technologies
at their facilities, those technologies were also not specifically designed to remove
Pharmaceuticals. Some studies suggest that both conventional and advanced treatment
will remove some Pharmaceuticals. EPA's Office of Water is conducting an extensive
literature search to determine to what extent conventional, advanced, and other treatment
technology is effective in removing certain pharmaceuticals from the waste stream. This
report is expected to be completed in late 2008.
Factors Influencing Disposal of Unused Pharmaceuticals
Unused pharmaceuticals can be disposed of in a number of ways: 1) redistribution to the
pharmaceutical manufacturer, 2) reuse/donation, 3) flushing down the drain, 4) disposal
in landfills, and 5) incineration. A number of factors influence the disposal mechanisms a
health care facility may use particular pharmaceuticals—classification as a controlled
substance or medical hazardous waste; federal, state, or local laws; size of the facility;
and ease of, access to, and cost of disposal.
Federal Regulations
Major federal regulations that influence disposal options for unused medications include:
• The Controlled Substances Act (CSA): The CSA provides for a closed
distribution system for controlled substances (e.g., narcotics, opiates, and
stimulants). CSA registrants, such as pharmacies and hospitals and their
employees, have several options for disposing of an unused controlled substance.
They may return it to the manufacturer; destroy it in accordance with state
guidance and with appropriate documentation; or transfer it to reverse
distributors, private companies that handle expired medications for manufacturers
and pharmacies. Under the CSA, disposal down the drain sewer (or flushing) is an
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acceptable destruction option. For the most part, long-term care facilities are not
CSA registrants so they cannot generally return pharmaceuticals to the
manufacturer or use reverse distributors.
• The Resource Conservation and Recovery Act (RCRA): Under RCRA, EPA
regulates the generation, storage, transportation, treatment, and disposal of
pharmaceutical wastes that are defined as hazardous. Common pharmaceuticals
that are hazardous when disposed of include nitroglycerin, warfarin, and some
chemotherapy agents. About 5 percent of pharmaceuticals on the market are listed
as hazardous waste. RCRA regulations require that these and other hazardous
wastes be transported in approved containers to permitted hazardous waste
disposal facilities by a hazardous waste transporter. RCRA also prohibits health
service facilities from disposing of hazardous pharmaceutical waste in municipal
waste landfills, municipal incinerators, or medical waste plants. EPA is
considering amending its hazardous waste regulations to add hazardous
pharmaceutical wastes to the universal waste system to facilitate the disposal of
pharmaceutical waste. In addition, the inclusion of hazardous pharmaceutical
wastes in the universal waste rule may encourage health care facilities to manage
all their pharmaceutical wastes as universal wastes, even wastes that are not
regulated as hazardous but which nonetheless pose hazards.
• The Health Insurance Portability and Accountability Act (HIPAA): HIP A A
requires long-term care facilities to destroy all pharmaceutical labels that contain
private information (e.g., name, birth date, address) and re-label the medication
prior to donation or redistribution. Most facilities that accept donations find that
the labor cost of re-labeling, auditing, and assuming the risk of administering
mislabeled redistributed pharmaceuticals exceeds the value of donated
medication, thereby discouraging this method of "disposal."
State and Local Regulations
State regulations vary widely and influence disposal practices. Many state regulations
require both hospitals and long-term care facilities to destroy unused pharmaceuticals but
often do not specify the process of destruction. Some states have hazardous waste
regulations that are more stringent than EPA's. For example, some wastes that are not
regulated as hazardous under RCRA are identified as hazardous in the state of California.
State regulations for reuse of medications also vary widely. Many states allow reuse of
uncontaminated pharmaceuticals (excluding controlled substances) that have been in a
controlled environment such as an automatic dispensing system. At least five states
strictly prohibit hospitals and long-term care facilities from reusing pharmaceuticals
entirely: Arizona, Kentucky, Mississippi, New Mexico, and Texas. Some state Medicare
and Medicaid requirements can also discourage long-term care facilities from donating or
redistributing their unused medications. In contrast, California allows county health
departments to collect unused pharmaceuticals from long-term care facilities,
wholesalers, and manufacturers and redistribute them for dispensing to the uninsured
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poor.
Other Factors
Besides legal requirements, the other major factors that affect how a medical facility
disposes of unused Pharmaceuticals are organization size, ease and access of disposal,
and cost. For example, some facilities use flushing to sewers as a primary means of
disposal since it is easy, is accessible, and complies with CSA requirements for
destruction. Facilities are most likely to flush pharmaceuticals if they do not have an
onsite pharmacy and/or do not have a pre-existing contract with a hazardous waste hauler
to dispose of the pharmaceuticals. In the past, public health agencies and health-related
nongovernmental organizations guided the public to destroy unused medications by
flushing them down the toilet. Many long-term care facilities have adopted this method
for destruction of unused controlled substances and have extended this practice to include
flushing all unused medications - controlled and non-controlled substances.
Moreover, the logistics for disposing of unused pharmaceuticals at hospitals are different
from long-term care facilities. Hospitals typically have onsite pharmacies. It is common
practice at hospitals to return some unused pharmaceuticals to the hospital pharmacy and
then to the manufacturer for credit or disposal. However, this option extends only to those
pharmaceuticals for which the hospital can receive credit and does not include unused
pharmaceuticals that are considered waste (e.g., pharmaceuticals in an intravenous bag,
drug samples brought into the hospital). Also, hospitals typically do not prescribe
medication far in advance or in large quantities. As a result, the potential for
pharmaceuticals to be wasted is less. In addition, hospitals typically have pre-existing
arrangements for disposal of unused pharmaceuticals as hazardous waste.
Management Practices
There are ways in which disposal of unused pharmaceuticals can be managed to reduce
their environmental impact. EPA examined guidance on managing pharmaceutical waste
from three leading organizations: Hospitals for a Healthy Environment (http://www.h2e-
online.org), Product Stewardship Institute (http://www.productstewardship.us/), and the
Joint Commission on Accreditation of Healthcare Organizations
(http://www.jointcommission.org/). The guidelines provided by these organizations all
aim to reduce health and environmental impacts due to current disposal practices of
pharmaceutical waste.
Some good management practices identified to date include the waste minimization and
reverse distribution systems used by hospitals in California, Minnesota, and Washington.
Waste minimization techniques include maintaining inventories of high-use
pharmaceuticals and identifying those that are close to expiring. Short-dated
pharmaceuticals are redistributed to other areas of the hospital where they are needed.
Dispensed pharmaceuticals can go unused at a hospital or long-term care facility if the
patient has an allergic or adverse reaction to the medication, no longer requires treatment,
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refuses treatment, or the medication expires. Hospitals and long-term care facilities can
reduce the amount of pharmaceutical waste generated by limiting the amount of
Pharmaceuticals dispensed to patients and residents at one time. This can be
accomplished by using unit-dose packaging, limited quantity dispensing, automatic
dispensing systems, and standardized medication dosages. Hospitals have the option of
hiring reverse distributors to manage their unused and/or expired medication that could
be returned to the manufacturer or wholesaler for credit. The reverse distributor
determines which medications may be returned to the manufacturer or wholesaler for
credit and arranges for disposal of unused medications that are waste.
Some state hazardous waste control agencies also recommend that health care facilities
develop a pharmaceutical waste management program. This management tool ensures
proper communication among the various departments, including pharmacy, nursing,
environmental services, safety, and building services. Program considerations include:
• Identifying unused Pharmaceuticals and pharmaceutical wastes and the
approved methods for returns or disposal.
• Communicating proper return or disposal practices to all staff involved
with pharmaceutical dispensing or disposal.
• Determining a method of segregating unused Pharmaceuticals and
pharmaceutical waste with different return or disposal requirements.
Example pharmaceutical waste management programs that are currently used in the
health care industry for pharmaceutical wastes include:
• Sorting unused Pharmaceuticals and pharmaceutical waste at the point of
health care delivery ("pre-sort" model) through use of different disposal
bins, disposal information incorporated with dispensing software, and
"Special Disposal Required" stickers applied to pharmaceutical packaging.
• Grouping together all unused Pharmaceuticals and pharmaceutical waste at
the point of health care delivery ("post-sort" model) for subsequent
segregation by waste management contractor.
• Managing all drugs as hazardous.
Preliminary Observations
Based on our data collection thus far, a number of preliminary observations can be made:
1. Federal, state, and local laws and regulations often require special handling of
pharmaceutical waste. These laws and regulations can influence the options hospitals
and long-term care facilities have for disposing of unused Pharmaceuticals.
2. Organization size, ease and access of disposal, and cost are also factors influencing
the disposal of unused Pharmaceuticals.
3. Fewer disposal opportunities exist for long-term care facilities because they are often
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not CSA registrants and cannot generally return pharmaceuticals to the manufacturer
or use reverse distributors.
4. Best management practices, if widely implemented, have the potential to reduce the
amount of unused pharmaceuticals entering our nation's waters from disposal.
Next Steps
EPA will continue to study the issue of how health care facilities are managing and
disposing of unused pharmaceuticals. However, EPA does not have nationwide
information on the amount of unused pharmaceuticals disposed of by health care
facilities, the means of disposal, or cost. EPA would like to gather further information on
current best management practices that might be adopted by others. Therefore, EPA plans
to conduct a nationwide survey of hospitals, long-term care facilities, hospices, and
veterinary facilities. EPA will use this information to estimate the amount of unused
pharmaceuticals disposed of in our nation's waterways, evaluate current disposal
practices and their cost, examine the barriers to alternate disposal methods, and evaluate
best management practices and their costs. EPA has begun the process required under the
Paperwork Reduction Act to receive Office of Management and Budget approval for this
survey. EPA expects to work closely with health care services industry representatives
and other affected stakeholders while designing the survey. EPA also plans to visit more
facilities to obtain first-hand information on how health care facilities manage, track, and
dispose of their unused pharmaceuticals.
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