Download Managing Pharmaceutical Waste

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts
no text concepts found
Transcript
>˜>}ˆ˜}ÊÊ
*…>À“>ViṎV>Ê7>ÃÌiÊ
ʈÃVÕÃȜ˜ÊՈ`iÊvœÀÊi>Ì…‡-ÞÃÌi“Ê*…>À“>VˆÃÌÃ
ÊvÀiiÊÜiL‡L>Ãi`ÊVœ˜Ìˆ˜Õˆ˜}Êi`ÕV>̈œ˜Ê«Àœ}À>“Êi˜ÌˆÌi`ÊÊ
º*…>À“>ViṎV>Ê7>ÃÌiÊ>˜>}i“i˜Ì\ÊÃÃÕiÃÊ>˜`Ê"«Ìˆœ˜ÃÊvœÀÊi>Ì…Ê-ÞÃÌi“ûÊÊ
ˆÃÊ>ÃœÊ>Û>ˆ>Li°Ê/…iÊ«Àœ}À>“ÊV>˜ÊLiÊ>VViÃÃi`Ê>ÌʅÌÌ«\ÉÉÃޓ«œÃˆ>°>Å«°œÀ}É«…>À“>Ü>ÃÌiÊ
ÝiVṎÛiÊ-Փ“>ÀÞ
“«Àœ«iÀÊ`ˆÃ«œÃ>ÊœvÊ«…>À“>ViṎV>ÃʈÃʅ>ۈ˜}Ê>˜Ê>`ÛiÀÃi
ˆ“«>VÌʜ˜Ê̅iÊi˜ÛˆÀœ˜“i˜ÌÊ>˜`ʜ˜Ê…Õ“>˜Ê…i>Ì…ÊܜÀ`܈`
-ÌÕ`ˆiÃʅ>ÛiÊ`i“œ˜ÃÌÀ>Ìi`Ê̅iÃiÊ>`ÛiÀÃiÊivviVÌÃÊ>˜`ʅ>Ûi
À>ˆÃi`ÊVœ˜ViÀ˜ÃÊ>LœÕÌÊÃiÀˆœÕÃÊVœ˜ÃiµÕi˜ViÃÊ̅>Ìʓ>ÞʜVVÕ
ˆvÊ>««Àœ«Àˆ>ÌiÊ>V̈œ˜ÃÊ>ÀiʘœÌÊÌ>Ži˜°£qÎÊ/…ˆÃÊ`ˆÃVÕÃȜ˜Ê}Ո`
«ÀœÛˆ`iÃʈ“«œÀÌ>˜Ìʈ˜vœÀ“>̈œ˜Êœ˜Ê«…>À“>ViṎV>ÊÜ>ÃÌi]
w˜ˆÌˆœ˜Ã]ÊÀi}Տ>̈œ˜Ã]Ê>˜`ʓ>˜>}i“i˜Ì]Ê>˜`ʈÌÊ
«…>À“>VˆÃÌýÊ̅ˆ˜Žˆ˜}Ê>LœÕÌÊ«œÌi˜Ìˆ>Ê܏Ṏœ˜Ã°
ÃÌÃ]ÊÜiÊ>ÀiʘœÌÊÀœṎ˜iÞÊi`ÕV>Ìi`ʜ˜Ê«Àœ«iÀ
…iÃiÊ«Àœ`ÕVÌÃʜÀʜ˜Êi˜ÛˆÀœ˜“i˜Ì>ÊÀi}Տ>̈œ˜Ã]Ê
«ÀœviÃȜ˜>ÊÀi뜘ÈLˆˆÌÞÊ̜ʏi>À˜Ê…œÜÊ̜ʫÀœÌiVÌÊ
i˜ÌÊ>˜`ÊvÕÌÕÀiÊ}i˜iÀ>̈œ˜Ã°
˜`ʈÌÃÊ>««ˆV>̈œ˜ÃÊVœ˜Ì>ˆ˜i`ʈ˜Ê̅ˆÃÊ}Ո`>˜ViÊ`œVՓi˜ÌÊ>Ài
}ÊLiV>ÕÃiʜvʜ˜}œˆ˜}ÊÀiÃi>ÀV…Ê>˜`ʈ“«ÀœÛi“i˜ÌÃʈ˜ÊÌiV…˜œ‡
iVÌÊ̜Ê̅iÊ«ÀœviÃȜ˜>ÊÕ`}“i˜ÌÊ>˜`ʈ˜ÌiÀ«ÀiÌ>̈œ˜ÊœvÊ̅iÊ«À>V‡
œvÊ̅iÊ՘ˆµÕi˜iÃÃʜvÊi>V…Ê«…>À“>VÞ½ÃÊÀœiʈ˜Ê“>˜>}ˆ˜}Ê«…>À‡
À
°Ê/…iÊÜÀˆÌiÀ]ÊÀiۈiÜiÀÃ]Êi`ˆÌœÀÃ]Ê-*]Ê>˜`Ê6iÃÌ>À>ʅ>Ûiʓ>`i
ÃÊ̜Êi˜ÃÕÀiÊ̅iÊ>VVÕÀ>VÞÊ>˜`Ê>««Àœ«Àˆ>Ìi˜iÃÃʜvÊ̅iʈ˜vœÀ“>̈œ˜
`œVՓi˜Ì°ÊœÜiÛiÀ]Ê>˜ÞÊÀi>`iÀʜvÊ̅ˆÃʈ˜vœÀ“>̈œ˜ÊˆÃÊ>`ۈÃi`
ۈiÜiÀÃ]Êi`ˆÌœÀÃ]Ê>˜`Ê-*ʜÀÊ6iÃÌ>À>Ê>ÀiʘœÌÊÀi뜘ÈLiÊvœÀ
Ài˜VÞʜvÊ̅iʈ˜vœÀ“>̈œ˜]ÊvœÀÊ>˜ÞÊiÀÀœÀÃʜÀʜ“ˆÃȜ˜Ã]Ê>˜`ɜÀÊvœÀ
ÃÊ>ÀˆÃˆ˜}ÊvÀœ“Ê̅iÊÕÃiʜvÊ̅iʈ˜vœÀ“>̈œ˜Êˆ˜Ê̅iÊ`œVՓi˜Ìʈ˜Ê>˜ÞÊ
iÌ̈˜}ðʘÞÊÀi>`iÀʜvÊ̅ˆÃÊ`œVՓi˜ÌʈÃÊV>Ṏœ˜i`Ê̅>ÌÊ-*
iʘœÊÀi«ÀiÃi˜Ì>̈œ˜]Ê}Õ>À>˜Ìii]ʜÀÊÜ>ÀÀ>˜ÌÞ]ÊiÝ«ÀiÃÃʜÀʈ“«ˆi`]Ê
ÞÊ>˜`Ê>««Àœ«Àˆ>Ìi˜iÃÃʜvÊ̅iʈ˜vœÀ“>̈œ˜ÊVœ˜Ì>ˆ˜i`ʈ˜Ê̅ˆÃÊ`œVՇ
>ÀʘœÊÀi뜘ÈLˆˆÌÞʜÀʏˆ>LˆˆÌÞÊvœÀÊ̅iÊÀiÃՏÌÃʜÀÊVœ˜ÃiµÕi˜ViÃʜvÊ
Managing Pharmaceutical Waste:
A Discussion Guide for Health-System Pharmacists
Overview and regulatory history
The term “chemical pollutants” most often calls to
mind pesticides and industrial sewage, yet since
the 1980s pharmaceuticals have increasingly been
recognized as chemical pollutants of the environment.1 Environmental Protection Agency (EPA)
reports in recent years have cited multiple studies
by analytical chemists on the problem of pharmaceutical waste.2
In 2002, Kolpin et al.3 reported that of 139 streams
sampled in 30 states across the country, 80%
contained one or more organic wastewater contaminants (OWCs). The study tested for 95 OWCs,
including pharmaceuticals. Most (82) of the OWCs
were found in at least one stream sample, and
13% of the streams contained more than 20 OWCs.
Many of the OWCs were pharmaceuticals from
common prescription and nonprescription products. Similarly, in a U.S. Geological Survey study
of Minnesota wastewater, surface, ground, and
drinking waters, OWCs were found in 90% of the
samples.4 The highest levels detected were from
nonprescription drugs, antibiotics, and prescription drugs, respectively.3,4 Although pharmaceutical
contaminants have not been found at therapeutic
levels, they have potential adverse consequences,
including water quality degradation, endocrine
disruption (which translates into problems with
physical, mental, and sexual development), antibiotic resistance, and negative public perception
regarding water cleanliness.
The environmental and physical consequences of
improper pharmaceutical waste management are
serious. Human male sperm counts have dropped
50% on average since 1939, and there have been
increases in infertility, genital defects, cancers
caused by hormones (breast and prostate), and
neurological disorders in children.5 Endocrine disrupters found in U.S. waterways could have effects
on future generations; they interfere with normal
functioning of the endocrine system (thyroid, adrenals, ovaries, and testicles), mimic hormones, and
affect reproduction, development, and behavior.6
In addition, antibiotic resistance is on the rise; ampicillin-resistant bacteria were found in every U.S.
river tested in 1999.6 In a 2000 study, all samples
taken from the Ohio River contained Escherichia
coli with some resistance to penicillin, tetracycline, and vancomycin.7 Samples containing the
highest levels of antibiotics also contained bacteria
with the greatest resistance.
The assistance of William W. Churchill, M.S., R.Ph., Executive Director of Pharmacy
Services, Brigham and Women’s Hospital in Boston, Massachusetts, and Firouzan
‘Fred’ Massoomi, Pharm.D., FASHP, Pharmacy Operations Coordinator, Department
of Pharmacy Services, Nebraska Methodist Hospital, Omaha, Nebraska, who served
as content experts and reviewers of this document, is gratefully acknowledged.
3
■
M A N A G I N G P H A R M A C E U T I C A L WA S T E
What can we do to prevent these products from
entering our waterways and environment? Pharmaceutical waste from clinics, hospitals, and
health systems usually is thrown into the trash or
dumped into a sink or toilet and thereby placed in
the sewer waste stream.8,9 If these drugs are not
biodegraded or eliminated during sewage treatment, they eventually reach drinking water. In fact,
most sewage and water treatment facilities do not
take pharmaceutical contaminants into consideration, so these wastes are left untreated to enter
our surface, ground, and drinking water.10 Pharmaceutical waste can also contaminate the environment through improper incineration or landfill
placement. By educating ourselves about this issue
and the relevant regulations, pharmacists can help
reduce the amount of pharmaceutical waste and
potential OWCs entering the environment from
hospitals and other health care organizations.
Attempts to regulate the disposal of health care
waste are not new. The federal Resource Conservation and Recovery Act11 (RCRA) has been in
place since 1976. Enforced by EPA, it regulates
and tracks the disposal of solid waste, setting forth
strict rules for facilities that generate, transport,
store, and dispose of hazardous waste. RCRA
defines hazardous waste as chemicals or formulations so detrimental to the environment that they
must be separated for special disposal and cannot
be introduced into sewers or placed in landfills.6
Approximately 5% of all pharmaceutical agents are
considered “RCRA hazardous.”6 However, many
more pharmaceutical agents have RCRA-hazardous characteristics. One reason for this is due to
the fact that the RCRA hazardous pharmaceutical
agent list (Appendix A) has not been updated as
more agents have come to market. Recently, EPA
and some states have begun stricter enforcement
of RCRA and have levied significant corporate and
personal fines for noncompliance and negligence.
There is no statute of limitations on personal liability, and violations can involve prison sentences.8
Which waste is hazardous?
An environmentally sound approach to the complex issue of pharmaceutical waste management
has been hampered by the distinction between
medical waste (biohazardous, infectious waste
4
■
placed in the “red bag” waste stream) and hazardous waste (RCRA waste stream).12 Clearly defining pharmaceutical waste streams is the first step
toward effective management.
Nonhazardous pharmaceutical waste. Some
have considered that once the manufacturer’s
packaging is opened, any unused or partially used
product is nonhazardous pharmaceutical waste.13
Examples include unused or partially used vials,
ampuls, or bottles; unused or partially used i.v.
bags and tubing containing drugs; discontinued
medications that are not suitable for reuse; and
tablets and capsules that have been dropped or
spit out by a patient. Outdated drugs being discarded may be also be included in this category.6
Discontinued medications that patients have
brought from home and left are also considered
pharmaceutical waste that should be disposed of
in accordance with EPA, state, and Drug Enforcement Administration regulations.6
The impact of these types of pharmaceutical waste
on public health and the environment is unclear.
When permitted by both state regulations and
RCRA, this waste can be solidified and placed in a
landfill.14 However, a better management practice
is to have nonhazardous pharmaceutical waste
processed by a medical waste incinerator or a
properly permitted municipal waste incinerator.
An exception to this is i.v. solutions without drug
additives; these can be placed in sewer systems.
Disposal of devices used to administer nonhazardous medications, such as inhalers that use
propellants, is another consideration. In addition
to RCRA requirements, some states have regulations specific to the device and propellant used to
deliver drugs; these must be considered in establishing waste streams. In Nebraska, for example,
hospitals are required to either segregate inhaler
devices from the normal waste stream or puncture
and triple rinse the container before disposal in the
nonhazardous waste stream.
Hazardous pharmaceutical waste. As a starting
point for determining which pharmaceutical waste
is hazardous, RCRA definitions must be considered. Drugs deemed hazardous by federal EPA
regulations are categorized as “P list,” “U list,” or
M A N A G I N G P H A R M A C E U T I C A L WA S T E
“chemical (D-list) characteristic.”15 P-listed items
are considered acutely toxic (e.g., epinephrine,
phentermine, physostigmine, nicotine, nitroglycerin, and warfarin >3%); both the drug and the
container that held the drug are considered hazardous and must be disposed of in an RCRA-approved
container. U-listed items are considered toxic (e.g.,
phenol, lindane, choral hydrate, and selected antineoplastic waste). Items on the chemical characteristic list are pharmaceuticals that cause wastes
with any of the following characteristics: ignitability, corrosivity, reactivity, and toxicity. Ignitability
applies to an aqueous solution that contains 24%
alcohol or more by volume and has a flash point
less than 140 degrees F (e.g., rubbing alcohol,
topical preps, benzoin, paclitaxel). Corrosivity
applies to an aqueous solution having a pH of 2
or lower (acidic) or of 12.5 or higher (basic) (e.g.,
chemicals used for compounding, such as glacial
acetic acid and sodium hydroxide). Reactivity
applies to waste with properties that are normally
unstable and readily undergo violent changes without detonating; that react violently with water; or
that when mixed with water generate toxic gases,
vapors, or fumes in a quantity sufficient to cause
human and environmental harm (e.g., certain
nitroglycerin formulations, although some may be
considered exempt by individual states). Toxicity applies primarily to heavy metals that may be
above maximum concentration or regulatory levels
(e.g., barium, cadmium, selenium, thimerosal). It is
important to note that the diluent or preservative,
rather than the active ingredient, in a commercial
or compounded drug may be the culprit in regard
to RCRA regulations.
Determining the appropriate waste stream.
As new drugs are added to formularies, it is the
responsibility of each hospital to determine the appropriate waste stream for each new item. Clearly,
not all pharmaceutical waste is considered hazardous according to RCRA definitions. However,
RCRA does not adequately regulate a number of
hazardous drugs. Even if not classified as hazardous, some pharmaceutical wastes are dangerous to
the environment. For example, if a chemotherapy
i.v. bag has been hung but not completely used,
and if it can be separated from the patient-exposed
sharp without exposure of the employee, it should
5
■
be removed and disposed of as RCRA hazardous
waste. If chemotherapy residue cannot be removed
safely from the i.v. bag, it should be disposed of
in a trace chemotherapy container as infectious
chemotherapeutic waste.14
Pharmaceutical waste is considered dangerous if
it contains any of the following:
■
More than one P- or U-listed drug,
■
Chemotherapy agents,
■
Drugs meeting National Institute for Occupational Safety and Health (NIOSH) or Occupational Safety and Health Administration (OSHA)
criteria,
■
Drugs with LD50 (lethal dose in 50% of test
animals) less than or equal to 50 mg/kg,
■
Endocrine disrupters,
■
Immunosuppressants, and
■
Vitamins and mineral preparations with potential toxicity due to chromium, selenium, or
cadmium.
When hazardous drug waste is infectious, a double
hazard exists. Some states may require a separate
waste stream for infectious hazardous pharmaceutical waste. With the extra time and caution
required, this may be one of the most expensive
waste streams to manage. This waste must be
separated for proper handling by a RCRA-permitted incinerator.
Generator status and waste streams
Before implementing a formal waste stream
program, a facility must determine its “generator status.” RCRA defines a facility’s generator
status and the associated regulations according
to the amount and type of waste generated over
time. A large quantity generator (LQG) generates
more than 1000 kg/month of hazardous waste
or more than 1 kg/month of P-listed waste.6,16 A
small quantity generator (SQG) generates less
than 1000 kg/month but more than 100 kg/month
of hazardous waste, and no more than 1 kg/month
of P-listed waste, and accumulates less than 6000
kg of hazardous waste at any time.16 A conditionally exempt small quantity generator (CESQG)
generates no more than 100 kg/month of hazardous
M A N A G I N G P H A R M A C E U T I C A L WA S T E
waste and no more than 1 kg/month of P-listed
waste. Whether or not an organization notifies EPA
of its waste generation depends on the amount
of hazardous waste it generates. LQGs and SQGs
must have an EPA identification number. Knowing
the amount and type of waste generated, the facility can determine what improvements can be made
and whether new waste streams are warranted.
a variety of disposal methods.19 It was apparent
that the patients had not been properly educated
about pharmaceutical waste disposal. Pharmacies
had specific policies for expired or undispensed
pharmaceuticals but lacked uniform guidelines on
disposal. Only 5% of the 100 pharmacies surveyed
had consistent recommendations for their patients
on drug disposal.
The main waste streams that hospital pharmacists use to dispose of solid pharmaceutical waste
are (1) municipal incineration of pharmaceutical
packaging, empty/partial vials, empty/partial glass
and plastic bottles, ointments, and so forth, and (2)
incineration of chemotherapy sharps and chemotherapy soft waste in a medical waste incinerator.
Landfills are the ultimate destination of both of
these waste streams.
Pharmacists’ lack of awareness or understanding
of the cumulative effect of improperly disposed
pharmaceutical waste on human health and the
environment is an important challenge to be overcome.17 Educating health care professionals about
the issue, the relevant state and federal regulations, and the consequences of noncompliance will
go a long way toward promoting more effective
pharmaceutical waste management. Each health
care institution will need to make changes in its
processes for drug dispensing, administration,
wastage, return, and disposal.
RCRA regulates how these waste streams should
be used, and inappropriate use can have harmful
outcomes. Compliance with the regulations is a
best management practice for hazardous pharmaceutical waste. For example, the regulations state
that RCRA waste must be incinerated by a facility approved by EPA for managing this waste; a
company that normally incinerates or autoclaves
chemotherapy waste may not be set up to render
RCRA waste EPA-safe.
Compliance challenges
Fully complying with RCRA regulations will present both operational and financial challenges for
institutions.
Operational challenges. Processes that require
manual sorting of pharmaceutical waste are time
consuming, potentially dangerous to the sorter,
and labor intensive (for data entry and database
management as well as the actual sorting), and
they may not be in compliance with regulations.
Direct care providers’ general lack of knowledge
or misunderstanding of state and federal regulations is a potential contributor to noncompliance.17
Pharmacies need uniform guidelines for the safe
disposal of expired medications, and pharmacists
should include this information in routine patient
education.18 A survey of consumers and pharmacies about medication disposal habits revealed
6
■
Financial challenges. Complying with RCRA
regulations may place an additional financial burden on health systems. For example, newer, more
toxic pharmaceuticals may require more intensive
waste management. Changes in prescribing practices may place additional financial burden on
an institution due to additional wastes generated
from these changes. Also, institutions may face
fines for noncompliance. A facility that is not in
compliance with regulations for managing its listed
waste could be fined $32,500 per day. In addition,
failure to institute guidelines for proper segregation of waste and to educate staff about them
can be expensive, because processing costs vary
significantly by type of waste. Medical waste (red
sharps containers) costs 18 cents to 35 cents per
pound; chemotherapy waste (yellow containers),
$4 per pound; RCRA hazardous waste, $2 to $4 per
pound; and infectious hazardous waste, $4 to $8
per pound.
Potential solutions
New waste streams. For proper handling of hazardous pharmaceutical waste, health care organizations most likely will need to create additional
waste streams.17 All facilities must review their
current policies and procedures to ensure compli-
M A N A G I N G P H A R M A C E U T I C A L WA S T E
ance with state and federal pharmaceutical waste
management and environmental regulations.20
Computerization, automation, and bar-code scanning technology may be useful in the development
of safe and effective pharmaceutical waste management streams.
Smith8 has used diagrams to illustrate current and
potential waste streams. New pharmaceutical
waste management streams would include P-, U-,
and D-listed wastes; bulk and residue chemotherapy; chemotherapy spill clean-up materials; toxic
hazardous waste; ignitable hazardous waste; and
nonhazardous pharmaceutical waste. In addition,
infectious hazardous and compressed gas aerosols
should be considered as separate waste streams.
Ignitable hazardous waste should be segregated,
properly labeled, stored, transported, and disposed
of by a specialized broker and a federally permitted RCRA incineration firm.
Waste management team. An interdepartmental, multidisciplinary team could be formed to
be accountable for maintaining compliance with
RCRA and state regulations. By evaluating current
practices for compliance and potential harm, the
team could identify gaps in pharmaceutical waste
stream management and work quickly to resolve
them. The team could serve as the facility’s liaison
with the regional EPA office and possibly with the
state environmental or sanitary office and outside
consultants.
Online tools. Waste management companies have
made resources available on the Internet to assist
pharmacies in cost-effective and compliant segregation of waste streams. However, more comprehensive tools must be developed to meet the
needs of health care facilities across the nation.
Pharmaceuticals requiring special disposal can be
identified through online databases that enable
searches by NDC number and product or generic
name.8 Also available online are recommendations citing federal regulations and recommended
waste streams, state regulation alerts where the
state regulation is more stringent than the federal,
and risk management alerts based on professional
knowledge and experience.
7
■
Inventory management. To help control the
amount of hazardous pharmaceutical waste
generated, minimum inventory levels should be
maintained.16,21 Health care facilities should rotate
inventory and use the oldest stock first, minimize
amounts of unwanted or expired medications22
(original and repacked containers), use multidose
vials, prepare patient-specific oral syringes instead
of prepacks, centralize disposal of physicians’
samples, and avoid unnecessary prescriptions
(especially antibiotics). Items that do not require
special handling can go into the municipal trash or
sewer system (e.g., unit dose packaging for non-Plisted items, empty medication vials that contained
non-P-listed items, partially used nonhazardous
items). Empty containers of nonhazardous items
can also go in the trash.
Reverse distribution. Pharmacies can also minimize the amount of pharmaceutical waste by using
reverse distribution, in which unused but potentially usable pharmaceuticals are returned to the
manufacturer for credit.15 To facilitate this process,
EPA has determined that health care facilities do
not have to consider returned pharmaceuticals as
“discarded materials” and therefore do not have
to treat them as hazardous waste. The burden for
proper disposal thus shifts to the reverse distributor, which must comply with Return Industry Association (RIA) standards.15 Pharmaceutical waste
processed through reverse distribution does not
count toward a facility’s hazardous waste generator status.
State and county activity. Many states and some
counties have specific regulations that are much
more stringent than the federal RCRA regulations.
Facilities should contact their state EPA or regulatory body to learn what requirements apply.
EPA initiatives. EPA has at least four current
pharmaceutical waste initiatives. Two will specifically address pharmaceuticals that cannot be
disposed of in sewers.
Implementing a plan
Organizations that implement a comprehensive
pharmaceutical waste management plan can
realize several benefits. For example, the Joint
M A N A G I N G P H A R M A C E U T I C A L WA S T E
Commission Environment of Care Performance
Improvement Initiative23 reduces a facility’s EPA
liability and risk exposure to a minimum, protects
employees and patients, demonstrates responsible
care in dealing with hazardous substances and
hazardous wastes, and brings the organization
into compliance with several Joint Commission
standards.24 Standard EC.3.10 states, “The organization manages its hazardous materials and waste
risk” and “organizations must identify materials
they use that need special handling and implement
processes to minimize the risks of their unsafe use
and improper disposal.” Standard EC.9.10 states,
“The organization monitors conditions in the environment of care” and “establish and implement
processes for reporting hazardous materials and
waste spills, exposures, and other related incidents.” Standard EC.9.20 states, “The organization
analyzes identified environment of care issues and
develops recommendations for resolving them.”
Standard EC.9.30 states, “The organization improves the environment of care.”
Key points for implementation are as follows:
1. Hazardous waste storage accumulation sites
should be in the same locked area that houses
mercury, xylene, formaldehyde, and other
laboratory chemicals.
2. The maximum storage time should be 90 or
180 days, as determined by the facility’s waste
generator status.
3. Institutions should either contract with a
hazardous waste broker or develop internal
expertise in manifest preparation and land ban
preparation (preparing those agents that cannot
be disposed of in the landfill). The hazardous
waste manifest is a form that has both EPA and
Department of Transportation (DOT) components. It is used to document tracking of hazardous waste from the generator through the
transporter to the final disposer. This manifest
also provides emergency response information
for use if a spill occurs in transit. Proper completion of a hazardous waste manifest requires
knowledge of the contents of each container
of waste, as well as specific DOT training to
ensure that proper shipping names are used.
There are two approaches to manifesting
8
■
hazardous waste: profiling and lab packing. In
most states, hospitals can provide their vendor with a list of all P, U, and chemical (D-list)
waste codes being generated and the vendor
can precertify the list and create a waste profile.
All possible waste codes will be listed on the
manifest for a particular waste stream. This is
the simpler, more time-efficient approach. Otherwise, the nursing and pharmacy staffs need to
document what is discarded in each container
to be able to include all the appropriate waste
codes on the manifest; this is lab packing.
Hazard classes, such as ignitable and toxic, may
be mixed when waste profiling is used, but they
cannot be mixed in lab packs. Mixing of hazard
classes is dependent on the capabilities of your
vendor. A Land Disposal Restrictions form
must accompany the manifest. This document
indicates what wastes are being disposed of and
how they will be treated prior to application to
the land; it also ensures compliance with RCRA.
The hazardous waste vendor can prepare this.
For all of these services, facilities have the option of contracting with a federally permitted
RCRA hazardous waste incineration facility or
TDSF (treatment, storage, and disposal facility).
4. Nonhazardous drugs should be segregated
into non-red and non-yellow containers that
are labeled “Nonhazardous Pharmaceutical
Waste—Incinerate Only” and are disposed of at
a regular medical waste or municipal incinerator that is permitted to accept nonhazardous
pharmaceutical waste. Nonhazardous drugs and
municipal solid waste that can be disposed of
in sewers should not be placed in any container
that requires special incineration.
5. For the disposal of controlled substances, the
practice of two health care professionals witnessing the waste should continue unchanged.
(Needles and empty syringes used to administer
controlled substances are discarded in a sharps
container.)
Monitoring compliance
Some hospitals have posted a quick reference
guide near disposal areas to help staff comply with
pharmaceutical waste disposal practices. Logging
each item placed in the hazardous waste container
M A N A G I N G P H A R M A C E U T I C A L WA S T E
also helps ensure compliance with EPA and other
federal or state requirements; the log should include the date, name of the product, estimated
amount deposited in the container, and the initials
or name of the person disposing of the waste and
person hauling it away. To get started and keep
compliance on the right path, the facility might
choose to use a hazardous waste broker.
Key points for monitoring compliance are as follows:
1. Be prepared, in case EPA or the state agency
makes an unannounced visit.
2. Promote waste minimization whenever possible.
3. Perform periodic random audits to determine
level of compliance.
4. Check and verify staff knowledge of program
details.
5. Check waste containers to see if drugs are discarded appropriately.
6. Track quantities of waste generated by type and
location.
7. Track costs.
8. Document the entire process, including all policies and procedures, training and competency
assessment efforts, and the results of quality
assurance audits, for use during state and
federal audits.
For full compliance with a pharmaceutical waste
management program, it is vitally important to
ensure that all medications are disposed of in
the proper waste stream. Key points include the
following:
1. Flush nonhazardous liquid pharmaceuticals into
the sewer system, or, as best management, send
them to a medical waste incinerator or appropriately permitted municipal waste incinerator.
EPA is considering an initiative that will prevent
the placement of certain drugs in sewers.
2. Intravenous solutions: Leave the tubing attached
to the i.v. bag and clamp the tubing.
3. Free liquids: Avoid squirting free liquids into
hazardous waste containers.
4. If P-listed waste or infectious hazardous waste
is placed in the wrong container, then the whole
container becomes P or dual waste.
9
■
5. Compressed-container medications (aerosols)
must be separated for safety.
6. Infectious hazardous waste must be separated
from all other pharmaceutical waste, since it is
the most expensive type of waste to dispose of.
7. Hazardous waste containers must be closed at
all times except when waste is being added.
Enforcement
EPA is in the midst of an initiative to enforce
RCRA with regard to pharmaceuticals in the same
manner that has always been used for chemical
plants. In the past, health care institutions and
practitioners were given a “pass” on enforcing
rigorous disposal practices. That is no longer the
case. In addition, states such as California, Washington, Minnesota, and Florida have become more
active, and some states have regulations that are
more stringent than those of EPA.25 States are allowed to enact regulations that are more stringent
than federal regulations. It is the responsibility of
each facility to monitor waste stream management
compliance. Facilities should be aware that the
Joint Commission, Centers for Medicare and
Medicaid Services, state boards of pharmacy, and
the Drug Enforcement Administration can alert
EPA to violations. As problems are identified,
facilities should perform a gap analysis to understand and formally address each issue.
Conclusion
Regulatory involvement and environmental concerns are causing pharmacists to take a closer
look at how their organizations are managing
pharmaceutical waste. Each organization should
evaluate its current waste management practices
in comparison with federal EPA and state regulatory guidelines. Organizations must then develop
a comprehensive plan for full compliance through
segregation of waste into the appropriate waste
streams. New interpretations or changes in existing regulations may arise as government surveyors and health care providers and administrators
exchange information. Pharmacists can play a
significant role in reducing medication waste and
solving the pharmaceutical waste disposal problem.
M A N A G I N G P H A R M A C E U T I C A L WA S T E
References
1.
Daughton CG. Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human
health. II. Drug disposal, waste reduction, and future directions.
Environ Health Perspect. 2003;111(5):775–85.
2.
Daughton C. Introduction—Environmental stewardship of pharmaceuticals: the green pharmacy. U.S. Environmental Protection
Agency, National Exposure Research Laboratory, Environmental
Sciences. web.archive.org/web/20030627025308/www.epa.gov/esd/
chemistry/ppcp/greenpharmacy-intro.htm (accessed 2007 July 14).
13. Pai MP, Graci DM, Bertino JS. Waste generation of drug product
sample versus prescriptions obtained through pharmacy dispensing. Pharmacotherapy. 2000;20(5):593–5.
14. Pharmaceutical waste management issues and solutions. Vestara.
http://www.vestara.com/images/Issues_Solutions.pdf (accessed
2007 July 3).
15. Pharmaceutical waste in health care facilities. Hospitals for a
Healthy Environment. h2e-online.org/hazmat/pharma.html
(accessed 2007 September 5).
3.
Kolpin DW, Furlong ET, Meyer MY et al. Pharmaceuticals,
hormones, and other organic wastewater contaminants in
U.S. streams, 1999–2000: a national reconnaissance. Environ
Sci Technol. 2002;36(6):1202–11. http://pubs.acs.org/cgi-bin/
jtextd?esthag/36/6/html/es011055j.html.
4.
Lee KE, Barber LB, Furlong ET et al. Presence and distribution of
organic wastewater compounds in wastewater, surface, ground,
and drinking waters, Minnesota 2000–02, Reston, VA: U.S. Geological Survey; 2004.
17. Smith CA. Risk management of pharmaceuticals entering POTWs
and municipal landfills from routine hospital waste management
practices. www.keepantibioticsworking.com/new/resources_
library.cfm?refID=37598 (accessed 2007 July 3).
5.
Colborn T, Dumanoski D, Myers JP. Our stolen future: are we
threatening our fertility, intelligence, and survival? A scientific
detective story (with new epilogue by the authors). New York:
Penguin Group; 1997.
18. Pharmaceutical waste: disposing of unwanted medications. Minnesota Pollution Control Agency. www.pca.state.mn.us/oea/hhw/
pharmaceuticals.cfm (accessed 2007 July 3).
6.
Sheehan E, Wooliever P. Pharmaceutical waste: fish don’t need
anti-depressants. Pharmacology Associates, LLC.
7.
Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: a review of recent research data.
Toxicol Lett. 2002;131(1–2):5–17.
8.
Smith CA. Managing pharmaceutical waste. J Pharm Soc Wisc.
2002;6:17–22.
9.
Green S. Sewer disposal of pharmaceutical waste. Tri-Tac;
2003–07.
10. Kummerer K. Drugs in the environment: emission of drugs,
diagnostic aids and disinfectants into wastewater by hospitals
in relation to other sources—a review. Chemosphere. 2001;45
(6–7):957–69.
11. Resource Conservation and Recovery Act 42 U.S.C. s/s 6901 et seq
(1976). http://www.epa.gov/region5/defs/html/rcra.htm (accessed
2007 July 14).
12. Toxicological issues associated with PPCPs. Department of Toxic
Substances Control. www.dtsc.ca.goc/AssessingRisk/PPCP/PPCPTox.cfm (accessed 2007 July 15).
16. Managing pharmaceutical waste: a 10-step blueprint for health
care facilities in the United States. Hospitals for a Healthy Environment. www.premierinc.com/safety/topics/pharma-waste/downloads/h2e-pharma-blueprint-04-15-06.pdf (accessed 2007 July 14).
19. Kuspis DA, Krenzelok EP. What happens to expired medications?
A survey of community medication disposal. Vet Hum Toxicol.
1996;38(1):48–9.
20. Saljoughian M. Disposal of hazardous pharmaceutical waste. U.S.
Pharm. 2004;6:HS-22-HS-24.
21. Shafir W. Pharmaceutical waste: why is it an issue now? Environmental Protection Agency. www.wrppn.org/hospital/pdf/az/
07%20Pharms%20Waste%20(AZ).pdf (accessed 2007 July 3).
22. Reducing pharmaceutical waste from patient care settings. University of Minnesota. Minnesota Technical Assistance Program.
http://www.mntap.umn.edu/health/94-PharmWaste.htm (accessed
2007 July 14).
23. JCAHO Environment of Care Performance Improvement Initiative. Joint Commission. www.jcrinc.com/13519/ (accessed 23 July
2007).
24. The Joint Commission Standards. Section on Medication Management and Environmental Care. www.jointcommission.org
(accessed 30 July 2007).
25. Pharmaceutical waste management. Premier. www.premierinc.
com/quality-safety/tools-services/safety/topics/pharma-waste
(accessed 2007 July 2).
Appendix A
Environmental Protection Agency (EPA) Resource and Conservation and Recovery Act11
Regulated Pharmaceutical Wastes and Corresponding EPA Code Typea
P-LISTED
U-LISTED
EPA Code Regulated Agent
EPA Code Regulated Agent
P012
P042
P075
P081
P204
P188
P001
a
Arsenic trioxide
Epinephrine
Nicotine
Nitroglycerin
Physostigmine
Physostigmine salicylate
Warfarin >0.3%
U034
U035
U044
U058
U059
U075
U089
U122
U129
U150
This list is not all inclusive; items listed
may be additives to primary formulations.
10
■
Chloral hydrate
Chlorambucil
Chloroform
Cyclophosphamide
Daunomycin
Dichlorodifluoromethane
Diethylstilbestrol
Formaldehyde
Lindane
Melphalan
D-LISTED
U151
U010
U182
U188
U200
U201
U202
U205
U206
U237
U248
Mercury
Mitomycin C
Paraldehyde
Phenol
Reserpine
Resorcinol
Saccharine
Selenium
Streptozotocin
Uracil mustard
Warfarin <0.3%
M A N A G I N G P H A R M A C E U T I C A L WA S T E
EPA Code Regulated Agent
D004
D005
D022
D007
D024
D013
D009
D101
D011
Arsenic (5 mg/L)
Barium (100 mg/L)
Chloroform (6 mg/L)
Chromium (5 mg/L)
M-cresol (200 mg/L)
Lindane (0.4 mg/L)
Mercury (0.2 mg/L)
Selenium (1 mg/L)
Silver (5 mg/L)
««i˜`ˆÝÊÊ
*…>À“>ViṎV>Ê7>ÃÌiÊ>˜>}i“i˜ÌÊ>«Ê/œœ
Q (AVEYOUREADTHECURRENTREGULATIONSON
HAZARDOUSDRUGSANDWASTE
N /CCUPATIONAL3AFETYAND(EALTH!DMINISTRA
TION#ONTROLLINGOCCUPATIONALEXPOSURETO
HAZARDOUSDRUGS/3(!TECHNICALMANUAL
4%$!3ECTION6)#HAPTERHTTP
WWWOSHAGOVDTSOSTAOTMOTM?VIOTM?VI?
HTML
N 4ITLE#&20ARTˆ)DENTIlCATION
ANDLISTINGOFHAZARDOUSWASTEHTTP
WWWACCESSGPOGOVNARACFRWAISIDX?
CFR?HTML
N .ATIONAL)NSTITUTEFOR/CCUPATIONAL3AFETY
AND(EALTH.)/3(ALERTPREVENTINGOCCUPA
TIONALEXPOSURETOANTINEOPLASTICSANDOTHER
HAZARDOUSDRUGSINHEALTHCARESETTINGS
HTTPWWWCDCGOVNIOSHDOCS
N 2ESOURCE#ONSERVATIONAND2ECOVERY!CT
53#SSETSEQHTTPWWWEPA
GOVERGIONDEFSHTMLRCRAHTM
Q (ASYOURFACILITYCOMPLETEDA2#2!RISK
ASSESSMENTINCLUDINGACOMPREHENSIVE
mOWCHARTINGPROCESS
Q (ASYOURFACILITYCONDUCTEDAGAPANALYSIS
OFCURRENTPRACTICESANDCOMPAREDTHEM
TOFEDERALANDSTATEREGULATORYREQUIRE
MENTS
Q $OESYOURFACILITYHAVEAFORMALEDUCATION
PLANFORHAZARDOUSDRUGWASTEANDCORRE
SPONDINGWASTEMANAGEMENT
N
7RITTENPLANINPOLICY
N
/RIENTATIONPLANFORNEWEMPLOYEES
N #ONTINUOUSREVIEWOFNEWDRUGSADDEDTO
FORMULARIESINRELATIONTOhHAZARDOUSvSTATUS
ANDWASTESTREAMMANAGEMENT
Q (ASYOURFACILITYCOMPLETEDACOMPRE
HENSIVE2#2!HAZARDOUSMATERIALDRUG
INVENTORYCLASSIlCATIONPROCESS
Q $OYOUHAVEAFORMALMULTIDISCIPLINARY
TEAMTOOVERSEETHEMANAGEMENTOF
HAZARDOUSDRUGWASTE
££Ê
NÊ
Q $OESYOURFACILITYHAVEANOTIlCATIONSYSTEM
FORALERTINGALLEMPLOYEESTOHAZARDOUSDRUGS
N
0RINTEDSIGNS
N
3PECIALSTORAGEAREAS
N
3IGNAGEFORSTORAGEANDADMINISTRATIONAREAS
N
%LECTRONICNOTIlCATION
Q $OESYOURPHARMACYCURRENTLYSEGREGATE
HAZARDOUSDRUGS
N
#HEMOTHERAPYONCOLOGYDRUGSONLY
N
.)/3(LISTEDDRUGS
N &LAMMABLEDRUGSANDCHEMICALSSTOREDINA
lRERATEDCABINETEGBENZOINPACLITAXOL
CLINDAMYCINTOPICALSOLUTION
N #AUSTICANDREACTIVEDRUGSANDCHEMICALS
STOREDINSPECIALCABINET
N 2#2!CHARACTERISTICWASTE
Q $OESYOURFACILITYCURRENTLYSEGREGATE
PHARMACYWASTE
N 4RACECHEMOTHERAPYWASTESTREAMYELLOW
N %0!2#2!REGULATEDHAZARDOUSWASTESTREAM
BLACK
Q !REYOUPROPERLYSEGREGATINGBULKANDTRACE
CHEMOWASTEYELLOW
Q (AVEYOUASSESSEDYOURFORMULARYFOR0LISTED
5LISTEDAND2#2!CHARACTERISTICDRUGS
Q (AVEYOUESTABLISHEDASPECIALWASTESTREAM
FORYOURFORMULARY0LISTED5LISTEDAND2#2!
CHARACTERISTICDRUGS
Q !REYOUUSINGAREVERSEDISTRIBUTORFORUN
OPENEDUNUSEDPHARMACYWASTE
N $OYOUHAVEACOPYOFTHECERTIlCATEFROMTHE
REVERSEDISTRIBUTORSTATINGTHATITISABLETOTAKE
BACK0LISTEDAND5LISTEDWASTE
Q 7HATMETHODDOESYOURFACILITYUSETOMANAGE
THElNALDISPOSALOFPHARMACEUTICALWASTESCHE
MOTHERAPYWASTESAND53%0!2#2!WASTES
Q )SYOURCONTRACTEDINCINERATORVENDORFOR
0LISTEDAND5LISTEDWASTE53%0!2#2!
CERTIlED
Ê * , 1 / Ê 7 - / ``ˆÌˆœ˜>Ê,iÜÕÀViÃ
$AUGHTON#'4ERNES4!0HARMACEUTICALSANDPERSONAL
CAREPRODUCTSINTHEENVIRONMENTAGENTSOFSUBTLE
CHANGE %NVIRON(EALTH0ERSPECTSUPPL
n
$ISCUSSIONPAPERONPHARMACEUTICALDISPOSALTOSEWER
SYSTEMS7HITEPAPERPREPAREDBYTHE%MERGING
#ONTAMINANTS7ORKGROUPOFTHE3ANTA#LARA"ASIN
7ATERSHED-ANAGEMENT)NITIATIVE&EBRUARY
HTTPWWWBAYWISEINFOIMAGES7-)?0HARM?
7HITE?0APER?&INAL-ARCHPDF
%NDOCRINE$ISRUPTIING#HEMICALSHTTPEHORMONE
TULANEEDU
&OCUSONPHARMACEUTICALWASTE7ASHINGTON3TATE
$EPARTMENTOF%COLOGYWWWECYWAGOVPROGRAMS
HWTRPHARMACEUTICALSINDEXHTML
'UARDABASSI,0ETERSEN!/LSEN*%ETAL!NTIBIOTIC
RESISTANCEIN!CINETOBACTERR SPPISOLATEDFROM
SEWERSRECEIVINGWASTEEFmUENTFROMAHOSPITAL
ANDAPHARMACEUTICALPLANT !PPL%NVIRON-ICRO
BIOLn
(AZARDOUSWASTERELATEDPUBLICATIONS-INNESOTA
0OLLUTION#ONTROL!GENCYWWWPCASTATEMNUS
W
4HE*OINT#OMMISSIONWWWJOINTCOMMISSIONORG
.ATIONAL)NSTITUTEFOR/CCUPATIONAL3AFETYAND(EALTH
W
/CCUPATIONAL3AFETYAND(EALTH!DMINISTRATION
W
0HARMECOLOGYWWWPHARMECOLO
0OLLUTIONPREVENTIONSTRATEGIESFO
INDUSTRY3TATEOF-ASSACHUSE
ENVIROTAPUBSMEDSECTPDF
2#2!HOTLINE
2#2!ORIENTATIONMANUALWWW
GENERALORIENTAT
3AFERSOLUTIONS%FFECTIVELYMANA
WWWSAFERSOLUTIONSORGACCE
3TAPLES30ROZACANDPAINKILLERS
DRINKINGWATERCONTAINSTRACE
STUDYlNDS6ANCOUVER3UN.
3TATEOF&LORIDA0HARM7ASTE,IST
PHARMWASTE LISTSDEPSTATEm
53%NVIRONMENTAL0ROTECTION!
HAZARDOUSWASTEWWWEPAGO
MUNCPLHHWHTMACCESSED
53%NVIRONMENTAL0ROTECTION!GENCY0HARMACEUTICALS
ANDPERSONALCAREPRODUCTSWWWEPAGOVNERLESD
CHEMISTRYPHARMAACCESSED*ULY
6ESTARAWWWVESTARACOM
7ASTEREDUCTIONACTIVITIESFORHOSPITALS3TATEOF
#ALIFORNIAWWWCIWMBCAGOVBIZWASTEFACTSHEETS
HOSPITALHTMACCESSED*ULY
9OUNG$)MPROPERDISCARDOFTOXICDRUGSHURTSENVI
RONMENTLEADSTOlNES!M*(EALTH3YST0HARM
n
0HARMACEUTICALWASTEGUIDELINES5NIVERSITYOF
#
>}iÊ>˜`ÊÃÕ««œÀÌi`ÊLÞÊ>˜Êi`ÕV>̈œ˜>Ê}À>˜ÌÊvÀœ“Ê6iÃÌ>À>°
-*Ê`Û>˜Ì>}i
ÇÓÇÓÊ7ˆÃVœ˜Ãˆ˜ÊÛi˜Õi
i̅iÃ`>]Ê>Àޏ>˜`ÊÓän£{
ÊvÀiiÊÜiL‡L>Ãi`ÊVœ˜Ìˆ˜Õˆ˜}Êi`ÕV>̈œ˜Ê«Àœ}À>“Êi˜ÌˆÌi`
º*…>À“>ViṎV>Ê7>ÃÌiÊ>˜>}i“i˜Ì\ÊÃÃÕiÃÊ>˜`Ê"«Ìˆœ˜ÃÊvœÀÊi>Ì…Ê-ÞÃÌi“û
ˆÃÊ>ÃœÊ>Û>ˆ>Li°Ê/…iÊ«Àœ}À>“ÊV>˜ÊLiÊ>VViÃÃi`Ê>Ì …ÌÌ«\ÉÉÃޓ«œÃˆ>°>Å«°œÀ}É«…>À“>Ü>ÃÌi