PRESCRIPTION
OPIOIDS
Patient Options for
Safe and Effective
Disposal of Unused
Opioids
Report to Congressional Committees
September 2019
GAO-19-650
United States Government Accountability Office
______________________________________ United States Government Accountability Office
September 2019
PRESCRIPTION OPIOIDS
Patient Options for Safe
and Effective Disposal of
Unused Opioids
What GAO Found
The Food and Drug Administration (FDA), Drug Enforcement Administration
(DEA), and Environmental Protection Agency (EPA) recommend that patients
dispose of unused presciption opioids by bringing them to DEA-registered
collection sites or a DEA take-back event, or using mail-back programs. As of
April 2019, 70 percent of the U.S. population lived less than 5 miles from
permanent collection sites, which are often located at pharmacies. If collection
sites, take-back events, or mail-back programs are not feasible, FDA
recommends quickly and permanently removing the most dangerous prescription
opioids, such as hydrocodone and fentanyl, from the home by flushing them
down the toilet. For all other prescription opioids, the agencies recommend
disposal in the trash after mixing them with unpalatable substances, such as cat
litter. Commercial products to facilitate in-home disposal also exist, and FDA is
aware that patients may opt to use these products for disposal in the trash.
FDA Recommendations for Disposal of Unused Prescription Opioids
Available studies suggest that many patients are unaware of federally
recommended disposal methods or choose not to dispose of unused prescription
opioids. For example, five studies found that between one-quarter and three-
quarters of patients stored unused opioids for future use or had misplaced their
unused opioids. Further, federal data indicate that 85 percent of intentional
misuse occurs with the patient’s knowledge—for example, when a patient sells or
gives away unused prescription opioids. To educate and motivate patients to
dispose of unused opioids, FDA launched a public awareness campaign called
“Remove the Risk” in April 2019. Also, FDA and other stakeholders have created
educational materials for patients and providers on safe opioid disposal.
Why GAO Did This Study
In 2017, an estimated 11.1 million
Americans misused a prescription pain
reliever, which included opioids. This
misuse contributes to opioid abuse and
death, which has quintupled from 1999
to 2017; about 17,000 people died from
prescription opioid overdoses in 2017.
Government agencies and stakeholders
have attempted to address the potential
for misuse and abuse by facilitating safe
disposal of unused prescription opioids
and other drugs.
The SUPPORT for Patients and
Communities Act enacted in 2018
included a provision for GAO to review
patient disposal of unused opioids,
among other things. This report
examines (1) federally recommended
and other available methods patients
may use to dispose of unused
prescription opioids, and (2) what is
known about patients’ use of these
methods.
To do this work, GAO examined peer-
reviewed, academic literature on
outcomes for prescription opioid
disposal; reviewed federal agency
documentation; interviewed federal
agency officials, independent
researchers, and stakeholder group
representatives—such as those from
the
American Medical Association; and
analyzed DEA data as of April 2019 on
permanent drug collection sites. GAO
also interviewed representatives
of three
companies that manufacture
commercial in-home disposal products
and reviewed publicly available
documents about these products.
View GAO-19-650. For more information,
contact
James Cosgrove at (202) 512-7114 or
.
Highlights of GAO-19-650, a report to
congressional committees
Page i GAO-19-650 Patient Opioid Disposal
Letter 1
Background 4
Federal Agencies Recommend Take-Back Options as the
Preferred Disposal Method 9
Few Patients Use Federally Recommended Opioid Disposal
Methods; FDA and Others Have Taken Steps to Educate the
Public 17
Agency Comments 23
Appendix I GAO Contact and Staff Acknowledgments 24
Figures
Figure 1: Patient Use and Food and Drug Administration’s
Recommendations for Disposal of Prescription Opioids 10
Figure 2: Estimated Percentage of Population Living Less Than 5
Miles From a Drug Enforcement Administration (DEA)-
Registered Drug Take-Back Permanent Collection Site,
by State, April 2019 12
Figure 3: Ways People Obtained Opioids for Misuse in 2017
(percent) 20
Contents
Page ii GAO-19-650 Patient Opioid Disposal
Abbreviations
AMA American Medical Association
CDC Centers for Disease Control and Prevention
DEA Drug Enforcement Administration
EPA Environmental Protection Agency
FDA Food and Drug Administration
REMS risk evaluation and mitigation strategy
RCRA Resource Conservation and Recovery Act
SAMHSA Substance Abuse and Mental Health Services
Administration
SUPPORT Act SUPPORT for Patients and Communities Act
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Page 1 GAO-19-650 Patient Opioid Disposal
441 G St. N.W.
Washington, DC 20548
September 3, 2019
The Honorable Lamar Alexander
Chairman
The Honorable Patty Murray
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Frank Pallone Jr.
Chairman
The Honorable Greg Walden
Republican Leader
Committee on Energy and Commerce
House of Representatives
The Substance Abuse and Mental Health Services Administration
(SAMHSA) estimates that in 2017, 11.1 million people aged 12 or older
used a prescription pain reliever, which includes opioids, in a way not
intended by the prescriber.
1
Health care providers prescribe opioids to
treat chronic pain and after an acute medical event, such as a surgery, to
help patients manage pain while they heal.
2
Because patients may not
take all of the opioids that their providers prescribe, many possess excess
opioids that could be misused by the patient or someone else. This
misuse contributes to opioid abuse and can lead to overdoses.
Overdoses involving prescription opioids—hereafter referred to as
1
SAMHSA. Key Substance Use and Mental Health Indicators in the United States: Results
from the 2017 National Survey on Drug Use and Health, (2018). Misuse of prescription
opioids includes taking opioids in a manner or dose other than prescribed or taking opioids
for non-medical use. Abuse often starts as misuse of prescription opioids.
2
For the purposes of this report, we use the term opioids to refer to prescription opioid
pain relievers, such as hydrocodone or oxycodone, rather than illicit substances, such as
heroin. SAMHSA reports that in 2017, 97.2 percent of an estimated 11.4 million people
age 12 or older who misused opioids in the past year misused prescription opioids, and
2.8 percent of these people misused heroin only. Health care providers include
physicians, dentists, and mid-level practitioners (e.g., nurse practitioners or physician
assistants) who can be licensed, registered, or otherwise permitted to prescribe a
controlled substance.
Letter
Page 2 GAO-19-650 Patient Opioid Disposal
opioids—were five times higher in 2017 than in 1999, accounting for
about 17,000 deaths in 2017.
3
Federal, state and local government agencies, drug manufacturers,
communities, and others have attempted to address the potential for
misuse and abuse by identifying or providing safe, secure, and
convenient methods for disposing of unused, unneeded, or expired
opioids. However, there is no federal law or regulation imposing
requirements for how patients are to dispose of unused opioids.
The SUPPORT for Patients and Communities Act (SUPPORT Act)
included a provision for us to review options for patients to dispose of
unused opioids, including products intended to facilitate in-home
disposal.
4
In this report we describe:
1. The federally recommended and other available methods patients
may use to dispose of unused opioids, and
2. What is known about patients’ use of these methods to dispose of
unused opioids and examples of efforts to educate patients and
providers about opioid disposal.
To describe the methods that federal agencies recommend patients use
to dispose of unused opioids, we reviewed documentation and
interviewed officials from the three federal agencies that have authorities
related to the disposal of opioids—the Drug Enforcement Administration
(DEA), the Food and Drug Administration (FDA), and the Environmental
Protection Agency (EPA). We analyzed data from DEA as of April 2019
indicating the locations of permanent drug take-back collection sites in
conjunction with data from the U.S. Census Bureau’s population
estimates through 2017. We used these data to estimate the percentage
of the U.S. population living within varying distances of a permanent
3
Centers for Disease Control and Prevention (CDC), Prescription Opioid Data, accessed
June 13, 2019, https://www.cdc.gov/drugoverdose/data/prescribing.html.
4
Pub. L. No. 115-271, § 3032(d),132 Stat. 3894 (2018).
Page 3 GAO-19-650 Patient Opioid Disposal
collection site.
5
For all data used in these analyses, we reviewed related
documentation and conducted electronic testing and, based on these
steps, determined that the data were sufficiently reliable for our purposes.
To describe other disposal methods, we reviewed documents and studies
from vendors of three commercial in-home disposal products that patients
can use to help them dispose of prescription and nonprescription
medication in their home trash. We identified these products and
documents through stakeholder interviews, a related study, a patent
search using Google Patents, and a review of product websites.
6
Additionally, we conducted interviews with other stakeholders—including
researchers, a representative from the AmerisourceBergen Foundation,
and representatives from three companies that manufacture in-home drug
disposal products.
7
We asked these stakeholders about the effectiveness
of these other disposal methods at preventing misuse of opioids.
8
To describe what is known about which methods patients use to dispose
of unused opioids, we conducted interviews with stakeholders, such as
the Association for Accessible Medicines and the American Medical
Association (AMA), and reviewed results of SAMHSA’s 2017 National
5
We analyzed the most recent DEA and U.S. Census Bureau data available at the time of
our analysis. The U.S. Census Bureau’s American Community Survey 5-year estimates
are updated annually and are based on data collected continuously from a sample of
households during the entire 60-month period. We used the 5-year estimates rather than
1-year estimates because they are based on larger sample sizes and thus are more
reliable. To conduct this analysis, we calculated the distance between the central point of
each zip code and the nearest DEA-registered permanent collection site. For some zip
codes, depending upon whether their central point is located just within the distance
threshold or just beyond it, a portion of their population may be unintentionally included in
or excluded from the population subtotal and total, thus introducing a small degree of error
in the percentage calculation. The radius of each distance category was not limited by
state boundaries, and we chose these distance thresholds based on a review of available
information on convenient distances for accessing pharmacies.
6
Community Environmental Health Strategies LLC, Medicine Disposal Products: An
Overview of Products and Performance Questions, (2019). Community Environmental
Health Strategies is a consulting firm that prepared this report for the San Francisco
Department of the Environment.
7
We selected manufacturers of two products that are distributed in retail outlets and one
newer product that has not been broadly distributed.
8
The AmerisourceBergen Foundation is an independent not-for-profit charitable giving
organization established by the AmerisourceBergen Corporation to support health-related
causes that enrich the global community, including by supporting distribution of in-home
drug disposal products to communities.
Page 4 GAO-19-650 Patient Opioid Disposal
Survey on Drug Use and Health.
9
We also conducted a literature review.
Specifically, we performed a structured search of research databases—
such as Scopus, ProQuest, ProQuest Dialog, and Harvard Think Tank—
to identify literature published from January 1, 2009 through February
2019. In our search, we used a combination of terms such as “controlled
substance,” “disposal,” “drug,” and “prescription.” These searches
retrieved 846 results, of which 191 studies were selected by a librarian
based on general relevancy for further review. We selected 25 studies
based on the following criteria: if the study was published after January 1,
2014 and (1) presented findings that assessed the effectiveness of
certain methods for disposing of opioids and other medications, (2)
documented the quantity of unused opioids in the community, (3)
examined how patients disposed of unused opioids, or (4) evaluated
patient attitudes toward opioid disposal.
10
The findings from each
individual study are limited by the studies’ overall lack of national
representation and small patient populations; however, taken together,
we found that the methods and conclusions were sufficient for our
purposes. To describe examples of efforts to educate patients and
providers about opioid disposal, we interviewed officials from FDA and
the AMA and reviewed relevant documentation from each.
We conducted this performance audit from December 2018 to September
2019 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for
our findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our audit objectives.
Opioids, such as hydrocodone and oxycodone, can be prescribed to treat
both acute and chronic pain. Opioids can pose serious risks when they
are misused. These risks include addiction, overdose, and death. As a
9
The National Survey on Drug Use and Health collects data through interviews with U.S.
civilians who are not institutionalized. In the survey, respondents are asked about their
drug use, among other things. Based on these responses, SAMHSA estimates results for
the U.S. population. Results from the 2017 survey were the most recent data available at
the time of our analysis.
10
We selected studies published after January 1, 2014 because DEA’s final rule governing
disposal of controlled substances was released in 2014. See 79 Fed. Reg. 53,520, 53,548
(Sept. 9, 2014).
Background
Page 5 GAO-19-650 Patient Opioid Disposal
result, opioids are classified as controlled substances, which means that
their use and disposal are subject to additional oversight by DEA.
11
Some studies suggest that the majority of patients who received
prescriptions for opioids often do not use a large portion of the drugs
dispensed. A study that surveyed U.S. adults who had received opioids
found that approximately 60 percent of patients who were no longer using
the medication had unused opioids.
12
Two studies reported that over one-
half of patients did not use all of the opioids prescribed to them after
surgery; these studies found that patients reported leaving 15 to 20 pills
unused, representing 54 percent to 72 percent of the opioids they were
prescribed.
13
Another study on patient opioid use after a cesarean section
and thoracic surgery found that most patients, 83 percent and 71 percent
respectively, used less than half of the total opioids they were
prescribed.
14
There is no federal law or regulation imposing requirements for how
patients are to dispose of unused opioids. However, DEA, FDA, and EPA
all have authorities and initiatives related to patient disposal of opioids.
DEA regulations specify three take-back options that patients can opt to
use to dispose of their unused controlled substances: take-back events,
permanent collection sites, and mail-back programs. DEA hosts semi-
annual events called National Prescription Drug Take-Back Days, where
11
Controlled substances are regulated under the Controlled Substances Act, which is
enforced by DEA. See Pub. L. No. 91-513, tit. III, 84 Stat. 1236, 1242-84 (1970) (codified,
as amended, at 21 U.S.C. § 801 et seq.).
12
A. Kennedy-Hendricks et al., “Medication Sharing, Storage, and Disposal Practices for
Opioid Medications Among US Adults,” JAMA Internal Medicine, vol. 176, no. 7 (2016): p.
1027-1029.
13
M. V. Hill et al., “Wide Variation and Excessive Dosage of Opioid Prescriptions for
Common General Surgical Procedures,” Annals of Surgery, vol. 265, no. 4 (2017): p. 709-
714 and B. C. Maughan et al., “Unused Opioid Analgesics and Drug Disposal Following
Outpatient Dental Surgery: A Randomized Control Trial,” Drug and Alcohol Dependence,
vol. 168 (2016): p. 328-334.
14
K. Bartels et al., “Opioid Use and Storage Patterns by Patients after Hospital Discharge
following Surgery,” PLoS ONE, vol. 11, no. 1 (2016).
Federal Authorities
DEA
Page 6 GAO-19-650 Patient Opioid Disposal
temporary collection sites are set up in locations such as police stations.
15
Advertisements encourage community participation in the events and
educate the community on safe disposal of unused medications, including
opioids. DEA also registers collectors and provides information to the
public about the location of permanent collection sites for take-back, such
as at local retail pharmacies or hospital pharmacies, and sets
requirements for the provision of postage-paid envelopes that patients
can use to mail unused drugs to a collector for destruction.
16
DEA regulations establish a standard for the destruction of controlled
substances that applies to DEA registrants, which can destroy opioids on
patients’ behalf.
17
DEA registrants include pharmaceutical companies that
manufacture controlled substances, health care providers who prescribe
them, and pharmacies that dispense them. The standard for destruction
requires that controlled substances maintained or collected by DEA
registrants be rendered non-retrievable. This means that the physical and
chemical conditions of the controlled substance must be permanently
altered, thereby rendering the controlled substance unavailable and
unusable for all practical purposes. According to DEA, as of May 2019,
the only method currently used to meet this standard is incineration, and
DEA rulemaking states that DEA will not evaluate, review, or approve
methods used to render a controlled substance non-retrievable.
18
FDA has broad authority under the Federal Food, Drug, and Cosmetic Act
to evaluate whether a drug is safe and effective and ensure the benefits
of drugs outweigh the risks. FDA may require manufacturers to develop a
15
Federal, state, tribal, and local law enforcement may also collect unused controlled
substances through other take-back events, mail-back programs, or collection receptacles
located inside the law enforcement’s premises. See 21 C.F.R. §§ 1317.35 and 1317.65
(2018).
16
Under the Controlled Substances Act, all persons or entities that manufacture, distribute,
or dispense controlled substances are required to register with DEA, unless specifically
exempted. DEA regulates these entities to limit diversion and prevent abuse. DEA
registrants must receive authorization from DEA to collect controlled substances for
disposal. Authorized collectors may (1) receive and destroy mail-back packages; (2)
install, manage, and maintain collection receptacles located at their collection locations;
and (3) dispose of sealed inner liners from collection receptacles, including their contents.
21 C.F.R. § 1317.40(c) (2018).
17
A patient who receives a prescription for a controlled substance is not a DEA registrant
and therefore is not subject to this standard.
18
79 Fed. Reg. 53,520, 53,548 (Sept. 9, 2014). DEA regulations do not specify a test for
evaluating whether a method meets the non-retrievable standard.
FDA
Page 7 GAO-19-650 Patient Opioid Disposal
risk evaluation and mitigation strategy (REMS) for drugs with serious
safety risks, including the risk of abuse, to ensure that the benefits
outweigh the risks.
19
Under one REMS, for example, manufacturers of
opioids intended for outpatient use must make training available to health
care providers involved in the treatment and monitoring of patients who
receive opioids. The training must contain certain elements, including how
providers should counsel patients and caregivers about the safe use and
disposal of these opioids, among other things.
In October 2018, the SUPPORT Act authorized FDA to, at its discretion,
require specific packaging or disposal systems as a part of certain drugs’
REMS.
20
For drugs with a serious risk of overdose or abuse, FDA may
require the drug to be made available for dispensing to certain patients
with “safe disposal packaging” or a “safe disposal system” for purposes of
rendering the drug non-retrievable in accordance with DEA regulations.
21
Before imposing these requirements, FDA must consider the potential
burden on patient access to the drug and the health care delivery system.
As of May 2019, FDA had not imposed any REMS requirements using the
new SUPPORT Act authority.
Under the Resource Conservation and Recovery Act (RCRA), EPA has
authority to regulate the generation, transportation, treatment, storage,
and disposal of hazardous waste, including certain discarded opioids.
22
However, hazardous waste pharmaceuticals generated by households
are not regulated as hazardous waste even if the waste would otherwise
19
GAO has forthcoming work that examines risk evaluation and mitigation strategies.
20
Pub. L. No. 115-271, § 3032(a),132 Stat. 3894 (2018) (codified at 21 U.S.C. § 355-
1(e)(4)).
21
The SUPPORT Act also authorized FDA to require that certain drugs be made available
for dispensing in unit dose packaging, packaging that provides a set duration, or another
packaging system that FDA determines may mitigate serious risk of overdose or abuse.
On May 31, 2019, FDA issued a notice in the Federal Register soliciting comments about
unit dose packaging for opioids. 84 Fed. Reg. 25,283 (May 31, 2019).
22
A waste is "hazardous" under RCRA if EPA has specifically listed it as such by
regulation, or if it exhibits one of four hazardous characteristics (ignitability, corrosivity,
reactivity, or toxicity). See 40 C.F.R. § 261.3(a)(2)(2018). EPA may authorize states to
implement their own hazardous waste management programs in lieu of the federal
program as long as, among other things, the state programs are at least equivalent to the
federal program. Authorized states may implement regulations that are more stringent or
broader in scope than the federal regulations. 42 U.S.C. § 6926(b).
EPA
Page 8 GAO-19-650 Patient Opioid Disposal
be considered hazardous.
23
Opioids and other household waste
pharmaceuticals collected through a take-back option are also exempt
from most hazardous waste regulations, provided certain conditions are
met.
24
Some states and localities have imposed additional requirements
for pharmaceutical disposal, such as requirements for drug manufacturers
to manage or fund the disposal of collected household pharmaceuticals.
23
While a small percentage of pharmaceuticals discarded by households meet the
definition of hazardous waste under RCRA, EPA regulations specify that solid waste
generated by households, including pharmaceuticals, are not regulated as hazardous
waste. 40 C.F.R. § 261.4(b)(1) (2018) and 84 Fed. Reg. 5,816, 5,941 (Feb. 22, 2019) (to
be codified at 40 C.F.R. § 266.501(g)(7)). Household hazardous waste pharmaceuticals
are allowed to be disposed of as municipal solid waste when discarded by individuals at
their residences.
24
To meet the conditional exemption, collected household hazardous waste
pharmaceuticals must be: (1) managed in compliance with EPA’s prohibition on
discharging hazardous waste pharmaceuticals to a sewer system that passes through to a
public-owned treatment works; (2) collected, transported, stored, and disposed of in
compliance with all applicable DEA regulations for controlled substances; and (3)
destroyed by a method DEA has publicly deemed in writing to meet the non-retrievable
standard of destruction or combusted at one of five permitted types of hazardous waste
combustors. 84 Fed. Reg. 5,816, 5,945 (Feb. 22, 2019) (to be codified at 40 C.F.R. §
266.506). If these conditions are not met, it is the entity collecting the pharmaceuticals,
and not the consumer, that is subject to EPA’s hazardous waste regulations.
Page 9 GAO-19-650 Patient Opioid Disposal
According to DEA, FDA, and EPA, patients should use take-back options
to dispose of unused opioids, whenever feasible. Only if take-back
options are not feasible, FDA recommends flushing opioids on FDA’s
flush list down the toilet to remove them from the home as soon as
possible.
25
For opioids not on the flush list, the agencies recommend
placing the drugs in the household trash mixed with an unpalatable
substance.
26
(See fig. 1). Officials from FDA said that the primary goal of
these recommendations is to remove dangerous substances from the
home as soon as possible to reduce accidental poisoning, which also
may address issues related to intentional misuse. FDA officials explained
that the agency has not measured the effects of its recommendations for
disposing of opioids on opioid misuse, as of May 2019, because it is
difficult to establish a causal link between the recommendations and any
reductions in misuse.
25
See Environmental Health: Action Needed to Sustain Agencies’ Collaboration on
Pharmaceuticals in Drinking Water, GAO-11-346 (Washington, D.C.: Aug. 8, 2011) for
prior GAO work related to pharmaceuticals in drinking water.
26
FDA officials reported that these drug disposal recommendations were first developed
by the Office of the National Drug Control Policy in 2007.
Federal Agencies
Recommend Take-
Back Options as the
Preferred Disposal
Method
Federal Agencies
Recommend Take-Back
Options Whenever
Feasible, Followed by
Disposal Using the Toilet
or Trash
Page 10 GAO-19-650 Patient Opioid Disposal
Figure 1: Patient Use and Food and Drug Administration’s Recommendations for Disposal of Prescription Opioids
DEA, FDA, and EPA recommend using a take-back option as the
preferred method for patients to dispose of unused prescription opioids.
Under this method, patients can bring unused opioids to DEA’s semi-
annual take-back events or to DEA-registered permanent collection sites,
Take-Back Options
Page 11 GAO-19-650 Patient Opioid Disposal
or use mail-back to deliver opioids to a DEA-registered collector for
destruction. When patients use these take-back options, the drugs they
dispose of are ultimately incinerated, which is the only method that DEA
officials said is known to render the drugs non-retrievable, that is,
permanently and irreversibly destroyed.
Our analysis of DEA and U.S. Census Bureau data shows that as of April
2019, 71 percent of the country’s population lived less than 5 miles from a
permanent collection site, and in 42 states, at least half of the population
lived within 5 miles of a site. (See fig. 2). This number has increased
since our April 2017 report, when we found that about half of the country’s
population lived less than 5 miles away from a site.
27
Our analysis also
shows that 90 percent of the population lived within 15 miles of a site,
though in rural areas only 57 percent lived within 15 miles. In addition,
two studies found that patients were willing to bring unused opioids to a
take-back location as long as it was located within 5 to 8 miles of their
home address.
28
27
See GAO, Preventing Drug Abuse: Low Participation by Pharmacies and Other Entities
as Voluntary Collectors of Unused Prescription Drugs, GAO-18-25 (Washington, D.C.:
Oct. 12, 2017). Our analysis was limited to permanent DEA-registered collection sites that
use receptacles to collect unused prescription drugs from the public and does not include
disposal options provided by law enforcement agencies, which do not need to register with
DEA to collect controlled substances.
28
K. I. Stoddard et al., “Investigating Research Gaps of Pharmaceutical Take-Back
Events: An Analysis of Take-Back Program Participants’ Socioeconomic, Demographic,
and Geographic Characteristics and the Public Health Benefits of Take-Back Programs,”
Environmental Management, vol. 59 (2017): p. 871-884 and M. A. Kozak, “A Needs
Assessment of Unused and Expired Medication Disposal Practices: A Study From The
Medication Safety Research Network of Indiana,” Research in Social and Administrative
Pharmacy, vol. 12 (2016): p. 336-340.
Page 12 GAO-19-650 Patient Opioid Disposal
Figure 2: Estimated Percentage of Population Living Less Than 5 Miles From a Drug Enforcement Administration (DEA)-
Registered Drug Take-Back Permanent Collection Site, by State, April 2019
Note: We analyzed April 2019 data from DEA about the locations of non-law enforcement entities that
are authorized to install receptacles to collect controlled substances for disposal by the general
public. We also used 2017 U.S. Census Bureau population estimates to estimate, by zip code, the
portion of the population within certain distances of a permanent collection site.
Page 13 GAO-19-650 Patient Opioid Disposal
If take-back options are not feasible, FDA recommends flushing the
opioids on its flush list down the toilet, because a single dose can be fatal
to a child or a pet. Flushing is a permanent way to remove opioids from
the home.
29
FDA confirmed that as of June 2019, 11 of 14 drugs on the
flush list are opioids, which represents about three-quarters of the
approved opioid active ingredients intended for outpatient use (see
sidebar). Some portion of drugs that are flushed down the toilet ultimately
enter surface and wastewater streams. However, a 2017 FDA study on
the environmental impact of drugs listed on the flush list concluded that
flushing these opioids has negligible effects on the environment and
human health, particularly relative to the amount of opioids that are
excreted after taking them as prescribed, because not all of the drug is
metabolized.
30
(See text box for a summary of the effects of disposal
options on the environment.)
29
The flush list does not include antibiotics and hormones, which have known detrimental
environmental effects. See
https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-
should-know (accessed June 4, 2019). Opioids have been detected in wastewater
samples in the US, Canada, Europe, South America, and Asia. See Campos-Manas et al,
“Trends in Environmental Analytical Chemistry,” (2018).
30
U. Khan et al., “Risks Associated With the Environmental Release of Pharmaceuticals
on the U.S. Food and Drug Administration ‘Flush List’,” Science of the Total Environment,
vol. 609 (2017). This study did not examine the human and environmental impacts of
flushing drugs other than those on FDA's flush list.
Flushing
Food and Drug Administration’s Flush
List, as of May 2019
• Benzhydrocodone/Acetaminophen
• Buprenorphine
• Fentanyl
• Diazepam*
• Hydrocodone
• Hydromorphone
• Meperidine
• Methadone
• Methylphenidate*
• Morphine
• Oxycodone
• Oxymorphone
• Tapentadol
• Sodium Oxybate*
*These drugs are not opioids.
Source: Food and Drug Administration | GAO-19-650
Page 14 GAO-19-650 Patient Opioid Disposal
Source: GAO analysis of information from EPA and DEA | GAO-19-650
If an opioid is not on the FDA flush list and a take-back option is not
feasible, the agencies direct patients to take a series of steps to dispose
of their opioids in household trash by:
(1) mixing the drugs in an unpalatable substance such as dirt, cat
litter, or used coffee grounds,
(2) placing the mixture in a sealed container or plastic bag, and
(3) throwing the container in the trash.
An EPA official said that mixing the drugs with an unpalatable substance
is meant to deter misusers from searching through the trash to retrieve
the drugs. Disposal of opioids in the trash—either with an unpalatable
substance or in-home disposal product—removes them from the home,
but this option may not be permanent and the drugs still may be available
for misuse. Drugs that are disposed in the trash ultimately are introduced
to landfills, where they can escape landfill containment and enter
wastewater streams or ground water sources.
Environmental Effects of Disposal Options
The environmental impact of opioid disposal depends on the method used—take-back
options, flushing, or trash. According to Environmental Protection Agency (EPA) and
Drug Enforcement Agency (DEA) officials, disposal of drugs through take-back options
results in disposal by permitted incineration, which fully destroys the active form of the
drugs. EPA officials told us that flushing or placing opioids in the trash can introduce
active opioids into wastewater streams, groundwater, and surface waters.
Incineration of Drugs from Take-Back Options. Opioids disposed of using take-back
options are destroyed by incineration, which, according to DEA officials, is the only
method currently used to meet its non-retrievable standard for destruction. EPA officials
told us that based on data from DEA, the amount of household pharmaceutical waste
gathered and incinerated during DEA’s semi-annual take-back events is small compared
to the total amount of waste one incinerator burns on an average day. EPA officials
recommended take-back options as the preferred method of opioid disposal.
Flushing. Opioids enter the water supply when excreted by patients who take opioids as
prescribed and when patients intentionally flush unused opioids down the toilet. EPA
officials told us that most wastewater treatment facilities are not designed to eliminate
opioids from wastewater streams. Further, measureable concentrations of opioids have
been reported in surface and ground water sources around the world.
Trash. Disposal of unused opioids in the trash often introduces opioids into landfills.
Studies in scientific literature show that pharmaceutical ingredients have been observed
in the water that passes through landfills, called leachate. Similar to opioids that are
flushed, opioids in landfill leachate can end up in wastewater streams and other water
sources, according to EPA officials.
Household Trash
Page 15 GAO-19-650 Patient Opioid Disposal
FDA’s website notes the availability of commercial products for disposing
of unused opioids and other drugs in the home.
31
FDA officials stated
that, as of May 2019, the agency had not evaluated the effectiveness of
these products or made any recommendations related to their use, but
they are aware that patients may opt to use these products.
32
These
products, known as in-home disposal products, are proprietary
substances that patients can mix with their unused drugs, including
opioids, before disposing of them in the trash. In-home disposal product
vendors told us they sell or donate their products to pharmacies, local law
enforcement, and community groups, which then distribute them to
patients.
33
A representative from a group that distributes these products,
the AmerisourceBergen Foundation, noted that in-home disposal
products may be a convenient option for patients for whom take-back
options are not feasible, and marketing materials from a product vendor
instruct patients to use their product if a take-back option is not available.
Vendors indicate that their products can prevent misuse of opioids by
rendering drugs non-retrievable at home and by motivating patients to
dispose of unused opioids. According to DEA officials, rendering opioids
non-retrievable by using an in-home disposal product is challenging,
because the drugs have a variety of chemical and physical properties and
potencies. Furthermore, according to DEA officials, a lethal dose of
fentanyl can be as low as 250 micrograms in adults—and lower in
children—underscoring the importance of effective disposal.
Some vendors have presented evaluations of their commercial products.
A recent comprehensive review of eight in-home disposal products raised
concerns about the credibility of vendors’ evaluations and concluded that
additional independent laboratory analysis is needed to fully examine
product performance and assess how well these products achieve stated
31
See
https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-
should-know (accessed June 4, 2019).
32
The SUPPORT Act allows FDA to require as part of a REMS that certain drugs be
dispensed with safe disposal packaging or a safe disposal system for purposes of
rendering the drug non-retrievable in accordance with DEA regulations. Pub. L. No. 115-
271, § 3032(a),132 Stat. 3894 (2018) (codified at 21 U.S.C. § 355-1(e)(4)).
33
All three product vendors we spoke with said that all or nearly all of their sales are to
organizations that distribute products to patients rather than to patients themselves. For
example, one vendor representative said that the in-home disposal product is available to
patients for free at approximately 40 percent of all chain drugstores nationwide.
FDA Has Not Evaluated
Commercial Disposal
Methods
Page 16 GAO-19-650 Patient Opioid Disposal
goals.
34
Our review of evaluations from three vendors found that the
studies contained some inconsistencies and gaps in the evaluation
methods used, raising questions about the studies’ conclusions that the
products are effective for disposing of opioids.
• In some cases, studies included detailed, but inconsistent, methods.
For example, in four studies about one product, the researchers
concluded that the product deactivated most of an opioid dissolved in
water. However, one of the earlier studies reported that whole pills did
not dissolve in water, which could impact the results, but later studies
did not include similar data.
• In other cases, companies’ evaluations were summaries of results
that did not provide enough information to independently verify or
assess whether the products deactivate opioids and prevent misuse.
For example, one company’s research documents presented images
of a mixture as evidence that the drugs had degraded, rather than
results of a test measuring if drugs were still detectable.
• In addition, the studies included little information about the products’
effectiveness at treating mixtures of multiple drugs at the same time, a
scenario that stakeholders have referred to as “real world” use testing.
34
Community Environmental Health Strategies LLC, Medicine Disposal Products: An
Overview of Products and Performance Questions, (2019).
Page 17 GAO-19-650 Patient Opioid Disposal
Disposal methods—when patients use them promptly—remove unused
opioids from the home and therefore can be effective at reducing opioid
misuse. FDA officials said that the federally recommended methods for
disposing unused opioids are intended to remove these substances from
the home as soon as possible, and stated that as long as individuals
dispose of opioids promptly rather than storing them, then FDA has
achieved its goal.
However, the studies we reviewed suggest that most patients do not
dispose of unused opioids using a federally recommended method.
Specifically, three studies examined how patients disposed of unused
opioids and found that between 12 percent and 41 percent of patients
disposed of them using a federally recommended method.
35
For example,
one of the studies found that of 570 survey respondents who had unused
opioids, 12 percent of respondents reported using a take-back option, 14
percent reported that they flushed them down the toilet, and 6 percent
reported that they threw them in the trash after mixing with an unpalatable
substance.
36
35
M. V. Hill et al., “Wide Variation and Excessive Dosage of Opioid Prescriptions for
Common General Surgical Procedures,” 709-714 and A. Kennedy-Hendricks et al.,
“Medication Sharing, Storage, and Disposal Practices for Opioid Medications Among US
Adults,” 1027-1029 and M.J. Sabatino et. al., “Excess Opioid Medication and Variation in
Prescribing Patterns Following Common Orthopaedic Procedures,” Journal of Bone and
Joint Surgery, vol. 100-A, no. 3 (2018): p. 180-188.
36
Kennedy-Hendricks et al., “Medication Sharing, Storage, and Disposal Practices for
Opioid Medications Among US Adults,” 1027-1029.
Few Patients Use
Federally
Recommended
Opioid Disposal
Methods; FDA and
Others Have Taken
Steps to Educate the
Public
Few Patients Use
Federally Recommended
Methods to Dispose of
Unused Opioids
Page 18 GAO-19-650 Patient Opioid Disposal
Other studies we reviewed show that take-back options are often used to
dispose of drugs other than opioids. Two studies found that less than 10
percent of the catalogued drugs brought to DEA take-back days were
controlled substances, which included opioids, while another study
weighed drugs brought to take-back events and permanent collection
sites and reported less than 3 percent were controlled substances,
including opioids.
37
The same study found that annually, controlled
substances disposed of at take-back events and permanent collection
sites accounted for about 0.3 percent of those dispensed in the area, and
concluded that take-back events may have a minimal impact on reducing
the availability of unused opioids for misuse.
38
Studies indicate that patients who receive an in-home disposal product
may be more likely to dispose of unused opioids, but they may also be
less likely to use federally recommended options like take-back or
flushing. Two studies in our review found that patients who receive an in-
home disposal product have reported that they are more likely to dispose
of unused opioids than those who did not receive the product.
39
Use of in-
home disposal products—which may not be effective at permanently
destroying drugs—may deter patients from using federally recommended
options, like take-back, that have been proven effective. For example,
one of these studies found that only one of the 70 patients who received
37
DEA regulations prohibit authorized collectors from opening and cataloging the contents
of permanent collection receptacles. 21 C.F.R. § 1317.75(c) (2018). Evaluations of the
use and contents of collection receptacles are limited to receptacles maintained by law
enforcement agencies, which are not subject to this prohibition. We identified three studies
conducted in conjunction with law enforcement agencies that quantified the amount of
opioids collected via collection receptacles: C. S. Ma et al., “Drug Take Back in Hawai’i:
Partnership Between the University of Hawai’I Hilo College of Pharmacy and the Narcotics
Enforcement Division,” Journal of Medicine and Public Health, vol. 73, no. 1 (2014): p. 26-
30 and H. Stewart et al., “Inside Maine’s Medicine Cabinet: Findings From Drug
Enforcement Administration’s Medication Take-back Events,” American Journal of Public
Health, vol. 105, no. 1 (2015): p. e65-e71 and K. L. Egan et al., “From Dispensed to
Disposed: Evaluating the Effectiveness of Disposal Programs Through a Comparison with
Prescription Drug Monitoring Program Data,” The American Journal of Drug and Alcohol
Abuse, vol. 43, no. 1 (2017): p. 69-77.
38
K. L. Egan et al., “From Dispensed to Disposed,” 69-77.
39
C. M. Brummett , R. Steiger, M. Engelsbe, et. al., “Effect of an Activated Charcoal Bag
on Disposal of Unused Opioids After an Outpatient Surgical Procedure: A Randomized
Clinical Trial,” JAMA Surgery, (2019) and A. E. Lawrence, A.. J. Carsel, K. L. Leonhardt et
al., “Effect of Drug Disposal Bag Provision on Proper Disposal of Unused Opioids by
Families of Pediatric Surgical Patients: A Randomized Clinical Trial,”JAMA Pediatrics,
(Published online June 24, 2019).
Page 19 GAO-19-650 Patient Opioid Disposal
an in-home disposal product used a take-back option for disposal, despite
the study taking place in a state where we estimated that 77 percent of
the population lived less than 5 miles from a permanent collection site.
Studies indicate that patients are often unaware of federally
recommended disposal options. Three of the 25 studies we reviewed
suggest that many patients were not aware of federally recommended
methods for disposing of opioids.
40
For example, a study of cancer
patients who received opioid prescriptions reported that more than three-
quarters of these patients were unaware of proper opioid disposal
methods.
41
Another 2016 study of 1,032 patients found that nearly half of
the respondents did not recall receiving information on proper disposal
from pharmacists, medication packaging, or media outlets.
42
Studies also indicate that patients choose not to dispose of unused
opioids, and that they knowingly participate in the majority of opioid
misuse. Five of the studies we reviewed found that between one-quarter
and three-quarters of patients stored unused opioids for future use or had
misplaced their unused opioids.
43
For example, one of these studies
found that 49 percent of survey respondents kept or planned to keep
unused opioids for future use, and 14 percent were likely to let a family
member use their opioid medications in the future.
44
Federal data about
40
Kozak et al., “A Needs Assessment of Unused and Expired Medication Disposal
Practices,” 336-340 and Kennedy-Hendricks et al., “Medication Sharing, Storage, and
Disposal Practices for Opioid Medications Among US Adults,” 1027-1029 and J. Silvestre
et al., “Frequency of Unsafe Storage, Use, and Disposal Practices of Opioids Among
Cancer Patients Presenting to the Emergency Department,” Palliative and Supportive
Care, vol. 15 (2017): p. 638-643.
41
J. Silvestre et al., “Frequency of Unsafe Storage, Use, and Disposal Practices of Opioids
Among Cancer Patients Presenting to the Emergency Department,” 638-643.
42
Kennedy-Hendricks et al., “Medication Sharing, Storage, and Disposal Practices for
Opioid Medications Among US Adults,” 1027-1029
43
Hill et al., “Wide Variation and Excessive Dosage of Opioid Prescriptions for Common
General Surgical Procedures,” 709-714; Kennedy-Hendricks et al., “Medication Sharing,
Storage, and Disposal Practices for Opioid Medications Among US Adults,” 1027-1029; D.
D. Maeng et. al., “Unused Medications and Disposal Patterns at Home: Findings From a
Medicare Patient Survey and Claims Data,” Journal of the American Pharmacists
Association, vol. 56 (2016): p. 41-46; and M.J. Sabatino et. al., “Excess Opioid Medication
and Variation in Prescribing Patterns Following Common Orthopaedic Procedures,” 180-
188.
44
Kennedy-Hendricks et al., “Medication Sharing, Storage, and Disposal Practices for
Opioid Medications Among US Adults,” 1027-1029.
Page 20 GAO-19-650 Patient Opioid Disposal
the sources of misused opioids indicate that patients are complicit with
most misuse. SAMHSA estimates that 5 percent of people nationwide
who misused opioids in 2017 took these drugs from someone else
without asking. In contrast, SAMHSA estimates that 85 percent of opioid
misuse occurs with the patient’s knowledge or active participation, either
through the patient misusing his or her own prescription by taking the
drug for pain other than for which it was prescribed or by giving or selling
the prescribed opioids to another person. (See fig. 3).
45
Figure 3: Ways People Obtained Opioids for Misuse in 2017 (percent)
Note: “Other” sources for misused opioids include approximately 6 percent of misusers who bought
the opioids from a drug dealer or other stranger and about 5 percent who obtained them some other
way. These data are from the 2017 National Survey on Drug Use and Health, a nationally
representative survey that asks people about their drug use within the past year, among other things,
and includes a question about the source of the last opioids that a respondent misused. Misuse
occurs when a person uses a drug in a way not intended by the prescriber, such as a patient taking a
prescribed medicine to relieve pain other than the pain for which the drug was prescribed or taking a
prescription intended for another person.
45
SAMHSA, Key Substance Use and Mental Health Indicators.
Page 21 GAO-19-650 Patient Opioid Disposal
To motivate patients to use federally recommended methods to dispose
of unused opioids, FDA and some physician organizations have created
educational materials on safe disposal methods. For example, FDA
launched a public awareness campaign called “Remove the Risk” on April
25, 2019—complete with educational materials such as public service
announcements, social media posts, fact sheets, and other web-based
content.
46
AMA representatives reported that the AMA has provided
physicians with educational material on drug disposal and prescribing.
Specifically, AMA representatives told us that the association has
compiled a two-page document for physicians containing information
about drug disposal, links to DEA information on nearby permanent
collection sites and take-back events, and FDA guidance on safe disposal
of medications. This document included recommendations for physicians
to talk to patients about safe use of prescription opioids, remind patients
to store their medications in a safe place out of reach from children, and
have a conversation with patients about the most appropriate ways to
dispose of expired, unwanted, or unused opioids.
The AmerisourceBergen Foundation has also partnered with communities
to promote safe opioid disposal by providing education about take-back
options and commercial in-home disposal products to patients. A
representative from the Foundation explained that its Safe Disposal
Support Program provides non-profit organizations or municipalities with
commercial in-home disposal products, which then can be distributed free
of charge to other organizations, individuals, or households. It also
recommends that patients use take-back options when available. The
representative said that organizations are to demonstrate to patients how
these products work either through a brief in-person demonstration at an
event or through a video. According to the representative, these products
and demonstrations help people reflect on what is in their home and
needs to be disposed of, either using a product or a take-back option.
Despite such efforts, little is known about the extent to which
stakeholders’ efforts to educate the public are effective in increasing use
of federally recommended disposal methods. FDA officials said that they
are not aware of the extent to which providers are familiar with all
disposal methods or the extent to which providers discuss the importance
46
See
https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-o
utreach-toolkit (accessed June 11, 2019).
FDA and Others Have
Taken Steps to Educate
Patients and Providers
about Appropriate Opioid
Disposal
Page 22 GAO-19-650 Patient Opioid Disposal
of proper disposal with patients. As part of FDA’s REMS requirements for
outpatient opioids, manufacturers must make training available to health
care providers involved in the treatment and monitoring of patients who
receive opioids, which includes information about the need to
communicate with patients about disposal of unused drugs. FDA officials
said that opioid manufacturers must assess the effectiveness of their
REMS, including an assessment of prescribers’, other health care
providers including pharmacists’, and patients’ understanding of the key
risk messages conveyed through the educational materials. FDA expects
to receive the next REMS assessment with the results of these analyses
in 2020. The AMA has not been able to measure the effects of its
recommendations, but provided anecdotal feedback from its members
that many physicians do not consistently speak to their patients about
disposal.
FDA officials and AMA representatives indicated that in addition to
educating patients on opioid disposal methods, focusing efforts on
reducing the amount of unused opioids would be an effective approach
for reducing misuse and abuse. For example, FDA officials said that
adding packaging configurations that contain smaller quantities of certain
opioids could help prescribers to more carefully consider the amount of
opioid pain medication they prescribe.
47
This in turn may reduce the
number of unused opioids available in the home that could be
inappropriately accessed by family members or visitors, and could
potentially reduce the risk for misuse and abuse. Representatives from
the AMA explained that it and other organizations are working to provide
opioid prescribing resources and guidance to help physicians effectively
manage patients’ pain, which representatives said will reduce the number
of unused opioids available for misuse.
48
FDA officials and a researcher
also noted that dispensing opioids in packaging that makes it easy to
count the number of unused pills may help patients identify intentional
misuse.
47
On May 31, 2019, FDA issued a notice in the Federal Register soliciting comments
about unit-dose packaging for opioids. 84 Fed. Reg. 25,283 (May 31, 2019).
48
For example, CDC developed and published the CDC Guideline for Prescribing Opioids
for Chronic Pain to provide recommendations for the prescribing of opioid pain medication
for patients 18 and older in primary care settings. AMA representatives cautioned,
however, that opioid restriction policies have had unintended negative consequences on
substance use and pain care. Representatives from the AMA explained that it and other
organizations also provide resources and guidance to help physicians effectively screen
and refer patients for substance use disorders.
Page 23 GAO-19-650 Patient Opioid Disposal
The FDA and EPA provided technical comments on a draft of this report,
which we incorporated as appropriate; the DEA did not have comments.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Health and Human Services, the
Administrator of the DEA, the Administrator of the EPA, and other
interested parties. In addition, the report is available at no charge on the
GAO website at http://www.gao.gov.
If you or your staff members have any questions about this report, please
contact me at (202) 512-7114 or [email protected]. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. GAO staff who made key contributions to
this report are listed in appendix I.
James Cosgrove
Director, Health Care
Agency Comments
Appendix I: GAO Contact and Staff
Acknowledgments
Page 24 GAO-19-650 Patient Opioid Disposal
James Cosgrove, (202) 512-7114 or [email protected].
In addition to the contact named above, individuals making key
contributions to this report include Leslie V. Gordon (Assistant Director),
A. Elizabeth Dobrenz (Analyst-in-Charge), Sam Amrhein, Jieun Chang,
Diana Chung, Kaitlin Farquharson, and Dennis Mayo. Also contributing
were Giselle Hicks, Cynthia Khan, and Ethiene Salgado-Rodriguez.
Appendix I: GAO Contact and Staff
Acknowledgments
GAO Contact
Staff
Acknowledgments
(103180)
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