Methadone-Associated Overdose Deaths
Factors Contributing to Increased Deaths and Efforts to Prevent Them Gao ID: GAO-09-341 March 26, 2009Prescription drug abuse is a growing public health problem. In particular, methadone-associated overdose deaths--those in which methadone may have caused or contributed to the death--have risen sharply. Before the late 1990s, methadone was used mainly to treat opioid addiction but has since been increasingly prescribed to manage pain. Taken too often, in too high a dose, or with other drugs or alcohol, methadone can cause serious side effects and death. Methadone-associated overdose deaths can occur under several different scenarios, including improper dosing levels by practitioners, misuse by patients who may combine methadone with other drugs, or abuse--using the drug for nontherapeutic purposes. This report examines the regulation of methadone, factors that have contributed to the increase in methadone-associated overdose deaths, and steps taken to prevent methadone-associated overdose deaths. GAO reviewed documents, laws and regulations, data, and research from relevant state and federal agencies, including the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). GAO also interviewed federal officials, officials in five selected states, officials from professional associations and advocacy groups, and experts in pain management, addiction treatment, and forensic sciences.
Methadone is regulated as a controlled substance, under federal and state laws and regulations, when used for pain management and addiction treatment. When methadone is used for pain management, it is regulated under federal and state laws and regulations that apply to controlled substances generally and that do not impose requirements unique to methadone. For addiction treatment, however, federal and state laws and regulations impose additional requirements that are specific to the use of methadone in opioid treatment programs (OTP), which treat and rehabilitate people addicted to heroin or other opioids. GAO, however, only reviewed relevant state laws and regulations for five selected states. Although information on methadone-associated overdose deaths is limited, available data suggest that methadone's growing use for pain management has made more of the drug available, thus contributing to the rise in methadone-associated overdose deaths. Methadone prescriptions for pain management grew from about 531,000 in 1998 to about 4.1 million in 2006--nearly eightfold. Methadone has unique pharmacological properties that make it different from other opioids, and as a result, a lack of knowledge about methadone among practitioners and patients has been identified as a factor contributing to these deaths. DEA data suggest that abuse of methadone diverted from its intended purpose has also contributed to the rise in overdose deaths as the number of methadone drug items seized by law enforcement and analyzed in forensic laboratories increased 262 percent, from 2,865 in 2001 to 10,361 in 2007. Nonetheless, data and research from five states GAO reviewed suggest that the specific circumstances of these deaths are variable because of drug combinations and unknown sources of methadone. GAO identified selected efforts to prevent methadone abuse and overdose deaths that focused on education, safety, and monitoring. For example, to educate practitioners about using methadone for pain management and addiction treatment, SAMHSA is establishing a physician clinical support system for methadone. To improve safety, in 2006, the Food and Drug Administration (FDA) approved a revised label for methadone tablets that included new safety information regarding the use of methadone for pain and modified dosage instructions for those beginning pain management treatment with methadone. Additionally, to prevent diversion and abuse of controlled substances such as methadone, DEA reports that as of February 2009, 31 states have established prescription monitoring programs. Some officials and experts cautioned that any prevention efforts focused on methadone alone might unintentionally shift similar problems to a different drug. GAO received comments from the Department of Health and Human Services stating that FDA recently notified manufacturers of certain opioid drug products, such as methadone, that they must take certain steps to ensure that the benefits of these drugs continue to outweigh the risks. The Department of Justice provided GAO with technical comments.
GAO-09-341, Methadone-Associated Overdose Deaths: Factors Contributing to Increased Deaths and Efforts to Prevent Them
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
March 2009:
Methadone-Associated Overdose Deaths:
Factors Contributing to Increased Deaths and Efforts to Prevent Them:
GAO-09-341:
GAO Highlights:
Highlights of GAO-09-341, a report to congressional requesters.
Why GAO Did This Study:
Prescription drug abuse is a growing public health problem. In
particular, methadone-associated overdose deaths”those in which
methadone may have caused or contributed to the death”have risen
sharply. Before the late 1990s, methadone was used mainly to treat
opioid addiction but has since been increasingly prescribed to manage
pain. Taken too often, in too high a dose, or with other drugs or
alcohol, methadone can cause serious side effects and death. Methadone-
associated overdose deaths can occur under several different scenarios,
including improper dosing levels by practitioners, misuse by patients
who may combine methadone with other drugs, or abuse”using the drug for
nontherapeutic purposes.
This report examines the regulation of methadone, factors that have
contributed to the increase in methadone-associated overdose deaths,
and steps taken to prevent methadone-associated overdose deaths.
GAO reviewed documents, laws and regulations, data, and research from
relevant state and federal agencies, including the Drug Enforcement
Administration (DEA) and the Substance Abuse and Mental Health Services
Administration (SAMHSA). GAO also interviewed federal officials,
officials in five selected states, officials from professional
associations and advocacy groups, and experts in pain management,
addiction treatment, and forensic sciences.
What GAO Found:
Methadone is regulated as a controlled substance, under federal and
state laws and regulations, when used for pain management and addiction
treatment. When methadone is used for pain management, it is regulated
under federal and state laws and regulations that apply to controlled
substances generally and that do not impose requirements unique to
methadone. For addiction treatment, however, federal and state laws and
regulations impose additional requirements that are specific to the use
of methadone in opioid treatment programs (OTP), which treat and
rehabilitate people addicted to heroin or other opioids. GAO, however,
only reviewed relevant state laws and regulations for five selected
states.
Although information on methadone-associated overdose deaths is
limited, available data suggest that methadone‘s growing use for pain
management has made more of the drug available, thus contributing to
the rise in methadone-associated overdose deaths. Methadone
prescriptions for pain management grew from about 531,000 in 1998 to
about 4.1 million in 2006”nearly eightfold. Methadone has unique
pharmacological properties that make it different from other opioids,
and as a result, a lack of knowledge about methadone among
practitioners and patients has been identified as a factor contributing
to these deaths. DEA data suggest that abuse of methadone diverted from
its intended purpose has also contributed to the rise in overdose
deaths as the number of methadone drug items seized by law enforcement
and analyzed in forensic laboratories increased 262 percent, from 2,865
in 2001 to 10,361 in 2007. Nonetheless, data and research from five
states GAO reviewed suggest that the specific circumstances of these
deaths are variable because of drug combinations and unknown sources of
methadone.
GAO identified selected efforts to prevent methadone abuse and overdose
deaths that focused on education, safety, and monitoring. For example,
to educate practitioners about using methadone for pain management and
addiction treatment, SAMHSA is establishing a physician clinical
support system for methadone. To improve safety, in 2006, the Food and
Drug Administration (FDA) approved a revised label for methadone
tablets that included new safety information regarding the use of
methadone for pain and modified dosage instructions for those beginning
pain management treatment with methadone. Additionally, to prevent
diversion and abuse of controlled substances such as methadone, DEA
reports that as of February 2009, 31 states have established
prescription monitoring programs. Some officials and experts cautioned
that any prevention efforts focused on methadone alone might
unintentionally shift similar problems to a different drug.
GAO received comments from the Department of Health and Human Services
stating that FDA recently notified manufacturers of certain opioid drug
products, such as methadone, that they must take certain steps to
ensure that the benefits of these drugs continue to outweigh the risks.
The Department of Justice provided GAO with technical comments.
View [hyperlink, http://www.gao.gov/products/GAO-09-341] or key
components. For more information, contact Kathleen King at (202) 512-
7114 or kingk@gao.gov.
[End of section]
Contents:
Letter:
Background:
Methadone Is Regulated as a Controlled Substance and Subject to
Additional Requirements When Used for Addiction Treatment:
Increased Availability Combined with Lack of Knowledge and Abuse of
Diverted Methadone Have Contributed to Increasing Methadone-Associated
Overdose Deaths:
Education, Safety, and Monitoring Efforts to Prevent Methadone-
Associated Overdose Deaths Have Been Implemented by Government Agencies
and Other Organizations:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Comparison of Federal and Selected States' OTP
Regulations:
Appendix III: Data and Research regarding Methadone-Associated Overdose
Deaths in Five States:
Appendix IV: Comparison of Prescription Drug Monitoring Programs in
Four Selected States:
Appendix V: Comments from the Department of Health and Human Services:
Appendix VI: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Criteria for Take-Home Doses of Methadone:
Table 2: Methadone Distribution by Type of Business, 2002 to 2007:
Table 3: Top Five Drugs with Highest Percentage Increases in Analyzed
Drug Items Seized by Law Enforcement, 2001 to 2007:
Figure:
Figure 1: Number of OTPs by State That Have Been Certified by SAMHSA,
February 2009:
Abbreviations:
AMA: American Medical Association:
ARCOS: Automation of Reports and Consolidated Orders System:
CDC: Centers for Disease Control and Prevention:
CSAT: Center for Substance Abuse Treatment:
DEA: Drug Enforcement Administration:
FDA: Food and Drug Administration:
HARMD: Helping America Reduce Methadone Deaths:
HHS: Department of Health and Human Services:
KASPER: Kentucky All-Schedule Prescription Electronic Reporting System:
LAAM: levomethadyl acetate:
NDIC: National Drug Intelligence Center:
NFLIS: National Forensic Laboratory Information System:
ONDCP: Office of National Drug Control Policy:
OTP: opioid treatment program:
SAMHSA: Substance Abuse and Mental Health Services Administration:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 26, 2009:
The Honorable Edward M. Kennedy:
Chairman:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable John D. Rockefeller, IV:
Chairman:
Subcommittee on Health Care:
Committee on Finance:
United States Senate:
Prescription drug abuse is a serious and growing public health problem.
Drug overdoses, including those from prescription drugs, are the second
leading cause of unintentional injury deaths in the United States,
exceeded only by motor vehicle fatalities, according to the Centers for
Disease Control and Prevention (CDC).[Footnote 1] Of particular concern
is the sharp rise in methadone-associated overdose deaths--in which
methadone may have caused or contributed to the death.[Footnote 2] CDC
data show that from 1999 to 2005, the number of these deaths increased
more than fivefold, from 786 to 4,462, a rate higher than overdose
deaths associated with other prescription narcotics, such as oxycodone,
hydrocodone, and fentanyl.[Footnote 3]
Methadone has been approved by the Food and Drug Administration (FDA)
for the treatment of opioid addiction and pain, and it is relatively
inexpensive compared to other opioids.[Footnote 4] Methadone's unique
pharmacologic properties make it different from other opioids, so it
must be carefully administered. Particular vigilance is needed when
starting treatment and increasing dosages, regardless of whether
methadone is being used for addiction treatment or pain management. FDA
reports that side effects can include slow or shallow breathing,
dangerous changes in heartbeat, and death.
Until recently, methadone was primarily used in opioid treatment
programs (OTP) to treat and rehabilitate people addicted to such
opioids as heroin or certain prescription drugs.[Footnote 5] It works
as a replacement for such drugs by preventing withdrawal symptoms. Its
slow onset allows patients to be monitored as the drug takes effect,
and its 24-to 36-hour duration of action suppresses opioid withdrawal
symptoms with one daily dose. When used for addiction treatment,
methadone cannot be dispensed by a practitioner outside of an OTP.
Since the late 1990s, methadone has been increasingly prescribed by
practitioners[Footnote 6] to treat their patients' pain. However, while
a single dose suppresses opioid withdrawal symptoms for a day or more,
it generally relieves pain for 4 to 8 hours despite remaining in the
body much longer. Further, it may take 3 to 5 days to achieve full pain
relief, so dosage increases must be done more slowly than with other
opioids. As a result, patients may feel the need to take more methadone
before the previous dose has left the body. However, if taken too
often, in too high a dose, or with certain other medicines or
supplements, it may build up in the body to a toxic level. Variability
in methadone's absorption, metabolism, and relative pain relief potency
among patients requires a highly individualized approach to
prescribing. When used for pain management, methadone may be prescribed
by appropriately licensed and registered practitioners and obtained
through licensed and registered retail pharmacies.
Like many drugs, methadone can also be abused--that is, used for
nontherapeutic purposes or for purposes other than those for which it
was prescribed, and dangerous side effects or death can occur when
methadone is combined with other drugs or alcohol. Because of its
accepted medical use as well as its high potential for abuse and for
severe psychological or physical dependence, methadone is classified as
a Schedule II controlled substance under the Controlled Substances Act.
[Footnote 7]
Questions have been raised about the regulation of methadone for both
pain management and addiction treatment, as well as the factors
contributing to the increase in methadone-associated overdose deaths.
Such deaths can occur in a number of ways, including intentional
overdoses, or suicide, and accidental overdoses due to improper dosing
levels, abuse, or patient misuse, such as by combining methadone with
other drugs. While CDC collects limited information on overdose deaths
from state death certificates, there is no standard, nationwide method
to document detailed information about each death, such as the form or
source of the drug, nor is there a standard definition for a methadone-
associated overdose death, so state medical examiners and coroners
investigating these deaths may define and report them differently.
Defining methadone's role in a death is difficult because of
inconsistencies in determining and reporting causes of death, the
presence of other drugs in the deceased person's system, and a lack of
information about the deceased person's level of opioid tolerance. CDC
has also reported that it has been difficult to determine the extent to
which increases in methadone-associated overdose deaths have resulted
from specific prescribing practices, misuse by patients, diversion of
the drug such as by illegal sale, or other means.[Footnote 8]
To explore these issues, you asked that we further examine methadone-
associated overdose deaths. Specifically, we examined (1) the
regulation of methadone for pain management and addiction treatment,
(2) the factors contributing to the increase in methadone-associated
overdose deaths, and (3) the steps taken to prevent methadone-
associated overdose deaths.
To examine the regulation of methadone for pain management and
addiction treatment, we reviewed relevant provisions of the Controlled
Substances Act, implementing regulations, and federal case law. We
interviewed officials from the Drug Enforcement Administration (DEA)
and the Substance Abuse and Mental Health Services Administration
(SAMHSA), and we reviewed relevant agency policies. We also interviewed
officials and examined relevant codified statutes and regulations in
five selected states--Florida, Kentucky, Maine, New Mexico, and West
Virginia--to determine how these states regulate the use of methadone
for both pain management and addiction treatment. We chose these states
based on their meeting four of five criteria we selected, including
whether the state had one of the top 10 highest rates of increase in
methadone-associated overdose deaths from 1999 through 2004 and whether
there was research on methadone-associated overdose deaths in that
state.[Footnote 9] The findings from our review of these five states
cannot be generalized to any other state.
To determine the factors contributing to the increase in methadone-
associated overdose deaths, we interviewed officials from CDC, DEA,
FDA, the Office of National Drug Control Policy (ONDCP), and SAMHSA.
[Footnote 10] We also interviewed officials from relevant professional
associations and experts in pain management, addiction treatment, and
forensic science. In addition, we interviewed researchers and officials
in our five selected states regarding their views on what factors were
contributing to the increases in methadone-associated overdose deaths
in their states, and reviewed state data and studies. We reviewed
methadone poisoning death data from CDC's National Vital Statistics
System and relevant DEA data, including DEA data on methadone drug
items seized by law enforcement and analyzed in forensic laboratories.
We interviewed CDC and DEA officials to obtain information about the
reliability of their data, including quality control such as edit
checks, and any limitations of these databases. We determined that
these data were sufficiently reliable for use in this report, and
identified any limitations.
To identify steps taken to prevent methadone-associated overdose
deaths, we interviewed officials from CDC, DEA, FDA, ONDCP, and SAMHSA.
We also interviewed officials from relevant professional associations
and experts in pain management, addiction treatment, and forensic
science. We reviewed relevant studies and reports about efforts to
prevent methadone and other prescription drug overdose deaths. To
obtain additional information about prescription drug monitoring
initiatives, we examined relevant codified statutes and regulations in
our five selected states. We also interviewed officials in our five
selected states to learn about initiatives in their states to prevent
these deaths. However, we did not evaluate these efforts, and our
findings are not representative of all such efforts nor can they be
generalized to all states. (See appendix I for a detailed discussion of
our methodology.)
We conducted our work from November 2007 through February 2009 in
accordance with all sections of GAO's Quality Assurance Framework that
are relevant to our objectives. The framework requires that we plan and
perform the engagement to obtain sufficient and appropriate evidence to
meet our stated objectives and to discuss any limitations in our work.
We believe that the information and data obtained, and the analysis
conducted, provide a reasonable basis for any findings and conclusions.
Background:
Methadone, a long-acting opioid medication, is available as a liquid, a
solid tablet (5 and 10 mg), a rapidly dissolving wafer or diskette (40
mg), or a powder. Liquid methadone is most commonly used for addiction
treatment, while the 5 and 10 mg tablets are most often prescribed for
pain management. FDA considers methadone safe and effective for both
pain management and addiction treatment, although not all forms of
methadone are FDA approved for both of these purposes.
Use of Methadone for Addiction Treatment:
OTPs offer methadone maintenance treatment, including counseling, for
people addicted to heroin and certain prescription drugs. Daily doses
of methadone help normalize the body's neurological and hormonal
functions that have been impaired by the use of heroin or misuse or
abuse of other short-acting opioids. When starting treatment,
individuals go to an OTP daily to take their methadone dose under
observation, although patients may receive a single take-home dose for
a day that the clinic is closed for business. After a few months, they
may become eligible for unsupervised take-home doses. The National
Institute on Drug Abuse notes that 1 year is generally the minimum for
methadone maintenance treatment, and that some individuals will benefit
from treatment over several years. Buprenorphine and levomethadyl
acetate (LAAM) are also FDA-approved medications for treating opioid
addiction.[Footnote 11] When used for addiction treatment, methadone
must be dispensed by an OTP that is certified by SAMHSA and registered
with DEA.[Footnote 12] As of February 2009, about 1,200 OTPs were
operating nationwide, but not all states have OTPs.[Footnote 13] (See
figure 1.) OTPs are operated by private for-profit organizations,
private nonprofit organizations, hospitals, or government agencies.
Figure 1: Number of OTPs by State That Have Been Certified by SAMHSA,
February 2009:
[Refer to PDF for image: Map of the United States]
Indicated on the map are dots depicting a treatment facility within a
zip code.
Number of opioid treatment programs in each state:
Alabama: 20.
Alaska: 3.
Arizona: 29.
Arkansas: 3.
California: 147.
Colorado: 11.
Connecticut: 34.
Delaware: 7.
District of Columbia: 10.
Florida: 39
Georgia: 41.
Hawaii: 4.
Idaho: 1.
Illinois: 63.
Indiana: 14.
Iowa: 4.
Kansas: 6.
Kentucky: 9.
Louisiana: 8.
Maine: 10.
Maryland: 57.
Massachusetts: 49.
Michigan: 37.
Minnesota: 13.
Mississippi: 1.
Missouri: 10.
Montana: 0.
Nebraska: 3.
Nevada: 11.
New Hampshire: 9.
New Jersey: 36.
New Mexico: 8.
New York: 153.
North Carolina: 38.
North Dakota: 0.
Ohio: 15.
Oklahoma: 14.
Oregon: 14.
Pennsylvania: 64.
Rhode Island: 18.
South Carolina: 11.
South Dakota: 0.
Tennessee: 10.
Texas: 76.
Utah: 11.
Vermont: 7.
Virginia: 20.
Washington: 20.
West Virginia: 9.
Wisconsin: 15.
Wyoming: 0.
Source: SAMHSA.
Note: The total number of OTPs includes seven programs in Puerto Rico
and one in the Virgin Islands not listed on the figure.
[End of figure]
Use of Methadone for Pain Management:
FDA approved methadone for treating pain in 1947,[Footnote 14] but from
the early 1970s until the late 1990s the drug was primarily used for
treating addiction. In the mid-1990s, various national pain-related
organizations began to issue guidelines for treating and managing pain,
including using opioids to treat both cancer and noncancer pain. For
example, the practice guidelines issued by the Agency for Health Care
Policy and Research informed physicians and other health care
professionals about the management of acute pain in 1992 and cancer
pain in 1994.[Footnote 15] In 2001, health care providers and hospitals
were required to ensure that their patients received appropriate pain
treatment when the Joint Commission, a national health care facility
standards-setting and accrediting body, implemented pain standards for
hospital accreditation.[Footnote 16] At first, methadone was prescribed
more for the treatment of cancer pain, but it has been increasingly
prescribed for the treatment of chronic noncancer pain. Methadone's
advantages include that it costs less than other opioids used to treat
pain, and it comes in multiple forms.
Unlike methadone's use in addiction treatment where it generally must
be dispensed by OTPs, when used to treat pain methadone may be
prescribed by an appropriately licensed and registered practitioner and
dispensed by licensed and registered retail pharmacies. Licensed and
registered practitioners may also dispense methadone directly to
patients for pain management, but DEA officials said that it is not a
common practice.
Relevant Federal Agencies:
DEA, on behalf of the Attorney General of the United States, is the
agency primarily responsible for enforcing the Controlled Substances
Act.[Footnote 17] Under the act, controlled substances are classified
into five schedules based on the extent to which the drug has an
accepted medical use, and its potential for abuse and degree of
psychological or physical dependence.[Footnote 18] Schedule II
controlled substances--which include opioids such as morphine,
oxycodone, and methadone--have a currently accepted medical use and a
high potential for abuse, and may lead to severe psychological or
physical dependence. DEA's regulation of the manufacturing,
distribution, dispensing, and prescribing of controlled substances,
including Schedule II drugs, encompasses the following:
* Manufacturing. DEA limits the quantity of Schedule II controlled
substances that may be produced by each manufacturer in the United
States each year. DEA determines these quotas based on a variety of
factors, including disposal and inventories. DEA also sets aggregate
production quotas that limit the production of bulk raw materials used
to manufacture Schedule II controlled substances.
* Distribution. DEA regulates transactions involving the sale and
distribution of Schedule II controlled substances by manufacturers and
wholesale distributors. Manufacturers and distributors are required to
report their inventories of controlled substances to DEA, and these
data are available for monitoring the distribution of controlled
substances throughout the United States and identifying retail
registrants that received unusual quantities of controlled substances.
* Dispensing and prescribing. Practitioners who dispense, administer,
or prescribe controlled substances must obtain a valid registration.
SAMHSA is the lead federal agency addressing substance abuse and mental
health services. Its mission is to build resilience and facilitate
recovery for people with or at risk for substance abuse and mental
illness. SAMHSA's resources and programs are designed to expand service
capacity and improve service and infrastructure to address prevention
and treatment gaps. SAMHSA directly supports state and local service
systems and funds activities to improve practice through grants and
contracts. SAMHSA's Center for Substance Abuse Treatment provides
national leadership to expand the availability of effective treatment
and recovery services for alcohol and drug problems, and to improve
access, reduce barriers, and promote high-quality, effective treatment
and recovery services for people with substance abuse problems and
their families and communities.
Under federal law and regulations, drugs must be approved by FDA before
they can be marketed in the United States.[Footnote 19] The agency
reviews new drug applications to determine whether they provide
sufficient evidence that the drug is safe and effective for the
proposed use. In approving a drug, FDA may require that the drug be
dispensed only by a prescription by a licensed practitioner. Because
some risks may not become known until after a drug's approval and use
in a wider segment of the population, FDA has certain postmarket
oversight responsibilities once a drug is approved, such as assessing
sponsors' compliance with requirements for adverse event reporting. The
agency compiles data from sponsor reports on adverse events, and
voluntary reports submitted to its MedWatch program, a voluntary
reporting program through which health professionals and consumers can
report adverse reactions and other problems related to FDA-approved
drugs. In addition, as of 2008, if FDA identifies postmarket safety
concerns, the agency may take specific actions such as requiring drug
manufacturers to make safety-related changes to a drug's labeling and
requiring drug manufacturers to implement a Risk Evaluation and
Mitigation Strategy when necessary to ensure that the benefits of a
particular drug outweigh the risks.
Overdose Death Investigation and Reporting:
Death investigations in the United States are typically conducted by a
county, district, or state coroner system or a medical examiner system.
These systems investigate deaths due to external causes, such as injury
or poisoning; sudden and unexplained deaths; and deaths that occur
under medical care.[Footnote 20] Most coroners are elected, and they
may not be physicians. In contrast, medical examiners are usually
appointed and are, with few exceptions, required to be physicians and
are often pathologists or forensic pathologists.[Footnote 21]
The registration of deaths varies by state. Death certificates can be
completed by funeral directors, attending physicians, medical
examiners, or coroners and contain such information as the deceased
person's age, sex, and race; the circumstances and cause of death; and
the signature of the physician, medical examiner, or coroner. Each
disease, abnormality, injury, or poisoning that the medical examiner or
coroner believes contributed to the death generally is reported. The
original records are filed in state registration offices. Statistical
information is compiled in a national database through the National
Vital Statistics System by CDC's National Center for Health Statistics.
From these data, monthly, annual, and special statistical reports are
prepared for the United States and for cities, counties, states, and
regions by various characteristics, such as sex, race, and cause of
death. However, statistical data derived from death certificates can be
no more accurate than the information provided on the certificate. For
example, causes of death on the death certificate reflect a medical
opinion that might vary among the individuals completing the
certificates.
Methadone Is Regulated as a Controlled Substance and Subject to
Additional Requirements When Used for Addiction Treatment:
Methadone is regulated as a controlled substance, under federal and
state laws and regulations, when used for pain management and addiction
treatment.[Footnote 22] When methadone is used for pain management, it
is regulated under federal and state laws and regulations that apply to
controlled substances generally and that do not impose requirements
unique to methadone. For addiction treatment, however, federal and
state laws and regulations impose additional requirements that are
specific to the use of methadone.
When Used for Pain Management, Methadone Is Regulated as a Controlled
Substance under Federal and State Laws and Regulations:
The use of methadone for pain management is regulated under federal and
state laws and regulations that apply to controlled substances
generally and that do not impose requirements unique to methadone. DEA
has certain authorities, under the Controlled Substances Act, to
regulate the use of methadone for pain management, as part of its
oversight for controlled substances.[Footnote 23] For example,
practitioners must register with DEA in order to dispense, administer,
or prescribe Schedule II through V controlled substances.[Footnote 24],
[Footnote 25] The Controlled Substances Act and implementing
regulations also require that Schedule II controlled substances,
including methadone, only be dispensed by pharmacists upon a written
prescription,[Footnote 26] which must be issued for a legitimate
medical purpose by registered practitioners acting in the usual course
of professional practice.[Footnote 27] In addition, DEA uses its data
on the distribution of methadone and other controlled substances to
identify retail-level registrants, such as pharmacies, that receive and
dispense unusual quantities of these drugs. Under these authorities,
DEA may take action against practitioners that fail to prescribe or
dispense controlled substances, including methadone, for legitimate
medical purposes, one sanction of which is suspension or revocation of
DEA registration.[Footnote 28]
The use of methadone for pain management is also regulated under state
law and regulations that apply to controlled substances generally. In
the states we reviewed, some of these requirements were similar to
provisions of the federal Controlled Substances Act. For example, these
states require, in general, that Schedule II controlled substances may
only be dispensed by pharmacists upon a written prescription of a
practitioner.[Footnote 29] States also may impose requirements beyond
what is required under the federal Controlled Substances Act. For
example, officials in Maine said that they require the use of
tamperproof prescription notepads when writing prescriptions for
Schedule II drugs. However, none of the laws and regulations in the
five states we reviewed had any provisions specific to methadone when
used for pain management other than provisions that generally apply to
all Schedule II controlled substances.
Because states regulate the practice of medicine and pharmacy,
controlled substances that are prescribed, administered, or dispensed
by state-licensed practitioners are also generally regulated under
these state laws and regulations. For example, in the states we
reviewed, physicians must be licensed by their state boards of medicine
in order to engage in the practice of medicine, which includes the
prescribing of drugs.[Footnote 30],[Footnote 31] Similarly, pharmacists
must be licensed by their state boards of pharmacy in order to engage
in the practice of pharmacy, which includes the dispensing of
prescription drugs.[Footnote 32] Under this authority, the state
medical boards and state boards of pharmacy oversee the regulation of
the practice of medicine and pharmacy, respectively. As part of this
oversight, these boards or other related state agencies may investigate
complaints about practitioners, discipline practitioners that violate
applicable laws or regulations, and facilitate rehabilitation of
practitioners when appropriate.
States and professional licensing boards may further regulate the
prescribing or dispensing of controlled substances for the treatment of
pain. According to the Federation of State Medical Boards, a number of
states have implemented standards for the use of controlled substances
for pain, including the five states we reviewed. Some of these states
have based these standards on the model policy for use of controlled
substances for the treatment of pain published by the Federation of
State Medical Boards. For example, Florida law expressly provides that
physicians may prescribe or administer controlled substances for the
treatment of intractable pain.[Footnote 33] Under its regulations,
Florida's Board of Medicine and Board of Osteopathic Medicine also
impose standards that include steps physicians must take prior to
prescribing controlled substances for pain.[Footnote 34]
When Used for Addiction Treatment, Methadone Is Subject to Additional
Requirements under Federal and State Laws and Regulations:
Although methadone is subject to federal and state requirements that
apply to controlled substances, there are additional requirements
specific to methadone when used for addiction treatment.[Footnote 35],
[Footnote 36] For example, as part of its enforcement responsibilities
under the Controlled Substances Act, DEA has the authority to regulate
the use of methadone for addiction treatment. Under the act, OTPs must
register with DEA in order to dispense or administer methadone for
addiction treatment, and there are three conditions for this
registration.[Footnote 37] Under the first condition of this
registration, DEA must determine that the OTPs will appropriately
secure stocks of methadone and maintain appropriate records.[Footnote
38] DEA officials informed us that they also inspect OTPs in order to
ensure that OTPs are maintaining proper security, safety, and storage
of methadone and other narcotic drugs used for addiction treatment. DEA
officials said that inspections are conducted every 3 years, and there
are a series of graduated penalties if OTPs are not in compliance,
including suspension or revocation of OTP registration. If DEA suspends
or revokes a registration, that OTP would be unable to purchase,
administer, or dispense methadone to OTP patients for addiction
treatment.
As a second condition of DEA registration for OTPs, SAMHSA must
determine that OTPs are qualified to engage in methadone maintenance
treatment for addiction.[Footnote 39] Federal opioid treatment
regulations define SAMHSA's standards for determining whether OTPs are
qualified.[Footnote 40] Specifically, such standards include requiring
OTPs to obtain a current, valid certification from SAMHSA to dispense
methadone for addiction treatment. To obtain certification, an OTP must
have a current, valid accreditation by an accreditation body, such as
the Joint Commission or other entity designated by SAMHSA. An OTP also
must comply with a number of other requirements for certification
established by SAMHSA. These other requirements include maintaining a
diversion control plan that contains specific measures to reduce the
possibility of diversion of methadone from legitimate treatment to
illicit use and ensuring that all licensed professional care providers
comply with the credentialing requirements of their respective
professions.
The third condition of DEA registration for OTPs requires SAMHSA to
determine that OTPs will comply with standards regarding unsupervised
take-home doses of methadone.[Footnote 41] SAMHSA has established
specific criteria for unsupervised take-home doses of methadone under
federal regulations for OTPs.[Footnote 42] (See table 1.) These
criteria were established to limit the potential for diversion of
methadone to illicit uses. OTPs are also required to maintain
procedures for take-home doses of methadone that will allow
identification of the theft or diversion of these doses, such as by
labeling containers with the OTP's name, address, and telephone number.
For additional information on select aspects of the federal regulations
relating to OTPs, see appendix II.
Table 1: Criteria for Take-Home Doses of Methadone:
Criteria used to determine whether a patient is responsible in handling
opioid drugs for unsupervised use:
1. Absence of recent abuse of drugs, including alcohol;
2. Regularity of OTP clinic attendance;
3. Absence of serious behavioral problems at OTP;
4. Absence of known recent criminal activity (e.g., drug dealing);
5. Stability of the patient's home environment and social
relationships;
6. Length of time in comprehensive methadone maintenance treatment;
7. Assurance that take-home medication can be safely stored within the
patient's home;
8. Whether the rehabilitative benefit derived from decreasing the
frequency of OTP attendance outweighs the potential risks of diversion.
Source: SAMHSA regulations at 42 C.F.R. 8.12 (h)(4)(i)(2).
[End of table]
States may also regulate the use of methadone for opioid addiction
treatment under state laws and regulations, which may be equal to or
stricter than federal standards.[Footnote 43] For example, while
federal regulations do not specify the days or hours that OTPs must be
open, regulations in three of the states we reviewed--Kentucky, Maine,
and West Virginia--require that OTPs be open 7 days a week.[Footnote
44] Further, states may implement drug testing requirements that are
stricter than the federal standard of at least eight random drug abuse
tests per year for each patient in maintenance treatment. For example,
in Maine, drug tests on OTP patients must be conducted at least every
30 days unless the individual treatment plan indicates that drug
testing should be done more frequently. Appendix II compares OTP
regulations in the five states we reviewed.
Each state with OTPs also has a state agency or official designated to
oversee opioid treatment in that state. Each of the five states we
reviewed had an official designated as the state methadone authority or
state opioid treatment authority, although responsibilities for this
position varied and these officials had other duties in addition to
responsibilities in overseeing the state's OTPs. For example, a state
official told us that the primary responsibilities of the State
Methadone Authority in West Virginia were to approve or disapprove OTP
patients' requests for exceptions to methadone take-home policies and
to receive and refer patient appeals and grievances to the designated
state oversight agency. In contrast, in addition to approving or
disapproving take-home exception requests, a state official explained
that the State Opioid Treatment Authority in New Mexico has initiated
activities such as site audits of the eight existing OTPs in the state
to ensure compliance with state regulations. These officials also have
quarterly conference calls with SAMHSA and their counterparts from
other states to discuss issues regarding OTPs and best practices.
Increased Availability Combined with Lack of Knowledge and Abuse of
Diverted Methadone Have Contributed to Increasing Methadone-Associated
Overdose Deaths:
Although information on methadone-associated overdose deaths is
limited, available data suggest that methadone's growing use for pain
management has increased availability of the drug, therefore
contributing to the rise in methadone-associated overdose deaths. Lack
of knowledge about the drug's unique pharmacological properties among
practitioners and patients as well as abuse of diverted methadone also
appear to have contributed to these deaths. State data and research
support the idea that lack of knowledge and abuse of diverted methadone
contributed to deaths, but also suggest that the specific circumstances
of these deaths are variable.
Methadone's Growing Use for Pain Management Has Increased the Drug's
Availability, Contributing to an Increase in Overdose Deaths:
The growing availability of methadone through its increased use for
pain management is a contributing factor to the rise in methadone-
associated overdose deaths. DEA data show that from 2002 to 2007,
distribution of methadone to business types associated with pain
management--pharmacies and practitioners--almost tripled, rising from
about 2.3 millions grams to about 6.5 million grams. In contrast,
distribution to OTPs increased more slowly, from about 5.3 million
grams to about 6.5 million grams. See table 2 for the numbers for
methadone distribution to four business types from 2002 through 2007.
Similarly, data from IMS Health, a private company that tracks
prescription drug trends, showed that from 1998 through 2006 the number
of annual prescriptions of methadone for pain increased by about 700
percent, from about 531,000 in 1998 to about 4.1 million in 2006.
Table 2: Methadone Distribution by Type of Business, 2002 to 2007:
OTPs;
2002: 5,262,052;
2003: 5,743,272;
2004: 6,584,721;
2005: 6,892,025;
2006: 7,345,623;
2007: 6,451,288.
Hospitals[A];
2002: 309,315;
2003: 393,685;
2004: 466,352;
2005: 521,216;
2006: 584,144;
2007: 590,649.
Pharmacies;
2002: 2,329,083;
2003: 3,274,331;
2004: 4,246,007;
2005: 4,863,736;
2006: 5,986,488;
2007: 6,442,516.
Other practitioners[B];
2002: 10,381;
2003: 15,113;
2004: 35,492;
2005: 43,260;
2006: 51,046;
2007: 49,503.
Source: GAO analysis of DEA methadone distribution data.
Notes: Methadone distribution numbers are in grams. Prior to 2002 DEA's
methadone distribution data did not track sales to OTPs, therefore, we
did not include data prior to 2002 in our analysis.
[A] DEA reports that in hospitals methadone may be dispensed or
administered for pain management. Hospitals may also dispense or
administer methadone for addiction treatment when patients are admitted
to the hospital for another condition but require treatment for opiate
addiction during their stay.
[B] In addition to issuing prescriptions for controlled substances that
patients can have filled in retail pharmacies, appropriately licensed
practitioners may also dispense controlled substances directly to
patients. DEA officials said that while practitioners may dispense
methadone directly in their offices for pain management purposes, it is
not a common practice. Officials did not have information on the
specific types of practitioners who are dispensing methadone directly.
[End of table]
Most officials from federal and state agencies, as well as experts in
addiction treatment and pain management that we spoke with, cited the
increased availability of methadone due to its use for pain management
as a key factor in the rise in deaths, while some added that addiction
treatment in OTPs was not related to increased deaths. Federal
officials and experts in epidemiology, pain management, and addiction
treatment at SAMHSA's National Assessment of Methadone-Associated
Mortality in 2003 also acknowledged a correlation between the increased
distribution of methadone through pharmacies for pain management with
the increase in methadone-associated overdose deaths and reached
consensus that the increase in these deaths was not associated with
addiction treatment in OTPs. Additionally, in 2006 CDC researchers
suggested that the increase in deaths involving methadone was related
to physicians increasingly prescribing the drug for pain. The
researchers reported that the increase in deaths tracked the increase
in methadone used for pain management rather than its use in OTPs.
To explain the increasing prescribing of methadone for pain management,
many officials and experts we spoke with mentioned the publicity
surrounding the increased abuse and diversion of the drug OxyContin in
the early 2000s as a reason for the increased prescribing of methadone
for pain.[Footnote 45] A November 2007 report by the National Drug
Intelligence Center (NDIC) also noted that following increases in
OxyContin addiction and death rates, many practitioners began using
methadone instead to manage pain.
Lack of Knowledge about Methadone by Practitioners and Patients Has
Also Contributed to Methadone-Associated Overdose Deaths:
Lack of knowledge about the unique pharmacological properties of
methadone by both practitioners and patients has also been identified
as a factor contributing to methadone-associated overdose deaths.
Background information prepared for SAMHSA's 2007 Methadone Mortality
Reassessment meeting noted that physicians need to understand
methadone's pharmacology as well as specific indications and cautions
before using it to treat pain or addiction. FDA has issued similar
statements, adding that practitioners should closely monitor patients
when starting treatment with methadone or converting patients to
methadone from other opioids. Some experts we spoke with advocated a
"start low and go slow" approach with methadone. Additionally, some
pain management specialists we interviewed warned that practitioners
following conversion tables, which are commonly used to switch patients
to methadone from other drugs, may start some patients on too high a
dose. The specialists explained that using these conversion tables for
patients who have already developed a tolerance for other opioids may
be lethal, because tolerance for other opioids is not equivalent to
tolerance for methadone.
Several sources have also cited inadequate training among some
practitioners. NDIC reported in 2007 that some general practitioners
and novice pain management specialists may lack the training to
adequately monitor patients to whom they prescribe methadone. A 2005
survey by the National Center on Addiction and Substance Abuse found
less than half of surveyed physicians (48 percent) received instruction
in pain management while in medical school. DEA also noted that several
of the top prescribers of methadone have been practitioners with
specialties not generally associated with extensive training in pain
management. Reports based on SAMHSA's 2003 National Assessment of
Methadone-Associated Mortality and 2007 Reassessment recommended that
practitioners needed better training in how to manage pain and
addiction. Many experts, representatives of national associations, and
state officials we spoke with agreed that more training in both pain
and addiction treatment and about methadone's unique properties is
needed for medical professionals. However, opinions varied about
whether such training should be optional (e.g., offered for continuing
education credit) or mandatory (e.g., required for license renewal).
Insufficient patient education has also been cited as contributing to
methadone-associated overdose deaths. Patients may not understand how
methadone works, including that it can stay in the body long after the
pain returns. As a result, these patients might take methadone more
frequently than prescribed to manage their recurring pain, risking
overdose as the drug builds to toxic levels in their bodies. Unaware of
potentially lethal drug combinations, patients might also take
methadone with other drugs, including antianxiety drugs and other
opioids, or alcohol.
Abuse of Diverted Methadone Is an Additional Contributing Factor to
Methadone-Associated Overdose Deaths:
Data suggest that abuse of diverted methadone is also contributing to
the rise in methadone-associated overdose deaths. Increased thefts as
well as seizures of methadone by law enforcement indicate that more
diverted methadone is available for potential abuse. DEA tracks drug
abuse, including the diversion of legally manufactured drugs such as
methadone into the illegal market, through its National Forensic
Laboratory Information System, which collects the results of state and
local forensic laboratories' analyses of drugs seized as evidence by
law enforcement agencies. The DEA data on national estimates of the
most frequently analyzed drugs seized by law enforcement from 2001
through 2007 showed that the number of methadone drug items analyzed by
state and local labs increased 262 percent, though the estimated number
was smaller than that of some of the other drugs (see table
3).[Footnote 46] In 2007, DEA reported that per prescription, methadone
was more likely to be diverted and abused than either hydrocodone or
oxycodone based on its analysis of data from the National Forensic
Laboratory Information System and IMS Health.
Table 3: Top Five Drugs with Highest Percentage Increases in Analyzed
Drug Items Seized by Law Enforcement, 2001 to 2007:
Drugs/substances: Methadone;
2001: 2,865;
2002: 3,867;
2003: 4,967;
2004: 6,397;
2005: 7,302;
2006: 9,822;
2007: 10,361;
Percentage change, 2001 to 2007: 262.
Drugs/substances: Morphine;
2001: 1,842;
2002: 2,424;
2003: 2,534;
2004: 2,827;
2005: 3,619;
2006: 4,672;
2007: 5,343;
Percentage change, 2001 to 2007: 190.
Drugs/substances: Hydrocodone;
2001: 12,847;
2002: 16,869;
2003: 16,903;
2004: 18,608;
2005: 23,549;
2006: 30,480;
2007: 36,803;
Percentage change, 2001 to 2007: 186.
Drugs/substances: Oxycodone;
2001: 12,013;
2002: 17,619;
2003: 16,520;
2004: 18,962;
2005: 19,274;
2006: 25,041;
2007: 29,487;
Percentage change, 2001 to 2007: 145.
Drugs/substances: Carisoprodol[A];
2001: 1,890;
2002: 2,946;
2003: 3,297;
2004: 2,757;
2005: 3,020;
2006: 3,558;
2007: 4,420;
Percentage change, 2001 to 2007: 134.
Source: GAO analysis of data from DEA's National Forensic Laboratory
Information System.
Note: The numbers included in this table are national estimates
calculated each year by DEA based on a national sample model of state
and local laboratories. Therefore, DEA reports that the national
estimates should not be affected by the number of participating
laboratories in any given year. According to DEA officials, DEA did not
produce national estimates prior to 2001; therefore, we did not include
data prior to 2001 in our analysis.
[A] Carisoprodol is a centrally acting muscle relaxant.
[End of table]
Likewise, DEA data on drug theft and loss showed that methadone thefts
nationwide more than doubled, from 176 in 2000 to 393 in 2007. For the
five states we reviewed, the data showed that most thefts were reported
from pharmacies, while no thefts were reported from OTPs in four of
these states during the same time period.
Federal and state officials told us that abuse of prescription drugs,
including methadone, has become more of a problem in recent years than
abuse of illicit drugs, such as heroin or cocaine. Officials from ONDCP
said that overall opioid drugs are being increasingly diverted and
abused, while abuse of illicit drugs is decreasing. SAMHSA's National
Survey on Drug Use and Health provides some additional information
about where those who are abusing prescription pain relievers, such as
methadone, obtain their drugs. According to the 2007 survey, among the
estimated 5.2 million persons aged 12 or older who reported using
prescription pain relievers nonmedically in the past 12 months, 56.5
percent said they got the drugs from a friend or relative, another 18.1
percent reported that they got the drug from just one doctor, 4.1
percent reported that they got the pain relievers from a drug dealer or
other stranger, and 0.5 percent reported buying the drug on the
Internet.
State Data and Research Support That Lack of Knowledge and Abuse of
Diverted Methadone Contribute to Deaths, but Death Circumstances Are
Variable:
Data and research regarding methadone-associated overdose deaths in the
five states we reviewed support the idea that lack of knowledge and
abuse of diverted methadone contributed to deaths, but also suggest
that the circumstances under which people are dying are variable.
Specifically, state data and research show that death circumstances,
such as the source of the drug and the most commonly detected other
drugs, may vary by state. Furthermore, participants at SAMHSA's 2007
Methadone-Associated Mortality Reassessment concurred that the
circumstances of methadone-associated overdose deaths vary by state.
While research suggests that the source of methadone for those who die
from overdose deaths is often unknown, available information indicates
that there are three distinct populations who are dying: individuals
with a prescription for methadone; individuals undergoing methadone
maintenance treatment in OTPs; and individuals who obtained methadone
from some other source, such as diversion. However, generally more of
those who died had a prescription for methadone or obtained it through
diversion rather than receiving methadone for addiction treatment in an
OTP.[Footnote 47] For example, a Kentucky study of deaths from 2000 to
2004 found that of the 95 deaths for which coroners documented
methadone use, 48 percent of those who died had a physician's
prescription for methadone, 20 percent obtained methadone through
illicit means, 22 percent obtained methadone through unknown means, and
10 percent had received treatment in OTPs. Coroners' investigations
also documented that one-third of the victims had been undergoing pain
management. A New Mexico study of unintentional methadone-associated
overdose deaths from 1998 to 2002 found that although a much larger
percentage of deaths were related to methadone maintenance treatment
than in the other states we reviewed, more deaths overall were linked
with prescriptions for methadone. Specifically, of the 79 methadone-
associated overdose deaths for which a source of methadone was
available, 39 percent had methadone because they were undergoing
methadone maintenance treatment, while 47 percent had a prescription
for methadone. See appendix III for a summary of the findings of
research studies in the five states we reviewed.
In addition, data and research from the five states we reviewed show
that methadone is often found in combination with other drugs or
alcohol, suggesting a lack of knowledge about the dangers of combining
methadone with other drugs or that people are abusing methadone. In
Florida, for example, of the 1,095 methadone-associated overdose deaths
in 2007, 124 deaths were caused by methadone alone, while 971 deaths,
or about 89 percent, were caused by methadone in combination with other
drugs. The Kentucky study found that only 6 percent of the 176
methadone-associated overdose deaths were caused by methadone alone;
other frequently detected drugs included antidepressants,
benzodiazepines, and other opioids.[Footnote 48] The New Mexico study
showed somewhat different results, and found that of the 143 methadone-
associated overdose deaths, 22 percent were due to methadone alone, 24
percent were due to methadone and prescription drugs (no illicit
drugs), 50 percent were due to methadone and illicit drugs, and 4
percent were due to methadone and alcohol.
Education, Safety, and Monitoring Efforts to Prevent Methadone-
Associated Overdose Deaths Have Been Implemented by Government Agencies
and Other Organizations:
Education, safety, and monitoring efforts have been implemented to
prevent methadone abuse and methadone-associated overdose deaths--
either specifically or as part of broader efforts to prevent
prescription drug abuse and deaths--by various federal agencies,
states, and other organizations. Educational efforts include physician
training on the appropriate use of methadone to treat pain and opioid
addiction, and public education campaigns about the dangers of
methadone and other prescription drugs. Steps taken to improve the
safety of using methadone include limiting the distribution of a high-
dosage methadone tablet intended only for use in addiction treatment.
In addition, states may monitor prescriptions of controlled substances
as well as OTP patient enrollment through statewide registries.
Efforts to Educate Practitioners and the Public about Methadone and
Other Prescription Drugs Have Been Initiated by Federal Agencies,
States, and Other Organizations:
Because lack of knowledge of methadone's unique properties has
contributed to overdose deaths, federal and state officials and other
experts agreed that more education is needed for practitioners and the
public about how to safely use methadone and avoid its potential
dangers. A number of efforts to educate practitioners and the public
about how to use methadone and other prescription drugs safely have
been initiated by federal agencies, states, and other organizations.
Some of these efforts target methadone specifically while others are
more broadly focused on using opioids to treat pain and preventing
prescription drug abuse. Some officials and experts we spoke with
cautioned that methadone is part of a larger problem of prescription
drug abuse, and that prevention efforts focused on methadone alone
might have the unintended consequence of shifting similar problems to a
different drug--much like what occurred with methadone following
reports of abuse and diversion of OxyContin.
Educational Efforts Targeted at Methadone:
In August 2008, SAMHSA announced a 3-year grant of $1.5 million to the
American Society of Addiction Medicine to educate physicians and other
practitioners on the appropriate use of methadone to treat pain and
opioid addiction. The grant is to establish the Physician Clinical
Support System for methadone, offering free support to prescribing
physicians and other practitioners. SAMHSA reported that this system
would include mentoring support, observation of practice, and
consultative services by phone and e-mail. The system would also inform
prospective practitioners through a Web site and published resources
about science-based best practice guidelines for treating opioid
addiction. According to SAMHSA, this initiative would aim to address
the rise in methadone-associated overdose deaths spurred by misuse and
abuse.
SAMHSA also has several current or planned educational initiatives
focusing on OTPs. A risk management course for practitioners will focus
on the safe use of methadone in OTPs, with a special emphasis on the
beginning of treatment. The course will also educate OTP practitioners
about using other drugs in conjunction with methadone, including
benzodiazepines. In addition, SAMHSA is working with two work groups
that include experts from academia, medical associations, medical
researchers, and other federal agencies, such as FDA, to develop
additional methadone-specific guidelines. One work group is reviewing
available information to develop best practices on methadone and
cardiac issues. The guidance will help practitioners identify patients
at risk for cardiac arrhythmias that may be exacerbated by methadone,
and provide information on how to monitor those patients for ongoing
risks. Another work group is reviewing methadone interactions with
other common drugs, including HIV drugs. The ensuing guidelines will
help practitioners safely treat patients who may be receiving several
drugs simultaneously.
SAMHSA is also collaborating with FDA on a consumer education campaign
designed to increase awareness of the potential for serious, life-
threatening side effects in patients taking methadone for pain
management or addiction treatment. FDA reports that the multimedia
educational campaign would target OTPs and patients, pharmacies
dispensing methadone, practitioners, and the public. According to FDA,
materials developed for the campaign would include a brochure or flyer,
fact sheets, podcasts, and online information. SAMHSA reported that the
materials were scheduled to be finished by April 2009.
Educational Efforts Targeted at Opioids and Other Prescription Drugs:
SAMHSA, along with the American Academy of Pain Medicine, the American
Academy of Family Practitioners, and other medical organizations, has
developed a continuing medical education course on how to safely use
prescription pain relievers to treat pain. As of February 2009, 20
courses had been taught in 16 states. SAMHSA reported that 12 courses
would be taught in 2009 and that priority would be given to states or
regions with high per capita rates of opioid-associated overdoses and
deaths. A brief Web-based version of the course has been developed in
collaboration with MedScape, an online medical education company.
Further, a five-module online version of the course will be posted on
SAMHSA's Web site and disseminated through medical organizations and
medical schools that offer continuing education credits.[Footnote 49]
The Federation of State Medical Boards developed a book, Responsible
Opioid Prescribing: A Physician's Guide, in collaboration with a
national pain expert.[Footnote 50] The book includes strategies for
treating chronic pain and reducing the risk of addiction, abuse, and
diversion. The federation intends to distribute the book through state
medical boards, and reports that medical boards can customize the book
to include state-specific statutes, regulations, and guidelines. The
federation reported that more than 60,000 copies of the book had been
distributed in 13 states as of October 2008, and it intends to expand
distribution in 2009 as more funds are raised.
Officials in the five states we reviewed told us about their states'
efforts to educate practitioners and the public about controlled
substances and drug abuse. For example, Kentucky's Operation UNITE
(Unlawful Narcotics Investigations, Treatment, and Education) works to
rid communities of illegal drug use, coordinate treatment and support
for substance abusers, and educate the public on the dangers of drug
use. New Mexico's Board of Pharmacy participates in the New Mexico Pain
Policy Initiative, which educates practitioners on requirements for
prescribing controlled substances and for New Mexico's Prescription
Drug Monitoring Program. In West Virginia, law enforcement officials,
physicians, and others have formed a controlled substance advisory
board to address prescription drug abuse. One of its projects is to
educate patients on the dangers of diversion by providing them with
information when they pick up their prescriptions from pharmacies and
to educate physicians about how to reduce doctor shopping. In addition
to the five states we reviewed, Utah has also experienced rising
prescription drug overdose deaths and has implemented two notable
campaigns intended to reduce deaths and other harm from prescription
drugs. The Use Only as Directed campaign educates the public about
protecting themselves from unintentional overdose deaths. The Zero
Unintentional Deaths campaign educates physicians, chronic pain
sufferers, and communities about unintentional overdose deaths from
prescription drugs.
Federal agencies have also begun educating the public about
prescription drug abuse. For example, in January 2008, the ONDCP
through its National Youth Anti-Drug Media Campaign launched a national
television, print, and online advertising campaign to educate parents
about teen prescription drug abuse. The campaign includes tips for
preventing teen prescription drug abuse, such as safeguarding all drugs
at home, monitoring drug quantities, and properly concealing and
disposing of old or unused medicines in the trash. SAMHSA also piloted
a public education program called SMART Rx in which participating
pharmacies inform customers about controlled substances when they fill
prescriptions. The information provided covers the risks and dangers
associated with the opioid or benzodiazepine medication, steps to keep
the medication from adolescents, and safe disposal of unused
medications. SAMHSA reported that evaluations suggested that consumers
found the content useful and kept the information for future reference
or shared it with someone else.
DEA and FDA Have Taken Steps to Improve the Safety of Using Methadone:
Both DEA and FDA have taken steps to improve the safety of using
methadone. DEA officials told us that the agency formed a methadone
mortality working group in 2006 to review information related to the
increases in methadone-associated overdose deaths, including DEA
methadone distribution data and data from other federal agencies, such
as FDA and CDC. The data showed that methadone 40 mg diskettes had been
increasingly prescribed for pain, despite only being FDA approved for
addiction treatment in OTPs--a practice described as off-label
prescribing.[Footnote 51] Some experts said that if prescribed for pain
to a person without a tolerance to opioid drugs, an initial dose of 40
mg could potentially be deadly. DEA data show that distribution of the
methadone 40 mg diskettes to retail pharmacies increased almost sixfold
from about 350,000 grams in 2002 to about 2 million grams in 2007. At
the same time, distribution to OTPs fell slightly from about 1.4
million grams to 1.2 million grams. Following their review, DEA
officials told us that they became concerned about the diskette's
increased use for pain management. DEA then worked with methadone
manufacturers, which agreed to voluntarily restrict distribution of the
diskettes to only OTPs and hospitals. Because the restriction began
January 1, 2008, it is too soon to determine any effect on methadone-
associated overdose deaths. DEA reported that it would continue
monitoring methadone distribution and prescription data to evaluate the
impact of the initiative.
In November 2006, FDA approved a revised label for methadone 5 mg and
10 mg tablets that included new safety information regarding using
methadone for pain, such as warnings about life-threatening adverse
events and modified dosage instructions. The revised label states that
methadone can cause slow or shallow breathing and dangerous changes in
heartbeat that may not be felt by the patient. The new dosage
instructions for methadone prescribed for pain state that the usual
initial dose should be 2.5 mg to 10 mg taken every 8 to 12 hours, or a
maximum daily dose of 30 mg, slowly adjusted for effect. The previous
instructions allowed initial total daily doses up to 80 mg a day, which
several experts said could be hazardous or even deadly. As FDA approved
the revised methadone label, it also issued a public health advisory
for health care professionals and patients, stating that prescribing
methadone is complex and that it should only be prescribed for patients
with moderate to severe pain when their pain is not improved with other
non-narcotic pain relievers. The advisory noted that FDA had received
reports of life-threatening side effects and death in patients taking
methadone, both those newly starting methadone for pain control and
those who have switched to methadone after being treated for pain with
other strong narcotic pain relievers.
Additionally, in February 2009, FDA sent letters to manufacturers of
certain opioid drugs, including methadone, indicating that these drugs
will be required to have a Risk Evaluation and Mitigation Strategy to
ensure that the benefits of the drugs continue to outweigh the risks.
In the first of a series of meetings, FDA invited those companies that
market the affected opioid drugs to a meeting with the agency in March
to discuss strategy development. Additional steps will include
discussions with other federal agencies, patient and consumer
advocates, representatives of the pain and addiction treatment
communities, health care professionals, and other interested parties.
FDA is planning a public meeting in late spring or early summer to
allow for broader public input and participation in this process.
States May Monitor Prescriptions for Controlled Substances and OTP
Patient Enrollment to Prevent Abuse and Diversion:
States may monitor prescriptions for controlled substances and OTP
patient enrollment to prevent abuse and diversion. Prescription drug
monitoring programs facilitate the collection, analysis, and reporting
of information about the prescribing, dispensing, and use of controlled
substances such as methadone. DEA reported that as of February 2009, 31
states had operational prescription drug monitoring programs to help
prevent abuse and diversion of controlled substances, including
methadone, and 4 of the 5 states we reviewed had operational programs.
These programs may provide information to practitioners on patients and
to other entities, such as licensing boards, on prescribing and
dispensing practices of practitioners, or state law enforcement and
regulatory agencies, to assist in identifying and investigating
activities potentially related to the illegal prescribing, dispensing,
and procuring of controlled substances. According to the Alliance of
States with Prescription Monitoring Programs, states have found that
these programs are among the most effective tools to identify and
prevent drug diversion at the practitioner, pharmacy, and patient
levels. CDC officials told us that they have a study under way to
evaluate the impact of state prescription drug monitoring programs on
drug overdose deaths.
Prescription drug monitoring programs may vary in ways such as what
data must be submitted and who has access to the information. For
example, with respect to access to prescription monitoring data, West
Virginia allows authorized agents of the state police and federal law
enforcement agencies to have access to prescription monitoring data. In
contrast, in Maine, access by law enforcement is more limited as law
enforcement officials can access prescription monitoring data only by
grand jury subpoena for cases they are currently investigating. See
appendix IV for a comparison of some of the characteristics of the four
prescription drug monitoring programs we reviewed.[Footnote 52]
However, prescription drug monitoring programs have limitations. Their
usefulness depends on practitioners using the programs, and in the four
states we reviewed with prescription drug monitoring programs,
practitioners' use was not widespread, according to state officials. In
addition, not every state has a prescription drug monitoring program,
and state officials we spoke with said that people would sometimes
cross state borders to obtain prescription drugs in a state without a
program. Furthermore, while DEA reports that several states' programs
have the capability of generating reports on out-of-state prescribers
or patients, they do not routinely disseminate this information to
other states.[Footnote 53] Another limitation of prescription drug
monitoring programs mentioned by state officials was the lack of
patient data on methadone dispensed in OTPs and from federal facilities
such as Department of Veterans Affairs' hospitals or Indian Health
Service facilities. Therefore, in the four states we reviewed with a
prescription drug monitoring program, data on any prescription drugs
received by patients at these types of facilities would not be captured
by the program.
States may also create systems to monitor the population of patients
enrolled in OTPs. To monitor their patients, OTPs in Florida created a
central registry designed to ensure that patients do not enroll in
multiple OTPs within the state, thus preventing patients from receiving
unsafe levels of methadone or additional methadone that could be
diverted. Officials said that each OTP patient is given a unique
identifier and a picture is taken and entered into the registry. All
Florida OTPs, both nonprofit and for-profit, use the registry,
according to state officials.
Agency Comments:
We provided a draft of this report to HHS and the Department of Justice
for their review. We received general comments from HHS. (See appendix
V.) HHS provided clarification that in 1947 when federal law only
required that new drugs be shown to be safe, FDA approved methadone as
safe for pain management. When the law was amended in 1962 to impose
additional requirements for the approval of new drugs, FDA
retrospectively reviewed the efficacy of methadone for the treatment of
pain. In addition, HHS stated that an attempt by FDA to restrict the
distribution of methadone for pain was struck down by a court in the
1970s. HHS also reiterated that FDA recently sent letters to the
manufacturers of certain opioid drug products, including methadone,
indicating that these drugs will be required to have a Risk Evaluation
and Mitigation Strategy to ensure that the benefits of the drug
continue to outweigh the risks. Both HHS and the Department of Justice
provided technical comments on a draft of this report, which we
incorporated as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the Acting
Secretary of Health and Human Services, the Attorney General, and
others. The report also will be available at no charge on GAO's Web
site at [hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-7114 or kingk@gao.gov. 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 major contributions to
this report are listed in appendix VI.
Signed by:
Kathleen King:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
To examine the regulation of methadone for pain management and
addiction treatment, we reviewed relevant codified federal statutes and
regulations pertaining to the prescribing, administering, or dispensing
of methadone for pain management and addiction treatment. Our review
was limited to relevant provisions of the Controlled Substances Act and
implementing regulations, including Department of Justice, Drug
Enforcement Administration (DEA), and Substance Abuse and Mental Health
Services Administration (SAMHSA) regulations. We also examined federal
case law and relevant federal agency policies, including DEA's policy
statement on dispensing controlled substances for the treatment of
pain. We interviewed officials at relevant federal agencies, including
SAMHSA and DEA. We also interviewed officials and reviewed information
from relevant national associations, including the Federation of State
Medical Boards.
In addition, we interviewed officials and examined relevant codified
statutes and regulations in five selected states. The states we
reviewed were Florida, Kentucky, Maine, New Mexico, and West Virginia.
Each of the states met four or more of the following criteria:
* a top 10 rate of increase in methadone-associated overdose deaths
from 1999 through 2004,[Footnote 54]
* a top 10 number of methadone-associated overdose deaths per 1,000,000
people in 2004,
* a state or district medical examiner system,[Footnote 55]
* an operational prescription drug monitoring program,[Footnote 56]
and:
* state-focused, methadone-specific research.
We examined how the prescribing, administering, or dispensing of
methadone for pain management and addiction treatment were regulated in
our five selected states. We only examined codified state statutes and
regulations containing requirements relating to the administering or
dispensing of methadone in opioid treatment programs (OTP) and the
prescribing, administering, or dispensing of controlled substances to
individuals for medical purposes, including pain management.[Footnote
57] In each state we interviewed officials from the state agency with
oversight of OTPs, state boards of medicine and pharmacy, and law
enforcement officials. The findings from our review of these five
states cannot be generalized to all states.
To determine the factors contributing to the increase in methadone-
associated overdose deaths in recent years, we interviewed officials
from the Centers for Disease Control and Prevention (CDC), DEA, the
Food and Drug Administration (FDA), the National Drug Intelligence
Center (NDIC), the National Institutes of Health, the Office of
National Drug Control Policy (ONDCP), and SAMHSA. We also interviewed
professional association officials from the American Association for
the Treatment of Opioid Dependence, the Federation of State Medical
Boards, HARMD (Helping America Reduce Methadone Deaths), the National
Alliance of Methadone Advocates, the National Association of Boards of
Pharmacy, the National Association of Medical Examiners, the National
Association of State Alcohol and Drug Abuse Directors, and the National
Association of State Controlled Substances Authorities. In addition, we
interviewed pain management, addiction treatment, and forensic science
experts.
We reviewed national reports, including reports based on the 2003
SAMHSA Methadone Mortality Assessment and 2007 Reassessment and a
November 2007 NDIC report on methadone mortality. We reviewed CDC
methadone poisoning death data from the National Vital Statistics
System, which tabulates information reported on death certificates. We
interviewed CDC officials to obtain information about the reliability
of their methadone mortality data, including how CDC ensures the
quality of the data and any data limitations. In addition, we
interviewed officials in our five selected states' medical examiners'
offices about the factors contributing to the increase in methadone-
associated overdose deaths in their states. We also reviewed state data
and studies from our five selected states and interviewed researchers
about their efforts to investigate methadone-associated overdose deaths
in their states. However, because there is no standard definition for
what constitutes a methadone-associated overdose death, there may be
some variation in how states define this term and how they report these
numbers. For example, data from Florida distinguish whether methadone
was simply present or was the cause of death, but not all states make
this distinction. Defining methadone's role in a death can also be
complicated by inconsistencies in determining and reporting causes of
death, by the presence of other drugs, and by the absence of
information about the source of methadone and the deceased person's
level of opioid tolerance. Results from these five state studies cannot
be generalized to other states.
We reviewed relevant DEA data, including Automation of Reports and
Consolidated Orders System (ARCOS) data, DEA National Forensic
Laboratory Information System (NFLIS) data, and DEA Theft and Loss
data.
* ARCOS is an automated drug reporting system that monitors the flow of
DEA controlled substances from the point of manufacture through
commercial distribution channels to the point of retail sale or
distribution, including hospitals, retail pharmacies, practitioners,
midlevel practitioners, and teaching institutions. ARCOS summarizes
these transactions into reports, which give federal and state
government investigators information that can then be used to identify
the diversion of controlled substances into illicit channels of
distribution.
* NFLIS systematically collects results from solid dosage drug analyses
conducted by state and local forensic labs across the country. NFLIS
provides information for monitoring and understanding drug abuse and
trafficking involving both controlled and noncontrolled substances in
the United States, including the diversion of legally manufactured
drugs into illegal markets. As of March 2007, 44 state lab systems and
94 local lab systems, comprising 274 individual labs, were
participating. Because NFLIS is a voluntary reporting system and the
number of participating state and local laboratories has changed over
time, DEA officials recommended that we report the NFLIS national
estimates of analyzed drug items, instead of the actual numbers, to
show trends over time, which they said would not be affected by the
number of labs participating each year. DEA's national estimates are
calculated every year based on a national sample model of state and
local laboratories. DEA officials told us they began producing national
estimates in 2001.
* DEA's Theft and Loss database collects data on theft and loss of
controlled substances by number of thefts; drug and dosage forms;
business type, including pharmacies, hospitals, and manufacturers; and
type of theft, such as night break-in or armed robbery. DEA registrants
are required to report theft and loss of controlled substances to DEA.
Although the database contains information on the forms of controlled
substances lost or stolen, DEA officials told us there is no standard
liquid dosage unit that would allow us to provide the total volume of
liquid methadone stolen; therefore, we did not report thefts by form of
methadone.
We interviewed DEA officials to learn about data collection; quality
control, such as edit checks; and any limitations of these databases.
We determined that these three sources of data were sufficiently
reliable for use in this report, and included any limitations
identified.
To determine steps taken to prevent methadone-associated overdose
deaths, we interviewed officials at relevant federal agencies,
including CDC, DEA, FDA, ONDCP, and SAMHSA. We also interviewed
officials from relevant national associations, including the Federation
of State Medical Boards, National Association of Medical Examiners, and
National Association of State Controlled Substances Authorities, and
experts in pain management, addiction treatment, and forensic science.
In addition, we reviewed relevant studies and reports about efforts to
prevent methadone and other prescription drug overdose deaths and
interviewed officials in our five selected states to learn about
initiatives in their states. To obtain additional information about
prescription drug monitoring initiatives, we examined relevant codified
statutes and regulations in our five selected states. We only reviewed
codified state statutes or regulations relating to systems that monitor
the prescribing of controlled substances. The findings from our review
of these five states cannot be generalized to all states.
Because many efforts under way to prevent methadone-associated overdose
deaths are new, their effectiveness has not yet been evaluated. Also,
because we interviewed experts, officials from select organizations,
and state officials, our findings do not represent all efforts to
prevent these deaths. Finally, because methadone is part of a larger
problem of prescription drug abuse and overdose deaths, many of the
efforts are not focused on methadone alone.
We conducted our work from November 2007 through February 2009 in
accordance with all sections of GAO's Quality Assurance Framework that
are relevant to our objectives. The framework requires that we plan and
perform the engagement to obtain sufficient and appropriate evidence to
meet our stated objectives and to discuss any limitations in our work.
We believe that the information and data obtained, and the analysis
conducted, provide a reasonable basis for any findings and conclusions.
[End of section]
Appendix II: Comparison of Federal and Selected States' OTP
Regulations:
The following table describes selected requirements of the federal OTP
regulations, as well as selected requirements of the OTP regulations in
Florida, Kentucky, Maine, New Mexico, and West Virginia.[Footnote 58]
Authority:
Federal: 42 C.F.R. pts. 2, 8;
Florida: Fla. Admin. Code Ann. §§ 65D-30.004, 30.014;
Kentucky: 908 Ky. Admin. Regs. § 1:340;
Maine: Code Me. R. 14-188 Ch. 5 §§ 1-19;
New Mexico: N.M. Admin. Code tit. 7, § 32.8;
West Virginia[A]: W. Va. Code St. R. §§ 64-90-1 - 64-90-47.
Dosing[B]:
Federal:
* Oral form only; must be formulated so as to reduce its potential for
parenteral abuse. (§ 8.12(h)(3)(i));
* For each new patient, initial dose shall not exceed 30 mg and the
total dose for the first day shall not exceed 40 mg unless the program
physician documents in the patient's record that 40 mg did not work. (§
8.12(h)(3)(ii));
Florida: Before a client receives an initial dose of methadone or other
medication, physician must document current physiological addiction,
history of addiction and exemptions from criteria for admission. (§ 65D-
30.014(4)(e)(1));
Kentucky:
* Dose means a 1-day quantity of an approved controlled substance,
administered on site, in not less than 1 fluid ounce of an oral
solution, formulated to minimize misuse by injection (1:340.1(7));
* Proposed programs must include in their applications initial and
daily dosage levels and daily dosage levels. (1:340.4(3)(x), (y));
* Medical record must indicate reason for dose changes and must be
signed by the medical director or program physician. (1:340.6(5));
Maine: Initial doses of methadone must not exceed 30 mg unless the
physician documents the need for a higher dose. (§ 19.8.6.5);
New Mexico:
* Initial dose must not exceed 30 mg.;
* If 30 mg does not reduce withdrawal symptoms, may provide additional
10 mg only if documented;
* If 40 mg does not reduce withdrawal symptoms, may provide additional
dose only if documented;
* Subsequent doses are based on the patient's needs. (§ 7.32.8.21(D));
West Virginia[A]:
* The initial full-day dose of medication shall be based on the
physician's evaluation of the history and condition of the patient;
* Usual initial dose of methadone should be 20 to 30 mg. Reasons for
exceeding an initial dose of 30 mg must be documented;
* Initial dose should not exceed 40 mg unless physician or prescribing
professional documents that symptoms were not suppressed after a 3-hour
period of observation;
* Justification for daily doses above 100 mg must be documented. (§ 64-
90-35).
Take home conditions:
Federal: Decision made by medical director who must consider the
following criteria:
* Absence of recent drug abuse, including alcohol abuse;
* Regularity of clinic attendance;
* Absence of serious behavioral problems at the clinic;
* Absence of known recent criminal activity;
* Stability of patient's home environment and social relationships;
* Length of time in comprehensive maintenance treatment;
* Assurances of safe storage at patient's home;
* Rehabilitative benefit outweighs the potential risks of diversion. (§
8.12(i)(2));
Florida: Permitted only for clients participating in a methadone
maintenance regimen under following conditions:
* No evidence of recent drug abuse;
* Regular attendance at OTP;
* No serious behavioral problems at the OTP;
* No recent criminal activity;
* Stable home environment and social relationships;
* Sufficient length of time in treatment;
* Assurances that take-home medication can be stored safely;
* Satisfactory progress in treatment to warrant decreasing the
frequency of attendance;
* Verifiable source of legitimate income. (§ 65D-30.014(5)(d));
Kentucky: Conditions for entering each of the phases:
* Phase 1: No program infractions for 90 consecutive days;
* Phase 2: No program infractions for 180 consecutive days; pursuing
one of the following: gainful employment, vocational training, higher
education, volunteer opportunities, or parenting classes if a stay-at-
home parent;
* Phase 3: No program infractions for 270 consecutive days; same entry
requirements as for phase 2;
* Phase 4: Successful completion of phase 3 and adhered to program
requirements for 2 consecutive years. (1:340.11);
Maine:
* Results of drug tests must be reviewed and considered as part of the
treatment planning process and decisions for take-home dosing (§
19.8.6.6);
* All decisions regarding take-home privileges shall be documented in
the client record and shall comply with the requirements cited in 42
C.F.R. pt. 8. (§ 19.8.10.1);
New Mexico: Decision to be made by program medical director based on
the following criteria:
* Absence of recent drug abuse, including alcohol abuse;
* Regularity of program attendance;
* Length of time in comprehensive maintenance treatment;
* Absence of known criminal activity;
* Absence of serious behavioral problems at the program;
* Special needs such as physical health needs;
* Assurance that medication can be safely stored in patient's home;
* Stability of patient's home environment and social relationships;
* Patient's work, school, and daily activity schedule;
* Hardship traveling to and from the program;
* Rehabilitative benefit outweighs the potential risk of diversion. (§
7.32.8.23(B));
West Virginia[A]: Must consider the following criteria in determining
patient eligibility:
* Cessation of illicit drug use;
* Regularity of program attendance.
* Length of time and level of treatment in medication therapy (ability
to self-medicate);
* Absence of recent criminal activity;
* Absence of serious behavioral problems;
* Absence of abuse of drugs, including excessive use of alcohol;
* Other special needs of the patient, such as split dosing, physical
health needs, pain treatment, etc.;
* Capacity to safely store take-home medication;
* Stability of the home environment and social relationships;
* Patient's work, school, or other daily life activity schedule;
* Hardship in traveling to and from the program;
Program physician may approve temporary unsupervised take-home doses
for documented emergencies or other exceptional circumstances. (§ 64-90-
41).
Take-home dosing:
Federal:
* Any patient may receive a single take-home dose for days clinic is
closed (§ 8.12(i)(1));
* First 90 days of treatment - one single dose each week;
* 91-180 days - Two doses per week;
* 181-270 days - Three doses per week;
* 271 days to 1 year-maximum 6-day supply;
* After 1 year of continuous treatment - 2-week supply;
* After 2 years of continuous treatment - 1-month supply, but must make
monthly visits (§ 8.12(i)(3));
* No medications may be dispensed to patients in short-term
detoxification treatment or interim maintenance treatment for
unsupervised or take-home use. (§ 8.12(i)(4));
Florida:
* Must be available to all methadone clients during holidays, but only
if clinically advisable (§ 65D-30.014(4)(g));
* No take-home doses permitted during the first 30 days in treatment
unless approved by the state authority;
* Clients in continuous treatment may qualify with negative drug
screens as follows:
- Phase I: Days 31-90 - one take-home dose per week;
- Phase II: Days 91-180 - two take-home doses per week;
- Phase III: Days 181- 1 year - three take-home doses per week with no
more than a 2-day supply at any one time;
- Phase IV: After 1 year - four take-home doses per week with no more
than a 2-day supply at a time;
- Phase V: After 2 years - five take-home doses per week with no more
than a 3-day supply at a time;
- Phase VI: After 3 years in treatment - six take-home doses per week
(§ 65D-30.014(5)(e)).
Kentucky:
* Days 1-90: No take-home doses;
* Phase 1: One take-home dose per week;
* Phase 2 and 3: Up to two take-home doses per week;
* Phase 4: Up to three take-home doses per week;
* Under emergency conditions, a program may issue 14 consecutive days
of take-home doses without notification of Center for Substance Abuse
Treatment (CSAT); must notify state narcotic authority and request an
exception to dosing procedures;
* Medical director or program physician may grant an exception, subject
to written approval from state narcotic authority for clients with
serious physical disabilities or subject to exceptional hardship;
* State narcotic authority may grant additional exceptions for medical
emergency or natural disaster (1:340.11, 1:340.16).
Maine:
* Take-home methadone shall be dispensed in liquid form only in single
dose containers, or in dry form only in multiple dose containers;
* No take-home privileges during the first 90 continuous days of
treatment;
* 91-180 days: One take-home dose per week;
* 181-270 days: Two take-home doses per week;
* 271-360 days: Three take-home doses per week;
* 361 days onward: Six take-home doses per week (§ 19.8.10);
* Certain exceptions for emergencies. (§ 19.8.12).
New Mexico:
* A patient in comprehensive maintenance treatment may receive a single
dose of take-home medication for each day that a provider is closed;
* During the first 90 days, One take-home dose per week maximum;
* 91-180 days: Two take-home doses per week maximum;
* 181-270 days: Three take-home doses per week maximum;
* For the remaining months of the year, 6 days of medication maximum
per week;
* After 1 year of continuous treatment, maximum 2-week take-home
supply;
* After 2 years, maximum of 1-month take-home supply, but must make
monthly visits;
* Exceptions made only as provided by federal OTP regulations and as
approved by the state methadone authority (§ 7.32.8.23(C), (D)).
West Virginia[A]:
* For the first 90 days of treatment: A single take-home dose for the
week of each holiday that the clinic is closed;
* First 30 days of treatment: No take-home doses except the holiday
dose;
* 31-90 days: One take-home dose per week plus the holiday dose;
* 91-180 days: Two take-home doses per week;
* 181-270 days: Three take-home doses per week;
* Remainder of the first year: Maximum 6-day supply;
* Second year of treatment: Maximum 13-day supply;
* After 2 years of continuous treatment: Maximum 1-month supply with
monthly visits;
* State authority may approve exceptional unsupervised doses on a case-
by-case basis if the program physician applies (§ 64-90-41.6, 41.7).
Hours of operation:
Federal: No requirements specified.
Florida:
* Must be open Monday through Saturday;
* Must have medicating hours and counseling hours that accommodate
clients, including 2 hours of medicating time daily outside of 9:00
a.m. to 5:00 p.m;
* Must medicate on Sundays according to client needs;
* Must give a minimum of a 7-day notice for observed holidays;
* No two holidays can occur in immediate succession unless provider is
granted an exemption by the federal authority;
* On days when provider is closed, services must be accessible to
clients for whom take-out methadone is not clinically advisable (§ 65D-
30.014(4)(g));
Kentucky: Must be open 7 days a week with the optional exception of
nine specified holidays (1:340.6(16));
Maine: Must be open 7 days weekly, including all holidays. (§
19.8.4.2).
New Mexico: Must be open every day of the week except for federal and
state holidays, and Sundays, and be closed only as allowed in advance
in writing by CSAT and the state methadone authority (§ 7.32.8.18(C)).
West Virginia[A]:
* Must provide 24-hour, 7-day a week access to designated program staff
so that patient emergencies may be addressed and dosage levels verified
(§ 64-90-20.1.c);
* Must be open 7 days per week, but may close for eight holidays and
two training days per year (§ 64-90-41.6.a).
Recordkeeping (for purposes of enrollment in other OTPs):
Federal: Must document that OTP made a good faith effort to determine
if patient is enrolled in any other OTP. (§ 8.12(g)(2)); May disclose
patient records to a central registry or to any detoxification or
maintenance treatment program not more than 200 miles away for the
purpose of preventing the multiple enrollment of a patient only if
specified conditions are met:
* when disclosure is allowed;
* what information may be disclosed, and;
* written patient consent(§ 2.34).
Florida:
* Must participate in regional registry activities for the purpose of
sharing client identifying information with other providers located
within a 100-mile radius, to prevent the multiple enrollment of clients
at more than one provider;
* A record of violations by individual clients shall become part of the
record maintained in an automated system that may be accessed by all
participating providers (§ 65D-30.014(4)(f)(1), (7)).
Kentucky: Proposed programs must include in their applications a system
to prevent client's multiple program registration (1:340.4(3)(k)).
Maine: Prior to admitting a client, must confirm using the Office of
Substance Abuse's system that client is not currently enrolled in
another OTP. If system is unavailable, must check with all OTPs within
3 calendar days of admission (§ 19.8.4.4-5).
New Mexico:
-Must make and document good faith efforts to determine that a patient
seeking admission is not receiving opioid dependency treatment
medication from any other source, within the bounds of all applicable
patient confidentiality laws and regulations;
* Must confirm that the patient is not receiving treatment from any
other OTP, except under exceptional circumstances, within a 50-mile
radius of its location, by contacting any such program or by using the
central registry, when established;
* The Department of Health may establish an Internet-based registry of
all current patients of a New Mexico OTP for the purpose of creating a
system that prevents patients from receiving medication from more than
one OTP. Each OTP as a condition of approval to operate shall
participate in the central registry as directed by the Department of
Health (§ 7.32.8.19(F), (G)).
West Virginia[A]:
* Must have a procedure for ensuring that patients are not enrolled in
more than one OTP;
* When practicable, must obtain a release of information from the
patient in order to check the records by telephone or fax of every OTP
within 100 miles to ensure that the patient is not currently enrolled
in other programs;
* The release must state that only prior admissions may be the subject
of inquiry, not contacts without admission;
* Results of the check must be placed in the clinical record;
* The check shall be duplicated if the patient is discharged and
readmitted at any time (§ 64-90-30).
Source: GAO analysis of federal OTP regulations and selected
requirements of OTP regulations in Florida, Kentucky, Maine, New
Mexico, and West Virginia.
[A] West Virginia has adopted 42 C.F.R. pt. 8 in its entirety by
reference and provides that to the extent there is a conflict between
federal regulations or standards and the standards set forth in this
rule, the more stringent standard applies. W. Va. Code St. R. § 64-90-
2.3.
[B] Dosing refers to standards for doses of methadone.
[End of table]
[End of section]
Appendix III: Data and Research regarding Methadone-Associated Overdose
Deaths in Five States:
The following information on methadone-associated overdose deaths in
Florida, Kentucky, Maine, New Mexico, and West Virginia was taken from
data and research in these states.
State: Florida[A];
Years studied: 2007;
Number of methadone-associated overdose deaths: 1,095;
Decedent characteristics: Ages of decedents:
50: 17%;
n=785[B];
Drugs detected: Methadone only: 11%; Drugs in combination with
methadone: 89%; n=1,095;
Sources of methadone: No data available.
State: Kentucky[C];
Years studied: 2000-2004;
Number of methadone-associated overdose deaths: 176[D];
Decedent characteristics:
Caucasian: 100%;
Male: 60%;
Mean age: 38 years;
Drugs detected:
Methadone only: 6%;
Drugs in combination with methadone:[E]; Antidepressants: 40%;
Benzodiazepines: 32%; Additional opioids: 28%;
Sources of methadone: Private physician: 48%; Illicit means: 20%; OTP:
10%; Unknown: 22%; n=95[F].
State: Maine[G];
Years studied: 1997-2002;
Number of methadone-associated overdose deaths: 88[H];
Decedent characteristics:
All drug-related deaths: Caucasian: 96%; Male: 62%; Mean age: 40 years;
Other known health conditions: Mental illness: 55%; Drug abuse: 50%;
Drugs detected: Methadone deaths: Methadone primary or secondary causal
factor: 88%; Methadone a significant contributing factor: 12%; n=66[I];
Sources of methadone: Limited data available.
State: New Mexico[J];
Years studied: 1998-2002;
Number of methadone-associated overdose deaths: 143[K];
Decedent characteristics: White non-Hispanic: 55%; Male: 75%; Median
age: 40 years;
Other known health conditions: Mental illness: 24%; Drug abuse: 25%;
Drugs detected: Methadone only: 22%; Drugs in combination with
methadone:[E]; Prescription drugs (no illicit drugs): 24%; Illicit
drugs: 50%;
Sources of methadone: Methadone maintenance treatment: 39%;
Prescription for chronic pain: 34%; Prescription for unknown reason:
13%; Diversion: 14%; n=79[F].
State: West Virginia[L];
Years studied: 2006;
Number of methadone-associated overdose deaths: 112[M];
Decedent characteristics: All drug-related deaths:[N]; Male: 67%; Mean
age: 39 years;
Substance abuse indicators, all drug-related deaths:[N]; History of
substance abuse: 78%; Used diverted pharmaceuticals: 63%; Doctor
shopped (Five or more prescribing clinicians in the year before death):
21%;
Drugs detected: Methadone only: 26%; Drugs in combination with
methadone:[E]; Other prescription drugs: 63%; Illicit drugs: 13%;
Alcohol: 10%;
Sources of methadone: Diversion: 68%; Prescription: 21%; OTP: 11%.
Source: GAO summary of data and research from Florida, Maine, and
published manuscripts.
Note: Percentages may not total 100 percent because of rounding.
[A] Florida Department of Law Enforcement, Medical Examiners
Commission, Drugs Identified in Deceased Persons by Florida Medical
Examiners: 2007 Report (June 2008).
[B] Of the total 1,095 deaths, methadone was determined to be the cause
of death in 785 cases.
[C] L.B.E. Shields et al., "Methadone Toxicity Fatalities: A Review of
Medical Examiner Cases in a Large Metropolitan Area," Journal of
Forensic Sciences, vol. 52, no. 6 (2007).
[D] Deaths ascribed to methadone toxicity by the state of Kentucky's
Office of the Chief Medical Examiner.
[E] Many overdose deaths were found to have several drugs present;
therefore, these percentages should not be totaled.
[F] Number of methadone-associated overdose deaths for which
information was available about the source of methadone.
[G] Marcella H. Sorg and Margaret Greenwald, Maine Drug-Related
Mortality Patterns: 1997-2002, a special report prepared in cooperation
with the Maine Office of the Attorney General and Maine Office of
Substance Abuse, December 2002.
[H] Medical examiner cases in which a drug or toxic substance caused
the death; specifically, deaths in which methadone was found in
toxicology results.
[I] Methadone-associated overdose deaths in which methadone was listed
on the death certificate.
[J] N. Shah, S. L. Lathrop, and M. G. Landen, "Unintentional Methadone-
Related Overdose Death in New Mexico (USA) and Implications for
Surveillance, 1998-2002," Addiction, vol. 100, no. 2 (2005).
[K] Unintentional drug overdose deaths in which methadone was cited as
a cause of death, alone or in combination with another drug.
[L] A. J. Hall et al., "Patterns of Abuse Among Unintentional
Pharmaceutical Overdose Fatalities," JAMA, vol. 300, no. 22 (2008).
[M] Unintentional drug overdose deaths for which an autopsy was
performed that determined that methadone contributed to the death.
[N] This research was focused more broadly on overdose deaths rather
than methadone alone; therefore, the decedent characteristic statistics
apply to all drug overdose deaths studied.
[End of table]
[End of section]
Appendix IV: Comparison of Prescription Drug Monitoring Programs in
Four Selected States:
Program information: Name of program;
Kentucky: Kentucky All-Schedule Prescription Electronic Reporting
System (KASPER);
Maine: Controlled Substances Prescription Monitoring Program;
New Mexico: Controlled Substance Prescription Monitoring Program;
West Virginia: West Virginia Controlled Substances Monitoring.
Program information: Year established[A];
Kentucky: 1998;
Maine: 2003;
New Mexico: 2004;
West Virginia: 2002[B].
Program information: Oversight agency;
Kentucky: Drug Enforcement and Professional Practices Branch, Office of
Inspector General, Cabinet for Health and Family Services;
Maine: Office of Substance Abuse, Department of Health and Human
Services;
New Mexico: Board of Pharmacy;
West Virginia: Board of Pharmacy.
Program information: Controlled substances covered;
Kentucky: Schedule II, III, IV, and V;
Maine: Schedule II, III, and IV;
New Mexico: Schedule II, III, and IV;
West Virginia: Schedule II, III, and IV.
Program information: Who must provide information;
Kentucky: Authorized dispensers of controlled substances; Includes
dispensers located outside Kentucky but authorized by Kentucky's Board
of Pharmacy to dispense controlled substances[C];
Maine: Individuals authorized to dispense or administer controlled
substances;
New Mexico: Authorized dispensers; Does not include licensed hospital
pharmacies that distribute controlled substances for inpatient hospital
care;
West Virginia: Individuals authorized to dispense or administer
controlled substances[D]; Includes pharmacists or pharmacies located
outside the state but licensed by the Board of Pharmacy for delivery to
a person residing in the state.
Program information: Who may have access;
Kentucky: Practitioners or pharmacists for current patients; Board
representatives involved in a specific investigation of licensees who
are authorized to prescribe, administer, or dispense controlled
substances; Kentucky boards of medical licensure and nursing, regarding
reviews of improper prescribing practices related to geographic area or
business relationship; State Medicaid program for a Medicaid recipient
or provider; Certified peace officer engaged in a specific
investigation; Grand jury pursuant to a subpoena; Judge or probation or
parole officer regarding a criminal defendant eligible for a court-
ordered drug addiction program; Civil actions and criminal
proceedings[E]; Another state program via reciprocal agreement;
Maine: Prescribers for current patients; Pharmacists for customers
filling prescriptions; Patients; Board representatives for an
investigation of a licensed prescriber with reasonable cause; Office
personnel or personnel of any vendor or contractor, to establish and
maintain the program's electronic system; For public research purposes
if identifying information has been removed; Law enforcement for
limited purposes[F];
New Mexico: Authorized prescribers and dispensers; Patients; Boards for
licensees; Professional licensing authorities of other states if their
licensees practice in the state or prescriptions issued by their
licensees are dispensed in the state; State Medicaid program; Public or
private entities for research purposes, without identifying
information; Pharmacy board for oversight of this program; Law
enforcement or prosecutorial officials engaged in an ongoing
investigation; Courts under grand jury subpoena or criminal court
order;
West Virginia: Prescribing practitioners and pharmacists[G]; Inspectors
and agents of the Board of Pharmacy; Authorized agents of licensing
boards of practitioners in West Virginia and other states; Authorized
agents of the Bureau for Medical Services and the Workers' Compensation
Commission; Any person engaged in receiving, processing, or storing the
information received by the central repository; For educational,
scholarly, or statistical purposes, without identifying information;
Authorized members of the state police; Authorized local and federal
law enforcement agents who are members of a drug task force; Persons
with a court order or administrative subpoena.
Program information: Authorities;
Kentucky: Ky. Rev. Stat. Ann. §§ 218A.202; 218A.245; 902 Ky. Admin.
Regs. 55:110;
Maine: Me. Rev. Stat. Ann. Tit. 22, §§ 7245-7252; 14-118 Code Me. R.
ch. 11, §§ 1-9;
New Mexico: N.M. Stat. Ann. § 30-31-16; N.M. Admin. Code tit. 16, §§
19.29.1-.13;
West Virginia: W. Va. Code Ann. §§ 60A-9-1 -60A-9-7; W. Va. Code St. R.
§§ 15-8-1 - 15-8-7.
Source: GAO analysis of state prescription drug monitoring program laws
and regulations in Kentucky, Maine, New Mexico, and West Virginia.
Note: GAO selected five states to review for this study: Florida,
Kentucky, Maine, New Mexico, and West Virginia. However, Florida does
not have a prescription monitoring program.
[A] This references the effective year of the state law or regulation
that provided the authority to establish the state's prescription drug
monitoring program.
[B] West Virginia first established a monitoring program in 1995. The
current version of the program dates to 2002.
[C] In Kentucky, reporting is not required for drugs administered
directly to patients or drugs dispensed by practitioners at licensed
facilities if the quantity dispensed is limited to an amount adequate
for 48 hours of treatment.
[D] In West Virginia, reporting is not required for a drug administered
directly to a patient or dispensed by a practitioner at a state-
licensed facility, provided that the quantity dispensed is limited to
an amount adequate for up to 72 hours with no more than two 72-hour
cycles in any 15-day period.
[E] A Kentucky court recently determined that the state law prohibiting
disclosure of KASPER data for purposes of a civil action was
unconstitutional and therefore cannot be enforced. The court further
determined that such disclosures can be made for civil actions if a
court conducts a review prior to requiring disclosure. See
Commonwealth, Cabinet for Health & Family Services v. Chauvin, No. 2008-
CA-000027-OA, 2008 WL 2388671 (Ky. Ct. appendix June 13, 2008). A
Kentucky court also recently determined that a criminal defendant had
the right to obtain KASPER data for discovery purposes during a
criminal proceeding. The court found that the defendant's right to due
and compulsory process took precedence over any limitations in access
authority under state law. See Commonwealth, Cabinet for Health &
Family Services v. Bartlett, No. 2008-CA-000046-OA, 2008 WL 2388690
(Ky. Ct. appendix June 13, 2008).
[F] According to a Maine official, law enforcement officials also have
access to prescription monitoring data, but only by grand jury subpoena
for cases they are currently investigating.
[G] In West Virginia, information released must be related to a
specific patient for the purpose of providing treatment or a specific
individual or entity under investigation by any party that has access.
Prescribing practitioners may also request data related to their
federal registration for controlled substances.
[End of table]
[End of section]
Appendix V: Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
March 20, 2009:
Kathleen King:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. King:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: "Methadone-
Associated Overdose Deaths: Factors Contributing to Increased Deaths
and Efforts to Prevent Them (GAO-09-341).
The Department appreciates the opportunity to comment on this draft
report before its publication.
Sincerely,
Signed by:
Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Attachment:
General Comment For The Department Of Health And Human Services (HHS)
To The Government Accountability Office's (GAO) Draft Report Entitled,
Methadone-Associated Overdose Deaths - Factors Contributing To
Increased Deaths And Efforts To Prevent Them (GAO-09-341):
In the report, GAO provides a description of options available to FDA
to restrict distribution of a drug product, or to require other risk
management strategies. It must be clarified that methadone was
originally approved in 1947, when the prevailing laws and regulations
required only that a drug be shown to be safe. Subsequently, when the
law was amended in 1962 to require demonstration of efficacy, the
efficacy of - methadone for the treatment of pain and the appropriate
labeling for the product was reviewed under the Drug Efficacy Study
Implementation process, which retrospectively evaluated the efficacy of
all drugs approved prior to the efficacy requirement.
When the use of methadone for the treatment of opioid dependence was
approved, FDA attempted to implement restriction of distribution of
methadone for pain, but this effort was struck down in court in the
1970s.
On February 6, 2009, FDA sent letters to manufacturers of certain
opioid drug products, including brand name and generic drugs formulated
with the active ingredient, methadone, indicating that these drugs will
be required to have a Risk Evaluation and Mitigation Strategy (REMS) to
ensure that the benefits of the drugs continue to outweigh the risks.
See [hyperlink,
http://www.fda.gov/crier/ding/infopage/opioids/OpioidProducts_chart.htm.
FDA has determined that a REMS is necessary to help reduce the
occurrence of serious adverse events, abuse, diversion and addiction,
to facilitate safe and appropriate use of these drugs. FDA has begun to
hold a series of stakeholder meetings with those companies that market
the affected opioid drugs to discuss REMS development. Additional steps
will include discussions with other federal agencies and non-government
institutions, including patient and consumer advocates, representatives
of the pain and addiction treatment communities, other health care
professionals and other interested parties. FDA is planning a public
meeting in late spring or early summer to allow for broader public
input and participation.
[End of section]
Appendix VI: GAO Contact and Staff Acknowledgments:
GAO Contact:
Kathleen King, (202) 512-7114 or kingk@gao.gov:
Acknowledgments:
In addition to the contact named above, key contributors to this report
were Bonnie Anderson, Assistant Director; Lisa A. Lusk; Lisa Motley;
Christina Ritchie; Hemi Tewarson; and Timothy Walker.
[End of section]
Footnotes:
[1] CDC data regarding overdose deaths include those resulting from
accidental or intentional overdoses of a drug, being given the wrong
drug, taking the wrong drug in error, or taking a drug inadvertently.
The majority of overdose deaths are unintentional, according to CDC.
CDC's data on overdose deaths do not include deaths in which drugs are
present but the cause of death was determined to be something other
than a drug overdose, such as cancer or motor vehicle traffic crashes.
[2] In this report we are using "methadone-associated overdose deaths"
to refer to overdose deaths in which methadone was listed on a state
death certificate as contributing to the death.
[3] Narcotics are drugs derived from opium or opium-like compounds,
with potent pain relief effects and with the potential for dependence
and tolerance following repeated administration.
[4] Opioids are synthetic drugs, such as methadone, possessing narcotic
properties similar to opiates but not derived from opium.
[5] For purposes of this report, OTPs refers to when practitioners
dispense and administer narcotic drugs for maintenance or
detoxification treatment, which also may be known as narcotic treatment
programs.
[6] The types of practitioners who prescribe controlled substances such
as methadone vary among states. The majority of prescribing
practitioners are physicians, but nonphysicians may also prescribe,
including physician assistants, dentists, and certain types of nurses,
such as nurse practitioners and advanced practice nurses. For purposes
of this report, "practitioner" includes persons such as physicians or
nurse practitioners who may prescribe, administer, or dispense
controlled substances, or pharmacists who dispense controlled
substances.
[7] Under the Controlled Substances Act, drugs are classified as
controlled substances and placed into one of five schedules based on
the extent to which a drug has an accepted medical use, its potential
for abuse, and the degree of psychological or physical dependence.
Schedule I drugs have no accepted medical use and, along with Schedule
II drugs, have a higher potential for abuse than drugs in Schedules III
through V. Schedule II drugs have the highest potential for abuse of
any schedule drugs that have an accepted medical use. See Pub. L. No.
91-513, Tit. II, § 202, 84 Stat. 1242, 1247-1252 (1970) (codified, as
amended, at 21 U.S.C. § 812).
[8] Diversion can involve illegal sales of prescription drugs by
physicians, patients, or pharmacists, as well as obtaining controlled
substances from Internet pharmacies without a valid prescription.
Diversion can also involve such activities as "doctor shopping" by
individuals who visit numerous physicians to obtain multiple
prescriptions, prescription forgery, and pharmacy theft.
[9] When we made our state selection for this study, 2004 CDC data on
methadone-associated overdose deaths were the most current data
available. However, 2005 data have since been published.
[10] CDC, FDA, and SAMHSA are all part of the Department of Health and
Human Services (HHS).
[11] In October 2002, FDA approved certain forms of the drug
buprenorphine for use in opioid addiction treatment. Given this
approval and because buprenorphine is a Schedule III drug, the drug may
be prescribed, dispensed, or administered by qualified physicians for
the treatment of opioid addiction outside of an OTP. This means that
these physicians are not required to obtain the federal registration
and certification that are required for OTPs when they meet certain
conditions, including obtaining required training, holding appropriate
licensure and certifications, having the capacity to refer patients to
appropriate counseling, and limiting the number of patients treated at
any one time. LAAM is indicated as a second-line treatment for opioid
addiction if patients fail to respond to methadone or buprenorphine.
According to FDA officials, the manufacturer of LAAM discontinued
marketing this drug in 2003 and it is currently not available.
[12] Practitioners dispensing or administering Schedule II drugs for
opioid addiction treatment must register for this purpose with the
Attorney General on an annual basis. One condition of this registration
is being determined qualified by the Secretary of Health and Human
Services for the treatment of opioid addiction. An OTP must obtain a
valid certification from SAMHSA in order to be considered qualified by
the Secretary. There are, however, a few exceptions. For example, OTP
registration and certification is not required when a hospital provides
maintenance or detoxification treatment to a patient who is admitted
for a medical condition other than opioid addiction but who requires
this treatment during his or her stay.
[13] According to SAMHSA, Montana, Wyoming, South Dakota, and North
Dakota do not have federally certified OTPs.
[14] In 1947, when federal law only required that new drugs be shown to
be safe, FDA determined that methadone was safe for pain management.
Subsequently in 1962, when the law was amended to impose additional
requirements for the approval of new drugs, including the demonstration
of their efficacy, FDA retrospectively evaluated methadone and
determined that the drug was also effective for pain management.
[15] In 1999, the name of the Agency for Health Care Policy and
Research was changed to the Agency for Healthcare Research and Quality.
The agency, which is part of HHS, is responsible for supporting
research designed to improve the quality of health care, reduce its
costs, and broaden access to essential services.
[16] The Joint Commission was formerly known as the Joint Commission on
Accreditation of Healthcare Organizations or JCAHO.
[17] See Pub. L. No. 91-513, Tit. II, 84 Stat. 1242 (1970) (codified,
as amended, at 21 U.S.C. §§ 801, et seq.); see also 21 C.F.R. §§
1300.01, et seq.
[18] As Schedule II controlled substances have a high potential for
abuse and the potential for severe psychological or physical
dependence, these drugs are subject to certain federal requirements
including storage security and a quota on manufacturing. In addition,
Schedule II drugs may only be dispensed by pharmacists with
nonrefillable written prescriptions except in emergency situations when
the drugs may be dispensed upon an oral prescription. When used for
opioid addiction treatment, however, Schedule II drugs may only be
dispensed or administered but not prescribed by registered
practitioners. This means that for addiction treatment, patients cannot
obtain prescriptions from their physicians for Schedule II drugs.
[19] See 21 U.S.C. §§ 353, 355, 355-1; see also 21 C.F.R. Part 310.
[20] CDC reports that a poison is any substance that is harmful to your
body when ingested, inhaled, injected, or absorbed through the skin.
Any substance taken in excess, including a prescription drug, can be a
poison. Therefore, CDC categorizes drug overdoses as drug poisonings.
In this report, we refer to CDC poisoning data as drug overdose data.
[21] According to a 2007 article in the American Journal of Forensic
Medicine and Pathology, about 31 percent of counties in the United
States are served by a medical examiner at the county, district, or
state level. R. Hanzlick, "The Conversion of Coroner Systems to Medical
Examiner Systems in the United States: A Lull in the Action," American
Journal of Forensic Medicine and Pathology, vol. 28, no. 4 (2007).
[22] For purposes of this report, we only reviewed relevant state laws
and regulations from five states, Florida, Kentucky, Maine, New Mexico,
and West Virginia. Accordingly, references to state laws and
regulations in the report are limited to our findings in these five
states and cannot be generalized to include any other state.
[23] See 21 U.S.C. §§ 801, et seq.; see also 21 C.F.R. §§ 1300.01, et
seq. In guidance, DEA has also clarified that the legal standard for
prescribing controlled substances, including methadone, to treat pain
is the same as that for prescribing controlled substances generally.
See 71 Fed. Reg. 52,716 (2006).
[24] 21 U.S.C. §§ 822(a)(2), 823(f). The Attorney General may register
a practitioner to dispense, administer, or prescribe controlled
substances in Schedules II through V if the applicant meets certain
criteria, including being authorized to dispense, administer, or
prescribe controlled substances under the laws of the states in which
they practice. Practitioners must reapply for this registration every 3
years. 21 C.F.R. §1301.13.
[25] For purposes of this requirement, "practitioner" refers to any
person or entity that dispenses a controlled substance, including
physicians, hospitals, pharmacists, and pharmacies.
[26] 21 U.S.C. § 829(a), 21 C.F.R. § 1306.11. Pharmacists, however, may
dispense Schedule II drugs upon an oral prescription in emergency
situations, with the prescribing practitioner providing a written
prescription within 7 days of the oral prescription.
[27] 21 U.S.C. § 829(a), 21 C.F.R. § 1306.04(a). The Supreme Court has
stated that under the Controlled Substances Act, Congress regulates
medical practice insofar as it bars doctors from using prescription-
writing powers as a means to engage in illicit drug dealing and
trafficking. Beyond this, however, the act manifests no intent to
regulate the practice of medicine. This silence is understandable given
the structure and limits of federalism, which allow the states' great
latitude to legislate as to the protection of the health of their
citizens. See Gonzales vs. Oregon, 546 U.S. 243, 269-70 (2006).
[28] As discussed previously, as of 2008, if FDA identifies postmarket
safety concerns for drugs, the agency may take specific actions such as
requiring drug manufacturers to make safety-related changes to a drug's
labeling or to implement a Risk Evaluation and Mitigation Strategy.
Such oversight could have an impact on the dispensing, administering,
or prescribing of certain controlled substances, including methadone.
[29] There are certain exceptions to this requirement. For example, in
Florida, Maine, New Mexico, and West Virginia, pharmacists may dispense
Schedule II controlled substances upon an oral prescription of a
practitioner in an emergency situation.
[30] In Florida, the Department of Health issues a license to medical
doctors upon certification by Florida's Board of Medicine and also
issues a license to osteopathic physicians upon certification by
Florida's Board of Osteopathic Medicine.
[31] Oversight of nonphysicians, such as nurse practitioners who may be
licensed to prescribe controlled substances, may be provided by other
state agencies, such as boards of nursing.
[32] In Florida, the Department of Health issues a license to
pharmacists upon certification by Florida's Board of Pharmacy.
[33] Florida law defines intractable pain as pain for which, in the
generally accepted course of medical practice, the cause cannot be
removed and otherwise treated. Practitioners may prescribe controlled
substances for this pain provided that they do so in accordance with
that level of care, skill, and treatment recognized by a reasonably
prudent physician under similar circumstances. Fla. Stat. Ann. §
458.326.
[34] These steps include patient evaluations; establishment of a
written treatment plan; obtaining informed consent from the patient;
reviewing the course of treatment periodically; referring the patient
for additional evaluation, when necessary; and treatment and
maintaining complete records. Fla. Admin. Code Ann. § 64B8-9.013.
[35] There are certain distinctions in requirements that apply to
methadone as a controlled substance when used for different purposes.
For example, under federal law, prescriptions may not be issued for
Schedule II drugs, including methadone, when used for opioid addiction
treatment. Accordingly, federal requirements described previously,
which address prescriptions for Schedule II controlled substances, do
not apply to OTPs.
[36] These requirements also apply to buprenorphine, which is another
FDA-approved medication for treating opioid addiction.
[37] 21 U.S.C. § 823(g). Practitioners that dispense or administer
narcotic drugs to individuals for maintenance or detoxification
treatment must obtain a separate registration for that purpose from the
Attorney General on an annual basis. This registration is distinct from
the registration required for any practitioner that dispenses,
administers, or prescribes controlled substances in Schedules II
through V described previously.
[38] 21 U.S.C. § 823(g)(1)(B). In order for the Attorney General to
register an applicant to dispense or administer narcotic drugs for
maintenance or detoxification treatment, the Attorney General must
determine that the applicant will comply with federal standards for
securing stocks of narcotic drugs and maintaining records on such
drugs.
[39] 21 U.S.C. § 823(g)(1)(A). In order for the Attorney General to
register an applicant to dispense narcotic drugs for maintenance or
detoxification treatment, the Secretary of Health and Human Services
must determine that the practitioner is qualified to engage in the
treatment for which the registration is sought.
[40] Previously FDA, on behalf of the Secretary of Health and Human
Services, determined whether OTPs were qualified in accordance with the
agency's regulations. As part of its oversight role, FDA was required
to periodically inspect OTPs to determine whether they were in
compliance with regulations and therefore qualified for purposes of
registration with the Attorney General. In 2001, these federal
regulations were modified, replacing FDA with SAMHSA as the primary
agency responsible for implementation of OTP standards. The modified
regulations also introduced an accreditation and certification process
for OTPs. See 66 Fed. Reg. 4076 (2001).
[41] 21 U.S.C. § 823(g)(1)(C). In order for the Attorney General to
register an applicant to dispense narcotic drugs for maintenance or
detoxification treatment, the Secretary of Health and Human Services
must determine that the applicant will comply with the Secretary's
standards for quantities of narcotic drugs, which may be provided for
unsupervised use by individuals in such treatment.
[42] Any patient in comprehensive maintenance treatment may receive a
single take-home dose for the day that the OTP is closed. Beyond this,
however, the medical director of the OTP must determine which patients
may qualify for unsupervised use of methadone by considering the
criteria identified in table 1.
[43] One of the requirements for SAMHSA's certification for OTPs is the
OTPs' compliance with all applicable state laws and regulations.
[44] In Kentucky, OTPs may close for nine specified holidays. In West
Virginia, OTPs may close for eight holidays and two training days per
year.
[45] For additional information regarding OxyContin abuse and
diversion, see GAO, Prescription Drugs: OxyContin Abuse and Diversion
and Efforts to Address the Problem, [hyperlink,
http://www.gao.gov/products/GAO-04-110] (Washington, D.C.: Dec. 23,
2003).
[46] DEA defines a drug item as an exhibit that is an integral
component of physical evidence within a submission or case that is
examined and individually specified in a laboratory analysis report.
For example, a drug item could be a bottle of pills or a bottle of
liquid methadone.
[47] Data available from Florida do not include information on the
source of methadone for those who died, and research from Maine did not
contain information regarding the source of methadone for most deaths.
[48] The benzodiazepine family of depressants is used therapeutically
to produce sedation, induce sleep, relieve anxiety and muscle spasms,
and prevent seizures. It includes drugs such as Xanax and Valium.
[49] The American Medical Association (AMA) reports that many state
medical boards require continuing medical education for license re-
registration. The AMA also reports that some states mandate content
topics, such as HIV/AIDS, pain management, or prescribing controlled
substances. However, according to the AMA, none of the five states we
reviewed had continuing education requirements specific to prescribing
methadone.
[50] Scott M. Fishman, Responsible Opioid Prescribing: A Physician's
Guide (Washington, D.C.: Waterford Life Sciences, 2007).
[51] According to FDA, the prescribing of a drug product for an off-
label use by a physician in the course of the practice of medicine is
not a violation of federal requirements.
[52] Florida does not have a prescription drug monitoring program.
[53] DEA officials told us that states may not routinely disseminate
information to other states due to concerns such as patient privacy, or
technical difficulties in sharing data between different data systems.
[54] When we made our state selection for this study and interviewed
officials and collected data from these states, 2004 Centers for
Disease Control and Prevention data on methadone-associated overdose
deaths were the most current available; however, 2005 data have since
been published.
[55] We selected this criterion because these medical examiners would
be likely to have access to all the death records for the entire state.
Therefore, a broad perspective on what is occurring with methadone-
associated overdoses in the state is more likely.
[56] We selected this criterion because prescription drug monitoring
programs have been cited as a tool to prevent methadone abuse and
diversion. In addition, if a state has an operational prescription drug
monitoring program, researchers can often determine whether someone who
died from a methadone overdose had a prescription.
[57] For purposes of this report, OTPs refers to when practitioners
dispense and administer narcotic drugs for maintenance or
detoxification treatment, which also may be known as narcotic treatment
programs.
[58] For purposes of this table, we refer to federal and state programs
when practitioners dispense and administer methadone for maintenance or
detoxification treatment as OTPs. However, Florida designates these
programs as medication and methadone maintenance treatment and New
Mexico designates these programs as narcotic treatment programs.
[End of section]
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