Report to Congressional Requesters

United States Government Accountability Office

GAO 

METHADONEASSOCIATED 

OVERDOSE DEATHS 

Factors Contributing 

to Increased Deaths 

and Efforts to Prevent 

Them 

March 2009 

GAO-09-341 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

March 2009

METHADONE-ASSOCIATED OVERDOSE 

DEATHS 

Factors Contributing to Increased Deaths and Efforts

to Prevent Them Highlights of GAO-09-341, a report to 

congressional requesters 

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. 

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 methadoneassociated 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 GAO-09-341 or key components.

For more information, contact Kathleen King 

at (202) 512-7114 or kingk@gao.gov. 
Contents 

Letter 1

Background 5

Methadone Is Regulated as a Controlled Substance and Subject to 

Additional Requirements When Used for Addiction Treatment 12 

Increased Availability Combined with Lack of Knowledge and 

Abuse of Diverted Methadone Have Contributed to Increasing 

Methadone-Associated Overdose Deaths 18 

Education, Safety, and Monitoring Efforts to Prevent MethadoneAssociated Overdose Deaths Have Been Implemented by 

Government Agencies and Other Organizations 24 

Agency Comments 31 

Appendix I Scope and Methodology 32 

Appendix II Comparison of Federal and Selected States’ 

OTP Regulations 37 

Appendix III Data and Research regarding MethadoneAssociated Overdose Deaths in Five States 44 

Appendix IV Comparison of Prescription Drug Monitoring 

Programs in Four Selected States 46 

Appendix V Comments from the Department of Health and 

Human Services 48 

Appendix VI GAO Contact and Staff Acknowledgments 50 

Tables 

Table 1: Criteria for Take-Home Doses of Methadone 17 

Table 2: Methadone Distribution by Type of Business, 2002 to 2007 19 

Page i GAO-09-341 Methadone-Associated Overdose Deaths
Table 3: Top Five Drugs with Highest Percentage Increases in 

Analyzed Drug Items Seized by Law Enforcement, 2001 to 

2007 22 

Figure 

Figure 1: Number of OTPs by State That Have Been Certified by 

SAMHSA, February 2009 7 

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 

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Page ii GAO-09-341 Methadone-Associated Overdose Deaths
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).1

 Of particular concern is the sharp rise in 

methadone-associated overdose deaths—in which methadone may have 

caused or contributed to the death.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.

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.4

 Methadone’s unique 

 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. 

Page 1 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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 

practitioners6

 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. 

 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.

Page 2 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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 methadoneassociated 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.8

 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. 

Page 3 GAO-09-341 Methadone-Associated Overdose Deaths
 

To explore these issues, you asked that we further examine methadoneassociated 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.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 methadoneassociated overdose deaths, we interviewed officials from CDC, DEA, 

FDA, the Office of National Drug Control Policy (ONDCP), and SAMHSA.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 

 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. 

10CDC, FDA, and SAMHSA are all part of the Department of Health and Human Services

(HHS). 

Page 4 GAO-09-341 Methadone-Associated Overdose Deaths
 

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 app. 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. 

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. 

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 

Background 

Use of Methadone for 

Addiction Treatment 

Page 5 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.11 When used for 

addiction treatment, methadone must be dispensed by an OTP that is 

certified by SAMHSA and registered with DEA.12 As of February 2009, 

about 1,200 OTPs were operating nationwide, but not all states have 

OTPs.13 (See fig. 1.) OTPs are operated by private for-profit organizations, 

private nonprofit organizations, hospitals, or government agencies. 

 11In 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 secondline 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. 

12Practitioners 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. 

13According to SAMHSA, Montana, Wyoming, South Dakota, and North Dakota do not have

federally certified OTPs.

Page 6 GAO-09-341 Methadone-Associated Overdose Deaths
 

Figure 1: Number of OTPs by State That Have Been Certified by SAMHSA, February 2009 

Source: SAMHSA.

Treatment facility in a zip code

PA: 64

OR: 14

NV: 11

ID: 1

MT: 0

WY: 0

UT: 11

AZ:

29 NM:

8

CO: 11

ND: 0

SD: 0

NE: 3

TX:

76

KS: 6

OK: 14

MN:

13

IA: 4

MO: 10

AR: 3

LA: 8

IL:

63

MS:

1

IN:

14

KY: 9

TN: 10

AL:

20

FL:

39

GA:

41

SC: 11

NC: 38

VA:

 20

OH: 15

VT: 7

MA: 49

RI: 18

MI:

37

CA: 147

WA: 20

WI:

15

NY:

153

ME:

10

NH: 9

WV: 9

HI: 4

CT: 34

NJ: 36

DE: 7

MD: 57

DC: 10

AK: 3

Number of opioid 

treatment programs

in each state

Note: The total number of OTPs includes seven programs in Puerto Rico and one in the Virgin 

Islands not listed on the figure. 

Page 7 GAO-09-341 Methadone-Associated Overdose Deaths
 

FDA approved methadone for treating pain in 1947,14 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 1994.15 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.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. 

DEA, on behalf of the Attorney General of the United States, is the agency

primarily responsible for enforcing the Controlled Substances Act.17 Under 

the act, controlled substances are classified into five schedules based on 

Use of Methadone for Pain 

Management 

Relevant Federal Agencies 

 14In 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. 

15In 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.

16The Joint Commission was formerly known as the Joint Commission on Accreditation of 

Healthcare Organizations or JCAHO. 

17See 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. 

Page 8 GAO-09-341 Methadone-Associated Overdose Deaths
 

the extent to which the drug has an accepted medical use, and its potential 

for abuse and degree of psychological or physical dependence.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 

 18As 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. 

Page 9 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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. 

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.20 Most coroners are elected, and they may not be physicians.

In contrast, medical examiners are usually appointed and are, with few 

Overdose Death 

Investigation and 

Reporting 

 19See 21 U.S.C. §§ 353, 355, 355-1; see also 21 C.F.R. Part 310.

20CDC 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. 

Page 10 GAO-09-341 Methadone-Associated Overdose Deaths
 

exceptions, required to be physicians and are often pathologists or 

forensic pathologists.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.

 21According 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). 

Page 11 GAO-09-341 Methadone-Associated Overdose Deaths
 

Methadone is regulated as a controlled substance, under federal and state 

laws and regulations, when used for pain management and addiction 

treatment.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.

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.23 For example, practitioners must register with DEA 

in order to dispense, administer, or prescribe Schedule II through V 

controlled substances.24,25 The Controlled Substances Act and 

implementing regulations also require that Schedule II controlled 

substances, including methadone, only be dispensed by pharmacists upon 

Methadone Is 

Regulated as a 

Controlled Substance 

and Subject to 

Additional 

Requirements When 

Used for Addiction 

Treatment 

When Used for Pain

Management, Methadone 

Is Regulated as a 

Controlled Substance 

under Federal and State 

Laws and Regulations 

 22For 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. 

23See 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). 

2421 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. 

25For purposes of this requirement, “practitioner” refers to any person or entity that 

dispenses a controlled substance, including physicians, hospitals, pharmacists, and 

pharmacies. 

Page 12 GAO-09-341 Methadone-Associated Overdose Deaths
 

a written prescription,26 which must be issued for a legitimate medical 

purpose by registered practitioners acting in the usual course of 

professional practice.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.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.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. 

 2621 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. 

2721 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). 

28As 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. 

29There 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. 

Page 13 GAO-09-341 Methadone-Associated Overdose Deaths
 

Because states regulate the practice of medicine and pharmacy, controlled

substances that are prescribed, administered, or dispensed by statelicensed 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.30,31 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.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.33 Under its regulations, Florida’s Board of 

Medicine and Board of Osteopathic Medicine also impose standards that 

 30In 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. 

31Oversight 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. 

32In Florida, the Department of Health issues a license to pharmacists upon certification by 

Florida’s Board of Pharmacy.

33Florida 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. 

Page 14 GAO-09-341 Methadone-Associated Overdose Deaths
 

include steps physicians must take prior to prescribing controlled 

substances for pain.34

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.35,36 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.37 Under the first condition of this 

registration, DEA must determine that the OTPs will appropriately secure 

stocks of methadone and maintain appropriate records.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. 

When Used for Addiction 

Treatment, Methadone Is 

Subject to Additional 

Requirements under 

Federal and State Laws 

and Regulations 

 34These 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. 

35There 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. 

36These requirements also apply to buprenorphine, which is another FDA-approved

medication for treating opioid addiction. 

3721 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. 

3821 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.

Page 15 GAO-09-341 Methadone-Associated Overdose Deaths
 

As a second condition of DEA registration for OTPs, SAMHSA must 

determine that OTPs are qualified to engage in methadone maintenance 

treatment for addiction.39 Federal opioid treatment regulations define 

SAMHSA’s standards for determining whether OTPs are qualified.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.41 SAMHSA has established specific criteria 

for unsupervised take-home doses of methadone under federal regulations 

for OTPs.42 (See table 1.) These criteria were established to limit the 

potential for diversion of methadone to illicit uses. OTPs are also required 

 3921 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. 

40Previously 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).

4121 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. 

42Any 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.

Page 16 GAO-09-341 Methadone-Associated Overdose Deaths
 

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). 

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.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.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. 

 43One of the requirements for SAMHSA’s certification for OTPs is the OTPs’ compliance 

with all applicable state laws and regulations. 

44In Kentucky, OTPs may close for nine specified holidays. In West Virginia, OTPs may 

close for eight holidays and two training days per year. 

Page 17 GAO-09-341 Methadone-Associated Overdose Deaths
 

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. 

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. 

Increased Availability 

Combined with Lack 

of Knowledge and 

Abuse of Diverted 

Methadone Have 

Contributed to 

Increasing 

MethadoneAssociated Overdose 

Deaths

Page 18 GAO-09-341 Methadone-Associated 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 

Methadone’s Growing Use 

for Pain Management Has 

Increased the Drug’s

Availability, Contributing 

to an Increase in Overdose 

Deaths 

2002 2003 2004 2005 2006 2007

OTPs 5,262,052 5,743,272 6,584,721 6,892,025 7,345,623 6,451,288

Hospitalsa309,315 393,685 466,352 521,216 584,144 590,649

Pharmacies 2,329,083 3,274,331 4,246,007 4,863,736 5,986,488 6,442,516

Other practitionersb10,381 15,113 35,492 43,260 51,046 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. 

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 

Page 19 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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 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. 

Lack of Knowledge about 

Methadone by 

Practitioners and Patients 

Has Also Contributed to 

Methadone-Associated 

Overdose Deaths 

 45For additional information regarding OxyContin abuse and diversion, see GAO, 

Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem, 

GAO-04-110 (Washington, D.C.: Dec. 23, 2003). 

Page 20 GAO-09-341 Methadone-Associated Overdose Deaths
 

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. 

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 

Abuse of Diverted 

Methadone Is an 

Additional Contributing 

Factor to MethadoneAssociated Overdose 

Deaths 

Page 21 GAO-09-341 Methadone-Associated Overdose Deaths
 

increased 262 percent, though the estimated number was smaller than that

of some of the other drugs (see table 3).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 2001 2002 2003 2004 2005 2006 2007

Percentage

change, 

2001 to 2007

Methadone 2,865 3,867 4,967 6,397 7,302 9,822 10,361 262

Morphine 1,842 2,424 2,534 2,827 3,619 4,672 5,343 190

Hydrocodone 12,847 16,869 16,903 18,608 23,549 30,480 36,803 186

Oxycodone 12,013 17,619 16,520 18,962 19,274 25,041 29,487 145

Carisoprodola1,890 2,946 3,297 2,757 3,020 3,558 4,420 134

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.

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,

 46DEA 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. 

Page 22 GAO-09-341 Methadone-Associated Overdose Deaths
 

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 methadoneassociated 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.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 

 47Data 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. 

Page 23 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.48 The New Mexico study showed 

somewhat different results, and found that of the 143 methadoneassociated 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 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. 

Education, Safety, and 

Monitoring Efforts to 

Prevent MethadoneAssociated Overdose 

Deaths Have Been 

Implemented by 

Government Agencies 

and Other 

Organizations 

 48The 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. 

Page 24 GAO-09-341 Methadone-Associated Overdose Deaths
 

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. 

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 email. 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.

Efforts to Educate 

Practitioners and the 

Public about Methadone 

and Other Prescription 

Drugs Have Been Initiated 

by Federal Agencies, 

States, and Other 

Organizations 

Educational Efforts Targeted at 

Methadone 

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 

Page 25 GAO-09-341 Methadone-Associated Overdose Deaths
 

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, lifethreatening 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. 

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.49

Educational Efforts Targeted at 

Opioids and Other Prescription 

Drugs 

The Federation of State Medical Boards developed a book, Responsible 

Opioid Prescribing: A Physician’s Guide, in collaboration with a national 

pain expert.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 

 49The 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. 

50Scott M. Fishman, Responsible Opioid Prescribing: A Physician’s Guide (Washington,

D.C.: Waterford Life Sciences, 2007). 

Page 26 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.

Page 27 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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. 

DEA and FDA Have Taken 

Steps to Improve the 

Safety of Using Methadone 

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

 51According 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. 

Page 28 GAO-09-341 Methadone-Associated Overdose Deaths
 

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 

Page 29 GAO-09-341 Methadone-Associated Overdose Deaths
 

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.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.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. 

 52Florida does not have a prescription drug monitoring program. 

53DEA 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. 

Page 30 GAO-09-341 Methadone-Associated Overdose Deaths
 

We provided a draft of this report to HHS and the Department of Justice 

for their review. We received general comments from HHS. (See 

app. 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 

http://www.gao.gov. 

Agency Comments 

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 

Kathleen King 

listed in appendix VI. 

Director, Health Care 

Page 31 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix I: Scope and Methodology 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 2004,1

• a top 10 number of methadone-associated overdose deaths per 1,000,000 

people in 2004, 

• a state or district medical examiner system,2

• an operational prescription drug monitoring program,3 and 

 1

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. 

2

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. 

3

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. 

Page 32 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix I: Scope and Methodology 

• 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.4

 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 methadoneassociated 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

 4

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. 

Page 33 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix I: Scope and Methodology 

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 methadoneassociated 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 

Page 34 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix I: Scope and Methodology 

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. 

Page 35 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix I: Scope and 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. 

Page 36 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and Appendix II: Comparison of Federal and Selected States’ OTP Regulations 

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.1

 1

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. 

Page 37 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

Authority 42 C.F.R. pts. 2, 

8

Fla. Admin. Code 

Ann. §§ 65D30.004, 30.014

908 Ky. Admin.

Regs. § 1:340

Code Me. R. 

14-188 Ch. 5 

§§ 1–19 

N.M. Admin. 

Code tit. 7, § 32.8

W. Va. Code 

St. R. §§ 64-90-1 

– 64-90-47 

Dosingb-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)) 

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. (§ 65D30.014(4)(e)(1)) 

-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)) 

Initial doses of 

methadone 

must not 

exceed 30 mg 

unless the 

physician 

documents the

need for a 

higher dose. 

(§ 19.8.6.5) 

-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)) 

-The initial fullday 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 

Decision made by 

medical director 

who must 

consider the 

following criteria: 

-Absence of 

recent drug

abuse, including 

alcohol abuse.

Permitted only for 

clients 

participating in a 

methadone 

maintenance 

regimen under 

following 

conditions: 

-No evidence of

recent drug abuse.

Conditions for 

entering each of 

the phases: 

-Phase 1: No 

program 

infractions for 90 

consecutive 

days. 

-Phase 2: No 

program 

-Results of drug

tests must be 

reviewed and 

considered as 

part of the 

treatment 

planning 

process and 

decisions for 

take-home 

Decision to be 

made by program 

medical director 

based on the 

following criteria: 

-Absence of 

recent drug

abuse, including 

alcohol abuse.

Must consider the 

following criteria 

in determining 

patient eligibility: 

-Cessation of 

illicit drug use.

-Regularity of 

program 

attendance. 

Page 38 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

-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)) 

-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. 

(§ 65D30.014(5)(d)) 

infractions for 

180 consecutive 

days; pursuing 

one of the 

following: gainful 

employment, 

vocational 

training, higher

education, 

volunteer 

opportunities, or 

parenting 

classes if a stayat-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) 

dosing. 

(§ 19.8.6.6) 

-All decisions 

regarding takehome 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) 

-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)) 

-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 takehome 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) 

Page 39 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

Take-home 

dosing 

-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 shortterm 

detoxification 

treatment or 

interim 

maintenance 

treatment for 

unsupervised or

take-home use.

(§ 8.12(i)(4)) 

-Must be available 

to all methadone 

clients during

holidays, but only 

if clinically 

advisable. 

(§ 65D30.014(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 takehome dose per

week. 

-Phase II: Days 

91-180 – two takehome 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 takehome 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. 

-Days 1-90: No

take-home 

doses. 

-Phase 1: One 

take-home dose 

per week. 

-Phase 2 and 3: 

Up to two takehome doses per 

week. 

-Phase 4: Up to

three take-home 

doses per week. 

-Under 

emergency 

conditions, a 

program may 

issue 14

consecutive 

days of takehome 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. 

-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 takehome doses per 

week. 

-361 days 

onward: Six 

take-home 

doses per 

week. 

(§ 19.8.10) 

-Certain 

exceptions for 

emergencies. 

(§ 19.8.12) 

-A patient in 

comprehensive

maintenance 

treatment may 

receive a single

dose of takehome 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 takehome supply, but 

must make 

monthly visits. 

-Exceptions made 

only as provided

by federal OTP

regulations and 

as approved by

the state 

methadone 

-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 caseby-case basis if 

the program 

physician applies.

(§ 64-90-41.6, 

41.7) 

Page 40 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

-Phase VI: After 

3 years in 

treatment – six

take-home doses 

per week. 

(§ 65D30.014(5)(e)) 

-State narcotic 

authority may 

grant additional 

exceptions for 

medical

emergency or 

natural disaster.

(1:340.11, 

1:340.16) 

authority.

(§ 7.32.8.23(C),

(D)) 

Hours of 

operation 

No requirements 

specified. 

-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. (§ 65D30.014(4)(g)) 

Must be open 

7 days a week 

with the optional 

exception of nine 

specified 

holidays. 

(1:340.6(16)) 

Must be open 

7 days weekly,

including all 

holidays. 

(§ 19.8.4.2) 

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))

-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) 

Page 41 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

Recordkeeping 

(for purposes of

enrollment in

other OTPs) 

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) 

-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. 

(§ 65D30.014(4)(f)(1),

(7)) 

Proposed 

programs must

include in their 

applications a 

system to 

prevent client’s

multiple program 

registration. 

(1:340.4(3)(k)) 

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) 

-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 

-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) 

Page 42 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix II: Comparison of Federal and

Selected States’ OTP Regulations 

Federal Florida Kentucky Maine New Mexico West Virginiaa

approval to

operate shall 

participate in the 

central registry as 

directed by the

Department of 

Health. 

(§ 7.32.8.19(F), 

(G)) 

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. 

Page 43 GAO-09-341 Methadone-Associated Overdose Deaths
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 

Years 

studied

Number of 

methadoneassociated

overdose 

deaths Decedent characteristics Drugs detected Sources of methadone 

Floridaa2007 1,095 Ages of decedents: 

<18: 2% 

18-25: 21% 

26-34: 23% 

35-50: 38% 

>50: 17% 

n=785b

Methadone only: 

11% 

Drugs in combination with 

methadone: 

89% 

n=1,095 

No data available 

Kentuckyc2000-2004 176dCaucasian: 100%

Male: 60% 

Mean age: 38 years 

Methadone only: 

6% 

Drugs in combination with 

methadone:

e

Antidepressants: 40% 

Benzodiazepines: 32% 

Additional opioids: 28% 

Private physician: 48% 

Illicit means: 20% 

OTP: 10%

Unknown: 22%

n=95f

Maineg1997-2002 88hAll drug-related deaths: 

Caucasian: 96% 

Male: 62% 

Mean age: 40 years 

Other known health 

conditions: 

Mental illness: 55% 

Drug abuse: 50% 

Methadone deaths: 

Methadone primary or 

secondary causal factor: 88% 

Methadone a significant 

contributing factor: 12% 

n=66i

Limited data available 

New Mexicoj1998-2002 143kWhite non-Hispanic: 55% 

Male: 75% 

Median age: 40 years 

Other known health 

conditions: 

Mental illness: 24% 

Drug abuse: 25% 

Methadone only: 

22% 

Drugs in combination with 

methadone:

e

Prescription drugs 

(no illicit drugs): 24% 

Illicit drugs: 50%

Methadone maintenance 

treatment: 39%

Prescription for chronic 

pain: 34% 

Prescription for unknown 

reason: 13% 

Diversion: 14%

n=79f

Appendix III: Data and Research regarding 

Methadone-Associated Overdose Deaths in 

Five States 

Page 44 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix III: Data and Research regarding

Methadone-Associated Overdose Deaths in 

Five States 

State 

Years 

studied

Number of 

methadoneassociated

overdose 

deaths Decedent characteristics Drugs detected Sources of methadone 

West 

Virginial 

2006 112m All drug-related deaths:

n

Male: 67% 

Mean age: 39 years 

Substance abuse 

indicators, all drugrelated deaths:

n

History of substance abuse: 

78% 

Used diverted 

pharmaceuticals: 63% 

Doctor shopped (Five or 

more prescribing clinicians 

in the year before death): 

21% 

Methadone only: 

26% 

Drugs in combination with 

methadone:

e

Other prescription drugs: 63% 

Illicit drugs: 13% 

Alcohol: 10% 

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. 

Page 45 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix IV: Comparison of Prescription

Drug Monitoring Programs in Four Selected 

States 

Program information Kentucky Maine New Mexico West Virginia

Name of program Kentucky All-Schedule 

Prescription Electronic 

Reporting System 

(KASPER) 

Controlled Substances 

Prescription Monitoring 

Program 

Controlled Substance 

Prescription Monitoring 

Program 

West Virginia Controlled

Substances Monitoring 

Year establisheda1998 2003 2004 2002b

Oversight agency Drug Enforcement and 

Professional Practices 

Branch, Office of Inspector 

General, Cabinet for Health 

and Family Services 

Office of Substance Abuse, 

Department of Health and 

Human Services 

Board of Pharmacy Board of Pharmacy 

Controlled substances 

covered 

Schedule II, III, IV, and V Schedule II, III, and IV Schedule II, III, and IV Schedule II, III, and IV 

Who must provide 

information

Authorized dispensers of 

controlled substances 

Includes dispensers 

located outside Kentucky 

but authorized by 

Kentucky’s Board of 

Pharmacy to dispense 

controlled substancesc

Individuals authorized to 

dispense or administer 

controlled substances 

Authorized dispensers 

Does not include 

licensed hospital 

pharmacies that 

distribute controlled 

substances for inpatient 

hospital care 

Individuals authorized to 

dispense or administer 

controlled substancesd

Includes pharmacists or 

pharmacies located 

outside the state but 

licensed by the Board of 

Pharmacy for delivery to 

a person residing in the 

state 

Who may have access 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

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 purposesf

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 

Prescribing practitioners 

and pharmacistsg

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 

Appendix IV: Comparison of Prescription 

Drug Monitoring Programs in Four Selected 

States 

Page 46 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix IV: Comparison of Prescription

Drug Monitoring Programs in Four Selected 

States 

Program information Kentucky Maine New Mexico West Virginia

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 

proceedingse

Another state program via 

reciprocal agreement 

engaged in an ongoing 

investigation

Courts under grand jury 

subpoena or criminal 

court order 

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 

Authorities Ky. Rev. Stat. Ann. 

§§ 218A.202; 218A.245; 

902 Ky. Admin. Regs. 

55:110 

Me. Rev. Stat. Ann. Tit. 22, 

§§ 7245-7252; 14-118

Code Me. R. ch. 11, 

§§ 1–9 

N.M. Stat. Ann. § 30-

31-16; N.M. Admin. 

Code tit. 16, 

§§ 19.29.1–.13

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. App. 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. App. 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.

Page 47 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix V: Comments from the Department Appendix V of Health and Human Services : Comments from the Department 

of Health and Human Services 

Page 48 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix V: Comments from the Department 

of Health and Human Services 

Page 49 GAO-09-341 Methadone-Associated Overdose Deaths
Appendix VI: 

A

GAO Contact and Staff 

cknowledgments 

Page 50 GAO-09-341

Appendix VI: GAO Contact and Staff 

Acknowledgments 

GAO Contact Kathleen King, (202) 512-7114 or kingk@gao.gov

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. 

Methadone-Associated Overdose Deaths

Acknowledgments 

(290677) 
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